Hernia mesh surgeries are one of the most common surgeries performed in the United States today. Many different types of products can be used for surgical hernia repairs, including patches and plugs. Ethicon, a subsidiary of Johnson & Johnson, is the manufacturer of Physiomesh — a flexible composite mesh made of polypropylene that’s been recalled and the subject of class-action lawsuits.
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Update: an order from U.S. District Judge Richard Story in the Northern District of Georgia to delay trial on Physiomesh claims has some speculating that a settlement that could impact as many as 3,500 litigants is in the works. The Northern District of Georgia is leading multi-district litigation evaluating the alleged dangers of this product.
If you have sustained injuries and damages as a result of exposure to Physiomesh, our experienced defective products lawyers will be able to evaluate your case, safeguard your legal rights, and help you to obtain the monetary compensation you may be entitled to.
Physiomesh Hernia Repair
A hernia occurs when an organ, intestine, or fatty tissue squeezes through a hole or a weak area in a muscle. Although various types of activities that increase abdominal pressure may potentially cause a hernia, the most common causes of hernias are as follows:
- Lifting heavy weights
Hernias can look like an external bulge and often occur at the abdominal wall. The most common types of hernias are:
- Ventral (located at the abdominal wall)
- Umbilical (located at the belly button)
- Hiatal (located inside the abdomen on the diaphragm)
- Incisional (surgical incision or scar in the abdomen)
- Inguinal (located at the inner groin)
- Femoral (located at the upper thigh or outer groin)
Because hernias can reopen, surgeons may perform a procedure during which they stitch in a mesh patch or plug to help reinforce the muscles and connective tissues.
Physiomesh Recall: Facts and Problems
The purpose of Physiomesh is to repair hernias or reinforce weaknesses in a patient’s abdominal wall, which could lead to a hernia in the first place. When a surgeon implants Physiomesh over an opening or weak spot in a patient’s abdominal wall, a strong barrier is created, which in turn prevents internal organs from squeezing through.
The FDA approved Physiomesh composite mesh in 2010. However, prior to making it available on the market, no clinical trials were performed. As a result of two studies that were undertaken in Germany and Denmark — both of which linked Physiomesh to an increased number of hernia repair procedures — Ethicon withdrew Physiomesh flexible composite mesh from the worldwide market in May of 2016.
Common medical issues with Physiomesh
Some of the possible complications associated with Physiomesh implants include the following:
- Chronic or intermittent pain
- Intestinal migration, movement, or blocking
- Development and adherence of scar tissue
- Organ perforation or damage to nearby organs
- Surgical mesh migration
- Recurrence or reopening of hernia
- Need for revision or corrective surgery
Basis for Class-Action Lawsuits
Injured patients are currently filing class-action lawsuits against hernia mesh manufacturers, including Ethicon, based upon products liability and negligence theories of recovery.
In order to prevail on a product liability theory of recovery, there must be a defect in the product’s manufacture or design — or the warnings provided for the product must be inadequate or incomplete. Moreover, the defective product must be the proximate cause of the user’s injuries and damages. Under a negligence theory, the manufacturer must have ordinarily breached a duty to the public, proximately resulting in injuries and damages.
In the case of Physiomesh, injured patients are alleging that Physiomesh was defectively designed by Ethicon with a lower level of elasticity when compared with competing hernia mesh products on the market, resulting in poor attachment to the injured patient’s abdominal wall, retraction, contraction, and ripping. All of these can result in serious health consequences to the patient.
Moreover, injured patients allege that Ethicon negligently and prematurely placed Physiomesh on the market prior to undertaking extensive testing, research, or clinical trials, proximately resulting in serious injuries and damages to patients.
The most common types of potential damages available to injured patients in Physiomesh class-action lawsuits include the following:
- Payment of medical bills
- Payment of lost wages
- Damages for loss of earning capacity
- Damages for past, present, and future pain and suffering
- Damages for past, present, and future mental anguish or emotional distress
- Payment of costs for further corrective surgeries
Use of Physiomesh hernia mesh during hernia repair procedures has been shown to cause serious injuries and complications to patients — the most common of which is the need for corrective hernia mesh repair surgery. Injured patients may be able to recover damages under both a products liability and a negligence theory of recovery.
Mass Tort Lawsuits
Consider the fact that a product such as Phsyiomesh may have been implanted into hundreds of thousands of people. Now consider the effect on the legal system if the courts are clogged with hundreds of thousands of lawsuits. At the very least, great inefficiency would result as the same fact (that Physiomesh can cause certain symptoms, for example) will have to be proven repeatedly.
