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									       FOOD AND DRUG
          LAW JOURNAL
            Analyzing the Laws, Regulations, and Policies
                       Affecting FDA-Regulated Products




          Problems Associated with
       Direct-to-Consumer Advertising
           (DTCA) of Restricted,
        Implantable Medical Devices:
       Should the Current Regulatory
           Approach be Changed?

                  Bruce Patsner




FDLI           V OLUME 64    N UMBER 1 2009
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                         1

Problems Associated with Direct-to-Consumer Advertising
  (DTCA) of Restricted, Implantable Medical Devices:
 Should the Current Regulatory Approach be Changed?

                          BRUCE PATSNER, M.D., J.D.*

 I. DTCA OF RESTRICTED MEDICAL DEVICES IS AN EMERGING ISSUE
   Advertising and promotion of Food and Drug Administration (FDA)-approved
medical products has been one of the most controversial and bitterly litigated areas
in food and drug law in the U.S. for more than a decade.1 Hundreds of newspaper
articles and dozens of law review articles have been written on the subject of the
risks and benefits of direct to consumer advertising (DTCA) of medical products,2
but until very recently virtually all of this literature and commentary has focused
exclusively on prescription and over-the-counter drugs.3 Even when FDA has
sponsored public hearings to address the issue of DTCA of all medical products,
as it did in 2005,4 review of the content of the speakers’ presentations reveals that
almost all of the subject matter, nearly all of the data, and the majority of com-
ments concerned DTCA of drugs.5 Not a single law review article has ever been
devoted exclusively to the subject of advertising and promotion of medical devices
to consumers.
   A critical analysis of the topic of DTCA of medical devices is important, and
its relative neglect in the legal literature unfortunate, for several reasons. First,
the medical device industry is growing in size6 and is already enormous, though
not so large as the pharmaceutical industry. Second, the medical device industry
directly impacts the lives of millions of Americans every day and is the source of


      *
          Dr. Patsner is Research Professor, Health Law & Policy Group, University of Houston Law
Center, Houston, TX.
      1
          Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. (1999)). The Washington
Legal Foundation (WLF) is still pursuing FDA in federal courts. As recently as 2006, in a follow-up
to the 1999 litigation, WLF submitted a Citizen Petition to FDA requesting that the agency review
all of its policies regarding prescription drug advertising to ensure that they “comply” with the First
Amendment (FDA Docket No. 2006P-0319, (Aug. 7, 2006)).
      2
          For example, see Hall, Timothy S., The Promise and Peril of Direct-to-Consumer Prescription
Drug Promotion on the Internet, 7 DEPAUL J. HEALTH CARE L. 1 (2003).
      3
          At the time of this writing even the most prominent law journal in food and drug law—THE
FOOD AND DRUG LAW JOURNAL—has never had an article devoted specifically to the topic of adver-
tising and promotion of medical devices, whether restricted medical devices or not. The most recent
(2008) edition of the nationally recognized authoritative casebook on food and drug law (FOOD AND
DRUG LAW by Hutt, Merrill and Grossman, Foundation Press 2008) devotes almost thirty pages to an
exhaustive discussion of the legal and regulatory issues surrounding the advertising and promotion
of prescription drugs, yet no more than a paragraph or two to the same topic for restricted medical
devices.
      4
          Public Hearing on Direct-to-Consumer Promotion of Medical Products, Wash., DC, (Nov. 1-2,
2005). Only one of the 32 speakers at this conference directed all of her remarks to the issue of DTCA
of restricted medical devices.
      5
          Id.
      6
          The number of manufacturers of medical devices in the United States has effectively doubled
every 10-15 years since WWII. See Hutt, supra note 4, Chapter on Medical Devices.



                                                  1
 2                       Food and Drug Law Journal                                          Vol. 64

a significant amount of product-related patient death and serious injury.7 Third,
the statutory framework governing regulation of advertising and promotion of
medical products is grounded in the 1938 Federal Food, Drug, and Cosmetic Act
(FDCA)8 and takes a “one size fits all” approach even though drugs and devices
differ enormously. Fourth, the preponderance of FDA attention and enforce-
ment action has been devoted to drugs despite the fact that the volume of direct
to consumer advertising to both physicians and consumers has been increasing
steadily for more than half a decade.9 Fifth, device manufacturers have a generally
unrecognized but unique relationship with the different players in the medical
profession (surgeons, academic medical centers) compared to pharmaceutical
manufacturers. This allows device manufacturers to have some of their advertising
for their most important products done through the medical profession itself as a
surrogate.10 As a result, medical device manufacturers can circumvent direct FDA
oversight of some of their promotional practices in a way that pharmaceutical
manufacturers cannot.11 There is also more involvement directly in new technol-
ogy development, and direct financial incentive for use by the medical profession
for restricted medical devices than for pharmaceuticals.
   These points will be elaborated on in great detail later in this article. Sixth, be-
cause the medical device industry does promote its products directly to the medical
profession as well as to consumers just as the pharmaceutical industry does, and
has begun to advertise its high-end, restricted, implantable medical devices more
aggressively to consumers,12 the subject of DTC advertising of such medical devices
merits separate attention. There is already good evidence that consumers both lack
the level of medical sophistication to understand these advertisements, and that the
advertisements themselves do not fairly balance benefit and risk information. Lastly,
the lack of legal analysis of regulatory issues surrounding DTCA and promotion
       7
          Medical Devices: Problems on the Rise, CONSUMER REPORTS, (Dec. 2007). “Reports of deaths
linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double
the number in 1997.” FDA had issued its own report for fiscal year 2006, noting that it had seen a 25
percent increase in adverse events linked to medical devices over Fiscal Year 2005, including 2,830
deaths, 116,086 injuries and 96,495 medical device malfunctions.
       8
          FDCA, 21 U.S.C. §§ 301 et seq (1938).
       9
          Pololsky, Scott H. & Greene, Jeremy A., A Historical Perspective of Pharmaceutical Promotion
and Physician Education, 300 JAMA 831 (2008). “… by 2006, the world-wide sales of the pharmaceu-
tical industry had increased to more than $600 billion, and estimates of the amount of money spent
promoting new drugs to U.S. physicians range from $27.7 billion to $57.5 billion.” See also Gagnon,
MA & Lexchin, J, The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in
the United States, 5 PLOS MED. (2008).
       10
          Examples of this will be provided in Section VI of this article.
       11
          For example, in Perez v. Wyeth Laboratories 734 A.2d 1245 (1999) the learned intermediary
doctrine did not apply nor provide protection for pharmaceutical manufacturers when they advertised
their prescription drugs directly to consumers. Deceptive direct-to-consumer (DTC) advertising could
not, at least in the state of New Jersey, hide behind healthcare providers because the DTC advertis-
ing were no longer in a position to reduce the risk of harm from the medical products once they were
“bypassed” by DTC advertising. One important aspect of the case is that the medical profession is not
really involved in the marketing/promotion loop of DTC advertising for drugs. As will be shown, this
is not necessarily the case for some types of medical devices, where the medical profession is involved,
either directly or indirectly, with promotion of the products to consumers.
       12
          Testimony of Ami Gadhia, Consumer’s Union, Concerning the DTC Advertisements for Im-
plantable Medical Devices, at Hearing before the Senate Special Committee on Aging, 110TH CONGRESS,
(Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed
Sept. 30, 2008)., quoting a WALL STREET JOURNAL article published (Apr. 10, 2007) entitled New Medi-
cal-Device Ads; Old Concerns, Can a Knee Implant Be Sold This Way, and Should It Be? which described
the growth of DTCA for medical devices and pointed out that the warnings of side effects are generally
non-existent or minimal.
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                               3

of medical devices also places federal and state courts at a relative disadvantage
if and when they are faced with adjudicating enforcement actions against medical
device manufacturers over this issue.

A. General Remarks on DTCA of Medical Products
   Some general comments on advertising and promotion of FDA-approved
medical products are in order. Even though the majority of money (85 percent
or more) spent by manufacturers on the advertising of their products is spent on
promoting them directly to physicians and the medical community,13 most of the
controversy, legal writing, enforcement action and litigation has focused on promo-
tion to consumers instead. This should come as no surprise given the predominant
marketing-oriented focus of American business, the protection commercial speech
enjoys under the First Amendment, and the fact that, aside from New Zealand,14
DTCA is banned in every other Western industrialized nation except the United
States.15 One reason for this latter fact is differing government health policies and
priorities.16 The healthcare systems of most other countries (e.g., Canada,17 Great
Britain) are geared to limiting consumer access and demand for progressively more
expensive medical services which often have questionable, marginal or modest
incremental health benefits. The United States government does virtually nothing
to limit demand for medical services it subsidizes through entitlement programs,18
and our current payment system to physicians rewards prescribing more drugs and
using more implantable surgical and cardiac medical devices. Examples of these
include prescribing expensive new cancer chemotherapies to treat patients with
refractory end-stage cancers and high-technology medical devices such as 64-slice
      13
         Berndt, Ernst R., To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs,
352 N. ENGL. J. MED. 325 (2005).
      14
         New Zealand was supposed to ban direct to consumer advertising of medical products in 2006.
The New Zealand government had been seriously considering this for years.
      15
         Palumbo, Francis B. and Mullins, Daniel, The Development of Direct-to-Consumer Prescription
Drug Advertising Regulation, 57 FOOD AND DRUG L.J. 423 (2003).
      16
         Calfee, John E., American Enterprise Institute, Direct-to-Consumer advertising of prescription
medicines in the United States and New Zealand: An analysis of regulatory approaches and consumer
responses, FDA Public Hearing on Direct-to-Consumer Promotion of Medical Products, (Nov. 2, 2005).
The author points out that unlike the United States, New Zealand has a small economy, predominately
government-funded healthcare, regulated drug prices, and advertising self-regulation combined with
loose oversight by the Ministry of Health. Despite these differences, the author’s research indicated
that although DTC advertisements in the two countries differ, consumer surveys in both nations reveal
remarkably consistent results on several essential points such as little benefit and little evidence of direct
harm.
      17
         FDA Webview, No DTC in Canada, Group Says, (Jan. 31, 2006), available at http://www.fdaweb.
com/start.php?sa=v&aid=D5101807&cate=&stid=%241%24Zy1.us..%..(last accessed Feb. 1, 2006).
This note quotes the White Paper Direct-to-Consumer Advertising of Prescription Drugs in Canada:
What are the Public Health Implications, “The Health Council of Canada, a government-appointed
group charged with monitoring and reporting on the progress of health care renewal in Canada, says
DTC drug advertising in Canada should be curtailed ‘in the interest of patient safety and public health
…There is no reliable evidence that DTC improves patient compliance in taking medication or leads to
more appropriate early diagnosis of under-treated conditions, or prevents hospitalization and serious
disease consequences … exposure to DTC advertisements results in increased requests for prescription
medications.’”
      18
         Rago, Joseph, The Election Choice: Health Care, THE WALL STREET JOURNAL, Opinion, (Oct.
24, 2008), at A19. The Center for Medicare and Medicaid Services (CMS) has on occasions announced
that it would not pay for select medical services, but these are rare events. Federal spending on Medicare
and Medicaid is exploding, and over the past three decades has more than doubled its share of GDP
and will double again in 25 years.
 4                        Food and Drug Law Journal                                             Vol. 64

cardiac CT scanners and coronary artery stents. Prohibiting DTCA is one of the
most important ways in which foreign countries restrict demand for prescription
drugs and for expensive medical/surgical services which involve restricted medical
devices. It is easier to restrict access to new, expensive therapies if one is successful
in limiting demand.
   The potential consumer educational benefits of advertising of medical prod-
ucts aside,19 no one on either side of the DTCA debate disputes the fact that one
of the primary reasons for advertising medical products is to increase consumer
demand20 and product market share for the manufacturers, and to distinguish
a product from competitors.21 Growth of DTCA spending in the U.S. provides
some perspective on this statement. After passage of the Food and Drug Ad-
ministration Modernization Act of 1997 (FDAMA),22 growth of DTC spending
increased from $791 million in 1996 to over $3 billion in 2004.23 Given the fact
that physicians in the United States have strong financial incentives to prescribe
the most expensive cancer drugs or utilize the latest and invariably most expensive
diagnostic and therapeutic medical technologies, the production-marketing-use-
demand-production cycle becomes self-reinforcing. DTCA is a vital component of
this cycle as well, since some of what some physicians do is a reaction to patient
demands. Research has shown both that consumers are susceptible to directed
advertising of drugs,24 and that some medical practice is driven by this demand
as well.25 Research has also shown that demand for surgical therapies and devices
can be driven to some degree by advertising.26 Although there is no universally
      19
          Gilbody, S., Wilson, P. & Watt, I., Benefits and Harms of direct to consumer advertising: a system-
atic review, 14 QUAL. SAF. HEALTH CARE 246 (2005). The Pharmaceutical industry claims one of the main
benefits of DTCA is patient education. Although there is the potential for DTCA to be educational, the
primary benefit is for the manufacturer in the form of increased market share and profits.
      20
          Loden, D. John & Schooler, Caroline, Ph.D., How to Make DTC Advertising Work Harder,
MEDICAL MARKETING AND MEDIA, (Apr. 1998). A comment by these two DTC advertising executives
at FCB Healthworks stated, “The ultimate goal of DTC advertising is to stimulate consumers to ask
their doctors about the advertised drug and then, hopefully, get the prescription.”
      21
          See NY TIMES (July 1, 2008). For example, Myriad Genetics of Salt Lake City initiated a mass
direct to consumer advertising campaign for their BRCA genetic testing for predisposition to breast
and ovarian cancer which resulted in a doubling of revenue. No more than 5-10 percent of all women
in the U.S. could theoretically benefit from such genetic screening, yet the DTC advertising campaign
did not attempt to discriminate, and was directed at all women.
      22
          FDAMA, PUBLIC LAW 105-115.
      23
          Judith A. Cahill, Executive Director, Academy of Managed Care Pharmacy, Statement before
FDA Public Hearing on DTC Advertising, Wash., D.C., (Nov. 2, 2005). It was not stated whether there
was a direct cause-effect relationship between the passage of FDAMA and the increase in spending on
DTC advertising.
      24
          The Henry J. Kaiser Foundation, Impact of Direct-to-Consumer Advertising on Prescription
Drug Spending, (June 2003) p.7. The DTC advertising strategy works: “DTC advertising produces
a significant return for the pharmaceutical industry: every additional $1 the industry spent on DTC
advertising in 2000 yielded an additional $4.20 in sales.”
      25
          Kravitz, Richard I., Epstein, Ronald M., Feldman, Mitchell D., et. al., Influence of Patients’
Requests for Direct-to-Consumer Advertised Antidepressants. A Randomized, Controlled Trial, 293 JAMA
1995 (2005).
      26
          Jaffee, M.J., HealthpointCapital, Orthopedic and Dental Industry News, Impact of Direct-to-Con-
sumer Advertising, (Apr. 6, 2006), available at http://www. Healthpointcapital.com/research/2006/04/06/
impact_of_directtoconsumer_advertising (last accessed October 27, 2008). The article cites research by
Orthopedic Surgeon Kevin Bozic of the University of California San Francisco School of Medicine
which was presented at the Health Policy Symposium at the 2006 American Academy of Orthopedic
Surgery (AAOS) meeting. Dr. Bozic’s findings were that 50 percent of orthopedic surgeons polled said
that they found pressure to use a “particular surgical technique approach or specific type of implant”
by patient request based on viewing a DTCA. Some of the DTCA was internet-based and some televi-
sion broadcast. Sixty percent of the time patients had an opinion about what should be done surgically
before they ever spoke to the surgeon.
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                       5

accepted data which demonstrates that consumers are directly harmed by DTC
advertising, there is indirect data. However, because virtually all of the data is
based on studies involve promotion of drugs, not devices, the opposite is also
true: there is no real evidence of any educational benefit of advertising medical
devices directly to consumers, and already some data to suggest that consumers
do not really understand the information being conveyed in broadcast promotions
for restricted medical devices.27 If that is the case, and advertising to consumers
helps drive demand, little good will come of a situation in which “lacking expert
knowledge, they [consumers] are not in a position to make prudent purchasing
decisions.”28
   In all fairness, some commentators have pointed out that DTCA offers an oppor-
tunity for manufacturers to educate consumers about diseases; increase consumer
awareness about disease symptoms, inform consumers about treatment options,
alternative treatment options, and diagnostic procedures; stimulate patient-physi-
cian dialogue on vital health issues; and possibly encourage healthier lifestyles.29
Unfortunately, it is difficult to achieve all of these objectives, particularly in the
limited time span of broadcast media, when advertising promotes a specific medical
product (as opposed to awareness about a particular disease) whether it is a device
or a drug. Where there is promotion and advertising of a specific product, it is
possible and perhaps even more likely that DTCA will do consumers a disservice.
This is because the primary aim of that type of promotion is not educational, but
rather is to induce product name recognition and create patient demand for the
product.30 This is so even if there is no intent to be misleading about the benefits
and or risks of the product; not fully explain risks, particularly if surgery is involved
(e.g., it is an implantable device); or be silent about alternative treatment options,
particularly if alternatives are a competitor’s device or not using the device at all
and treating with medical therapy only.
   According to the 2002 report by the General Accounting Office (GAO)31 the
pharmaceutical industry’s track record on fair and balanced information in DTCA
is not encouraging. Importantly, there is absolutely no evidence that the restricted
medical device industry’s conduct is any better. The conclusions of the GAO re-
port on DTCA were that 1) DTC advertising appeared to increase drug spending
and utilization; 2) DTCA was concentrated among a small number of drugs32 and
conditions rather than directed at sweeping public health issues; and 3) some manu-
facturers repeatedly disseminated misleading ads for the same drugs, disregarded
repetitive warnings from FDA, and failed to submit in a timely manner (or at all)
newly disseminated advertisements to FDA for review. The limitations of FDA’s

