http://fortworth.legalexaminer.com/medical-devices-implants/depuy-pinnacle-hip-replacement-lawsuits-back-to-trial-in-texas/New Jersey and New York residents are the plaintiffs3:11-cv-02460Kathleen Riedhammer | 3:12-cv-04647Claudia and Alan Heroth | 3:13-cv-00244Susan H. Cousin | 3:13-cv-04119Hazel Miura | 3:14-cv-01776Michael A and Audra L Stevens | 3:14-cv-02341Eugen Jr. and Yolanda Stevens | 3:14-cv-02750Denise Buonaiuto | 3:15-cv-03489Ramon and Carole Alicea | 3:16-cv-01245Uriel and Aviva Barzel | 3:16-cv-01526Karen Kirschner
Showing posts with label product liability. Show all posts
Showing posts with label product liability. Show all posts
Tuesday, August 29, 2017
September 5, 2017: J&J Depuy Pinnacle hip fourth bellwether Dallas, Texas Federal jury trial begins
Friday, July 7, 2017
Gasp!: Surgeon/Designer Calls His Own Pelvic Mesh Device Garbage
Joanne McCarthy
4 Jul 2017, 12:04 p.m FiDA highlight
LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy
A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.
The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305
Tuesday, July 4, 2017
J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.
Joanne McCarthy
4 Jul 2017, 12:04 p.m
LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy
A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.
The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305
Tuesday, May 9, 2017
No Objective Patient Outcome Data: Sacrificial Lambs
Updated: May 07, 2017 9:51 AM CDT
By Kent Luetzen
MISSOULA -
Women from around the country who have been harmed by medical devices such as Essure -- a type of birth control -- used their voices to rally on Saturday. One rally was held in Missoula in hopes of raising awareness about what they call "hidden dangers" of some FDA-approved products.
The group says women deserve better communication from doctors on the side effects of products and for manufacturers to not hide behind the FDA's pre-market approval certification.
For some of these women, products which were said to be safe have caused serious health issues including autoimmune diseases such as eczema, lupus and celiac disease.
Ray Curtis, who’s wife died from hysterectomy complications, is hoping Montana legislators will continue their work to protect women.
"They're (treated) almost like human guinea pigs. These devices are being used for purposes they weren't intended to be used for," Curtis said. "Legislation can bring about awareness to begin with, but also get government to protect woman who are unsuspected like my wife and me... we didn't know.."
Missoula's rally was just one of over 20 throughout the United States.
Sunday, May 7, 2017
Verdict $110M: Johnson & Johnson Baby Powder and Ovarian Cancer
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Pharmaceutical firm Johnson & Johnson (J&J) has been ordered by a US court to pay more than $110m (£85m) to a woman who says she developed ovarian cancer after using its talcum powder.
Lois Slemp, 62, from Virginia, Missouri said she developed the cancer after four decades of using talc products.
Prosecutors argued the company did not adequately warn about the cancer risks associated with the items.
Experts say links with ovarian cancer are unproven. J&J says it will appeal.
The verdict in a St Louis state court is the largest so far to arise out of about 2,400 lawsuits against J&J over its talc-based products, Reuters news agency reports.
Ms Slemp is currently undergoing chemotherapy after her ovarian cancer initially diagnosed in 2012 returned and spread to her liver.
She said the products she used included J&J's Baby Powder and Shower to Shower Powder.
"Once again we've shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America," said Ted Meadows, a lawyer for Ms Slemp.
The verdict included $5.4m in compensatory damages and $105m in punitive damages against J&J.
The company said it planned to appeal. "We are preparing for additional trials this year and we continue to defend the safety of Johnson's Baby Powder," it said in a statement.
"We deeply sympathise with the women and families impacted by ovarian cancer."
J&J lost three jury verdicts last year in cases related to its talc-based products, but won its first trial in March, when a jury in Missouri sided with the company.
There have been concerns for years that using talcum powder, particularly on the genitals, may increase the risk of ovarian cancer.
But the evidence is not conclusive. The International Agency for Research on Cancer classifies talc used on the genitals as "possibly carcinogenic" because of the mixed evidence.
Why is there any debate?
The mineral talc in its natural form does contain asbestos and does cause cancer, however, asbestos-free talc has been used in baby powder and other cosmetics since the 1970s. But the studies on asbestos-free talc give contradictory results.
It has been linked to a cancer risk in some studies, but there are concerns that the research may be biased as they often rely on people remembering how much talc they used years ago. Other studies have argued there is no link at all and there is no link between talc in contraceptives such as diaphragms and condoms (which would be close to the ovaries) and cancer.
