Stryker Settles More Rejuvenate and ABG II Hip Claims: Projects Liability Exceeding $1B

Five of the Eight Stryker Rejuvenate/ABG II failed hip cases have settled at court ordered mediation early in the litigation process.  Before removing the systems from the market, approximately 20,000 were sold.

To date, in excess of 1200 lawsuits have been filed with more filings daily.  Stryker has reported that its liability could exceed $1B.

Biomet Agrees To Settlement of Metal on Metal Hips

Biomet, Inc. has agreed to pay at least $56 million to settle claims involving their metal on metal hips known as the M2a Magnum.  The lawsuits were consolidated in Indiana, home to Biomet's headquarters.

In order to qualify, you must file suit in Federal Court by April 15, 2014.  The base award is $200,000 and applies to individuals who had the implant installed and removed more than 180 days after it was implanted.

Biomet has denied liability and never recalled the hip system; however, it is doubtful any surgeons are implanting metal on metal hip devices in light of the massive failure rates seen with this class of implants.

If you think you may have a Biomet metal on metal hip, please act immediately.  If you have any questions or would like your claims evaluated, please feel free to contact me at 1.866.515.8880 or email me at ChrisH@PittmanDutton.com

Life Imitates Art: Episode of "House" Results in Diagnosis of Failed Hip Implant

Dr. Juergen Schaefer, who specializes in puzzling cases, is a big fan of the t.v. show "House."  In, 2012, in a case of life imitating art, he was presented with a case straight off the pages of the show.

According to The Lancet, a London-based medical journal, a German man presented at this clinic with strange symptoms that continued to worsen.  He had low thyroid levels, inflammation of his esophagus and fever.  His lost so much vision he was almost blind and so much hearing he was almost deaf.   His heart was so weak he could not supply enough blood to his body.  However, he did not have any problems with his arteries.

No one could diagnose the problem.

Remembering an episode of House, he recalled the same problems suffered by a woman played by the actress Candice Bergen.   So, Dr. Schaefer tested the man's cobalt level and determined that it was several times the level considered normal.  He then preformed a scan of the hip and determined that his metal hip had eroded.  The hip implant was removed, cobalt levels fell and his heart function improved; however, his eyesight and hearing barely got better.

Failed Hip Implants Result in Heart Transplant

A New England Journal of Medicine article recently outlined the tragic facts regarding a Denver woman.  The woman, whose identity was kept secret to protect her privacy, began having symptoms in 2011.  She gained 10 pounds on her 4'10" frame.  He abdomen was swollen, as were her arms and legs.

Doctors ordered a CT scan of her heart.  They drained the fluid, but she still felt ill.  Normally, with these symptoms, you would have an enlarged heart, but her's was normal.  She was seen by a transplant surgeon, who was baffled.  Her work-up revealed nothing.  She was placed on a transplant list and in September of 2011, she received a heart transplant.

Sometime later, orthopedic surgeons who had replaced her metal hips took blood test related to metal hips.  It was at this time that her cobalt level was  more than 300 times the normal rate.  Cobalt poisoning can seriously damage organs, particularly the heart.  The implants were removed and her cobalt level declined.  In an interview, she said "[I] have much of my old energy back."

The link to metal implants leaves many unanswered questions.  Tens of thousands and perhaps hundreds of thousands of people have these implants and unfortunately these types of problems continue to be reported.

It is for this reason that anyone with a metal implant should have regular blood tests for cobalt and chromium.

Just How Many Recalled Stryker Hip Systems Were Installed in Alabama Residents?

It seems as though daily, a new case is filed against Stryker related to their recalled Rejuvenate and ABG II hip systems.  Many of these filings are transferred into the MDL (Multi-District Litigation) which is being overseen by United States District Judge Frank.

In Alabama, we continue to receive calls from individuals who have not been advised, or just recently been advised, that they have the recalled product.  Just this week, we received calls from Birmingham, Anniston, and Fairhope from individuals who received the recalled product.  I believe there may be hundreds, and perhaps thousands, of the recalled devices in Alabama.

Many believe they don't have a recalled product because their hip "is not a metal on metal."  While the Rejuvenate and ABG II are not metal on metal constructs, they have been recalled and unfortunately, the damage caused by the Stryker hip is often as bad, and sometimes worse, than the metal on metal devices recalled by Depuy and others.

Why is this the case?  The reason is that the Stryker problem is in the stem, not the ball and the cup.  Fretting  in the stem causes the same problem as the metal on metal ball and cup designs; however, because the failure is in the stem, in order to correct the problem, the stem must be removed from the femur. Stryker stems were often selected by physicians because they adhered so tighly to the femur.  Unfortunately, surgeons are describing revisions of Rejuvenates and ABG IIs as askin to breaking rebar out of concrete.

