The Progeny of Pliva v. Mensing: Generic Immunity Does Not Equal Brand-Name Liability
In the wake of the Supreme Court’s Pliva v. Mensing decision (previously discussed here and here), the Sixth Circuit Court of Appeals in Smith v. Wyeth followed suit, holding that state law failure-to-warn claims against generic pharmaceutical manufacturers were pre-empted by federal law. According to the Sixth Circuit, “[t]he plain language of the Pliva Decision compels the same result here”:
The Supreme Court held unequivocally…that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims.
However, these cases are different than a straight-forward Pliva-type case in that the plaintiffs also sued the brand-name manufacturers of the drug for injuries caused by the generic manufacturers’ drug under a vicarious liability, failure-to-warn theory. In brief, the theory is based on the federal regulatory structure governing drugs where brand-name drug manufacturers are the only entity in the position to propose label changes. The generic drug label must mirror the brand-name drug's label, leaving generic manufacturers largely with no power or avenue to request label changes. According to plaintiffs, it is foreseeable that doctors and patients will rely on the label controlled solely by the brand-name manufacturer—whether that label is on the brand-name drug or the generic drug. Consequently, the brand-name manufacturer thus has a duty to all of the drug’s users, both brand-name and generic, to maintain an adequate label warning of the risks associated with the drug.
Despite plaintiffs' best efforts, the Sixth Circuit wasn't sold and quickly dismissed this theory, stating that it has been rejected by all but one of the courts that have considered it. (The one beingConte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 313 (Cal. Ct. App. 2008) (“[W]e have no difficulty concluding that [the name-brand defendant] should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide.”)). The Sixth Circuit stated that:
…adopting [plaintiffs'] theory of liability would require the court to attribute any deficiency in a name-brand manufacturer’s labeling and marketing of its products to products manufactured by its generic competitors. Such a theory, however, fails to satisfy the threshold requirement of a products-liability action – that the defendant’s product have injured the plaintiff. As the district court stated, “Just because a company is in the same business as a tortfeasor, the company is not automatically liable for the harm caused by the tortfeasor’s product.”
The Court relied upon “the leading case” that considered this issue, Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), in “reject[ing] the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company.”
As previously discussed here, there has been speculation that plaintiffs using this vicarious liability theory would increase as a result of the Pliva decision. The Sixth Circuit Court seems to want to nip that theory in the bud...quickly. However, the Court does leave the door slightly open, emphasizing that its decision primarily rests upon the inability of plaintiffs to show this theory was viable under state law: “Moreover, and most significantly, the plaintiffs have not convinced us that the state courts of Kentucky would adopt their vicarious-liability argument under the Kentucky Products Liability Act.” (emphasis added). This could imply that if a state’s product liability statute could be construed by a plaintiff in a manner that would hold a brand-name drug manufacturer liable under a vicarious liability theory for “controlling the warning label of a drug” then a plaintiff’s state law failure-to-warn claim may proceed against the brand name manufacturer for injuries caused by the generic drug.