Sunday, September 22, 2013

First Bellwether Trial in Federal DePuy ASR Lawsuit Litigation Scheduled to Begin after Two-Week Postponement

The first federal trial for a DePuy ASR hip lawsuit (http://www.depuy-asr-hip-recall.com/) is scheduled to begin Tuesday in the U.S. District Court, Northern District of Ohio, Bernstein Liebhard LLP reports.

According to an Order issued September 6th by the federal judge overseeing the litigation, the trial is set to commence on September 24, 2013 at 9:00 a.m. after being postponed for two weeks pending additional discovery and further consideration of legal matters relevant to the case. The start date for this DePuy ASR hip lawsuit, which was selected to serve as the proceeding’s first bellwether trial in July, had originally been scheduled for September 9th.

Included in this case are claims filed by a Rochester, New York woman whose alleged injuries caused by the DePuy ASR metal-on-metal hip replacement forced her to undergo revision surgery to remove the device. (McCracken v. DePuy Orthopaedics Inc., et al., No. 1:11-dp-20485)
Court records indicate that over 8,000 claims filed by individuals affected by the DePuy ASR recall are now pending in the federal litigation underway in the Northern District of Ohio


Read more: http://www.digitaljournal.com/pr/1481470#ixzz2ff2U21vk

Stryker Hip Implant Lawsuit News: Cases Moving Along in Federal Court

SB Wire (Excerpts

New York, NY -- (SBWIRE) -- 09/18/2013 -- Stryker hip lawsuits are moving along in federal court in Minnesota. A status conference held on Sept. 9 oversaw the creation of some basic foundations for the federal consolidation of cases, including the selection of plaintiffs’ counsel and a leadership structure, according to court documents. The Rottenstein Law Group LLP encourages those interested in getting more information on Stryker hip lawsuits and side effects to visit this page.

The consolidation, called a “multidistrict litigation,” includes about 200 federal Stryker lawsuits. The Judicial Panel on Multidistrict Litigation ordered the formation in June 2013, 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).

"Multidistrict litigation is a method for the federal court system to increase the efficiency of a collection of lawsuits with similar claims and parties,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “One of the first things that the court overseeing an MDL will do is establish a framework for efficient leadership, including the selection of lead counsel and liaison counsel."

The Stryker ABG II and Rejuvenate hip implant devices have been under FDA scrutiny, owing mostly to one alleged side effect: “metal poisoning,” also called “metallosis.” According to the FDA,* cobalt and chromium ions could enter into the patient’s bloodstream because of friction from the devices’ metal parts. This could lead to potentially severe health problems.

J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases

Bloomberg

Johnson & Johnson (JNJ), the world’s biggest seller of health-care products, has discussed paying more than $3 billion to settle lawsuits over its recalled hip implants, according to five people familiar with the matter.

J&J seeks to resolve as many as 11,500 lawsuits in the U.S. and has considered paying more than $300,000 per case, according to the people. Such a settlement would exceed $3 billion if most plaintiffs accept the terms, an amount 50 percent larger than that proposed in previous discussions.
                

J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases

J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases
 
Michael Kelly, attorney for plaintiff Loren Kransky, holds up an ASR XL hip implant made by Johnson & Johnson during his opening statement to the jury at the trial of Kransky v. DePuy, at the California Superior Court in Los Angeles, on Jan. 25, 2013.
 
A $3 billion settlement would dwarf a 2001 accord Sulzer (SUN) AG reached with patients who claimed that company’s hip and knee implants were defective. Sulzer, a Winterthur, Switzerland-based pump maker, agreed to pay $1 billion to resolve those suits, then the largest settlement involving hip implants.

Any accord would be affected by the outcome of seven product-liability trials between September and January, according to the people, who aren’t authorized to make the negotiations public.
“It’s going to be a fascinating case to watch settle because of the level of complexity of the injuries and the amount of money that will be involved,” said Bruce Cranner, a medical device defense lawyer not involved in the case. “You don’t see a lot of mass-tort implant cases settle for a substantial amount of money.”

Replacement Surgeries

The company is pushing to resolve U.S. cases by early next year, according to the people. J&J’s DePuy unit recalled 93,000 implants in 2010, including 37,000 in the U.S., after more than 12 percent failed within five years. That rate is climbing, along with suits by patients blaming the chromium and cobalt devices for pain, metal debris and replacement surgeries.

