United States: Could Preemption Rulings For Generic Manufacturers Be Bitter Pill For Name-Brand Manufacturers?

For more than a decade, courts across the country have rejected the premise that a manufacturer of a name-brand medication is liable for injuries resulting from a plaintiff's use of the generic version of that medication. Until recently, courts declined to hold that the generic manufacturer could escape liability for the medication's warnings based on its similarity to the name-brand label.

In a June 17, 2008, opinion, however, the District Court of Minnesota joined what may prove to be a trend of decisions finding that inadequate warning claims against generic manufacturers are preempted by a conflict with federal law. The application of these two doctrines—one that applies to name-brand manufacturers and the other to generics—may well result in cases where a plaintiff alleging injury from generic medications based on inadequate warnings can recover from neither manufacturer. In fact, that is the very result that was reached in the District of Minnesota case, Mensing v. Wyeth, at the end of October.

While such a result may at first strike observers as surprising because plaintiffs can be left without a remedy for their injuries, the outcome is an ordinary consequence of preemption principles. That said, an even more recent decision by the appellate court of California suggests that some courts may not look with favor on such a result—and may reverse the tide altogether.

Foster Established Scope of Name-Brand Manufacturer Liability

In the landmark case Foster v. American Home Products, 29 F.3d 165, 169 (4th Cir. 1994), the Fourth Circuit Court of Appeals held that a plaintiff who used a generic medication could not sue the manufacturer of the name-brand product on failure-to-warn theories.

Plaintiffs in Foster had brought suit based on the death of a child that occurred after administration of the generic version of Phenergan®, a medication manufactured by Wyeth. Plaintiffs had sued both the generic manufacturer of the medication and Wyeth, alleging that the warnings were inadequate. Wyeth argued it could not be held liable based on the unremarkable proposition that it did not manufacture the drug at issue. The Fourth Circuit agreed, holding that, as a matter of law, statements by a manufacturer about its own product could not constitute the basis for liability for "injuries caused by other manufacturers' products, over whose production the name brand manufacturer has no control."

Courts addressing the same issue had, until November 7, 2008, uniformly agreed with the Fourth Circuit's reasoning that name-brand manufacturers cannot be held liable for injuries allegedly resulting from inadequate warnings on generic medications. See, e.g., Pustejovsky v. Wyeth, Inc., No. 4:07-CV-103-Y, 2008 WL 1314902, at *2 (N.D. Tex. Apr. 3, 2008); Goldych v. Eli Lilly & Co., No. Civ. A. 04-0611, 2006 WL 2883030, at *6 (W.D. La. Oct. 5, 2006); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 540-41 (E.D. Pa. 2006), aff'd, 521 F.3d 253 (3d Cir. 2008). But see Conte v. Wyeth, Inc., Nos. A116707 & A117353, 2008 Cal. App. LEXIS 1736 (Cal. Ct. App. Nov. 7, 2008) (rejecting Foster and holding that plaintiff could pursue negligent misrepresentation claims against name-brand manufacturer even though she had taken generic medication).

In Foster, the court explicitly addressed the equivalence of warnings for generic products to that of the name-brand medications. In considering the Maryland law at issue, the Fourth Circuit rejected the argument that the similarity of the generic label to Wyeth's label defeated ordinary principles of causation in products liability cases: "We are persuaded that Maryland courts would reject this effort to circumvent the necessity that a defendant be shown to have manufactured the product that caused an injury prior to being held liable for such injury." In dicta, the Fourth Circuit also noted that generic manufacturers could be liable based on the warnings that were equivalent to that of Phenergan.

Generic Manufacturers Score Broad Preemption Victories

The Fourth Circuit's dicta regarding liability of the generic manufacturers in Foster has received a different reaction from courts as of late.

