DePuy Hit With $1 Billion Jury Verdict

Last week, a Texas federal jury found Johnson & Johnson’s DePuy Orthopaedics Inc., unit liable for more than $1.04 billion in a six-plaintiff bellwether trial targeting metal-shedding artificial hips that are part of its Pinnacle line.

This MDL bellwether trial involved the DePuy Pinnacle implant, not to be confused with the recalled DePuy ASR implant. The Pinnacle implant was designed with a metal, rather than a safer ceramic or polyethylene, socket. The metal-on-metal design causes the socket to rub against the ball head, which can lead to corrosion and can cause bone and surrounding tissue to erode over time. All of the Plaintiffs in the trial had to undergo revision surgeries to replace the implants and repair the damage. Jurors heard testimony that Johnson & Johnson and DePuy aggressively marketed the implants and employed tactics that included paying kickbacks to surgeons for using the device although they were aware of safer alternatives.

The verdict includes more than $30 million in actual damages for the six plaintiffs and more than $1 billion in punitive damages assessed against Johnson & Johnson and DePuy.

This is the not the first loss for J&J and DePuy over the Pinnacle. In March 2016, a Dallas jury awarded more than $500 million to five individuals who suffered similar physical and medical complications caused by the controversial Pinnacle hip implant. DePuy did win the first bellwether trial.

The case is IN RE: DePuy Orthopaedics Inc., Pinnacle Hip Implant Products Liability Litigation, MDL 3:11-md-0244

Another bellwether trial, which will involve 10 patients, has been scheduled by U.S. District Judge Ed Kinkeade in Dallas for September, 2017.

First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.

Johnson & Johnson ASR Hip Settlement Announced

The much anticipated Johnson & Johnson Depuy ASR Hip settlement agreement has been announced. The agreement was announced during an open court hearing in Judge Katz’s courtroom. Of course, the agreement has to be approved by Judge Katz. Another caveat for the agreement to go through is that 94% of all claimants must opt-in and agree to the settlement.

Details of the agreement are now readily available for the general public. In what was rumored to be a $4 Billion settlement, in actuality is more in line with a $2.5 Billion settlement. The settlement only covers those claimants who have had a revision surgery on their DePuy ASR metal-on-metal hip prior to August 31, 2013. This number is estimated to be close to 8,000 claimants.

Those claimants who have not yet had a revision surgery are technically shut out of receiving any compensation in this agreement. It is anticipated that another round of settlements will occur as the device fails in these claimants and they need revision surgery.

The base payment for a revision claimant will be about $250,000. That payment will fluctuate based on a number of factors including age, weight, length of time the implant was in, and if the claimant smoked. There will also be a pool of $475 Million for the most severely injured.

Rumored $4 Billion Settlement in DePuy ASR Reached

Major news outlets are reporting breakthrough in settlement negotiations in the DePuy ASR hip litigation. DePuy, a subsidiary of Johnson & Johnson, is rumored to have agreed in principle to a $4 Billion agreement to settle lawsuits over their metal-on-metal hip product.

Neither the Plaintiff or Defendant leadership committees-nor the Court for that matter-has confirmed these reports.

The reports claim that the settlement will resolve more than 7,500 lawsuits in federal and state courts against J&J. The 7,500 number is an estimate for how many filed lawsuits are for Plaintiffs who have had a revision surgery. That number is important because as of right now, it appears the settlement would only be for those Plaintiffs who have already had a revision surgery, with an average payout of $300,000-$350,000. It is rumored that the agreement does not bar Plaintiffs whose artificial hips fail in the future from seeking compensation from J&J. Of course, there are many different factors to this agreement including those Plaintiffs who cannot have a revision surgery because of their current health conditions.

There is an open court hearing next week in the MDL Court in Ohio, where many people think the settlement will be announced.

The settlement will be the second multibillion-dollar agreement this month for J&J, the world’s largest seller of health-care products. The corporation agreed on November 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of Risperdal and other medicines. I will be posting a blog on that subject in the next few days.

J&J has spent about $993 million on medical costs and informing patients and surgeons about the recall. J&J set aside an undisclosed amount for litigation, which it increased before June 30. See my previous blog posts regarding that subject.

Details of the rumored are sketchy, but it has been reported that 94 percent of eligible claimants must sign up for the settlement or J&J can withdraw from the deal. This is often times referred to as a Defendant’s ‘Opt-out clause’ and is very common in mass tort global settlement agreements.

J&J recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years. About one-third of that number were sold in the United States. The product went on the market in 2003.

J&J had touted the metal-on-metal implants, first sold in the U.S. in 2005, as a new design that would last 20 years and offer greater range of motion. DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the discovery phase of the ongoing litigation showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate. Those documents revealed that internal DePuy projections estimated that it will fail in 40 percent of patients in five years-a rate eight times higher than for many other hip devices. Other documents showed that the head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw.

As failures mounted, patients complained in lawsuits that the metal-on-metal implant caused soft tissue necrosis, pseudo tumors, metalossis, pain and follow-up surgeries known as revisions. They claimed that debris from the chromium and cobalt device caused tissue death and increased metal ions in the bloodstream.

