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Winds of Healthcare Regulatory Change in the US W yeth v. Levine & Related Matters. BIICL – Product Liability Forum April 28, 2009. 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.”

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winds of healthcare regulatory change in the us w yeth v levine related matters

Winds of Healthcare Regulatory Change in the US Wyeth v. Levine & Related Matters

BIICL – Product Liability Forum

April 28, 2009

Tripp Haston

wyeth v levine pre argument hype

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 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 levine pre argument hype1

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

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

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 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

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

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

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 rationale1

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

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

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

Medical Devices - Riegel v. Medtronic & 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

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”

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