Why Jury Trials/Verdicts Do Not Stop Medical Device Harm-for-Profit

Listen to this link: J&J defense lawyers attempt to void a $502 federal trial verdict by disassociating the 'parent' company from toxic metal-on-metal DePuy Pinnacle hips

This took place on December 7 at the New Orleans 5th District Federal Court of Appeals.

All the Patient Outcome Information the Hip Surgeons Want You to Know . . . M/M failures mentioned???

8 key trends on hip and knee replacement surgeries 

Written by  Laura Dyrda | Friday, 03 November 2017 17:06

The American Joint Replacement Registry released its 2017 Annual Report, outlining data on hip and knee replacements.

The report, released at the 2017 American Association of Hip and Knee Surgeons Annual Meeting in Dallas, Nov. 2 to Nov. 5, includes data from 654 institutions and 4,755 surgeons who performed 860,080 hip and knee replacements.

"The AJRR has seen significant growth since the previous report; this year's report has a 101 percent increase in procedures, a 57 percent increase in reporting institutions and a 50 percent increase in surgeons," said AJRR Board of Directors Chairman Daniel Berry, MD. The data includes primarily procedures performed in the hospital, although eight ASCs reported data for 1,020 procedures.

Key highlights from the report include:

1. Hip revision surgery burden: 8.6 percent (down from 14.6 percent in 2012)

2. Knee revision burden: 5.1 percent (down from 6.2 percent in 2012)

3. Primary knee implant design:

• Posterior stabilized: 48.5 percent

• Cruciate retaining: 35.3 percent

• Ultracongruent: 5.6 percent

• Other: 8 percent

4. Unicompartmental knee replacements: 3.2 percent of all primary knee replacements

5. Surgeons performing unicompartmental knee replacement: 24.3 percent

6. Surgeons performing patellofemoral arthroplasty: 4.7 percent

7. Average length of stay for primary hip replacements: 3.5 days

8. Average length of stay for primary knee replacements: 2.9 days

https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/38792-8-key-trends-on-hip-and-knee-replacement-surgeries.html

A Small Victory: But Justice Would Stop PREVENTABLE Harm

ZIMMER HIP IMPLANT LAWSUIT RESULTS IN $2M AWARD FOR FAULTY HIP REPLACEMENT

By Heba Elsherif   FiDA highlight

April 17, 2017

Two million dollars has been awarded to an Albuquerque man for a faulty Zimmer hip implant.

Plaintiff Brian M., a former University of New Mexico economist, received a metal hip replacement in 2010. Shortly following the surgery, however, Brian suffered from metallosis, the medical condition that involves the accumulation and deposition of metal debris specifically in the body’s soft tissue. Metallosis occurs when the metallic parts grate or abrade against one another in implant surgeries such as joint replacements.

Brian was 62 at the time of his surgery and suffered from extensive excruciating pain in his hip. He claims that the pain was limiting his enjoyment of his active life and that he had to, inevitably, cut his golf and tennis days short, according to the Zimmer hip implant lawsuit.

The U.S. District Judge Nan Nash said that, “Zimmer Inc., created a faulty device and should pay for past expenses, lost wages, and future medical expenses necessary to remove the dead flesh.”

The judge also contended Zimmer was responsible for causing the infection that further developed because of the hip replacement surgery.

Brian claims that before his surgery, there were already lawsuits being filed about the occurrences of metallosis from hip replacement surgeries. As a result, he had looked at a multitude of option beforehand with his surgeon, and concluded that such incidences with hip replacement surgeries had been resolved, the Zimmer hip implant lawsuit explains.

According to Brian, however, that problem with the device that had been inserted, stemmed from metal debris deriving from the femoral joint, and not the hip socket joint. That metal debris resulted in sending the toxic metal into his leg and drove the deterioration of his leg muscle.

After surgery was performed to remove the metal pieces from his leg, a third operation had to take place to remove the deteriorated muscle that had been killed by the infection.

Treatment for the infection was prescribed and he had to have intravenous antibiotics twice a day for several weeks. Per the Zimmer hip implant lawsuit, “the threat of that infection re-emerging remains for the rest of his life.” Judge Nash had taken this into account when allotting the plaintiff, the $2 million.

Personal injury attorneys throughout the nation celebrate the victory and say that the lawsuit is one of many more to come against Zimmer..

Brian is unable to play as many sports but he sustains his walking ability.

