Dangerous Product Alert: Transvaginal Mesh Manufacturer Agrees to Pay Injured Women

Endo International has agreed to pay $830 million to resolve legal claims in transvaginal mesh litigation against its subsidiary American Medical Systems without admitting liability or fault. Approximately 22,000 lawsuits have been filed by women who allege they have suffered injuries from the mesh devices such as painful sex, bleeding, and other complications. Reuters reports that the agreement is still subject to several conditions, including confirmation of medical records from plaintiffs.

According to an FDA News Release, on April 29, 2014, the US Food and Drug Administration issued two proposed orders to address the health risk associated with surgical mesh used for transvaginal repair of pelvic organ prolapse. If finalized, surgical mesh would be reclassified from a moderate-risk device to a high-risk device and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.

Dangerous Product Update: Judge Throws Out Trans-Vaginal Mesh Case; Appeal Expected

Preliminary reports out of Charleston West Virginia are that U.S. District Judge Joseph Goodwin has granted a “directed verdict” for Johnson and Johnson in the “pelvic mesh” or “trans-vaginal mesh” (TVM) trial that had been underway in that state.  In a move that is very likely to be appealed, the judge apparently took the decision away from the jury stating that the plaintiffs failed to present sufficient evidence to support her claim that a defect in the J&J “TVT Retropubic sling” caused her injury. Judge Goodwin is handling about 50,000 cases over the implantation of trans-vaginal mesh as part of the federal “multi district litigation” (MDL).

The ruling comes as a shock to many, given the link between the use of these trans-vaginal mesh products and vaginal injury.   The ruling is particularly surprising given that a New Jersey jury in state court ordered J&J’s Ethicon to pay a woman implanted with trans-vaginal mesh $3.35 million in compensatory damages and $7.76 million in punitive damages, so there was clearly enough evidence for that jury to reach the conclusion that J&J’s TVM products cause injury.  What is worse, the Court ignored its own ruling that J&J improperly destroyed documents about some vaginal mesh implants.

Though disappointing, the battle over this controversial product will continue.  The next trial is set for April against American Medical Systems, according to the federal court calendar. SGB and firms like it will not be deterred by this setback and will continue to fight for the rights of the women who have suffered injuries due to trans-vaginal mesh.

Dangerous Product Update: Trans-vaginal Mesh Trial Begins in West Virginia Federal Court

Trans-vaginal mesh (TVM) products, produced by several companies and used in surgical repairs in tens of thousands of female patients, has been found to degrade and shrink, requiring replacement and causing other medical problems. The FDA alerted the public in 2008 and further in 2011 of serious complications associated with TVM used to repair pelvic organ prolapse.

On Monday, February 10, the first federal trial against Johnson & Johnson, makers of the “TVT Retropubic” and “Gynecare Prolift” pelvic mesh products, began. Johnson & Johnson will face answering charges that the TVM products are defective and have injured tens of thousands of women.  Over 10,000 lawsuits filed against Johnson and Johnson (and about 50,000 against all manufacturers) have been collected into a federal “multi district litigation” (MDL).  The federal judge in charge has selected several cases to be “bellwether” test cases. Lewis v Ethicon is the first suit against Johnson and Johnson to proceed in Charleston, WV, according to the Gazette-Mail newspaper.

In August 2013, a Charleston jury told another TVM manufacturer, C.R. Bard Inc., to pay $2,000,000  to a woman who suffered serious injuries due to the faulty mesh.  The award included $250,000 in compensatory damages and $1.75 million in punitive damages, the latter because Bard officials put profits ahead of safety by ignoring warnings about defects in its “Avaulta” mesh implant.

Our firm, Schroeter, Goldmark & Bender, is handling several of these TVM cases and will be closely monitoring the national results.

Endo To Pay $54 million to settle Americal Medical Systems Transvaginal Mesh Lawsuits

The American Medical Systems (AMS) Inc. unit of Endo Healthy Solutions Inc. has agreed to pay $54 million to settle lawsuits alleging its transvaginal mesh implants have injured women. The actual number of the lawsuits encompassed by this settlement is unknown at this time. Some of the names of the products this covers include Apogee, Elevate and Perigee.

This is just the beginning for Endo; the majority of the 5,000 lawsuits filed against AMS have been consolidated before U.S. District Court Judge Joseph Goodwin in Charleston, West Virginia. The first AMS trial is scheduled for December of this year.  But that won't be the first mesh trial before Judge Goodwin:  C.R. Bard is slated to defend its mesh product in a trial that will start on July 8th.

