Depuy vs. Stryker: Will Stryker Employ The Same Litigation, Settlement, and Trial Strategies (Part 1)

Now that the claims against Stryker have been centralized in Minnesota, speculation has begun as to what litigation strategy Stryker will employ.

Lets start with what we know.  First, Stryker has employed Broadspire as an administrator to handle claims.  Broadspire first showed up in the Depuy ASR litigation.  In the ASR litigation, Broadspire has handled the payment of co-pays, deductibles, and in some cases, lost wages for individuals claiming injuries as a result of catastrophic failure of the recalled ASR hip system.  At one time it was thought that Broadspire would engage in the wholesale settlement of claims but, to date, that has not occurred (more about that later).  At issue in the Depuy ASR litigation is whether Depuy will be allowed to introduce at trial the services performed, and the funds paid out by Depuy via Broadspire.  Depuy wants to use this evidence at trial in an attempt to show that they are a good corporate citizen and they did they right thing when they recalled the product.  Depuy needs this evidence to offset the horrible evidence showing they knew of the problems with their ASR hip system and placed profits over safety until the evidence of failures overwhelmed them.

Back to Stryker.  No, let go back to Depuy for a minute because I think it will be important for context.

From the moment the Depuy ASR MDL (multi-district litigation) kicked off, lawyers for Depuy have taken every opportunity to state time and time again that Depuy wanted to settle with claimants.  That was three years ago.  Depuy has not made any real efforts, it appears, to engage in the settlement of claims.  You just don't go three years trying to settle with any of the ten or so thousand of claimants and thousand or so of lawyers, and not get any takers.

In the meantime, Depuy has vigorously defended the cases and developed their strategy.  They have tried two cases.  One win, one loss.  They lost the first one, then re-tooled and won the second case in state court.   Claimants are dying without the opportunity to settle their claims, others are in financial distress, and others want to move on with their lives.  They want to be compensated for what they have been through and they are pressing their lawyers.

Advantage Depuy.

Depuy now sits at a crossroads.  Despite the disaster now known as the ASR, Depuy has drawn even at trial.  The second trial proved Depuy can use their massive resources to convince juries that individual issues, despite how off base or misguided, caused the failure of that specific device and not a RECALLED PRODUCT THAT ULTIMATELY RESULTED IN THE END OF METAL ON METAL HIPS.  This should be considered a huge win for Depuy. Many thought that the losses would continue to mount and that Depuy would be forced to settle claims on unfavorable terms.

What will Depuy do at this time?  I would argue they have ultimate bargaining power.  They have proved that they have the lawyers and the resources to pull of an upset win.  They have drug out this litigation out for three years telling anyone who would listen that they want to settle, while making no real apparent attempts to settle.

What happens from here?

There has yet to be an MDL bellwether trial.  That is coming up.  I would argue that the result is immaterial to either side.  The die has been cast.   There are ten thousand cases out there to be tried.  Shortly, the judge presiding over the MDL will be forced to send them back to the jurisdictions they came from for trial.  Depuy will be trying cases every month and the war of attrition will continue, but this time the advantage will be against Depuy as thousands of lawyers get their chance to become famous by taking down the $1000 per hour lawyers and unlimited resources of Depuy in places like Alabama, Florida, California, New York, Texas, South Carolina..................

Back to Stryker in part 2.

BBC Interview with British Health Regulatory Agency Director

Surgeons in the United Kingdom fear metal debris from the failed metal hip joints have possible long term damage. The metal in the joint has been shown to wear down and these "hip replacements may be leaking metal fragments". The UK health regulator, the MHRA, announced that 49,00 patients with metal on metal hip replacements will to be required to have annual checks up due to medical fears. Engineer Tom Joyce of Newcastle University, in his analysis of the wearing metal joint, claims that "these metal on metal hips are failing at rates we just wouldn't expect". Professor Sir Kent Woods, who is a medicine and health product regulator in the UK, admits there were "no clinical trials" were conducted prior to administering these metal on metal hips.



http://www.bbc.co.uk/news/health-17192520 

Stryker Timeline of Events

TIMELINE OF EVENTS

June 3, 2008:  FDA approved the Stryker Rejuvenate modular-neck stem. According to Stryker, the Rejuvenate hip stem was designed to re-create the anatomy and the biomechanics of individual patients. Stryker claimed the Rejuvenate hip stem provided enhanced stability, proven modularity and intra-operative flexibility.

February 2009:  Stryker began marketing the Rejuvenate Modular Primary Hip System.

November 4, 2009:  FDA approved the Stryker ABG-II modular-neck stem. Stryker marketed these two products as the new generation of stems and targeted a younger demographic. Stryker touted them as “high performance” in terms of corrosion resistance and improved fatigue strength.

February 2010:  Stryker issued an “Urgent Field Safety Notice” to surgeons – reiterating technique for implantation and identifying less than 1% failure rate due to metallosis between the neck and stem morse taper junction. Stryker failed to notify consumers of any problems.

