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 about the the status of the complex litigation (Physiomesh MDL) in Federal District Court in the United States legal system. You also need to learn about the Physiomesh State Court proceeding in New Jersey. Please contact us for a case review of your hernia mesh lawsuit.
- Will there be a Physiomesh lawsuit settlement 2020?
- What will the average Physiomesh settlement be?
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 and hernia mesh lawsuits. There is no need to suffer the devastating complications of this mesh in silence. If you are suffering as a result of PHYSIOMESH™ hernia mesh, please speak up and retain a top hernia mesh lawsuit law firm.
- Physiomesh hernia mesh lawsuit. ETHICON PHYSIOMESH™ is Flexible Composite Mesh manufactured by Johnson and Johnson’s (NYSE: JNJ) subsidiary Ethicon.
- Physiomesh is made of non-absorbable polypropylene.
- Physiomesh flexible composite mesh was never recalled in United States markets.
- On May 26, 2016 Ethicon initiated a medical device removal (voluntary withdrawal) of physiomesh from US markets.
- There are now hundreds of physiomesh lawsuits pending in Federal Court as multidistrict litigation in the Northern District of Georgia (Physiomesh mdl) before the Honorable Justice Story.
- On July 17, 2018 the Supreme Court of New Jersey designated all pending and future New Jersey state court actions against Ethicon Inc. related to Physiomesh Flexible Composite Mesh are centralized for management by the Superior Court in Atlantic County.
- There has been no reported Physiomesh hernia mesh settlements.
Update- 5/08/20- On March 19, 2020 Justice Richard Story issued an ORDER TEMPORARILY SUSPENDING ACTIVITIES REQUIRING IN-PERSON INTERACTION. The order states,”In light of the logistical and other challenges resulting from the COVID-19 pandemic, and the public health risk to counsel, witnesses, and court reporters associated with travel and in-person activities at the present time, it is ORDERED that all depositions and activities requiring personal interaction are hereby SUSPENDED pending further order of the Court. Litigation activities that do not require in-person interaction should continue to the extent possible. The Court will conduct regular telephone status conferences with Lead Counsel to determine when it is safe and appropriate to lift this suspension and resume normal litigation activities.”
Atlantic County New Jersey State Physiomesh lawsuit:
- Many people are unaware that the Federal Court Physiomesh MDL is not the only consolidated Physiomesh proceeding in the United States.
- On July 17, 2018 the Supreme Court of New Jersey designated all pending and future New Jersey state court actions against Ethicon Inc. and Johnson and Johnson related to Physiomesh Flexible Composite Mesh be centralized for management by the Superior Court in Atlantic County. NJ orders
- The case Name is: “IN RE: Physiomesh Litigation (Flexible Composite Mesh) Superior Court of New Jersey Law Division: Atlantic County.” Case NO: 627
- This state consolidated proceeding is a separate, unrelated and in addition to the Federal Court consolidated Physiomesh MDL presently consolidated in Federal Court in Georgia.
Federal Court consolidated Phsyiomesh MDL
- “as of May 2018, there were 872 Ethicon Physiomesh lawsuits in Federal Court” Drug watch
- As of May 15, 2020 there are 2089 Physiomesh lawsuits in an MDL in Georgia Federal Court in front of the Honorable Richard Story, Sr. District Judge. mdl-statistics-kugel-hernia-mesh-lawsuit
Is there a Physiomesh hernia mesh class action?
- There are no Physiomesh class actions in the United States.
- There is a Physiomesh Multidistrict litigation, MDL 2782- Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation
- There is a Physiomesh class action pending in Canada for Canadian Physiomesh victims.
Is there a physiomesh recall?
- Surprisingly, there was no Physiomesh recall in the United States!
- Many victims are incredulous and angry that Ethicon Physiomesh was not recalled in the United States markets.
- Ethicon and Johnson and Johnson was able to figuratively ‘rob the bank’ by issuing a voluntary medical device removal rather than a hernia mesh recall.
- Physiomesh was not technically recalled in 2016 by the FDA, pursuant to FDA regulations. Ethicon voluntarily withdrew it from the marketplace in the United States. Nonetheless, Ethicon Physiomesh flexible composite mesh was recalled in Canada and other countries.
- 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™.
Recent Case history of Federal Court MDL
- There was a case management conference in the mdl on August 1st 2017 and an order entered. The Federal Court ordered in pertinent part that: “Proposed Counsel Organizational Structure” (Doc. 192) is granted. Any additional applications for membership in the Plaintiffs’ Steering Committee shall be filed with the Court by not later than August 8, 2017″)
- The Honorable Justice Richard Story of the Northern District of Georgia issued a PRACTICE AND PROCEDURE ORDER AND NOTICE OF INITIAL CONFERENCE
- Justice Story scheduled a case management conference for August 1st 2017. Here is the 411 for the conference: August 1, 2017, at 2:00PM in Courtroom 2105, United States Courthouse, 75 Ted Turner Drive, S.W., Atlanta, Georgia 30303. “(c) Preliminary Reports. Counsel will submit to the Court by July 25, 2017, a brief consolidated written statement indicating their preliminary understanding of the facts involved in the litigation and the critical factual and legal issues. Counsel should include in these statements a list of all pending motions and a list of all related cases pending in state or federal courts and their current status, to the extent known. The statements should be sent to the Courtroom Deputy Clerk, Ms. Stacey Kemp (email omitted) These statements will not be filed with the Clerk, will not be binding, will not waive claims or defenses, and may not be offered into evidence against a party in later proceedings.”)
- 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)
- 4/15/18- “In the Court’s recent Practice and Procedure Order No. 7, the Court established the following timeline for the litigation:
- By May 15, 2018, twenty-four (24) cases will be selected by the parties for the “Initial Discovery Pool” (12 selected by plaintiffs and 12 selected by the defense). The 24 cases will be subject to case-specific factual discovery after the exchange of fact sheets.
- On June 22, 2018, an additional 10 cases will be selected for the Initial Discovery Pool.
- By December 1, 2018, the parties will select 10 cases from the Initial Discovery Pool for expert discovery (“Trial Pool Cases”).
- By May 15, 2019, the Court will determine the manner of trial, the order of selection of plaintiffs for trial, and timing of the trials (“Trial Cases”).
- The first Physiomesh bellwether trial was scheduled for September 16, 2019.” Sandiego Legal Examiner
- 3/12/18- Judge Story issues PRACTICE AND PROCEDURE ORDER NO. 8 RECORDS COLLECTION
- “A Georgia court issued the order May 29, 2018. It sets rules to preserve and store Physiomesh hernia mesh for trial. The order gives new guidance for the hundreds of people suing Ethicon over Physiomesh… The order requires people to tell their surgeons to preserve both hernia mesh and tissue. Hernia mesh lawyers will arrange to send all samples to a company called Steelgate Inc. It is a biomedical storage and management company in Florida.” Drug Watch
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 propaganda, “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
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. It cannot be stated enough that there was no physiomesh recall in The United States.
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. HSA
Types of hernia mesh lawsuits we are reviewing against Ethicon:
Many victims are unaware that there are hernia mesh lawsuits against Ethicon/ Johnson and Johnson related to other types of hernia mesh manufactured by Ethicon. We are reviewing the following types of surgical mesh lawsuits on behalf of victims:
Thousands of potential Physiomesh ™ victims across 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.”
ETHICON PHYSIOMESH™ Scientific Studies:
- 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
What types of information are victims searching for?
Many victims are searching google to determine Physiomesh symptoms and complications as well as determining what is physiomesh made of? It is surprising to many victims that there was no Physiomesh recall in 2016 but instead the mesh was voluntarily removed from the United States marketplace.There was a physiomesh recall in Canada.
What do I need to know before I file an Ethicon Physiomesh lawsuit?
Victims are desperately searching online for the following: “Average settlement for Physiomesh surgical mesh settlement” and “ethicon mesh lawsuit update.” Even if you contact the best hernia mesh law firm in the United States to represent you in a physiomesh mesh lawsuit, they will not be able to inform you of the average settlement for a Physiomesh hernia mesh lawsuit. This is because there have been no reported Physiomesh settlements 2020.
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….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” CTV
“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
According to CTV News, as many as 30,000 Canadians may have received Physiomesh™ Flexible Composite Mesh during hernia repair surgery. – See more hereat is ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device and has that product been recalled?
Peanuts in Canadian class action?
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’s lawyer describes Physiomesh
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
How did Ethicon get 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.
