DePuy Orthopaedics and Johnson & Johnson are facing a lawsuit brought by a woman over a defective Pinnacle Acetabular Cup System. The plaintiff had her hip replacement procedure in mid-January 2007. A Pinnacle metal-on-metal device including a metal liner was implanted in place of her left hip.
According to her lawsuit, “after the replacement surgery, friction and wear between the metal-on-metal parts caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the plaintiff’s blood and tissue and bone surrounding the implant.”
The Arizona woman’s physician believed the implant to be the cause of her “hip pain, disability, elevated metal levels,” and other symptoms, and recommended removal of the Pinnacle Acetabular Cup System. The plaintiff has experienced severe pain in her groin and left thigh, in addition to functional difficulties after the implantation of the Pinnacle device. The plaintiff is scheduled for hip revision surgery at the end of January 2017.
Parker Waichman LLP has long and successfully represented individuals who have suffered from serious life-changing injuries allegedly associated with metal-on-metal hip implant devices, including Pinnacle hip implants.
Pinnacle Acetabular Cup System Not Tested Pre-Market
Because of a loophole in U.S. Food and Drug Administration (FDA) regulations, DePuy was “able to market the Pinnacle Device with virtually no clinical or non-clinical trials or FDA review of the implant for safety and effectiveness.”
The lawsuit against the Pinnacle Acetabular Cup System maintains that if clinical trials had been performed, the manufacturer would have been aware of the “high percentage of patients developing metallosis, biologic toxicity and an early and high failure rate due to the release of metal particles… implantation of the Pinnacle Device results in nearly immediate systemic release of high levels of toxic metal cobalt-chromium ions into every hip implant patient’s tissue and blood stream.”
This reaction happens because the metal femoral head rotates inside the metal liner. This rubbing or friction, causes cobalt-chromium particles to be released into the surrounding tissue where metallosis and pseudotumors (an enlargement resembling a tumor) can develop.
Metal poisoning occurs when toxic levels of metal build up in the body. This can cause damage to tissue, bone, and the nervous system. Symptoms of metallosis may vary, but one of the most common symptoms is tissue or bone death, called necrosis.
With tissue or bone necrosis, the tissue around the implant becomes gray or black from being exposed to the metal debris flaking off the implant. This creates pain and instability, which may lead to spontaneous dislocation, bone loss and fracture, according to drugwatch.com.
Lawsuits such as the Arizona plaintiff’s, allege that if clinical trials had been performed before the market release of the Pinnacle System, DePuy and Johnson & Johnson would have known of the problems before patients had the devices implanted.
The all-metal hip devices came under increased scrutiny in 2010 when Johnson & Johnson’s DePuy Orthopaedics unit issued a worldwide recall due to high failure rates associated with its ASR metal-on-metal device. Since then, other manufacturers have also issued recalls.
In another case, a plaintiff had undergone a total hip replacement surgery in February 2005 due to osteoarthritis. She is currently in litigation in the U.S. District Court for the Northern District of Texas.
In July 2014, the plaintiff returned to her doctor and reported “feeling terrible, hurting all over, and felt a ringing in her ear,” according to her DePuy Pinnacle hip implant lawsuit. Her doctor ordered a hip MRI (magnetic resonance imaging) which revealed fluid collection.
A few months later, she returned to her physician with complaints of left hip pain, tinnitus, hoarseness, and anxiety, which the woman believed came from metallosis. Her doctor recommended hip revision surgery.
The plaintiff brought forth numerous counts against DePuy including strict liability for defective design, manufacturing defect and failure to warn, negligence, negligent misrepresentation, fraudulent misrepresentation, and loss of consortium (spousal companionship).
Pinnacle System Marketed as Safe and Effective
DePuy and Johnson & Johnson are accused of promoting the Pinnacle System as a superior hip replacement device “featuring TrueGlide technology, allowing the body to create a thin film of lubrication between surfaces, which enables ‘a more fluid range of natural motion.’”
In materials promoting the Pinnacle device, there was a young lady featured trying on tennis shoes at an athletic shoe store. The words used were that the Pinnacle System was “uniquely designed to meet the demands of active patients like you – and reduce pain.”
The Pinnacle Acetabular Cup System lawsuit claims of the manufacturers “negligently advertising and recommending the use of the Pinnacle Device despite the fact that defendants knew or should have known of its dangerous propensities.”
Have You Been Injured by a Metal-on-Metal Hip Implant?
If you or someone you know has sustained injury associated with a Pinnacle metal-on-metal hip implant, you may be eligible for valuable compensation. Parker Waichman personal injury law firm has handled many cases involving a broad spectrum of device makers, including Pinnacle Orthopaedics. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).