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Case Basics
Docket No. 
Mutual Pharmaceutical Co.
Karen L. Bartlett
Decided By 
(for the petitioner)
(Assistant to the Solicitor General, Department of Justice, for the United States as amicus curiae supporting the petitioner)
(for the respondent)
Facts of the Case 

In December 2004, Karen Bartlett’s doctor prescribed Sulindac, a generic anti-inflammatory medication, to help treat her shoulder pain. Within months she began suffering from a severe reaction called Stevens-Johnson syndrome, which caused the skin condition toxic epidermal necrolysis. This condition deteriorated over 60 percent of her skin to the point of causing open wounds. As a result, she has suffered permanent and serious injuries, including near-blindness.

Bartlett filed a lawsuit against the Sulindac medication manufacturer, Mutual Pharmaceutical Company. Bartlett initially presented several negligence and product liability claims, but only her design defect product liability claim made it to trial. Beginning in August 2009, a jury at the Federal District Court for the District of New Hampshire heard evidence that Sulindac was unreasonably dangerous to consumers and therefore was defectively designed. Mutual countered, among several other defenses, that federal law governs generic drug manufacturers’ conduct; therefore Karen could not pursue a state design defect claim.

After 14 days of trial, the jury deliberated and sided with Bartlett, awarding over $20 million in compensatory damages. Mutual appealed the decision for several reasons, including the following: the district court misunderstood New Hampshire product liability law; and, the court improperly admitted several pieces of evidence and the jury award of damages was excessive. Mutual also reasserted its claim that federal law should prevail over a state defective design claim. Despite Mutual’s arguments, the United States Court of Appeals for the First Circuit affirmed the lower court’s decision. Mutual appealed further to the Supreme Court of the United States, which granted certiorari.


Does federal law preempt a state design defect claim against a generic drug manufacturer?

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MUTUAL PHARMACEUTICAL CO. v. BARTLETT. The Oyez Project at IIT Chicago-Kent College of Law. 26 May 2015. <>.
MUTUAL PHARMACEUTICAL CO. v. BARTLETT, The Oyez Project at IIT Chicago-Kent College of Law, (last visited May 26, 2015).
"MUTUAL PHARMACEUTICAL CO. v. BARTLETT," The Oyez Project at IIT Chicago-Kent College of Law, accessed May 26, 2015,