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
Ethicon evades 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. Proceed hernia mesh is allegedly defective and is subject to a consolidated State Court Proceeding in New Jersey
Ethicon’s attorney description of FDA approval process
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 approves Physiomesh 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.
FDA’s rationale for approving 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.
Ethicon’s lawyers describe the testing process?
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
Ethicon utilize a controversial FDA fast track program to get 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.
How many people are victims of 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 According to Ethicon’s hernia mesh lawyers in 2107 , “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
Status of Physiomesh hernia mesh lawsuits in the United States Federal courts?
Ethicon Physiomesh™ litigation is pending in Federal Court against Johnson and Johnson and their subsidiary Ethicon. OnMay 2017 there we 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” As of May 15, 2020 there are 2089 Physiomesh lawsuits pending in MDL 2782.
Physiomesh mesh lawsuit: 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 requested to consolidate lawsuits 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 attorneys oppose Physiomesh lawsuit transfer motion
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 want to challenge whether Physiomesh caused each victim injury
“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 legal strategy: other factors caused injuries- obesity, age, 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.
Ethicon’s lawyers seek a more favorable venue:
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.
- On 6/12/14 the United States Food and Drg Administration (FDA) received a 510k application (K141560) for Physiomesh open. The FDA issued a decision on 10/23/14 The decision stated, “You may, therefore, market the device, subject to the general controls provisions of the Act… We remind you; however, that device labeling must be truthful and not misleading.”
- Trade/Device Name: ETHICON PHYSIOMESH™ Open Flexible Composite Mesh
- “Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdraw” the regular Physiomesh from the market.” Hollis law firm https://hollislawfirm.com/case/hernia-mesh-lawsuit/ethicon-physiomesh-hernia-mesh-lawsuit/
- ETHICON PHYSIOMESH™ Open Flexible Composite Mesh has not been recalled or removed from the market.
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:
- Chronic Pain
- Bowel Obstructions
- 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
What is Physiomesh made of?
Ethicon Physiomesh is composed of polypropylene and is utilized for hernia repair. Physiomesh hernia repair was a serious matter causing victims serious side effects and Physiomesh complications. Physiomesh settlement amounts in the future are not known at this time. Will there be a physiomesh hernia mesh settlement 2020? Will there be a physiomesh hernia mesh settlement 2020?
Is there a physiomesh class action?
No. The Physiomesh lawsuits are not a Physiomesh class action. The Ethicon Physiomesh lawsuits in Federal Courts are consolidated into a Federal Court Multidistrict litigation pending in Georgia.
Are these hernia mesh lawsuits class actions or individual lawsuits?
In the United States, these lawsuits are individual lawsuits, not a class action. If you file a Physiomesh lawsuit, as a result of physiomesh complications, physiomesh symptoms and ethicon physiomesh problem, it will not be part of 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
Victims will not find any information about a physiomesh recall when they search the following: ethicon physiomesh recall fda.
Ethicon’s history of judge shopping
This article exposes Ethicon’s concerted effort to judge shop and forum shop in the PHYSIOMESH™ Federal Court multidistrict litigation.This is an expose of Ethicon’s organized attempt, acting by and through their hernia mesh lawyers, to engage in what appears to be judge shopping and forum shopping. It appears that they are trying to find judges who may be favorable to their legal positions. Ethicon’s hernia mesh defense attorneys utilized many pretexts and rationalization to explain their rationale for judge shopping. Ethicon’s lawyers are seeking to avoid paying mesh settlements to victims. Because of these command and control litigation tactics, there has been no Physiomesh mesh settlement in the first part of 2020 and a surgical mesh settlement 2020 seems unlikely. Victims should check this blog to determine whether there will be Ethicon mesh settlements 2020. part 2
PHYSIOMESH hernia mesh alleged to be defective
Ethicon is a division of Johnson and Johnson. In May 2016, Ethicon withdrew its ETHICON PHYSIOMESH hernia mesh medical devices from the marketplace. “Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.” Mesh News Desk There have been many hernia mesh lawsuits filed against Ethicon alleging that ETHICON PHYSIOMESH™ is defective, unreasonably dangerous and proper warnings were not provided to victims. Victims must be vigilante to seek out a mesh medical device news desk or a online information portal such as this blog to get mesh updates.
Panel transfers Ethicon Physiomesh lawsuits to Georgia
The Panel on Multi District Litigation transferred all of the ETHICON PHYSIOMESH™ cases to the Northern District of Georgia. The panel 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. See the transfer order here: Transfer order
Ethicon Physiomesh victims are interested in learning what types of legal arguments are being asserted by attorneys who are representing Physiomesh victims. When a potential mesh lawsuit Plaintiff is investigating and evaluating the merits of a Physiomesh hernia mesh lawsuit, he or she is seeking important and relevant information. Most importantly mesh victims are wondering about the hernia mesh settlement amounts other victims have received. This law article, by a hernia mesh lawsuit attorney, explains the legal reasoning and arguments of hernia mesh victims litigating Ethicon Physiomesh claims in federal Court. It cannot be emphasized enough that victims must be careful to follow applicable state hernia mesh lawsuit statute of limitations. There can be no hernia mesh lawsuit 2018 if the applicable statute of limitations for mesh claims has been missed. Average hernia mesh settlements and all the information a victim must know before he or she files a hernia mesh lawsuit are all irrelevant if a victim misses a mesh statute of limitations.
Many hernia mesh victims were implanted with Ethicon Physiomesh Flexible Composite hernia mesh. Ethicon Physiomesh was manufactured by Ethicon, a subsidiary of Johnson and Johnson. Many victims have filed hernia mesh lawsuits in Federal Courts asserting that Physiomesh was defective and that the manufacturer failed to properly warn the victims about those defects. These victims are seeking a hernia mesh settlement to compensate them for their pain and suffering. An Ethicon Physiomesh settlement has not occurred but a Physiomesh 2018 settlement is possible but highly unlikely.
Hernia mesh lawsuit victim’s legal arguments
Several top hernia mesh lawyers in the United States filed a motion and brief in United States Federal Court attempting to to have all cases consolidated in one court as multi-district litigation. These lawyers sought to have all Ethicon Physiomesh lawsuits heard in the Middle District of Florida. As a fall back argument, the hernia mesh attorneys asserted that if the Court does not transfer the cases to the Middle District of Florida then the Southern District of Illinois was the appropriate forum.
The victims’ Physiomesh attorneys argued in pertinent part, “that all pending Physiomesh Composite cases be transferred pursuant to 28 U.S.C. § 1407 to the Middle District of Florida….. In the alternative, Plaintiffs propose that the Court consider transfer to the Southern District of Illinois…” Plaintiff’s brief
Federal Panel rejects victims’ proposed venues for lawsuits, cases sent to Georgia
These Ethicon Physiomesh hernia mesh lawyer fought the good fight but ultimately the federal court rejected the proposed venues suggested by the victim’s lawyers. Even though the mesh lawsuit attorneys lost a couple of battles, they won the war so to speak. Despite rejecting the victim’s proposed venues for the Physiomesh lawsuits, the panel determined that the lawsuits would be consolidated into multi-district litigation.
At the end of the day, the Physiomesh lawsuits were transferred to the Northern District of Georgia, the Honorable Justice Richard Story presiding. Court Name: U. S. District Court, Northern District of Georgia Georgia Northern District Court President Nominating: William J. Clinton, Party Affiliation of President: Democratic Commission Date: 2/4/1998 More information here
At that time of the consolidation, there were 18 Physiomesh lawsuits according to Plaintiff’s lawyers
Plaintiff hernia mesh lawyers determined on March 9th, 2017 that, “To date, 18 plaintiffs (and, in many instances, their spouses) have filed civil actions arising from the implantation of the Physiomesh device designed, manufactured and sold by defendants Ethicon, Inc. and Johnson & Johnson. There are 18 actions pending in 9 federal districts. The breakdown is: Middle District of Florida (6 actions); Southern District of Illinois (2 actions); Northern District of Georgia (2 actions); District of Colorado (2 actions); Middle District of Georgia (1 action); District of South Carolina (1 action); Eastern District of Kentucky (1 action); District of Massachusetts (1 action); Northern District of Oklahoma (1 action); District of New Jersey (1 action).” BEFORE THE JUDICIAL PANEL ON MULTIDISTRICT LITIGATION, In re Ethicon Physiomesh Flexible Composite MDL-17-22 Hernia Mesh Products Liability Litigation 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
Multidistrict litigation basics:
Pursuant to 28 U.S.C Section 1407 “(a) When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings. Such transfers shall be made by the judicial panel on multidistrict litigation authorized by this section upon its determination that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions(Added Pub. L. 90–296, § 1, Apr. 29, 1968, 82 Stat. 109; amended Pub. L. 94–435, title III, § 303, Sept. 30, 1976, 90 Stat. 1396.) https://www.law.cornell.edu/uscode/text/28/1407
In sum and substance Physiomesh Victims assert that:
- The Physiomesh medical devices implanted in their bodies were “defectively designed and/or manufactured.” Plaintiff’s motion
- “…the defendants failed to provide appropriate warnings and instructions regarding the dangers posed by these devices.” Id.
