(PRWEB) June 21, 2012
Parker Waichman LLP, a national law firm dedicated to protecting victims from defective drugs and medical devices, is notifying the public about a recent discovery concerning Fresenius Medical Care and two dialysis products, GranuFlo and NaturaLyte. According to the New York Times, GranuFlo and NaturaLyte are associated with elevated bicarbonate levels, a problem that is linked to a six-fold increased risk for cardiopulmonary arrest. http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html
According to an internal memo dated November 4th 2011, 941 hemodialysis patients experienced cardiac arrest from 667 Fresenius facilities in 2010. The company conducted an analysis of these patients, comparing them to over 80,000 other dialysis patients in the same center. Overall, the data indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients. graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
GranuFlo and NaturaLyte are powder and liquid dialysis products, respectively. They both contain acetate, but GranuFlo contributes twice as much as NaturaLyte. The liver rapidly metabolizes acetate to the alkaline substance bicarbonate, which is used in dialysis to counteract the acidity that can build up in the blood. But according to the New York Times, these products contain more acetate than its competitors, and thus results in more bicarbonate in the body. These excess bicarbonate levels increase the risk for heart attack, according to the memo.
While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the U.S. Food and Drug Administration (FDA) about the findings until the agency received an anonymous copy of the memo and inquired about it. When Dr. Franklin W. Maddux, chief medical officer of Fresenius North America, was questioned about the company’s lack of action, he said “that it was not in a condition for general consumption,” according to the New York Times. When the company did inform its customers in late March, the issued letter did not mention the 941 patients who had suffered cardiac arrest, nor did it include other statistics highlighted in the memo. fmcna.com/fmcna/idcplg?IdcService=GET_FILE&allowInterrupt=1&RevisionSelectionMethod=LatestReleased&Rendition=Primary&dDocName=PDF_300045654
“Here we have a textbook example of a company trying to minimize the dissemination of information outside of its walls,” says Matthew McCauley, attorney at Parker Waichman LLP. “Fresenius clearly chose not to advise its outside customers about these documented cardiac risks and that is reprehensible conduct.”
The issue has prompted an FDA probe to determine whether or not their failure to warn violated federal regulations. According to Law360, the investigation may even come to encompass the entire company. Last month, the FDA issued a Safety Communication warning about alkali dosing errors for products like GranuFlo and NaturaLyte in hemodialysis patients. massdevice.com/news/leaked-fresenius-memo-spurs-fda-probe-legal-news; law360.com/lifesciences/articles/350581/fda-probe-could-grow-to-encompass-fresenius-empire;fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm
Parker Waichman LLP offers free lawsuit consultations to victims of Fresenius GranuFlo and NaturaLyte side effects. If you or a loved one experienced sudden cardiac arrest or sudden heart attack following dialysis with GranuFlo or NaturaLyte, please visit the firm's GranuFlo and NaturaLyte injury page at yourlawyer.com.
Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Fresenius GranuFlo and NaturaLyte lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney