Back in May 2016, Ethicon recalled its Physiomesh hernia mesh after reports determined recurrence and reoperation rates were higher than average. Following these reports, many patients who had been implanted with the defective mesh filed lawsuits seeking compensation.
In 2017, the U.S. Judicial Panel on Multidistrict Litigation (JMPL) consolidated all federally filed Physiomesh lawsuits into one court in the Northern District of Georgia, with The Honorable District Judge Richard W Story overseeing pretrial proceedings. Judge Story ordered the first bellwether trial in the litigation to begin in December of this year.
The Ethicon Physiomesh gained FDA approval back in April of 2010; however, the product did not go through the standard approval process. Rather, these devices went through the FDA’s fast-track 510(k) approval process, which requires only that the manufacturer prove their product is significantly similar to others already approved and on the market.
Ethicon Physiomesh is a medical device made of polypropylene materials that form a net-like patch which doctors use to help repair abdominal hernias. The patch itself is designed to help support and stabilize weak and stretched tissues around the hernia bulge to provide for a better and longer-lasting repair.
Unfortunately, however, the product didn’t perform as expected and was soon found to result in higher revision rates after laparoscopic repair than other available hernia mesh products. Plaintiffs who filed lawsuits against Ethicon alleged the product can cause infections, abscesses, inflammatory reactions, scar formation, device migration, and improper healing, among other serious medical problems.
The Litigation Process
The MDL court has revised the schedule guiding the parties toward the first bellwether trials. First, the parties were to select 24 cases from the pool of all Physiomesh cases by January 11, 2018. The plaintiffs were to select 12, and the defendants were to select the remaining half. Then both parties worked on fact sheets, with the plaintiffs delivering them by June 15, 2018, and the defendants by July 31, 2018.
Fact sheets, if not already completed on these cases, were due from plaintiffs by July 13, 2018, and from defendants by August 21, 2018. Once these were completed, fact discovery began.
The parties will again select a final 10 cases from the initial discovery pool on or before February 14, 2019, which will then proceed to expert discovery. This group will be called the “trial pool cases.” Depositions of experts will begin on June 14, 2019. All discovery for the trial pool cases is to be completed by August 15, 2019.
The court will then set the first trial date for December 2, 2019. Depending on the outcome of this Physiomesh side effects lawsuit and the other subsequent trials, the parties may be find themselves wanting to start settlement negotiations.