PENNSYLVANIA RECORD

PHILADELPHIA - Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty has created

a mass tort docket for Xarelto blood thinner injury cases filed against Janssen Pharmaceuticals and Bayer Healthcare Pharmaceuticals, according to an order issued Wednesday.

The order says that approximately 75 cases alleging uncontrollable and sometimes fatal bleeding will be transferred to the court’s Complex Litigation Center, following a petition filed by the plaintiffs attorneys.

"The creation of a mass tort program benefits the Court system and the parties by eliminating duplicative discovery, inconsistent rulings and promoting the efficient prosecution and resolutions of similar cases," attorney Michael Weinkowitz said in an emailed statement.

"The defendants (Bayer and Janssen) have strong ties to Pennsylvania making this an appropriate and convenient forum.”

Janssen responded to the decision with a press statement defending Xarelto's importance in the drug marketplace. According to the statement, the medication's risks have been openly provided to prescribing doctors and their patients through the accompanying literature.

"We will defend against the claims raised in this litigation," the statement says. "Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots. After more than three years on the U.S. market, to date, the benefit-risk profile of Xarelto remains favorable and consistent with clinical trials. All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks. Blood thinners are important and potentially life-saving medicines that should be taken by patients as prescribed should not be discontinued without a discussion with a physician."

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

According to the petition submitted to Dougherty last week, Xarelto has been marketed as the next generation of blood-thinning drugs designed to replace Warfarin, which has been on the United States market for more than 50 years.

Xarelto has been widely prescribed to prevent pulmonary embolism and deep vein thrombosis, as well as strokes in patients suffering from atrial fibrillation. However, the petition says, Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding – and there is no reversal agent available if serious bleeding occurs.

In addition, Xarelto has been marketed as a single daily dose pill that does not require the need to measure the blood plasma levels, and thus touted as the more convenient option to warfarin (which does require testing and monitoring), the petition claims.

The approved use of Xarelto was expanded months later to include treatment to reduce the risk of strokes or embolisms in patients with non-valvular atrial fibrillation. According to the petition, the makers of Xarelto highlighted the positive results of their clinical studies while failing to equally inform patients of reports showing increased gastrointestinal bleeding requiring transfusions.

According to court papers, the defendants' aggressive marketing efforts resulted in Xarelto becoming a blockbuster drug, going from $582 million in global sales for 2011 to more than $2 billion in 2013. In the U.S., the petition says, more than one million prescriptions for Xarelto were ordered by the end of 2013.

The petition claims that the drug's success was made possible by concealing Xarelto's deadly effects from prescribing doctors. The makers are also accused of failing to warn emergency rooms that Xarelto had no reversing agents.

"Therefore, Xarelto treatment leaves trauma professionals without effective means to treat and stabilize patients who experience uncontrolled or excessive bleeding while taking Xarelto," the petition says.

The court documents say that more than 1,000 Xarelto-related adverse events were filed with the FDA in the year leading up to June 30, 2012, including at least 65 deaths. The attorneys anticipate that there will be thousands of Xarelto claims filed throughout the country, with large numbers in Pennsylvania.