C.R. Bard’s new owner, Becton, Dickinson and Company, scored a hernia mesh victory in a New Jersey State appeals court, learning on Monday, March 19, 2018 that a lawsuit filed over the company’s 3DMax Mesh will not be revived for a second go at legal proceedings.
Bard Hernia Mesh Lawsuit Loses Out On Appeal
As MassDevice.com reports, a three-judge panel for the appellate court ruled that the plaintiff’s expert witnesses were unable to provide sufficient evidence to suggest that Bard’s 3D Max Mesh product, designed for the laparoscopic repair of inguinal hernia, is defective.
The plaintiff filed suit against C.R. Bard after suffering severe alleged injuries due to the company’s 3D Max hernia mesh patch, an implant he received in 2006.
Chronic Pain, Nerve Ingrowth & Revision Procedures
In court records, the Georgia man claims that, after being implanted with two 3D Max products in his groin, he was left with chronic pain. Subsequent surgical interventions, in which the plaintiff lost one of his testicles, found evidence of nerve ingrowth.
In many patients, natural body tissues become intertwined within the mesh lattice of a hernia patch over time. That can lead to pain and debilitating discomfort in extreme cases, as the mesh shrinks and moves, pulling on nerve endings that communicate pain signals and other bodily sensations.
In his lawsuit, the 3D Max patient blames his own pain, along with multiple corrective surgeries, on the hernia mesh patch, accusing C.R. Bard of manufacturing and marketing a defectively-designed product without sufficient warnings.
Appeals Court Finds Testimony Insufficient To Prove Defects
C.R. Bard moved for, and was granted, summary judgement, a decision the plaintiff quickly appealed, arguing that the lower court had “erred in granting summary judgment to the defendant on the […] claims of design defect and negligence.”
That brings us to the New Jersey Superior Court’s Appellate Division, which just delivered what may well be the final word on the matter. Upon further review, the Appeals Court writes, none of the plaintiff’s three expert witnesses, including his own surgeon, could muster acceptable evidence to prove that Bard’s 3DMax mesh is defective, or that the company committed negligence in the product’s design, manufacture or marketing.
“In the instant case,” the Court writes, none of the experts specifically opined that 3DMax is defective and that this defective design caused the medical complications complained of by the plaintiff. Instead, plaintiff’s three experts gave general opinions about the various medical risks of the product that can cause complications. This is not enough to overcome the summary judgment standard.”
Negligence Claims Thrown Out Due To “Learned Intermediary” Doctrine
The Appellate Court also affirmed the dismissal of negligence claims, noting that, in order to substantiate such a claim, the plaintiff was required to show that C.R. Bard “had a duty to warn, that the defendant breached that duty, and the breach proximately caused the plaintiff’s injury.”
To decide this question, the Appeals Court turned to the “learned intermediary” doctrine, a defense theory recognized in many states, including New Jersey. Under the learned intermediary doctrine, medical device manufacturers can’t be held liable for failing to warn a patient if they’ve provided a “learned intermediary,” like a surgeon, with all necessary risk information.
Operating Surgeon Discussed Risks, Undercut Plaintiff’s Argument
The plaintiff’s operating surgeon, Dr. Mark Middleton, had testified that he was aware of the risks posed by synthetic mesh products, including the likelihood of chronic pain and complications related to nerve ingrowth. He said he discussed the risks of chronic pain and numbness with the patient before surgery, but hadn’t read the specific prescribing documents that come with 3DMax Mesh.
“Dr. Middleton testified he went over the risks of the mesh surgery with plaintiff prior to the surgery, including the risk of chronic pain, numbness, hematoma, and mesh infection,” according to the Appellate Court. “As plaintiff’s physician, Dr. Middleton was serving in the role a learned intermediary. Despite the doctor’s decision to not read the manufacturer’s warnings, that decision does not alter his learned intermediary role nor does it impose liability on defendants for failure to warn.”
Just as critical, however, was Dr. Middleton’s belief that the 3DMax patch had not caused his patient’s complications. The surgeon said his 3DMax patients suffered fewer complications than with any other mesh product he had ever used.
Bard Faces Thousands Of Mesh Lawsuits
C.R. Bard is one of the world’s leading hernia mesh manufacturers, but thousands of patients have sued the company over the last two decades, arguing that many of the patches, including the Composix Kugel mesh and PerFix Plug, are defective and dangerous. Becton, Dickinson and Company acquired the New Jersey-based medical device manufacturer at the end of 2017 in a deal worth $24 billion, Qmed reports.