An association of attorneys that represent victims of personal injuries have grouped together to ask the Food and Drug Administration to be cautious and possibly amend a proposed change regarding the safety approval process of all-metal hip replacements. The concern is that the rule as it is currently proposed could possibly shift liability from the manufacturer’s of a certain type of all-metal hip replacements that have been linked to a great deal of problems.
According to Thomson Reuters, the type of hip replacements that have recently been causing problems are all-metal artificial hips, which were created because it was believed they would be more durable than those that included plastic or ceramic parts. However, recent studies have shown that the all-metal hips may shed bits of metal which can damage the person’s bone and soft tissue.
The proposed change in the safety approval procedure was brought up by the Federal Drug Administration in response to the growing problem, and would require that the manufacturers go through a more strenuous and extensive safety review process with their all-metal hip replacements. While initially this sounds like a great idea, because the metal hip replacements would have to be more thoroughly checked out before they become available to the public, there is a big concern that this new procedure will allow the manufacturers to shield themselves from liability in personal injury lawsuits that involve their products.
The change would require that manufacturer’s submit clinical studies to the FDA for
“pre-approval” before placing their item on the market, which is different than the current process in which the manufacturer must only show that the metal implant design of their product is similar enough to another metal implant product already on the market. The worry is that adding in this “pre-approval” step may shift the liability off of the manufacturer if a consumer files a hip replacement injury lawsuit in the future, because previous case law has suggested that the court may find that the manufacturer’s cannot be held liable in this type of situation.
While hopefully the new procedure would lead to safer metal hip replacements on the market, there will still inevitably be cases where the consumer of the product ends up suing for a personal injury and the manufacturer should be accountable for their product’s errors and problems. Further, many worry that manufacturer’s would try to use the new rule to try to protect the company from liability for injuries that happened prior to the proposed new change in the law. It is unclear how the courts would come out on the issue of whether the change could be used by manufacturers as a way out of liability from injuries that occurred prior to the change.
It is important that people retain the ability to sue the manufacturer responsible for a product defect or problem in cases where the problem is the result of the manufacturer’s work. By losing the opportunity to sue the manufacturer, injured parties may not have a viable way to be recover damages in connection with their personal injuries. If you or a loved one suffered injury as a result of an all-metal hip replacement, please contact our Chicago attorneys today.