Lawsuits

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http://www.bloomberg.com/news/2013-...astic-found-unfit-for-humans-by-supplier.html

Bard Used Mesh Plastic Found Unfit for Humans by Supplier
CR Bard Inc. (BCR) sold vaginal-mesh devices made of a plastic that its manufacturer warned wasn’t suitable for human implantation, according to unsealed court records.

Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh after the material’s supplier officially registered a warning that it shouldn’t be permanently implanted in people, according to e-mails and documents in a lawsuit over Bard’s implants. Plaintiffs suing Bard contend the same mesh was used in some of Davol’s vaginal-mesh products.

In 2004 and 2007 e-mails filed in federal court in West Virginia, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.

Suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” Roger Darois, the Davol executive, now a Bard vice president, said in a March 2004 e-mail. “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”

Lawyers for thousands of women who blame Bard’s Avaulta line of implants for their injuries said the files show Davol officials knew the resin-based mesh wasn’t proper for human implantation and tried to cover up their use of the material.

Bard Statement

In a statement yesterday, Bard didn’t respond to a question about its desire to keep the information from suppliers. Company officials declined to elaborate on the statement.

Bard, based in Murray Hill, New Jersey, faces a July 8 trial in Charleston, West Virginia, over claims its mesh device harmed Donna Cisson, 54.

“During the upcoming trial, Bard will provide all the relevant evidence for the jury to consider and render a decision, which will demonstrate that Bard acted appropriately in its acquisition of polypropylene resin,” Scott Lowry, a Bard vice president, said in yesterday’s e-mailed statement.

“We believe that the Avaulta polypropylene mesh implant is a safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions,” Lowry said. “To this day, after more than 50 years of use, polypropylene remains one of the most widely implanted and best materials for mesh products in medical applications in the human body.”

Lowry didn’t comment on the e-mails filed in federal court.

Judge’s ruling

U.S. District Judge Joseph Goodwin ruled June 4 that the e-mails regarding the resin-based mesh raised “a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.”

Lawyers for Cisson, who lives in Georgia, will use the e-mails in next month’s trial over whether the Avaulta design was defective and Bard failed to warn of the risks. Cisson claims the device caused her pain, bleeding and bladder spasms that required follow-up surgeries.

She can seek punitive damages if jurors hold Bard liable for compensatory damages and find the company’s conduct justifies the additional award, the court ruled.

Goodwin is overseeing 20,000 lawsuits against Bard, Johnson& Johnson (JNJ), Endo Health Solutions Inc. (ENDP)’s American Medical Systems, Boston Scientific Corp. (BSX), Coloplast Corp. and Cook Medical Inc. alleging injuries from vaginal mesh implants. The companies have denied wrongdoing in court filings.

Cisson’s case will be the first against any of those companies to go to trial before Goodwin, who is coordinating the pretrial exchange of information.

Bellwether Trials

Three more “bellwether trials” involving Bard’s vaginal inserts are scheduled before Goodwin after Cisson’s case. The trials will be used to gauge the validity of the two sides’ conflicting claims.

The women who sued contend erosion of the inserts, designed to shore up weakened pelvic muscles and treat urinary incontinence, can cause organ damage and bleeding and make sexual intercourse painful. They said the meshes, threaded in place through vaginal incisions, degrade and shrink over time.

U.S. Food and Drug Administration officials estimate that 300,000 women had pelvic organ prolapse surgery in 2010 and mesh was used in a third of the procedures. Agency data showed more than 250,000 incontinence surgeries for women that year, about 80 percent involving vaginal-mesh implants, the FDA said.

The agency last year ordered Bard, J&J and other mesh makers to make three-year studies of rates of organ damage, infection and painful sex linked to the devices after women’s groups called for their removal from the market.

Sales Halted

J&J, based in New Brunswick, New Jersey, said last year it would stop selling four lines of vaginal-mesh implants after complaints and lawsuits about the devices. The company acted for reasons unrelated to safety concerns, it said at the time.

A jury in Atlantic City, New Jersey, decided in February that J&J and its Ethicon unit must pay more than $11 million in damages to a woman who blamed the company’s Gynecare Prolift implant for her injuries.

A California state court jury last year awarded $3.6 million to a woman who blamed Bard’s Avaulta Plus implant for injuring her. It was the first such case to be tried in any court. The Avaulta inserts, sold in the U.S. since 2005, were pulled off the market last year.

A Bard official said in a January 2012 internal e-mail that, in response to the FDA ordering safety studies on vaginal-mesh devices, the company planned to pull Avaulta devices off the market that year.

‘Business Decision’

The company “is simply making a business decision not to invest in clinical trials on this product,” Brenda Hammans, a vice president, said in the e-mail.

In Cisson’s case, the Georgia woman alleged the Avaulta device, inserted in May 2009, caused pelvic and rectal pain, bleeding and bladder spasms and required surgeries to remove.

Goodwin unsealed Bard documents and witness depositions about how its vaginal-mesh products were designed, tested and marketed. Cisson’s lawyers fault Bard for not testing the mesh on people before selling it. Plaintiffs’ lawyers obtained e-mails in the pretrial exchange of information with the company.

Medical companies have used polypropylene for years to make items such as sutures, catheters and artificial-heart components because the material is considered to be “biocompatible” and won’t be rejected by the human body.

Safety Document

Cisson’s lawyers said in court papers that Phillips Sumika, a Woodlands, Texas-based unit of Chevron Phillips Chemical, filed a required safety data document, called a “Material Safety Data Sheet,” with the U.S. Occupational Safety and Health Administration about the Marlex polypropylene used in some Bard hernia and vaginal implants.

On the 2007 document’s front page, Phillips Sumika put a “Medical Application Caution” about the product. Chevron Phillips is a petrochemical venture involving U.S. oil producer Chevron Corp. (CVX) and refiner Phillips 66. (PSX)

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to the disclosure unsealed in Cisson’s case.

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use,” according to the warning.

Chemical Reactions

The caution stated that the resin-based plastic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides.” Cisson’s lawyers said human bodies can produce such oxidizing agents and the reaction can cause the mesh to erode.

Despite the warning, officials of Cranston, Rhode Island-based Davol purchased Phillips Sumika’s resin-based plastic from other companies that bought it in their own names, according to Cisson’s lawyers. Davol used the material as the base for hernia-repair and vaginal-mesh devices, the attorneys said in court papers.

