Document Sample
					                                                                                                       Drug	      	Developed	by	       						Use	 																																	Background	     																																							Action	Summary
                                                                                                 1   Duragesic      Johnson         Fentanyl is an          The Duragesic pain patch was released to the U.S.      Warnings and Alerts: To date more that
                                                                                                     Pain Patch    & Johnson        opioid type pain        market in 1994 by Johnson & Johnson subsidiar-         400 Fentanyl lawsuits for wrongful death
                                                                                                     (Fentanyl)    subsidiar-       medication that is      ies, Janssen Pharmaceutica, Inc. and Alza Corp.        have been filed against Johnson and Johnson
                                                                                                                   ies, Janssen     used in the treat-      Since it was introduced to patients, makers of         subsidy, Alza Corp., and Janssen Pharmaceu-
                                                                                                                   Pharmaceutica,   ment of chronic         the Duragesic patch, as well as makers of generic      tica Products. Many of these lawsuits are still
                                                                                                                   Inc. and Alza    pain and is also used   versions, have faced several defective drug lawsuits   pending a verdict or settlement. In June of
                                                                                                                   Corp.            for anesthesia and      by patents alleging that the patches cause serious     2007 a jury awarded $5.5 million dollars to
                                                                                                                                    a variety of other      injuries and deaths. Watson Pharmaceuticals            the family of Adam Hendelson. Adam was 28
                                                                                                                                    purposes. The pain      August 2009 Recall Watson Pharmaceuticals              years old when he died of an overdose after a

                                                                                                                                    patches are designed    makes the generic version of the popular Fentanyl      defective Fentanyl pain patch that was placed
                                                                                                                                    to steadily release     pain patch Duragesic. In August of 2009 Watson         on his arm. In November 2008 Johnson and
                                                                                                                                    the Fentanyl gel        Pharmaceuticals Inc. announced that they were          Johnson subsidy, Alza Corp., and Janssen
                                                                                                                                    over the course of      voluntarily recalling a lot a Watson Fentanyl pain     Pharmaceutica Products lost another Fentanyl

                        MASS TORT
                                                                                                                                    three days.             patches. The Fentanyl pain patch recall covers a lot   lawsuit when a jury awarded the family of
                                                                                                                                                            of 100 mcg/hr patches that were sold in the United     Janice DiCosolo $16.5 million dollars.
                                                                                                                                                            States. The lot number for the patches is 145287A
                                                                                                                                                            with the expiration date of February 2011 and they
                                                                                                                                                            were shipped to consumers between early April
                                                                                                                                                            and late May of this year. PriCara December 2008
                                                                                                                                                            Recall PriCara, a division of Ortho-McNeil-Janssen

                        DRUG CHART
                                                                                                                                                            Pharmaceuticals, voluntarily recalled one lot of its
                                                                                                                                                            50 microgram per hour Duragesic pain patches
                                                                                                                                                            (lot number 0817239), as well as one lot of Sandoz
                                                                                                                                                            50 microgram per hour patches (lot number
                                                                                                                                                            0816851). The patches were manufactured by Alza
                                                                                                                                                            Corp., an affiliate of PriCara. PriCara February
                                                                                                                                                            2008 Recall PriCara voluntarily recalled all lots of
                                                                                                                                                            25 microgram per hour Duragesic CII patches sold
                                                                                                                                                            by PriCara and all 25 microgram per hour fentanyl
                                                                                                                                                            patches sold by Sandoz Inc. in February of 2008.
                                                                                                                                                            All of the recalled patches were manufactured by
                        MASS TORT LITIGATION REFERS TO ISSUES IN                                                                                            Alza Corp. with an expiration date on or before
                                                                                                                                                            December 2009. Actavis February 2008 Recall
                        WHICH A COMPANY OR INDIVIDUAL DOES                                                                                                  Actavis Inc. announced a voluntary recall of 14
                                                                                                                                                            lots of its Fentanyl transdermal system CII patches
                        HARM TO A NUMBER OF PEOPLE AS A RESULT                                                                                              sold in the United States. Corium International
                                                                                                                                                            Inc. manufactured the affected lots on contract for
                                                                                                                                                            Actavis. The patches have expiration dates between
                        OF AN ACTION OR PRODUCT. Pharmaceutical Mass                                                                                        May and August of 2009 and come in the 25, 50,
                                                                                                                                                            75, 100 microgram per hour patch form.
                        Torts have become an increasing part of the trial lawyer vocabulary.
                        Many firms today have attorneys handling all types of “Mass Torts”.
                                                                                                 2   Depak-        Abbott Labora-   Depakote is used to     Since 1983, doctors have prescribed Depakote in        Warnings and Alerts: The FDA released
                        The following Pharmaceutical Mass Tort-Quick Reference may serve             ote®          tories           treat patients with     the United States to treat patients with epilepsy.     reports concluding that the use of Depak-
                                                                                                                                    epilepsy.               Approximately two million Americans have some          ote (valproic acid) during the first trimester
                                                                                                                                                            form of epilepsy, and 125,000 new cases of epilepsy    of pregnancy has been associated with an
                        as a simple guide to some of the most common Pharmaceutical Mass                                                                    are reported each year. In 1995, the FDA ap-           increased risk of spinal cord defects (e.g., spina
                                                                                                                                                            proved Depakote® ER for the treatment of acute         bifida) in the fetus. Bleeding and liver prob-
                        Torts currently in litigation. This summary is not a guide or chart                                                                 manic or mixed episodes associated with bipolar        lems, as well as other birth defects have been
                                                                                                                                                            disorder, with or without psychotic features. The      reported too. If you are already pregnant and
                        designed to assist attorneys litigating a particular type of Mass Tort                                                              FDA first approved Depakote for treating seizures      on valproic acid, call your doctor immediately
                                                                                                                                                            in adults and children 10 years of age or older.       to discuss your options as quickly stopping
                                                                                                                                                            Later, the FDA approved Depakote for use in treat-     valproic acid may lead to harmful effects such
                        case, but instead provides a general summary of drugs and products                                                                  ing migraine headaches in adults.                      as seizures.

                        involved in mass tort evaluation or litigation.
                                                                                                 3   Digitek       Actavis Totowa   Digitek is prescribed   Digitek was originally approved by the FDA for         Warnings and Alerts: In April of 2008, with
                                                                                                     (Digoxin)                      to help patients deal   treatment of the heart conditions mentioned            the news of the dangerous pills exposed to
                                                                                                                                    with different heart    above, and it’s a member of a class of drugs known     many, Actavis Totowa decided to voluntarily
                                                                                                                                    problems, and it was    as cardiac glycosides. These medications work by       initiate a recall of Digitek. On April 25, 2008,
                                                                                                                                    administered both       affecting sodium and potassium inside the heart’s      the FDA issued a Class I recall of the drug.
                                                                                                                                    in pill and injection   cells. This process reduces the constant strain on     Since then lawsuits have arisen all over the
                                                                                                                                    form. Conditions        a troubled hear and restores it to normal working      United States on behalf of people who have
                                                                                                                                    for which Digitek       order.                                                 been harmed as a result of using Digitek and
                                                                                                                                    was used are: •Ir-                                                             taking defective pills.
