By Robert Barnes,
The Washington Post
Karen Bartlett’s burn surgeon called her life “hell on Earth,” and there is no reason to believe that is an exaggeration.
In 2004, after she took the anti-inflammatory drug sulindac at her doctor’s direction to relieve shoulder pain, she developed a rare but known side effect: a form of Stevens-Johnson Syndrome, or SJS/TEN.
It caused the outer layer of her skin to deteriorate until it became an open wound over more than 60 percent of her body. She spent months in a medically induced coma. She underwent 12 eye surgeries, with more to come. She has lung damage and esophageal damage and is now legally blind.
She sued Mutual Pharmaceutical, which manufactured the drug, and a New Hampshire jury awarded her $21 million.
But Mutual’s attorney told the Supreme Court on Tuesday that because sulindac is the generic version of the brand-name drug Clinoril, the company could not take the precautionary actions the New Hampshire jury said it should have.
“Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version,” attorney Jay P. Lefkowitz told the court. But the jury found the company liable “because sulindac didn’t have a different safety profile, meaning a different ingredient or a different warning.”
It is impossible for the company to comply with both, he said, and federal law takes precedence.
The case presents issues that have divided the court before. In 2009, it ruled that the Federal Drug and Cosmetics Act did not shield a brand-name drug manufacturer from a state suit that its warning label was inadequate, despite federal regulators’ involvement in writing the label.
But in 2011, it did protect a generic-drug company against a state tort because it said the warning label was dictated by requirements imposed by the U.S. Food and Drug Administration on its brand-name counterpart.
Lefkowitz and David Frederick, representing Bartlett, received tough questioning.
Justice Elena Kagan told Lefkowitz that although the case purported to be only about generic drugs, his arguments about the protections provided by FDA regulation would apply to brand-name drugs as well.
“It seems as though what we have in the FDCA is a statute that authorizes — that says you can sell this,” Kagan said. “But it doesn’t say you must sell it, and it doesn’t give you a right to sell it.”
Justice Sonia Sotomayor said Lefkowitz is asking the court for very broad protection. “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?” she asked.
“Absolutely not,” he replied.
Assistant Solicitor General Anthony A. Yang supported Lefkowitz and 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,” Yang said.
But Chief Justice John G. Roberts Jr. said this case might be different from previous ones.
“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. The New Hampshire jury, on the other hand, simply said, “If you do this, you’re going to have to pay for the damage.”
Frederick said New Hampshire is trying to “impose liability where there is proof of an unreasonably dangerous product.”
But Justice Antonin Scalia wondered who would make such an evaluation of a drug and was not happy to hear Frederick agree that it would be a jury.
Twelve people, he said, “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,” Scalia said, adding, “Wonderful.”
The drug is still on the market, with a more detailed warning label after Bartlett’s ordeal.
The case is Mutual Pharmaceutical Co. v. Bartlett.