The Supreme Court of California today issued a decision on an important question for many consumers. In T.H. v. Novartis Pharmaceuticals Corp., the question before the court was whether brand-name drug manufacturers can be held liable for injuries caused by inadequately labeled generic drugs.
The question arose primarily because, under regulations of the Food and Drug Administration, manufacturers of generic drugs cannot initiate labeling updates to provide new warnings; instead, the labeling of generic drugs generally must mirror that of the brand-name products. For this reason, the U.S. Supreme Court held in 2011, in a case called PLIVA v. Mensing, that, in most circumstances, generic drug manufacturers cannot be sued by injured patients for failure to warn.
In today's decision, the California court held that the court held that “[b]ecause the same warning label must appear on the brand-name drug as well as its generic bioequivalent, a brand-name drug manufacturer owes a duty of reasonable care in ensuring that the label includes appropriate warnings, regardless of whether the end user has been dispensed the brand-name drug or its generic bioequivalent.”
Because the question is a matter of state tort law, the answer may differ from state to state. And, indeed, several states have reached the opposite conclusion. Until the FDA revises its regulations to allow generic-drug manufacturers to take responsibility for maintaining labeling that provides adequate warnings, the decision today is helpful not only to the plaintiff here, but for all of us, and it reinforces the need for brand-name manufacturers to keep patients and physicians apprised of up-to-date safety information.
The decision is here.