Fwd: Supreme Court Rules Against Pharma Preemption Argument

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIIn a 6 to 3 ruling, the U.S. Supreme Court has ruled against Wyeth--and byextension, the pharmaceutical industry--which claimed immunity fromliability for failure to warn about risks associated with drugs by claimingFDA approval preempts state consumer safety laws.The Court Held: Federal law does not pre-empt Levine's claim thatPhenergan's label did not contain an adequate warning about the IV-pushmethod of administration of the drug-- Pp. 6-25.And, "Wyeth's argument that requiring it to comply with a state-law dutyto provide a stronger warning would interfere with Congress' purpose ofentrusting an expert agency with drug labeling decisions IS MERITLESSbecause it relies on an untenable interpretation of congressional intent andan overbroad view of an agency's power to pre-empt state law.  The history of the FDCA shows that Congress did not intend topre-empt state-law failure-to-warn actions. In advancing the argument thatthe FDA must be presumed to have established a specific labeling standardthat leaves no room for different state-law judgments, Wyeth relies not onany statement by Congress but on the preamble to a 2006 FDA regulationdeclaring that state-law failure-to-warn claims threaten the FDA'sstatutorily prescribed role.  Although an agency regulation with the force of law can pre-emptconflicting state requirements, this case involves no such regulation butmerely an agency's assertion that state law is an obstacle to achievingits statutory objectives. Where, as here, Congress has not authorized afederal agency to pre-empt state law directly, the weight this Courtaccords the agency's explanation of state law's impact on the federal schemedepends on its thoroughness, consistency, and persuasiveness. Cf.,e.g., Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA's2006 preamble does not merit deference: It is inherently suspect inlight of the FDA's failure to offer interested parties notice or opportunityfor comment on the pre-emption question; it is at odds with the availableevidence of Congress' purposes; and it reverses the FDA's own longstandingposition that state law is a complementary form of drug regulationwithout providing a reasoned explanation. Geier v. American Honda MotorCo., 529 U. S. 861, is distinguished. Pp. 17-25.Stevens, J., delivered the opinion of the Court, in which Kennedy, Souter,Ginsburg, and Breyer, JJ., joined. Breyer, J., filed a concurring opinion.Thomas, J., filed an opinion concurring in the judgment. Alito, J., filed adissenting opinion, in which Roberts, C. J., and Scalia, J., joined.http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf Contact: Vera Hassner Sharavveracare212-595-8974REUTERSU.S. top court rules against Wyeth in liability caseWed Mar 4, 2009 10:32am ESTBy Lisa Richwine and James ViciniWASHINGTON (Reuters) - The U.S. Supreme Court on Wednesday ruled against thedrugmaker Wyeth, holding that pharmaceutical companies can be held liablefor harm from medicines which carry warnings approved by federal regulators.By a 6-3 vote, the high court ruled that labeling approvals by the U.S. Foodand Drug Administration do not pre-empt state laws and shield companies fromlegal damages as part of liability claims.A Vermont jury awarded $7 million in damages to a guitarist, Diana Levine.Part of her arm had to be amputated after she was improperly injected withthe anti-nausea drug Phenergan made by Wyeth as part of treatment for amigraine.The justices affirmed a Vermont Supreme Court ruling that upheld the awardand rejected Wyeth's argument that labeling approvals by the FDA pre-emptsstate law liability claims."The question we must decide is whether the FDA's approvals provide Wyethwith a complete defense to Levine's tort claims. We conclude that they donot," Justice John Paul Stevens concluded in the court's majority opinion.Levine's attorneys said Wyeth should have given stronger warnings about thedangers of administering the drug in the way she received it. But Wyeth saidit acted properly by including the FDA's approved warnings on the label forthe drug.Federal pre-emption has been a goal of the pharmaceutical industry for yearsand had been supported by the Republican Bush administration and businessgroups upset by large damage awards.Wyeth and other drug companies argued state juries looking at the experienceof one patient do not have the expertise to determine if a drug has properwarnings.Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alitodissented. "This case illustrates that tragic facts made bad law," Alitowrote.(Reporting by Lisa Richwine and James Vicini, editing by Gerald E.McCormick, Dave Zimmerman)FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. _____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.