After the GranuFlo Recall: FDA Launches Investigation Over Company’s Legal Obligation to Warn Customers of Product Risks
Did the makers of GranuFlo and NaturaLyte violate federal regulations by keeping under wraps the lethal safety hazards associated with the dialysis drugs that may have cost more than 900 patients their lives?
That’s what the mounting GranuFlo lawsuits, and the U.S. Food and Drug Administration (FDA) are trying to find out by investigating the controversy surrounding these dialysis products. The agency pulled these dialysis drugs from shelves in June by way of a Class I GranuFlo and NaturaLyte recall.
The Class I recall, which is only issued when the agency determines there to be serious risk of side effects or death associated with a particular product, was announced after they anonymously received a copy of an internal memo written by the Germany-based Fresenius Medical Care late last year.
Dated Nov. 4, 2011, the company warned doctors practicing in the company’s dialysis centers that failure to use these products properly may lead to an increased risk of death from cardiac arrest in patients. Only when the news broke that the FDA had received this information in late March did Fresenius formally notify customers of the risks associated with GranuFlo and NaturaLyte.
Now, the FDA is investigating whether Fresenius had a legal obligation to alert its entire customer base of safety concerns associated with the drugs that were administered during dialysis treatments. GranuFlo and Naturalyte work to clear toxic waste from the blood by creating bicarbonate, a substance that neutralizes acid build-up.
In June, Steven Silverman, who serves as director of compliance for the FDA’s medical devices division, released the following statement regarding Fresenius’ actions via the New York Times: “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risk,” he said.
“If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it.”
The recent GranuFLo and NaturaLyte recall is likely to spawn hundreds of wrongful death lawsuits to be filed around the U.S. against Fresenius Medical Care.
The latest to be filed against the company was by a Florida woman who alleges that GranuFlo caused her husband’s heart attack in 2008. This case has yet to be scheduled for trial.