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

1. Winds of Healthcare Regulatory Change in the US Wyeth v. Levine & Related Matters BIICL – Product Liability Forum April 28, 2009 Tripp Haston

2. 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.

3. 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.

4. 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…

5. 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”

6. 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.

7. 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.

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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”