The case opened July 28 in state court in Providence, Rhode Island. Paul Trevino, says his Bard Ventralex hernia mesh caused a cascade of problems from its erosion into his bowel.
Since 2008 he has undergone nine surgeries, is in constant pain, and can’t play with the kids, his wife said.
MND has checked in with the case, courtesy of a live feed from Courtroom View Network. The following report is just a glimpse of what has transpired, not a full accounting.
This is a high-stakes trial watched by the industry, law firms, and patients with more than 30,000 defective hernia mesh product cases being readied for trial. Bard/Davol is one of the largest hernia mesh manufacturers, the same plastic material that makes up the transvaginal mesh.
Trevino’s is the first hernia mesh case to be heard in state court. More than 15,000 cases are filed in Rhode Island, the headquarters of Bard.
The plaintiff has the burden to prove their case, so they usually present their most compelling evidence first.
In this case, Trevino’s attorneys contend that Bard purchased the polypropylene plastic used in the Ventralux, Pro-fax6523, hiding its end use as a hernia mesh from the supplier. That’s because the Material Safety Data Sheet (MSDS) that accompanies the production of the resin states specifically it is NOT to be used for an implantable medical device.
See the last story here.
The first witness, Steven Eldridge, works for Becton Dickinson, the parent company of Bard Davol, as a Research and Development manager.
Plaintiff attorney, Jonathan Orent of Motley Rice, showed Eldridge the technical data sheet for the polypropylene (PP) resin that said in no event should a Lyondell product be used in any FDA class 2 medical device without prior written approval by LyondellBasell.
Had he received the Prohibited and Restricted Applications policy? Yes, said Eldridge.
Did Bard have that written permission? Eldridge was asked.
It didn’t apply to us, Eldridge said, insisting they got their products approved with this PP material, conflating FDA clearance with permission from the supplier.
In 2019, Bard converted its hernia mesh sourced from Phillips Sumica Marlex PP to manufacturer LyondellBasell’s (LB) Pro-fax 6523. At the same time, LB called a meeting and wanted Eldridge there since he had a background in testing the mesh. Eldridge insisted the material was “absolutely safe” for implantation. He had no notes from that meeting.
Ultimately, LB denied Bard’s request to use Pro-fax 6523 in hernia meshes.
Earlynn Trevino lives on the Big Island of Hawaii with her husband, the plaintiff Paul. She appeared to be sympathetic and pleasant. She accompanied her husband to his many medical appointments.
Paul underwent hernia repair surgery in 2007 with a mesh implant, but when that failed, he had the Ventralex Hernia Patch implanted the following year. By 2017, Mr. Trevino returned to the emergency room in extreme pain, and doctors found the Ventralex patch had eroded into his bowel. The mesh and a portion of his bowel were surgically removed.
Earlynn learned how to wound vac infection from the gaping hole left after surgery when her husband spent 40 days in the hospital.
Defense attorney Lauren DiFrancesco’s (Greenberg Traurig) asked if she was aware of the litany of medical problems suffered by Paul Trevino – high blood pressure, high cholesterol, high blood sugar or hypoglycemia, and fatty liver disease.
I didn’t go to all his medical appointments, Earlynn said.
The defense also interjected that Mr. Trevino suffered stabbing wounds to his abdomen and chest in the 1990s. An incisional hernia developed above the belly button where that prior surgery occurred.
That information was not intended to be revealed to jurors as the reason for the major surgery in the 90s is redacted in the medical records.
Surgeon Dr. Andrew Fedder had operated on Mr. Trevino in Hawaii before relocating to Clovis, California.
He made it clear he relies on industry to inform him about the mesh material, its physical characteristics, and coatings. Dr. Fedder said he understood very little about the 510(k) FDA clearance process to market, which does not require clinical trials.
He was unaware the Bard Ventralex design is based on Composix Kugel mesh, which was the subject of a Class I FDA recall and thousands of lawsuits due to the breakage of the memory ring.
Was that information he would like to have had? Yes, said the doctor.
He was also unaware that the resin supplier had told Bard not to use their product in the mesh. Would that information affect his decision to use the Ventralex? Yes, he said.
Mr. Trevino suffered recurrent bowel obstruction from 2016 forward. The bowel obstruction was found under the mesh, according to the surgeon.
Dr. Fedder treated Mr. Trevino for over 12 years and agreed the lion’s share of nine surgeries was due to mesh erosion and a fistula that developed.
Under cross-examination by the defense attorney, Jason Oklelshen, Fedder admits he uses mesh about 90 percent of the time. Defense established that the surgeon is not critical of Ventralex or Bard, and mesh is the standard of care for an incisional hernia.
Just because it’s explanted doesn’t mean something is wrong, right? The surgeon agreed.
Dr. Uwe Klinge is a 63-year-old surgeon from the University Hospital in Aachen, The Netherlands. His center treats complex abdominal wall hernias. He has spent more than 30 years investigating hernia disease and its treatment with a focus on biomaterial of the meshes. he has performed more than 300 hernia surgeries.
His opinion about Ventralex mesh is that it’s too strong and stiff for its needs; in other words, it is overengineered and defective.
Ventralex contains small open pores, which can form the basis for a scar plate, causing curling, shrinkage, inflammation, and stiffness; therefore is defective.
He blames the anti-adhesion ePTFE layer for preventing tissue ingrowth leading to breaking, buckling, contracture, curling, shrinkage, stiffness, migration, and erosion into tissue.
The PET ring inside the Ventralex is designed to keep flat and in place, instead potentially breaks, buckles, contracts, migrates, and erodes into tissue; therefore is defective.
Associate Justice Richard Licht reminded the six jurors and three alternates that defective is a legal conclusion they will need to decide at the conclusion of the trial. “Defective” is the opinion of Dr. Klinge.
The jurors will convene Monday morning as the trial begins to wrap up.
The case is captioned Paul Trevino, et al. v. Davol Inc., et al., case number PC-2018-8437 in Providence/Bristol County Superior Court.