Preview Newsletter
Ethicon 5/20
-
Pelvic mesh maker AMS claims women were lured into needless surgeries
May 20, 2016 | Reuters (In The Daily Mail)
By Alison Frankel and Jessica Dye
American Medical Systems, a major defendant in litigation over controversial vaginal mesh devices, is accusing "a pyramid of businessmen, doctors and lawyers" of luring women into unwarranted surgeries to remove the implants and inflate their damages claims. -
The medical device implanted into hundreds of women which is now no longer legal to use
May 19, 2016 | Australian Broadcasting Corporation
By Matt Wordsworth
Hundreds of women suffering from a serious but common ailment have been implanted with a medical device that's no longer legal to use in Australia.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Pelvic mesh maker AMS claims women were lured into needless surgeries
May 20, 2016 | Reuters (In The Daily Mail)
By Alison Frankel and Jessica Dye
American Medical Systems, a major defendant in litigation over controversial vaginal mesh devices, is accusing "a pyramid of businessmen, doctors and lawyers" of luring women into unwarranted surgeries to remove the implants and inflate their damages claims.
The company, a unit of Ireland-based Endo International, has set aside $1.9 billion to settle as many as 49,000 lawsuits alleging injury from the devices, but it asserts it should not have to pay for unnecessary medical procedures.
Reuters previously reported that a new breed of financier is profiting from surgery on patients involved in litigation against mesh makers: These medical funders, often working through specialized brokers, put up the money for operations in anticipation of recouping their investment, plus a hefty return, when the patients' lawsuits settle.
Now AMS says it has evidence that at least four women were persuaded to undergo surgeries that their own doctors did not recommend. Funding for their procedures was arranged by a lending company working with the doctors who performed them.
Hundreds more women may have been similarly steered into mesh removal procedures by a network of lenders, doctors and attorneys "orchestrating the exploitation of unsophisticated medical and legal consumers and seeking to perpetrate a fraud," AMS said in a May 12 filing in West Virginia federal court.
Members of this alleged network deny wrongdoing. They say they helped injured women receive necessary medical care they could not afford or could not obtain from nearby doctors. They say AMS is trying to divert attention from its own liability for flawed devices.
AMS is seeking court authorization to obtain more testimony from members of the alleged network. A spokeswoman for Endo, which has ceased selling the mesh devices, declined to comment.
CALLS FROM TELEMARKETERS
One example cited by AMS is Judy Buzzell, who was implanted with a mesh device to treat urinary incontinence in 2009.
In 2014, according to Buzzell's testimony, she received unsolicited phone calls from telemarketers who falsely said her device had been recalled by the U.S. Food and Drug Administration. The callers said they could find her a lawyer and arrange travel to a surgeon who would remove the mesh at no upfront cost.
AMS sought testimony from the doctor who implanted Buzzell's device, who said that when Buzzell consulted him after the telemarketers' phone calls, he found no mesh-related symptoms and did not recommend removal.
Buzzell testified that she decided to proceed anyway because she was experiencing pain and bleeding. Although she had health insurance, the telemarketer and another go-between helped her arrange a $21,000 advance from LawCash, a litigation funder, to pay for surgery and travel from her home in Maine to a doctor in Georgia.
According to her contract, which is part of the court record, Buzzell owes 39 percent annual interest, payable if her lawsuit settles. As of August, the total will be $46,500.
Based on AMS's $1.9 billion fund and the number of eligible claims, the average amount available per plaintiff is approximately $39,000, although actual payments are confidential and vary based on individual facts.
"I'm screwed on it as far as paying it back, I know that," Buzzell testified. "But for me to get rid of my pain that I wanted to get rid of, it was worth the trip down and back to get it done."
Buzzell declined to comment for this story.
LawCash general counsel Lew Fidler said his company advanced money only to patients who "were desperate for surgery, needed surgery and complained about their circumstances."
According to court filings, Buzzell's surgery was arranged by another company that acted as a matchmaker between patients and doctors and received a commission from LawCash. Buzzell's surgeon in Georgia, Michael Hulse, worked frequently with that intermediary, Surgical Assistance. Hulse received about $10,000 for Buzzell's procedure.
