“Safe and Effective,” Without More, Does Not Warrant Unqualified Safety and Efficacy

The Third Circuit in In re: Avandia Marketing Sales Practices & Products Liability Litigation recently refused to revive a putative class action accusing GlaxoSmithKline PLC (“GSK”) of violating an express warranty allegedly contained on the label of its diabetes drug, Avandia, which declared the drug “safe and effective.” In so doing, the Court reaffirmed the narrow scope of a breach-of-express-warranty claim under New Jersey law and the requirements necessary to sustain such a claim.

Richard V. D’Apuzzo filed a class action complaint against GSK for economic, but not physical, harm alleging that he would have paid less for a safer, more effective drug had GSK not expressly warranted Avandia to be safe and effective in treating his condition. The United States District Court for the Eastern District of Pennsylvania (where approximately 4,900 Avandia-related lawsuits have been centralized under Multidistrict Litigation No. 1871 granted GSK’s Rule 12(b)(6) motion to dismiss the entire complaint with prejudice.

On appeal, D’Apuzzo alleged that GSK “expressly warranted on its labels and packaging . . . that Avandia would provide assist[ance] ‘in the management of type 2 diabetes mellitus’ in safe and efficacious matter.” The label in question stated “[t]he 8 mg daily dose has been shown to be safe and effective in clinical studies,” which the Third Circuit determined was a representation only that a particular dose of Avandia had been shown to be safe and effective in such studies and not a claim that Avandia will be safe and effective in every case for every consumer. Because GSK disclosed Avandia’s contraindications, risk factors, and possible side effects on the drug’s label, the Court concluded that the “safe and effective” statement cannot be read as an unqualified guarantee that Avandia would be safe and effective for all consumers.

Although courts around the country have permitted express warranty claims based on representations that a drug or medical device was safe and effective, these cases often involved more substantial representations than those at issue here. As far as the Third Circuit is concerned, however, this holding clearly indicates that a “safe and effective” representation on a label that also contains information about risks and contraindications is insufficient to create an express warranty to all consumers under New Jersey law.