But in a 5-4 decision, the high court said this same legal duty to warn patients of newly revealed dangers does not extend to the makers of copy-cat generics.
Justice Clarence Thomas reasoned that the warning labels are the responsibility of the brand name maker and the Food and Drug Administration. He said that because generics are just copycats, their makers cannot be sued for inadequate warnings.
Thomas said federal regulatory law trumps state liability law in this instance and shields the generic makers.
"We acknowledge the unfortunate hand" that was dealt to the patients whose suits were dismissed, he wrote.
Gladys Mensing and Julie Demahy developed a severe neurological disorder after taking metoclopramide, a generic drug for digestive problems, including acid reflux. They sued, alleging the maker failed to warn them of the danger of taking the drug for more than 12 weeks. In tossing out their claims, Thomas put the blame on "the special, and different regulation of generic drugs."
They are supposed to be copy-cat versions of the original, he said, so the makers cannot be sued for failing to give patients new warnings.
But the dissenters, led by Justice Sonia Sotomayor, said the blame lies with the court's majority. She said the generic drug maker should have alerted the FDA of the danger and then updated their warning label. "This outcome makes little sense," she said. Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan agreed.
In the second decision, the court by a 6-3 vote struck down a Vermont law that barred pharmacies, drug makers and others from buying or selling prescription records from patients for "marketing" purposes. Vermont's physicians had sought passage of the law, arguing their prescriptions were intended for private use of patients and should not become a marketing tool.
Drug makers buy this data to gear their sales pitches to physicians. Several data-mining firms have made a billion-dollar business out of buying and selling the prescription data to drug makers and researchers.