Hulse did not respond to requests for comment. Blake Barber, who runs Surgical Assistance, said he encouraged women who contacted him for mesh removal surgery to first seek care from local physicians and use their health insurance.
AMS contends the heart of the "illicit enterprise" was a Florida-based marketing company that found potential mesh plaintiffs and supplied client leads to Surgical Assistance. The company, Law Firm Headquarters, bills itself as a "legal marketing and support organization." As Reuters has reported, AMS subpoenaed Law Firm Headquarters, and several related law firms in March.
An attorney for Law Firm Headquarters, Abbe Lowell, said the company was trying to help women harmed by AMS's products.
"[AMS's] tactics will only delay resolution of these cases, to the further detriment of those who have been injured," Lowell said.
http://www.dailymail.co.uk/wires/reuters/article-3600328/Pelvic-mesh-maker-AMS-claims-women-lured-needless-surgeries.html
-
The medical device implanted into hundreds of women which is now no longer legal to use
May 19, 2016 | Australian Broadcasting Corporation
By Matt Wordsworth
TranscriptTONY JONES, PRESENTER: Hundreds of women suffering from a serious but common ailment have been implanted with a medical device that's no longer legal to use in Australia. It's called TFS, marketed for a decade as safe and minimally invasive treatment for the condition known as pelvic organ prolapse. Australia's Therapeutic Goods Administration struck the product off its register amid safety concerns. Lawsuits have been filed in Australia and the US and the powerful American health regulator the Food and Drug Administration has placed an import ban on the device. Now parents and doctors are asking whether TFS was properly tested. Matt Wordsworth reports.
MATT WORDSWORTH, REPORTER: When they reached retirement, Barb and Steve Jobson felt it was time to have some fun.
BARB JOBSON, PATIENT: I've always wanted a sports car since I was 17, it had to be red and I could never afford one. And a lady we knew was trading in her sports car and she was only offered very little money for it. It's an old sports car, but we were excited and thought, "We can put that money together and buy it." We got it and I was really excited because I had one grandchild with autism that comes and stays with me and his dog and I was really excited I could take them in it, which I did.
MATT WORDSWORTH: The only thing standing in the way of Barb's retirement dreams was nagging discomfort due to persistent urinary tract infections.
Her doctor, Richard Reid, told her she needed to fix her pelvic organ prolapse. It's a condition common after childbirth. Stretched muscles and ligaments cause pelvic organs such as the bladder to droop.
BARB JOBSON: I was told that hat - if I had that prolapse fixed, that my urinary tract infections should stop and that I'd be able to get on with my life, so I was so excited. I thought, "This is great." Over the moon.
MATT WORDSWORTH: He recommended surgery to insert a device called tissue fixation system, or TFS. It's a thin mesh tape fixed inside the pelvic region with a barbed anchor at each end, in theory to mimic ligaments, support the organs again and cure prolapse.
BARB JOBSON: There was no indication that there was going to be any problems. It was God's answer to women.
MATT WORDSWORTH: As she went under the surgeon's knife, she didn't know there were already serious concerns about TFS implants. In 2011, a team of doctors in Perth wrote a medical paper on TFS after treating 11 different women. "... we must approach the introduction of such devices with caution in light of these unfolding case complications."
The problems stem back to when TFS was first approved in the mid-2000s. After its invention by Australian doctor Peter Petros, the regulator, the TGA, did not require extensive testing, satisfied that it was similar to other devices on the market.
ANDREW KORDA, UNI. OF WESTERN SYDNEY: Well the TFS device has not been adequately tried and evaluated, to my understanding.
MATT WORDSWORTH: So does it concern you that there have been thousands of operations around the world using this TFS device without that testing or research?
ANDREW KORDA: Well, I don't know how many operations have been done around the world, but it is always of concern when these sort of operations are done without proper assessment.
PETER DIETZ, UNIVERSITY OF SYDNEY: As far as I'm aware as of today, there is no such trial that shows that the TFS actually works as a prolapse procedure.
