If you or a friend or family member have suffered complications resulting from a hernia repair procedure, you should carefully read this pertinent informational article concerning defective hernia mesh.
If you or a loved one have suffered complications from ETHICON PHYSIOMESH™ Flexible Composite Mesh, it is imperative that you become informed about the history of this medical device. You also should become informed of the status of the complex litigation in Federal District Court in the United States legal system.
(Editor’s notes | update 6/2/17 : The Panel on Multi District Litigation ordered that “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)
What is ETHICON PHYSIOMESH™ Flexible Composite Mesh?
The focus of this hernia mesh liability article is definitely ETHICON PHYSIOMESH™. ETHICON PHYSIOMESH™ is Flexible Composite Mesh manufactured by Johnson and Johnson’s (NYSE: JNJ) subsidiary Ethicon. Ethicon Physiomesh™ is made of non-absorbable polypropylene.
“ETHICON PHYSIOMESH™, Flexible Composite Mesh, is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed polydioxanone film marker has been added for orientation purposes.” 510 (K) summary for Ethicon
According to Ethicon, “Physiomesh™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.” More information
Holding Ethicon accountable for PHYSIOMESH™
If you suffered through revision surgery or suffered pain and suffering caused by defective hernia mesh, you should consult with a high powered, deep pocket hernia mesh litigation attorney. If you have suffered through hernia recurrence after the surgical implantation of Physiomesh™ you need to find out whether you qualify to receive compensation and damages in Federal District Court utilizing the best hernia mesh lawsuit lawyers.
Thousands of potential Physiomesh ™ victims across the United States and Canada
If you are a victim in Canada, you may want to become informed as to whether the United States Federal Courts are a more hospitable and lucrative forum to seek damages against Johnson and Johnson and it’s subsidiary Ethicon. If ETHICON PHYSIOMESH™ has caused you and your family suffering and misery, you need to be informed of your legal option to get justice and hold Ethicon responsible.”
Scientific Studies related to ETHICON PHYSIOMESH™
Tissue Integration and Inflammatory Reaction in Full-Thickness Abdominal Wall Repair Using an Innovative Composite Mesh | Outcomes of Bridging Versus Mesh Augmentation in Laparoscopic Repair of Small and Medium Midline Ventral Hernias | Comparison of Two Different Concepts of Mesh and Fixation Technique in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial | Long-Term Evaluation of Adhesion Formation and Foreign Body Response to Three New Meshes | Biaxial Analysis of Synthetic Scaffolds for Hernia Repair Demonstrates Variability in Mechanical Anisotropy, Non-Linearity and Hysteresis | Ventralight ST and SorbaFix Versus Physiomesh and Securestrap in a Porcine Model
Why get peanuts in Canadian Courts if you could possibly secure a lucrative six or seven figure settlement or judgment in the US Courts?
Victims from Toronto, Montreal, Vancouver, Ottawa, and other bustling urban areas in Canada such as Calgary, Edmonton, Quebec City, Winnipeg and Hamilton may find the information set forth in this expose helpful in making informed choices. The relative pros and cons of victims utilizing the Canadian or American Courts to get justice, accountability and compensation resulting from defective hernia mesh is beyond the scope of the article.
Victims need to know that lawsuits in Canada appear to be a “class action”. Whereas the victims in the United states have filed potentially more lucrative individual lawsuits seeking compensation. This legal article authored by an attorney focuses on obtaining compensation in the United States legal system. We are not Canadian attorneys, so we cannot comment on how the Canadian legal system operates.
Ethicon Physiomesh ™ | Hernia mesh individual lawsuit attorney
According to Ethicon’s corporate counsel, “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. ” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407 William M. Gage MS Bar No. 8691 Butler Snow LLP 1020 Highland Colony Pkwy, Suite 1400 Ridgeland, MS 39
What types of hernia mesh devices are we reviewing for aggrieved victims:
We are reviewing potential cases of defective hernia mesh, made of non-absorbable polypropylene that may have caused injuries as well as pain and suffering, including:
- Ethicon Physiomesh™
- Atrium C-QUR
- Composix® Kugel® mesh patches (manufactured by C.R. Bard subsidiary Davol)
- All C.R. Bard mesh patches made of Marlex polypropylene
High powered national litigation attorneys are reviewing potential cases of defective hernia mesh, made of non-absorbable polypropylene that may have caused injuries.
Other defective hernia mesh devices made of non-absorbable polypropylene are beyond scope of article
Future informational articles on this product liability law blog will address other hernia mesh devices, in which litigation is pending, also made of non-absorbable polypropylene such as Atrium C-QUR, Composix® Kugel® mesh patches (manufactured by C.R. Bard subsidiary Davol), and C.R. Bard mesh patches made of Marlex polypropylene.