      27
         Statement by William E. Boden, M.D., Professor of Medicine SUNY at Buffalo School of
Medicine, at Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?:
Hearing before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available
at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008).[hereafter
Boden statement].
      28
         Relman, Arnold, McCain, Obama, and the National Health, THE NY REVIEW OF BOOKS, (Nov.
6, 2008), at 27.
      29
         Pines, Wayne L., A History and Perspective on direct-to-consumer promotion, 54 FOOD AND DRUG
L.J. 489 (1999).
      30
         See fn 21.
      31
         UNITED STATES GENERAL ACCOUNTING OFFICE, REPORT TO CONGRESSIONAL REQUESTERS, PRE-
SCRIPTION DRUGS. FDA OVERSIGHT OF DIRECT-TO-CONSUMER ADVERTISING HAS LIMITATIONS, (Oct., 2002),
available at http://www.gao.gov/new.items/03177.pdf (last accessed Oct. 27, 2008).
      32
         Id.
 6                       Food and Drug Law Journal                                           Vol. 64

oversight over DTCA were apparent to the GAO as well.33 Even FDA surveys34 on
consumer behavior associated with DTC advertising campaigns for prescription
drugs provide further evidence of the legitimacy of these concerns.
   Within the field of DTCA, the overwhelming financial expenditures, emphasis,
controversy, and amount of enforcement action is on the advertising and promo-
tion of drugs, not medical devices, to consumers.35 There are likely several reasons
for this. First, the pharmaceutical industry is larger, more profitable, and has
more products, than that of the medical device industry despite the fact that the
growth of the medical device industry in the United States has increased almost
exponentially every decade.36 In aggregate and as individuals, more patients take
prescription and over-the-counter drugs, and take more kinds of drugs, than use
medical devices. Second, for the past eight years there has been dramatically more
controversy and Congressional oversight for the Center for Drug Evaluation and
Research (CDER) than there has been at either the Center for Biologics Evalu-
ation and Research (CBER) or the Center for Devices and Radiological Health
(CDRH).37 Third, litigation follows the money and the volume of business. Lastly,
the pharmaceutical industry has much more experience with DTC advertising and
promoting, and much more litigating over its presumed right to do so, than the
medical device industry. These facts notwithstanding, DTCA of medical devices
is a new and growing presence. The amount of money spent by medical device
makers in 2007 on television and internet advertising was $193 million, up from
$116 billion in 2005. By comparison, pharmaceutical manufacturers spent over $4
billion on DTCA in 2005.38

B. A New Type of DTCA for a Restricted, Implanted Medical
   Device
   The relative lack of attention to direct to consumer restricted medical device
promotion by manufacturers may be changing. Despite the much greater empha-
sis on DTCA of drugs, there are some signs that more attention is being paid to


     33
         Id.
     34
         Aikin, Kathryn J., Division of Drug Marketing, Advertising, and Communications (DDMAC),
FDA, Attitude and Behaviors Associated with Direct-to-Consumer Advertising of Prescription Drugs:
Summary of Survey Results, FDA Scientific Rounds, (Mar. 30, 2005), available at http://www.cdernet.
cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30, 2005). DDMAC’s survey noted
that although DTC advertisements increase awareness of possible treatments, DTC advertisements did
not convey information about risks and benefits equally well. In particular, it was clear that physicians
believe patients understand benefits much better than risks (no surprise actually if more benefit than
risk information is presented). The physicians also believed that DTC advertisements confuse patients
about relative risks and benefits of drugs.
      35
         Weinberg, Matthew R., Direct-to-Consumer Advertising: U.S. and European Perspectives, FDLI
UPDATE (Nov./Dec. 2004). “From 1996 to 2001 annual spending of U.S. pharmaceutical companies on
DTC advertising for prescription drugs tripled, reaching nearly $2.8 billion.” No such comparable data
is available for medical device manufacturers for that period of time.
      36
         Cooper, Theodore H., Device Legislation, 26 FOOD DRUG COSMETIC L.J. 165 (1971). In 1937
there were 463 medical device manufacturers. By 1947 this number had increased to 980, and then again
to over 1,500 by 1967.
      37
         United States Government Accountability Office, Report to Congressional Requesters, Drug
Safety. Improvement Needed in FDA’s Post-market Decisionmaking and Oversight Process, (Mar.
2006).
      38
         Mitka, Mike, Direct-to-Consumer Advertising of Medical Devices Under Scrutiny, 300 JAMA
1985 (2008).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                           7

DTCA of medical devices by prestigious medical journals39 and Congress.40 Both
may have the medical device industry and its new, more aggressive DTCA market-
ing campaign to thank.41
   Recently a threshold of sorts was crossed in the arena of direct to consumer
advertising of restricted medical devices when DTCA for medical devices reached
a national level, and audience, which previously had traditionally been reserved
only for drugs. During a Thanksgiving Day football game between the New York
Jets and the Dallas Cowboys on November 22, 2007, U.S. consumers were treated
to something they had virtually never experienced before: a nationally advertised
DTC advertisement for a drug-eluting coronary artery stent, an implantable, re-
stricted, Class III medical device. The advertisement was for Cypher, a drug-eluting
coronary artery stent manufactured by the Cordis division of Johnson and Johnson,
Inc. of New Brunswick, New Jersey.42 Consumers were also exposed to the need
for the interventional cardiology procedure (percutaneous transluminal coronary
angioplasty or PTCA) required to insert the stent into the human heart.
   The targeted audience for this restricted device was the middle-aged male with
known coronary artery disease, or multiple risk factors for the same, sitting on a
couch watching the football game. The Cypher medical device and procedure for
implantation into the heart are so complicated that there was virtually no way that
the average reasonable consumer viewing the advertisement could possibly derive
any educational benefit from the advertisement. Nor was there any meaningful way
for the viewer of the advertisement for this medical device to know that such devices
have been surrounded by controversy for years over safety issues (e.g., breakage
issues for Boston Scientific’s comparable device),43 efficacy issues (i.e., whether a
drug eluting stent works any better than a plain metal stent),44 and fundamental
questions about whether the clinical trials FDA uses to approve devices were inferior
to those used for new drug approvals.45 The only thing missing was an endorsement
by a major medical center or group of physicians for the product.46 What was not
missing from this new type of promotion was the fact that the road to the device
went right through the physician’s office, either on referral from a primary care
physician or by going directly to a cardiologist.
   The actual degree of direct involvement of the medical profession in the promo-
tion of this product was negligible; there was no medical center sponsorship or
      39
         Boden, William E. & Diamond, George A., DTCA for PTCA—Crossing the Line in Consumer
Health Education? 358 N. ENGL. J. MED. 2197 (2007).
      40
         Meier, Barry, Consumer Ads for Medical Devices Subject of Senate Panel, THE NY TIMES, (Sept.
17, 2008, available at http://www.nytimes.com/2008/09/17/business/17device.html?_r=2&oreg=slogin&
ref=today (last accessed Sept. 17, 2008).
      41
         Boden statement, supra note 28.
      42
         The coronary artery stent market is one of the largest and most lucrative medical device markets
in the United States, for both plain metal and drug-coated stents. The coated devices are newer and more
commonly used than bare-metal stents, and at $2000 apiece, cost more than twice as much as bare metal
devices. The global coronary artery coated stent market was valued at about $4 billion a year in 2007.
See Kamp, Jon, Cleveland Clinic Foregoes Boston Scientific Stent, THE WALL STREET JOURNAL, (Aug. 13,
2008) at B1, available at http://online.wsj.articles/SB121859886184436023.html?mod=2_1566_leftbox
(last accessed Oct. 18, 2008).
      43
         Winstein, Keith J., Boston Scientific Stent Study Flawed, WALL STREET JOURNAL, (Aug. 14, 2008)
at B1.
      44
         Mauri, Laura, Silbaugh, Treacy S., Garg, Pallav, et. al., Drug-Eluting or Bare-Metal Stents for
Acute Myocardial Infarction, 359 N. ENGL. J. MED. 1330 (2008).
      45
         Winstein, supra note 44.
      46
         This would actually come later, when the Cleveland Clinic announced its preference for the
stent of one manufacturer over another’s in an advertisement of sorts to consumers.
 8                      Food and Drug Law Journal                                         Vol. 64

endorsement by celebrity scientists such as Robert Jarvik.47 There was certainly no
shortage of negative commentary48 from many prominent cardiologists in academic
medicine about the shortcomings of the information, and the complexity of the
medical problem glossed over when presented to a carefully targeted audience. Real
concern was also expressed about what appeared to be the ominous development
of a likely new front in the wars over commercial speech protection of the rights of
companies to advertise and promote their prescription medical products to naïve
and vulnerable patient populations, a phenomenon noted even by knowledgeable
food and drug law attorneys used to representing industry.49
   This restricted medical device advertising was a new development, and demon-
strated a new, more aggressive trajectory for DTCA for certain medical devices.
There was also a new public and medical profession awareness of the old issue of
direct to consumer advertising for a new industry: medical device manufacturers.
More importantly, new questions arose about the potential role the medical profes-
sion itself played in this process. This newly found scrutiny of medical device DTCA,
particularly in the medical literature, continues to raise questions, and continues to
make physicians and legislatures uneasy at the time of this writing.50
   Our attention must now turn to these issues. We will first review some basic
FDA regulation of medical devices, then examine the regulation of advertising and
promotion of medical devices, particularly compared to that for drugs. Lastly we
will examine the potentially unique role the learned intermediary or its institutions
can play in restricted, implantable medical device promotion.

                          II. RESTRICTED MEDICAL DEVICES
   It is assumed that the reader is familiar with FDA’s risk-based classification of
medical devices and the pathways to commercialization.51 A prescription medical
device is one which has been approved for marketing via the PMA process or 510(k)
clearance mechanism and which is deemed safe for use only when administered
under the supervision of a licensed practitioner (physician). Some Class II, and
virtually all Class III medical devices, are prescription medical devices.
   In the past, FDA declared that all prescription medical devices would be deemed
restricted medical devices, but this position was rejected by the courts.52 One way
to view restricted medical devices is as a subset of prescription medical devices
since a prescription device may or may not be restricted device.53 It is better to
think of restricted devices as analogous to prescription drugs though the statute
      47
         The cholesterol drug advertisements which featured “Dr.” Robert Jarvik caused considerable
controversy, both because of the ostensible imprimatur of endorsement by a “heart doctor” and the fact
that Dr. Jarvik was not a physician, a fact impossible to ascertain from viewing the advertisement.
      48
         Medical Design Technology, Device Firms Go Direct to Consumers Amid Physician Skepticism,
available at http://www.mdtmag.com/scripts/ShowPR.asp?PUBCODE=046&ACCT=0006418&ISSUE
(last accessed Oct. 6, 2008). A typical comment was that of William E. Boden, M.D., an academic
cardiologist and Clinical Chief, Cardiovascular Medicine at SUNY at Buffalo School of Medicine,
who pointed out that the Cypher ad was particularly problematic because it omitted important adverse
event information included in the company’s patient information brochures.
      49
         Reeves, Kelly N., Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or
Manipulating a Vulnerable Population? 53 FOOD & DRUG L. J. 661 (1998).
      50
         Mitka, supra note 38.
      51
         For additional information the reader is directed to the CDRH website, available at www.cdrh.
fda.gov.
      52
         Becton Dickinson v. FDA, 589 F.2d 1175 (2nd Cir. (1978)).
      53
         FDCA § 502(f) and 502(e), 21 U.S.C. 352(f) and 360j(e).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                        9

is crafted in such a way as to give FDA, through the Secretary of the Department
of Health and Human Services (HHS), more flexibility in restricting device use
or distribution.54
    Medical devices may become restricted in one of three ways.55 A restricted medical
device is a medical device which can be sold, distributed, used or ordered 1) only
upon the written or oral authorization of a practitioner licensed by law to administer
or use such a device (i.e., based on a valid prescription written by a physician); or 2)
upon other conditions which might be set by the Secretary of HHS in a regulation
if, because of its potentiality for harmful effect or the collateral measures necessary
for its use that there cannot otherwise be reasonable assurance of its safety and ef-
fectiveness.56 This can occur either as a condition of approval of a Class III device
that its sale and distribution be restricted; or as part of a performance standard
requiring that the sale and distribution of the device be restricted.57 A medical
device can also become restricted by separate regulation.
    Most, but not all, restricted medical devices are Class III devices, because
Class III devices are either prescription devices or their distribution is restricted
as a condition of premarket approval (PMA). There are exceptions though. For
example, diagnostic kits for genetic testing which employ analyte-specific reagents
(ASRs) in house (so called “home brew” diagnostic tests) are regulated by FDA
as restricted as Class II, not Class III, medical devices. Another large group of re-
stricted medical devices which are Class II devices are those used in the operating
room by surgeons. Advanced laparoscopic equipment, innovative intra-operative
lasers and similar equipment are all types of medical devices which would not
normally be used by anyone other than a licensed physician yet are classified as
Class II medical devices by FDA. Lastly, although restricted medical devices may
be generally thought of as a subset of prescription medical devices, some restricted
devices are over or behind-the-counter. For example, FDA has issued a restricted
device rule for over-the-counter test sample collection systems for drugs tested for
in substance abuse programs.
    Both prescription and restricted medical devices are subject to FDCA medical
device general labeling requirements. Restricted medical devices may also be subject
to additional labeling and misbranding requirements, as noted, as a condition of
their use. The regulatory requirements for a prescription medical device which help
prevent the device from being misbranded include 1) the device is in the possession
of the practitioner or firm licensed by law to use or order the use of the device; 2)
the device is sold only to or on the prescription or other order of such practitioner
for use in the course of professional practice; 3) the label of the device bears the
legend “Caution: Federal (U.S.) law restricts this device to sale by or on the order of
a physician (this does not apply to surgical instruments); 4) if the labeling is included
in the device package it contains “adequate information for use,” defined to mean
indications, effects, routes of administration, relevant hazards, contraindications,
side effects and precautions under which practitioners licensed by law to employ the
device can use the device safely and for the purposes for which it is intended; and

     54
         American Pharmaceutical Ass’n v. Weinberger, 377 F.Supp. 824 (D.DC (1974)).
     55
         Statement by Daniel Schultz, MD, Director, CDRH at Marketing or Medicine: Are Direct-to-
Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee on Aging,
110th Congress, (Sept. 30, 2008) available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085
(last accessed Sept. 30, 2008) [hereafter Schultz statement].
      56
         FDCA § 520(e).
      57
         Id. and 514(a)(2)(B)(v) of FDCA.
10                  Food and Drug Law Journal                               Vol. 64

5) if the labeling is not packaged with the device (e.g., a promotional brochure), it
must contain “adequate information for use” if it furnishes any information about
the intended use or indications for use of the device
    Even though FDA regulates the labeling of all medical devices its statutory au-
thority does not extend to regulation of advertising of all medical devices. In this
sense the regulatory framework for medical devices is similar to that for drugs: FDA
only regulates the advertising and promotion of prescription drugs even though
it regulates the labeling for all drugs. Advertising of all other drugs and devices is
the jurisdiction of the Federal Trade Commission (FTC).58 Thus, the classification
of a medical device as a restricted device is of critical importance because FDA
regulates the advertising and promotion only of restricted medical devices.