April 2012:  Stryker issued another “Urgent Field Safety Notice” to surgeons and hospitals in the United States for the two hip replacement systems. The alert listed the potential hazards in these devices, including: “Excessive metal debris and/or ion generation,” caused by: “Fretting and/or corrosion at or about the modular neck junction,” which “may lead to increased metal ion generation in the surrounding joint space.”

May 2012:  Stryker publishes report stating mechanical problems with the modular-neck stems. Stryker says these stems have the potential to cause similar metal toxicity problems that some patients with metal-on-metal hip implants have experienced.

May 28, 2012:  The Canadian equivalent of the FDA announced that the Stryker Rejuvenate was being recalled.

July 6, 2012:  Stryker voluntarily recalled its Rejuvenate and ABG-II modular neck system from the United States market. Stryker also ceased global production and sale of these devices. By this time, the FDA received more than 45 adverse event reports of metal toxicity requiring revision surgery.

August 2012:  Stryker urges surgeons to send letters to clients notifying of these recalls and encouraging patients to contact Stryker.

Stryker Hip MDL Goes to Minnesota

The Judicial Panel on Multi-District Litigation entered an order centralizing the Stryker Rejuvenate Hip Litigation, MDL 2441 to the District of Minnesota before Judge Donovan W. Frank.  The MDL panel made clear that the judge presiding over the litigation was the most important factor in selection, [s]uccessful coordination....hinges on the efforts of the involved judges.

It will be interesting to see if claimants feel comfortable with the District of Minnesota or opt to file claims in other available venues.

Where will the MDL Panel send? MDL No. 2441 - IN RE: STRYKER REJUVENATE AND ABG II HIP IMPLANT PRODUCTS LIABILITY LITIGATION

All eyes are on the MDL panel to see what judge and jurisdiction MDL No. 2441 - IN RE: STRYKER REJUVENATE AND ABG II HIP IMPLANT PRODUCTS LIABILITY LITIGATION will be sent. The general consensus is New Jersey, with Illinois and Arkansas as long shots. The choice of venues is extremely important. Depending on the selection, attorneys for claimants could decide to file into the MDL, or seek to file in various state court jurisdictions.

Depuy ASR Hip Verdict Affirmed by Trial Judge

A California Superior Court judge has denied DePuy Orthopaedics’ motions for new trial or judgment notwithstanding the verdict, upholding the $8.3 million judgment that resulted from the state’s first trial of a DePuy ASR hip implant case. The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County.

In March, the jury hearing the DePuy ASR recall lawsuit in California found the ASR hip was defectively designed, and awarded more than $8.3 million to the Plaintiff, Loren Kransky. Mr. Kransky sued the company under the theory that the ASR was defectively designed as well as DePuy's failure to warn his doctors that its product was dangerous. He claimed that the ASR hip caused him to suffer severe side effects, including metal poisoning. The jury found in favor of Mr. Kransky on the design defect claim and in favor of DePuy on the failure-to-warn claim.

During that trial, evidence was introduced which indicated Johnson & Johnson and its subsidiary, DePuy Orthopaedics, had knowledge that the ASR hip product was defective years before the recall was announced. The recall occurred in August 2010. However, that information was not shared with the public at large or the medical community. According to a New York Times report published on April 16th, much of the same evidence was introduced in a second trial that concluded last month in Illinois state court. However, the jury hearing that case found for Johnson & Johnson.

Los Angeles Superior Court Judge J. Stephen Czuleger issued his decision from the bench following a hearing May 24 and has scheduled a hearing in June on the plaintiff’s attorneys’ request for approximately $1.2 million in costs. DePuy submitted its motion for JNOV April 17^th in the corporation’s bid to persuade Judge Czuleger to throw out the verdict. In their motion, Depuy argued that the jury had erred and its verdict was inconsistent.Thus far, there has been no written order.

Judge Czuleger ruled that although there was a "legitimate conflict" in the evidence at trial as to when DePuy knew that its ASR hip implants were dangerous, this did not bar Mr. Kransky's ability to hold DePuy liable for a defectively designed product. The judge also rejected DePuy's claim that the overall body of evidence was insufficient to support Mr. Kransky's verdict, noting that there was "strong evidence" in support of his claim.

Court records indicate that there are more than 11,000 DePuy ASR hip lawsuits currently pending throughout the United States, most of which have been filed in a multidistrict litigation underway in U.S. District Court, Northern District of Ohio. The first trials in the MDL are expected to begin in September 2013. That date is subject to change as the first bellwether case has been continued already this year. The ASR MDL is titled In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197.


Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.
 

