VAGINAL MESH IMPLANT

JULY 28, 2014By: Jacky Gale

Judge Carol E. Higbee upheld an $11.1 million jury verdict, which resolved a vaginal mesh lawsuit filed in 2008 on behalf of a woman and her husband. Johnson & Johnson and the company’s subsidiary, Ethicon, had sought to overturn the verdict. However, Judge Higbee rejected the company’s post-trial motions and denied their request for a new trial. The vaginal mesh lawsuit verdict awarded the plaintiff $3.35 million in compensatory damages, plus $7.76 million in punitive damages.

According to the plaintiff’s complaint, she had received the defendant’s Gynecare Prolift sling device during a surgery in 2006 for the purpose of treating pelvic organ prolapse (POP).

Her lawsuit claimed the device hardened improperly while it was inside her and subsequently eroded through the vaginal wall. Her lawsuit pointed to 18 subsequent surgeries she was forced to undergo, which removed pieces of the mesh. Despite the revision surgeries, the plaintiff alleged significant and unresolvable pain that interfered with her ability to sit and caused intercourse to be painful.

Vaginal mesh lawsuit verdict upheld for Gynecare plaintiff

The plaintiff received the favorable verdict in February 2013, after which Johnson & Johnson attempted to appeal. The defendants claimed in their post-trial motions that the punitive damages were not allowable by the law and that the plaintiff’s evidence did not adequately prove her claims. Ethicon further argued that the jury verdict involved an excessive amount of money.

Judge Higbee rejected the defendants’ arguments, stating that the evidence presented at trial was sufficient to support the plaintiff’s claim that Ethicon had withheld warnings of the risks of the Gynecare mesh, despite knowing that there were problems with it.

Johnson & Johnson had attempted to argue that punitive damages were erroneously awarded because, under New Jersey law, the FDA’s approval preempted them. However, as the Judge noted in her ruling, the plaintiff’s injuries were sustained two years before the FDA granted approval for the medical device. Therefore, the Judge ruled the plaintiff could be granted punitive damages. Judge Higbee further noted that the substantial size of the vaginal mesh lawsuit verdict was not excessive because the jury could have granted even more in damages.

Gynecare mesh withdrawn from the market

On May 10, 2012, Ethicon informed the FDA that it planned to withdraw many of its Gynecare mesh products from the market. This move did not constitute a recall of the device. The company still planned to continue selling its Gynecare Gynemesh product, with the caveat that it be inserted only through the abdomen, rather than the vagina. The defendants planned to withdraw the products gradually, phasing them out completely by the beginning of 2013.

Industry experts speculated that the withdrawal of the products from the market was in response to the numerous adverse event reports involving serious complications, in addition to several deaths reportedly associated with the devices. Additionally, while the plaintiff in this particular vaginal mesh lawsuit has achieved resolution of her case, Johnson & Johnson still faces thousands of product liability lawsuits filed by plaintiffs who received the product.

To date, there are still over 18,000 lawsuits pending against Johnson & Johnson, with a total of almost 60,000 lawsuits filed against manufacturers who designed and sold similar vaginal mesh devices. The federal cases have been consolidated as part of various transvaginal multidistrict litigation [MDL]

Bloomberg News

By Jeff Feeley April 04, 2014

Johnson & Johnson  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. 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).

New York, NY: Over 40,000 transvaginal mesh lawsuits have been filed in federal court involving vaginal mesh pelvic repair systems manufactured by multiple medical device companies. While some claims have been settled, a staggering 3,000 TVM lawsuits a month are still being filed.

Thousands upon thousands of women claiming injuries due to transvaginal mesh products have filed in multidistrict litigation in federal court in Charleston, West Virginia. As of January 2014, the following manufacturers have either settled some claims, begun bellwether trial proceedings or are scheduled for trial:

(Bellwether trials take place to help both plaintiffs and defendants by determining how juries are likely to respond to evidence and testimony presented. These trials are the norm in complex medical device litigation, particularly in the case of transvaginal mesh products involving multiple medical device companies. Representative cases for bellwether selection include women aged 40 and 60 years old at the time when they had the pelvic mesh surgeries, with three or less revision surgeries. A successful outcome typically indicates a global settlement.)

