$21 Million Awarded in Generic Drug Suit

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$21 Million Awarded in Generic Drug Suit

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Generic drug manufacturers cannot use federal law as a bar to personal injury suits that allege flaws in a drug’s design, a federal appeals court has ruled.

On May 4^th, the 1st U.S. Circuit Court of Appeals upheld a $21 million jury award to Karen Bartlett. Miss Bartlett is New Hampshire woman who suffered a severe skin reaction after taking the generic anti-inflammatory drug sulindac for shoulder pain. Miss Bartlett suffered burns on two-thirds of her body. She also became nearly blind from an adverse reaction to the drug. Sulindac is manufactured by Mutual Pharmaceutical Co. Miss Bartlett sued Mutual alleging design defects under New Hampshire law.

As a defense, Mutual argued that federal law prohibits suits like that of Karen Bartlett. The U.S. Supreme Court’s 2011 ruling in Pliva v. Mensing, found that federal law preempts state-law claims against generic drug companies for failing to provide adequate label warnings about potential side effects. In the Mensing case, the court found that generic pharmaceutical claims directly conflict with federal drug regulations that require generics to carry the same labels as the brand name drug. (See Longo Legal blog for more about the Mensing case https://www.longolegal.com/will-congress-overturn-mensing/).

The 1^st Circuit sees the Bartlett case as different from Mensing. Mensing was primarily a failure to warn case. The panel the three judges in the Bartlett case affirmed the lower court’s decision to allow Bartlett to show that sulindac had a design defect. A lawyer for Bartlett, Keith Jensen, argued that because of its risk of causing the life-threatening skin reaction, Stevens Johnson syndrome, the product was unreasonably dangerous. The 1^st Circuit made it clear by their ruling that the U.S. Supreme Court needs to expand the Mensing ruling to cover design defect claims if that is what they intended.

Bartlett v. Mutual Pharmaceutical Company Inc, U.S. Court of Appeals for the 1st Circuit, No. 10-2277.

Source: Thomson Reuters News & Insight, “1^st Circuit affirms $21 mln award in generic drug suit,” Terry Baynes, May 4, 2012.

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