J&J, based in New Brunswick, New Jersey, has spent about $993 million on medical costs and informing patients and surgeons about the ASR recall, Lorie Gawreluk, a spokeswoman for DePuy, said in an e-mail. J&J set aside an undisclosed amount for litigation, which it increased before June 30, she said.

“The company also continues to support ASR patients with a reimbursement program to address recall-related testing and treatment costs,” she said. “Reports about a possible resolution of the litigation are premature and speculative, including any estimates of resolution amounts.”
Steven Skikos, a plaintiffs’ lawyer leading efforts to prepare lawsuits against DePuy, said his group is preparing for jury trials, which include the first case in federal court.

‘Dangerous Guess’

“With the trials rapidly approaching, and our continuing efforts to obtain more information and data about the patients, it’s easy to speculate about settlement,” Skikos said in an e-mail. “However, any comment relating to settlement that does not come from the plaintiff’s leadership, the court, or from the company itself remains premature, uninformed and a dangerous guess.”

J&J lost an $8.3 million verdict in the first trial over the ASR device and won the second. In the first case, a California jury in March awarded damages to a retired Montana prison guard. The panel also ruled the device was defectively designed, that DePuy properly warned of the risks, and that the company didn’t owe punitive damages. DePuy is appealing.

A Chicago jury ruled six weeks later for DePuy in rejecting a defective design claim by an Illinois nurse.

Other Trials

Seven other trials of lawsuits by plaintiffs blaming the ASR hips for injuries will help lawyers for both sides frame questions over liability and damages. The first is scheduled to begin Sept. 9 in federal court in Cleveland. U.S. District Judge David Katz is overseeing that lawsuit by Ann McCracken, 58, a resident of Rochester, New York, who needed two replacement surgeries known as revisions after her ASR implant.

Katz is overseeing about 8,000 federal cases consolidated before him for the pre-trial collection of evidence. About 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

Trials also are scheduled in state courts in San Francisco in October; in Hackensack, New Jersey, in October and January; in West Palm Beach, Florida, in November; in Chicago in December; and in Los Angeles in January.

“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” Gawreluk said. “The ASR hip system was properly designed, physicians were properly informed of the product’s risks, and DePuy’s actions concerning the product were appropriate.”

Broad Outline

Lawyers for hip recipients are still reviewing more than 50 million pages of J&J documents and conducting pre-trial interviews of company officials and experts to prepare for those cases, Skikos said.

While settlement talks continue, J&J and lawyers for hip claimants have agreed on the broad outline of a so-called “global settlement” covering all U.S. cases, the people said.

In January, five people familiar with the talks had said J&J officials were willing to pay about $2 billion to resolve the cases. Lawyers for plaintiffs rejected that amount as too little, the people said.
Any overall accord would compensate patients based on such factors as age, extent of injuries and whether they had one or more surgeries to replace defective implants, according to the people. Negotiators would likely rank those and other factors on a matrix or grid, the people said.
“J&J’s strategy will be to find a way to negotiate a grid to settle each of the claims based on five or six variables that could be plugged in and changed up or down to determine the value of any claim,” said Cranner, a lawyer with the New Orleans-based law firm of Frilot LLC. He is past chairman of the Medical Liability and Health Care Law Committee of DRI, an organization of lawyers who represent corporations and insurers.

Obstacles Remain

Several obstacles to a final settlement still must be overcome, the people said. One includes the number of years that J&J may potentially have to pay future claims. Another is whether the settlement would include reimbursing Medicare for claims paid. A third is the amount of compensation for extreme medical cases, which include dual hip surgeries or cases where infection prompted long hospital stays, the people added.

“There are a significant subset of clients who got very badly hurt by the device, and their injuries are much more than a simple revision,” said Matthew Davis, a lawyer at Walkup Melodia Kelly & Schoenberger in San Francisco whose firm represents 270 ASR clients.

“If those cases went to trial and there was a finding of liability, a jury would award them general damages in the seven figures,” said Davis, who isn’t involved in the negotiations.

