2.3 Davol – C.R. Bard: ST hernia patch products

ST hernia mesh is a resorbable coated mesh line. Genzyme was the original make of the Sepramesh IP and Sepra Technology (ST) coating, but in December 2007, Bard acquired the licensing rights to this technology. Bard used the technology to create its own ST coating line for ventral hernia meshes, which included:

• Ventralight ST
• Ventralex ST
• Ventrio ST.

The ST coating uses polypropylene, a substance we know directly causes harm to patients.

2.4 Davol – C.R. Bard: Composix Kugel patch

One of the first hernia mesh implants to be recalled, the Composix Kugel has been the subject of three recalls in 2005, 2006, and 2007, including a Class I recall – for devices that can cause serious harm. Made of a polypropylene base and a layer of ePTFE (polytetrafluoroethylene), the materials worked against each other. The mesh would buckle, and there may be shrinkage. Plus a memory coil ring – called a PET ring – used on the mesh would break, causing perforation and fistulas.

Note that, unlike the kugel mesh, the Composix E/X mesh does not have metal memory rings between the fibrous layer and the mesh.

One of the Composix Kugel victims is Vicky Sanders, whose complaint claimed the Bard used,

“substandard, adulterated, and/or non-medical grade polypropylene and raw materials used to make the Composix Kugel product which deviated from their material and supply specifications.”

2.5 C.R. Bard: 3DMax

The 3DMax is a heavy-weight mesh using polypropylene. A lighter version was released in 2008. This mesh is specifically used to treat inguinal hernias, but the mesh erodes through soft tissue and then adheres to the spermatic cord, causing great pain and sexual dysfunction. A curved device used with no sutures or tacks, this mesh is also known to fold over and migrate, causing injury, too. Mesh removal surgery places the person at risk of losing a testicle.

Note that many inguinal hernias do not even need meshes to be fixed. The Shouldice, Bassini, and McVay Repair techniques – involving only sutures – have a high success rate by surgeons.

One plaintiff who brought a 3DMax lawsuit was Michael Miller, who got the mesh implanted in Saratoga Springs, New York. He had a recurrence within a month, requiring an additional operation and implantation of a PerFix Plug. His pain and hernias persisted, and he developed eating and sexual problems.

There is also evidence that Bard used the plastic resin Pro-fax 5623 even though the plastic supplier said that it should not be used in hernia mesh.

2.6 C.R. Bard: PerFix Plug and Marlex

Bard’s PerFix Plug came on the market in the late 1990s and uses polypropylene mesh, too, to treat inguinal hernias. This type of plug looks like a shuttlecock but can also come as an onlay patch. This patch has been shown to erode and migrate, causing organ perforation and intense pain. The cone tip applies severe pressure that results in additional pain. These injuries have been known to take years before it materializes as pain and the injury is discovered. See also our article on the Bard Marlex hernia mesh.

Note that other Bard products with problems include the Mesh Dart, the Visilex, the Sperma-Tex, the Modified Kugel Hernia Patch, and Sepramesh IP Composite Mesh.

2.7 Ethicon – Johnson & Johnson: Proceed Mesh

The Proceed is a lightweight mesh that came onto the market in 2003. It uses fabric over polypropylene so that the polypropylene does not come into contact with internal organs. The fabric is oxidized regenerated cellulose, and the problem with this fabric is it separates from the polypropylene, despite being adhered to by polydioxanone (PDS). The primary risk is bowel complications and necessitated mesh removal surgery.

2.8 Ethicon Physiomesh

The Physiomesh was taken off the market in 2016 even though its maker claims it did not recall the mesh. Numerous complications, however, have been linked to this mesh by thousands of people. It is believed the absorbable coating called Monocryl prevents the mesh from properly incorporating with the host tissues.

Note that in 2018, the judge in the Ethicon multi-district litigation (discussed below in section 4) published Rules for Preserving Physiomesh. Patients must instruct their doctors to keep the mesh when it is removed during surgery and then ship it to Steelgate in Florida. Both the defense and prosecution can then evaluate the samples, and each side is entitled to be present when the other side is inspecting it.

One plaintiff who brought a Physiomesh lawsuit is Lillian Graham. Following her implant operation at Jacksonville, Florida, she developed a fistula, infection, organ damage, and adhesions, and her mesh wadded up. She needed two revision surgeries.

