C.R. Bard Hernia Mesh Trial Gets the Green Light

Santa Clara, CAFederal hernia mesh lawsuits filed against C.R. Bard are proceeding with the first bellwhether trial scheduled for January 2021 (it was postponed due to COVID), despite numerous efforts by the medical device maker to have the case dismissed. This trial may well indicate the future of hernia mesh litigation and significantly impact up to 10,000 pending hernia mesh cases.

C.R. Bard faces over 8,000 product liability claims, and U.S. District Judge Edmund A. Sargus expects at least another 2,000 complaints, all alleging Bard’s polypropylene mesh products are defective. Plaintiffs claim that design problems with the company’s Ventralight, Bard Ventralex, Bard Perfix, Bard 3DMax and other similar mesh systems caused severe complications, often resulting in additional surgery (sometimes multiple surgeries) in an attempt to remove the defective hernia patch.

Bellwether Case

Steven Johns‘ case was selected for the bellwether trial, which was scheduled to commence in May 2020. Johns filed his personal injury product liability case in October 2018, claiming Bard knew that:

• the component parts of the mesh were dangerous and unsafe for use in medical devices
• polypropylene is not suitable for permanent implantation in the human body, as the ST coating resorbs too quickly
• the PGA fibers created an increased inflammatory response.

Johns underwent surgery in 2015 to repair a hernia and was implanted with Ventralight ST Mesh. His symptoms returned a few months later and he had a second surgery, which revealed adhesions from the mesh implant. “Plaintiff's doctor then removed the original device and implanted another Ventralight ST.

Plaintiff was diagnosed with another hernia in April 2019 and underwent a third surgery to repair the hernia, but the second Ventralight ST device was not removed.” By November Johns complained of abdominal pain and believes he will need additional surgery for either chronic pain or possible complications, such a bowel obstruction or fistulization. (Case No. 2:18-md-2846)

Expert Testimony

Bard seems to have exhausted its attempts to prevent this trial. It tried (and was subsequently denied) several motions for summary judgment and numerous requests to the court that crucial expert testimony supporting the plaintiff’s claim be dismissed. Judge Sargas on September 1 determined that several expert witness opinions are based on enough sound science for jury consideration, specifically testimony (49 pages) of Plaintiff’s Expert Dr. David Grischkan and Dr. Julia Babensee, Ph.D. 

Dr. Grischkan opined the following:

“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.”

Bard argued that Dr. Grischkan’s opinions and testimony should be excluded because they are “not based on reliable methods, facts, and data, were undisclosed in his report, and/or his proposed testimony is beyond the scope of his expertise.”

However, Dr. Grischkan is a surgeon specializing in hernia repairs for over thirty years.

Dr. Babensee testified as an expert “in host responses to implanted biomaterials, including Defendants’ polypropylene mesh implanted in humans.” Her research has been funded by the NIH and other organizations; she has served as an editor of various journals, authored dozens of peer-reviewed articles, papers, and book chapters, and presented her research at conferences. Dr. Babensee opined the following:

“It is my opinion that the Bard Bellwether Products 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. I further find that the failure of the adhesive barrier subjects the visceral organs to all the deleterious consequences of polypropylene. Material incompatible for inclusion in a device is also demonstrated with the co-knitted PGA fibers of the Ventralight ST mesh, exposing the body to its proinflammatory degradation environment and revealing the underlying polypropylene mesh.”

Bard contended that “Dr. Babensee’s opinions do not fit the issues in this case, are offered outside of her area of non-litigation expertise, and/or are derived from an unreliable methodology.”

But Bard’s argument against Babensee did not sit well with the court. “The Court notes that Bard previously made similar, if not identical, arguments regarding Dr. Babensee’s lack of qualifications in another MDL involving Bard’s polypropylene mesh products. Judge Goodwin rejected those arguments and found Dr. Babensee was qualified to render opinions related to polypropylene…”

Bard is also on the hook for punitive damages, despite its attempts to prevent the jury from considering the award. This bellwhether trial may not bode well with Bard.