He states of his success that although he was not surprised that the Zimmer hip implant lawsuit developed the way it had, the award granted is a “pleasant end to an ugly ordeal.”

https://topclassactions.com/lawsuit-settlements/lawsuit-news/611511-zimmer-hip-implant-lawsuit-results-in-2m-award-for-faulty-hip-replacement/

Johnson & Johnson toxic metal-on-metal hips: trial 'discovery' exposes secrets of scandal

Hip implant maker was alerted to safety fears, as surgeon told them: ‘It borders on unethical to market’

• Edward Malnick Claire Newell Lexi Finnigan  FiDA Highlight

11 APRIL 2017 • 10:00PM  The Telegraph

British patients were fitted with controversial hip implants despite the company behind them being warned by experts that the type of device was unsafe, secret documents reveal.

A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted in Britons.

More than 20,000 patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear. Thousands  were left in agony and had to have costly operations to have them replaced with safer alternatives.

Andrew Selous, a Conservative MP on the Commons health committee,  described the disclosure as “appalling”, saying: “If the company was aware of problems, they should have acted on the precautionary principle.”

A Daily Telegraph investigation today exposes a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.

Dr Graham Isaac, a senior engineer based in DePuy’s Yorkshire factory, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris.

In the same year, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc ... perception of metal debris and metal ion release.” 

More than two decades later, the firm faces thousands of legal claims by patients who say they have suffered as a result of the metal-on-metal joint subsequently produced by DePuy wearing away in their bodies.

The Telegraph’s investigation also reveals how: 

• Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants; 
•  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”; 
• An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”; 
• Tony Nargol, a surgeon based in North Tees, repeatedly told DePuy from around 2008 about problems with its implants but was labelled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”; 
• A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”. 

The papers, filed in a US court, include an email from John Irving, a US orthopaedic surgeon, in 2010, forwarded internally to the company’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. 

The metal ions released have killed the bone and soft tissues around the hip replacement resulting in:

a. Fluid retention often under high pressure causing pain

b. Tendon rupture causing hip dislocation

c. Bone death resulting in fractures around the implant

Excerpt from Investigation into the Performance of the Ultima Metal-on Metal Hip Replacement, East Norfolk and Waveney Research Consortium, 2008

He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.

DePuy’s Pinnacle implant was first used in the UK in 2002, with the ASR, another metal-on-metal device, released two years later. They were promoted as offering better mobility than devices that used a metal ball and plastic socket.

In his 1995 memo, Dr Isaac, now “distinguished engineering fellow” at the firm, examined data on metal-on-metal hips produced by rival companies. He wrote: “It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory.

Paul Peters MD: We need to be cautious of the legal/litigation issues and lawyers etc… perception of metal debris and metal-ion release.

Minutes from the first Alternate Bearing Project designing surgeon meeting, May 1995

“Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”

He quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.

I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have asymptomatic osteolysis!

Excerpt of letter to DePuy head of US marketing, Paul Berman, from John F Irving MD

The document was part of papers read out in a Texas court, where patients are suing DePuy over the Pinnacle implant. They were passed to the Telegraph by their lawyers. 

Mark Lanier, a lawyer,  said: “These documents show that DePuy knew this hip would fail.”

DePuy’s lawyers have said in court that the company had “always warned about the potential for a tissue reaction in a metal-on-metal device”.

A spokesman said patient safety was its “first priority” and it “acted appropriately and responsibly in the design and testing” of the Pinnacle.

The implant was cleared for sale by national regulators and “is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain”.

The spokesman added that the plastic and ceramic alternatives also “wear and produce debris”, and “the body reacts to any foreign material”.

Boz Michalowska Howells, representing more than 300 UK claims, said  it “appeared to be commonly known in the 90s that metal-on-metal hips cause could adverse reactions and it should have rung alarm bells”. 