     III. GENERAL PRINCIPLES OF FDA REGULATIONS AND GUIDANCE
          GOVERNING ADVERTISING AND PROMOTION OF MEDICAL
                      PRODUCTS TO CONSUMERS

A. The Critical Questions Regarding FDA Regulation of DTCA
   Is advertising and promotion of restricted medical devices regulated by FDA
the same way that it is for drugs? If it is, should it be? If there are no important
differences between restricted medical device and prescription drug advertising,
then their DTC advertising should be regulated the same way, even if they are
not. To answer these important questions, several things must be examined. First,
the basic FDA statutory requirements governing advertisement of prescription
drugs and restricted medical devices should be compared to see if the criteria
for determining that an advertisement is false, deceptive or misleading are the
same for prescription drugs and restricted devices. Second, the FDA Guidance
Documents for advertisement and promotion of prescription drugs should be
compared to those for restricted medical devices, both for printed advertisements
as well as broadcast advertising, to determine if the general regulatory recom-
mendations are both similar and adequate to ensure consumer safety for these
two classes of products. Lastly, the manner and content of prescription drug and
restricted medical device advertisements should be examined to see if there are
significant enough differences to suggest that the way they are regulated should
not be the same. The latter question is particularly important because of the role
the medical profession itself plays as a surrogate advertiser for medical device
manufacturers.
   A discussion of FDA regulation of advertising and promotion of restricted
medical devices and prescription drugs first requires certain terms be defined.
For purposes of FDA regulation, label means “a display of written, printed or
graphic mater upon the immediate container,”59 Labeling means “labels and all
other written, printed or graphic matter 1) upon any article or any of its containers
or wrappers, or 2) accompanying such article.”60 Labeling is viewed expansively
by FDA and may encompass virtually any written or oral communication with
customers, whether the customer is a physician who may use the device or a con-

   58
      Memorandum of understanding (MOU) with FTC Concerning Exchange of Information,
FDA-225-71-8003 (Oct. 1, 1980).
   59
      FDCA § 201(k), 21 U.S.C. § 321(k).
   60
      FDCA § 201(m), 21 U.S.C. § 321(m).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                           11

sumer to whom the device is being advertised. The label, which is packaged with
the device, is generally considered separate from labeling materials which promote
the device either to physicians or consumers; the latter are usually referred to as
promotional labeling or promotional material in FDA enforcement letters sent
to the manufacturer. The same rules, however, apply to promotional labeling as
well as to all other labeling.
   One of the critical items contained in the label for a medical product are the
claims being made about the product. A claim is a representation about the expected
performance, efficacy, safety or clinical utility of a medical device.61 Because they
appear in the label and must be consistent with the approved intended use, FDA
regulates claims appearing in the labeling of all medical devices and drugs.
   Advertising, as opposed to labeling, is not a term defined in the FDCA.62 FDA
has defined advertising in the Federal Register63 for drugs only; there is no specific
advertising definition for medical devices which is the counterpart to that for
drugs. By consensus though, the drug advertising definition is what FDA uses
to determine whether a promotional material for a device is advertising. As with
labeling, advertising is also viewed or defined expansively by FDA. Advertising
can include information published in consumer or medical magazines, newspapers,
medical journals or other periodicals or written materials, or broadcast through
media such as radio, television, telephone or the internet. Both restricted and non-
restricted medical devices are advertised in printed and broadcast media. FDA
possesses only limited authority to regulate only the advertising and promotion
of “restricted devices” which are those expressly designated as such in the relevant
PMA approval order, or a regulation because of the “potentiality for harmful
effect or the collateral measures necessary for ‘safe and effective’ use.”64
   The general rules and First Amendment case law65 which govern DTCA are
the same for prescription drugs and restricted medical devices. Manufacturers
cannot advertise off-label uses of either prescription drugs or restricted devices
to consumers, although in general the extent of FDA monitoring of this activ-
ity is unknown and data on the prevalence of promotion of off-label uses of
restricted medical devices to consumers are sparse. Manufacturers can advertise
and promote uses/indications for the drug or device which appear in the approved
drug or device label.66 Sections 502(q) and 502(r) of the FDCA provide FDA
with the regulatory authority to regulate restricted medical device advertising
and promotion.
      61
         Shapiro, Jeffrey K., Labeling and Advertising of Medical Devices, in PROMOTION OF BIOMEDICAL
PRODUCTS, Colonna, Thomas E. & Shapiro, Jeffery K. eds. (Food and Drug Law Institute, (2006)).[Here-
after Colonna].
      62
         Id.
      63
         21 C.F.R. § 202.1(l)(1).
      64
         FDCA § 502(q), 502(r), 515(d)(1)(B)(ii), 21 U.S.C. § 352(q), 352(r ), 360j(e), 360j(e),
360e(d)(1)(B)(ii). There are some devices that are designated as restricted devices just on the basis of a
regulation: these are hearing aids and ASRs. See 62 Fed. Reg. 62,259 (Nov. 21, 1997) and 42 Fed. Reg.
9296 (Feb. 15, 1977).
      65
         PETER BARTON HUTT, RICHARD A. MERRILL & LEWIS GROSSMAN, FOOD AND DRUG LAW. CASES
AND MATERIALS (3rd ed. 2007), p. 535-560.
      66
         FDA, 2008 Guidance for Industry: Good Reprint Practices for the Distribution of Medical
Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical Devices, available at http://www.www.fda.gov/oc/op/goodre-
print.html (last accessed May 16, 2008). Federal Register, (Feb. 20, 2008), Vol. 73 No. 34. “the [FDCA]
and FDA’s implementing regulations generally prohibit manufacturers of new drugs or medical devices
from distributing products in interstate commerce for any intended use that FDA has not approved as
safe and effective or cleared through a substantial equivalence determination.”
12                     Food and Drug Law Journal                                        Vol. 64

B. Statutory Requirements for DTCA of Restricted Medical
   Devices
   The main content for any advertisement for a prescription drug or restricted de-
vice are the claims made to physicians and/or consumers about the product. There
are several fundamental principles which govern DTCA regulation of restricted
medical devices. Sections 502(q) and 502(r) of the FDCA67 impose specific require-
ments on the advertising of restricted medical devices. Section 502(q)68 provides
that a restricted medical device is misbranded if its advertising or promotion is
false or misleading in any particular, i.e., if any of the claims about the product
are false or misleading in any particular. Section 201(n)69 of the Act provides that
many factors may be taken into account in determining whether an advertisement
is misleading. This includes not only representations about device use in the spe-
cific advertisement, but also whether the advertisement fails to reveal important,
material facts about the device or the potential adverse consequences of its use. As
will be discussed, there are differences between prescription drugs and restricted
medical devices in what information constitutes an important material fact and
what potential adverse consequences of use are.
   Section 502(r) of the FDCA70 provides that a restricted medical device is mis-
branded if any advertising relating to the device does not contain a brief state-
ment of the device’s intended use/intended patient population, as well as relevant
warnings, side effects, contraindications, and precautions about the device. This
statute71 also notes that the brief summary must have fair balance. The result of
these statutes is that all restricted medical device advertising must affirmatively
include:72 1) a true statement of the medical device’s name or trade name; and 2)
a brief statement of the intended uses of the device and relevant warnings, pre-
cautions, side effects and contradictions73 which present a “fair balance” of risk
and benefit information. The risk information must be provided in “consumer
friendly” language; and there must be “adequate provision” for dissemination of
more information provided in the package label if the actual label is not provided.
These are the minimum requirements. What the “brief statement” must contain
in an advertisement in order to avoid being considered “false or misleading in any
particular” also depends on several other factors: 1) the particular promotional
medium; 2) whether it is a device-specific claim, (i.e., whether it is a product claim
or advertisement); and 3) whether it is a help-seeking or disease awareness ad. In
2004 FDA issued two guidance documents relating to advertising and promotion
of restricted medical devices which will be discussed in the next section.
   FDA may impose additional advertising restrictions and requirements as part
of the PMA approval process. In general, the brief summary must include “each
specific side effect and contraindication” (i.e., all risk concepts). Manufacturers
have historically complied with this by reprinting risk-related sections of product
labeling, though verbatim reprinting is not required.74
     67
         FDCA § 502(q), 502(r).
     68
         FDCA § 502(q), 21 U.S.C. § 352(q),
      69
         FDCA § 201(n).
      70
         FDCA § 502(r), 21 U.S.C. § 352(r).
      71
         21 C.F.R. 202.1(e)1.
      72
         FDCA § 502(e), 21 U.S.C. § 352(e).
      73
         FDCA § 502(q)-®, 21 U.S.C. § 352(q)-(r)
      74
         Melissa Moncavage, Leader, DTC Review Group, DDMAC, FDA. CDER Scientific Rounds,
(Mar. 30, 2005), Current DTC Promotion Activities and Environment, available at http://www.cdernet.
cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30, 2005).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                        13

    In evaluating whether claims made about a medical device by its manufacturer
meet the statutory requirement of being truthful and non-misleading, FDA typi-
cally will look at all of the promotional materials in a product-specific advertising
campaign to obtain a general sense of whether the advertisement is false or mis-
leading. Much of this is a subjective sense of whether the material fairly balances
safety risks and touted benefits or if potential adverse effects are minimized. In-
terestingly, it is permissible75 for a medical device advertisement to consumers to
reference the fact that a medical device was approved by FDA via a PMA, but not
via a 510(k) clearance. Advertising to consumers that a device reached the market
via 510(k) clearance is considered false and misleading,76 even though consumers
are: 1) likely completely oblivious to the difference in marketing mechanisms; and
2) unaware of the fact that only a PMA approval generally rests on an agency de-
termination that they have reasonable assurance that a device is safe and effective
rather than a conclusion that the device is merely substantially equivalent to an
already marketed device.
    Another decisive factor for determining whether an advertising claim is truth-
ful and non-misleading is that the claim be must be adequately substantiated77 by
real-world data which existed at the time the advertising claim was made. Again,
the type of marketing application for the device is relevant for advertising. For
medical devices which were approved via a PMA data normally would not be a
problem since submission of substantial, independent safety and efficacy data is a
requirement of FDA’s marketing approval application. For medical devices which
reached the market via 510(k) clearance though, the amount of safety and effi-
cacy data sent to FDA may vary enormously from little to none to a clinical trial.
It is possible, and even likely, that the safety and efficacy data for the device are
actually those of the predicate device, which are presumably similar to the device
being advertised. If there are only bench (lab) or animal data for the device being
advertised, this information must be conveyed to consumers via a disclaimer even
though the limited data on the usefulness of disclaimers suggests they are ignored
by consumers.78 Drug superiority claims require data to support this, and FDA
generally has taken the same approach for comparative device claims even though
there is no guidance document specifically on this subject.
    There are other major significant statutory requirement differences. Although it
is true that there is no statutory requirement that prescription drug advertisements
be submitted to FDA for review prior to their being printed or broadcast, there
is an important exception for new drugs reaching the market through accelerated
approval. These are the drugs being used to treat life-threatening illnesses with few
or any therapeutic options, the very situation in which some restricted implant-
able medical devices are used.79 By contrast, there is no statutory requirement that
advertisements for restricted medical devices be submitted to FDA prior to dis-
semination, and no situation or exception to this either as there is for drugs. CDRH
acknowledges80 that, as a rule, it never reviews restricted medical device advertise-
ments prior to their appearance in print or television, except on that rare (if ever)
occasion where a manufacturer elects to send it to CDRH ahead of time.
     75
          21 C.F.R. § 808.97.
     76
          Id.
       77
          Id.
       78
          Id.
       79
          An important difference is that Subpart H approvals are based on surrogate endpoints, whereas
it is not certain that PMA approvals require additional clinical study validation.
       80
          Schultz statement, supra note 55.
14                      Food and Drug Law Journal                           Vol. 64

   Another major statutory difference between DTC drug and restricted medical
device promotion occurs at the time of actual dissemination in print or broadcast.
Prescription drug manufacturers are required, by submission of a form 2253, to
submit copies of advertisements to FDA at the time of media distribution, whereas
medical device manufacturers are not required to submit any copies of printed or
broadcast ads to FDA at the time they are being shown to consumers.
   There are also more subtle differences in the regulatory requirements. FDA’s
device regulations contain more general requirements for advertising and promo-
tion than those for prescription drug advertising, which are both more specific and
broken down into specific and differing requirements for printed ads and broadcast
ads. The general requirements for restricted medical device promotion arise from
§§ 502(q) and (r) of the FDCA and merely note first, that advertisements and
promotions cannot be false or misleading in any particular, and second, that ad-
vertisements and promotions must contain the brief statement which describes the
restricted medical devices intended use, side effects, contraindications, precautions
and relevant warnings. These general requirements for restricted medical device
advertising have been supplemented with the 2004 guidance documents only for
broadcast advertisements; this will be discussed shortly. For prescription drugs the
general requirement for advertisements mandate that they cannot be false or mis-
leading in any particular or omit material facts, and they must present a fair balance
between safety risks and potential benefits. For printed ads there is the brief sum-
mary requirement which must contain the most serious as well as the most common
risks which appear in the label. For broadcast ads manufacturers have the option
of providing either the brief summary, the same as for a printed advertisement, or
the option of making adequate provision of the information in the approved label
by providing an 800 number, manufacturer or product website, a statement telling
the consumer to call their physician to get more information, etc.
   Lastly, the recently enacted FDA Amendments Act of 2007 (FDAAA) contained
a section81 which included greater authorization for FDA to require pre-review of
DTC drug advertisements to ensure that consumers are adequately informed of
safety risks.

C. FDA Guidance Documents for DTCA Differ for Drugs and
   Devices
   In addition to the statutory requirements governing advertising and promotion
of medical products, FDA has also published a series of Draft Guidances for In-
dustry designed to improve information provided both to consumers and healthcare
providers in advertisements about medical products and related health conditions.
Although guidance documents are not legally binding, they do represent current
FDA thinking on topics of importance and are designed to help sponsors comply
with FDA regulatory requirements.
   There is no single guidance document on advertising and promotion that com-
prehensively addresses both prescription drugs and restricted medical devices.
There are separate guidance documents for printed and broadcast advertisements,
two Draft Guidances directed at products regulated by both CDER and CBER,
and only one draft guidance which is device-specific and directed only at products
regulated by CDRH.

     81
          FDAAA, PUBLIC LAW 110-85, § 503B.
2009      DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                 15

   The first Draft Guidance on “Consumer-Directed Broadcast Advertisements”
as well as its related publication on “Questions and Answers” was published in its
final version in August, 1999;82 this document applied both to drugs, biologics, and
animal drugs but not to restricted medical devices.
   Given that devices have not received much in the way of separate regulatory and
media attention until recently, it should not be surprising that the only Draft Guid-
ance for Industry which deals specifically with restricted medical devices was not
released until four years ago. On February 4, 2004 FDA announced83 in the Federal
Register84 the availability of three Draft Guidances for industry dealing with three
issues arising out of discussions and presentations at an open public meeting on
consumer directed advertising that FDA held in September 2003.85 The three recent
Draft Guidances were: 1) Guidance for Industry. Brief Summary: Disclosing Risk
Information in Consumer-Directed Print Advertisements (directed only to CDER
and CBER); 2) Draft Guidance for Industry and FDA: Consumer-Directed Broad-
cast Advertising of Restricted Devices (directed only to CDRH);86 and 3) Draft
Guidance for Industry and FDA: “Help-Seeking” and Other Disease Awareness
Communications by or on Behalf of Drug and Device Firms. This last is the only
guidance document which deals with drugs and devices together and addresses
“disease awareness communications” by manufacturers, a form of advertising and
promotion that is not covered by the labeling and advertising statutory rules in the
FDCA and which FDA does not regulate. None of the three Draft Guidances have
been finalized since their initial publications early in 2004.
   The 2004 “Draft Guidance for Industry and FDA: Consumer-Directed Broadcast
Advertising of Restricted Medical Devices” did not deal with printed advertisements,
but did provide an approach for companies to meet the requirements of 502(r) in
their broadcast advertisements. Such advertisements are supposed to contain a
brief statement describing the intended uses of the device as well as relevant warn-
ings, precautions, side effects and contraindications.87 Because it is allegedly more
difficult for a broadcast advertisement to contain all of this information than it is
for a printed advertisement, FDA’s guidance document recommended that DTCA
via broadcasts provide a way for consumers to gain convenient access to all of this
information which appears in the printed label. This may be done in a broadcast
advertisement by referring consumers to four other, different sources to obtain this
information or its equivalent: 1) a toll-free number (e.g., a 1-800 number); 2) the
manufacturer’s website; 3) a print advertisement which is running at the same time;
4) and a statement to viewing consumers that they should talk to their physicians
(about the restricted medical device).88
   Serious concerns about the recent FDA guidance documents remain. First, it
is not clear why the Draft Guidance for Industry Brief Summary: Disclosing Risk

