Levine Goes Generic: Eighth Circuit Weighs In on Preemption and Innovator Liability

On November 27, 2009, a three-judge panel of the U.S. Court of Appeals for the Eighth Circuit weighed in on two issues critical to manufacturers of generic and branded drugs: (1) whether failure-to-warn claims against generic manufacturers are preempted by federal law and (2) whether failure-to-warn claims against name-brand manufacturers are cognizable under state law where the plaintiff ingested only the generic version of the drug. Mensing v. Wyeth, Case No. 08-3850, slip op. (8th Cir. Nov. 27, 2009). The court answered "no" to both.

Mensing represents the first U.S. court of appeals to apply to makers of generic drugs the rationale of Wyeth v. Levine, 129 S. Ct. 1187 (2009). Mensing also is the first U.S. court of appeals since Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), to reject name-brand liability for generic-only use—a ruling in keeping with 34 other judicial decisions.

Appellant Gladys Mensing brought suit in U.S. District Court for the District of Minnesota against manufacturers of generic and branded metoclopramide (Reglan®), alleging the drug caused her to develop tardive dyskinesia, a severe neurological movement disorder, and that defendants had misrepresented and failed to warn of the risk.

Mensing, who had been prescribed name-brand Reglan® by her doctor, had her prescription filled at the pharmacy with metoclopramide, the generic form of the drug. The district court dismissed her complaint in its entirety, ruling that claims against the generic manufacturers were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) and that claims against the name-brand manufacturers failed for lack of duty.

Manufacturer Bears Responsibility for Content of Its Label

On appeal, the generic defendants argued that federal law requires that their product labeling mirror that of the name-brand drug. Thus, they asserted, Congress intended to preempt state tort law claims of inadequate labeling and insulate generic manufacturers from liability for failure to warn. The Eighth Circuit rejected this argument, guided by the U.S. Supreme Court's admonition in Levine that "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times." And, while Levine turned on whether failure-to-warn claims against a branded manufacturer were preempted by the FDCA, the Eighth Circuit found a straightforward analog in generic manufacturers. The court concluded that the FDCA's regulatory framework permitted generic defendants to "at least propose[] a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved."

Safety of Marketed Drugs a Fundamental FDCA Requirement

Guided again by Levine, the court found that to support a preemption defense the generic defendants must show the likelihood of FDA inaction in the face of a generic-initiated label change. The record in Mensing was devoid of any such evidence. On the contrary, the court remarked that the FDA itself had mandated that metoclopramide manufacturers heighten the warning as to the risk of developing tardive dyskinesia.

Significantly, the court also noted that, while requests for label changes must be supported by scientific substantiation, nothing in the regulations required that the information be acquired through a manufacturer's own clinical tests. Rather, the court observed that generic manufacturers are required by regulation to collect and report adverse drug experiences and, as appellant argued, have access to published medical studies about the drugs they manufacture.

Notably, the Eighth Circuit reached its decision in Mensing without deciding whether generic manufacturers may unilaterally strengthen their labels through the Changes Being Effected procedure, a provision heavily relied on by the district court. In sum, the court observed that the FDCA and the Hatch-Waxman Amendments "provided for cheaper, expedited approval of generic drugs, not relief from the fundamental requirement of the FDCA that all marketed drugs remain safe. Congress and the FDA have long viewed state tort law as complementing, not obstructing, the goals of the FDCA." Indeed, the court concluded "we decline to assume that Congress intended to shield from tort liability the manufacturers of the majority of the prescription drugs consumed in this country and leave injured parties … no legal remedy."

Claims Against Name-Brand Manufacturers Fail for Lack of Duty

As to the name-brand manufacturers, the court aligned itself with the vast weight of authority. The court upheld the district court's ruling that, because Mensing did not purchase or ingest the branded drug, the name-brand defendants had no duty to her under Minnesota law. Moreover, the court concluded, citing the seminal case of Foster v. Am. Home Prods. Corp., that holding a name-brand manufacturer liable for harm caused by a generic product "stretch[es] the concept of foreseeability too far."

Profound Implications Possible for Generic Manufacturers

Mensing represents the first U.S. court of appeals to apply the Supreme Court's rationale in Levine to manufacturers of generic drugs. It is also the first U.S. appellate court since the Fourth Circuit's decision in Foster in 1994 to truncate liability for failure-to-warn claims against name-brand manufacturers for generic only use. By recognizing an affirmative duty under state law to seek FDA approval to strengthen its labeling where scientific substantiation—in the form of adverse drug reports and the medical literature—merits, this decision could well portend profound implications for manufacturers of generic drugs.

For the full opinion, please click here.