Friday, December 27, 2013

DePuy ASR Settlements May Leave Thousands Without Recourse

Injury Lawyer News

The DePuy ASR recall has cost Johnson & Johnson millions of dollars in litigation and medical expenses, and despite a $2.5 billion settlement proposal to compensate 8,000 hip replacement patients, the accord may still leave thousands of injured recipients in a financial lurch.

depuy infographic, depuy hip lawsuit infographic, depuy hip settlementsConcern is centered around the many hundreds of patients who had their hip revision surgery after the accord’s deadline – August 31, 2013. For these individuals, or those who have yet to need corrective surgery, it’s unclear whether they will see a dime of compensation for DePuy hip problems, even though the modular device is known to suffer design flaws and high failure rates.

Under the terms of the agreement, DePuy ASR settlements would offer patients a base award of $250,000, but this figure would be adjusted based on several factors including the patient’s complications and extent of injuries, medical history, age and length of hospitalization.
Critics of the settlement argue that the deal’s payout structure is vague. Do ASR settlements include lost wages for those who couldn’t work while they were recuperating? And what about patients who were implanted with the metal-on-metal hip but have yet to experience any problems, though they are bound to suffer complications in the near future?

Injured patients in outrage over proposed DePuy ASR settlements

In order for the DePuy hip settlement to proceed, at least 94 percent of ASR recipients must agree to the accord’s stipulations and file claims on or before April 1, 2014. Should participation levels fall short, DePuy reserves the right to walk away from the deal on June 1, 2014.  According to the New York Times, the accord was proposed to Ohio District Judge David A. Katz on Tuesday, November 19.

DePuy voluntarily pulled all Articular Surface Replacement (ASR) hip systems off the U.S. market in 2010 after the National Joint Registry of England and Wales published alarming failure rates of the device.  The report revealed that ASR hip implant failure, which required replacement surgery, was between 12 and 13 percent within the first years of implantation. However, the manufacturer has since stated that ASR hip complications and failure is likely in 40 percent of recipients within the first five years.

The DePuy ASR recall affected roughly 37,000 units in the United States and 93,000 globally.
An estimated 12,000 DePuy ASR hip lawsuits are currently pending in state and federal courts, with nearly 8,000 of these claims brought by patients who endured hip revision surgery. The remaining 4,000 product liability cases involve claimants who suffered metal contamination and other debilitating side effects from the modular components, which were prone to corrosion and fretting.

Compensation for DePuy hip problems

If enough claims are made, the settlement would cover around 8,000 patients in the U.S. who had the ASR hip implant explanted due to premature wear and complications.

The amount awarded to each person would depend on:

  • If the patient smoked at the time of revision surgery
  • How long the ASR device was implanted
  • If the person had hip replacement on the same hip before receiving the ASR
  • A body mass index (BMI) of more than 35 before ASR implantation
  • The patient’s age
Those who sustained “extraordinary injuries” related to the metal hip implant – such as double revision surgery in both hips – would qualify for supplemental compensation, according to hip replacement lawyers and other settlement administrators.


 

Steve Tower MD lecture at Columbia on the issues surrounding the MoM hip--How did it happen; What are the solutions; Symptoms to look for in Cobalt toxicity

Published on Nov 7, 2013
          
Consumer Reports forum on Ending Medical Harm, the 3rd leading cause of death in the US, at Columbia University November 6, 2013. Stephen Tower, MD orthopedic surgeon who got a metal on metal hip implant shares his journey becoming an authority of the health hazards of such implants

You Tube Video worth listening to.  Dr. Steve Tower speaks about

 Ending Medical Harm Forum: Choosing Hip Replacements

http://www.youtube.com/results?search_query=Ending+Medical+Harm+Forum%3A+Choosing+Hip+Replacements+&sm=3

A few slides that might be of interest from the presentation:



 
 
 
 
 
 
 






 
 
 
 
A  few additional recommendations from the presentation:
 
1.  Make sure you have metal levels taken for both Cr and Co annually if you have not yet had a  MoM hip revision.
 
2.  Have a metal suppression MRI Hip done annually if you have not had a MoM  hip revision
 
3.  Look out for cobalt toxicity from a symptom perspective:
 

 
 
 
 

Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution

Searcy Denney Law

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. In announcing the plea and fine, Holder said Johnson & Johnson “recklessly put at risk” the elderly and children.

