Winds of Healthcare Regulatory Change in the US

Wyeth v. Levine & Related Matters

BIICL – Product Liability ForumBIICL – Product Liability ForumApril 28, 2009April 28, 2009

Tripp HastonTripp Haston

Wyeth v. LevineWyeth v. Levine – Pre-Argument Hype – Pre-Argument HypeHyped 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 forty-seven 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. LevineWyeth v. Levine – Pre-Argument Hype – Pre-Argument HypeNew England Journal of Medicine – July 3, New England Journal of Medicine – July 3, 20082008Preemption willPreemption will

Strip[ ] patients of their right to seek Strip[ ] patients of their right to seek redress . . .redress . . .

Result in the reduced safety of drugs Result in the reduced safety of drugs and medical devices for the American and medical devices for the American people. people.

Undermine the confidence that doctors Undermine the confidence that doctors and patients have in the safety of drugs and patients have in the safety of drugs and devices. and devices.

If injured patients are unable to seek If injured patients are unable to seek legal redress from manufacturers of legal redress from manufacturers of defective products, they may instead defective products, they may instead turn elsewhere.turn elsewhere.

Wyeth v. LevineWyeth v. Levine – Post-Argument – Post-Argument Interpretation Interpretation Wall Street Journal – March 5, 2009Wall Street Journal – March 5, 2009

[The] ruling will expose drug companies [The] ruling will expose drug companies to a kind of double innovation jeopardy. to a kind of double innovation jeopardy.

Now they will have to contemplate Now they will have to contemplate paying up front -- and paying later, even if paying up front -- and paying later, even if the tragic mistake in applying the drug is the tragic mistake in applying the drug is someone else's. someone else's.

WyethWyeth is a dream come true for the is a dream come true for the plaintiffs bar.plaintiffs bar.

New York Times – March 5, 2009New York Times – March 5, 2009[A] major setback for business groups [A] major setback for business groups that had hoped to build a barrier against that had hoped to build a barrier against injury lawsuits seeking billions of injury lawsuits seeking billions of dollars…dollars…

Wyeth v. LevineWyeth v. Levine – Preemption Primer – Preemption PrimerDual Federal-State Governmental SystemDual Federal-State Governmental System

U.S. Constitution – Supremacy ClauseU.S. Constitution – Supremacy Clause In conflicts of state & federal – federal law In conflicts of state & federal – federal law preempts state lawpreempts state law

Forms of PreemptionForms of Preemption Express - Congress has Expressly EndowedExpress - Congress has Expressly Endowed Implied – Conflict Exists Between State & Implied – Conflict Exists Between State & Federal LawFederal Law

““Impossibility”Impossibility” ““Objects & Purposes”Objects & Purposes”

Wyeth v. Levine Wyeth v. Levine – Background - Facts– Background - FactsWyeth’s anti-nausea medicine, Phenergan Wyeth’s anti-nausea medicine, Phenergan administered via “IV push” administration. administered via “IV push” administration. Label details preferential administration Label details preferential administration methods (IM, IV Drip) with lower risksmethods (IM, IV Drip) with lower risks Intra-arterial blood exposure during Intra-arterial blood exposure during administration results in gangrene & administration results in gangrene & amputationamputation

The warning label included, The warning label included, inter alia, inter alia, in in uppercase letters: uppercase letters:

INADVERTENT INTRA-ARTERIAL INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.OF THE AFFECTED EXTREMITY.

Wyeth v. Levine Wyeth v. Levine – Background - Legal– Background - LegalLegal PositionsLegal Positions

LevineLevine: Wyeth should have : Wyeth should have contraindicated “IV push” based on contraindicated “IV push” based on awareness of SAEs.awareness of SAEs. WyethWyeth: Claims preempted due to FDA’s : Claims preempted due to FDA’s approval of label which expressly approval of label which expressly referenced the relevant risk and its referenced the relevant risk and its awareness of SAEs.awareness of SAEs.

VT Supreme CourtVT Supreme Court Claims are not preempted; compliance not Claims are not preempted; compliance not impossible. Wyeth could have submitted impossible. Wyeth could have submitted stronger label.stronger label. FDA’s approved label entitled to no FDA’s approved label entitled to no deference.deference.

Wyeth v. LevineWyeth 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. LevineWyeth 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. LevineWyeth 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 ofFalse Assumptions of Wyeth Wyeth Opinion Opinion ILLNESS? Creates True “Objects/Purposes” Conflict

Failure to appreciate post-marketing pharmaco-vigilanceFailure to understand true scope of CBE changesFailure 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 ?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 - Medical Devices - Riegel v. Medtronic Riegel v. Medtronic & 2009 MDSA& 2009 MDSA 2008 – US Supreme Court found preemption for PMA-approved 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 AdvertisementsProhibition of Marketing of Class of Pain MedicationsStated intent to review classification of 25 medical devices

Unlikely to be Preemption Sympathetic

Likely to be More Demanding on “Safety”