2.9 Ethicon: Prolene Hernia System (PHS)

On the market since 1997, the prolene is a plug similar to Bard’s PerFix plug that uses polypropylene. The original prolene mesh used heavy-weight polypropylene while a newer version uses a light-weight polypropylene (“Ultrapro Hernia System) and may be less prone to complications.

Another product posing problems is the Prolene 3D.

2.10 Gore-Tex: DualMesh

Gore-Tex’s DualMesh was released in 1995 and is not used to any great extent today. This mesh product was made of ePTFE. This material has a propensity to degrade and allows bacteria to grow in the pockets caused by the degradation. Other complications include adhesion, bowel obstruction, organ perforation, and seromas. Additional surgeries may be necessary.

3. What compensation can I get if I sue for hernia mesh injuries?

Compensation is available to lawsuit plaintiffs who suffer injury from hernia mesh implants. Compensation covers economic and non-economic damages. The value of these damages can be:

• determined via negotiations and finalized in a lawsuit settlement, or
• decided upon by a jury and entered as a judgment by the court.

The amount of compensation you receive is dependent in part on:

• the value of your economic damages; and
• an estimation of your non-economic damages.

Knowing what can be claimed can help you better understand what the value of your own lawsuit may be.

3.1 What specific compensatory damages can you claim?

Patients who have suffered complications or have otherwise been injured by a hernia mesh product are eligible for compensation for those injuries. This includes economic losses and non-economic damages.

Economic Damages

Economic damages are easier to determine because they have a value already attached to it or a value relatively easy to determine. Most common examples include:

• Medical bills
• Lost wages if you suffered a partial or total disability, and
• Miscellaneous out-of-pocket expenses, like travel to and from medical appointments.

Past and future expenses, like future medical bills and future wage losses, can also be claimed. These claims are usually made when the complications are long-term and complex. There are many factors, like prognosis and personal medical history, that go into the projections of these costs.

For example, imagine your hernia mesh perforated an organ, caused an MRSA infection, and required mesh removal. Your current medical expenses may have already amounted to $25,000. It is anticipated the MRSA infection may need to be treated with long-term therapy/suppression at an estimated cost of another $10,000. In the short term, while recovering, you missed work for several months at a total of $8,000, but in the long term, you are anticipating another year off work or reduced work hours estimated at $16,000. Your economic damages would – hypothetically – total $43,000 – $59,000.

There is no cap on economic damages regardless of the state where your injury occurred. The total sum of your economic damages is the total sum of the compensation owed to you under this type of damages.

Non-Economic Damages

Non-economic damages are more complicated to determine because there is no value already attached – just the pain and suffering. In hernia mesh lawsuit cases, non-economic compensation is usually limited to pain and suffering as well as mental or emotional anguish. Though it could also include loss of enjoyment, loss of quality of life, or loss of consortium.

Pain and suffering include the physical pain you may experience from the complications. Including any surgical procedures required to address the complications.

Mental and emotional anguish refers to your mental and emotional state caused by the injury. Of course, this type of compensatory damages does not come with a monetary value. No amount of money can compensate truly for your pain and emotional distress.

But, that said, fair and just compensation includes compensation for non-economic damages. Determining the value of your non-economic damages can be tricky. It may require experts assigned to determine this very thing.

In California, like most other states, there is no standard formula to make calculating non-economic damages relatively easy or consistent. Some lawyers may say it is a matter of multiplying economic damages by two or three — three reserved for more severe cases — to arrive at a figure, but this “formula” does not take into consideration important factors.

In all actuality, to arrive at a fair and just figure, factors that should be considered include:

• The type and severity of your hernia mesh complications and injury
• The length of time recovery is expected to take
• Whether there will be any permanent disability, scarring, or disfigurement
• How the injury will affect daily activities
• How the injury will affect relationships with family and friends; and
• Your medical prognosis.

A person, for example, who develops chronic, debilitating pain from the damage due to the hernia mesh will have greater pain and suffering than a person who had revision hernia surgery without complication and recovered quickly.

Manufacturers of hernia mesh implants will do what they can to minimize your pain and suffering. Their efforts are meant to lower the value of the sum of your compensatory damages.

