Defective Medical Products Comments Off
An 18-year-old patient is suing a medical device manufacturer blaming the company for a superbug outbreak at the UCLA Medical Center, which infected at least seven patients and has been blamed for the death of at least two.
According to a CBS Los Angeles news report, the lawsuit was filed by Aaron Young in Los Angeles Superior Court against Olympus America, Inc. seeking unspecified damages, alleging products liability, fraud and negligence.
Lack of Protocols for Sanitizing
Young still remains a patient at the hospital after he and many others were exposed to a contaminated endoscope between October and January.
The lawsuit alleges that the company redesigned its duodenoscope last year. However, it did not offer a clear method to clean and disinfect the scopes, which have a complex construction and many tiny parts.
The lawsuit alleged that Olympus failed to take the critical step of establishing cleaning and disinfecting protocols with medical facilities and professionals.
Instead, the manufacturer provided doctors and hospitals with a safety cleaning protocol for an older endoscope that had a significantly different design.
As a result, users were not able to properly clean and sanitize the redesigned scope, the lawsuit states. The lawsuit does not blame UCLA for the superbug outbreak.
So far, the hospital has notified 179 patients who underwent these endoscopic procedures between October and January that they may have been exposed to the superbug, also known as CRE. Hospital officials were able to trace the infections to the tainted duodenoscopes.
Holding Product Manufacturers Liable
Based on statements made by experts to media, it appears that this superbug is tough to treat even with antibiotics.
The U.S. Food and Drug Administration (FDA) has issued a safety alert to hospitals and doctors warning about the potential for contamination with this particular device. About 500,000 people get treated and diagnosed with these types of endoscopes.
It is not clear if the manufacturer is planning on issuing a recall for these endoscopes.
It is unacceptable for a manufacturer to put a product, especially a medical device used on cancer patients and other seriously ill individuals that could pose an infection risk.
Apparently, this device has so many nooks and crannies that it may be impossible to thoroughly clean and disinfect it.
How is such as product even in the market?
As product liability attorneys, we certainly hope the FDA is looking into this issue to ensure the safety of thousands of patients who may be exposed across the nation.