Earl's View » Johnson & Johnson

OUT OF CONTROL – Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution

earlstevens58 — Tue, 19 Nov 2013 19:56:40 +0000

Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts.

Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution

Posted on November 19, 2013 by Cal Warriner

One has to wonder how this will play with stockholders. Johnson & Johnson, the healthcare giant, has agreed to pay more than $2.2 billion to settle criminal charges over the marketing of its antipsychotic drug, Risperdal. The company’s Janssen Pharmaceuticals division is accused of marketing the drug to treat elderly patients with dementia, children and the disabled.

This case, brought by the Department of Justice, is a big win for American patients.

Risperdal was approved 20 years ago by the U.S. Food and Drug Administration (FDA) for managing psychotic disorders, not to keep the elderly subdued or children quiet.

In announcing the settlement this week, U.S. Attorney General Eric Holder called it among the largest healthcare fraud settlements in U.S. history.

J&J marketed Risperdal for unapproved uses from 1999 through 2005. And it had help. Omnicare, which dispenses drugs to nursing homes, billed the government for the unapproved drugs, and received kickbacks from Risperdal sales reps to prescribe the drug as well as another antipsychotic, Invega (for the treatment of schizophrenia) and Natrecor, a heart drug, according to a report in Bloomberg.

- See more at: http://www.searcymasstort.com/blog/2013/11/19/johnson-johnson-fined-2-2-billion-for-reckless-drug-distribution/#sthash.exfHp6zJ.dpuf

Johnson & Johnson illegally paid doctors and pharmacies kickbacks to promote prescription drugs for “unapproved uses” (undergroundhealth.com)
Johnson & Johnson to Settle Risperdal Improper Marketing Case (nytimes.com)
Johnson & Johnson to pay $2B to settle psychiatric drug charges (newsday.com)
Johnson & Johnson fined $2.2 billion for faulty drug claims (abc.net.au)
Johnson & Johnson To Pay $2.2 Billion To Settle Deceptive Marketing Claims (consumerist.com)
Johnson & Johnson fined $2.2bn to settle drug cases (onntimes.com)
Johnson & Johnson pleads guilty to fraud (thehindu.com)
Johnson & Johnson Will Pay $2.2B Over Kickbacks (newser.com)
Johnson & Johnson to pay $2.2B in health care fraud settlement (cbsnews.com)
DOJ: Johnson & Johnson agrees to pay $2.2B (abqjournal.com)

Filed under: elderly, Elderly Patients, Hip Replacement, Johnson & Johnson, Johnson & Johnson lawsuit Tagged: $2.2 billion, Antipsychotic, Eric Holder, Food and Drug Administration, Johnson, Johnson & Johnson, Nesiritide, Omnicare, Risperidone

Johnson & Johnson – It ALL about the MONEY – NOT Patients…

earlstevens58 — Tue, 19 Nov 2013 19:46:58 +0000

Johnson & Johnson to Offer $2.5 Billion Hip Device Settlement – NYTimes.com.

Johnson & Johnson to Offer $2.5 Billion Hip Device Settlement

By BARRY MEIER

Published: November 19, 2013

Lawyers for Johnson & Johnson and patients injured by a flawed hip implant were expected to introduce a multibillion-dollar plan Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.

Under the agreement, according to people briefed on the plan, the medical products giant will pay some $2.475 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.

Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to some $3 billion, said those familiar with the proposal, who did not want to be identified.

The typical patient payment for pain and suffering caused by the device will be about $250,000 before legal fees, under the plan. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners.

Read the full NY Times article here.

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (earlsview.com)
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (nytimes.com)
Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
Johnson & Johnson Investors Sweat, but the Dow Bounces Back (fool.com)
Johnson and Johnson Agrees to Settlement To Reach as High as $4 Billion to Resolve Patient Lawsuits With Flawed Hip Replacement Devices (ducknetweb.blogspot.com)
Johnson & Johnson Reaches $4 Billion Settlement Over Hip Implants (theatlanticwire.com)
J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
Johnson & Johnson to pay $4 billion settlement over metal-on-metal hip implants: Report (cbsnews.com)
How Did This Company Lose Over $6 Billion in 2 Weeks? (fool.com)
Gray and White Law Provides Expert Commentary on $4 Billion Expected Settlement in Johnson & Johnson DePuy ASR LawsuitsWhich Is Higher Than Previously Estimated (prweb.com)

The Myth of the Medical-Device Tax

earlstevens58 — Thu, 14 Nov 2013 21:27:15 +0000

The Myth of the Medical-Device Tax

WASHINGTON — IN the last few days of negotiations in Congress, repeal of the Affordable Care Act’s tax on medical devices emerged as a key Republican demand. The medical-device industry waged an intense lobbying campaign — even garnering the support of many Democrats who favored the law — arguing that the tax would stifle innovation and increase health care costs.

