Shooting down a preemption argument in a defense summary judgment motion, US District Judge Eldon E. Fallon allowed plaintiffs’ state-law design-defect claims against Xarelto to go ahead against Janssen Pharmaceuticals and Bayer Parma Inc.
The plaintiffs’ success came IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana were 16,285 case are pending. As a bellwether trial is looming in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.
The defendants argued that the defective design claims are preempted by federal law, and that it would be impossible for them to simultaneously comply with both federal and state law. But the judge didn’t buy the argument.
“Impossibility pre-emption is a demanding defense,” the court said. “While this Court acknowledges that pharmaceutical companies generally cannot take unilateral action or alter an FDA-approved drug, Defendants are stretching the law beyond its current bounds.”
“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.
It added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”
One size fits all?
Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.
The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:
- Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
- Defendants have not designed and marketed an antidote to counteract a major bleeding event.
- In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.
“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.