The sales force was offered additional incentives to sell the drug for unapproved uses. Bonuses were based on overall sales, not just the sale of an FDA-approved drug, according to the DOJ. The government does not like to overpay hundreds of millions of dollars for drugs used in a way not approved by the FDA and at the heart of the conviction is not just the danger presented to the most vulnerable members of society, but in having U.S. taxpayers pick up the tab for the elderly, through Medicare, or the disabled, through Medicaid.

 The civil complaint was filed in federal court for the Eastern District of Pennsylvania. J&J says the settlement is not an admission of fault, even though the settlement was filed along with a corporate guilty plea. Specifically, Janssen pled guilty to introducing Risperdal into interstate commerce, a violation of the Food Drug and Cosmetic Act. Besides the fine, the punishment includes pleading guilty to a single misdemeanor for the illegal promotion of Risperdal. In this case, the civil settlement involved 45 states along with the Department of Justice. Other states, including South Carolina and Louisiana, will file actions separately with fines expected to total into the billions of dollars.

 Janssen also agreed to a five-year Corporate Integrity Agreement with the Inspector General of Health and Human Services (HHS), according to the plea. You have to love corporate integrity.

Despite record fines, drug companies do not seem to learn from their mistakes. Other large settlements include one paid by Pfizer Inc. in 2010 which amounted to $2.3 billion for the improper marketing of 13 drugs. GlaxoSmithKline Plc paid $3 billion amid criminal charges it targeted the depression drug Paxil to children, antidepressant Wellbutrin for unapproved uses and failed to provide a warning of the Avandia diabetes drug. At the end of the day, even after paying a hefty fine, the balance sheet still generally tilts in the favor of the drug manufacturer, so these examples could be called the cost of doing business, very big business. -

See more at: http://www.searcymasstort.com/blog/2013/11/19/johnson-johnson-fined-2-2-billion-for-reckless-drug-distribution/#.UovBWu5Rgf4.wordpress

The Myth of the Medical-Device Tax

New York Times

OP Ed

Opinion Twitter Logo.
 

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.
      
Topher Spiro is the vice president for health policy at the Center for American Progress.

Artificial hips and knees need a lemon law, says Consumer Reports

 

Consumer reports
 

Joint replacements often fail, while consumers and insurers are left with with the bill

Imagine if you had to take a new car back to the dealer to get a defective part fixed and you, not the manufacturer, had to pay for the work. Well, that’s the situation with artificial knees and hips.
Nearly 20 percent of the hip replacements done each year and 10 percent of the knee replacements are revisions, often done because the original device was defective. Those follow-up surgeries tend to require longer hospital stays than the initial procedures, pose additional risks, and have a higher price tag, too. Yet their costs are passed onto consumers or their insurance companies, including Medicare.
That’s one of the reasons Consumers Union, the policy arm of Consumer Reports, says manufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That, they say, is not only fairer to patients, but might encourage companies to make their devices safer and more durable.

“While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

The SafePatientProject recently gathered information from the Food and Drug Administration on hip and knee implant recalls over the past 10 years, and found that all major manufacturers had recalled a product or line of products. And some of those recalls involved products that posed real risks.
 
For example, since 2003 about 750,000 Americans received metal-on-metal hips, which were supposed to last longer than devices made with ceramic and plastic. Not only were such hips more likely to fail, but also some patients experienced debilitating symptoms from metal debris that flakes off the device over time, including heart damage and neurological problems.
Knee implants have not failed as often or as dangerously, but the Safe Patient analysis found that hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part, or a part built for the left side etched as a right, or vice versa.

As our earlier report on dangerous medical devices found, most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the FDA. Instead, under current law, the companies simply have to demonstrate that the devices are “substantially equivalent” to a product already being sold. Since most new hip and knee implants are similar to ones already on the market, manufacturers can gain approval through the FDA’s fast track 510(k) clearance process without having to prove the device is safe and effective.

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”

The Safe Patient has urged the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc., to provide a 20-year warranty that:
  • covers the full cost of the revision surgery, including the device itself, the surgeon and hospital costs, and patient out-of-pocket costs;
  • establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and
  • does not eliminate the patient’s right to sue if he or she uses a warranty.