                                                                                                                                    regular heartbeat,
                                                                                                                                    which is also known
                                                                                                                                    as atrial fibrilla-
                                                                                                                                    tion • A faster than
                                                                                                                                    normal heartbeat,
                                                                                                                                    which is also known
                                                                                                                                    as an atrial flutter
                                                                                                                                    • Congestive heart
                                                                                                                                    failure after other
                                                                                                                                    medications have
                                                                                                                                    not succeeded with

34 x The Trial Lawyer                                                                                                                                                                                                                        The Trial Lawyer x 35
              Drug	        	Developed	by	        						Use	 																																	Background	     																																							Action	Summary                    Drug	      	Developed	by	        						Use	 																																	Background	       																																							Action	Summary
     4     Botox and       Allergan Inc’s    Botox® is a popular,     On Feb. 8, 2008, the FDA issued Warning on             Warnings and Alerts: On May 14, 2009,             7   Heparin       Baxter Health-    Heparin is an anti-      Heparin was available for decades before negative        Warnings and Alerts: On December 20,
           Botox           Botox and         anti-wrinkle drug        Botox Deaths: FDA issued an early communica-           the FDA issued additional warnings about                            care Corpora-     blodding clotting        reports of the development of side effects began to      2007, an initial recall was announced after a
           Cosmetic        Solstice Neu-     derived from a ster-     tion about an ongoing safety review regarding          Botox®, Botox® Cosmetic and Myobloc,                                tion              drug placed in pre-      surface. The first set of negative reports that gener-   lot of heparin pre-filled syringes, lot number
           (Botulinum      roscience Inc’s   ilized form of botu-     Botox and Botox Cosmetic. FDA has received             after some children died or suffered severe                                           filled syringes that     ated negative attention in regards to Heparin began      070926H, was confirmed as being contami-
           toxin Type      Myobloc           linium toxin. The        reports of systemic adverse reactions including        injuries when the drug spread away from the                                           are usually used to      to surface in 2007, and these side effects were very     nated with Serratia marcescens. This lot of
           A) and                            well-known drug          respiratory compromise and death following the         injection site. Federal drug authorities stated                                       flush out long-term      serious in nature. In response to negative reports,      heparin pre-filled syringes was distributed
           Myobloc                           works by temporar-       use of botulinum toxins types A and B for both         that Botox® was never approved for use in                                             intravenous (IV)         investigations revealed that the problem was cen-        nationwide, but primarily to Florida, Texas,
           (Botulinum                        ily paralyzing and       FDA-approved and unapproved uses. The reactions        pediatric patients. Nor was it approved in the                                        lines, such as PICC      tered on the lab in which Heparin was manufac-           Illinois, Pennsylvania, and Colorado. Injuries
           toxin Type                        impeding muscle          reported are suggestive of botulism, which occurs      doses required to affect spastic muscles. On                                          lines or metaports.      tured. As it turned out, Baxter had outsourced the       from infected syringes from this lot have been
           B)                                movement.                when botulinum toxin spreads in the body beyond        April 29, 2011, a Virginia U.S. District Court                                        Heparin was origi-       production of Heparin to a lab in China. Given the       confirmed in Florida, Texas, and Illinois.
                                                                      the site where it was injected. The most serious       jury ordered Allergan Inc (AGN.N) to pay                                              nally discovered as      reality that the location of this lab was outside the    The FDA inspected the facility where the
                                                                      cases had outcomes that included hospitalization       $212 million to a man who claimed that injec-                                         a potential medical      jurisdictional reach of the federal government, the      syringes were manufactured and determined
                                                                      and death, and occurred mostly in children treated     tions of wrinkle-smoothing Botox left him                                             benefit in 1916,         scope of the investigation was limited to the analy-     that the facility was “not in compliance with
                                                                      for cerebral palsy-associated limb spasticity. Botox   with brain damage.                                                                    passed through           sis of samples of Heparin. Ultimately, investigators     the quality System regulation and failed to
                                                                      Deaths Reported: Of the 180 reports tracked by                                                                                               several trials in the    concluded that the side effects that developed in        have adequate controls to ensure necessary
                                                                      Public Citizen, 16 people died, and four were                                                                                                1930’s and was ulti-     patients were the result of the presence of contami-     sterility of its pre-filled syringes.” A month
                                                                      under the age of 18.                                                                                                                         mately approved for      nants in batches of Heparin that set off dangerous       later, on January 25, 2008 AM2 PAT, INC.,
                                                                                                                                                                                                                   use in 1937. Hepa-       allergic reactions in more than 300 people.              announced a second recall of all lots of
                                                                                                                                                                                                                   rin is a medication                                                               heparin pre-filled syringes and also all lots of
                                                                                                                                                                                                                   that’s been available                                                             saline pre-filled syringes manufactured by the
                                                                                                                                                                                                                   for approximately                                                                 company. This second recall of syringes, lot
                                                                                                                                                                                                                   75 years and has                                                                  number 070917A, were confirmed contami-
                                                                                                                                                                                                                   been used in mil-                                                                 nated with Serratia marcescens, which can be
     5     Crestor         AstraZeneca       Crestor (rosuvas-        In August 2003, the FDA approved Crestor, the          Warnings and Alerts: Crestor side effects could                                       lions of surgeries                                                                severe and life threatening.
           (rosuvastatin                     tatin calcium) is        latest of six cholesterol reducing drugs called        prove crippling or even deadly - rhabdomy-                                            of several types. It’s
           calcium)                          manufactured and         statins. Crestor is approved as an adjunct therapy     olysis occurs when a large number of skeletal                                         administered via
                                             marketed by Astra-       accompanied by a low-cholesterol diet and exercise     muscle cells die, resulting in the release of a                                       injection prior to a
                                             Zeneca Pharmaceu-        program to reduce the overall level of bad cho-        massive amount of muscle protein into the                                             surgical procedure.
                                             ticals and is a statin   lesterol in the blood stream. A study published        bloodstream. The muscle protein becomes
                                             drug; i.e. a medicine    September 10, 2007 by the Institute for Safe           trapped in the kidneys, affecting the filtering
                                             that lowers “bad”        Medication Practices, in Huntingdon Valley, Pa.        process of the kidneys and leading to kidney
                                             cholesterol and tri-     illustrated that the number of serious adverse drug    failure. Related Crestor side effects include     8   Cipro (Cip-   Bayer A.G.        Cipro is a drug          Ciprofloxacin was first patented in 1983 by Bayer        Warnings and Alerts: On February 25, 2011
                                             glycerides, and raises   events more than doubled between 1998 and 2005         serious liver damage and liver death.                 rofloxacin)                     that’s known as a        A.G. and subsequently approved by the U.S.               an additional Black Box warning was added
                                             “good” cholesterol       in the United States.                                                                                                                        general antibiotic,      Food and Drug Administration (FDA) in 1987.              to all the drugs within this class, including
                                             in the blood.                                                                                                                                                         which means that         Ciprofloxacin has 12 FDA-approved human uses             ciprofloxacin, stating that the fluoroquinolone
                                                                                                                                                                                                                   it’s used to treat a     and other veterinary uses, but it is often used for      class may cause worsening of myasthenia gra-
                                                                                                                                                                                                                   number of bacterial      unapproved uses (off-label). Ciprofloxacin interacts     vis symptoms, including muscle weakness and
                                                                                                                                                                                                                   infections.              with other drugs, herbal and natural supplements,        breathing problems. Such an adverse reaction
                                                                                                                                                                                                                                            and thyroid medications. While some patients             is a potentially life-threatening event and may
                                                                                                                                                                                                                                            may have experienced these types of symptoms             require ventilatory support. Additionally the
                                                                                                                                                                                                                                            and events as a result of nicotine withdrawal, some      manufacturers of ciprofloxacin (Bayer A.G.)
                                                                                                                                                                                                                                            patients taking Chantix who experienced serious          received numerous warning letters from the
                                                                                                                                                                                                                                            neuropsychiatric symptoms and events had not yet         United States Food and Drug Administra-
     6     Seroquel        AstraZeneca       Seroquel is              Seroquel was approved by the FDA in 1997 for           Warnings and Alerts: In 2004, the FDA and                                                                      discontinued smoking. In most cases, neuropsychi-        tion regarding false advertising and failure
           (quetiapine)    Pharmaceuti-      prescribed for the       treating schizophrenia and bipolar disorder.           Seroquel manufacturer AstraZeneca notified                                                                     atric symptoms developed during Chantix treat-           to provide adequate warnings within their
                           cals LP           treatment of depres-                                                            healthcare professionals of revisions to the                                                                   ment, but in others, symptoms developed following        promotional materials.
                                             sive episodes in bi-                                                            ‘Warnings’ section of the labeling, describ-                                                                   withdrawal of Chantix therapy.
