T.H. v. Novartis Pharmaceuticals Corp.

Brief Fact Summary.

Plaintiff’s mother used a generic form of a drug that was previously manufactured by defendant. As a brand-name drug manufacturer, defendant was responsible for providing an adequate warning label for the drug that generic manufacturers had to follow. Plaintiffs brought a products liability suit against defendant due to the deficiencies in the warning label on the generic drug.

Synopsis of Rule of Law.

Brand-name drug manufacturers have a duty of care in warning about the safety risks of their drugs, regardless of whether the injured party relied on the warning label dispensed on the brand-name or generic version of the drug.

Facts.

Novartis Pharmaceutical Corporation (“Novartis”) (defendant) manufactured the brand-name drug Brethine until 2001. Six years later, T.H.’s mother, who was pregnant at the time, suffered injury from use of a generic form of Brethine. Under California law, a brand-name drug manufacturer has a duty to warn of known or reasonably knowable adverse effects arising from use of its drug. This duty to provide an adequate warning label applies to both the brand-name drug and its generic equivalents. Only the brand-name drug manufacturer may modify the drug’s label. Generic manufacturers must strictly follow the brand-name manufacturer’s label. T.H. (plaintiff) brought suit against Novartis, alleging the generic drug’s warning label failed to warn about the risks to fetal brain development and falsely represented that the drug was safe for use by pregnant women.

Issue.

Whether a brand-name drug manufacturer owes a duty of care to those who may be injured by deficiencies in its warning label?

Held.

Yes. Brand-name drug manufacturers have a duty of care in warning about the safety risks of their drugs, regardless of whether the injured party relied on the warning label dispensed on the brand-name or generic version of the drug. The appellate court’s holding is affirmed.

Discussion.

To determine whether to create an exception to a brand-name drug manufacturer’s duty to warn, three factors must be balanced: (1) foreseeability, (2) certainty of the injury, and (3) closeness of connection between plaintiff and defendant. Here, the generic form of Brethine was legally required to bear an identical label to its brand-name drug equivalent. Novartis could reasonably have foreseen that deficiencies in its label could mislead physicians about the safety of the generic drug.  The burden for Novartis to satisfy a duty of care is zero since a continuing duty to warn already exists. Novartis’s concerns that brand-name drug manufacturers would end up insuring the entire market unless the duty is narrowed is unpersuasive. Brand-name manufacturers hold only a small fraction of the combined brand-name and generic drug sales. Novartis’s additional concerns that warning label liability would lead to overwarning and that it would stifle innovation are also unpersuasive. There has been no surge in overwarning since warning label liability emerged. Moreover, the risks associated with a drug could incentivize manufacturers to create new and safer alternatives.