Issuance of New Orders in Federal Transvaginal Mesh Litigations

New York, New York (PRWEB) November 18, 2013

More than 30,000 transvaginal mesh lawsuit filings continue to move forward in federal multidistrict litigations now underway in U.S. District Court, Southern District of West Virginia. According to Orders issued by the Court on November 14, 2013, a revised Short Form Complaint and Amended Short Form Complaint have been approved for all proceedings, including those naming American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp., (MDL No. 2326); C.R. Bard, Inc. (MDL No. 2187) and Ethicon, Inc. (MDL No. 2327) as defendants.

Vaginal Mesh Lawsuits
All of the vaginal mesh lawsuits pending in the Southern District of West Virginia accuse the manufacturers of various transvaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence of failing to provide adequate warnings about their serious risks to doctors and patients. In August, the proceedings’ first bellwether trial concluded with the jury awarding $2 million in compensatory and punitive damages to a woman who suffered serious vaginal mesh complications following implantation of an Avaulta mesh device manufactured by C.R. Bard. (Cisson v. C.R. Bard Inc., 11-cv-00195)

The litigation surrounding transvaginal mesh got underway shortly after the U.S. Food & Drug Administration (FDA) issued a 2008 Public Health Alert revealing that it had received 1,000 reports of serious injuries associated with vaginal mesh products over a three year period. In July 2011, the FDA warned that the number of injuries reported in relation to transvaginal prolapse repair had grown three-fold since its prior alert. Most significantly, the rise in these types of vaginal mesh complications prompted the FDA to modify its previous stance that such injuries were rare.

Alleged victims of vaginal mesh complications may be entitled to compensation for their medical bills, pain and suffering, and other injuries. Learn more about the litigation involving transvaginal mesh at http://www.newmexicomesh.com To arrange for a free vaginal mesh lawsuit consultation, please call 505-247-9333.

 

Multi District Litigation by Thomas Mucci 11/13/13

The purpose of Multi District Litigation is to create an alternative. Take into consideration the vaginal mesh cases; you have multiple plaintiffs living in many different parts of the country, throughout all fifty states. Instead of overwhelming the court system and the manufacturers over many different jurisdictions, the federal courts have created this system of Multi District Litigation.  The plaintiff’s are given the option to file their case in one jurisdiction, in the case of mesh, filing is done in the Southern district of West Virginia. That court is allowed to create the procedures which administer high volumes of cases with in many ways share a common fact patterns. These cases also share a common medical device, the vaginal mesh or also referred to as a pelvic sling. This large number of cases can be centralized and administered by a more efficient system. Frequently on the news we see criticisms of the federal government and whether those criticisms are justified or not, what is clear is that the federal judiciary system is an extremely efficient, user friendly and well organized entity.  In the case of vaginal mesh lawsuits, the court has created a mechanism in which discovery (documents provided by the plaintiffs and defendants), is well organized through a series of court scheduling orders. Everyone knows what is going on; it really is a testament to the federal judiciary and its ability to adapt its structure to complex litigation.  By complex litigation I mean a litigation that involves many plaintiffs, multiple defendants, and a very complicated fact pattern. As potential plaintiffs or defendants look at the experience of the federal court system, you should be aware of the alternative was and still is, plaintiffs have the right to file in their local jurisdiction but the fact that the federal courts have adapted and organized this system is really an advantage to both the plaintiffs and the defendants  in terms of an organized process.

