News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
Lawyers for consumers and injured people.(No advice on this blog, though)
Thursday, January 17, 2013
Granuflo Update for January 2013
The litigation involving a recalled dialysis drug continues, and here is our update for January.
Currently there are several requests to consolidate cases involving Granuflo/Naturalyte before one Court. Parties have asked the Joint Panel on Multidistrict Litigation to centralize cases in either Massachusetts, or Mississippi, or California. The JPML hearing will be in California in March.
What Is GranuFlo?
Fresenius Medical Care’s dialysis product GranuFlo is a “dialysate,” i.e., a substance that physicians can use to treat acute and chronic renal (kidney) failure.
The kidneys clean the blood of waste chemicals and help maintain the body’s pH level. When they fail, the body’s pH level become more acidic than is should be. Dialysates used to treat kidney failure include chemicals that the body can convert into the alkaline substance bicarbonate, which neutralizes some of the acid buildup in the blood stream.
GranuFlo: Heart Attack Side Effects
GranuFlo contains more bicarbonate than other dialysates, and a June 2012 New York Times article describes Fresenius’s knowledge of the risks posed by its product’s high bicarbonate level. According to the article, Fresenius sent a memo to its clinics warning that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own, however, until March 29, 2012, when the FDA consequently began investigating Fresenius for possible violations of federal regulations, the Times reports.
The most difficult part of our investigations? Patients don't go for dialysis treatment and ask for this product.