Granuflo Injury Claims Mount in Wake of FDA Warning Letter

The number of Granuflo lawsuits continues to mount in the aftermath of Fresenius Medical Care’s recall of Granuflo and Naturalyte kidney dialysis concentrates. Most recently, another Fresenius entity received a warning letter from the U.S. Food and Drug Administration (FDA) over concerns about problems at a manufacturing plant in Puerto Rico. Reuters reports that the letter cited issues with labeling and complaint handling procedures at a Fresenius Kabi facility that manufactures blood bags. This marks the second time since March 2013 that the FDA has issued a warning letter to a Fresenius entity. Earlier this year, Fresenius Medical Care North America was cited by the agency for issues at an Ogden, Utah plant. Also in March 2013, the FDA issued a Class 1 Recall of Granuflo and Naturalyte after the drugs were linked to rapid and potentially lethal elevations of bicarbonate in dialysis patients. Unsafe levels of bicarbonate are associated with serious heart problems including, increased risk of cardiopulmonary arrest, and death. Last summer, the New York Times reported that the FDA had launched an inquiry into the handling of the Granuflo recall by Fresenius Medical Care. In November of 2011, the company circulated a memo to its own clinics warning of the heart risks associated with Granuflo and Naturalyte, but neglected to notify the thousands of dialysis centers outside the Fresenius network about the potential dangers associated with the dialysates. Court records show that over 300 Granuflo lawsuits alleging personal injury and death due to Granuflo and Naturalyte use have been filed in a federal multidistrict litigation underway in U.S. District Court, District of Massachusetts. The court is scheduled to hold a conference on the proceedings on September 27, 2013. The pending claims allege that Fresenius Medical Care failed to provide adequate warnings about the risks associated with using Granuflo and Naturalyte. The claims further allege that the company continued to vigorously market the drugs even after becoming aware of their dangers.

National Granuflo Lawsuit Attorneys

I If you or a loved one has suffered serious heart problems, including cardiac arrest, heart attacks, stroke, and sudden cardiac death, within 48 hours of a dialysis treatment with Granuflo or Naturalyte, you may be entitled to compensation for your injury-related damages. The national Granuflo lawsuit attorneys at Phillips Law Firm are currently representing patients and families across the United States who have been injured or killed after receiving Granuflo. If you are interested in learning more about your legal options, call us at 1-800-708-6000. Our national Granufo lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation. Remember our no fee promise. If we do not recover anything for you, you do not owe us an attorney fee.

Real People. Real Justice. (800) 708-6000