Michael A. Swit, Esq. Vice President, The Weinberg Group Inc.

1. Michael A. Swit, Esq.Vice President, The Weinberg Group Inc. Top 20 Food & Drug Cases

2. Wyeth v. Levine • Facts: • Diana Levine – musician; migraines; went to clinic and given Demerol for pain and Phenergan (promethazine HCl) for nausea – both first IM and later in day via IV-Push method • Gangrene; amputated arm • Sued health care facility, clinician, and Wyeth; settled with all but Wyeth • Core allegation – labeling should have included a clear warning not to use IV-Push method. Top 20 Food & Drug Cases

3. Wyeth v. Levine … • Trial Court: • Jury verdict -- $7.4 million • Jury instructions -- not objected to by Wyeth -- FDA regulations allow a drug maker to strengthen label warnings without FDA prior approval • Rejected motion to dismiss verdict: • No direct conflict between FDA law and state law claims because FDA regulations allow strengthened claims • Record of at least 20 similar amputations going back to the ‘60’s • Verdict here would not obstruct FDA’s work because FDA paid only “passing attention” to the issue of IV-Push • State law plays a compensatory function not present in federal regulation Top 20 Food & Drug Cases

4. Wyeth v. Levine … • Vermont Supreme Court – affirmed trial court • Wyeth at Supreme Court – Two issues • It would have been impossible to meet the state law duty to change label without violating Federal law.Impossibility preemption • Allowing state law claim creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress” by substituting a lay jury’s opinion for FDA’s expert judgment on the labelingImplied Conflict Preemption Top 20 Food & Drug Cases

5. Wyeth v. Levine … • Net result if Wyeth had won: might have preempted all state tort failure-to-warn claims due to FDA’s approval of labeling • USSC: On preemption, two principles guide: • Purpose of Congress • Presumption -- Historic police powers of state were not to be superseded by federal law unless “was the clear and manifest purpose of Congress.” Top 20 Food & Drug Cases

6. Wyeth v. Levine … • Impossibility Preemption – would Wyeth have violated federal law by complying with state’s expectation of including a warning on the IV-Push? • Supreme Court – No. You could have filed a Changes Being Effected (CBE) supplement • Rejected a claim that FDA would not have approved a CBE supplement on basis of nothing in trial record to substantiate • Impossibility preemption – a “demanding defense” Top 20 Food & Drug Cases

7. Wyeth v. Levine … • “Obstruct Purposes” Issue • USSC – all evidence exists that Congress intended for state law claims to remain. Examples: • did not create a private right of action in 1938 • never has created express preemption for drugs (contrast devices) • USSC – FDA’s 2006 declaration that it preempted state law on labeling – weight given that conclusion is a factor of the ”thoroughness, consistency and persuasiveness” of the agency statement • USSC – 2006 preamble “does not merit deference” • Preemption not discussed in 2000 proposal; “inherently suspect in light of this procedural failure” • Contradicts Congressional intent and years of FDA stance on matter Top 20 Food & Drug Cases

8. Wyeth v. Levine … • “Obstruct Purposes” Issue … • Benefits of state law do not conflict with FDA’s mission • Uncover unknown drug hazard • Provide incentives for manufacturers to disclose safety risks promptly • Distinct compensatory function (not present in fed system) • In sum, Wyeth did not show that the state law requirement of greater warning would frustrate FDA’s purposes Top 20 Food & Drug Cases

9. Wyeth v. Levine … The Future? • Might still claim preemption if you can show you did all that was possible and FDA would not allow you to put it on your label • CBE’s will multiply • SSRI’s – might prevail on failure to warn because FDA has reviewed and rejected need for suicidal warnings • But – Mason v. SKB – ignored Levine • No impact on Buckman – that fraud on FDA claims are preempted Top 20 Food & Drug Cases

10. Perez v. Nidek • Facts: • Nidek has PMA approval for excimer lasers for LASIK and PRK for myopia, but not hyperopia • Plaintiffs – Nidek and doctor defendants conspired to use lasers for hyperopia uses not approved in PMAs • Claims: numerous California state law violations based on FDA violations • Filed in U.S. District Ct. for Southern District of California Top 20 Food & Drug Cases

11. Perez v. Nidek • Federal Question Jurisdiction claimed due to the alleged FDCA violations. • COURT: no; the alleged violations clash with Section 337(a) of FDCA – • “… all proceedings for the enforcement, or to restrain violations [of the Act] shall be by and in the name of the United States.” Courts: no private right of action under the FDCA • “When there is no private right of action under a federal statute such as the FDCA, “the presence of a claimed violation of the statute as an element of a state cause of action is insufficiently ‘substantial’ to confer federal question jurisdiction.”…” Top 20 Food & Drug Cases

12. Perez v. Nidek • Plaintiffs – Preemption Defense conferred Fed. Question Jurisdiction. • Court -- rejected • “… [t]he fact that a defendant might ultimately prove that a plaintiff’s claims are preempted … does not established federal jurisdiction. Caterpillar v. Williams, 482 U.S. 386, 398 (1987). Preemption gives rise to federal question jurisdiction only when an area of state law has been completely preempted by federal law. Id. At 393.” Top 20 Food & Drug Cases