Court ruling favors makers of generic drugs

NEW YORK — The Supreme Court ruled on Monday that generic drug manufacturers could not be sued by patients who claim that drugs they took were defectively designed.

The decision is a significant victory for the generic drug industry, but further narrows the recourse for people who are injured by such drugs.

The 5-to-4 decision overturned the verdict of a New Hampshire jury, which in 2010 awarded $21 million to a woman who developed a debilitating skin disease after taking a generic version of the pain medication sulindac.


The court found that because the drug’s manufacturer, the Mutual Pharmaceutical Co., was required by federal law to make a copy of the brand-name drug, Clinoril, it could not be held responsible for claims that the drug was unsafe. Writing for the majority, Justice Samuel A. Alito Jr. acknowledged the horrific injuries sustained by Karen Bartlett, who lost nearly two-thirds of her skin, was placed in a medically induced coma, and is legally blind after suffering a reaction to the medication she took for a sore shoulder.

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“But sympathy for respondent does not relieve us of the responsibility of following the law,” Alito wrote.

The ruling is similar to a decision by the court in 2011, in Pliva v. Mensing, which found that generic drug makers could not be held liable for failing to warn about a drug’s dangers because they must use the same safety label as the brand-name version. Monday’s decision further limits the legal avenues for people who take generic drugs.

“Now, presumably, a patient harmed by those drugs has no remedy, either through a defective warning or a defective design argument,” said Bill Curtis, a Houston lawyer who specializes in pharmaceutical cases.

Generic drug manufacturers hailed the decision, arguing that the decisions of state courts should not supplant the authority of the Food and Drug Administration, which approves drugs.