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The Pharma, Biotech and Device Colloquium June 2005 Kaye Scholer llpKaye Scholer llp 0
Mass Tort LitigationMass Tort Litigationv.v.
FDA RegulationFDA Regulation
Jay P. Mayesh
Drug Safety, Product Liability and Litigation
Track II A
June 7, 2005
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 1
FDA Approved DevicesFDA Approved Devices
Dalkon Shield IUD
Artificial Heart Valves
Pacemakers
Pedicle Screws
Silicone Breast Implants
Hip Implants
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 2
Dalkon Shield IUD andSilicone Breast ImplantsDalkon Shield IUD andSilicone Breast Implants
Two (A.H. Robbins and Dow Corning) of the 6 manufacturers of FDA approved devices went bankrupt because of mass
tort liability.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 3
Artificial Heart Valves, Pacemakers, Pedicle Screws, and Hip Implants
Artificial Heart Valves, Pacemakers, Pedicle Screws, and Hip Implants
Four of the 6 manufacturers of approved devices incurred $$$$$ liabilities.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 4
The FDA is Your Best Friend
The Courtroom is Your Worst Nightmare
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 5
Welcome To My WorldWelcome To My World
Injured Plaintiffs
Judges
Juries
Evidence
Standard of Proof
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 6
JudgesJudges
Appointed Appointed for LifeElected
(partisan or non-
partisan)
Advisory Committees and FDA Staff
FederalState CourtsFDA
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 7
Judicial Selection in the StatesTable 1: Helland and Tabarrok
Judicial Selection in the StatesTable 1: Helland and Tabarrok
Illinois, MississippiTexas, West Virginia
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 8
Judge Richard NeelyAuthor, The Product Liability MessJudge Richard Neely
Author, The Product Liability Mess
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 9
A Jury of Your PeersA Jury of Your Peers
FDA
• Scientifically educated
• Chosen by merit
• Make decisions based upon known data and reasonable forecast
• Your colleagues
Courtroom
• Scientifically ignorant
• Chosen by lot
• Decisions infected with retrospective bias
• Injured plaintiff “colleagues”
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 10
Juries Do Not UnderstandProof of Cause and EffectJuries Do Not UnderstandProof of Cause and Effect
Association is not cause.
The plural of anecdote is not data.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 11
“In a world of cause and effect, coincidence is always suspect.”
Dr. Marcia Angell, former Editor In Chief of the New England Journal of Medicine
Juries will not accept chance.
Human nature wants to find a cause.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 12
Evidence available to Plaintiffs:Evidence available to Plaintiffs:
Adverse Event Reports
Labeling
Advertising
Marketing
Sales and Profits
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 13
The Pirate and the Hook
Hammers, Ladders, the Garden of Eden
and
Black Box Warnings
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 14
A society obsessed with avoidance of risk embraces the fiction that risk and uncertainty can
be controlled by WARNINGS.
It should have been in a Black Box.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 15
Jury Charge re FDACompliance is the minimum standard
Jury Charge re FDACompliance is the minimum standard
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 16
Take home message:Take home message:
• Compliance with law is minimum standard.
• Juries may overrule FDA and hold you to a higher standard.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 17
Get the picture?Get the picture?
The Courtroom is not friendly.
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 18
Kaye Scholer llpKaye Scholer llpThe Pharma, Biotech and Device Colloquium June 2005 19
ProphylaxisProphylaxis
• Do not resist strong warnings suggested by FDA. Strong warnings are your best friend.
• Do not write e-mails you wouldn’t want to see on the front page of the New York Times.
• Prominently include in all DTC advertising the message that all drugs and devices have risks as well as benefits.