Alloy Used

The J&J hips were made from a cobalt-and-chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revisions, and 12 percent of the ASR Hip Resurfacing System failed.

At the first trial in Los Angeles, lawyers for plaintiff Loren Kransky argued DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008.

Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels.

J&J set up a help line for patients that is “available in dozens of countries and has served tens of thousands of callers,” Gawreluk said. J&J runs a worldwide reimbursement program resulting in “thousands of payments to patients for testing and treatment of other out-of-pocket expenses.”
The McCracken DePuy case is McCracken v. DePuy, 11-dp-20485, U.S. District Court, Northern District of Ohio (Toledo). 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).

DePuy ASR Hip Lawsuit News: Calif. Judge to Determine If Metal-On-Metal Case Will Go to Trial, Rottenstein Law Group LLP Reports

News Channel 5 Nashville web site

A California mans DePuy ASR hip lawsuit is set to be the first bellwether trial in a state court consolidation on Oct. 10, but that could change if a judge grants Johnson & Johnson, its subsidiary DePuy and related defendants a summary judgment on Sept. 13, according to court documents. The Rottenstein Law Group LLP, a metal-on-metal hip implant law firm, maintains a comprehensive DePuy ASR information page at http://www.rotlaw.com/depuy-asr-hip.

Johnson & Johnson and the other defendants filed the motion for summary adjudication with Judge Richard A. Kramer in July, and plaintiff Robert Eugene Ottman had until Aug. 30 to respond, according to court documents (Robert Eugene Ottman v. Johnson & Johnson Services Inc. et al, CGC-12-517391; Superior Court of California, County of San Francisco). Kramer oversees Californias consolidation of more than 600 ASR metal-on-metal lawsuits, according to court documents (DePuy ASR Hip System Cases, JCCP-4649, Superior Court of California, County of San Francisco).

The defendants are asking the judge to rule in their favor on the facts and the law without the necessity of a trial, said Rochelle Rottenstein, principal of the Rottenstein Law Group. This is common. Ottman will oppose summary judgment in favor of the defendants, of course. Summary judgment is rarely granted, however, because the bar for proving that it is appropriate is very high.

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

Consumer Reports

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.
xxxxxxxxx
 
What a great idea!  Connie
 


Friday, September 13, 2013

Study finds pseudotumor formation in more than a quarter of hips with metal-on-metal bearings


High Prevalence of Pseudotumors in Patients with a Birmingham Hip Resurfacing ProsthesisA Prospective Cohort Study of One Hundred and Twenty-nine Patients
R. Bisschop, MD1; M.F. Boomsma, MD2; J.J.A.M. Van Raay, MD, PhD1; A.T.M.G. Tiebosch, MD, PhD1; M. Maas, MD, PhD3; C.L.E. Gerritsma, MD, PhD1                        

J Bone Joint Surg Am, 2013 Sep 04;95(17):1554-1560. doi: 10.2106/JBJS.L.00716

Abstract

Background: 
Recently, concern has emerged about pseudotumors (lesions that are neither malignant nor infective in the soft tissues surrounding total hip arthroplasty components) after hip arthroplasties with metal-on-metal bearings. Patients treated in our hospital for degenerative arthritis of the hip with a Birmingham Hip Resurfacing (BHR) prosthesis were invited to return for follow-up evaluation. The prevalence and clinical relevance of pseudotumors were investigated. Risk factors for pseudotumor formation were sought.
 
Methods: 
A single-center cross-sectional prospective cohort study was conducted and included all patients who received a BHR from 2005 to 2010 in Martini Hospital, Groningen, The Netherlands. Data were collected on patient and surgical characteristics, clinical hip outcome scores (Harris hip score and Oxford score), serum metal ion levels (cobalt and chromium), and radiographs. A computed tomographic scan (without metal suppression) was made. In patients who had a revision, tissue samples were histologically examined.
 
