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Ethicon 19/1
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‘The worst medical issue’ I’ve seen says MP supporting women’s health campaign
Jan 18, 2016 | The Wisbech Standard
By Kath Sansom
A women’s health campaign that has been running for just seven months reached Parliament when it was discussed at a summit in Westminster. -
Victory for Transvaginal Mesh Victims
Jan 18, 2016 | US Recall News
On January 14, 2016, the U.S. Court of Appeals for Fourth Circuit issued a ruling in favor of transvaginal mesh injury victims in Cisson v. C.R. Bard, Inc. T -
Boston Scientific sued over alleged counterfeit component
Jan 18, 2016 | Securing Industry
By Phil Taylor
Boston Scientific has been drawn further into the vaginal mesh controversy, with a lawsuit claiming the company knowingly used counterfeit material in its products. -
Cisson $2 million Compensatory and Punitive Verdict against C.R. Bard Upheld by Appellate Court
Jan 18, 2016 | Mesh Medical Device News Desk
By Jane Akre
The pelvic mesh trial against manufacturer C.R. Bard was the first bellwether case to be held in the newly formed multidistrict litigation in Charleston, West Virginia. -
Pelvic Mesh-Injured Women Plan April Rally in Charleston, WV
Jan 18, 2016 | Mesh Medical Device News Desk
By Jane Akre
Organizers of mesh-injured women want the public to know a rally is planned for Charleston, West Virginia on Monday, April 11, 2016.
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‘The worst medical issue’ I’ve seen says MP supporting women’s health campaign
Jan 18, 2016 | The Wisbech Standard
By Kath Sansom
A women’s health campaign that has been running for just seven months reached Parliament when it was discussed at a summit in Westminster.
Ten action points were outlined as part of a pledge to look at problems with an NHS operation given to support weakened pelvic floor muscles, often caused by childbirth.
For some women the mesh sling operation leaves them in life-altering crippling pain which cannot be fixed.
Reporter Kath Sansom launched Sling the Mesh after having the operation last year and going from a super fit mum to taking a daily cocktail of painkillers to cope.
She said: “There are two version of this operation. One is called a TVTO, if this causes problems, it is almost impossible to fix.Owen Smith MP, Welsh Shadow Work and Pensions Secretary, is supporting Sling the Mesh. He says it is the worst medical issue he has seen.
“The other is a TVT, if this causes complications, it’s possible to be removed, there is no guarantee as mesh can leave lasting damage, but at least women stand a chance of getting their lives back. My TVT mesh was removed and I’m recovering well.
“I want to see the TVTO version stopped to prevent women suffering so badly.”
NE Cambs MP Steve Barclay spearheaded the Parliamentary meeting. He said: “This is not about party politics this is about getting the right care for women.
“Kath deserves huge credit for the work she has done to raise awareness of the risks involved when vaginal mesh implants go wrong, and following my meeting with Professor Willet in the summer at the House of Commons it was great this time to have the benefit of Kath’s input and first hand experience.MP Steve Barclay is supporting the Sling The Mesh campaign
“A number of actions were identified to better raise awareness, make it easier for women to report problems and improve the data collection of these reports.
“There is still much more to do to ensure women are aware of the risks of these implants, but is welcome that the NHS now recognises the seriousness of the problem and that it is taking steps to improve surgical procedures and patient information.”
Owen Smith, Labour MP for Pontypridd and Shadow Secretary of State for Work and Pensions, who joined the summit, said: “In six years this is the worst medical issue I have come across.
“To hear of my constituent’s suffering and terrible pain because of an operation that was supposed to help is awful.”Gosport MP Caroline Dinenage is supporting Sling the Mesh
Gosport MP Caroline Dinenage, minister for women and equalities, who is among 20 MPs supporting Sling the Mesh, said: “The impact of mesh surgery to treat stress urinary incontinence has caused serious unintended medical problems for many women throughout the UK.
“That is why I am working alongside other MPs to see how we can tackle this complex issue and ensure that women who have suffered from complications associated with mesh surgery are listened to and supported.”
Issues discussed included:
• Better information on the NHS website about mesh risks
• National Register to track the true number of women with mesh implant problems - figures currently rely on women reporting it themselves.
• Possibility of upping the device to a higher risk category so it needs stricter testing before being given a CE mark
• Why Scotland has raised concerns for the TVTO and another mesh procedure called POP, yet in England the same concerns have not been expressed - despite six of the same people sitting on both the English and Scottish mesh working groups.
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Victory for Transvaginal Mesh Victims
Jan 18, 2016 | US Recall News
On January 14, 2016, the U.S. Court of Appeals for Fourth Circuit issued a ruling in favor of transvaginal mesh injury victims in Cisson v. C.R. Bard, Inc. The decision is not just a victory for the plaintiff in this case and other victims of transvaginal mesh with pending lawsuits, there are more than 70,000, but a victory for anyone who has been injured by a defective medical device that was cleared by the U.S. Food and Drug Administration’s 510(k) process.THE RULING
Originally, a jury ruled in favor of transvaginal mesh injury victims, Donna and Don Cisson awarding them $2 million, including $1,750,000 in punitive damages in their lawsuit against the device maker Bard.
