T.H. v. Novartis Pharmaceuticals Corporation

Topic(s): 
Drug Safety
Preemption of Consumer Remedies
Documents:
Case Description: 

The primary issue presented in this case before the Supreme Court of California was whether brand-name drug manufacturers can be held liable for injuries caused by inadequately labeled generic drugs. Following passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments, sales of generic drugs have grown dramatically, fundamentally reshaping the pharmaceutical market. The increased availability of generic drugs has made many prescription drugs more affordable for patients. And a majority of prescriptions are now filled with generics. Despite these market changes, the law places responsibility for labeling firmly on brand-name manufacturers. Generic drug manufacturers cannot initiate labeling updates; the labeling of generic drugs must mirror that of the brand-name products. A patient’s reliance on the brand-name labeling, regardless of whether the patient took the branded or the generic version of the drug, is thus intended by the regulatory scheme. In light of this unusual fact—that one manufacturer is required to copy the safety information provided by another—patients should be able to hold brand-name drug manufacturers accountable for injuries resulting from misrepresentations about the safety of their drugs, even if those injuries are caused by a generic version of the drug.

Public Citizen filed an amicus brief in the California Supreme Court to explain that allowing patients to hold the brand-name manufacturer accountable for inadequate labeling, even when the patient took the generic form of the drug, makes sense under traditional tort law principles and as a matter of policy.

In a decision issue on December 21, 2018, 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.” The court also held that, if the injured patient can reasonably allege that the brand-name drug manufacturer’s failure to update its warning label foreseeably and proximately caused physical injury, the brand-name manufacturer’s liability for its negligence does not automatically terminate when the manufacturer transfers its rights in the brand-name drug to another manufacturer.