As of November 2021, more than 21,000 lawsuits were pending against Ethicon Inc./Johnson & Johnson, Atrium Medical Corp., and Davol Inc./C.R. Bard, Inc. in three separate federal multidistrict litigations (MDL).

The first set of hernia mesh bellwether trials was rescheduled several times between late 2020 to late 2021 because of court closures related to the COVID-19 pandemic. To date, only one bellwether trial has taken place this year in relation to Bard/Davol, while most remaining trials (except Ethicon’s) were postponed until 2022. Most recently, the Ethicon MDL reached a global settlement—the details of which will be expanded upon below.

Below is a summary list of the recent changes in hernia mesh products litigation. We will update this list periodically to include breaking news and additional information on upcoming trials.
August 7, 2020 — Covidien’s MDL request rejected by the JPML
In 2020, the Judicial Panel on Multidistrict Litigation (JPML) denied a motion from Covidien that sought to consolidate all its hernia mesh cases (around 12 at the time) within the MDL format.

In its order denying the transfer, the Panel stated that creating a Covidien MDL would disrupt actions that have already been pending for several years in federal court. The benefits of starting the MDL for a relatively small number of cases didn’t outweigh the potential disruption.

To date, the courts continue to deal with the Covidien hernia mesh lawsuits on an individual basis. However, it is possible that the JPML may reconsider their decision if a significant increase in the number of Covidien trials occurs at the federal level.

For further information on key topics and trending events in hernia mesh litigation, check out our recent stream interview with Kelsey Stokes. Kelsey is an attorney at Fleming Nolen Jez in Houston and a prominent figure in hernia mesh litigation. In 2018, Kelsey was appointed the co-lead counsel for the Plaintiff Steering Committee.
August 12, 2021 – The first Atrium bellwether trial settled
In 2019, the court formed the Atrium MDL from a collection of more than 2,600 separate lawsuits. Parties scheduled the first of three bellwether cases (Barron v. Atrium Medical Corp., 1:17-cv-742-LM) to start on July 7, 2021, after several attempts at rescheduling.

A few weeks prior to the commencement of the trial, the two parties (Barron and Atrium) informed the court of their intentions to settle the case. The first bellwether case was settled before the deadline and then finally dismissed on August 12, 2021.

Following the settlement of the Barron case, all parties involved have agreed that the second (Luna v. Atrium Medical Corp., 1:16-cv-372-LM) and the third (Shumaker v. Atrium Medical Corp., 1:17-cv-00741-LM) bellwether trials should continue. However, the trial dates for both cases are yet to be confirmed.
September 8, 2021 – The outcome of the first Bard/Davol bellwether trial
After forming the Bard/Davol MDL in 2018, the court selected and scheduled the first three bellwether trials for 2020. The first bellwether case (Johns v. C.R. Bard, Inc., et al., 2:18-cv-01509) began on August 2, 20212021, after several postponements.

The case ran for 21 days until it ended on September 8, 2021, with a jury handing down a verdict in favor of Bard on all counts. This opening case was the first loss for a plaintiff in the ongoing litigation. In October 2021, Johns asked for a new trial, claiming C.R. Bard and its subsidiary Davol Inc. ignored court orders about evidence. This resulted in a prejudiced jury.

The judge scheduled the second bellwether trial (Milanesi et al. v. C.R. Bard., Inc., et al., 2:18-cv-01320) for January 10, 2022, with pre-trial filing deadlines set as of September 29, 2021. Plaintiffs’ attorneys are optimistic that this case will yield better results than the first bellwether trial.
September 20, 2021 – Ethicon’s global settlement agreement
Court filings dated September 20, 2021, announced that the parties had agreed to a global settlement of Ethicon’s Physiomesh Flexible Composite Mesh claims. The settlement applies to all claims filed by May 13, 20212021, in the federal MDL.

Judge Richard K. Story issued orders to establish a Qualified Settlement Fund and appointed Ellen K. Reisman as Special Master to oversee global settlement implementation. Other specific terms and details of the settlement remain confidential.

The Judicial Panel on Multidistrict Litigation (JPML) originally created the Ethicon MDL in 2017. Since then, the court has scheduled and d, then rescheduled , the first bellwether trial (Crumbley v. Ethicon, Inc. and Johnson & Johnson, 1:18-cv-00748). It also delayed the second bellwether trial indefinitely (Guffey v. Ethicon, Inc. and Johnson & Johnson, 1:18-cv-00402) and paused the scheduling for all other trial pool cases.

