Comment K to Section 402A of the Restatement (Second) of Torts has caused confusion in prescription drug litigation for years, as courts across the country have taken a variety of stances regarding the viability of negligent design claims related to prescription drugs. Just last month, it looked like clarity on this issue would be provided for Massachusetts, but the First Circuit declined to answer the issue of whether Massachusetts courts would recognize a negligent design claim in a prescription drug case. Instead, the First Circuit found that Plaintiff’s claim failed because he did not proffer evidence of a safer reasonable alternative, as is required to maintain a negligent design case in Massachusetts. See Tersigni v. Wyeth, No. 14-1927, 2016 WL 1128256, at *4 (1st Cir. Mar. 23, 2016).

Section 402A of the Restatement (Second) of Torts imposes strict liability on certain sellers of defective or unreasonably dangerous products. Critically, however, Comment K to Section 402A exempts from strict liability the manufacturer of certain products, including drugs that are “highly beneficial but may carry known risks.” Tersigni, 2016 WL 1128256, at *2. Specifically, Comment K provides that:

“There are some products which . . . are quite incapable of being made safe for their intended and ordinary use. . . . The seller of such products, . . . with the qualification that they are properly prepared and marketed, and proper warning is given, . . . is not to be held to strict liability . . . merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

Some states, including Nevada, have rejected Comment K altogether, while others, such as New Hampshire, have rejected Comment K as it relates to prescription drugs. See Allison v. Merck & Co., 878 P.2d 948, 953-55 (Nev. 1994); Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 655 (1st Cir. 1981) (“We are unwilling to say that under New Hampshire’s balancing test no drug can ever be classified as unreasonably dangerous”). On the other hand states such as New York, California, and Connecticut have approved the application of Comment K to prescription medical products. See Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) (“even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is ‘not defective, nor is it unreasonably dangerous’”) (quoting comment k); Plenger v. Alza Corp., 11 Cal. App. 4th 349, 360, 13 Cal. Rptr. 2d 811, 818 (1992); Breen v. Synthes-Stratec, Inc., 108 Conn. App. 105, 113, 947 A.2d 383, 388 (2008).

In Tersigni v. Wyeth, Plaintiff’s doctor prescribed Pondimin, a weight loss drug developed and sold by Wyeth. Id. at *1.  By the mid-1990’s, clinical research showed a link between valvular heart disease and primary pulmonary hypertension (“PPH”); and the FDA subsequently banned the drug. In 2011, several years after Plaintiff had stopped taking Pondimin, he filed suit against Wyeth, alleging that the drug (brand name Fenfluarmine) had caused him to develop PPH, or high blood pressure in his lungs. Id. Plaintiff’s claims included negligent design and negligent failure to warn, alleging Weyth knew or should have known that the drug was unreasonably dangerous, but continued to market it nonetheless. Id.

The lower court granted summary judgment for Wyeth on Plaintiff’s negligent design claim, explaining that Massachusetts courts do not recognize negligent design claims involving a prescription drug. Id. at *2.  Later, at the conclusion of an eleven day trial, the jury also found in Wyeth’s favor on Plaintiff’s negligent failure to warn claim, holding that Wyeth had not negligently failed to warn Plaintiffs’ physicians of the risk posed by Pondimin. Id. The Plaintiff appealed the summary judgment ruling, as well as separate rulings that allowed evidence of his past cocaine use and incarceration for failure to pay child support.

According to the First Circuit, and as acknowledged by both parties, Massachusetts courts recognize claims based on the negligent design of consumer products and other goods; citing cases involving snowmobiles and cigarettes, for example. As the Court pointed out, however, it is not clear whether Massachusetts courts would recognize negligent design claims involving a prescription drug. Id. at *3. The lower court, in granting Defendant’s motion for summary judgment, reasoned that because Massachusetts’ highest state court (Supreme Judicial Court or “SJC”) had adopted Comment K to 402A, Massachusetts courts would not recognize a negligent design claim where the product in question is a prescription drug. Id. at *2 (citingPayton v. Abbott Labs, 437 N.E.2d 171, 189-190 (Mass. 1982).

While the First Circuit admitted that this issue “lacks an obvious answer,” it explained that because Massachusetts courts have cited to Sections 395 and 398 of the Restatement (Second) of Torts, which address negligent design claims as related to chattel, “this raises the possibility that Massachusetts courts might consider a negligent deign claim related to a prescription drug, notwithstanding the SJC’s embrace of Comment K.” Id. at *3.  The Court noted that it is “thus quite uncertain whether Massachusetts courts would recognize [Plaintiff’s] negligent design claim.” Id.

The Court ultimately ruled that it did not need to decide this issue, because “even if [the Court] were to assume that such a claim is cognizable under Massachusetts law, the claim would nonetheless fail based on [Plaintiff’s] inability to proffer evidence of a reasonable alternative design.” Id. (citing Evans v. Lorillard Tobacco Co., 465 Mass. 411, 443-44 (2013) (“In claims alleging negligence in the design of a product…the plaintiff must show an available design modification which would reduce the risk without undue cost or interference with the performance of the product.”) (internal quotation omitted). Here, Plaintiff did not contend that there was a reasonable alternative design which would have made Pondimin less likely to cause PPH. And therefore, the Court ruled that he had failed to make out an adequate claim against Wyeth. As an aside, the Court also found that any error in allowing evidence of incarceration and cocaine use was harmless, as it likely had no effect on the jury’s consideration of whether Wyeth had inadequately warned physicians about Pondimin’s risks.Id. at *5.

Thus, for now, the question of whether Massachusetts will recognize a negligent design claim in a prescription drug case will remain unanswered. We will continue to monitor what courts decide when considering the viability of a negligent design claim as it relates to prescription medical products.