Advocates in the third case against Xarelto’s side effects are arguing whether the drug manufacturers Johnson & Johnson’s unit Janssen Pharmaceuticals and Bayer should have mentioned on the blood thinner’s label to suggest a blood clotting test that might have brought the attention of the physician to the plaintiff’s risk of bleeding. Around 18,000 lawsuits against Xarelto lie pending in U.S. District Court, Eastern District of Louisiana, and all of them involve the medication’s bleeding side effect.
The plaintiff in the third bellwether case, a resident of Mississippi, has sued Johnson & Johnson’s unit, claiming that Xarelto, the blood thinner caused her gastrointestinal bleeding and she had to be hospitalized. She said that she was prescribed the drug to treat her deep vein thrombosis. She developed this condition after she underwent a hip replacement surgery. She stated that the drug makers should have notified the doctors on the safety levels of Xarelto. According to her, a standard blood test called Neoplastin PT should have been recommended so that the doctors can know about the patient’s risk of bleeding when they are on Xarelto medication.
The drug manufacturers, in their defense, argued that they had put the information on the drug’s safety label but the Food and Drug Administration (FDA) struck off the language when the drug was sent for approval. Hence, as per the defendants, the case is subject to debate.
The same argument had also come up in two previous cases concerning Xarelto’s side effects, and the jury had ruled in favor of the drug company in both of them. But on July 24, U.S. District Judge Eldon E. Fallon gave a ruling stating that Janssen and Bayer were not constrained to stick to the FDA’s decision to remove Neoplastin PT from the drug’s safety label. The pharmaceutical company should have urged the FDA to allow the language proposed by them, especially if there was a safety issue.
The trial for this case began on Aug 7, 2017. Her case has been taken up in the U.S. District Court, Southern District of Mississippi. A nine-member jury (comprising of four men and five women) has been impaneled, and it is expected that the trial will last for two to three weeks. The plaintiff has asked the jury not to put an end to her case and wants them to decide on her case. The jury is yet to give a ruling.