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Friday, July 12, 2024 | Back issues
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Pain Reliever Side Effect Case Heads to High Court

WASHINGTON (CN) - A drugmaker can keep fighting a $21 million jury award to a woman whose skin was burned off by a rare side effect associated with pain relievers, the Supreme Court ruled.

Karen Bartlett's doctor prescribed her sundilac, a nonsteroidal anti-inflammatory drug (NSAID), in 2004 when she complained of shoulder pain. Though the doctor prescribed the name-brand Clinoril, her pharmacist dispensed a generic manufactured by Mutual Pharmaceutical and other companies.

"The consequences were disastrous," according to a May 2012 ruling from the 1st Circuit, upholding the jury award.

A rare side effect of sulindac is a hypersensitivity reaction called Stevens-Johnson Syndrome or the more etreme toxic epidermal necrolysis (SJS/TEN).

A bout of SJS/TEN in 2005 ultimately caused Bartlett to lose 60 to 65 percent of the outer layer of her skin.

She was hospitalized for 70 days, nearly two-thirds of which were spent in the burn unit, and she became permanently near blind.

Mutual Pharmaceutical appealed to the 1st Circuit after a federal jury in New Hampshire awarded her $21.06 million for design defect.

Bartlett had claimed that sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, even though the federal Food and Drug Administration never withdrew the statutory "safe and effective" designation given to the original manufacturer.

Mutual had countered that New Hampshire law precludes design defect claims as to generic drugs. It also said that Bartlett had failed to prove causation, that the jury relied on inadmissible expert evidence, that the trial judge gave inaccurate jury instructions as to the label warnings, that Bartlett's lawyers engaged in misconduct that tainted the trial, and that the damages award was excessive.

A three-judge panel of the Boston-based federal appeals court sided with Bartlett.

"Mutual says that this is the largest award in New

Hampshire history," the judges noted.

But the court found that "Bartlett's injuries were truly horrific."

"She spent almost two months in MGH's burn unit, spent months in a medically-induced coma, and suffered burns over nearly two-thirds of her body," the judges continued. "Her burn surgeon described the experience as 'hell on earth.' She spent a year being tube fed and endured two major septic shock episodes. She suffered through 12 eye surgeries and has many more ahead of her. ...

"In addition, the permanent damage is severe. Bartlett cannot eat normally due to esophageal burns, cannot have sexual relations due to vaginal injuries, and cannot engage in aerobic activities due to lung injuries. She is almost blind now and faces some likelihood of complete and permanent blindness. She cannot read or drive or work. And she is seriously disfigured in face and body. In sum, the jury's award is not so clearly disproportionate to the harm suffered that a court must set it aside.

"The outcome of this case, at least on this record, is not surprising or, with respect to sulindac, patently alarming. True, that drug has a minuscule risk of causing SJS/TEN, but sulindac is a recognized cause of SJS/TEN - potentially a leader among NSAIDs in that respect - and the drug carries other risks as well. And how far it has advantages over similar medicines with less or no risk is unclear in light of the limited defense offered."

As per its custom, the Supreme Court did not comment Friday on its decision to grant Mutual Pharmaceutical's petition for certiorari.

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