In a bellwether decision for patients injured by the generic version of Reglan (metoclopramide), the Alabama Supreme Court ruled 8-1 that a plaintiff could sue Wyeth, Inc., the drug’s manufacturer, for injuries caused by a generic version produced by another manufacturer. The decision distinguished Pliva, Inc. v. Mensing, holding that Wyeth could be liable for its misrepresentations about the drug’s risks even when a patient is treated only with the generic version of the medication. (Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11, 2013).)
The state court considered the case on certification from a federal district court in Alabama after a series of conflicting federal district court decisions interpreting Alabama law in generic drug cases.
The plaintiff in Weeks was treated solely with the digestive drug metoclopramide, the generic version of Reglan, and later developed tardive dyskinesia, a severe muscle disorder linked to the drug. He sued five current and former branded and generic manufacturers of metoclopramide. In holding that Weeks’s misrepresentation claims were actionable under Alabama law, Justice Michael Bolin focused on Wyeth’s responsibility for misrepresentations of the dangers metoclopramide posed in all its forms, whether branded or generic. He concluded that the Supreme Court’s decision in Mensing did not preclude liability for a brand-name manufacturer’s misrepresentations that necessarily extend to its generic formulation and on which a physician relies.
In Mensing, the Supreme Court ruled that most failure-to-warn claims against generic drug companies were preempted by an FDA requirement that branded and equivalent generic drug labels be identical. Applying Alabama’s learned intermediary doctrine, however, the state court held that because physician warnings are necessary for a branded drug, those warnings extend to misrepresentations for its generic equivalent.
Bolin emphasized that the issue was founded in the foreseeability of harm. “A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug,” Bolin reasoned. He also concluded that notions of fundamental fairness supported the holding, observing that “many insurance plans are structured to promote the use of generic drugs, even though the physician may prescribe either the branded or generic drug as acceptable to treat a patient.”
Bolin wrote, “In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.” He also opined that the Supreme Court has recognized that “the FDA traditionally regarded state law as a complementary form of drug regulation.”
Hundreds of lawsuits against Wyeth (which was purchased by Pfizer in 2009) and metoclopramide manufacturers are pending.
Louis Bograd, senior litigation counsel for the Center for Constitutional Litigation in Washington, D.C., called the ruling “a lifeline to plaintiffs injured by inadequately labeled generic drugs.”
Bograd said that because the generic drug labeling must be identical to the branded drug labeling, the brand-name manufacturer should be responsible for any inadequate warnings a physician relies on. “The Alabama Supreme Court rejected numerous precedents that had prohibited misrepresentation liability under these circumstances on the grounds that it was the generic drug manufacturer that was primarily responsible for its label; the Weeks court correctly recognized that such reasoning could no longer be considered valid after Mensing,” he said.
Bograd emphasized that while the Alabama decision does not fully address the effect of Mensing—or the disparity between legal redress for injuries caused by a branded drug and its generic equivalent—it is another tool for plaintiff lawyers. “Any lawyer representing a person injured by a generic drug must at least consider the possibility of pursuing recovery from the brand-name manufacturer on a misrepresentation theory," he said.