In a narrow decision that hands the pharmaceutical industry a significant victory, the US Supreme Court ruled that state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because these are pre-empted by federal law.
The case was closely watched because the decision clarifies the extent to which consumers will be able to file lawsuits against generic drug makers stemming from alleged harm caused by their medicines. However, the issue had the entire pharmaceutical industry on edge because brand-name drugmakers feared the same notion might also be applied to their practices.
In fact, the Obama administration earlier this year had filed a brief in support of the pharmaceutical industry over concerns that the entire FDA regulatory review process could be undermined if medicines deemed safe and effective by the agency could later be considered “unreasonably dangerous.”
At issue was a lower court ruling that was being appealed by Mutual Pharmaceutical, which wanted to overturn a $21 million jury award to Karen Bartlett. The background: in 2004, the New Hampshire woman had taken its generic non-steroidal anti-inflammatory, or NSAID, called sulindac for shoulder pain. But a few months later, she developed Stevens-Johnson Syndrome and toxic epidermal necrolysis.
As a result, she is nearly permanently blind and suffered burn-like lesions on 65 percent of her body due to a hypersensitivity reaction. She spent 10 weeks at Massachusetts General Hospital, most of that in the burn unit; suffered two septic shock episodes and 12 major eye surgeries;, she is unable to read, drive or work, and must use a feeding tube, according to court documents.
Barlett and her husband subsequently sued Mutual for alleged design defects under New Hampshire state law, and last May, a federal appeals court upheld the award. Mutual, however, argued that federal law preempts this type of claim because the FDA had already approved sulindac and federal law requires a generic drug to have the same design as the brand-name medication.
In arguing to have the verdict overturned, Mutual pointed to a Supreme Court ruling in June 2011, which found generic drugmakers are not required to strengthen product labeling if alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine (back story). The case was known as Pliva vs. Mensing.
Bartlett, however, argued that the FDA should never have approved the drug in the first place and claimed the medicine was inherently dangerous based on the number of incident reports of the skin reaction that were filed with the FDA. On that basis, Bartlett and her attorneys had maintained that the design of the drug was “unreasonably dangerous” and defective.
But a majority of the Supreme Court disagreed. While calling the Bartlett case a “tragedy,” Justice Samuel Alito wrote in the 5-to-4 opinion. that the earlier Pliva ruling “makes clear that federal law prevents generic drug manufacturers from changing their labels. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law” (here is the ruling).
“…State law design-defect claims like New Hampshire’s that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling,” he continued.
In explaining the decision, Alito then wrote the appeals court settled on an inadequate notion that Mutual could be held liable, unless its medicine was withdrawn entirely. “The court of appeals’ solution – that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law – is no solution. Rather, adopting the courts’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this court’s pre-emption case law.”
What was meant by impossibility pre-emption? As Leslie Kendrick of the University of Virginia School of Law explained recently on Torts Prof Blog, “state tort liability for design defect or failure-to-warn is predicated on a judgment that a drug or drug label was not designed safely. But (drugmakers) generally cannot alter drugs or labels without FDA approval. Thus, (drugmakers) argue, it is impossible for them to comply with both tort law and FDA requirements.”
“Certain individual consumers are the losers,” says Victoria Davis Lockhard, an attorney with Greenberg Traurig, who represents drugmakers. “But this stems from Hatch-Waxman and the regulatory and statutory scheme to get generic drugs to consumers faster. It’s one of the side effects… And if the court came out differently, we may see manufacturers not sell certain products which can save lives. They would have to weigh overall benefits and risks, and that’s what the court recognized here.”
In a dissent, Justice Stephen Breyer disagreed, however, that it was impossible for Mutual to comply with both federal and state law and reiterated the notion that state tort litigation can serve as an adjunct to FDA regulation. In a separate dissent, Justice Sonia Sotomayor wrote that “if state and federal laws are properly understood, it is clear that New Hampshire’s design-defect claim did not impose a legal obligation that Mutual had to violate federal to satisfy… Nothing in Pliva vs. Mensing, nor any other precedent, dictates finding impossibility pre-emption here.”
She continues that the majority view “could have serious consequences for product safety. State design-defect laws play an important role not only discovering risks, but also in providing incentives for manufacturers to remove dangerous products from the market promptly.
“If manufacturers of products that require pre-approval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.”