- “They suffered serious and often permanent physical injuries from the implantation of the Physiomesh, often requiring additional surgeries, additional medical expenses, and unresolved medical complications. Where applicable, these implant plaintiffs’ spouses have alleged claims for loss of consortium.” Plaintiff’s motion to transfer
Victim’s attorneys describe Physiomesh as:
- “a synthetic mesh hernia repair device” Id.
- “implantable synthetic surgical mesh product sold for use in hernia repair implanted through laparoscopic herniorrhaphy.” Id.
- “Physiomesh has a unique design incorporating five (5) distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh.” Id.
How widespread is this Physiomesh liability problem?
“Upon information and belief, there were more than 330,000 Physiomesh devices sold worldwide, and Plaintiffs believe approximately 50% of those products were sold in the United States. It is the expectation of the undersigned that there will be hundreds of additional cases filed in the near future involving these products.” About Lawsuits
Previous Arguments made by victims to have case heard in Florida Federal Courts:
The hernia mesh lawyers representing the Plaintiffs (victims) argued passionately for the Physiomesh lawsuits to be heard in the Middle District of Florida. In sum and substance the hernia mesh lawyers argued:
- The most cases are pending in Florida and the first case was filed in Florida. As a result ,the Florida judges are more familiar with the claims
- The Courts in Florida have better “Docket conditions” and better resources and management than other Federal Courts
- Florida Courts are convenient and very accessible
The Plaintiff’s mesh attorneys case for the middle District of Florida
“The Middle District of Florida has the most filed cases, and one of the first-filed cases. Of the 18 filed cases, the Middle District of Florida has the most pending constituent civil actions (6) of any federal district court where these actions are filed. See, In re Multi-Piece Rim Products Liability Litigation, 464 F.Supp. 969, 975 (J.P.M.L. 1979) (district in which more cases pending than any other district was proper transferee forum); In re the Dept. of Energy Stripper Well Exemption Litigation, 472 F.Supp. 1282, 1286 (J.P.M.L. 1979) (choosing district where majority of actions pending); In re Data Gen. Corp. Antitrust Litigation, 470 F.Supp. 855, 859 (J.P.M.L. 1979) (preferable transferee district is where most actions pending). The 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 the country. Since Quinn, five additional cases have been filed in
the Middle District of Florida. These six cases are each assigned to different judges. No other District Court presently has more than two cases filed. While none of the cases in any District Court are so advanced procedurally that MDL coordination would impair significant progress, an Answer has been filed, Initial Disclosures and a Case Management Report have been served, and a Case Management Order has been entered in Quinn. Thus, of the Middle District of Florida judges who are assigned constituent actions, the Hon. Paul G. Byron in Quinn has had an opportunity to become familiar with the issues and parties in the case. In re American Investors Life Ins. Co. Annuity Marketing and Sales Practices Litigation, 398 F.Supp.2d 1361 (J.P.M.L. 2005) (appropriate forum where five constituent actions already proceeding, and judge who “has already developed familiarity with the issues present in this docket as a result of presiding over
motion practice and other pretrial proceedings in the actions pending before her for the past year.”). Id.
Victim’s lawyers argue that “The Middle District of Florida has favorable docket conditions, and the resources and ability to manage this litigation.”
“The Federal Court Management Statistics show that the Middle District of Florida has 617 pending civil cases per judgeship, a median time of 22.0 months from filing to disposition for civil cases, and only 3.5% of civil cases in the district are more than three years old.(See, Fed. Court Management Statistics for M.D. Florida is attached hereto as “Exhibit 1”). None of the Middle District of Florida Judges to whom constituent cases have been assigned are currently handling any MDL proceedings. Judge Byron, who presides over the first
case filed in the Middle District of Florida (Quinn), in particular would be well-suited to handle this litigation as he has never previously had an opportunity to handle an MDL proceeding. The Hon. James D. Whittemore (Gilman) and the Hon. Susan C. Bucklew (Sunter) who have the second and third filed cases within the Middle District of Florida are likewise well-suited to preside over an MDL proceeding.” Id.
“The Middle District of Florida is convenient and accessible.”
“The majority of the pending constituent cases are filed in district courts in the Southeastern portion of the United States, with 11 of the 18 cases pending in districts in the Southeast (M. Dist. of Florida; N. Dist. and M. Dist. of Georgia; Dist. of South Carolina; and, E.
Dist. Of Kentucky). The Southeast is the “center of gravity” for these cases. Therefore, for purposes of this litigation, the Middle District of Florida is a centrally located district. See, e.g., In re American Gen. Life and Accident Ins. Co. Industrial Life Ins. Litigation, 175 F.Supp.2d 1380, 1381 (J.P.M.L. 2001) (transfer to Dist. of S. Carolina litigation that had “a Southern tilt.”); In re Columbia Univ. Patent Litigation, 313 F.Supp.2d 1383, 1385 (J.P.M.L. 2004) (transfer to Dist. of Massachusetts based in part on fact that most of the parties were located “in the eastern part of the United States.”)” Id.
“The Middle District of Florida is readily accessible to all parties involved in this litigation.”
“The cases pending in the Middle District of Florida are filed in Orlando, Tampa and Jacksonville. All three of these major cities have international airports serviced by multiple daily direct flights throughout the country. Plaintiffs note that in all but one of the cases where the Defendants have filed their Answer, they are represented by one or more attorneys from the Mississippi office of the Butler Snow law firm. In the one case where the Butler Snow firm has not made an appearance (Franklin, M.D.Ga. C.A. No. 4:17-CV-00031), the defendants are represented by attorneys from the Atlanta, Georgia office of the Troutman Sanders law firm.” Id.
The Plaintiff’s lawyers arguments that Physiomesh hernia mesh is defective
“Physiomesh has a unique design incorporating five (5) distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design has never been used in any other
hernia repair product sold anywhere in the world. The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation and fixation of the mesh into the abdomen. However, Plaintiffs intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications. In addition, the polypropylene mesh portion of the Physiomesh was insufficient to withstand normal abdominal forces, which often resulted in herniation through the mesh itself, recurrent hernia formation and/or rupture and
deformation of the mesh itself. The defendants ultimately voluntarily withdrew the Physiomesh device from the market in May 2016, which Plaintiffs intend to establish was a direct consequence of the frequency and severity of the complications experienced with this product worldwide.” Id.
The Victim’s attorneys legal arguments seeking to establish multi- district litigation
“All of the constituent cases involve the Physiomesh device, and common defendants Ethicon, Inc. and Johnson & Johnson.” Id. “These actions are appropriate for centralization and transfer for coordinated and/or consolidated pretrial treatment under 28 U.S.C. § 1407. The constituent cases satisfy the criteria for MDL coordination and/or consolidation. These cases involve many common questions of fact, and transfer of these cases to a single court will serve the convenience of the parties and witnesses. These 18 actions currently pending in 9 separate federal district courts all involve similar product liability design defect and warnings claims against the manufacturer/seller defendants (Ethicon, Inc. and Johnson & Johnson) regarding the same Physiomesh hernia repair device that was implanted in each of these men and women.” Id.
