Janssen, Bayer Lose Preemption Bids As Xarelto Trial Nears

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Law360, New York (April 13, 2017, 8:52 PM EDT) — Days before a first bellwether trial begins in multidistrict litigation over the alleged dangers of blood thinner Xarelto, a Louisiana federal judge on Wednesday refused to drop some claims against Bayer AG and Janssen Pharmaceuticals Inc., saying they can’t necessarily blame U.S. Food and Drug Administrationred tape for their lack of label updates or for any noncompliance with Louisiana law.

U.S. District Judge Eldon Fallon denied two motions for partial summary judgment, both filed on Jan. 20, that cited federal preemption as a defense to claims over alleged Xarelto misdosing and a label with allegedly inadequate warnings. Patients in the MDL say Xarelto can cause uncontrollable internal bleeding.

Judge Fallon said the companies hadn’t made a convincing showing that FDA regulations prevented them from updating labels or creating more tailored dose-analysis guidelines.

He said, quoting a 2016 ruling in the same district in Guidry v. Janssen Pharmaceuticals, that state law requires drugmakers to consider alternative designs and reasonably weigh their products’ risks and utility before they are released, and that federal law complements rather than contradicts the state requirements.

“This is exactly the plaintiffs’ contention in the instant case,” the judge said. “Accordingly, Guidry is directly on point and the court finds plaintiffs’ pre-market design defect claims under the LPLA are not preempted.”

His conclusions were similar for the other partial summary judgment motion: drug companies have room to comply with laws and to take action in the context of the FDA approval process or after.

“Manufacturers remain the master of their labels even after FDA approval, and there are clear pathways through which a brand-name drug manufacturer can make changes to their label without FDA approval,” he said.

Even when the FDA rejects certain data, companies shouldn’t take it as proof that the agency would reject a label change, he said.

“’Clear evidence’ that the FDA would not approve the change … requires more than a prior refusal to add similar language,” he said.

In the first bellwether, set to start April 24, plaintiff Joseph Boudreaux says that he started taking Xarelto to control his atrial fibrillation in January 2014 and less than a month later was hospitalized for dangerous gastrointestinal bleeding requiring blood transfusions. He says Janssen and Bayer misrepresented the safety of the drug to both the public and the FDA and that there are issues surrounding certain clinical trial results.

Representatives for Janssen and Bayer both stressed that they believe Xarelto is safe.

“The allegations made in Xarelto lawsuits contradict years of data on the medicine and the FDA’s determination, and repeated confirmation, of its safety and efficacy,” Janssen spokesman William Foster said.

“Bayer stands behind the safety and efficacy of Xarelto, and will vigorously defend it,” Bayer spokesman Chris Loder said.

The plaintiffs’ steering committee is represented by Leonard Davis of Herman Herman & Katz LLC, Gerald Meunier of Gainsburgh Benjamin David Meunier & Warshauer LLC and Andy Birchfield of Beasley Allen Crow Methvin Portis & Miles PC.

Janssen is represented by Susan Sharko of Drinker Biddle & Reath LLP. Bayer is represented by William Hoffman of Arnold & Porter Kaye Scholer LLP.

The case is In re: Xarelto (Rivaroxaban) Products Liability Litigation, case number 2:14-md-02592, in the U.S. District Court for the Eastern District of Louisiana.

–Editing by Brian Baresch