This argument is doubly disingenuous. Not only can the medical-device industry easily afford the tax without compromising innovation, but the industry’s enormous profits are a result of anticompetitive practices that themselves drive up medical-device costs unnecessarily. The tax is a distraction from reforms to the industry that are urgently needed to lower health care costs.

The medical-device industry faces virtually no price competition. Because of confidentiality agreements that manufacturers require hospitals to sign, the prices of the devices are cloaked in secrecy. This lack of transparency impedes hospitals from sharing price information and thus knowing whether they are getting a good deal.

Even worse, manufacturers often maintain personal relationships (sometimes involving financial payments like consulting fees) with physicians who choose the medical devices that their hospitals purchase, creating a conflict of interest. Physicians often don’t even know the costs of the devices, and individual physicians often choose devices on their own, which weakens a hospital’s ability to bargain for volume discounts.

Such anticompetitive practices help generate a wide variation in the prices of medical devices — and contribute to higher prices in general. For example, the Government Accountability Office found that prices for cardiac implantable medical devices in the United States vary by several thousand dollars. And even the lowest-priced devices in the United States are expensive compared with those in other developed countries. According to the consulting firm McKinsey & Company, the United States spends about 50 percent more than expected on the top five medical devices, compared with Europe and Japan. McKinsey calculates that this amounts to $26 billion in excessive spending each year. Medicare, private health insurers and patients end up paying these inflated prices.

Excessive prices fuel enormous profits — profits that dwarf both the medical-device tax and the industry’s investments in research and development. Consider the device division of Johnson & Johnson, which in 2012 had an operating profit of $7.2 billion. By the company’s own estimate, the device tax would amount to at most $300 million, and its investment in research and development amounts to only $1.7 billion.

There are several ways policy makers could lower device costs. The first step would be to end the anticompetitive practices that prevent hospitals from getting the best deals. Senator Charles E. Grassley, Republican of Iowa, has sponsored legislation that would foster transparency by posting online price information for implantable medical devices.

In addition, instead of simply paying hospitals based in part on what they have spent on devices, Medicare should force manufacturers to compete for business based on a product’s price and quality.

Medicare should also pay hospitals a single lump sum for all of the associated costs of a given procedure (like a hip replacement). This approach, known as “bundling” the costs, would create incentives for hospitals to lower device costs. Savings should be shared with the physicians, so that their incentives are aligned with the hospital’s.

Bundling has been used successfully in pilot programs. Under Medicare’s Acute Care Episode Program — which bundled payments for cardiac and orthopedic procedures — physicians worked together to choose high-quality, cost-effective devices. Baptist Health System in Texas, which participated in the program, used clinical evidence to choose devices and negotiated lower prices for both Medicare and non-Medicare patients.

States could adopt similar payment reforms for private insurance and their Medicaid programs. In Arkansas, the Medicaid program and private payers — including Walmart — have collaborated to adopt bundled payments for several procedures, including hip and knee replacements.

To complement these efforts, the new Patient-Centered Outcomes Research Institute, a nongovernmental body created by the Affordable Care Act, should pay for research that compares the effectiveness of devices so physicians can make informed choices. (Three years into its existence, the institute has initiated few, if any, studies of medical devices.) Medicare or the Food and Drug Administration should also require the use of registries that track when devices fail.

Currently, medical-device manufacturers allocate only a sliver of profits to research and development and often focus on “tweaks” to existing devices, without providing any evidence that they are of better quality. Competitive pressures from public and private payers would provide incentives for the industry to become more innovative, producing technologies that actually lowered costs and offered truly advanced breakthroughs.

Instead of using its clout to lobby against the device tax — which helped foment opposition to the Affordable Care Act — the medical-device industry needs to share the responsibility of lowering costs for patients, businesses and taxpayers.

