Failure To Update Generic Metoclopramide Label Not Preempted, 6th Circuit Says

CINCINNATI - (Mealey's) A plaintiff's claim that PLIVA Inc. failed to add a 2004 warning from the Reglan label to its label for generic metoclopramide is not preempted, a panel of the Sixth Circuit U.S. Court of Appeals said March 13 in what it described as question of first impression in the circuit (Eleanor Fulgenzi v. PLIVA, Inc., No. 12-3504, 6th Cir.).

(Opinion available. Document #28-130321-005Z.)

For three months in 2004 and for more than a year from 2006 to 2007, Eleanor Fulgenzi took metoclopramide, the generic version of Reglan, to treat gastroesophageal reflux disease. She alleged that as a result of her long-term use of the drug, she developed tardive dyskinesia, a permanent neurological disorder with symptoms similar to those of Parkinson's disease.

In 2009, Fulgenzi sued several drug manufacturers, including generic drug maker PLIVA, in the U.S. District Court for the Northern District of Ohio, alleging that they failed to warn her of the risk of tardive dyskinesia. Since Fulgenzi only took metoclopramide made by PLIVA, the court dismissed all other defendants.

Mensing Preemption Applied

In 2011, the U.S. Supreme Court issued its opinion in PLIVA, Inc. v. Mensing (131 S. Ct. 2567 [2011]) [enhanced version available to subscribers], another metoclopramide case in which it held that because the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act (FDCA) require generic drugs to have the same label as their predecessor, or "listed" brand-name drugs, generic drug makers are unable to add warnings about new risks, and state law tort claims for failure to warn are preempted by federal law.

The District Court allowed Fulgenzi to amend her complaint. She did and argued that PLIVA's failure to include an updated 2004 warning against long-term use of metoclopramide violated PLIVA's federal duty of sameness and rendered its warning inadequate under Ohio law.

The District Court granted PLIVA's motion to dismiss, finding that Fulgenzi's claims were failure-to-warn claims clearly preempted by Mensing. In addition, the court found that Fulgenzi's Ohio claim fails because there is no private cause of action for violation of Food and Drug Administration regulations.

Fulgenzi appealed, arguing that when PLIVA failed to update its label, it was no longer impossible for the defendant to comply with its federal and state duties.

Duty To Match Reglan Label

In a published ruling, the panel, citing the Supreme Court's brand-name drug preemption ruling in Wyeth v. Levine (555 U.S. 555 [2009]) ][enhanced version] and Mensing, said, "In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE [changes being effected] process . . . but it had a federal duty to do so. . . . As a result, compliance with federal and state duties was not just possible; it was required."

"Impossibility preemption is inappropriate in such a case," the panel continued. "It is true that the FDA had the authority to reject PLIVA's labeling change after the fact. But this is precisely the 'possibility of impossibility' that Wyeth found insufficient to warrant preemption."

"Indeed, as PLIVA had a clear federal duty to update its label, it is even less likely here that the FDA would have rejected the change," the panel said. "This case, therefore, presents an even weaker case for impossibility preemption than Wyeth."

Plaintiff's Options

The panel said Fulgenzi's claims "survive only to the extent PLIVA's actions were permitted by federal law." It said she cannot claim that PLIVA should have included an "aggressive" black-box warning because those allegations are preempted by Mensing.

"Instead, she is left to argue only that PLIVA's warning was inadequate to the extent that it did not include the language contained in the updated Reglan label from 2004," the panel wrote. "This leaves her with a weaker case than if she were suing a branded-drug manufacturer, but that is the statutory scheme provided to us by Congress."

The panel rejected PLIVA's argument that Fulgenzi's claim would frustrate the intent of the Hatch-Waxman Amendments to speed the approval of generic drugs by dispensing with clinical trials to prove safety and efficacy and requiring warning labels to be identical to those of brand-name, predecessor drugs. "Here, it is uncontested that PLIVA's failure to update was in violation of its federal duty of sameness, and thus federal safety and effectiveness policies," the panel said.

Policy Not Frustrated

"Further, the duty of sameness does not involve the delicate balancing that other regulatory decisions (e.g., whether a life-saving but dangerous drug should be approved for marketing) require the FDA to make," the panel continued. "It is hard to see how permitting state tort suits to go forward against sameness-violating generic defendants frustrates federal policies where permitting suits against FDA-compliant branded defendants does not."

"We hold therefore that state laws that provide damages for inadequate warnings in violation of the federal duty of sameness do not conflict with federal drug policy, with respect to purposes-and-objectives preemption," the panel said.

PLIVA argued that Fulgenzi's claim is an attempt to enforce a federal violation through state law, something the Supreme Court precluded in its fraud-on-the-FDA ruling in Buckman Co. v. Plaintiffs' Legal Comm. (531 U.S. 341, 348 [2001]) [enhanced version]. The panel said Fulgenzi's suit "is not even premised on violation of federal law, but rather on an independent state duty."

"The alleged breach arises from the same act, but the legal basis is different," the panel said. "This is simply not grounds for preemption."

Ohio Law Not Violated

"Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law," the panel said. "Her suit instead relies upon the adequacy of the warnings and the causation of her injuries."

PLIVA also argued that Fulgenzi failed to state a claim under Ohio law, which it says does not require a generic drug manufacturer to update its label to match it branded equivalent. The panel said that misstates Fulgenzi's claim.

"On the merits, whether PLIVA has violated its federal duties is irrelevant to the adequacy of its warnings," the panel wrote. "A jury need not know about the duty of sameness at all to determine whether the warning label used by PLIVA in 2004 and 2006 was inadequate, and whether the failure to include the updated warning was a proximate cause of Fulgenzi's injuries."

Plausible Claim

Fulgenzi does not fail to properly state a claim, the panel said. "At the motion-to-dismiss stage, it is sufficiently plausible that the use of a neutral warning disavowing approval instead of a bold-faced warning affirmatively discouraging long-term use proximately caused Fulgenzi's injury. Whether in fact these allegations are true is a matter for further proceedings."

The panel cautioned that Fulgenzi's claims "must pass through the 'narrow gap' between Mensing and Buckman." It said that under Mensing, "she must argue that PLIVA should have included new warnings from the 2004 Reglan label and that its failure to do so proximately caused her injuries."

It added that Fulgenzi must rely on the 2004 warning in her proximate cause argument, not merely the fact that the PLIVA label was not updated.

Panel, Counsel

The opinion was written by Circuit Judge Danny J. Boggs. The other panel members were Circuit Judge Helene N. White and Chief U.S. Judge Jon Phipps McCalla of the Western District of Tennessee, sitting by designation.

Fulgenzi is represented by Louis M. Bograd of the Center for Constitutional Litigation in Washington, D.C., and Richard W. Schulte of Behnke, Martin & Schulte in Vandalia, Ohio. PLIVA is represented by Jeffrey F. Peck, Linda E. Maichl and Joseph P. Thomas of Ulmer Berne in Cincinnati.

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