US Supreme Court rules in favor of generics firms over law suits and Rx over data mining

There were victories for both the branded prescription and generic drugmakers in the USA yesterday, as the US Supreme Court handed out verdicts on two cases that impact their operations. The court ruled by a narrow margin of five to four that generic drugmakers are immune from state law suits for failure to warn consumers about possible side effects as long as they copy the warnings that are presented on originator brand-name drugs.

The five-justice majority admitted that its opinion creates a double standard, with users of brand names retaining the ability to sue, and users of generic drugs unable to sue for injuries resulting from inadequately labeled drugs.

Representing the court majority, Justice Clarence Thomas acknowledged that the decision dealt what he called an "unfortunate hand" that "makes little sense" to those who are harmed by generic drugs and are unable to sue. But the court nevertheless said that the federal law requiring generics to have the same warnings as their brand-name equivalents trumps state laws that require all drug manufacturers to provide warnings about side effects to consumers.