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Supreme Court Grants Big Pharma Co. Immunity for Defectively Designed Drug

Supreme Court Grants Big Pharma Co. Immunity for Defectively Designed Drug

Today, ruling 5 to 4, the U.S. Supreme Court dramatically limited generic drug companies’ liability for manufacturing defectively designed drugs. The case is Mutual Pharmaceutical Co., Inc. v. Bartlett.

In Bartlett, Public Justice filed an amici brief with the American Association for Justice.

Plaintiff Karen Bartlett took a generic drug called sulindac (pictured) and developed a condition called Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN). Sixty to sixty-five percent of the surface of Bartlett’s body deteriorated, burned off, or turned into an open wound. She survived but is severely disfigured, has a number of physical disabilities, and is nearly blind.

Bartlett sued Mutual Pharmaceutical. After hearing evidence that sulindac is more likely to cause SJS/TEN than any other pain medication in its category and no more effective than similar drugs, a New Hampshire jury held the drug manufacturer liable. The jury found that sulindac was “unreasonably dangerous” because its risks outweigh its benefits and ordered the drug company to pay Bartlett over $21 million in damages to compensate her for the medical care she will need and pain she will suffer the rest of her life.

Today, the U.S. Supreme Court held that Mutual Pharmaceutical could not be held liable and did not have to pay anything at all.

“The decision is a travesty,” said Public Justice Executive Director Arthur Bryant.

Two years ago, the Supreme Court held in PLIVA v. Mensing that generic drug manufacturers could not be held liable for inadequately labeling their drugs. (It had previousy held that name-brand drug manufacturers could be held liable for inadequately labeling their identical name-brand drugs. In PLIVA, Justice Thomas conceded that this difference made no sense.) In Bartlett, the Court today held that Mutual Pharmaceutical could not be held liable for defectively designing its generic drug because that claim was “impliedly” preempted by federal law.