The Myth of the Medical-Device Tax (nytimes.com)
Does medical device price gauging really contribute to wide variation in hospital charges? (medcitynews.com)
Medical device makers see hope for tax relief in federal shutdown talks (bizjournals.com)
Questions raised on medical devices supplied by doctor firms (jsonline.com)
New OIG study finds physician self-referral leads to increased spinal surgeries (pathologyblawg.com)
5 Ways mobile Is revolutionizing medical device sales (medcitynews.com)
Merit Medical Engineers to Present at Compamed 2013 (hispanicbusiness.com)
The new reality for medical devices: Justify your existence (medcitynews.com)

Filed under: Cobalt chrome, Cobalt Poisoning, DePuy ASR Hip, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Baptist Health System, Food and Drug Administration, Johnson & Johnson, McKinsey & Company, Medical device, Medicare, Patient-Centered Outcomes Research Institute, UNited States

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

earlstevens58 — Thu, 14 Nov 2013 09:05:42 +0000

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Andrew Testa for The New York Times

A faulty Articular Surface Replacement, or A.S.R., removed from a patient in 2010.

By BARRY MEIER

Published: November 12, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

Read the full article here – New York Times

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (nytimes.com)
J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
Johnson & Johnson said to reach settlement for hip-implant suits (denverpost.com)
Johnson & Johnson Reaches $4 Billion Settlement Over Hip Implants (theatlanticwire.com)
Johnson & Johnson Investors Sweat, but the Dow Bounces Back (fool.com)
Johnson & Johnson Offer Two Settlement Deals for the DePuy ASR Hip Replacements (prweb.com)
Johnson & Johnson said to reach $4 billion accord to settle hip-implant claims (nj.com)
Johnson & Johnson to pay $4 billion settlement over metal-on-metal hip implants: Report (cbsnews.com)
DePuy ASR Settlement Update: Rottenstein Law Group LLP Comments on $4 Billion DePuy Hip Settlement News (businesslawdaily.net)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, Food & Drug Administration, Health, Hip Replacement, hip replacement failure, hip resurfacing, Human settlement, Johnson, Johnson & Johnson, Medical device, New York TImes, Patient, Product Liability

J&J pressured to settle Australian hip lawsuits – FierceMedicalDevices

earlstevens58 — Tue, 26 Mar 2013 23:40:32 +0000

J&J pressured to settle Australian hip lawsuits – FierceMedicalDevices.

J&J pressured to settle Australian hip lawsuits

March 26, 2013 | By Mark Hollmer

Johnson & Johnson’s ($JNJ) $8.3 million defeat in a U.S. jury trial over its ASR metal-on-metal hip implant could force it to settle a massive class action lawsuit in Australia over the same product.

Lawyers representing 4,500 ASR implant patients in Australia may ask the country’s Federal Court to order Johnson & Johnson (and executives from DePuy division that made the implants) to focus on negotiating a settlement in the wake of the company’s defeat at the hands of a Los Angeles jury earlier this month, the Sydney Morning Herald reports this week. The negotiations would take place through a week of mediation in May.

Beyond the outcome itself, some of the testimony during the Los Angeles trial has also given their case a shot in the arm: J&J executives appear to have been told they didn’t act to address faulty ASR implants even though they knew about the product’s mounting safety and mechanical problems.

Presumably, J&J is prepared. The company pursued a global recall of the ASR implant system in 2010, and has boosted the amount of money set aside to handle rising legal costs stemming from lawsuits and settlement cases around the world. To date, J&J has already spent nearly $1 billion on ASR-related settlements.

More than 10,000 ASR-related lawsuits against J&J remain, and, since the Los Angeles case, a New Jersey jury ordered it to pay $11.2 million to an ASR plaintiff whose device failed and then faced a number of repeat surgeries. The lawsuits allege J&J designed a defective product and didn’t pursue proper safety and regulatory practices, but J&J denies any wrongdoing and has countered that patients complaining of ASR-related health problems endured unrelated issues. Many plaintiffs claim the implant damaged tissue around it and released metal fragments into their bodies.

Meanwhile, as the Sydney Morning Herald reports, the ASR hip implant had a 44% failure rate in Australia within seven years, according to Australian registry data cited by the story.

- here’s the story

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
Pressure rises for settlement of hip implants case (theage.com.au)
Compensation hopes for faulty hip implant victims (smh.com.au)
VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com (earlsview.com)
Common Problems Associated With Titanium Hip Replacements (orthopedics.answers.com)
Learning the Truth About Sulzer Orthopedics (arthritis.answers.com)
HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
Signs Your Hip Implants Are Hurting You (earlsview.com)
Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Australia, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy Hip Recall Litigation, DePuy Lawsuit, Food & Drug Administration, Hip Replacement, Johnson, Johnson & Johnson, lawsuit, Los Angeles, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, Sydney Morning Herald

Stuart Cain Reports – A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

earlstevens58 — Sun, 17 Mar 2013 21:09:53 +0000

A Warning for all MOM Patients – It is NEVER over, and your health is never, ever going to be the same!