In the appeal, Bard claimed that, during trial, it should have been able to use the fact that the mesh was cleared through the FDA’s 510(k) process as evidence that the device was safe. The district court had not allowed the device maker to admit evidence regarding 510(k) compliance.
The Fourth Circuit agreed with the district court’s decision not to allow Bard’s 510(k) compliance to be used as evidence, and affirmed the original judgement.WHY THIS IS IMPORTANT TO VICTIMS OF DEFECTIVE MEDICAL DEVICES
The FDA’s 510(k) process is an expedited clearance process that allows medical devices to go to market without extensive safety testing. Instead, the device maker needs only to show that the new device is substantially similar to an approved device, which is called a predicate device. If the predicate device is found to be defective and recalled, subsequent devices that were based on the recalled device’s approval are not affected. They remain on the market.
Compliance with the 510(k) process does not show that a device is safe, but rather that the device maker was able to avoid the rigorous, expensive, and lengthy process normally required to prove device safety.
To put this in perspective, a 2011 study found that 71% of high risk medical devices recalled from 2005 through 2009 had been cleared through the 510(k) process. Furthermore, when the Institute of Medicine (IOM) reviewed the 510(k) process, at the request of the FDA, it found the process to be so flawed that it should be scrapped entirely and replaced with a new process.
If Bard’s appeal had been successful, it would have opened the door for device makers to misleadingly use 510(k) clearance as evidence of safety in future product liability cases.
If you have been harmed by transvaginal mesh or another defective medical device, please talk to an experienced defective medical device attorney right away to learn more about your rights.
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Boston Scientific sued over alleged counterfeit component
Jan 18, 2016 | Securing Industry
By Phil Taylor
Boston Scientific has been drawn further into the vaginal mesh controversy, with a lawsuit claiming the company knowingly used counterfeit material in its products.
Houston-based lawfirm Mostyn Law is alleging that Boston Scientific was part of a conspiracy to source substandard polypropylene resin used in its vaginal mesh products "from a known counterfeiter in China" after losing its US supplier for the material (Phillips Sumika's Marlex).
The medical device group says it rejects and will vigorously defend itself from the allegations, which include that it smuggled material into the US, failed to conduct thorough tests and defrauded regulators.
The lawsuit - filed on behalf of plaintiff Teresa Stevens who claims to have been injured by a vaginal mesh product - further alleges that the company sold faulty mesh implants "that have put thousands of women at risk." Other companies named in the suit include EMAI Plastic Raw Materials of Guangzhou, China, Proxy Biomedical Ltd of Ireland and Luxilon Industries based in Belgium.
Boston Scientific and other mesh manufacturers, including Ethicon, are already facing lawsuits from women who claim to have been injured from use of the products, although these are generally on safety grounds and do not relate to the use of counterfeit material.
Mostyn Law has called on Boston Scientific to make internal documents public, and last Friday said it had carried out independent testing that showed the resin "contains dangerous selenium." It also says Boston Scientific sells $120m-worth of vaginal mesh annually, with the product used in around 55,000 women a year.
Vaginal mesh products have been used for years to treat pelvic organ prolapse (POP) and stress urinary incontinence in women and were recently re-classifiedby the FDA as a class III medical device - one which carries a high risk - from class II (moderate risk).
The regulatory action came after a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and the new regulations include a requirement for manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh products.
There are five manufacturers of vaginal mesh products in the US market, according to the FDA, which have been given 30 months to submit a retrospective PMA for their already-marketed products.
"Over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair," said the FDA in a statement issued on January 4.
"The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues."
Other forms of surgical mesh products have also been counterfeited and introduced into the US supply chain. In 2011, medical device distributor Ram Medical has admitted selling counterfeit and contaminated surgical mesh in the USA that it had purchased from suppliers in the Middle East and India.
The prior year, the FDA warned that counterfeit versions of flat polypropylene meshes sold under the Bard or Davol brand names had also been found in circulation. -
Cisson $2 million Compensatory and Punitive Verdict against C.R. Bard Upheld by Appellate Court
Jan 18, 2016 | Mesh Medical Device News Desk
By Jane Akre
The pelvic mesh trial against manufacturer C.R. Bard was the first bellwether case to be held in the newly formed multidistrict litigation in Charleston, West Virginia.
Right out of the gate, Donna Cisson’s attorney, Henry Garrard, presented to the jury the Material Safety Data Sheet that accompanied the raw polypropylene resin used to make her Avaulta Plus transvaginal mesh.
Garrard showed jurors company emails exchanged between high ranking executives, that they would form a dummy company so the supplies of the resin would not be disrupted. That’s because the supplier, Chevron Phillips, included a warning on the MSDS, not to use the resin to make implantable medical devices and would not sell to Bard had it known that was exactly what C.R. Bard would do.
That was how the trial of Donna Cisson v. C.R. Bard began in July 2013.
