Hernia Mesh Lawsuits: History and Developments

Thousands of patients have received special mesh implants to help treat hernia injuries and related health issues. But when hernia mesh fails because of a defect in the material or due to a health care provider's mistake, serious complications can result, and thousands of lawsuits have been filed over problems like these. Let's look at the legal basis for lawsuits over hernia mesh complications, and provide a snapshot of recent court action.

How Hernia Mesh Works

A hernia occurs when an organ or other tissue in the body works its way through an internal wall designed to contain that organ or tissue. This wall is usually a muscle or fascia, a type of connective tissue.

Not all hernias are painful or problematic enough to require surgery, so doctors sometimes recommend leaving a hernia alone. But for more severe hernias, surgery remains the primary form of treatment, especially to prevent recurrence.

Hernias usually occur in the abdominal area, often during a moment of exertion, such as:

• heavy lifting
• sneezing
• coughing
• constipation, or
• diarrhea.

Starting in the 1980's, surgeons began using special meshes to surgically strengthen the opening created by the hernia. This strategy has worked with many patients, but hernia mesh implants have led to serious complications.

What Problems Have Been Linked to Hernia Mesh?

Most hernia meshes available in the United States consist of synthetic materials or animal tissues, typically from a pig or cow. According to the U.S. Food and Drug Administration (FDA), the most common problems that arise with hernia meshes are:

• infection
• pain
• adhesion (clumping of tissue)
• blockage of the intestines
• internal bleeding
• fistula (this occurs when there is an abnormal bonding between two or more components inside the abdomen, such as organs)
• seroma (fluid buildup)
• perforation (hole or tear in tissue)
• shrinkage of the mesh, and
• shifting of the mesh.

Cases like these require diagnosis of the problem, and assessment of the right course of care. Often a second surgery is required in order to replace the malfunctioning mesh and repair any surrounding damage.

Hernia Mesh Lawsuits

There are thousands of personal injury lawsuits pending against companies that design and manufacture hernia meshes. In the interest of judicial economy, courts have consolidated many of these cases into the following multi-district litigation (MDL) or multicounty litigation (MCL).

Davol/Bard's Kugel Mesh Hernia Patch MDL No. 1842 (Settled for $184 million)

This is the most notable of settlements among hernia mesh lawsuits. Begun in 2007, the first bellwether trial resulted in a defense verdict in April 2010. A few months later, the plaintiff won $1.3 million in the second bellwether trial. Almost a year later, all of the cases in the MDL settled for $184 million. This resulted in about $60,000 for each of the roughly 2,700 plaintiffs.

Atrium Medical Corporation's C-Qur Mesh MDL No. 2753

This MDL started in late 2016 in the District of New Hampshire. It consists of thousands of cases alleging defective design (among other claims). Specifically, many of the plaintiffs contend that the meshes use substandard materials, resulting in bowel obstructions, adhesions, and infections due to allergic reactions to the fatty acid coatings used on the mesh. The parties are still in the pre-trial phase of exchanging discovery.

Davol/Bard's Polypropylene Hernia Mesh MDL No. 2846

Established in August 2018, this MDL (in Ohio federal court) involves more than 3,000 plaintiffs who make two primary allegations: the mesh had a defective design, and the mesh manufacturer did not properly warn doctors and patients of risks of using Davol/Bard mesh. This MDL is currently in the pre-trial phase of litigation. Learn more about MDL 2846 on the U.S. District Court - Southern District of Ohio's special web page.

Johnson & Johnson/Ethicon's Physiomesh MDL No. 2782

In addition to a failure-to-warn allegation, the plaintiffs in this MDL claim that the various hernia meshes had faulty designs that prevented the mesh from incorporating into the tissue as intended. They also argue that the meshes had various flaws that resulted in tears, deterioration, and movement. The MDL consists of around 2,500 lawsuits in the Northern District of Georgia. The parties are in the process of conducting discovery with the first bellwether trial scheduled to start in 2021.

Physiomesh New Jersey MCL No. 627

Plaintiffs primarily allege that Physiomesh had a defective design, that the instructions and warnings accompanying the mesh were inadequate, and that the meshes were improperly manufactured. On July 17, 2018, the New Jersey Supreme Court ordered all current and future Physiomesh lawsuits brought in New Jersey into multicounty litigation in Atlantic County. At the time, the consolidation included at least 62 cases. The case is currently in the discovery stage.

These represent the five major consolidations concerning hernia mesh litigation. But there are still many individual cases pending, including suits against Medtronic and Covidien (for their Parietex meshes).

Know Your Defendant: A Cautionary Tale for Hernia Mesh Plaintiffs

In March 2020, a New Jersey appeals court ordered the dismissal of a hernia mesh lawsuit against Johnson & Johnson based on the plaintiffs' failure to adequately demonstrate that J&J (or its subsidiary Ethicon) actually manufactured the mesh that caused the alleged harm. It's a good reminder that even with an experienced lawyer and a team of expert witnesses on your side, proving a hernia mesh case can be a challenge.

September 2020: Pelvic Mesh Manufacturer Settles 48-State Lawsuit

In the same product safety arena as hernia mesh, C.R. Bard Inc., a manufacturer of pelvic mesh, agreed to pay $60 million to 48 states and the District of Columbia, to settle charges that the company engaged in deceptive marketing in connection with the safety of its pelvic mesh implants. According to a statement from the office of New York Attorney General Letitia James:

C. R. Bard misrepresented or failed to adequately disclose serious and life-altering risks of surgical mesh devices, such as chronic pain, scarring and shrinking of bodily tissue, painful sexual relations, and recurring infections, among other complications.

A number of similar actions have been brought by state attorneys general against other pelvic mesh manufacturers, including a $344 million judgment won by California's Department of Justice against Johnson & Johnson in January 2020. While hernia mesh and pelvic mesh work in very similar ways, hernia mesh strengthens and supports tissue around a herniated muscle, while pelvic or "transvaginal" mesh is implanted to treat pelvic organ prolapse and related conditions in female patients. Notably, in 2019, escalating safety concerns prompted the U.S. Food and Drug Administration to order manufacturers to stop selling all surgical mesh products intended to treat pelvic organ prolapse.

The Future of Hernia Mesh Litigation

The large settlement for the Davol/Bard Kugel MDL 1842 group of cases could indicate that most hernia mesh lawsuits (at least those in MDL's and MCL's) can avoid a full trial and result in at least some compensation for the affected plaintiffs. However, the remaining consolidated cases are still in the early stages of litigation and have yet to have their bellwether trials. So it may be a few more years before there's more clarity on any trends.

For a more complete picture of the current legal landscape of hernia mesh, and a sense of where your potential claim fits in, it may be time to discuss your situation with an attorney. Learn how to find the right lawyer for you and your hernia mesh case.