      82
         HHS, FDA, DDMAC, Guidance for Industry. Consumer-Directed Broadcast Advertisements.
(Aug.1999).
      83
         HHS, FDA, Consumer-Directed Broadcast Advertisements Guidance, Questions and Answers,
available at http://www.fda.gov/cder/guidance/1804.1&a.htm (last accessed Oct. 15, 2008).
      84
         Draft Guidance for Industry on Improving Information About Medical Products and Health
Conditions; Withdrawal; Availability, Fed. Reg. 69, 27 (Feb. 10, 2004)
      85
         Available at http://www.fda.gov/cder/ddmac/DTCmeeting2003.html (last accessed Oct. 12,
2008).
      86
         HHS, FDA, CDRH, Office of Compliance, Draft Guidance, Consumer-Directed Broadcast Ad-
vertising of Restricted Devices, (Feb. 10, 2004). [hereafter CDRH Broadcast Guidance Document].
      87
         21 U.S.C. 352(r)(2).
      88
         Id.
16                      Food and Drug Law Journal                                        Vol. 64

Information in Consumer-Directed Print Advertisements should exclude medical
products from CDRH. As will be seen, restricted medical devices are advertised
and promoted in print, either by the manufacturers themselves or by their surro-
gate, the medical profession, in the form of either hospital or physician marketing.
At present, there is no specific Guidance, draft or otherwise, which specifically
addresses how sponsors can use FDA-approved patient labeling or highlights
of the professional label for the restricted medical device to provide the best risk
information in a brief summary format in consumer-directed print advertisement
for medical devices. Guidance on this issue from FDA exists only for prescription
drugs and biologics. The Draft Guidance recommendations apply to medical de-
vices by inference only.
    Second, the standards for required information content for printed media and
those required for broadcast media do differ. Even though broadcast advertisements
for consumers are more expensive, more “intensive” in terms of attracting attention,
more likely to minimize safety information,89 more distracting because of visual
signals and more likely to be shown to a designated “target” marketing segment
of the consumer population, the amount of required information concerning risk
concepts from the medical product is greater for printed ads. DTC prescription drug
ads in printed media must include the brief summary90 which generally contains all
of the important safety risk concepts from the product’s approved label.
    Based on the assumption that broadcast DTC advertisements cannot convey
this information, broadcast DTC advertisements may, instead of the brief sum-
mary, make “adequate provision … for dissemination of the approved or permitted
package labeling in connection with the broadcast presentation.”91 What does this
adequate provision consist of ? According to the Guidance for Industry document,92
the acceptable information substitute by a DTC broadcast for the required printed
advertisement substantive Brief Statement is a reference in the broadcast to the four
items noted earlier: references to the device’s printed advertisement (if they can find
it), the manufacturer’s website, a toll-free number where consumers can gather more
information and a suggestion to contact their physicians (even though the physi-
cian may have little or nothing to do with the restricted implantable device itself).93
These alone are for provision of critical safety information for a group of products
(such as implantable surgical devices) which are perhaps more difficult to explain to
consumers than drugs, and which (depending on the marketing application used)
may actually have no original safety or efficacy information to begin with.
    Even if broadcast advertisements were less aggressive and less compelling prod-
uct promotion than printed advertisements, this still would not be acceptable. The
difference in current requirements between print and broadcast advertisements
aside, there is no definitive data which either establishes that the information
standard for print advertisements cannot be met in a broadcast advertisement or
that there should not be a uniform standard—the current print standard—for all
DTC advertising.94
      89
         Statement of Gary Ruskin, Executive Director of Commercial Alert, before FDA, Hearings
on Direct-to-Consumer Prescription Drug Advertising, (Nov. 2, 2005). [hereafter Ruskin statement].
      90
         The Act requires DTC advertisements to contain “information in brief summary relating to
side effects, contraindications and effectiveness,” 21 U.S.C. § 352(n).
      91
         21 C.F.R. § 202(e)(1).
      92
         CDRH Broadcast Guidance Document, supra note 89.
      93
         Id.
      94
         No substantive data was provided during the 2005 Hearings on DTC prescription drug advertis-
ing sponsored by FDA or the Sept. 2008 Congressional hearings on DTC medical device advertising.
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                         17

   The question of whether FDA’s recommended guidance document approach for
broadcast advertisements, which mimics that for DTC advertising of prescription
drug broadcast advertisements, is just as good for restricted, implantable medical
devices will be explored in subsequent sections of this article. If significant differ-
ences exist between prescription drug and restricted medical device DTC adver-
tising, the same regulatory approach will not be equally successful in protecting
consumers. This “loophole” in required safety information is problematic for all
FDA-approved medical products but is more severe for restricted, implantable
medical devices. The harm from omission of equivalent information in a medical
device broadcast advertisement is potentially greater for restricted medical devices,
compared to prescription drugs, for reasons related to consumer knowledge base
and intrinsic differences between complicated medical devices and drugs that will
be explained in Section VI.

IV. MAJOR RESTRICTIONS ON FDA’S REGULATION OF ADVERTISING AND
               PROMOTION OF MEDICAL DEVICES

A. A restricted device is not necessarily a prescription medical device,
   a Class III medical device, one approved via a PMA, or one
   promoted just by the sponsor.
   FDA jurisdiction over the regulation of advertising and promotion of medical
devices also differs from the degree of jurisdiction it has over prescription drugs.
FDA regulation of medical devices is more restricted than it is for drugs. By statute,
FDA can regulate advertising and promotion of medical devices only if they are
restricted medical devices. By contrast, FDA regulates advertising and promotion
of all prescription drugs. FTC jurisdiction over medical devices is thus broader, in
a sense, than its jurisdiction over only over-the-counter drugs.
   The definition of a restricted medical device (as provided earlier in Section III)
can be the source of some confusion. The term “restricted device” is not synonymous
with “prescription device.” Nor does a restricted medical device does not have to
be a device approved via PMA either; as a number of Class III devices reach the
U.S. market via the 510(k) clearance mechanism. A restricted medical device also
does not have to be a Class III device, though many are.95
   There is one other surprising and unanticipated omission in FDA’s jurisdiction
over restricted medical devices which points to another major difference between
drug and medical device DTCA. It is no longer sufficient to say that FDA regulates
the advertising and promotion of restricted medical devices because this statement
does not really address who is doing the advertising and promoting. It would be
more accurate to say that FDA regulates the advertising and promotion of re-
stricted medical devices only when the advertising and promotion is being done
by the medical device manufacturer. For restricted medical devices, particularly
the implantable devices such as coronary artery stents which are being advertised
and promoted directly to consumers, this generates an entirely different set of
regulatory problems.
   For prescription drugs the issue of who is doing the advertising and promot-
ing is a non-issue; with the exception of pharmacy compounding of prescription

    95
         Colonna, supra note 61.
18                    Food and Drug Law Journal                                   Vol. 64

drug products,96 virtually all advertising and promotion of prescription drugs to
consumers is done by the pharmaceutical manufacturer. Neither physicians, hos-
pitals, medical schools nor academic medical centers do any direct, or indirect,
promotional activity for particular prescription drugs to consumers. Investigational
drugs, or new prescription drugs or drug combinations undergoing clinical trials
for new indications might be mentioned on a medical school/cancer center website,
but even this rarely mentions the particular drug manufacturer.
   This is not the case with some restricted medical devices, particularly implantable
restricted medical devices such as coronary artery stents and orthopedic implants.
Examination of how some of these medical devices are promoted to consumers
demonstrates a much different role for learned intermediaries, the healthcare in-
stitutions they are affiliated with, or academic medical centers themselves. FDA
does not have jurisdiction over these physicians or hospitals in this setting. This
surrogate advertising has received little or no publicity, and is one of the major
problems with the current regulatory framework for advertising and promotion of
restricted medical devices. The question is: if learned intermediaries or their affili-
ated institutions advertise that they use a restricted medical device, who regulates
this advertising and promotion, and does it constitute an end-run around FDA
regulation? This issue must now be addressed.

   V. DTCA OF PRESCRIPTION DRUGS AND RESTRICTED IMPLANTABLE
      DEVICES DIFFER: FOUR DISTINGUISHING FEATURES OF DTCA
                  OF RESTRICTED MEDICAL DEVICES

    Because the general framework for regulating the advertising and promotion of
prescription drugs and restricted medical devices is similar, the general assumption
is that the problems faced by FDA in its efforts to regulate both industries are the
same. This major assumption is not correct.

A. DTCA of Prescription Drugs and Restricted Medical Devices
   Differs
   The differences between prescription drug and restricted medical device adver-
tising and promotion are significant and problematic. The role played by learned
intermediaries and the institutions they are either employed by or are affiliated with
in promoting medical devices is far greater than it is for pharmaceuticals. There are
fundamental differences between drugs and devices in terms of meaningful infor-
mation content for consumers in advertisements, the core medical knowledge and
familiarity consumers have with these products, and the likely ability of consumers
to comprehend the limited safety and clinical information contained in the adver-
tisement. There is also a dramatic difference in the amount of safety information
provided between prescription drug and restricted medical device advertisements,
and more importantly, in the type of safety information which is necessary for
consumers. The advertisements themselves also differ greatly: there is dramatically
less, or essentially no, critical safety information in many restricted medical device
advertisements particularly for those implanted medical devices requiring techni-
cally complex surgical implantation into the human body.
     96
        Bruce Patsner, Pharmacy Compounding of BHRT: A New Approach to Justify FDA Regulation
of These Prescription Drugs, 63 FOOD AND DRUG L.J., 459 (2008).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                        19

    First a look at the issue of surrogate promotion by learned intermediaries. In
general, particular prescription drugs are promoted to consumers exclusively by
the manufacturers of the drugs themselves, with no role played by the physicians
who prescribe them, or the physician medical groups, hospitals, academic medical
centers or regional cancer centers where they may be administered to large numbers
of patients. At most, the websites for pharmaceutical manufacturers may list all of
the investigational or prescription drug or biologic drug trials available or being
conducted; the websites of academic medical centers and cancer centers may list
their investigational trials, and drugs available, but rarely mention the manufac-
turer. Exceptions to this usually involve investigational biological drug products
(cancer vaccines, gene therapy products) which are undergoing clinical testing.97
One obvious reason why pharmaceutical drug development and marketing is done
exclusively by the manufacturers, with the role of the medical profession restricted
to that of learned intermediary using the products at more of an arm’s length trans-
action aside from participation in clinical trials is that the cost of bringing a new
prescription drug to market in the United States is enormous.98 Without new drug
development costs averaging close to $700 million or more from bench to bedside,99
the financial barrier to active new drug development and testing is so high that only
manufacturers themselves can do this. When physicians are involved in this process,
it is either as clinical investigators participating in clinical drug testing (a fact which
may be made known to patients in promotional brochures or websites for a medical
center),100 or they may be involved in speaker’s bureaus or educational symposia for
physicians, but learned intermediaries themselves virtually never directly promote
to consumers about the prescription drug products. It is different when one exam-
ines medical devices and how the medical profession is involved in new restricted
implantable medical device development, testing, and promotion.

B. The Medical Device Industry—Learned Intermediary Relationship
   Is Unique, Less Arms-Length and Involves Surrogate Advertising
   Surrogate advertising may be defined as the promotion of named specific medical
products to consumers by health professionals or institutions, either intentionally
or otherwise, on behalf of the manufacturers. “Cutting-edge” implantable restricted
devices are precisely the kinds of devices hospitals use to market their services and
attract patients. This is seen in the way that individual physicians, surgical specialty
groups (orthopedics, plastics, cardiovascular, interventional radiology or cardiol-
ogy), hospitals, medical school and medical school-affiliated academic medical
centers routinely advertise the availability of such devices to consumers, sometimes
with pictures of the specialized members of the physician medical or surgical staff.
This does not happen with prescription drug advertising. This surrogate advertising


     97
         An example of this is contained in Duke Medical Review 2008, a publication mailed out to
physicians all over the United States and which can be perused in waiting rooms at Duke. On p. 22
there is a discussion of the CDX-110 vaccine which in undergoing testing at Duke. The clinical trial is
being underwritten in large part by Pfizer Pharmaceuticals, and is mentioned in the article.
     98
         CONGRESSIONAL BUDGET OFFICE, RESEARCH AND DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY
(2006).
     99
         Id.
     100
         For example, see the promotion brochure for Duke Medical Center or M.D. Anderson Cancer
Center. Booher, Bridget, The future of the CDX-110 vaccine, DUKE MEDICINE REVIEW (2008).
20                       Food and Drug Law Journal                                          Vol. 64

may occur on billboards along major highways, in popular regional magazines101
distributed either nationally or in the catchment area for these medical institutions,
and occasionally on television. All of this is part of the costly and essential mar-
keting strategy these institutions or physicians employ to differentiate themselves
from their competition and to attract patients. This marketing of devices and health
providers in tandem occurs because of the unique role learned intermediaries and
their institutions have in implementing the use of cutting edge restricted medical
devices. Advertising surgical services sometimes requires advertising specific medi-
cal products. This is not true for prescription drugs.
   One need not go far to find examples of surrogate advertising from different parts
of the United States and from individual physicians, surgical groups or medical cen-
ters. For example, the Providence Medical Center in Anchorage, Alaska advertises102
the exclusive availability of the DaVinci robotic surgical platform in its website for
patients. This format allows this public hospital to market the superiority of its
medical device equipment directly to consumers, while at the same time providing
free advertising not only for the product but for the manufacturer as well. Adver-
tisements for this type of minimally invasive robotic surgical technology invariably
tout its superiority in minimizing blood loss and length of hospitalization, yet there
is no way that a consumer would know that there is little or no data demonstrating
the superiority of this expensive equipment over conventional laparoscopic surgical
techniques103 in many of the areas (surgical treatment of gynecologic cancers, for
one) in which it is used and which may be more universally available.
   It is not just in internet-based broadcast promotions for medical centers that
proxy advertising for restricted medical devices occurs. Similar advertisements for
this robotic surgical system appear in print in metropolitan magazines in Texas
for major cancer centers such as M.D. Anderson in Houston and Baylor Medical
Center in Dallas, invariably accompanied by a picture of one of the surgeons with
presumed expertise in that surgical technology.104 It is not just regional academic
or cancer centers which advertise medical device technology to attract patients;
individual surgeons, interventional cardiologists, radiologists, neurosurgeons,
orthopedic surgeons or groups of such physicians advertise their medical services
directly to consumers, sometimes highlighting the restricted medical devices, and
occasionally the manufacturer, which they use.
   A perusal of the October 2008 issue of D (Dallas/Forth Worth) Magazine’s “Top
Doctors 2008” issue105 nicely illustrates this, though the same point could be made
      101
          Boston, Los Angeles, Wash., D.C., New York, Chicago, Houston, Philadelphia, Dallas-Fort
Worth are all cities which have “metro” magazines (e.g., NY Magazine, Boston Magazine, Washingto-
nian Magazine) which not only carry this type of advertising by physicians, surgical groups, university
hospitals and regional medical centers in every issue but all have a much-anticipated “Best Doctor’s”
issue which is an especially valuable marketing tool.
      102
          Providence Health & Services, Robotic-Assisted Surgery Now Available, available at http://www.
providence.org/alaska/pamc/surgery/robotics.htm (last accessed Oct. 6, 2008). “Providence has installed
the DaVinci surgical robotics system manufactured by Intuitive Surgical, Inc. of Sunnyvale, California
… It is the best in patient care … Providence has a long history of bringing technology to the state,
ensuring Alaskans have access to the very best technology available, right here at home.”
      103
          At the time of this writing no prospective, randomized study comparing conventional laparo-
scopic cancer surgery with robotic-assisted surgery has been performed demonstrating either superior
clinical outcomes or cost-savings. It may be true that a manufacturer’s claims may be supported by
their own data on file which has never appeared in a randomized study, but even if so the absence of
peer-review of such data does not help the situation.
      104
          The University of Texas M.D. Anderson Cancer Center, Making Cancer History®: Advance-
ments in Minimally Invasive Cancer Surgery, TEXAS MONTHLY (July 2008), p 76.
      105
          D. DALLAS/FORTH WORTH MAGAZINE, Volume 35 No. 10, Top Doctors 2008 [hereafter D
Magazine].
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                               21