Darois, the Davol executive, told colleagues in a Nov. 27, 2007, e-mail that a Jarden Corp. (JAH) unit involved in the mesh manufacturing process refused to continue working on the material once it learned Phillips Sumika barred its use in medical devices.

Data Sheet

Managers at the Jarden unit “obtained a copy of Phillips MSDS data sheet which specifically discloses that this resin should not be used for medical implants,” Darois said in the e-mail, referring to the material safety data sheet.

That prompted the company to renege “on a prior verbal commitment to supply one last run” of material used in the mesh, he said. Jarden’s Shakespeare Co. subsidiary, based in Columbia, South Carolina, makes materials used in fishing line and other products containing polypropylene.

In another e-mail the same day, Jim Brann, now Bard’s director of business development, told Darois and other company officials that Shakespeare’s managers refused to continue working on the Phillips Sumika plastic even after Davol executives agreed to cover any resulting legal costs or damages.

The Jarden unit’s officials “responded that under no circumstance, even with indemnity from us” would they produce another shipment of the mesh material, Brann said.

Alecia Pulman, a spokesman for Rye, New York-based Jarden, didn’t immediately return a call and an e-mail seeking comment on the refusal to continue working with Bard’s mesh. Jarden is the maker of Crock-Pot Slow cookers and Mr. Coffee machines.

Business Professor

Erik Gordon, a University of Michigan business professor, said the Avaulta case shows an abuse of the 510(k) process.

“The alleged conduct is unconscionable,” Gordon said in an e-mail. “How can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”

The judge also unsealed Bard officials’ and medical experts’ pretrial testimony on the lack of human testing of the mesh before the company began selling it in the U.S. in 2005.

The mesh was cleared through the FDA’s 510(k) system, which allows medical devices to reach the market without human testing if regulators decide they’re similar to products already for sale. JNJ, Bard and other competitors already had vaginal-mesh inserts on the market when the Avaulta Plus insert Cisson received was approved in 2007, according to court filings.

Dozens Cleared

“The FDA cleared Bard’s mesh devices after scrutiny of Bard’s submission, including substantial biocompatibility testing, just as the FDA had already cleared dozens of other companies’ mesh products made of polypropylene,” Lowry, the Bard spokesman, said in the company’s statement.

Jim Ross, a Salinas, California-based gynecologist who worked as a Bard consultant on the vaginal implants, testified in a deposition that he suggested clinical trials of the devices, to no avail.

“I felt at least a pilot study would have been good to do,” he said.

Ross said he and Bard officials concluded the vaginal-mesh technology was developing so quickly that a multiyear clinical trial wouldn’t be worthwhile.

“We were able to determine that it was going to cost several million dollars and there was no way that we could do it, collect the evidence, write it up and get it in publication for probably three to four years minimum,” Ross said. “The field was moving so rapidly” that the results would be outdated by that time, he said.

Clinical Trials

Melissa Johnson, a Bard manager involved in the marketing of vaginal-mesh implants, testified that doctors and company salespeople asked for clinical-trial results showing Avaulta was superior to competing implants.

“There wasn’t anything published that I was at liberty to provide,” she said.

Robert Orr, a Bard manager who helped oversee product research, said in a deposition that a company study of vaginal mesh in sheep didn’t yield needed data on its use in women.

“I would say it gives you an indication of how the body will incorporate it and the type of response that you will achieve,” Orr testified, referring to a clinical trial. “Does it totally simulate the clinical response? No, it’s not the whole product.”

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
 






Bard Settles Second Federal Transvaginal Mesh Lawsuit for Undisclosed Amount

CHARLESTON, W.Va. — A company at the center of thousands of lawsuits regarding its transvaginal mesh devices settled with a plaintiff today just moments before trial proceedings were set to begin. The trial was supposed to be one of four “bellwether” federal lawsuits of more than 26,000 consolidated in U.S. District Court for the Southern District of West Virginia. The jury of five men and four women, chosen Monday, were thanked for their time and sent home before 10 a.m. EDT today.
In Queen v. C.R. Bard Inc., plaintiffs Wanda and Greg Queen alleged an Avaulta Solo device caused permanent injury, pain and suffering, and will require one or more surgeries to remove, after it was implanted to treat pelvic organ prolapse. Mr. Queen also sued for loss of consortium related to his wife’s injuries.
Laura Yaeger, who is part of the Plaintiffs’ Steering Committee for the federal mesh cases, told Drugwatch: “As with any verdict or settlement, it may set the tone for other pending cases and might be an indication of the manufacturers’ willingness to settle cases instead of going to trial again and again.
“However, it is important to remember that each case has its own individual set of facts and injuries that affect any potential outcome.”

Trial Delayed for Private Meeting
Just before 9 a.m. today, observers in the court witnessed attorneys for the plaintiffs and defendant, as well as the plaintiffs themselves and representatives from Bard, walk into Judge Joseph R. Goodwin’s chambers to speak privately. About 30 minutes later, they all emerged and Mrs. Queen tearfully hugged several of her attorneys.
Once the jury was called into the courtroom, the judge explained that the parties in the lawsuit had reached a settlement and the jurors were excused. Attorneys for both sides, as well as the plaintiffs and defendants, refused to comment on the settlement.
On Tuesday, observers in the courthouse speculated that a settlement might be in the works as attorneys for both sides met with the judge in closed-door sessions, while a notation on the courthouse schedule for the day indicated the parties were in “mediation.”

$2M Verdict Against Bard
The settlement comes just days after a jury found Bard liable for another patient’s injuries and awarded her $2 million. After the verdict, Greg Dadika, Bard’s associate general counsel for litigation, told Drugwatch.com they planned to appeal it.
“We will appeal and continue to rigorously defend against all of the lawsuits regarding this product,” he said after the verdict.
Today’s settlement belies that statement, but it’s unclear how it will affect the thousands of other cases against Bard related to its transvaginal mesh devices.
The next case against Bard is scheduled to begin Oct. 8 in the same courtroom, although it’s unclear if the schedule will change after today’s settlement. With one loss in state court, one loss in federal court and one settlement in federal court, Bard executives were mostly silent today about their plans to resolve thousands of cases pending against them.
Scott Lowry, a Bard spokesman, told Bloomberg that today’s accord covers only Queen’s claims and isn’t part of a larger resolution.
“This is a large, complex litigation, and Bard will consider each case based on the facts and merits,” Lowry said in an e-mailed statement to Bloomberg. “We will continue to vigorously defend against all other lawsuits involving Avaulta.”

