Over the past several years, medical device manufacturers have been facing a growing number of lawsuits stemming from hernia mesh products—surgical implantations used to repair torn hernias. While hernia mesh has been a common treatment, with over one million repairs done each year, there is also a relatively high probability of complications, including infection, bowel obstruction, and perforation of organs and tissues. A 2016 study found that 1,050 out of 3,242 patients required additional surgery after the hernia implantation to either repair the hernia or fix a complication.
As of October 2020, there were 14,900 hernia mesh lawsuits pending in three separate multidistrict litigations against medical device manufacturers C.R. Bard, Ethicon, and Atrium. Each case has yet to go to trial and have also experienced delays due to COVID-19. However, with bellwether trials now rescheduled for 2021, it seems that hernia mesh litigation may be slowly moving toward resolution.
The manufacturer C.R. Bard is no stranger to product liability lawsuits. Its hernia mesh devices were recalled in 2005 through 2007 due to the danger of bowel perforation, among other injuries. In 2011, the company entered into the largest hernia mesh settlement to date—$184 million to settle approximately 3,000 cases. Currently, Bard is facing 9,394 multidistrict litigation lawsuits that were consolidated in the United States District Court of the Southern District of Ohio back in August 2018. The presiding judge estimates this case total will reach 10,000 by the time of the first trial date scheduled for January 11, 2021. The trial has been postponed twice—in May 2020 and then to September 2020—due to the COVID-19 pandemic.
Steven Johns, the first plaintiff to go to trial, alleges that he suffered from pain and hernia reoccurrence after implantation of Bard’s Ventralight ST mesh which required another surgery to fix. As the bellwether trial for the Bard litigation, Johns won a small victory in his motion to exclude defense expert testimony. The court partially granted the motion, ruling that defense experts cannot opine as to the facts at issue and cannot state that the device was “in no way” defective or that its warnings were sufficient.
Since C.R. Bard is headquartered in Rhode Island, a number of lawsuits have also been filed in Rhode Island state court, with approximately 8,000 cases pending. Over 20 of Bard’s polypropylene mesh products are alleged to have caused injury and will be at issue in upcoming trials.
Ethicon, a subsidiary of Johnson & Johnson, is also facing thousands of hernia mesh lawsuits, 3,128 of which were coordinated and consolidated in the United States District Court of the Northern District of Georgia in June 2017. Four bellwether cases were selected and scheduled to go to trial in 2021. They’re set for January, March, and June, respectively (with the fourth trial date to be determined) after previous postponements due to COVID-19. The first trial, scheduled for January 25, 2021, will be that of plaintiff Jim Crumbley, who alleges that the implantation of Ethicon’s Physiomesh in 2014 caused complications that required additional surgery to repair.
Like C.R. Bard, Ethicon has a history of mesh settlements, though most are related to their transvaginal mesh implant devices. In 2017, a Philadelphia jury awarded $20 million to a plaintiff who had suffered complications related to Ethicon’s defective TVT-Secur—a device made out of polypropylene similar to Ethicon’s hernia mesh products. Although reluctant to settle most of its lawsuits, in 2016, Johnson & Johnson settled 2,790 vaginal mesh lawsuits for $120 million. The New Jersey-based company is also facing lawsuits in consolidated state court proceedings, none of which have been scheduled for trial.
Currently, there are 2,378 lawsuits pending in the District Court of New Hampshire against Atrium, the manufacturer of C-QUR hernia mesh products. Consolidated in December 2016, the first bellwether trial was originally scheduled for May 2020, but was subsequently postponed because of the pandemic and at the request of the defendant. Carrie Barron is the first plaintiff scheduled for trial, on January 20, 2021. A first of its kind, the presiding judge has indicated that Barron’s trial may be conducted virtually so that parties can participate remotely during the pandemic. The judge plans to rule on specific recommendations at the requests of the parties.
According to the complaints, Atrium’s C-QUR mesh caused allergic reactions and immune system responses which adversely affected the plaintiffs. It is alleged the reaction might be caused by C-QUR’s coating, which is derived from fish oil and intended to reduce inflammation. The company maintains that it removes any proteins that could cause allergic reactions prior to applying the coat. However, its coating safety has long been questioned, such as in a 2009 study in the British Journal of Surgery. Researchers found that the coating may contribute to the mesh sticking to organs and tissues. The Food and Drug Administration had similar concerns after inspections of Atrium’s New Hampshire plant between 2009 and 2013, eventually requesting an injunction against Atrium to close its plant until the problems were addressed. The injunction was granted in 2015.
With all three manufacturers facing their first bellwether trial in January after COVID-19-related postponements, there is no guarantee if these trials will, in fact, timely proceed. However, with virtual technology on the table for at least the Altrium MDL, it might be seemn that the courts are ready to proceed despite any pandemic setbacks.