Transcript Wyeth v. Levine

BIICL – Product Liability Forum
April 28, 2009
Winds of Healthcare Regulatory Change in the US
Wyeth v. Levine & Related Matters
Tripp Haston
Wyeth v. Levine – Pre-Argument Hype
Hyped
by the U.S. Chamber of Commerce as “the
most important business case of the Century.”
Over
thirty amicus briefs from interests as diverse as
the U.S. Government, Attorneys General from fortyseven States, former F.D.A. Commissioners, and
professors at leading U.S. Universities.
Subject
of editorials in both the New England Journal of
Medicine and the Journal of the American Medical Association.
Wyeth v. Levine – Pre-Argument Hype
New England Journal of Medicine – July 3, 2008
Preemption will
Strip[ ] patients of their right to seek redress . . .
Result
in the reduced safety of drugs and medical
devices for the American people.
Undermine
the confidence that doctors and
patients have in the safety of drugs and devices.
If
injured patients are unable to seek legal redress
from manufacturers of defective products, they may
instead turn elsewhere.
Wyeth v. Levine – Post-Argument Interpretation
Wall Street Journal – March 5, 2009
[The] ruling will expose drug companies to a kind of
double innovation jeopardy.
Now
they will have to contemplate paying up front -and paying later, even if the tragic mistake in applying
the drug is someone else's.
Wyeth
is a dream come true for the plaintiffs bar.
New York Times – March 5, 2009
[A] major setback for business groups that had hoped
to build a barrier against injury lawsuits seeking billions
of dollars…
Wyeth v. Levine – Preemption Primer
Dual Federal-State Governmental System
U.S. Constitution – Supremacy Clause
 In conflicts of state & federal – federal law preempts state
law

Forms of Preemption
Express - Congress has Expressly Endowed
 Implied – Conflict Exists Between State & Federal Law

 “Impossibility”
 “Objects
& Purposes”
Wyeth v. Levine – Background - Facts
Wyeth’s
anti-nausea medicine, Phenergan administered
via “IV push” administration. Label details preferential
administration methods (IM, IV Drip) with lower risks
Intra-arterial
blood exposure during administration
results in gangrene & amputation
The
warning label included, inter alia, in uppercase
letters:
INADVERTENT
INTRA-ARTERIAL INJECTION
CAN RESULT IN GANGRENE OF THE
AFFECTED EXTREMITY.
Wyeth v. Levine – Background - Legal
Legal Positions
Levine: Wyeth should have contraindicated “IV push”
based on awareness of SAEs.
 Wyeth: Claims preempted due to FDA’s approval of
label which expressly referenced the relevant risk and its
awareness of SAEs.

VT Supreme Court
Claims are not preempted; compliance not impossible.
Wyeth could have submitted stronger label.
 FDA’s approved label entitled to no deference.

Wyeth v. Levine - Ruling
J. Stevens, Kennedy, Souter, Ginsberg, Breyer & Thomas (ccing in result)
HOLDING: FDA’s Approval of Phenergan label did not
preempt Levine’s state law failure to warn claim
BASIS:
 Compliance with federal labeling requirements and
Vermont failure to warn law not “impossible”
 Compliance with VT law did not interfere with
FDA’s role to such an extent as to create a basis for
“purposes & objectives” conflict preemption
Wyeth v. Levine - Rationale
J. Stevens, Kennedy, Souter, Ginsberg, Breyer & Thomas (ccing in result)
Compliance with both federal labeling requirements and
Vermont failure to warn law not “impossible”
 Changes
Being Effected (“CBE”) label regulation allows
sponsors to make unilateral label changes without FDA
approval
 Wyeth
could have unilaterally added a stronger warning via
CBE and no evidence FDA would have rejected such a label
change
 Wyeth
(and all sponsors), not the FDA, bears ultimate
responsibility for adequacy of its label
Wyeth v. Levine - Rationale
J. Stevens, Kennedy, Souter, Ginsberg, Breyer & Thomas (ccing in result)
No “objects and purposes” conflict with FDA’s role and
Vermont failure to warn law
 No
Congressional intent to allow FDA’s label decisions to
preempt state law
 FDA’s
Jan 2006 Preamble “inherently suspect” and rejected
as a basis for preemption



FDA failed to allow public comment after initially
indicating no preemptive effect on state law
Inconsistent with longstanding FDA position that state
law complimented FDA’s role
At odds with available information on Congressional
intent
False Assumptions of Wyeth Opinion
ILLNESS?
Creates True “Objects/Purposes” Conflict
Failure to appreciate post-marketing pharmaco-vigilance
Failure to understand true scope of CBE changes
Failure to appreciate FDA’s expertise in labeling

CURE? Legislation or New/More Specific FDA Regulation
 Better public awareness of drug development, approval &
post-marketing safety surveillance processes
 Better industry-agency-medical community collaboration
 Finding the proper balance between uniformity and proper
incentives for individual medicine’s monitoring
Future of FDA Preemption ?
Available
but Narrowed – a return to 2005
Must show “impossible” to comply with federal law (FDA
approved label) and state law (Plaintiff proposed label)


Will likely lead to more labeling proposals

Colaccio v. Apotex & GSK (USCA - 3rd Cir)
 First “impossibility” test case post-Levine
 Good record of FDA’s consideration & rejection of
plaintiff’s proposed label
Medical Devices - Riegel v. Medtronic & 2009 MDSA
2008
– US Supreme Court found preemption for PMAapproved devices based on express preemption provision in
Medical Device Amendments Act (Riegel v. Medtronic)
2009
Medical Device Safety Act – Proposed legislation that
would remove the express preemption provision of the MDAA
Broad support of Democrats in House & Senate
 Broad support of key interest groups – AARP, ABA
 Hearings not yet scheduled

Today’s FDA

Signs of More Aggressive Regulatory Action
14 Warning Letters regarding Internet Advertisements
Prohibition of Marketing of Class of Pain Medications
Stated intent to review classification of 25 medical devices


Unlikely to be Preemption Sympathetic

Likely to be More Demanding on “Safety”