Bayer Scientists Issue Study Contradicting What Their Own Experts Testified to in a Recent Xarelto Trial
Plaintiff lawyers are seeking a new trial in a recent Xarelto trial where the jury ruled in favor of Bayer. Plaintiff lawyers point out that prominent Bayer scientists recently published a medical research study directly contradicting Bayer expert testimony submitted at trial.
Specifically, Bayer scientists published an article in the Journal of Thrombosis and Haemostasis in September. The article specifically recommends the use of a “prothrombin time,” or PT test, as part of Xarelto use, which test “may be used to assess anticoagulant activity and has been shown to be sensitive to rivaroxaban.”
This new evidence flies in the face of testimony given by defendants in the most recent trial, held in a federal court in Mississippi. Plaintiff Dora Mingo alleged that she suffered from life-threatening gastrointestinal bleeding as the result of taking Xarelto. She further alleged that the defendants had failed to provide adequate warnings about the risk of hemorrhage and that her injury might have been prevented if such warnings had been given.
The PT test is one method of determining the effects and potency of an anticoagulant. This test measures the amount of time required for a patient's blood plasma (the liquid component) to form clots. During the Mingo trial, witnesses for Bayer and Johnson & Johnson testified that “no practical and effective lab test exists to protect patients taking Xarelto from excessive bleeding and sometimes death,” calling the PT test “meaningless [and] dangerous to use with Xarelto.”
However, the recent journal article, based on Bayer's own clinical research, states that the PT test “may be used to assess anticoagulant activity and has been shown to be sensitive to rivaroxaban (Xarelto).” Mingo's counsel, Andrew Birchfield, maintains that if the jury had access to this information, the verdict would have been quite different. He said, “The study by the Bayer scientists is just the latest example that they knew otherwise.”
Significantly, Xarelto labels in Canada advise doctors that a PT test can be used on patients under certain circumstances. However, U.S. labels for the product contain no such advisory. Birchfield puts this responsibility squarely on the drugmakers. “[Such] inconsistencies are inexcusable. Yet the defendants continue to try to put the blame on the U.S. Food and Drug Administration. Manufacturers, not the FDA, are the rulers of their label. Changes can be made without FDA approval,” he said.