K&F IN THE NEWS: James L. Ferraro, Equity Partner of Kelley & Ferraro, LLP representing 52 former Black franchisees of McDonald's for racial discrimination.

An FDA Class I recall means the potential for fatalities

When a recall is announced, people here in Ohio and elsewhere need to understand how dangerous the product in question is. The Food and Drug Administration developed a system to identify the severity of the problem. The most dangerous classification the FDA has is a Class I recall, which means the potential for fatalities is high.

When the FDA announces a Class I recall, everyone involved with the product should take notice. For instance, a recent recall by Edwards Lifesciences, LLC could lead to deaths. The company’s SAPIEN 3 Ultra Delivery System is a component of its Edwards SAPIEN 3 Transcatheter Heart Valve System. These medical devices allow surgeons to replace damaged aortic valves without opening a patient’s chest. 

The company received notifications regarding the fact that the balloons burst during the surgical procedure. This made, and will make, it difficult for surgeons to get the valve back into the catheter and out of the patient. This difficulty could lead to unnecessary and dangerous bleeding, vascular injury and/or surgical intervention. Edwards Lifesciences, LLC issued instruction with the recall to potentially reduce the risk of injury and or death, but that does not mean the information reached — or will reach — everyone in time.

The FDA does its best to make sure that the parties affected by dangerous products such as this one are notified, but it cannot always prevent the harm done to innocent people. The losses incurred are often life-altering and expensive. Ohio residents who suffer serious injury or lose a loved one to a defective medical device such as this one may be able to seek a monetary judgment as restitution for the harm done.

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