My apologies for not writing for some time! I have been following the progress of the many brave people who have been using Earl’s awesome blog and I continue to admire every one of you who have been able to speak up and even more so, those of you who are unable to share but use the site as a communication tool and information gathering service! I implore all of you to continue to speak out and seek answers, as I have found out (as has Howard, Bob, Brooks, Earl, Meg, Anna, Connie and so many others) these answers are often not there to be discovered, but if we all continue to push the medical world, the device manufacturers, governments and regulators, they may actually realise the importance of this and provide the funding to the researchers who are crying out for the opportunity to look into this terrible situation. My best wishes for 2013 to all, mine hasn’t started very well but I hope that the following will give each of you renewed vigour and the strength not to accept mediocrity in your treatment by the device manufacturers or the medical world!

Thanks to Johnson and Johnson/DePuy, Smith and Nephew and all the other companies that pushed MOM (Metal-on Metal) technology into the market place our lives will never be the same. Not only for the current issues that each and every one of us is experiencing, but for those that are going to continue to develop until we all die. I wanted to share with you my latest ‘issue’ and let it be a warning that there are darker days ahead for many of us who are yet to find out the true impact of what these implants and their associated ‘side-effects’ are doing to us.

I don’t know what each person was told, but I was assured that this ‘Rolls Royce’ of implants would allow me as a young person (37 at the time of implantation), to go back to my previous level of activity (with some obvious limitations) and that it would last longer than the alternatives. This was probably where the biggest mistake was made (apart from using the bloody thing in the first place). After 3 revisions of the hip, the insertion of a plate and 9 screws to hold my femur together and of course the painful rehab associated with this, I am now in a worse condition than I was before the initial implant. I know many of you will relate to this (30 operations now isn’t it Howard!). I almost wish the suspected infection that they thought was in my bone actually was there this week as even though it would suck, the treatment was possible! Unlike the ‘holding pattern’ I have been placed in whilst the medical world try to come up with why my health has deteriorated to the point that it has!

My ‘ASR experience’, as Johnson and Johnson/DePuy like to refer to it as, has come crashing down on me in the last week. After a rapid deterioration in my health over the last 2 months I had an x-ray which showed that not only had my 15 month-old fracture in my femur not healed (as it previously appeared to finally be), but it has now increased in size and ‘crossed’ over 2 of the screws in my femur. This has occurred during a month where I was virtually chair and bed bound as I had incredible pain, increasing fatigue without actually being able to sleep and couldn’t weight bear without a great deal of assistance. I had also developed intense pain in the foot on the opposite side to the implant, pain in my opposite shoulder and lower back. After a series of blood tests (to rule out infection), Nuclear Bone Scans and CT Scans, it is confirmed that I have ‘stress fractures’ in my foot and signs of developing fractures in my shoulder and lower back. No, I wasn’t in a car crash, these ‘fractures’ have developed ‘spontaneously’ as described by my surgeon. In his words: “how can an otherwise healthy individual (not counting my destroyed hip of course) develop stress fractures, especially when you haven’t been doing anything”.

In the absence of research and evidence (as no-one either has the funding or genuine interest, or if it has been done is too damning for us to see!) on the effects of Cobalt and Chromium toxicity on the body, my surgeon after seeing ‘some very interesting side effects’ in his other patients firmly believes that we are now starting to see the true effects of Cobalt and Chromium toxicity in the human body. He also notes that it is an interesting correlation between the higher levels of side effects in those people who were more ‘active’ after being implanted with a MOM device. I should note that my surgeon has never used any MOM technology as he felt when it was released that it wasn’t tested and investigated enough for not only its long term sustainability but also for the possible side effects that it may create. This was on the basis of research in the 1990’s and early 2000’s into the ‘wear’ of such devices and how there was little evidence of what this ‘wear’ might do to the patient. It is amazing that the very small number of surgeons, such as him, are now given almost ‘charlatan’ status now if they have the courage to speak out amongst their own colleagues about MOM implants, I am sure that Dr Steve may well appreciate this!

