The New York Times reported last summer that the FDA had launched an investigation of Fresenius Medical Care’s handling of the GranuFlo recall, after learning that the company had issued a memo in November 2011 to its own clinics that warned of the heart risks associated with GranuFlo and NaturaLyte. However, nothing was done at that time to notify thousands of dialysis centers outside the Fresenius network about the potential dangers associated with the products.***
According to court records, more than 300 GranuFlo lawsuits alleging personal injury and death due to the use of GranuFlo and NaturaLyte have been filed in a federal multidistrict underway in U.S. District Court, District of Massachusetts. All of the pending claims allege that Fresenius Medical Care failed to provide adequate warnings regarding the use of the products, and assert that the company continued to aggressively market the drugs even after the company became aware of their dangers. The Court is scheduled to hold a conference in the proceeding on September 27, 2013. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
Dialysis patients who 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 may be entitled to compensation for their injury-related damages. Learn More about the GranuFlo recall by visiting Bernstein Liebhard LLP’s website. For additional information, please call 800-511-5092.
*reuters.com/article/2013/08/23/fresenius-fda-idUSWEB00AFY20130823, Reuters, August 23, 2013
**fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm, FDA March 29, 2012
***nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html; New York Times, June 1
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