Watch our interview with Kelsey Stokes or read the full transcript of our interview on Hernia Mesh Updates here.

January 2023 Update

On April 15, 2022, the jury sided with the plaintiff in the second bellwether case, Milanesi et al vs. C.R. Bard, Inc., et al. In the verdict, the jury agreed with the plaintiff on the claim of negligent product design, but rejected the plaintiffs’ claims of strict product liability, failure to warn, negligent misrepresentation, and fraudulent representation. The jury awarded Antonio Milanesi $250,000 in damages and awarded $5,000 to his wife for loss of consortium. This award was significantly lower than expected.

In August 2022, a Rhode Island jury awarded $4.8 million to a Hawaii man in a similar case. This jury in that case had also accepted the negligent design claim while rejecting the strict liability claims. 

Neither party was satisfied with the verdict in the Milanesi case. Both parties filed motions for a new trial. The defense argued it was entitled to a new trial as a matter of law. The plaintiffs argued that the judge had improperly instructed the jury. On July 12, 2022, the court denied both motions. 

The third bellwether trial is case number 2:18-cv-01022, Stinson vs. C.R. Bard et al. It is set for May 15, 2023.  

The hernia mesh MDL is the third largest MDL, and it is growing every month. As of December 15, 2022, 18,227 cases had been transferred to the MDL.

Hernia mesh lawsuits allege that hernia mesh manufacturers’ products failed and led to severe injuries that required additional surgeries to resolve. Plaintiffs claim these products are defective, the products weren’t properly tested, and manufacturers failed to warn the public about the risk of injury.

Injuries claimed in lawsuits include bowel obstruction, fistulas, perforation, adhesions and other severe injuries.
According to the FDA, Americans undergo about one million hernia operations each year and most surgeons use mesh. Surgeons use hernia meshes to repair hernias, weakened spots in muscle or connective tissue that allow organs or fatty tissue to squeeze through. These meshes are intended to be permanent implants and are the gold standard of care because they have lower hernia recurrence rates than non-mesh repairs.

The FDA allowed many newer hernia mesh products, including C-QUR by Atrium and Ethicon’s Physiomesh, on the market through the 510(k) clearance process. This clearance pathway allows manufacturers to sell products without intensive clinical trials as long as the product is comparable to a product already on the market.
According to hernia mesh lawsuits, the problems with newer hernia mesh devices often stem from polypropylene, the material most meshes are made of. Manufacturers claim polypropylene is inert, or chemically inactive. But studies have shown that polypropylene may cause immune responses in the body, leading to mesh degradation and severe adverse reactions. Manufacturers may also add coatings to the mesh, such as fish oil, that are supposed to combat inflammation. However, these coatings may pose problems when they come into contact with tissue.

Some hernia mesh complications require patients to undergo additional corrective surgery to remove the hernia mesh, adding further costs and distress. In addition, some injuries may be permanent, resulting in chronic pain, health problems, financial hardship, emotional suffering, and reduced quality of life.

Usually, the plaintiffs seek compensation for damages, including lost wages, medical bills, loss of quality of life, and pain and suffering. Attorneys like Kelsey Stokes may come across many cases involving hernia mesh products. This can eventually lead to them becoming experts in the health problems caused by hernia mesh.
Settlement amounts for hernia mesh cases depend on the severity of each individual’s injuries and their total damages. Some attorneys estimate that individual hernia mesh lawsuits may settle for between $50,000 and $250,000, with claimants who suffer more severe injuries on the higher end of the scale.

Bellwether trial verdicts usually provide a benchmark for estimating global settlement amounts. So far, there haven’t been any settlements in the current hernia mesh MDLs except for the confidential settlement agreement between Ethicon and plaintiffs. This makes it more challenging to provide accurate estimates of settlement value.

Previously, Bard/Davol agreed to settle several hernia mesh lawsuits in an older MDL related to safety failures of its Kugel hernia mesh patch. In 2011, the company paid out $184 million to settle more than 2,000 lawsuits after losing a 2010 trial and paying $1.5 million in damages.
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