Hernia mesh products—medical devices used to repair torn hernias—are big business, with over one million implantations done each year. However, with their popularity also comes a high frequency of complications. One study found that nearly one-third of patients experienced adverse side effects including bowel obstruction, perforation of organs and tissues, and the need for corrective surgery.
Over the years, there have been over 50,000 lawsuits related to hernia mesh products. The lawsuits reached a settlement for a collective $1.1 billion. But hernia mesh litigation is far from over. C.R. Bard, one of three medical device manufacturers facing lawsuits for hernia mesh products, recently lost a bellwether trial. With over 16,400 lawsuits still pending against C.R. Bard in a multidistrict litigation, its April trial loss may set the tone for future trials.
The Lawsuit Allegations
C.R. Bard’s hernia mesh products have a long history. The company is one of the earliest pioneers in permanent mesh implants. Unlike absorbable implants, the manufacturers designed C.R. Bard’s devices to permanently remain in the body after implantation. The company makes the mesh from polypropylene. The purpose of the mesh is to strengthen and reinforce the surgically repaired tissue without attaching it to any adjacent tissue. However, patients began experiencing problems with the implant, such as immune system responses triggered by the mesh material. As a result, patients would experience pain and inflammation.
In other cases, the mesh coating would dissolve or not properly function. This results in the mesh attaching to adjacent tissue and organs. Subsequently, this can cause internal infections, bowel obstructions, and severe abdominal pain. The lawsuits against C.R. Bard claim that the mesh material was defectively designed and inadequately tested. Furthermore, the lawsuits claim that the mesh material was not fit for permanent implantation inside the body.
Hernia Mesh Lawsuits
The Multidistrict Litigation
Four years ago, the hernia mesh lawsuits against C.R. Bard were consolidated into a multidistrict litigation in the United States District Court of the Southern District of Ohio (In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 18-MD-2846). In 2019, 12 cases were selected as a bellwether discovery pool, which permitted a brief period of discovery review before both the plaintiff and defense side each picked three cases to be scheduled for trial. The scheduling of these six trials experienced delays and complications due to the COVID-19 pandemic.
In September 2021, the first bellwether trial finally began for a case that the defense selected. The defense selected Johns v. C.R. Bard Inc., et al., 2:18-cv-01509. The plaintiff, Steven Johns, had C.R. Bard’s Ventralight ST hernia mesh implanted to repair an abdominal hernia. According to Johns, the mesh’s defective design caused it to adhere to his bowel tissue. As a result, he suffered severe pain and needed additional surgery. The plaintiff’s case-in-chief lasted for five weeks. Ultimately, the jury found in favor of the defendant on all counts of negligence and strict liability.
The Latest Trial
This past March, the second bellwether trial began for plaintiff Antonio Milanesi and his wife, Alicia Morz De Milanesi (Milanesi, et al. v. C.R. Bard, et al., 2:18-cv-01320). Milanesi had C.R. Bard’s Ventralex mesh implanted in 2007. Subsequently, he then developed an infection and bowel abscess which required a second surgery in 2017. The plaintiffs claimed that the company defectively designed the product because the polypropylene material degrades when implanted in the human body. The jury then found in favor of the plaintiffs on design defect claims, awarding them $255,000 in damages. The damages amount included $5,000 for Mrs. Milanesi for loss of consortium. However, the jury rejected claims regarding strict liability, failure to warn, negligent misrepresentation, fraudulent misrepresentation, and gross misconduct. The judgment was entered against Becton, Dickinson and Co., a company that acquired C.R. Bard in 2017.
The next two cases that were selected for bellwether trials, Stinson, 18-cv-01022 and Miller, 18-cv-01143) do not appear likely to begin trial any time soon, as no trial dates have yet to be scheduled.
How Can the Experts Help?
A hernia occurs when an internal organ pushes through a weak area in the body’s muscle or tissue. There are different types of hernias that can occur in different areas of the body. As such, the specific type of medical expert plaintiff attorneys need in a hernia mesh case may vary. A general surgery expert can attest to the procedures and standards of care when implanting such a device. A bariatric surgeon can be particularly useful in testifying to the procedures of implanting a device in the abdominal area.
Because the adequacy of C.R. Bard’s materials is called into question in many of these cases, with the coating allegedly defectively designed and not intended for permanent implantation, an expert in the implantation of medical devices can also help establish (or defend against) such claims.
The Future of Hernia Mesh Litigation
C.R. Bard is not the only company facing litigation over its hernia mesh products. Ethicon, a subsidiary of Johnson & Johnson, was facing over 3,600 lawsuits which were consolidated into an MDL. In September 2021, prior to Ethicon’s first bellwether trial, the parties entered into a global settlement agreement. The specific terms and dollar amounts of the settlement remain confidential. The MDL’s presiding judge appointed a special master to assist in the implementation of the settlement.
Because C.R. Bard currently holds a 1:1 win/loss record, there is no precise prediction as to whether the company will follow Ethicon’s example and enter a global settlement. As is the case with any bellwether trial, the results of the Johns and Milanesi cases give both sides the opportunity to gauge how a jury reacts to their witnesses and evidence. With over 16,000 lawsuits pending and no future trial dates in sight, both the plaintiffs and C.R. Bard have time to determine which way they ultimately want to go in deciding whether a settlement is in their future.