Trial is now underway in a New Orleans Federal Court in the first Xarelto bellwether trial. Days before trial was to begin in the multidistrict litigation (MDL) over the dangers of the blood thinner, a Louisiana federal judge refused to drop some claims against Bayer AG and Janssen Pharmaceuticals Inc., saying they can’t necessarily blame U.S. Food and Drug Administration (FDA) red 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 that cited federal preemption as a defense to claims over alleged Xarelto misdosing and a label with inadequate warnings.
Judge Fallon ruled that the companies had failed to make 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. Judge Fallon wrote in his order:
This is exactly the Plaintiffs’ contention in the instant case. Accordingly, Guidry is directly on point and the court finds Plaintiffs’ pre-market design defect claims under the LPLA are not preempted.
Judge Fallon’s 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. His order said:
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.
Even when the FDA rejects certain data, companies shouldn’t take it as proof that the agency would reject a label change, Judge Fallon said. He added: “’Clear evidence’ that the FDA would not approve the change … requires more than a prior refusal to add similar language.”
In this first bellwether trial, 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. Janssen and Bayer claim that it believes Xarelto is safe.
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 from Beasley Allen. The case is in the U.S. District Court for the Eastern District of Louisiana.
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