How did Johnson and Johnson get Ethicon Physiomesh™ approved by the FDA?
Ethicon was first introduced in 2010 into the hernia mesh medical device marketplace. Ethicon fast tracked Physiomesh™ using the controversial FDA 510 (k) premarket approval process. 2010 510(k) summary This 510 (k) premarket approval application was submitted by Ethicon on March 18, 2010 to the FDA.
Ethicon evades FDA clinical trials with ill-fated, controversial legal maneuver!
“Physiomesh™ was marketed after clearance under the FDA’s 510(k) process in April 2010, which does not require clinical trials for safety and efficacy.” MeshNews desk In that 510k process, Ethicon asserted that ETHICON Physiomesh™ is substantially equivalent to: PROCEED Mesh, ULTRAPRO® Hernia System and ULTRAPRO® Mesh. Id.
Ethicon’s corporate attorney description of the FDA approval process for ETHICON Physiomesh™
Ethicon’s corporate counsel, in Federal Court, gave a detailed description of how ETHICON Physiomesh™ was approved: “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 a 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.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407
FDA determination in 2010
The FDA determined that “ETHICON PHYSIOMESH, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.” Approval letter from FDA to Ethicon dated April 9, 2010
The FDA’s decision in 2010 was that the device ETHICON PHYSIOMESH was “Substantially Equivalent (SESE)” to previous Ethicon hernia mesh products.
On April 9th, 2010, the DEPARTMENT OF HEALTH & HUMAN SERVICES, food and drug administration (FDA) approved Ethicon’s pre-market notification. “We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce…” Id.
Surgeons begin implanting device
Surgeons across the United States, Canada and the world implanted Ethicon Physiomesh™ into patients to repair hernias. Physiomesh™ was voluntarily removed from the United States Market on May 26th, 2016.
What was the FDA’s rationale for approving Ethicon Physiomesh™
Ethicon evaded FDA scrutiny using a 90 day 501k premarket notification process. Ethicon now asserts that they performed animal testing. Did Ethicon figuratively play judge and jury as to its determination that Physiomesh™ was safe for the marketplace? If they did this, it is unfortunate since Ethicon is not unbiased and had a substantial profit motive to get the device to the market.
What do Ethicon’s lawyers say about Ethicon’s testing process of Physiomesh™ ?
Ethicon has retained some of the best product liability defense lawyers in the United states. These product liability attorneys will in all likelihood argue that Physiomesh™ is not defective and that Physiomesh™ did not cause injury or complications to particular victims.
These top hernia mesh defense attorneys asserted in Federal Court that: “ETHICON PHYSIOMESH, Flexible Composite Mesh underwent a comprehensive bench, and animal testing program and passed all intended criteria in accordance with appropriate test protocols and standards. During bench testing the device was subject to testing such as device thickness, pore size, burst strength, device weight, tensile strength, device stiffness, suture pullout strength, burst strength and tear resistance. Additionally, invitro and in-vivo testing was provided showing that the device performed as intended. https://www.accessdata.fda.gov/cdrh_docs/pdf9/k093932.pdf
What exactly is a 510(k)?
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.” 510 (k) clearances under FDA
Did Ethicon act appropriately by utilizing a controversial FDA fast track program to get ETHICON PHYSIOMESH™ approved?
If Johnson and Johnson’s corporate subsidiary had gone through rigorous drug testing protocol for ETHICON PHYSIOMESH™ from the FDA, it is possible that this device may have never been approved by the FDA for surgical use! This may have prevented all of the issues that confront Ethicon PHYSIOMESH™.
Ethicon got PHYSIOMESH™ approved by going through the expedited 90 day 501 (k) premarket FDA approval process rather than the normal FDA protocol for new medical devices.
Ethicon’s market removal from the United States
On May 26th 2016, Ethicon issued an “urgent” field safety notice concerning ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes). These product codes are: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, PHY3050R.
In that notice Ethicon declared: “We have initiated a worldwide medical device removal of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). 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 DatabaseDHDB). 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. http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf
Were Ethicons’ “medical device removal” actions in the United states a recall?
No. Technically under FDA regulations, Ethicon’s actions did not constitute a recall. But as far as victims are concerned it probably makes no difference. In some other countries, Ethicon recalled PHYSIOMESH™.
How many people are victims of Ethicon Physiomesh™ ?
According to Drug Watch, “Ethicon sold about 330,000 Physiomesh™ hernia mesh implants worldwide. It sold about 50 percent of those products in the U.S., according to the Plaintiffs in Federal court.. Ethicon voluntarily pulled the mesh from the market in May 2016 after it found higher rates of re-operation and hernia recurrence.” More Here
How many cases were pending in Federal court in May of 2017
According to Ethicon’s hernia mesh lawyers, “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. ” (May 2017) https://i3jl420on823u34pi27m8yq1-wpengine.netdna-ssl.com/wp-content/uploads/2017-04-13-Response.pdf
What is the status of litigation in the United States Federal courts?