So now as I enter a new week of more doctors and tests, the ever-present company of pain, not being able to walk without crutches and the mental anguish of not only ‘not knowing’ where to turn from here, let alone what effect this is having on my wonderful wife and amazing family, I want all of you to be aware that there is so much more that none of us are aware of about the effects of MOM implants and as I have now experienced, the medical world have even fewer answers when it does happen! I even approached Johnson and Johnson/DePuy direct to see what they are doing about research into the effects of these devices, surprisingly they were more concerned about the multitude of pending legal cases than what these wonderful devices will continue to do to us patients as long as we live! I implore each and every one of you who have had a MOM implant (or your loved ones) to monitor your health with diligence, as I found out it isn’t just the area of concern (your implanted hip/s) that you need to consider, this poison can hit you anywhere! I should have known as part of my ‘initial’ raft of side effects was a very rare form of anaemia caused by of all things “heavy metal poisoning”, this is a systemic problem we all need to be aware of now. Please also remember, the removal of the offending device is not the ‘end of the road’ as far as your problems go, if you had a recognised toxicity to Cobalt or Chromium, or even one that wasn’t investigated, the damage has been done, we are all just waiting to see now how that damage presents to us all!

I would be very interested to hear from anyone else, who has had problems with either poor fracture healing after Cobalt/Chromium toxicity or of course the development of ‘random fractures’, I also encourage anyone who has had any as yet ‘unexplained’ side effects to please let us know as I would like to try to develop a data base of any side effects that have or may be attributed to Cobalt or Chromium toxicity. I have tried to see if such a list exists and I am yet to find one (please let me know if I have had a ‘boy look’ and missed it if it does indeed exist), although I suspect that as many of these effects are only now coming to prominence that a list would be inaccurate anyway. I would be very interested to hear if anyone has had any luck with any sorts of treatments (western or eastern medical, alternative or otherwise) to do with their complications from their MOM implant so that these can be shared to the wider group.

I hope that everyone has a better week! I am going to fight to get to the bottom of this in my circumstance as to be honest I am truly scared of where this might lead and I think my family have suffered enough through all of this without having to sit back and watch me slide even further into the mire of declining health! I am very aware that there are many of you out there in a worse position than me so please don’t think I am in any way diminishing your experiences, I can only imagine what you are going through and lend my support in any way I can! I am also determined that regardless of compensation payouts and court cases, that Johnson and Johnson/DePuy, Smith and Nephew and any other ethically challenged medical device manufacturer is truly held to account for what has happened to each of us and apparently what is continuing to happen to each of us! I encourage you to keep up the fight, share your experiences with us or at the very least seek answers to any questions regardless of what people (especially doctors who may have a reason (financial or conscience) to keep you in the dark) try to tell you, if you don’t believe them or have doubts about the answer/s you have been given look elsewhere until you are satisfied!

One final thought: “Hope is the essence of life, no-one can live without hope!”, this Buddhist quote is one that I wear (literally) around my neck every day, I think that we can all draw some strength from it as I believe it is vital to us all getting through this (although it has been sorely tested in the last couple of weeks!! J).

Take Care, Stuart Cain

Metal-on-metal hip replacement toxicity | NPS MedicineWise (earlsview.com)
FDA cracks down on all-metal hip replacements (earlsview.com)
Biomet M2a Metal Hip destroys 46 year olds life… (earlsview.com)
J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
Metal Debris in Patients’ Bloodstream is “Harmless,” J&J Toxicologists Say (earlsview.com)
J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
Expert Witness Says Hip Implant Harmless (polymersolutions.com)
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: chromium, chromium toxicity, Cobalt, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Earl, Health, Hip Replacement, hip resurfacing, hip revision, Johnson, Johnson & Johnson, metal, Metal on metal hip, Smith & Nephew

VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com

earlstevens58 — Sat, 09 Mar 2013 06:47:08 +0000

Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com.

VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.

The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.

In a statement, the company described the verdict as “mixed” and said that it planned to appeal the damage award. It disputed the finding by the jury that the A.S.R. was defectively designed.

It was impossible to say what the verdict, which came in a Los Angeles state court, would mean for other A.S.R.-related cases. A trial on a second lawsuit is scheduled to begin Monday in Chicago, with other cases expected to proceed later this year.

In its decision, the panel ordered Johnson & Johnson to pay the case’s plaintiff, a retired Montana prison guard, Loren Kransky, $338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.

Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve.

Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.

The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.

It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.

However, the A.S.R.’s design caused the cup and ball to strike against each other as a patient moved, resulting in the shedding of metallic debris. That debris inflamed and damaged tissue and bone, causing pain and, in some cases, permanent injuries to patients.

Today, all-metal hips like the A.S.R. are rarely used by surgeons because most models suffered from similar problems. But data from orthopedic registries suggests that the A.S.R. was far worse than many competing products.

An internal Johnson & Johnson document introduced at the Los Angeles trial estimated that close to 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced. In a recent filing with the Securities and Exchange Commission, Johnson & Johnson said that there are 10,750 A.S.R. lawsuits.