Thursday, December 19, 2013

Stryker agrees to settle four metal hip lawsuits as hundreds more loom

Fierce Medical Devices

Stryker ($SYK) is settling the first of hundreds of lawsuits it faces alleging it sold defective metal hip implants that harmed patients. Expect the Kalamazoo, MI, orthopedic device company to pursue this path more often in the coming months, considering the mounting costs it has faced in the matter.
The Record reported that four patients settled their claims against the company in New Jersey state Supreme Court alleging its Rejuvenate all-metal hip implants injured them, Attorneys representing the patients would not disclose the financial terms, citing confidentiality agreements. But they told the newspaper that a deal came through after two weeks of mediation hearings.
Sure, it's not to the level of Johnson & Johnson's DePuy division ($JNJ), which recently submitted a $2.5 billion-plus settlement offer to resolve 8,000 lawsuits over its now-recalled ASR implants. But the settlement offers could be the precedent of something larger down the line. The Record noted that Stryker already must content with 600 metal hip lawsuits filed, with the anticipation of thousands more to come. Stryker voluntarily recalled its Rejuvenate implant in July 2012, and plaintiffs have charged that the implants didn't meet the promise of long-term durability, failing in under two years and injuring patients in the process as they broke down. (Stryker is also dealing with lawsuits alleging it sold a defective ABG II hip replacement.)


Read more: Stryker agrees to settle four metal hip lawsuits as hundreds more loom - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/stryker-agrees-settle-four-metal-hip-lawsuits-hundreds-more-loom/2013-12-18#ixzz2nyKauue4

Saturday, December 14, 2013

Stryker Hip Injury Claims Number Nearly 400 in Federal Court, Rottenstein Law Group LLP Reports

The Stryker lawsuits involve two of the company’s metal-on-metal hip implant products, the Rejuvenate and the ABG II, both recalled in 2012. Claims against Stryker range from metal poisoning to device failure, according to court documents (In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation; MDL-2441, U.S. District Court for the District of Minnesota). The U.S. Food and Drug Administration has issued a warning about metal-on-metal hip implants that supports claimants’ allegations.*

The news about the increase in cases follows Stryker’s announcement that it will set aside between $700 million and more than $1 billion for metal-on-metal hip-related litigation, according to an Oct. 23 Wall Street Journal report.** Stryker recalled the metal-on-metal hip implants in July 2012.

Friday, December 13, 2013

DePuy ASR Lawsuit Settlement Update: Rottenstein Law Group LLP Comments on Report of Proposed Additional Compensation


Digital Journal

On top of a multibillion dollar DePuy ASR settlement, Johnson & Johnson could pay an additional $1 billion in patients’ medical expenses related to the company’s recalled DePuy ASR metal-on-metal hip implant. The Rottenstein Law Group LLP, which represents clients in ASR lawsuits and maintains the website ASR informational website http://www.hiprecallnewscenter.com, explains what it means for those considering an agreement to settle.

The additional funds set aside would cover insurers’ medical costs associated with revision surgery (i.e., surgeries required to replace an ASR hip implant), according to a Nov. 27 Bloomberg report.* The exact amount is unknown, the article said, but would likely be somewhere between $500 million and $1 billion

xxxx

Looks like the payment to the insurance companies will occur outside of the $250K settlement

Relationship of Plasma Metal Ions and Clinical and Imaging Findings in Patients with ASR XL Metal-on-Metal Total Hip Replacements

Metal ion analysis should be used in conjunction with clinical and imaging evaluation and not as a sole indirect screening test when evaluating patients following metal-on-metal hip arthroplasty.

By J Bone Joint Surg Am - December 3, 2013


Abstract

Background:


Plasma metal ion levels are commonly used in the postoperative follow-up evaluation of patients who have had a metal-on-metal hip arthroplasty. However, the relationship between these levels and clinical and imaging findings is not well known.

Methods:

We evaluated 156 consecutive patients who received a unilateral ASR XL total hip replacement. Patients presented, regardless of symptoms, in response to a voluntary recall of the hip replacement by the manufacturer and were assessed with regard to the presence and type of symptoms and plasma cobalt-chromium levels. In addition, radiographic and magnetic resonance imaging studies were performed and analyzed.

