Impact_corporatecouncil_0911.qxd:technology times medtech
September 2011 Corporate Council The U.S. Supreme Court’s Pliva, Inc., et al. v. Mensing closes the courthouse door to people who take generic drugs — for now
By Debra S. Dunne, Elizabeth Ann Livingston and Julia M. Rafferty
“The central theme of this term is [that of] closing the courthouse doors,” said renowned legal scholar
Erwin Chemerinsky, Founding Dean, University of California — Irvine School of Law, in the Anti-DefamationLeague 12th Annual Supreme Court Review (July 6, 2011), a review of recent decisions by the UnitedStates Supreme Court.
Pliva Inc., et al. v. Mensing exemplifies this theme where the Supreme Court ruled, in a five-to-four decision, that federal law pre-empts state law failure-to-warn claims brought against generic drug manufacturers, closing the courthouse door for plaintiffs who have taken generic drugs and sufferedadverse side-effects allegedly caused by those drugs. [Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011)].
Gladys Mensing and Julie Demahy were prescribed the prescription medication Reglan (metoclopramide),to address symptoms associated with slow stomach emptying. Both Mensing and Demahy received genericsubstituted metoclopramide from their pharmacists, as permitted by state law. Mensing and Demahy developedtardive dyskinesia. In separate lawsuits, Mensing and Demahy alleged that generic metoclopramide
caused them to develop tardive dyskinesia and that the manufacturers of the drug failed to adequately
warn of the risk of tardive dyskinesia, a neurological condition that includes symptoms of involuntary,repetitive body movements. The Supreme Court consolidated Mensing and Demahy’s petitions for certiorariand in one opinion, reversed the Courts of Appeals for the Fifth and Eighth Circuits’ holdings that a plaintiff’sstate failure-to-warn claim against a generic drug manufacturer is not pre-empted by federal law.
Writing for the majority, Justice Clarence Thomas pronounced that generic drug manufacturers have an“ongoing duty of sameness” that requires generic drugs to carry the same warning labels as their brandname counterparts. See Mensing, 131 S.Ct. at 2576. Although a generic drug manufacturer theoreticallycould effectuate a label change if it learned that the current label was inadequate, the generic drugmanufacturer would require approval from the Food & Drug Administration (FDA) before it couldchange the warnings on its label. Using a new test for impossibility pre-emption — whether a privateparty could independently do under federal law what state law requires of it — the Court found thatMensing and Demahy’s claims were pre-empted by federal law because effecting a label change to
comply with state failure-to-warn laws would require action by a third-party, here the FDA. Thus, a
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manufacturer of generic metoclopramide cannot independently comply with its federal “duty of sameness” andits state law duty to adequately warn of potential side-effects.
Superficially, the majority “acknowledge[d] the unfortunate hand that federal drug regulation has dealt Mensing,Demahy and others similarly situated,” because, unlike plaintiffs who were prescribed and insisted on receivingbrand name drugs, plaintiffs who take generic drugs are now barred from pursuing state law remedies for theirinjuries. (See Mensing, 131 S.Ct. at 2581.) The difference in rights between a plaintiff who takes a brand namedrug and a plaintiff who takes generic drugs takes on even more significance because the government hassponsored the development of the generic market, and currently, 75% of all prescription drugs dispensed in thiscountry are generic. (See Mensing, 131 S.Ct. at 2583.) The effect of the Supreme Court’s decision in Mensing isthat a large sector of the American public cannot sue the manufacturer of the drugs dispensed to them under atheory of failure to warn and have lost the opportunity to recover for injuries allegedly caused by those drugs. (Plaintiffs who have taken brand name drugs may still sue the manufacturer and bring state tort law claims.) Themajority’s only response to this situation was to state that, “[a]s always, Congress and the FDA retain the authorityto change the law and regulations if they so desire.” (See Mensing, 131 S.Ct. at 2582.)
