Preview Newsletter
Ethicon Media Monitoring 08/30/16
-
‘A tragedy created by greed’. Mounting pressure for a women’s mesh sling operation to be withdrawn
Aug 29, 2016 | Wisbech Standard
By Kath Sansom
The news comes amid changes at Addenbrooke’s in Cambridge, which until recently, marketed mesh as the gold standard treatment -
FDA Funding: Medical Device Makers and Lap Dog Watchdogs
Aug 29, 2016 | Mesh Medical Device Newsdesk
The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. -
Patient Advocate Tells Story of ” I Am Not Alone”
Aug 29, 2016 | Mesh Medical Device Newsdesk
his unnamed patient advocate reports to Mesh News Desk on the condition of a mesh implanted woman who is fighting for her life at this hour. -
Bankruptcy strikes corporate sister of controversial mass torts case generator
Aug 29, 2016 | Reuters
By Alison Frankel
A Florida corporation called Excelium Management petitioned for Chapter 11 bankruptcy last week in federal bankruptcy court in Miami. The filing comes as one of Excelium’s corporate relatives is fighting to stave off accusations of improper conduct in the sprawling litigation accusing makers of transvaginal pelvic mesh of injuries to women implanted with the device.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
-
‘A tragedy created by greed’. Mounting pressure for a women’s mesh sling operation to be withdrawn
Aug 29, 2016 | Wisbech Standard
By Kath Sansom
A third American state is suing the makers of a pelvic mesh sling which is the most commonly used brand in UK hospitals.
The news comes amid changes at Addenbrooke’s in Cambridge, which until recently, marketed mesh as the gold standard treatment
In a quiet change to its website, however, it now says that the traditional hitch and stitch bladder support surgery is the gold standard.
Mark Slack, head of gynaecology at Addenbrooke’s said during a lecture that the American litigation made him feel that: “The TVT will go after all.
“We really should have been saying to these companies take your tape and go away because you have no evidence, but we didn’t,” he told members of the British Association of Urological Surgeons (BAUS) conference.
“It was a tragedy created by greed, history is going to judge us quite badly.
“We may now lose an outstanding operation because we failed to police the situation.”
The TVTO, introduced in 2004, should be avoided, he said, because it is an: “awful, awful operation that we knew was going to misbehave by the construct and design of it.”
He added he was not convinced that the mini slings, about to be trialled in England after trials stopped in Scotland, were a good idea.
He said: “Patients and their advocacy groups are very concerned and very vociferous and very active.
“There’s mounting pressure for the tapes to be withdrawn.”
Addenbrooke’s website says that “Although mid-urethral slings offer an average success rate of 85%, there are potential complications of which the patient needs to be aware of.
The traditional hitch and stitch - known as a Burch colposuspension - “is still considered the gold standard for stress incontinence surgery because of the impressive long-term data.” the web site says.
Lawyers in the states of Kentucky, Washington and California have all filed lawsuits against Johnson & Johnson, whose medical unit Ethicon make the most popular slings used to treat incontinence and prolapse in British women,
They are suing because they say J&J has deceptively marketed the product as safe.
The permanent implant has caused devastating injuries to victims, according to all three Attorney Generals, and they seek millions of dollars in penalties from the health care giant.
In the latest law suit Kentucky alleges J&J introduced products into the marketplace using false, misleading, deceptive or unfair acts.
“The way this company clearly chose profits over people is outrageous,” Kentucky Attorney General Andy Beshear said.
“My office has talked to victims whose lives have been devastated by this company’s deceitful practices.
“We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
According to an Ethicon spokeswoman the lawsuit is, “unjustified, and the company plans to vigorously defend itself against the allegations.
Johnson & Johnson/Ethicon has the greatest number of product liability lawsuits filed in the US - around 50,000 women.
The legal cost of mesh litigation in the US currently stands at around $9 billion, according to Mr Slack.
http://www.wisbechstandard.co.uk/news/a_tragedy_created_by_greed_mounting_pressure_for_a_women_s_mesh_sling_operation_to_be_withdrawn_1_4676143
-
FDA Funding: Medical Device Makers and Lap Dog Watchdogs
Aug 29, 2016 | Mesh Medical Device Newsdesk
The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates.
The Medical Device User Fee Agreement IV (MDUFA IV) will be delivered to Congress in January.
It represents the work of more than a year of negotiations between FDA regulators, industry and patient and consumer groups, all known as “stakeholders” according to FDA jargon.
The agreement promises the FDA will collect close to $1 billion in fees (plus inflation) to improve the industry including hiring more reviewers and enhance their training. The CDRH is known to have tremendous turnover which in turn, slows the medical device approval process.
The fees come from industry whether a premarket application to have their medical device approved (PMA) or a 510(k) clearance. The fee for a 510(k) application on average was just under $3,000.
However, for the 68 % increase in the current device user fees, there is a catch.