Results:

Eighty patients were asymptomatic, and seventy-six patients were symptomatic. The median cobalt level was 1.8 ppb, and the median chromium level was 1.0 ppb (at or below measurement threshold). Pseudotumors that could be detected on magnetic resonance imaging were seen in 69% (107) of 156 patients, and radiographic osteolysis was evident in 7% (eleven patients). At a threshold of 5 ppb, no association was detected between abnormal metal ion levels and patient symptoms, prosthetic femoral head size, or acetabular cup inclination. An abnormal cobalt level was significantly associated with the presence of periprosthetic lucency on radiographs and pseudotumor on magnetic resonance imaging (p < 0.05). An abnormal chromium level showed a similar pattern, but the relationships did not reach significance. Both abnormal plasma cobalt and chromium levels were associated with larger sizes of pseudotumor when present (p < 0.05).

Conclusions:


In our sample, with a threshold of 5 ppb, abnormal plasma metal ions were associated with larger sizes of pseudotumors when present, but were not predictive of patient symptoms. Abnormal plasma cobalt levels have a significant association with periprosthetic lucency and presence of pseudotumor. Plasma chromium shows a similar pattern of association with lucency and presence of pseudotumor, although the relationships were not significant. Metal ion analysis should be used in conjunction with clinical and imaging evaluation and not as a sole indirect screening test when evaluating patients following metal-on-metal hip arthroplasty.

Level of Evidence:

Diagnostic Level III

Source

Journal of Bone Joint Surgery, November 20, 2013, volume 95, number 22, pp 2015-2020. doi: 10.2106/JBJS.L.01481. http://www.jbjs.org/article.aspx?articleid=1766446

Sunday, December 8, 2013

Lawyers will earn $1B from the DePuy Metal-on-Metal Hip settlement


Ortho Streams

Lawyers representing over 8,000 plaintiffs in DePuy ASR hip lawsuits are recommending that their clients accept Johnson & Johnson’s (J&J) $2.5 billion settlement offer.
For good reason. According to a November 25, 2013 New York Times article by Barry Meier, the lawyers stand to earn almost $1 billion.

Those lawyers have publicly praised the deal and described it as an “innovative plan” that will compensate patients who had to have hip revision surgery. After the lawyers’ fees, Meier reported that patients will get about $160,000 on average to compensate for their pain and suffering. There is also a $475 million pool for added payments to the most severely injured. In addition, J&J agreed to pay claims from private insurers and agencies like Medicare seeking to recover the costs of operations and other medical treatments related to the device.

According to Meier, the lawyers will receive about one-third of the settlement, or about $800 million. The single biggest chunk of those fees will go to the firms most involved with developing cases and negotiating the settlement; they will get a bonus of about $160 million.

One lawyer, not involved in the settlement fees, could earn about $90,000. Meier reported that that lawyer’s patient said he believed his lawyer paid about $400 on filing fees and between $2,000 to $3,000 to get copies of the medical records.

But the lawyers will only get paid by J&J if they convince 94% of the 8,000 eligible plaintiffs to accept the deal. J&J can walk away if that threshold is not met. Roughly 4,000 ASR patients who have filed claims against J&J but have yet to have a replacement procedure will not qualify for the plan.

Acceptance does not appear to be a foregone conclusion.

Several patients like Celeste Laney, a former occupational therapist, told Meier it was impossible to know what their claims might be worth if they went forward because the only two cases that went to trial ended with wildly disparate outcomes.

Some patients will see their payouts reduced based on their age, weight, or whether they were smokers. In addition, those who had an ASR for more than five years will get $25,000 less for each additional year they had the device before its replacement.

“I’m not taking it, it’s a joke,” said Laney who continues to have significant medical issues.
The $475 million pool in the settlement will be used to supplement the basic payouts to patients like Laney. Along with patients who had to have repeated operations, extra payments will also be available to patients who developed infections, experienced joint dislocation or had other problems related to a procedure like a heart attack or a blot clot.

The size of such payments will be determined by how many patients qualify for special funds, a group the lawyers think will be about 10% of claimants.

The lawyers for both sides have convinced and congratulated each other and received the praise of the court. Now, they just have to convince their clients they were worth almost a third of their pain and suffering.

Facts re the settlement dates for those of you who have not filed a suit

All ASR hip replacement patients must register their lawsuits no later than January 6, and decide whether to enroll by April 1. However, if 94 percent of claimants decide not to enroll in the accord by April 1, J&J can abandon its offer and walk away from the ASR settlement by June 1.

