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Ethicon Media Monitoring 3/14/2018
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McGinnis Pelvic Mesh Trial Against Bard to Start Monday
Mar 13, 2018 | Mesh Medical Device Newsdesk
McGinnis v C.R. Bard will start Monday, March 19th in a New Jersey courtroom, almost seven years to the day after it was filed, with attorney Adam Slater representing the McGinnis family. -
Bristol surgeon 'fully suspended' from hospital as 50 patients make claims over controversial rectal procedure
Mar 14, 2018 | Bristol Post
By Alex Ballinger
... Last month, the government announced a nine-month review into the safety of medical devices, including surgical mesh.
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McGinnis Pelvic Mesh Trial Against Bard to Start Monday
Mar 13, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 13, 2018~ McGinnis v C.R. Bard will start Monday, March 19th in a New Jersey courtroom, almost seven years to the day after it was filed, with attorney Adam Slater representing the McGinnis family.
She was implanted with a Bard Avaulta pelvic mesh, which is no longer on the market.
This is a product liability trial which will attempt to prove the polypropylene pelvic mesh, Bard Avaulta, was defective in design and warnings to doctors were insufficient. Case no. BER-L-17543-14, Superior Court, Bergen Co., N.J.
On March 12, 2009 McGinnis was implanted with a Bard Avauta Support System at Wake Medical Health and Hospitals in Raleigh, NC.
See McGinnis Complaint, Avaulta Jan 2018
It was used in the treatment of both pelvic organ prolapse and stress urinary incontinence.
Soon afterward she suffered erosion, scar tissue, dyspareunia, loss of bladder functioning, and neurologic injury to her structures and tissues.
According to the complaint, the defendant marketed these products as “safe, trusted products” of “unsurpassed stability” implanted by “a minimally invasive surgical procedure,” which would offer a quick recovery time. Defendants should have known that was not true yet they continued to design, manufacture and market and distribute their products.
Even after the 2008 FDA initial Public Health Notification about “Serious Complications Associated with Transvaginal Placement of Surg
ical Mesh,” Bard continued to market its products, exposing the plaintiff and others to risk of serious and permanent harm. The Defendants have long been award of its dangers and “propensity to fail, erode, migrate throughout the body, and cause significant medical complications and damage to the patient’s anatomy.”
Once placed, the Bard product failed to perform as intended “due to its defects.”
C.R. Bard is located in Murray Hill, New Jersey, while Bard’s Medical Device Division is located in Covington, Georgia. Bard Urological Division is located in Covington, GA and does business in NJ.
Lori Cohen will represent the defense, the same attorney who represented Bard in the case filed by Donna Cisson and heard in Charleston, WV.
BARD AVAULTA
The Avaulta was taken off the market in June 2012 after the FDA required mesh manufacturers to conduct a three-year post-approval monitoring of women already implanted with the mesh product to assess their condition. The company said it was making a business decision not to invest in the clinical trials for the Avaulta.
Bard manufactured various medical devices including:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Faslata® Allograft
Pelvicol® Tissue
PelviSoft® Biomes
Pelvitex™ Polypropylene Mesh
Which are still on the market?
Bard Align Urethral Support System, used to treat stress urinary incontinence was taken off the market in the summer of 2016. It and PelviLace were the last two on the market. See here and here.
In April, 2017, it was announced that Bard was to be sold to Becton Dickinson (BD) for $24 billion. The last day Bard could sell all of its SUI products was December 31, 2016, according to the company.
Bard Davol still sells hernia repair and Fixation devices which includes the 3DMax Mesh, (polypropylene), 3DMax Light Mesh, AlloMax (human collagen), AlloMax (human collagen), Bard Soft Mesh (large monofilament pP), Bard Flat Mesh Sheets ( PP), Perfix Plus, and Ventralex Hernia Patch ( PP and ePTFE materials).
In 2015, Bard agreed to settle 3,000 mesh cases for $200 million and 6,254 cases are now listed as closed in this federal consolidated court case. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
C.R. BARD CASES SO FAR
Bard has had a few cases go before juries and either settle or be resolved in the plaintiffs’ favor.
The case of Debra Wise v CR Bard (2:12-cv-01378) received a settlement offer in February 2015 just as it was about to go to trial. The settlement dollars were undisclosed, She too was implanted with the Avaulta Plus Anterior and Posterior BioSynthetic Support System.
Donna Cisson was awarded $2 million by a Charleston, WV jury in August 2013 due to complications from her Bard Avaulta mesh. Since that was the only case against Bard and resulted in a compensatory damages to the plaintiff of only $250,000, (the rest was punitive damages) it set a low bar on compensatory damages to Bard plaintiffs.
Cisson was from Georgia, one of a few states that takes 75% of punitive damages. See MNDcoverage here.
Avaulta Plus was the same mesh Christine Scott of Bakersfield, California was implanted with in January 2008. She won her trial in a Bakersfield, California trial and was awarded $5.5 million. Bard appealed but eventually ran out of options and the case was finally closed in Scott’s favor.