A skilled attorney will use evidence to maximize your settlement or award, allowing only a state’s cap on non-economic damages to limit what you receive. That said, not all states have damage caps. The states that do have them run the gamut from $250,000 to $750,000. Also, damage caps can differ within these states depending on if the tort case is personal injury, product liability, or medical malpractice.

Moreover, spouses may file a derivative claim, too, for loss of consortium. This type of claim occurs when the injury has directly impacted the marriage negatively. For example, if the spouse with the hernia mesh injury suffers from severe depression and/or is unable to enjoy a physical relationship with the spouse.

3.2 What are some settlements and compensation already received by victims?

There have already been settlements and verdicts throughout the United States for hernia mesh complications. These cases may help you understand what to expect from pending lawsuits today.

One notable settlement specific to hernia mesh includes C.R. Bard. In 2014, it settled 6,000 lawsuits, committing to pay out $319 million. Plus in 2011, C.R. Bard paid $184 million to settle about 2,600 Kugel Mesh cases.⁵

The transvaginal mesh contains many of the same dangerous materials as hernia mesh. More than 107,000 lawsuits were filed against the makers of transvaginal mesh, and that litigation – consolidated in West Virginia – settled for approximately $8 billion.

4. Is the hernia mesh litigation a class action or individual lawsuits?

Individual lawsuits. But in the majority of cases, these lawsuits will be filed and managed as part of multi-district litigation (MDL). There is often more strength in numbers than in a one-off lawsuit.

An MDL resembles a class action. Similar victims band together to sue the same defendant in one federal court. In a class action, all plaintiffs are together in one lawsuit. In a mass tort MDL, each plaintiff has his or her own claim against the defendant.

Currently, the hernia mesh MDLs are coming out of the pre-settlement phase where both sides file pre-trial motions and exchange “discovery” (evidence). Though currently or in the near future, the judge is allowing a small, select number of plaintiffs to go to trial. These are called “bellwether” trials.

The results of these bellwether trials will set the stage for settlement negotiations with the remaining plaintiffs. If the plaintiffs win their trials and get awarded high damages, this will likely translate to higher value settlements for all the plaintiffs. From start to finish, MDLs may take several years.

Currently, there are three federal hernia mesh MDLs, amounting to more than 25,000 lawsuits as of 2022. Each is against a different medical device manufacturer:

• Ethicon, MDL No. 2782 for Physiomesh Flexible Composite. Established in 2017, this MDL is out of the U.S. District Court for the Northern District of Georgia. It currently has more than 3,617 cases. Judge Richard Story is presiding. The four bellwether trials were scheduled for 2021, but then a global settlement was reached that September. Washington D.C. lawyer, Ellen Reisman, was appointed as special master to administer the claims and oversee the payout.
• Bard and Davol, MDL No. 2846 for polypropylene hernia mesh products. Established on August 2, 2018, this MDL is out of the U.S. District Court for the Southern District of Ohio. It currently has nearly 18,000 cases. Judge Jolson and Judge Sargus are presiding.
• Atrium, MDL No. 2753 for C-QUR hernia mesh. Established in 2016, this MDL is out of the New Hampshire District Court. It currently has about 2,931 cases. The first trial was set for July 7, 2021, but it seems to have settled out of court. Judge Landya McCafferty will preside over the upcoming bellwether trials.

Unfortunately, the first Bard bellwether – Johns v. C.R. Bard Inc., et al., 2:18-cv-01509 – ended in a victory for Bard on September 9, 2021. Though this defeat for the plaintiffs probably will not have any significant effect on eventual hernia mesh lawsuit settlements. Bard picked the plaintiff in this particular bellwether trial, so this case was predictably weak to begin with.

Though the second Bard bellwether trial – Milanesi, et al. v. C.R. Bard, et al., 2:18-cv-01320 – resulted in a resounding victory for the plaintiff on April 15, 2022. The jury found that the Ventralex hernia mesh was defectively designed and unreasonably dangerous. The jury award amounted to $255,000. The third Bard bellwether trial – Stinson v. C.R. Bard, et al. –  was even more successful: The jury awarded the plaintiff $500,000.

Note that Covidien Parietex mesh lawsuits have let not been consolidated into an MDL. Victims may file a complaint on an individual basis. (Medtronic purchased Covidien in 2015.) Also note that the W.L. Gore & Associates Gore-Tex DualMesh lawsuits have not been consolidated into an MDL either. Victims can file on an individual basis.