                                             polar disorder, acute                                                           ing the increased risk of hyperglycemia,
                                             manic episodes in                                                               high blood pressure and diabetes in patients
                                             bipolar I disorder,                                                             taking Seroquel. Further, elderly patients with
                                             and schizophrenia.                                                              dementia-related psychosis treated with this      9   Yasmin, Yaz   Bayer Health-     Yasmin is a birth        Yasmin was approved by the FDA in 2001. Yasmin           Warnings and Alerts: In 2008 and 2009,
                                                                                                                             type of medicine are at an increased risk of          and Ocella    Care Pharma-      control product          contains drospirenone, a progestin that can increase     FDA issued a third warning to Bayer Health-
                                                                                                                             death. AstraZeneca has found itself at the cen-                     ceuticals, Inc.   that’s known by          the body’s potassium levels. According to the drug’s     Care Pharmaceuticals, Inc. regarding what
                                                                                                                             ter of ongoing controversy regarding patient /                                        many names,              label, the potassium increase may put women with         it termed as “misleading” advertising. FDA
                                                                                                                             doctor warnings about the potential develop-                                          including Yasmin,        liver and kidney problems at higher risk for serious     warning letters indicated that Yaz ads made
                                                                                                                             ment of diabetes resulting from Seroquel use.                                         Yaz and Ocella,          health problems. Yaz, which also contains drospi-        exaggerated claims about the drug’s benefits
                                                                                                                             US regulators have argued that such warnings                                          which is basically       renone and a lower dose of estrogen, was approved        and failed to mention important side effects.
                                                                                                                             were not made readily available to those most                                         the generic version      by the FDA in 2006 as both a contraceptive and           The FDA said the ads misleadingly broadened
                                                                                                                             in need of them, putting Seroquel users at risk                                       of the brand-name        a treatment for premenstrual dysphoric disorder          the drug’s indications, overstated the products
                                                                                                                             of developing a serious and potentially fatal                                         equivalent.              and moderate acne. The drugs’ popularity is due in       efficacy, and minimized serious risks associ-
                                                                                                                             diabetic condition. As such, people who have                                                                   part to multimillion-dollar advertising campaigns,       ated with use of the drug. This most recent
                                                                                                                             been injured as a result of using Seroquel may                                                                 and together Yasmin and Yaz brought in about             warning was issued following reports linking
                                                                                                                             be eligible to receive compensation for their                                                                  $1.8 billion in worldwide sales in 2008 for Bayer.       the manufacturer’s popular oral contraceptives
                                                                                                                             injuries.                                                                                                      From 2004 through 2008, the U.S. Food and Drug           with life-threatening injuries, including deep
                                                                                                                                                                                                                                            Administration (FDA) received reports of more            vein thrombosis (DVT), stroke, heart attack,
                                                                                                                                                                                                                                            than 50 deaths of women, some as young as 17             pulmonary embolism, kidney failure and even
                                                                                                                                                                                                                                            years old, who were taking Yasmin, Yaz and Ocella.       death. As a result of increased FDA pressure,
                                                                                                                                                                                                                                            Because of underreporting, the actual number of          Bayer has agreed to spend $20 million on a
                                                                                                                                                                                                                                            deaths was likely far higher.                            corrective advertising campaign. The Judicial
                                                                                                                                                                                                                                                                                                     Panel on Multi-District Litigation has central-
                                                                                                                                                                                                                                                                                                     ized all federal court cases involving Yaz/
                                                                                                                                                                                                                                                                                                     Yasmin/Ocella in the United States District
                                                                                                                                                                                                                                                                                                     Court for the Southern District of Illinois,
                                                                                                                                                                                                                                                                                                     MDL No. 2100.

36 x The Trial Lawyer
             Drug	      	Developed	by	        						Use	 																																	Background	        																																							Action	Summary                      Drug	       	Developed	by	       						Use	 																																	Background	           																																							Action	Summary
 10       Trasylol/     Bayer Pharma-     Trasylol is the brand    Trasylol has been on the market for more than 14          Warnings and Alerts: On November 5,                13   Zyprexa        Eli Lilly &      Zyprexa is the            In November 2001, the Journal of the American              Warnings and Alerts: ● diabetes ● heart attacks
          Aprotinin     ceuticals Corp.   name for aprotinin,      years, during which time it has been one of Bayer’s       2007, Bayer Pharmaceuticals Corp. issued a                             Company          brand name for the        Medical Association, the FDA’s Center for Drug             ● comas ● other diminished quality-of-life
                                          a type of protein        more profitable drugs. The ability of Trasylol to en-     worldwide suspension of the production and                                              drug olanzapine           Evaluation and Research, and a Duke University             blood glucose.           Warnings and Alerts:
                                          that can be used         hance blood clotting and limit the need for blood         marketing of Trasylol following increased                                               and is an atypical        Medical Center physician first possibly linked             Most recently, the FDA has identified at least
                                          during major sur-        transfusions during complex surgical procedures           evidence of a heightened risk of death. On                                              antipsychotic used        between the Zyprexa side-effect of hyperglycemia           384 reports of diabetes linked to Zyprexa,
                                          gery (such as heart      made it an instant hit within the medical commu-          February 21, 2008, two studies were published                                           in the treatment of       in adolescents with the drug. FDA staff mem-               with the majority of cases appearing within
                                          bypass surgery) to       nity. Experts believe that Trasylol has been used in      in the New England Journal of Medicine.                                                 schizophrenia and         bers published a report in the December 2001               six months of starting Zyprexa treatment.
                                          limit patient bleed-     approximately one-third of all heart bypass opera-        Both studies confirmed that Trasylol causes                                             bipolar disorder.         American Journal of Medicine linking Zyprexa to            This has been a major focus in the Zyprexa
                                          ing. Trasylol inhibits   tions performed in the United States since 1993.          an increased risk of death and kidney damage                                                                      diabetes. Both Zyprexa reports used information            litigation. With demands made by the FDA,
                                          the natural process                                                                compared to alternative medicines or no                                                                           from the FDA’s adverse drug reaction database.             in March 2004 Eli Lilly finally put safety
                                          by which blood                                                                     medicine at all. The study performed between                                                                      Unfortunately, what is being done about Zyprexa            information on Zyprexa side effects. In a letter
                                          clots are broken                                                                   1996 and 2005 at Duke University Medical                                                                          diabetes side effects is too little, too late especially   to doctors, Eli Lilly informed doctors about
                                          down, allowing for                                                                 Center, determined that approximately 640 of                                                                      when one out of one thousand people taking Zy-             labeling changes with a warning describing the
                                          prolonged coagula-                                                                 the 10,000 Trasylol patients died within one                                                                      prexa may have already developed life threatening          increased risk of hyperglycemia and diabetes in
                                          tion and reduced                                                                   month of their bypass surgery. One year after                                                                     side effects.                                              patients taking these medications.
                                          bleeding.                                                                          surgery, this number climbed to approximately
                                                                                                                             1,600 patient deaths. These figures become
                                                                                                                             even more alarming when compared with
                                                                                                                             those evaluating patients who underwent
                                                                                                                             bypass without receiving Trasylol. The bypass
                                                                                                                             patients who received Trasylol had a mortality
                                                                                                                             rate roughly two and a half times greater than
                                                                                                                             patients who received an alternative drug or
                                                                                                                             nothing at all during surgery. The Trasylol
                                                                                                                             controversy gained momentum following              14   Gadolinium/    GE Healthcare    Gadolinium is a           Gadolinium is used in pre and post surgical                Warnings and Alerts: The Danish Medicines
                                                                                                                             studies linking the drug with an increased              NSF            Inc., Bayer      contrast material in-     patients, but more commonly for post-operative             Agency (DMA) issued a press release on
                                                                                                                             mortality rate. On May 15, 2008, Bayer AG                              HealthCare       jected at the time of     imaging. The most commonly used gadolinium                 May 29, 2006, that reported patients with
                                                                                                                             to remove remaining supplies of its heart-                             Pharmaceu-       an MRI to provide         contrast agent is OmniScan (gadodiamide); how-             renal failure developing a rare, potentially
                                                                                                                             surgery anti-bleeding drug Trasylol from the                           ticals Inc.,     greater contrast be-      ever, there are five different types that have been        life-threatening condition called Nephrogenic
                                                                                                                             U.S. market.                                                           Mallinckrodt     tween normal tissue       approved for use by the FDA: OmniScan (gado-               Systemic Fibrosis/Nephrogenic Fibrosing
                                                                                                                                                                                                    Inc., Bracco     and abnormal tissue       diamide)/ OptiMark (gadoversetamide)/ Prohance             Dermopathy (NSF/NFD) after being ad-
 11       Tequin        Bristol-Myers     Tequin is an anti-       The U.S. Food and Drug Administration approved            Warnings and Alerts: On April 27, 2006                                 Diagnostics      in the brain and          (gadoteridol) / Magnevist (gadopentate dimeglu-            ministered Gadolinium-containing contrast
                        Squibb            biotic used to treat     Tequin in 1999. In 2006, Bristol-Myers an-                Bristol-Myers Squibb Co. announced that it                             Inc., & Nova-    body. Gadolinium is       mine) / MultiHance (gadobenate dimeglumine).               agents. The DMA was concerned because all
                                          adults with lung,        nounced labeling changes for Tequin. The labeling         would stop making & selling Tequin, as the                             tion LLC         also helpful in find-                                                                patients received a Gadolinium enhanced MRI
                                          sinus, or urinary        changes, announced in a letter to healthcare profes-      drug has been associated with hyperglycemia                                             ing small tumors by                                                                  procedure a few weeks to a few months before
                                          tract infections and     sionals, updated the prescription information as a        and hypoglycemia, both of which are poten-                                              making them bright                                                                   developing NSF/NSD. According to recent
                                          also to treat certain    result of continued reports of serious cases of hypo-     tially fatal blood-sugar disorders.                                                     and easy to see.                                                                     FDA reports, a single injection of gadolinium
                                          sexually transmitted     glycemia and hyperglycemia in patients receiving                                                                                                  The FDA declared                                                                     could potentially result in the development of
                                          diseases.                Tequin. Since the approval of Tequin, there have                                                                                                  Gadolinium safe for                                                                  NSF / NFD.
