In December, I wrote a blog discussing the likelihood of MultiDistrict Litigation (MDL) for two manufacturers of a hernia mesh surgical device—Atrium Medical who produces C-Qur mesh and Ethicon, Inc., a subsidiary of Johnson & Johnson, who recalled their Physiomesh product in May 2016. Since that time, C-Qur MDL 2753 has been created in the U.S. District Court of New Hampshire, bringing together more than three dozen cases in 26 different federal districts.
While the FDA has yet to recall Atrium’s C-Qur mesh, they have conducted several investigations into the company and they even sued the company for introducing adulterated medical devices into interstate commerce in 2015. As a result of ongoing litigation and alleged medical issues, many surgeons and hospitals have stopped utilizing the hernia mesh. Initially touted as unlikely to create scar tissue or fuse with abdominal muscle tissue due to its unique fish oil coating, the product is now blamed for allergic reactions, chronic inflammation, bowel obstructions, infections and more.
In March, litigation against Physiomesh flexible composite mesh took a similar turn, as Plaintiffs filed a motion to create MDL 2782 in either Illinois or Florida—to date, there are 40 actions pending in 10 federal court districts. Ethicon and Johnson & Johnson recently opposed that motion and are asking the Judicial Panel on Multidistrict Litigation (JPML) to deny the formation of an MDL, or alternatively place one in New Jersey, Kentucky, or Georgia.
First approved by the FDA in 2010, Physiomesh quickly became the subject of adverse event reports from both surgeons and medical providers, reaching an estimated 90 reports by the end of 2012. At the time of Physiomesh’s recall in 2016, there were approximately 650 adverse event reports filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Current cases claim that Physiomesh was defective in either design or manufacture, pointing out that the unique five-layer polypropylene portion was not capable of withstanding typical abdominal forces—resulting in a re-herniation and often requiring additional surgeries and medical expenses. It has also been alleged that neither patients nor surgeons were made aware of such risks.
It’s expected that hundreds more cases could be included in an MDL action against Ethicon, as more than 330,000 Physiomesh devices have been sold worldwide with an estimated half of those being implanted in the United States. The answer should be forthcoming, as the JPML is scheduled to hold a hearing on May 25th in San Antonio—where they will consider MDL 2782 for consolidating Physiomesh lawsuits. In addition to this action, the Panel will also consider which district will receive the transferred cases if the MDL is created.
Derek T. Braslow is a partner of Pogust Braslow & Millrood, LLC. He is one of the first attorneys to file suit on behalf of families who lost a child, spouse or parent to suicide as a result of psychotropic medication and one of the first to file a suit against investigators, sponsors and institutional review boards for conducting unethical human clinical trials. Derek was voted by his colleagues as a Rising Star and SuperLawyer in the area of Pharmaceutical and Mass Tort litigation.