Faster Review Times
Chief among what industry wants is more “timely” access to the marketplace with with less red tape. “Least burdensome” is how the FDA refers to the ideal arrangement.
Most medical devices make it to market after a 290 day 510(k) clearance process. Medical device makers want that fast-tracked to 108 days by 2022. For a De Novo submission (or a novel or new medical device), that time would be extended to 150 days.
MDUFA IV also requires the the FDA to provide feedback to industry at least five days before they meet over the pre-submission and to document in detail the reasons for a deficiency letter.
So far this year the FDA has had 11 meetings with industry including representatives fromAdvaMed, a Washington DC lobbying group, Medical Device Manufacturers Association, Johnson & Johnson, Cook, Boston Scientific, Laboratory Corporation of America, as well as some consumer group representatives. Industry groups were reported to be optimistic over the reauthorized MDUFA.
“This tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” said Scott Whitaker, AdvaMed president and CEO. “This agreement will allow for continued progress in improving the efficiency and predictability of the agency’s review process, and that means doctors and patients will have more timely access to the innovative tests, treatments and cures they are depending on.”
Consumers Stakeholders
The FDA has been regulating medical devices since 1976 but with very little oversight. Often a high-risk device can make it to market with just one clinical trial. Some with none.
The 510(K) clearance process requires a paper submission and naming a “substantial equivalent” and a “predicate” medical device already being sold. The 510(K) clearance process does not require clinical trials but in some cases, such as pelvic mesh for pelvic organ prolapse (POP), post-approval monitoring may be required. This allows the manufacturers to monitor their devicesafter they are already permanently implanted in patients, as is the case with POP mesh.
The 510(k) clearance process is the FDA process that has allowed polypropylene transvaginal surgical mesh onto the market as well as metal-on-metal hip prosthesis, defective defibrillators and stents, leading consumers to ask “least burdensome to whom?”
An Institute of Medicine report in 2011 (here) called the 510(k) approval process “fatally flawed” and suggested it be abolished.
Consumers Union’s Safe Patient Project argued that in years past the politically powerful medical device industry successfully blocked much needed patient protections from the House and Senate versions of MDUFA, despite that most Americans polled believe the safety of patients should be the FDA’s most important mission. See a MND background story here. See the Safe Patient Project.
The consumer group reminds the public that the FDA currently does not have the power to require a medical device maker to fix a defective design flaw that can injure consumers. A flawed medical device can still serve as a “predicate” devices upon which others name to seek approval of subsequent devices.
Consider ProteGen by Boston Scientific. Approved through the FDA’s fast-track 510(k) clearance process in 1997, two years later it was recalled by Boston Scientific after hundreds of complications were reported including chronic pain and life-threatening infections. There is no mechanism within the FDA to stop using ProteGen as a “predicate” and today it is the device that serves as the predicate for a generation of pelvic meshes to follow.
Consumers Unions wants lawmakers to give the FDA the authority to require that industry fix a defective medical device. Background story on MND here.
“Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed? The answer is obvious. But for months, their lobbyists have been working to block Congress from giving the FDA the power to require this proof. Meanwhile, thousands of women have suffered devastating injuries from vaginal mesh products based on an older, recalled model. And device makers are also free to market hip implants and defibrillators based on recalled versions. Consumers Union is calling on Congress to close this dangerous loophole in the law and give the FDA the power it needs to protect patients. Because sometimes a loophole is more than an error – it’s a disaster.”
By 2012, Public Citizen found Congress had introduced 14 bills to accelerate medical devices’ path to the market with one goal in mind – a more permissive process to gain market access. MDUFA in 2002 and 2007 did not substantially change the regulatory framework but in 2007 MDUFA gave stakeholders and Congress the opportunity seek changes in the approval process unrelated to user fees. Public Citizen reports at least 36 device makers hosted campaign fundraisers for members of Congress in 2011.
Read the history of MDUFA in this 2012 Public Citizen report, Substantially Unsafe.
The Sound Devices Act, introduced by Rep. Edward Markey in 2012 would have given the FDA the authority not to approve a medical device where the “substantial equivalent” was found to be defective or recalled. The House voted 46-0 to defeat the legislation. See MND story here.http://www.meshmedicaldevicenewsdesk.com/fda-funding-medical-device-makers-lap-dogs/
-
Patient Advocate Tells Story of ” I Am Not Alone”
Aug 29, 2016 | Mesh Medical Device Newsdesk
his unnamed patient advocate reports to Mesh News Desk on the condition of a mesh implanted woman who is fighting for her life at this hour.
“One of Caldera Medical, Inc”s. co-inventing surgeons who owns patents with Caldera Medical, Inc.’s CEO has an implant victim laying in a hospital tonight with an estimated forty percent risk of losing her life. She is being treated for Urosepsis, her fever has been so high it has altered her physical and mental health, she is my friend.