Claims by unrevised Plaintiffs may be handled in a second round of settlements.

The $4 billion settlement will provide compensation to hip patients based on factors including age, extent of injuries and whether they had one or more surgeries to replace defective implants. Typically, a matrix-type grid is used to categorize Plaintiffs based on these factors.

The accord also provides more compensation to hip recipients who suffered “extreme injuries” from the device’s failure, or endured long hospital stays after removal surgeries.

Also reported was that J&J also has agreed to set aside funds to reimburse Medicare and other insurers for claims paid on behalf of hip-implant patients, which could add hundreds of millions of dollars to the value of the settlement.

Of course, any proposed settlement would have to win Court approval.

DePuy continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.

Rumor of Global Settlement in DePuy ASR Cases

 

It is rumored that Johnson & Johnson, the world’s biggest seller of health-care products, has discussed paying more than $3 billion to settle lawsuits over its recalled hip implants. However, any comment relating to settlement that does not come from the plaintiff’s leadership committee, the court, or from the company itself remains premature, uninformed and a guess. Despite this, major news sources such as Bloomberg News has reported on the rumor.

 

According to the news bulletins, New Brunswick-based 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. Such a settlement would exceed $3 billion if most plaintiffs accept the terms, an amount 50 percent larger than that proposed in previous discussions last 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 proposed global settlement would be affected by the outcome of seven bellwether trials set between September and January. There have already been two cases tried to a jury on the defective hips. 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 the spring of this year awarded damages to a retired Montana prison guard. But the jury did not find exclusively for the plaintiff, finding that although the device was defectively designed, DePuy did properly warn of the risks. Also, the jury did not find that DePuy was liable for punitive damages. DePuy is appealing that verdict.

 

Six weeks later, in the second ASR case tried in the country, a Chicago jury ruled for DePuy in rejecting a defective design claim by an Illinois nurse. Both of those cases have been extensively covered on this blog.

 

Seven other similar trials are coming up that will help lawyers for both sides realize the strengths and weaknesses over damages and liability. This will help in negotiating any global settlement. The first trial is scheduled to begin September 9th 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. This case was originally set to begin in June, but was continued until September. See my previous blog posts for more information on that case.

 

Judge Katz is the presiding judge in the MDL, and is overseeing about 8,000 cases. About 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco. The remaining cases have been filed throughout the United States in various jurisdictions.

 

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 2014.

 

The corporation is pushing to resolve U.S. cases by early next year, according to the unnamed sources. 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 appears to be climbing, along with lawsuits brought by patients blaming the chromium and cobalt devices for pain, metal debris and replacement surgeries.

 

It is estimated that J&J has spent about $993 million on medical costs and informing patients and surgeons about the ASR recall. J&J has also set aside an undisclosed amount for litigation, which it increased before June 30. For more information on that side of the story, see some of my previous blog posts.

 

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

 

According to the unnamed sources, any proposed global settlement would compensate patients on a sliding scale. This sliding scale is best referred to as a matrix or grid. A plaintiff would be placed into a grid or matrix category on such factors as age, extent of injuries, and if they were bilateral. This system would be very similar to the Total Body Formula global settlement negotiated by Pittman, Dutton & Hellums managing partner Chris Hellums.

 

Any chance at a global settlement will still have to overcome several obstacles. 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 and other health insurance companies such as Blue Cross Blue Shield for claims paid. A third is the amount of compensation for outlier cases, which would include dual hip surgeries, cases where infection prompted long hospital stays, and claimants who are unable to undergo a revision surgery because of their health.

 

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

 

California Judge Denies DePuy's Motion to Toss Out $8.3M Verdict

 

 

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. For more information on that case, see my previous blog posts.

 

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 Booth Samuels toll free 1-866-515-8880 or by email at booths@pittmandutton.com.



 

 

 

First DePuy ASR Case in MDL Rescheduled

The first bellwether trial for thousands of DePuy ASR hip lawsuits pending before the U.S. District Court, Northern District of Ohio, has been rescheduled. Originally slated to begin on June 3rd, the trial will now begin on September 9th, as per an order issued by U.S. District Judge David A. Katz on May 7th. Judge Katz continued the setting to allow time for further briefing and possible oral arguments on pre-trial motions. The next status conference in the federal DePuy ASR litigation will be held on May 14th, according to the Order.

There are about 10,750 lawsuits filed over the recalled all-metal hip implant. Approximately three-quarters of them are pending in the MDL.

J&J Wins Its First Trial Over ASR

Johnson & Johnson gained a major victory in defending its subsidiary DePuy. The behomoth corporation succesfully defended at trial an Illinois woman’s claim she was harmed by a defectively designed metal-on-metal hip implant. The case is Strum v. DePuy, 2011-L-9352, Circuit Court of Cook County (Chicago).

