A new lawsuit has uncovered the possible rigging of a European clinical Xarelto trial in order to gain customer confidence.

In Pennsylvania state court, a lawsuit was recently filed by a female plaintiff from Indiana. Plaintiff Lynn H. essentially claims that drug manufacturers Bayer and Janssen rigged a Xarelto trial that took place in Europe in order to make their drug, Xarelto, seem as if it was as safe as previous blood thinning drugs.

Lynn began taking Xarelto for her atrial fibrillation condition in 2013. She was prescribed Xarelto for the prevention of stroke and blood clots. In June 2014, a little over a year after she began taking the drug, she suffered a severe gastrointestinal bleed.

She was forced to stay in the hospital for four days as a result and needed two blood transfusions. Her doctors stated that her bleeding was complicated by Xarelto use. Additionally, her doctors noted that after she was taken off the drug and put on a different blood thinner, she did not suffer any more bleeding.

Lynn and her attorneys claim that a Xarelto trial that took place in Europe was packed with patients who would more likely suffer problems while taking warfarin, a drug that has for a long time held the market for blood thinning drugs. This, they say, altered the results to make Xarelto look as if its adverse effects were not as bad as they were.

Essentially, it is alleged Bayer and Janssen stacked the European Xarelto trial with individuals who had been taking warfarin. Warfarin, or Coumadin, is a competing drug that requires much more blood and dosing monitoring than other blood thinners.

The plaintiff claims that in Europe, it was known by Bayer and Janssen that warfarin dosing is not as well regulated as it is in North America. By adding these Eastern European warfarin patients to the Xarelto trial, the results made it look as if warfarin and Xarelto had similar instances of adverse effects, making Xarelto seem as safe as the industry standard drug.

One of the attorneys for the plaintiff said of the Xarelto trial, “They made sure the warfarin patients did not receive the right amount of medicine, and they did it on purpose.”

These warfarin users experienced strokes and internal bleeding events at similar rates as did Xarelto users. He went on to add that this European Xarelto trial was “rigged” in order to profit Janssen and Bayer billions of dollars. Allegedly, when the data was looked at for North America alone, Xarelto patients had higher incidents of stroke and bleeding incidents than warfarin users. In North America, warfarin dosing is more often given properly than in Europe, the plaintiff claims.

The label, they say, reflected data only retrieved from the Xarelto trial in Europe and thus was misleading to patients and doctors.

Bayer’s attorneys commented and noted that thousands of people take Xarelto without incident.

The Xarelto Trial Lawsuit is Case No. 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

UPDATE: On Dec. 5, 2017, a Philadelphia jury slammed the makers of Xarelto with an almost $28 million verdict after finding the companies failed to adequately warn about the Xarelto bleeding risks associated with the blood thinner.