Dive Brief:
- A Rhode Island jury found that Becton Dickinson subsidiary C.R. Bard must pay $4.8 million to a man who alleged that Ventralex hernia mesh made by the company caused him severe gastrointestinal injuries, according to a statement Monday by the law firm representing the plaintiff in the case.
- The case is the latest loss for a medical device firm in lawsuits over surgical mesh. BD said recently that it’s facing more than 30,000 liability claims for its hernia repair devices.
- BD said that it plans to appeal the decision, and disagrees with the jury’s finding of negligence. The company said it agrees with the jury that “no design or warning defect” was involved.
Dive Insight:
Patient Paul Trevino of Hawaii alleged that C.R. Bard made the mesh with a low-quality polypropylene plastic that wasn’t safe to use in humans, according to law firm Motley Rice, which represented Trevino. Trevino said he suffered severe medical complications, including corrective surgeries, after the mesh “burrowed into his intestinal tissue over the course of several years.”
The award of compensatory damages came after a month-long trial in Rhode Island Superior Court. “In the end, the jury saw through the blame game and ruled in favor of justice,” Motley Rice lead attorney Jonathan Orent said in a statement.
BD spokesman Troy Kirkpatrick wrote in an emailed statement that the company is “empathetic” to Trevino and anyone who experiences a medical complication, and added that all implantable medical devices “carry inherent risks as well as significant clinical benefits that outweigh those risks.”
BD said in its latest quarterly filing with the Securities and Exchange Commission that it is facing almost 30,300 product liability claims for its line of hernia repair devices. The company said that the majority of those claims are pending in a coordinated proceeding in Rhode Island State Court and in federal multidistrict litigation (MDL) established in the Southern District of Ohio, adding that “claims are also pending in other state and/or federal court jurisdictions.”
Kirkpatrick, the BD spokesperson, took issue with the jury’s decision.
“We agree with the jury’s finding that there is no design or warning defect in our product at issue, as other juries have also found. However, we respectfully disagree with the jury’s finding of negligence in this case,” Kirkpatrick wrote. “Our hernia mesh products are cleared for use by [the Food and Drug Administration,] and we are confident in both the design of our products and fulfilling our obligation to provide information about both the risks and the benefits of these products in order that physicians, in consultation with their patients, can determine whether those benefits outweigh the potential risks in a particular instance.”
In September 2021, a court sided with the company in the first bellwether MDL hernia trial. However, in April, the second bellwether hernia MDL trial resulted in a $255,000 verdict against the company, according to BD.
In September 2020, BD agreed to pay $60 million to settle multistate litigation that C.R. Bard deceptively marketed transvaginal surgical mesh devices to patients, by failing to note the potential risks involved for patients. BD acquired C.R. Bard for $24 billion in 2017.
Surgical mesh used in hernias or pelvic surgeries has been the center of several lawsuits involving large medical device companies, particularly over alleged deceptive marketing tactics.
In April, a California appeals court ordered Johnson & Johnson to pay $302 million for deceptive marketing of pelvic mesh implants. The judges upheld a prior ruling that found J&J’s subsidiary Ethicon minimized or omitted the health risks of transvagical pelvic mesh products in instructions and marketing to doctors and patients.
J&J also ordered to pay $344 million in 2020 for falsely and deceptively marketing mesh devices for stress urinary incontinence and pelvic organ prolapse, which are now off the market.
In March 2021, Boston Scientific agreed to pay $188.6 million to 47 states and the District of Columbia to settle allegations that it deceptively marketed transvaginal surgical mesh devices to patients.
