Tersigni v. Wyeth
817 F.3d 364
1st Cir.2016Background
- Tersigni took Wyeth's prescription weight-loss drug Pondimin for ~6 months in early 1997; FDA later required a Black Box warning and ordered withdrawal after links to valvular disease and primary pulmonary hypertension (PPH) emerged.
- In 2011 Tersigni was diagnosed with PPH and sued Wyeth in federal court (Mass.) asserting claims including negligent design and negligent failure to warn.
- The district court granted summary judgment to Wyeth on most claims, concluding Massachusetts law would not recognize negligent-design claims for prescription drugs (relying on Comment K), leaving only negligent-failure-to-warn for trial.
- Two motions in limine by Tersigni to exclude evidence of a 2008 incarceration (for nonpayment of child support) and decades-old occasional cocaine use were denied, with limits on how the incarceration evidence could be used.
- After an 11-day trial the jury found for Wyeth on negligent failure to warn; because the jury decided Wyeth had not negligently failed to warn the doctor, it did not reach causation (whether Pondimin caused Tersigni’s PPH).
- Tersigni appealed summary judgment on negligent design and the evidentiary rulings; the First Circuit affirmed in all respects.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Massachusetts recognizes negligent-design claims for prescription drugs | Tersigni: state law could recognize negligent design for drugs (SJC hasn’t expressly barred it) | Wyeth: Comment K adoption by the SJC precludes such claims for prescription drugs | Court assumed arguendo such a claim might exist but affirmed summary judgment on other grounds; declined to decide definitively |
| Whether plaintiff offered proof of a reasonable alternative design | Tersigni: invoked general availability of safer weight-loss methods; argued Restatement (Third) might eliminate need for alternative design proof | Wyeth: plaintiff must show a reasonable alternative design of the product itself; Tersigni offered none | Held for Wyeth: under Massachusetts law plaintiff must prove an available safer design of the product; Tersigni produced no such evidence, so summary judgment proper |
| Admissibility of prior incarceration evidence | Tersigni: excluded because prejudicial and character‑undermining under Rule 403 | Wyeth: relevant to stress as an alternative cause of cardiopulmonary symptoms | Even if admission were error, it was harmless because jury resolved negligent‑warning issue against plaintiff and never reached causation where incarceration would matter |
| Admissibility of remote cocaine use | Tersigni: should be excluded as prejudicial and remote | Wyeth: relevant to alternative causation; district court reserved ruling for expert linkage | Tersigni waived review by introducing the cocaine evidence himself during opening and witness examination; appellate relief denied |
Key Cases Cited
- Payton v. Abbott Labs, 437 N.E.2d 171 (Mass. 1982) (SJC adoption of Restatement (Second) § 402A Comment K regarding prescription drugs)
- Evans v. Lorillard Tobacco Co., 990 N.E.2d 997 (Mass. 2013) (explaining negligent-design requirement to show available design modification)
- Smith v. Ariens Co., 377 N.E.2d 954 (Mass. 1978) (SJC permitting negligent-design claim for consumer product)
- McDonough v. Whalen, 313 N.E.2d 435 (Mass. 1974) (negligent design/manufacture principles under Massachusetts law)
- Bingham v. Supervalu, Inc., 806 F.3d 5 (1st Cir. 2015) (standard of review for summary judgment)
- Gill v. Thomas, 83 F.3d 537 (1st Cir. 1996) (preemptive introduction of damaging evidence can waive right to appeal its admission)
- Ohler v. United States, 529 U.S. 753 (2000) (waiver by introducing evidence to blunt prejudice)