Class Action Article

  • File A Talcum Powder Lawsuit: Talcum Powder Ovarian Cancer Lawsuits Talcum Powder Fallopian Tube Cancer Lawsuits Baby  Powder Ovarian Cancer Lawsuits Filed If you or a loved one used talcum powder products and were diagnosed with ovarian cancer, or fallopian tube can...

Class Action News

Drug Class Actions

  • Taxotere Lawyers for Permanent Hair Loss: Taxotere Baldness Lawyers For  Permanent Hair Loss Lawsuits Have you received Taxotere for breast cancer? Taxotere can result in hair loss or baldness  that is permanent. Taxotere  is a chemotherapy drug used for the treatment of breas...

Medical Device Lawsuits

  • Zimmer Hip Replacement Lawyers: Network Zimmer Hip Replacement  Lawyer Win $2 Million Against Zimmer Hip Replacement Do You Have A Faulty Zimmer M/L Taper Hip Prothesis With Connective Technology and Cobalt Chromium Head? Do You Have Have Metallosis or Chromium Cobalt T...

Gynecare Mesh Lawyers, Gynecare Mesh Lawsuit Lawyers

Written by lisaspitzer on . Posted in Medical Device Lawsuits

Gynecare mesh lawyers are filing lawsuits for Gynecare mesh complications for a Mutli District Litigation consolidated in West Virginia. Gynecare Mesh malfunction cases are being accepted from all women nationwide for consolidation in one jurisdiction, Your case is still on an individual basis but part of what is called an MDL.

Ethicon Gynecare Mesh Problems? Consider filing a Vaginal Mesh Lawsuit like 1000's of other women acroos the United States.
 

Mesh lawyers are acceoting cases for the Gynecare vaginal sling usually used for urinary incontinenence. 

Currently, Ethicon Inc. and Johnson & Johnson are defending hundreds of lawsuits in both state and federal courts filed by women who suffered from Ethicon pelvic mesh complications. The lawsuits state that these women suffered from mesh erosion and other mesh complications.

One of The Most Common Mesh Complications

Serious infection is another Gynecare complication frequently reported to the FDA. According to news reports, Gynecare mesh infection most likely occurs in one of two ways. First, Gynecare mesh infection may be caused by trauma that occurs during insertion of the mesh. Second, the Gynecare mesh design may inhibit surrounding tissue from receiving nutrients and oxygen, causing impaired healing, which can lead to infection.
 

 

 

.

DePuy Metal on Metal Hip Replacement Lawyers, DePuy Recall

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers

DePuy Metal on Metal

DePuy ASR Metal on Metal Hip Replacement Settlements  Have Begun. DePuy Hip Replacement Lawyers Take Notice As Lawsuit Filing

Increases At a Rapid Rate.

J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., after finding that more than 12 percent of the devices failed within five years.

According to the allegations in filed lawsuits, both in federal and state courts, many patients are in pain and immobilized by joint dislocations, infections and bone fractures and have to undergo painful and expensive hip replacement surgeries.

Over 90,000 people were fitted with the following DePuy devices. Many  have become part of an MDL litigation for the:

    ASR Hip Resurfacing Systems
    ASR XL Acetubular Systems

. Problems with the ASR systems include:

    Devices becoming loose or dislocated
    Small metal particles flaking off and getting into surrounding tissues, causing pain and inflammation
 

Patients suing J&J, allege that metal debris is released by the grinding of artificial metal hips, and causes local tissue death around the joint and may increase metal cobalt and chromium ions in the bloodstream.

New Settlement News

Johnson & Johnson (JNJ), which faces about 8,000 lawsuits over hip implants it recalled in 2010, agreed to pay about $600,000 to resolve three cases in the first settlements of the litigation, people familiar with the accords said.

Contact our DePuy Hip Replacement Multi District Litigation department Today

Time is running our for DePuy lawsuit lawyers to file your hip replacement lawsuit. Filings depend on the statute of limitations for each state.DePuy Metal on Metal DePuy Hip Replacement lawsuit lawyers

Bard Vaginal Mesh Lawsuit Trials to Begin, Bard Vaginal Mesh lawyers

Written by lisaspitzer on . Posted in Arizona Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Transvaginal mesh, Utah Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

C.R Bard is one of the manufacturers of the Prolene vaginal mesh products and is the focus of vaginal mesh lawsuits by transvaginal mesh lawsuit lawyers. 1000's of women have been injured by vaginal mesh implants manufactured by a number of corporations including C.R Bard. Multi district litigation lawyers of the vaginal mesh department are filing 100's of lawsuits for mesh complications.

