Johnson & Johnson ordered to pay $1 billion settlement
Three DePuy hip replacements have been subject to recalls, or have exhibited dangerous side effects for their recipients:
- The Pinnacle Acetabular Cup (metal-on-metal version), 48-66 mm
- The ASR XL Acetabular Total Hip Replacement System
- The ASR Hip Resurfacing System
These products are examples of the flawed metal-on-metal hip replacement systems or components which have resulted in serious hip complications.
Thousands of patients in the U.S. have been implanted with these DePuy products and many who have endured the associated complications have decided to take legal action against DePuy in some of the highest profile product liability litigation in recent history.
An overview of hip complications and lawsuits associated with these DePuy hip replacement systems reveals the troubling state of the clearance process for medical devices such as artificial hips.
Get a Free Hip Replacement Case Review GET HELP NOW
DePuy (pronounced DePew) Orthopaedics is proud of its 200 products, but some of those products cost the company billions of dollars in injury settlements. The Pinnacle Hip Replacement System, the ASR XL Acetabular System total hip replacement and the ASR Hip Resurfacing System all were designed to accommodate younger hip replacement patients by providing more flexibility and range of motion than existing hip replacement devices.
They were supposed to eliminate the problem of device failure because of overuse. One of the features of the systems – metal-on-metal construction – was supposed to help the failure rates. Instead, studies show the construction creates other, more serious problems.
According to lawsuits and studies, these metal-on-metal hip systems have inherent problems with their design, leading to an increased failure rate, metallosis, infection, dislocation and immobility. Some studies even mention an increased cancer risk. A study by The National Joint Registry of England and Wales revealed 13 percent of ASR XL patients required revision surgeries in five years. For people who received the ASR resurfacing system, the failure rate was 12 percent within five years. Court documents that surfaced during Loren Kransky’s DePuy Orthopedics trial showed the failure rate was closer to 40 percent.
DePuy, a division of Johnson & Johnson, has recalled some of its hip systems. Others, like the metal-on-metal version of the Pinnacle system, were discontinued but not recalled.
The reason for so many options for bearing surfaces – the surfaces in which the head replacement for the thigh bone and the cup replacement for the hip socket rub together – was to allow a surgeon to select a model according to the individual needs of the patient receiving the total hip implant.
The more durable the material that these components were made from, the more they supposedly could withstand use by increasingly younger patients without failing prematurely.
Pinnacle Metal-on-Metal Acetabular Cup Metal Liner
The Pinnacle Metal-on-Metal Acetabular Cup Liner is a metal liner that was designed for use only with Pinnacle Acetabular Shells and 28mm cobalt-chromium-molybdenum (Co-Cr-Mo) femoral heads. The Pinnacle metal liner was approved by the FDA based on a nearly identical DePuy product already approved – the Ultima Metal-On-Metal Acetabular Cup, a device with a metal liner and shell.
However, the Pinnacle metal-on-metal system generated adverse reactions in patients, and so did the Ultima. Doctors from the UK published a study on the failure rate of the Ultima metal liner in 2010 and found that out of 545 patients who used the Ultima, 90 hips (13.8 percent) in 82 patients were revised after they failed. During revision surgery, doctors found cloudy fluid in pockets in the hip, severe necrosis (tissue death) and ruptured tendons.
Doctors are also tracking groups of patients who received the DePuy Orthopedics Pinnacle and estimate that more than 10 percent of the devices will fail in the next two to three years.
The Pinnacle and Ultima metal liners cause friction between the cup and the ball-shaped replacement head of the thigh bone. This can cause the device to prematurely erode and release metal ions that have short-term side effects and possible long-term effects.
Over the short term, the cobalt and chromium particles that are released can cause inflammation in the joint. That results in pain and difficulty of movement. Long term, possible adverse side effects include cobalt poisoning, which could cause cognitive and cardiac damage. Despite these known issues with the Pinnacle system, DePuy never recalled it. Instead, the metal liner was discontinued in mid-2013.
DePuy’s ASR XL Acetabular System Recalled
The DePuy ASR XL Acetabular System total hip replacement and ASR Hip Resurfacing System were used in more than 93,000 hip replacement surgeries internationally. Both systems were members of a class of large-diameter hip resurfacing and replacement devices created from a single sheet of metal. They were designed to be more stable, making them less prone to dislocation.
Launched in the United States in 2005, the ASR XL System was developed for use in total hip replacements. The DePuy ASR Hip Resurfacing System, which was sold only internationally beginning in 2003, was intended to be used in hip resurfacing, which eliminates the need to remove a lot of the natural hip structure.
DePuy Orthopedics issued a recall in August 2010 of both ASR hip systems, citing a higher-than-normal failure rate of the devices. The British Orthopaedic Association and the British Hip Society cited the failure rate of these devices as anywhere from 21 to 49 percent after six years and evidence presented during trial puts the rate at close to 40 percent in five years. The cost of hip revision surgery can be in the tens of thousands of dollars. The pain and the loss of mobility causes distress, making the cost of a faulty hip replacement both financial and emotional.
Complications Associated with Metal-on-Metal Hip Implants
An increasing number of patients who received a DePuy hip implant have experienced serious complications after their initial hip replacement surgery.
Contact a Skilled Hip Replacement Attorney Today
The Law Office of Joel A. Nash has the skill and experience to hold the manufacturers of hip replacement systems accountable for the harm caused by these medical devices when they fail unnecessarily. Call our law firm nationwide at (855) 755-2978 to schedule an appointment to discuss your case. It is not too late to receive compensation from manufacturer settlements, but acting quickly is imperative.