Innovator Liability Still Not Viable After Pliva v. Mensing - Pharmaceutical Technology

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Innovator Liability Still Not Viable After Pliva v. Mensing
Recent legal decisions have further divided generic and brand manufacturer cases.


Pharmaceutical Technology
Volume 36, Issue 1, pp. 88-90

Current innovator liability

This so-called "innovator liability" theory is not new. In fact, it pre-dates Mensing by at least 17 years, with the most often cited case being a decision from the US Court of Appeals for the Fourth Circuit in Foster v. American Home Products Corporation (7). Interpreting Maryland law, the Fourth Circuit rejected the idea of liability for the branded drug manufacturers when the plaintiff ingested only the generic equivalent, regardless of whether the cause of action asserted was a traditional products liability claim (i.e., strict liability, breach of warranty, negligence) or a claim for negligent misrepresentation. The Court first noted that traditional products liability claims are not viable against defendants who did not manufacture the product in question. The Court then questioned whether the cause of action for negligent misrepresentation was simply "an effort to recover for injuries caused by a product without meeting the requirements the law imposes in products liability actions, which limits liability to defendants who manufactured the product at issue" (8).

Nonetheless, the Fourth Circuit assumed the theoretical viability of a negligent misrepresentation cause of action in a products liability case and went on to analyze the existence of a duty of branded manufacturers to consumers who ingest only the generic equivalents of their drugs. The question turned to whether it was foreseeable to the branded manufacturer that alleged misrepresentations regarding its drug would result in injury to users of the generic equivalent. In the most often quoted line of the case, the Foster Court held, "We think to impose a duty in the circumstances of this case would be to stretch the concept of foreseeability too far" (9).

During the next 14 years, courts interpreting the laws of at least 10 other states, approved of Foster's reasoning and rejected the innovator liability theory. But in 2008, a California intermediate state appellate court case called Conte v. Wyeth went against the grain (10). In Conte, the Court acknowledged Foster but reached the opposite conclusion when it held that under California law, the branded manufacturer of Reglan owed a common law duty to consumers who never ingested their product, but rather ingested only the generic equivalent, because it was foreseeable that doctors and patients would rely on the safety information provided by the branded manufacturer.

In the past three years, a single federal court interpreting Vermont law is the only court outside of California that has followed Conte and disagreed with Foster. During this same period of time, numerous courts interpreting the laws of at least 20 states have continued to follow the majority rule by explicitly approving Foster and/or rejecting Conte.

Despite this overwhelming majority rule, plaintiffs will undoubtedly argue that Mensing changes the analysis and requires that someone (i.e., the branded manufacturers) must be held accountable for injuries to a consumer injured by a generic drug with allegedly inadequate warnings. Indeed, several of the cases following the majority rule, including Foster, state the (now known to be mistaken) belief that the generic-drug manufacturers are liable for such injuries. But while that belief may have given some courts comfort in the equities of dismissing the claims against the branded manufacturers, courts following the majority rule before and after Mensing have recognized that generic manufacturer liability is not a prerequisite for rejecting innovator liability. In fact, in 2004, seven years before Mensing, the Eastern District of Pennsylvania correctly predicted the outcome of Mensing's pre-emption conclusion, yet still followed the majority rule rejecting innovator liability.

"Accordingly, we find that state tort law which would hold a generic drug manufacturer liable for failing to modify a label when, pursuant to the Hatch–Waxman Amendments to the FDCA [FD&C Act], the ANDA approval process required that the labeling be the same as that approved for the innovator drug, and when the FDA would have deemed any post-approval enhancements 'false and misleading,' would actually conflict with the FDCA. For these reasons, as well as our conclusion that we must afford deference to the FDA's position that the claims are pre-empted, we find that Plaintiff's failure-to-warn claims are impliedly preempted.

"Thus, this Court holds that under Pennsylvania law, there is no duty of care owed by a brand-name prescription drug manufacturer to a plaintiff allegedly injured by a generic equivalent drug manufactured by another company. Thus, even if this Court's conclusion regarding pre-emption were found to be improper, the claims against [the branded manufacturer] Defendant GSK must still be dismissed" (11).

Moreover, post-Mensing, there are no published cases questioning the validity of the majority rule rejecting innovator liability, and at least three courts have continued to follow the majority rule despite arguments from plaintiffs that Mensing should change the analysis.

In Smith v. Wyeth, the Sixth Circuit affirmed the dismissal of claims against both the generic-drug manufacturer (based on Mensing) and the branded manufacturer (based on the majority rule from Foster and its progeny) by plaintiffs who alleged injuries as a result of taking generic metoclopramide, thereby leaving the plaintiffs with no remedy (12). The federal District Courts of Maryland and the Western District of Louisiana have reached the same conclusion.

"[T]he Supreme Court's opinion in Mensing in fact gave this Court no reason to reconsider its entry of final judgment in favor of [the branded manufacturer] Defendants.... The Supreme Court's holding in Mensing neither created nor abrogated any duty under Maryland law with regard to brand name manufacturers like Defendants" (13).


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