Johnson & Johnson Hit Third Time Over Pinnacle Metal-on-Metal Hips

A Dallas federal jury on Thursday found in favor of six plaintiffs and against Johnson & Johnson and its DePuy Orthopaedics unit. The $247 million verdict is the third loss J&J has had in four civil jury trials. The verdict includes $78 million in compensation for the plaintiffs’ injuries and more than $168 million in punitive damages.

J&J won the first Pinnacle test trial in 2014, but subsequent juries determined the companies to be liable. A jury in March 2016 awarded five Texas plaintiffs $500 million in damages. That award was later cut to $150 million. 

J&J and DePuy were also found liable at a trial in March, during which a jury awarded six California patients $1 billion - a verdict that was later reduced to $543 million. 

Six New York residents implanted with the devices said they experienced tissue death, bone erosion and other injuries they blamed on design flaws. The jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks. 

J&J faces more than 9,700 Pinnacle lawsuits in state and federal courts across the United States. It is more likely than not that J&J will appeal the verdict, as they have the other three. Three more bellwether trials have been scheduled. These gigantic losses could weaken the company’s position in any settlement talks with plaintiffs in the MDL. A previous DePuy hip-implant settlement cost the company billions. Johnson & Johnson agreed to resolve more than 9,800 lawsuits over DePuy’s ASR hip implants for $4.4 billion in 2013 and through a settlement extension in 2015.

The ASR model was recalled. The Pinnace model was never recalled, however DePuy ceased selling the metal-on-metal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations.

Pittman, Dutton & Hellums is actively filing cases on behalf of individuals allegedly injured by both types of artificial metal-on-metal hip implants- ASR and Pinnacle models. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

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.

Jury Finds For Victims of DePuy Pinnacle Hips

Today, a jury found Johnson & Johnson liable with a $497.6 million verdict in the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit. The case involved five separate plaintiffs. The first bellwhether case tried last fall was a defense verdict.

The trial took place in Texas after hearing 37 days of testimony. The jury received the case late in the afternoon on March 10th and deliberated for four more days before reaching the verdict.

This is the second major defeat for Johnson & Johnson in a little over a month. The first defeat resulted a St. Louis jury awarded an injured plaintiff $72 million against Johnson & Johnson for their talc-based powders. That theory involved the powder creating an increased risk of ovarian cancer.  

Our firm has been handling Pinnacle and ASR hip cases for nearly six years. If you or a loved one were implanted with a DePuy Pinnacle or ASR metal-on-metal hip and suffered injuries, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Jury Finds For J&J DePuy In First Pinnacle Bellwether Case

Yesterday, a nine member panel found for the defendant Johnson & Johnson and their subsidiary DePuy Orthopaedics in the first MDL bellwether case to go to trial over the Pinnacle Metal-On-Metal hip replacement device. The jury deliberated for a little more than two days. The trial lasted eight weeks.

In what is a huge blow to the nearly 6,000 other claimants in the MDL, the jury found that the devices were safe when used and implanted properly. Lawyers for the defendants basically blamed the surgeons who implanted the plaintiff’s devices for not properly positioning them when implanted.

The plaintiff in the trial claimed that the metal-on-metal wear from the device resulted in exposure to extremely high levels of cobalt and chromium which affected poisoned her blood and caused soft tissue damage. She ultimately had to have bi-lateral hip surgeries to remove to the devices.

The Pinnacle device is different than DePuy’s ASR Metal-On-Metal hips in several facets, although they appear to be extremely similar. The ASR was recalled by J&J, whereas J&J just stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the FDA said it would require device makers to submit new versions of the artificial hips for pre-market approval. J&J settled the ASR MDL last year for an estimated $4 Billion.

Of course, this is just the first chapter in what will most likely be a long and drawn out fight. J&J and DePuy face several other Pinnacle trials in different jurisdictions that are set soon, and there were will most likely be several other bellwether trials coming out of the MDL. 

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.

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.

DePuy Files Summary Judgment in California ASR Case

Johnson & Johnson, DePuy Orthopaedics Inc. and their affiliated companies have moved for summary adjudication in an ASR hip implant case scheduled to be California’s first bellwether trial on October 1, 2013.

The Defendants filed their summary judgment motion in San Francisco Superior Court July 26. This was the deadline given by Judge Richard A. Kramer, who presides over the coordinated DePuy ASR hip cases in California.

 

The Plaintiff in the case is Robert Eugene Ottman. His opposition motion is due August 30. The judge has already scheduled a hearing on dispositive motions for September 13.

 

In related news, Judge Kramer has ruled that some plaintiffs who are in the consolidated action in California can add DePuy Pinnacle hip implant claims to their lawsuits. The ruling came as a result of a motion filed jointly by seven plaintiffs. DePuy recalled the metal-on-metal ASR in 2010, but has not yet recalled the metal-on-metal Pinnacle hip replacement system. All signs from the Defendants point to no recall in sight.

The two DePuy products have been under U.S. Food and Drug Administration scrutiny, primarily because of one dangerous alleged side effect called “metal poisoning,” or “metallosis.” According to the FDA, metal ions could peel off into the patient’s bloodstream when the device’s metal parts rub together. This could lead to potentially severe health problems such as tissue damage, necrosis and pseudo-tumors.

Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, ASR, Pinnacle, and all other metal-on-metal hips. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

 

 

 

 

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.

California Jury Hits J&J with $8.3M Verdict

In the first case to try in the United States, a California jury found Johnson & Johnson liable for $8.3 Million in damages over the DePuy ASR prosthetic hip. DePuy is a subsidiary of Johnson & Johnson. Loren Kransky, the plaintiff in the California case of Kransky v. DePuy Orthopedics, filed suit over injuries from his implantation and revision of the recalled DePuy ASR XL hip implant.

Even though Dr. Trotsky, Mr. Kransky’s surgeon, felt that Mr. Kransky might not live through the revision surgery, Dr. Trotsky felt that removal and replacement of the DePuy ASR XL implant was absolutely necessary due to Mr. Kransky’s highly elevated levels of cobalt and chromium ions in his bloodstream, which were being shed from his recalled hip implant.

Johnson & Johnson and DePuy aggressively marketed and sold over 33,000 of these recalled hip implants to be distributed and implanted in patients across the United States, despite their knowledge that high levels of cobalt and chromium ions posed a serious threat for unaware patients.

In addition to the $ 8.3 million award for for Mr. Kransky’s damages, over 10,000 other lawsuits filed on behalf of patients that have been injured by the DePuy ASR XL are still pending.

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.