The jury of seven women and five men in state court in Chicago deliberated for slightly more than a day before returning its verdict in favor of DePuy Orthopaedics Inc. Plaintiff Carol Strum’s lawyers had asked the jury for an award of at least $5 million.

Jurors had sent a note during the deliberations to Cook County Circuit Judge Deborah Mary Dooling, who presided over the five-week trial, asking if they must be unanimous in their verdict. It appears that the jurors could not reach a unanimous verdict as polling of the panel after the verdict revealed that four jurors wanted to side with the injured Plaintiff.

Strum’s case was the second to go trial of almost 11,000 filed in the United States. The J&J unit was hit with a $8.3 million verdict in compensatory damages by a Los Angeles jury that found the design of its ASR XL hip implant was defective and that the company had properly warned of associated risks. The jury rejected punitive damages in that case.

Johnson & Johnson, based in New Brunswick, New Jersey, is the world’s largest seller of health-care products. J&J recalled the implants in August 2010 after an estimated 93,000 were sold because it said 12 percent failed within five years. Data last year showed 44 percent failed in Australia within seven years. Analysts have said the cases could cost J&J billions of dollars.

Details of the Case

The Plaintiff, Carol, Strum, was a 54-year-old nurse, who had an ASR XL implanted in her in 2008. It was replaced three years later. While her attorneys told jurors the chromium and cobalt implant shed metal into her body, poisoning tissue and sending metal ions into her blood stream, defense lawyers argued Strum had a hyper-sensitivity to the implant and that she got no pain relief when it was replaced with a different device. Defense attorneys also argued that DePuy’s product was not defectively designed.

Needless to say, the jury rejected Strum’s request that they impose punitive damages.

About 500 of the cases against DePuy are pending in Illinois. It is expected that at least one more case in Illinois will try this year

The verdicts are now evened up: one for the plaintiffs and one for the defendants in the "Bellwether

Trials". The Bellwether Trials are designed to gauge the settlement ranges on the remaining 11,000

cases still pending. Since each side already has a victory under its belt, there is sure to be more

cases brought in front of juries to see exactly where the public's perception is as to DePuy's liability

in the timing of the recall.

DePuy ASR California Trial Update

A California Superior Court judge has issued a final judgment of $8,260,790.85 after the recent trial in a DePuy ASR hip implant case, representing a reduction of $77,345.27 in the jury’s award of compensatory damages.

Los Angeles Superior Court Judge J. Stephen Czuleger said in issuing the judgment March 22 that the parties agreed that the $338,136.12 awarded for medical expenses should be reduced under Montana law to account for amounts payable by a collateral source.

The judgment left intact the jury’s award of $8 million in non-economic damages to plaintiff Loren Kransky.

 

Stryker's Rejuvenate and ABG II May Be Worse Disaster Than DePuy's ASR

Stryker recalled its Rejuvenate and ABG II modular hip implant systems on July 6, 2012, after the implants showed signs of corroding and fretting – wear that occurs from the constant rubbing together of two pieces, causing bits of metal to crack or flake. Stryker aggressively marketed these products as safe and effective and claimed its patented metal mixture of titanium and cobalt chrome resisted corroding and fretting. Instead, after the devices were already implanted, the implant released bits of metal debris causing premature failure, pain, and tissue and bone death.

Metallosis, an injury attributed to metal-on-metal hips, is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations. Typically, hip implants are expected to last 15 to 20 years. In some cases, the Stryker Rejuvenate hips are failing in less than five years.

Approximately 20,000 Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012. Before the recall, Stryker acknowledged that it was aware of the problems by sending an Urgent Field Safety notice to doctors in April 2012. Stryker, based in Kalamazoo, Michigan, is a subsidiary of Howmedica Osteonics Corporation of Mahwah, New Jersey.

The Stryker Rejuvenate hip implant is functionally different from other hip replacement devices that are being litigated because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices. Like the DePuy ASR, it was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better. This was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.

Some patients reportedly developed metallosis from the Stryker Rejuvenate hip. It was initially believed that such a condition was not possible because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design, which is basically what the DePuy ASR and Pinnacle models are.  However, it does have a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.

Stryker has responded to concerns about the Rejuvenate failure rate by alleging patients did not properly undergo rehabilitation following surgery, or by blaming doctors' implantation techniques. In a Product Correction Bulletin posted on April 4, 2012, Stryker representatives noted, "Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant." To this writer, this claim is preposterous. How could elevated cobalt levels be attributed to diabetes, much less infection? I doubt this ‘blame the victim’ defense will hold up to a jury.

Lawsuits have already been filed in the United States over these devices. Many have been consolidated in the New Jersey Superior Court, Bergen County, Case 296. A case management conference has been scheduled regarding the Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem litigation on March 19, 2013. It is not certain yet if other cases filed nationwide will be consolidated by the JPML into an MDL.

The attorneys at Pittman, Dutton & Hellums, P.C., are investigating claims against Stryker for the Rejuvenate and ABG II hips. If you or a loved one have been implanted with a Stryker Rejuvenate Hip or the ABG II Modular Hip, contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.