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cassandradodds · 8 years ago

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First Ethicon Physiomesh Trial Scheduled for January 2018

Ethicon Faces Mounting Lawsuits Over Physiomesh Hernia Mesh

The litigation against Ethicon and parent company Johnson & Johnson continues to mount over the Physiomesh hernia mesh device, which was withdrawn from the market last May due to a high rate of recurrence and reoperation. The first Physiomesh lawsuit is slated to go to trial on Jan. 22, 2018.

The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.

According to court records, the plaintiff had the Physiomesh implanted in 2013 to repair an abdominal wall hernia. The lawsuit states that the plaintiff experienced severe abdominal pain, fever, chills and redness on his abdomen two years later, prompting him to return to the hospital. The complaint states that the plaintiff suffered an infection, allegedly due to the defective nature of the Physiomesh.

The lawsuit states that the infection led to other complications, two abdominal abscesses and intestinal fistulas from the mesh. The plaintiff underwent another surgery to address these adverse events. The lawsuit alleges negligence, strict liability, and breach of warranty. The plaintiff also accuses Ethicon of making an “unreasonably dangerous and defective product”. Additionally, the suit alleges that Ethicon failed to adequately test the product before placing it onto the market.

Other lawsuits have also been filed over the Physiomesh, alleging that that hernia mesh is defective and caused injuries such as hernia recurrence (where the hernia returned) and adhesion, a surgical complication where the organs and tissues stick to one another after a surgery.

For example, court records show that a recent Physiomesh lawsuit was filed on Feb. 2, 2017 in the U.S. District Court for the Middle District of Georgia. The lawsuit is filed on behalf of a woman who suffered hernia recurrence and intestinal obstruction, allegedly due to the defects of the Physiomesh. The plaintiff had the hernia mesh implanted as part of an incisional hernia repair, and subsequently experienced pain, nausea, and vomiting. Due to complications, she underwent a second surgery.

The lawsuit alleges that the patient’s intestines ruptured through the mesh and caused intestinal blockage. “The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of” the plaintiff’s “intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of [her] intestines,” according to the complaint. Although surgeons tried to remove the mesh, portions of the material remain stuck inside her body.

Litigation mounted after Ethicon withdrew Physiomesh in May 2016. The company issued an Urgent Field Safety Notice citing a high rate of recurrence and reoperation with the Physiomesh compared to other devices in two large, independent hernia mesh registries. “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” Ethicon stated.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,”

Parker Waichman notes that lawsuits are also being filed over other hernia mesh products, including: Atrium Medical’s C-Qur (pronounced “secure”), C.R. Bard‘s Sepramesh, C.R. Bard’s Ventralex ST Hernia Patch, and C.R. Bard’s 3DMAX Mesh.

Hernia mesh products were approved through the U.S. Food and Drug Administration’s (FDA) 510(k) process. This means that device makers did not need to conduct clinical testing to prove that their products are safe and effective prior to marketing them. Companies only need to prove that the new product is at least as safe as a previous device; this is known as “substantial equivalence”. The use of 510(k) has been criticized for certain medical devices. Many medical device injury lawsuits are filed over products that were approved via 510(k).

Atrium Medical Sued Over C-Qur Hernia Mesh

Substantial litigation is growing against Atrium Medical over its C-Qur hernia mesh. Plaintiffs allege that the hernia mesh is defective and causes injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, bowel obstruction and abnormal liver function. Some lawsuits allege injuries related to the mesh’s fish oil coating, including adhesions and allergic reactions.

Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court, District of New Hampshire. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML). In an MDL, similar lawsuits are grouped together in one court to make legal proceedings more efficient.

Researchers Study Long-Term Complications Associated with Hernia Mesh

In October 2016, a study published in the Journal of the American Medical Association (JAMA) assessed the rate of complications in patients undergoing hernia repair. Researchers compared Danish patients undergoing repair with hernia mesh (looking at both open and laparoscopic procedures) to patients undergoing open repair without the use of mesh.

The JAMA study found that the benefits of hernia mesh are partially offset by the risk of long-term complications. The study involved 3,242 patients in Denmark undergoing hernia repair.

Although hernia mesh was associated with a lower rate of reoperation for recurrence, these patients also had increased rates of complications. “For the entirety of the follow-up duration, there was a progressively increasing number of mesh-related complications for both open and laparoscopic procedures,” the authors wrote.

