Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, March 24, 2016

Negligent design claim requires proof of alternative for diet pill

By Pamela C. Maloney, J.D.

A negligent design claim brought against the manufacturer of a prescription diet drug could not proceed without proof of a reasonable design alternative, the U.S. Court of Appeals for the First Circuit held, affirming the lower court’s summary judgment in favor of the drug’s maker. The court refused to decide whether the Massachusetts would recognize a claim for negligent design as an exception to the unavoidably unsafe product doctrine embodied in comment k to Section 402A of the Restatement (Second) of Torts (Tersigni v. Wyeth, March 23, 2016, Stahl, N.).

A patient had been prescribed Pondimin, a weight loss drug developed and sold by Wyeth for a period of time in 1997. Sometime later, the patient was diagnosed with primary pulmonary hypertension (PPH), which his treating physician attributed to the patient’s ingestion of Pondimin. The patient filed a lawsuit against Wyeth, setting forth claims that included negligent design and negligent failure to warn.” Wyeth moved for and was granted summary judgment on the patient’s negligent design claim and the jury found in favor of Wyeth on the patient’s negligent failure-to-warn claim [see Products Liability Law Daily’sDecember 16, 2013 analysis]. The patient appealed the decision granting summary judgment on the negligent design claim.

Negligent design and prescription drugs. In granting summary judgment on the patient’s negligent design claim, the district court reasoned that because the Massachusetts’s Supreme Judicial Court (SJC) had adopted comment k, the state courts would not recognize a negligent design claim when the product in question is a prescription drug. However, in arguing that the Massachusetts courts would allow a negligent design claim involving a prescription drug, the patient pointed out that the SJC repeatedly had cited to Restatement (Second) of Torts Sections 395 and 398, which pertain to the negligent design and manufacture of chattel, not to Section 402A, which involves strict liability. According to the First Circuit, this raised at least a possibility that Massachusetts courts might consider a negligent design claim relating to a prescription drug.

That being said, the First Circuit explained that it did not need to decide this issue because even if such a claim was cognizable under Massachusetts law the patient’s claim could not stand because he failed to offer evidence of a reasonable alternative design. Cases applying Massachusetts law had determined that the existence of a safer alternative design was an essential element of a design defect claim. In this case, the patient did not contend that there was a reasonable alternative design that would have made the drug less likely to cause PPH. Instead, he argued that the drug company could be held liable because, at the time the drug was marketed, there were other safer methods of weight loss available. According to the First Circuit, the patient’s argument misconstrued the focus of the reasonable design inquiry which requires the patient to show that the product in question could have been designed more safety, not that a different product was safer.

The patient also argued that Massachusetts courts would not require proof of a reasonable alternative design when the product in question was a prescription drug. This argument would require the federal court to find that the state courts would allow “a heretofore unrecognized exception” to the general requirement that proof of an alternative design was required in a negligent design claim. The First Circuit refused to cross that bridge.

The case is No. 14-1927.

Attorneys: Keith L. Altman (Finkelstein & Partners LLP) for Michael J. Tersigni. Anand Agneshwar (Hughes Hubbard & Reed LLP), James A. Frederick (Goodell DeVries Leech & Dann LLP) and Heidi K. Hubbard (Williams & Connolly LLP) for Wyeth, LLC, American Home Products Corp., Wyeth Ayerst Laboratories, Wyeth Pharmaceuticals, Inc. and Wyeth-Ayerst Pharmaceuticals, Inc.

Companies: Wyeth, LLC; American Home Products Corp.; Wyeth Ayerst Laboratories; Wyeth Pharmaceuticals, Inc.; Wyeth-Ayerst Pharmaceuticals, Inc.

MainStory: TopStory DesignManufacturingNews DrugsNews MaineNews MassachusettsNews NewHampshireNews PuertoRicoNews RhodeIslandNews

Back to Top

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.