New Jersey Court: No Dice on “Innovator Liability”
A basic principle of products liability law is that liability follows the product in the chain of distribution. In other words, if the manufacturer did not make the product, it cannot be held liable. But precedent and legal principles be damned, plaintiffs’ attorneys have been pushing a new theory of liability called “innovator liability.” Under this theory, brand-name drug manufacturers (the “innovators”) may be liable for injuries to plaintiffs who only ingested generic versions of their drugs. In other words, it requires brand-name manufacturers to answer for injuries allegedly caused by drugs they did not manufacture. Sounds a bit ridiculous, right? Fortunately, a New Jersey court recently said “no dice” to innovator liability in the case of Coundouris v. Wyeth, et al., No. ATL-L-1940-10, 2012 WL 2401776 (N.J. Super. Jun. 26, 2012) [PDF].
The plaintiffs alleged that the brand-name defendants were liable for injuries caused by generic versions Reglan/metoclopramide. Specifically, they alleged that that the defendants owed a duty to exercise reasonable care to adequately warn doctors and users about the risks of metoclopramide. The defendants argued that under the New Jersey Products Liability Act (“PLA”), 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.
The court concluded that the PLA governed the plaintiffs’ claims, noting that the focus of plaintiffs’ claims was the defendants’ failure to warn about metoclopramide’s dangers and that the state legislature’s intent was for such claims to fall under the PLA. The court further noted 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. As such, the court held that the plaintiffs’ claims must fail under the PLA to the extent that the plaintiffs never ingested products sold or manufactured by the brand-name manufacturers.
The court’s decision seems based on sound legal precedent and is in line with the decisions of other states that have evaluated the viability of innovator liability. In case you’re counting home, so far California is the only state to adopt the theory of innovator liability. It did so in the case Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008). We’re every bit as shocked as you are that California would be on the outside looking on any legal issue (insert sarcasm here).
(Hat tip to John J. Sullivan at the Drug and Device Law blog).