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Did the FDA Know about (& Ignore) the Continued Use of Defective Scopes for Some Medical Procedures?

Has the the U.S. Food and Drug Administration (FDA) known about the ongoing use of an allegedly defective scope that’s used in nearly a half million common medical procedures every year?

That’s the question some are now asking, as it appears that risky medical scopes are still being widely used across the U.S.

The scopes in question, which are made by Olympus, are used to examine patients’ digestive systems when evaluating whether they suffer from cancer, ulcers, and other ailments. The scope is said to be defective because its design allegedly traps bacteria within the tube, which can result in serious infections.

Even when thoroughly cleaning the scopes between uses, these scopes can reportedly still contain infectious bacteria. Despite the fact that this flaw is known, many hospitals across the nation are still reportedly using this scope in diagnostic procedures. In fact, according to FDA data, this year alone, there have reportedly been at least eight infections and two known deaths related to infections caused by these scopes.

A Closer Look at the Scope of the Possible Problem

Did the FDA Know about (& Ignore) the Continued Use of Defective Medical Scopes?

Did the FDA Know about (& Ignore) the Continued Use of Defective Medical Scopes?

The following provides some of the latest details associated with the allegedly defective Olympus scopes, as well as the FDA’s actions regarding these scopes:

  • Reports of infections caused by these scopes have come from various medical facilities across the U.S., including (but not limited to) UCLA Medical Center, New York Presbyterian Hospital, the Hartford Hospital in Connecticut, Massachusetts General in Boston and Thomas Jefferson University Hospital in Philadelphia.
  • Medical Safety Expert Lawrence Muscarella has explained that hospitals don’t generally warn their patients about the possibilities of infection from the use of these scopes. This failure to warn, according to Muscarella, violates the notion of “informed consent.”
  • Recent reports indicate that the FDA, as well as the Centers for Disease Control and Prevention (CDC), have been in collusion to keep a tight lid on which hospitals are having problems and where the most recent deaths related to these scopes have occurred.
  • From 2012 to 2013, 38 patients at Chicago’s Advocate Lutheran General Hospital reportedly contracted a deadly “superbug” after being exposed to the problematic scopes.
  • While the CDC has issued a report related to the Chicago hospital infections, it has reportedly neglected to list the model number and manufacturer of the faulty scope.
  • Another 39 patients contracted a ‘superbug’ at Virginia Mason Medical Center in Seattle, which eventually saw 18 patients die as a result of developing infections after they had been exposed to the problematic scope.
  • The FDA claims it lost paperwork for the aforementioned incidents. It reportedly began its investigation into the problematic scopes in September 2013. It then took another 17 months before the FDA alerted the public and medical professionals of the risks and issues linked to this scope.
  • Another two patients treated with the scope died at the UCLA Ronald Regan Medical Center, which didn’t start using the scope until June 2014.

As more news about this story becomes available, we’ll report the latest details to you in a future blog. Until then, let us know what you think about this story – and the FDA’s alleged failures to protect the public from infection – on Facebook & Google+.

Contact Kingston Personal Injury Lawyer Charles N. Rock

If you or someone you love has been harmed by a defective, faulty or dangerous medical device, contact Kingston Personal Injury Lawyer Charles N. Rock by calling (845) 3831170 or by emailing our firm using the contact form on this page.

To ensure that you have the legal support you need as soon as possible, Attorney Charles N. Rock can meet you at your home or a hospital when needed.