Bard Faces First Federal Trial Over Vaginal Mesh Next Year
By Jef Feeley and David Voreacos – May 2, 2012 5:05 PM ET

C.R. Bard Inc. will face its first federal-court trial next year over claims that the company’s vaginal-mesh implants injured women.

U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 federal cases contending that Bard’s Avaulta device caused organ damage. Goodwin is overseeing a consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

The order of trials for the first federal cases over Avaulta “will be determined after completion” of pretrial information exchanges between Bard and the plaintiffs, Goodwin said in his order yesterday.

Bard, based in Murray Hill, New Jersey, and a unit of New Brunswick, New Jersey-based J&J also face litigation in U.S. state courts over their mesh products. More than 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse, or to deal with incontinence.

Scott Lowry, a Bard spokesman, didn’t immediately return a call for comment on the judge’s decision to set the trial date.

A U.S. Food and Drug Administration report in August 2011 found that vaginal-mesh products should be classified as posing a high risk to patients based on a review of side-effect reports submitted to regulators from January 2008 to December 2010. Women’s groups are demanding that the devices be recalled.
More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of studies on the devices’ safety and effectiveness, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.

Some mesh suits blaming Bard and J&J for injuries are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases. Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.

In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The judge is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. (BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.

Endo’s AMS unit also faces claims in state courts in Delaware and Minnesota over its Perigee, Apogee and Elevate surgical mesh products, according to court filings.
‘Day In Court’

Goodwin has appointed Bryan Aylstock, Fred Thompson III and Henry G. Garrard III to lead a group of plaintiffs’ lawyers who will oversee the progress pretrial information exchanges over the consolidated federal cases.

Aylstock, a Pensacola, Florida-based lawyer, said he was pleased Goodwin set the first trial over Bard’s mesh product for early next year.

“We have a lot of women who have suffered devastating consequences from the Avaulta product and they deserve their day in court,” the plaintiffs’ lawyer said in a telephone interview.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

Dangerous Devices Harming Women, Vaginal Mesh Lawyers File Mesh Lawsuits

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Tennessee Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Transvaginal mesh, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

Vaginal mesh lawyers are filing lawsuits the vaginal mesh and bladder sling. These prolene mesh devices have been used  and surgically implanted in over 300,000 women and severe complications are being reported. The vaginal mesh lawyers demand justice and are filing lawsuits on behalf of these thousands of injured women nationwide. We are filing mesh lawsuits in L.A, Houston, Dallas, NYC, Phiiadelphia, Baltimore, Detroit, Chicago, San Fransisco, Miami, Jacksonville, Atlanta, Los Angeles, Phoenix, San Antonio, San Diego, Dallas, San Jose, Indianapolis, Austin, Columbus, Fort Worth, Charlotte, El Paso, Memphis, Boston, Seattle, D.C. Nashville, Denver, Milwaukee, Portland, Las Vegas, Oklahoma City, Albuquerque, Tucson, Fresno,Sacramento,Long Beach,Kansas City, Mesa, Virginia Beach,Colorado Springs, Omaha, Cleveland, Tulsa, Oakland, Minneapoplis, Wichita, Arlington and just about every city in the United States; even Alaska and Hawaii.

Women are suffering and husbands and families are suffering along with them, The vaginal mesh lawsuits being filed by our mesh lawyers  are multi-deistrct litigations, not  class actions. That means that the cases are assigned to certain jurisdictions in the country. The current largest mesh lawsuit filings are in West Virginia and New Jersey.

There are approximately 11 manufacturers involved in the vaginal mesh lawsuits. The primary  ones are: Johnson and Johnson, Bard, Boston Scientific and American medical Systems. To start the mesh lawsuit process contact our vaginal mesh lawyers today. Our mesh hotline is open 24hr, 7days.

If you have a vaginal mesh implant with complications from these manufacturers call us to learn your rights in the vaginal mesh lawsuit.

