DePuy Hip
Replacement Devices
DePuy hip replacement devices, specifically, the ASR and Pinnacle hip components, have been the subject of tumultuous litigation since 2010. These two hip devices are considered metal-on-metal component products which means that the device design places at least two metal hip parts next to each other in the body.
This metal-on-metal placement has the capacity to result in metal-on-metal wear from the two device parts rubbing together in the body. The metal-on-metal wear releases metal ions into the body causing metallosis and triggering pseudotumor (abnormal fluid and tissue formation) buildup around the hip. The impact of metallosis on the body can be monumental. Not only does metallosis have the capacity to cause adverse local tissue reaction and pain, but it also can severely damage the tissue and muscle around the hip area, making it difficult to ever have a functioning hip again.
Case Quick Facts
DePuy Pinnacle Hip Systems
DePuy Pinnacle hip devices were released onto the U.S. market in 2002. The Pinnacle hip device is made up of the acetabular components of an artificial hip piece; a cup, liner, and ball. These parts were designed to comprise of either metal-on-metal components or metal-on-polyethylene components. If metal-on-metal components were implanted, that is a metal head, liner, and cup, these pieces had the potential for metal-on-metal wear in the body, causing dangerous metal ion release, metallosis, pseudotumor formation, and need to revision surgery.
DePuy ASR Hip Replacements
The DePuy ASR hip system, like the Pinnacle hip system, is made of the acetabular components of an artificial hip joint. The ASR devices were released onto the U.S. market in 2003, but in 2010, were recalled by the company due to higher than anticipated failure rates. The device was designed with a shallow cup and a metal-on-metal articulation surface at the ball and cup juncture. Many other systems have a liner inside of the cup that can be switched out. The ASR was a monoblock system, which meant the cup stood by itself and did not hold a liner. Due to the metal-on-metal structure and the way the cup was designed, the metal wore at an even faster rate than other metal-on-metal hips.
The DePuy ASR and Pinnacle devices cause metal-on-metal ion release, metallosis, pseudotmumor formation, and need for revision. The metallosis incurred from a metal-on-metal hip failure can be severe, causing damage to the tissue and muscle around the hip, resulting in permanent issues:
- Serious pain
- Necrosis (death) of surrounding tissue
- Adverse Local Tissue Reaction
- Elevated metallic ion levels (chromium and/or cobalt) in bloodstream (metallosis)
- Inflammation
- Loosening of the implant, with possible detachment
- Dislocation of the hip implant
- Fracture of the bone around the hip implant
- Difficulty walking
- Need for a second hip implant surgery (revision surgery)
Both the ASR and Pinnacle hip devices were manufactured by Johnson and Johnson and DePuy, Inc.
DePuy Pinnacle Hip Systems
In 2010, after several incidences of failures of the Pinnacle metal-on-metal hip components, a multidistrict litigation against the manufacturers of the Pinnacle hip device was generated in the Northern District of Texas. While the manufacturers of the DePuy Pinnacle hip device, DePuy and Johnson and Johnson, never recalled the Pinnacle metal-on-metal hip from the U.S. market, they stopped selling it around 2013.
There have been several trials within the multidistrict litigation against the manufacturers of the Pinnacle hip. All, but one of those trials resulted in massive monetary verdicts against the companies, where juries held the manufacturers responsible for the injuries sustained to the plaintiffs.
While a global settlement has not been achieved to compensate victims of this hip device, more trials are scheduled to occur within the multidistrict litigation. GoldenbergLaw is currently accepting Pinnacle metal-on-metal hip failure cases. If you have been implanted with a metal-on-metal Pinnacle hip that had to be removed for metal-on-metal wear, please contact our office to learn more about your potential claim.
DePuy ASR Hip Replacements
In 2010, a multidistrict litigation was generated to hold the manufacturers of the DePuy ASR implants responsible for the injuries caused. This multidistrict litigation is ongoing in the Northern District of Ohio. Since 2010, there have been several trials and, ultimately, a global settlement was reached to compensate thousands of victims of this product failure. GoldenbergLaw is currently accepting ASR hip failure cases. If you have been implanted with a metal-on-metal ASR hip that had to be removed for metal-on-metal wear, please contact our DePuy hip replacement lawsuit lawyers in Minneapolis for a free consultation.
Do I QualifyAdditional Defective Hip Resources
GoldenbergLaw is well-versed in hip replacement litigation. With over 30 years of experience in medical device lawsuits, we have the knowledge to help you explore your legal options during this trying time. You shouldn’t be staying up all night worrying about these issues. Leave the sleepless nights to us.
Here are some other defective hip replacement cases we are pursuing.
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Contact Us Call 800-903-1643DePuy ASR Timeline Leading to Trials
In August of 2010 DePuy Orthopedics – a subsidiary corporation of Johnson & Johnson – recalled approximately 93,000 hip implants, admitting to a failure rate of 13% within the first five years after initial hip replacement surgery.
A multidistrict litigation (MDL) was centralized in the Northern District of Ohio for the DePuy ASR litigation. The MDL is still ongoing.