Traditional artificial hips, which are made of metal and plastic, are expected to last 15 years or more before needing to be replaced, and the normal replacement rate for early unexpected failures is about 5 percent after five years.

The lawsuit heard in Los Angeles was not originally scheduled to be the first over the A.S.R. but it was moved up because Mr. Kransky was found to have terminal cancer. Before the start of the Los Angeles trial, which began in late January, Mr. Kransky’s lawyers had not expected him to live through it.

Internal Johnson & Johnson documents that became public during the trial indicated that company executives were told by surgeons, who were also paid consultants to the device maker, that the design of A.S.R. was flawed. In addition, some surgeons also urged the device maker to slow sales of the implant or stop them completely, records show.

In the case, evidence was also presented that showed that Johnson & Johnson considered redesigning the A.S.R. to reduce its problems, but then abandoned the project because the implant’s sales did not justify the costs of the redesign. One of the DePuy executives involved in that decision was Andrew Ekdahl, who now heads Johnson & Johnson’s orthopedics division.

Johnson & Johnson executives like Mr. Ekdahl have said throughout the A.S.R. episode that they acted responsibly and moved to recall the device in 2010 when data from an orthopedic registry in Britain showed that its failure rate was higher than normal.

Before reaching its verdict Friday, the jury that heard Mr. Kransky’s case deliberated for more than five days. Mr. Kransky’s lawyers, citing what they described as the unethical behavior of DePuy executives in failing to warn doctors and patients of the device’s defects, asked jurors to punish Johnson & Johnson by awarding their client $36 million to $144 million. Jurors declined to do so.

Nonetheless, lawyers representing Mr. Kransky hailed the verdict.

“This is a victory for Mr. Kransky and thousands of other badly damaged A.S.R. patients who have yet to get their day in court,” Brian Panish, one of Mr. Kransky’s lawyers, said in a statement. “Jurors across the country will return similar verdicts until J.&J. takes full responsibility.”

A DePuy spokeswoman, Lorie Gawreluk, said in the company’s statement that it planned to appeal Friday’s verdict, contending that the A.S.R.’s design was not defective.

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
Damages awarded in J&J’s DePuy hip implant case (wfaa.com)
Parker Waichman LLP Weighs-In on $8.3 Million Verdict in DePuy ASR Hip Implant Trial (prweb.com)
Johnson & Johnson to award security guard $8.3m over faulty implant (guardian.co.uk)
Recalls-R-US… Johnson & Johnson Confirms Inquiry Into Hip Devices – NYTimes.com (earlsview.com)
DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
Johnson & Johnson Pays Out $8 Million In Lawsuit (huffingtonpost.com)
Jury awards damages in Johnson & Johnson hip case (kfwbam.com)

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: Chicago, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Hip Replacement, Johnson, Johnson & Johnson, Kransky, lawsuit, Los Angeles, metal, Metal on metal hip, metal-on-metal hips, metallosis, New York TImes, science, Smith & Nephew, UNited States

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

earlstevens58 — Tue, 05 Mar 2013 10:07:33 +0000

Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants.

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

Orthopaedic surgeons
Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

Traditional total hip replacement systems
Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers. This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal). Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
- Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated. Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years). If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Female patients
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity.
Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant. Please be aware of the FDA’s recommendations:

Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
Review the available device-specific labeling from manufacturers for MRI Conditions; and
Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream. Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results. Please be aware of the FDA’s recommendations:

The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention. The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

Consider the benefits and risks of all bearing surfaces for each patient.
Check the specific device labeling for compatibility of device components.
If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

	Symptomatic Patients	Asymptomatic Patients
Regular Clinical Evaluation	At least every six months	Typically at least once every 1 to 2 years
Soft Tissue Imaging	Consider the benefits and risks of MRI, CT and ultrasound for each patient.	Not necessary if you feel the hip is functioning properly.
Metal Ion Testing	Consider monitoring serial metal ion levels. Currently, the most reliable test results are available for cobalt in EDTA-anticoagulated blood*. In repeat tests, use same sample type, measurement method and preferably the same laboratory.	Not necessary if you feel the hip is functioning properly.

