Supreme Court to Decide if Generic Drug Makers Can Be Sued

The U.S. Supreme Court today heard arguments in a case that will further refine to what extent the makers of generic pharmaceutical drugs can be sued in state court.

In Bartlett v. Mutual Pharmaceuticals, the justices will decide if federal law that governs the design of generic drugs preempts state consumer protection laws in cases where the drugs injure patients.

Karen Bartlett was blinded and suffered horrific skin problems in 2004, with two-thirds of her body becoming an open wound, after taking Sulindac, a generic anti-inflammatory drug manufactured by Mutual. Bartlett sued over what she called a defective drug, and was awarded $21 million by a New Hampshire jury in 2010. The 1st U.S. Circuit Court of Appeals upheld the award last year.

At issue is the fact that generic drugs must be replicas of their FDA-approved name-brand predecessors, including the chemical composition as well as the label on the bottle. To protect the manufacturers, generics cannot be the subject of federal lawsuits, and a broadening interpretation of the concept of preemption has made lawsuits in state courts an ever more difficult proposition.

The Supreme Court considered a similar situation in Pliva v. Mensing, in which the justices ruled in a 5-4 decision in 2011 that generic drugs could not be sued in state courts for failing to properly warn about side effects. The logic was that generics are required by law to have the same labeling as the prescription drugs they mimic; the flip side is that manufacturers are off the hook for selling dangerous products without warning even if they know the label is insufficient.

Bartlett actually brought a “failure to warn” suit against Mutual originally, but it was dismissed. The distinction in the case the Supreme Court is now hearing is that the plaintiff is claiming the drug is defective to begin with, not that the labeling was wrong.

“The only state-law obligation is to compensate consumers for injuries caused by an unreasonably dangerous product,” the respondent’s brief reads. “Nothing in federal law prohibits petitioner from paying compensatory damages.”

Just Stop Selling It

The appeals court in the Bartlett case pointed out that a generic manufacturer that knows a drug is dangerous can just stop selling it.

 ”The question presented to the Court is whether the First Circuit Court erred when it ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic drug manufacturer stops selling its products,” writes Kurt R. Karst, an attorney with Hyman, Phelps & McNamara, on the FDA Law Blog.

During Tuesday’s arguments, Justice Elana Kagan gave credence to the 1st Circuit logic. “What we have in the FDCA is a statute that authorizes, that says, ‘You can sell this,’” she said. “But it doesn’t say you must sell it, and it doesn’t give you a right to sell it.”

Chief Justice John Roberts, on the other hand, expressed concern that in deeming the drug defective, the New Hampshire jury decision could eliminate Sulindac from the market altogether. “They said the risks outweigh the benefits, period,” Roberts said. “So you should not market this at all. And it does seem inconsistent with the federal regime [that approved the drug in the first place].”

Justice Stephen Breyer compared Sulindac to chemotherapy as a treatment that could help many people but cause terrible side effects for some.

The federal government argued in favor of Mutual. “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,” said Anthony Yang, assistant to the Solicitor General.

Justice Sonia Sotomayor appeared concerned about preserving states’ autonomy, saying to Yang, “You’re basically saying the minute that the FDA gives you permission to sell, it’s a right to sell. And it can’t be altered by any state police power.”

A big change could be coming regardless of the court’s decision: A brief filed by the  government in support of Mutual notes that the FDA is considering a regulatory change to allow generics to change their labeling, which would eliminate a large chunk of the controversy over their liability.