Guest Commentary

by Kelly Day Savage, Sedgwick LLP*

Many commentators (including this one) correctly predicted that savvy plaintiffs and sympathetic courts would create exceptions to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)– that state-law tort claims against manufacturers of generic drugs based on insufficient product warnings are preempted by federal law–to permit plaintiffs to recover damages in otherwise barred actions.

In Whitener v. PLIVA, Inc., No. 10-1552, 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012), the Federal District Court for the Eastern District of Louisiana created yet another legal loophole by permitting “a state-law tort claim based on alleged promotion of metoclopramide [the generic version of Reglan] for off-label purposes in violation of federal law” to escape preemption on defendants’ motion to dismiss.

The Whitener plaintiffs alleged that Lucas Whitener suffered congenital defects, and his mother suffered injuries too, after she took the generic version of the brand-name drug Reglan to treat nausea and morning sickness.  To avoid preemption of the entire action under Mensing, plaintiffs claimed the generic manufacturers were liable for promoting the generic drug off-label to doctors for prescription to pregnant women to treat morning sickness.  They maintained that their off-label promotional claim was not based on a failure to warn, but instead a violation of state law not related to the generic product’s labeling, and therefore not barred under Mensing.

The District Court unfortunately agreed and denied the generic manufacturers motion to dismiss plaintiffs’ off-label claims on preemption and standing grounds. While noting that plaintiffs barely “pleaded enough facts to have a reasonable expectation that discovery will reveal evidence of such conduct,” the Court concluded:

The hard question . . . is whether the Mensing analysis changes if a generic defendant actively promotes the drug for off-label use in violation of federal law . . . .  [T]here is something troubling about permitting a generic defendant to violate federal law by actively and aggressively promoting a drug for a purpose not contemplated by the label approved by the FDA while also hiding behind an inability to provide warnings connected to that off-label use because it cannot change the approved label.”

Whitener, 2012 WL 3948797, at *2.  The Court recently denied defendants’ motion for reconsideration on standing grounds noting it was “hesitant to hold as a matter of law that there is not a kernel of a viable claim somewhere in Plaintiffs’ allegations.”

The Court’s decision was erroneous.  To the extent that plaintiffs were attempting to bring a claim based on defendants’ alleged off-label promotion of metoclopramide to treat morning sickness, the cause of action represents an impermissible attempt to directly enforce the federal Food, Drug and Cosmetic Act (FDCA) via a private right of action in violation of 21 U.S.C. § 337 and Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  The FDCA grants exclusive authority to the FDA to oversee the safety of drugs and provides that “all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.”  21 U.S.C. § 337(a).

This statutory provision bars any private right of action to “redress alleged violations of the FDCA” including those related to the off-label promotion of a drug.  In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litig., 590 F. Supp. 2d 1282, 1287-90 (C.D. Cal. 2008) (finding that “allegations of off-label promotion are in essence misbranding claims that should be reviewed by the FDA[,]” and plaintiffs could not attempt to “create indirectly” a private right of action that “the FDA does not create directly”), aff’d sub nom, United Food & Commercial Workers Cent. Pa. & Reg’l Health & Welfare Fund v. Amgen, Inc., No. CV 09-56118, 2010 WL 4128490 (9th Cir. Oct. 21, 2010).  This prohibits plaintiffs from seeking to enforce the FDCA, as well as using state unfair competition laws as a vehicle to bring a private cause of action that is based on violations of the FDCA [premised on any off-label promotion].”  Id. at 1290-91.  Plaintiffs’ “off-label” claim should have been dismissed based on standing grounds.  Period.  End of story.

Although a majority of courts have concluded that similar types of misbranding claims are barred under 21 U.S.C. § 337, generic manufacturers should anticipate similar claims as more plaintiffs’ counsel attempt to circumvent the Mensing bar through citation to decisions like this one.

*Ms. Savage is Special Counsel with the law firm Sedgwick LLP.