“Among patients undergoing incisional repair, sutured repair was associated with a higher risk of reoperation for recurrence over 5 years compared with open mesh and laparoscopic mesh repair,” authors concluded. “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”

Filing a Hernia Mesh Lawsuit

If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/first-ethicon-physiomesh-trial-scheduled-for-january-2018/

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#First Ethicon Physiomesh Trial Scheduled for January 2018

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parkerwaichmanlaw · 8 years ago

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First Ethicon Physiomesh Trial Scheduled for January 2018

Ethicon Faces Mounting Lawsuits Over Physiomesh Hernia Mesh

Atrium Medical Sued Over C-Qur Hernia Mesh

Researchers Study Long-Term Complications Associated with Hernia Mesh

The JAMA study found that the benefits of hernia mesh are partially offset by the risk of long-term complications. The study involved 3,242 patients in Denmark undergoing hernia repair.

Filing a Hernia Mesh Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/first-ethicon-physiomesh-trial-scheduled-for-january-2018/

#First Ethicon Physiomesh Trial Scheduled for January 2018

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davidslepkow · 7 years ago

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(via First Physiomesh hernia mesh lawsuit set for trial in Jan. 2018 - Hernia Mesh Recall Attorney | Individual Lawsuits)

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 and 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

Physiomesh hernia mesh lawsuit 2018- jury trial on the merits

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 recieve a hernia mesh settlement 2017

CLAIMS WE ARE REVIEWING FOR POTENTIAL MESH LAWSUITS AGAINST JOHNSON & JOHNSON AND ETHICON INC:

Physiomesh

Prolene Hernia System (PHS)

Prolene 3D Patch

Ultrapro

Proceed hernia mesh

JUSTICE PHIL GILBERT WILL BE PRESIDING JUDGE OF THE MESH LAWSUIT TRIAL

The Mathew Huff trial will be the first Ethicon Physiomesh lawsuit to go to trial. The trial will be 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: [email protected] Illinois # 6220600 see also, ETHICON’S ATTORNEYS “JUDGE SHOP” FOR FAVORABLE FORUM TO AVOID PHYSIOMESH LIABILITY

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,

Physiomesh hernia mesh lawsuit compensation and settlement

and a presumptive trial date was issued for July 31, 2017.” https://theproductlawyers.com/wp-content/uploads/2017/02/Huff_v_Ethicon-Trial-Scheduling-Order.pdf 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.

JUDGE GILBERT’S RESUME:

“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

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, ethicon physiomesh problems

physiomesh recall 2016, physiomesh settlement amount

physiomesh complications, what is physiomesh made of, physiomesh infection

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

#meshsettlement2017

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lindamcsherry · 8 years ago

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Physiomesh Complications After Hernia Surgery Results in Lawsuit Against Ethicon, J&J

According to allegations raised in a product liability complaint filed against Johnson & Johnson and it’s Ethicon subsidiary, complications after Physiomesh hernia surgery resulted in severe injury for a Florida woman, who indicates the hernia mesh adhered to her internal organs and had to be removed.

The complaint (PDF) filed by Sarah Ann Gilman in the U.S. District Court for the Middle District of Florida on December 27, alleging the Ethicon Physiomesh was defectively designed and unreasonably dangerous for hernia repair.

Gilman received a 15 x 20 cm Physiomesh Composite mesh on February 3, 2016, during a laparoscopic procedure to repair a ventral hernia. According to the lawsuit, complications after the hernia surgery resulted in the need for revision surgery on August 17, due to an abdominal bulge, return of the hernia and severe pain associated with adhesion to other organs.

“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,” the lawsuit states. “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.”

The case joins a growing number of similar Ethicon Physiomesh lawsuits filed in courts nationwide, each involving individuals who experienced severe complications following hernia repair, with at least one case scheduled for trial to begin as early as January 2018.

Gilman’s case comes after an Ethicon Physiomesh recall was issued by the manufacturer in several countries last year, due to a higher-than-expected rate of problems resulting in recurrent hernias and revision surgery. Although the action was classified as a “Market Withdrawal” by the FDA, Ethicon has required all unexpired products be returned and decided to remove the hernia mesh from the market, after failing to identify the cause of the problems or come up with ways surgeons may be able to reduce the recurrence rate.

Gilman presents charges of defective design, failure to warn, and negligence. She seeks both compensatory and punitive damages.

The post Physiomesh Complications After Hernia Surgery Results in Lawsuit Against Ethicon, J&J appeared first on AboutLawsuits.com.

