Hernia Mesh Lawsuit

Hernia mesh lawsuits stem from device complications like infection, pain, bowel obstruction, organ or tissue perforation and adhesion. Manufacturers claim their products are not defective but have still settled 50,000+ hernia mesh lawsuits to the tune of $1.1 billion total.

Why People File Hernia Mesh Lawsuits

Hernia mesh implants have become a widely popular solution for patients facing any kind of hernia. This kind of mesh implantation has become common, with the U.S. Food and Drug Administration (FDA) estimating there are over one million hernia repairs each year. Many hernia repairs use surgical mesh, which can be made out of several different materials, to add support to the weakened tissue.

Unfortunately, mesh implants can also cause a variety of severe side effects, including perforation, migration, and infection, among others. Many patients (or their loved ones) are seeking compensation by filing lawsuits against hernia mesh makers for failing to inform them of these and other side effects. The plaintiffs claim they would have avoided the surgery and sought out other treatments had they known about hernia mesh complications in advance.

Hernia Mesh Complications and Injuries

While hernia mesh has been a popular surgical solution for many years, the safety of some of these implants has been called into question due to serious complications in some patients. Atrium's C-QUR mesh and Ethicon's Physiomesh, in particular, are facing dozens of legal claims because of the injuries caused by the hernia surgical mesh implants.

Some studies found that certain materials used to make hernia mesh are unsafe for humans and can degrade in quality over time. For instance, C-QUR mesh is coated in a fish oil substance that may affect the rate of adhesion (abnormal scar tissue that causes tissues and organs to become attached). Some studies suggest the coating reduces adhesions in the short term, but may increase the number of adhesions over longer time periods.

C-QUR mesh, various Ethicon products and a variety of other surgical meshes are created using a polymer called polypropylene, which is known to degrade over time. As the material wears, this often leads to the mesh shrinking, causing irritation to the surrounding area and provoking an immune response.

Researchers noted that while hernia mesh is often considered necessary in treating any kind of hernia, the long-term side effects of these medical devices are still uncertain. While some complications may arise even within days of surgery, a 2016 study found that 1,050 out of 3,242 hernia repair patients (the substantial majority of whom had mesh repairs) required an additional operation within 5 years of the original surgery to repair the hernia again or manage a mesh-related complication. The researchers stated that many benefits of hernia mesh were offset by the late-term injuries.

Claims Against Hernia Mesh Manufacturers

Many of these hernia mesh lawsuits allege that manufacturers of these implants, like Atrium and Ethicon, were well aware of the dangers of their products and didn't properly warn doctors and consumers of potential complications. Many of the claims allege that these manufacturers didn't perform the proper safety protocols to ensure that the hernia mesh products would perform as intended. For some of these medical devices, including the C-QUR and Physiomesh, the FDA allowed for 510(k) premarket clearance, meaning the devices were alleged to be as safe and effective as a similar device already on the market.

Those suffering from complications from hernia mesh implants are claiming these manufacturers didn't do their due diligence with proper research and studies before putting these products to market. These medical device lawsuits claim the manufacturers ultimately produced defective devices, which lead to undue pain and suffering and further surgeries for many of these patients.

FDA Studies and Adverse Event Reports

There have been many adverse event reports against these hernia mesh implants, such as C-QUR and Ethicon's Physiomesh. The FDA has documented dozens of adverse event reports against Physiomesh with some as recent as spring 2017, including events where the mesh was broken into pieces, had a hole in the center, ruptured after surgery, and presented bowel obstruction among other problematic events. In some of these reports, the surgeons even stated that the surgical mesh was a failure.

Physiomesh isn't the only hernia mesh product with a number of adverse event reports. Atrium's C-QUR, certain devices from C.R. Bard like the PerFix and 3DMax devices, and some devices from Covidien like the Parietex ProGrip have all been the subjects of many such reports. The FDA noted that the majority of these adverse events were related to bowel obstructions, pain, infection, adhesion and hernia recurrence.

Hernia Mesh Recalls

As a result of some of the complications arising from these surgical meshes, the FDA has recalled a variety of hernia mesh implants over the years. One of the first surgical meshes to be recalled was the Kugel hernia mesh, manufactured by C.R. Bard. Their devices were recalled in 2005, 2006 and 2007 because of the dangers of the mesh breaking and leading to bowel perforation or enteric fistula, an abnormal connection between organs.

Atrium, the manufacturer of C-QUR, also received warning letters from the FDA beginning in 2012 because the company didn't address issues with the device, like its cause of infection and inadequacies in the sterility of the manufacturing environment. When the company still didn't address these issues, the FDA put out a Class 2 recall for C-QUR, meaning exposure to this violative product could cause temporary health risks. Following this recall, the FDA later filed a lawsuit against Atrium in 2015 because of poor quality control at their plant in New Hampshire, which temporarily stopped production of C-QUR and other similar devices.

Ethicon's Physiomesh faced a different kind of recall, as well. Ethicon, a subsidiary of Johnson & Johnson, underwent a market withdrawal of the product in 2016, meaning the company voluntarily removed the product because of a violation of FDA guidelines. Ethicon decided to remove the product following a review of various studies revealing high hernia recurrence rates and other complications.

Hernia Mesh Lawsuit Settlements and Verdicts

Companies have paid more than $1.1 billion in vaginal mesh and hernia mesh lawsuit settlements. Prior settlements and verdicts for hernia mesh and vaginal mesh lawsuits can give claimants an idea of what to expect in future cases.