  •     AMS Elevate Prolapse Repair System
  •     AMS Apogee Vault Suspension System
  •     AMS Perigee System
  •     AMS Monarc Sling System
  •     AMS Sparc Sling System
  •     Bard Avaulta Support System
  •     Boston Scientific Pinnacle Pelvic Floor Repair Kit
  •     Boston Scientific Uphold Vaginal Support System
  •     Ethicon Gynecare Gynemesh
  •     Ethicon Gynecare Prolene Soft Mesh
  •     Ethicon Gynecare Prolift Pelvic Floor Repair System
  •     Ethicon Gynecare TVT Transvaginal Sling
  •     UGYTEX Dual Knit Mesh
  •     Coviden IVS Tunneler Sling

 

Call now, Vaginal Mesh representatives are here to take your call and foward it to a mesh lawyer for respone.

Mirena IUD Having Severe Complications in Women, Perforated Uterus

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Kentucky Multidistrict Litigation Lawyers, Louisiana Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mirena IUD Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, NYC Class Action Lawyers, Ohio Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, Tennessee Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers

Criteria for the Mirena lawsuit is a perforated Uterus.

The lawyers of Class Action Lawyer Network are reviewing cases for  perforated Uterus from the Mirnena IUD and gathering facts for the formation of a Mult district litigation action. Women implanted with the Mirena IUD are having serious side effects. The most serious is e gravitation of the IUD to a nearby organ causing it to become embedded in the Uterus or other organ. Organ perforation is another hazard of this gravitation. This is the only criteria right now for the Mirena lawsuits.

Lawyers are seeking all women with organ perforation from the Mirena IUD to submit theor medical records and documentation to be reviewed for a Mirena IUD lawsuit against the Mirena manufacturer.

Serious Side Effects of The Mirena IUD

The numbers of women are starting to grow who have had Mirena implanted and are experiencing serious and even debilitating or life-threatening side-effects. The device has been migrating from its original position after being inserted, perforating the uterus or embedding itself in the uterus. In both instances, a doctor must locate and surgically remove the device. Mirena also migrates outside the uterine cavity and cause adhesions or scarring that can lead to infertility. Depending on the damage caused, you may require a complete hysterectomy, and more serious complications could result in death. You must be aware of any and all changes when you have this device and see an emergency physician immediately if you are experiencing any symptoms.

Be Alerted to the following side effects:

  •     Abscesses
  •     Embedment in the uterus
  •     Erosion of adjacent areas such as the vagina
  •     Infertility
  •     Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
  •     Intestinal perforations or obstruction
  •     Pelvic Inflammatory Disease
  •     Perforation of the uterus

Contact us for a Mirena IUD case review.

Women Sueing For Vaginal Mesh Malfunction

Written by lisaspitzer on . Posted in Medical Device Lawsuits, Transvaginal mesh

Thousands of women nationwide are sueing the manufacturers of various vaginal mesh and bladder sling implants for the complications that have destroyed their lives and marriages.

The vaginal mesh is a Prolene sling device used for bladder, bowel or Uterine prolapse and incontinence. However is has had vary severe complications including: erosion into the vaginal canal, bladder and bowel, organ perforation, infections that never go away, bleeding,lower back pain and the inability to have sexual intercourse.

Manufacturers:

Transvaginal Mesh, Vaginal Mesh and Bladder Sling  Manufacturers

Bard, Gynecare, ( a J & J Ethicon product ), AMS (American Medical Systems) and Boston Scientific  have the largest market shares of transvaginal mesh products.

C.R. Bard's products include:

        Bard Pelvitex
        Bard Pelvisoft
        Bard Pelvilace or Pelvicol
        Bard Utrtex
        Bard Uretex TO
        Bard Uretex TOO2
        Bard Uretex TOO3

Gynecare/Ethicon/Johnson & Johnson products include:

        Gynecare Prosima
        Gynecare TVT Exact
        Gynecare TVT Abbrevo
        Gynecare TVT Retropubic System
        Gynecare TVT
        Gynecare TVT Obturator
        Gynecare TVT Secur
        Gynecare Gynemesh PS
        Gynecare Prolift
        Gynecare Prolift+M

AMS's products include:

        AMS MiniArc Precise Single-Incision Sling
        AMS MiniArc Single Incision Sling
        AMS Monarc Subfascial Hammock
        AMS In-Fast Ultra Transvaginal Sling
        AMS BioArc
        AMS Sparc Self-Fixating Sling System
        AMS Elevate
        AMS Perigree
        AMS Apogee

Boston Scientific products include:

        Boston Scientific Arise
        Boston Scientific Pinnacle
        Boston Scientific Advantage Fit
        Boston Scientific Lynx
        Boston Scientific Obtryx
        Boston Scientific Prefyx PPS
        Boston Scientific Solyx

Tyco Covidian (which manufacturers the Tyco Covidian Duo and Mentor ObTape)

The mesh litgations are not class actions but, multi -district litigations. They are consolidated in certain courtrooms in the country. For an experienced multi district litigation lawyer handing the mesh call our network today.