Also there does not seem to be a "dose-response" for talc, unlike with known carcinogens like tobacco where the more you smoke, the greater the risk of lung cancer.
What should women do?
The charity Ovacome says there is no definitive evidence and that the worst-case scenario is that using talc increases the risk of cancer by a third.
But it adds: "Ovarian cancer is a rare disease, and increasing a small risk by a third still gives a small risk. So even if talc does increase the risk slightly, very few women who use talc will ever get ovarian cancer."
Tuesday, May 2, 2017
Plastic Mesh Surgically Implanted in Mothers: What Could Go Wrong?
April 28, 2017 FiDA highlight
Kim Blieschke had no idea her life would change irreparably when she was advised to undergo a “straightforward” surgery to correct pelvic organ prolapse – a complication from childbirth that results in surrounding organs to bulge or sag down into the vagina.
But moments after waking up from her transvaginal mesh implant procedure in 2006, where a web of polypropylene plastic was embedded into her vaginal wall, the mum-of-four knew “something wasn’t quite right”.
“I was in intense pain that they couldn’t control,” Kim told me over the phone from her Port Pirie home, in the South Australian countryside.
“I woke up with quite substantial bruising all over my buttocks and perineum and upper thighs. The bruises were the size of my hand.”
"I had necrotic flesh in there." (Image supplied)
"It was a pain like you wouldn't believe," she said. "Doctors said I'd be in the hospital for two or three days, but I was there for seven. On the three-hour car ride home, sitting was almost unbearable."
From there, Kim's condition spiralled.
"My doctor kept saying it will be better, it will be better, but I ended up taking three months off work," she told me. "I couldn't drive, I couldn't lift, I couldn't even sweep the floor."
Doctors made Kim feel like she was imagining the pain, but as a seasoned paramedic, she knew something was awry when her vagina developed a "foul smell".
"I told my GP something wasn't quite right, and it turned out I had necrotic flesh in there."
The polypropylene - a material used to create everything from plastic chairs to water bottles - had ignited Kim's natural foreign body reaction. Her body wasn't just trying to fight the mesh, it was trying to kill it.
The Therapeutic Goods Administration says transvaginal meshes were approved by "conformity assessment certification either from a EU certification body or the TGA".
By 2014 the TGA admitted its assessment process for the mesh was not “mature” and lacked “rigour”, and subsequently announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.
By 2015 - a decade after mesh was first approved for embedding within the vaginas of thousands of Australian women - 72 of the 100 mesh products on the Australian market were delisted.
Despite this, where the TGA acknowledged shortcomings of the devices, it mostly blamed "the skill and training of the surgeon and the patient selection".
While the TGA said in a statement to Channel 10 it has only received 205 adverse event reports, and "the reported rate of complications was low", Kim argues this is because the channels of reporting post-surgical problems is convoluted and lacks transparency.
The implant that Kim was told to not worry about, the one she was told was simple and straight forward, was eroding away, and destroying her body with it.
"I felt like I was rotting from the inside," she describes.
By the time 2013 rolled around - some seven years after Kim's surgery - her surgeon had retired. The South Australian mum had developed chronic nerve damage which consumed her right hip, knee and two of her toes.
The fetid mesh was deeply affecting her sex life with longterm partner Jared, too.
"When I had intimate relations with my partner, he could feel the hard and brittle arms of my implant against him. It was unbearable.
"A lot of women's partners and husbands have just walked away and left them because of the impact it has on their sex lives, but thankfully my partner has been wonderfully supportive."
The "disastrous" effect the mesh has had has seen Kim spend "hundreds of thousands of dollars", take months at a time off work, and use up all of her long service leave just to find some relief from the constant pain.
Because the real clincher is this: While Australian surgeons are more than happy to insert mesh into women's pelvic floors, they're not so willing to remove it. In fact, there are only two doctors in the world who offer to take out transvaginal mesh, and both live in the United States.
To have the toxic mesh removed requires a six-month stint off work to visit the US, and an upfront payment of $50,000, something Kim pursued and succeeded with.
There are only two doctors in the world who offer to take out transvaginal mesh. (Image supplied)
While the mesh might be out of her body, the havoc it wreaked is irreversible and will stay with Kim forever.
"My mesh was embedded in my bowel, my rectum, and my urethra," Kim told me. "Now, my whole pelvic floor is just a massive scar tissue. I am now incontinent, my nerve damage and muscle damage is permanent, and I live on medications."
Kim also lives with a level of anxiety she likens to post traumatic stress disorder.
