Hernia Mesh Lawsuit

Hernia Mesh Lawsuit
  • Hernia mesh lawyers have won settlements that are worth a total of $2 billion.
  • Each plaintiff received anywhere between $3000 to $1 million in compensation, with an average settlement between $40,000 to $60,000.
  • In 2014, Boston Scientific settled two claims for $34.5 million for using defective hernia mesh devices.
  • In 2015, C.R. Bard settled almost 3000 hernia mesh failure lawsuits for $119 million. In August of the same year, the company paid another $200 million to settle 3,000 more cases.
  • In 2016, Johnson & Johnson paid a settlement of $120 million as a result of over 42,000 lawsuits.
  • Patients who underwent hernia mesh implantation can file a claim if the hernia mesh resulted in a revision surgery, had a defective design, manufacturing fault, or inadequate labeling.

A hernia mesh is a device that is used to support damaged tissue as a result of a hernia, and quicken its healing process. However, some patients who underwent hernia mesh implant surgery complained of severe complications, which they believe were caused by the device. As a result, these patients experienced a recurrence of hernia, and had to undergo one or multiple surgeries again.

Patients who suffered complications at the hands of manufacturers Ethicon, Atrium, and C.R. Bard are now filing hernia mesh lawsuits, alleging the companies designed defective products and failed to warn about the potential hernia mesh complications.

Reason for Hernia Mesh Implant

A hernia is an internal tissue that exits abnormally through an opening in the cavity where it is normally located. Hernias may occur in your thigh or outer groin, navel, diaphragm, or an incision site. However, the most common types of hernias occur in the inner groin. Naturally, this condition is extremely painful.

Unfortunately, a hernia cannot heal by itself and requires surgery. These surgeries can be laparoscopic, which involves poking surgical tools into small incisions; or open surgery, which involves traditional surgery by making large incisions. Regardless, 90% of all hernia surgeries involve the implantation of a hernia mesh.

A hernia mesh is a sheet, patch, or plug of netting which offers additional support to the damaged and weakened tissue. A hernia mesh can be constructed from organic material like tissues from a human donor, or from cows or pigs. However, these days, they are often also constructed from synthetic material like plastic.

Depending on the type of damage, a hernia mesh may be absorbable and non-absorbable. Absorbable hernia mesh is not meant to be permanent, and provides only temporary support to the tissue as it heals. Over time, it degrades and gets absorbed into the body. Non-absorbable hernia mesh, however, is a permanent implant that offers support to the repaired hernia for a lifetime.

Hernia implant procedures are performed 800,000 times every year in the United States. Unfortunately, thousands of these devices have resulted in serious side effects and complications for their patients. Some types of hernia mesh can further damage the abdomen, intestines, and bowels, which may require revision surgery.

Hernia mesh manufacturers like C.R. Bard, Ethicon, and Atrium Medical are facing thousands of lawsuits because of their devices. Patients allege that hernia mesh devices, including Physiomesh, Kugel Patch, and C-Qur, are defective and dangerous, and their manufacturers did not warn them of their potential risks.

Side Effects of Hernia Mesh Implants

Since there are so many similar products in the medical market, manufacturers of hernia mesh were not required to follow the strict, expensive, and comprehensive FDA clinical trials with human patients that could ascertain whether the devices were safe for use or not. Instead, they were approved by the FDA’s fast-track 510 (k) Clearance program.

There have been several recalls for Ethicon's Physiomesh, which is owned by Johnson & Johnson. Physiomesh touted a revolutionary hernia mesh, which was made of a type of plastic covered by a thick synthetic film. The synthetic film was aimed to stop adhesion. However, while the patient's body absorbed the film coating, the tissues that grew inside the mesh would adhere to other organs.

This lead to complications so severe that many patients required additional surgery to remove the mesh. Some patients also alleged that their conditions continued even after the revision surgery.

Some injuries that plaintiffs claim include:

  • Adherence of the mesh to internal tissues and organs
  • Bowel obstruction
  • Breakage, erosion, or shrinkage of the mesh
  • Infection
  • Puncture of abdominal organs
  • Development of an abnormal passage or fistula
  • Perforation of the tissues and organs
  • Mesh shifting from the place where it was implanted
  • Development of fluid-filled pockets that required surgeries.
  • Inflammation of the peritoneum
  • Abdominal wall tears

Research has questioned the effectiveness of these meshes, and many products have been pulled off the market by the FDA. The brand names in the existing MDL all contain polypropylene, a thermoplastic polymer that is prone to erosion, shrinkage, and breakage. This can lead to tissue damage.

