Lawsuits

[Anonymous]

Here we go...

Thousands of transvaginal mesh lawsuits filed against American Medical Systems, Inc. are moving forward as a federal court set new dates for the multi-district litigation’s bellwether trials. A court order issued on Tuesday indicated that the first trial is scheduled to begin on June 2, 2014 and the second will begin on July 7.

http://www.ringoffireradio.com/2014/03/bellwether-trial-dates-set-endo-transvaginal-mesh-mdl/

Bellwether Trial Dates Set in Endo Transvaginal Mesh MDL

Posted on March 17, 2014 by Alisha Mims •


Thousands of transvaginal mesh lawsuits filed against American Medical Systems, Inc. are moving forward as a federal court set new dates for the multi-district litigation’s bellwether trials. A court order issued on Tuesday indicated that the first trial is scheduled to begin on June 2, 2014 and the second will begin on July 7.

American Medical Systems is a subsidiary of Endo Pharmaceuticals, an international healthcare company. More than 16,000 transvaginal mesh lawsuits have been filed against the company. Mesh lawsuits have also been filed against Johnson & Johnson, Boston Scientific, and C.R. Bard.

Transvaginal surgical mesh is used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence in women. In 2008, the Food and Drug Administration (FDA) issued a warning letter to physicians regarding complications associated with the placement of mesh products. During the past 3 years, the FDA has received over 1,000 adverse event reports related to mesh products from 9 different manufacturers.

Transvaginal mesh products were approved by the FDA under the 510(k) expedited process, allowing the products to enter the market as FDA-approved without extensive trials or testing. It was not until last year that the FDA ordered over 30 manufacturers of transvaginal mesh products to conduct post-market safety tests.

Endo Pharmaceuticals, American Medical Systems’ parent company, was recently ordered to pay nearly $200 million to resolve criminal and civil charges over the company’s false marketing of Lidoderm, a topical, pain-relieving patch.

The government alleged that Endo promoted Lidoderm for off-label uses, causing federal health care programs to pay false claims. The patch was only approved by the FDA for the relief of post-herpetic neuralgia. A large part of the company’s $192.7 million settlement involved False Claims Act charges filed under the qui tam or whistleblower provision of the False Claims Act.

“Big pharmaceutical companies will underplay the dangers of their manufactured drugs and devices, and unfortunately some will take extreme measures to hide these risks from the public,” commented Robert Price, a drug and medical device attorney with the Levin, Papantonio law firm and a member of the TVM Plaintiffs Steering Committee. Unfortunately, these companies often focus on profit over consumer safety.”

 

[Anonymous]

Danish Medical Manufacturer to Settle Claims
March 29, 2014

Coloplast A/S, a Danish manufacturer of a wide range of medical products, has recently agreed to settle a number of lawsuits arising from claims that its vaginal mesh inserts caused patients to suffer unnecessary injury and discomfort. The settlement, which will resolve approximately 400 lawsuits that have been brought against the company, will be in the area of $16 million in total payments, for an average payment per claim of approximately $40,000.

This settlement marks an important step for women who have been affected by Coloplast’s products. However, the 400 lawsuits settled by this agreement represent only a small fraction of the total number of suits that have been brought against vaginal mesh manufacturers. Indeed, some estimate that the total number of claims that may eventually be filed could be in the tens of thousands.

Coloplast Vaginal mesh is a product that has been used for the treatment of a number of different issues, particularly stress urinary incontinence and pelvic organ prolapse. However, as noted by the website for Pohl & Berk, LLP, a law firm based in Nashville, the side effects of vaginal mesh can be extremely serious, ranging from urinary pain to infection and organ damage. In many cases, the impact these effects can have on patient health is devastating.

The settlement of these suits has been seen by some observers as signaling an increasing likelihood that other outstanding claims for injuries caused by vaginal mesh use may soon be settled as well. Companies such as C.R. Bard Inc. and Endo Health Solutions are in the process of conducting settlement talks in an effort to resolve the thousands of claims they are currently facing, and the successful resolution of claims with Coloplast A/S is seen as possibly providing a reasonable baseline for settling some of these claims.

The effects that transvaginal mesh damages have had on the lives of women throughout the country have often been devastating, and for many, compensation through a legal claim, whether it is ultimately settled or goes to trial, can be essential in order to ensure that individuals in these positions have the ability to cover the costs of any medical treatment that they may need. The recent settlement decision by Coloplast A/S hopefully represents a step in the right direction for victims of
transvaginal mesh and other defective medical devices, and could make a world of difference in the lives of those affected by defective medical products.