Finally, note that several dozen Physiomesh lawsuits were consolidated into multi-county litigation in New Jersey’s Atlantic County in 2018. That is like a state-level MDL.

4.1 How big will the hernia mesh settlement be?

That is uncertain and will depend in large part on how the “bellwether” trials turn out. The final settlement will be either “global” or “inventory.”

A global settlement is when the hernia mesh manufacturer gathers all the plaintiffs’ law firms together and settles with everyone collectively. An inventory settlement is when the manufacturer goes to individual law firms and reaches individual deals.

Most likely some of the settlements will be on an inventory basis. When this happens, the manufacturer will usually go first to the law firms that have the most cases and do the best job of working up their cases.

Note that plaintiffs who had revision surgery and/or serious injuries will probably get the highest settlements.

4.2 When will the hernia mesh settlement be?

This too is uncertain. Bard and Ethicon jury trials were expected throughout 2020. Though the COVID-19 crisis caused postponements.⁶

The plaintiffs’ attorneys are pressing for things to proceed as quickly as possible. Plus the hernia mesh manufacturers are also anxious for these MDLs to settle to help stem bad publicity.

4.3 Pros and cons of MDLs

MDLs are usually beneficial to hernia mesh plaintiffs for the following reasons:

1. The playing field against Big Pharma and their army of political lobbyists and attorneys is evened when all the victims join forces.
2. MDLs are efficient because the judge’s pretrial rulings apply to every plaintiff.
3. The negotiation and settlement process is quicker and easier.

MDLs do have their drawbacks:

1. Individual plaintiffs may feel powerless or removed from the case. This is especially true if the MDL is in a court far away from where they live.
2. Individual plaintiffs do give up some of their individual bargaining power by joining an MDL.
3. Unlike class actions, MDLs do not allow plaintiffs to “opt-out.”

But in general, MDLs are the quickest and easiest way for medical device victims to get paid.

(MCLs – multi-county litigations – are similar to MDLs but on a state rather than the federal level.)

5. How does the FDA oversee hernia mesh safety?

The Food & Drug Administration (FDA) must approve all medical devices on the market. The FDA also monitors their safety. They use adverse event reports and post-market studies to identify problems. Then if necessary, they issue recalls.

Still, millions of consumers suffer injuries from FDA-approved devices. Here is what you should know about the FDA and hernia mesh.

5.1 What is the FDA approval process?

The FDA’s approval process is generally rigorous. It is called the premarket approval (PMA) process. It requires the manufacturer to prove a medical device is safe and effective. Proof generally involves clinical and laboratory results.

But for hernia mesh products, the FDA uses the 510(k) clearance process. It is quicker and does not require results from studies. The main requirement is showing there is another equivalent device on the market. All that needs to be shown is that — compared to the marketed device — the new device has:

• The same intended use and technological characteristics, or
• The same intended use but different technological characteristics. Plus they do not raise new questions regarding safety and effectiveness.

This process is problematic because it allows surgeons to use untested devices. If a defective hernia mesh gets by the normal FDA approval process, then 510(k) clearance opens the door to all other similar meshes that are also defective to get quick approval.

If proper studies have been required for each new device, then the defects may have been determined before anyone was injured.⁷

Note that many coatings in flexible composite meshes (that have coatings) have not been tested. Manufacturers get away with this by not calling these coatings a barrier, which would require PMA. Meanwhile, coated meshes are in high demand and sell for much more than uncoated meshes.

5.2 What is the FDA’s monitoring process?

After the FDA approves a medical device for the market, it monitors it for safety. Though it relies on external entities or persons reporting problems. The FDA does not take any proactive steps itself.

For example, when consumers experience mesh complications, they may complain to their doctor. The doctors or patients or both may file an adverse event report with the FDA. It is these reports that the FDA monitors. Though in many cases where there may be problems, no one files an adverse event report. (Note that medical manufacturers must report any lawsuits to the FDA.)

When it becomes clear a specific device has problems, the FDA investigates and may send warning letters. If a problem is found, the device is recalled.⁸

A recall can be voluntary or mandatory, depending on the issues. If the problem is corrected, the recall is removed and the device can return to the market. If the problem is not corrected and unfixable, the device is permanently recalled.

In short, it takes more time to remove a defective device from the market than it does to approve it.

