Update: J&J Ordered to Pay $1 Billion in DePuy Hip Bellwether Trial
December 2, 2016 – A Texas jury has found Johnson & Johnson’s DePuy Orthopaedics unit liable for over $1.04 billion in a 6-plaintiff bellwether trial alleging injuries from its Pinnacle line of hip replacement devices. Following a two month trial that ended Wednesday, jurors deliberated for less than a day before finding that DePuy had negligently designed its Pinnacle hip, failed to warn surgeons about dangerous conditions associated with the implant, and concealed its risks from the public.
Metal-on-Metal Hip Implant Risks & Complications
The metal-on-metal hip replacement design has many inherent problems and higher rates of failure than plastic or ceramic hip replacements. The problem is that the metal components can grind together and release toxic nano-particles of chromium and cobalt. Chromium forms an irritating residue around the hip, which can cause painful inflammation, bone loss, soft-tissue growths, and loosening of the hip. Cobalt is water-soluble and leeches into the bloodstream, where it can cause metallosis (metal poisoning) and systemic reactions in other areas of the body.
In March 2012, the Lancet published a study linking all-metal hips to a 6.2% five-year failure rate. In comparison, just 2.3% of ceramic-on-ceramic implants failed within five years, and only 1.7% of metal-on-plastic implants failed. This study led researchers to recommend banning metal-on-metal hip replacements.
What is the DePuy Hip ASR Replacement?
DePuy Orthopedics manufactures the ASR XL Acetabular System and ASR Hip Resurfacing System, which were launched in 2005 and used in more than 93,000 hip replacement surgeries worldwide. Both systems are large-diameter hip replacements made from chromium-cobalt metal alloy. They were marketed to be implanted in younger, more active patients because DePuy believed the metal-on-metal design would last longer.
DePuy ASR Recalled, Linked to 40% Failure Rate
In August 2010, DePuy issued a recall for both ASR hip replacement systems after data from the UK joint registry system indicated a 13% five-year failure rate, which is nearly triple the “acceptable” rate for hip replacements. However, during a trial in January 2013, internal documents proved that DePuy knew in 2011 that the ASR had a 40% five-year failure rate. Hip implants are supposed to last 15 years or more.
DePuy ASR Lawsuits Settle for $2.5 Billion
More than 8,300 DePuy ASR lawsuits have been filed in a federal litigation in the U.S. District Court for the Northern District of Ohio, overseen by Judge David A. Katz. In November 2013, DePuy’s parent company Johnson & Johnson offered to pay $2.5 billion to settle 8,000 lawsuits, with a base payment of $250,000 to plaintiffs who had revision surgery less than five years after implantation, and additional payments for future medical expenses.
Another 2,000 DePuy ASR lawsuits are pending in a California state court. In March 2013, a jury in California awarded $8.3 million to plaintiff Loren Kransky in the first ASR lawsuit to go to trial, including $338,000 in compensatory damages and $8 million in punitive damages. Kransky, a 65 year-old retired prison guard from Montana, had the ASR implanted in December 2007 and removed in February 2012.
What is the DePuy Pinnacle Hip?
The Pinnacle Hip Replacement System was created by DePuy Orthopedics and approved by the FDA in 2000. It is a metal-on-metal hip implant that is designed with a chromium-cobalt alloy. When the FDA approved the Pinnacle, DePuy was not required to conduct new safety studies because they claimed it was “substantially equivalent” to the ASR. However, unlike the ASR, the Pinnacle was not recalled after thousands of people were severely injured.
DePuy Withdraws Pinnacle Hip Implant Liners
In May 2013, DePuy announced that they would stop selling the Ultamet and Complete metal liners, used exclusively with the Pinnacle hip implant. Although DePuy claimed the withdrawal “is not related to safety or efficacy, and is not a recall,” there is evidence of serious safety problems with the Ultamet and Pinnacle hip replacements.
In December 2012, the journal Orthopedics published a case report of a 54 year-old woman who developed extreme leg swelling caused by the Pinnacle hip implant and Ultamet liner. Examination revealed high levels of metal debris in the tissue surrounding her hip.
They also found a bursal cyst, which is a non-cancerous soft-tissue growth (sometimes called a “pseudo-tumor”), which was cutting off circulation to her leg and causing severe swelling. When drained, the cyst oozed greenish-black fluid stained with metal debris. After the woman underwent revision surgery with a ceramic hip implant, the cyst was drained again and produced “copious amounts of milky, gray fluid.” The doctors hypothesized that the cyst was caused by an inflammatory reaction to metal debris from the Pinnacle hip and Ultamet liner.
DePuy Pinnacle Lawsuits
More than 4,000 DePuy Pinnacle lawsuits are pending in a centralized federal litigation in the U.S. District Court for the Northern District of Texas, overseen by Judge James K. Kinkeade:
- Multi-District Litigation (MDL No. 2244) — In Re: DePuy Orthopedics, Inc., Pinnacle Hip Implant Products Liability Litigation
Risks & Complications of DePuy Hip Implants
- Hip pain
- Swelling, inflammation
- Dislocation, looseness, or instability
- Bone loss (osteolysis)
- Tissue necrosis
- Bone fracture
- Bursal cyst
- Pseudo-tumors (soft-tissue growths)
- Metallosis (metal poisoning)
- Corrosion of hip implant
- Failure in less than five years
- Revision surgery
- Permanent disability
Systemic Reactions from Metal-on-Metal Hip Implants
The FDA has issued a Safety Warning about the risk of systemic reactions (side effects or illnesses in other areas of the body) from defective hip replacements .
Systemic side effects of metal hip implants:
- General hypersensitivity reactions (skin rash)
- Neurological changes
- Hearing or vision loss
- Psychological changes
- Cognitive impairment
- Kidney function impairment
- Thyroid dysfunction (neck discomfort, fatigue, weight gain, feeling cold)
Do I have a DePuy Hip Implant Class Action Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DePuy hip lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free DePuy Hip Lawsuit Evaluation: Again, if you or a loved one was injured by a DePuy hip replacement, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and we can help.