Plaintiffs, when faced with a legal bar to traditional negligence claims, frequently try to cloak them in new theories of liability. This tactic is reminiscent of dialogue in William Shakespeare's play Romeo and Juliet, in which Juliet argues that the names of things do not matter, only what things "are" is truly important.
An upsurge in this practice took place following the Supreme Court’s decision in Pliva Inc., v. Mensing, 131 S.Ct. 2567 (2011), which held that state-law claims based on a failure to warn of the risks of a generic medication are preempted by federal law. New theories presented by plaintiffs included: (1) that generic manufacturers should have warned healthcare providers of (Metoclopramide’s) risks through means other than the product’s package insert, such as by way of a “Dear Doctor” letter; (2) that state-law liability can be predicated on duties that arise solely from the FDCA; (3) that state-law liability can be premised on an alleged duty to ask the brand-name drug manufacturer to make a labeling change; and (4) that a generic drug manufacturer can be held liable for failing to stop selling a drug with allegedly inadequate warnings.[i]
Recent Defense Ruling
Wyeth-Ayerst Pharmaceuticals, Inc. (“Wyeth”) recently beat back such an effort in Tersigni v. Wyeth-Ayerst Pharm., Inc., 2014 U.S. Dist. LEXIS 86993 (D. Mass. June 25, 2014). Plaintiff Michael J. Tersigni filed suit on March 11, 2011 against Defendant Wyeth alleging that his primary pulmonary hypertension was caused by his use of its diet drug “Fen-Phen.”[ii]
The Fen-Phen Craze
During the height of the 1990s the market was flooded with diet and weight loss drugs to combat America’s increasing problem with obesity. One such weight loss drug was known as “Fen-Phen,” which was a pharmaceutical cocktail that combined phentermine and fenfluramine. [iii] This combination was not approved by the Food and Drug Administration (FDA), yet was prescribed by doctors across the nation.[iv] Fen-Phen worked by increasing serotonin levels in the brain which had a twofold effect – the consumer would feel satiated, while also experiencing a loss in appetite.[v]
Despite contentious debate about the safety of this pharmaceutical combination, dexfenfluramine, a derivative of the Fen-Phen cocktail and the active ingredient in “Redux,” was approved by the FDA in 1996.[vi] Sales of the product were very strong, with nearly 2 million individuals taking dexfenfluramine in the U.S. alone.[vii] An article published in The New England Journal of Medicine in August 1997, however, revealed that Fen-Phen led to a host of illnesses including heart valve problems and pulmonary hypertension.[viii]
Wyeth was the distributor and manufacturer of Pondimin, a version of fenfluramine that had been on the market in the United States since the early 1970s, as well as Redux.[ix] Wyeth withdrew both of these products from the market in September 1997 following a request by the FDA. This led to a torrent of litigation in which thousands sought financial compensation due to medical conditions allegedly caused by consuming these drugs, including the case brought by Mr. Tersigni.[x]
Tersigni brought five claims against Wyeth alleging “Breach of Warranty – defective design (Count I), Breach of Warranty – failure to warn (Count II), Negligence or Products Liability (Count III), Fraudulent Misrepresentation (Count IV), and Fraudulent Concealment (Count V).”[xi] Tersigni maintained that the action should not be limited to a “failure to warn” theory of negligence, but it should also be construed to allow a “failure to discontinue marketing” theory of liability. Judge Sterns recognized defense counsel’s argument that such a theory was simply an attempt at a “backdoor” resuscitation of Plaintiff’s claims in violation of Massachusetts’ consistent adherence to the legal principles stated in comment k of Restatement (Second) of Torts § 402A (1965).[xii]
Defense counsel should be on the lookout for preempted claims cloaked in new theories of liability. Defense Counsel in Tersigni did so, thereby limiting available theories of liability, and obtained a defense verdict on July 31, 2014. The Court entered judgment on August 4, 2014.[xiii]
[i] PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011).
[ii] Tersigni v. Wyeth-Ayerst Pharm., Inc., 2014 U.S. Dist. LEXIS 86993 (D. Mass. June 25, 2014).
[iii] Kate Cohen, Fen Phen Nation, FRONTLINE – PBS.com (Nov. 13, 2003) http://www.pbs.
[v] Tersigni v. Wyeth-Ayerst Pharm., Inc., CIV.A. 11-10466-RGS, 2013 WL 6531118 (D. Mass. Dec. 13, 2013).
[vi] Gina Kolata, How Fen-Phen, A Diet ‘Miracle,’ Rose and Fell, N.Y. Times, Sept. 23, 1997 at F6.
[vii] Cohen, supra note 3.
[ix] Tersigni, 2013 WL 6531118.
[x] Tersigni, 2013 WL 6531118; Cohen, supra note 3.
[xi] Tersigni, 2013 WL 6531118.
[xii] Tersigni v. Wyeth-Ayerst Pharm., Inc., 2014 U.S. Dist. LEXIS 86993 (D. Mass. June 25, 2014); citing Vasallo v. Baxter Healthcare Corp., 428 Mass. 1, 22 (1988) and Payton v. Abbott Labs, 386 Mass. 540, 573 (1982). Comment k states, in relevant part, that,
[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs . . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
RESTATEMENT (SECOND) OF TORTS § 402A cmt. k (1965).
[xiii] See Tersigni v. Wyeth-Ayerst Pharm., Inc., No. 11-10466-RGS ( D. Mass. July 31, 2014), ECF No. 255; Jury Verdict in Favor of Defendant, Tersigni v. Wyeth-Ayerst Pharm., Inc., No. 11-10466-RGS ( D. Mass. Aug. 4, 2014), ECF No. 257.