A Single judge PRESIDING is the best
“Having a single judge preside over the pretrial proceedings in these cases would promote efficiency and economy by avoiding duplicative discovery from similarly situated claimants who have asserted common product liability claims, will prevent potentially inconsistent pretrial rulings regarding factual and legal issues common to all cases, and will help preserve the resources of the parties, their counsel and the judiciary by eliminating redundancy of effort. The Panel has previously found that product liability actions involving similar legal claims relating to similar implantable surgical mesh devices are appropriate for centralization under 28 U.S.C. § 1407. In re Protegen Sling and Vesica Systems Prods. Liab. Litig., MDL No. 1387 (J.P.M.L. 2001); In re Kugel Mesh Hernia Patch Litigation, 493 F.Supp.2d 137, MDL No. 1842 (J.P.M.L. 2007); In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 588 F. Supp. 2d 1374, MDL No. 2004 (J.P.M.L. 2008); In re Avaulta Pelvic Support Sys. Prods. Liab. Litig., MDL No. 2187 (J.P.M.L. 2010); In re American Medical Systems, Inc., et al., Pelvic Repair Systems Prods. Liab. Litig., 844 F.Supp.2d 1359, MDLs Nos. 2325, 2326, 2327 (J.P.M.L. 2012) (3 separate pelvic mesh MDLs); In re Coloplast Corp. Pelvic Repair Support Sys. Prods. Liab. Litig., 883 F.Supp.2d 1348, MDL 2387 (J.P.M.L. 2012); In re Cook Medical, Inc., Pelvic Repair Sys. Prods. Liab. Litig., 949 F.Supp.2d 1373, MDL 2440 (J.P.M.L. 2013); In re Neomedic Pelvic Repair Sys. Prods. Liab. Litig., 999 F.Supp.2d, MDL 2511 (J.P.M.L. 2014); In re Atrium Medical Corp. C-Qur Mesh Prods. Liab. Litig., MDL 2753 (J.P.M.L.2016). Like each of these surgical mesh MDLs, the constituent cases involve multiple common questions of fact relating to the Physiomesh product, including its manufacture, design, sale and warnings, and the defendants’ corporate conduct and knowledge. Transfer of these related product liability cases to a single court would eliminate inconsistency and redundancy, would promote efficiency and judicial economy, and allow for effective coordination in accordance with 28 U.S.C. § 1407.” Id.
“The Middle District of Florida is uniquely situated to serve as the proper forum”
“The Middle District of Florida is uniquely situated to serve as the proper forum for coordinated and/or consolidated pretrial proceedings of these actions. Transfer of these common hernia mesh repair product cases to a single Court before a single judge for purposes of pre-trial discovery and coordination is necessary for the effective and efficient management of this litigation. From a practical standpoint, the Middle District of Florida is uniquely situated as the appropriate forum to handle these cases because that Court has
the most constituent cases filed, and one of the first-filed cases in the country. Although Section 1407 does not specify criteria for selecting a transferee forum, the overarching goal is to find a court that will advance “the convenience of the parties and will
promote the just and efficient conduct” of the transferred cases. To that end, the Panel has generally favored districts in which a number of constituent cases are pending, and whose judges have had the opportunity to become familiar with the relevant issues. See, e.g., 15 Charles A. Wright, Arthur R. Miller & Edward H. Cooper, Federal Practice and Procedure § 3864 (2007); David H. Herr, Multidistrict Litigation Manual, § 6 (2016). The Panel has also favored courts that are convenient and accessible, have favorable docket conditions, and districts for which the parties have stated a preference. See, e.g., Wright, Miller & Cooper, supra at § 3864; Herr, supra
at § 6. In the context of this litigation, the district that best satisfies these criteria is the Middle District of Florida.” Id.
“In the alternative, these cases should be transferred to the Southern District of Illinois.”
“The Southern District of Illinois is also well-suited for receipt of an MDL in this litigation. The Hon. David R. Herndon presides over one of two constituent actions filed in the Southern District of Illinois (Worrell, C.A. No. 3:17-CV-11172). Judge Herndon has substantial
product liability MDL experience, and he has proven to be an innovative and well-qualified MDL judge. Although Judge Herndon is currently presiding over two MDLs, In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Prods. Liab. Litig., MDL 2100, and In re Pradaxa (Dabigatran Etexilate) PL, MDL 2385, both of those MDLs are presently in a settlement posture, largely owing to Judge Herndon’s efficient management of those litigations. This Panel has previously noted Judge Herndon’s experience handling complex product liability MDLs:” Id.
Judge David R. Herndon SHOULD preside over this matter
“[B]y selecting Judge David R. Herndon to preside over this matter, we are selecting a jurist with the willingness and ability to handle this litigation. Judge Herndon, an experienced MDL judge, has deftly presided over In re: Yasmins and Yaz (drospirenon) Marketing Sales Practices, 655 F. Supp. 2d 1343 (J.P.M.L. 2009), another large pharmaceutical products liability litigation. In re: Pradaxa (Dabigatran Etexilate) Products liability Litigation, 883 F. Supp. 2d at 1356. In the Praxada MDL, Judge Herndon helped to facilitate a global settlement of over 2,600 constituent cases in under 22 months. Judge Herndon managed this settlement quickly and
efficiently. Similarly, in the Yaz MDL which involved nearly 12,000 cases, Judge Herndon facilitated a mass settlement initiative in under 27 months. Judge Herndon’s experience, and his innovative and aggressive approach to moving cases forward, make him particularly qualified to serve as transferee judge in this proposed MDL.” Id.
Other mesh consideration:
Many victims wonder whether hernia mesh lawsuit settlement amounts 2017 will be similar to mesh settlement amounts 2018. Avid readers of this blog are well aware that many surgical mesh lawsuit settlements are not reported and also based on other factors it is impossible to determine an average hernia settlement. Other victims are looking ahead to 209 and wondering if there will be a Physiomesh hernia mesh settlement 2019?
Ethicon attempts to avoid paying victims
Johnson and Johnson and their corporate subsidiary, Ethicon, are doing everything to avoid paying hernia mesh victims. They do not want to pay innocent victims compensation for their pain and suffering, medical bills and revision surgeries. They retained high powered hernia mesh attorneys to attempt to move the PHYSIOMESH lawsuits to judges who may be more favorable to their legal positions. These hernia mesh lawyers engaged in blatant “forum shopping” and “judge shopping” to evade paying victims fair and just compensation for their hernia mesh complications and injuries.
Johnson and Johnson and Ethicon’s judge shopping trip
It appears they engaged in judge shopping. In my opinion, Ethicon engaged in forum shopping. Do not take our word for it! Just read the excerpts of the motions and paperwork, set forth below, submitted by Ethicon’s corporate defense mesh lawyers to the Federal Court!
Laughably, Ethicon’s attorneys accuse plaintiffs of judge shopping and state that it is deleterious in the midst of a judge shopping expedition Hypocritically, Ethicon’s lawyers accuse Plaintiff’s attorneys of judge shopping while stating “(“The Panel . . . will act to avert or deflect attempts by a party or parties to ‘game’ the system”); David F. Herr, Multidistrict Lit. Manual §§ 5:41, 7:7 (2016) (noting “the judiciary’s traditional opposition to tactics designed merely to permit forum-or judge-shopping,” that “[t]he Panel does not give the parties an opportunity to judge-shop,” and that “[t]he Panel is quite ready to ignore the positions taken by the parties, especially when the odor of forum shopping is present”)” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION
The mesh companies requested that the PHYSIOMESH cases be decided in New Jersey
Johnson and Johnson and Ethicon fought strenuously to get the PHYSIOMESH cases into New Jersey Federal Courts. Sadly, as far as New Jersey hernia mesh lawyers are concerned, the case were not transferred to New Jersey. These hernia mesh attorneys sought to relocate the defective product causes of action to New Jersey Federal Courts. If Ethicon acting through their mesh lawyers could not get the judges they sought in New Jersey they argued, “Alternatively, these cases should be centralized in the Eastern District of Kentucky or the Northern District of Georgia.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation MDL No. 2782 Oral Argument Requested- Author: William M. Gage MS Bar No. 8691 Butler Snow LLP 1020 Highland Colony Pkwy, Suite 1400 Ridgeland, MS 39157 Counsel for Defendants Johnson & Johnson and Ethicon, Inc.
Pretextual reasons for moving the hernia mesh cases cited by Ethicon
In their argument’s to the Federal Court, Ethicon’s hernia mesh attorney relied on numerous pretexts to disguise the real reason Ethicon was shopping for judges. Here is a summary of the hernia mesh defense lawyer’s arguments of why the hernia mesh lawsuits should be resolved in New Jersey:
- “New Jersey has the closest connection to the facts” Id.
- “at least one of the cases filed so far is pending in New Jersey” Id.
- “this district is the most convenient.”Id.
- “District of New Jersey is equipped to handle a products liability MDL. This district has extensive experience in pharmaceutical and medical device litigation” Id.
- “Fifth, the Camden and Newark divisions are very accessible to the parties, witnesses, and counsel.” Id.