Don't expect any checks from this settlement until August 2014 IF this settlement passes.

Asymptomatic pseudotumours after metal-on-metal hip resurfacing show little change within one year







  1. R. G. H. H. Nelissen, MD, PhD, Professor in Orthopaedic Surgery4

Abstract (study funded by Biomet)

The aim of this study was to establish the natural course of unrevised asymptomatic pseudotumours after metal-on-metal (MoM) hip resurfacing during a six- to 12-month follow-up period. We used repeated metal artefact reduction sequence (MARS)-magnetic resonance imaging (MRI), serum metal ion analysis and clinical examination to study 14 unrevised hips (mean patient age 52.7 years, 46 to 68, 5 female, 7 male) with a pseudotumour and 23 hips (mean patient age 52.8 years, 38 to 69, 7 female, 16 male) without a pseudotumour. The mean post-operative time to the first MARS-MRI scan was 4.3 years (2.2 to 8.3), and mean time between the first and second MARS-MRI scan was eight months (6 to 12). At the second MRI scan, the grade of severity of the pseudotumour had not changed in 35 hips. One new pseudotumour (Anderson C2 score, moderate) was observed, and one pseudotumour was downgraded from C2 (moderate) to C1 (mild). In general, the characteristics of the pseudotumours hardly changed.
                 
Repeated MARS-MRI scans within one year in patients with asymptomatic pseudotumours after MoM hip resurfacing showed little or no variation. In 23 patients without pseudotumour, one new asymptomatic pseudotumour was detected.
                 
This is the first longitudinal study on the natural history of pseudotumours using MARS-MRI scans in hip resurfacing, and mirrors recent results for 28 mm diameter MoM total hip replacement

J&J May Pay $1 Billion in Medical Costs Under Hip Accord

Bloomberg

Johnson & Johnson (JNJ) may pay as much as $1 billion to insurers who covered the medical costs of removing its recalled hip implants under a settlement announced last week, according to a lawyer involved in the accord.

J&J, the world’s largest seller of health-care products, said Nov. 19 it would pay patients at least $2.47 billion to settle about 8,000 lawsuits against its DePuy unit. J&J will also reimburse insurers for some costs of hip-removal surgeries known as revisions, Michael Kelly, a San Francisco-based lawyer who represents hip patients, told other plaintiffs’ lawyers in a Nov. 22 letter.
   
“The amount being paid by DePuy across the United States to satisfy medical-lien claims under this proposed program has been estimated to be between $500 million and $1 billion,” Kelly said in the letter, obtained by Bloomberg News. The letter was marked as “confidential communication for plaintiffs’ attorneys only.”

Paying $1 billion for hip surgeries, along with other expenses related to J&J’s push to resolve cases over DePuy’s ASR implants, will drive the cost of the accord to more than $4 billion, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

“When everything is all said and done, J&J may wind up paying double that $4 billion to resolve all current and future litigation over those devices,” he said.

Second Accord

The ASR settlement, which doesn’t require the judge’s approval, was the second multibillion-dollar accord this month for J&J. The company, based in New Brunswick, New Jersey, agreed Nov. 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of Risperdal and other medicines.

Lorie Gawreluk, a J&J spokeswoman, declined to comment on the lien estimate in Kelly’s letter. “We don’t comment on speculation,” she said in an e-mailed statement today.

J&J has spent about $1 billion on medical costs and informing patients and surgeons about the hip recall, Gawreluk said earlier this month. J&J set aside an undisclosed amount for litigation, which it increased before June 30, she said.

The company recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years. Internal J&J documents show 37 percent of ASR hips failed after 4.6 years. Last year, the failure rate in Australia climbed to 44 percent within seven years.

Eligible Patients

Under the terms of the accord, only plaintiffs who had an ASR hip implanted in the U.S. and had it removed by Aug. 31 are eligible for this settlement. The patients must have had the implant for at least 180 days before its removal, according to the terms.

J&J’s lawyers have said the average payment under the settlement for a hip removal will be $250,000. Those who suffered extraordinary injuries as a result of the procedures will be entitled to more.

The settlement doesn’t bar patients whose hips fail in the future from seeking compensation, which may add billions of dollars to the accord’s ultimate cost.

