Who is liable when a contaminated medical device causes injury?

If an infected medial device injures a patient, should the manufacturer be liable under a products liability claim? For example, are some devices unreasonably difficult to sterilize or clean? The answer requires more factual context. 

Under current law, hospitals are required to report device-related serious injuries to the manufacturer within 10 business days of the incident. In the case of death, notice must also be give to the U.S. Food and Drug Administration. Yet this framework may not be enough. A reporting obligation is also independently imposed upon manufacturers, who must notify the FDA via a written report within 30 days of learning about any injury or death possibly caused by a device.  

In a recent example involving contaminated medical scopes, the hospital notified the device manufacturer. The company, in turn, sent investigators and ultimately quarantined the scope at that particular facility. The infected scopes apparently contained drug-resistant bacteria, or superbugs. For some patients, exposure to the contamination was deadly.

Despite the investigation, however, however, other devices across the country may have been allowed to remain in operation. The public disclosure of the potential health risks posed by the scope may also have been inadequate.

Although FDA regulations may allow outbreak information to remain confidential, a product liability lawsuit is one way to increase transparency. Such lawsuits are a matter of public record, and often attract the media’s attention. In addition, a lawsuit requires the manufacturer to legally answer potentially hard questions about its product. If you suspect you were injured by a defective or dangerous product, our personal injury attorneys can help evaluate the details of your case and explain your options. 

Source: MedCity News, “An example of how healthcare transparency fails: The battle against superbugs,” Feb. 22, 2016

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