Dialysis Product GranuFlo Recalled Due to Deadly Heart Risks
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
Each year, approximately 400,000 patients receive dialysis treatment in the United States. As one-third of these treatments utilize products manufactured by Fresenius Medical Care, one would assume that Fresenius is a trusted name in the dialysis industry. However, that could not be farther from the truth, based on Fresenius’ actions in the debacle surrounding its dialysis products GranuFlo and NaturaLyte.
In November 2011, Fresenius circulated an internal memo discussing serious risks linked to GranuFlo (and similar component NaturaLyte). The company acknowledged that its research and studies by other sources revealed
- a 6 to 8 times increased risk of cardiopulmonary arrest and sudden cardiac death following dialysis in Fresenius facilities
- that 941 incidents of cardiac arrest occurred among GranuFlo patients in Fresenius clinics in 2010
Armed with this damning evidence, Fresenius should have contacted the FDA, its patients and all doctors utilizing GranuFlo to warn them of the risks. Instead, the leading dialysis product manufacturer chose to keep the information secret, putting thousands of people nationwide at risk for potentially fatal heart complications.
Only in March 2012, when the document was anonymously leaked to the FDA, was action taken to protect the American public. The FDA leapt to action, issuing a warning in March, followed by a recall of all GranuFlo and NaturaLyte products in June 2012.
So extreme are the dangers linked to GranuFlo that the FDA issued its most serious recall, a classification reserved for when evidence shows “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”
The New York Times reports that Fresenius is under investigation by the FDA for potentially violating federal laws by failing to warn of risks.
The seven months between when Fresenius learned of the risks and when GranuFlo and NaturaLyte were finally recalled were likely the difference between life or death for many dialysis users across the country. If you have lost a loved one to any heart complication after dialysis treatment, contact The Michael Brady Lynch Firm immediately to learn about how you may receive compensation for the related emotional, financial and physical burdens. We are determined to hold Fresenius responsible for the harm caused to your family.
About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Actos Bladder Cancer, Fosamax Femur Fractures, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.