The Legal Aspects Behind a Medical Device Recall

The recall of any product is a process during which the manufacturing company requests consumers to return a specific product normally because of safety issues.

The recall of any product is a process during which the manufacturing company requests consumers to return a specific product normally because of safety issues. The process involves different steps, during which the manufacturer notifies the responsible authorities, recall announcements are made on the specific government agency’s website, in the newspaper or television, the public is notified in various ways, consumers are required to return the goods regardless of condition and possible refunds or compensations are established.

Such actions involve great amount of money the company will have to pay. However the main purpose behind every product recall is to limit the liability for negligence. So no matter how costly the recall is, it is still better than to deal with a large number of product liability lawsuits and to damage the brand name and affect the client’s trust.

Unfortunately for both company and clients, if the defective product is a medical device, already implanted in patients’ bodies, the situation becomes more complicated. The term medical device includes all products and equipments used to diagnose, cure, treat or prevent diseases or conditions. They are designed to solve health issues, not to cause additional problems. Unfortunately if a device is defective, the consequences can be tragic.

This is what some of the hip implant patients experienced lately. In 2010 DePuy Orthopaedics, one of the major medical device manufacturing companies recalled two hip implant types. The devices were in use since 2004 and they have been implanted to thousands of individuals. The reason behind the recall was early implant failure. As a normal hip implant should work properly for around 15 years, these devices were showing signs of failure within the first five years after implant. The problem seems to be caused by the fact that the devices were metal-on-metal hip implants. As the two major metal parts were rubbing against each other every time a patient moves, tiny particles of metal debris are released into the surrounding tissues. Metal ions once they enter the blood stream are toxic, and they affect different organs and the nerve system. Besides this problem, the devices has also been reported to become loose, a situation that can lead to bone tissue damage or even hip fracture.

In case the problems a patient experiences are severe enough, the only way of solving them is to perform a revision surgery, during which the defective implant is removed and replaced with a new one. Unfortunately the surgical procedure is complicated, painful and requires a long recovery period, during which patients will be unable to move. Considering all this, it is a good thing that the company recalled the defective product and prevented other patients from being injured.

But what about patients who are already using a device, about which now they know that it is not safe? The company cannot ask them to have it removed surgically because this is exactly the worst outcome they can expect. These patients are more than entitled to sue the manufacturing company for product liability. Their claims can be based on the presumption that the company knew or should have known about the problem sooner. More consistent tests should have been performed before the product was released on the market, or it should have been recalled once the first failures were reported. Anyway patients who were affected by the recalled hip implants are advised to consult a personal injury lawyer to discuss the possibility of financial compensation.

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