Pennsylvania State Court Starts Xarelto Trial

By | September 3, 2015

PHILADELPHIA — A Pennsylvania state court has created a mass tort docket for Xarelto blood thinner injury cases filed against Bayer Healthcare Pharmaceuticals and Janssen Pharmaceuticals.

Pursuant to a Jan. 21 order issued by Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas, about 75 cases alleging uncontrollable and occasionally deadly bleeding will be transferred to the court’s Complex Litigation Center and coordinated under a master docket.

Xarelto, an oral anticoagulant indicated for prevention of deep vein thrombosis, pulmonary embolism and strokes in patients with atrial fibrillation, was accepted by the FDA in July 2011.

Xarelto makers touted the drug as a first-class alternative to warfarin because the once-a-day treatment is taken and doesn’t need regular monitoring with blood tests or some dietary limitations. Nevertheless, plaintiffs contend that the studies also shown an increased danger of internal bleeding compared to individuals who were given placebo — findings that were purportedly downplayed in promotional materials for Xarelto.

“Defendants used the results of the ROCKET AF study, the RECORD studies, along with the EINSTEIN studies to promote Xarelto in their promotional materials, including the Xarelto site, which tout the favorable results of all these studies,” plaintiffs assert. “Nonetheless, Defendants’ promotional materials fail to likewise highlight the increased risk of gastrointestinal bleeding and other bleeding events requiring transfusions presented by these studies.”

According to the MDL plaintiffs, there were more than 1,000 Xarelto-related serious adverse event Medwatch reports filed with the FDA in the year immediately following drug the of ‘s approval Among those reports were 65 patient deaths, the data shown. The variety of adverse event reports jumped to more than 2,000 by the end of 2012.

Based on revenues of more than $2 billion, Xarelto has reached “blockbuster” status, due in big part to multi-million dollar direct-to-consumer advertising campaigns that failed to highlight, divulge or adequately warn that there is really no strategy to reverse the anticoagulation effects of the drug, the xarelto lawsuits plaintiffs claim.

In moving for the creation of a mass tort in Philadelphia, plaintiffs claimed the legal theories and facts asserted in the activities “are almost indistinguishable and appear from the identical conduct of defendants.”


“The common allegations in the Associated Activities are that defendants’ merchandise causes serious, potential deadly injuries, including severe internal bleeding. The Related Activities involve common claims including negligence, strict liability, breach of warranty, negligent misrepresentation and fraud, among others,” plaintiffs asserted in the Dec. 2 brief. “The common problems in those claims include whether Xarelto typically caused certain injuries, whether Defendants knew of the hazards, or should have known of the risks; if so, whether Defendants did not disclose the hazards to the medical community and/or consumers; and whether Xarelto was marketed in a way that misrepresented the benefits and dangers of Xarelto to the medical community and consumers.”

Resolution of these and other common issues in one district will help the parties and witnesses, while functioning to promote the efficient prosecution and resolution of the lawsuits, plaintiffs contended. They declared that consolidation will result in substantial financial savings and boost the convenience of efficiency and the parties during pretrial proceedings, duplicative discovery will be removed, and there’ll not be any risk of inconsistent judicial rulings.

In their Dec. 19 resistance, defendants countered that a mass tort isn’t warranted because almost all of the activities involve out-of-state plaintiffs and have no connection to Pennsylvania and therefore should be dismissed on forum non conveniens grounds.

“That issue is pending before the judge to whom all of the existing cases are delegated on eight completely briefed motions to dismiss, so this request is at best premature,” defendants contended. “When the out of state plaintiffs are dismissed, there apparently WOn’t be enough cases to warrant a mass tort. And none of the few Pennsylvania residents who chose to sue here reside in Philadelphia.”

Defendants included that a Philadelphia mass tort is unnecessary because Xarelto cases are being coordinated in the federal MDL in Louisiana.

Counsel for Janssen is David Abernethy and Molly Flynn of Drinker Biddle & Reath in Philadelphia.

Bayer is represented by Albert Bixler and Leslie Hayes of Eckert Seamans Cherin & Mellott in Philadelphia.