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cassandradodds · 7 years ago

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Surgical Hernia Mesh May Increase Patient’s Problems

The decision to have surgery is always a difficult one, especially if there is controversy in the medical device involved. A woman in Canada suffering from a hernia was advised by her physician to have abdominal mesh surgically implanted to avoid possible hernia complications, including bowel obstruction. What was meant to be a routine surgical procedure has resulted in the patient suffering debilitating pain and thinking she might have been better off if she had avoided the surgery.

What increased the woman’s frustration was that after she had the surgery, she found out that not all hernias need surgery and in some cases, it is better to wait. In 2006, studies revealed that “watchful waiting” may be an acceptable alternative to surgery, according to research published in the Journal of the American Medical Association. The researchers based this on men with inguinal (groin) hernias who have few or no symptoms.

Studies Involving Hernia Mesh Surgery

Based on a statement from researcher Dr. Robert J. Fitzgibbons, Jr., historically, hernias that have no symptoms should be surgically repaired as they become more difficult to fix with time, reports WebMD. However, he went on to say, that is not the case. David R. Flum, MD, MPH, a gastrointestinal surgeon said this study confirms that watchful waiting is a suitable strategy for the treatment of hernias that do not have symptoms other than bulging.

The question arises who to blame: the doctor, the hospital, or the mesh manufacturer. The woman who had crippling pain after receiving the hernia mesh, maintains she had a large lump in that area significantly larger than before her mesh implant surgery. She also was constantly fatigued and had a low-grade fever. She decided her only option was to have the mesh removed, and that the mesh device was most likely defective.

The product liability attorneys at Parker Waichman LLP have extensive experience representing clients in medical device injury litigation. Associates at the firm are available to answer questions for anyone seeking legal information for filing a hernia mesh lawsuit.

Potentially Permanent Damage

It is necessary for the woman to follow up on her suspicion to determine if the hernia mesh is truly defective and the reason for her bowel obstruction. There is a possibility that some of the damage caused by a potentially defective mesh, especially nerve damage, may be permanent. The woman maintains that she was never told about any possible risks linked to this mesh and believes her doctor was unaware of those risks.

Scar tissue typically forms post-surgery at the stitching or surgical site. This is to be expected and is normal, according to the Journal of the Society of Laparoendoscopic Surgeons (JSLS). However, any foreign body, such as a faulty hernia mesh, may produce enough scar tissue to interfere with nearby organs like the small and large intestines. These adhesions, or scar tissue may in turn be the trigger for a bowel obstruction.

Statistics in Canada

In Canada, in April 2017, CTV News reported that hernia mesh complications are a serious concern. Since 2000, some 12 brands of hernia mesh have been removed or recalled from the Canadian market, according to data from health regulators. Reported injuries include perforations and infections. Hernia mesh implant devices were linked to 185 reports of serious injury, including three fatalities.

The president of the Canadian Hernia Society, Dr. John Morrison remarked, “I’ve seen pictures of it in the bladder, I’ve seen mesh in the stomach. The mesh can erode into other organs over a period of time.” Dr. Morrison added that studies suggest that 10 to 20 percent of hernia mesh patients are left with chronic pain.

Lawsuits Against Hernia Mesh Manufacturers

Hernia mesh lawsuits are being filed against Johnson & Johnson and Ethicon over the Physiomesh Flexible Composite Hernia Mesh. In May 2016, the device was withdrawn from the market subsequent to data from two large, independent hernia mesh registries that revealed that Physiomesh was associated with higher rates of recurrence and reoperation.

Physiomesh plaintiffs claim that the device is defective and caused injuries. Ethicon is accused of failing to warn about the potential risks. The first Physiomesh trial in the United States is scheduled to begin January 22, 2018, according to court documents. The plaintiff is a man who suffered an infection, two years after having the hernia mesh implanted. His infection led to subsequent complications, including intestinal fistulas and two abdominal abscesses.

Legal Help for a Hernia Mesh Lawsuit

If you or someone you know suffered injuries related to the use of a hernia mesh device, you may be eligible for compensation. The lawyers at Parker Waichman offer free, no-obligation case evaluations. For more information, we urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/surgical-hernia-mesh-may-increase-patients-problems/

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#Surgical Hernia Mesh May Increase Patient’s Problems

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parkerwaichmanlaw · 7 years ago

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Surgical Hernia Mesh May Increase Patient’s Problems

Studies Involving Hernia Mesh Surgery

Potentially Permanent Damage

Statistics in Canada

Lawsuits Against Hernia Mesh Manufacturers

Legal Help for a Hernia Mesh Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/surgical-hernia-mesh-may-increase-patients-problems/

#Surgical Hernia Mesh May Increase Patient’s Problems

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