Results: 
Originally, there were 129 patients with 149 BHRs. Four patients (six hips; 4%) were lost to follow-up. Our final cohort consisted of 125 patients (143 hips). From this final cohort, eleven patients (twelve hips) had a revision, and three of them (three hips) had the revision before the present study was conducted. Seven patients (eight hips; 5.6%) had a revision because of a symptomatic pseudotumor. Survival analysis showed an implant survival rate of 87.5% at five years (failure was defined as a revision for any reason). A pseudotumor was found on computed tomography in thirty-nine patients (forty hips; 28%). Of those patients, ten (eleven hips; 28%) had complaints involving groin pain and discomfort, a noticeable mass, or paresthesia. Symptomatic pseudotumors were significantly larger than asymptomatic pseudotumors (a mean volume of 53.3 cm3 compared with 16.3 cm3; p = 0.05). A serum cobalt level of >85 nmol/L was a predictor for pseudotumor formation (odds ratio, 4.9).
 
Conclusions: 
Pseudotumor formation occurred in 28% of hips after an average follow-up of forty-one months. Most pseudotumors (72.5%) were asymptomatic. Larger pseudotumors were associated with more complaints. Survival analysis showed an implant survival of 87.5% at five years. Failure occurred in 5.6% (eight) of 143 hips because of a symptomatic pseudotumor.

Periprosthetic Tissue Metal Content but Not Serum Metal Content Predicts the Type of Tissue Response in Failed Small-Diameter Metal-on-Metal Total Hip Arthroplasties

Journal of Bone and Joint Surgery
                    
C.H. Lohmann, MD1; H. Meyer, MD1; J.V. Nuechtern, MD2; G. Singh, FRCSEd(Orth)3; S. Junk-Jantsch, MD4; H. Schmotzer, PhD5; M.M. Morlock, PhD6; G. Pflüger, MD4
 

Abstract

Background: 
Tissue responses to periprosthetic metal wear debris are complex and poorly understood. There are two predominant tissue responses: a nonspecific macrophage-mediated granulomatous response and lymphocyte-dominated response, which has immunological memory and is mediated by T cells. Delayed hypersensitivity-type responses may accelerate aseptic loosening of arthroplasty implants. We hypothesized that the metal content of periprosthetic tissue but not of serum would be predictive of the type of tissue response to metal wear debris.
 
Methods: 
We examined twenty-eight total hip arthroplasty implant retrievals from twenty-seven patients who had undergone revision arthroplasty at one institution. Indications for revision were pain and/or osteolysis; one patient had recurrent dislocations. Tissue samples were analyzed microscopically and the metal (Co, Cr, and Ni) content was determined. Explanted prosthetic components were examined for linear wear. Intraoperatively, periprosthetic metallosis was observed in twelve cases and formation of a bursa (pseudotumor) was observed in thirteen. The acetabular cup was loose in eleven cases, the femoral stem was loose in five, and both components were loose in five.
 
Results: 
The metal (Co, Cr, and Ni) content of the periprosthetic tissue ranged from 1.4 to 4604.0 μg/g. Histologically, macrophages containing metal particles as well as diffuse and perivascular lymphocytic infiltration were observed. Fibrin exudation was also visible. Tissues that displayed a predominantly lymphocytic response had a mean metal content of 222.2 ± 52.9 μg/g, whereas those that displayed a macrophage-dominated response had a metal content of 3.0 ± 0.9 μg/g; this difference was significant (p = 0.001). The mean serum metal content did not differ significantly between the two subgroups (60.7 ± 13.4 compared with 43.7 ± 3.8 μg/L, p = 0.105).
 
Conclusions: 
An association between periprosthetic tissue metal content and hypersensitivity appears likely but needs to be validated with larger-scale retrieval studies.
 
Clinical Relevance: 
This study contributes to the understanding of tissue responses to metal wear debris after joint
 
  

Tuesday, September 10, 2013

Johnson & Johnson Q2 Profit Up 172% Thanks To A Brutal 2012

Forbes

Health care giant Johnson & Johnson JNJ +0.46%‘s profit more than doubled in the second quarter, partly driven higher from a recent sale and strong medical-device sales, but also made possible by an easy comparison to a figures from a year ago. In addition, the company increased its full-year profit forecast, offering investors another optimistic signal that it’s successfully moving past a period marred by product recalls and manufacturing problems.