Mr. Slater has represented plaintiffs implanted with pelvic mesh made by Ethicon.
He has yet to lose a pelvic mesh product liability case, though at least one, Budke, settled before going to the jury. ###
https://www.meshmedicaldevicenewsdesk.com/mcginnis-pelvic-mesh-trial-bard-start-monday/
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Mar 14, 2018 | Bristol Post
By Alex Ballinger
More than 50 patients who underwent mesh surgery by specialist Anthony Dixon have complained
A Bristol surgeon specialising in a controversial rectal surgery has been 'fully suspended' from a private hospital, while he is still being investigated by the NHS.
Dozens of women and a handful of men have been left in “complications and damage” after undergoing a ventral rectopexy procedure, also known as a rectal mesh implant.
Anthony Dixon, who previously worked at the Spire private hospital in Bristol and for the NHS at Southmead Hospital, was one of the pioneers of the procedure, which is used to treat rectal prolapse.
The Spire has now revealed that Mr Dixon was has all his practising privileges at the private hospital suspended, which means he no longer works there.
Southmead Hospital is also investigating and said Mr Dixon is not providing any clinical services to patients.
Bristol woman Avril Bleaken underwent the surgery at The Spire in 2013.
The 41-year-old said: “I am still suffering from health implications due to this procedure; my bowel will never fully recover.
“Mr Dixon made the operation seem very straightforward and I thought that there weren’t any other options. I wasn’t warned of any possible complications or future damages, other than the normal risks that come with any type of surgery – there was certainly nothing specific about mesh.
"If I knew then what I know now, I would never have had the operation.”
The procedure is carried out under general anaesthetic by keyhole surgery and involves a piece of mesh being stitched into the rectum to pull the bowel up out of the pelvis.
It is used to treat rectal prolapse, which is when the last part of the large intestine becomes detached inside the body and falls through the anus.
Group medical director at the Spire, Dr Jean-Jacques de Gorter, said: "We have been deeply concerned by the complaints raised by a number of patients who underwent pelvic organ prolapse operations conducted by a specialist who used to practice in one of our hospitals.
“Since our priority is first and foremost the welfare and safety of patients, Spire Bristol Hospital took action to suspend Mr Anthony Dixon from undertaking surgical procedures in July 2017. This was followed by a full suspension of his practising privileges in early November 2017, which means he is no longer working at the hospital.
"Whilst the NHS trust, supported by the Royal College of Surgeons, complete their investigation into Mr Dixon’s practice, we are also reviewing the care provided to Mr Dixon’s patients in our hospital."
Last November, the Bristol Post reported that North Bristol NHS Trust, which runs Southmead Hospital, is investigating Mr Dixon over concerns about the rectal mesh surgery.
A statement from the trust said: "The welfare and safety of our patients is our absolute priority. We understand that patients may have concerns about pelvic floor procedures which are performed to treat rectal prolapse. We would like to re-assure patients affected by this that we are taking this very seriously and our investigations are continuing.
"It is very important that we investigate this matter fully and it would be inappropriate for us to comment on specific details while our investigations are ongoing.
"The surgeon under review is not currently providing any clinical services to patients at our hospital."
The statement added that some patients with concerns about the procedure have contacted the hospital and are being offered follow-up appointments where appropriate.
Sam Van der Heijden, from Hastings, told the Post at the time how she travelled to Southmead Hospital in 2011 for a ventral rectopexy procedure.
She said that, 48 hours after the operation, she was taken back into hospital after becoming “severely ill”.
She added: “I am in constant pain, stress and discomfort because I can no longer go to to the toilet without the help of drugs and a rectal irrigation unit.
“I have lost my job as a result of having so much time off for sickness and I now have to sell my house, because I can’t afford to stay there. The whole ordeal has also cost me my marriage.”
Mr Dixon previously said he was unable to comment on specific allegations due to patient confidentiality, adding: "As with any surgical procedure, there may be complications, but I would like to reassure patients that the overwhelming majority of operations I have completed have been successful."
Last month, the government announced a nine-month review into the safety of medical devices, including surgical mesh.
The Labour MP for Pontypridd Owen Smith, who has been campaigning against mesh implants, said: “The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary. Mesh devices should be seen against that history of medicalisation and miss-selling and should be subject to the most stringent clinical trials before being deployed in surgery.”
Concerns have also been raised about vaginal mesh surgery, as women have reported painful complications after having implants to treat pelvic prolapse and incontinence, which women can suffer after childbirth.
Personal injury law firm Thompsons Solicitors said that it is acting on behalf of more than 50 patients, including three men, to seek claims over rectal mesh surgery.
Senior medical negligence laywer at the firm, Madeleine Pinschof, said: “The fact that both males and females have been impacted is significant, as there is a tendency for mesh procedures to be perceived as a women-only issue.
“These patients were not sufficiently warned, among other things that we consider they should have been, of the possible complications and have all been left in worse pain after undergoing the surgical procedures.”
https://www.bristolpost.co.uk/news/bristol-news/bristol-surgeon-fully-suspended-hospital-1332117
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