On March 30 a case was argued before the US Supreme Court that has the potential to impact the use of nearly every generic prescription drug sold in America. The court heard oral arguments in a case involving generic drug manufacturers and their contention that they should be held to less strict labeling laws – and receive greater immunity from lawsuits – than the manufacturers of brand-name medications. This case has clear, significant implications for personal injury and medical malpractice law here in Oregon. The court’s final decision, expected in the late spring or early summer, will bear close scrutiny
According to a detailed account of the case on the website of the American Association for Justice, generic drug makers are arguing that a federal law requiring them to use the same labels as their brand-name rivals prohibits them from strengthening warnings to consumers and also, in effect, prohibits consumers injured by generic drugs from suing the manufacturers over labeling issues. They are making this claim, AAJ notes, despite a court brief filed by one of the congressmen who write the law saying that his, and Congress’, intent was nothing like what the drug makers claim.
At issue is a piece of legislation known as “Hatch-Waxman” that requires “a generic label to match that of its associated brand-name drug.” Lawyers for the plaintiffs, two women injured by a generic prescription drug for stomach conditions, described the case as turning on the manufacturers’ belief that “in the face of considerable information that the warnings on their products were inadequate” generic drug manufacturers did nothing to protect consumers, and feel they should suffer no consequences for that decision. The case is especially important since, as AAJ reports, “70 percent of all prescriptions in the United States are filled with generic drugs and that, of the drugs that have both a generic and a brand-name available, more than 90 percent of the prescriptions are filled with generics.”
The article notes that the plaintiffs’ attorneys say even the manufacturers concede that they could have phoned the Food and Drug Administration to ask for a ruling mandating stronger warning labels (for generics and brand-names alike) but failed to do so. AAJ reports that during oral arguments several of the justices on the Supreme Court seemed to find the manufacturers’ claims implausible at best. “Do you think Congress really intended to create a market in which consumers can only sue brand-name products?” Justice Sonia Sotomayor asked.
However it is resolved, this case is an important reminder of the role personal injury lawyers here in Oregon and elsewhere play in helping to protect consumers from corporations that use loopholes in complex laws to improve their bottom lines at the expense of public health or safety.
American Association for Justice – Trial News: Supreme Court takes up preemption in generic drug case