Stressing that the test for impossibility pre-emption is traditionally a demanding standard, Justice Sotomayor’s dissent argued that the majority “strained” to reach the conclusion of pre-emption and “invented new principles ofpre-emption out of thin air to justify its dilution of the impossibility standard.” (See Mensing, 131 S.Ct. at 2582.) Thedissent agreed that generic drug manufacturers could not unilaterally strengthen their labels, but argued that theyhad not proven that this inability rendered it impossible for them to comply with state failure-to-warn laws. Instead,the dissent reminded us that “the existence of a hypothetical or potential conflict is insufficient to warrant pre-emption”and that, under the facts as described by the majority, the generic drug manufacturers must have petitioned theFDA for a label change and been denied approval of that change before they could argue that federal laws madeit impossible for them to comply with state law duties. (See Mensing, 131 S.Ct. at 2587.)
Taking a cue from a footnote in the dissent (“The question of ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” See Mensing, 131 S.Ct. at 2571.), Mensing andDemahy have petitioned for rehearing, arguing that the Court’s June 23, 2011 judgment does not follow from thepre-emption rule that it announced in the case. (See Mensing, 131 S.Ct. at 2582 n.8.) Specifically, Mensing andDemahy argue that the majority opinion “overlook[ed] the fact that the Petitioner generic drug companies couldhave ‘independently’ complied with both state and federal law simply by suspending sales of generic metoclopramidewith warnings that they knew or should have known were inadequate.” (See Respondent’s Petition for Rehearingat 1.) In essence, state failure-to-warn laws require generic drug manufacturers not to sell a drug with an inadequatewarning. Even though a generic drug manufacturer may not have had the ability to alter its warning label absentapproval from the FDA, it could have complied with its state law duties by stopping production and distributionafter learning of the label’s inadequacy — or so Mensing and Demahy now claim. Thus, manufacturers of genericmetoclopramide independently could have complied with their federal and state law duties — the Court’s June23, 2011 majority opinion is based on the opposite premise.
If Mensing and Demahy’s petition for rehearing convinces just one of the concurring Justices that the majority’s decision is irreconcilable with the pre-emption rule that it announced, then this case could go back to the SupremeCourt for reconsideration. For now, generic drug manufacturers, plaintiffs in state law actions and the rest of ussimply await word from the Court as to whether this case will proceed or whether the June 23, 2011 decision is final.
As Chair of Stradley Ronon Stevens & Young, LLP’s Life Sciences Practice Group, Debra Dunne counsels FDA-regulated companies on regulatory, commercial, compliance and risk-management issues, and litigatespharmaceutical and medical-device commercial and products liability cases. Her practice includes working withcross-functional client teams on complex legal and regulatory issues related to drug development and post-marketing, including REMS evaluation and planning, FDA advisory board preparation, safety, promotional and scientific reviews. She is a frequent speaker and was a pharmacist prior to getting her law degree. www.philadelphiapact.com September 2011 Corporate Council
Elizabeth Livingston is an attorney with Stradley Ronon Stevens & Young, LLP, who focuses on general litigation,primarily in the areas of products liability and commercial litigation. She works directly with the firm’s life sciencespractice group, which offers expertise in representing pharmaceutical, medical-device and other FDA-regulatedcompanies. In addition to serving clients, Livingston is extensively involved in the community. This spring, sheserved as a committee member of The Drueding Center’s Stairway to Our Future gala, which raised over $150,000to support the women and children at The Drueding Center. Livingston graduated with a B.A. from The Collegeof New Jersey, earned an M.A. from The University of Delaware and received her J.D. from Rutgers UniversitySchool of Law — Camden.
Julia Rafferty is an attorney with Stradley Ronon Stevens & Young, LLP, who focuses on general litigation, primarily in the area of products liability and mass tort. She is a member of the firm’s life sciences practice group, which offers extensive experience representing pharmaceutical, medical-device and other FDA-regulatedcompanies. Rafferty is dedicated to her involvement in the community. She currently serves as a member of theboard of trustees at the Gesu School in Philadelphia. Rafferty graduated with a B.S. from Boston College and received her J.D. from Villanova University School of Law. www.philadelphiapact.com
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