Fresenius GranuFlo® and NaturaLyte® Whistleblowers Protected Under False Claims Act

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Fresenius has been under scrutiny for failing to warn about complications associated with their GranuFlo® and NaturaLyte® dialysis products. Dialysis is a procedure that helps filter toxins from the blood in patients who have had kidney failure. The alkaline substance bicarbonate is used in dialysis to help neutralize the acid that builds up in the blood. Fresenius’ GranuFlo® and NaturaLyte® contain acetate, which gets converted into bicarbonate once it is metabolized by the liver. These products, however, contain higher levels of acetate and therefore contribute higher levels of bicarbonate than competing products.
An internal company memo, dated November 4, 2011, warned that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. The memo attributed part of the problem to dosing errors, where doctors did not account for the extra alkalinity from GranuFlo® and NaturaLyte®. Fresenius did not warn outside consumers or the public about these risks until prompted by the U.S. Food and Drug Administration (FDA).
In June 2012, the FDA issued a Class I recall for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. The agency warned about higher bicarbonate levels with these products, stating that “This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

False Claims Act Whistleblower Provisions
A whistleblower lawsuit, filed under the False Claims Act, is when a former or current employee of a company tells the government about misconduct occurring within the organization. The False Claims Act allows the federal government to recover three times the amount of money lost due to the Defendant’s fraud; the whistleblower is entitled to 15 to 25 percent of this amount. If the government chooses to not join the case, the whistleblower can continue to pursue it privately and is then entitled to 25 to 30 percent if successful.
Whistleblowers are protected from retaliatory actions by the employer or former employer, including being discharged, demoted, suspended, threatened or harassed. If this does occur, the whistleblower can be reinstated with the same seniority and is entitled to recover double back pay with interest and other compensatory damages.

The False Claims Act also gives whistleblowers the opportunity to report illegal or unethical activity anonymously by filing a claim through an attorney. While the Justice Department investigates the case, the identity of the whistleblower remains under seal. Unless the claim is pursued privately, the identity of the whistleblower will not be revealed if the government does not pursue the case.

Legal Help for Fresenius Whistleblowers

If you have knowledge that Fresenius was involved in illegal activity or misconduct involving GranuFlo® or NaturaLyte®, you may have valuable legal rights as a Fresenius whistleblower. For a confidential, no obligation evaluation of your potential Fresenius whistleblower lawsuit, please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) today.