for the “best doctors” issue of New York Magazine, Los Angeles Magazine, Boston
Magazine, or any of the other major metropolitan area city magazines which allow
healthcare professionals, hospitals and academic medical centers to advertise their
medical and surgical services directly to consumers. Examination of the full and
half-page advertisements reveals advertisements by ophthalmic surgeons for specific
Lasik machines106 (advertisements which interestingly note that this newest device
is FDA-approved even though the very same type of claim in an advertisement by
a manufacturer would render the device misbranded if the device reached markets
via a 501(k) clearance); advertisements by neurosurgeons107 for BrainSUITE iMRI
advanced operating room equipment as well as Gliadel chemotherapy wafers for
brain tumors (a consumer doing an internet search on either immediately comes up
with Baylor Medical Center’s press release108 that it is the first in the United States
to acquire GE Healthcare’s MRI surgical suite and MGI Pharma’s advertisement109
for the chemotherapy wafer); advertisements110 by spine surgeons for the PRESTIGE
artificial disc for the neck (also noting it is FDA-approved) and Maverick artificial
lumbar disc replacement; advertisements111 by general surgeons at the Nicholson
Clinic for Obesity Surgery at Baylor Regional Medical Center in Plano for the Johnson
& Johnson Swedish Lap Band bariatric surgery device and advertisements by obstetri-
cian-gynecologists advertising multiple specific manufacturers’ medical devices for
endometrial ablation to treat abnormal uterine bleeding.112 The use of DTC advertis-
ing of particular medical device equipment appears to be most prevalent, and most
competitive, in the world of ophthalmologists, where “promotion is okay.”113 As a
rule, it appears that the only restricted, implantable medical devices being advertised
and promoted to consumers are those for which there are alternatives, particularly
medical alternatives or non-surgical therapies, to use of the device itself.
   All of these physicians and/or their affiliate institutions use their access to restricted
medical device technology to promote their medical/surgical services as integral parts
of their marketing efforts to attract patients. In so doing, it is routine for both the
name of the medical device, as well as the name of the company which developed
the device (and on some occasions the city and state where the medical device manu-
facturer is located), to appear in the medical center or physician advertisement. By
any name, this is surrogate marketing of the medical device by the medical profes-
sion, even if the intention is to market the hospital or the doctor. The name of the
manufacturer sometimes is, but need not be, mentioned along with the name of the
product, though it sometimes is. In the internet age, a consumer reading the adver-
     106
          Id. at 159.
     107
          Id. at 202.
      108
          Imaging Economics Press Release, Baylor University Medical Center First in US to Acquire
Combination BrainSUITE) iMRI and GE Healthcare MR Surgical Suite, (Sept. 29, 2008), available at
http://www.imagingeconomics.com/press_release.asp?id=1021181 (last accessed Oct. 17, 2008).
      109
          MGI Pharma, Products, Gliadel (polifeprosan 20 with carmustine implant) Wafer, available at
http://www.mgipharma.com/wt/page/gliadel (last accessed Oct. 17, 2008).
      110
          D. MAGAZINE, supra note 105, p. 214.
      111
          Id. at 237.
      112
          Id.
      113
          Rundle, Rhonda L., Eye Doctor to Elite Blazes New Trail in Selling Surgery. In a Patient-Pays-All
World, Dr. Maloney Treats Lasik Like a Luxury Product, THE WALL STREET JOURNAL, (Oct. 26, 2004), at A1.
This article highlights the integral role promotion of the latest Lasik (laser-assisted in situ keratomileusis)
equipment to consumers to generate business. “Although insurance almost never pays for it, more Lasik
surgeries are performed every year than nose jobs, face lifts or tummy tucks … including 1.2 million last
year … ‘Promotion is OKAY’, says Bradley Straatsma, chairman emeritus of UCLA’s Jules Stein Eye
Institute. ‘Part of our American medical system is to inform the public of their options and to try to get
information to them that is valid and accurate.’” There was no comment on the lack of complication rates,
and minimization of complications per se, in such advertisements.
22                        Food and Drug Law Journal                                             Vol. 64

tisement is literally only one click away from the medical device company website
once a search on the product name is done. Whether the concomitant marketing of
device and physician/hospital is intentional or one is merely “piggy-backing” on the
other is irrelevant, though one would assume that a hospital or physician could not
name a medical device and its manufacturer by name without either permission to
do so or a specific agreement in place that it actually do so.114
   Another difference between prescription drugs and restricted medical devices in
the role learned intermediaries play in DTCA concerns the active participation of
physicians or hospitals/universities in the actual drafting of the advertisement. In
a depressing commentary on a blurring of roles, a recent study on internet DTCA
of “minimally invasive hip replacement” revealed that the content of the internet
advertisements for such surgery and its accompanying manufacturer’s products were
written by a hospital/university or a private medical group for about 70 percent of
the advertisements.115
   None of this physician or medical center proxy advertising of restricted medical
devices for the respective medical device manufacturer is regulated by FDA because
none of this advertising and promotion is being done directly by the manufacturer.
The regulation of this physician and hospital advertising instead is left to the medical
board of the state in which the ad originated, as well as relevant state laws on decep-
tive trade practices and consumer protection from false advertising claims.116

     1. The Unique Role Surgeons, Hospitals and Academic Medical
        Centers Have In Development of and Reimbursement for
        Restricted Medical Devices
   There is a critical difference between the medical profession-restricted medical
devices industry relationship and medical profession-prescription drug relationship
in that physicians, medical schools and hospital systems may be much more involved
in the development of high-end medical device technology and the marketing of that
technology than they ever would be for pharmaceuticals. This is not to say that some
medical centers have not partnered closely with the pharmaceutical industry in the
clinical testing of new drugs, nor that some institutions such as The National Institutes
of Health (NIH) have not forged stronger ties in translational research.117
     114
           This may be handled through a grant from the manufacturer supporting the advertisements.
     115
           Jaffe, supra note 26. THE ORTHOPEDIC AND DENTAL INDUSTRY NEWS cites a study UCSF Or-
thopedic Surgeon Kevin Bozic did on internet DTCA. “He did a search for ‘minimally invasive hip
replacement’ on three popular search engines, excluded duplicate matches and examined the top 50
sites. A hospital/university or private medical group wrote the content for about 70 percent of the sites,
and of the original 150 sites, 45 percent allowed the reader to make an appointment. When looking at
risks and benefits, 91 percent claimed a shorter recovery time, where as only 13 percent even described
risks. Only nine percent of the sites referenced some peer-review literature.”
       116
           MPA §153.002. For example, in Texas the Medical Practice Act (MPA) provides regulations on
physician advertising and states that physicians may not engage in false, misleading or deceptive adver-
tising not readily subject to verification. These are codified in the Texas Administrative Code, Title 22,
Part 9, Chapter 164 (Physician Advertising, §§ 164.1-164.5). The state law provisions on advertisement
content are more specific, as well as more expansive, than the federal regulatory matrix of statutes and
guidance documents which FDA uses. For example, there cannot be material misrepresentation of fact
or omission of a fact necessary to make the statement as a whole not materially misleading, nor can
there be either representation likely to create an unjustified expectation about the results of a healthcare
service or procedure, testimonials from physicians or patients, or representation that causes confusion
or misunderstanding as to the credentials, education or licensure of a healthcare professional.
       117
           HHS, Moving Medical Innovations Forward—New Initiatives from HHS, FDA Critical Path and
Other Initiatives, (Jan. 2005).
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                            23

   This is still dramatically different from the in-house development of new pharma-
ceuticals, something few if any medical schools and academic medical centers have
the financial or bench laboratory resources for. The medical device industry, however,
is designed around the notion of predicate medical devices, and approvals by CDRH
favor “follow-on” technologies. Academic medical centers, such as the Cleveland
Clinic,118 and their affiliated medical schools with biotechnology programs, have
moved towards bringing medical device technology development by their own doctors
and researchers to market.119 In short, there may be a much greater investment in the
intellectual property of the restricted medical device than there ever would be for a
pharmaceutical,120 particularly for implantable devices for orthopedic and cardiovas-
cular indications. Patients are unlikely to be aware that the relationship between the
medical institution and the cutting-edge medical device technology it is using may not
be arm’s length. Consumers will also be unaware of the financial interest the medical
organization has in particular restricted medical device development, widespread use,
and marketing of medical devices which were developed in-house. This also means
that there is greater potential for conflict of interests between the best interests of
the patient and developing in-house restricted medical device technology which a
healthcare institution has a non-arm’s length financial interest in.121
   This highlights a final difference between prescription drugs and restricted de-
vice advertising involvement of learned intermediaries which concerns financial
incentives for physicians, both for direct-to-physician as well as DTC advertising.
The current payment system between medical device companies and surgeons or
hospitals creates financial incentives to perform the surgery or procedures that
implant the devices. Although physicians presumably act only in their patients’ best
interests, there is no question that surgeons and interventional cardiologists and
radiologists only get paid when they are operating or implanting devices. There
already is a small but growing lay literature questioning the objectivity of physi-
cian “learned intermediaries” in fully informing patients of the risks of implant
surgery122 as well as the skewed nature of monetary incentives showered on promi-
nent surgical groups.123 The only comparable situation for prescription commercial
pharmaceuticals is in medical oncology, where medical oncologists have an incentive
to continue treating patients with expensive chemotherapeutic agents, even near


      118
          Morona, J., Clinic-led heart center commits to $2.90 million in grants, (Sept. 8, 2008), available
at http://blog.cleveland.com/medical_impact/2008/09/clinicled_heart_center_commits/print.html (last
accessed Oct. 6, 2008).
      119
          Pettypiece, Shannon, Clinic spinoffs gain momentum for ‘06, CRAIN’S CLEVELAND BUSINESS,
(Dec. 19, 2005), available at http://www.crainscleveland.com/apps/pbcs.dll/article?AID=/200512219/
SUB/51216024&te (last accessed Oct. 6, 2008).
      120
          MEDICAL DESIGN, Cleveland Clinic Hosts 2005 Medical Innovation Summit, (Oct. 1, 2005),
available at http://www.printthis.clickability.com/pt/cpt?action=cpt&title=Cleveland+Clinic+hosts (last
accessed Oct. 6, 2008).
      121
          Schwitzer, Gary, Univ. of MN School of Journalism & Mass Communication, Health News
Blog, Cleveland Clinic’s Stunning Conflict of Interest Story, (Dec. 12, 2005), available at http://www.
blog.lib.umn.edu/schwitz/healthnews/034015.html (last accessed Oct. 6, 2005). “The Cleveland Clinic
for years has touted a procedure for atrial fibrillation, calling it the ‘AtriCure procedure’… A venture-
capital partnership that the Clinic helped found and invested in owns about 4.1 percent of AtriCure’s
stock … another Clinic surgeon who performs the AtriCure procedure is a paid consultant to the
company … The Clinic did not disclose these ties to AtriCure to patients on whom it performed the
AtriCure procedure.”
      122
          Russell, John, Docs bristle at suggestion of kickbacks,; Feds probe orthopedic surgeons’ fees from
artificial devices makers, INDIANAPOLIS STAR, (Nov. 12, 2007).
      123
          Wall Street Journal Health Blog posting reporting that 40 surgeons or surgical groups each
received at least $1 million in payments from medical device manufacturers in 2007, available at http://
blogs.wsj.com/health/2007/10/31/device-makers-post-payments-to-docs-online/?mod=WSJBlog.
24                       Food and Drug Law Journal                                             Vol. 64

the end of their lives when patients have failed multiple lines of therapy and have
little chance of significant prolongation of life and no chance of cure.124
    The effect of all of these differences is that the physicians and medical institu-
tions act as surrogate advertisers and promoters for some restricted medical devices
for the manufacturers of these products. Presumably, any specific mention of the
manufacturer could only be done with permission, but sometimes the developer of
the technology and the manufacturer is the learned intermediary or affiliated medi-
cal institution. This is not only promotion of a particular device, and sometimes
a particular company, but if the medical institution is prestigious enough, may
create the appearance of the superiority of one device over another. For example,
the Cleveland Clinic publicly announced that of the four drug-coated cardiac stent
manufacturers (Boston Scientific, Johnson & Johnson, Medtronic, and Abbott)
on the market, cardiologists at the Clinic would not be using medical devices from
Boston Scientific.125 Even though the reason for this decision was not necessarily
medical (the prior deal with Boston Scientific had recently expired) and there is a
lack of substantive data directly comparing all of the different drug-eluting stents,
this type of announcement is both positive advertising for three of the manufactur-
ers and negative for one of them. By contrast, no similar announcement restricting
the Cleveland Clinic formulary for anti-cholesterol prescription drugs on the U.S.
market (more than half a dozen are available) was made.

C. There are Significant Limits on Consumer Product Information
   and Comprehension of Restricted Implantable Medical Device
   Advertisements
   DTCA promotion of prescription drugs, and by extension restricted medical de-
vices, is at best an uneasy balance among claimed protection of commercial speech
for manufacturers under the First Amendment, a Supreme Court which generally
favors more information for consumers over restriction of information (even if the
information may be potentially misleading), and an understandable concern on the
part of FDA that advertising be more balanced and educational than misleading
and promotional. Although blatantly false or misleading commercial speech re-
ceives no First Amendment protection,126 potentially misleading information may
be permitted if it is accompanied by a disclaimer even though the value of such
disclaimers, at least in the food and drug arena, is dubious at best.
   Clearly there are more issues at stake here than just lack of regulation of the
medical profession by FDA and limits on FDA jurisdiction over DTCA of select
medical devices. There are serious issues surrounding informed consent, the vulner-
ability of patients in general at the hands of the medical profession when faced with
      124
          Harrington, Sarah Elizabeth & Smith, Thomas J., The Role of Chemotherapy at the End of
Life: “When is Enough, Enough?”, 299 JAMA 2667 (2008). See also Wright, Alexi A., Zhang, Baohui,
Ray, Alaka, et. al., Associations Between End-of-Life Discussions, Patient Mental Health, Medical Care
Near Death, and Caregiver Bereavement Adjustment, 300 JAMA 1665 (2008).
      125
          Kamp, Jon, Cleveland Clinic Foregoes Boston Scientific Stent, THE WALL STREET JOURNAL, (Aug.
13, 2008) at B1, available at http://online.wsj.articles/SB121859886184436023.html?mod=2_1566_leftbox
(last accessed Oct. 18, 2008).
      126
          DANIEL A. FARBER, THE FIRST AMENDMENT (2D ED. (2003)). The current test for regulation of
commercial speech was announced in Central Hudson Gas & Elec. Corp. v. Public Service Comm’n, 447
U.S. 557 (1980). The threshold inquiry which must first be met is whether the regulated speech is false
or misleading, or concerns an illegal activity. If either is the case the speech receives no constitutional
protection.
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                          25

potentially life-threatening conditions, and concerns over consumer vulnerability
and exposure to “medical” information that are too paternalistic. Also, some of the
issues involved in DTCA of select restricted medical devices cannot be separated
from the general problems of over utilization of medical technologies for clinical
conditions equally well treated by lifestyle change instead of a pill or a device, and of
the problems with the way we reimburse physicians and provide incentives for them
to prescribe more drugs and implant more devices in the absence of federal oversight
which assess technology and methodically evaluates cost-benefit. Although a full
exploration of all of these issues is beyond the scope of this article, the fact that
they are concerns at all simply serves to emphasize just how different DTCA of
restricted medical devices is when compared to DTCA of pharmaceuticals.
   The “safety valve” and default protection for manufacturers for DTC advertis-
ing for any medical product is the learned intermediary doctrine.127 Even within
the confines of printed advertisements, which generally allow manufacturers to
potentially convey more, and more balanced, safety and efficacy information to
consumers than short broadcast advertisements on television and radio, all parties
concerned predicate their content on the understanding that consumers will seek
additional information about the product from their physicians—the “learned
intermediaries”—who are generally held responsible for this information because
they are responsible for knowing the contents of the FDA-approved label and
(presumably) have both read it and understood it.
   This approach may work, with some difficulties, for DTCA of prescription drugs,
but there are problems when it is applied to DTCA of restricted medical devices
even if one ignores the greater financial incentives, greater development role, and
greater promotional role which learned intermediaries have for restricted medical
devices just described. There are other reasons why the learned intermediary is a
less viable source of information for consumer; these reasons revolve around several
basic facts: 1) consumers often may not know as much about medical devices and
the surgical procedures involved in their implantation as they do about prescrip-
tion drugs;128 2) the “learned intermediary” from whom they would need to obtain
meaningful and balanced information is not the primary care physician (internist,
family practitioner, even obstetrician-gynecologist) who normally provides infor-
mation, but rather is another physician at least one degree of separation away to
whom they would have to be referred and who, in the absence of a referral, they
are unlikely to be able to call directly; 3) primary care physicians are likely more
limited in knowledge about medical devices, the surgical procedures involved in
their use, labeling information about the device and are more constrained in their
ability to obtain such information because there is no equivalent compendium
      127
          The phrase “learned intermediary” was coined in Sterling Drug, Inc. v. Cornish 370 F.2d 82, 85
(8th Cir. (1966)). The doctrine holds, at least as far as pharmaceuticals are concerned, that a prescrip-
tion drug manufacturer takes care of its duty to warn the eventual user of its drug product’s risks by
supplying physicians with information about the drug. Prescribing physicians are expected to know
about potential dangers from a drug’s use by being familiar with the FDA-approved label, package
inserts, and are presumed to be in the best position to provide individualized warnings to a particular
patient based on knowledge about the individual patient’s medical condition and whether the drug is
suitable for him/her.
      128
          There will be exceptions to this statement of course, with limitations. The mechanism of ac-
tion of some implantable devices such as an artificial hip or knee may be easier to understand than
the complex pharmacology of some pharmaceuticals such as SSRI’s. Despite this, it may be easier for
consumers to understand the side effects of a drug (even if they do not understand the mechanism
of action of a drug) than to appreciate the risks of surgical implantation and the complexities of de-
vice-related surgery, items which are essential to the understanding of the safety profile of restricted,
implanted medical devices.
26                        Food and Drug Law Journal                                             Vol. 64

of labels for medical devices, such as the Physicians’ Desk Reference (PDR)129 for
prescription and over-the-counter drugs; and lastly 4) critical safety data for im-
planted, restricted medical devices is not independent of the learned intermediary
itself,130 unlike adverse event data for pharmaceuticals. One cannot present vital
safety information about the risks and complications of some medical devices in
a vacuum, independent of performance information on the learned intermediary
himself (or herself), and their affiliate medical institutions.

