Ethicon Physiomesh® lawsuit

Ethicon Physiomesh® Lawsuit: Injured by an Ethicon Physiomesh® implant?

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Ethicon Physiomesh® Lawsuit - How You Qualify:

  • You've had a revision mesh surgery (2nd surgery in the same area)
  • Your first mesh surgery was after 2006
  • Your doctor recommends a revision mesh surgery (2nd surgery in the same area)

Ethicon Physiomesh® Lawsuit - You Don't Qualify if:

  • You haven't had a mesh revision surgery (2nd surgery in the same area)
  • Your first mesh surgery was before 2006
  • Your doctor has not scheduled a revision surgery (2nd surgery in the same area)

Are You Injured After A Ethicon Physiomesh® Implant?
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Do you qualify for a Ethicon Physiomesh® lawsuit?
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Ethicon Physiomesh® Mesh Implant

A large number of individuals throughout the United States have reported suffering severe and debilitating problems following Ethicon Physiomesh® hernia mesh surgery. In fact, thousands of lawsuits are expected to be filed.

Physiomesh is a flexible composite mesh that are used to repair hernias and reinforce weaknesses in the abdominal wall which could cause hernias. Surgeons implant the mesh over an opening or weak spot on the abdominal wall. The idea is that the mesh creates a strong barrier to prevent your internal organs from squeezing through.

However, the failure rates for Ethicon Physiomesh mesh appear to be unreasonably high, potentially resulting in the need for revision surgery and leaving patients with permanent and debilitating health problems.

Ethicon Physiomesh were introduced to the medical device market using the 510(k) FDA approval system. This system allows companies to introduce medical devices without rigorous pre-market research and studies. Both manufacturers only had to demonstrate that it was “substantially equivalent” to a previously approved hernia mesh system. As a result, the manufacturer was not required to conduct thorough testing or research to establish whether users may face an unreasonable risk of problems following Physiomesh hernia repair.

Health Problems Caused by Ethicon Physiomesh® Hernia Mesh Implant

No company has done less to earn the name “Ethicon” than Ethicon. We’re willing to wager that Ethicon is one of the most unethical pharmaceutical companies around – and that’s saying something.

The U.S. Food and Drug Administration (FDA) knew that Johnson & Johnson’s Ethicon Physiomesh was an inferior, dangerous product. That’s why the agency strongly encouraged Ethicon to recall the Physiomesh in 2016.

Even though Ethicon did recall the Physiomesh, the company won’t admit it. Johnson & Johnson calls the recall a “voluntary withdrawal.”

The problems with the Ethicon Physiomesh can be traced back to the problems with its design. In fact, the things that make the Ethicon Physiomesh stand out in a medical marketplace crowded with hernia mesh products are not its benefits, but its flaws. Sadly, it is now believed that the Ethicon Physiomesh hernia mesh can cause major complications for patients. These complications can include:

Possible Ethicon Physiomesh® Complications

  • Mesh Erosion or Failure;
  • Twisted or perforated bowel causing gastric ulcers or other intestinal problems, including infections like sepsis and gangrene;
  • Infections;
  • Slowly healing wounds;
  • Chronic pain;
  • Revision Surgery;
  • Allergic Reactions (some mesh is covered with omega 3 fatty acids, called the O3FA layer. It now appears that some patients may suffer allergic reactions to the C-Qur O3FA layer) or
  • Abdominal Pain, Bowel Adhesions, Ulcers or Organ Perforation.

All hernia mesh devices are made of polypropylene, a strong, lightweight plastic with a million and one uses. But polypropylene, even when sterilized, has been shown in countless clinical trials to decay when implanted in the human body. When it decays, it can cause infection. It can even cause severe bleeding and trauma in internal organs.

Nevertheless, the manufacturers of the Ethicon Physiomesh decided to compromise its quality by using an especially lightweight polypropylene.

So Johnson & Johnson made an unsafe product even less safe. Not only is it more prone to decaying, but the Physiomesh can easily rip. The sole purpose of a hernia mesh is to keep internal tissues in place. A ripped hernia mesh is utterly useless. More than that, it’s dangerous.

Kind of makes you wonder why any doctor or surgeon would recommend the use of the Ethicon Physiomesh.

And that’s why it’s important to remember that your doctors are as much as victim of Johnson & Johnson’s greed as you are. Your doctors and surgeons were on the receiving end of countless sales pitches – both high-pressure and subtle – from Johnson & Johnson. Whether they knew it or not, they were coerced by Johnson & Johnson to recommend the Physiomesh.

And now you’re paying the price.