Mesh Liability
To date, Bard has been ordered to pay a total of more than $5 million to two plaintiffs, not counting the confidential settlement with the Queens. More than 3,000 federal cases remain pending against Bard, plus state cases.
Last month, American Medical Systems, another company facing lawsuits over its transvaginal mesh products, settled with an unknown number of plaintiffs for $54.5 million. That company faced more than 6,000 lawsuits, and SEC filings from last year indicate it expects total liability for the mesh devices to exceed $160 million.
More than 26,000 complaints over the mesh devices have been consolidated as multidistrict litigation. Boston Scientific, Johnson & Johnson’s Ethicon, Coloplast and Cook Medical also face similar suits. Last week’s verdict against Bard and today’s settlement could be indicators of what will happen with the remaining cases.
 






Anonymous said:
http://www.wvsd.uscourts.gov/MDL/pdfs/minuteentry032113.pdf



MDL update.
http://www.wvsd.uscourts.gov/MDL/amsinc/
Click to expand...
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http://www.wvsd.uscourts.gov/MDL/pdfs/Agenda_052313.pdf

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
In re: American Medical Systems, Inc., Pelvic Repair System MDL No. 2325
Products Liability Litigation
__________________________________
In re: Boston Scientific Corporation Pelvic Repair System MDL No. 2326
Products Liability Litigation
___________________________________
In re: Ethicon Inc., Pelvic Repair System MDL No. 2327
Products Liability Litigation
___________________________________
In re: Coloplast Corp. Pelvic Support Systems MDL No. 2387
Products Liability Litigation
____________________________________
THIS DOCUMENT RELATES TO ALL CASES
AGENDA ITEMS FOR MAY 23, 2013 CONFERENCE
1. General & Specific MDL Issues – Judge Goodwin
a. Tolling agreement
b. Case management/Scheduling Orders for 2014 cases
c. Agenda Issues for MDL 2325 (American Medical Systems, Inc.)
1. Scheduling of hearing on bellwether picks
d. Agenda Issues for MDL 2327 (Ethicon, Inc.)
1. Ethicon/J&J Stipulation
2. Involvement of Plaintiffs’ Executive Committee Members in State Court proceedings/coordination of discovery
3. Scheduling of hearing on bellwether picks
2
e. Agenda Issues for MDL 2326 (Boston Scientific Corporation)
1. Scheduling of hearing on bellwether picks
f. Agenda Issues for MDL 2387 (Coloplast)
1. Progress report on early case assessment program
2. Discussion regarding deadline for submission of docket control order
3. Show Cause Order/Dismissal of Certain Coloplast Entities
g. Upcoming deadlines
2. General & Specific MDL Issues – Judge Eifert
a. Agenda Issues for MDL 2326 (Boston Scientific Corporation)
1. Report on deposition and discovery progress
b. Agenda Issues for MDL 2325 (American Medical Systems, Inc.)
1. Motion pertaining to Dr. Robert Moore
2. Discovery and deposition scheduling
3. Sales representative depositions
 












Anonymous said:
--------------------------------------------------

http://www.wvsd.uscourts.gov/MDL/pdfs/Agenda_052313.pdf

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
In re: American Medical Systems, Inc., Pelvic Repair System MDL No. 2325
Products Liability Litigation
__________________________________
In re: Boston Scientific Corporation Pelvic Repair System MDL No. 2326
Products Liability Litigation
___________________________________
In re: Ethicon Inc., Pelvic Repair System MDL No. 2327
Products Liability Litigation
___________________________________
In re: Coloplast Corp. Pelvic Support Systems MDL No. 2387
Products Liability Litigation
____________________________________
THIS DOCUMENT RELATES TO ALL CASES
AGENDA ITEMS FOR MAY 23, 2013 CONFERENCE
1. General & Specific MDL Issues – Judge Goodwin
a. Tolling agreement
b. Case management/Scheduling Orders for 2014 cases
c. Agenda Issues for MDL 2325 (American Medical Systems, Inc.)
1. Scheduling of hearing on bellwether picks
d. Agenda Issues for MDL 2327 (Ethicon, Inc.)
1. Ethicon/J&J Stipulation
2. Involvement of Plaintiffs’ Executive Committee Members in State Court proceedings/coordination of discovery
3. Scheduling of hearing on bellwether picks
2
e. Agenda Issues for MDL 2326 (Boston Scientific Corporation)
1. Scheduling of hearing on bellwether picks
f. Agenda Issues for MDL 2387 (Coloplast)
1. Progress report on early case assessment program
2. Discussion regarding deadline for submission of docket control order
3. Show Cause Order/Dismissal of Certain Coloplast Entities
g. Upcoming deadlines
2. General & Specific MDL Issues – Judge Eifert
a. Agenda Issues for MDL 2326 (Boston Scientific Corporation)
1. Report on deposition and discovery progress
b. Agenda Issues for MDL 2325 (American Medical Systems, Inc.)
1. Motion pertaining to Dr. Robert Moore
2. Discovery and deposition scheduling
3. Sales representative depositions
Click to expand...

More depositions to happen prior to March 2014.
 






Boston Scientific sees flood of suits over surgical mesh

Don Seiffert
BioFlash Editor- Boston Business JournalEmail

Boston Scientific Corp. (NYSE: BSX) and five other medical device companies are facing a flurry of new lawsuits over a product to treat pelvic organ prolapse in women, as a two-year statute of limitations in many states approaches.

Thousands of lawsuits have piled up against several companies, including Boston Scientific, that make transvaginal mesh to treat pelvic discomfort and urinary incontinence since the U.S. Food and Drug Administration issued a warning on July 13, 2011. The warning updated a 2008 one from the FDA, which found serious complications in some patients who used the products, but said such problems were rare. The 2011 warning not only said the problems actually were not rare, but also conceded that it’s not clear if these products are more effective than traditional procedures that don’t use the mesh.

The FDA found that about 10 percent of women with transvaginal mesh inserts for pelvic repair experienced erosion of the mesh within 12 months of surgery, and has said that more than 4,000 women filed complaints about the products from 2005 to 2010. In addition to the mesh erosion, the FDA also cited complications including pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems.

Natick-based Boston Scientific launched its first transvaginal mesh device, called Protegen, in 1996. Other companies named in these lawsuits are C. R. Bard Inc., American Medical Systems Inc., Johnson & Johnson subsidiary Ethicon Inc., Coloplast Corp. and Cook Medical Inc. Lawsuits filed in federal courts have been consolidated for discovery phase into a multidistrict litigation in federal court in West Virginia, while other lawsuits have been filed in state courts, including in Middlesex County, where Boston Scientific is based.