Vaginal Mesh Lawsuit Update: Ethicon Cases Progressing in Federal Court

By Long Island News & PRs Published: October 07 2013
The firm is currently offering vaginal mesh lawsuit evaluations for women who allege that they sustained injuries from vaginal mesh implants.
Vaginal Mesh Lawsuit Update: Ethicon Cases Progressing in Federal Court, Rottenstein Law Group LLP Reports
New York, NY – October 7th, 2013 – Ethicon vaginal mesh lawsuits are progressing in federal court notwithstanding a possible mass settlement involving five other mesh manufacturers, according to court documents. The Rottenstein Law Group LLP, which represents clients in vaginal mesh implant injury lawsuits, notes that a recent judicial order offers pretrial recommendations for planning for the first Ethicon bellwether trial.
Judge Joseph R. Goodwin, who is overseeing the consolidation of federal court cases involving six different vaginal mesh manufacturers, issued an order outlining the schedule for pretrial proceedings in the run-up to the February 2014 trial of plaintiff Carolyn Lewis’s lawsuit against Ethicon, according to court documents (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation; MDL-2327, U.S. District Court for the Southern District of West Virginia.)
“So far, news stories indicate that Johnson & Johnson subsidiary Ethicon is not involved in the mass settlement talks,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “That could change, though. It is certainly not unheard of for cases to be settled on the eve of trial, so to speak.”
Although Ethicon is not involved in talks about a mass settlement, there are five manufacturers who are. C.R. Bard, Endo Health Solutions (American Medical Systems), Boston Scientific Corp., Coloplast and Cook Medical are the vaginal mesh manufacturers reported to be involved in the talks, according to Bloomberg.
There are currently more than 30,000 lawsuits pending in a federal court consolidation. The settlement talks are looking to resolve nearly all of those, the article said. So far this year Endo has already paid out more than $50 million in vaginal mesh settlements.
Women are filing transvaginal mesh lawsuits alleging that they have suffered adverse side effects such as pain and discomfort, in addition to device erosion, according to court documents.

Bard, Vaginal-Mesh Makers, Said to Be in Settlement Talks

By Jef Feeley & David Voreacos - Sep 30, 2013 9:41 AM MT

Inc. and four other makers of vaginal-mesh implants accused of injuring women are in talks to settle thousands of lawsuits, people familiar with the discussions said.

Lawyers for Bard, Endo Health Solutions Inc. (ENDP)Boston Scientific Corp. (BSX) and two other companies making vaginal inserts to support women’s pelvic muscles and treat incontinence have begun talks about settling all suits over their products, the people familiar with the matter said. Johnson & Johnson, which also faces suits over the inserts, isn’t involved in the talks, said the people, who asked not to be identified because they weren’t authorized to speak publicly.

Patients’ lawyers want U.S. District Judge Joseph Goodwin in Charleston, West Virginia, who is overseeing federal suits targeting the implants, to appoint a settlement committee, the people said. The group would include plaintiffs’ lawyers Henry Garrard, lead counsel on the Bard cases, and Joe Rice, a lawyer who helped negotiate a $246 billion tobacco-litigation accord on behalf of state attorneys general, the people said.

“I know you all are considering settlement protocols and the possibility of resolutions,” Goodwin said at a Sept. 18 court hearing. He noted the talks were going on “behind the scenes.”

The discussions are aimed at resolving more than 30,000 implant suits already filed that have been consolidated before Goodwin for pre-trial information exchanges, the people said. The talks also include insert makers Coloplast A/S (COLOB) and Cook Medical Inc., they said.

50,000 Claims

The total number of suits could swell to more than 50,000 as more claimants seek to join the potential settlement, the people said.

“The liability seems pretty clear on these cases, so settlement makes sense,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in an interview. “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion-dollar settlement.”

Scott Lowry, a spokesman for Murray Hill, New Jersey-based Bard, didn’t return a call and an e-mail seeking comment on the settlement talks. Ulla Lunhus, a Coloplast spokeswoman, said she couldn’t comment on the talks.

Following Process

“We are following a process that is in accordance with U.S. law,” she said in a phone interview. “As long as that process is ongoing, we are not able to make any comment about it.”

Marsha Lovejoy, a spokeswoman for Bloomington, Indiana-based Cook; Peter Lucht, a spokesman for Natick, Massachusetts-based Boston Scientific; and Blaine Davis, a spokesman for Malvern, Pennsylvania-based Endo declined to comment on the talks.

Bard’s implants have been targeted in more than 12,000 cases while Boston Scientific said in an August regulatory filing it faces more than 12,000 suits over its vaginal devices.

Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, Davis said in an interview. Coloplast and Cook face about 1,000 claims combined, the people added.

J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing. Sheri Woodruff, a spokeswoman for the Ethicon unit of New Brunswick, New Jersey-based J&J, said it would be “inappropriate” to discuss litigation involving other manufacturers.

‘Possibly Unfounded’

“Ethicon is now focusing on trying to efficiently manage thousands of unverified and possibly unfounded complaints,” Woodruff said in an e-mail. The company will “request dismissal of meritless claims, including claims with no compensable injury, claims barred by the statute of limitations, misfiled claims, and improperly filed claims.”

Some manufacturers, such as Bard and Endo, already have settled some suits over the devices. Earlier this year, Endo officials paid $54.5 million to settle an unspecified number of cases alleging the company’s vaginal-mesh inserts were defective.

Coloplast, based in Humlebaek, Denmark, is the furthest along with talks to settle all of the more than 600 cases it faces over its vaginal implants, the people said. The company is aiming to resolve all litigation over the devices by the end of the year, they added.

Trial Losses

Bard officials also have settled some vaginal-mesh cases after losing two trials over the devices. A California state court jury last year found Bard liable for a woman’s injuries related to an Avaulta implant in the first case to go trial in a U.S. court. Jurors said the company should pay $5.5 million in damages. Bard is liable for $3.6 million under that state’s law.

Goodwin presided at the first federal trial of claims over Bard’s Avaulta Plus vaginal mesh in August. A jury ordered the company to pay a total of $2 million in damages to a Georgia woman who said the device damaged her organs.

Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and pain during sex linked to their products.

Bard faces more than 8,000 federal claims over Avaulta, which women allege can cause organ damage and make sexual intercourse painful when the devices erode.

J&J, which opted out of settlement talks, has battled court claims against its withdrawn line of vaginal implants. A New Jersey jury ruled in February the company must pay $11.1 million in damages to a woman who blamed J&J’s Gynecare Prolift for her injuries. It was the first case over the devices to go to trial.

J&J Sales

Officials of J&J’s Ethicon unit told Goodwin last year they would stop selling some vaginal implants after suits over the devices. The company’s executives have declined to participate in settlement talks, the people said.

“I expect Johnson & Johnson (JNJ) to discuss settlement when they think the time is right,” Adam Slater, a New Jersey lawyer who won the February verdict against the company over vaginal devices, said in an interview. Slater said he is preparing for his next trial in March 2014.

Goodwin said in the September hearing that he’s struggling to find ways to move the “mountain” of vaginal-mesh cases through the federal courts and is considering combining multiple plaintiffs’ claims for trial.

“I’m going to keep the bulldozer moving to deal with these cases,” he said.

Settlement Architect

Lawyers for women suing over the inserts have recommended that Goodwin tap plaintiff lawyers Garrard, Rice, Bryan Aylstock of Florida and Clayton Clark, a Texas-based litigator, for a settlement committee empowered to conduct talks with all mesh manufacturers, the people said.

Rice, one of the architects of the 1998 tobacco settlement, is known for his ability to put together accords in high-profile cases. Last year, the 59-year-old lawyer helped negotiate a now $9.6 billion settlement of suits against BP Plc (BP/) over the 2010 oil spill in the Gulf of Mexico. He declined to comment on his role in the vaginal-mesh talks.

The vaginal-mesh litigation poses a challenge for Rice and other settlement negotiators because they are faced with cases over more than 50 different implants manufactured by six different companies, the people said. Some of those products have been pulled from the market while others are still being implanted, they added.

Rice is focusing his attention first on cases involving American Medical Systems’ inserts, the people said. Ellen Reisman, a Los Angeles-based lawyer representing the device maker, was one of BP’s lawyers in Gulf oil spill settlement announced last year, they noted. Reisman was at the Sept. 18 hearing in West Virginia.

