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Ethicon Media Monitoring 12/6/2016
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Record $1 Bill Against J&J Over Defective Metal Hip
Dec 5, 2016 | Mesh Medical Device Newsdesk
Johnson & Johnson and its subsidiary DePuy Orthopaedics has been hit with more than $1 billion in damages to be paid to six plaintiffs injured by their Pinnacle metal hip implant. -
FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?
Dec 5, 2016 | Mesh Medical Device Newsdesk
Imagine 5.6 million pieces of data collected by the U.S. Food and Drug Administration (FDA) concerning adverse events, the FDA term for complications. -
Scottish Official Resigned Before Official Inquiry into Pelvic Mesh
Dec 6, 2016 | Mesh Medical Device Newsdesk
Journalist, Marion Scott is back at her craft writing about the pelvic mesh scandal in Scotland, after leaving The Daily Record. Now she is writing for a new newspaper, the Sunday Post.
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Record $1 Bill Against J&J Over Defective Metal Hip
Dec 5, 2016 | Mesh Medical Device Newsdesk
Johnson & Johnson and its subsidiary DePuy Orthopaedics has been hit with more than $1 billion in damages to be paid to six plaintiffs injured by their Pinnacle metal hip implant. The jurors found the metal-on-metal (MoM) Pinnacle was defective designed and that warnings to consumers and doctors were not adequate.
Plaintiffs claim that bone erosion and tissue death are due to design flaws of the Pinnacle even though it was promoted as being an improved design over plastic or ceramic hips.
J&J and DePuy denies any wrongdoing.
Attorney Mark Lanier, headed the plaintiffs group, which made an offer of $1.8 million to settle prior to trial. J&J rejected that offer.
The total of $1.041 billion includes $32 million in compensatory damages including pain and suffering. The remainder was punitive damages, a message jurors send to a company to punish it for its behavior.
J&J is facing almost 9,000 lawsuits claiming Pinnacle hip prosthesis is defective in its design and instructions and the cases are consolidated in Texas federal court where bellwether cases are being readied for trial.
The second trial yielded a $500 million verdict while J&J faced no liability in the first trial in 2014.
J&J plans to ask the appeals court to stop any further trials over Pinnacle, while it reviews trial errors, says an attorney for J&J to Bloomberg.
This is not the first defective metal hip prosthesis made by the company.
J&J and DePuy had to pay $2.5 billion over its ASR metal-on-metal hip implants, which were were called in 2010. The Food and Drug Administration toughened regulations on metal hips in 2013 and J&J stopped selling them at that time.
http://www.meshmedicaldevicenewsdesk.com/record-1-bill-jj-defective-metal-hip/
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FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?
Dec 5, 2016 | Mesh Medical Device Newsdesk
Imagine 5.6 million pieces of data collected by the U.S. Food and Drug Administration (FDA) concerning adverse events, the FDA term for complications.
Yet the agency has trouble identifying early warning signs for thousands of troublesome medical devices.
Technical programmer, Madris Tomes, who worked on the FDA adverse event reporting program, knew there was a better way of making data useful to consumers, hospitals, doctors and even attorneys.
The fixes being sought by the current programmers to the MAUDE (Manufacturer and User Facility Device Experience) adverse event database used an Oracle-based system. Tomes thought that works for day-to-day data entry, but not for identifying the big picture safety signals.
With 70,000 new adverse events reports coming into the FDA every month, Tomes knew it was impossible for the FDA to keep up with needed recalls. So she quit the agency two years ago to build her own user-friendly system with Marklogic developers.
Device Events is her website and she consults with doctors, lawyers, hospitals, consumers, anyone who wants to know what is going on with complication reports registered with the FDA by doctors, hospitals, manufacturers and patients.
In other words, what devices are working in real – life, and which are not.
“I knew there were lots of death reports and malfunctions and injuries from medical devices. The data is so dirty, you never see the true scope of any device company,“ she told Mesh News Desk.
PELVIC MESH COMPLICATIONS
What do we know about pelvic mesh and its complications?
Well, it depends on how you ask.
And there is no shortage of search terms, which essentially describe the same thing.
To do some practice runs, we used a few terms – “mesh,” “surgical,” “polymeric,” “synthetic,” “urogynecologic” “sling,” “pubovaginal,” and “sepsis,” among them.
Running some numbers for Mesh News Desk, Tomes found:
Using the search terms “Mesh” in general, and “Sling” showed 126,349 adverse event reports. And there were 49 recalls. (When J&J pulled its Prolift off the market, that does not qualify as a recall).
“Mesh Surgical” and “Polymeric” yields 66,000 complication reports. How many were deaths?
It’s hard to tell because they are sometimes incorporated into terms like “malfunction” or”injury”.
Tomes tells MND, “Each company has its own way of saying how a patient died. Use the terms “autopsy,” “failed to live,” “patient expired,” “injury,” or “malfunction”. So I created an algorithm to say the way the patient died rather than say ‘death’.”
*Various search terms found 5,900 death reports. The word “autopsy” uncovered another 500 deaths.
*Put in mesh, “near death,” yields 1,500 deaths from mesh, but only 400 boxes are checked, which could be misinterpreted, she says.
*The terms can be broken down by company, using “mesh” or “sling” and J&J there were 43,552 adverse events. If you used the term “pelvic” you wouldn’t see that.
* “Mesh/Sepsis” found 287 AE reports, but you can also look at “perforate” and “rupture” which found 378.
*”Mesh/colon” and “colon removed” found 722 reports and 26 deaths.
* “Tension-free” and “polymeric mesh” found 65,062 adverse events and 18 recalls. Deaths in that group – 281 have death box checked.
*”Polymeric sling”- showed 23,392 adverse event reports, 430 deaths. Of those, 7,762 reports came from physicians.
*”Physiomesh”, the recalled J&J hernia mesh, shows 689 adverse event reports and two recalls.
THE DOWNSIDE TO DATA
As has been reported in the past, the FDA’s database is not particularly user-friendly or even known to some who work with medical devices. The number of reports coming into the agency represent only about 14 percent of actual real-life adverse events, according to the Office of Inspector General.
Tomes says some reports are redacted by FDA reviews. She doesn’t know why. When looking up a particular super bug, there was a Freedom of Information clause that said it was protected information or HIPPA and the information was redacted. She doesn’t know whether companies tell the FDA to redact information.
“That worries me,” she adds.
Also clouding the true picture of medical devices is that when the FDA adds a new year of data, it removes a year. MAUDE shows the last 10 years, but the raw data goes back 20 years. It isn’t a question of space on the server. The government requires record are kept a certain amount of time, that’s all.
Reports are still not coming in from the Veterans Administration for some unknown reason, she says.
“There is an entire universe out there the FDA doesn’t see.”
REPORTS COMING IN AND ITS USE
But Tomes admits the reports that are coming in are “scary.”
For example, recently Essure activists asked Tomes to run the numbers and she found 303 fetal deaths from the permanent birth control device. The FDA data had shown only five deaths.
This information was used by Rep. Mike Fitzpatrick and a press release pushing for in legislation to get Essure off the market.
Based on a subscription service, hospitals will be able to use the Device Events reports to find out which devices are yielding the most complications so they do not reorder them.
“There was a group purchase of 200,000 Essure devices in June. They weren’t supposed to purchase anymore but the person didn’t know that and put through another order. Once you make a decision, there has to be some way to turn off the mechanism,” says Tomes.
Tomes believes this work is needed now to support true patient advocacy.
“With 70,000 new reports coming in every month, how can a doctor and provider keep up with this? They rely on the FDA, but the agency takes two months to two years to recommend a recall. Rather than wait for the FDA, I’m trying to put the data in front of the public so they can decide.”
http://www.meshmedicaldevicenewsdesk.com/fda-pelvic-mesh-data-thousands-deaths-not-reported/
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Scottish Official Resigned Before Official Inquiry into Pelvic Mesh
Dec 6, 2016 | Mesh Medical Device Newsdesk
Journalist, Marion Scott is back at her craft writing about the pelvic mesh scandal in Scotland, after leaving The Daily Record. Now she is writing for a new newspaper, the Sunday Post.
Scott reports that Dr. Lesley Wilkie, who headed the government inquiry into pelvic mesh and medical negligence, has quit just weeks before her final report was due to be published. The Wilkie report was two years in the making and the mesh-implanted community fear there may be further delays as a result.
The report was initially estimated to take six months to complete.
Elaine Holmes, of Scottish Mesh Survivors says the departure couldn’t have come at a worse time.
"We’ve spend two – and-a –half-years battling health professionals to have evidence included proving mesh implants have more side-effects in the long run than non-mesh surgical methods.”
Ms. Holmes spends most of her time in a wheelchair due to nerve damage after her pelvic mesh implant.
The group of activists fears Dr. Wilkie may have been unhappy with intrusion into the report by the medial establishment and the Scottish Government. Officially, Dr. Wilkie says she is leaving because of other commitments.
Since an interim report, published last year, three of four mesh implants were removed from Scottish hospitals, unless approved by a multi-disciplinary medical team.
In Scotland, more than 400 women claim the mesh implant, used to treat incontinence and pelvic organ prolapse, has injured them some permanently. The former Health Secretary Alex Neilordered a suspension of the surgery in June 2014, but some doctors continued to use them. About 2,000 Scottish women are implanted with a polypropylene mesh every year.
The industry-funded health department, MHRA, continues to insist the benefits outweigh the risk.
In September, the Scottish campaigners called on a criminal investigation into allegations that Boston Scientific used counterfeit raw materials obtained from China to make its pelvic mesh implants used on Scottish women. Houston Attorney, Steve Mostyn held a press conference at the Scottish Parliament.
Reporter Scott has consistently covered the mesh scandal and the campaigners who have taken their petition for change directly to Parliament
http://www.meshmedicaldevicenewsdesk.com/scottish-official-resigned-official-inquiry-pelvic-mesh/
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