                                                                   been rare cases of life-threatening events reported                                                                                               use in MRI scans
                                                                   globally in patients treated with the drug.                                                                                                       in 1988 to provide
                                                                                                                                                                                                                     greater image detail
                                                                                                                                                                                                                     when viewing the
                                                                                                                                                                                                                     brain and connec-
                                                                                                                                                                                                                     tive tissues such as
                                                                                                                                                                                                                     spinal discs, carti-
                                                                                                                                                                                                                     lage, scar tissue, soft
                                                                                                                                                                                                                     tissue tears, tumors,
 12       Depuy ASR     DePuy Ortho-      The U.S. Food and        The high and early rate of failure of DePuy’s plat-       Warnings and Alerts: On August 26, 2010            15   Avandia        GlaxoSmith-      Avandia is used to        Avandia was approved by the FDA in 1999. In                Warnings and Alerts: On November, 14,
          Hip Implant   paedics Inc.,     Drug Administra-         form was compared to the Birmingham Hip Resur-            DePuy Orthopaedics Inc., the orthopedics                (rosigli-      Kline            treat Type 2 diabe-       May 2007, the New England Journal of Medicine              2007, the FDA announced that the manu-
                        the orthope-      tion (FDA) ap-           facing (BHR) replacements by researchers from the         unit of Johnson & Johnson, announced a                  tazone male-                    tes, a leading cause      published an analysis linking Avandia to increased         facturer of Avandia (rosiglitazone) has agreed
                        dics unit of      proved DePuy’s ASR       Joint Replacement Unit at the University Hospital         voluntary recall of the ASR XL Acetabular               ate)                            of coronary heart         risk of heart attacks. In an analysis of 40 studies        to add a new black box warning on the drug’s
                        Johnson &         implant cup and          of North Tees in Stockton, England. There were 17         System (the cup portion of a replacement hip                                            disease, blindness,       and more than 28,000 patients, researchers found           labeling about potential increased risk for
                        Johnson           metal ball in 2005.      failures or a 3.5 percent failure rate in patients with   joint) and the ASR™ Hip Resurfacing System                                              kidney failure as         that those taking Avandia were between 30 to 40            heart attacks. On November 24, 2008, The
                                          In the autumn            DePuy’s ASR platform compared to no failures in           (a partial hip replacement in which a metal                                             well as limb ampu-        percent more likely to suffer heart attack and heart-      New York Times reported that a new study
                                          of 2009, DePuy           the BHR group.                                            cap is positioned on the ball of the hip bone or                                        tation. A serious         related deaths than those taking a placebo or other        published in The Archives of Internal Medi-
                                          stopped distribu-                                                                  femur) voluntarily recalled the product.                                                condition affecting       diabetes drugs. As of May 2007, the FDA said data          cine found that Avandia (the drug also known
                                          tion of the system                                                                                                                                                         approximately 20          analyses were ongoing to confirm the risks. Glaxo-         as rosiglitazone) was linked to a higher rate of
                                          worldwide.                                                                                                                                                                 million Americans.        SmithKline has made billions of dollars in profits         mortality than a similar drug sold under the
                                                                                                                                                                                                                                               from Avandia, one of the most popular diabetes             brand name Actos (also known as piogli-
                                                                                                                                                                                                                                               drugs in the world.                                        tazone). This was an observational study, and
                                                                                                                                                                                                                                                                                                          representatives of GlaxoSmithKlein criticized
                                                                                                                                                                                                                                                                                                          it for being inconsistent with and not being
                                                                                                                                                                                                                                                                                                          as rigorous as randomized clinical trials they

38 x The Trial Lawyer                                                                                                                                                                                                                                                                                                                The Trial Lawyer x 39
              Drug	      	Developed	by	       						Use	 																																	Background	      																																							Action	Summary                        Drug	        	Developed	by	        						Use	 																																	Background	       																																							Action	Summary
 16        Paxil         GlaxoSmith-      Paxil is prescribed     In 1992, the FDA approved Paxil to treat the             Warnings and Alerts: In March 2004, the              19   Risperdal       Janssen Phar-     Risperdal (risperi-      Risperdal was approved by the FDA in 1993                Warnings and Alerts: A 2003 study reported
                         Kline            for a variety of        symptoms of depression, obsessive-compulsive             FDA placed a black box warning on SSRI and                (risperidone)   maceuticals       done) is an atypical     for the treatment of autistic spectrum disorders,        that there were 49% more cases of diabetes
                                          illnesses including     disorder (OCD), post-traumatic stress disorder           other antidepressants, including Paxil, warning                                             antipsychotic            schizophrenia, and other forms of psychosis in           among patients taking Risperdal than among
                                          generalized anxiety     (PTSD), panic disorder, generalized anxiety              of the risk of potential suicidal thinking. It has                                          medication used to       children and adults. It is also used in combination      patients using older anti-psychotic drugs. After
                                          disorder, social        disorder (GAD), social phobia/social anxiety             been suggested that Paxil may cause depres-                                                 treat schizophrenia,     with lithium or valproate for the treatment of acute     the study, the FDA required Risperdal to carry
                                          anxiety disorder,       disorder, and premenstrual dysphoric disorder            sion to worsen and even lead to suicide in a                                                bipolar I disorder,      manic or mixed episodes associated with bipolar I        a new warning label that recommends its users
                                          obsessive-compul-       (PMDD). Since Paxil was released in 1992 it has          small number of patients. These potential side                                              and acute manic or       disorder. Risperdal has been linked to type 2 diabe-     be monitored for blood sugar abnormalities.n
                                          sive disorder, and      become one of the most prescribed antidepres-            effects are difficult to evaluate in depressed                                              mixed episodes asso-     tes, juvenile diabetes, hyperglycemia, other blood       addition, in April 2005, the FDA issued an
                                          depression.             sants on the market due to its apparent efficacy in      patients because depression can progress with                                               ciated with bipolar      sugar disorders, diabetic coma, and pancreatitis- a      alert stating that elderly patients treated with
                                                                  treating a spectrum of anxiety disorders ranging         or without treatment, and suicide is itself a                                               mania. Risperdal         dangerous inflammation of the pancreas.                  Risperdal for dementia had a higher chance
                                                                  from depression to panic attacks to phobias. Paxil       consequence of depression. For pregnant                                                     works by readjust-                                                                for death by stroke and cardiac arrest than
                                                                  works by inhibiting the reuptake of serotonin by         women, there is also a potential risk to the                                                ing the balance of                                                                patients who did not take the drug. Other
                                                                  the nerves that release it--an action which allows       fetus when taking Paxil (paroxetine). Some                                                  these chemicals,                                                                  dangerous side effects of Risperdal include
                                                                  more serotonin to be available to be taken up by         studies of paroxetine in pregnant women have                                                helping to control                                                                excessive weight gain, Neuroleptic Malignant
                                                                  other nerves.                                            suggested an increased risk of heart malforma-                                              symptoms                                                                          Syndrome (NMS) and Tardive Dyskinesia.
