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FDA Approval Does Not Guarantee the Safety of a Medical Device

In February 2015, the LA Times reported disturbing news: The Food and Drug Administration (FDA) failed to take action to protect patients even though they knew about potentially-deadly design flaws in duodenoscopes for two years. When two people died of infections caused by the devices, questions immediately arose.

Did the FDA’s failure amount to liability? Based on the information provided in the story, our Charlotte medical malpractice lawyers recognize that a number of individuals may share liability for the deaths. We believe that doctors and patients must be actively involved in decisions pertaining to complex medical procedures.

Weighing Risks Versus Benefits
It is now well-known that the design of the duodenoscopes makes them difficult to clean thoroughly. Although the FDA failed to report the design issue, it was generally known within the medical community as a concern prior to February.

It is important to understand that the FDA’s failure to issue a recall was based on their belief that the benefits of the device in helping detect cancer without risky, invasive surgery outweighed the risks.

From a legal standpoint, patients do not have a responsibility to attempt to search out information from medical providers. That said, even seemingly simple procedures can involve risks, so patients can benefit by asking questions such as the following before authorizing procedures:

  • Are there any known risks associated with this procedure?
  • What does the hospital or medical facility do to reduce these risks?
  • Do alternative procedures exist with less risk?
  • If one of the risks happens, is there an effective treatment available to deal with it?
  • What outcome can I expect if I avoid any procedure?

In the case of the duodenoscopes, a change in design does not currently seem feasible, but device manufacturers are working to better educate the medical community in more effective sterilization techniques. Some hospitals take duodenoscopes out of service for two days after cleaning to provide the opportunity to test them for bacteria before re-use.

Failure to Inform Patients Can Amount to Medical Negligence
Of course, well-informed patients must ultimately weigh risks and rewards to make decisions on medical treatment. However, even when patients do not ask questions, medical providers have a responsibility to provide all information necessary to allow them to make educated medical decisions. Failure to properly warn patients can amount to medical negligence.

Naturally, no medical provider can be expected to definitively know every possible outcome. Still, if you or a loved one sustains injuries or dies after undergoing a medical procedure, it makes sense to seek legal advice. Call us at 844-452-3688 or use our convenient online contact form to find out if you have a case and to learn your available legal options.