Looking ahead, J&J expects to earn between $5.40 to $5.47 a share in 2013, above an earlier range of $5.35 to $5.45 a share. Analysts had expected J&J to make $5.41 a share.
In the most recent quarter, J&J’s net income was $3.83 billion, $1.33 a share. That’s up dramatically from $1.41 billion, 50 cents a share, from a year earlier. Excluding one-time items, J&J earned $4.29 billion, $1.48 a share. Analysts expected J&J to earn $1.39 a share. The second quarter included the April sale of J&J’s stake in Elan ELN -0.45% Corp., the Irish biotech company that J&J teamed up with to create an Alzheimer’s drug. It was the second consecutive quarter in which a special item added a one-time gain, after a reversal of a Medicaid payment provided a boost in the first quarter.
Sales rose 8.5% to $17.88 billion, ahead of the $17.72 billion estimate from analysts.

Shares of J&J rose 1% to $91.27 in early morning trading. J&J is a $256 billion behemoth that dwarfs even top U.S. competitors like Merck Merck, Eli Lilly, Stryker SYK +0.33% Corp. and Medtronic. It’s the world’s largest health care-products manufacturer, ahead of Swiss Roche Holdings and French Sanofi SA.

A year ago, it was a different story entirely for the New Brunswick, N.J. company. J&J wrote off $2.2 billion for troubled acquisition, litigation and assets costs in the second quarter of 2012. What’s more, recalls have continually plagued J&J, with the company issuing four dozen or so recalls since 2009. Pulling consumer staples like Tylenol and Motrin off shelves damaged J&J’s reputation, and the company last year turned to a new CEO, Alex Gorsky, to lead the company.

The after-effects remain apparent in J&J’s second-quarter numbers: sales in its consumer-health business, which include drugs like Tylenol, rose just 1.1% to $3.66 billion. J&J today is still trying to return all the recalled products to stores.

To withstand the loss in its consumer-health business,  J&J is pinning its hopes on medical devices, its largest division. It paid $19.7 billion for Synthes last June, a company that makes surgical trauma equipment. J&J’s sales of medical devices and diagnostics increased 9.6% to $7.19 billion in the second quarter.

Prescription drugs sales also experienced a large jump. That revenue rose 12% to $7.03 billion with strong demand for prostate cancer drug Zytiga and immune disorder drug Remicade.
Reach Abram Brown at abrown@forbes.com.
                    
 
                    

 


DePuy ASR Trial Postponed for Two Weeks

The Legal Examiner

Posted by Joseph H. Saunders
September 6, 2013 5:35 PM

The first federal Johnson & Johnson DePuy ASR metal hip implant trial was scheduled to start on September 9, 2013. The judge has delayed the start of the trial because there are legal rulings that need to be made before the jury is impaneled. This is not uncommon in complex cases. There have been two prior trials in state courts involving the DePuy ASR hip implant recall. One in California this spring resulted in an 8 million dollar award for the injured hip patient and a verdict for zero this summer in Chicago. DePuy has not paid the 8 million dollar award and is appealing to a higher court to try to reverse that judgment.

The federal trial which is now scheduled to start in two weeks is the first of eleven thousand federal lawsuits involving the ASR metal hip implant. This first case is designated as a “bellwether” case to test the value of these cases. Obviously, DePuy cannot have eleven thousand jury trials to determine the payment on these cases. There will have to be some kind of settlement of most of them. Since DePuy does not want to pay what the lawyers for the injured hip patients think DePuy should pay the judge has scheduled some trials to “test the waters”.

The cases selected for trial were selected as average cases to be representative of most of the cases in the litigation so that the jury verdicts will be helpful in trying to value the rest of the cases.
Bloomberg News reported a rumor of a discussion of a three billion dollar settlement for the ASR cases. At that figure, if it is true, the average settlement for a revised hip would likely be over $300,000. The numbers would work out that way because about 20% of the lawsuits involve people with hips that have not yet failed and those cases would likely get less that those who have had hips replaced. There would also likely be a fund to pay extra for those with significant complications or loss of earnings.

It has been over three years now since the DePuy ASR was recalled and those harmed by this defective product are frustrated and angry that DePuy has failed to put forth any settlement program to compensate those who have been harmed.

Johnson & Johnson can exclude recall evidence in DePuy ASR bellwether lawsuit

As a reminder prior to the new Depuy trial which started yesterday re certain evidence

Mass Device

Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month.