This summer, the District Court of Minnesota held that inadequate warning claims against the generic manufacturers of a medication were preempted by federal law. In Mensing v. Wyeth, 562 F. Supp. 2d 1056 (D. Minn. 2008), the plaintiff brought suit in Minnesota against defendants including Wyeth, the manufacturer of Reglan®, and two generic pharmaceutical manufacturers. Mensing had not taken name-brand Reglan, but claimed that its generic version, which she had taken from 2001 through 2005, caused her to develop tardive dyskinesia, "a neurological movement disorder." The generic manufacturers brought a motion to dismiss Mensing's claims, arguing that the regulations governing generic medication labels required their labels to be the "same as" Reglan and therefore Mensing's state-law tort claims were preempted because of their conflict with federal law.

The District Court agreed. Citing the relevant statute, its regulatory framework and comments by the FDA, the court concluded "there is no dispute" that the generic manufacturers' labels "were required to be 'the same as the labeling approved'" for Reglan when they were introduced. The court also determined that "a generic drug manufacturer may not unilaterally strengthen a label without prior approval of the FDA." Therefore, it "would be impossible" for the manufacturers to abide by federal law requiring that metoclopramide have the same label as Reglan and the state-law warning required under Mensing's theory that stronger warnings regarding tardive dyskinesia should have been given. This "direct[ ] conflict" meant that Mensing's claims against the generic manufacturers were preempted. See also Gaeta v. Perrigo Pharms. Co., No. 05-04115 (C.D. Cal. June 13, 2008) (same).

Other federal courts have since reached the same conclusion, relying on the court's decision in Mensing. Smith v. Wyeth, Inc., No. 07-18 (W.D. Ky. Oct. 24, 2008); Masterson v. Apotex, No. 07-61665, 2008 WL 3262690 (S.D. Fla. Aug. 7, 2008).

The Consequence—No Remedy

The full impact of preemption for generic manufacturers was recently made apparent in Mensing. On October 27, the District Court granted the motions for summary judgment brought by the remaining defendants. Mensing v. Wyeth, No. 07-cv-03919 (D. Minn. Oct. 27, 2008). The court followed Foster and its progeny, holding that the name-brand manufacturers could not be held liable for injuries caused by another manufacturer's product. Yet—unlike Foster's presumption—the generic manufacturer was not left with potential liability because any warnings that plaintiffs allege should have been given under state law are preempted by federal law. Thus, neither the generic nor the name-brand manufacturers could be held liable for plaintiff's alleged injuries.

The inability of plaintiffs that use generic medications to recover from pharmaceutical manufacturers after Mensing is the natural consequence of a preemption ruling. Preemption prevents plaintiffs from pursuing their claims against defendants whom they allege caused their injuries. See Riegel v. Medtronic, 552 U.S. __ (Feb. 20, 2008) (holding that claims against defendant medical device manufacturer stemming from rupture of catheter inserted into arteries of plaintiff's heart were preempted).

The preemption doctrine is based on a choice of the superior method for regulation; it is not a liability determination for an individual case. Id. (describing differences in FDA cost-benefit analysis of a medication's effects in society and a jury's determination in an individual case in which the jury is "not concerned with the benefits" because "the patients who reaped those benefits are not represented in court"). The District Court recognized the effect of its decision, stating that it was "sympathetic to the fact that Plaintiff may lack a legal remedy due to the fact that she did not ingest name-brand Reglan and that her claims against the generic manufacturers are preempted by federal law." Yet the court concluded, "That plaintiff is left without a remedy is an issue for the legislature, not this Court."

An aversion to the lack of remedy facing plaintiffs may explain the California Court of Appeal's decision in Conte v. Wyeth. In that case, the court rejected Foster and its long line of followers, deciding for the first time that manufacturers owe a duty of care to those whose doctors may reasonably rely on the name-brand's product information, even if the prescription is filled with (and injuries arise from) the generic version. The court held that plaintiffs who took generic medications may pursue a negligent misrepresentation claim against the name-brand manufacturer.

This term, in Levine v. Wyeth, the Supreme Court will address the issue of preemption of claims against name-brand manufacturers. Mensing addresses a separate issue: preemption for generic manufacturers. Thus, the question of whether—as courts hold that claims against generic manufacturers are preempted by federal law—name-brand manufacturers will remain free from liability for injuries incurred from generic products as in Mensing, or liable as in Conte, will continue to play out in courts across the country.

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