High Court Sides With Drugmakers

The Supreme Court has ruled that generic drug manufacturers, which account for nearly 75% of all drugs dispensed in the U.S., cannot be sued under state laws for inadequate warning labels. Federal law says generic drug companies have to use exactly the same warning labels on products as their name-brand counterparts use. But some state laws require changes or updates to all drug labeling as new information about dangerous side effects is discovered. Justice Clarence Thomas, writing for the 5-4 majority in Pliva v. Mensing, said it is impossible for manufacturers of generics to comply with both a state obligation to attach a safer label and a federal duty to keep the label the same as the name-brand drug label. In the face of that conflict, he said, federal law preempts state tort claims. Bob Billings, executive director of the Generic Pharmaceutical Association, a Washington, D.C.-based industry group, says the high court “has appropriately recognized that current law leaves generic manufacturers with no alternative but to make certain that its products have labeling that is identical to the labeling of the reference brand product.”