New Jersey Superior Court Judge Carol E. Higbee issued a ruling yesterday in the New Jersey state Reglan®/metoclopramide litigation in which she refused to adopt a novel theory of liability termed "innovator liability." Under this theory, manufacturers of brand-name drugs (the so-called innovators) can be held liable for the claims of plaintiffs who only ingested generic versions of their drugs. In other words, innovator liability requires brand-name manufacturers to answer for injuries allegedly caused by drugs they did not manufacture.
The brand-name defendants, Wyeth LLC, Wyeth Pharmaceuticals, Inc., Wyeth Holdings Corporation, Schwarz Pharma, Inc., and Alaven Pharmaceutical LLC (the "defendants"), filed motions to dismiss plaintiffs' claims, which included claims for conscious misrepresentation, negligent misrepresentation, negligence. The parties agreed that New Jersey law applied, as the cases involved in the motions were filed by New Jersey resident plaintiffs. The main dispute between the parties was whether the plaintiffs' claims were product liability claims governed by the New Jersey Products Liability Act ("PLA"). The defendants argued that under New Jersey law, brand-name drug manufacturers could not be held liable for injuries allegedly caused by the use of a generic drug manufactured by another company. The plaintiffs asserted that their claims were not governed by the PLA and were instead negligence claims governed by common law, and that the defendants owed a duty to exercise reasonable care to adequately warn doctors and users about the risks of metoclopramide and disseminate accurate information about metoclopramide.
The court observed that the PLA broadly defines product liability actions to include any claim brought by a plaintiff due to harm caused by a product. The court concluded that the PLA governed the plaintiffs' claims, observing that the focus of plaintiffs' claims was the defendants' failure to warn about metoclopramide's dangers and that the New Jersey Legislature clearly intended such claims to be controlled by the PLA. Noting that it is well-established that product identification (proof that the product that allegedly harmed the plaintiff is actually the defendant's product) is an essential element of a plaintiff's prima facie product liability action, the court held that the plaintiffs' claims must fail under New Jersey law to the extent that the plaintiffs never ingested products sold or manufactured by the brand-name manufacturers.
The ruling appears to be limited to the handful of cases in which the defendants filed motions to dismiss, though there may be additional cases involving New Jersey resident plaintiffs to which the ruling may apply. There may be choice of law issues that impact any future similar motions relating to other plaintiffs. Yesterday's ruling was preceded by Judge Higbee's opinion and order in May dismissing all counts of the Reglan®/metoclopramide plaintiffs' complaints as to the generic metoclopramide manufacturers pursuant to the U.S. Supreme Court's holding last summer in Pliva v. Mensing, which held that negligent failure to warn tort actions against generic drug manufacturers are preempted by the Food, Drug and Cosmetic Act, effectively barring state law failure to warn claims against generic drug manufacturers.
Stephen C. Matthews, Esq., Principal, Porzio, Bromberg and Newman, PC
Kenneth R. Meyer, Esq., Principal, Porzio, Bromberg and Newman, PC
Genevieve M. Spires, Esq., Counsel, Porzio, Bromberg and Newman, PC