In re Reglan Litigation: No Federal Preemption of State Law Claim That Generic Drug Carried Inadequate Warning

In re Reglan Litigation, 226 N.J. 315 (2016).  Plaintiffs in this mass tort matter claimed that defendants, who are generic manufacturers of metoclopramide, the generic version of the drug Reglan, were liable under New Jersey’s Product Liability Act, N.J.S.A. 2A:58C-1 to -11 (“PLA”), for failure to warn about the health effects of taking metoclopramide for too long.  The warning on the generics’ labels differed from the warning that the Food and Drug Administration had approved for Reglan itself.  The FDA-approved warning said that “[t]herapy should not exceed 12 weeks in duration,” while the generics’ labels said only that “[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.”

Defendants moved to dismiss the master complaint that plaintiffs had filed, on the ground that federal law, specifically the Food, Drug and Cosmetic Act, 28 U.S.C. §301 et seq., preempted plaintiffs’ state law claims.  The Law Division denied that motion and, on leave to appeal, the Appellate Division affirmed.  The Supreme Court granted leave to appeal and today affirmed, applying de novo review to the legal issue of preemption.  Justice Albin wrote the Court’s 5-0 decision.

After laying the groundwork for the appeal by discussing the Supremacy Clause of the United States Constitution, general principles of preemption, and the FDCA scheme that surrounds labeling of drugs, Justice Albin turned to the key case in this area, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  That case, which formed the basis for defendants’ position, held that “generic drug manufacturers are obligated to provide the same warning labels as those provided by the brand-name manufacturer.”  Demands for “warnings exceeding those on brand-name labels,” Mensing said, are preempted by federal law “because generic drug manufacturers could not comply with state law without violating federal law.”

Justice Albin concluded that preemption did not apply to this case.  “Here, however, defendants did not provide the same warning labels that the FDA approved for the brand-name manufacturers.  As alleged, defendants’ inadequate labeling breached a duty of care under the [PLA].  Complying with both federal and state law was not impossible because, unlike in Mensing, defendants could have updated their labeling without violating the FDA’s sameness requirement.”

Today’s case was more like Wyeth v. Levine, 555 U.S. 555 (2009).  There, the Supreme Court stated that Congress did not intend “to pre-empt common-law tort suits,” but instead for them to serve “as a complementary form of drug regulation.”  There, as here, though the FDA had approved Wyeth’s label, “federal law did not preempt a state-law tort action against it for giving inadequate warnings about the significant risks of administering its drug,” because it was not impossible for Wyeth to comply with both federal and state law.

Justice Albin then distinguished two other cases that defendants relied upon, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and Cornett v. Johnson & Johnson, 211 N.J. 362 (2012) [Disclosure:  I argued Cornett, which is discussed further here, for the plaintiffs in that case, in which the Supreme Court found certain claims not preempted].

Buckman involved “a state-law tort action premised on a claim that the defendant medical-device manufacturer committed a fraud on the FDA.”  A fraud-on-the agency claim was not based on traditional state tort law because a “critical element” of the claim was dependent on certain amendments to the FDCA, resulting in preemption in Buckman.  Here, however, the “critical element” of plaintiffs’ claim “is not defendants’ violation of the FDCA, but defendants’ failure to give adequate warnings about the prolonged use of metoclopramide.”  Cornett did not aid defendants because that case had made clear that a failure to warn claim falls “within a traditional area of state concern and regulation,” unlike a claim of fraud on the FDA.

Finally, Justice Albin noted that a number of cases elsewhere had reached the result that the Court did today.  A lone Fifth Circuit case to the contrary was not persuasive.  The case was remanded to the trial court for further proceedings.