5th Circuit: Mensing Doesn't Make Brand-Name Defendants Liable For Injuries

NEW ORLEANS - (Mealey's) The U.S. Supreme Court's ruling that preempts failure-to-warn claims involving generic drugs does not change Louisiana state law and make manufacturers of brand-name versions liable, a Fifth Circuit U.S. Court of Appeals panel ruled Oct. 25 (Julie Demahy v. Schwarz Pharma, Incorporated, et al., No. 11-31073, 5th Cir.).

(Opinion available. Document #28-121101-010Z.)

In addition, the Fifth Circuit panel said plaintiff Julie Demahy does not have any claims against generic manufacturing defendant Actavis Inc. that survived post-Mensing dismissal by the U.S. District Court for the Eastern District of Louisiana.

Demahy was prescribed metoclopramide from 2002 to 2007 and developed tardive dyskinesia, a permanent neurological disorder that causes involuntary movements similar to Parkinson's disease. In 2008, Demahy sued Wyeth Inc. and Schwarz Pharma Inc., which had made Reglan, the brand-name predecessor of metoclopramide.

Demahy also sued Actavis, which made the metoclopramide she took and was allegedly injured by. She asserted various tort claims against all defendants under Louisiana state law.

Brand-Name Defendants Dismissed

In 2008, Demahy agreed to dismiss her claims against Wyeth and Schwarz without prejudice.

Actavis moved to dismiss claims against it as preempted by federal law. The District Court denied the motion, and on appeal, the Fifth Circuit affirmed.

Actavis petitioned the U.S. Supreme Court for a grant of certiorari, and in 2010, the court granted the petition in that and another metoclopramide case that raised the same preemption issue. In 2011, the Supreme Court issued its ruling in the other case, Pliva, Inc. v. Mensing (131 S. Ct. 25676, 2573 [2011]) [enhanced version available to subscribers], which found that failure-to-warn claims against generic drug manufacturers are preempted.

The high court said federal law requires generic drugs to contain the same warnings as their brand-name predecessor drugs. It said that generic drug makers cannot change their labels and that it would be impossible for the generic defendants to comply with state law failure-to-warn requirements.

Remand, Dismissal, Motions

Demahy's case was remanded, and the District Court entered judgment in favor of Actavis and dismissed the case with prejudice.

Demahy then filed a motion under Federal Rule of Civil Procedure 60(b)(5) for relief from the 2008 order dismissing Wyeth and Schwarz. She also moved, under Rules 59(e), 52(b) or 60(b)(6), to amend the court's dismissal of Actavis to state that not all her claims are dismissed.

The District Court denied both motions, and Demahy appealed.

State Law Not Altered

Demahy argued that Mensing significantly altered case law that had protected brand name drug makers from liability for injuries caused by generic versions of their drugs.

In a per curiam, unpublished and nonprecedential order, the Fifth Circuit panel considered Demahy's Rule 60(b)(5) motion as a motion to amend under Rule 59(e). It said the only ground for amending judgment against Actavis was an intervening change in the Louisiana Products Liability Act (LPLA), which provides exclusive remedies for product liability claims.

Demahy argued that Mensing undermined the logic of the Fourth Circuit U.S. Court of Appeals' ruling in Foster v. American Home Products Corp. (29 F.3d 165 [4th Cir. 1994]) [enhanced version], which was the foundation for Louisiana rulings protecting defendants from liability for injuries caused by products they did not make.

"We do not view Mensing as overruling Foster because the court in Foster did not reach its holding by relying on the ability of a plaintiff to sue generic manufacturers," the Fifth Circuit panel wrote. "The Foster court's opinion in dicta on the viability of suits against generic manufacturers was proved wrong, but this fact does not impose on name-brand manufacturers a duty of care to customers using generic products. Likewise, decisions that relied upon Foster to create a similar rule in Louisiana remain valid."

No Effect On Louisiana Law

Even if Mensing did undermine Foster, the panel said, the implicit reversal of the Fourth Circuit "would have no effect on Louisiana law."

"The Court is bound by Louisiana law and we cannot create a new remedy," it said. "Thus, because the Supreme Court's decision in Mensing had no effect on Louisiana state law, the district court's denial of Demahy's motion to amend the judgment under Rule 59(e) was not an abuse of discretion."

The panel affirmed the District Court's denial of the motion to reinstate alleged nonpreempted claims against Actavis, saying the court was bound by the mandate rule.

Demahy argued that the District Court's dismissal was only for her failure-to-warn claim.

All Actavis Claims Dismissed

The panel said Actavis sought to dismiss all claims as preempted. It said that on remand and under mandate, the District Court dismissed all claims, leaving Demahy with none.

Therefore, the panel said, the District Court could not grant Demahy's motion to alter or amend its judgment without being in derogation of the mandate rule. The panel said the District Court did not err in dismissing the claims against Actavis.

The panel said that even if it were to find that Demahy's failure-to-warn claim survived dismissal, it would still affirm the dismissal "insofar as the claims are, at base, failure-to-warn claims, which would be preempted in light of Mensing."

Majority Of Federal Courts

The only claims that are arguably not failure-to-warn are those for breach of express warranty and design defect, the panel said, the former applying only to Wyeth and the latter to Actavis. The panel said that since Mensing, a majority of federal district courts have found state-law tort claims to be preempted "based on the fact that the plaintiff's claims are failure-to-warn claims under different names."

In addition, the panel said the courts have held that design defect claims against metoclopramide defendants are preempted by Mensing. "Thus, although unnecessary for the disposition of this case, we are persuaded that Demahy's design defect claim would be preempted," the panel wrote.

The panel was composed of Senior Circuit Judge Fortunato P. Benavides and Circuit Judges Priscilla R. Owen and Leslie H. Southwick.


Demahy is represented by Terrence J. Donahue Jr. of McGlynn, Glisson & Mouton in Baton Rouge, La., and Brian L. Glorioso, Kristine K. Sims and Richard A. Tonry II of Tonry, Brinson & Glorioso in Slidell, La.

Wyeth (now Pfizer Inc.) is represented by Kannon K. Shanmugam and James M. McDonald of Williams & Connolly in Washington, D.C. Schwarz is represented by Henniger Simmons Bullock and Andrew J. Calica of Mayer Brown in New York and Megan Haggerty Guy, Gregory F. Rouchell and Martin A. Stern of Adams & Reese in New Orleans.

Actavis is represented by Richard A. Dean, Irene C. Keyse-Walker and Kristen Lepke Mayer of Tucker Ellis in Cleveland.

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