 

Metal On Metal Hip Replacement Trials Continue, DePuy Hip Replacement Lawyers

Written by lisaspitzer on . Posted in Medical Device Lawsuits

The metal on Metal hip replacement lawyers are still filing DePuy Hip Replacement lawsuits and Stryker lawyers are filing lawsutis for the latest Stryker Hip Replacement recall.

 Court Discusses Scheduling of First Bellwether Trial, and DePuy Hip Replacement lawyers continue to file lawsuits. The latest Stryker Hip replacement recall is getting notice by hip replacement lawyers
.The DePuy Pinnacle hip lawsuits are progressing in the multidistrict litigation (“MDL”). A status conference was held today in In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), currently underway in the U.S. District Court for the Northern District of Texas before the Honorable James E. Kinkeade. According to court documents, the Court discussed scheduling and issues relating to preserving important evidence in the hip implant cases. Over 1800 lawsuits have been filed in the Pinnacle hip MDL, alleging that the metal-on-metal hip implants were defectively designed.*

DePuy Pinnacle Hip Replacement And Other Metal-On-Metal Hip Replacement Lawsuits Continue, The latest is the Stryker Recall

Stryker Hip replacement lawyers are investigating cases concerning the Wright Profemur and Conserve hip replacements and the recalled Stryker Rejuvenate and ABG II hip implants. Those who have experienced complications or underwent revision surgery due to a metal hip implant may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more about filing a metal hip replacement lawsuit. See DePuyHipreplacementHelpline.com.

New Dangerous Medical Devices, Medical Device Lawsuits

Written by lisaspitzer on . Posted in Medical Device Lawsuits

The Following dangerous medical devices have been added to the list of dangerous devices our lawyers are accepting clients for. These include:

  •     AlloDerm Lawyers,
  •     Bard IVC Filter Lawyers,
  •     Charite Artificial Disc Lawyers,
  •     Metronic Injuse Bone Graft Lawyers,
  •     Mirena IUD lawyers for uterus perforation
  •     Stryker Rejuvenate Lawyers.,
  •     ABG II modular-neck stem Lawyers
  •     Depuy ASR Hip Implant Lawyers, statute of limitations up in many states
  •     Modular-Neck Hip Stems by Stryker Orthopedics Lawyers,
  •     R3 Acetabular System Hip Replacement Lawyers,
  •     Vaginal Mesh Lawyers.
  •     Dow Corning Breast Implant Lawyers

Manufacturers of medical devices are also liable for harm caused by their products. Sometimes these products contain design flaws, were not tested adequately, or were marketed to doctors and patients for uses other than those approved by the U.S. Food and Drug Administration. Examples of medical devices include: defibrillators, breast and other cosmetic implants, orthopedic screws, hip implants, knee implants, heart valves and many other items.

 

J & J Sold Vaginal Mesh Without Approval, Vaginal Mesh Lawyers filing Vaginal Mesh Lawsuits For Injured Women

Written by lisaspitzer on . Posted in Medical Device Lawsuits, Transvaginal mesh

Vaginal Mesh Multi District Litigation lawsuits are being filed by the Vaginal mesh Multi District  litigation division of Class Action Lawyer Network. It appear Johnson and Johnson was selling the vaginal mesh product on it's own initiative.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
By DVoreacos and A Nussbaum – Jun 26, 2012 2:23 PM ET

Johnson & Johnson (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.

The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
Enlarge image J&J Sold Vaginal Mesh Implant After FDA Ordered Sales Halted

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. Photographer: Daniel Acker/Bloomberg

“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women said the device’s approval history could increase J&J’s cost to resolve the litigation.

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e- mail.

J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said.
Fines, Injunctions

Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said.

The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”

Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients.

“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a telephone interview.

“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
‘Water Pistol’

The Prolift negotiations point out “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan, in an e-mail. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.”

The U.S. Senate is to vote today on changes to the FDA’s device-review system, which has drawn scrutiny for allowing implants like vaginal mesh on the market without human testing.

The bill increases funding for reviews and the FDA’s power to order safety studies after a product is cleared. It doesn’t include powers sought by consumer groups to let the FDA require clinical trials for more implants before they reach the market. The House of Representatives approved the measure last week.
Implants Threaded

Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year.

