FMC knew of the potential life threatening dangers associated with their GranfuFlo® and NaturaLyte® products for months but failed to promptly get the word out to non-FMC healthcare providers
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Houston, Texas (PRWEB) October 10, 2012
Reich & Binstock, LLP, a Houston-based law firm, is currently investigating claims against Fresenius Medical Care AG, the makers of dialysis products GranuFlo® and NaturaLyte®. According to an internal memo(1) from Fresenius Medical Care, these products have been linked to causing alkalosis, a condition associated with an increase in cardiovascular death and catastrophic cardiovascular injuries in patients undergoing dialysis.
Fresenius Medical Care North America (“FMC”) is the largest division of Fresenius Medical Care AG, headquartered in Germany. Fresenius treats more than a third of the estimated 400,000 dialysis patients in the United States. Chronic kidney failure is a condition that affects about 2 million individuals worldwide. Dialysis takes the place of the kidneys in clearing toxic waste from the blood. Part of this involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. GranuFlo contains more of this ingredient than other products. On March 29, 2012, Fresenius issued an “urgent production notification” with “important prescribing information” highlighting the increased risk associated with its dialysis products GranfuFlo® and NaturaLyte®(2).
According to the FMC Internal Memo in November 2011, using GranuFlo® or NaturaLyte® has been associated with causing alkalosis. The New York Times(3) stated that the memo was sent to doctors practicing in FMC Dialysis centers but FMC allegedly failed to notify non-FMC centers using the product GranuFlo®. The memo warned doctors that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.
“The internal memo from FMC indicates that FMC had knowledge that there was a significantly increased risk of cardiac arrest and death during hemodialysis treatments associated with its Granuflo dialysis concentrate product,” said attorney Robert J. Binstock.
According to the New York Times article, it was not until March 2012 that FMC warned other centers, after “the FDA received, anonymously, a copy of the internal memo and questioned the company about it.” The FDA then issued a recall of GranfuFlo® and NaturaLyte®(4).
“FMC knew of the potential life threatening dangers associated with their GranfuFlo® and NaturaLyte® products for months but failed to promptly get the word out to non-FMC healthcare providers,” Binstock said. “This behavior is totally unacceptable and has potentially resulted in injury or death to thousands of dialysis patients across the country.”
For more information about this investigation, please contact Reich & Binstock, LLP or visit http://www.reichandbinstock.com.
About Reich & Binstock, LLP
Reich & Binstock, LLP, a Houston, Texas-based law firm, was founded in 1984 and since that time has enjoyed extensive trial practice and significant experience in virtually every area of civil litigation including medical malpractice, all areas of personal injury trial law, products liability, toxic and environmental torts , consumer class actions involving consumer protection against insurance fraud, physician protection against insurance bundling and down coding, vanishing life insurance premiums and securities violations. The firm has been successful in numerous defective drug and medical device cases against major healthcare and pharmaceutical corporations.
The partners of the firm have also served on several national MDL Steering committees. The firm was awarded Texas Super Lawyers status in 2007, 2008, 2009, 2010, 2011 and 2012. As the law has become more specialized and complex, Reich & Binstock, has kept apace and is consistently on the cutting edge of litigation throughout the United States. Reich & Binstock is committed to providing top-quality legal representation through academic excellence, professional expertise and teamwork. The firm’s stellar reputation in the legal community has afforded Reich & Binstock, LLP, the opportunity to partner with leading law firms across the country, setting precedents and providing unparalleled service to its clients.
(1) Fresenius Medical Care Internal Memo: http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
(2) Fresenius Medical Care “Important Prescribing Information”: http://www.fmcna.com/fmcna/idcplg?IdcService=GET_FILE&allowInterrupt=1&RevisionSelectionMethod=LatestReleased&Rendition=Primary&dDocName=PDF_300045654
(3) “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” published June 14, 2012, New York Times: http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0
Contact: Juven Jacob Cano
Address: 4265 San Felipe, Suite 1000
Houston, TX 77027
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