Metal implants put under scrutiny

• 2002
  
  
  Pinnacle hip implants, including metal-on-metal type, sold in UK by DePuy
  
  
  
  
  
• March 2004
  
  
  DePuy sells its ASR metal-on-metal implants in Britain
  
  
  
  
  
• 2008
  
  
  DePuy aware some metal-on-metal parts for Pinnacle Ultamet “were slightly outside our manufacturing specifications”. Internal investigation finds it would not cause “safety issues”
  
  
  
  
  
• August 2010
  
  
  DePuy recalls its ASR Hip System “after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data”
  
  
  
  
  
• June 2011
  
  
  US Food and Drug Administration report states that “production capabilities for the Pinnacle metal-on-metal liners and femoral heads at the Leeds facility should be reviewed”
  
  
  
  
  
• June 2012
  
  
  Medicines and Healthcare Products Regulatory Agency guidelines say larger metal-on-metal hip implants should be checked for “life”, not just five years, with tests for metal particles in patients’ blood
  
  
  
  
  
• March 2013
  
  
  DePuy announces “discontinuation” of Pinnacle Ultamet device “because of low clinician use”

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

J&J Medical Devices Cut 6% of Staff: No Mention of Patient Harm/Pending Lawsuits

Johnson & Johnson to cut about 3,000 jobs in medical devices

JANUARY 19, 2016 3:04 PM

BY MATTHEW PERRONE AND TOM MURPHY

AP Business Writers

Johnson & Johnson said Tuesday that it plans to cut about 3,000 jobs over the next two years as the health care conglomerate works to restructure its medical devices business.

The New Brunswick, New Jersey, company said that amounts to more than 2 percent of its global workforce of around 127,000 people and 4 percent to 6 percent of its employee total in medical devices.

The cuts come after a tough year for the healthcare bellwether, which has seen sales of its prescription drugs, devices and consumer medicines squeezed by a weakening global economy and unfavorable currency exchange rates.

"These actions recognize the changing needs of the global medical device market," said Gary Pruden, chairman of Johnson & Johnson's medical device unit, in a statement.

The restructuring focuses on the company's orthopedics, surgery and cardiovascular businesses. It won't affect consumer medical devices, pharmaceuticals or consumer businesses.

J&J has struggled to revive sales of medical devices, particularly brands like DePuy orthopedic implants and Ethicon surgical equipment. In October the company said device sales dropped 7.3 percent to $6.1 billion in the previous fiscal quarter. In the same month, J&J sold its Cordis heart devices unit, which previously accounted for about one-quarter of device sales.

Wells Fargo analyst Lawrence Biegelsen noted that medical devices have been "one of the weaker performing businesses in recent years."

"As such, we believe that the restructuring should be a positive step towards driving longer term growth of the business and enhance profitability over time," Biegelsen said in a note to investors.

The company's actions will lead to annual pre-tax savings of $800 million to $1 billion, much of which will be realized by the end of 2018. J&J said it will consider "strategic options" for underperforming business units.

J&J will book a fourth-quarter charge of about $600 million in connection with the restructuring.

Leerink Swann analyst Danielle Antalffy said Tuesday's announcement increases the likelihood of an acquisition to boost the company's medical device prospects. She notes J&J has roughly $37 billion in cash.

Citing conversations with J&J executives, Antalffy states "it's clear to us that it's a matter of when, not if J&J does a deal."

J&J shares rose 4 cents to $97.04 in trading Tuesday. Its shares have fallen more than 6 percent over the past year.

Read more here: http://www.kentucky.com/living/health-and-medicine/article55408700.html#storylink=cpy

NHS in England: Medical device "hospitality" may land doctors in jail.

Jeremy Hunt: NHS bosses face jail over links to drug firms

By Tim Ross,   @TimRossDT  Senior Political Correspondent

10:00PM BST 22 Aug 2015

Senior medical staff will be forced to declare all gifts and hospitality they receive from drug companies or face the sack and the threat of jail.

In a major crackdown on corruption in the NHS, all hospitals and GP groups will be required to keep a register of hospitality and gifts from pharmaceutical firms to health service staff.

Jeremy Hunt, the Health Secretary, says he was forced to act after the Telegraph uncovered “disturbing” evidence of senior NHS managers being paid thousands of pounds and taken on expensive trips by firms lobbying to get their drugs used.

The transparency, or “Sunshine rule”, will be mandatory from next year and any member of staff who fails to declare full details of perks they receive will face disciplinary action.

If they are found guilty of wrongdoing – such as for accepting gifts or luxury foreign trips in exchange for influencing the NHS to buy particular products – they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail.

The NHS in England buys £7 billion of drugs each year, meaning that the taxpayer-funded health service is a lucrative business opportunity for drug companies and manufacturers of medical devices and equipment.

