Defective product attorneys at Pintas & Mullins report on a recent FDA proposal that will prohibit manufacturers from selling all-metal artificial hip implants. If approved, manufacturers will have to submit pre-market approval applications before implants can be placed back on market.
About 500,000 artificial hip recipients in the United States have suffered from early device failure, which requires painful corrective surgery and can result in catastrophic internal injuries. Because of these complications, thousands of lawsuits have been filed on behalf of the injured victims. Most cases are filed against DePuy, which is a faction of Johnson & Johnson, and Biomet, among others.
Metal-on-metal hip implants were initially approved by the FDA in a special process that did not require the devices to undergo clinical trials in humans. This was made possible by the Medical Device Amendments, which was enacted in 1976. The law set different standards of regulation for different types of medical devices, depending on the perceived risks and benefits. For example, high-risk devices, such as heart defibrillators, were required to conduct clinical trials before FDA approval. Other devices perceived to be less harmful, such as hospital pumps, were only required to demonstrate that they were similar to hip implants already on the market.
Lawmakers temporarily classified hip implant devices as a moderate risk, and never officially determined how they should be regulated. As a result, hip implants have remained in a sort of authoritarian limbo since the 70s, as manufacturers lobbied for the device to be classified as a lesser risk. There are currently about 20 devices still awaiting official classification.
Unfortunately, these implants generate high levels of metal ions that can release into the body, often causing severe metallosis and premature failure. Symptoms of metallosis include swelling, pain, loosening of the implant, change in walking ability, and sounds coming from the implant. Metallosis causes severe bone and tissue damage, and can render patients permanently disabled. Cobalt poisoning is the result of long-term metal ion release, and leads to severe cognitive and cardiac damage.
Traditionally, hip implants were made from plastic and lasted for about 15 years before wearing out. The costs of a replacement surgery are extensive and take a large toll on the body. In 2011, the FDA required the implant manufacturers to conduct post-market studies in order to determine whether, and how much, the implants were releasing metallic debris. The deputy director of science at the FDA stated that he believes many manufacturers will use the results of these studies to satisfy the required approval applications.
If a manufacturer does not submit a pre-market approval application, or if the clinical results submitted does not meet FDA standards, it will be forced to stop selling the device completely. The FDA will also require doctors to monitor patients implanted with the device, and recommends that patients experiencing any pain or other symptoms should undergo testing to determine metallic ion blood levels.
Lawsuits against DePuy just recently began going to trial. In August 2012, the company agreed to pay about $600,000 to settle the first three cases over the ASR implants. More than 6,000 other ASR cases are consolidated into a multi-district court in Ohio. Johnson & Johnson has reportedly put aside more than $2 billion to cover the implant litigation.
With the help of a skilled defective implant attorney, compensation may be available for those who received a metal-on-metal hip implant and suffered injuries. Victims may be entitled to receive compensation for lost wages, medical bills, and pain and suffering. Hip implant lawyers at Pintas & Mullins will continue to report on FDA updates and defective implant litigation.