The company faces a total of about 12,000 hip suits filed or consolidated in federal and state courts in Ohio, California, Illinois and New Jersey. The settlement covers about 8,000 patients who’ve already had DePuy hips removed. The remaining claims were filed by patients who haven’t yet had such surgeries.

The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

To contact the reporter on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net
                                          

Frustration From a Deal on Flawed Hip Implants

Published: November 25, 2013
New York Times

Patients injured by a flawed hip implant sold by Johnson & Johnson have directed their anger at myriad places over the years. The regulatory system that allowed the product’s sale. The company that repeatedly denied problems with the device. Even the doctors who implanted the hips.

Now, some patients have found a new target for their ire: the legal system and the lawyers they hired to sue Johnson & Johnson.
      
At issue is the $2.5 billion plan announced last week to settle an estimated 8,000 lawsuits involving the all-metal hip device known as the Articular Surface Replacement or A.S.R.
      
Both Johnson & Johnson and those lawyers have praised the deal, describing it as an innovative plan that will compensate patients who had to have an added operation to have an A.S.R. removed and replaced. After the lawyers’ fees, patients will get about $160,000 on average to compensate for their pain and suffering.
      
The plan also creates a $475 million pool for added payments to the most severely injured. And Johnson & Johnson agreed to pay claims from private insurers and agencies like Medicare seeking to recover the costs of operations and other medical treatments related to the device.
      
But some patients contend that the deal’s real winners are Johnson & Johnson and the plaintiffs’ lawyers. Those lawyers are set to receive about one-third of the settlement, or about $800 million. The single biggest chunk of those fees will go to the firms most involved with developing cases against Johnson & Johnson and negotiating the settlement; they will get a bonus of about $160 million.
      
Some patients like Van Fleming, a retired mortgage loan officer, wonder why they bothered to hire a lawyer. After published reports of A.S.R.-related problems began to appear several years ago, lawyers flooded television stations and the Internet with solicitations seeking clients.
       
Mr. Fleming, 66, said he believed his lawyer spent about $400 on filing fees and from $2,000 to $3,000 to get copies of his medical records. Lawyers like Mr. Fleming’s who were not involved in settlement talks could walk away with $90,000 a case, and some firms, by advertising aggressively, gathered hundreds of claims.
       
“I don’t think it is fair at all,” said Mr. Fleming, who lives in Greenville, N.C., referring to the terms of the deal.
      
Several patients like Celeste Laney, a former occupational therapist who lives in Albuquerque, N.M., added that it was impossible to know what their claims might be worth if they went forward because the only two A.S.R. cases that went to trial ended with wildly disparate outcomes. They also expressed dismay over several elements of the plan, saying they appear to favor Johnson & Johnson at the expense of the injured.
      
Some patients will see their payouts reduced based on their age, weight, or whether they were smokers. In addition, claimants who had an A.S.R. for more five years will get $25,000 less for each additional year they had the device before its replacement.
      
“I’m not taking it, it’s a joke,” said Ms. Laney.
      
Several lawyers involved in the plan said that they anticipated patients like Ms. Laney and Mr. Fleming might appreciate the settlement more once they had a chance to review its details. Those lawyers added that they were eager to get funds to A.S.R. patients, some of whom have taken loans from legal firms to cover their living expenses.
      
One of the plaintiffs lawyers involved in the settlement, Ellen Relkin, said her firms and others spent millions of dollars preparing cases for trial. She added that she and other lawyers had also reviewed the medical files of thousands of A.S.R. patients and had a good sense about the range of their injuries and needs.
      
“The settlement provides certainty and payment within a short period of time,” Ms. Relkin said in a statement
      
The A.S.R. — which was implanted in 93,000 patients, about one-third of them in the United States — ranks as one of the most-flawed medical implants in recent decades. The device’s ball and cup components, both of which were made of metal, rubbed together as a patient moved, producing shards of metallic debris that destroyed tissue and bone.
      
The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of patients. Traditional artificial hips, which are made of metal and plastic, typically last 15 years or more before replacement.
 
DePuy officials have insisted that they acted properly in handling the device, including waiting until 2010 to recall it. However, internal company documents show that company officials were warned years before by their own consultants that the device was so problematic they would not use it in their patients.

 

Several lawyers involved in the case said the plan would most likely appeal to patients who did not have any complications after the device’s removal, a group presumed to comprise the vast bulk of claimants.
      