However, a report from Lord Carter earlier this year found huge variations in the amounts different hospitals pay for particular items –such as latex gloves or syringes - and in the cost and effectiveness of certain treatments, including varieties of replacement hips. This prompted concerns that billions of pounds was being wasted on inefficient systems.

Last month, an undercover investigation by The Telegraph disclosed that senior health staff who help choose drugs for the NHS were paid to work as consultants to pharmaceutical firms keen for the health service to "switch" to their products.

Some NHS managers charged up to £15,000 to organise “advisory board” meetings for drugs companies – often in luxury hotels around the world, the investigation found.

Writing in The Telegraph today, Mr Hunt says it is "shocking" that thousands of sales reps are targeting the NHS. He says he has seen evidence that 65 reps were on site at one hospital at the same time.

Mr Hunt pays tribute to the Telegraph investigation for shedding further light onto the practice and uncovering “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”

A government report by Lord Carter found some hospitals paid 2p for one particular medicine, while one hospital spent £150 on a slightly different variant.

“Even worse, the Telegraph’s investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality," Mr Hunt says. "It’s hard not to conclude that some sales reps have ben ripping the NHS off, and diverting taxpayers’ money away from patient care.”

The minister says he does not want to stop “sensible” collaboration between private firms and the health service “but we must not tolerate abuse”. Only a tiny minority of staff have been accused of wrongdoing “and the overwhelming majority would be horrified” that drugs and equipment were being bought for any reasons other than that they were best for patients and taxpayers, Mr Hunt says.

The Sunshine rule is based on a similar initiative that was introduced in 2013 in America. The Department of Health said corrupt health staff would face disciplinary action, including the sack, and potentially prosecution which could result in fines or even jail.

The Human Medical Regulations 2012 ban the offering of gifts in connection with the promotion of medicines to anyone who is qualified to supply or prescribe medicines. Convictions under these laws can result in a two year jail term. Acts of bribery or fraud are covered by the Bribery Act 2010 and the Fraud Act 2006. Convictions under the Bribery Act can lead to up to 10 years imprisonment and an unlimited fine.

The Sunshine rule registers will be maintained by NHS hospital trusts, and Clinical Commissioning Groups, which oversee GP services and are responsible for purchasing drugs and equipment.

http://www.telegraph.co.uk/news/health/11818749/Jeremy-Hunt-NHS-bosses-face-jail-over-links-to-drug-firms.html

New Zealand: Stryker strikes out with FAILED metal hips!

One woman's toxic surgery ordeal

9:55 AM Saturday Aug 22, 2015

David Fisher

David Fisher is a senior reporter for the NZ Herald.

Lynne McKay had both her hips replaced in 2007 with metal implants.
• The implants failed, causing her intense physical pain and violent mood swings.
• When the implants were eventually removed in 2012, a company representative attended the surgery and took photographs.
• A Health and Disability Commission investigation found no fault with McKay's medical care.
• About half the 5,000 metal hip implants given to New Zealanders have proved defective in some way but follow-up is left to the companies and surgeons involved.

"When I licked my lips I could taste metal," says Lynne McKay, who has had six hip replacements in six years. "There was a metallic film on top of the water in the toilet and I was having to clean it every day. I was peeing [metal] ions."

The new life she expected to come with her double hip replacement in 2007 never arrived. Instead came fears of madness and near-constant misery, which only partly abated when the metal hips were removed after being recalled as faulty in 2012.

The time in between was awful. Almost immediately, there was pain. Inside McKay's body, the connection between the ball and the cup created a "grinding" which produced an "ionic soup".

When McKay walked, she heard "click, click" as the ball ground against the edge of the cup. Unknown to her, there were "actual chips coming off the back. And the [metallic] dust". The joints - when they eventually came out - were abraded, ground and scratched.

Her body was "trying desperately to sort it out" by collecting the metal fragments into tumours around the hip area. "There was a tumour the size of a small hen's egg."

Then came other changes. "About two years after having my hips done, in hindsight, I started to experience toxicity."

McKay had yellow, green and blue curtains, which first dulled, and then lost their yellow tones. At first she thought the curtains were fading, then she realised she was losing her ability to see colours. She started to experience hearing loss and tinnitus, and had frequent unexplained rashes.

McKay thought she was losing her mind. "I couldn't hold a thought. I was always in tears. My words weren't coming out right. I was cutting my nose off with all my friends. I thought I had Alzheimer's. I really thought I was losing the plot."

