Steven Johns’ case has been chosen for a bellwether trial against hernia mesh maker C.R. Bard. His case is one of more than 8,000 product liability claims against the company, all of which allege that Bard’s hernia mesh devices are defective. According to U.S. District Judge Edmund A. Sargus, another 2,000 similar complaints will be coming around the bend.
Plaintiffs in these cases cite design problems with Bard’s Ventralight, Bard Ventralex, Bard Perfix, Bard 3DMax, and other mesh systems. The defects allegedly caused plaintiffs to suffer severe complications, often requiring additional—in some cases multiple—surgeries aimed at removing the hernia patches from patients.
About Steven Johns’ Case
Johns received a Ventrlalight ST Mesh implant in 2015 when he underwent a hernia repair surgery. Months passed, and Johns found himself back in the operating room for a second surgery to address the return of his symptoms. It was during this operation that surgeons identified adhesions from the hernia mesh implant. It was removed and replaced with another Ventralight ST device.
In April 2019, Johns returned again to the hospital for a third surgery on a new hernia. Doctors did not remove the second Ventralight ST device during this procedure. November came around, and Johns complained he was suffering abdominal pain. He will likely require yet another surgery to address his chronic pain and possible complications from his hernia mesh implants. Possible complications include fistulisation and bowel obstruction.
Johns filed his lawsuit against Bard, accusing the company of knowingly making its device:
- With dangerous component parts that were both dangerous and unsafe for this purpose
- Using polypropylene, which Bard knew had an ST coating that reabsorbs too quickly, making it unsuitable for permanent implantation in a human body
- Using PGA fibers, which create a heightened inflammatory response
Medical Expert Testimony
Despite Bard’s best efforts to have the court dismiss expert testimony, Judge Sargas ruled that the opinions of Plaintiff’s Expert Dr. David Grischkan and Dr. Julia Babensee, Ph.D. are admissible.
In his opinion, Dr. Grischkan wrote, “It is the failure of the Ventralight ST device to perform in the manner expected as advertised by Bard that has caused Mr. Johns’ injuries and has the potential to cause additional disastrous complications in patients such as Steven Johns.”
Dr. Babensee opined that Bard’s hernia mesh devices “…were not suitable for implantation in the human body because of the polypropylene mechanical mismatch, degradation of the polypropylene, chronic inflammatory response, hyper-fibrotic reaction, lack of adequate tissue ingrowth, encapsulation, and micro-motion.” The medical expert also wrote about the “deleterious consequences of polypropylene.”
FDA’s Analysis of Hernia Mesh Complications
According to the U.S. Food & Drug Administration (FDA), several adverse events are linked to hernia repair with mesh. They include:
- Hernia recurrence
- Bowel obstruction
- Mesh shrinkage
- Mesh migration
The FDA also reveals many complications of hernia repair with surgical mesh, based on reports that patients and doctors have filed via the agency’s MedWatch program. The most common complications, according to these reports, are bowel perforation and obstruction.