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COURT UPHOLDS WOMAN'S $21M AWARD AGAINST DRUGMAKER

COURT UPHOLDS WOMAN'S $21M AWARD AGAINST DRUGMAKER

A federal appeals court recently upheld a $21.06 million jury award in a pharmaceutical product liability case. The case was brought by a woman who suffered severe personal injuries after experiencing an allergic reaction to sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID).

The woman received a prescription for sulindac for shoulder pain in December 2004. She developed a hypersensitivity reaction called Stevens-Johnson syndrome and its more severe form called toxic epidermal necrolysis (SJS/TEN) in early 2005. Both conditions involve an allergic reaction that can cause the outer and lower layers of the skin to separate. Lesions may also develop on a patient's internal organs and other symptoms such as eye pain and blindness are common.

SJS is upgraded to a diagnosis of TEN when 30 percent of a patient's outer skin layer has deteriorated either by burning off or consisting of an open wound. Doctors say that during the woman's 70-day stay at the hospital, approximately 65 percent of her skin deteriorated. The woman also suffered permanent near-blindness as a result of her SJS/TEN reaction.

The woman brought a variety of product liability claims against the manufacturer of the generic sulindac that caused her illness. During a two-week trial, the woman presented expert testimony from a pharmacologist/toxicologist that helped her win her case. The toxicologist testified that sulindac had a dismal safety profile that was similar to other drugs that were considered dangerous enough to be pulled from the market, including valdecoxib, another NSAID.

The toxicologist also testified that more SJS/TEN cases were reported with sulindac use than with other available drugs.

In its appeal, the drugmaker said that the jury's $21 million award was excessive. The appeals court judge disagreed with the drugmaker's assessment and noted that the woman'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 judge wrote. "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."

The judge went on to note that the permanent physical damages the woman sustained were severe. The woman cannot eat normally due to her esophageal burns, cannot have sex due to severe vaginal injuries, and has lungs so badly damaged that she can no longer exercise.

"She is almost blind now and faces some likelihood of complete and permanent blindness," the judge wrote. "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 drugmaker has appealed this case to the U.S. Supreme Court, saying that the woman's claims were pre-empted by federal law, but it is unclear whether the Supreme Court will decide to hear the case.

Source: Bartlett v. Mutual Pharmaceutical Co., Inc., 678 F.3d 30, Prod.Liab.Rep. (CCH) P 18, 851

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