With her life falling apart, McKay tried harder to keep it together. She walked the streets for hours doing letterbox drops to build a massage business, which was suffering. "I was desperate for work. I was begging people. I really lowered my professional life. I was fighting for my life on a lot of different levels without knowing what was going on."

Understanding arrived in 2012, when the Stryker Mitch THR (total hip replacement) System was subject to a recall notice. A blood test showed McKay had high levels of chromium and cobalt in her bloodstream. Normal levels are between zero and 20 microscopic nanomoles per litre. McKay had 326 nmol/l. Cobalt was also high - safe was 0-16 nmol/l but she had a 378 nmol/l reading.

Mackay believes her metal hips poisoned her. It's a belief shared by other implant patients with elevated cobalt and chromium readings. The British Medical Journal raised this in 2012 in a story on regulatory failure around metal-on-metal implants, saying the ongoing uncertainty around the impact of the metal ions would never be tolerated in drug regulation.

There is still argument in medical circles as to whether the high levels have any effect, even though concerns have been raised for more than 40 years. The official position is that the long-term effects are unknown.

For McKay, not knowing is unacceptable. She says efforts should be made to find out the effects of metal ions in her body, rather than adopting a "wait and see" approach.

But then, she's long lost faith that the medical system will listen to her.

Back when she was a believer, the former registered nurse anticipated life-changing results from the metal hips surgeon Rocco Pitto put into her body during surgery at Middlemore hospital in 2007.

She was 50 at the time and life had become increasingly painful. "I got to a place where I could only walk to the letterbox with two walking sticks."

Diagnosed with dysplasia, a condition in which abnormal growths form at the joints, she had both hips replaced in March 2007. In hip replacements, the femur is removed for an artificial replacement; in McKay's case, the metal stem was attached to a metal ball that moved inside a metal cup, mimicking the worn-out original.

The metal hip replacements were enjoying a resurgence in surgical popularity, with the belief they would be more durable and last longer than ceramic or plastic alternatives. But by 2010, concerns were raised widely about the safety of metal-on-metal with the recall of a DePuy-branded device.

In April 2012, the recall notice for McKay's device went out.

The Lancet medical journal raised the alarm with a study showing 6.2 per cent of implants had to be replaced five years after being put in. It compared to 2.3 per cent for ceramic-on-ceramic implants and 1.7 per cent for metal-on-plastic types. British figures showed McKay's implants - the Stryker Mitch THR System with an Accolade femoral stem - had a revision rate of 8.8 per cent over four years. The alert to surgeons in Britain included advice that they screen patients annually for the presence of chromium and cobalt in the body.

In New Zealand, documents released under the Official Information Act show Stryker initially wanted to class the notice as a "safety alert", saying it no longer distributed the device in New Zealand. Medsafe wrote back to say it did not agree and insisted the notice be classified as the more serious "hazard alert", effectively matching the British response.

The letter announcing the recall on the Mitch head went out to surgeons on April 13 2012. Under the New Zealand system, the state has no role to play in contacting surgeons.

Instead, the regulator - Medsafe - asks the medical device company to make contact with the surgeons to whom it sold the implants and for them to notify patients. The OIA papers show Stryker didn't hear back from all surgeons (who it calls "customers" in emails to Medsafe) who used the device until three months later on July 6 2012.

McKay believes her metal hips poisoned her. Photo / Jason Oxenham

In McKay's case, Pitto's recalls were handled through Middlemore Hospital. Furious at the impact on her life over the past five years, she says she developed strong feelings of anger and frustration towards Stryker.

She wanted to sue. She wanted justice: "I had asked for medical photographs to record the damage to my hip. The kids had started to tell me I needed to collect things for class action."

She wanted to get Stryker into court and sue the company for the grief it had caused.

When McKay went into surgery in July 2012, she says she had no knowledge of - and did not consent to - a Stryker representative being among the gowned and masked surgical team preparing to operate. She says she objected strongly and was even more upset on waking after surgery to see on her notes: "The representative of Stryker Medical was attending today's surgery and also took some photos."

McKay: "That's when I lost it. Those photos were my evidence of what had happened to me." The faulty parts were also removed.