It's unclear what the per case average is on these settlements.  As a result we can't fully assess this settlement.  But it has the court's approval, so it looks like it will hold up.  As we learn more details, we'll be able to comment on whether this is a good settlement or to low of a settlement.

 Regardless of valuation, we can say that the mesh manufacturers may well be starting to see the incredible exposure they face here. Lawyers from around the country have been working up mesh cases. As more and more make their way to trial, we might see the beginnings of more active settlement.

Washington State victims of transvaginal mesh:  So how does this affect victims of transvaginal mesh who reside in Washington State or elsewhere in the Pacific Northwest? First, if you have a potential claim, you should see a Washington State transvaginal mesh attorney right away. Second, if you already have an attorney, the attorney should be tracking these developments so as to assess your lawsuit.  Like with any mass-tort, the TVM cases are new and continue to evolve.

Post-note: Endo Pharmaceutical Holdings Inc purchased AMS for $2.9 billion back in 2011. AMS had been an attractive target; it's devices and treatments generated $542.3 million in revenue in 2010. The purchase propelled a 32% increase in the stock of AMS.  AMS certainly has been a profit machine, so much that at the time of the acquisition, Endo's CEO, Dave Holveck was hoping to generate $1 billion in urology sales the subsequent year. For those suffering from the complications of mesh, it must be difficult to hear about the drive for business in the "urology or pelvic area."  It's no surprise that as massive amounts of baby boomers continue to age, that the markets will seek to provide products for this demographic. But since the manufacturers and distributors of  transvaginal mesh put business profits ahead of safety testing, resulting in great harm to  countless women around the world,  listening to this kind of business focused talk solidifies the point, and reopens a painful emotional wound. These companies have the money to right the wrong they have done here. It's up to us to remember that and to relentlessly push to make them pay.

Endo To Pay $54 million to settle Americal Medical Systems Transvaginal Mesh Lawsuits

The American Medical Systems (AMS) Inc. unit of Endo Healthy Solutions Inc. has agreed to pay $54 million to settle lawsuits alleging its transvaginal mesh implants have injured women. The actual number of the lawsuits encompassed by this settlement is unknown at this time. Some of the names of the products this covers include Apogee, Elevate and Perigee.

This is just the beginning for Endo; the majority of the 5,000 lawsuits filed against AMS have been consolidated before U.S. District Court Judge Joseph Goodwin in Charleston, West Virginia. The first AMS trial is scheduled for December of this year.  But that won't be the first mesh trial before Judge Goodwin:  C.R. Bard is slated to defend its mesh product in a trial that will start on July 8th.

It's unclear what the per case average is on these settlements.  As a result we can't fully assess this settlement.  But it has the court's approval, so it looks like it will hold up.  As we learn more details, we'll be able to comment on whether this is a good settlement or to low of a settlement.

 Regardless of valuation, we can say that the mesh manufacturers may well be starting to see the incredible exposure they face here. Lawyers from around the country have been working up mesh cases. As more and more make their way to trial, we might see the beginnings of more active settlement.

Washington State victims of transvaginal mesh:  So how does this affect victims of transvaginal mesh who reside in Washington State or elsewhere in the Pacific Northwest? First, if you have a potential claim, you should see a Washington State transvaginal mesh attorney right away. Second, if you already have an attorney, the attorney should be tracking these developments so as to assess your lawsuit.  Like with any mass-tort, the TVM cases are new and continue to evolve.

Post-note: Endo Pharmaceutical Holdings Inc purchased AMS for $2.9 billion back in 2011. AMS had been an attractive target; it's devices and treatments generated $542.3 million in revenue in 2010. The purchase propelled a 32% increase in the stock of AMS.  AMS certainly has been a profit machine, so much that at the time of the acquisition, Endo's CEO, Dave Holveck was hoping to generate $1 billion in urology sales the subsequent year. For those suffering from the complications of mesh, it must be difficult to hear about the drive for business in the "urology or pelvic area."  It's no surprise that as massive amounts of baby boomers continue to age, that the markets will seek to provide products for this demographic. But since the manufacturers and distributors of  transvaginal mesh put business profits ahead of safety testing, resulting in great harm to  countless women around the world,  listening to this kind of business focused talk solidifies the point, and reopens a painful emotional wound. These companies have the money to right the wrong they have done here. It's up to us to remember that and to relentlessly push to make them pay.