American Medical Systems (AMS)

AMS transvaginal mesh cases were scheduled to begin last December. AMS has already agreed to settle a number of cases for $54.5 million, and the company is expected to attempt a global settlement in many more of the 6,000 cases pending in federal court in West Virginia before Judge Joseph R. Goodwin (In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation; MDL-2187, U.S. District Court for the Southern District of West Virginia).

According to court documents, at least two bellwether trials resulted in compensation for the plaintiff. In August 2013, a jury awarded plaintiff Donna Cisson about $2 million in damages and plaintiff Wanda Queen settled out of court for an undisclosed sum.

Court documents also show that more than 14,000 vaginal mesh lawsuits now pending in the Southern District of West Virginia involve AMS. Every complainant alleges that AMS was used to treat pelvic organ prolapse or stress urinary incontinence, but their TVM surgery resulted in mesh erosion, organ damage, chronic pain and other serious vaginal mesh complications.

The first AMS bellwether trial is scheduled to begin on April 7, 2014. The second trial is set for May 5, 2014.

According to a Bloomberg report (September 30, 2013), Bard in September joined Endo Health Solutions (American Medical Systems), Boston Scientific, Cook Medical Systems and Coloplast in talks to settle tens of thousands of federal and state vaginal mesh lawsuits.

C.R. Bard

C. R. Bard, the maker of Avaulta transvaginal mesh, settled the first of four bellwether trials (U.S. District Judge Joseph R. Goodwin presiding) last summer with a $2 million verdict including punitive damages. Bard was accused of failing to warn women about the risk of side effects. The second trial resulted in an agreement to settle during the first trial day. The third trial was voluntarily dismissed by the plaintiff. Another bellwether trial slated for January 10, 2014 has been postponed until May 19, 2014 (Jones v. C.R. Bard, Inc., No. 2:11-cv-00114, U.S. District Court for the Southern District of West Virginia).

More than 6,500 claims have been filed against Bard on behalf of women who suffered severe side effects allegedly due to its Avaulta mesh. Court documents indicate that an additional 940 Avaulta transvaginal mesh lawsuits pending in a multicounty litigation are underway in New Jersey (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
Boston Scientific

Thousands of Boston Scientific Corp. (MDL No. 2326) transvaginal mesh lawsuits are pending in the Southern District of West Virginia, and the first Boston Scientific bellwether trial is slated for March 10, 2014. The second is set for trial on July 14, 2014.

A Pretrial Order dated December 19, 2014 has established that the Court schedule two “waves” of 100 cases each in discovery in the proceeding. The parties have each been directed to select 50 cases for each wave, with the selections for the first wave due by January 21, 2014. Second wave case selections are to be submitted by May 21, 2014. (In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation – MDL No. 2326.)

The cases are limited to women who received only the Boston Scientific Obtryx, Advantage/Fit, Pinnacle or Uphold products, excluding cases where multiple different products were used.

Ethicon Gynecare

Johnson & Johnson’s subsidiary Ethicon Gynecare transvaginal mesh lawsuits are scheduled for trial in August 2014. Ethicon’s Prolift mesh went to trial in New Jersey and ended with the jury awarding the plaintiff $11 million in compensatory and punitive damages (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).

The Ethicon MDL in West Virginia federal court is preparing for its first bellwether trial in February 2014, which involves about 13,000 cases. The selected case for the trial involves plaintiff Carolyn Lewis ( Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301). The Ethicon MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL no. 2327 in the U.S. District Court for the Southern District of West Virginia.

As well, Ethicon is being investigated by government agencies for making false claims and engaging in deceptive marketing of its surgical mesh. According to documents filed in In re: Ethicon Inc., Pelvic Repair System Products Liability Litigation; MDL-2327, U.S. District Court for the Southern District of West Virginia, on January 23, 2014, the federal court overseeing the multidistrict litigation involving vaginal mesh products manufactured and sold by Ethicon heard arguments related to a motion accusing Ethicon and its parent company, Johnson & Johnson, of either losing or destroying “at least tens of thousands, maybe hundreds of thousands, of documents that likely contain information relevant to plaintiffs’ claims.”

