What Happened In The MassTorts World Last Week? 2018-May-21

Antidote AndexXa to have a Restricted Release: Portola CEO

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 for Xarelto 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 Eliquis after two years, with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, sudden death, and other serious and life-threatening adverse events.

Philadelphia state jury overseeing the second Xarelto linked gastrointestinal bleeding lawsuit announced the verdict in favor of the defendants Bayer Healthcare Pharmaceuticals Inc. and J&J subsidiary Janssen Pharmaceuticals Inc. The plaintiff from New Jersey claimed his injury could have been avoided had he and the medical community be warned about the internal bleeding risks associated with Xarelto.

Xarelto lawsuits are centralized in the U.S. District Court for the Eastern District of Louisiana before Judge Eldon E. Fallon as a part of MDL No.- 2592. Currently, more than 22,000 Xarelto cases are pending in several courts across the country.

Nearly 20,000 Xarelto 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.

3M To Face 1st Bair Hugger System Bellwether Trial on May 14

The first Bellwether trial in Bair Hugger System multidistrict litigation (MDL) commenced on May 14, 2018, in Minnesota Federal Court. According to the plaintiff from South Carolina, who underwent a total knee replacement surgery in November 2016, 3M’s forced-air heating blanket was defectively designed, which led to the surgery site infection eight months post-surgery. The plaintiff 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 the plaintiff 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.

Earlier, two 3M Bair Hugger System cases were selected for the upcoming trial to begin on or after April 30, on the basis that the plaintiffs involved allegedly suffered infections caused by 3M’s Bair Hugger warming blankets used during their total knee replacement surgeries. Claims made by both the cases are similar that defendants 3M Company and its Arizant Healthcare subsidiary sold a dangerous and defectively designed product that caused severe and debilitating deep joint infections. The selected cases were filed by a plaintiff from South Carolina and a couple from Idaho.

The Bair Hugger system is a surgical warming blanket that treats, prevents, and monitors unintended hypothermia and its associated problems in surgical patients. It is marketed under the 3M Bair Hugger brand name. It was approved by the U.S Food and Drug Administration (FDA) in 1988 as the first surgical blanket that worked on a forced-air system. The company offers 25 Bair Hugger blankets in various styles and sizes offering a warming tool for any surgical procedure.

It works on a system devised by Dr. Scott D. Augustine and consists of a portable heater/blower connected by a flexible hose to a blanket that blows warm air around the patient’s body to help maintain his body temperature during surgery. Faster recovery time and less bleeding are a few of the benefits that have been revealed by a study performed in patients who were kept warm during surgery.

In October 2017, Judge Joan N. Ericksen, presiding over the centralized litigation, MDL No: 2666, in the District of Minnesota, released an order for the case-specific discovery and disposition motions of these cases to be trial-ready by April 30, 2018.

This month, Judge Ericksen denied a defense motion seeking to dismiss a design defect claim made by a plaintiff and also denied the defense request to exclude the plaintiff’s expert witness testimonies. The judge did grant the defense motion to dismiss the plaintiff’s failure to warn claims. 

Jury Supports AbbVie Again in The Fifth Bellwether Trial

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, a man 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 federal multidistrict litigation (MDL) 2545. In the month of March, as per the federal jury's order, AbbVie paid  $3.2 million to the plaintiff who claimed he suffered a heart attack while using AndroGel.

Approximately more than 6,500 TRT lawsuits filed against AbbVie, Actavis, Inc. (formerly Watson Pharmaceuticals), Eli Lilly and Company, Teva Pharmaceuticals, Pharmacia & Upjohn Company, Endo Pharmaceuticals, Columbia Laboratories, and Auxilium Pharmaceuticals.

Allegations include severe side-effects linked to TRT, such as heart attacks, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and other serious medical conditions.

Testosterone Replacement Therapy (TRT) is a hormone replacement therapy which has evolved in recent years; within a short period of time it reached its highest level of prescriptions in the US. When the testes fail to produce an adequate amount of testosterone and/or to conduct normal spermatogenesis, the result is hypogonadism also called ‘low t.’

In 2015, the Food and Drug Administration (FDA) approved TRT to treat male hypogonadism due to disorders of the testicles, pituitary gland, or brain. The FDA stated that the benefit and safety of testosterone was not established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

As the onset of normal effects of aging could be delayed or lessened with TRT prescription, the FDA became aware that testosterone was being used extensively in attempts to relieve symptoms in men with low testosterone for no apparent reason other than aging.

Testosterone is made available in forms like topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. The manufacturers involved are AbbVie, Actavis, Inc. (formerly Watson Pharmaceuticals), Eli Lilly and Company, Teva Pharmaceuticals, Pharmacia & Upjohn Company, Endo Pharmaceuticals, Columbia Laboratories, Auxilium Pharmaceuticals.

Popular brand names include: Andriol, Androderm, AndroGel, Axiron, Delatestryl, Depo-Testosterone, Intrinsa, Nebido, Omnadren, Primoteston, Sustanon, Testim, TestoGel, TestoPatch, Testoviron, and Tostran.

Another trial is scheduled to begin on June 5 for a plaintiff 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.

Update Invokana Black Box Warning Label Swiftly: FDA

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.

Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have also faced a product liability lawsuit filed by a man from Texas for undergoing transmetatarsal and guillotine amputations of the right foot above the ankle. The plaintiff here holds the defendants responsible for not adequately warning the users and the medical community about a large number of leg and foot amputation problems linked with Invokana. The case was filed in the U.S. District Court for the District of New Jersey.

According to the guidelines published by ADA (American Diabetes Association), Invokana may be considered to reduce major cardiovascular events after lifestyle management and metformin in patients with T2D and established cardiovascular disease.

Over a period of time, Invokana has been linked to aggravating certain medical conditions one of them being 'Ketoacidosis,' a condition in which the body produces high levels of blood acids known as ketones. If left untreated, this condition can be fatal. Since its launch in the U.S. markets, several patients have developed ketoacidosis to the point of needing an emergency room visit or hospitalization.

The most common side effects include genital yeast infections, urinary tract infections, and changes in urination. The side effect listed by the manufacturer is weight loss of between two to three percent. It is also known to lower blood pressure anywhere between three to five mmHg. However, the major side effects mentioned in various lawsuits, are not listed by the manufacturer.

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.