With more than 7,000 lawsuits currently pending against Xarelto manufacturers, the litigation is reaching a fever pitch. Because of an increase in filings, plaintiffs were recently given an additional two months to file Xarelto complaints, but the number of lawsuits is likely not what Xarelto manufacturers are currently worried about.
Xarelto is manufactured and sold by Bayer A.G. internationally, but is manufactured by Janssen Pharmaceuticals in the U.S. Janssen, a subsidiary of healthcare giant Johnson & Johnson (J&J), stands beside Bayer as another defendant in the Xarelto lawsuits.
A judge presiding over the Xarelto litigation ordered Bayer to produce redacted personnel records of two doctors on its payroll. These doctors could testify regarding the plaintiffs’ claims that Xarelto’s clinical trials were rushed in an effort to get the drug onto the market.
When Xarelto was introduced to the market, it replaced the traditional blood thinner Warfarin, which had been safely used for more than 50 years to manage a patient’s risk of blood clots. Warfarin requires regular blood monitoring and a strict diet to ensure patients receive the optimum medication dosage; so, when Xarelto was released in 2011, it presented a much more convenient option for patients because required neither routine monitoring nor special diets.
Xarelto hit the market with one major disadvantage – it didn’t have an antidote. Warfarin patients experiencing internal or external bleeding can have the drug’s effects reversed with doses of vitamin K, but Xarelto patients aren’t as lucky. There is currently no effective way to reverse Xarelto’s effects.
Without an antidote, Xarelto patients have experienced serious and life-threatening bleeding events. Plaintiffs in the Xarelto litigation believe that without an antidote, the drug is too dangerous to be on the market. Now that a judge has ordered the production of personnel files of Bayer doctors, plaintiffs might discover that Bayer’s own doctors agree with them.