Drugmaker Cleared Over Woman’s ‘Horrific’ Injury

WASHINGTON (CN) - A drugmaker does not owe $21 million to a woman whose skin was burned off by a rare side effect associated with pain relievers, the Supreme Court ruled Monday.

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 by Mutual Pharmaceutical and other companies.

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

Bartlett ultimately developed SJS/TEN in 2005 and lost 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.

A federal jury in New Hampshire ordered Mutual Pharmaceutical to pay Bartlett $21.06 million for design defect, the largest award in New Hampshire's history, and the 1st Circuit affirmed in May 2012.

It noted 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."

Though the Supreme Court also expressed sympathy for the tragedy that befell Bartlett, a five-justice majority concluded Monday that federal pre-emption warrants reversal.

"New Hampshire law imposes a duty on manufacturers to en­sure that the drugs they market are not unreasonably unsafe, and a drug's safety is evaluated by reference to both its chemical properties and the adequacy of its warn­ings," Justice Antonin Scalia wrote for the court. "Because Mutual was unable to change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings. But, as this court recog­nized just two Terms ago in PLIVA, Inc. v. Mensing , ... federal law prohibits generic drug manu­facturers from independently changing their drugs' labels. Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are 'without effect.'

"The Court of Appeals' solution - that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law - is no solution. Rather, adopting the Court of Appeals' stop-selling ra­tionale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.

"Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug's warnings are pre­empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below."

The court's four dissenting judges split off into two camps, with Justice Elena Kagan joining an opinion by Justice Stephen Breyer, and Justice Ruth Bader Ginsburg joining an opinion by Justice Sonia Sotomayor.

"Here, ... I cannot give special weight to the FDA's views," Kagan wrote. "For one thing, as far as the briefing reveals, the FDA, in developing its views, has held no hearings on the matter or solicited the opinions, arguments, and views of the public in other ways. For another thing, the FDA has set forth its positions only in briefs filed in litigation, not in regulations, interpretations, or similar agency work product.

"Finally, the FDA has set forth conflicting views on this general matter in different briefs filed at different times," she added.

With that in mind, Mutual could have found a way to comply both with state and federal regulatory schemes, the dissent states.

In addition to noting that the statute also does not contain a general pre-emption clause, Kagan "found no con­vincing reason to believe that removing this particular drug from New Hampshire's market, or requiring damage payments for it there, would be so harmful that it would seriously undercut the purposes of the federal statutory scheme."

In the second dissent, Sotomayor slammed the majority opinion as unnecessary and unwise.

"The court laments her 'tragic' situa­tion, but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this court," Sotomayor wrote. "If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett's recovery. I re­spectfully dissent."

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