FDA Hernia Mesh Recalls

The below chart lists hernia mesh product recalls.

5.3 What if the FDA recalled your hernia mesh?

When people’s hernia mesh is recalled, their case against the manufacturer is strengthened. The recall is proof the device may be defective. The plaintiff’s attorney then just has to connect that defect to the patient’s injuries.

Consider a recent study that identified two-thirds of all recalled mesh implants were approved through the 510(k) process:⁹ Researchers reviewed 113 recalls of problematic hernia mesh products. These recalls occurred between 2005 and 2009. The findings of the study were startling:

• Only 21 devices of the 133 recalls were approved via the PMA process.
• 80 of the 113 recalled devices were approved via the 510(k) process.
• 12 recalled products were exempt from any FDA regulation.

Most meshes receive FDA approval without being rigorously vetted. Plus some that do get vetted turn out to be defective anyway. An FDA recall can only help a plaintiff’s attorney demonstrate that the device was defective and caused the plaintiff’s injuries.

6. What is a hernia?

When there is a weak spot in the abdominal wall, organs and tissues (fascia) can protrude through it. This lump is called a hernia. Some are born with hernias (“congenital”), and others are acquired with age.

Either way, hernias are unsightly and can be tremendously painful. Common risk factors including lifting heavy objects, pregnancy, age, and repeated vomiting or coughing. Men are more likely to develop hernias than women.

The two main types of hernias are abdominal and groin. Groin hernias make up three-fourths of every hernia case. They, in turn, include several different subtypes.

Abdominal hernias:

• Umbilical – Intestines pushing through belly button area
• Incisional – A sac of fat protruding through surgery incision, and this can occur years after the operation; high-risk factors include having taken corticosteroids, having respiratory problems, being overweight, or being elderly
• Spigelian – The bowel protruding below the navel
• Hiatal – When the stomach protrudes through the diaphragm, particularly in obese patients
• Epigastric – Fat protruding between navel and sternum
• Muscle – Common after sports injuries, when muscles protrude through the abdomen
• Paraesophageal – The stomach protrudes along the esophagus, which can lead to volvulus (the stomach twisting)
• Traumatic diaphragmatic – A hernia following an injury, such as a gunshot or stabbing
• Congenital diaphragmatic – During fetal growth, the diaphragm fails to close, leading to lung problems

Groin hernias:

• Inguinal – More common in males due to descending testicles, when intestines protrude through the lower belly
• Femoral – More common in women due to wider pelvises, when belly fat protrudes into the thigh
• Obturator – More common in pregnant women, when fat protrudes into the thigh

Ideally, surgeons can use patients’ native tissues and sutures to repair a hernia. Though in some situations, a mesh may be necessary. Surgeons place meshes in one of three ways:

1. Overlay – Between subcutaneous tissue and the rectus abdominis
2. Inlay – Between rectus abdominis layers
3. Underlay – Between rectus abdominis and peritoneum

When mesh started being researched in the 1950s, doctors presumed thicker was better. Though now doctors agree thinner, light-weight meshes are preferable.¹⁰

7. What to do if your pain and suffering are the result of a hernia mesh implant?

You must seek medical attention, especially if the complications have not stopped 30 days after the implant surgery. There are several causes of hernia mesh device failure and resulting injuries. For instance, if you have severe headaches and never before experienced these kinds of headaches until after hernia repair surgery using mesh – regardless of whether the headaches started immediately or years later – it could be a symptom of a defective hernia mesh implant. Always make sure your doctor or other healthcare provider knows about your hernia mesh repair surgery.

Then call the Shouse Law Group. You do not want to wait to call an attorney because the statute of limitations sets limits on how long you have to file a claim. If you fail to sue within the time limit – set on a state-by-state basis – you lose your eligibility to file. In the hernia mesh litigation, statutes of limitations run anywhere from one year to six years, again depending on the state. Plus there may be factors in your specific case that shorten or lengthen your deadline to file suit.

When you phone, we will ask you to give us the following information:

For additional help…

Have you suffered from hernia mesh failure? Our medical device attorneys have the commitment, the resources, and the legal capabilities to help you with your hernia mesh lawsuit. Contact us today for a case evaluation by a hernia mesh attorney. Someone is available 24 hours a day, 7 days a week to speak with you and your loved ones.

We represent clients throughout the United States from all 50 states and Washington, D.C.

References