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Defective medical device still in use after causing many deaths

The public relies on both the Food and Drug Administration as well as the Centers for Disease Control and Prevention to keep dangerous products out of hospital facilities. When a defective medical device does happen to make it to the market, it is not necessarily unreasonable for California patients to expect the device to be removed from circulation in a timely manner. Unfortunately, the FDA does not always act in in a manner befitting the situation.

A defectively designed scope was last discussed on this blog in Feb. 2015 ("Spread of Bacteria Linked to Alleged Defective Medical Device"). Its flawed design makes it nearly impossible to properly sterilize, exposing patients to harmful bacteria that has been linked to infections and death. The FDA was aware of the problem since at least 2012, yet the scope remains in hospitals across the United States, putting more patients at risk for deadly infections. Recently, the FDA was notified of another eight infections and two deaths.

The FDA is apparently reluctant to release additional information concerning the most recent deaths, including where they occurred. This is especially troubling, as hospitals are not required to inform their patients of the risks of using this scope. The father of a teenage boy who was killed by a superbug infection claims that the FDA and CDC have had four years to handle the situation but have chosen to side with industry interests. A particularly nasty outbreak in Sept. 2013 took the lives of 18 people, but the FDA waited 17 months before issuing alerts to area hospitals and the rest of the public.

Continued distribution and use of a defective medical device despite knowledge of its hazards is extremely irresponsible. Not only are patients suffering superbug infections, but many have lost their lives after being wrongly exposed to bacteria. In California, product liability suits are generally effective at achieving compensation for victims and their families. While money can never replace a life or truly make amends for permanent injury, addressing the related financial damages can help victims focus on their own recoveries.

Source:, "Secrecy of hospitals, FDA results in fatal superbug infections", Betsy McCaughey, April 7, 2016

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