On May 27th 2016, Ethicon issued an “urgent” field safety notice concerning ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes). Ethicon voluntarily withdrew its surgical mesh product, Physiomesh, due “to higher-than-average revision rates after use. The J&J subsidiary decided to withdraw the flexible composite mesh following analysis of data from two large independent hernia registries that showed higher than average rates of recurrence after laparoscopic ventral hernia repair compared to other meshes.” FDA News Ethicon is a subsidiary of Johnson and Johnson. After the market withdrawal, victims commenced filing Physiomesh lawsuits against Ethicon. There has been no recall of Physiomesh but the voluntary withdrawal by Ethicon is effectively a recall for all intensive purposes. There is no Physiomesh class action in the United States.
Ethicon’s hardball litigation maneuvers
As soon as these hernia mesh lawsuits were filed, Ethicon’s mesh law firm commenced hardball litigation maneuvers blaming and denigrating victims. Ethicon’s surgical mesh lawyers asserted that the victims’ complications “including recurrence, has many different accepted potential causes (e.g., surgical technique) and different risk factors (e.g., medical history, concomitant injuries, obesity, smoking, age, genetics, size of hernia, infections, and chronic cough) that could independently explain the patient’s alleged injuries.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407
Update- 2/12/2022- Sources have informed this author that a Physiomesh global settlement is in the works in the consolidated MDL lawsuit in Georgia Federal Court. It is unclear what the average Physiomesh settlement will be.
Ethicon removes hernia mesh medical device PHYSIOMESH from US markets
The urgent field safety noticed issued by Ethicon stated, “We are removing the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
After the voluntary removal, PHYSIOMESH victims began filing lawsuits
After the voluntary removal, PHYSIOMESH victims from across the United States began filing lawsuits in different federal courts across the United States. In June of 2017, The Panel on Multi District Litigation ordered that all pending and future PHYSIOMESH cases would be transferred to a multidistrict litigation in the the Northern District of Georgia. “IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside the Northern District of Georgia are transferred to the Northern District of Georgia and, with the consent of that court, assigned to the Honorable Richard W. Story for coordinated or consolidated pretrial proceedings. Transfer order) As part of the transfer of the federal court cases to Georgia, both Plaintiff and Defendant’s law firms filed legal memorandum. Read the DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407
Ethicon’s lawyers argued that hernia mesh did not cause the victim’s injuries
Does Ethicon have no shame? Ethicon acting by and through their hernia mesh attorneys have made it clear that they will blame the victim’s for their own hernia mesh complications. Ethicon is already arguing to the Federal Courts that the victim’s history, obesity, age and other factors caused their injuries.
There argument are essentially: It is not the mesh that caused the injuries, symptoms and complications, it is a panoply of other factors. These product liability defense lawyers will throw out everything but the kitchen sink to avoid compensating PHYSIOMESH victims. Thankfully, a global settlement of physiomesh lawsuits in Federal Court is imminent. Ethicon’s scorched earth litigation attempting to deprive victims of compensation and justice will not end up being successful. Ethicon has done everything possible to avoid paying a hernia mesh settlement. It is impossible to know the average hernia mesh settlement for PHYSIOMESH.
Hire the best hernia mesh law firm 2022
Victim’s need to retain high powered hernia mesh law firms who will fight corporate America to get justice and compensation on behalf of victims. Do not retain a local car accident attorney who is handling mesh cases on the side when you could have one of the best mesh law firms in the United States on your side. The best hernia mesh law firms in 2022 will have the best hernia mesh lawyers going head to head against corporate America. These lawyers will fight Ethicon to get a lucrative hernia mesh settlement for the victims.
Hernia mesh victims have tons of questions they need answered such as:
- What are hernia mesh symptoms?
- What is the average settlement for hernia mesh?
Hernia mesh lawsuit settlement amounts could vary greatly based on numerous factors. Hernia mesh lawsuit settlement amounts 2022 may even differ from Hernia mesh lawsuit settlement amounts 2021. I wrote this defective product hernia mesh lawsuit blog because so many victims were asking a simple question: What should you know before you file hernia mesh lawsuit? Many people are asking about hernia mesh problems years later.
Ethicon’s mesh lawyers furnish the above mentioned arguments despite the fact that Ethicon voluntarily removed PHYSIOMESH from the United States market and the medical devices were recalled in Canada and other countries. If blaming victims for being fat, old and coughing too much is not effective, then Ethicon may blame the surgeons who implanted the mesh, other injuries, the victims’ genetics and “chronic coughing.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407
Ethicon blames the surgeons who performed the surgery
Blaming the surgeons for your allegedly defective products? Talk about biting the hand that feeds you. It is surgeons across the United States who took a leap of faith deciding to implant PHYSIOMESH in their patients. These same surgical mesh surgeons authorized millions of dollars of payments to purchase PHYSIOMESH to Johnson and Johnson and their corporate Subsidiary Ethicon.
