Deciding where the preemptive effect of federal rules governing drug manufacturing ends and states’ ability to impose liability on drug makers begins has never been an easy task — not even for the justices of the U.S. Supreme Court.
Last week, the justices wrangled once again over the preemptive reach of the federal Food, Drug and Cosmetic Act in an effort to decide whether the law prevents design defect claims against generic drug manufacturers.
The case, Mutual Pharmaceutical Co. v. Bartlett, gives the justices a chance to draw a line between two previous rulings: the 2009 holding in Wyeth v. Levine that state-law failure-to-warn drug claims are not automatically preempted by federal law; and the 2011 ruling in PLIVA Inc. v. Mensing that federal regulations governing generic drugs directly conflict with, and thus preempt, those claims.
Attorneys representing plaintiffs say that design defect suits play an important role in regulating drug manufacturers to ensure that products are safe and that victims are compensated when drugs are dangerous.
“Drug suits are complementary to the FDA’s mission in making drugs safe and effective,” said Keith Jensen, of Jensen Associates PLLC in Fort Worth, Texas, who has represented plaintiff Karen L. Bartlett since the trial level.
But tort defense attorneys say that design defect claims against generic drug makers, which have been on the rise since the court handed down Mensing, should be preempted just as failure-to-warn cases are. It’s up to the Food and Drug Administration, not members of juries, to decide whether a drug is safe to market, they say. As cases like this one demonstrate, they argue, it is impossible to comply with both, so federal law trumps.
“These claims are definitely an attempt to find a way around Mensing,” said James Beck, counsel in the Philadelphia office of Reed Smith.
And plaintiffs may be a tougher sell this time around. Unlike in Mensing, when the Justice Department backed the patient as amicus, in Bartlett it is backing the drug company — a move that confounds Jensen.
“The FDA commissioner last week said that the FDA cannot ensure safety,” Jensen said, referring to a speech Commissioner Margaret Hamburg gave in Boston warning of the effect of the federal budget sequester on the agency. “This week they are arguing they are the sole arbiter of that.”
Identical drug, competing standards?
Federal law requires that the design and labeling of generic drugs be materially identical to that of their brand name counterparts. Bartlett, who developed a degenerative skin disease after being given the generic version of the pain reliever Clinoril called sulindac, argues that she should be able to bring drug design defect claims. Preemption does not apply, her attorneys argue, because it is not impossible to comply with both federal regulations and state tort laws: Drug makers can either pay tort judgments for defective products, such as the $21 million verdict Bartlett won in New Hampshire, or choose not to sell the drug. The 1st U.S. Circuit of Appeals agreed with her and affirmed the judgment.
Mutual Pharmaceutical argues that the stop-selling argument fails because the same argument would have applied in Mensing, but the Supreme Court still found preemption there.
“There is no principled basis for treating design defect claims any differently than failure-to-warn claims,” Jay Lefkowitz, a senior litigation partner in the New York office of Kirkland & Ellis LLP arguing on the drug company’s behalf, told the justices Tuesday.
“Suppose that New Hampshire had a real strict liability regime, so that if you sell a drug, whether it’s unreasonably dangerous or not, if it causes an injury, you pay?” asked Justice Samuel Alito Jr.
Lefkowitz acknowledged that such a law probably would not rise to the level of impossibility preemption, but stressed that is not what New Hampshire did here.
“States are free to do lots of different things,” Lefkowitz said. “They only are not free to do things when they conflict directly with federal obligations.”
Anthony Yang, assistant to the U.S. solicitor general arguing as amicus in support of the pharmaceutical company, said that states cannot impose duties on manufacturers that conflict with the federal regime.
“When you … make an obligation to pay tort liability [contingent upon] meeting a standard under state law, that is a duty that could conflict with a federal duty,” Yang said.
But Chief Justice John Roberts Jr. asked whether it would be impossible to meet both standards.
“If you follow the same federal standard and market this in [the] state, you’re going to pay the compensation for the reason of spreading the costs,” Roberts said.
David Frederick, a partner in the Washington office of Kellogg, Huber, Hansen, Todd, Evans & Figel PLLC, argued on the patient’s behalf that the state is simply trying “to impose liability where there is proof of an unreasonably dangerous product.”
“The jury decides all of this, right?” asked Justice Antonin Scalia.
“That’s correct,” Frederick said.
“That’s wonderful,” Scalia said sarcastically. “Twelve [jurors] 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.”
A ruling is expected later this term.