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A Recall Doesn’T Necessarily Require Product To Be Removed

On behalf of Soloff & Zervanos, P.C. Posted in Products Liability on Friday, December 27, 2013.

When many people in Philadelphia hear that a product has been recalled, they immediately stop using it, try to return it or look up information on what to do next. Those are all reasonable responses to a recall, which is generally only issued when a product has been deemed dangerous. So, it may come as a surprise to learn that hospitals may not always have the same approach, continuing to use defective medical products after they have been recalled. In fact, it may be even more shocking that even the most serious recall, a Class I recall, does not require a product to be pulled off shelves right away.

One area that has seen a particularly significant increase in the number of medical device recalls has been in infusion pumps. An infusion pump is designed to provide a precise amount of medication to a patient without having to manually do it or monitor the process. The problem is, however, that if an infusion pump fails, it is either not dispensing medicine or it is dispensing far too much medicine. Either way, it is dangerous.

It is not just infusion pumps, however, that are causing significant injuries. There are thousands of people across the country who are injured by malfunctioning medical devices. To put it in perspective, however, the federal Food and Drug Administration gathers approximately 10,000 reports each year of infusion pump problems alone, causing about 3,800 injuries and 120 deaths.

As with any consumer product, medical devices should not injure people, but when they do, the manufacturers should be held responsible via a product liability lawsuit.

Source: KUOW, “How A Recalled Medical Device Killed A Vet At Seattle’s VA Hospital,” John Ryan, Dec. 5, 2013