     1. Limitations on Consumer Knowledge
   Consumers cannot know enough about restricted medical device safety and efficacy
issues which arise from any printed or broadcast advertisement, at least compared
to what they know or might know about pharmaceuticals, because of the nature of
the information required to understand an implantable restricted medical device in a
meaningful way. This needed information is not only just medical, but is also surgical
and in some cases engineering. Consumers (and many physicians) are likely unaware
of this, and have little or no idea that some potentially dangerous medical devices or
equipment may have been approved for marketing without any independent, con-
firmatory safety or efficacy information being submitted to the agency at all.131 Not
only are consumers unaware of the entire predicate medical device-510(k) clearance
aspect of restricted medical device approval, consumers may also be unaware that
the device being promoted to them may have not been compared a predicate medi-
cal device that is the gold standard medical device, or that the device on which the
comparative safety and efficacy information is based is no longer very similar to the
restricted device they are going to be exposed to. If for no other reason, it is impos-
sible for a DTCA for some restricted medical devices to have fair balance of risk
information.132 Insofar as the referenced Cypher coronary artery direct to consumer
television broadcast ad is concerned, there is no reasonable way that the risk infor-
mation presented could approach the brief summary requirement that each specific
side effect and contraindication be presented to the viewing consumer.
   The average health consumer watching a DTCA for a restricted medical device
may have an inherently more complicated decision tree than he or she does for a
prescription drug advertisement for medical conditions which have medical and well
as surgical therapies.133 This makes any brief statement or equivalent included in the
advertisement more brief, and the information inherently less fairly balanced. For a
consumer with a medical condition such as high cholesterol or high blood pressure
      129
          PHYSICIANS’ DESK REFERENCE (62nd Ed. (2008)). The PDR is a compilation of pharmaceutical
manufacturers’ prescribing information (drug labels included as a package insert). The PDR is updated
annually, is available online, and though not an official medical publication (it is supported in large part
by the pharmaceutical industry) it is an indispensable tool for office-based medical practice.
      130
          Patients rely on the ability of their physicians to practice good medical practice, both in pre-
scribing and monitoring medications correctly as well as implanting medical devices. There are different
degrees of dependence.
      131
          In this set of circumstances, consumers would actually have to identify the predicate medical
device and find the safety and efficacy information for that device, assuming they were aware of the
predicate medical device issue at all.
      132
          Drugs are usually not compared against other drugs in clinical trials unless the goal of the
study is to enable the manufacturer to make a superiority claim. Restricted implanted medical devices
which obtain 510(k) clearance, on the other hand, are always compared to the predicate device.
      133
          There clearly are some medical conditions (e.g., a cerebral aneurysm) which can only be treated
surgically and for which no medical therapy is available. Even if these surgical treatment-only conditions
are treated with restricted, implantable medical devices, such devices are not generally directly-advertised
to consumers, in part because there is no drug treatment alternative, as there is for coronary artery
disease or a knee replacement.
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                          27

only, the decision matrix is do nothing, lifestyle change only, lifestyle change plus
drug, life style change plus alternative drug, or life style change plus combination
of drugs. For a patient with high-cholesterol or high-blood pressure who may
or may not have underlying coronary artery disease and to whom recent DTCA
coronary artery stent device ads have been targeted, the decision tree necessarily
involves all of the decisions which have to be made for drug therapy alone (since
that is one of the alternatives to the medical device) as well as deciding about the
advertised device, alternative medical devices (there are at least three others on the
market, some plain metal and some drug-eluting), or using both medical therapy
and the device.
   The consumer medical device decision is thus inherently more complicated
because restricted medical devices are more likely to be used in patients who are
already on medical therapy, not being managed optimally on medical therapy, or
who are more likely to be symptomatic. In the latter situations DTCA ads for medi-
cal devices do not have the same function as prescription drug advertisements for
asymptomatic individuals who may not be aware they have a disease at all. Most
individuals on the receiving end of implantable, restricted medical devices are aware
of their diseases, are more likely to have already had medical therapy, and to make
a balanced decision would need to be knowledgeable enough to compare medical
data on medical therapy versus surgical therapy. Medical device ads rarely, if ever,
discuss medical therapy alone as a meaningful alternative to use of the restricted
device, and certainly do not go into the surgical complications which might occur
as a result of device implantation. Even if they did, the learned intermediary they
would first be calling is not a surgeon or an interventional cardiologist.
   The little formal investigation into consumer comprehension of DTCA of re-
stricted medical devices would seem to confirm all of these concerns.134 Evaluation
of advertisements for a group of implantable medical devices (coronary artery
stents, knee and hip joint replacements, implantable defibrillators, breast implants)
revealed an absence of risk information in many advertisements, heavy reliance
on patient “testimony” as to the merits of the device, and consistent reporting of
twice as many benefits as risks, consistent with the same pattern seen in DTCA
of prescription drug advertisements.135 Because consumers are not used to seeing
advertisements for restricted medical devices, particularly implantable ones, and
have no information framework for understanding such advertisements, they lack
the reference point of other advertisements for comparison. The consumer market
may be more targeted for a restricted medical device advertisement (middle-aged
men watching football on television are the perfect audience for a medical device
used in individuals who either have or are at risk for coronary artery disease), but
most consumers are not knowledgeable enough to know if they are appropriate
candidates. This is more of a problem for a device than a prescription drug because
the use of restricted devices often follows use of prescription drug therapies.
   Lastly, the statement “Talk to your doctor” which appears in all print, television
and internet advertisements for drugs, and in the few for devices, is simply not as re-
alistic where medical devices are concerned. Which physician should the patient talk
to? Many restricted devices are used by physicians to whom patients are going to be
     134
         Day, Ruth S., Direct-to-Consumer Ads for Medical Devices: What Do People Understand and
Remember? Testimony at Hearing before the Senate Special Committee on Aging, 110TH CONGRESS,
(Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed
Sept. 30, 2008).
     135
         Id. “Overall, risk information is seriously disadvantaged relative to benefits in medical device
ads-the techniques used to present them often render them lower in cognitive accessibility.”
28                  Food and Drug Law Journal                               Vol. 64

referred by other physicians, and who will not spend, as a rule, nearly as much time
explaining things to patients. It is not the same as for drugs, where therapy is being
prescribed by a general internist, internal medical sub-specialist (e.g., oncologist,
cardiologist), family practitioner or other primary care practitioner. In the absence
of any substantive, good data on consumer comprehension of restricted, implanted
medical device advertisements, the presumed education benefits of DTCA for such
devices claimed by their manufacturers must at present be speculative.

     2. Learned Intermediaries May Be Less Learned or Less Arm’s
        Length from the Medical Device Industry
   The safeguards and required information which are inherent in DTC broadcast
advertising for prescription drugs (the “talk to your doctor” statement, an 800
number for consumers to call, a website about the product to go to on the inter-
net) are less meaningful in the restricted medical device context. The net result
must be that the device information must be less interpretable and educational for
consumers. Most physicians do not have an engineering background and primary
care physicians are neither surgeons nor internists who perform the interventional
procedures using implantable restricted medical devices such as coronary artery
stents. The first source of medical information for the consumer is going to be a
primary care physician, but for restricted, implantable medical devices he or she
will not be the best source. The most knowledgeable medical person would be the
surgeon or interventional cardiologist to whom the consumer would have to be
referred by the primary care physician. This is not the person whom the advertise-
ments tell the consumer to consult, if the DTCA tells the consumer exactly who
they should talk to at all.
   Primary care physicians are unlikely to understand the critical engineering and
safety aspects of restricted implantable medical devices, and will understand less
about of the fundamentals of the device and the surgery involved in its placement,
than they will understand about the fundamentals of a drug they might prescribe.
In all likelihood they do not know the surgical literature on an implanted, restricted
medical device, or that for alternative devices, well enough to counsel a patient with
a safety or efficacy question about the restricted device the patient saw advertised.
This situation is made unavoidable because of the extensive, essential engineer-
ing (electrical, mechanical, other) data submitted during the approval process for
restricted medical devices if the device’s marketing application was a PMA, the
absence of this information if the device were marketed through a 510(k) clearance,
and the surgical nature of many restricted medical devices.
   Because of these learned intermediary knowledge limitations, the entire notion
of DTC advertising for restricted medical devices is inherently more problematic
for devices than it is for prescription drugs. Most medical professionals are inher-
ently less learned on surgical and implantable devices than they are about pharma-
ceuticals. The situation is further aggravated by the absence of a readily available,
comprehensive PDR-equivalent desk reference for medical devices to serve as
a ready compendium of labeling information for restricted devices. This results
in a dramatic difference in the amount of standardized information available to
consumers and physicians alike. Even if surgeons and interventional cardiologists
and radiologists were willing to talk to patients prior to a referral for a procedure,
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                            29

there is no guarantee that they will have actually read the medical device label, or
if they read it follow the instructions.136
   Ironically, all of this should make a learned intermediary defense offered by
restricted medical device manufacturers for tort actions against them in state court
less reliable than when it is offered by pharmaceutical manufacturers. The opposite
is the case. Because of the express preemption protection for manufacturers of
some restricted medical devices affirmed in the recent Riegel v. Medtronic137 deci-
sion under the preemption clause of the 1976 Medical Device Amendment to the
1938 FDCA, at the end of the day only physicians can be sued for tort damages
for injuries from some of the most dangerous and complicated medical devices on
the market. The pending Wyeth v. Levine138 decision in the prescription drug arena
will also likely leave learned intermediaries as the only ones standing without a
chair when consumers are injured by pharmaceuticals they sought out because of
advertisements for the products in print and on television.

     3. The safety calculus is broader and requisite safety information
        different for restricted medical devices. The data shows that
        device ads are more likely to omit important safety information.
   The results of the first of the two studies139 of the actual risk-benefit content of
direct-to-consumer advertisements for restricted, implantable medical devices (such
as total knee replacement or TKR) and consumer comprehension of the same were
not encouraging. In general, implanted medical device ads minimized or omitted
significant safety information140 and consumers were twice as likely to remember
benefit information than risk information. In the context of a procedure such as
TKR, where the morbidity and mortality for a procedure that is performed more
than 600,000 times a year worldwide are both relatively common,141 and a major
contributor to rising healthcare costs,142 this data on poor consumer comprehen-
sion, and deficient safety content of advertisements, should give FDA and Congress
pause. In the context of what is now aggressive promotion directly to consumers,
the lack of important, balanced safety information is both an unacceptable and a
direct challenge to the public health mission of FDA itself.
      136
          This was exactly what happened in Riegel v. Medtronic, Inc. Although the medical device manu-
facturer was sued, the interventional cardiologist who used the inflatable coronary artery balloon failed
to follow the specific instructions in the device label for either patient eligibility or balloon inflation
pressures.
      137
          Riegel v. Medtronic, 552 U.S.__ (2008).
      138
          Wyeth v. Diana Levine, No. 06-1249 U.S. Supreme Court (2008).
      139
          Aikin, Kathryn J., DDMAC, FDA, Attitude and Behaviors Associated with Direct-to-Consumer
Advertising of Prescription Drugs: Summary of Survey Results, FDA Scientific Rounds, (Mar. 30, 2005),
available at http://www.cdernet.cder.fda.gov/dtd/Rounds/Fall04/bg3-30.htm (last accessed Mar. 30,
2005).
      140
          Id.
      141
          Soohoo, Nelson F., Lieberman, Jay R., Ko, Clifford Y. & Zingmond, David, Factors predicting
complication rates following total knee replacement, 88(3) J. BONE JOINT SURG. AM. 480 (2006). Between
1991 and 2001 a study was performed on the 222,684 cases of TKR in California: 1,176 deaths (0.53
percent), 1,586 infections (.71 percent), and 914 pulmonary emboli (0.41 percent), with worse figures
in elderly patients with co-morbid conditions or when surgeries were performed in institutions with
lower surgical volumes.
      142
          Statement of Kevin J. Bozic, MD, MBA, at Hearing before the Senate Special Committee on
Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.
cfm?id=303085 (last accessed Sept. 30, 2008). [hereafter Bozie statement]. “A ten percent decrease in
the number of revision hip and knee arthroplasties in 2005 would have saved the Centers for Medicare
and Medicaid Services (CMS) over $100 million that year.” [hereafter Bozic statement].
30                        Food and Drug Law Journal                                              Vol. 64

   The second and only other well-designed study143 was by a large group of ortho-
pedic surgeons who examined the impact of DTCA in their specialty. The results of
this study confirmed the limitations of essential safety information consumers get in
DTCA advertisements for implanted medical devices, and noted further problems
with the advertisements not mentioned in other studies. The orthopedic surgeons
found that the advertisements do not inform patients about differences in product
design, composition of materials, strength of the devices, proper clinical indications
or the need for and frequency of requisite replacement.144 Investigators pointed out
that individual surgeon group, and hospital, variations in infection rates, anesthetic
complications, or mortality rates related to implanted medical restricted medical
device use were absent from DTCA for these orthopedic devices. The same could
be said for the advertisements for coronary artery stents.
   This data highlights another critical difference between prescription drug and
restricted medical device advertising on product safety. For prescription drugs the
adverse events and critical safety information are more independent of the actions
of the practitioner, in the sense that a prescribed drug’s adverse events and critical
safety information about the drug are actions independent of which physician is
prescribing it.145 For restricted medical devices (particularly implanted restricted
medical devices such as spinal bone replacements, TKR, or coronary artery stents)
the exact opposite is the case. The safety issues and critical safety information for
restricted medical devices is broader than it is for prescription drugs. The critical
safety information a consumer would need about use of a restricted implanted medi-
cal device is a direct function of both the institution in which the surgery is taking
place, and the skill and experience of the surgeon or interventional cardiologist.
In an absolute sense, restricted medical device safety information is tied directly to
the learned intermediary in a manner in which it is not for drugs.
   Restricted medical device safety information is thus a function of all of the issues
surrounding pay for performance146 and not paying for medical errors,147 particularly
infectious complications following orthopedic and cardiac surgery. A consumer
viewing a DTCA for a restricted medical device cannot possibly make an intel-
      143
          Bozic, Kevin J., Smith, A.R. & Hariri, S., et. al., The Impact of Direct-to-Consumer Advertising
in Orthopedics, 5 CLIN ORTHOP RELAT. RES. 458 (2007).
      144
          Id. The recent travails of New England Patriots quarterback Tom Brady highlight this point.
At the time of this writing ABC Nightly News on Friday, Oct. 24, 2008 noted that Mr. Brady was
about to undergo his second surgery to treat infectious complications of his recent knee surgery, with
the potential of long-term loss of function. Printed advertisements for surgical groups for orthopedic
implant procedures never mention the possibility of infectious complications, and more importantly,
never provide their own infectious morbidity or complication rate in advertisements to consumers, thus
omitting perhaps the most critical information a consumer would need in order to make an educated
decision about such surgery or a restricted medical device such as a TKR.
      145
          Again, as noted, physicians can prescribe drugs or monitor drug therapy negligently. Even so,
safety data on individual surgeons, and hospital, complication data for implantable restricted devices
may be more accessible than data on physician medication-related complications. The recent initiatives
on pay-for-performance will almost certainly guarantee that more data will be available for consumers
on hospital and individual surgeon complication rates and experience than there will be for primary care
physicians who provide non-surgical therapies. See Bruce Patsner, Preventable Hospital-Acquired Errors:
Lowering Costs by Refusing to Pay, HEALTH LAW PERSPECTIVES (June 2008), Univ. of Houston Law Center,
available at http;//www.law.uh.edu/healthlaw/perspectives/homepage.asp (last accessed Jan. 14, 2009).
      146
          Mitka, Mike, Public, Private Insurers Refusing to Pay Hospitals for Costs of Avoidable Errors,
299 JAMA 2495 (2008).
      147
          Rosenthal, Meredith B., Nonpayment for Performance? Medicare’s New Reimbursement Rule,
357 N. ENGL. J. MED. 1573 (2007). Five of the eight “never events” (object left in patient during surgery,
air embolism, catheter-associated urinary tract infection, vascular-catheter-associated infection, and
mediastinitis after coronary-artery bypass grafting) are occurrences directly or indirectly related to use of
restricted medical devices. There is enormous public pressure for consumers to know the safety “report
card” for institutions, and for surgeons. This information is precisely the type of safety information
which should accompany certain restricted, implantable device promotions yet rarely if ever does.
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                        31

ligent and accurate viewing or decision about the device in the absence of specific
hospital and surgeon/surgical group morbidity and mortality data. This is precisely
the type of data which is rarely, if ever, provided during restricted, implantable
medical device advertisements.148 The device and the device ad cannot be divorced
from the learned intermediary in general, and in particular the one promoting it.
This is simply not the case with promotions for prescription drugs, where the drug
side effects are largely independent of the physician prescribing.
   There are other critical differences between DTCA of prescription drugs and
restricted medical devices on the issue of safety and learned intermediaries. Surveys
indicate that most internists do not believe that the majority of DTCA advertise-
ments for drugs are misleading; the same cannot be said for surgeons.149 Medical
devices fail, and need to be replaced, in a manner which does not apply to drugs.
Even if this event were completely independent of the institution where the sur-
gery was performed as well as the surgeon (which is not the case), this is another
bit of critical information a consumer viewing a DTCA would need to have for
the promotion to be both educational and balanced on risks. Yet this information
never appears in advertisements for restricted, implantable medical devices such as
coronary artery stents or artificial joint replacements. Lastly, the differences in the
ways devices are approved compared to drugs touch directly on the issue of safety.
Medical device trials can be based on bench data, data for a predicate device which
may be several generations earlier and several degrees of separation in similarity, or
based on a predicate device which need not be the best device in that class. Admit-
tedly, this is not an issue for the most cutting-edge Class III restricted, implantable
medical devices without a predicate device and approved via a PMA, but it is a
viable issue and concern for some. Consumers are unaware and uninformed about
these critical safety data concerns as well.

