Supreme Court Says State Law Design Defect Claim For Generic Drug Is Preempted

Supreme Court Says State Law Design Defect Claim For Generic Drug Is Preempted

WASHINGTON, D.C. - (Mealey's) In a 5-4 decision, the U.S. Supreme Court on June 24 ruled that state law design defect claims that turn on the adequacy of a drug's warning are preempted by federal law (Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett, No. 12-142, U.S. Sup.). [ subscribers may access Supreme Court briefs for this case and read the enhanced opinion].

The majority ruling by Justice Samuel A. Alito Jr., Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas overturns a $21 million verdict for Karen L. Bartlett, who is nearly blind and suffers severe permanent damage after a reaction to sulindac, the generic version of the nonsteroidal anti-inflammatory drug Clinoril. 

Defendant Mutual Pharmaceutical Co. Inc. appealed the verdict, and the First Circuit U.S. Court of Appeals held that Bartlett's design defect claim under New Hampshire law was not preempted and that if federal law prohibited Mutual from changing the drug's design to make it more safe, the company could stop selling the drug. 

Would Upend Preemption Case Law 

Justice Alito said pulling sulindac from the markets "is not a solution" and would instead "render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law." 

"Accordingly, we hold that state law design-defect claims that turn on the adequacy of a drug's warning are pre-empted by federal law under PLIVA [PLIVA, Inc. v. Mensing, 564 U.S. ___ (2001) [enhanced version]," Justice Alito wrote, referring to the 2011 high court ruling that failure-to-warn claims involving generic drugs are preempted. 

"In the instant case, it was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac's label and its federal-law duty not to alter sulindac's label," Justice Alito continued. 

Plaintiff's Interpretation Rejected 

The majority said that contrary to Bartlett's interpretation, New Hampshire's design defect cause of action does impose a duty on a manufacturer.  It said that Mutual would have to have changed the drug or the label and that either action is preempted by federal law, which requires Food and Drug Administration approval for any change. 

Under federal laws for generic drugs and under PLIVA, Justice Alito said, Mutual had to keep the sulindac label the same as the label for Clinoril. 

As to withdrawing sulindac from the market, Justice Alito said the Supreme Court's preemption law presumes that a company "is not required to cease acting altogether in order to avoid liability."  Adopting the "stop-selling" rationale would mean that all the high court's preemption rulings were wrongly decided, he added. 

Dissent:  Cease Or Pay Penalty 

Justice Stephen G. Breyer wrote a dissenting opinion, joined by Justice Elena Kagan.  "A company can comply with both [state and federal law] by not doing business in the relevant State or by paying the state penalty, say damages, for failing to comply with, as here, a state-law tort standard," Justice Breyer wrote. 

Justice Breyer gave no weight to the FDA's opinion in the matter, noting that the agency has had conflicting views "in different briefs filed at different times."  As such, he said, "I would conclude that it is not impossible for petitioner to comply with both state and regulatory schemes and that the federal regulatory scheme does not pre-empt state common law." 

"Furthermore, I have found no convincing reason to believe that removing this particular drug from New Hampshire's market, or requiring damage payments for it there, would be so harmful that it would seriously undercut the purposes of the federal statutory scheme," he continued.   

2nd Dissent:  Liability-Free? 

Justice Sonia Sotomayor wrote the second dissent, joined by Justice Ruth Bader Ginsburg.  Justice Sotomayor said "the Court appears to justify its revision of respondent Karen Bartlett's state-law claim through an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability." 

"Remarkably, the Court derives this proposition from a federal law that, in order to protect consumers, prohibits manufacturers from distributing new drugs in commerce without federal regulatory approval, and specifically disavows any intent to displace state law absent a direct and positive conflict," she continued. 

"The Court laments her 'tragic' situation . . . , but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this Court," Justice Sotomayor said.  "If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products.  And consumers injured by those products will have no recourse." 

Skin, Eyes Burned By Reaction 

Bartlett was prescribed sulindac to treat shoulder pain and developed toxic epidermal necrolysis (TEN), reactions that resulted in burn-like damage to 60 to 65 percent of her body.  Bartlett spent 70 days in a hospital, including a burn unit, some of it in a medically induced coma, and suffered permanent tissue damage and near blindness. 

In 2010, a jury in the U.S. District Court for the District of New Hampshire awarded Bartlett $21 million against Mutual.  Design defect was the sole surviving claim at trial. 

Both the District Court and the First Circuit U.S. Court of Appeals ruled that a design defect claim under New Hampshire law is not preempted by the Supreme Court's generic drug preemption ruling. 


Mutual is represented by Jay P. Lefkowitz of Kirkland & Ellis in New York and Michael W. McConnell, Michael D. Shumsky and John K. Crisham of Kirkland & Ellis in Washington.  Bartlett is represented by David C. Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington; Brendan J. Crimmins, Joshua D. Branson and Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel in Washington; Steven M. Gordon and Christine M. Craig of Shaheen & Gordon in Concord, N.H.; and Keith M. Jensen of Jensen & Associates in Fort Worth, Texas. 

The United States, which participated in argument, is represented by Solicitor General Donald B. Verrilli Jr., Anthony A. Yang, Stuart F. Delery, Edwin S. Kneedler, Scott R. McIntosh, and Jonathan H. Levy of the U.S. Justice Department and William B. Schultz, David Horowitz, Elizabeth H. Dickinson and Julie Dohm of the U.S. Department of Health and Human Services, all in Washington.

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