These lawyers need to “man up” and just admit the real reasons they sought New Jersey jurisdiction. Ethicon believed they have a better chance to win with a particular judge in New Jersey. It appears that any other reasons given are pure pretexts and rationalizations. Winning for Johnson and Johnson means depriving seriously and severely injured victims from justice and compensation. Do we really believe Ethicon’s primary motivation to relocate the cases to a different forum was convenience or accessibility?
A nice story! PHYSIOMESH cases in the hands of the Honorable Richard W. Story
A nice story! Ethicon PHYSIOMESH lawsuits are in the capable hands of the Honorable Richard W. Story At the end of the day, the Federal Court decided to hear the lawsuis in the Northern District of Georgia. The Panel on Multi District Litigation ordered, “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 Georgia hernia mesh lawyers and Atlanta Georgia hernia mesh attorneys must be rejoicing about the PHYSIOMESH lawsuits being transferred to their home field.
Ethicon’s lawyers tried to steer clear of Florida Federal Judges
The hernia mesh defense lawyers retained by Ethicon did not only “judge shop” and “forum shop.” They actively tried to prevent Florida Federal court Judges from handling the hernia mesh lawsuits. They argued that, “The Middle District of Florida is not an appropriate venue.” Id. Perhaps, Johnson and Johnson should have been spending their time and resources settling the PHYSIOMESH hernia mesh claims rather than trying to block esteemed Federal Court judges in Florida from deciding the Physiomesh lawsuits.
Ethicon’s corporate defense lawyer’s arguments for a New jersey Forum:
“The District of New Jersey would be the best venue for any MDL. Should the Panel decide to centralize these cases, the District of New Jersey would be the most appropriate forum when considering the Panel’s traditional selection criteria. First, the District of New Jersey has the closest connection to the facts giving rise to these claims. To this end Ethicon’s decisions concerning the design, development, labeling, regulatory submission and clearance, and launching of PHYSIOMESH primarily took place in New Jersey and Europe. See, e.g., In re: Nutramax Cosamin Mktg. & Sales Prac. Litig., 988 F. Supp. 2d 1371, 1371-72 & n.2 (J.P.M.L. 2013); In re: Darvocet, 780 F. Supp. 2d at 1382.” Id.
Ethicon argues that New Jersey is most convenient forum
“Second, at least one of the cases filed so far is pending in New Jersey (Ramey), which is assigned to Judge Freda L. Wolfson. Third, this district is the most convenient. Section 1407(a) specifically identifies the “convenience of parties and witnesses” as a relevant consideration in the centralization decision. Defendants are headquartered in New Jersey, and many of the relevant documents and witnesses are located there. As such, coordinating the actions in the District of New Jersey will facilitate swift and convenient discovery and allow Plaintiffs access to the court and Ethicon’s pertinent corporate witnesses in one trip. See In re: Johnson & Johnson Talcum Powder Prod. Mktg., Sales Practices & Prod. Liab. Litig., MDL No. 2738, 2016 WL 5845997, at *2 (J.P.M.L. Oct. 4, 2016) (transferring to this district and noting that “[a]s Johnson & Johnson is headquartered in New Jersey, relevant evidence and witnesses likely are located in the District of New Jersey).” Id.
Ethicon claims New Jersey has”extensive experience in pharmaceutical and medical device litigation.”
“Fourth, the District of New Jersey is equipped to handle a products liability MDL. This district has extensive experience in pharmaceutical and medical device litigation. Moreover, it has one of the fastest median times among all district courts from filing to disposition in civil cases—8 months—and only 6% of the civil cases currently pending in the district are more than three years old.(See http://www.uscourts.gov/sites/default/files/data_tables/fcms_na_distprofile1231.2016.pdf (hereinafter “Judicial Caseload Profile). The Panel has recognized that the District of New Jersey “has the resources and capacity to efficiently handle” an MDL. In re: Nickelodeon Consumer Privacy Litig., 949 F. Supp. 2d 1377, 1377-78 (J.P.M.L. 2013). Judges Robert B. Kugler, Jerome B. Simandle, and Madeline Cox Arleo are particularly well-suited to preside over a products liability MDL given their experience with such litigation. Id.
See, e.g., In re: Blood Reagents Antitrust Litig., 652 F. Supp. 2d 1373, 1374 (J.P.M.L. 2009) (“Centralization in this district permits the Panel to effect the Section 1407 assignment to a judge with experience presiding over multidistrict litigation . . . .”); In re: Bank of Am. Home Affordable Modif. Program (HAMP) Contract Litig., 746 F. Supp. 2d 1359, 1361 (J.P.M.L. 2010) (assigning coordinated proceedings to judge who had “a wealth of prior MDL experience”); In re: Oil Spill by the Oil Rig “DeepWater Horizon” in the Gulf of Mexico, on April 20, 2010, 731 F. Supp. 2d 1352, 1355 (J.P.M.L. 2010). Judge Kugler in the Camden Division presides over In re: Benicar (Olmesartan) Products Liab. Litig. (MDL No. 2606). Not currently assigned an MDL, Judge Simandle in the Camden Division has extensive MDL experience, including In re: Ford Motor Co. Ignition Switch Prods. Liab. Litig. (MDL No. 1112), and In re: Caterpillar, Inc., C13 & C15 Engine Prods. Liab. Litig. (MDL No. 2540). One of the state’s most distinguished jurists—having served on the federal judiciary since 1992 Judge Simandle would also be a logical choice. Judge Arleo in the Newark Division presides over AZEK Building Prods., Inc. Mktg. & Sales Prac. (MDL No. 2506), which only has three cases. Before she became a district judge in 2014, Judge Arleo served as a magistrate judge for nearly 15 years and gained extensive MDL experience, including with the In re: Zimmer Durom Hip Cup Prods. Liab. Litig. (MDL No. 2158) proceedings.” Id.
“Fifth, the Camden and Newark divisions are very accessible to the parties, witnesses, and counsel. Most of Ethicon’s anticipated witnesses and documents are located in Somerville, New Jersey, while some witnesses may be located in Europe. The Camden federal courthouse is just 14 miles from Philadelphia International Airport, an American Airlines hub which serves approximately 1000 flights per day, including direct flights to 88 domestic locations and 18 international destinations. (Ex. 1, airport data). The Newark federal courthouse is less than five miles from Newark Liberty International Airport. A United Airlines hub, that airport has over 1200 flights per day, including direct flights to 82 domestic locations and 77 international destinations.”
“The courthouses in Camden and Newark, therefore, are much more “convenient and accessible” to most of the parties, witnesses, and counsel than the venues suggested by Plaintiffs, and the Panel has noted the accessibility of this district on several occasions. See, e.g., In re: Nickelodeon, 949 F. Supp. 2d at 1377-78; In re: Insurance Brokerage Antitrust Litig., 360 F. Supp. 2d 1371, 1373 (J.P.M.L. 2005); In re: Comp. of Managerial, Prof’l & Tech. Employees Antitrust Litig., 206 F. Supp. 2d 1374, 1375-76 (J.P.M.L. 2002) (“[T]he District of New Jersey [is an] accessible, urban district equipped with the resources that this complex docket is likely to require”).” Id.
“(See also In re: Propecia (Finasteride) Prods. Liab. Litig., 856 F. Supp. 2d 1334, 1335 (J.P.M.L. 2012) (transferring to a district near pharmaceutical manufacturer defendant’s headquarters and “close to where relevant evidence and witnesses are likely located”); In re: KDur Antitrust Litig., 176 F. Supp. 2d 1377, 1378 (J.P.M.L. 2001) (“[T]he District of New Jersey stands out as the most appropriate transferee district for this docket” because, among other reasons, defendants’ principal place[s] of business [is] located in New Jersey, [and] relevant documents and witnesses will likely be found there”)” Id.
Ethicon’s mesh attorneys argue that the PHYSIOMESH lawsuits should be decided in Kentucky or Georgia
Kentucky hernia mesh lawyers would have rejoiced if the Ethicon cases had been transferred to the Eastern District of Kentucky. The Federal Court rejected Ethicon’s request to have the Ethicon cases litigated in Kentucky. “Alternatively, these cases should be centralized in the Eastern District of Kentucky or the Northern District of Georgia. Defendants alternatively suggest that any MDL be assigned to Judge Danny C. Reeves in the Eastern District of Kentucky or Judge Timothy C. Batten in the Northern District of Georgia. These experienced MDL judges sit in geographically-accessible districts where at least one constituent action is pending, and the most recent government statistics indicate that neither of these judges presides over any civil cases pending more than three years or any motions pending more than six months. (See Civil Justice Reform Act of 1990 Report, pp. 32, 64 (Mar. 31, 2016), http://www.uscourts.gov/sites/default/files/data_tables/cjra.na.0331.2016.pdf). Id.