Share Activity

Coloplast rose 1.5 percent to 314 kroner ($56.98) in Copenhagen on news of the vaginal-mesh litigation settlement talks. The company’s shares have climbed 13.8 percent this year.

Boston Scientific also rose 1.4 percent to $11.68 in New York trading at 11:36 a.m. JNJ fell 4 cents to $86.69 while Bard fell 81 cents to $114.93. Endo rose 4 cents to $45.65 in Nasdaq trading.

The Bard consolidated cases are In re C.R. Bard Inc. (BCR) Pelvic Repair System Products Liability Litigation, 10-md-02187, U.S. District Court, Southern District of West Virginia (Charleston). The J&J consolidated cases are: In re Ethicon Pelvic Repair System Products Liability Litigation, 12-md-2327 U.S. District Court, Southern District of West Virginia (Charleston).

Transvaginal Mesh Lawsuit News: Federal Judge Overseeing Boston Scientific Vaginal Mesh Lawsuits Selects Bellwether Cases

The bellwether trials will provide important clues into how other juries might weigh claims in similar transvaginal mesh lawsuits involving Boston Scientific.

New York, New York (PRWEB) September 01, 2013

Transvaginal mesh lawsuit claims involving products manufactured by Boston Scientific Corp. continue to move forward in a federal multidistrict litigation underway in U.S. District Court, Southern District of West Virginia, Bernstein Liebhard LLP reports. According to a Pretrial Order issued by the Court on August 29th, four vaginal mesh lawsuits have been selected for the litigation’s first two rounds of bellwether trials. The first round of trials will begin on February 11, 2014, and will involve lawsuits filed over injuries allegedly related to the use of Pinnacle mesh products. The second round will start on June 17, 2014, and will involve cases brought against Obtryx pelvic mesh. (In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation – MDL No. 2326)

“The bellwether trials will provide important clues into how other juries might weigh claims in similar transvaginal mesh lawsuits involving Boston Scientific. We are pleased to see this litigation moving forward,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm’s vaginal mesh lawyers are currently representing hundreds of women who allegedly suffered mesh erosion, pain, scarring, infection and other serious injuries, allegedly due to transvaginal mesh products marketed by a number of manufacturers. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is serving on the Plaintiffs’ Steering Committee in the Boston Scientific litigation.

Vaginal Mesh Lawsuits
Court documents indicate that Boston Scientific has been named in more than 5,800 lawsuits filed on behalf of women who claim that the company’s pelvic mesh products caused them to suffer mesh erosion, chronic pain, infections and other life-altering vaginal mesh complications. Plaintiffs further allege that Boston Scientific failed to provide adequate warnings regarding the risks associated with surgical mesh it marketed for the transvaginal repair of pelvic organ prolapse and stress urinary incontinence.

The litigation surrounding transvaginal mesh devices used to treat pelvic organ prolapse and stress urinary incontinence has been growing since October 2008, when the U.S. Food & Drug Administration (FDA) warned the public that it had received more than 1,000 reports of serious complications associated with vaginal mesh products over a three year period.* Less than 3 years later, in July 2011, the FDA warned that complaints associated with transvaginal prolapse repair had grown five-fold since the 2008 alert, and stated that it no longer considered these types of injuries to be rare.

Boston Scientific is just one of several manufacturers involved in litigations for surgical mesh lawsuits established in the Southern District of West Virginia. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is also serving on the Plaintiffs’ Steering Committees for proceedings involving American Medical Systems, Inc. (MDL No. 2325), C.R. Bard, Inc.(MDL 2326) and Ethicon, Inc. (MDL No. 2327). The first bellwether trial in the federal C.R. Bard litigation concluded earlier this month, with the jury awarding $2 million in compensatory and punitive damages to a woman who suffered vaginal mesh complications following implantation of the company’s Avaulta Plus device. (Cisson v. C.R. Bard Inc., 11-cv-00195)

Mr. Grand has also been named Co-Liaison Counsel in two consolidated litigations established for C.R. Bard and Ethicon transvaginal mesh lawsuits that are currently underway in New Jersey’s Atlantic County Superior Court. He was also a member of the trial team on the first Ethicon trial in that proceeding, which ended in March with an $11 million verdict for the Plaintiff. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10)

