Hernia Cases Move Forward with MDL

Hernia mesh issues across the United States are quickly gaining steam. While hernia mesh has not yet reached the level of lawsuits and injuries associated with transvaginal mesh, litigation against hernia mesh manufacturers is increasing rapidly. Atrium Medical C-Qur hernia mesh cases have been consolidated into a federal MDL in the U.S. District Court for New Hampshire. Likewise, Plaintiffs filed a motion to create an MDL in either Illinois or Florida for Ethicon and Johnson & Johnson’s Physiomesh.

There are currently more than 40 actions against Physiomesh across 10 federal court districts. Regarding the potential Physiomesh MDL, Johnson & Johnson is asking the court to deny the MDL request, or, if the MDL formation request is granted, to place it in Georgia, Kentucky or New Jersey, rather than Illinois or Florida.

Problems with C-Qur Hernia Mesh

Ethicon and Johnson & Johnson voluntarily recalled Physiomesh in May 2016, however the FDA has not yet mandated a recall of the C-Qur hernia mesh. The FDA has conducted multiple investigations into Atrium, the manufacturer of C-Qur hernia mesh, even suing the company in 2015, alleging Atrium introduced adulterated medical devices into interstate commerce. Because of alleged medical issues as well as the ongoing litigation against Atrium, many hospitals and surgeons voluntarily stopped using C-Qur hernia mesh, despite the fact that Atrium claimed the mesh was much less likely to fuse with muscle tissue in the abdomen or create scar tissue due to a unique Omega-3 (fish oil) coating.

Atrium’s claims aside, C-Qur is now being tied to patient infections, chronic inflammation, bowel obstructions and allergic reactions. Plaintiffs in the lawsuits against Atrium claim the polypropylene mesh hernia patches were negligently designed, and that executives and scientists in the firm knew the patches had potential problems, yet fraudulently convinced surgeons the mesh was safe. As an example, one of the current plaintiffs in the C-Qur MDL is a 56-year old, who underwent hernia repair surgery four years ago. The patient experienced severe abdominal pain following his hernia repair, however; it was not until a couple of years had passed that the C-Qur mesh was identified as the culprit.

Although this patient’s mesh was eventually removed, he continues to experience constant pain. Doctors believe the patient’s body “fought” against the incompatible foreign product (the hernia mesh), creating a major cell reaction. The patient currently has extensive scar tissue surrounding the hernia repair site.

Physiomesh Dangers

Physiomesh racked up 90 adverse event reports after being on the market less than two years, and by the time of the 2016 Physiomesh recall, there were 650 adverse event reports filed with the FDA. The current lawsuits pending against Physiomesh claim defective manufacture and/or design, in that the five-layer polypropylene portion of the hernia mesh could not withstand typical abdominal forces, leading to additional surgical procedures and medical expenses.

In many cases, patients experienced re-herniation, yet it appears neither surgeons nor patients were made aware of the potential risks of Physiomesh. With well over 330,000 Physiomesh devices sold worldwide—and at least half of those implanted in the United States—the number of Physiomesh lawsuits is expected to significantly increase, making a solid case for establishing an MDL.

FDA’s 510(k) Approval Process

Both the Physiomesh and C-Qur hernia meshes received FDA approval through the controversial 510(k) fast-track approval process. Through this approval process, the device in question must only be shown to be substantially similar to another device currently on the market. In the case of the C-Qur mesh, Atrium garnered approval for the mesh by claiming it was substantially similar to another hernia mesh which was approved in the 1990’s, even though the C-Qur implemented an entirely different coating than the original mesh. Another C-Qur patient claims to have suffered from chronic pain, nausea, infections, vomiting and other adverse issues after receiving a C-Qur hernia mesh implant in 2016. It was later discovered that the mesh had “bunched up,” and “folded up” within the woman’s body, causing serious injury.

National Defective Medical Device Lawyers

If you have suffered injury from a hernia mesh device such as C-Qur or Physiomesh, it is important that you speak to an experienced attorney as soon as possible. Call the defective medical device lawyers at Golomb Legal today for a consultation and to learn about your legal options. Our goal is to get you the greatest maximum recovery for your physical and emotional suffering.

To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national defective medical device lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States