“I cannot go to her, help her, change anything but I can write her story. I can ask you to remember her and pray she survives. She is a high-risk patient—she has a prior history of fistula, diverticulum, urethral injury. She has had multiple mesh procedures,
“With each surgery factor for mesh complications, involving a five-fold increased hazard over time. It is in the horror she lives in while those who injured her get to go about conducting business as usual.
“How tired, sad, wounded and frighten her beloved husband sounded when he called. ‘What do we do?’
“How do we do it? He wanted help and answers. I have done my best, it is not enough and it may never matter, without a law firm to hold Caldera Medical, Inc. and all those involved accountable. We will die one by one and most of us in poverty. We are medical professionals, nurses, teachers, we are smart women fighting with our hands and feet bound by litigation and corporate brutality. They just want us to disappear so they can continue to push their product line into the third world. There is no true effort to help us happening.
“I have listen to my friend fight, scream, beg, plead and pray.
“The last conversation I had to tell her she had to stop the legal fight and lay it aside and let all her attention be on surviving longer and being her for her dear husband. My sorrow is so deep, it is the fear of so many things with surgical mesh, urosepsis is the killer, the infections that we battle daily, can kill each of us.
“She needs a miracle to wake up and she gets better. I am not the same when I began these series of articles, I know too much to believe there is any justice for us and I will be a wreck if my friend dies. I think someone must step up and take all Caldera objectors and fight for us. Why are we not important? I think it is because of the powerful persons who are behind the veil of Caldera Medical, Inc.
“I remember my dear friend’s first conversation to me she said, “Thank you for calling me, we are the same, I am not alone”. “
Here is an article concerning the urosepsis we all fear:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2840933/
http://www.meshmedicaldevicenewsdesk.com/patient-advocate-tells-story-not-alone/
-
Bankruptcy strikes corporate sister of controversial mass torts case generator
Aug 29, 2016 | Reuters
By Alison Frankel
A Florida corporation called Excelium Management petitioned for Chapter 11 bankruptcy last week in federal bankruptcy court in Miami. The filing comes as one of Excelium’s corporate relatives is fighting to stave off accusations of improper conduct in the sprawling litigation accusing makers of transvaginal pelvic mesh of injuries to women implanted with the device.
Excelium Management is one component in a complex network of small Florida companies operating under the umbrella Excelium Group. Among the Excelium Group businesses, which are run from the same Ft. Lauderdale office building, is Law Firm Headquarters – a legal marketing business that says it has generated more than 20,000 personal injury cases in the past few years, including more than 10,000 cases against manufacturers of pelvic mesh. In 2015, the Houston firm AkinMears allegedly paid $45 million to four tiny law firms with close ties to Law Firm HQ in order to acquire mass torts dockets generated by Law Firm HQ.
Last March, the mesh defendant American Medical Systems subpoenaed Law Firm HQ, AkinMears and the other law firms, alleging that Law Firm HQ improperly solicited plaintiffs in the 100,000-case mesh litigation, which is centered in federal court in Charleston, West Virginia. AMS has since claimed Law Firm HQ was at the heart of an “illicit enterprise” that steered mesh plaintiffs into unnecessary surgery in order to inflate damages claims.
As I’ve reported, Law Firm HQ and related defendants are fighting the AMS subpoenas. Their lawyers at Chadbourne & Parke contend AMS is improperly attempting to invade attorney-client privilege and that the defendant’s demands for information are irrelevant to the real issue of AMS’ liability to women implanted with mesh.
Chadbourne partner Abbe Lowell, lead outside counsel for the Law Firm HQ defendants, has called the AMS subpoenas a delay tactic. He has also said Law Firm HQ’s intention was to help women harmed by AMS products.
In an email Monday, Lowell said Excelium’s bankruptcy will have no effect on Law Firm HQ’s fight against AMS’ demand for documents and testimony. “Excelium Management’s filing has nothing to do with, does not result from, has no connection to and has no impact on LFHQ’s subpoena litigation with AMS,” he said. U.S. Magistrate Judge Cheryl Eifert of Charleston, who is overseeing the discovery dispute, is holding a hearing tomorrow on AMS’ subpoenas.
Excelium Management’s bare-bones Chapter 11 petition lists the company’s landlord as its largest creditor, with claims of more than $320,000. According to the filing, the company has less than $50,000 in assets. The bankruptcy court in Miami has set a Sept. 7 deadline for additional information from Excelium, including the company’s equity holders and liabilities.
The lawyer who filed the bankruptcy petition, Paul DeCailly, said in an email statement that Law Firm HQ is not a creditor of Excelium, which he described as “one of many vendors to LFHQ.” He said the bankruptcy filing will facilitate a restructuring of Excelium’s relationships with creditors and is not related to Law Firm HQ.
http://blogs.reuters.com/alison-frankel/2016/08/29/bankruptcy-strikes-corporate-sister-of-controversial-mass-torts-case-generator/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
Add recipients
Suggested