Though Pitto later told a Health and Disability Commission investigation he did discuss consent with Ms McKay, the Counties-Manukau District Health Board has said he didn't need her permission to have a Stryker representative in surgery and didn't ask her. The board also told the Herald - and Ms McKay says it's the first she's heard - that the Stryker photographs were not of the surgery but only of the faulty parts, removed from her body. She can't see the images to assure herself - the board says Stryker has deleted the photographs.

There are no signed consent forms showing permission was granted for either Stryker's presence, or the company's decision to take photographs or for the removal of the faulty parts. In all those cases, the health board says no consent was needed. It says consent is not required when someone is part of a surgical team.

For McKay, it felt as if the system was aligned against her - and even aligned with the company she blamed for the faulty part

In the end, McKay had a further three operations - a total of four hip replacements in 13 months after the recall. The replacement of the first metal hip in July 2012 was a failure - it dislocated less than two months later and needed replacing in November 2012.

One foot after another, neither working properly, "I fought to keep moving," says McKay. The replacement hip went in backwards so was replaced again on May 29, 2013. And then it was the other side. The right hip was revised in August 2013 and she then went into recovery for a year, getting $257 a week from ACC with a small accommodation top-up. Now, at least, "the metal taste was gone and energy levels were back up. But I'm in constant pain." She hisses with frustration.

"I'm sick of saying that actually. I walk like a drunk woman. I've no sense of stability in my hips. It hurts me to walk upstairs. My body is managing the indiscrepancies in core balance muscles but I pay for it in other ways. The body reorganises itself around weak muscles.

"I'm back massaging but I have to do it differently. I do my gardening and my housework on my knees."

McKay doesn't want anyone's sympathy. She's angry with nothing to strike out at. A complaint to the Health and Disability Commission talked of the "benefit of hindsight" and said Pitto's professional practice was appropriate given the knowledge at the time. Pitto declined to speak to the Weekend Herald.

And that's it. The metal hips that went bad inside her body were never approved for use in New Zealand, because our system doesn't require approval for medical devices.

The surgery took place largely in public hospitals, paid for with public money, and the taxpayer has since supported her recovery with a (meagre) salary supplement. ACC has never kept track of how much it cost the public to cover surgery to replace defective products or to cover rehabilitation afterwards.

No public body is taking action to discover the extent of the issue and whether it could have been handled better. When a group of Kiwi patients set off to Britain courts to unsuccessfully sue Stryker for negligence, they did so without Government support.

A spokeswoman for the Counties Manukau District Health Board pointed to a Health and Disability Commission investigation which found "the care provided to Mrs McKay was appropriate in the circumstances.

The DHB acknowledges the distress and pain that Mrs McKay has suffered as a result of the metal on metal hip implant and apologises that she had to undergo further surgery to replace the device."

A spokeswoman for Stryker said the company had "strict policies" guiding the behaviour of its staff in and out of operating theatres and investigated any complaints against them. The company would not provide a copy of its policies and would not comment on the specific case.

The scale of the issue is difficult to gauge. A Medsafe briefing counted about 1200 metal-on-metal devices that were recalled or subject to hazard notices. A further 1300 metal-on-metal devices had failure rates so high that surgeons were advised to check on their patients regularly.

In some cases, the surgeons who carried out the operations have died or retired - Medsafe's hope is that their successors will reach out on their behalf.

Health Minister Jonathan Coleman's office hasn't had any briefings on the issue in the past two years.

A spokeswoman says the regulatory system worked as it was meant to - but that system is about to be completely overhauled. "Health care is always rapidly changing, including emerging technologies, and we need to look at how legislation can better support that."

A law for the new regulatory scheme is expected to be put before Parliament next year and will "regulate the quality, safety and efficacy/performance of all therapeutic products across development and manufacture, market entry, and use".

Among the patients given the 2500 implants that were never good enough, McKay and a small cluster of unknowns have had extreme adverse experiences.

"I worry about what the future holds after being toxic for so long," McKay says. "Sometimes you just have to suck it up and get on with it - but somebody should be accountable."

Implants approved before risk known

Metal hip implants were recognised as a risk to patients after they were approved for use, says a surgeon who advised the Australian Government on the technique.

Surgeon Peter Devane - a hip replacement and revision specialist - says metal implants and metal caps on affected joints grew in popularity through the 2000s although use varied around the world. New Zealand was more conservative than most.

