At first, Paul Trevino’s hernia surgery was considered a success.
A polypropylene mesh made by the Rhode Island company Davol Inc., a C.R. Bard Inc. subsidiary, was implanted in 2008 during a procedure in Hawaii, and it appeared to repair Trevino’s ailment.
But by 2017, other medical complications had arisen. Trevino and his lawyers say that over time the mesh burrowed into his intestinal tissue, leading to an additional 10 corrective surgeries, including a bowel resection, and 49 nights in the hospital.
“He was very severely injured,” said attorney Jonathan Orent, who works out of the Providence office of Motley Rice LLC.
Trevino sued Davol and Bard, a subsidiary of Becton, Dickinson and Co., one of the largest medical device manufacturers in the world. In August, a Rhode Island jury sided with Trevino, a Hawaii resident, and awarded him $4.8 million. Bard is readying its appeal.
The implications of the jury decision go far beyond that one judgment.
The Trevino case may serve as a precedent for a tidal wave of additional lawsuits in federal and Rhode Island courts alleging the Davol mesh was not fit to be implanted in the human body.
The case was a test, what legal observers refer to as a “bellwether trial,” selected by a judge among the thousands to streamline the judicial process with a single deposition of the defendant. The individual claims now number more than 17,000 and continue to grow. Orent said he is fielding about 50 new claims a week. About 4,500 cases were settled out of court last year.
“[The Trevino] case was chosen so that ultimately the parties will find a way to reach a conclusion,” he said. “It was designed to give us information.”
According to claims made by plaintiffs in the thousands of civil lawsuits now making their way through the courts, Bard knowingly sold unsafe mesh implants, leading to further medical complications.
Becton Dickinson, a conglomerate with revenues in the billions, employs 70,000 people worldwide, including about 450 people in Rhode Island, according to the Providence Business News 2022 Book of Lists. BD acquired Bard in 2017.
Troy Kirkpatrick, Becton Dickinson vice president of public relations, said in a statement that patient safety and product quality are top priorities for the company, and expressed empathy for Trevino’s medical complications.
All implantable medical devices carry risks, as well as clinical benefits that can outweigh those risks, Kirkpatrick said.
“The company’s hernia mesh products have benefited thousands of patients over many years, and those patients have improved lives because of them,” Kirkpatrick said. “We intend to appeal this verdict.”
While many plaintiffs do not live in Rhode Island, many of the lawsuits have been filed in R.I. Superior Court because the facility that created the polypropylene mesh used in the hernia procedures is located in Warwick. “A lot of the misconduct we allege [relates] to the harms stemming from Rhode Island,” Orent said.
Bard is no stranger to civil litigation. In 2011, Bard reached a $184 million settlement with 2,600 plaintiffs who alleged they had been injured by a different hernia mesh called Composix Kugel, a product later recalled by the Food and Drug Administration.
Bard also reached a settlement with multiple states in September 2020 related to its surgical mesh marketing. Rhode Island’s share of the settlement was $636,000, according to the R.I. Office of the Attorney General.
The FDA, which regulates medical devices, did not respond to requests for comment. Under the current classification, hernia meshes do not require clinical testing before being brought to market.
Stricter regulation is needed, Orent said.
“This is a consequence of the regulatory structure,” he said. “The FDA isn’t a regulatory powerhouse when it comes to [medical] devices. These companies don’t need to prove that these devices are safe.”
Documents obtained during the pretrial discovery process indicated that Davol acquired plastics through a third-party company called Red Oak after executives were warned by the plastics supplier not to use the mesh for implants because of a resin in the design that might be unsafe.
Using Red Oak created a “diversion to hide the fact that the raw polypropylene resin would be crafted into mesh for use in the human body,” argued Orent in court filings.
Emails presented to the jury in Trevino’s lawsuit quote a message from a former Bard executive, warning the buyers to “keep the Bard name secret in discussions with the resin manufacturer and distributor. … In fact, I would advise purchasing the resin through a [third] party, not the resin supplier to avoid a supply issue once the medical application is discovered.”
Bard attorneys attempted to cast doubt on the claims.
“The typical defense we heard … [was Trevino] had comorbidities and certain lifestyle decisions that affected his injures,” Orent said. “Or that it was the doctor’s or the hospital’s fault. It was everyone’s fault but the defense.”
Meanwhile, the need for medical innovation must march along. And litigation can sometimes get in the way of this progress, said Dr. Charles Adams Jr., professor of surgery at the Warren Alpert Medical School of Brown University.
Adams worries the publicity of these lawsuits can scare patients into thinking that all mesh hernia patches are dangerous.
“It’s one of the problems with the way we do things in the United States,” he said. “Some products are brought to market with not a lot of long-term data. We often don’t know what happens over time. And that can open the floodgates for all kinds of lawsuits. Meshes are now being maligned because there is money to be made.”
But the issue is extremely complex, he said.
“These choices need to be individualized,” he said. “Patients are willing to accept risk but want to be informed of that risk. The difference is the intentional cutting of corners. Unfortunately, it has taken a difficult problem and made it even worse.”