There have been more than 6,500 lawsuits filed against Boston Scientific in the Southern District of West Virginia since July 13, 2011, with more than half of those filed since the beginning of this year. In May and June, there were more than 1,600 suits filed.

Boston Scientific declined to comment about the suits. But the company has previously said that transvaginal placement of mesh for incontinence and pelvic organ prolapse remains an important treatment option, and that it continues to work with the FDA to ensure that appropriate information about the mesh products is provided to patients and their doctors.

Andrew Fink, an attorney with Solis Law Firm in Chicago who represents some plaintiffs, said many states require product liability lawsuits against medical device companies to be filed within two years of an FDA warning. He said there have been about 16,000 lawsuits filed so far on behalf of patients and their families against six of the makers of the products, and he estimates that many more are expected. “It was considered kind of a miracle product,” he said of transvaginal mesh, in use since the 1990s. “However, ... it really can cause a lot of people problems.”

Public Citizen, a consumer advocacy group that filed a petition with the FDA in 2011 to ban transvaginal mesh, estimates there were 67,500 surgical procedures in the U.S. in 2010 for repair of pelvic organ prolapse using transvaginal mesh.

“You can boil it down to, the manufacturers knew, or should have known, that there were problems with the product,” said Marianne LeBlanc, a principal at Sugarman & Sugarman, a Boston law firm that represents a number of plaintiffs in suits against Boston Scientific.

LeBlanc said that Massachusetts’ statute of limitations in such cases is three years. But many patients are filing lawsuits now ahead of a bellwether case — one chosen by the court as representative of several other cases filed on the same issue — scheduled to go to trial in January 2014 in Middlesex Superior Court. LeBlanc said that the damages that are being sought vary widely — ranging from the cost of medical care, to lost income, to spouses of patients who claim they’re no longer able to have sex with their partners.

“There are cases where women have died,” she said.
 






Anonymous said:
Boston Scientific sees flood of suits over surgical mesh

Don Seiffert
BioFlash Editor- Boston Business JournalEmail

Boston Scientific Corp. (NYSE: BSX) and five other medical device companies are facing a flurry of new lawsuits over a product to treat pelvic organ prolapse in women, as a two-year statute of limitations in many states approaches.

Thousands of lawsuits have piled up against several companies, including Boston Scientific, that make transvaginal mesh to treat pelvic discomfort and urinary incontinence since the U.S. Food and Drug Administration issued a warning on July 13, 2011. The warning updated a 2008 one from the FDA, which found serious complications in some patients who used the products, but said such problems were rare. The 2011 warning not only said the problems actually were not rare, but also conceded that it’s not clear if these products are more effective than traditional procedures that don’t use the mesh.

The FDA found that about 10 percent of women with transvaginal mesh inserts for pelvic repair experienced erosion of the mesh within 12 months of surgery, and has said that more than 4,000 women filed complaints about the products from 2005 to 2010. In addition to the mesh erosion, the FDA also cited complications including pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems.

Natick-based Boston Scientific launched its first transvaginal mesh device, called Protegen, in 1996. Other companies named in these lawsuits are C. R. Bard Inc., American Medical Systems Inc., Johnson & Johnson subsidiary Ethicon Inc., Coloplast Corp. and Cook Medical Inc. Lawsuits filed in federal courts have been consolidated for discovery phase into a multidistrict litigation in federal court in West Virginia, while other lawsuits have been filed in state courts, including in Middlesex County, where Boston Scientific is based.

There have been more than 6,500 lawsuits filed against Boston Scientific in the Southern District of West Virginia since July 13, 2011, with more than half of those filed since the beginning of this year. In May and June, there were more than 1,600 suits filed.

Boston Scientific declined to comment about the suits. But the company has previously said that transvaginal placement of mesh for incontinence and pelvic organ prolapse remains an important treatment option, and that it continues to work with the FDA to ensure that appropriate information about the mesh products is provided to patients and their doctors.

Andrew Fink, an attorney with Solis Law Firm in Chicago who represents some plaintiffs, said many states require product liability lawsuits against medical device companies to be filed within two years of an FDA warning. He said there have been about 16,000 lawsuits filed so far on behalf of patients and their families against six of the makers of the products, and he estimates that many more are expected. “It was considered kind of a miracle product,” he said of transvaginal mesh, in use since the 1990s. “However, ... it really can cause a lot of people problems.”

Public Citizen, a consumer advocacy group that filed a petition with the FDA in 2011 to ban transvaginal mesh, estimates there were 67,500 surgical procedures in the U.S. in 2010 for repair of pelvic organ prolapse using transvaginal mesh.

“You can boil it down to, the manufacturers knew, or should have known, that there were problems with the product,” said Marianne LeBlanc, a principal at Sugarman & Sugarman, a Boston law firm that represents a number of plaintiffs in suits against Boston Scientific.

LeBlanc said that Massachusetts’ statute of limitations in such cases is three years. But many patients are filing lawsuits now ahead of a bellwether case — one chosen by the court as representative of several other cases filed on the same issue — scheduled to go to trial in January 2014 in Middlesex Superior Court. LeBlanc said that the damages that are being sought vary widely — ranging from the cost of medical care, to lost income, to spouses of patients who claim they’re no longer able to have sex with their partners.

“There are cases where women have died,” she said.
Click to expand...

Died?
 












Next Bard vaginal mesh trial set for December; settlement rumors remain

November 20, 2013 | By Mark Hollmer

C.R. Bard ($BCR) is gearing up for yet another lawsuit from a patient alleging injury from an unsafe vaginal mesh implant, but speculation remains that the company and at least some of its rivals will reach a massive, collective settlement in the coming weeks.

The next trial is scheduled to begin on Dec. 3 in U.S. District Court in West Virgina (Jones v. C.R. Bard). So far, the track record in cases involving Bard's Avaulta Plus vaginal mesh implants have been pretty mixed. In August, for example, a West Virgina jury awarded a woman $2 million in compensation and damages in a trial where she alleged the device left her with bladder spasms, bleeding, pelvic and rectal pain. And a West Virginia U.S. district court judge later upheld that verdict in October. Bard has lost at least one other case.

Here's the thing: thousands of lawsuits are pending against Bard and its rivals alleging that their vaginal mesh implants caused injury. But Bard, plus rivals Boston Scientific ($BSX), Endo Health Solutions ($ENDP), Coloplast and Cook Medical are rumored to be negotiating to resolve the remaining cases.