D. FDA Enforcement Options Are Limited for DTCA of Restricted
   Medical Devices.
   The Office of Compliance at CDRH is the department responsible for monitor-
ing advertising and promotion of medical devices by manufacturers to ensure that
the information is not false or misleading. The tools available to FDA to enforce
statutory rules and guidelines for DTCA of restricted medical devices against manu-
facturers are limited and, from a practical point of view, of relatively little value.
Between the warning letter and the injunction there is no effective intermediate
mechanism (such as the ability to impose a civil monetary penalty on infractions)
that will have any meaningful chance of rapidly impacting the sponsor’s advertising
cycle in a significant way. Absent a demonstrable risk to public safety, it is virtu-
ally impossible for FDA to take severe disciplinary action against a medical device
manufacturer. The end result of this paucity of remedies against false advertising
effectively limits FDA to only issuing warning letters to the manufacturers. There
is no evidence that FDA’s meeting with a sponsor, the only other enforcement tool
FDA uses, has any real value. Warning letters are simply that: a warning, and one
which may be ignored temporarily while the false or misleading advertisement
cycle continues to run.
   In the recent (September 2008) Congressional hearings on restricted medical
device DTC advertising, the only speaker who specifically stated that the current
enforcement system was perfectly adequate was Mr. Stephen Ubl, the representa-
    148
          Bozic, supra note 142.
    149
          Id.
32                       Food and Drug Law Journal                                            Vol. 64

tive from Advanced Medical Technology Association (AdvaMed), an association
which represents over 1,600 manufacturers of medical devices.150 Ironically, Mr.
Ubl’s comment151 that there was a relatively short 18-24 month lifecycle of some
innovative, restricted medical device products compared to that for pharmaceuti-
cals only served to magnify the significance of any delay on FDA’s part in sending
warning letters to manufacturers about their DTCA campaigns.
   Follow-up comments152 at the same Congressional hearing by Daniel Schulz, MD,
Director of CDRH, failed to specifically address whether current enforcement tools
available to FDA were adequate despite the fact that that very issue was one of the
topics the conference was supposed to address. Dr. Schulz instead focused almost
exclusively on FDA surveillance and enforcement activities relating to promotion
of off-label uses of medical devices to physicians. No specific comments were made
on the level of enforcement activity in the area of DTCA either.
   FDA does not regulate the practice of medicine, nor does it regulate hospital ad-
vertising practice. FDA’s ability to regulate surrogate advertising and promotion of
restricted medical devices by hospitals, physicians or surgical groups and academic
medical centers/ cancer centers is nonexistent. As noted in section V, regulation
of physician advertising is regulated by individual state regulations, administered
through the oversight of the individual state medical board. State laws on physi-
cian advertising vary from state to state, and for this reason there is no guaranteed,
uniform approach to surrogate DTCA of restricted medical devices by physicians.
No formal administrative bridge exists between FDA and state medical boards to
address this problem.

  VI. RECENT PUBLIC HEARINGS BY FDA ON DTCA OF RESTRICTED
                       MEDICAL DEVICES
   All of the discussion thus far on the significant differences between restricted
medical device and prescription drug DTC advertising strongly suggests that the
current regulatory approach by FDA on DTC advertising and promotion of re-
stricted, implantable medical devices is not adequate. FDA has been aware of the
controversy surrounding DTC advertising of its approved medical products for
more than a decade, particularly since the bruising legal battles with the Washing-
ton Legal Foundation,153 although virtually all of the controversy, until recently,
has concerned DTCA of prescription and over-the-counter drug products. This
may now be changing.
   The most recent FDA activity on DTCA relating to restricted medical devices
was a “Public Hearing on Direct-to-Consumer Promotion of Medical Products”


      150
          Statement by Stephen J. Ubl, President & CEO, AdvaMed at Marketing or Medicine: Are Di-
rect-to-Consumer Medical Device Ads Playing Doctor?: Hearing before the Senate Special Committee
on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.aging.senate.gov/hearing_detail.
cfm?id=303085 (last accessed Sept. 30, 2008).[hereafter Ubl statement].
      151
          Id. “A Federal requirement for a moratorium for DTC advertising of medical devices would ignore
the unique nature of our industry. Most medical devices have a lifecycle of 18 to 24 months and many
of our industry’s technologies are new devices that provide relief for patients who suffer from conditions
that currently have no treatment.” The latter statement cannot be correct if most of these devices reach
market via 510(k) clearance since this means that a predicate device must already be on the market.
      152
          Schultz statement, supra note 55.
      153
          Washington Legal Foundation v. Henney, 128 F.Supp. 2d 11 (D.D.C. (2000)). “… after six
years; worth of briefs, motions, opinions, Congressional acts, and more opinions, the issue remains 100
percent unresolved, and the country’s drug manufacturers are still without clear guidance as to their
permissible conduct.”
2009      DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                               33

held in Washington, D.C. on November 1, 2005.154 A wide range of experts from
government, academia and industry met for two days to present their data, help
FDA formulate policy, and discuss a series of questions FDA posed to the panel-
ists. The six questions were: 1) Does current DTC promotion present the benefits
and risks of using medical products in an accurate, non-misleading, balanced
and understandable way? 2) Could changes in certain required prescription drug
disclosures—the package insert for print “promotional” labeling and the brief
summary for print advertisements—improve the usefulness of the information
for consumers?; 3) Could changes in the requirements for disclosure of certain
information in broadcast advertising improve the usefulness of this information
for consumers?; 4) As new communication technologies emerge, they create oppor-
tunities for novel approaches to DTC promotion. What issues should the agency
consider with regard to the effect of these technologies on DTC promotion?; 5)
What action should FDA take when companies disseminate violative promotional
materials to consumers?; and 6) Does current DTC promotion present the benefits
and risks of using medical products in an accurate, non-misleading, balanced and
understandable way? It is important to note that the questions FDA posed to the
panelists and speakers referred collectively to “medical products,” inherently lump-
ing drugs and devices together as if the answers for one (drugs) would naturally
apply to the other (devices).
   The 2005 conference had 38 presentations of which 20 were slide presentations.
Of these 20 only one—by Marlene K. Tandy, a Senior Counsel at Johnson & John-
son—was specifically asked about DTCA of medical devices.155 Of the 442 slides
presented at the Public Hearing on DTCA of medical products, only six were spe-
cifically on DTCA of restricted medical devices. Everything else concerned DTCA
of prescription drugs, as were virtually all of the policy recommendations of all of
the speakers. With the exception of the Tandy presentation, not one of the other
speakers addressed any of the six fundamental questions posited by FDA at the start
of the conference specifically in terms of DTCA of restricted medical devices.
   In addressing the six questions specifically in the context of restricted medical
devices, Ms. Tandy stated that in her opinion, existing statutory requirements
were sufficient for DTCA advertisements to communicate to consumers the ap-
propriate, relevant information for the device being advertised, device-specific
advertisements did disclose adequate and relevant safety information and exist-
ing FDA enforcement action is sufficient and legal authority adequate.156 Given
her position as a representative of the major trade organization that represented
medical device manufacturers’ advertising interests, this statement was no surprise.
Nor was it surprising that no substantive data was provided to support either of
her contentions;157 there is in fact no current substantive data to support any of
industry’s contentions on the adequacy or comprehensibility of DTC advertise-
ments for restricted medical devices. Also not surprisingly, Ms. Tandy noted that
pre-review of DTC advertisements by FDA should be an option, not mandatory,
though acknowledging that there was a need for FDA guidance to address the issue
of presenting technical information in language which was consumer-friendly.158
She also correctly pointed out that CDRH would need a substantial increase in
personnel, as well as a new system in place, if it were going to attempt to review
    154
         Public Hearing on DTC Promotion of Medical Products, Wash., DC, (Nov. 1-2, 2005).
    155
         Marlene K. Tandy, MD, JD, Co-Chair, AdvaMed Advertising and Promotion Working Group,
Senior Counsel, Johnson & Johnson, Presentation at FDA Public Hearing on Consumer-Directed
Promotion of Regulated Medical Products, (Nov. 1, 2005). [hereafter Tandy statement].
     156
         Id.
     157
         Id.
     158
         Id.
34                       Food and Drug Law Journal                                             Vol. 64

DTC advertisements prior to either restricted medical device approval or at the
time of publication or broadcast.159
   Insofar as DTCA of restricted medical devices is concerned, the question FDA
did not ask at this conference, should have asked and should now be asking is
whether the answers to the six questions it posed at the 2005 conference are the
same for restricted medical devices as they are for prescription drugs. The answer,
based on the data and concerns discussed in this paper, is no. The baseline fund of
knowledge an adult consumer would be required to have to correctly comprehend
a 30-60 second television ad for a restricted medical device such as a coronary ar-
tery stent is greater than the amount needed to for that of a drug to treat the same
condition, and in all likelihood is beyond most viewers.160 The limited amount of
time allotted to these expensive ads, the complicated nature of both the medical
condition being treated and its technological “fix,” and the absence of critical safety
information on and for learned intermediaries essentially eliminates the ability to
present necessary risk and benefit ratio in either a meaningful or fairly balanced
way. There are no data thus far which suggest that manufacturers of restricted,
implanted medical devices are presenting risk data in a balanced way, if data are
provided in advertisements at all. On the physician side the individual possessing
this expertise might not even be the consumer’s primary care physician but rather
a physician to whom the patient’s primary source of medical information would
refer him/her; primary care physicians also lack an organized guide of restricted
medical device approved labels to consult for patients on appropriate risks and
indications for the device, as they do for prescription drugs.

       VII. RECENT CONGRESSIONAL AWARENESS OF THE POTENTIAL
         PROBLEM OF DTCA FOR SOME RESTRICTED, IMPLANTED
         MEDICAL DEVICES IS AN ENCOURAGING DEVELOPMENT

A. Congress is clearly concerned that DTCA for restricted medical
   devices is inherently less educational, more promotional, poten-
   tially more misleading and subject to less oversight by FDA than
   DTCA is for drugs.
   DTC advertising of medical devices made the official Congressional radar
screen in September, 2008 in a hearing before the Senate Special Committee on
Aging161 convened by Senators Herb Kohl (D-WI) and Gordon H. Smith (R-OR)
as part of an on-going 15-month series of oversight hearings on medical device
and pharmaceutical marketing. The purpose of the committee meeting was to hear
testimony from representatives from the medical device industry, physician-surgeons
with expertise in medical device advertising, consumer groups, advertising groups,
CDRH/FDA representatives, as well as academics with extensive clinical research
     159
          Id.
     160
          Most of these restricted medical device ads for implanted medical devices would be incompre-
hensible to most Americans if they really did attempt to discuss safety in a meaningful way; studies have
shown that the American public, on average, reads at an eighth grade level. See Kunter Greenberg, M.,
Jin Y., E., et.al., Literacy in Everyday Life: Results from the 2003 National Assessment of Adult Literacy,
(Apr. 2007). United States Department of Education, NCES 2007-480.
      161
          Marketing or Medicine: Are Direct-to-Consumer Medical Device Ads Playing Doctor?: Hearing
before the Senate Special Committee on Aging, 110TH CONGRESS, (Sept. 17, 2008), available at http://www.
aging.senate.gov/hearing_detail.cfm?id=303085 (last accessed Sept. 30, 2008).
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                        35

experience in consumer comprehension of medical product advertisements in or-
der to determine whether appropriate risk and safety information about restricted
medical devices is being provided to consumers, particularly the elderly.
   The Special Committee appeared acutely aware of the fact that direct to con-
sumer advertising of restricted medical devices, particularly restricted implanted
devices such as coronary artery stents and artificial knees, is a growing but recent
phenomenon and one which had yet to be highly scrutinized.162 With the exception
of testimony from the representative of the medical device advertising industry,163
virtually all of the speakers emphasized the glaring deficiencies in safety risk infor-
mation, and comprehension of such information, for consumers viewing DTCA
of restricted, particularly implanted, medical devices. The testimony confirmed
the general impression of most surgeons that most patients do not understand the
safety risk information they view or are able to determine whether they are suit-
able candidates for the device.164 One of the physicians who testified was the first
speaker to point out in a Congressional hearing the entrepreneurial relationship
physicians are more likely to have with medical device manufacturers compared to
pharmaceutical companies, and the role of medical device technology in hospital
and surgical group marketing efforts.165
   The Senate hearing reviewed the television ad campaign for Johnson & John-
son/Cordis’s Cypher sirolimus-eluting stent and replayed the television ad in its
entirety. Despite the comment by an aide to Senator Kohl that the advertisement was
reviewed and okayed after edits by CDRH before its release166 (and a conspicuous
absence of comment on this point by CDRH Head Daniel Schultz, MD), William
E. Boden, chief of cardiology at Buffalo General Hospital, was highly critical
of the device advertisement, noting that it had “crossed the line” because “the
decision to employ a coronary artery stent required “a very sophisticated medical
understanding” which few, if any, members of the lay public would have before or
after viewing such an advertisement.167
   Some of the Congressional testimony on DTCA of restricted medical devices
was predictable and some disappointing. The testimony168 by Stephen J. Ubl,
President and CEO of the trade association which represents the advertising in-
terests of many medical device manufacturers predictably advocated no change in
the current way DTCA of restricted implantable medical devices is regulated by
FDA, while at the same time listing some of the ways these medical devices were
different and more complicated than pharmaceuticals. Mr. Ubl repetitively stated
the mantra that advertisements to consumers are educational, yet provided no data
to demonstrate that this is so for such devices, while at the same time pointed out
how much more complicated devices and their requisite surgery are than pharma-
ceuticals (“the idea that a patient would decide to undergo complex and invasive
procedures based on an advertisement, or that a physician would agree to perform

     162
         Opening Statement of Senator Herb Kohl, Special Committee on Aging Hearing, Marketing
or Medicine: Are DTC Medical Device Advertisements Playing Doctor?, (Sept. 17, 2008).
     163
         Ubl statement, supra note 150.
     164
         Bozic statement, supra note 142.
     165
         Id.
     166
         [THE GRAY SHEET], Senate Explores Restrictions on Direct-To-Consumer Devices Ads, (Sept. 22,
2008), available at http://www.medicaldevicestoday.com/2008/09/senate-explores.html (last accessed Oct.
27, 2008).
     167
         Boden, supra note 28.
     168
         Ubl statement, supra note 150.
36                       Food and Drug Law Journal                                            Vol. 64

them, is difficult to imagine.”)169 All of this seemed inherently contradictory: if the
surgery and the devices are so complex and difficult to understand, why attempt
to promote them to consumers at all, given the well-known problems consumers
already have with DTCA of drugs which are not so complicated? It would be one
thing if the advertisements were only about specific conditions, such as arthritis,
since a claim could then be made that the advertisement is educational, (i.e., it is a
disease-awareness advertisement). But there is little controversy over disease aware-
ness advertisements, FDA has no jurisdiction over such advertisements, and such
advertisements do not increase market share for a device, which is why nearly all
of the advertisements are device-specific.170
   The testimony by Daniel Schultz, Director of CDRH, was remarkable for what it
did not say.171 Dr. Schultz provided an overview of basic medical device regulation-
classification of devices, how devices become restricted, the two draft guidance FDA
issued on restricted medical device advertising and promotion, and reviewed some,
but not all, of the differences between regulation of drugs and restricted medical
devices by FDA. All of the comments on enforcement, however, concerned adver-
tising and promotion of restricted medical devices by manufacturers to physicians,
not consumers, and the examples cited concerned off-label use of biliary stents,
not on-label use of coronary artery stents. More importantly, no recommendations
for reforming FDA’s current approach, or any possible limitations on protecting
consumers from false or misleading restricted medical device advertising due to
FDA’s current lack of specific guidance and lack of premarketing advertisement
evaluation were noted.172
   The Senate hearings occurred during the same month that Senator Charles Grassley
(R-IA) was continuing his probe173 into the business relationship between the medical
device maker Medtronic and multiple orthopedic surgical groups which used their
spinal surgery devices. Allegations of kickbacks and financial and other incentives
between Medtronic and unnamed surgical groups over promotion of use of spinal
devices and off-label use of Medtronic bone grafts formed the basis of several qui
tam lawsuits by former employees of Medtronic. One of these suits resulted in a $40
million private settlement agreement between the federal government and Medtron-
ic.174 Medtronic now claims that since 2004 it has overhauled its code of conduct for
relations with surgeons who use its products, though Senate hearings are ongoing to
determine if corporate and physician misconduct has persisted.


