Supreme Court Rules Design Defect Claims That Turn on Warnings Are Preempted – Mutual Pharmaceutical Co. v. Bartlett

I’ve written here many times about the ways injured people are seeking compensation from generic drug companies after PLIVA v. Mensing. In that case, the U.S. Supreme Court ruled that failure to warn lawsuits are preempted by federal law. It reasoned that state-court lawsuits make a kind of state law about how drug labels should look, which is impossible to comply with because federal law requires labels for generics to be exactly the same as the label for the name brand. Because failure to warn claims are most of the claims made by defective drug lawyers like me, this forced plaintiffs to come up with other theories of liability—when possible. The U.S. Supreme Court foreclosed another such theory this week with its ruling in Mutual Pharmaceutical Co. v. Bartlett, saying Karen Bartlett may not bring a design defect claim that turns on arguments about the adequacy of the drug’s label. Bartlett, of New Hampshire, suffered burns over 60 percent of her body after taking generic sulindac for shoulder pain. She is largely blind and has several other disabilities, and had to be fed from a tube for a year. Bartlett had a rare reaction to the sulindac called toxic epidermal necrolysis, which happens in a minority of people who take non-steroidal anti-inflammatory drugs. At the time, sulindac’s warning label was not required to carry warnings about toxic epidermal necrolysis (or its less serious cousin, Stevens-Johnson syndrome). The next year, after Bartlett had already been injured, the FDA ordered that the label warn of that risk. She eventually sued Mutual alleging a design defect and was awarded $21 million. The First U.S. Circuit Court of Appeals affirmed, finding that the suit wasn’t preempted by Mensing because generic manufacturers, faced with the choice to follow state “laws” on warning labels or federal regulations, could simply choose not to make the drug at all. The U.S. Supreme Court reversed this. The New Hampshire common law imposes strict liability on manufacturers for unreasonably dangerous products. Its state supreme court has ruled that they can ensure this by changing either the label or the design (which latter option is not possible for generic drugs). The jury in this case was instructed to consider whether Mutual had labeled the drug in a way that was not unreasonably dangerous. But, the majority said, Mensing already held that federal law prevents generic manufacturers from unilaterally changing their labels, thus creating “impossibility preemption.” It rejected the First Circuit’s suggestion that manufacturers could stop selling their products as “incoherent,” saying accepting it would make impossibility preemption meaningless. After rejecting arguments made by Justice Sotomayor’s dissent, the majority noted that intervention by Congress would be helpful in resolving preemption issues that have “vexed” the court in recent years. I strongly agree that Congressional intervention would be welcome—but as a pharmaceutical liability attorney, I worry that there’s too much money at stake for Congress to act without being influenced by drug companies’ money. At the moment, the regulatory regime the Supreme Court has created requires zero accountability from manufacturers of generic drugs. Injured people, even people who have suffered tragic injuries like Bartlett’s, may not sue a generic manufacturer over its label. Furthermore, state laws and insurance company rules ensure that consumers have little control over whether they receive the name brand or the generic at the pharmacy, making it difficult to control one’s own legal rights. The majority here did say it makes no ruling on design defect claims alleging the drug is “misbranded” because new information shows it’s unsafe when used correctly. As a dangerous drug lawyer, I appreciate that the court left at least this one avenue of liability open. If your family has suffered a loss or a serious injury because of a dangerous drug, don’t hesitate to call Carey, Danis & Lowe. For a free consultation, you can contact us online or call 1-877-678-3400. Similar blog posts: First Circuit Upholds Design Defect Verdict for Woman Burned and Blinded by NSAID – Bartlett v. Mutual Pharmaceutical Co. Federal Government Will Argue Against Lawsuits Against Generic Drug Manufacturers Supreme Court Rules State Drug Tort Claims Preempted by Federal Drug Regulations – PLIVA Inc. v. Mensing