One such patient, Paula Laverty of Cape Elizabeth, Me., said the basic payout seemed to be reasonable. “I have been fortunate in my recovery,” Ms. Laverty wrote in an email.
      
That has not been the case for other patients like Ms. Laney. The operation to replace her A.S.R. set off a series of procedures that have left her disabled, unemployed and struggling to walk with a cane, she said. In the process, she lost her health insurance.
       
“I am in pain 24 hours a day,” said Ms. Laney. “My main concern is my health.
       
Lawyers say that the $475 million pool in the settlement will be used to supplement the basic payouts to patients like Ms. Laney. Along with patients who had to have repeated operations, extra payments will also be available to patients who developed infections, experienced joint dislocation or had other problems related to a procedure like a heart attack or a blot clot.
      
The size of such payments will be determined by how many patients qualify for special funds, a group that plaintiffs’ lawyers estimate at 10 percent of claimants. Also, the estimated value of the settlement — $2 billion for basic payouts and $475 million for the special fund — is predicated on 8,000 patients taking the deal.
       
The size of both pools is prorated based on patient participation. For example, the values will fall by 12.5 percent if 7,000 patients take part in the settlement and rise by 12.5 percent if 9,000 patients do.
Roughly 4,000 A.S.R. patients who have filed claims against Johnson & Johnson but have yet to have a replacement procedure will not qualify for the plan.
      
Johnson & Johnson can walk away from the settlement if fewer than 94 percent of eligible plaintiffs participate.
      
Patients like Ms. Laney who are unhappy with the plan may have few alternatives. They are unlikely to see a courtroom for years, if ever, and there are no guarantees that Johnson & Johnson will settle their claims for more money, lawyers said.
      
Ms. Relkin said she anticipated that 96 percent to 99 percent of the several hundred claimants her firm represents would participate in the settlement. However, another lawyer, who spoke on the condition of anonymity, said that he planned to recommend that clients who had potentially high-value claims stay out of the settlement and take their chances, either in court or in separate deals with Johnson & Johnson.
      
“I think that is about 10 percent of my clients,” that lawyer said.
 

Did patients draw the short stick in $2.5B J&J metal hip settlement?

Mass Device

MASSDEVICE ON CALL — When Johnson & Johnson (NYSE:JNJ) agreed to a $2.5 billion settlement to close some 8,000 cases over its metal-on-metal hip implants, about 1/3 of that money went to the lawyers and legal teams representing the cases.

Lawyers took an average of $90,000 of each patient's $250,000 award, according to a New York Times report, a hefty cut that has some patients irked about the value that their legal representation brought to their cases. One patient told the Times that he estimates that his lawyer did less than $4,000 worth of work, gathering medical records and paying legal fees.

Law offices ramped up their internet and television marketing in the weeks and months preceding Johnson & Johnson's DePuy ASR hip implant lawsuit, some gathering hundreds of claims.
The 33% cut has some patients up in arms and refusing to accept the settlement, especially those whose award was lowered due to the length of time that they had the implant or by other limiting factors such as age and weight, according to the report.

Healthcare giant Johnson & Johnson confirmed earlier this month that it agreed to a $2.5 billion settlement to close the books on one of the multi-patient lawsuits over recalled metal-on-metal hip implants made by subsidiary DePuy Orthopaedics.

The settlement closes a major chapter, but the story is far from over. There remain some 4,000 other lawsuits over the metal-on-metal hip replacement systems and patient advocacy groups want more than compensation; they want tighter oversight of the medical device industry.

xxxx

From Connie,

I finally did sign on with a firm but I do understand the issue surrounding the attorney's fees.  The question is what constitutes lawyer's fees?  The lawyers will collect something in the way of 33 and 1/3rd percent   of the net amount recovered.  Costs are taken out from the gross amount recovered which also goes to the lawyers.  (The net amount recovered is the amount remaining after all costs incurred in the preparation for , and prosecution and resolution of the case (filing fees, expert witnesses, depositions, medical records, research costs, expenses associated with coordinating and conducting discovery, trial preparation and trial.)

This is likely how it might shake out IF over 90% of the filers agree to the terms of the agreement.

                                                          $250K (gross amount recovered)
                                              minus   $ costs noted above incurred by
                                                               net amount recovered
                                              minus    33.3% of the net for attorney fees
                                                            patient gets what is left.