Johnson & Johnson's (NYSE:JNJ) DePuy Orthopaedics division pulled the DePuy ASR device from the market in 2010, prompting thousands of personal injury lawsuits across the country.

Many of the suits filed in federal courts have been consolidated into multi-district litigation overseen by Judge David Katz of the U.S. District Court for Northern Ohio. The 1st bellwether trial in that litigation, Ann McCracken v. DePuy Orthopaedics, is slated for trial in September, according to court documents.

Katz ruled last month on a number of pre-trial motions from both sides, granting DePuy's bid to keep evidence about the recall out of the trial. McCracken had argued that the recall shouldn't count as a "subsequent remedial measure" following the 2009 implantation of a DePuy ASR LX model.
Katz disagreed, on the grounds that McCracken is likely to assert her claim as having begun at the time of her hip replacement surgery in 2009 (a revision surgery was performed in January 2011, according to the documents).

"Her injury began with the initial implantation and, but for that event, she would not have suffered injury, including the revision surgery," Katz wrote. "Assuming the plaintiff will claim her harm commenced before the recall, in this instance, the recall is a subsequent remedial measure which, if it had occurred prior to the implantation, would have prevented the harm. As such, the recall is inadmissible."

DePuy can present evidence of the FDA granting 510(k) clearance for the DePuy ASR hip implant, Katz ruled.

"The court is persuaded that Defendants are entitled to present evidence of the 510(k) clearance as it represents the process by which the device came to be on the market and is, therefore, relevant," he wrote. "Despite plaintiff's protestations, the probative value outweighs the danger of unfair prejudice or jury confusion and this evidence will also be subject to a special jury
instruction. Therefore, plaintiff's motion to exclude evidence of 510(k) clearance is denied."
The judge also granted DePuy's motion to use split-screen video depositions, writing that "the presentation of a split-screen method is no different from what the jury would see in the live courtroom, therefore, no prejudice results to either side."

DePuy can also exclude evidence of compensation paid to expert witnesses in prior trials (but must divulge if asked evidence of payments to experts in this trial). Evidence of payments from Broadspire Services, a 3rd-party administrator that handled DePuy ASR claims, can be included in the trial, the judge ruled.

In a separate ruling, Katz granted McCracken's bid to exclude any reference to lawyer advertising and any suggestion that the high revision rates on the ASR devices "are driven by lawyers," according to the documents. DePuy withdrew a motion to exclude "evidence and argument that DePuy misled the FDA, violated federal law, or should have conducted clinical testing," but can re-file the motion later, the judge ruled.

The 1st trial over the DePuy ASR implant settled in August 2012 before it could go to trial. In March, a jury awarded another plaintiff, Loren Kransky, $8.3 million after deciding that the device was defectively designed (California Judge J. Stephen Czuleger rejected DePuy's request for a new trial in May). In April, an Illinois state jury found for DePuy in Carol Strum vs. DePuy Orthopaedics & Premier Orthopaedic Sales.

And plaintiffs in 7 lawsuits filed over the device can add claims over the DePuy Pinnacle implant, a state judge in California ruled last month.

The August 2010 recall of the DePuy ASR devices was "due to the number of patients who required a second hip replacement procedure," according to a company report. An internal review in 2011 found that 37% of DePuy's ASR hip implants would require revision or replacement in less than 4.6 years.

Prosecutors say DePuy hid risks in ASR hip recall

Mass Device
Sept 6th

September 6, 2013 by Sony Salzman

As the DePuy bellwether metal hip implant trial prepare to begin next week, attorneys for plaintiffs say they’ve uncovered new evidence suggesting that J&J subsidiary hid critical information about patient harm.
 
Prosecutors involved in the high-profile bellwether lawsuit of Johnson & Johnson's (NYSE:JNJ) DePuy orthopedics division said there is growing evidence that company hid key information about the risks of its ASR metal-on-metal hip implant.

That hip implant was pulled from the market in 2010, prompting a cascade of personal injury lawsuits that are now trickling into court rooms. After some delays and out-of-court settlements, the next bellwether trial of DePuy's ASR implant will begin in federal court on September 9.

