On January 26, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear arguments regarding the centralization of several Eliquis lawsuits under a new MDL in Miami, Florida. The drug’s manufacturers Bristol-Myers Squibb and Pfizer Inc. filed a motion to transfer at least 34 litigations currently pending in various district courts across the country. They aim at consolidating all those cases which are based on similar claims, including failure to warn the public about the alleged bleeding dangers, and the request for compensation for damages sustained due to the lack of a proper antidote to reverse the blood thinner’s action. If the motion to consolidate the cases under a Multidistrict Litigation is approved by the JPML, the defendants requested all current and future Eliquis lawsuits to be moved to the U.S. District Court for the Southern District of New York. The goal is to speed up the proceedings by saving the parties’ resources, avoid inconsistent pretrial rulings, and prevent duplication of discovery.
Eliquis (apixaban) is a new generation anticoagulant that has been recently approved by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of stroke in patients suffering from deep vein thrombosis (DVT), pulmonary embolism (PE) and atrial fibrillation (AFib). Despite its apparent similarities with the other two Novel Oral Anticoagulants (NOACs) Xarelto and Pradaxa, apixaban’ mechanism is somewhat different since it inhibits the last step of the coagulation cascade, preventing the formation of dangerous blood clots. Widely advertised as a safer and more effective alternative to the other blood thinners that have been used in the last four decades, apixaban does not require patients to observe dietary restrictions or constantly monitor their coagulability in clinics or hospitals.
However, all the three drugs in this category have been associated with serious side effects which may lead to life-threatening consequences. Since no reversal agent has ever been manufactured, once a bleeding occurs while the patient is taking the drug, there’s no effective strategy to stop it, risking the patient’s very life. A storm of lawsuits was thus filed over the course of the last few years against the manufacturers of the three NOACs. In 2011, Boehringer Ingelheim, the company that manufactures Pradaxa, has been accused by almost 4,000 plaintiffs of releasing a dangerous medication to the market without properly testing it. Eventually, the drugmaker chose to settle the claims by paying $650 million, but in 2014 a new massive litigation emerged against Bayer and Janssen who are facing similar allegations. Over 14,500 Xarelto lawsuits have been brought to court by attorney groups in the MDL No. 2592, housed in the Eastern District of Louisiana. Although the current number of the Eliquis litigations is much smaller, the pre-trial hearings have just begun, and they’re expected to grow rapidly over the course of 2017.
Article by Dr. Claudio Butticè, Pharm.D.