With thousands of lawsuits against these hernia mesh devices, there have been many notable settlements and verdicts already. Many of the current lawsuits against manufacturers of surgical mesh have been consolidated under two multidistrict litigation (MDL) procedures in the United States District Court for the District of New Hampshire and the United States District Court for the Northern District of Georgia. Prior settlements and verdicts in hernia mesh lawsuits and similar lawsuits against vaginal mesh implants may help pave the way for what claimants can expect in these lawsuits moving forward.

Engelman vs. Ethicon - $20 Million Verdict

In a related 2017 lawsuit, Ethicon was found liable in the case of a New Jersey woman who experienced complications as a result of their transvaginal mesh implant, the TVT-Secur transvaginal tape. Much like their hernia mesh devices, Ethicon's TVT-Secur was made with a polypropylene mesh and moved to market in 2006 through the FDA's 501(k) clearance program, meaning the product didn't have to undergo numerous clinical trials for approval.

The Philadelphia jury concluded that Ethicon had made a defective product. In fact, in 2012, Johnson & Johnson voluntarily removed the product from the market, like they later had to with their Physiomesh hernia mesh product. Ethicon faced a verdict in this trial of $2.5 million in compensatory damages and $17.5 million in punitive damages.

Johnson & Johnson - $120 Million in Settlements

While Johnson & Johnson has refused to settle many of the lawsuits against them, the company decided to settle 2,790 mesh lawsuits in 2016. The allocated $120 million for these lawsuits was again against vaginal mesh products produced by the company's subsidiary, Ethicon. Even after making this large settlement, the company is still facing thousands of vaginal mesh and hernia mesh lawsuits.

Endo International & C.R. Bard Pay Over $1 Billion in Settlements

In 2014, manufacturer Endo International paid out $830 million to settle 20,000 lawsuits against their vaginal mesh implants. Just a year before, the company had paid $54 million to settle an undisclosed number of claims also against their transvaginal mesh devices, though the company continues to stand by their products.

That same year, C.R. Bard settled 6,000 mesh lawsuits with $319 million. C.R. Bard has faced thousands of claims against many of their mesh implants for hernias and pelvic surgeries for being faulty and causing serious complications. A few years before settling these 6,000 claims, the company paid nearly $200 million for a few thousand other similar claims. Even with these large payouts, the manufacturer continues to face a mounting number of lawsuits.

Current Hernia Mesh Litigation

Today, most hernia mesh lawsuits have been consolidated under one of two MDL dockets:

• Ethicon Physiomesh Flexible Composite Hernia Mesh (MDL 2782)
• Atrium Medical Corp. C-Qur Mesh Products (MDL 2753)

As of May 2020, MDL 2782 has more than 2,900 pending lawsuits. The first trial for this Ethicon MDL was rescheduled for July 2020. Given the ongoing novel coronavirus (COVID-19) pandemic, that date may change again in the near future.

MDL 2753 against Atrium Medical Corporation has more than 2,200 pending lawsuits. At this time, MDL 2753 does not have an estimated start date.

In one of the most recent related cases against Ethicon, Johnson & Johnson was found liable with a $35 million verdict, which included $25 million in punitive damages. The lawsuit was brought against Ethicon's Prolift surgical mesh implant after the plaintiff suffered post-implant injuries. With this recent verdict, as well as numerous other settlements against similar devices, experts expect to see many other losses for these manufacturing companies once these trials get underway.

In addition to these MDLs against Atrium and Ethicon, there are a number of other manufacturers and numerous hernia mesh implants currently involved in lawsuits.

Hernia Mesh Class Action Lawsuit

In addition to the MDLs and individual lawsuits, there have also been a number of hernia mesh class action lawsuits filed against Ethicon and other hernia mesh manufacturers. A class action lawsuit occurs when multiple plaintiffs with similar cases bring forth a claim against a defendant or defendants.

In 2014, C.R. Bard faced a class action lawsuit against the Kugel hernia mesh patch, which led to the company paying out hundreds of millions of dollars in settlements. In 2017, multiple hernia mesh class action lawsuits were brought against Johnson & Johnson, Atrium, and other manufacturers, though the outcomes remain to be seen.

Hernia Mesh Lawsuit FAQs

Am I Eligible to File a Hernia Mesh Lawsuit?

If you or a loved one has suffered complications of injuries as a result of a hernia mesh implant, you may be eligible to file a hernia mesh lawsuit, especially if the mesh was made by any of the following companies:

• Johnson & Johnson - Ethicon Physiomesh
• Atrium - C-QUR hernia mesh
• Covidien - Parietex mesh
• C.R. Bard - PerFix, Kugel, 3DMax, or Ventralex mesh

How Much Compensation Will I Receive?

Hernia mesh manufacturers have already been found liable for hundreds of millions of dollars in various legal damages. While some verdicts have been several million dollars for individual claimants, it's important to remember the compensatory damages awarded in hernia mesh lawsuits will vary depending on the individual case. However, the damages awarded in these types of cases will keep the following in consideration:

• Medical expenses
• Lost income (past and future)
• Pain and suffering caused by the hernia mesh complications

In some cases, punitive damages could also be awarded by juries to penalize companies that have failed to live up to their safety obligations.

What Does it Cost to File a Hernia Mesh Lawsuit?

Many people feel nervous about pursuing legal action because of the potential costs of legal action. However, you can file a hernia mesh lawsuit on a contingency basis. In doing so, you will not be required to pay legal fees until you receive compensation for your claim.