In March of 2011, the British Orthopaedic Association published a study show that the rate of second hip replacement surgeries (revision surgeries) ranges from 21% after four years to 49% after six years. At higher risk for failure were hip implants with smaller sized parts.
David Floyd, the President of DePuy Orthopedics since 2007, announced his resignation in March of 2011 following an announcement made by J&J stating that the company had set aside approximately $1 billion to deal with potential settlements and litigation involving the ASR.
Following DePuy’s attempts to compensate doctors for obtaining extracted ASR hips and sending in X-Rays and medical records of revision patients, Judge David Katz, who is presiding over DePuy ASR lawsuits, issued a preservation order that banned destruction of DePuy ASR components after they are explanted from patients. A preservation order is a judicial mandate rendering all parties responsible for the preservation of certain “documents, data, and tangible things” related to the litigation. The extensive 40-page order explained the procedures that both parties must follow in preserving the device after it is taken out in revision surgery.
The retrieved components are the centerpiece of product liability litigation against DePuy. They often show signs of degradation that expose their deficiency as well as their responsibility for the victims’ injuries. Should the unit be destroyed, the plaintiff has a much harder time meeting his or her burden of proof.
The DePuy ASR Trials
Two cases were tried – one in California and one in Chicago. The jury awarded $8.3 million to the Plaintiff in California. The jury did not find liability on the part of Defendants in the Chicago case.
DePuy Questioned for Cover-Ups in California ASR Trial Resulting in Verdict of $8.3 Million in Favor of Plaintiff
In the first ASR trial beginning in January 2013, plaintiff attorneys introduced evidence that proved DePuy was aware of design flaws in their ASR hip devices for years before they initiated a recall. Internal documents disclosed at the ASR trial revealed that the company had received complaints even as they started to market the U.S. version of the device in 2005.
Another document used in the DePuy ASR trial, an internal research and development report from June 2007, stated that the ASR did not meet acceptance criteria when compared to a similar metal-on-metal (MoM) device. The report showed that metal-on-metal wear with the ASR was above the already concerning level of wear found in the Ultamet, made by Biomet. They discussed redesigning the device later that year, but nothing was done.
Further, an email from May 2008 proves that the following was known about the devices:
- In “certain conditions,” the ASR is susceptible to extreme metal ion levels, whereas in the hands of the same surgeon, another MoM device does not have the same problems. (This was based on clinical data comparing ion levels of the ASR and yet another MoM device).
- Females are more susceptible [to higher metallic ion levels] because the difference seemed to be related to the use of small cups.
- Data expected to appear in medical journals would “seriously affect” their business.
In September 2009, still almost a year before a recall was announced, another email discussed the amount of business they could expect to lose by phasing the device out. It pointed out that more customers would be retained if they did so within 6 months than if they did so immediately.
In late 2009, the company announced plans to phase out the model but cited tapering sales, not safety concerns. Before the recall, executives insisted that the device was performing up to standard.
According to The New York Times, DePuy attorney Alexander G. Calfo reiterated this to jurors, maintaining that DePuy had behaved ethically leading up to and after the recall.
In March 2013, the Los Angeles jury awarded DePuy ASR hip recipient, Loren “Bill” Kransky, $8.3 million for his injuries involving his hip replacement. This was the first DePuy ASR hip lawsuit to go to trial. The jury’s verdict, which came after 6 days of deliberation, included $338,136 in damages for medical expenses and $8 million for physical pain and emotional suffering.
Pinnacle Hip Systems: A Timeline
A multidistrict litigation was consolidated in the Northern District of Texas for the Pinnacle hip litigation.
DePuy pulled the Pinnacle System’s Ultamet metal liner component from the market, but refused to issue a recall.
The first Pinnacle bellwether case was tried with a defense verdict due to very specific details of that Plaintiff’s case.
In December 2015, the second Pinnacle trial began. It involved five Texas plaintiffs. The jury awarded $500 million in total to the five plaintiffs – including $360 million in punitive damages. The judge overseeing the trial later reduced the verdict to $151 million in compliance with Texas state law. DePuy and Johnson and Johnson have appealed the verdict. Appeal is currently pending decision.
The third Pinnacle bellwether trial began in early October of 2016. The jury returned a $1.04 billion verdict in favor of the plaintiffs sending a clear message of disapproval to J&J for their actions
Pinnacle Trial Update: Combined Verdict of $247 Million
A federal jury in Texas awarded six individual plaintiffs a total of $247 million in a bellwether trial involving the Pinnacle metal-on-metal hip. This represents the third win in a row for plaintiffs against DePuy and Johnson & Johnson. However, all verdicts are under appeal.
The verdict was unanimous that Johnson & Johnson and DePuy were liable for design defects and fraud. The verdict included $168 million in punitive damages and found the companies had acted with wanton, reckless or malicious conduct.
There are currently more than 9,000 Pinnacle hip cases filed against these defendants. Johnson & Johnson continues to say they will fight these cases and refuses to accept responsibility. Only time will tell if this will bring them to the negotiating table. We may see all these cases remanded to Federal Courts around the country if a settlement isn’t reached shortly.
GoldenbergLaw has been very active in this litigation and is continuing to accept Pinnacle and other hip failure cases.