Hernia mesh complications have led to tens of thousands of lawsuits from people all across the United States. Complaints alleged that hernia mesh implants have caused intense pain, infection, organ perforations, and a host of other problems. Hernia mesh manufacturers have responded to these lawsuits with claims that their products are not defective, but some have settled the claims anyway, many lawsuits are still winding their way through federal courts.
Individuals who have experienced severe hernia mesh complications should talk to a medical device lawyer to learn about their legal rights.
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Why People File Hernia Mesh Lawsuits
Hernia mesh implants have become a widely popular solution for patients facing any kind of hernia. These types of repairs are common, with the U.S. Food and Drug Administration (FDA) estimating there are over one million hernia repairs each year. In general, hernias may be treated by simple observance to determine if there are worsening symptoms or complications from the injury or with a surgical repair, which may or may not entail the use of hernia mesh.
These medical devices, which can be made out of a number of materials, can help add support to the weakened or damaged tissue. For the most part, surgeons rely on hernia mesh to help reduce the high recurrence rate of hernias and also potentially reduce recovery time. It’s estimated that today more than 90% of groin hernia repairs use surgical mesh.
By the early 2000s, however, patients began to experience a variety of complications and injuries from many types of hernia mesh implants, which called into question the safety of these products and if they were being properly tested by manufacturers.
Hernia Mesh Complications and Injuries
While hernia mesh has been a popular surgical solution for many years, the safety of a variety of these implants have been called into question on numerous occasions after patients faced serious complications. Atrium’s C-QUR mesh and Ethicon’s Physiomesh, in particular, are facing dozens of claims because of the injuries caused by the hernia surgical mesh implants.
Because of how some of these implants are made, studies found some of the materials to actually be rather unsafe for humans or drastically degrade in quality over time. For instance, the C-QUR mesh is coated in a fish oil substance, which has led to some patients facing severe allergic reactions and an alarming rate of substantial adhesions, or abnormal scar tissue sticking together tissues and organs.
C-QUR mesh, various Ethicon products and a variety of other surgical meshes are largely 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.
Common Hernia Mesh Injuries and Complications
- Bowel obstruction
- Migration, the implant moving from its original application
- Perforation of organs and tissues
- Adhesion, scar-like tissue that sticks together
Researchers noted that while hernia mesh is often considered necessary in treating any kind of hernia, there have not been many studies into the long-term side effects of these medical devices. While some complications may arise even within days of surgery, a 2016 study found 1,050 out of 3,242 patients had the device in place for five years or more before facing complications and requiring additional surgery. The researchers stated that many benefits of hernia mesh were offset by the late-term injuries.
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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 note that these manufacturers didn’t perform the proper safety protocols to ensure that the hernia meshes would perform as they are meant to. For some of these 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 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 product with numerous adverse event reports piling against it. 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, like their ongoing trials against their talcum powder products, 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 Lawsuits
Today, many recent hernia mesh lawsuits fall have been consolidated under one of two MDL dockets in relation to Ethicon Physiomesh Flexible Composite Hernia Mesh (MDL 2782) and Atrium Medical Corp. C-Qur Mesh Products (MDL 2753). As of January 2018, MDL 2782 has nearly 500 pending lawsuits, while MDL 2753 against Atrium Medical Corporation has 30 pending lawsuits. At this time, MDL 2753 does not have an estimated start date, though the first trial under the Ethicon MDL is slated for September 2019.
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.
Manufacturers Facing Hernia Mesh Lawsuits
|Ethicon (Johnson & Johnson)|
|Atrium (Maquet, Getinge Group)|
|C.R. Bard (Davol)|
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.
How to File a Hernia Mesh Lawsuit
If you or a loved one have suffered complications of injuries as a result of a hernia mesh implant, you may be eligible to file a hernia mesh lawsuit. It’s important to speak to an experienced medical device attorney about your legal rights and eligibility as soon as possible, as the statute of limitations in some states may be as little as one year after injury.
How Much Compensation Will I Receive?
Hernia mesh manufacturers have already been found liable for hundreds of millions of dollars in these class action and individual claims. 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
What Does it Cost to File a Hernia Mesh Lawsuit?
Many people feel nervous about pursuing legal action because of the potential costs of hiring a lawyer. But most hernia mesh lawyers will first offer a free case review to determine an individual’s eligibility and will move forward with the case on a contingency basis. In other words, a claimant will only have to pay their hernia mesh attorney a fee if the case is successful.
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