On March 23, 2016, the First Circuit Court of Appeals affirmed several defense rulings in a case involving the prescription weight loss drug Pondimin, one of the drugs frequently prescribed as part of the then popular “fen-phen” diet treatment.
Plaintiff Michael Tersigni took Pondimin for weight loss in 1997, but stopped taking the drug after learning the FDA had required the addition of a “black box” warning for elevated risk of valvular heart disease and primary pulmonary hypertension. The product carried the warning label at the time Pondimin was prescribed to Tersigni.
Tersigni was diagnosed with primary pulmonary hypertension in 2011 and brought suit alleging negligent design and negligent failure to warn. The negligent design claim was dismissed on summary judgment. Following an eleven-day trial in 2014, the jury returned a defense verdict on the failure to warn claim.
The First Circuit affirmed the grant of summary judgment on the negligent design claim. In granting summary judgment, the trial court relied upon the adoption of Comment K to the Restatement (Second) of Torts § 402A by the Supreme Judicial Court of Massachusetts. Comment K exempts from strict liability the manufacturer of “useful and desirable” products, like prescription drugs, that are “attended with a known but apparently reasonable risk.” See Tersigni, 2016 WL 1128256 at *2 (quoting Restatement (Second) of Torts § 402A cmt. K). The trial court reasoned that, having adopted Comment K, Massachusetts would not recognize a negligent design claim involving a prescription drug.
In affirming, the First Circuit side-stepped the issue, holding that Tersigni’s negligent design claim failed regardless because Tersigni failed to offer evidence of a reasonable alternative design.
The First Circuit also affirmed two evidentiary rulings – one, allowing evidence of plaintiff’s imprisonment for nonpayment of child support and another allowing evidence of plaintiff’s occasional cocaine use.
See Tersigni v. Wyeth et al., --- F.3d ----, 2016 WL 1128256 (1st Cir. 2016)