Attorneys are closely watching bellwether trials - as they believe these cases will have an important impact on state and federal cases.

February 1, 2014, 08:00:00AM. By Jane Mundy

12/09/2013 // West Palm Beach, Florida,

West Virginia –Johnson& Johnson officials have been accused of getting rid of files linked to its transvaginal mesh implants that they were ordered by executives to maintain. As reported by Bloomberg, patients’ attorneys have asserted in a court filing that the company should not be allowed to rely on certain defenses in pending trials over the implants due to the loss of the documents, which are stated to potentially be hundreds of thousands.

The attorneys are quoted as writing in the recent court filing, “Ethicon’s document destruction has severely prejudiced the plaintiffs for the upcoming bellwether trials…Defendants should not benefit from the gaps in plaintiffs’ story that defendant created.”

Matthew Johnson, a spokesman for Ethicon, is quoted in the report as stating in an emailed statement in response to the claims, “We have never intentionally destroyed, withheld or failed to produce relevant documents.”

As noted in the report, the U.S. Food and Drug Administration ordered J&J and other mesh manufacturers to study organ damage rates and other health complications linked to vaginal mesh implants last year.

This report is provided by Justice News Flash – 

DECEMBER 4, 2013By: Katherine Thomas

The last of the Bard bellwether transvaginal mesh trials began on December 3 in West Virginia federal court.  The Bard Avaulta mesh lawsuit was originally scheduled to be tried in November, but the judge on the case issued a notice postponing it for a month.  The Avaulta line of vaginal mesh products had been used to treat pelvic organ prolapse (POP) and female stress urinary incontinence before it was taken off the market by Bard in July 2012 rather than comply with FDA-mandated testing.

Why women file a Bard Avaulta mesh lawsuit

There are more than 4,800 transvaginal mesh lawsuits in the federal court system against New Jersey-based-C.R. Bard over the Avaulta line of mesh, which many women claim can erode, leading to organ damage and painful sexual intercourse.  The complaints against Bard involve similar allegations that the vaginal mesh was defectively designed and sold without adequate warnings about the risks associated with it. Bard officials pulled the Avaulta mesh off the market in 2012 after the FDA ordered manufacturers of transvaginal mesh to study rates of organ damage, infection, and other complications associated with pelvic mesh devices.

The lawsuits are pending before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of a litigation. They were consolidated into multidistrict litigation with the goal of streamlining the pretrial process by conserving resources and judicial time.

As part of the coordinated pretrial proceedings, four cases were selected for early trial dates.  These cases are known as “bellwethers,” because they are designed to help the parties in the lawsuit gauge how juries are likely to respond to evidence that may be repeated throughout each case.

Results of Bard transvaginal mesh trials

The first bellwether trial began in July 2013.  The plaintiff, a nurse from Georgia, won a jury award of $250,000 in compensatory damages and $1.75 million in punitive damages, which are designed to punish the defendant for its actions in the manufacture and sale of the transvaginal mesh.  The nurse had alleged that the mesh damaged her organs and caused other ailments. In the second bellwether hearing the parties reached a settlement agreement during the first day of trial.  Bard agreed to pay an undisclosed amount to a North Carolina woman who said she experienced pain and suffering, permanent injury, and physical deformity because of the transvaginal mesh.  The third bellwether case was cancelled after the plaintiff voluntarily dismissed the case.

Pelvic mesh lawsuits coordinated as Multi-District Litigation

Judge Goodwin is also presiding over five other multidistrict litigations involving transvaginal mesh made by other companies, including American Medical System, Ethicon, Boston Scientific, Coloplast, and Cook Medical.  These companies face a combined total of over 30,000 lawsuits in the federal courts over injuries allegedly caused by the transvaginal mesh.

The legal proceedings for five of the multidistrict litigations are being handled in the U.S. District Court for the Southern District of West Virginia.  There is also a multidistrict litigation for Mentor Corp., another manufacturer of vaginal mesh, which has been established in the U.S. District Court for the Middle District of Georgia.

