Hartman alleges in her Xarelto bleedout lawsuit that she required hospitalization across four days in June 2014 and received two blood transfusions as medical personnel attempted with some difficulty to locate the source of internal bleeding. Hartman had been taking Xarelto for a little over a year to treat an irregular heartbeat when she suffered gastrointestinal bleeding.
Coinciding with her arrival in the hospital suffering from a Xarelto bleeding issue, doctors switched Hartman from Xarelto (rivaroxaban) to another blood thinner. After successfully stemming the Xarelto bleeding complications suffered by Hartman and releasing the plaintiff from the hospital, Hartman has experienced no other complications similar to those associated with her use of Xarelto. Hartman now uses Eliquis for prevention of blood clots, without bleeding issues.
The trial commenced earlier this month following a delay. On Tuesday (November 14, 2017), a Philadelphia jury heard testimony from David Kessler, a former Commissioner of the FDA who served under Presidents G.H.W. Bush and Bill Clinton. Kessler testified that in his view the product label was inadequate, and did not provide the necessary data and warnings with respect to the potential for Xarelto side effects to properly inform consumers and the medical community in the US.
“They did not adequately notify physicians that some patients are at higher risk than others,” he said, in comments published Tuesday by Law360 (11/14/17). “That’s what I believe.”
Referencing the ROCKET AF clinical trial jointly conducted by Bayer and Janssen Pharmaceuticals (Janssen, a subsidiary of Johnson & Johnson), Kessler noted that trial results reflected a 3.6 percent risk for Xarelto bleeding complications when extrapolated across the full measure of trial participants globally. However, Kessler observed that when data was confined to trial participants in the US group, the risk for Xarelto bleedout rose to 8.06 percent.
Kessler, the former FDA Commissioner, indicated Bayer and Janssen should have shared that increased risk amongst US clinical trial participants with doctors, but allegedly did not.
“It’s important information to me,” he said. “I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be in the label.”
Bayer and Janssen were required to undertake a clinical trial in order to provide data in support of their FDA application to have Xarelto approved for marketing in the US.
Counsel acting on behalf of the defendants noted during cross-examination that a post-marketing review of Xarelto issued in August 2013 concluded no changes to the product label were necessary.
READ MORE XARELTO LEGAL NEWS
The three Xarelto bellwether lawsuits in Louisiana all ended in defense verdicts.
The Xarelto lawsuit is Lynn Hartman v. Janssen Pharmaceuticals Inc. et al., Case No. 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.