*For chromium testing, a validated method that resolves potential interferences must be used. Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

General hypersensitivity reaction (skin rash)
Cardiomyopathy
Neurological changes including sensory changes (auditory, or visual impairments)
Psychological status change (including depression)
Renal function impairment
Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

Be aware that every hip implant has benefits and risks.
Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices. Recent activities include:

On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices. Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans. Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications. Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

Date of implantation
Date of implant removal (if applicable)
Clinical cause for revision (if available)
System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Filed under: Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Hip Revisions, Metal on metal hip, Total Hip Replacement Tagged: Cobalt chrome, Cobalt poisoning, DePuy, FDA, Food & Drug Administration, Health, Hip implants, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson & Johnson, joint replacement, Medicine, Metal on metal hip, metal-on-metal hips, metallosis, Patient, Radiology, Research, science, Smith & Nephew, soft tissue damage, Specialty, UNited States

DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable

earlstevens58 — Tue, 05 Mar 2013 09:56:43 +0000

Trial plaintiff says J&J hips defective, company says not liable.

Trial plaintiff says J&J hips defective, company says not liable

3/1/2013

By Deena Beasley

(Reuters) – Johnson & Johnson‘s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.

The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.

Kransky attorney Brian Panish told Los Angeles Superior Court jurors that J&J should be ordered to pay around $5 million for Kransky’s pain and suffering, and as much as $179 million in punitive damages. The proceedings were monitored over the Courtroom View Network.

J&J recalled 93,000 of its ASR metal hips after determining that they were failing at a higher-than-expected rate.

Kransky’s attorneys argued that the design of the hip was defective, leading to the shedding of metal debris that caused tissue poisoning and pain as well as the need for the plaintiff to undergo hip revision surgery.

“Any compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person,” Panish said.

Both sides in the case agreed that Kransky’s medical problems, including diabetes, cancer, kidney disease, heart disease and vascular disease, were not related to the ASR hip implant.

J&J attorney Michael Zellers argued that Kransky’s ASR hip was implanted at an incline that was steeper than company guidelines advised. He also said the plaintiff’s need for revision surgery was caused by an infection.

Testimony in the trial included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

“We know there is no perfect hip design. There are always trade-offs,” Zellers said, adding that the company designed the all-metal device with the aim of developing a longer-lasting hip that would show less wear than existing devices.

The J&J attorney argued that there is no medical consensus on what levels of chromium and cobalt, the metals shed by ASR hips, could cause harm to patients.

“Ultimately the product did not perform as DePuy wanted it to perform or expected it to perform,” he said.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

Michael Kelly, another Kransky attorney, told jurors the evidence shows that J&J’s DePuy unit was primarily focused on making money from the all-metal ASR hips at the expense of patient safety.

DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)
Parker Waichman LLP Reviews Closing Arguments of DePuy ASR Trial and Discusses Risks of Metal-on-Metal Hip Implant (prweb.com)
J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
DePuy ASR Hip Lawsuit News: Plaintiff’s Attorney Alleges J&J Pursued Profits Over Safety; Asks for as Much as $180 Million in Damages (prweb.com)
US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
Business: Washington Post Business Page, Business News (earlsview.com)

Filed under: 510k process, Cobalt chrome, Cobalt Poisoning, Cobaltism, DePuy ASR Hip, DePuy Hip Litigation, Hip Replacement, Hip Revisions, Johnson & Johnson, Metal on metal hip, Total Hip Replacement Tagged: arthritis, Cobalt chrome, Cobalt poisoning, Courtroom View Network, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, FDA, Food & Drug Administration, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, Johnson, Johnson & Johnson, joint replacement, Kransky, Medicine, metal, Metal on metal hip, metal-on-metal hips, Plaintiff, Reuters, Smith & Nephew, Zellers

Some Justice at Last – Damages top $11M against J&J in vaginal-implant lawsuit | MedCity News

earlstevens58 — Tue, 05 Mar 2013 09:50:49 +0000

Damages top $11M against J&J in vaginal-implant lawsuit | MedCity News.

Damages top $11M against J&J in vaginal-implant lawsuit

March 1, 2013 11:12 am by Sell, David | 2 Comments

A jury in Atlantic City ordered Johnson & Johnson on Thursday to pay $7.8 million in punitive damages to a former hospice nurse for the pain and suffering she endured after using a vaginal mesh implant sold by J&J’s Ethicon subsidiary.

The verdict follows a $3.35 million award for compensatory damages, delivered Monday.

The Gynecare Prolift implant was supposed to help support muscles and sagging internal organs near the pelvis, a condition, referred to as prolapse, that affects some women in years after giving birth. The device did not work for Linda Gross, 47, who had 18 surgeries in hope of relieving the pain after the initial operation.

Gross, who lives with her family in Watertown, S.D., missed so many days of work because of health issues that she was fired from her job.

She was unavailable for comment Thursday, but testified during the seven-week trial that her life after surgery was a “living hell.”

