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Generic-Drug Makers Get Top Court Review on Patient Suits

The U.S. Supreme Court will take up calls by the generic-drug industry for stricter limits on lawsuits by patients, agreeing to review a $21 million award to a woman who suffered debilitating injuries after taking a painkiller.

The justices today said they will hear an appeal of that ruling by the Takeda Pharmaceutical Co. unit that made the generic drug, known as sulindac.

The appeal comes less than two years after the court ruled 5-4 that patients can’t sue generic-drug companies for failing to warn about possibly dangerous side effects. In upholding the award against the Takeda unit, a federal appeals court in Boston said Karen L. Bartlett, was pressing a different legal theory, claiming that sulindac was so dangerous it shouldn’t have been on the market.

The lower court ruling “blasts a gaping hole” in the 2011 Supreme Court ruling, Takeda’s Mutual Pharmaceutical Co. argued in its appeal.

Bartlett suffered what the appeals court called “truly horrific” injuries after taking sulindac for shoulder pain. The anti-inflammatory medicine triggered an allergic reaction that caused Bartlett to lose more than 60 percent of her outer skin layer.

Bartlett spent months in a medically induced coma, spent a year being tube-fed and endured 12 eye surgeries. She is almost blind, can’t eat normally because of esophageal burns, can’t have sex because of vaginal injuries and can’t engage in aerobic activities because of lung injuries. A federal jury in New Hampshire issued the award in 2009.

Failure to Warn

In the 2009 Supreme Court case, generic-drug companies successfully argued that they should be exempt from failure-to-warn suits because federal law requires them to copy the packaging inserts used by brand-name manufacturers. The high court had previously ruled that brand-name companies had to defend against similar suits.

Ruling in Bartlett’s case, the 1st U.S. Circuit Court of Appeals said so-called design defect claims were different. Mutual “certainly can choose not to make the drug at all,” the appeals court said.

The Supreme Court will hear arguments, probably in March, and rule by June. The Generic Pharmaceutical Association, an industry trade group, is backing Mutual in the case. Takeda, Asia’s largest drugmaker, is based in Osaka, Japan.

The case is Mutual Pharmaceutical Co. v. Bartlett, 12-142.

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