The U.S. Food and Drug Administration (FDA) has warned the manufacturers of Invokana, Invokamet, and Invokamet XR, which are drugs prescribed for treating Type 2 diabetes, to speed track the process to include a Black Box Warning Label to warn about the increased risk of leg and foot amputations.
In 2016, the product labels were updated to reflect acute kidney disorder after taking Invokana following FDA's order. In 2017, the FDA issued a similar notice to Johnson & Johnson to alert the patients about the risk of amputations of the leg and foot. Unfortunately, more than 1,000 patients underwent leg amputation after taking Invokana, and related lawsuits have been filed against J&J and its subsidiary Janssen.
Invokana injury lawsuits are mounting in the consolidated multidistrict litigation (MDL) in the U.S. District Court, District of New Jersey (MDL No: 2750), and the first of Invokana amputation trial is expected to begin in September 2018.
The fifth bellwether trial in the multidistrict litigation (MDL) over AbbVie Inc.'s testosterone replacement therapy (TRT) drug AndroGel, saw Illinois Federal Jury supporting the defendant. During the trial that began on May 7, 2018, plaintiffs Arthur Myers and his wife claimed AndroGel led to his diagnosis of bilateral pulmonary embolism in February 2008. The jury stated that the drug was not responsible for the incident and announced the verdict in favor of the defendant.
Testosterone Replacement Therapy lawsuits are centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois as part of a federal multidistrict litigation (MDL) 2545. In the month of March, as per federal jury's order, AbbVie paid $3.2 million to the plaintiff who claimed he suffered a heart attack while using AndroGel.
Another trial is scheduled to begin on June 5 for Robert Rowley, who filed a lawsuit in 2014 after suffering deep vein thrombosis (DVT) in April 2013 as well as in 2015 and blames AndroGel for both the incidents.
The first Bellwether trial in Bair Hugger System multidistrict litigation (MDL) commenced on May 14, 2018, in Minnesota Federal Court. According to Louis Gareis, the plaintiff from South Carolina, who underwent a total knee replacement surgery in November 2016, stated that 3M’s forced-air heating blanket was defectively designed, which led to the surgery site infection eight months post-surgery. Gareis sued 3M Co. and Arizant Healthcare Inc. in the U.S. District Court for the District of Minnesota, alleging that his infection was caused by microorganisms aerosolized in the operating room floor.
In October 2017, Judge Joan N. Ericksen, the presiding Judge for MDL No: 2666, in the District of Minnesota, released an order for the case-specific discovery of similar 3M cases to be trial ready by April 30, 2018.
The trial for Louis Gareis’ case is expected to last three weeks. Verdicts from this bellwether trial will provide insights into how the jury will react in similar cases. There are more than 4,000 lawsuits pending against 3M in the federal multidistrict litigation.
AndexXa, the only antidote for Factor Xa blood thinner, approved by the U.S. Food and Drug Administration(FDA) on May 4 to reverse uncontrollable bleeding problems, will be initially available in only those 40 to 50 hospitals where the clinical trials were held. It will later be provided to about 1,000 different providers after Portola manages to get an FDA nod for the new manufacturing process.
Despite the urgent requirement for a reversal agent forXarelto and Eliquis, CEO of Portola Pharmaceuticals Bill Lis announced that AndexXa will have a limited release until next year.
AndexXa was approved by the FDA as an antidote for Xarelto and Eliquisafter two years, with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, sudden death, and other serious and life-threatening adverse events.
Nearly 20,000Xarelto lawsuits are pending before Judge Eldon Fallon in the U.S. District Court as part of a federal multidistrict litigation (MDL) in the Eastern District of Louisiana.