An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift.

An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) and other manufacturers to study organ damage and complications related to the products.
Sales Estimates

Manufacturers including J&J sold about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments in 2010, C.R. Bard executives estimated on a conference call that year. Even for top sellers of the devices, the products made up no more than 2 percent of company sales, said Michael Matson, a Mizuho Securities USA analyst in New York.

The numbers declined as lawsuits were filed, he said in a telephone interview.

“The doctors aren’t implanting them,” Matson said. “The patients don’t want them.”

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices, Johnson said. The company won’t withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months, he said.

“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” he said.
Label Update

In letters to state and federal judges, the company said that it will update labeling for one device, the Gynemesh, to allow only abdominal, not vaginal, insertion.

The FDA learned of the Prolift after J&J cited it in an application to sell a related device, the Prolift+M, Liscinsky said. The agency told J&J to file for the Prolift as well, and it combined the review for both devices before the August 2007 letter.

“Due to the complexity of this procedure and potential high risk for organ perforation, bench testing is not sufficient to demonstrate device safety and efficacy,” the FDA said in the letter. Bench testing refers to laboratory testing to determine how a device will function in a person.

In the August 2007 letter, the FDA asked 16 questions about the Gynemesh and Prolift, which are made of the same nonabsorbable polymer. The Prolift kit includes pre-shaped mesh and instruments to help surgeons implant the device.
Complications

One FDA query was about a “significant number” of complications from 2004 to 2007 on the earlier device, the Gynemesh. The agency got 174 such reports, including for infection, abscess and organ perforation. Most of the cases required additional surgery.

The agency’s letter also found that labeling for the Prolift+M device was deficient because it couldn’t support claims that the mesh has “elastic properties that allow adaptation to physiological stresses.” In its response, J&J agreed to remove that claim.

Many of the documents unsealed last month include e-mails between J&J and the FDA over the wording of product labeling about the benefits and risks.

Six days before the FDA cleared the Prolift, J&J agreed in a written response to say in the label that the safety and effectiveness of the device, compared to conventional surgical repair without mesh, “have not been demonstrated in randomized controlled clinical trials.”

Rather, J&J wrote, the substantial equivalence to earlier approved devices had been demonstrated through other tests.

The federal cases are In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, 12-md-02327, U.S. District Court, Southern District of West Virginia (Charleston).

If you have a Gynecare Vaginal mesh and are having complications call us today. We are also accepting cases for Yaz, Yasmin, Mirena IUD, NuvaRing and all drugs and devices harming women.

 

Mirena IUD Lawyers, Vaginal Mesh lawsuit Lawyers

Written by lisaspitzer on . Posted in Medical Device Lawsuits

Mirena IUD lawyers are reviewing cases for the Mirena IUD for a perforated uterus only. Vaginal mesh lawyers are filing lawsuits for the severe complications resulting from the Prolene vaginal mesh and bladder sling.

Women throughout the United States who received Mirena IUD for birth control are calling the Mirena IUD Helpline with serious complications. The stories we are hearing include complications of the  implanted device where it has punctured or perforated the uterus. Many of our callers tell us the Mirena IUD has migrated through the intra-abdominal cavity.  Many of the stories we hear are consistent with the following

  •     Perforation of the Uterus or nearby organs
  •     Migration of the device where it becomes embedded in the Uterus or abdominal cavity
  •     Expulsion of the IUD
  •     The need to have the IUD surgically removed and difficulty in finding the IUD

Our Mirena Silicone IUD lawyers are reviewing cases to seek justice for injured women. The lasuits will claim that the manufacturer failed to adequately warn women about the risk of Mirena perforating the Uterus and the additonal complications where the device punctures or embeds in the uterine wall. This can lead to infections, internal scarring and the need for surgery to repair the torn tissues.

In some cases, the Mirena IUD may migrate through the uterine wall, causing serious intestinal problems or other internal injuries, including  serious damage to nearby organs.

The Mirena IUD is manufactured by Bayer pharmaceuticals who has recently settled on Blood Clots from Yaz birth control pills. Mirena is a soft, flexible IUD that releases small amounts of hormone locally into your uterus. According to ther manufacturer  "It gives you birth control you can count on" However that is not taking into account the side effects we have been hearing daily.

Call now to speak to a Mirena IUD lawyer. We are also handling Yaz birth control pills lawsuits and the vaginal mesh litigations.