Ethicon Physiomesh® recall

Ethicon is a division of Johnson & Johnson. Ethicon issued an urgent field safety notice and withdrew their product from the market in May 2016. The notice included a recall of all existing stock held by healthcare facilities for all variations of the Physiomesh product line. Health Canada issued a recall for Physiomesh products. It’s estimated that as many as 300,000 people have been implanted with Physiomesh in the United States since the product was approved in 2010. Approximately 30,000 patients in Canada also received the mesh.

JOHNSON & JOHNSON’S HERNIA MESH DEVICES, PROFITS AND LITIGATION There are dozens of hernia mesh products on the market, but only one is backed with the full force and might of one of the biggest and most powerful corporations in the world: Physiomesh.

The label on the Physiomesh packaging says that it was made by a company called Ethicon. Look a little closer, and you’ll see that Ethicon is a subsidiary of Johnson & Johnson, the gigantic corporation responsible such safe, homey medicine-cabinet staples as Band-Aids and baby powder.

Well, “Band-Aid” has come to mean “a superficial solution,” and baby powder has been implicated in countless deaths from ovarian cancer. So much for safe and homey.

Like Johnson & Johnson’s baby powder, the Ethicon Physiomesh is another seemingly harmless, helpful product that turns out to be a silent killer.

In 2016, the World Economic Forum listed Johnson & Johnson as the 8th-largest company in the world, and the single largest healthcare company in the world.

Johnson and Johnson's Initiatives

  • the Ethicon Physiomesh was rammed through the FDA’s approval process
  • the Ethicon Physiomesh was marketed extremely aggressively to doctors and patients
  • the Ethicon Physiomesh was implanted in a very large number of surgical procedures
  • the Ethicon Physiomesh’s design cuts corners to maximize profit.
  • The flaws in the Ethicon Physiomesh can cause serious health complications in the patients in whom it has been surgically implanted.
  • Johnson & Johnson knew full well of the dangers of the Ethicon Physiomesh – but concealed and lied about that information in the name of maximizing profit.

Hernia Mesh Lawsuit Update: Despite Pause, Ethicon Physiomesh MDL Continues to Add Cases

June 22, 2021
Author: Daniel Gala

Despite few developments having taken place in multidistrict litigation (MDL) over Ethicon Physiomesh hernia mesh since the judge tossed out the entire pretrial schedule in May, the MDL continues to add cases, with the total number nearing 3,600 as of mid-June, court records show. The Physiomesh MDL remains one of the top ten largest active MDLs in the United States.

The Ethicon Physiomesh MDL centralized federal products liability lawsuits alleging that Ethicon was negligent in designing and manufacturing its Physiomesh hernia mesh implants, resulting in serious and sometimes lifelong injuries to the plaintiffs. The first bellwether trial had been scheduled to begin June 7, but in a May 18 order, US District Judge Richard W. Story abruptly postponed the trial indefinitely. Additionally, Judge Story suspended all deadlines associated with all trial pool cases.

The pretrial schedule for non-trial pool cases was not impacted by the order. As of mid-June, no subsequent order has been issued giving any indication as to if or when a new bellwether trial schedule will be established.

Many plaintiffs in the Ethicon Physiomesh MDL have been forced to undergo revision surgery in an attempt to remove the offending hernia mesh device and alleviate their symptoms, yet, in many instances, these surgeries do not prove entirely successful. In some cases, surgeons are unable to completely remove the mesh, which can become embedded in the flesh.

Plaintiffs also include spouses of those who have suffered serious complications as a result of their Ethicon Physiomesh implants, suing defendants Ethicon and its parent company Johnson & Johnson for loss of consortium.

If you have been forced to undergo revision surgery after receiving an Ethicon Physiomesh implant, contact TheLawFirm.com today for a free consultation!

Sources:

United States Judicial Panel on Multidistrict Litigation (JPML). (15 June 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending. MDL Statistics Report

United States District Court Northern District of Georgia Atlanta Division. (18 May 2021). Practice and Procedure Order No. 27 (Amended Discovery, Scheduling, and Case Management Order - Trial Pool Cases). In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. MDL No. 2782

Hernia Mesh Lawsuit Update: Ethicon Physiomesh Bellwether Trial Postponed Until Further Notice

May 31, 2021
Author: Daniel Gala

A trial in multidistrict litigation (MDL) over Ethicon Physiomesh implants, originally scheduled to begin June 7, has been postponed indefinitely, according to a court order issued May 18. The order also nullified the existing schedule relating to the MDL's other bellwether cases.

