Plaintiff Trial Lawyers Group Weighs in on FDA Process for Metal Hips
The American Association for Justice (AAJ), a leading plaintiff trial lawyers association, has asked the U.S. Food and Drug Administration (FDA) to prevent the manufacturers of metal-on-metal hip implants from using a proposed change in the approval process to protect themselves from liability.
metal hip implants were originally developed to be more long-lasting compared to plastic or ceramic devices. However, various studies worldwide have shown that the all-metal implants not only deteriorate sooner but also shed debris, damaging bone and tissue and causing metal toxicity in the patient’s blood, which could potentially lead to organ damage.According to a Reuters news report, the defective
A Flawed System
Several brands of metal implants have been recalled after manufacturers have been barraged with product liability and defect lawsuits. In January, the FDA issued a proposed rule that would require the manufacturers to go through a more extensive safety review process in order to market and sell these products or to introduce new devices.
This differs from the current process where manufacturers can get FDA approval by showing that there are other similar products in the market. This was essentially a loophole in the law through which manufacturers were able to sneak in medical devices into the market without having to do human testing or clinical studies.
Protecting Consumers’ Rights
AAJ submitted letter to the FDA in support of the more stringent approval process. The organization emphasized that when a medical device is approved through the older process, consumers lose the ability to sue the manufacturer in court because the corporations almost always argue that their product has FDA’s stamp of approval. The plaintiff lawyers’ group also warned the FDA in the letter that a manufacturer could obtain premarket approval for an existing all-metal hip implant, and then use that to shield themselves from liability even for alleged injuries that occurred before the product met the heightened safety test.
As a product liability attorney who represents victims of defective medical devices, I absolutely support AAJ’s position that the FDA should not relax its proposed rule despite pressure or lobbying from medical device manufacturers. Companies that make inferior products and fail to properly test them before they are implanted into unsuspecting consumers’ bodies, must be held accountable. The civil justice system is the last resort for victims who have suffered debilitating injuries and lifelong health effects as a result of receiving these defective metal hip implants.