Mass tort lawsuits were designed to simplify and streamline the personal injury compensation process when a multitude of claims involve similar facts.
- In Multidistrict Litigation (MDL) lawsuits, federal cases are consolidated into a single court, which establishes certain facts that become binding upon every plaintiff. Each plaintiff is expected to prove the individual aspects of their case in a separate lawsuit.
- In class action lawsuits, a few individuals (or even a single individual) represent the interest of many victims, even those who don’t hire a lawyer and are not named in the lawsuit. The results of the lawsuit bind everyone who is considered a member of the class action (anyone injured by Product X, for example), even if they don’t even know of the lawsuit.
Bellwether Trials in Multidistrict Litigation
Bellwether trials are a handful of individual lawsuits that the MDL judge presides over. The results of bellwether trials can clarify the issues, help to resolve pending lawsuits, and convince plaintiffs and defendants to settle their disputes without a trial. If the juries in bellwether trials turn out to be extremely plaintiff-friendly, for example, the defendant might become more willing to settle without a trial.
So far, tens of thousands of plaintiffs from throughout the nation have filed product liability claims against Physiomesh manufacturer Ethicon, part of the Johnson & Johnson Medical Devices Companies. Although Etnicon took Physiomesh off the market in 2016, it never formally recalled it.
Lawsuits allege (i) a design defect and (ii) failure to warn of the device´s known and foreseeable risks. Plaintiffs have asserted that Physiomesh´s five-layer design is cytotoxic, immunogenic, not biocompatible, and prevents the attachment of the mesh to the body. Plaintiffs also fault Ethicon for putting the product onto the market without testing it first, even though the US Food and Drug Administration (FDA) did not require testing.
Multidistrict Litigation (MDL)
MDL will determine some of the issues that are outstanding in the federal court lawsuits. So far, the U.S. District Court for the Northern District of Georgia has centralized over 3,500 cases of these cases.
The rules for preservation and testing of the device
In 2018, the judge in the Physiomesh MDL issued the rules for the preservation and testing of Physiomesh. These rules require patients to instruct their doctors to preserve the mesh after they remove it during surgery, and then send it to Steelgate, a biomedical specimen storage and management company in Florida. Representatives of the plaintiffs and the defendant can inspect and evaluate the samples in the presence of the opposing party.
The Physiomesh bellwether trials
The COVID-19 crisis paralyzed the courts for quite some time. Even after activity resumed, courts had to deal with large backlogs. As a consequence, by June 30, 2021, no court had heard any of the Physiomesh bellwether trials. Courts have docketed all of these cases for 2021, however.
Judge Richard Story will preside over the bellwether lawsuits. The four plaintiffs are Danielle Guffy, James Bovian, Jeffrey Smith, and Diane and Jim Crumbley.
Ethnicon has reached very few settlements with individual plaintiffs, because it prefers a comprehensive solution. A comprehensive private settlement could come at any time, however. This would result in the cancellation of any trial, at least for the plaintiffs involved in the private settlement.
Two types of settlement are common in the situation: (i) global settlement with all plaintiffs in the action, and (ii) a partial settlement with the clients of a particular law firm. Previous settlements indicate that the average settlement value should be $70,000 or more, although there can be no guarantees.
Multi-County Litigation (MCL)
On July 17, 2018, the Supreme Court designated pending and future New Jersey state court Physiomesh litigation as multicounty litigation (MCL), and it assigned these cases for centralized management to Atlantic County. MCL works like a state-level MDL.
The Ethicon MCL litigation should surpass 3,000 plaintiffs sometime in 2021. Not all of these plaintiffs are complaining about Physiomesh, however–some are complaining about other Ethican-manufactured hernia meshes such as Proceed and Prolene.
The MDL and MCL lawsuits cover almost every plaintiff in the Physiomesh litigation. Although the plaintiffs must litigate the individual aspects of their claims (their specific amount of damages, for example) in separate lawsuits, the MDL and MCL consolidations will determine important issues. Fully independent lawsuits are impossible at the federal level, and possible in only certain states (not including New Jersey) at the state court level.
Contact our Ohio Hernia Mesh Lawyers
If you or someone you love has been exposed to Physiomesh during a hernia repair surgery and injuries resulted, you may be entitled to legal compensation and monetary damages. Our experienced defective products attorneys at Dyer, Garofalo, Mann & Schultz can review the facts and circumstances of your case with you and take the necessary legal actions to help you obtain compensation for your injuries. We’ve handled several medical devices cases, such as those against Johnson & Johnson DuPuy hip implants, da Vinci Robotic Surgery, and transvaginal mesh.
Contact us anytime, via telephone or email, for a free case review.