There are whispers that such a deal may be close, perhaps involving a combination of at least some of the companies. Legal-Bay, a firm that bills itself as a "lawsuit settlement funding company," noted in a release that Bard, Boston Scientific, American medical Systems and Coloplast are still rumored to be negotiating on a "global settlement" involving up to 50,000 cases, a deal that could be resolved in early 2014. (No word on whether Johnson & Johnson ($JNJ) or Gynecare are involved yet, Legal-Bay noted.)

Legal-Bay certainly has a stake in the matter, and the outfit is urging potential plaintiffs to file their lawsuits soon "because the time to file a lawsuit claim is limited."

But the settlement rumors remain. Considering that Johnson & Johnson just agreed to a $2.5 billion settlement involving lawsuits over faulty metal hip implants, the company's decision to resolve the issue might very well inspire other device companies to do the same.

Read more: Next Bard vaginal mesh trial set for December; settlement rumors remain - FierceMedicalDevices http://www.fiercemedicaldevices.com...lement-rumors-remain/2013-11-20#ixzz2lIwvOnNr
 






INVESTIGATION: Oklahoma women injured by surgical mesh

Posted on: 10:44 pm, April 26, 2013, by Ali Meyer

OKLAHOMA CITY – Hundreds of Oklahoma women are suing the makers of a surgical mesh product they said they believe caused serious injuries following urological or gynecological procedures.

In each case the patients had a procedure years after childbirth that was designed to correct organ prolapse or urinary incontinence.

But, for many of the women the surgery ended in catastrophic injuries.

The topic is a bit taboo, but still an important health issue for aging women.

For many years, women simply lived with the embarrassing issue.

However, for many years surgeons have offered a fix, a bladder sling.

In recent years, surgeons started using a surgical mesh first developed for hernia surgery, to construct a transvaginal mesh bladder sling.

Transvaginal mesh is a pliable, gauze-like product inserted into a woman’s body to form a sling to support the bladder or uterus and help alleviate urinary incontinence.

Noble resident Lori Eggenberg had a mesh bladder sling surgery in 2010.

Eggenberg said she thought she was having the newest, most advanced, minimally-invasive technique.

She, and thousands of other mesh surgical patients who are now suing the manufacturers, had no idea the problems the mesh would allegedly cause.

The outcome for some patients included the mesh tearing their body apart from the inside.

Attorneys now say the mesh makers did not properly test their product for use on bladder and vaginal tissue.

Patients say they were never adequately warned about what could happen if their body didn’t tolerate the mesh.

“The problem with these meshes is they’re becoming very rigid and very sharp,” personal injury attorney Noble McIntyre said. ”It’s almost like taking a soft piece of fiberglass material and running a blow torch over it until it shrivels up, gets hard. It’s cutting through the vagina wall. It’s cutting into organs. It’s actually acting like a knife inside a woman’s body. The pain is just horrible. I have so many clients who tell me they can’t have sex anymore. It’s impacting their marriages. I have one client, it’s caused a divorce. The husband said, ‘I love you but I don’t want 20 more years of not having sex.’”

McIntyre represents 400 Oklahoma women who have had catastrophic side-effects they believe were caused by the mesh.

The FDA first warned about the problems with transvaginal mesh back in 2008 citing “1,000 reports of complications associated with surgical mesh.”

The problems in the report included erosion, infection, pain, incontinence and vaginal scarring.

The worst part for many women there has been no way to undo the harm.

The mesh is so embedded in their tissue that removing it could tear their organs apart.

Lori Eggenberg has been trying to have revision surgery for almost three years.

However, she no longer has health insurance and to complicate her situation, at least one Oklahoma City urologist has refused to treat her because of her involvement in the ongoing litigation.

“Even work is hard,” Eggenberg said. “I don’t feel like I’m pulling my load at work because I’m constantly leaving to go to the restroom.”

In 2011, the FDA released a second report about the dangers of transvaginal mesh.

According to the report, one in 10 mesh surgeries fail.

“These mesh products should have never been used the way that they have been used,” McIntyre said. “The documents supplied to the FDA in order to get approval in order to sell this product were fraudulent and misleading.”

The first transvaginal mesh case went to trial this year and the jury awarded the plaintiff more than $11 million because the manufacturer, Johnson and Johnson and subsidiary Ethicon, failed to warn her and her doctor about the risk.

Ethicon provided the following statement regarding the $11 million award:

“Ethicon acted appropriately and responsibly in the research, development and marketing of our pelvic mesh products and we are appealing the jury’s verdict.”

Some Oklahoma patients travel out-of-state to find a doctor who is willing and capable of fixing a failed mesh surgery.

“It just turned out so wrong and it was because of the mesh,” an Oklahoma City executive said, who asked not to be identified because she is embarrassed about her failed surgery. “Mine turned out just incredibly wrong and no one knew how to fix it. I think that’s the problem is they put it in, and then when they see there’s a problem, they don’t have the slightest idea what to do to fix it.”

One year after her mesh surgery this unidentified patient still could not empty her bladder.

She has had six revision surgeries to remove the mesh in pieces and life is still a struggle.

“The thing is, I don’t even want to go to the doctor anymore,” she said. “I don’t want to go in there, hear them say, ‘Well, we can fix that.’ I don’t think I can stomach another surgery. Whatever is left, I want to be left with it. Knowing what I know now, if I could go back, I would not have the surgery at all.”

Just a handful of Oklahoma surgeons are helping women heal from failed mesh surgeries.

“I absolutely agree with all the organizations, the FDA and The American Urologic Association, that patients, prior to any surgical procedure, should clearly have informed consent,” Integris urologist Dr. William Barnes said. “There are alternatives for repairing prolapse that don’t require implantation of synthetic material. They can have repair with their own tissue.”

Many surgeons like Dr. Barnes are still using transvaginal mesh but much less frequently.

According to the FDA, 90 percent of women will not have devastating side effects from the implantation of transvaginal mesh.