                                                                                                                           tions. In July 2006, the FDA issued an alert                                                                                                                                  NMS is a potentially fatal condition that can
                                                                                                                           stating that a life-threatening condition called                                                                                                                              cause severe muscle rigidity and spikes in
                                                                                                                           Serotonin Syndrome can occur when medi-                                                                                                                                       blood pressure and pulse.
                                                                                                                           cines called Serotonin and Norepinephrine
                                                                                                                           Reuptake Inhibitors (SNRIs, such as Paxil)
                                                                                                                                                                                20   Topamax®        Janssen Phar-     Topamax® is              The FDA approved Topamax® (topiramate),                  Warnings and Alerts: On March 4, 2011,
                                                                                                                           and medicines used to treat migraine head-
                                                                                                                                                                                     (Topiramate)    maceuticals,      a medication             an antiepileptic medication, in January 1997, to         fourteen years after Topamax’s® approval, the
                                                                                                                           aches known as 5-hydroxytryptamine receptor
                                                                                                                                                                                                     Inc.              prescribed alone         reduce the occurrence of seizures, especially for        FDA released a warning saying new data on
                                                                                                                           agonists (triptans), are taken together.
                                                                                                                                                                                                                       or in addition to        patients in whom other antiepileptic medications         the drug showed it could cause birth defects.
                                                                                                                                                                                                                       other medications        do not work. New research from the North Ameri-          The admonition said Topamax® could result
 17        Accutane®      Hoffmann-La     Accutane® (isotreti-    The FDA approved Accutane® in 1982 and has               Accutane News: ● $2 Million Jury Verdict                                                    to treat epilepsy in     can Antiepileptic Pregnancy Registry shows that          in cleft lip and cleft palate in babies born to
           (isotretinoin) Roche, Inc.     noin) severe nodular    been used by more than 16 million people world-          for Accutane Plaintiff ● $10.5 Million, 3rd                                                 patients with certain    Topamax® increases the risk of oral clefts (cleft lip    mothers taking the medication early in the
                                          acne treatment          wide since it was first introduced as a treatment for    Straight Plaintiff ’s Verdict, And Largest To                                               kinds of seizures. It    and cleft palate) in fetuses exposed to the drug early   first trimester of pregnancy.
                                                                  severe acne. Accutane was first developed as a che-      Date ● $7 Million Roche Must Pay Accutane                                                   also is prescribed to    in their mother’s first trimester of pregnancy.
                                                                  motherapy for certain types of cancer. However, the      User ● A number of Accutane lawsuits will                                                   prevent migraine         According to the new data, the risk of being born
                                                                  inventors discovered that it was effective in treating   be going to trial this year in New Jersey state                                             headaches but does       with oral clefts is: 1.4 percent in children born to
                                                                  severe acne as well. Due to an aggressive market-        court and there are currently more than 2,500                                               not relieve the pain     mothers taking Topamax® 0.7 percent in infants
                                                                  ing campaign by the manufacturer, Accutane was           individuals who have filed an Accutane lawsuit                                              of migraines once        born to mothers who were not epileptic or not
                                                                  frequently prescribed for common acne. Accutane          over bowel problems. ● Hoffman-La Roche,                                                    they have begun.         taking any antiepileptic medication 0.38 to 0.55
                                                                  has a number of Serious And Lethal Side Effects,         Inc. has lost all 7 cases that have reached a jury                                          The drug also is         percent for infants exposed to antiepileptics other
                                                                  including Birth Defects, Depression, Suicide, IBD,       in the litigation, with many resulting in multi-                                            approved for use in      than Topamax®
                                                                  Crohn’s Disease, Colitis, and many other Accutane        million dollar awards for Accutane damages.                                                 combination with
                                                                  side effects. There have been nearly 150 suicides                                                                                                    other antiepileptic
                                                                  with direct links to Accutane, over 1,000 reported                                                                                                   drugs for seizures
                                                                  birth defects, and over 10,000 miscarriages. Roche                                                                                                   known as partial
                                                                  discontinued Accutane in June 2009 due to the                                                                                                        onset seizures.
                                                                  increasing costs of the litigation, but a number
                                                                                                                                                                                21   Zicam           Matrixx Initia-   Zicam Cold Rem-          Zicam Cold Remedy is a zinc-based solution that          Warnings and Alerts: FDA Advises Consum-
                                                                  of generic versions remain available under names
                                                                                                                                                                                                     tives, Inc.       edy is an over-the-      can be taken as a tablet or a nasal spray. The medi-     ers Not To Use Certain Zicam Cold Remedies
                                                                  such as Claravis, Sotret, Amnesteem and generic
                                                                                                                                                                                                                       counter homeo-           cation works by delivering a dose of zinc gluconate      Despite the manufacturer’s assurances that
                                                                                                                                                                                                                       pathic medicine that     to the nasal passages, throat and pharynx.               Zicam adheres to FDA guidelines and restric-
                                                                                                                                                                                                                       acts to reduce the                                                                tions, lawsuits have been filed by Zicam users
                                                                                                                                                                                                                       duration and sever-                                                               against both Matrixx Initiatives and Zicam
                                                                                                                                                                                                                       ity of the common                                                                 LLC, claiming that taking Zicam has caused
 18        Propulsid     Jansen Phar-     Propulsid               The FDA approved Propulsid in 1993. Propulsid            Warnings and Alerts: In March 2000, Jansen                                                  cold when taken at                                                                anosmia, or a loss of smell and taste. Many
           (Cisapride)   maceutica, a     (Cisapride) was         was used to treat severe nighttime heartburn in pa-      Pharmaceutica, a subsidiary of Johnson &                                                    the first sign of cold                                                            Zicam users have also reported experiencing
                         subsidiary of    a prescription          tients with gastroesophageal reflux disease (GERD)       Johnson voluntarily halted the marketing                                                    symptoms.                                                                         horrific, almost unbearable burning after using
                         Johnson &        drug designed           who did not respond well to other treatments.            of Propulsid (cisapride) because of reports                                                                                                                                   the nasal spray. On June 16, 2009 the FDA
                         Johnson          for the treatment       GERD is the backward flow of stomach contents            of heart rhythm abnormalities and death. a                                                                                                                                    advised consumers to stop using Zicam due to
                                          of severe gastro-       to the esophagus. Some doctors also prescribed it to     multi-district litigation center (MDL) has                                                                                                                                    its link to 130 reports of loss of sense of smell
                                          esophageal reflux       infants. In 1999, Propulsid’s worldwide sales were       been set up in New Orleans to handle lawsuits                                                                                                                                 after using the products.
                                          disease (GERD),         approximately $950 million.                              filed against Jansen Pharmaceutica and John-
                                          a disorder more         From 1993 until January 2000, Propulsid’s label          son and Johnson.                                     22   Fosamax®        Merck Sharp       Fosamax® (alendro-       In 2004, the FDA issued a written warning to             Warnings and Alerts: Medical studies suggest
                                          commonly known          was revised five times to warn doctors and patients                                                                (alendro-       & Dohme           nate) osteoporosis       Merck about false and misleading statements about        that bisphosphonate compounds like Fosamax
                                          as acute nighttime      against the risks of taking the drug. The FDA                                                                      nate)           Corp., a          prevention and           Fosamax in some of its advertising and marketing         restrict blood flow to the bone and cause
                                          heartburn.              reported in March 2000 that 381 cases of heart                                                                                     subsidiary of     treatment. Fosamax       materials, and demanded removal of all misleading        Osteonecrosis of the Jaw (ONJ); a progres-
                                                                  rhythm abnormalities and 80 deaths were recorded.                                                                                  Merck & Co.,      (alendronate) was        statements. The FDA also urged Merck to make             sively debilitating condition that results in
                                                                                                                                                                                                     Inc.              approved by the          certain Fosamax labeling changes include a warning       actual bone death. Also known as “Dead Jaw
                                                                                                                                                                                                                       FDA in 1995 to           that ONJ has been reported in patients taking            Syndrome,” ONJ is associated with minor jaw
                                                                                                                                                                                                                       prevent and treat        bisphosphonates. Merck was advised by the FDA            trauma such as tooth extractions that do not
                                                                                                                                                                                                                       the bone-thinning        in 2004 to include a warning in the drug label but       heal properly, typically leading to exposure of
                                                                                                                                                                                                                       disorder osteopo-        failed to comply until almost a year later.              the bone. Serious complications often follow
                                                                                                                                                                                                                       rosis and was one                                                                 this exposure including extreme pain, virulent
                                                                                                                                                                                                                       of several drugs                                                                  infections, tooth loss and disfigurement.
