FDA Investigating Dialysis Company for Failure to Warn of Product Risk

The U.S. Food and Drug Administration (FDA) is investigating why Fresenius Medical Care, the nation’s largest operator of dialysis centers in the U.S., failed to inform customers about the potentially lethal risk posed by one of its products.

It is estimated that the company treats one-third of the 400,000 Americans who currently receive dialysis treatment. The German-based supplies dialysis machines and products for its clinics and for many other non-company dialysis clinics as well.

In November of 2011, the company sent an internal memo to the physicians working at its clinics stating that improper use of one of its products, GranuFlo, could substantially increase the risk of patients dying of cardiac arrest.

According to the New York Times, Fresenius did not immediately warn other non-company centers about the problem, and the FDA only learned of the GranuFlo concerns after the internal memo was leaked to the agency in March of this year. The company did warn other centers after it learned the memo had been leaked.

The Fresenius memo issued in November indicated that 941 patients had suffered cardiac arrest at its dialysis centers in 2010. GranuFlo, which contains more bicarbonate than rival products, was seen as a possible link. Company medical staff concluded that elevated bicarbonate levels in the blood could lead to a sixfold increase in cardiac arrest risk.

The FDA issued an alert in late May about GranuFlo and like products. Physicians at dialysis clinics nationwide now check bicarbonate levels in patients and can adjust doses as necessary.

Those that manufacture and sell medical devices and products must ensure that their products do not cause harm. They also owe a moral and legal obligation to inform patients, customers, and the proper authorities if they find their products may possibly be injuring patients. If you believe that you, or a loved one, has been harmed by a medical product, the Florida medical product injury attorneys at Farah & Farah want to hear from you. Call us at (800) 533-3555 to find out what your legal options might be.