 

[Anonymous]

Safety of Pelvic Mesh Products Being Investigated in Europe

Date Published: Wednesday, March 26th, 2014

The executive body of the European Union (EU) has asked its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) to launch an investigation into safety issues surrounding pelvic mesh products that are surgically implanted in women to treat gynecological conditions.

“Based on the latest scientific and technical knowledge the committee is requested to assess the risk of meshes used in urogynecological surgery and more generally for other uses,” the commission said, according to MassDevice.com.

The EU asked SCENIHR to determine whether some types of pelvic mesh are riskier than others. Tens of thousands of lawsuits have been filed in federal and state courts against pelvic mesh makers – including C.R. Bard, Boston Scientific, Johnson & Johnson’s Ethicon subsidiary, Endo Health Solutions, Cook Medical, and Coloplast – on behalf of patients who allege they were injured by the companies’ products, MassDevice.com reported.

The panel has also been asked to look into whether certain surgical techniques or a combination of techniques carry a higher risk. SCENIHR has until January 2015 to issue a report, which must also identify high-risk patient groups and whether pelvic mesh is the appropriate treatment of other conditions. Additionally, the panel will decide whether a registry of pelvic mesh procedures should be created, according to MassDevice.com.

Thousands of mesh cases have been consolidated into multidistrict litigation (MDL) under Judge Joseph Goodwin for the U.S. District Court for Southern West Virginia. In February, a judge ordered the creation of a mass tort to amass product liability lawsuits filed over pelvic mesh products, MassDevice.com reported.

Pelvic mesh is intended to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These products, however, have been associated with high rates of erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Women who experience these serious complications often suffer through additional surgery, emotional distress, financial trouble, and a decreased quality of life.

The U.S. Food and Drug Administration (FDA) released a Safety Communication on July 13, 2011, stating that complications from pelvic mesh was “not rare” and that there is no evidence to support the conclusion that pelvic mesh is any more effective at treating POP and SUI than traditional surgical methods.

 

[Anonymous]

Bellwether Trial Dates Set in Endo Transvaginal Mesh MDL

Posted on March 17, 2014 by Alisha Mims •


Thousands of transvaginal mesh lawsuits filed against American Medical Systems, Inc. are moving forward as a federal court set new dates for the multi-district litigation’s bellwether trials. A court order issued on Tuesday indicated that the first trial is scheduled to begin on June 2, 2014 and the second will begin on July 7.

American Medical Systems is a subsidiary of Endo Pharmaceuticals, an international healthcare company. More than 16,000 transvaginal mesh lawsuits have been filed against the company. Mesh lawsuits have also been filed against Johnson & Johnson, Boston Scientific, and C.R. Bard.

Transvaginal surgical mesh is used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence in women. In 2008, the Food and Drug Administration (FDA) issued a warning letter to physicians regarding complications associated with the placement of mesh products. During the past 3 years, the FDA has received over 1,000 adverse event reports related to mesh products from 9 different manufacturers.

Transvaginal mesh products were approved by the FDA under the 510(k) expedited process, allowing the products to enter the market as FDA-approved without extensive trials or testing. It was not until last year that the FDA ordered over 30 manufacturers of transvaginal mesh products to conduct post-market safety tests.

Endo Pharmaceuticals, American Medical Systems’ parent company, was recently ordered to pay nearly $200 million to resolve criminal and civil charges over the company’s false marketing of Lidoderm, a topical, pain-relieving patch.

The government alleged that Endo promoted Lidoderm for off-label uses, causing federal health care programs to pay false claims. The patch was only approved by the FDA for the relief of post-herpetic neuralgia. A large part of the company’s $192.7 million settlement involved False Claims Act charges filed under the qui tam or whistleblower provision of the False Claims Act.

“Big pharmaceutical companies will underplay the dangers of their manufactured drugs and devices, and unfortunately some will take extreme measures to hide these risks from the public,” commented Robert Price, a drug and medical device attorney with the Levin, Papantonio law firm and a member of the TVM Plaintiffs Steering Committee. Unfortunately, these companies often focus on profit over consumer safety.”

Looks like there will be the Endo Annual layoffs around the holidays.

 

[Anonymous]

J&J Must Pay Damages Mesh Incontinence Implant Verdict

By Jef Feeley Apr 4, 2014 12:29 AM ET

Johnson & Johnson (JNJ) was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.

Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.

J&J, based in New Brunswick, New Jersey, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.

The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. (BCR) and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.

Appeal Planned

J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.

“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.

J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.

“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.

NJ Verdict

Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.

Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.

In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was defective.

The Texas case is Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas (Dallas). The West Virginia case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).