Women who have allegedly suffered serious vaginal mesh complications may be entitled to compensation for their medical bills, pain and suffering, and other injuries.To arrange for a free legal consultation call 505-247-2211

kim_fin legal_question_fin

Transvaginal Mesh Claims Continue to Mount as More Women Step Forward

2013-09-23 18:58:35 (GMT) (JusticeNewsFlash.com – Personal Injury, Top Stories)

West Virginia – Recent reports on a defective products/transvaginal mesh (TVM) trial that is moving forward in West Virginia help illustrate the serious nature of the widespread problem for women who have been treated with the vaginal mesh or sling. As the news updates on the transvaginal mesh trial in West Virginia note, the case against C.R. Bard Inc. is one of numerous lawsuits that are part of Multi-District Litigation (MDL) in the state linked to injuries sustained by women because of the medical device. As more women step forward to bring light to the pelvic mesh complications they have experienced, the issue of surgical mesh risks is steadily becoming more of a staple in national headline news.

The Life Care Solutions Group has been tracking the latest news about vaginal mesh for the benefit of those who need more information about these matters along with the progress being made in courts for women who have brought forth transvaginal mesh claims. The group has been established to assist women who have been injured by a mesh or sling implant to better understand their medical and legal options as well as assess any life care planning costs associated with a related claim.

Women who have been injured by the mesh or sling may need to seek assistance to determine whether their TVM claim has merit. Many of these cases involve allegations that the manufacturers of the medical devices used in the treatment of conditions such as pelvic organ prolapse and stress urinary incontinence were aware of the risks associated with them.

Thousands of cases reportedly remain that are part of the MDL in West Virginia. Two upcoming trials are scheduled for August 19 and September 9th.

Mesh MDL Litigation by Attorney Thomas Mucci September 16 2013

Featured

The structure of the litigation is to focus plaintiff’s cases in one form and allow for a procedure in which the federal courts can administer a large number of cases at once. In the present Bellwether cases there are multiple defendants. The mesh products were made by Johnson and Johnson or one of their subsidiaries, Boston Scientific and many others. It is important for people to know who their product was made by.  If you file a case against the wrong manufacturer you can get your case dismissed. Once those cases are filed, there are a series of what is termed “steering committees” , these committees steer the progress of the litigation. The court decides to select what it termed “Bellwether cases” , these are cases selected by both sides to go to trial early. To date a Bellwether case has gone to trial, this resulted in a judgment for the plaintiff of several million dollars and another of these cases was settled. These cases create a mechanism for the court to look at the relative merits of mesh litigation as it relates to specific types of injuries. As you know these injuries can include continued incontinence, thinning of the vaginal walls, urinary tract infections and in more severe cases, cause a need for reconstructive surgery and surgery to remove the device. There is a wide range of symptoms that people suffer, and weather those symptoms can or cannot be attributed to the device, and if they are attributed to the device, what the damages are appropriate for a series of injuries outlined in litigation are important to determine.

Contact Kim Brusuelas  at 505-247-9333

Recent Transvaginal Mesh Verdicts and Settlements

A number of women have chosen to hold mesh manufacturers accountable after suffering damages from these products by taking their fight to court. Manufacturers have already paid millions in compensation to these injured women and their husbands. American Medical Systems paid $54.5 million to settle an undisclosed number of cases, and individual women have also received jury awards, including:

$5.5M

Christine Scott’s Verdict

In July 2012, a California jury awardedChristine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

$11.11M

Linda Gross’s Verdict

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries.

$2.0M

Donna Cisson’s Verdict

A West Virginia jury awarded Donna Cisson $2 million in August 2013. Cisson sued C.R. Bard after she was implanted with the company’s Avaulta Plus mesh and suffered serious complications.

