WASHINGTON — In 2010, a New Hampshire jury awarded Karen Bartlett $21 million for the ordeal she endured from taking a generic pain pill for an aching shoulder. It caused two-thirds of her skin to slough off, damaged her lungs and esophagus and rendered her legally blind.
At Supreme Court arguments on the drug maker’s appeal in Ms. Bartlett’s case on Tuesday, several justices seemed inclined to let her keep the money — if they could find a path through the court’s precedents about injury suits for harm from drugs that had been approved by the Food and Drug Administration.
The task turned out to be challenging. The court’s decisions have drawn distinctions between suits against manufacturers of brand-name drugs and those against the makers of their generic equivalents. Because generic manufacturers are required in many ways to mimic the composition of and warning labels for brand-name products, the court has said, it would not be appropriate to subject them to some kinds of liability.
In 2009, the court allowed Diana Levine, a musician who lost an arm after taking a brand-name drug, to keep a $6.7 million award against its manufacturer, Wyeth. The company had argued that its compliance with the drug agency’s labeling requirements immunized it from lawsuits.
The court’s decision in the case, Wyeth v. Levine, turned in large part on the fact that makers of brand-name drugs can sometimes change the labels on their products without permission from the agency.
Two years later, the court heard a similar case brought by women who took generic metoclopramide, which is sold under the brand name Reglan, for stomach ailments and developed a serious neurological disorder. The court ruled against the women, saying that the makers of generic drugs had no choice but to use the same warning labels as the corresponding brand-name drugs.
Justice Clarence Thomas, writing for the majority in the later case, Pliva Inc. v. Mensing, acknowledged that the distinction between generic and brand-name drugs “makes little sense” from the perspective of injured consumers. In dissent, Justice Sonia Sotomayor wrote that “a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic.”
The case heard on Tuesday, Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, presented a new wrinkle. A lawyer for Ms. Bartlett, who had taken generic sulindac, a nonsteroidal anti-inflammatory drug sold under the brand name Clinoril, argued that her complaint was not with the warning label but with the very design of a drug that could cause such grievous injuries.
Jay P. Lefkowitz, a lawyer for the drug company, said the new theory was little different from the old one. A generic drug must be identical in composition to the corresponding brand-name drug and makers of generic versions are powerless to change it. “There is no principled basis,” he said, “for treating design defect claims any differently from failure to warn claims.”
In any event, he said, Ms. Bartlett’s case relied heavily on asserted shortcomings in the warning label. That meant, he said, that the 2011 decision required the court to rule for his client.
Justice Elena Kagan appeared to agree that the case did not present a clean opportunity to decide whether design-defect suits are subject to different rules than ones concerning failures to warn. “It does seem to me that this case was litigated such that the adequacy of the warning is really all over this case,” she said.
Ms. Bartlett’s lawyer, David C. Frederick, argued that references to the warning label played a different role in his client’s case than they had in others, but it was not clear whether the justices followed or accepted his distinctions.
But some justices sounded intrigued by another distinction advanced by Mr. Frederick. He said his client was not asking the company to improve its warning, but only to be compensated under what he characterized as New Hampshire’s “strict liability” injury laws. Such laws do not require proof of fault where unreasonably dangerous products cause harm.
Chief Justice John G. Roberts Jr. asked a series of questions based on the distinction.
“Our cases are focused on the concern that the state is going to impose on the manufacturer a different duty than the federal government,” he said. “That’s not what’s going on in a strict liability regime.”
“The standard is the same,” he added, referring to state and federal requirements. “It’s just a question under strict liability that if you follow the same federal standard and market this in our state, you’re going to pay the compensation for the reason of, you know, spreading the costs.”
Mr. Lefkowitz said the point could have some force in the abstract, but said New Hampshire did not have the sort of law that made manufacturers the insurers of their products.
Anthony A. Yang, a lawyer for the federal government, which supported the drug company, said, “what we are trying to do is preserve the F.D.A.’s role here, not have juries second-guess on a case-by-case and state-by-state basis imposing different safety obligations on manufacturers.”
Justice Antonin Scalia agreed that juries were not well suited to making “the cost-benefit analysis for a very novel drug that unquestionably has some deleterious effects, but also can save some lives.”