Ethicon Physiomesh™ litigation is pending in Federal Court against Johnson and Johnson and their subsidiary Ethicon. As of May 2017 there are 37 cases pending before the Judicial Panel on multidistrict litigation (MDL). These cases are now termed: Multidistrict litigation Case MDL No.2782, “In re Ethicon Physiomesh Flexible composite Hernia Mesh Products Liability Litigation”
Plaintiff’s argue that Ethicon is not safe
The hernia mesh lawyers for the plaintiffs set forth legal arguments claiming that Physiomesh™ devices, “were defectively designed” and “failed to provide appropriate warnings” resulting in the Defendant’s “voluntarily withdrew the Physiomesh™ device from the market.” BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR TRANSFER TO THE MIDDLE DISTRICT OF FLORIDA, OR IN THE ALTERNATIVE TO THE SOUTHERN DISTRICT OF ILLINOIS, PURSUANT TO 28 U.S.C. § 1407 – Details here
Plaintiff’s request to consolidate all cases filed in Federal District Courts to the Middle District of Florida
The hernia mesh victim’s attorneys are asserting that all Ethicon Physiomesh™ claims should be consolidated, heard and decided before one court and one justice in the United States District Court, Middle District of Florida. Id. Among other arguments, The Plaintiff’s counsel argue that the first physiomesh™ causes of action was filed in that district. The deep pocketed Plaintiff’s attorneys also argue that the most amount of Physiomesh™ claims are pending before the US Middle District of Florida. Id.
Ethicon’s corporate counsel oppose lawsuit and state following:
Ethicon’s high powered lawyers opposed the victims motion to transfer. “Johnson & Johnson and subsidiary Ethicon Inc. on April 13 opposed a motion by nine plaintiffs to centralize federal lawsuits alleging injury from the Physiomesh™ Flexible Composite hernia patch (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL Docket No. 2782, JPMDL).” Lexis legal news
Ethicon’s lawyers appears to want to challenge whether Physiomesh™ caused each injury for each victim
“Centralization is not warranted because individualized factual inquiries predominate over common issues. ” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407 – Source “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.” Id.
Ethicon’s attorneys’ apparent legal strategy: other factors may have caused injuries such as obesity, age or medical history
In Ethicon’s memorandum, Ethicon’s lawyers state: “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. The Panel has denied centralization in such instances where there are “differences in the health risks alleged.” Id.
Apparently, Ethicon’s lawyers are trying to find a more favorable venue for these causes of action
Ethicon’s hernia mesh attorneys argue that: “Should the Panel determine that centralization is appropriate, the Panel should assign the MDL to one of several experienced MDL judges in the District of New Jersey, or alternatively, in the Eastern District of Kentucky or the Northern District of Georgia. The Panel should reject Plaintiffs’ venue requests of the Middle District of Florida or the Southern District of Illinois. “Id.
What is the status of litigation in Canada?
According to CTV News, as many as 30,000 Canadians may have received Physiomesh™ Flexible Composite Mesh during hernia repair surgery. – See more here
Canada class action
“Some Canadian hernia surgery patients have launched a class-action lawsuit against the maker of a now-recalled surgical mesh, claiming they weren’t warned of its dangers.” CTV
“In June 2016, Health Canada issued a recall for Physiomesh after the manufacturers learned that the recurrence and reoperation rates after hernia repair using the mesh were higher than the average rates of other meshes” Id.
“Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. Recurrence/reoperation rates (respectively) after Laparoscopic Ventral Hernia Repair using ETHICON PHYSIOMESH Flexible Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Ethicon is unable at this time to characterize all factors contributing to higher rates and is, therefore, removing the product from the global market.” http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58846r-eng.php
What are complications of hernia mesh:
When complications from hernia mesh repairs do occur, they can be severe and potentially life-threatening. Hernia mesh side effects may include:
- Mesh migration
- Bacterial infections
- Hernia recurrence
- Additional surgeries to treat hernia recurrence
Some complications may be so severe that they may even lead to death.
“with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).” FDA
Are these lawsuits class actions or individual lawsuits?
In the United States, these lawsuits are individual lawsuits, not a class action. A class action in the United States is: “One or more members of a class may sue or be sued as representative parties on behalf of all members only if: (1) the class is so numerous that joinder of all members is impracticable; (2) there are questions of law or fact common to the class; (3) the claims or defenses of the representative parties are typical of the claims or defenses of the class; and (4) the representative parties will fairly and adequately protect the interests of the class.” Rule 23 of the Federal Rules of Civil procedure