Current Issues in
Pharmaceutical and Medical
Thursday, November 11, 2010
Hosted by Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey
Sponsored by the Pharmaceuticals and Medical Device Subcommittees
of the Products Liability Committee and by the Pharmaceuticals and Medical
Device Subcommittee of the Mass Torts Committee
of the ABA Section of Litigation
CURRENT ISSUES IN
PHARMACEUTICAL AND MEDICAL DEVICE LITIGATION
Thursday, November 11, 2010
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, New Jersey
9:00 a.m. – 9:15 a.m. Registration/Continental Breakfast
Welcome & Introduction
Kara Trouslot Stubbs, Baker Sterchi Cowden & Rice LLC, Kansas City, MO
Alan Vickery, Sedgwick, Detert, Moran & Arnold, LLP, Dallas, TX
9:15 - 10:25 a.m. What You Need to Know About Product Recalls
Kim M. Schmid
Bowman and Brooke LLP
The Honorable John R. Tunheim, United States District Court for Minnesota,
Ellen Relkin, Weitz & Luxenberg, New York, NY
Jim Rogers, Nelson Mullins Riley & Scarborough, LLP, Columbia, SC
Susan J. Thompson, Senior Counsel, Boston Scientific Corporation, St. Paul,
There have been a number of significant government and industry-initiated re-
calls in the medical device industry within the past year. This panel will discuss
issues such as company document production, issue of “notice,” pre- and post-
production testing and surveillance, corporate representative depositions and the
“due care” story, evidentiary restrictions on recalls, possible retention of a media
consultant to get out a controlled message, public perception of the company re-
10:25 - 11:35 a.m. The Concurrent Defense of Civil Actions and FDA Regulatory Actions
Sedgwick, Detert, Moran & Arnold LLP
Los Angeles, CA
The Honorable Marina Corodemus, Iselin, NJ
Robert K. Jenner, Janet Jenner & Suggs, Baltimore, MD
Diane Sullivan, Dechert LLP, Princeton, NJ
This panel will examine the potential land mines when a company is faced with
defending a civil action and an FDA regulatory action concurrently and strategies
for negotiating around them.
11:35 - 11:50 a.m. Break
11:50 - 1:00 p.m. FDA and Social Media Rules
Elizabeth S. Raines
Baker Sterchi Cowden & Rice L.L.C.
Kansas City, MO
Elizabeth Forminard, Senior Counsel, Johnson & Johnson, New Brunswick, NJ
William Hoffman, Kaye Scholer, Washington, D.C.
Like the rest of America, pharmaceutical companies have embraced blogging,
tweeting and making friends on Facebook even though federal guidelines regu-
lating those activities are evolving. This activity has caused concern within the
FDA that the social media may encourage false claims and misleading advertis-
ing and may complicate the reporting of adverse events. The panel will discuss
the anticipated FDA guidelines for regulation of social media sites and its poten-
tial impact on the industry.
1:00 - 2:15 p.m. Lunch
2:15 - 3:25 p.m. Current Developments in Pharmaceutical and Medical Device Litigation
David L. Ferrera
Nutter McClennen & Fish, LLP
Edward W. Gerecke, Carlton Fields, Tampa, FL
John B. Merchant, III, The Merchant Law Firm, P.C., Atlanta, GA
Andrew C. White, Senior Corporate Counsel, U.S. Litigation, Sanofi-Aventis,
U.S., Bridgewater, NJ
Rebecca K. Wood, Sidley Austin, LLP, Washington, D.C.
This panel will discuss significant recent developments in the law governing
pharmaceutical and medical device manufacturers. Panelists will update you on
the latest relevant decisions impacting the preemption defense, the learned in-
termediary doctrine, and e-discovery. Following brief overview presentations,
each topic will be explored further in a Q&A format offering the unique perspec-
tives of individuals from the in-house, plaintiffs’ and defendants’ bars.
3:25 - 3:40 p.m. Break
3:40 – 4:50 p.m. If You Settle, You May Have to Report…Mandatory Reporting Under the
Oppenheimer Wolff & Donnelley, LLP
Sylvius von Saucken, Chief Compliance Officer, Garretson Firm Resolution
Group, Inc., Cincinnati, OH
Franklin Solomon, Locks Law Firm, LLC, Cherry Hill, NJ
Janice Ziegler, Sonnenschein, Nath & Rosenthal, LLP, Washington, D.C.
This panel will discuss the mandatory reporting requirements under the Medicare
Secondary Payer Act and the Medicare, Medicaid and SCHIP Extension Act of
2007 and how those requirements will impact the settlement of personal injury
claims related to pharmaceuticals and medical devices, particularly those cases
involving multiple plaintiffs and/or class actions.