During early trial proceedings, attorneys for the patients said that new evidence emerged that DePuy had failed to report known risks to the FDA. According to court documents, the law firms Bernstein Liebhard LLP and Walkup Melodia Kelly & Schoenberger say there is new testimony that DePuy misled regulators from 2006 to 2010.

Last week, prosecutors asked the federal watchdog agency investigate possible wrongdoings during the 2010 recall.

The FDA probe will not affect the trajectory of the other trials already set to begin next week. In July a federal judge ruled that evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial.

Bone-like metal improving joint-replacement outcomes

HindustanTimes

Implants made from Trabecular Metal, a special bone-like metal with high-fixation and weight-bearing capacity, are changing the face of joint-replacement surgeries in India.

“It is closest to the natural bone in terms of flexibility and load-bearing capacity,” said Dr Ashok


“It’s a cement-less option where bone grows into the implant within merely six to eight weeks after the surgery. Earlier, it would take up to six months or may not grow at all,” he added.

“It’s technically more advanced as the coating at the back helps the implant fix well,” said Sean F O’Hara, managing director, Zimmer (Shanghai) medical international trading co. Ltd., the manufacturerers of the implant.

Three people have received TM implants for hip replacement in India - one at the All India Institute of Medical Sciences (AIIMS) and two in Medanta. For knee replacement surgeries in India, the metal has been used successfully for almost four years.  
   
Options such as this one benefits patients needing bone grafts as India’s only bone bank at AIIMS has received only 32 cadaver bone donations since 2001.

“Apart from longer shelf life, there are also less infection issues and failure rates with the metal,” said Dr Suri Narayanan, senior orthopaedician, Chennai’s Apollo Hospital.

“It is proving to be a boon for a section of patients. We have nearly stopped using allograft (transplant of tissue from one individual to another of the same species with a different genotype) for sockets because there are hardly any available, but for the thigh bone we still don’t have an option,” said Dr Rajesh Malhotra, professor, department of orthopaedics, AIIMS.
 
However, this wonder metal cannot be used for all patients. “It is not something that everybody would use on everybody, but it’s a great bailout option for patients who are on the verge of losing the bone and young patients in whom we would otherwise prefer delaying revision surgery,” added Dr Narayanan. Since most people in India seek treatment at a late stage when the joint or bone has degenerated and there are not too many options left to save it.

Severe arthritis, hip fractures, tuberculosis, steroid and heavy alcohol consumption leads to rapid bone loss and are common reasons for joint replacement surgeries.

DePuy ASR Hip Implant Settlement Amounts

The Legal Examiner

It has now been over three years since the Johnson & Johnson DePuy ASR metal on metal hip was recalled and there is still no settlement program for injured consumers. There are over eleven thousand lawsuits pending and more being filed every week.

Bloomberg News recently reported or speculated that a 3 billion dollar settlement was being discussed. So what would that mean to individuals who have been injured if that number is accurate? It would appear that a 3 billion dollar settlement might mean individual settlements of between $300,000 to $400,000 per case where there has been a hip revision that was reasonably succesful without major complications.

Any proposed settlement program that is set forth, and one will be an some point, will have to rank cases so like cases receive similiar amounts. Individuals who had more than one revision or who suffered infection during the revision will certainly receive more than the basic revision case. Those individuals who have a DePuy ASR hip and have not needed a revision are not likely to get settlements above low 5 figures in my opinion.  Perhaps 20% of the lawsuits filed involve cases without a revision. Some of these cases may be serious cases where the revision could not be performed for health reasons. It is likely that these cases may receive more than the basic case. However, most of these non revision cases will not be serious cases but are people who had to file a lawsuit to protect their rights against the statute of limitations. The statute of limitations is a time period that is different in different states but which requires a lawsuit to be filed or it might be too late and might be dismissed as untimely by the Court. These unrevised cases are unlikely in my opinion to be allocated more than low five fugures per case. That is why there would be funds in a 3 billion dollar settlement for eleven thousand people that could allocate over $300,000 to pay the average revision case.

There will also likely be some type of extraordinary injury fund to pay extra to people who have died or had a stroke during revision surgery or had an extended hospital stay from complications. Any proposed settlement program will likely provide a fund for payment later of these unrevised cases if they later need surgery to remove the ASR hip.