"[A]ll deadlines in Trial Pool Cases are hereby suspended until further order of the Court," read the one-page order issued by US District Judge Richard W. Story.

The brief order did not state a reason for the indefinite postponement of the MDL's bellwether cases, but the order does not appear to impact the thousands of other cases involved in the centralized litigation. Less than a week earlier, on May 13, Judge Story issued a detailed order establishing a number of rules and deadlines governing the pretrial discovery process for all plaintiffs.

The MDL's first trial is scheduled to feature the case of plaintiff Danielle Guffey of Louisiana, whose lawsuit alleges that she suffered serious injury after having Ethicon Physiomesh surgically implanted in December 2013. Guffey sued Ethicon and its parent company Johnson & Johnson on seven counts, including defective design, failure to warn, manufacturing defect, and negligence, as well as a claim brought under Louisiana's Products Liability Act. Guffey is seeking punitive damages and has requested a jury trial.

Neither the docket for the MDL nor the docket for Guffey's individual case give any indication as to why the court has indefinitely postponed that trial or why it has suspended all deadlines related to the other trial pool cases.

On May 3, in a standard pretrial practice, the parties in Guffey's case filed a series of written responses to motions submitted by the other side. No subsequent entries appear on the docket until the May 18 order indefinitely postponing the trial.

As of May 17, the Ethicon Physiomesh MDL contained a total of 3,561 cases, making it the tenth largest active MDL in the United States, according to the Judicial Panel on Multidistrict Litigation (JPML) , the body responsible for overseeing multidistrict litigation in the US.

These thousands of plaintiffs have sued Ethicon and Johnson & Johnson claiming that Physiomesh is defectively designed and manufactured, causing them to suffer serious—and in some cases, life-altering—injury. Many plaintiffs have been forced to undergo revision surgery—or an additional surgery to remove the offending mesh device—in an effort to alleviate their symptoms, which can include chronic severe pain.

Other alleged complications arising from Ethicon Physiomesh include "herniation through the mesh, recurrent hernia formation, and/or rupture, and deformation of the mesh," noted the JPML in the transfer order that created the MDL and assigned it to the Northern District of Georgia.

If you have undergone revision surgery after receiving an Ethicon Physiomesh implant, contact TheLawFirm.com now for a free legal consultation!

Sources:

United States District Court Northern District of Georgia Atlanta Division. (18 May 2021). Practice and Procedure Order No. 27 (Amended Discovery, Scheduling, and Case Management Order - Trial Pool Cases). In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. MDL No. 2782

United States District Court Northern District of Georgia Atlanta Division. (26 January 2018). Short Form Complaint. Civil Action No. 1:18-cv-00402-RWS. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. MDL No. 2782

United States Judicial Panel on Multidistrict Litigation (JPML). (17 May 2021). MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending

Judicial Panel on Multidistrict Litigation (JPML). (2 June 2017). Transfer Order. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. MDL No. 2782

Hernia Mesh Lawsuit Update: Ethicon Physiomesh MDL Nears 3,700 Cases; Judge Issues Preservation Order

May 20, 2021
Author: Daniel Gala

Multidistrict litigation (MDL) over Ethicon Physiomesh hernia mesh continues grow, adding plaintiffs on a near-weekly basis as the total number of cases approaches 3,700. The thousands of centralized lawsuits allege that Ethicon and its parent company Johnson & Johnson were negligent in designing and manufacturing the Physiomesh implants, resulting in serious physical injury to plaintiffs.

On May 13, the presiding judge issued an order requiring, among other things, that all plaintiffs send preservation notices to a number of individuals and entities who may possess records relating to their cases, including pharmacies, "physicians, medical facilities, other healthcare providers and/or other persons who implanted or explanted Physiomesh in or from Plaintiff or otherwise treated the Plaintiff related to any and all claims in the case, including abdominal surgeries and/or hernia-related pain or injuries."

Per US District Judge Richard W. Story, upon a case being docketed with the MDL court, the defendants are to provide the plaintiff(s) with a copy of the May 13 order detailing the preservation requirements. Within 14 days of receipt of that order, the plaintiff(s) or counsel for plaintiff(s) must issue all required notices. Judge Story makes clear that these mandatory requirements apply equally to plaintiffs represented by lawyers and those representing themselves (also called known as proceeding per se).

The May 13 order also outlines which documents and information must be provided by all plaintiffs. These include "[a]ll medical records relating to the Plaintiff from all healthcare providers" who were provided with preservation orders, and the information produced must contain "product identification, implant and explant records, and any records relating to Physiomesh, the claims and/or alleged injuries."

Additionally, all plaintiffs must complete and submit a Plaintiff Fact Sheet, a form issued by the court in order that the thousands of different plaintiffs might submit important information relevant to their cases in a standardized way. The Plaintiff Fact Sheet and the other healthcare records must be produced by the plaintiff within 60 days of receiving a copy of the May 13 order.

Further, plaintiffs have 90 days from receipt of the order to produce reports on expert witnesses, Judge Story required.

With such strict deadlines applying to both plaintiffs represented by counsel and those without highlights the significant advantage that plaintiffs represented by experienced lawyers have in navigating the complex, demanding, and uncompromising world of litigation.

As of May 18, the Ethicon Physiomesh MDL included 3,682 cases, according to an analysis of court documents conducted by TheLawFirm.com.

These thousands of plaintiffs have sued Ethicon and Johnson & Johnson on numerous counts, including defective design, manufacturing defect, and negligence. A number of spouses of Physiomesh recipients also have joined their loved one's lawsuits, claiming loss of consortium.

If you have undergone revision surgery after receiving an Ethicon Physiomesh implant, contact TheLawFirm.com today for a free legal consultation! You might be entitled to compensation.

Sources:

United States District Court Northern District of Georgia Atlanta Division. (13 May 2021). Practice and Procedure Order No. 26 Requirements for Record Preservation and Prima Facie Evidence of Implant, Injury and Causation. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. MDL No. 2782

United States District Court Northern District of Georgia Atlanta Division. (18 May 2021). Court Docket. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. MDL No. 2782

Hernia Mesh Lawsuit Update: First Ethicon Physiomesh Bellwether Now Scheduled For September 2021

May 11, 2021
Author: Daniel Gala

Following a number of delays, the first bellwether trial in litigation over Ethicon Physiomesh hernia mesh has been scheduled to begin in September 2021, according to a court order issued April 26.

The case involves plaintiffs Jim B. Crumbley and his wife Diane Crumbley, Georgia residents who have sued Ethicon and its parent company, Johnson & Johnson, on a total of nine counts, including defective design, failure to warn, manufacturing defect, negligence, as well as Georgia state consumer protection laws and loss of consortium. Jim Crumbley had Ethicon Physiomesh surgically implanted into his body in July 2014, and he and his wife sued the defendant companies fewer than 4 years later, filing their complaint in February 2018, according to court documents.

Multidistrict litigation (MDL) over Ethicon Physiomesh was established in June 2017, grouping together—at the time —49 cases from 29 different federal districts that were all based on similar allegations against Ethicon and J&J.

"All of the actions share common factual questions arising out of allegations that defects in the defendants' Physiomesh hernia mesh can lead to complications when implanted in patients, including herniation through the mesh, recurrent hernia formation and/or rupture, and deformation of the mesh," wrote the Judicial Panel on Multidistrict Litigation (JPML) in the transfer order creating the MDL and assigning it to the Northern District of Georgia.

Plaintiffs allege that these complications have caused serious, life-altering conditions, including debilitating, chronic pain. Many have undergone so-called revision surgeries in an effort to remove the offending mesh and repair the damage done. In some cases, multiple revision surgeries have been performed, and the patients' symptoms still have not been fully alleviated.

As of May 10, 2021, the Ethicon Physiomesh MDL had included a total of 3,680 cases, according to court records.

After the parties had narrowed the thousands of cases in the MDL down to four "trial cases", the plaintiffs selected the Crumbley case to be the first bellwether trial. These decisions were formalized in a January 6, 2021 court order that set the date of the first trial for March 18, 2021, a date which now has been postponed to September 13, 2021, pursuant to the April 26 order.

With September 13 originally having been the start date for the third bellwether trial (and June 7 the scheduled start date for the second bellwether), the subsequent bellwether trials have been postponed, as well.

Sources:

United States District Court Northern District of Georgia Atlanta Division. (26 April 2021). Amended Discovery, Scheduling, and Case Management Order for Crumbly Matter. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. Jim B. Crumbley and Diane Crumbley—Case No. 1:18-cv-00748

United States District Court Northern District of Georgia Atlanta Division. (20 February 2018). Amended Discovery, Scheduling, and Case Management Order for Crumbly Matter. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS. Jim B. Crumbley and Diane Crumbley—Case No. 1:18-cv-00748

Judicial Panel on Multidistrict Litigation (JPML). (2 June 2017). Transfer Order. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. MDL No. 2782

United States District Court Northern District of Georgia Atlanta Division. (Last Updated 10 May 2021). Member Case List for 1:17-md-2782. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Case No. 1:17-md-02782-RWS

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Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article. 

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