There are several companies which manufacture surgical mesh including:
•CR Bard (Avaulta Solo, Avaulta Biosynthetic Support System, Avaulta Plus Biosynthetic Support System)
•Johnson & Johnson and subsidiary Ethicon (Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling)
•American Medical Systems (Elevate, Apogee, Perigee, Monarc, Sparc Sling)
•Boston Scientific (Pinnacle, Uphold System)
•Ugytex (Dual Knit Mesh)
•Mentor Corporation (OB Tape)

Most of those companies tell News Channel 4 they are unable to make any public comment because of the ongoing litigation.

http://kfor.com/2013/04/26/investigation-oklahoma-women-injured-by-surgical-mesh/
 












Anonymous said:
http://www.bloomberg.com/news/2013-...astic-found-unfit-for-humans-by-supplier.html

Bard Used Mesh Plastic Found Unfit for Humans by Supplier
CR Bard Inc. (BCR) sold vaginal-mesh devices made of a plastic that its manufacturer warned wasn’t suitable for human implantation, according to unsealed court records.

Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh after the material’s supplier officially registered a warning that it shouldn’t be permanently implanted in people, according to e-mails and documents in a lawsuit over Bard’s implants. Plaintiffs suing Bard contend the same mesh was used in some of Davol’s vaginal-mesh products.

In 2004 and 2007 e-mails filed in federal court in West Virginia, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.

Suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” Roger Darois, the Davol executive, now a Bard vice president, said in a March 2004 e-mail. “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”

Lawyers for thousands of women who blame Bard’s Avaulta line of implants for their injuries said the files show Davol officials knew the resin-based mesh wasn’t proper for human implantation and tried to cover up their use of the material.

Bard Statement

In a statement yesterday, Bard didn’t respond to a question about its desire to keep the information from suppliers. Company officials declined to elaborate on the statement.

Bard, based in Murray Hill, New Jersey, faces a July 8 trial in Charleston, West Virginia, over claims its mesh device harmed Donna Cisson, 54.

“During the upcoming trial, Bard will provide all the relevant evidence for the jury to consider and render a decision, which will demonstrate that Bard acted appropriately in its acquisition of polypropylene resin,” Scott Lowry, a Bard vice president, said in yesterday’s e-mailed statement.

“We believe that the Avaulta polypropylene mesh implant is a safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions,” Lowry said. “To this day, after more than 50 years of use, polypropylene remains one of the most widely implanted and best materials for mesh products in medical applications in the human body.”

Lowry didn’t comment on the e-mails filed in federal court.

Judge’s ruling

U.S. District Judge Joseph Goodwin ruled June 4 that the e-mails regarding the resin-based mesh raised “a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.”

Lawyers for Cisson, who lives in Georgia, will use the e-mails in next month’s trial over whether the Avaulta design was defective and Bard failed to warn of the risks. Cisson claims the device caused her pain, bleeding and bladder spasms that required follow-up surgeries.

She can seek punitive damages if jurors hold Bard liable for compensatory damages and find the company’s conduct justifies the additional award, the court ruled.

Goodwin is overseeing 20,000 lawsuits against Bard, Johnson& Johnson (JNJ), Endo Health Solutions Inc. (ENDP)’s American Medical Systems, Boston Scientific Corp. (BSX), Coloplast Corp. and Cook Medical Inc. alleging injuries from vaginal mesh implants. The companies have denied wrongdoing in court filings.

Cisson’s case will be the first against any of those companies to go to trial before Goodwin, who is coordinating the pretrial exchange of information.

Bellwether Trials

Three more “bellwether trials” involving Bard’s vaginal inserts are scheduled before Goodwin after Cisson’s case. The trials will be used to gauge the validity of the two sides’ conflicting claims.

The women who sued contend erosion of the inserts, designed to shore up weakened pelvic muscles and treat urinary incontinence, can cause organ damage and bleeding and make sexual intercourse painful. They said the meshes, threaded in place through vaginal incisions, degrade and shrink over time.

U.S. Food and Drug Administration officials estimate that 300,000 women had pelvic organ prolapse surgery in 2010 and mesh was used in a third of the procedures. Agency data showed more than 250,000 incontinence surgeries for women that year, about 80 percent involving vaginal-mesh implants, the FDA said.

The agency last year ordered Bard, J&J and other mesh makers to make three-year studies of rates of organ damage, infection and painful sex linked to the devices after women’s groups called for their removal from the market.

Sales Halted

J&J, based in New Brunswick, New Jersey, said last year it would stop selling four lines of vaginal-mesh implants after complaints and lawsuits about the devices. The company acted for reasons unrelated to safety concerns, it said at the time.

A jury in Atlantic City, New Jersey, decided in February that J&J and its Ethicon unit must pay more than $11 million in damages to a woman who blamed the company’s Gynecare Prolift implant for her injuries.

A California state court jury last year awarded $3.6 million to a woman who blamed Bard’s Avaulta Plus implant for injuring her. It was the first such case to be tried in any court. The Avaulta inserts, sold in the U.S. since 2005, were pulled off the market last year.

A Bard official said in a January 2012 internal e-mail that, in response to the FDA ordering safety studies on vaginal-mesh devices, the company planned to pull Avaulta devices off the market that year.

‘Business Decision’

The company “is simply making a business decision not to invest in clinical trials on this product,” Brenda Hammans, a vice president, said in the e-mail.

In Cisson’s case, the Georgia woman alleged the Avaulta device, inserted in May 2009, caused pelvic and rectal pain, bleeding and bladder spasms and required surgeries to remove.

Goodwin unsealed Bard documents and witness depositions about how its vaginal-mesh products were designed, tested and marketed. Cisson’s lawyers fault Bard for not testing the mesh on people before selling it. Plaintiffs’ lawyers obtained e-mails in the pretrial exchange of information with the company.

Medical companies have used polypropylene for years to make items such as sutures, catheters and artificial-heart components because the material is considered to be “biocompatible” and won’t be rejected by the human body.

Safety Document

Cisson’s lawyers said in court papers that Phillips Sumika, a Woodlands, Texas-based unit of Chevron Phillips Chemical, filed a required safety data document, called a “Material Safety Data Sheet,” with the U.S. Occupational Safety and Health Administration about the Marlex polypropylene used in some Bard hernia and vaginal implants.

On the 2007 document’s front page, Phillips Sumika put a “Medical Application Caution” about the product. Chevron Phillips is a petrochemical venture involving U.S. oil producer Chevron Corp. (CVX) and refiner Phillips 66. (PSX)

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to the disclosure unsealed in Cisson’s case.

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use,” according to the warning.

Chemical Reactions

The caution stated that the resin-based plastic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides.” Cisson’s lawyers said human bodies can produce such oxidizing agents and the reaction can cause the mesh to erode.

