Stryker Settles Another Hip Case: Says Liability Could Exceed $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 Settle Metal Hip Claims

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

File Your Tax Return Before A Hacker Files For You

If you are not already motivated to file you tax returns, the thought of a hacker filing with your information and obtaining your refund should be motivation enough.

As part of what we are seeing from the unraveling of the Target data breach scandal, it is clear that hackers are fully engaged in tax fraud.  According to a 2013 report from the Treasury Inspector General's office, The IRS issued $4 billion in bogus tax refund checks in 2012.  The money went to sophisticated criminal enterprises who stole social security numbers and filed returns under an alternative address.

If you have been a victim of such a scam, you should contact The Identity Protection Inspection Unit of the IRS at 1-800-908-4490.  If you are the victim of identity theft and think you need to take legal action, you can contact me and I will evaluate your legal claims.

Metal Hip Implant Results 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.

Episode of House Results in Diagnosis of Cobalt Poisoning from Metal Hip Implant as Source of Heart Failure, Blindness

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.

Johnson & Johnson fights to keep Risperdal documents under seal.

The FDA has issued warnings that boys and young men who have taken the drug Risperdal are at risk for gynecomastia.  So far, there have been about 450 lawsuits filed and J&J has paid billions to settle federal and state government claims involving the illegal marketing of the drug.

J&J is also trying to keep documents from being made public.  The company has asked a Pennsylvania state judge to keep confidential a series of clinical studies that were put under seal in 2011.

The plaintiffs claims that there is a tremendous public interest in the documents being public, that the documents are not proprietary, and that for the well-being of the public and for full and unfettered review by regulatory authorities and healthcare providers, they should be made public.

Pradaxa Manufacturer hit with Million Dollar fine by Federal Judge for Improperly Withholding Documents

Boehringer Ingelheim GmbH (Boehringer) was hit with almost $1 Million in sanctions for withholding documents requested by Plaintiffs’ attorneys in the Pradaxa MDL.  Boehringer, the German family-owned drugmaker, is the manufacturer of the blood thinner Pradaxa. The allegations against Boehringer over the drug are that Pradaxa® causes excessive internal bleedings which can cause serious complications, including death.

U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits in the MDL concluded that Boehringer executives acted “in bad faith” by failing to ensure that documents and files about the drug’s development and marketing were preserved. In his 51 page ruling, Judge Herndon stated, “The wrongs here are egregious,” and that he was, “stunned” by their discovery violations. He went on to add that the company’s efforts to safeguard the documents amounted to, “…gross inadequacy”.

In his December 9^th ruling, Herndon wrote that he was forced to deal with claims that Boehringer was improperly withholding documents from the inception of the case consolidation in 2012. He characterized Boehringer as acting in, “bad faith”.

The Plaintiffs argued that Boehringer should have forced employees to preserve documents about the drug’s development and the company’s marketing plan. They also argued that Boehringer failed to order employees to save phone messages, including texts, about their work on Pradaxa® which allowed countless records to be destroyed. Such protocol is often referred to as a “litigation hold”; a routine and regulated aspect of the discovery process in federal and state litigation.

Among other malfeasance, Boehringer could not produce files of a high-level scientist involved in developing Pradaxa® or documents by consultants who worked on the marketing plan. The Court’s Order indicates that the files of Professor Thorsten Lehr may be among the evidence that allegedly was destroyed by Boehringer. Court documents describe Professor Lehr as a prominent scientist who played a key role in developing Pradaxa® and who authored a study that initially concluded that Pradaxa®’s safety was related to the therapeutic range of the drug. The Court’s Order explains that Professor Lehr’s desire to publicly disclose the existence of a therapeutic range for Pradaxa® was highly controversial within the company. The order quotes Boehringer employee, Dr. Andreas Clemens, who stated, “The world is crying for this information – but the tricky part is that we have to tailor the messages smart.” The Order further states that, ultimately, Boehringer required that the study be revised to exclude information about therapeutic range.

Judge Herndon ruled that all of these actions justified sanctions amounting to $931,000.

Along with the fine, Boehringer executives must turn over files that are in their possession or officially inform the court that they cannot. Judge Herndon did not leave out the opportunity to levy additional sanctions against the corporation over the missing files.

Plaintiffs allege that Boehringer executives knew Pradaxa® posed a deadly risk when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, Pradaxa® has no antidote to reverse its effects, which can lead to so-called bleed-out deaths. FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011.

This is not the first time in this litigation Boehringer has been sanctioned. In a September 18, 2013 Order, the Court sanctioned Boehringer in the amount of $29,540. The Order stated that the Court was a firm believer in progressive discipline, and that Boehringer was required to abide by the discovery rules.

Pittman, Dutton & Hellums, P.C. is currently investigating claims for patients injured by Pradaxa®.  Contact Chris Hellums at 1-866-515-8880 or at chrish@pittmandutton.com for a free consultation.