 For further information, contact the Foulston Law Firm by using the contact form at the top of the page. 

October 10, 2013By: Ava Lawson

Bloomberg reports that several pelvic mesh manufacturers including C.R. Bard, Boston Scientific and Endo Health Solutions may be entering behind-the-scenes talks with plaintiffs in an effort to negotiate transvaginal mesh settlements. Insiders who are familiar with the ongoing vaginal mesh litigation told the news source that plaintiffs are hoping U.S. District Judge Joseph Goodwin, who is presiding over the federal suits, will appoint a settlement committee that would include legal counsel for both parties, including an attorney who facilitated a monstrous $246 billion tobacco-litigation settlement on behalf of state attorneys general.

The federal judge who is overseeing all pelvic mesh injury lawsuits consolidated in multidistrict litigations in West Virginia district court noted that vaginal mesh lawsuit settlement talks are taking place behind closed doors at the moment, and may also include defendants Cook Medical and Cotoplast, though this information has not been confirmed.

Possible transvaginal mesh settlements in the works

While the federal products liability litigation concerning serious and often debilitating transvaginal mesh complications has swelled to include more than 25,000 cases against six different manufacturers, many suspect that claims could easily exceed 50,000 in the coming months. Any settlement agreement would take into account a plaintiff’s medical expenses related to her injuries or mesh revision surgery, and would attempt to compensate for damages including lost wages, physical and emotional trauma, and loss of spousal consortium.

Carl Tobias, a teacher of products liability law at University of Richmond, VA told Bloomberg, “The liability seems pretty clear on these cases, so settlement makes sense.” Meanwhile, spokespersons for Boston Scientific, Cook Medical, Bard and others have declined to comment on any pending transvaginal mesh lawsuit settlements.

At present, there are six separate transvaginal mesh MDLs, all involving various types of mesh implants, surgical slings and patches. Though the devices are designed and manufactured by different companies, many of the allegations made by plaintiffs are similar in nature. Women who’ve filed a vaginal mesh lawsuit claim they’ve suffered chronic infections, painful sexual intercourse, mesh erosion, internal organ damage and other complications caused by faulty design or materials that were incompatible with human tissue.

Vaginal mesh lawsuit trial losses

Bard stopped selling its Avaulta pelvic mesh implants last year after the FDA ordered that all mesh manufacturers conduct additional studies on the safety and efficacy of its products. Bard has also negotiated settlements with some cases after jurors handed down two verdicts in favor of the plaintiffs.

In an Avaulta mesh lawsuit last year, a California state jury awarded a woman $5.5 million in compensatory damages for her injuries, of which Bard was liable for $3.6 million under California law. Under the guidance of Judge Goodwin, the first federal case against Bard was heard this past month. The Charleston, West Virginia panel decided Bard was liable for a Georgia woman’s organ damage and rendered a $2 million verdict for the plaintiff.

If Goodwin appoints a settlement committee, thousands of injured plaintiffs may finally achieve resolution of their claims and secure just compensation for their pain, suffering and other losses. However, the mesh litigation poses a challenge for potential settlement negotiators since they are faced with suits involving more than 50 different products (some of which have already been pulled off the market) made by several companies.

More than 30,000 Women Have Filed Vaginal Mesh Defective Product Lawsuits

A medical product that was supposed to make women’s lives better has reduced the quality of life for many. Vaginal mesh and slings  have had a very negative impact on the lives of many women and now lawyers for Boston Scientific Corp. and two other companies making vaginal inserts to support women’s pelvic muscles have begun talks to deal with the defective product lawsuits that more than 30,000 women have filed so far.

As many as thirty to fifty percent of women may experience Pelvic organ prolapse in their lives and it occurs when a pelvic organ-such as your bladder-drops (prolapses) from its normal spot in your lower belly and pushes against the walls of your vagina. This can happen when the muscles that hold your pelvic organs in place get weak or stretched from childbirth or surgery. The medical device chosen to fix this problem in many women was vaginal mesh or a vaginal sling. Vaginal mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue.