Devane was part of the system that cleared the devices for use in Australia. Between 1998 and 2008 he sat on the orthopaedic committee of Australia's Therapeutic Goods Association, the body that advises government on which devices can be used. The Australian system approved products under guidelines developed by the Global Harmonisation Task Force, a collection of volunteer regulatory bodies and medical device companies from around the world. At the time, metal-on-metal hips were in the "2b" category which meant they faced few regulatory hurdles because they were considered to be a modification of a previously-approved product.

From about 2007, work began to upgrade the categorisation to reflect a higher risk, but metal-on-metal hips had already gone through. Devane says governments were left playing catch-up. A British Medical Journal article later labelled it regulatory failure.

In New Zealand, the use of the products peaked in 2007. "Then those reports on metal-on-metal started coming out. We were aware of them - regulatory bodies were aware of them. By 2010, metal-on-metal was down to 3 per cent (of hip replacements)."

The comparative low number of replacements here - about 5000 replacements - tempered the surgeons' responses. "We didn't want to create a panic culture because it's not as big a problem (as abroad)," says Devane.

New Zealand's regulator Medsafe doesn't have an "approval process". In a statement, it told the Herald: "The [New Zealand] legislation does not require any form of pre-market assessment of medical devices." Medsafe takes guidance from other regulatory authorities -including the TGA - while medical device companies sell direct to surgeons.

Medsafe has "no mandate to approve medical devices or to monitor their import into the country", the statement said. Instead, companies are obliged to register devices on a database. "A notification on the database does not signify that a medical device has been 'approved' in any way."

ProPublica consumer-accessible Surgeon Scorecard for hip & knee surgeons!

We Go Behind the Scenes on Surgeon Scorecard

by Minhee Cho

ProPublica, July 20, 2015

Last week, ProPublica launched Surgeon Scorecard, our new database showcasing the complication rates of nearly 17,000 surgeons nationwide. For the first time, patients can now weigh surgeons’ past performance before going under the knife and doctors themselves can see where they stand relative to their peers.

Our Surgeon Scorecard team – Marshall Allen, Olga Pierce and Sisi Wei – joined ProPublica’s Eric Umansky on the podcast to discuss how they tackled this ambitious, all-hands-on-deck project.

Highlights from their conversation:

• The lack of incentive for hospitals to track their own surgeons’ complication rates. It’s difficult to do and also very uncomfortable politically, Allen says. Surgeons are powerful, they bring in a lot of revenue to the institution, and there’s the risk that they’ll take their cases to another hospital. (7:38)
• What makes a compelling data story: “If there are relentless numbers in a story, it's often a sign that your data is not as strong as you think it is,” Pierce says. “The best data stories are ones where you've reached some sort of interesting finding and that is a launching plane for the rest of the story.” (21:15)
• How all ProPublica apps, including Surgeon Scorecard, have “a near view and a far view,” offering not only a look at broader trends but specific data on specific localities that journalists can use to power their reporting. “There are going to be so many local stories that we can't focus on,” Wei says. “But other journalists can use our app to do that.” (25:06)http://www.propublica.org/podcast/item/we-go-behind-the-scenes-on-surgeon-scorecard/?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter&utm_content=&utm_name=
• 
  

You can listen to this podcast on iTunes, SoundCloud or Stitcher, and use our Surgeon Scorecard app to look up your doctor.

Dallas Federal Court Trial Begins: J&J DePuy Pinnacle Hip

http://www.wfaa.com/story/news/health/2014/09/03/hip-implantspinnaclelawsuit/15041145/

National hip implant trial begins in Dallas

Byron Harris, 1:51 p.m. CDT September 4, 2014

Plaintiffs claim the DePuy Pinnacle hip was not properly tested before being marketed to orthopedic surgeons

DALLAS — A national court case involving thousands of hip implant patients suing a subsidiary of Johnson & Johnson is now underway in Dallas.

The focus is the DePuy Pinnacle hip, which the company quit selling in August 2013.

The pool of plaintiffs is so large that a handful of so-called "bellwether" plaintiffs have been selected from more than 6,000 people who have filed suit. This smaller pool of cases will be argued before juries, and the verdicts will be used to determine settlements against Johnson & Johnson.

Opening arguments in Kathleen Herlihy-Paoli vs. DePuy began Wednesday before U.S. District Judge Ed Kinkeade in downtown Dallas.

Paoli, of Missoula, Montana, got a DePuy Pinnacle implant in 2009. She has now had a combined total of five implants on both her hips, and was hurt by metal-on-metal wear in the DePuy devices that were placed in her body.

