Nearly two dozen lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto have been consolidated in Louisiana federal court. The U.S. Judiciary Panel on Multidistrict Litigation found the cases have enough common complaints to warrant centralization. Xarelto has been linked to serious side effects including internal bleeding, gastrointestinal bleeding, brain bleed and death.

Defendants unsuccessfully argued that there were too many discrepancies in patients’ medical histories and drug dosages to justify consolidating the lawsuits. However, panel members found that the lawsuits had posed similar factual issues including whether the drug’s label adequately warned of the risk of severe bleeding.

Virginia Stuntebeck, who filed her lawsuit in the Philadelphia Court of Common Pleas, claimed the drug was so dangerous it should not have been marketed in the first place. Her lawsuit states she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding after using Xarelto. She claims she was never warned by the drug company of these risks.

The Xarelto lawsuits come on the heels of the recent $650 million Pradaxa settlement. Researchers linked Pradaxa, also a blood thinning medication, to more than 500 deaths.

Xarelto is a novel oral anticoagulant approved in the United States for six indications including reducing the risk of stroke in patients with nonvalvular atrial fibrillation; treating deep vein thrombosis and pulmonary embolism, and reducing the reoccurrence of these conditions; and preventing blood clots in patients following knee or hip replacement surgery.

Xarelto carries a black box warning for an increased risk of blood clots with premature discontinuation of therapy and a risk of epidural or spinal hematomas resulting in long-term or permanent paralysis in patients treated with Xarelto receiving neuraxial anesthesia or undergoing spinal puncture. Black box warnings are the most serious type of warning issued by the Food and Drug Administration (FDA), and is reserved for drugs that carry a significant risk of serious or life threatening adverse effects.

Xarelto blood thinner litigation has been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, who, in 2007, presided over suits against Merck & Co. over its medication Vioxx. The Vioxx litigation resulted in a $4.85 billion settlement.

For more information, contact Beasley Allen attorney Melissa Prickett at 334-269-2343 or 800-898-2034, or email melissa.prickett@beasleyallen.com.

Source: Law360



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