Ethicon: ‘We are not responsible, you’re old and fat etc. and it is your fault’
In a submission to the Federal Court, Johnson and Johnson and Ethicon’s attorneys argued that the victims conditions and complications may not have been caused by defective PHYSIOMESH hernia mesh. These hernia mesh defense lawyers argued that the victim’s conditions and injuries may be a result of:
- poor surgical technique
- The victim’s obesity
- The victim’s age
- The mesh victim’s medical history
- Associated injuries
- The victim’s history of smoking
- The mesh victims “genetics, size of hernia, infections, and chronic cough” Ethicon’s memo of law
Read Ethicon’s legal argument below:
“Moreover, the fundamental question of whether a defect in the design and/or warnings of PHYSIOMESH caused each of the plaintiffs’ purported injuries requires an individualized determination unsuitable for centralized supervision. Even if these cases shared a common issue as to whether PHYSIOMESH has a defect capable of causing the numerous types of injuries alleged, each case will involve a detailed inquiry into the numerous risk factors for recurrence following any hernia surgery—irrespective of whether PHYSIOMESH was even used—in order to determine the specific medical cause of the patient’s alleged injury. For instance, each of the claimed conditions, including recurrence, has many different accepted potential causes (e.g., surgical technique) and different risk factors (e.g., medical history, concomitant injuries, obesity, smoking, age, genetics, size of hernia, infections, and chronic cough) that could independently explain the patient’s alleged injuries.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407 In re: Ethicon Physiomesh Flexible Composite ) MDL No. 2782 Hernia Mesh Products Liability Litigation ) Oral Argument Requested. William M. Gage MS Bar No. 8691 Butler Snow LLP 1020 Highland Colony Pkwy, Suite 1400 Ridgeland, MS 39157(601) 985-4561 firstname.lastname@example.org Counsel for Defendants Johnson & Johnson and Ethicon, Inc.
If blaming the victim’s complications on being fat does not work – confuse and delay
Determining whether Ethicon had proper warnings on their medical device, Physiomesh, should be relatively simple. However, Ethicon’s product liability lawyers are trying to confuse, delay and muddle the issue. Ethicon argues that their instructions for use for PHYSIOMESH:
- have changed over time
- “under the laws of most states, there is no legal causation if the treating physician did not rely on the warnings” Id.
- ‘there is no legal causation if the treating physician already knew the risks.’ In other words: If your surgeon knew Physiomesh was dangerous, we are not responsible for providing inadequate warnings.
- The victims “cannot show that a different warning would have altered the physician’s prescribing decision.” Id. This means: Even if we had provided proper warnings, your physician would still have used our product.
Ethicon’s legal argument: failure to warn did not cause injuries
“Regarding the failure to warn claims in Plaintiffs’ complaints, this too will be a highly fact-specific inquiry. PHYSIOMESH’s IFUs* have differed over time. Further, questions of warnings proximate cause will be case-specific because, under the laws of most states, there is no legal causation if the treating physician did not rely on the warnings or already knew the risks, or if the plaintiff cannot show that a different warning would have altered the physician’s
prescribing decision.” Id.
*instructions for use
Background supplied by Ethicon’s mesh attorneys:
“For many years, surgeons have repaired inguinal, ventral, and umbilical hernias (the exit of an organ through the wall of the cavity in which it resides) using devices containing mesh. The mesh in many of these devices is made from sterile, polypropylene-based materials. Depending on the surgeon’s repair technique, the mesh is typically placed either under or over the hernia and held in place utilizing one of several methods. The mesh acts as “scaffolding” for new growth of the patient’s own tissue, which eventually incorporates the mesh into the surrounding area to provide the needed support.”
“For more than 50 years, Defendant Ethicon, Inc. (“Ethicon”) has manufactured and sold a number of hernia mesh devices, such as PROLENE® Soft Polypropylene Mesh, ULTRAPRO® Partially Absorbable Lightweight Mesh, and PROCEED® Surgical Mesh. About seven years ago, Ethicon launched PHYSIOMESH, a mesh comprised of Prolene fibers that is laminated between MONOCRYL™ (poliglecaprone-25) and PDS™ (polydioxanone) films. The MONOCRYL layers dissolve and allow for a gradual in-growth of tissue into the mesh. In December 2009, Ethicon submitted to the United States Food and Drug Administration (“FDA”) a Section 510(k) premarket notification of its intent to market PHYSIOMESH. By letter dated April 9, 2010, FDA cleared PHYSIOMESH as a Class II prescription device on the basis that it was at least as safe and effective as—that is, substantially equivalent to—Ethicon’s PROCEED Mesh, ULTRAPRO Mesh, and ULTRAPRO Hernia System, all of which had been previously cleared by FDA under the 510(k) process. Thereafter, Ethicon began marketing PHYSIOMESH to surgeons. Ethicon decided to withdraw PHYSIOMESH from the global market in May 2016.”
“At present, there appear to be 37 cases pending in various federal district courts in which the plaintiffs are alleged to have sustained various complications and/or injuries as a consequence of PHYSIOMESH. In their brief, Plaintiffs claim that “[t]he first-filed case in the Middle District of Florida (Quinn, C.A. No. 6:16-CV-01663) was the second constituent action to be filed in this country.” (Doc. 1-1, p. 5). In fact, two pending cases were filed in federal court before the Quinn complaint was filed in October 2016, including a case pending in the Northern District of Georgia that was filed in December 2015.1 The following map shows the location, by district, of pending PHYSIOMESH cases in federal court:” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407In re: Ethicon Physiomesh Flexible Composite ) MDL No. 2782 Hernia Mesh Products Liability Litigation ) Oral Argument Requested. William M. Gage MS Bar No. 8691 Butler Snow LLP 1020 Highland Colony Pkwy, Suite 1400 Ridgeland, MS 39157(601) 985-4561 email@example.com Counsel for Defendants Johnson & Johnson and Ethicon, Inc.