On the day that a national tort reform group claimed that Philadelphia’s Court of Common Pleas was a “judicial Hellhole” for coming up with biased verdicts against businesses, a jury demanded that the makers of Xarelto, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer AG pay $2 million in compensatory damages and $26 million in punitive damages for not adequately warning patients of the risk of internal bleeding if they took the drug.
It was the first verdict in a rash of Xarelto lawsuits to go against the manufacturers who had won three previous cases in federal court. Moreover, it was the first of about 1,400 Xarelto lawsuits to reach a Pennsylvania state court. The verdict was announced after a one-month trial.
Xarelto is a blood thinning medication.
The 75-year old Plaintiff in the case, Lynn Hartman, was prescribed Xarelto by Dr. Josephine Randazzo in Plymouth, Indiana and she took the drug starting in March 2013 to June 2014. She suffered gastrointestinal bleeding on June 26, 2014 and stopped taking it.
Xarelto has been available since 2011 when the Food & Drug Administration approved it for prescription to patients who suffer atrial fibrillation, a rhythmic heart disorder. It is also used to prevent blood clots that can cause heart attacks, strokes and pulmonary embolisms.
Hartman claimed that the manufacturers of Xarelto failed to properly warn patients that the use of the drug offered a major risk of cranial and gastrointestinal bleeding when taken once a day without properly monitoring. She claimed that the companies were guilty of liability, manufacturing and design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violation of consumer protection laws in both Indiana and Pennsylvania, plus loss of consortium.
Documents filed in the case showed that the rate of bleeding that occurred in clinical trials was significantly higher for patients from the United States than patients from other locations in the world. Evidence also showed that the rate among participants in the United States was 8.1 percent a year and was 3.6 percent a year among global participants.
The plaintiff also claimed that the manufacturers failed to appropriately warn doctors that some patients had a higher risk of bleeding when the drug was combined with aspirin and also failed to tell doctors that some patients had significantly higher levels of Xarelto in their bloodstream than other blood thinning medications. Moreover, she claimed that the risk of bleeding associated with Xarelto was significantly higher than it was for Eliquis and Pradaxa.
Former Food & Drug Administration director David Kessler backed up Hartman’s case when he testified that he believed Xarelto’s warning label ignored key information about the severity of the potential bleeding risk.
In closing arguments, Beth Wilkinson of Wilkinson Walsh & Eskovitz, attorney for the Xarelto manufacturers noted that the label warning on the medication that read that it “… can cause serious and fatal bleeding” was clear and unequivocal.
Bayer AG and Janssen said that they would appeal the verdict. Janssen added that the jury’s decision contradicted years of scientific data and repeated confirmation by the U.S. Food And Drug Administration of the drug’s safety.
More than 18,500 lawsuits are now pending in federal court. The cases have been consolidated into a multidistrict lawsuit at the U.S. District Court for the Eastern District of Louisiana.
Attorneys at the law offices of the Eichholz Law Firm are studying reports concerning dangerous side effects of Xarelto and would like to speak with anyone who may have had a negative reaction to the drug. If you took Xarelto and had an adverse side effect, please call us today.