My opinions here are based upon the past Sulzer Hip Class Action Settlement and my 30 years experience as a trial lawyer. I have no inside information on whether the Bloomberg report is accurate or not.

I know those harmed by the ASR hip implant are frustrated by the delay in justice but it looks to me like there will need to be a few more jury trials before DePuy will come forward with a settlement program. Of course, any settlement program is not mandatory and this is not a class action lawsuit so each person retains his or her right to take DePuy to jury trial in an individual case if they do not wish to accept whatever is offered in the settlement program.

Sunday, September 1, 2013

First Bellwether Trial in Multidistrict Litigation for DePuy Orthopaedics Inc.’s All-Metal Hip Implant to Commence on September 9 in Ohio’s Northern District

Parker Waichman


U.S. District Judge David A. Katz, who is presiding over the DePuy ASR hip implant multidistrict litigation (MDL) in U.S. District Court, Northern District of Ohio, has ordered that the first bellwether trial’s start date remain September 9, 2013, even though an earlier Order had vacated what was originally supposed to be the first bellwether trial, the case of Dorney-Madgitz v. DePuy (Case No. 1:11 dp 20112). The start of the new initial trial, McCracken v. DePuy (Case No 1:11 dp 20485), remains September 9. The overall litigation is entitled: In Re DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197).

The Plaintiff, Ann McCracken, was implanted with the DePuy ASR metal hip on or around Aug. 24, 2009. According to the Complaint, she alleges that, as a result of the procedure, “she suffered and continues to suffer serious bodily injury and was forced to undergo revision surgery on or around Jan. 17, 2011,” according to court documents. McCracken resides in Rochester, New York.


Biomet’s Preemption Bid Fails, Company Proceeds To Trial Over Metal Hips

The Legal examiner
Posted by Shezad Malik MD JD
August 28, 2013 3:40 PM

The federal judge overseeing the Biomet M2A Magnum hip failure lawsuits has denied a motion to dismiss the lawsuits based on federal preemption. Many plaintiffs have filed product liability lawsuits over early hip failure and metallosis involving the Biomet metal hip replacement device.

biomet hip recall attorney

Plaintiff Biomet Injuries
The plaintiff, Leslie Caccia, had to undergo multiple revision surgeries after his Biomet ReCap Femoral Resurfacing System and M2A-Magnum metal-on-metal hip replacement system prematurely failed.

According to Biomet, the case should be dismissed because the implant was approved by the FDA. Biomet claimed that it should not be held liable for design defects, stating that federal law preempts any state law claims.

According to the judge, “The FDA approved Biomet’s ReCap System under the investigational device exemption, the IDE process, for use in a specific clinical trial to determine the device’s safety and effectiveness. The use of the ReCap System outside the controlled study, without proper monitoring, record-keeping, and FDA oversight, wouldn’t advance the aims of the clinical trial. I’m not persuaded that a manufacturer that obtains IDE status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from the liability for use of that device outside the clinical trial.”

Biomet M2A-Magnum Lawsuits
Judge Miller is currently overseeing all product liability claims involving the Biomet M2A-Magnum metal-on-metal hip replacement system in the Northern District of Indiana. There has been no trials involving the Biomet M2A Magnum hip device to date.

What is the Biomet M2A Magnum Hip?
The Biomet M2A Magnum is a metal-on-metal artificial hip replacement system, which is associated with premature hip failure according to some experts. The plaintiffs allege metallosis with the Biomet hip, in which metal debris are released as the metal components grind against each other during daily activity.


587 Biomet Magnum Lawsuits and Climbing
According to the courts, there are at least 587 cases centralized and consolidated before Judge Miller. According to experts, that number is expected to increase in the coming months and years as these devices age and increasingly fail. To date there has been no recall or admission of liability by Biomet.
This early hip failure and metallosis lawsuits are not unique to Biomet, there are several federal multidistrict litigations (MDLs) involving metal-on-metal hip implants.

 There are at least 7,860 DePuy ASR hip lawsuits, 4,278 DePuy Pinnacle hip lawsuits and about 46 Wright Conserve hip lawsuits pending in the federal court system. There are ongoing federal MDLs involving the Stryker Rejuvenate and ABG II hip replacement system and Zimmer Durom Cup.