On August 15, 2013, jurors awarded Ms. Cisson $250,000 in compensatory damages and $1,750.000 in punitive damages to send Bard a message. The company immediately appealed.
One year ago, Judge Joseph Goodwin, who is overseeing the mesh trials, denied Bard’s request for a new trial. See background story on MND here.
A federal appeals court on Thursday, January 14, upheld the $2 million verdict. The 41-page decision is written by Judge Roger L. Gregory.
It puts her one step closer to finally resolving her lawsuit against the mesh maker.
BACKGROUND
Ms. Cisson filed a lawsuit in March 2011 in the Northern District of Georgia. She had received a Bard Avaulta Plus pelvic mesh on May 6, 2009 to address prolapse and incontinence. Dr. Brian Raybon performed the surgery. He had been a preceptor or teacher/consultant to Bard. Eventually Dr John Miklos explanted most of the Avaulta.
Testimony was presented that the pores of Avaulta are too small and the mesh shrank after it was implanted. What resulted was a rigid scar plate. The mesh was attacked by the patient’s body causing inflammation of the tissue and degradation of the mesh, and causing Ms. Cisson’s permanent injuries.
THE APPEAL
The 4th U.S. Circuit Court of Appeals rejected arguments presented in the appeal by attorneys for Greenberg Traurig (Lori Cohen) that represented Bard.
The company sought to have a reduction of the $1.75 million punitive damage or a new trial.
The company argued that it complied with the Food and Drug Administration’s 510(k) process for approval (implying safety) and that information should have been allowed to be presented to the jury. The U.S. Chamber of Commerce supported that argument a friend of the court.
Readers of Mesh News Desk understand that the FDA’s 510(k) approval is a “clearance to sell” and does not require the company meet the higher standards of premarket approval (PMA) required of drugs.
The appellate court agreed with Cisson:”…. [w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.” Thus, the Court concluded, “it is clear that the court did not abuse its discretion by excluding Bard’s evidence of 510(k) clearance.”
Bard also challenged the decision to include the Material Safety Data Sheet (MSDS) as hearsay. The three-judge appellate panel decided the Material Safety Data Sheet was not prejudicial to the defendant company.
Judge Goodwin one year ago had called creating the dummy company evidence of “This secretive conduct in an effort to sidestep the MSDS warnings suggests reprehensible conduct, weighing against remittitur.”
Also part of the appeal, Bard said that under Georgia law, causation needs to be demonstrated by expert testimony stated to a “reasonable degree of medical probability” and that jurors were presented with insufficient evidence of causation. Punitive damages were excessive and in violation of the Due Process Clause, said the mesh maker. The appeals court did not agree.
Cisson’s attorneys asked the appeals panel to rule that the Georgia state law (Georgia Tort Reform Act of 1987) that splits the punitive damages is unconstitutional. However, the appellate court said she had provided no basis to find the state’s actions unconstitutional.
The state of Georgia will receive 75% of the punitive award of $1,750,000. Ms. Cisson receives the remaind
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Pelvic Mesh-Injured Women Plan April Rally in Charleston, WV
Jan 18, 2016 | Mesh Medical Device News Desk
By Jane Akre
Organizers of mesh-injured women want the public to know a rally is planned for Charleston, West Virginia on Monday, April 11, 2016.
That is the date that 37 transvaginal mesh trials will be heard on the same day before U.S. District Court Judge Joseph Goodwin. . The defendant corporation is Ethicon, Johnson & Johnson, the manufacturer with the largest number of mesh cases consolidated in this federal court.
In an effort to speed up litigation in this multidistrict litigation, Judge Goodwin is allowing plaintiffs to consolidate cases with a common issue of fact. All of the women in this trial Mullins et al, (Case No. 2:12-cv-02952.) were implanted with the TVT (transvaginal tape) mesh made by Ethicon and all were implanted by different doctors in West Virginia. Ms. Mullins is the lead plaintiff.
Last June 2, Mesh Awareness Movement (MAM) brought women and their families from Kentucky, Ohio, Pennsylvania, Florida and beyond to join in solidarity and send a message that pelvic mesh should not be allowed to continue to injure unsuspecting women and that mesh manufacturers need to financially care for the women they’ve harmed.
“Exciting” is what women told Mesh News Desk today. All of the television stations were here and we will be featured on their noon news. Finally we are getting the attention we deserve and the message is getting out,” said organizer Lisa Mason.
Pelvic mesh, used to shore up pelvic organs, was never approved for safety or efficacy by the U.S. Food and Drug Administration. Instead it was approved by the FDA 510(k) approval process that does not require any clinical trials. Assurances of safety rely on the integrity of the manufacturer.
Litigation was consolidated in federal court in Charleston by the Judicial Panel on Multidistrict Litigation in January, 2012. Since then, seven manufacturers now face more than 86,000 lawsuit alleging they sold defective transvaginal mesh which was promoted to doctors as part of an aggressive, yet deceptive campaign. The plaintiffs allege defective manufacturing instructions to doctors and a breach of warranty, negligence, fraud, and more. They are asking for punitive damages.
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