Some people who used C-QUR hernia mesh said that they suffered from additional injuries. Atrium manufactures their hernia mesh coating from Omega-3 fish oil, and some plaintiffs claimed that it led to allergic and inflammatory reactions. Additionally, it is made of polypropylene plastic, the same material used to make transvaginal meshes that have resulted in over 100,000 personal injury lawsuits.

Physiomesh is also covered with Monocryl, an absorbable material that was supposed to prevent adhesion and inflammation, but which plaintiffs said is not suitable for implantation.

FDA Recalls for Hernia Mesh

In October 2012, the FDA sent a warning letter to Atrium, the manufacturers of C-Qur hernia mesh, for their failure to fix the infection and sterility concerns associated with their device. Additionally, thirty-five complaints were made when clients discovered that the device also contained human hair.

In July 2013, Atrium recalled their C-Qur mesh because its coating would stick to the package lining when it was exposed to high humidity. The separation of the coating from the mesh could result in an increased risk of infection.

In February 2015, the FDA filed a lawsuit against Atrium for producing poor quality C-Qur mesh at their New Hampshire facility.

In July 2016, Physiomesh was also recalled by Ethicon after the manufacturer cited its product resulted in a high risk of revision surgery.

History of Hernia Mesh Lawsuits

Thousands of lawsuits have been filed against the various manufacturers of hernia mesh. Patients claim that the manufacturers knew about the hazards of using the devices, but still failed to warn doctors and patients about the potential side effects. Additionally, the devices were not subject to full FDA approval.

Lawsuits related to Physiomesh assert that its multi-layered coating stops the mesh from sufficient incorporation, causing serious issues. Moreover, the mesh is not strong enough to withstand normal abdominal forces, which caused herniation through the device itself.

Cases related to Atrium's C-Qur mesh claim that the fish oil coating not only caused allergic reactions, but also detached from the mesh, resulting in the mesh adhering to internal organs. Plaintiffs also claimed that they experienced severe abdominal pain and recurrence of the hernia, which required surgery, in some cases, several times, to remove the defective mesh.

Complaints related to Covidien hernia mesh, manufactured and marketed by C.R. Bard, assert that the implant device was made of resin-based plastic. The plastic rings on the mesh caused pain, obstructions, perforations, and infections. This plastic was a subject of a manufacturer’s Material Safety Data Sheet submitted to OSHA to inform that the material is not suitable for implantation in the human body or contact with internal tissues and fluid.

The first Ethicon Physiomesh lawsuit was filed in 2013 by Matthew Huff, who was implanted with the device to treat an abdominal hernia. Huff received a revision surgery two years later after the Physiomesh caused two abdominal abscesses, intestinal fistula, and infection.

Atrium also faced multiple personal injury lawsuits that have been consolidated in an MDL. One of the high-profile cases included James Brown and his wife, who filed a lawsuit against C-Qur. Brown was implanted with the C-Qur device in 2013 for hernia, but he continued to have severe abdominal pain. In January 2016, he underwent abdominal surgery to remove the mesh and found that the device had triggered a “foreign body giant cell reaction” that is one of the symptoms of hernia mesh rejection, and resulted in scarring on the surrounding tissue.

The lawsuit claimed that Atrium convinced doctors and surgeons that the hernia mesh was safe despite knowing that it was incompatible with human biology.

The complaint also said that Atrium used stealth recall of the hernia mesh, which failed to inform the FDA and the medical community of the complications related to the product.

Bard also recalled their Kugel Patch in 2005, citing that it caused bowel perforations and fistulas. In 2007, a federal panel combined the 150 hernia mesh lawsuits into an MDL in a Rhode Island federal court. Soon after, more than 3,000 cases were filed against the manufacturers.

In 2010, two bellwether trials were held against Bard. The first one was won by Bard, but the jury awarded $1.5 million to the plaintiffs in another trial. The second trial was brought by North Carolina residents, Christopher and Laura Thorpe. Christopher Thorpe underwent a hernia repair with a Kugel Patch in 2005, but had to undergo multiple surgeries between 2007 and 2008 after the mesh caused fistula and infection.

After that verdict, Bard also offered to pay $184 million to settle the remaining 2,600 hernia mesh lawsuits.

In September 2017, the Kugel Patch MDL was closed after ten years.

Like many personal injury cases, not all hernia mesh lawsuits go to court. Many cases are settled before the trial date while others are settled during the actual trial. Below are some settlements that the various defective hernia mesh manufacturers had to pay over the last half-decade.

In 2014, Boston Scientific settled two claims for $34.5 million for using defective hernia mesh devices, which were made of cheap material smuggled in from China.

In 2015, C.R. Bard settled almost 3,000 hernia mesh failure lawsuits for $119 million. In August of the same year, the company paid another $200 million to settle 3,000 more cases. Each plaintiff received approx. $67,000.