4:50 p.m. Closing Remarks
5:00 p.m. Reception at Johnson & Johnson
The Pharmaceuticals and Medical Device Subcommittees of the Products Liability
Committee and The Pharmaceuticals and Medical Device Subcommittee of The Mass
Torts Committee of the ABA Section of Litigation
Kara Trouslot Stubbs Alan R. Vickery
Baker Sterchi Cowden & Rice, L.L.C. Sedgwick, Detert, Moran & Arnold, LLP
Kansas City, MO Dallas, TX
Pharmaceuticals Subcommittee Chairs:
Sam L. Felker
Bass Berry & Sims PLC
Medical Device Subcommittee Co-Chairs:
James C. Barton, Jr. Neville H. Boschert
Johnston Barton Proctor & Rose LLP Watkins Ludlam Winter & Stennis, P.A.
Birmingham, AL Jackson, MS
Products Liability Committee Co-Chairs:
Jerry G. Bradford Nathaniel Cade, Jr. Lori B. Leskin
Alcon Laboratories, Inc. Michael Best & Friedrich Kaye Scholer, LLP
Fort Worth, TX LLP New York, NY
Mass Torts Committee Co-Chairs:
Andrew J. Maloney, III Beatrice O'Donnell Rudy Perrino
Kreindler & Kreindler LLP Duane Morris LLP Fulbright & Jaworski L.L.P.
New York, NY Philadelphia, PA Los Angeles, CA
Pharmaceuticals and Medical Device Subcommittee of Mass Torts Committee Co-Chairs:
Oppenheimer Wolff & Susan Friery, M.D. Eric Hudson Karen Woodward
Donnelly LLP Kreindler & Kreindler LLP Butler, Snow, O’Mara, Sedgwick, Detert, Moran
Minneapolis, MN New York, NY Stevens & Cannada, & Arnold LLP
PLLC Los Angeles, CA
We recommend attendees stay at the Hyatt Regency New Brunswick due to its close proximity
to Johnson & Johnson. Please contact the hotel directly to make reservations at 1-888-421-
1442 and reserve your room within the “Pharma/Medical Device Meeting” block of rooms, which
have a special guest room rate of $149. It is recommended that room reservations be made
early, as the block will fill quickly.
Visit http://www.abanet.org/litigation/programs/programs_future.html to register online or return
the Registration Form on the following page with your payment (checks only) to Kara Stubbs at
Baker Sterchi Cowden & Rice, L.L.C., 2400 Pershing Road, Suite 500, Kansas City, MO 64108.
Requests for refunds must be made in writing and received no later than November 4th, in the
ABA Section of Litigation office. Please email your request to Matthew Thurman, at
email@example.com. There will be a $10 administrative fee deducted from the refund.
Cancellations received after November 4th will not be refunded; however, the Section will gladly
accept substitutions for those unable to attend.
For registrants who need transportation from New York City or Newark International Airport to
New Brunswick, there are numerous roundtrip options via the New Jersey Transit from Penn
Station and Newark Airport to New Brunswick. You may then take a taxi from the train station to
Johnson & Johnson. Click on this link for transit schedules and details:
Accreditation has been requested for this program from every state with mandatory continuing
legal education requirements for attorneys. Please be aware that each state has its own rules
and regulations, including its definition of CLE as well as ‘Ethics’. Therefore, certain programs
may not receive credit in some states. Please check with your state agency for confirmation of
general as well as ethics approval for any program. You may contact Matthew Thurman at the
ABA at firstname.lastname@example.org for confirmation of the number of credits approved by any
Business casual dress is encouraged for all participants.
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the individual and private use of ABA members in connection with the ABA’s mission, goals and
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City State Zip Code
ABA Member No.
The information submitted on this registration form will be used only to create an attendance list for the
Current Issues in Pharmaceuticals and Medical Device Litigation CLE Workshop.
$125.00 (Section of Litigation members and Government attorneys)
$180.00 (Non-Section members)
Pre-registration deadline is November 4, 2010. Checks for attendance and course materials should be
made payable to the AMERICAN BAR ASSOCIATION (no credit cards).
I will attend the meeting and my check for $ .00 is enclosed.
I am unable to attend the meeting, but please send the course materials to the above address, at a
cost of $35.00, a check for which is enclosed.
Please send your Registration Form and check to: Kara Stubbs, Baker Sterchi Cowden & Rice, L.L.C.,
2400 Pershing, Suite 500, Kansas City, Missouri 64108.
For additional information about the program, please contact:
Kara Stubbs (816 471-2121 / email@example.com
Alan Vickery (469) 227-4604 / firstname.lastname@example.org