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  • Get A Hernia Mesh Lawyer | Hernia Mesh Lawsuits Filed: The hernia mesh lawyers of Class Action Lawyer Network are filing hernia mesh lawsuits for victims of a failed hernia mesh. We have Ethicon, Bard and Cook hernia mesh lawyers. Hernia Mesh Lawsuits Filed  For: Ethicon: Physiomesh Pro...

Posts Tagged ‘Yaz Help’

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.

Mirena IUD and A Perforated Uterus

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

The Mirena IUD along with the vaginal mesh, Yaz, Yasmin are devices and Drugs harming women. Mirena IUD Class Action lawyers are currently reviewing cases for a Mirena IUD Class Action, MDL Lawsuit. If you have a perforated uterus from the Mirena IUD contact us today for a case review.

Birth control drugs and devices  have been the central focus  of lawsuits. Yaz, Yasmin, Beyaz, NuvaRing and the related Vaginal Mesh are just some of the birth control medications, devices and related women problem devices that are causing  injuries, death and destroying lives.
The Mirena IUD is being currently reviewed by our Mirena IUD lawyers. Mirena is manufactured by Bayer ,which also manufacturers Yaz and Beyaz. It is a flexible silicone  intrauterine device that is placed into the uterus through the vagina by a physician. Mirena releases a continuous dose of the hormone levonorgestrel to prevent pregnancy for up to five years.

The first-generation IUD Dalkon Shield was well known for its complications, including :infection, sepsis, miscarriage and even death. Ther Over 300,000 IUD  Dalkon Shield lawsuits were filed.

The problems Mirena IUD  lawyers are accepting  Mirena Silicone  IUD  cases for include puncture of the uterus or the device becoming firmly embedded in the uterus. This can cause bleeding and other serious complications. The device must have moved or gravitated, and can not be located. If you have had the device surgically removed we want to hear from you.

The vaginal mesh lawsuit trials are underway. Lawyers are beginning the depositions of key players. The clock is ticking File you vaginal mesh lawsuit now.

 

Yaz showing signs of Blood Clots, Yaz Lawyers Filing Cases

Written by Class Action Lawyer on . Posted in Class Action Articles

Class Action Lawyer Network lawyers are reviewing Yaz  cases for blood clot complications as well as stroke and pulmonary embolism.

If you or a loved one has been injured by yaz contact our Yaz Women's legal department  for a Yaz  case review. Some interesting new news on Yaz and  Blood Clots problems follows:

Yaz pulmonary embolism among side effects

The oral contraceptive Yaz and the related drug Yasmin have been associated with a number of significant adverse side effects. Researchers believe that the drugs’ active ingredient, drospirenone, is to blame.

Drospirenone is a synthetic hormone that affects the body’s chemistry. One of its unintended consequences is to increase potassium levels, sometimes high enough to cause a dangerous condition known as “hyperkalemia.” Increased potassium levels are associated with the development of Yaz blood clots and gallbladder disease.

Yaz blood clots can have life-threatening consequences throughout an individual’s body. They can cause stroke, heart attack, and Yaz pulmonary embolism. Thousands of women who have been injured by Yaz pulmonary embolism and other significant side effects have hired a Yaz lawyer and filed claims against Bayer.

A Litttle Bit of yaz History

Class Action lawyer network, Yaz blood clots, stroke, pulmonary embolism, deep vein thrombosis lawyers are reviewing and accepting cases for review on Gallbladder complications and removal due to yaz.