First DePuy Trial Set for Monday January 7

 

The first DePuy ASR hip trial in the nation is scheduled to begin on Monday, January 7, 2013, in Prince George's Maryland Circuit Court. Bellwether trials in the federal DePuy ASR hip litigation will commence later this year. The trial is expected to last three weeks, according to court documents. (Jackson, et al. v. Chesapeake Surgical Ltd., et al., CAL 10-32147)

Thousands of DePuy ASR hip lawsuits are also pending in a multidistrict litigation underway in U.S. District Court, Northern District of Ohio, MDL No. 2197. According to court documents, the first trial in the federal DePuy ASR hip litigation will begin on May 6, 2013, with a second trial set for July 8, 2013.

6,000 DePuy ASR hip replacement lawsuits have been consolidated into the MDL based in Toledo, Ohio. Those proceedings are overseen by U.S. District Judge David A. Katz.  There are another 2,000 cases filed against Johnson & Johnson’s subsidiary DePuy across the United States, including lawsuits filed in Nevada, Maryland, California, Wisconsin, Florida and Utah.

The MDL is due to convene for a status conference in January 2013, during which time the court will most likely detail preparations for the first bellwether trials.

Although the statute of limitations has run in many states, people who have not yet filed a lawsuit should contact Chris Hellums toll free at 866-515-8880.

 

FDA: Little Use for Metal on Metal Hips

Fda (Photo credit: Wikipedia)Source:  AP


The Food and Drug Administration has asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

The FDA has not said that the devices should be removed from the market,  but most panelists said there were few, if any, cases where they would recommend implanting the devices.  "I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.  This is consistent with physicians in Great Britain and Australia who stopped installing metal on metal hips several years ago.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants. If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas. Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market. FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.

Smith and Nephew Withdraws Metal Hip Liner

Business Week reports that London based medical device company Smith & Nephew PLC is withdrawing a metal liner used in its R3 Acetabular Metal-on-Metal hip replacement system. The company stated that it pulled the device because it was "not satisfied with the clinical results" of the liner, and some patients needed an additional surgery to have the liner removed. The company reports that this device is an optional metal liner for its R3 Acetabular System hip device and current patients needing surgery will use a different plastic liner. Smith & Nephew claims that the pulling of this device is a precautionary move. These metal liners were developed with the hope of producing longer lasting results than the traditional plastic liner, but unfortunately, did not live up to expected standards.

The primary reason for recall is that the device produced a higher than desired level of patient problems or a higher than expected failure rate. Patients using this Smith & Nephew metal liner experience problems including infections, fractures and dislocations. There have been no reported instances of this particular device causing  "metallosis" or the build up of other metallic debris in the body, as reported in problems with other Metal-on-Metal hip implants. This liner was introduced in 2009 and 7,700 of the devices have been implanted in patients.

This is not the first time metal-on-metal hip implants have been subject to scrutiny. Metal-on-Metal hip implants generally have been linked to high rates of revision surgery and systemic complications, apparently because of component erosion and leaching of metal ions both locally and into blood circulation. In 2010, DePuy Companies issued a recall of its ASR metal-on-metal hip due to early failure rates. Problems surrounding the ASR device include increased blood levels of chromium and cobalt ions and possible necrosis, intense hip, thigh, and groin pain, a loss in overall mobility, and component misalignment and loosening.

Related articles

• Smith & Nephew pulls metal-on-metal hip component - Reuters

  ---

• Smith & Nephew's profit rises after restructuring

  ---

David Langton talks about configuration issues with the Depuy ASR

Training Orthopedic Surgeon David Langton from Newcastle University in the UK has dedicated the last three years of his life studying metal on metal hip replacements, specifically the ASR model, in an effort to attain his PHD. He believes that there is a problem with the configuration of the metal on metal hip replacement, namely the size of the cup. This causes wear to take in the "rim of the cup". "Chromium Cobalt ions concentrate in the hip fluid" and are also released into the blood. This subsequent accumulation of metal ions is "directly related to soft tissue damage and bony damage around the joints". His study has found that hip pain and groin pain are often noted side effects from these metal on metal hip replacements.  

Site: David Langton on Metal on Metal Hips

Related articles

• US Drug Watchdog Now Offers to Help All California Recipients of the Recalled DePuy ASR Hip Implant get Identified to the Best Attorneys Because of a Possible Deadline (prweb.com)
• US Drug Watchdog Rings Alarm Bells about Helping All Recalled DePuy ASR Hip Implant Recipients Getting Identified to the Best Possible Attorneys Before Time Runs Out (prweb.com)
• The US Drug Watchdog Now Calls Its Recalled DePuy ASR Hip Implant Recipients Initiative Vital Because of The Low Numbers Of People Identified & Offers The Best Attorneys (prweb.com)
• US Drug Watchdog Now Offers to Help All Recipients of a DePuy ASR or a DePuy Pinnacle Implant Failure Get to the Best Possible Attorneys-Why Get Left Holding The Bag? (prweb.com)
• US Drug Watchdog Offers To Help Every Recipient Of A DePuy Pinnacle Or Recalled DePuy ASR Hip Implant Get To The Best Attorneys Because Of The Device Failure Potential (prweb.com)