The problem with this medical device is that it can begin to erode and damage other organs. In some cases the mesh breaks through the incision or intact vaginal lining. This results in symptoms such as bleeding, vaginal discharge, odor, and often scratching of the male partner with intercourse.

The FDA issued the warning that serious complications associated with the surgical meshfor transvaginal repair of POP were not rare. This was a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

However despite the warnings from the FDA manufacturers kept producing and distributing the product. Now the lives of many women have taken a turn for the worse. This can be a difficult issue for some women to speak with a lawyer about. However not speaking up can mean forgoing any compensation to help repair or move on from the injury.

Bard Loses $2 Million Verdict in Vaginal-Mesh Implant Trial

C.R. Bard Inc. was told by a jury to pay $2 million to a woman who alleged the company hid flaws within some of its vaginal-mesh implants in the first federal trial of claims over the devices.

Jurors in Charleston, West Virginia, deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable for injuries Donna Cisson blamed on its Avaulta line of devices. The jury awarded $250,000 in compensatory damages for Cisson’s injuries plus $1.75 million in punitive damages.

Bard, based in Murray Hill, New Jersey, still faces more than 8,000 other claims over its Avaulta devices, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson,Endo Health Solutions Inc. and Boston Scientific Corpface similar claims that their implants, threaded in place through vaginal incisions, shrink over time.

“This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.”

Bard officials said they dispute the jury’s finding that Cisson’s injuries were caused by the vaginal implant and will appeal.

‘Compelling Grounds’

“We disagree with the verdict reached by the jury and believe there are compelling grounds for reversal. We will appeal,” Scott Lowry, a Bard spokesman, said yesterday in an e-mailed statement. “Our Avaulta mesh products are safe and effective medical devices, cleared by the FDA.”

Bard fell 1.7 percent to $133.47 in New York Stock Exchange composite trading. The shares have gained 16 percent this year.

The implant cases against Bard and other manufacturers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges. Goodwin, who presided over Cisson’s case, also will preside over an Aug. 19 trial. Two other trials are set for next month.

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.

A California state court jury last year found Bard liable for a woman’s injuries tied to an Avaulta implant in the first case to go trial in any U.S. court. Jurors ordered the company to pay $5.5 million in damages. Bard is liable for only $3.6 million of that award under state law.

Mesh Removed

Cisson, a public-health nurse from Toccoa, Georgia, got an Avaulta Plus implant in 2009 to buttress organs that were collapsing into her pelvic region, according to evidence in the case. Cisson had several surgeries to remove the mesh after she began suffering pain, bleeding and bladder spasms.

Her lawyers argued during the two-week trial that Bard officials put profits ahead of safety by ignoring warnings about defects in the Avaulta implants.

Bard officials knew the company was making the implants out of plastic which carried a warning that it shouldn’t be permanently implanted in humans, Garrard, an Atlanta-based lawyer, told jurors.

“You have not heard Bard come here and say we accept responsibility and want to make amends,” Garrard told jurors in the punitive-damages phase of the case. He urged them to return an award that would “get the attention” of the company’s executives in New Jersey.

‘No Intent’

Bard’s lawyer countered that company officials properly designed and manufactured the implants and had shown “no intent to harm” Cisson or other women with the mesh.

The company “complied with industry standards” in producing the implants and didn’t deserve to be punished, Lori Cohen, one of Bard’s lawyers, told jurors.

Jurors found that Bard officials defectively designed the Avaulta implants and failed to properly warn doctors and women about the mesh’s flaws. They also found that company officials ‘mishandling of the devices amounted to “malice, fraud or wantonness” that deserved punishment, according to the verdict form in the case.

“The economic cost of ignoring patient safety just got a little more expensive,” Paul Farrell Jr., a Huntington, West Virginia-based lawyer representing Cisson, said after the verdict was announced.

Under Georgia law, 75 percent of Cisson’s $1.75 million punitive-damages award will be handed over to the state’s general fund.

Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. Goodwin ruled earlier that plaintiffs couldn’t mention Bard had withdrawn the products.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).