 

Transvaginal Mesh Lawsuits

August 31, 2013, By Lucy Campbell

 

Tens of thousands of transvaginal mesh (TVM) lawsuits have been filed against the makers of TVM devices. To date, two lawsuits pending against C.R. Bard Inc, the manufacturer of Avaulta, Faslata, Pelvicol and PelviSoft products have been settled.

In March 2013, an $11 million verdict was rendered for the Plaintiff in the first Ethicon trial (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).

All the transvaginal mesh lawsuits allege the products are defective and have resulted in severe health issues ranging from pain during sex to erosion of vaginal tissue and infection to death.

Also known as transvaginal slings, the specific complications associated with TVM include the following:
• mesh erosion into the vagina, bladder, intestines and uterus
• infection
• pelvic pain
• urinary problems, including recurrence of prolapse and/or incontinence
• development of urinary retention
• bowel, bladder and blood vessel perforation during insertion
• vaginal scarring
• dyspareunia (pain with sexual relations),
• fistulas and recurrence of prolapsed organs
• neuropathic pain

Some women have undergone additional surgical procedures, often to remove the mesh, along with IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Here we provide an update on Bard, Johnson & Johnson, and American Medical Systems TVM litigation.

Bard TVM Multidistrict Litigation (MDL)
•The Bard Avaulta litigation was consolidated in October 2010 as part of an MDL in the US District Court for the Southern District of West Virginia.

•A jury hearing the first Bard transvaginal mesh personal injury lawsuit has awarded the plaintiff $2 million in damages. In her lawsuit, Donna Cisson alleges that the mesh, one of the line of Avaulta transvaginal mesh products made by C.R. Bard Inc, which she had surgically implanted, caused her bleeding and pain.

• With thousands of transvaginal mesh lawsuits pending in a multidistrict litigation (MDL) in West Virginia, Cission’s case is a bellwether. The jury found that Bard indeed failed to issue warnings regarding the transvaginal mesh design defect. Consequently, they awarded Cisson $250,000 in compensatory damages and $1,750,000 in punitive damages.

• A second bellwether trial to go to federal court in a West Virginia was settled August 21 against Bard. The plaintiff, Wanda Queen, alleged her implanted Avaulta transvaginal mesh caused her injury and complications, forcing her to undergo six surgeries. Settlement terms between the company and the court were not released. Scott Lowry, a spokesman for C.R. Bard, said the settlement only covered this particular case, and not the thousands of pending lawsuits against the company.

• The implant cases against Bard and other manufacturers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges. Two other trials are set for October, according to court dockets.

• The Bard consolidated cases are In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187. Queen’s case is Queen v. C.R. Bard Inc., 11-cv-00012, U.S. District Court, Southern District of West Virginia (Charleston).

• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for the trying of all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.

• Bard also faces the first trial in state court coordinated litigation in Atlantic City, New Jersey, on September 23, the National Law Journal reports.

• Bard, based in Georgia, manufactures, distributes and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:

Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Faslata® Allograft
Pelvicol® Tissue
PelviSoft® Biomesh

Transvaginal mesh lawsuits involving Johnson & Johnson
• TVM lawsuits pending against J&J’s subsidiary Ethicon are also progressing in federal court in West Virginia, according to court documents.

• The next status conference, in which pretrial proceedings will be discussed, will be held at 10 a.m. on Sept. 19, according to court documents (In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation; MDL-2327, U.S. District Court for the Southern District of West Virginia).

Transvaginal Mesh Lawsuits Involving American Medical Systems
• Transvaginal mesh lawsuits filed against American Medical Systems, Inc. continue to move forward in a federal MDL also underway in U.S. District Court, Southern District of West Virginia.

• According to a Pretrial Order issued on July 29, the Court has granted the parties’ Joint Motion for an Agreed Order and Stipulation Regarding Third-Party Subpoenas.

• Court documents indicate that more than 8,860 vaginal mesh lawsuits are now pending against American Medical Systems in the federal litigation (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation – MDL No. 2325).