“One constituent case is currently pending in the Eastern District of Kentucky and assigned to Judge Amul R. Thapar, who was recently nominated to the United States Court of Appeals for the Sixth Circuit. This district is only the 69th busiest district in the country by pending civil cases per judge—thus it has far more capacity to accommodate a new MDL than the venues suggested by Plaintiffs. (Judicial Caseload Profile, supra). See also In re Tyco Int’l, Case MDL No. 2782 Document 30 Filed 04/13/17 PLtd. Sec. Litig., MDL No. 1335, 2000 U.S. Dist. LEXIS 5551, at *3 (J.P.M.L. Apr. 26, 2000) (coordinating proceedings in district where “the docket [was] significantly less congested than that of the other preferably suggested transferee district”).The Eastern District of Kentucky has recent experience handling medical products liability MDLs, as Judge Danny Reeves presided over In re: Darvocet, supra (MDL No. 2226). During those proceedings, which have now concluded, Judge Reeves agreed to sit in the Covington, Kentucky courthouse, which is only minutes away by car from the Cincinnati/Northern Kentucky International Airport. A Delta Airlines hub, that airport is situated in a central location, and it has direct flights to 48 domestic destinations and seven international destinations. (Ex. 1, airport data). See also In re: Inter-op Hip Prosthesis Prods. Liab. Litig., 149 F. Supp. 2d 931, 933 (J.P.M.L. 2001) (assigning MDL to “an accessible, geographically central metropolitan district”); In re: Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 398 F. Supp. 2d 1371, 1372 (J.P.M.L. 2005) (same).” Id.
Ethicon pimps Atlanta as a good forum for the hernia mesh lawsuits
T”he Atlanta division of the Northern District of Georgia is one of the most accessible venues in the country and is especially convenient to many of the current parties’ counsel. Hartsfield-Jackson International Airport is the world’s busiest airport, accommodating 2500 flights per day and direct flights to approximately 150 domestic destinations and 70 international destinations—many more than the airports serving Plaintiffs’ suggested venues. (Ex. 1, airport data). Eighty percent of the U.S. population is within a two-hour flight from the Atlanta airport, which is the primary hub of Delta Airlines. This airport is also uniquely capable of accommodating overseas witnesses.” Id.
“Three constituent cases are currently pending in the Northern District of Georgia, including the Lucas case, which is the longest pending case in the country. See In re: Quaker Oats Maple & Brown Sugar Instant Oatmeal Mktg. & Sales Prac. Litig., 190 F. Supp. 3d 1349, 1351 n.4 (J.P.M.L. 2016) (“The ‘first-to-file rule’ is a doctrine of federal comity, pursuant to which, when related cases are pending before two federal courts, the court in which the case was last filed may refuse to hear it if the issues raised by the cases substantially overlap”) (citations and internal quotation marks omitted); In re: Uber Techs., Inc., Tel. Consumer Prot. Act Litig., No. MDL 2733, 2016 WL 5846034, at *2 n.5 (J.P.M.L. Oct. 3, 2016) (quoting same); In re: Genetech Herceptin (trastuzumab) Mktg. & Sales Prac. Litig., 178 F. Supp. 3d 1374, 1376 (J.P.M.L. 2016) (assigning MDL to district on the basis that the “first-filed and most procedurally advanced action is pending in that district” ); In re: Prudential Ins. Co. of Am. SGLI/VGLI Contract Litig., 763 F. Supp. 2d 1374, 1375 (J.P.M.L. 2011) (“As we have previously held, it is appropriate to give the first-filed criterion some weight in selecting a transferee district”); In re: Refined Petrol Prods. Antitrust Litg., 528 F. Supp. 2d 1365, 1367 (J.P.M.L. 2007) (transferring to the district where the pending action was the “most advanced”). Judge Timothy Batten (appointed in 2006) is currently presiding over the In re: Delta/AirTran Baggage Fee Antitrust MDL (MDL No. 2089). That MDL appears to be concluding.” Id.
“Further, this district has significant experience handling MDLs and appears to have more capacity to accommodate a new MDL than Plaintiffs’ suggested venues.The plaintiffs in that case did not join in the motion for transfer, and that case was omitted from Plaintiffs’ filings. Lucas and two other PHYSIOMESH cases are assigned to Senior Judge Harold L. Murphy, who sits in the Rome division. Rome, Georgia, is in a relatively remote location in the northwest corner of the state and is not nearly as accessible as Atlanta. Judge Richard W. Story in the Atlanta division of that district (appointed in 1998) is also a very experienced jurist. Caseload Profile, supra). In fact, the six-month average time between filing and disposition of civil cases in that district is the sixth quickest in the entire country. (Id.).” Id.
SHERI ANNE JAMES and ALFRED GEORGE JAMES Plaintiffs v. JOHNSON & JOHNSON and ETHICON, INC., Defendants
On June 30th, 2017 Sheri James and Alfred James filed a hernia mesh lawsuit against Ethicon, Inc. and Johnson and Johnson as a result of allegedly defective Physiomesh impanted into Sheri’s body. This mesh lawsuit was filed IN THE UNITED STATES DISTRICT COURT, MIDDLE DISTRICT OF FLORIDA ,JACKSONVILLE DIVISION.
According to the complaint, “Plaintiff, Sheri James, was implanted with a 15 x 25 cm Physiomesh device (PHY2325V, Lot DH5CJWAG) during a procedure to repair a massive multiple anterior abdominal wall recurrent incisional ventral hernia at Memorial Hospital on or about May 9, 2012. This operation included a laparotomy with adhesiolysis and reduction of incarcerated small bowel and omentum, and resection of multiple hernia sacs and previously placed failed synthetic mesh.” Sheri James hernia Mesh lawsuit
Sheri James’ mesh lawsuit further alleged the following:
- “Plaintiff experienced pelvic pain, urinary frequency, and a fistula was confirmed by cystoscopy. On or about December 10, 2012, Plaintiff underwent a procedure of over 3 hours
in duration at St. Vincent’s Medical Center Southside, which included laparoscopic lysis of adhesions, laparoscopic removal of bladder from hernia and abdominal wall, and mesh repair of
the abdominal wall hernia. A 10 x 15 cm Physiomesh device (PHY1015V, Lot EA8KPQA0) was used to repair the hernia.” Id.
- “On or about July 17, 2013, Plaintiff Sheri James underwent an open repair of recurrent incisional hernia with mesh and bladder repair. Some of the previously-placed Physiomesh was explanted during this procedure.” Id.
- “Since the failure of Defendants’ Physiomesh implants, Plaintiff has suffered and been treated for additional pain, hernia recurrence and additional adhesion and scarification which may require additional surgery to repair.” Id.
Allegations of negligence in Sheri Jame’s hernia mesh lawsuit
- “Defendants represented to Plaintiff and Plaintiffs physicians that Physiomesh was a safe and effective product for hernia repair.” Id.
- “Defendants’ Physiomesh was defectively designed, was not reasonably safe for its intended use in hernia repair and the risks of the design outweighed any potential benefits
associated with the design. As a result of the defective design of Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including, chronic pain; recurrence of hernia; foreign body response; infection; rejection; inadequate or failure of incorporation/in-growth; migration; scarification; deformation ofmesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complication.” Id.
HENRY LEE BROWN v. JOHNSON & JOHNSON and ETHICON, INC.,
- “Plaintiff Henry Lee Brown was implanted with a 15CM x 20CM Physiomesh (PHY1520V) device at Redmond Regional Medical Center in Rome, Georgia.” Physiomesh hernia mesh lawsuit
- “Defendants manufactured, sold, and/or distributed the Physiomesh device to Plaintiff, through his doctors, to be used for treatment of hernia repair.” Physiomesh hernia mesh lawsuit
- “On or about July 21, 2015, Plaintiff underwent an invasive surgical procedure at Redmond Regional Medical Center in Rome, Georgia to remove the Physiomesh deviceimplanted in his body, which failed and necessitated additional surgical repair of the same hernia it was implanted to treat. As a direct result of the failed, defective Physiomesh device, which eroded into Plaintiff’s intestines, Plaintiff endured surgical resection of his small bowel with primary anastomosis and enterolysis to remove adhesions to the bowel” Id.