                                                                                                                                                                                                                       classified as bisphos-
                                                                                                                                                                                                                       phonates which act
                                                                                                                                                                                                                       to decrease cells that
                                                                                                                                                                                                                       damage bones.

40 x The Trial Lawyer                                                                                                                                                                                                                                                                                                              The Trial Lawyer x 41
             Drug	      	Developed	by	       						Use	 																																	Background	     																																							Action	Summary                        Drug	       	Developed	by	        						Use	 																																	Background	       																																							Action	Summary
 23        Zelnorm      Novartis Phar-   Zelnorm is a            Zelnorm was first approved by the FDA back in           Warnings and Alerts: On March 30, 2007,              26   Levaquin       Ortho-McNeil      Levaquin is a broad      Levaquin was originally approved in its current          Warnings and Alerts: After more than 12 years
                        maceuticals      prescription drug       2002 after undergoing clinical trial testing engi-      Swiss pharmaceutical giant Novartis sus-                                 Pharmaceu-        spectrum antibiotic,     brand name form by the FDA in 1996. After a few          on the market, Levaquin had generated a high
                                         designed to counter     neered to measure drug efficacy. In late February       pended all marketing and sales of Zelnorm, a                             ticals            which means that         years on the market, Levaquin began to be linked         enough number of negative incident reports
                                         the bothersome          and early March 2007, Novartis Pharmaceuticals          popular prescription medication used to treat                                              it’s used to treat a     to reports of serious and painful side effects.          that were noticed by the FDA to warrant
                                         effects associated      gave FDA the results of new analyses of 29 clinical     the “constipation predominant” aspects of                                                  long list of bacterial                                                            action. In July of 2008, the FDA issued a
                                         with constipation.      studies of Zelnorm for treatment of a variety of gas-   the debilitating condition known as Irritable                                              infections and it is                                                              statement that it was ordering the makers of
                                         The drug has also       trointestinal tract conditions; the data from all the   Bowel Syndrome, or IBS. Zelnorm is also                                                    also approved for                                                                 Levaquin, Ortho-McNeil Pharmaceuticals, to
                                         been prescribed to      studies were combined to assess the chance of side      believed to be linked to a number of gastro-                                               treatment of bron-                                                                place a “Black Box Warning” on all labels of
                                         some women for          effects on the heart and blood vessels. In these 29     intestinal problems such as Ischemic Colitis,                                              chitis and pneumo-                                                                Levaquin.
                                         the short-term treat-   studies 11,614 patients were treated with Zelnorm       Intestinal Ischemia, and Colonic Ischemia.                                                 nia.
                                         ment of irritable       and over 7,000 were given a sugar pill placebo.         The FDA issued the recall of Zelnorm because
                                         bowel syndrome and                                                              they determined that the risks of the drug out-
                                         for patients under                                                              weigh the benefits. After reviewing the results
                                         the age of 65 suf-                                                              of a study wherein 13 people out of 11,614
                                         fering from chronic                                                             suffered serious cardiac events as opposed to
                                         constipation.                                                                   one case out of 7,031 people taking placebos,        27   Chantix        Pfizer Pharma-    The drug has been        Without the nicotine-induced dopamine release,           Warnings and Alerts: On February 1,
                                                                                                                         Novartis and the FDA concluded that this was                             ceuticals         linked with more         smokers no longer experience the same amount of          2008, the FDA issued an Alert to highlight
                                                                                                                         a statistically significant coincidence, and thus                        Chantix acts      than 15 reports of       pleasure they once did while smoking. This method        important revisions to the WARNINGS and
                                                                                                                         determined further review was necessary in                               at sites in the   traffic accidents        differs from traditional anti-smoking treatments,        PRECAUTIONS sections of the full prescrib-
                                                                                                                         order to prevent potential injury to the public                          brain affected    and 52 injuries          which help ease nicotine addiction through wean-         ing information for Chantix regarding serious
                                                                                                                         at large.                                                                by nicotine       caused by blackouts.     ing. Unlike other anti-smoking treatments, Chantix       neuropsychiatric symptoms. The FDA has
                                                                                                                                                                                                  and may help      Chantix is strongly      works on a neurological level to help smokers break      received more than 1,000 reports of serious in-
                                                                                                                                                                                                  those who         discouraged for          their nicotine addictions. Although it has shown         jury associated with Chantix, a figure that ex-
                                                                                                                                                                                                  wish to stop      those operating          promise as a smoking cessation drug, Chantix, also       ceeds the total amount of reports filed against
                                                                                                                                                                                                  smoking by        heavy machinery          known as varenicline, is believed to cause loss of       the top ten best-selling drugs combined.
                                                                                                                                                                                                  providing         and has already been     consciousness and other adverse mental problems,
                                                                                                                                                                                                  some nicotine     banned for airline       including suicidal ideation and suicidal behavior.
                                                                                                                                                                                                  effects to ease   pilots. Chantix’s
 24        NUVAR-       Organon USA,     NUVARING®               The FDA approved NUVARING® October of                   Warnings and Alerts: Wrongful death                                      the withdrawal    active ingredient,
           ING®         Inc, Organon     is a birth control      2001.                                                   complaints allege that the parties named as                              symptoms.         varenicline tartrate,
                        Pharmaceuti-     product that releases                                                           defendants, which includes Organon USA,                                                    prevents nicotine
                        cals USA, Inc.   two synthetic hor-                                                              Inc., Organon Pharmaceuticals USA, Inc.,                                                   from reaching
                        LLC              mones, etonogestrel                                                             Organon International, Inc., Akzo Nobel NV,                                                neuroreceptors in
                                         (a progestin) and                                                               Organon Biosciences, N.V., and Schering-                                                   the brain, prevent-
                                         ethinyl estradiol                                                               Plough Corporation, not only knew about                                                    ing the release of
                                         (an estrogen), into                                                             the potential side effects associated with                                                 dopamine.
                                         the woman’s body.                                                               NUVARING®, but concealed those risks
                                         These substances are                                                            from the public, including the FDA during            28   Viagra         Pfizer Pharma-    Viagra (sildenafil) is   Viagra has been manufactured and sold by Pfizer          Warnings and Alerts: In October 2007, the
                                         supposed to prevent                                                             the approval process. More than 50 lawsuits               (sildenafil)   ceuticals         an oral medication       since 1998 for treatment of Erectile Dysfunction         FDA updated the warning label for Viagra and
                                         ovulation as well                                                               have been filed against the entities associated                                            used to treat male       (ED). The medication has been heavily advertised         other impotence drugs to warn about possible
                                         as minimize any                                                                 with the birth control product NUVARING®                                                   sexual function          and promoted through television and media not            hearing loss which can occur suddently, within
                                         sperm penetration,                                                              in the United States, but news was recently                                                problems, i.e. im-       only for treatment of erectile dysfunction in men,       a few hours of taking the drug. In many cases
                                         thereby preventing                                                              released that the latest lawsuit filed was not for                                         potence or erectile      but as a sexual aid. The manufacturer failed to          the hearing loss is permanent.