     169
          Id.
     170
          Id. The statement by Mr. Ubl touted the potential educational benefits of device advertise-
ments yet provided no data. The data that was provided at the Congressional hearing by the orthopedic
surgeon and the interventional cardiologist strongly indicated that consumers do not derive some of the
educational benefits, which is not only making one aware of a condition but whether one is actually an
appropriate candidate for the treatment or has awareness of the risks. Mr. Ubl’s discounting of the notion
that a patient might decide to undergo a complex and invasive procedure based on an advertisement or
that a physician might agree to perform a surgery using a device he is reimbursed for at a higher rate
merely suggests that he does not get out much. The U.S. Department of Justice has been investigating
financial incentives to orthopedic surgeons for years, and the data on patient demand for prescription
medications and genetic testing indicates that advertising drives demand, particularly for complicated
medications such as cancer chemotherapy and BRCA-screening for cancer predisposition.
      171
          Schultz statement, supra note 55.
      172
          Id.
      173
          Armstrong, David, Lawsuit Says Medtronic Gave Doctors Array of Perks, THE WALL STREET
JOURNAL, (Sept. 25, 2008), at B1.
      174
          Id.
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                               37

B. Recent Proposed Legislation
   The recent Congressional hearings on the problem of DTCA of restricted medi-
cal devices is not the only evidence indicating that Congressional attention has now
focused on this issue. Within the past three years, two separate bills were introduced
in the House of Representatives to address problems in DTC advertising. The first,
H.R. 3696,175 was introduced as the “Medical Advertising Reform Act” on Sep-
tember 8, 2005 and referred to the House Committee on Energy and Commerce,
from which is was referred to the Subcommittee on Health. Although this bill never
made it out of Committee, it contained five interesting provisions. The bill would
have 1) instituted a two-year moratorium on DTC advertising of newly approved
prescription drugs, 2) required prior approval of content for an advertisement for a
restricted medical device, 3) authorized a study by the Government Accountability
Office (GAO) on the impact of consumer-directed advertising on restricted medi-
cal device utilization and spending for the purpose of evaluating whether current
regulatory controls are adequate to ensure that DTCA of restricted medical devices
provides consumers with “complete and accurate information concerning the safety
and effectiveness”176 of the device, 4) ensured that FDA had sufficient resources
for the task of monitoring DTCA of restricted medical devices and undertaking
appropriate enforcement action and 5) required that the GAO report be submitted
to the House Committee no later than July 1, 2006.177
   Although H.R. 3696 apparently died in Committee, another bill on restricted
medical device advertising was introduced by Representative Rosa DeLauro (D-CT)
on May 22, 2008.178 H.R. 6151, entitled the “Responsibility in Drug and Device
Advertising Act of 2008,” is currently now in the House Committee on Energy and
Commerce. H.R. 6151 proposes to amend the 1938 FDCA by prohibiting DTC
advertising for three years from FDA approval of either a new prescription drug
or “a Class II or Class III device for which a premarket notification is submitted
under section 510(k) or a Class III device for which a premarket approval is sought
under section 515;”179 the prohibition could be extended if advertisements were not
fairly balanced. In addition to proposing a longer moratorium than H.R. 3696 did,
the bill now in Committee proposed that §303(g) of the FDCA180 be amended so
that manufacturers who violate any section of the Act which deals with advertising
of a drug or device could be subject to civil penalties of up to $1,000,000 for first
violations and up to twice this amount for subsequent violations. The fate of this
newest bill remains to be seen.

         VIII. ADDRESSING THE PROBLEMS OF DTCA OF RESTRICTED,
                       IMPLANTED MEDICAL DEVICES
  For the past decade almost every major law review article, food and drug law
casebook, significant litigation controversy, and conference on advertising and
promotion of medical products to consumers has invariably focused on direct
    175
          H.R. 3696, 109th Cong., (2005), Medical Advertising Reform Act.
    176
          Id.
    177
          Id.
    178
          H.R. 6151, 110th Cong. (2008), “Responsibility in Drug and Device Advertising Act of
2008.”
    179
          Id.
    180
          21 U.S.C. 333.
38                   Food and Drug Law Journal                               Vol. 64

to consumer advertising of drugs. The end result of all of this is a relative gap in
scholarly writing, and analysis, of the issue of direct to consumer advertising of
restricted medical devices. The implicit assumption has been that because advertis-
ing and promotion of prescription drugs and restricted medical devices are both
regulated by FDA, the advertising and promotion issues are similar and can be
regulated in similar manner. This might be the case if the advertising of prescrip-
tion drugs and restricted medical devices by the manufacturers were conducted the
same way, or if the safety information required were the same. As has been shown,
neither of these is true
   The critical issue which must be resolved may be stated as follows: are the dif-
ferences in advertisement content, consumer comprehension, FDA review, and
learned intermediary involvement and danger of inadequacies in risk presentation
for restricted, implantable medical devices so great that a different regulatory ap-
proach to DTCA of such medical devices is needed? For all of the reasons discussed
in this article, it is this author’s opinion that the regulation of the advertising and
promotion of restricted devices which are surgically implanted requires differ-
ent regulation, greater and more stringent safety information, and poses greater
challenges for consumers to properly understand than that for prescription drugs.
Absent a different regulatory approach to DTCA of restricted medical devices,
consumers cannot be protected from misleading and inadequate promotions that
could ultimately result in suboptimal healthcare decisions on their part.
   The role of the medical profession in medical device development, financial
investment, and direct advertising and promotion is less arm’s length than it is for
prescription drugs, and both state and federal regulators have yet to fully come
to terms with this difference. The ability of companies to advertise and promote
their most technologically advanced and potentially dangerous medical devices to
consumers through marketing efforts by individual physician groups, hospitals,
university/ academic medical centers and regional cancer centers allows sponsors
to circumvent FDA regulation of their activities. Lastly, all of the safety data omis-
sions in promotion for restricted implanted medical devices which are highlighted
in the few clinical studies that have methodically examined DTCA of restricted,
implanted medical devices for both consumer comprehension and safety informa-
tion content have all shown alarming problems, and generally ignored the significant
links of restricted medical device safety to hospital and physician performance in
a way that simply does not apply to prescription drug DTCA. A “one size fits all”
regulatory approach by FDA which addresses advertising and promotion of drugs
and devices as if they can be treated the same way simply will not work. Much can
be and should be done to rectify this situation.

A. What FDA Should Do
   FDA should conduct a greater level of oversight of DTC advertisements for
restricted, implantable medical devices than the agency is now doing and be given
the financial and personnel resources to do this. Review of all printed and broadcast
advertisements for restricted, surgically implanted Class III medical devices should
be the rule, not the exception.
   There are fewer enforcement actions against medical device manufacturers over
DTCA because FDA pays less attention to the issue and, in an era of financial,
legal and personnel resources stretched thin due to the nature of its work and the
2009       DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                          39

continually increasing administrative burden placed on it by Congress, FDA may
not be able to adequately police the medical device industry because it cannot. The
recently enacted FDAAA contained a section which included greater authorization
for FDA to require pre-review of DTC advertisements to ensure that consumers are
adequately informed of safety risks; this authority should now be exercised. Further
amendment of the FDCA may be necessary to empower FDA to adequately police
DTCA of restricted, implanted medical devices.
    Even with its relatively limited resources, there are other things FDA can and
should do now that do not require amending the FDCA. FDA should issue a separate
guidance document for DTCA of medical devices for print advertisements similar
to the Brief Summary: Disclosing Risk Information in Consumer-Directed Print Ad-
vertisements which was issued as a Draft Guidance by FDA in January 2004. This
new document should describe the type of safety information which would need to
be included in any printed advertisement for restricted medical devices. This risk
information would have to disclose the fact that the primary care doctor might not
be the most knowledgeable person to talk to about the surgical aspects and potential
complications of some of these devices. More importantly, this document should also
state that the required safety information provided to consumers for any implantable
medical device such as knee, hip, heart valves and coronary artery stents in an adver-
tisement in any medium should be required to have a core of safety information on
the real possibility of infections and complications from implantation, the expected
life span of the device before replacement is required, information relating to the
surgical aspects of implanting the device, and a statement that any advertisement
for an implanted, restricted medical device by a surgeon, surgical group or academic
medical center must present appropriate and necessary safety information such as
complication rates in a comprehensible manner.
    FDA should remove the current loophole for broadcast advertisements which
allows a stronger standard (the brief summary) to exist for printed media advertise-
ments than for broadcast advertisements on radio and television. Instead of the
brief summary for these advertisements, device manufacturers are allowed to only
make adequate provision for dissemination of the approved package labeling in
conjunction with the advertisement.181 There is no reason why the same informa-
tion, and same standard, should not apply equally to printed and broadcast media
for complex restricted medical devices; a new guidance document should reflect
this position. One consequence of this approach might be that if both printed and
broadcast advertisements for restricted, implanted medical devices have the same
standard for safety information content, there may not be broadcast advertise-
ments for some medical devices if a way cannot be found to convey the full brief
summary for these devices in a manner easily understood by the average consumer.
The guidance approach, rather than a proposed rule, is consistent with FDA’s
recent preferred approach of issuing documents which reflect its current thinking
on a controversial subject without it being binding on industry.182 This route would
     181
         Ruskin statement, supra note 89.
     182
         Rakoff, Todd D., The Choice Between Formal and Informal Modes of Administrative Regulation,
52 ADMIN. LAW REV. 159 (2000). “If we compare the mid-1990s with the late 1970s or early 1980s we
find that the number of FDA regulations adopted each year in accordance with the APA’s rulemaking
procedures declined by about fifty percent. By contrast, since the start of this decade [the 1990s] there
has been a striking increase in the number of FDA-issued documents intended to give guidance to the
regulated industry but not adopted through public procedures.” Although the Guidance documents are
statements of no legal consequence they are of enormous practical consequence since industry can conform
its conduct to current agency thinking and expedite the medical product marketing review process.
40                      Food and Drug Law Journal                                          Vol. 64

also allow FDA to get feedback from industry and to also undertake or contract
for much-needed additional study of consumer understanding of information in
restricted medical device advertisements. This behavioral data183 could be used to
ultimately ground the basis of a proposed rule it could publish and entertain formal
notice and comment on.
   FDA should also require pre-broadcast advertisement submission and clearance
for television promotion of restricted medical devices at the time of approval, rather
than publication/broadcast, to avoid repeating the scenario which accompanied the
aftermath of the Cypher cardiac stent television advertisement. This may require
more personnel and administrative resources than CDRH currently has, and if so,
will require attention by Congress to correct this.
   FDA should also end its policy of Chief Counsel’s Office review and approval
of all enforcement letters.184 Ultimately, the determination that a restricted medical
device advertisement is false or misleading is a medical decision based on evaluation
of clinical information, not a legal one (for example, DDMAC already has medical
personnel and attorneys in the division and is capable of conducting this activity
independently). Present policy, as constructed, amounts to little more than a gift
to sponsors which ensures that fewer warning letters will go out and when they do
they will be sent after such a long delay that the misleading or false advertising will
have already accomplished the bulk of its marketing objectives.
   One final action which FDA should undertake is to call for a two-year morato-
rium on DTC advertising of restricted medical devices which are implanted into
the human body. In so doing, FDA would simply be acknowledging that all of the
available data on the safety content and consumer comprehension of these adver-
tisements demonstrates that they are typically misleading and non-educational.
The American Medical Association (AMA) called for a moratorium on DTCA of
new prescription drugs and implantable medical devices in 2006;185 it is now time
to heed this call. The moratorium would allow more data and formal study on ap-
propriate content, safety and consumer comprehension to be undertaken, with an
eye towards revision of Guidance documents and rules for DTCA of such devices.
As of this writing AdvaMed has not advocated adoption of voluntary restraint
for restricted, implanted medical device advertisements in the same way PhRMA
has for new prescription drugs.

B. What Other Parties Should Do
  Medical societies such as the AMA should renew their calls for a moratorium as
well as insist on full financial disclosure by physicians, surgeons and hospitals of all
potential conflicts of interest for use of restricted medical devices they are either
developing or promoting. State medical boards should also take aggressive action
against physicians who engage in fraudulent or misleading promotion of medical
      183
          Harold, Rosemary C. & Kamp, John F., Grounding Regulation in Behavioral Science: Strength-
ening FDA’s Approach to DTC Risk Disclosures, FDLI UPDATE MAGAZINE, (Nov./Dec. 2004).
      184
          GAO, Report to Congressional Requesters, Prescription Drugs. Trends in FDA’s Oversight of
Direct-to-Consumer Advertising, (MAY 8, 2008), available at http://www.gao.gov/new.items/03177.pdf
(last accessed Oct. 27, 2008). The basic conclusion of the GAO Report was that FDA bureaucracy
gummed up DTC ad reviews, with the result that there was no longer an effective system to track and
prioritize review of DTC advertisements, with the result that the gap between violative advertisements
and the issuance of regulatory letters had widened considerably. In addition, the Assistant Director of
DDMAC at CDER is an attorney and specialist in food and drug law; involvement of more attorneys
in the Chief Counsel’s Office would appear to add little value to the review DTCA review process.
      185
          AMA, Position Statement, Direct-to-Consumer Advertising 2007, available at http://www.ama.
com.au/web.nsf/doc/ween-7am7ch (last accessed Oct. 16, 2008).
2009        DTCA OF RESTRICTED, IMPLANTABLE MEDICAL DEVICES                                   41

devices they use or when physicians fail to disclose potential conflicts of interest
they have. The Department of Justice should continue its investigations into the
financial incentive relationships between restricted medical device manufacturers
and physician surgical specialty groups.186 Congress should pass legislation which
would give FDA power to impose civil monetary penalties on medical device
manufacturers who promote restricted devices in a fraudulent, false or misleading
manner. Lastly, Congress should authorize the GAO to formally study the effect
of DTCA of restricted medical devices on consumer behavior, and incorporate
those findings into any legislation amending the FDCA which Congress passes to
specifically address problems with DTCA of restricted medical devices.

                                      IX. CONCLUSION
   There are significant differences between the methods and implications of re-
stricted, implantable medical device advertising and promotion when compared
to prescription drugs. These differences include greater direct involvement by the
medical profession, a closer relationship to the development of medical device tech-
nologies for learned intermediaries, dramatic differences in consumer knowledge and
comprehension and routine omission of critical safety information consumers need
to make educated decisions. For all of these reasons the advertising and promotion
of such medical devices to consumers merits separate consideration, and requires
different regulatory and guidance standards, than that for prescription drugs. FDA
and Congressional action specifically directed to assert more control of the grow-
ing problem of DTCA of implantable, restricted medical devices is overdue, and
if done in a timely manner could prevent some of the problems endemic to DTCA
for pharmaceuticals from becoming part of the culture of DTCA of restricted,
implanted medical devices.
   The medical device industry will likely continue to advertise restricted implant-
able medical devices directly to consumers now that the “barrier” has been broken,
and will do so in a progressively more aggressive manner until there is regulatory
“push back” by FDA and Congress considers, or passes, legislation. A moratorium
on DTCA of implantable, restricted medical devices for two years should provide a
much needed opportunity to generate clinical and consumer behavioral data. This
should allow both sides to contribute to any revamping of the regulatory approach
of DTCA, permit manufacturers to exercise their First Amendment rights while
maximizing meaningful and adequate consumer health information and allow
FDA to fulfill its mission.




    186
          Rhea, Shawn, Medtronic reveals investigation, MODERN HEALTHCARE, (Dec. 10, 2007).

								
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