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May 2, 2013 - May 3, 2013, Philadelphia

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FDA vs. State Courts: Supreme Court Hears Generic Liability Suit

The Supreme Court heard a case on Tuesday which will decide whether generics firms can be held liable and sued over alleged design flaws in their medications.



Generics are required by federal law to carry the same labelling as their brand name equivalent, labelling which has been dictated by the FDA – this means the case has the potential to challenge not just the liability of generic drugmakers, but also the authority of FDA rulings on a drug’s safety, branded or generic. At the heart of the issue is an uncertainty over whether decisions in state courts over personal injury claims regarding generic medicines controvert the authority of federal law.

The background to the case involves a New Hampshire woman, Karen Bartlett, who suffered burn-like injuries over 65 percent of her body and became permanently blind in 2004 after taking Sulindac, a generic Non-Steroidal Anti-Inflammatory Drug (NSAID) manufactured by Mutual Pharmaceutical. Bartlett and her husband sued Mutual for design defects under New Hampshire Law, and last May the federal court upheld the decision to award the couple $21 million in compensation. The Supreme Court is now reviewing an appeal by Mutual to overturn this ruling, based on the fact that the FDA had already approved Sulindac, and that as a generic manufacturer it is required by law to include only what is on the label of the branded drug.

Mutual’s lawyer, Jay P Lefkowitz, alluded to a 2011 Supreme Court ruling, known as Pliva vs. Mensing, which found that generic drugmakers are not required to change product labelling in response to additional information on side-effects, if the same change has not been made to the corresponding branded drug. Lefkowitz argued that it is impossible for a company to comply with state requirements for label changes and FDA requirements over labelling – and that federal law takes precedence. One of the judges presiding over Mutual’s appeal, Justice Elena Kagan, said that just because a company is authorized by the FDA to manufacture a drug with a certain label, this doesn’t prevent it from ceasing to manufacture if new safety information arises; in other words, Mutual were not forced to continue selling their drug by federal law, so they still remain liable.

She also pointed out that Lefkowitz’s arguments about the protections afforded to generics by federal law would also apply to branded drugs. Another judge, Justice Sonia Sotomayor, similarly highlighted the scope of the protection that was being sought by Mutual, asking “Is it now your position, and it seems to be, that anytime the FDA approves a product that there can never be a tort liability claim?”

The other side of the argument came from Assistant Solicitor General Anthony A. Yang, who said in support of Mutual that “What we are trying to do is preserve the FDA’s role here, not have juries second-guess on a case-by-case and state-by-state basis imposing different safety obligations on manufacturers — when Congress has established a regime for FDA to control this.” Justice Antonin Scalia was also uneasy over the possibility that the evaluation of a drug’s safety, depending on the result of the case, could in future be decided not by the FDA but by a court’s jury. The twelve members of the jury, he said, would be in a position to decide “for the whole state what the [. . .] cost/benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives.”

While the eyes of U.S pharma (particularly generic firms) will be fixed on this trial for indications of their future liability in personal injury claims, there are signs that the FDA may be taking matters into its own hands and mulling a change in the law. A footnote in a friend-of-the-court brief that the US Department of Justice filed in a similar case in January (see p15 of the brief) stated that “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labelling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate pre-emption of failure-to-warn claims against generic-drug manufacturers”

In short, if this measure was adopted, generics would be liable in court over failure to change labelling after becoming aware of serious side-effects to their drugs. The case continues. 



Patient Summit USA

May 2, 2013 - May 3, 2013, Philadelphia

Understand the patient journey to build better adherence and engagement platforms