Medical device company, C.R. Bard, suffered a huge loss in New Jersey court over its pelvic mesh products. A Bergen County jury awarded the plaintiff, Mary McGinniss, $33 million in compensatory damages and $35 million in punitive damages against C.R. Bard, with a total award of $68 million. The case of Mary McGinnis v. C.R. Bard, Inc., Docket No.: BER-L-17717-14, New Jersey Superior Court, was the first bellwether trial as part of the state’s mass tort program. With thousands of lawsuits still pending against C.R. Bard and other pelvic mesh manufacturers, the verdict in New Jersey court may be a strong indicator of the future of pelvic mesh litigation.
The Allegations at Trial
The plaintiff, a 62-year old North Carolina resident, alleged that the pelvic mesh device implanted in her to treat pelvic organ prolapse and stress urinary incontinence had caused her chronic pain. The plaintiff used two of Bard’s meshes, the Avaulta and Align.
Soon after implantation, she began suffering from erosion, scar, tissue, dyspareunia, pudendal neuralgia, and loss of bladder functioning. She further alleged that the device, which is clear plastic and made of polypropylene, caused her vaginal tissue to become inflamed. The mesh, which was too large for plaintiff, led her body’s cells to launch protective attacks onto the foreign device, causing damaged tissue in the area. The device, which constricted inside the plaintiff after implantation, proved to be very difficult to completely remove. As a result, the plaintiff underwent three separate mesh removal surgeries which involved extensive groin dissections to remove pieces of the devices. The plaintiff alleged that Bard knowingly disregarded the risks associated with their devices and failed to adequately warn her of the potential dangers. In 2012, Avaulta was taken off the market after the U.S. Food and Drug Administration announced manufacturers were now required to conduct a three-year post-approval monitoring study. In 2016, Align devices were taken off the market as well.
The plaintiff’s attorney put forth evidence that Bard knew its devices were unsafe and failed to adequately warn patients and doctors about the potential dangers. At trial, numerous witnesses with an expertise in medical devices testified. The plaintiff called Adam Silver, the Vice President of Marketing of Bard’s Medical Division and Ronald Bracken, a medical device marketing researcher and former Vice President for Strategic Initiatives for Bard. Bracken is an expert in design controls, failure investigations, 510(k) clearances, test methods, and polymer science. The plaintiff also called Jonathan Conta, a marketing representative for a project team that developed medical devices to treat pelvic organ prolapse. Conta testified that he was responsible for the marketing of the Avaulta Classic device and was aware of the potential side effects, including chronic pain and vaginal erosion. In response to questions concerning the lack of clinical studies, Conta states that: “Any product marketer would want as much clinical data as they could get, and I always wanted more.”
Dr. William R. Welch, a surgical pathologist, testified that the amount of scar tissue found in the plaintiff was abnormal. Dr. Elizabeth Barbee, the gynecologist who implanted the device into the plaintiff, testified that she received training from Bard which included practice on a human cadaver. Barbee testified that she advised plaintiff of the potential side effects but did not believe that such side effects would lead to a catastrophic condition that could not be safely and effectively treated. Bard countered these allegations by maintaining that its products were extensively tested and that the plaintiff’s injuries were caused by other underlying medical conditions.
The defendant’s arguments proved to be unpersuasive as the jury found in favor of the plaintiff and awarded a total of $68 million in damages, making it the highest paid verdict thus far in Bard pelvic mesh litigation. Bard previously went to trial in other pelvic mesh cases. Jury trials in the state courts of California and West Virginia returned verdicts of $5.5 million and $2 million, respectively. A 2016 Missouri state court trial, however, found in favor of the defense.
Other Pelvic Mesh Litigation
According to its regulatory filings, Bard has settled more than 13,000 cases since 2014, with more than 500 lawsuits settling for $21 million in 2014 and another 3,000 cases settling for $200 million in 2015. However, Bard’s days in court are far from over. There are still more than 3,000 pending lawsuits against Bard, which were consolidated before a federal judge in West Virginia, along with 150 lawsuits in New Jersey state courts.
Bard is not the only medical device manufacturer facing hefty litigation over its pelvic mesh products. Both Johnson & Johnson and Boston Scientific, two major medical device manufacturers, have been litigating similar issues for the past few years.
In November 2014, Boston Scientific lost major two products liability trials. On November 13, 2014, a Florida jury awarded $26.7 million to four plaintiffs who were implanted with the company’s Pinnacle mesh devices. Within the same week, a West Virginia jury awarded $18.5 million to plaintiffs who suffered injuries from Boston Scientific’s Obtryx mid-urethral slings, which included $4 million in punitive damages.
Johnson & Johnson, along with its Ethicon mesh products, have been named defendants in more than 55,000 transvaginal mesh lawsuits. Similar to the allegations against bard, the plaintiffs are all women who suffered complications such as mesh erosion, scarring, and organ damage. A majority of lawsuits have been consolidated in multidistrict litigation in the United States District Court of the Southern District of West Virginia. A number of lawsuits are also pending in the Pennsylvania mass tort program. In January 2016, Johnson & Johnson agreed to pay $120 million to settle thousands of mesh lawsuits. The cases that have proceeded to trial and resulted in favorable verdicts for the plaintiffs had awarded damages in the amounts of $20 million, $12.5 million, $13.5 million, and $2.1 million.
New Jersey is the home of the U.S. headquarters for both Johnson & Johnson and Bard, making the state a major hub for pelvic mesh litigation. It is likely that the recent Bard verdict will have implications for the remaining pelvic mesh lawsuits, particularly those pending in New Jersey.