Ethicon Physiomesh Lawsuit
A Florida woman, Sarah Gilman, filed a hernia mesh complaint against Ethicon in December 2016, about six months after the medical device manufacturer quietly “withdrew” its Physiomesh Composite mesh. According to the law firm of Bernstein Liebhard LLP, Ethicon voluntarily withdrew--not recalled-- some of its Physiomesh products from the market “after unpublished data from two European registries indicated the recurrence and revision rates following laparoscopic ventral hernia pair were higher with the Physiomesh than rates associated with comparative mesh on the market.” (The Physiomesh was fast-tracked in 2010 to market via the 501k process, whereby the new product is substantially equivalent to another product that was approved by the FDA.)
Gilman’s complaint against Johnson & Johnson and Ethicon, filed in the U.S. District Court for the Middle District of Florida, alleges severe complications after Physiomesh hernia surgery resulted in the plastic mesh adhering to other vital organs. She underwent another surgery to have the mesh removed. And the hernia returned. The lawsuit claims that Ethicon Physiomesh was defectively designed and unreasonably dangerous for hernia repair and that the risks of the design outweighed any potential benefits. (Case No. 8:16-cv-03502-JDW-JSS)
Atrium C-Qur Lawsuit
The latest lawsuit against Atrium filed by a New Hampshire man contends the maker was negligent and hid the dangers of its C-Qur mesh. James Brown had a hernia surgically repaired with Atrium's C-Qur at the end of 2013. When he had the mesh removed in January 2016, after experiencing abdominal pain, a pathology report indicated a "foreign body giant cell reaction" in his body, including the scarring of the tissue around the mesh implant.
Law360 reports that James Brown and his wife, Kimberly, claim Atrium negligently designed and fraudulently convinced doctors that its C-Qur mesh product was safe when in fact the company knew the polypropylene surgical netting was biologically incompatible with human tissue and carried the risk of causing serious medical complications in patients.
Brown’s lawsuit further alleges that Atrium failed to properly investigate and disclose adverse reaction reports to the FDA, and failed to implement adequate procedures to track and evaluate those complaints. Wait, it gets worse: Atrium allegedly "stealth recalled" the C-Qur mesh and other mesh products numerous times by stopping production and without any notification to physicians, the FDA or consumers.
The case is James D. Brown et al. v. Atrium Medical Corp., case number 1:17-cv-00004, in the U.S. District court for the District of New Hampshire.
READ MORE SURGICAL MESH LEGAL NEWS
Atrium was founded in 1981 and according to its website, delivers over 2.7 million medical products a year. But it may not be delivering its mesh devices for much longer. A number of surgeons and hospitals have recently stopped using the C-QUR mesh due to high rates of infections, bowel obstructions, and allergic reactions to the fish oil coating on the C-QUR mesh. Unfortunately, the C-QUR mesh is very difficult to remove once it attaches to the bowel.