                                         unwanted pregnan-                                                               injuries suffered as a result of the side effects                                          dysfunction, by          warn of about serious side effect which may cause a
                                         cies.                                                                           that have been allegedly linked to the product.                                            blocking the enzyme      vision problem known as NAION (Non-Arteritic
                                                                                                                         The latest lawsuit was for a claim of wrongful                                             phosphodiesterase-       Anterior Ischemic Optic Neuropathy) or sudden
                                                                                                                         death, filed in Essex County, New Jersey.                                                  PDE5 in the body.        hearing loss . As a result of a lack of blood flow to
                                                                                                                                                                                                                    In combination with      the optic nerve, users may experience sudden vision
                                                                                                                                                                                                                    sexual stimulation,      loss and there have been several reported cases of
                                                                                                                                                                                                                    Viagra works by          losing the ability to hear.
                                                                                                                                                                                                                    helping blood flow
 25        Ortho Evra   Ortho McNeil     Ortho Evra is a         In 2001, the FDA approved Ortho Evra, the first         Warnings and Alerts: On November 10,                                                       into the penis to
                        Pharmaceu-       transdermal (skin)      transdermal patch approved for birth control. The       2005, Ortho McNeil, a division of Johnson                                                  achieve and main-
                        ticals           weekly birth            weekly prescription patch releases norelgestromin       & Johnson, warned millions of women us-                                                    tain an erection.
                                         control patch that      and ethinyl estradiol to prevent ovulation and preg-    ing Ortho Evra that the birth control patch          29   Zoloft         Pfizer Pharma-    Zoloft (sertraline       Zoloft was approved by the FDA in 1991. In               Warnings and Alerts: In July 2006, the
                                         is prescribed to        nancy. Ortho Evra has been aggressively marketed        exposes them to significantly higher doses of             (sertraline    ceuticals         HCl) is an antide-       2007, it was the most prescribed antidepres-             FDA issued two alerts related to Zoloft. The
                                         prevent preg-           to consumers and doctors as a convenient alterna-       hormones and may put them at greater risk for             hydrochlo-                       pressant medication      sant on the U.S. retail market, with 29,652,000          first FDA alert announced the results of a
                                         nancy by delivering     tive to oral birth control pills. Approximately 4       blood clots and other serious side effects than           ride)                            known as a selective     prescriptions. Zoloft has been linked to several         study concerning the use of antidepressant
                                         continuous levels       million women have used the Ortho Evra Patch            previously disclosed.On January 21, 2008, the                                              serotonin reuptake       types of birth defects in newborns whose mothers         medicines during pregnancy by mothers of
                                         of the hormones         since it went on sale in 2002. The Associated Press     FDA modified the prescribing information for                                               inhibitor (SSRI),        were taking Zoloft (sertraline). In many cases,          babies born with a serious condition called
                                         norelgestromin and      reported that patch users die and suffer blood clots    the Ortho Evra Contraceptive Transdermal                                                   and is used to treat     the manufacturer did not fully disclose the actual       persistent pulmonary hypertension of the
                                         ethinyl estradiol       at a rate three times higher than women taking the      (Skin) Patch to include the results of a new                                               depression, social       risk of these injuries to the FDA and doctors and        newborn (PPHN). The second FDA alert
                                         (progestin and es-      pill.                                                   epidemiology study that found that users of                                                anxiety disorder,        patients, even though the company had such infor-        states that a life-threatening condition called
                                         trogen) through the                                                             the birth control patch were at higher risk of                                             posttraumatic stress     mation. The birth defects associated with Zoloft         Serotonin Syndrome can occur when SSRIs,
                                         skin and into the                                                               developing serious blood clots, also known                                                 disorder (PTSD),         include: congenital heart defects, particularly atrial   such as Zoloft, and medicines used to treat
                                         bloodstream.                                                                    as venous thromboembolism (VTE), than                                                      panic disorder, ob-      ventricular defects (ASD) and ventricular septal         migraine headaches known as 5-hydroxytryp-
                                                                                                                         women using birth control pills. VTE can lead                                              sessive-compulsive       defects (VSD). Other serious conditions linked to        tamine receptor agonists (triptans) are taken
                                                                                                                         to pulmonary embolism. The label changes                                                   disorder (OCD),          Zoloft include: Persistent Pulmonary Hyperten-           together. The FDA over the last few years
                                                                                                                         are based on a study conducted by the Boston                                               and premenstrual         sion of the Newborn (PPHN); and abdominal                has worked closely with the manufacturers of
                                                                                                                         Collaborative Drug Surveillance Program on                                                 dysphoric disorder       congenital defects such as omphalocele (abdominal        Zoloft to fully evaluate the risk of suicidality
                                                                                                                         behalf of Johnson and Johnson. The patch was                                               (PMDD) in adults.        wall defects); and cranial congenital defects, such as   in children, adolescents, and adults treated
                                                                                                                         studied in women aged 15-44. These findings                                                                         craniosynostosis.                                        with these medications. Zoloft maker Pfizer
                                                                                                                         support an earlier study that also said women                                                                                                                                Pharmaceuticals added a black box warning
                                                                                                                         in this group were at higher risk for VTE.                                                                                                                                   to Zoloft’s prescribing information describing
                                                                                                                                                                                                                                                                                                      the increased risk of suicidal thoughts and
                                                                                                                                                                                                                                                                                                      behavior in children and adolescents taking

42 x The Trial Lawyer                                                                                                                                                                                                                                                                                                           The Trial Lawyer x 43
              Drug	       	Developed	by	       						Use	 																																	Background	      																																							Action	Summary                      Drug	      	Developed	by	       						Use	 																																	Background	     																																							Action	Summary
 30        Depo-          Pfizer, Inc.     Depo-Provera is a        Depo-Provera is commonly prescribed as a birth         Warnings and Alerts: On November 17,                34   Prempro       Wyeth Phar-      Prempro is a drug      Until 1996, many menopausal women com-                    Warnings and Alerts: On August 18, 2006,
           Provera                         hormonal contra-         control method. However, Depo-Provera is also          2004, the FDA issued a “black box” warning                             maceutical       used for hormone       bined Premarin, which contained estrogen, with            Bloomberg reported that Wyeth was facing
                                           ceptive administered     used in treating certain types of cancer, including    regarding the long-term use of Depo-Provera                                             replacement therapy    Provera, which contains progestin, to relieve their       5,000 lawsuits over the menopause drug, alleg-
                                           by intramuscular         cancer of the endometrium (lining of the uterus).      and its strong causal relationship to significant                                       used to alleviate      symptoms. In 1996, Wyeth combined the two                 ing that Wyeth misled the plaintiffs through
                                           injection once every     Studies have shown that women taking DEPO              loss of bone mass density, including develop-                                           menopausal symp-       substances in its Prempro pill. In January 2003           deceptive marketing about the cancer risks
                                           eleven to thirteen       PROVERA, for more than five years, increased           ment of osteoporosis and osteopenia. The                                                toms.                  the FDA (Federal Food and Drug Administration)            associated with estrogen and progestin.
                                           weeks.                   their risk of developing osteoporosis by 50%.          warning reads: “Use of Depo-Provera may                                                                        required a black box warning for Prempro. This
                                                                                                                           cause you to lose calcium stored in your bones.                                                                action was based on the results of the Women’s
                                                                                                                           The longer you use Depo-Provera the more                                                                       Health Initiative (WHI) study conducted by the
                                                                                                                           calcium you are likely to lose. The calcium                                                                    National Institute of Health (NIH). The 2003
                                                                                                                           may not return completely once you stop us-                                                                    labeling change required Wyeth, the manufacturer
                                                                                                                           ing Depo-Provera.”                                                                                             of Prempro, to include information from the WHI
                                                                                                                                                                                                                                          study, which reported increased risks of myocardial
                                                                                                                                                                                                                                          infarction (heart attack), stroke, invasive breast can-
                                                                                                                                                                                                                                          cer, pulmonary emboli, and deep vein thrombosis
 31        Provera        Pharmacia &      Medroxy progester-       Progesterone is a female hormone and provera 10        The FDA approved Provera in 1959 and has                                                                       in postmenopausal women who took Prempro for
           (Medroxy-      Upjohn           one is a progestin       mg can help to treat irregular or missing periods      been prescribed to millions of women. Provera                                                                  5 years. The new label also included the warning
           progesterone                    and helps regulate       and abnormal bleeding of the uterus. Provera can       (Medroxyprogesterone acetateis) is derived                                                                     that Prempro should be prescribed at the lowest
           acetateis)                      menstruation and         also help to decrease your risk of hyperplasia of      from the female hormone progesterone.                                                                          effective dose for the shortest duration that was
                                           ovulation.               the endrometrium. Endometrial hyperplasia is a                                                                                                                        consistent with treatment goals.