- “Defendants’ Physiomesh was defectively designed, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation / ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.” Id.
The first Physiomesh hernia mesh medical device trial, Matthew Huff v. Ethicon Inc, will take place on January 22nd, 2018 in the Southern District of Illinois, United States District Court. The Plaintiff victim in that case, Matthew Huff, is alleging that Physiomesh is defective and unreasonably dangerous and caused him severe complications and symptoms. Huff also alleges that Physiomesh “was negligently manufactured, tested, distributed, and marketed” by Ethicon. Huff did not stop there. He alleged that “the mesh at issue was not reasonably tested to determine if it was fit for its intended purpose of implantation into the human body.” See complaint
Huff’s surgical mesh lawsuit is against Ethicon Inc. Ethicon Inc. is the manufacturer of the hernia mesh medical device, Physiomesh. Ethicon Inc. is a corporate subsidiary of Johnson and Johnson. Matthew Huff filed a complaint against Ethicon Inc. on 04/01/16 in the United States District Court, Southern District of Illinois. Plaintiff complaint Matthew Huff is a resident of West Frankfort, Illinois. He was one of the first Physiomesh victims to file a lawsuit. Since, Mr Huff filed his hernia mesh lawsuit, there have been dozens of additional lawsuits filed by mesh victims against Ethicon, alleging Physiomesh caused them severe complications and symptoms. see also ETHICON PHYSIOMESH™ HERNIA MESH INDIVIDUAL LAWSUITS: INFORMATION
It is unknown whether Ethicon made any settlement offers to Mr. Huff. Will Mr. Huff receive a hernia mesh settlement 2017?
Justice Phil Gilbert will be presiding judge of the mesh lawsuit trial
The Mathew Huff trial was scheduled be the first Ethicon Physiomesh lawsuit to go to trial. The trial was in the capable hands of *Senior Judge J. Phil Gilbert from the Southern District of Illinois, United States District Court. On March 14th, 2015 Judge Gilbert assumed his important duties as Senior District Judge for the Southern District of Illinois, United States District Court. The attorney for Ethicon Inc. is Bettina J. Strauss from BRYAN CAVE LLP One Metropolitan Square 211 North Broadway, Suite 3600 St. Louis, MO 63102-2750 E-Mail: firstname.lastname@example.org Illinois # 6220600 see also, ETHICON’S ATTORNEYS “JUDGE SHOP” FOR FAVORABLE FORUM TO AVOID PHYSIOMESH LIABILITY
“Appointed by: President George H.W. Bush, 1992.
Law School: Loyola University of Chicago School of Law, J.D., 1974.
Prior Legal Experience: Gilbert & Gilbert, 1974-1988; Special Assistant Attorney General,
1974-75; Assistant City Attorney, City of Carbondale, 1985-78; Vice Chairman and
Chairman of the Illinois State Board of Elections, 1981-1985.
Prior Judicial Experience: Illinois Circuit Judge, 1988-1992” http://faculty.rwu.edu/dzlotnick/profiles/gilbert_files/gilbert.pdf
Read Judge Gilbert’s case management procedures here
Mesh attorneys sought continuance of mesh lawsuit
This hernia mesh lawsuit was originally scheduled for a trial on July 31st, 2017. “On July 12, 2016, this case was assigned to Track B, and a presumptive trial date was issued for July 31, 2017.” Productlawyers Court filings indicate that the hernia mesh attorneys and mesh law firms representing Johnson and Johnson and the victim needed more time to prepare for the hernia mesh lawsuit. The mesh law firms sought to continue the hernia mesh trial for six additional months. The surgical mesh law firms cited “the complex issues in this case” as the basis for seeking a continuance. The hernia mesh attorneys were able to continue the trial from the original date of July3, 2017 to the new trial date of January 22nd, 2018 Read the JOINT MOTION FOR REASSIGNMENT OF CASE TO TRACK C
Matthew Huff filed his defective hernia mesh lawsuit in 2016. Huff was seeking justice and compensation as a result of an allegedly defective Physiomesh hernia mesh medical device implanted in order to repair a ventral hernia.
Allegations made by victim in Hernia mesh lawsuit:
Mathew Huff alleged that “…Ethicon Physiomesh® Flexible Composite Mesh, was defective, unreasonably dangerous, and not suitable for implantation in Matthew Huff and others similarly situated and was the producing cause of the injuries and damages to Plaintiff.” Huff also went on to state that “The mesh at issue was not reasonably tested to determine if it was fit for its intended purpose of implantation into the human body.” complaint
“Huff was overcome with severe abdominal pain, fever, nausea, chills, and redness in July 2015. Doctors diagnosed him with an infection, two abscesses and an intestinal fistula. He was treated appropriately, but is now left with serious health problems associated with the failed hernia mesh including two open abdominal wounds that require cleaning and dressing every day.” Rightinginjustice According to Drugwatch, “Two years after Huff initially received the mesh in 2013, he developed severe pain, fever, chills and nausea. Huff went to the hospital where doctors found infection surrounding the implant.Huff’s lawsuit claims he suffered abscesses and an intestinal fistula — a condition where organs abnormally fuse together — that required additional surgery to treat.” Drugwatch
What happened to Matthew Huff
“In 2013, Plaintiff Matthew Huff was treated for a hernia of the abdominal wall. The surgeon, Udaya Liyanage, M.D. used Ethicon Physiomesh® Flexible Composite Mesh for the hernia repair. Ethicon Physiomesh® Flexible Composite Mesh was manufactured, designed, tested, and marketed by Defendant Ethicon, Inc. The Ethicon Physiomesh® Flexible Composite Mesh is an implantable tissue-separating mesh designed to be physiologically compatible with the abdominal walL In July of 2015, Mr. Huff began experiencing severe pain in his abdomen, along with fever, nausea, chills, and redness which developed on the skin of his abdomen. Mr. Huff was hospitalized and found to have an infection in and around the mesh causing two abdominal abscesses, intestinal fistula, and underwent a procedure to debride the two abscesses, and the placement of a V.A.C. Since that time, Plaintiff Matthew Huff has suffered severe and serious problems and complications with two open abdominal wounds which have to be deaned and packed daily, and continues to suffer various infirmaries due to complications caused by the, product, Ethicon Physiomesh® Flexible Composite Mesh, that was designed, marketed, tested,and manufactured by Defendant Ethicon, Inc.” complaint
Allegations made in Matthew Huff v. Ethicon Inc, hernia mesh lawsuit:
- “Plaintiff believes and alleges that the specific mesh in question was unreasonably dangerous in that the benefits of the specific mesh were outweighed by the risks of harm.”
- “Plaintiff believes and alleges there were, at the time of the original manufacture and sale of the mesh in question, reasonable economically and technologically alternative feasible designs which would have afforded users such as and including Plaintiff with the same or greater benefits, while reducing the risk of harm.”
- “Plaintiff believes and alleges that the mesh in question did not, at the time of manufacture and sale, comport with Ethicon, Inc’s own standards and requirements for the product.”
- “Plaintiff believes and alleges that the deviation from intended design has made the product unreasonably dangerous.”
- “Plaintiff believes and alleges that this defect existed at the·time·the product left the manufacturer.”
- “Plaintiff believes and alleges that the defect caused the product to adhere to Plaintiffs internal organs in such as way that has caused him severe infection and further injuries”
- “Defendant Ethicon, Inc. did not provide foreseeable customers such as and including Plaintiff, his physicians, hospital staff, and/or other members of the medical community with reasonably sufficient technical information about the risks of using the Ethicon mesh in question and was negligent in such conduct which was a proximate cause of Plaintiffs injuries and damages.”
- “Plaintiff further believes that Defendant Ethicon, Inc. was on notice of the problems with the product due to adverse event reports and complaints that were made to Ethicon, Inc. by users such as physicians and patients after which a reasonably prudent manufacturer would have removed the product from the market prior to the time that Matthew
Huff was implanted with the Ethicon Physiomesh® Flexible Composite Mesh.”
- “Plaintiff alleges that the surgical mesh in question was negligently manufactured, tested, distributed, and marketed by Defendant Ethicon, Inc , therefore Ethicon, Inc. is liable under a theory of implied warranty in that the Ethicon, Inc. mesh was not reasonably suited for its intended purposes, such as implantation in the human body. The mesh was also unfit for the ordinary purposes for which it was used and the implied warranty of merchantability was breached. Such breach of implied warranties were a proximate cause of Plaintiffs injuries and damages. Plaintiff has provided the required notice for breach of warranties to Defendant Ethicon, Inc.” https://www.clg.org/pdf/9/0/1/1/U.S.-Complaint-1—Physiomesh—Ethicon.pdf
What types of information are Ethicon Physiomesh victims searching for:
Victims in the United States, Canada and across the world are seeking information about the following:
- physiomesh settlement,
- physiomesh symptoms and
- ethicon physiomesh problems.
