Mutual Pharmaceutical Co. v. Bartlett

Supreme Court Case involving: pharmaceuticalsFDA regulationmedical industry

Background: In 2004, a New Hampshire woman, Karen Bartlett, took Mutual Pharmaceutical Co.’s generic non-steroidal anti-inflammatory drug, sulindac. Bartlett suffered a known, but rare, skin hypersensitivity reaction. It was extremely severe and ultimately left here severely disfigured as two-thirds of her body was covered in burn-like lesions and even after 12 eye surgeries she is nearly blind.

At the time she was prescribed the drug, its label did not contain any specific warning about the serious skin reaction. Later the FDA required this warning be on the drug label. Bartlett sued the drug company under New Hampshire state law for “failure-to-warn” and “design-defect “claims. The District Court dismissed the “failure-to-warn” claim after Bartlett’s physician admitted he hadn’t read either the label or an FDA required package insert that warned about the risk of that potential side effect. She was able to go forward with the “design-defect” claim, the New Hampshire law that “requires manufacturers to ensure that the products they design, manufacture, and sell are not ‘unreasonably dangerous.’” She was awarded $21 million dollars.

Opinion Summary: In a five to four decision, the Court overturned the award and held that Mutual Pharmaceutical Co. was not liable. The majority found that the New Hampshire law imposes a duty on drug 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.” 

Obviously, Mutual couldn’t change the composition of sulindac as it was based on the name-brand drug that had been approved by the FDA. Likewise, federal law prohibits generic drug manufacturers from independently changing drugs’ labels. New Hampshire law was effectively requiring Mutual to violate federal law and the majority maintained that in such a case federal law wins.

For further review.

Implications: Generic manufacturers are given much less of a burden with this ruling. They have to make and sell the same product with the same label as the original drug approved by the FDA. Anyone injured by the drug cannot sue generic drug manufacturers on the ground that the drug is unreasonably dangerous.

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