Generic Pharma Liability Ambiguous Post-Mensing

The U.S. District Court for the Eastern District of Louisiana has permitted state common law claims to proceed against a generic drug manufacturer, in stark contrast to the U.S. Supreme Court's holding in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) that such claims are preempted. (Whitener, Sr. v. Pliva, Inc.,2012 U.S. Dist. LEXIS 127993). While numerous other courts have followed Mensing, the Whitener decision highlights the opportunity for ambiguity and inconsistent interpretations of the law. We recognize that many generic drug manufacturers do not engage in any promotion or direct sales of their products. However, for those that do, this recent development may be of particular interest.

In Mensing, the Supreme Court held that all state-law tort claims based on failure to warn of the risks of generic medications are preempted by federal law because it is impossible to comply with both a state law which requires the strengthening of a generic drug warning and the federal mandate that a generic drug's labeling be the same as that of the brand-name drug. (Mensing, 131 S.Ct. at 2577-2578).

In Whitener, plaintiffs allege that Mrs. Whitener and her son were injured as a result of her taking metoclopramide, the generic form of the brand-name drug Reglan, during pregnancy for nausea. The FDA-approved label for Reglan, required to be used with the generic version, did not include prescription to pregnant women for morning sickness. Plaintiffs' initial complaint was dismissed as preempted under Mensing, but the Court granted plaintiffs leave to amend to assert a non-preempted state-law claim predicated on "alleged promotion of metoclopramide for off-label purposes in violation of federal law." (Whitener, 2012 U.S. Dist. LEXIS 127993 *4 citing Rec. Doc. 130 at 9). 

Defendants brought a motion to dismiss the amended complaint on the ground that it failed to plead the requisite factual specificity that any Defendant promoted the drug for off-label use in violation of federal law. In response to that motion, the Court held that, "Plaintiffs have (barely) pleaded enough facts to raise a reasonable expectation that discovery will reveal evidence of such conduct."  (Id. at 6 citing Rec. Doc. 145 at 5 (internal quotation marks omitted)). The Court further stated that, "[e]ven if a generic manufacturer knows that its product is prescribed for some other purpose, that manufacturer has no mechanism to unilaterally provide any additional warnings relevant to the off-label use; that inability is the crux of the Mensing opinion…" (Id. citing Rec. Doc. 145 at 6-7). Nonetheless, the Court was troubled by the question of whether the preemption analysis changes if a defendant is actively promoting the drug for off-label use in violation of federal law. (Id.). Thus, the Court allowed the state law claims to survive, but noted that "it may be appropriate to revisit the issue at a later time." (Id. at 7).

Defendants next brought a motion for reconsideration based on Mensing, and argued that off-label promotion was among the plaintiffs' allegations found to be preempted in Mensing. Nevertheless, the Court held that, "Defendants simply have not managed to overcome the fundamental distinction between this case and Mensing: unlike in Mensing, Plaintiffs in this case do not allege that Defendants should have changed the contents of the label in violation of federal law. Instead, they allege that Defendants simultaneously violated both state and federal law by actively engaging in off-label promotion despite known risks not listed on the label." (Id. at 16).

Meanwhile, numerous other courts have stood by the Mensing decision and broadly found failure to warn claims brought under state law to be preempted¹.

On April 18, 2012, Senator Patrick Leahy sponsored a bill to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so. Despite the language of the bill, Senator Leahy's intent is clearly to eliminate the federal preemption defense available to generics, and to impose on them exposure to all product liability theories confronting the brands. The Bill was referred to the Senate committee and has since been referred to the Committee on Health, Education, Labor, and Pensions. We are keeping a close eye on any developments.

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¹ See, Guarino v. Wyeth, LLC, 823 F. Supp.2d 1289, 1292 (2011) (Plaintiff's claims are, on their face, premised on an allegedly inadequate warning" are preempted under Mensing); Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (dismissing three lawsuits as preempted by Mensing); Henderson v. Sun Pharm. Indus. Ltd., 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011) granting defendant's motion to dismiss because plaintiff's proposed amended complaint failed to state a claim other than failure to warn, which was preempted under Mensing; Gross v. Pfizer 825 F. Supp.2d 654, 658 (Md. 2011) disposing of state law claims post Mensing.