"I'm certainly not the woman and I am not the mother I once was," she said. "I feel like I've lost a big part of myself. I can't be with my kids as much as I'd like, I can't play or do all the things I wanted to do with them. There are some days when I can't get out of bed."
If there is any solace in this tragedy, it's that Kim Blieschke can find comfort in the other Australian women who have also lived this hell. In fact, hundreds have reported serious health complications as a result of transvaginal mesh implants to the TGA, and a medical review predicts there are 4000 more silently suffering in the shadows behind them.
When Kim found someone who had experienced what she had online, she was overwhelmed.
"I just burst into tears because I honestly thought that I was on my own," she said. "I was told that it was all in my head, and to find that there was someone else, and for all these women to come forward was incredible.
"It's something that nobody really wants to talk about because people feel embarrassed, but as far as I'm concerned I want everyone to know about it."
"I want everyone to know about it." (Image supplied)
Kim is now one of the handful of women who are leading the charge to have transvaginal mesh implants banned. Her meeting with Victorian Senator Derryn Hinch last year proved pivotal in pushing discussion forward about what Hinch describes as "one of the greatest medical scandals and abuses of mothers in Australia's history".
It falls in line with the opinion of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, who state that "very little robust information is available on the efficacy and long term safety" of polypropylene mesh to treat pelvic organ prolapse, warning women of "adverse" effects.
Thanks to women like Kim, and Senator Hinch, there is now a Senate inquiry into the mesh, which has a reporting date of November 30.
But the aim is to do more than just have the mesh banned - it's to get justice.
"We would like someone to be answerable to this," Kim explained. "Because none of the surgeons are mandated to report the complications, they don't. We want women to have informed consent, because a lot of women are just told this is a straight forward operation when it's not, it can ruin lives."
And on behalf of Mamamia, we dearly hope Kim, and the many women beside her, succeed.
If you are a victim of transvaginal implants, Mamamia encourages you to lodge a complaint by clicking on your state:
Victoria; New South Wales/ACT; Queensland; South Australia; Western Australia; Tasmania; Northern Territory.
http://www.mamamia.com.au/transvaginal-mesh-implants/
Friday, April 28, 2017
Johnson & Johnson shareholders: are you listening? Divest or be complicit!
POSTED:APR 28 2017 03:07PM EDT
UPDATED:APR 28 2017 03:09PM EDT FiDA Highlight
PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.
The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.
The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.
Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.
She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.
As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.
“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."
The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.
"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.
“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”
Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”
The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.
The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.
Friday, April 21, 2017
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
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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Wednesday, April 5, 2017
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
Friday, June 10, 2016
Please Support Ariel Grace's Law HR5403
June 10, 2016
The Honorable __________________
___________________ HOB
Washington, DC 20515
Dear ________________________,
H.R.5403 Ariel Grace’s Law https://www.govtrack.us/congress/bills/114/hr5403
On June 8, 2016, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced an important new bi-partisan bill. This bill seeks to remove the preemption protection granted to Class III medical devices which receive initial premarket approval by the FDA. Accordingly, manufacturers of medical devices, which later may be shown to be defective and dangerous, will not be automatically shielded from liability. Often the threat of civil litigation is the necessary force to ensure that manufacturers provide medical devices that are both effective and more importantly, safe. A similar bill had over 100 cosponsors several years ago, and we hope to drive similar bipartisan support.
The bill is aptly named, Ariel Grace’s Law, after Ariel Grace Burrell, whose stillborn birth was caused by a Class III medical device. Kristiana Burrell has given her blessing to have the bill named after her daughter and the bill was introduced on the one year anniversary of the birth/death.
This bill is applicable to all Class III medical devices. It is an amendment to an already existing statute and merely amends the statute to allow access to courts for those injured by defective medical devices and is states as follows:
This Act may be cited as the “Ariel Grace’s Law
(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:
(b) NO EFFECT ON LIABILITY UNDER STATE LAW- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”
(c) EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall
(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and
(2) Apply to any civil action pending or filed on or after the date of the Act.
As your constituent, I strongly urge your support of this bill. It is unconscionable and unjust that manufacturers who have a medical device approved by the FDA pursuant to a premarket approval process can be forever shielded from liability and immune from suit even when the device later proves to be dangerous and/or defective and causes injury to device users. It was never the intent of the Federal Food, Drug and Cosmetics Act to provide blanket immunity for medical device manufacturers for defective devices placed into the stream of commerce. Quite simply, there is no plausible reason nor rationale for the failure to support this amendment, which serves to protect your constituents. Accordingly, I strongly urge you to join forces with Representatives Fitzpatrick and Slaughter and make this bill into law as soon as possible.
My best,
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