J&J began selling the implant in 2005 before withdrawing it in 2012 in the face of reports of problems and lawsuits. J&J said it would appeal the jury decision and both awards.

“Ethicon acted appropriately and responsibly in the research, development, and marketing of the Prolift pelvic organ prolapse repair kit,” J&J said in a statement.

The statement angered Gross’ attorney, Adam Slater.

“We’re going to need more and bigger punitive-damage awards against Johnson & Johnson before they ever have the humility to realize they are not above the law,” Slater said in an interview.

There are thousands of implant cases in state and federal courts around the country against multiple manufacturers of vaginal implants. This was just the second verdict, and both verdicts have gone to the plaintiffs.

New Jersey Superior Court in Atlantic County has, like Philadelphia’s Court of Common Pleas, become a common venue for multidistrict litigation in cases of a similar nature.

In March 2006, Slater filed his first implant suit. Gross and her husband, Jeff, researched the matter and contacted Slater that year. He now has 250 implant cases pending in state court.

J&J, which is based in New Brunswick, N.J., and has operations in several places in the Philadelphia region, faces about 1,800 implant lawsuits in New Jersey. Multiple J&J divisions face product lawsuits and are dealing with product recalls.

The company’s McNeil Consumer Healthcare plant in Fort Washington has been closed since April 2010 after dozens of product recalls and will not reopen until a federal judge approves.

In the implant case, J&J lawyer Christy Jones urged jurors — six women and three men — not to award punitive damages because J&J had not acted in a way to warrant it, according to Bloomberg News.

“I understand that you have found that we could have done a better job and that we in fact fell short,” Jones said Tuesday. “My clients understand that. We hear you, I promise you. While I confess to you from the bottom of my heart that it hurts, and we’re disappointed in the verdict, we nonetheless appreciate what you have said and recognize and respect your verdict.”

J&J was less apologetic Thursday after the punitive-damages award and said the jury decision was conflicted. The company argued that the jury said the implant was not defective in design and that J&J did not misrepresent the product to surgeons.

“While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications,” the company said in its statement.

Attorney Jeff Grand joined Gross’ attorneys because his firm is involved in implant litigation and he serves as a liaison among groups of plaintiffs’ attorneys. He said the $11.15 million total award was a message from the jury.

–

Contact David Sell at dsell@ phillynews.com or 215-854-4506. Read his blog at http://www.philly.com/ phillypharma and on Twitter @phillypharma.

Vaginal Mesh Lawsuit Punitive Damages of $7.76 Million Awarded by New Jersey Jury Against Johnson & Johnson, Reports Wright & Schulte LLC (prweb.com)
Damages top $11M against J&J in vaginal-implant lawsuit (philly.com)
Damages top $11M against J&J in vaginal-implant lawsuit (medcitynews.com)
Jury Awards $3.35 Million to Woman in Vaginal Mesh Case against Johnson & Johnson: Bisnar | Chase Product Liability Lawyer Pleased with Verdict (prweb.com)
Jury adds $7.8 million in J&J punitive damages (wfaa.com)
NJ jury awards woman $3.35 M in J&J implant suit (wfaa.com)
J&J Failed to Warn of Vaginal Mesh Risks, N.J. Jury Rules – Bloomberg (bloomberg.com)
$7.76 Million Punitive Damages Award in Prolift Vaginal Mesh Case Indicative of Jury’s Mindset, Rottenstein Law Group’s Principal Says (prweb.com)
Jury delivers verdict in J&J Prolift Mesh Trial, New Jersey (tvtinfo.wordpress.com)
Jury awards $3.35 million in vaginal mesh case (healthnexercise.com)

Filed under: Johnson & Johnson, Johnson & Johnson lawsuit, Metal ions, metallosis, Pelvic mesh, Pelvic organ prolapse, surgical mesh problems, Transvaginal Mesh, Vaginal Mesh Tagged: Court of Common Pleas, Damages, Ethicon, gynecare prolift, hospice nurse, Johnson, Johnson & Johnson, New Jersey, New Jersey Superior Court, Prolapse, punitive damage awards, Punitive damages

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Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants

FDA Safety Communication: Metal-on-Metal Hip Implants

Audience:

Device:

Summary of Problem and Scope:

Recommendations for Orthopaedic Surgeons:

Before Surgery

Patient Follow-Up

Imaging

Assessing Metal Ion Levels

Device Revision

Recommendations for Health Care Providers:

Recommendations for Patients Considering Hip Implants:

Recommendations for Patients with Metal-on-Metal Hip Implants:

FDA Activities:

Other Resources:

Reporting Problems to the FDA:

Contact Information:

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