MATT WORDSWORTH: Does that surprise you, that this has been in use for at least eight years without any of this research to back it up?
PETER DIETZ: Yes, it's a disgrace.
MATT WORDSWORTH: TFS continued to be advertised as proven, safe and effective here and overseas.
MATT WORDSWORTH: Barb Jobson says she wasn't warned about any of the potential complications when she had her surgery in 2013. For her, the implant was a disaster.
BARB JOBSON: The pain I have now, I can do nothing about. Nothing I take or do takes it away.
MATT WORDSWORTH: She became incontinent for months and within two weeks of surgery, chronic pain set in.
BARB JOBSON: If you sit for too long, it's like as though the pressure is on the anchor and it's just pushing, pushing into the nerve tool. If I'm in the car, I have to ask my husband to stop. I have to get out. Standing for too long, I feel like everything's going to fall out.
MATT WORDSWORTH: It wasn't till the following year that the TGA moved on TFS, demanding proof that it met safety guidelines. It wasn't satisfied with the answers. So 13 months after Barb Jobson had her operation, the product was effectively banned. The United States followed, placing an import ban on the company's products.
So I guess you're not surprised that the TGA and the FDA have both deregistered this device.
PETER DIETZ: I'm surprised that it took so long.
MATT WORDSWORTH: In a letter obtained by Lateline the TGA explains its standards have since been lifted. "TGA now has a higher expectation of what comprises adequate clinical data."
BARB JOBSON: It does seem strange to me that it's giving so many problems. Like, was it ever been tested? I wondered has it been proven that it was alright to use? But I wouldn't know. I just assume from a very highly-respected medical field that it would be alright.
MATT WORDSWORTH: Paul Zadow, managing director of TFS Manufacturing, told Lateline the company is, "appealing the deregistration," and TFS is safe if it's, "in the hands of skilled surgeons". "... most of these occasions relate to one particular surgeon who is not affiliated or associated with TFS Manufacturing." He appears to be referring to Richard Reid.
Even though the device isn't available anymore, patients like Barb Jobson are left dealing with its aftermath. She's trying yet another specialist to see if there's anything that can be done to relieve her pain.
After an hour and a half, she emerges.
Hey, Barb. How did it go?
BARB JOBSON: Um, not really good.
MATT WORDSWORTH: Not good?
BARB JOBSON: Not really, no. Um, it's the anchors. And they really can't take the anchors out.
MATT WORDSWORTH: Why can't they take them out?
BARB JOBSON: They are so embedded that you haemorrhage so badly, no-one's been able to do it. It just looks like it might be one of those situations where you can't get the anchors out. Just gotta live with it.
MATT WORDSWORTH: Professor Peter Dietz has treated more than a dozen former patients of Richard Reid.
PETER DIETZ: The number of unusual complications that have arisen after implantation of TFS exceeds anything and everything I've seen in the past.
MATT WORDSWORTH: And that's 20 years of surgery.
PETER DIETZ: Almost. Almost. 18 or 19 years, yeah.
MATT WORDSWORTH: Does it worry you that there are hundreds of women out there who you don't know about who've had this surgery ...
PETER DIETZ: Yes.
MATT WORDSWORTH: ... internationally?
PETER DIETZ: Yes. Thousands, actually. Internationally, thousands.
MATT WORDSWORTH: Lawsuits are already underway in Australia and the United States. Joseph Triscaro in Ohio says his client, Carol Proper, suffered catastrophic injuries due to TFS surgery, an operation attended by the inventor, Peter Petros.
JOSEPH TRISCARO, US LAWYER: I can tell you that Mrs Proper's medical expenses have accrued to now over $600,000, and that's US dollars. But from my perspective, the pain, the suffering and the permanent harm that she sustained is almost incalculable.
MATT WORDSWORTH: He says more women have since come forward to complain about TFS. Authorities here are also taking action. The Health Care Complaints Commission has launched investigations into both Richard Reid and Peter Petros.
But for women like Barb Jobson, the complications show no end.http://www.abc.net.au/lateline/content/2015/s4465788.htm
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested