Federal Court Essential 'Discovery' !!!!!!

A Ban on Hernia Mesh? NICE !

Welsh patients call for ban on vaginal mesh to treat hernias

10 January 2018  FiDA highlight

Experts are currently looking at the use of vaginal mesh implants in Wales, but the impact on hernia patients is not being considered in the study.

Last month the National Institute for Health and Care Excellence (NICE) recommended mesh operations should be banned from treating organ prolapse.

The Welsh Government said it was outside the scope of its review.

Richard, 67, from Penarth, said the exclusion of hernia patients has been "pretty upsetting".

He has had to give up work as an actor because of the pain, and can no longer stand for too long after several mesh implants for hernias.

"It feels at times like a knife sticking into the wound," he said. "I had hoped to be doing an awful lot more with my time.

What is a hernia?

A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall.

In many cases, it causes no or very few symptoms, although people may notice a swelling or lump in their abdomen or groin.

The Royal College of Surgeons said mesh can be the "most effective" way to treat a hernia.

"There's always a small risk with any type of surgery but hernia mesh implants have a lower risk of infection than those used to treat prolapse," it added.

But one former surgeon based in Kent said there needed to be more awareness about any potential complications.

Peter Jones said patients were becoming more aware but "in the main, no they are not warned about the risks".

Plastic mesh implants were also used to ease incontinence and to support organs which have prolapsed after childbirth, but some have caused painful and debilitating complications for patients.

Last month, NICE recommended vaginal mesh operations should be banned for treating organ prolapse in England.

The Welsh Government said the review group has focused on the "use of vaginal mesh and tape for pelvic stress urinary incontinence and vaginal pelvic organ prolapse".

It added all NHS Wales organisations were expected to follow the NICE guidelines. It said the group's work will be completed by the end of the month.

http://www.bbc.com/news/uk-wales-42641633#

21% of clinical trials published in high- impact general medicine journals were motivated by marketing purposes rather than scientific objectives

http://www.tandfonline.com/doi/full/10.1080/08989621.2017.1405259
FiDA highlight

Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system
Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon & David S. Egilman
To cite this article: Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon & David S. Egilman (2018) Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system, Accountability in Research, 25:1, 37-66, DOI: 10.1080/08989621.2017.1405259

ABSTRACT

In 2001, DePuy, a wholly-owned subsidiary of Johnson & Johnson (J&J/DePuy), initiated a seeding study called the “Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This arti- cle, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/ DePuy’s research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of stan- dards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/ DePuy used PIN Study results as the “fundamental selling point” for the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science.

Introduction

Seeding trials are clinical trials designed by pharmaceutical and medical device companies to promote the use of their products. They are typically conducted as part of a marketing strategy for products that are either under review, cleared, or recently approved by the U.S. Food and Drug Administration (FDA) (Hill et al. 2008; Krumholz, Egilman, and Ross 2011; Sox and Rennie 2008). Hill et al. recognize that “[s]eeding trials are
CONTACT David S. Egilman degilman@egilman.com Department of Family Medicine, Brown University 8 North Main St, Suite 404 Attleboro, MA 02703, USA
Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/GACR.

Published with license by Taylor & Francis Group, LLC © 2017 [Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon, and David S. Egilman] This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http:// creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

designed to appear as if they answer a scientific question but primarily fulfill marketing objectives” (Hill et al. 2008). Seeding trials typically demonstrate four traits as follows (Hill et al. 2008; Kessler et al. 1994):

1. (1)  Marketing objectives influence study conception and design.
   
2. (2)  Marketing objectives influence data collection and analyses.
   
3. (3)  The study’s marketing goals are concealed from doctors, patients, and
   Institutional Review Boards (IRBs).
   
4. (4)  The study sponsor implements unscientific research practices.
   

In a recent descriptive study, Barbour et al. also found that seeding trials tended to recruit patients from a large number of study sites so that the average number of patients per site was very small (Barbour et al. 2016). These researchers concluded that 21% of clinical trials published in high- impact general medicine journals were motivated by marketing purposes rather than scientific objectives (Barbour et al. 2016).
There are several systematic reviews of company documents regarding the use of seeding trials to promote pharmaceuticals (Hill et al. 2008; Krumholz, Egilman, and Ross 2011). This is the first study of a seeding trial that was designed to promote the sale of a medical device.
Confidential internal documents made public as a result of recent litiga- tion against Johnson & Johnson and its subsidiary DePuy Synthes, offer an insight into a seeding trial conducted with the Pinnacle Hip System (PHS) implant. The PHS is a four-part modular artificial hip for total hip replace- ment surgeries, including metal, polyethylene, and ceramic liners (see Figure 1). The metal-on-metal (MoM) configuration of the PHS was the subject of recent litigation against J&J/DePuy alleging product liability and personal injury for this product.

This analysis focuses on J&J/DePuy’s clinical trial of the PHS: the “Multi- center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy’s previously-confidential internal documents were systematically reviewed for characteristics of a seeding trial, and it was found to display all four features described above. Internal documents show that J&J/DePuy’s marketing department conceived of the PIN Study in 1999 and subsequently had an integral role in the design, funding, implementation, analysis, and dissemination of the findings. Document review and analysis also revealed the impact of marketing parti- cipation in the study conception, design, data collection and analysis, IRB, and informed consent. This systematic review contributes to the literature on seeding trials and litigation-generated data on corporate and regulatory behavior.

Follow the link to the remainder of the article!  

Published with license by Taylor & Francis Group, LLC © 2017 [Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon, and David S. Egilman]

This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

Madris Tomes: CEO Device Events -- Medical Device Patient Outcomes Research

American Healthcare Giant J&J Stonewalling in Australia: Transvaginal Mesh

Exposed: how Johnson & Johnson cut its risk in vaginal mesh lawsuit.

July 20, 2017  FiDA highlight

* The world’s biggest healthcare group has quietly cut its exposure to victims in its vaginal mesh class-action lawsuit.

* Seven Johnson and Johnson subsidiaries are in breach of the Corporations Act.

* With no explanation, J&J and its auditor PwC reduced accounting disclosures and transparency.

The 700 women suing Johnson and Johnson for faulty vaginal mesh implants will not be pleased to hear that the healthcare giant has quietly reduced its exposure to medical negligence lawsuits.

Buried in Johnson and Johnson’s disclosures to the corporate regulator is a letter from the group’s lawyers King & Wood Malleson to the corporate regulator which shows a Deed of Cross Guarantee between seven of the group’s subsidiaries has lapsed. By allowing the Deed to lapse, the company has effectively reduced the pool of assets which creditors can access in a legal claim.

Previously, this Deed had ensured that the seven Johnson and Johnson companies had, until this year, guaranteed each others’ debts. This no longer appears to be the case. In the event therefore of a successful class action lawsuit, a claim potentially worth hundreds of millions of dollars, the 700 women may have less access to the assets of the world’s biggest healthcare company.

The company, whose market value in the US is $US370 billion, refused to respond to questions for this story. Communications director Meshlin Khouri claimed, “We are endeavouring to respond to your questions in the timeframe that you’ve requested …”.

We extended the timeframe and Khouri failed to respond to all questions. Gavin Fox-Smith, managing director of Johnson and Johnson Medical Australia/NZ was approached for comment but also declined to respond.

Johnson and Johnson is being sued in a class action lawsuit in the Federal Court. The plaintiffs claim faulty pelvic implants have caused them debilitating pain and that Johnson and Johnson failed to properly test the devices. The case is expected to run for six months. It follows a successful class lawsuit last year in which a $250 million settlement was struck with victims of faulty Johnson and Johnson hip implants.

An analysis of ten years of Johnson and Johnson financial statements shows a swathe of irregularities. Unlike its Big Pharma peers Abbvie and Gilead, Johnson and Johnson pays a reasonable amount of tax. Over ten years, the company racked up $12 billion in revenues and paid $238 million in income tax. In comparison to aggressive transfer pricing culprits Gilead and Abbvie, Johnson and Johnson showed gross margins of 40 per cent in Australia over the period; an indication that it is not pillaging the Australian tax base quite as aggressively as its peers.

However, enshrining the trend towards increasingly shoddy accounting and poor financial disclosure by multinational companies and their Big Four auditors – PwC, Deloitte, KPMG and EY – the financial statements of Johnson and Johnson are littered with faults.

For a start, its seven subsidiaries which had been covered by the aforementioned Deed of Guarantee, have failed to file accounts and are now two and a half months late. We can safely assume that the Australian Securities & Investments Commission (ASIC) has failed to fine the company for these myriad breaches.

Without any explanation by its directors or by its auditor PwC, Johnson and Johnson quietly changed from lodging General Purpose financial statements to the inadequate and skimpy Special Purpose variety in 2009.

Here is a company therefore which deems there are no other “users” of its financial statements than its parent company in New Jersey. Here is a company, the world’s largest healthcare group, an institution which has attracted billions of dollars in taxpayer support from Australia’s Pharmaceutical Benefits Scheme, but which deems that no other party apart from its parent company could be interested in its financial statements.

That is, directors and their auditors at PwC deem the victims of Johnson and Johnson lawsuits, the company’s staff, its creditors and the taxpaying public which subsidises the PBS – none of these stakeholders are deemed to have any interest in its financial statements.

PwC, which cooly picked up $6.6 million over the decade for audit and tax advice can’t even get its numbers straight. According to its “Auditors’ Remuneration” note, PwC earned $1.07 billion in audit fees over the past two years, rather than $1.07 million.

Moreover the accounts are larded with completely spurious information about accounting policies relating to items which don’t exist. All this mirrors a systemic failure: a failure of the Australian Accounting Standards Board (AASB) a failure of successive governments and their Ministers for Finance, a failure of accounting peak bodies, a failure of ASIC to police the sector and above all a failure of the global accounting firms to which all these governments, agencies and peak bodies kow-tow.

If the government really had the backbone to fix this problem it could instruct ASIC to issue a guidance note requiring all foreign multinational companies to lodge General Purpose financial statements. This damaging failure of accountants to be accountable could be fixed in a week. Instead, the world’s largest companies operating in Australia, jagging billions in taxpayer subsidies, file inadequate financial statements which allow them to hide critical information and avoid tax.

michaelwest.com.au has been sponsored by GetUp! and the Tax Justice Network to conduct an investigation into the financial statements and tax affairs of 20 multinational companies. 

https://www.michaelwest.com.au/exposed-how-johnson-johnson-cut-its-risk-in-vaginal-mesh-lawsuit/

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.

Court told how Johnson & Johnson conducted 'tidal wave of promotion'

By Hannah Sinclair

Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.

“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.

Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.

“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.

“This is about accountability and ensuring this never happens again.”

The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.

Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."

The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.

Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."

The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.

More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.

Some of the products involved in the suit are still available to purchase.

“There’s too many women who are injured,” implant victim Joanne Maninon said.

“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.”

Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.

A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.

“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.

“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.

http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.

Women harmed by sterilization coils push FDA to act

Updated: JUNE 6, 2017 — 7:38 PM EDT

by Marie McCullough, Staff Writer mmccullough@phillynews.com

The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook

“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”

Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure

This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.

Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.

Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”

But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.

“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.

The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”

Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Regulatory Watchdogs Complicit With Medical Device Industry: A Case In Mesh

NHS and medical devices regulator tried to limit scandal over vaginal mesh implants

Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women

Denis Campbell and Carmen Fishwick

Friday 21 April 2017 11.19 EDT

Last modified on Friday 21 April 2017 12.43 EDT

NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.

Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.

More than 800 women sue NHS and manufacturers over vaginal mesh implants

The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be incorporated into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.

The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by the health secretary, Jeremy Hunt – to be open and transparent over patient safety failings.

NHS England and the Department of Health both refused to comment on the minutes of the meeting.

MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.

The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed. 

An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”

One possible reason for the NHS to want to limit exposure of the issue could be to reduce the number of potential lawsuits faced by the health service.

More than 800 women are suing the NHS and the manufacturers of the implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.

About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.

Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

What's your experience of vaginal mesh implants?

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.

“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”

Data from the MHRA, which has been looking at the issue since 2011 after complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years. 

Despite the problems that have emerged the MHRA insists the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.

A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media

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Zimmer MLTK Hip Replacement: Unreasonably Dangerous Design

Judge rules Zimmer liable for $2 million in hip implant case FiDA highlight

New Mexico court cites 'unreasonably dangerous design'; plaintiff represented by Joseph Osborne of Boca Raton Fl., and Randi McGuinn of Albuquerque

BOCA RATON, FLORIDA, UNITED STATES, April 4, 2017 /EINPresswire.com/ -- Medical device manufacturer Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective hip implant with an “unreasonably dangerous design,” following a two-week bench trial.

“This is the first case we know of that has gone to trial in the country, and a growing number of these are going to court,” said Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla., who represents medical device plaintiffs around the country. Osborne tried the case with Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love, P.A., of Albuquerque, N.M.

The product in question is Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”) and a cobalt-chromium head.

In a 27-page decision, New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in “metallosis,” or a buildup of cobalt debris harming the hip joint and contaminating blood.

“It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient,” Nash wrote, ruling for the patient on grounds of strict products liability.

In February 2010, Michael Brian McDonald, an Albuquerque economist then in his sixties, was suffering right hip pain that was preventing him from his usual tennis and golf. That June, McDonald received the MTLK implant. 

Initial recovery went well, but by May 2011, McDonald suffered from hip and groin pain and loss of flexibility, resulting in two corrective surgeries that October and November, during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head. 

After a lengthy recovery, McDonald sued and the case went to bench trial before Judge Nash December 12-23, 2016, in the Second Judicial District Court in Albuquerque. 

In her March 31 ruling, Judge Nash wrote that the ordeal has forced McDonald to a permanent course of antibiotics, an end to golf and tennis, and the likelihood of a recurrent infection.

“It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future,” Nash wrote. “This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound. If the infection can be successfully eradicated, another hip prosthesis will be implanted, necessitating the same type of physical therapy and recovery period as the first two revision surgeries.”

The judge traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm.

“In designing the MLTK, Defendants knew that the use of dissimilar metals can result in a

higher potential for corrosion and that wear debris from a junction of two dissimilar metals had

been documented to be toxic and harmful to the human body,” she wrote. 

In determining the damages of $2.027 million, Judge Nan apportioned it into $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses.

SECOND JUDICIAL DISTRICT, New Mexico County for Bernalillo, McDonald v. Zimmer Inc. and Zimmer Holdings, Case No. D-202-CV-2013-0406

Osborne & Associates: www.oa-lawfirm.com

McGinn, Carpenter, Montoya & Love, P.A., www.mcginnlaw.com

http://www.einnews.com/pr_news/374449551/judge-rules-zimmer-liable-for-2-million-in-hip-implant-case

Mark Sell

Mark Sell Media

3052065397

Pelvic Surgical Mesh Scandal: FDA Wrongly Cleared Predicate Device

Dr Peter Petros said he warned women about the 'very frightening' symptoms of his procedure 

Joanne McCarthy  FiDA highlight

15 Mar 2017, 5 a.m.

A DOCTOR whose invention is at the centre of a global medical scandal told a court in 2004 that women could experience “very frightening” symptoms after a pelvic surgical procedure he developed, but that was “how the operation works”.

“Even though it’s not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it,” Dr Peter Petros told a Western Australian court after a woman took civil action against him following mesh surgery using nylon tape.

Judge Roger Macknay awarded the woman more than $136,000 after finding Dr Petros “undoubtedly” failed to warn her of risks associated with Dr Petros’s intravaginal slingplasty (IVS) procedure, based on his “integral theory” to treat urinary incontinence.

The woman, 45 when she had the surgery in 1997, suffered “significant” injury which had a “substantial” effect on her life, with symptoms continuing over the long term, Judge Macknay found.

Dr Petros’s mesh delivery device through a woman’s vagina, the IVS tunneller, which was later developed by a subsidiary of Tyco Healthcare and incorrectly cleared for use in America in 2001 for both urinary incontinence and prolapse in women after childbirth, became the “predicate case” which major medical device companies used to “clear” and market multiple other pelvic mesh devices for prolapse.

Investigation: Dr Peter Petros

Global legal cases brought by women alleging serious injuries after pelvic mesh surgery are estimated to cost $20 billion.

In a paper in 2012 Dr Petros distanced himself from the global mesh scandal, saying his “early experimental studies” had been “wrongly” used as “an intellectual cornerstone to justify the use of mesh in prolapse surgery”.

During the 2004 Western Australian court case Dr Petros denied being “somewhat blinded” to possible risks associated with his (IVS) surgical procedure.

“Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it? You see it as your baby and you can’t see any bad elements?” the woman’s barrister, Geoffrey Hancy, put to Dr Petros.

Dr Petros replied: “Absolutely not. The role of the scientist is to seek the truth, whether it’s good or bad. That’s the way it is.”

The court was told Dr Petros received a royalty of about $15 per instrument for the IVS tunneller and he performed about 400 operations a year. 

Judge Macknay found Dr Petros had “a proprietary attitude towards the IVS procedure, as well as great pride in events associated with its development”.

In his dealings with the woman Dr Petros “was concerned to extol what he perceived to be the many advantages of the IVS procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and the risks”.

“The defendant did not, it would seem, and apparently still does not, believe there was or is any real detriment associated with ‘his’ procedure,” Judge Macknay said.

Dr Petros “lacked to some extent a complete understanding of the obligation owed by a medical practitioner to a patient who was contemplating surgery”, and was “at times argumentative, anxious to debate, unwilling to answer questions as put, anxious to display his knowledge”, the judge found.

Specialists who gave evidence said the IVS procedure had no independent studies to support it in 1997 and the majority of specialists who performed surgery to treat incontinence did not use the procedure.

By 2003 Newcastle obstetrician/gynaecologist Dr Alan Hewson and his Brisbane colleague Dr Chris Maher said the IVS procedure “cannot be recommended” after treating women dealing with complications after its use, and because of the lack of independent evidence of its safety and efficacy.    

Dr Petros’s name no longer appears on the Australian Health Practitioner Regulation Agency register. He did not respond to questions from the Newcastle Herald about whether he had retired in November. 

The NSW Health Care Complaints Commission advised the Herald it has finalised an investigation of complaints against him and has referred the case to “the Director of Proceedings for the consideration of appropriate disciplinary action”.

http://www.theherald.com.au/story/4524242/doctor-denies-being-blind-to-mesh-risk/?cs=305