Despite the warning, officials of Cranston, Rhode Island-based Davol purchased Phillips Sumika’s resin-based plastic from other companies that bought it in their own names, according to Cisson’s lawyers. Davol used the material as the base for hernia-repair and vaginal-mesh devices, the attorneys said in court papers.

Darois, the Davol executive, told colleagues in a Nov. 27, 2007, e-mail that a Jarden Corp. (JAH) unit involved in the mesh manufacturing process refused to continue working on the material once it learned Phillips Sumika barred its use in medical devices.

Data Sheet

Managers at the Jarden unit “obtained a copy of Phillips MSDS data sheet which specifically discloses that this resin should not be used for medical implants,” Darois said in the e-mail, referring to the material safety data sheet.

That prompted the company to renege “on a prior verbal commitment to supply one last run” of material used in the mesh, he said. Jarden’s Shakespeare Co. subsidiary, based in Columbia, South Carolina, makes materials used in fishing line and other products containing polypropylene.

In another e-mail the same day, Jim Brann, now Bard’s director of business development, told Darois and other company officials that Shakespeare’s managers refused to continue working on the Phillips Sumika plastic even after Davol executives agreed to cover any resulting legal costs or damages.

The Jarden unit’s officials “responded that under no circumstance, even with indemnity from us” would they produce another shipment of the mesh material, Brann said.

Alecia Pulman, a spokesman for Rye, New York-based Jarden, didn’t immediately return a call and an e-mail seeking comment on the refusal to continue working with Bard’s mesh. Jarden is the maker of Crock-Pot Slow cookers and Mr. Coffee machines.

Business Professor

Erik Gordon, a University of Michigan business professor, said the Avaulta case shows an abuse of the 510(k) process.

“The alleged conduct is unconscionable,” Gordon said in an e-mail. “How can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”

The judge also unsealed Bard officials’ and medical experts’ pretrial testimony on the lack of human testing of the mesh before the company began selling it in the U.S. in 2005.

The mesh was cleared through the FDA’s 510(k) system, which allows medical devices to reach the market without human testing if regulators decide they’re similar to products already for sale. JNJ, Bard and other competitors already had vaginal-mesh inserts on the market when the Avaulta Plus insert Cisson received was approved in 2007, according to court filings.

Dozens Cleared

“The FDA cleared Bard’s mesh devices after scrutiny of Bard’s submission, including substantial biocompatibility testing, just as the FDA had already cleared dozens of other companies’ mesh products made of polypropylene,” Lowry, the Bard spokesman, said in the company’s statement.

Jim Ross, a Salinas, California-based gynecologist who worked as a Bard consultant on the vaginal implants, testified in a deposition that he suggested clinical trials of the devices, to no avail.

“I felt at least a pilot study would have been good to do,” he said.

Ross said he and Bard officials concluded the vaginal-mesh technology was developing so quickly that a multiyear clinical trial wouldn’t be worthwhile.

“We were able to determine that it was going to cost several million dollars and there was no way that we could do it, collect the evidence, write it up and get it in publication for probably three to four years minimum,” Ross said. “The field was moving so rapidly” that the results would be outdated by that time, he said.

Clinical Trials

Melissa Johnson, a Bard manager involved in the marketing of vaginal-mesh implants, testified that doctors and company salespeople asked for clinical-trial results showing Avaulta was superior to competing implants.

“There wasn’t anything published that I was at liberty to provide,” she said.

Robert Orr, a Bard manager who helped oversee product research, said in a deposition that a company study of vaginal mesh in sheep didn’t yield needed data on its use in women.

“I would say it gives you an indication of how the body will incorporate it and the type of response that you will achieve,” Orr testified, referring to a clinical trial. “Does it totally simulate the clinical response? No, it’s not the whole product.”

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
Click to expand...

Crazy shit.
 












http://www.massdevice.com/news/medtech-tax-will-be-repealed-and-other-predictions-2014?page=3

Prediction #2: Pelvic mesh settlements could rival metal-on-metal hips

Five medical device companies that make pelvic mesh implants have more than 30,000 pending lawsuits in the U.S., according to a Bloomberg report.

Endo Health Solutions (NSDQ:ENDP) subsidiary American Medical Systems agreed in June to pay $54 million to settle personal injury lawsuits filed over its pelvic mesh products. Also this summer, in a verdict against C.R. Bard (NYSE:BCR), a plaintiff was awarded $250,000 in compensatory damages and $1.75 million in punitive damages.

Bloomberg cites anonymous sources suggesting the following companies are participating in a potential group settlement: C.R. Bard (12,000+ cases), Boston Scientific (NYSE:BSX) (12,000+ cases), Endo Health Solutions (13,500 cases), Cook Medical and Coloplast (1000 cases combined).

Healthcare giant Johnson & Johnson (NYSE:JNJ) agreed to a $2.5 billion settlement to close the books on one of the multi-patient lawsuits over recalled metal-on-metal hip implants made by subsidiary DePuy Orthopaedics in November.

If the settlement numbers come anywhere near that level, the pelvic mesh cases could be even more significant. Either way, we won't have to wait long for an answer, as Bard's bellwether trial is set for January 10, 2014.
 






Anonymous said:
http://www.massdevice.com/news/medtech-tax-will-be-repealed-and-other-predictions-2014?page=3

Prediction #2: Pelvic mesh settlements could rival metal-on-metal hips

Five medical device companies that make pelvic mesh implants have more than 30,000 pending lawsuits in the U.S., according to a Bloomberg report.

Endo Health Solutions (NSDQ:ENDP) subsidiary American Medical Systems agreed in June to pay $54 million to settle personal injury lawsuits filed over its pelvic mesh products. Also this summer, in a verdict against C.R. Bard (NYSE:BCR), a plaintiff was awarded $250,000 in compensatory damages and $1.75 million in punitive damages.

Bloomberg cites anonymous sources suggesting the following companies are participating in a potential group settlement: C.R. Bard (12,000+ cases), Boston Scientific (NYSE:BSX) (12,000+ cases), Endo Health Solutions (13,500 cases), Cook Medical and Coloplast (1000 cases combined).

Healthcare giant Johnson & Johnson (NYSE:JNJ) agreed to a $2.5 billion settlement to close the books on one of the multi-patient lawsuits over recalled metal-on-metal hip implants made by subsidiary DePuy Orthopaedics in November.

If the settlement numbers come anywhere near that level, the pelvic mesh cases could be even more significant. Either way, we won't have to wait long for an answer, as Bard's bellwether trial is set for January 10, 2014.
Click to expand...

Amazing that BSCI has fewer cases than AMS.
 