                                                                    condition that may lead to uterine cancer that may
                                                                    be at risk of increase if you are taking an estrogen
                                                                    supplement.                                                                                                35   Premarin      Wyeth Phar-      Premarin is used to    Premarin, approved by the FDA in 1942, is derived         Warnings and Alerts: On January 6, 2003,
                                                                                                                                                                                    (conjugated   maceuticals      reduce moderate to     from the urine of pregnant mares. Premarin has            the FDA and Wyeth revised the prescribing
                                                                                                                                                                                    estrogens)    Inc.             severe symptoms of     been prescribed to millions of women for many             information to include a boxed warning,
                                                                                                                                                                                                                   menopause such as      decades. Premarin (conjugated estrogens) is a             which states that estrogens and estrogens plus
                                                                                                                                                                                                                   hot flashes, night     synthetic estrogen and a common medication used           progestin therapies should not be used for
                                                                                                                                                                                                                   sweats, vaginal        for hormone replacement therapy (HRT).                    the prevention of cardiovascular disease. The
                                                                                                                                                                                                                   dryness and sleep                                                                boxed warning includes risk information from
                                                                                                                                                                                                                   disturbances.                                                                    the Women’s Health Initiative (WHI) study.
 32        Ketek          Sanofi-Aventis   Ketek (telithromy-       Ketek was approved by the FDA in April 2004            Warnings and Alerts: In May 2006, the FDA                                                                                                                                The study reported increased risks of myocar-
           (telithromy-                    cin) is a prescription   and has been prescribed over five million times in     recommended that a black box warning be                                                                                                                                  dial infarction, stroke, invasive breast cancer,
           cin)                            antibiotic drug          the treatment of bacterial sinusitis, pneumonia,       added to the Ketek label, stating that “severe,                                                                                                                          pulmonary emboli, and deep vein thrombosis
                                           made by Aventis          and chronic bronchitis. It has been shown to cause     life-threatening, and in some cases fatal” liver                                                                                                                         in postmenopausal women during 5 years of
                                           Pharmaceuticals          liver damage, liver failure, and death. Ketek had      toxicity has been reported in patients taking                                                                                                                            treatment with conjugated equine estrogens
                                           indicated for the        been disapproved twice by the FDA prior to 2004;       the drug. The recommendation came after                                                                                                                                  (0.625 mg) combined with edroxyprogester-
                                           treatment of pneu-       once in 2001 and again in 2003. The FDA claimed        FDA safety reviewers found that Ketek has                                                                                                                                one acetate (2.5 mg) relative to placebo.
                                           monia, throat and        that both disapprovals were prompted by concerns       been linked to 12 cases of liver failure, includ-
                                           sinus infections and     regarding the safety of Ketek.                         ing four deaths, in the U.S. In some cases,
                                           chronic bronchitis,                                                             liver damage worsened rapidly and happened          36   Amiodarone    Wyeth Phar-      Amiodarone is a        Amiodarone was developed by a Belgian company             Warnings and Alerts: In 2004 doctors
                                           as well as serious or                                                           after just a few doses of Ketek. While this              (Brand        maceuticals      benzofluran pre-       in 1961 as a drug for treating angina (chest discom-      prescribed Amiodarone to approximately
                                           multi-drug resistant                                                            FDA advisory panel did not recommend a                   names:        Inc. by Sanofi   scription drug used    fort related to coronary artery disease), and quickly     2.3 million patients, and 82 percent of these
                                           infections. Ketek is                                                            Ketek recall, according to a December 13,                Cordarone,    Winthrop         to treat atrial and    became a popular anti-angina drug in Europe and           prescriptions were not for approved condi-
                                           in a class of drugs                                                             2006 report by CBS News, there is a new                  Pacerone)     Industrie I      ventricular cardiac    South America. Marketed under the brand name              tions. Sever side effects including lung dam-
                                           called ketolide an-                                                             Congressional probe underway to determine                                               arrhythmias.           of Cordarone, amiodarone was approved for use             age, Toxic Epidermal Necrolysis (TEN), and
                                           tibiotics, and is the                                                           whether Ketek should remain on the market.                                                                     by the Food and Drug Administration in 1985.              blindness are associated with Amniodrone.
                                           first FDA-approved                                                                                                                                                                             Although amiodarone was developed in the 1960s,           Many patients experiencing these side effects
                                           antibiotic of that                                                                                                                                                                             the FDA was reluctant to approve the drug earlier         said their doctor did not adequately inform
                                           class.                                                                                                                                                                                         because of reports linking it with serious pulmo-         them of the risks associated with this drug. In
                                                                                                                                                                                                                                          nary side effects. Amiodarone is used by both men         certain studies, up to 17% of patients suffered
                                                                                                                                                                                                                                          and women suffering from arrhythmia, but its              from lung damage with 10% of patients dying
                                                                                                                                                                                                                                          serious side effect only appears to affect women.         as a result of these lung damages.
                                                                                                                                                                                                                                          Some doctors prescribe Amiodarone for off-label
                                                                                                                                                                                                                                          use without informing their patients of possible
                                                                                                                                                                                                                                          side effects or advising them that the FDA had not
                                                                                                                                                                                                                                          approved their treatment as safe and effective.
 33        Permax®        Teva Phar-       Permax® (per-            Permax® (pergolide) was approved by the FDA in         Warnings and Alerts: In March of 2007, the
           (pergolide)    maceutical       golide) isused to        1988. Permax and Dostinex are chemically related       FDA notified consumers that companies
                          Industries and   treat Parkinson’s        to the diet drug “Fen-phen”, which was also related    manufacturing and distributing pergolide have       37   Darvocet®     Xanodyne         Darvocet® is a         Since 1978, the FDA has received two requests to          Warnings and Alerts: On Nov. 19, 2010, the
                          marketed by      disease and restless     to the development of valvular heart disease and       agreed to withdraw this drug from the market                           Pharmaceu-       narcotic painkiller    withdraw propoxyphene from the market. Until              FDA announced the results of the new safety
                          Valeant Phar-    leg syndrome. It         another very rare condition call Primary Pulmonary     due to the potential for heart valve damage.                           ticals           used to treat mild     the drug was recalled, however, its benefits always       study indicating that the medications, even
                          maceuticals      works by stopping        Hypertension (PPH).                                    Two new studies showed that patients with                                               to moderate pain.      were deemed to outweigh its risks, reports the            when taken at recommended doses, pose a
                          International    the brain from mak-                                                             Parkinson’s disease who were treated with                                               It is a combina-       agency.                                                   serious threat to patients’ hearts. Electrocar-
                                           ing and releasing the                                                           pergolide had an increased chance of serious                                            tion of two active     In January 2009, an FDA advisory committee met            diograms show the drugs caused dangerous
                                           prolactin hormone                                                               damage to their heart valves when compared                                              ingredients:           to review the efficacy and safety of propoxyphene.        electrical changes in the heart that result in
                                           from the pituitary.                                                             to patients who did not receive the drug.                                               Propoxyphene (the      The committee reviewed the original application           potentially fatal arrhythmias, or abnormal
                                                                                                                                                                                                                   ingredient causing     for the drug and results of subsequent studies.           heart rhythms.
                                                                                                                                                                                                                   the drug with-         It voted 14 to 12 to take the medication off the
                                                                                                                                                                                                                   drawal), a narcotic    market. But, in July 2009, the FDA went against
                                                                                                                                                                                                                   that can become        its advisory committee’s recommendations and
                                                                                                                                                                                                                   addictive              refrained from recalling the drug. The FDA said it
                                                                                                                                                                                                                   Acetaminophen (Ty-     believed that the benefits still outweighed the risks.
                                                                                                                                                                                                                   lenol is an example
                                                                                                                                                                                                                   of acetaminophen)
                                                                                                                                                                                                                   which is a pain
                                                                                                                                                                                                                   reliever and fever

44 x The Trial Lawyer

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