On Thursday, July 28, a Rhode Island jury listened to opening arguments in the first state trial over a popular hernia mesh. The defendant is Davol (DAY-vohl) Inc. and C.R. Bard, and the mesh in question is Ventralex, a polypropylene hernia mesh that contains an expandable ring.
The plaintiff, Paul Trevino, 61, a municipal employee in Hawaii, claims Ventralex left him with side effects such as chronic pain, infection, bowel obstruction, and nerve damage after the mesh eroded into his bowel.
This is the fourth bellwether case selected for trial in the Rhode Island docket. The first case was continued, and the other two were settled before trial. Becton Dickinson & Co. owns C.R Bard and Davol (DAY-vohl).
So far, in the Bard MDL (multidistrict litigation) in federal court in Ohio, the defendant won the first trial, and the second brought the plaintiff, Milanesi, just $255,000.
Bard and Davol are facing allegations of a defective device and failure to warn, which Bard denies.
The case is captioned Paul Trevino, et al. v. Davol Inc., et al., case number PC-2018-8437 in Providence/Bristol County Superior Court.
Courtroom View Network is monitoring the proceedings and allowed Mesh Medical Device News Desk Access to trial coverage.
Mr. Trevino is represented by Jonathan Orent of Motley Rice, who on Thursday recounted how Trevino experienced a hernia at an incision site created after major abdominal surgery in the 1990s. He told the six jurors and three alternates that Davol and Bard sold the devices even though they understood the risk to patients.
In 2007, Trevino had a non-mesh surgery to repair the hernia, but after that failed, a Ventralex hernia patch was implanted the following year. The patch was removed in a follow-up surgery, and the bowel was resected after the mesh allegedly migrated to the bowel.
Orent explained that Ventralex has two layers of polypropylene (P.P.) heavyweight small-pore mesh and a layer of ePTFE, a non-adhesive barrier to prevent the mesh from attaching to internal organs. A ring, called a PET ring, helps the surgeon insert the device.
After the Ventralex implant, an inflammatory storm allegedly erupted causing the mesh to twist and buckle inside Trevino. But the anti-adhesion layer didn’t work, said the lawyer. Not only did it not do its job, but Bard never provided doctors with instructions on removing the hernia mesh.
Dr. Andrew Fedder accidentally nicked the bladder during its removal and had to remove a section of the bowel during that surgery.
By 2017, Trevino had undergone nine surgeries to correct a fistula, a tube connecting his bowel to the abdominal wall. The fistula and infection had to be cleaned, and Mr. Trevino spent more than 40 days in the hospital. He still has not recovered, said Orent.
These complications are not surprising, said Orent. In Europe, the medical community is mandated to report the outcome of every surgery so doctors can analyze real-world performance works. In 2021, a look at incisional hernias showed this device worked well in patients for the first six years, then the complications more than doubled to a 25% failure rate by year eight.
One in four needed it surgically removed, proving the device is defective.
Bard used the wrong plastic, said Orent. The company was notified it was not to be used in humans.
In what could be called the closest to a smoking gun, Mr. Orent told jurors about Red Oak Sales Company. This name may be familiar to readers of Mesh News Desk.
In the Donna Cisson pelvic mesh case, jurors there were told that Red Oak was a dummy company created as a diversion to hide the fact that the raw polypropylene resin would be crafted into mesh for use in the human body. See MND coverage here.
This directly violated a warning in the Material Safety Data Sheet (MSDS) that accompanies any raw material to protect workers. Both the MSDS and the Technical Data Sheet (TDS) warn not to use polypropylene resin for use in anything to be implanted in the human body.
When the large Ventralex was released in 2006, it contained polypropylene mesh derived from a polypropylene (PP) resin known as Pro-fax 6523, manufactured by LyondellBasell. That company sold Pro-fax 6523 to Red Oak Sales Company, which then made a P.P. monofilament, which eventually went into Ventralex mesh.
Keep the Bard name secret in discussions with the resin manufacturer and distributor, said Roger Darois, a VP of research at Bard.
“IMPORTANT: Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered.”
By 2019, the resin broker sent a letter to stop all sales of Pro-fax 6523 because they had no idea they were using it for devices to be implanted in the human body. Instead, the broker thought the company was creating fibers used by the automotive industry and in tapes and food containers.
Had they known it had a medical application, they never would have sold it to Red Oak.
The plaintiff in these cases has the burden of proof and that means the defense must create doubt that the PP mesh is defective.
The defendants say the plaintiffs’ injuries resulted from many surgeries and other medical conditions. Jeff Scott of Greenberg Traurig also blamed pre-existing conditions.
Scott continued to detail Mr. Trevino’s medical history, including the fact that he is chronically obese, which complicates any hernia mesh surgery.
The plaintiff cannot meet its burden to show there is a defect in the Ventralex design, he insisted.
These hernia mesh cases will be closely watched as post-covid courts open to the more than 30,000 lined up for trial. Many more cases could be in the pipeline as more than one million hernia mesh implants are placed in the U.S. every year.
Ultimately transvaginal mesh cases, amassed in multidistrict litigation in West Virginia, settled and were tried causing the four companies to pay more than $8 billion to injured women.
C.R. Bard joined Johnson & Johnson, Boston Scientific, and American Medical Systems as the four major manufacturers of polypropylene transvaginal mesh, the same PP used to make hernia mesh.