In any negligence cause of action, foreseeability of harm is a factor in determining whether or not a defendant has a legal duty to a plaintiff. Generally, a defendant has no duty to protect a plaintiff from an unforeseeable harm arising out of the acts of a third party, but innovator liability is seemingly an exception to this well-established rule. Innovator liability is a controversial theory that is valid in only a minority of states. The theory holds that a brand-name pharmaceutical manufacturer of a brand-name drug can be held liable for defective warnings found on generic versions of their drugs manufactured by their competitors.
The California Court of Appeals was the first court in the United States to recognize this theory of recovery in Conte v. Wyeth (2008) 168 Cal.App.4th 89. There, the appellate court held that Wyeth, a name brand manufacturer of Reglan®, a prescription drug used to treat gastroesophogeal reflux disease, had a duty to warn patients whose doctors allegedly relied on Wyeth's labeling information when prescribing both brand-name and generic versions of the drug. In 2011, the U.S. Supreme Court's opinion in
Pliva, Inc. v. Mensing (2011) 131 S.Ct. 2567 opened the doors for "innovator liability" lawsuits on a larger scale when the Court immunized generic-drug manufacturers from all state-law failure-to-warn claims. The Court reasoned that because the Food and Drug Administration (FDA) does not allow generic drugs to provide warnings different than those provided by the innovator of the drug, any such state law claims are preempted. (Id. at 2580-81.) Accordingly, it comes as no surprise that a lawsuit combining the theory of innovator liability from
Conte, coupled with the immunization of generic-drug manufacturers from liability under
Mensing, has led to another ruling that innovators of brand-name drugs are liable for the warnings of generic forms of their drugs.
In Weeks v. Wyeth (2014) Ala. LEXIS 109, WL 4055813, the Alabama Supreme Court found that a plaintiff who alleged his long-term use of metoclopramide, the generic form of Reglan®, resulted in his development of a movement disorder and was a foreseeable user of the drug. Accordingly, the court found that the manufacturers of Reglan® had a duty to provide sufficient warnings regarding hazards associated with its use. Although the plaintiff admitted that he never ingested the brand-name version of metoclopramide, the Court upheld the plaintiff's causes of actions against Wyeth LLC, Pfizer Inc., and Schwarz Pharma, Inc., the brand-name manufacturers of Reglan®. The plaintiff alleged that the brand-name manufacturers engaged in misrepresentation and fraud by failing to adequately warn his treating physician of the potential side effects from long-term use of the drug. Although the Alabama Supreme Court explicitly stated that it was not creating "a new tort of 'innovator liability'" through their holding, the court's reasoning relied heavily upon the analysis of
Mensing in reaching their conclusion. Accordingly, even if the Alabama Supreme Court was attempting to follow the majority of jurisdictions in not recognizing innovator liability, the court's holding is indistinguishable from
Conte and seemingly undermines any notion that innovator liability is not an available theory of recovery in Alabama.
Arguably, a plaintiff has no choice but to go after the brand-name manufacturer of drugs after generic manufacturers became immune from liability under Mensing, but innovator liability simply does not comport with the well-established rule that a defendant owes no duty to an unforeseeable plaintiff. Further, the recent Alabama Supreme Court decision has re-raised the possible application of innovator liability outside the realm of pharmaceuticals. Currently, there are no cases which extend the rationale of innovator liability outside the pharmaceutical drug industry, but it is not farfetched to imagine that plaintiffs will begin making such allegations in general products liability matters in the near future. All we can do is hope that the judiciary will keep innovator liability within the confines of pharmaceutical drugs and someday reaffirm the well-established rule that an innovator has no duty to protect an unforeseeable plaintiff from harm.