Metal-on-metal wear of chrome and cobalt components can create adverse health effects in some patients.

Paoli's attorney, Mark Lanier of Houston, argued that DePuy did not properly test the Pinnacle device before releasing it to the market. Under an FDA provision called 510K, medical devices that substantially resemble other devices already on the market can be released with less stringent testing than original designs.

Lanier told the jury that DePuy ignored failures of the Pinnacle device, and made hundreds of millions of dollars in profits while marketing the device to orthopedic surgeons.

DePuy's attorney, Richard Sarver of New Orleans, said Paoli's problems were caused by improper implantation of the device. He also contended that DePuy never improperly paid physicians to use its devices, and that the medical community has long known of the risks of metal particles.

Joleen Chambers of the Failed Implant Device Alliance has been arguing for increased scrutiny of medical devices for years.

"Before these companies get to market their product, they should have post-market surveillance in place so we can track the devices in real time, permanently," she told News 8.

Chambers has been a vocal opponent of the FDA's role in approving hip implants. "It's [the FDA] not working to prove that these devices are safe before they go to market," she said.

The trial is expected to continue for several weeks.

Last fall, Johnson & Johnson settled a case for $2.5 billion relating to another DePuy hip design involving 8,000 patients.

E-mail bharris@wfaa.com

COURTROOM RULES DO NOT ALLOW PATIENT ADVOCATE TO TAKE NOTES ON COMPUTER 

FOLLOW THE TRIAL HERE.

 _______________________________________________________________________________ 

https://www.linkedin.com/jobs2/view/19275115?trk=biz-overview-job-post

Director, Federal Affairs, Medical Devices

Johnson & Johnson - Washington, DC, US

Posted September 4, 2014

Job description

Director, Federal Affairs, Medical Devices-8659140703

Johnson & Johnson is currently recruiting for a Director, Federal Affairs, Medical Devices. This position is located in Washington, DC and requires up to 25% travel.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Federal Affairs will be responsible to develop, implement and direct federal lobbying activities in support of the corporation’s medical device legislative and policy priorities primarily focused on J&J’s Global Orthopedics business (world’s largest orthopedics company).

A key component of the position is to represent the corporation both internally and externally on federal affairs matters relating to the Centers for Medicare and Medicaid Services, Food and Drug Administration, congressional relations, Administration outreach, relevant trade associations and affiliated patient and physician stakeholder organizations. Some of the official assignments may also require coordination with additional business partners including the pharmaceutical and consumer operations within the Enterprise.

The Director, Federal Affairs will work internally and externally on matters relating to the specific medical device & diagnostics businesses in collaboration with specific franchises as well as represent federal affairs on numerous broader-based healthcare issues and activities. He or she will also work on health care policy and corporate priority assignments within US Government Affairs as determined by managers, such as building relationships with identified stakeholders i.e.: congressional caucuses, patient, physician and other professional societies and stakeholder organizations.

This position requires the incumbent to interact with internal J&J colleagues including US Government Affairs, International, Health Policy Group, J&J Corporate Communications, Law, J&J operating company and Corporate personnel and senior management – specifically J&J’s Global Orthopedics business. External customers including: Members of the US Congress, Administration, state officials and additional J&J customers. This position will report to the Senior Director, Federal Affairs, Medical Devices & Diagnostics.

Qualifications

A minimum of a Bachelor’s Degree is required. An MBA, Masters, JD and/or equivalent graduate degree is preferred with concentration in healthcare policy, political science, communications or business administration preferred. A proven record of success in policy development and advocacy is required. A minimum of 10 years of experience in government affairs or public policy is required. A minimum of 5 years of health policy experience is required. Thorough knowledge of communications, Federal and/or State government policy and legislative process is required. Candidate must be a self-starter with exceptional initiative and ability to work effectively with minimal supervision. Excellent oral and written skills are required.

BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-District of Columbia-Washington

Organization: Johnson & Johnson Services Inc. (6090)

Job Function: Government Affairs

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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EEO is the Law GINA Supplement

About this company

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Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:

The world's premier consumer health company.

The world's largest and most diverse medical devices and diagnostics company.

The world's third-largest biologics company.

And the world's sixth-largest pharmaceuticals company.

We have more than 250 operating companies in 57 countries employing 120,200 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

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