Re: Lawsuits -Bard 1/10/14

http://www.prweb.com/printer/11469013.htm


Vaginal Mesh Lawsuit News: C.R. Bard Motion to Exclude Certain Evidence Denied in Federal Bellwether Trial, Bernstein Liebhard LLP Reports

The Firm currently represents hundreds of women who suffered mesh erosion, organ damage, chronic pain, and other serious vaginal mesh complications in transvaginal mesh lawsuits filed against C.R. Bard, Inc. and other companies.

New York, New York (PRWEB) January 07, 2014

The federal multidistrict litigation underway in U.S. District Court, Southern District of West Virginia, for vaginal mesh lawsuits (http://www.transvaginalmeshlawsuitclaims.com/) filed against C.R. Bard, Inc. continues to prepare for the litigation’s second bellwether trial, Bernstein Liebhard LLP reports. According to court documents issued January 3, 2014, the judge overseeing the proceeding has denied C.R. Bard’s motion in limine to exclude certain evidence relating to the company’s pelvic mesh devices. (Jones v. C. R. Bard, Inc. 2:11-cv-00114)

“We are following this bellwether case closely, as we are representing numerous women in transvaginal mesh lawsuits that have been filed in this proceeding. The finding of the jury in this case could provide clues as to how other juries might rule in similar claims pending against C.R. Bard,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. Firm partner, Jeffrey S. Grand, is a member of the Plaintiffs' Steering Committee in the federal C.R. Bard litigation. Bernstein Liebhard LLP continues to offer free legal evaluations to women who allegedly suffered mesh erosion, chronic pain, infections, and other complications following implantation of devices manufactured by C.R. Bard, Inc., as well as American Medical Systems, Inc., Ethicon, Inc. and Boston Scientific Corp.

Transvaginal Mesh Lawsuits
Court documents indicate that more than 6,200 vaginal mesh lawsuits have been filed against C.R. Bard in the Southern District of West Virginia. All of the claims pending in the proceeding allege that the company’s Avaulta pelvic mesh products were defectively designed and manufactured. Plaintiffs further allege that C.R. Bard failed to provide adequate warnings to doctors and patients about their risks. (In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2187)

The second federal bellwether trial in the C.R. Bard litigation is scheduled to begin Friday, January 10, 2014. According to court documents, the first bellwether case concluded in August, with the jury awarding $2 million in damages to Plaintiff. (Cisson v. C.R. Bard Inc., 11-cv-00195)

According to court documents, C.R. Bard was ordered to pay $3.6 million of a $.5.5 million judgment rendered by a California Superior Court jury in July 2012, after the panel found that the company was partly liable for the complications suffered by another Avaulta mesh recipient. The surgeon who implanted the device was assessed the remaining portion of the judgment. (Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California (Bakersfield))

Along with the federal multidistrict litigation for claims involving C.R. Bard, court filings indicate that five other consolidated proceedings involving vaginal mesh lawsuits have been established for claims naming other manufacturers as defendants. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is also serving on the Plaintiffs’ Steering Committees for the following federal litigations: In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2325; In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation - MDL No. 2326; and In re: Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation - MDL No. 2327.

Mr. Grand was also named Co-Liaison Counsel in two consolidated proceedings established for C.R. Bard and Ethicon mesh lawsuits in New Jersey’s Atlantic Superior Court. He was also a member of the trial team on the first Ethicon trial, 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).
 






Transvaginal Mesh Lawsuits Progress, as Bernstein Liebhard LLP Notes Issuance of New Pretrial Orders Governing Federal Vaginal Mesh Lawsuits

NEW YORK, Jan. 6, 2014 /PRNewswire/ -- Thousands of transvaginal mesh lawsuits (http://www.transvaginalmeshlawsuitclaims.com/) filed against various manufacturers of pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse continue to progress in U.S. District Court, Southern District of West Virginia, Bernstein Liebhard LLP reports. On January 3, 2014, the Court issued Pretrial Orders to clarify procedures regarding certain case filings and the application of the statute of limitations for claims filed in four of the proceedings currently underway in the Southern District of West Virginia. The Orders apply to the multidistrict litigations established for vaginal mesh lawsuits filed against 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).

(Logo: http://photos.prnewswire.com/prnh/20120202/MM47134LOGO )

"Our Firm is pleased to see these proceedings moving forward, and we anticipate even greater progress in the year ahead, as bellwether trials get underway in several of these litigations. We are currently representing hundreds of women in transvaginal mesh lawsuits that have been filed in the Southern District of West Virginia," says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free legal evaluations to women who allegedly suffered mesh erosion, pain, scarring, infection and other serious vaginal mesh complications following the implantation of pelvic mesh to treat pelvic organ prolapse or stress urinary incontinence.

Vaginal Mesh Lawsuits

According to court documents, well over 40,000 lawsuits have been filed in the Southern District of West Virginia on behalf of women who allegedly suffered serious vaginal mesh complications following implantation of transvaginal mesh devices. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is serving on the Plaintiffs' Steering Committees in the federal multidistrict litigations involving American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon.

According to documents filed in the Southern District of West Virginia, the Court's second bellwether trial of a vaginal mesh lawsuit is scheduled to get underway in the C.R. Bard multidistrict litigation on January 10, 2014. Court documents further indicate that the first federal bellwether trial involving a C.R. Bard product concluded in August with a judgment of $2 million in favor of the plaintiff. (Cisson v. C.R. Bard Inc., 11-cv-00195).

Court papers filed in the federal Ethicon multidistrict litigation indicate that its first bellwether trial will begin on February 10, 2014. The first federal trial of a Boston Scientific transvaginal mesh lawsuit will start on March 10, 2014, while the first bellwether case in the federal litigation for claims filed against American Medical Systems is scheduled to get underway on April 7, 2014.

Along with his work on the Plaintiffs' Steering Committees in the federal vaginal mesh litigations, Mr. Grand is also serving as Co-Liaison Counsel in two multicounty litigations for state claims filed against C.R. Bard and Ethicon that are currently underway in New Jersey's Atlantic County Superior Court. He was also a member of the Plaintiff's team on the first Ethicon trial in that proceeding, which ended in March with an $11 million verdict for a woman who experienced serious vaginal mesh complications associated with the Gynecare Prolift device. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10)
-------------
40,000 lawsuits have been filed in the Southern District of West Virginia

first bellwether case in the federal litigation for claims filed against American Medical Systems is scheduled to get underway on April 7, 2014.
 






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