If you think that you may have a recalled Stryker hip system, it is important that you evaluate your options and take special care to select a revision surgeon, should revision surgery become necessary.

McKesson CEO pay: $130 Million for 2011 and $159 Million Pension

Show me the money!!!

The Wall Street Journal is reporting that McKesson CEO John Hammergren was paid $130 million in 2011 and has a guaranteed pension of $159 million.   Over the last 7 years, he has made $355 million in cash and stock.   This, at a time when most companies, including McKesson have done away with corporate pensions.

McKesson distributes medical supplies, equipment, and pharmaceutical products.  In other words, they live off the government----and we wonder why medical costs continue to skyrocket.

We all love the free market, but this just seems like one more example of a Chairman and CEO who appoints his buddies to the board who then turn around and allow him to loot the company.

Depuy vs. Stryker: Will Stryker Employ The Same Litigation, Settlement, and Trial Strategies (Part 2)

My previous post started out as an analysis of Stryker and ended up being about Depuy, but I think it was important in order to put into context.

Here is some additional information needed to continue this discussion.  Johnson & Johnson is 10 times the size by market capitalization as Stryker.  The global universe of recalled Stryker Rejuvenate  is roughly 2/3rds the size of Johnson & Johnson's Depuy ASR.

Johnson & Johnson's market capitalization is roughly $250 billion.  They have set aside billions to fund the litigation and pay claims related to the Depuy ASR.  Stryker has roughly a $25 billion dollar market capitalization.

So, what strategy does Stryker employ?  We already know that Stryker has hired Broadspire, just like Depuy.  We also know that Depuy talked settlement to anyone who would listen, but never offered any money.  I would argue that Stryker cannot go down that road, for the following reasons:

1.  They are too small and to employ a strategy will cause them to hemorrhage money.  Lawyers alone are going to cost them a fortune.

2.  The lawyers representing plaintiffs have already built up their knowledge base litigating Depuy ASR, Depuy Pinnacle, Wright Conserve, Biomet, etc.

3.  Unlike Depuy, where most lawyers opted for the MDL (and got stuck for 3 years), lawyers with Stryker cases are going to employ strategies which may have Stryker defending themselves in state court jurisdictions from California to New Jersey to Florida to Massachusetts.

That takes us back to Stryker's options:

Option 1:  Set a value on claims and publicize it.  In certain litigation, defendants will basically tell lawyers what they are going to pay for uncomplicated claims---simple revision claims (if there is such a thing).  If you want it, come get it, but we will not pay a penny more.  This strategy comes with the requirement that a company keep to its word when a lone ranger lawyer or disruptive claimant comes in and wants more just so they can tell everyone else they got more.  As for complicated claims, in this case people who cannot be revised but have serious problems, or people who are totally disabled, those are handled on an individual basis.

Option 2:  I call this the "find the weak link" option.  Find lawyers or claimants who are willing to settle at a value that the majority of lawyers would think was less than the value than the case, settle with those people as quickly as possible, and let the word get out that you are open for business.  Not a bad strategy, if you pull it off and get enough people to bite.  The downside is that those who want full value will stay in the litigation and continue to fight, and all the while you are still hemorrhaging attorneys fees.

Option 3:  I call this the "pick off the big fish strategy" option.  Locate respected lawyers or groups of lawyers who have inventories of cases and immediately engage them in settlement discussions.  If those lawyers are reasonable (many should at this time in light of the fatigue of Depuy ASR) and start settling claims.  Once clients of other lawyers know that claims are being settled, and the values are fair and reasonable, clients of the outlier lawyers will begin to pressure them to settle their claims.  Of course, if you don't do this in conjunction with option 1, every lawyer will claim he got more money than every other lawyer or that the settling lawyers are sell out lawyers.  However, in the end, a fair and equitable settlement is just that.  I would argue this is the best strategy for Stryker.

Option 4:  MDL Strategy:  This option can incorporate parts of Options 1, 2, or 3.  The MDL strategy uses the MDL as a mechanism to either settle cases or delay cases.  As we have seen with Depuy, the MDL can be used to delay.  It can also be utilized by a defendant to evaluate their liability until they can determine what strategy to deploy.  It can also be utilized to try and force all claims to one venue and force a global settlement.  The problem with this strategy is that it is not quick.  It gets everyone in one place, but once they are there, it is like herding cats---virtually impossible.  Also, lawyers in leadership have a vested interest in common benefit work, which is ultimately paid out of any settlement of any case that touches the MDL, and is over and above the contingency fee they receive on their own cases.

What Stryker chooses to do remains to be seen.  I would suspect that they will deploy one or more of these options.  Time will tell.

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.