Hernia mesh litigation against Bard is scheduled to begin early next year with the defective product case filed by Pensacola, Florida residents, Antonio Milanesi and Alicia Morz De Milanesi.
The trial is set for January 10, 2022, before Judge Edmund A. Sargus in the Southern District Court of Ohio.
The Milanesi lawsuit (2:18-cv-01320) is the second bellwether trial selected among 14,295 filed in the Ohio multidistrict litigation (MDL) naming defendant Bard. Another 14,000 similar cases are pending in state court in Rhode Island.
The Milanesi case is a plaintiff pick and the first For Ventralex, just one of the family of hernia meshes made by Bard.
Last September the first bellwether Johns v Bard ended in a jury verdict for Bard after a five-week trial. That case was a defense pick and attorneys argued it was not typical of the injury profile for mesh hernia mesh plaintiffs.
The hernia mesh in question produced by Bard is the Ventralex Hernia Patch Mesh. Cleared by the FDA through its 510(k) process on July 16, 2002, Bard claimed the Ventralex was “substantially equivalent” to the Bard Composix Kugel Mesh Patch, containing the same memory recoil ring.
Bard settled 2,600 Kugel defective product cases for $184 million in 2013.
It is multi-layered polypropylene and expanded polytetrafluoroethylene (ePTFE), a thermoplastic polymer, on one side which is intended to face the intestines in the intra-abdominal space so it does not adhere to the body.
Gor-Tex is a brand of expanded ePTFE and PTFE is used to coat non-stick pans.
It contains two layers of polypropylene mesh and a memory recoil ring component which is left implanted along with the polypropylene mesh. In this case, the complaint says the ring is used to place the mesh but its presence can cause the mesh to deform and buckle and the forces on the mesh can cause the ring to break.
Bowel perforation is the fear when that happens.
Mr. Milanesi had the Ventralex Hernia Patch mesh implanted July 11, 2007, at Sacred Heart Hospital in Pensacola. He says he was not informed of the known complications and risks associated with Ventralex, and that his surgeon, Dr. Karanbir Gill, had not been informed either.
Ten years later on May 26, 2017, Mr. Milanesi had another surgery to remove the infected Ventralex and a small bowel fistula. The surgeon noted a loop of small bowel was densely attached to the mesh. The small bowel had experienced an erosion involving a portion of the mesh, causing the surgeon to perform a resection on the small bowel, removal of the bowel fistula, and infected hernia mesh. Mr. Milanesi claims he is severely and permanently injured as a result.
One month later in June 2017, Mr. Milanesi underwent another surgery to repair a high-grade small bowel obstruction.
Plaintiffs are alleging negligence, a manufacturing defect, design defect, infliction of emotional distress, and a failure to warn. Last October, an Ohio federal court threw out their claim that the hernia mesh was defectively manufactured. The couple may seek punitive damages.
Ventralex is similar to Bard’s three others that are the subject of defective product actions – Ventralight ST, Prefix, and 3D Max.
Defendant Davol is incorporated in Rhode Island. Bard is incorporated under New Jersey laws. Bard is the parent company of Davol and controls the largest market share of the hernia mesh market. Davol owns the patent on the device.
Attorneys for Milanesi are Levin Papantonio, Tim O’Brien, and Robert Price.