• All of the mesh lawsuits pending in the American Medical Systems litigation allege the company failed to provide adequate warnings regarding the risks associated with its transvaginal mesh devices.

• According to court documents, the first bellwether trial of an American Medical Systems vaginal mesh lawsuit is set to begin in December.

Other TVM Manufacturers
• Endo Health Solutions Inc, and Boston Scientific Corp face similar claims to Bard and J&J, specifically that their implants, threaded in place through vaginal incisions, shrink over time – a design defect that can result in severe health consequences.

•The FDA has also received many adverse reports regarding other transvaginal mesh devices, including the Gynecare TVT sling. TVT systems typically involve mesh tape with vaginal sling surgery, also known as a TVT sling procedure, which results in a transvaginal sling to correct urinary incontinence.

MDLs pending in West Virginia & Georgia
• The implant cases against Bard and other manufacturers have been consolidated before US District Judge Joseph Goodwin in Charleston for pretrial information exchanges.

• Two other trials are set for October, according to court dockets.

• To date, more than 20,000 mesh lawsuits have been filed against a number of other implant manufacturers in separate litigations: Mentor Corp.; MDL-2004, U.S. District Court for the Middle District of Georgia. C.R. Bard, American Medical Systems, Boston Scientific, Ethicon, Coloplast and Cook Medical; MDLs-2187, 2325, 2326, 2327, 2387, and 2440, U.S. District Court for the Southern District of West Virginia.

TVM History & Facts
• The US FDA approved the Avaulta transvaginal mesh device using a fast-track approval process known as 510(k) in 2005.

• The expedited process does not require formal review of a product’s safety, and has allowed many controversial products, which were later recalled, to be introduced to the market.

• Since the device was approved, the FDA has received over a thousand reports of complications associated with surgical mesh.

• In October 2008, the FDA issued an alert about complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). At the time, the FDA noted that in the previous three years, it received more than 1,000 reports from nine surgical mesh manufacturers of complications associated with their surgical mesh devices.

• On July 13, 2011, the FDA issued a public notice regarding the use of transvaginal mesh (TVM) for the treatment of POP and SUI. Doctors and their patients are now advised to consider alternatives to TVM.

 

Endo Health offers $54.5 million to settle some vaginal mesh cases

By Jessica Dye

NEW YORK, June 21 | Fri Jun 21, 2013 2:55pm EDT

(Reuters) – A unit of Endo Pharmaceuticals Inc said it has agreed to pay $54.5 million to settle some of the thousands of lawsuits in North America that it is facing over injury claims stemming from the use of transvaginal surgical mesh products.

Endo unit American Medical Systems Inc announced the settlement in a regulatory filing with the U.S. Securities and Exchange Commission on Thursday. The company did not disclose how many cases would be resolved by the agreement, in which the company did not admit any liability or fault.

AMS estimated its potential liability as of March 31 from all current and future vaginal mesh cases to be at least $160 million, according to another SEC filing. Settlement details were not disclosed.

AMS is one of several companies facing thousands of lawsuits over transvaginal mesh devices in U.S. state and federal courts, as well as Canada. The devices are designed to treat pelvic organ prolapse and stress urinary incontinence.

Market data submitted to the FDA showed that in 2010, approximately 300,000 women underwent surgery for pelvic organ prolapse, and roughly one in three of those used mesh. That same year, about 260,000 women underwent surgery for stress urinary incontinence, 80 percent of which involved transvaginal mesh.

Plaintiffs in the lawsuits have alleged a variety of injuries stemming from the devices, including chronic pain and incontinence.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other transvaginal device makers to conduct post-market safety studies and monitor the rate at which adverse events were reported.

AMS said it has been hit with thousands of lawsuits since 2008 and expects the number to climb, according to a regulatory filing from May. As of April 26, there were approximately 7,700 mesh cases pending against AMS, Endo and certain subsidiaries, an SEC filing said.

A spokesman for Endo did not immediately return a request for comment Friday.

Shares in Endo were down .32 percent or 12 cents to $37.38 in late afternoon trade.