A Texas jury ruled unanimously against the plaintiff Kathleen Herlihy-Paoli, who accused DePuy of negligence, after receiving two Pinnacle hips in 2009, which were used with the Ultamet metal liner. This created a metal-on-metal hip, which was allegedly defective.
The problem stems from metal parts rubbing together and shedding toxic debris around her artificial hip. The level of cobalt in her bloodstream elevated to 85-times normal levels, she developed an infection, and incurred a series of revision surgeries.
DePuy had said the implants were improperly positioned, and not to blame for her injuries. Jurors deliberated for two days, after a seven-week trial. The jury found that the Ultamet artificial hips sold by Johnson & Johnson’s DePuy Orthopaedics unit as part of its Pinnacle line of implants had no design defects and the company adequately warned patients and doctor’s about the devices’ risks.
In August 2013, the Ultamet was withdrawn from the market reportedly for marketing reasons and not safety concerns.
More than 6,400 lawsuit cases over the allegedly defective Pinnacle hip implants have been consolidated in the Dallas, Northern District of Texas federal court.
Jurors are hearing the first Pinnacle hip replacement lawsuit of a 58-year old Montana woman. In September 2006, she received a Pinnacle hip system on her right side, and left side in April 2007, respectively.
After suffering from complications, she underwent revision surgery in 2010, and subsequently has undergone additional procedures since, according to court documents. In January 2013, the U.S. Food and Drug Administration (FDA) issued a warning that metal-on-metal hips were more likely to fail compared to other options.
J & J and its subsidiary, DePuy Orthopaedics, announced that the company would discontinue sales of its all-metal hip implants in May 2013, including those related to the Pinnacle Hip System.
The lawsuit alleges surgeons discovered that the hip turned black due to metallosis upon removal. Additionally, the device allegedly caused her to suffer elevated levels of cobalt in the blood, allegedly as a result of the Pinnacle’s defective design.
Metal-on-metal hip systems are regulated under the Food and Drug Administration (FDA) 510(k) premarket notification program and classified as Class III (higher risk) devices. In addition, the medical devices are not required to undergo premarket testing or clinical trials before they are used in patients. Under the 510(k) program, manufacturers simply have to state that their medical devices are similar to medical devices already on the market.
In May 2011, the FDA ordered 21 prosthesis manufacturers to conduct post-market studies on their metal-on-metal hip systems. A year later, an FDA panel concluded that there is little benefit for surgeons to continue using metal-on-metal hip implant systems. The FDA said “a decision on the proper classification of metal-on-metal hip systems is forthcoming.”
This fails to bring comfort to those seriously injured by these all-metal implant systems. People are stunned to learn Congress entrusted the FDA with protecting the general public. However, the FDA’s actions appear to be favorable to business, but offers little protection for those injured by metal-on-metal hip implants with the 510 (k) premarket approval.
Most manufacturers have already pulled their metal-on-metal hip implants from the market due to the growing number of patient injuries. These widespread patient injuries prompted an increased regulatory focus, numerous medical studies, and negative publicity. In addition, manufacturers are also faced with thousands of product liability lawsuits from patients seeking compensation for their injuries. Some manufactures have agreed to settle these hip replacement lawsuits. For instance, DePuy Orthopedics, a subsidiary of Johnson & Johnson, reportedly agreed to settle some 8,000 lawsuits for an estimated $2.5 billion.
Nearly one-third of surgeries performed in the U. S. have been with metal-on-metal hip implants over the past several years. This is a vital concern because hundreds of thousands of hip recipient’s undergo hip replacement surgery in the U.S. each year. The manufacturers of these devices taunted in the past that the chromium and cobalt pieces that make up the ball and socket joints are more durable than other similar implants.
This option became quite attractive for many younger patients with the desire to have an active lifestyle and improved quality of life. However, the metal-on-metal hip implants have recently come under fire by many critics with voiced concerns that all-metal hip implants may be responsible for tissue and bone damage. The tissue and bone damage has led to the need for revision procedures for hip recipients much sooner than surgeons originally projected. Revision procedures are not only risky for patients but costly as well.
Metal-on-metal (MoM) hips were originally marketed as an alternative to the traditional ceramic or plastic hips and were targeted for the younger, more active patients. Many of these younger patients are in their 40s and 50s, faced with a lifetime of injury and complications ahead. Patients with a lifetime injury and complications allegedly caused by the metal-on-metal hips are likely to endure a longer recovery process after revision surgery.
Many hip recipients with hip replacement failure have reported numerous problems. These problems include: breakage (primarily caused by constant weight-bearing stress), fractures (typically near the artificial joint), loosening of the attachment between the bone and the artificial device (both in cemented and un-cemented artificial joints), wear and tear on the parts, pain and stiffness caused by the loosening of the attachment between the implant and bone, instability (typically occurs when the artificial joint dislocates), and infection.
These problems can lead to the need for revision surgery, and may require a lengthy recovery process. There are no guarantees revision surgery will ever fix the problem (s). Your surgeon will explain this to you during your surgical consultation.
According to British Medical Journal (2012), hundreds of thousands of patients around the world are suffering the consequences of failing metal hip implants. These people may have been exposed to dangerous levels of toxic metals. Patients who receive metal-on-metal implants risk cobalt and chromium ions leaking into the tissue, which can result in local reactions that damage bone and muscle, causing long-term disability in some cases.
Studies have shown if metal ions seep into the bloodstream that they can spread into the kidneys, lymph nodes, spleen and liver, before exiting the body in urine. Some experts have concerns whether there might be chromosome destruction, leading to genetic alterations. Scientist first described in detail a link between local tissue reaction and metal ions in 1975. Regardless of the harmful risk, makers continue to produce metal-on-metal implants despite increasing evidence of risk.
As recently as 2010, it was estimated that as many as one-third of the 250,000 hip replacement surgeries performed each year in the U.S. involved the use of metal-on-metal hip replacements. Such devices were marketed to younger, more active patients, and it was believed that they would prove to be more durable than hip implants constructed of other materials.
However, the U.S. Food & Drug Administration (FDA) allowed metal-on-metal hip replacements to come to market under its 510(k) approval process, which doesn’t require any human testing for medical devices that are shown to be “substantially equivalent” in design to a product already approved by the agency. Unfortunately, this type of FDA clearance means that any problems with a medical device are not usually detected until it has been used in hundreds, if not thousands, of patients.