On May 27th, 2016 a subsidiary of Johnson and Johnson, Ethicon, issued an urgent medical device removal of its “ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes. In the letter, Johnson and Johnson stated, “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. ” Medical Device Removal of Ethicon Physiomesh Flexible Composite Mesh
Ethicon unfortunately fast tracked regulatory approval of Physiomesh™ utilizing the lawful, controversial yet unsettling Federal drug Administration’s (FDA) 510k Premarket Notification process. Ethicon was able to evade more stringent Federal Drug Administration clinical trials with this controversial tactical maneuver! Pathetically, large medical device manufacturers regularly, willfully and deviously evade FDA scrutiny by utilizing the flawed 510k process. Many victims are searching for information about: “maude fda” and “fda maude reports.”
Rather then force Johnson and Johnson’s subsidiary, Ethicon to recall Physiomesh™, the empty suits at the FDA allowed Ethicon to not only steal people’s lunch money but to spit in their face at the same time. Ethicon, was allowed to have it both ways, remove Ethicon’s allegedly defective hernia mesh from the market place while at the same time Ethicon denies that Physiomesh™ is dangerous and defective. Will there be a Physiomesh mesh settlement 2018? Will there be a Physiomesh lawsuit settlement 2109?
Many victims of Physiomesh are looking into filing a hernia mesh lawsuit. The best hernia mesh law firms are filing mesh lawsuits in Federal and State Courts across the nation and in other countries. If you did not file a hernia mesh lawsuit 2017, should you file a hernia mesh lawsuit 2018? Many victims are reaching out to surgical mesh attorneys and defective hernia mesh lawyers asking about mesh settlements and whether they will qualify for a hernia mesh settlement 2018. Other victims are merely seeking an Ethicon mesh lawsuit update.
IS ETHICON PHYSIOMESH™ SURGICAL HERNIA MESH DEFECTIVE?
“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 It has been alleged that Johnson and Johnson’s corporate subsidiary, Ethicon put profit motive over safety. Medical device companies have shamelessly utilized the FDA 510k premarket approval process to dump defective hernia mesh into the open market. This has caused untold pain and suffering among mesh victims. This has also lead to thousands of hernia mesh revision surgeries.
SHOULD JOHNSON AND JOHNSON SETTLE THE MESH CAUSES OF ACTION?
Ethicon Physiomesh™ hernia mesh was introduced in 2010 into the hernia mesh medical device marketplace. This was the beginning of a sad and disturbing course of events. This course of events culminated in Ethicon’s voluntary removal of Physiomesh from the marketplace in 2016. Some people are wondering: if Ethicon implicitly admits to the dangerous of this medical device, shouldn’t Ethicon open their pocketbook and reach a global mesh settlement 2018. Sadly, Ethicon has decided to engage in scortched earth litigation rather than reaching a settlement with the victims.
PHYSIOMESH™ WITHDRAWN AND REMOVED FROM UNITED STATES MARKETS- RECALL IN CANADA
On May 26th 2016, Ethicon uncharacteristically issued an “urgent” field safety notice. Ethicon’s actions were technically not a recall. In some other countries such as Canada, Ethicon recalled PHYSIOMESH™.
HAS THE FDA BEEN ASLEEP AT THE WHEEL CONCERNING ETHICON PHYSIOMESH™ HERNIA 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 a letter dated April 9, 2010, the 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
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.
WHAT MESH DID ETHICON CLAIM WAS THE PREDICATE DEVICE THAT PHYSIOMESH WAS SUBSTANTIALLY SIMILAR TO?
MANY ADVERSE EVENT REPORTS WERE SUBMITTED TO THE FDA PRIOR TO THE DEVICE BEING REMOVED FROM THE UNITED STATES MARKETS
- Event Date 11/08/2010 MAUDE Adverse Event Report: ETHICON, INC. PHYSIOMESH MESH, SURGICAL – “It was reported that a pt underwent a primary incisional anterior abdominal wall hernia repair procedure on (b)(6) 2010 and mesh was placed using intraperitoneal onlay mesh technique. The pt developed severe pain with a visible recurrence and bulging. The pt underwent a second laparoscopic procedure on (b)(6) 2010. The surgeon discovered that the mesh came loose partially. The mesh was frayed especially where the tackers were placed. Minimal adhesion were removed and the mesh was removed. The surgeon used tension technique to close.” Catalog Number PHY1520R Device Problem Tears, rips, holes in device, device material
- Event Date 05/20/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC- “It was reported that a patient underwent an open ventral/incisional hernia repair procedure on (b)(6) 2011 and mesh was used. On (b)(6) 2011, the patient presented with abdominal pain and a high white blood cell count. The patient developed an intrabdominal infection that was (b)(6). The patient underwent reoperation on (b)(6) 2011 and seroplueralant fluid on the visceral side and parietal side of mesh was observed. The mesh was explanted. Currently, the patient is intubated in icu with sepsis. The surgeon opines the cause of the patient and (b)(6) event was renal failure at time of reported symptoms on (b)(6) 2011.” Catalog Number PHY0715R, Report Number: 2210968-2011-00780
- Report Date:08/03/2012 MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC “It was reported by a patient that the patient underwent a hernia repair procedure on an unknown date and mesh was used. Approximately one year after the procedure, the patient experienced a relapse. A second procedure was performed on an unknown date and the mesh was removed. The surgeon reported that the mesh was not incorporated in the abdominal wall and was adherent to the small intestine. Additional information was requested.” Report Number2210968-2012-04287 , MDR Report Key2707404
- Report Date: 08/04/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC”It was reported that a patient underwent an incisional hernia repair on an unknown date and mesh was used. The patient developed an ileus. During reoperation, heavy ingrowth of the mesh and bowel was noted. The bowel could only be separated from the mesh with sharp instrument. The mesh was removed. The ileus was repaired by skin closure and no new mesh was placed. An additional surgery for hernia repair with mesh is planned after four to six weeks.” MDR Report Key2217482, Report Number: 2210968-2011-01135d
- Report Date04/04/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC- “It was reported that a patient underwent a laparoscopic surgical procedure on (b)(6) 2010 to repair a ventral hernia and mesh was implanted. The patient experienced a recurrent hernia on an unknown date. The patient underwent an open hernia repair procedure (b)(6) 2011. During the procedure, the mesh was very easily removed because it was hardly attached to the peritoneum with almost no ingrowth. A different mesh was used complete the repair procedure.” Catalog Number PHY1520V, Report Number2210968-2011-00517
- Event Date 04/15/2011 MAUDE Adverse Event Report: ETHICON ETHICON PHYSIOMESH ETHICON HERNIA MESH “Laparoscopic ventral hernia repair with ethicon mesh. Mesh pulled away from abdominal wall resulting in 2nd surgery laparoscopic & open (laparotomy) removal of mesh, repair of recurrent ventral hernia using bard mesh.” Report Number 2069574
WHAT IS MAUDE – MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE
“The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1(manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
“Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
Below you will find a hernia mesh victim’s lawsuit against Johnson and Johnson and Ethicon alleging that Physiomesh hernia mesh is defective. This mesh lawsuit was filed on 03/24/17 in the United States District Court, Middle District of Florida, Tampa Division. In pertinent part, the Plaintiff / victim alleged that “Plaintiff was forced to undergo multiple revision surgeries due to complications from Defendant’s defective hernia mesh, eventually resulting in a surgery to remove the mesh.”
The hernia mesh law firm representing the victim asserted that: “Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation / ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.”
There is no doubt that Ethicon Physiomesh problems, physiomesh symptoms, physiomesh infection and physiomesh complications are pervasive in victims. Many victims wonder whether there will be a Physiomesh settlement and what physiomesh settlement amounts will be. Other victims wonder why there was no physiomesh recall 2016 and it ended up being a Physiomesh market removal. Many victims wonder: what is physiomesh made of and why didnt the FDA issue an ethicon physiomesh recall? Many victims are searching the internet for Physiomesh hernia mesh lawsuit information.
Hernia mesh individual lawsuit attorney
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.