In 2016, Johnson & Johnson paid a settlement of $120 million as a result of over 42,000 lawsuits.

If you add up just these figures, you will see that hernia mesh lawyers recovered settlements that were worth $2 billion. Based on the above figures, each plaintiff received anywhere between $3000 to $1 million, with an average settlement between $40,000 to $60,000.

Who Can File a Claim For a Hernia Mesh Lawsuit?

Patients who underwent hernia mesh implantation may file a claim if:

The hernia mesh had a defective design: When the design of the hernia mesh is flawed, not even high-quality manufacturing and transparent warning labels can make up for it. Sometimes, a manufacturer may be unaware of the defects. However, many times, they are aware of the faulty design but still choose to market the device. An example of defective design is using polypropylene to create a mesh, as happened with Ethicon, Atrium, and C.R. Bard; or using rings that are prone to breakage, as happened with Bard’s Kugel hernia mesh.

The hernia mesh had a manufacturing fault: No matter how safe the material of the device is, if the mesh is constructed poorly, it can become dangerous. An example is Atrium's C-Qur, which could not withstand abdominal forces and was made in unsanitary facilities.

If the defect was responsible for causing significant harm to the plaintiff, they are eligible to file a lawsuit. Surveillance videos and testimonies of workers constructing the mesh may prove valuable during the trial.

The hernia mesh had inadequate labeling: The labeling on the product failed to warn doctors and patients of the potential pitfalls of using the hernia mesh. Every medical device comes with risks, but hernia mesh manufacturers must warn doctors of the non-obvious dangers of using the device, as well as inform them of how to avoid the dangers. Moreover, the labeling needs to show the necessary warnings, and the marketing needs to be accurate so that patients have the choice not to get the hernia mesh placed in their bodies.

You underwent hernia revision surgery: Many plaintiffs complained they suffered from severe complications after having the hernia mesh implanted, which often required more than one revision surgery to remove the mesh and fix the damage.

A hernia mesh lawsuit can possibly help you recover compensation for pain and suffering, medical bills, and past, current, and future lost wages.

You should get a copy of your medical records from the surgeon who implanted the hernia mesh into your body. Once you determine that you were implanted with one of the above brands of hernia mesh and required revision surgery, it can help you make an informed decision on whether you should be a part of the ongoing litigation.

How Long Do I Have to File a Hernia Mesh Lawsuit

If you think that you may have a hernia mesh claim, we advise you to seek legal action as soon as possible. Depending on the state where you live, there are different Statutes of Limitations that could expire if you wait too long to file a claim. If you have any questions, please contact your attorney for guidance.

How Many Hernia Mesh Lawsuits Have Been Filed Against the Manufacturers?

As of 2019, thousands of lawsuits have been filed against the hernia mesh manufacturers, including Bard Davol, Atrium, and Ethicon. The largest hernia mesh settlement amounted to $184 million, which was paid by C.R. Bard in 2011 to 3,000 plaintiffs.

As of August 2019, there were 6,818 hernia mesh lawsuits pending in three separate MDLs.

Bard Davol Hernia Mesh MDL: As of July 2019, there have been over 3,003 pending lawsuits over different brands of Bard’s mesh products. The MDL panel was established in August 2018.

Atrium C-Qur Mesh MDL: As of August 2019, 1,499 hernia mesh lawsuits were pending in New Hampshire District Court. The MDL was established in December 2016.

Ethicon Physiomesh Flexible Composite Mesh MDL: The MDL was first created in June 2017 and has amassed 2,316 lawsuits over the hernia mesh by August 2019.

The Bard Davol MDL is still in its earliest stages, but the Ethicon Physiomesh trial is expected in late 2019 or early 2020, and the Atrium C-Qur Mesh MDL trial is scheduled for February 19, 2020.

Moreover, other cases are also pending in state courts. The plaintiffs are also filing litigation against Covidien for its Parietex mesh.

Contact a Personal Injury Lawyer for your Hernia Mesh Lawsuit

If you have had surgery that involved these brands of recalled hernia mesh and if the surgery led to complications, the injury lawyers at Frankl & Kominsky can try to assist you with your claim.

Our personal injury lawyers have recovered over $75 million in settlement in accident and injury claims. We can try to investigate your claim, get a copy of your medical records from your doctor, try to find out which type of mesh was used in your surgery, and fight to help hold the hernia mesh manufacturers accountable.

The best part is that filing a hernia mesh lawsuit may cost you nothing unless we recover a settlement or a jury verdict on your behalf. If you are still uncertain, schedule a free, no-obligation case consultation appointment with us by calling us at 855-800-8000.

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