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January 2014: Quinn Emanuel Persuades New York Court to Reject New Theory of Liability Against Pharmaceutical Innovators

January 2014

On October 8, 2013, the New York Supreme Court dismissed claims against Quinn Emanuel client Pfizer Inc., holding as a matter of New York law that a brand-name pharmaceutical manufacturer does not owe a duty in tort to the consumer of the generic equivalent of that medication. Weese v. Pfizer, Inc., 2013 WL 5691993 (N.Y. Sup. Ct. Oct. 8, 2013) (notice of appeal filed). This ruling is the first time that a New York state court has ruled on this novel theory of liability, which has also been rejected by other state and federal courts across the country under different state laws. This ruling is particularly significant for Pfizer because it is headquartered in New York and will have positive implications for all brand-name pharmaceutical manufacturers.

The plaintiffs’ theory of liability—which has been dubbed “innovator liability”—touches upon a fundamental principle of tort law: whether a defendant owes a duty of care to the plaintiff. Innovator liability was concocted after the U.S. Supreme Court held in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), that manufacturers of generic medications cannot be liable under state tort law for failing to adequately warn about the risks associated with taking their medications. Those claims are preempted by federal law. In light of that ruling, plaintiffs redirected their generic drug cases against brand-name manufacturers like Pfizer. Because federal law requires generic manufacturers to copy the label from the corresponding brand-name drug, the plaintiffs posited that the brand-name manufacturer should be liable to those who are injured from a generic copy of their drug, which bears a copy of their warning label. It is argued that these consumers of generic medications are foreseeable and so are injuries resulting from inadequacies in the warming labels that accompany those medications.

Although innovator liability has received mostly negative treatment from federal and state courts, it has met with some success in state courts, and no one had yet tested this theory in New York state courts. Whether a duty in tort exists is often a challenging exercise that requires balancing long-standing precedent and public policy considerations. Weese is the first time a New York state court has addressed whether innovator liability is cognizable under New York law.

In Weese, the Court held that Pfizer did not owe a duty of reasonable care and was thus not subject to tort liability as a matter of law to a consumer of a generic equivalent of its medication. The Court ruled that unlike in cases that trace the boundaries of tort duties under New York law, under these circumstances, “Pfizer had no intentional role in placing the specific product with the plaintiff. It was not the seller. Indeed, a third party—a competitor—manufactured and sold the product.” The connection between Pfizer and the warning label accompanying a generic medication “is even more attenuated” because “[t]he label existed as a requirement of another third party, the federal government, aimed at the generic manufacturer.” The Court held that Pfizer’s duties with respect to its products and labels “should not extend to products and labeling over which it has no control, even if those products and labels mirror its own, because it has done nothing toward putting them in the hands of consumers.”