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Medical Device Maker Tied to Deadly Super Bug Receives FDA Warning

The U.S. Food and Drug Administration (FDA) recently issued warning letters to three manufacturers of duodenoscopes. The letters highlight a range of violations committed by the medical device makers, including the failure to report infections tied to the scopes.

The FDA’s warning letter to Olympus Corp. confirms that the medical device maker was aware of the risk of infection prior to the deadly outbreak. The agency alleges that the company failed to timely notify the FDA about 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with the manufacturer’s devices. According to the FDA, Olympus became aware of the infections on May 16, 2012, but did not notify the agency until 2015.

Under the Federal Food, Drug, and Cosmetic Act, medical device makers must notify the FDA no later than 30 calendar days after receiving or otherwise becoming aware of information, from any source, that reasonably suggests that a device may have caused or contributed to a death or serious injury.

As the Los Angeles Times reports, federal lawmakers and patient safety experts applauded the FDA’s actions, while also expressing concern regarding how long the issues went unreported. “The fact that it took the leading scope manufacturer three years to report patient infections is flat out unacceptable,” Rep. Ted Lieu (D-Los Angeles) stated. “If scope manufacturers had reported infections earlier, then lives might have been saved.”

If you or someone you love has been seriously injured by a dangerous or defective medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.