My key  questions would be as follows:

  • Are the lawyer fees double counted?  That is, are their fees included in any way in the costs? 
  • How will the State cases be settled and are they anticipated to be settled for an average cost that is higher than the Federal MDL?
  • Will there be any funds set aside to study the long term systems effects of the metals?
  • Will this recovery address the outstanding bills from health care providers like Blue Cross and how will that be handled?
  • If future claims arise from the complications, how will those claims be handled?  If the deal is that you must accept the settlement and this covers no future claims, I can't personally see taking this deal given I suspect there will be continued systemic issues which will arise from the metals.
If I have more questions, I will post them.  In any event, all of the filers get to vote.  If I am not mistaken, If at least 90% of those who actually filed a suit in Federal court through the MDL do not agree to the overall settlement, it won't go through.

Mortality rates at 10 years after metal-on-metal hip resurfacing compared with total hip replacement in England: retrospective cohort analysis of hospital episode statistics

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6549 (Published 27 November 2013)
Cite this as: BMJ 2013;347:f6549
 

Abstract

Objectives To compare 10 year mortality rates among patients undergoing metal-on-metal hip resurfacing and total hip replacement in England.
Design Retrospective cohort study.
Setting English hospital episode statistics database linked to mortality records from the Office for National Statistics.
Population All adults who underwent primary elective hip replacement for osteoarthritis from April 1999 to March 2012. The exposure of interest was prosthesis type: cemented total hip replacement, uncemented total hip replacement, and metal-on-metal hip resurfacing. Confounding variables included age, sex, Charlson comorbidity index, rurality, area deprivation, surgical volume, and year of operation.
Main outcome measures All cause mortality. Propensity score matching was used to minimise confounding by indication. Kaplan-Meier plots estimated the probability of survival up to 10 years after surgery. Multilevel Cox regression modelling, stratified on matched sets, described the association between prosthesis type and time to death, accounting for variation across hospital trusts.
Results 7437 patients undergoing metal-on-metal hip resurfacing were matched to 22 311 undergoing cemented total hip replacement; 8101 patients undergoing metal-on-metal hip resurfacing were matched to 24 303 undergoing uncemented total hip replacement. 10 year rates of cumulative mortality were 271 (3.6%) for metal-on-metal hip resurfacing versus 1363 (6.1%) for cemented total hip replacement, and 239 (3.0%) for metal-on-metal hip resurfacing versus 999 (4.1%) for uncemented total hip replacement. Patients undergoing metal-on-metal hip resurfacing had an increased survival probability (hazard ratio 0.51 (95% confidence interval 0.45 to 0.59) for cemented hip replacement; 0.55 (0.47 to 0.65) for uncemented hip replacement). There was no evidence for an interaction with age or sex.
Conclusions Patients with hip osteoarthritis undergoing metal-on-metal hip resurfacing have reduced mortality in the long term compared with those undergoing cemented or uncemented total hip replacement. This difference persisted after extensive adjustment for confounding factors available in our data. The study results can be applied to matched populations, which exclude patients who are very old and have had complex total hip replacements. Although residual confounding is possible, the observed effect size is large. These findings require validation in external cohorts and randomised clinical trials.

Sunday, December 1, 2013

Important Date for Claim filing in the Depuy Law Suit

Important Information for filing and participating in the settlement for the Depuy recall.

All potential claimants must register for the DePuy ASR settlement no later than January 6, 2014. Registration in no way signifies a claimant’s commitment or intent to enroll in the settlement program

Fortunately, the accord will not bar individuals who have the ASR implant from requesting future compensation should the device fail down the road. This caveat will ultimately tack millions if not billions of dollars to the final amount of the settlement, which was outlined to Judge Katz less than two weeks ago. Judge Katz is overseeing the DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, in the U.S. District Court, Northern District of Ohio.

ASR hip plaintiffs may demand more compensation

Some attorneys representing plaintiffs in the ASR hip litigation have said they will advise their clients to hold out for more compensation and reject the terms outlined in J&J’s proposed settlement. A base award of $250,000 may seem like a lot, but in the scope of products liability claims and a recalled medical device, this sum may prove to be insufficient for many.  While Johnson and Johnson’s $2.47 billion payout may settle 8,000 cases, an additional 4,000 DePuy hip lawsuits are still pending – filed by individuals who have not had their implants removed.