The Granuflo Dialysis Lawsuit gained a great deal of publicity when, in November of 2012 the New York Times published an article on the subject of Granuflo and NaturaLyte. For months leading up to the publishing of this article, patients using Granuflo and NaturaLyte were experiencing various unexpected side effects, believed to have been from those drugs. Most notable among these side effects were heart attacks. Prior to this article, Fresenius had claimed that they were unaware that these side effects would present themselves. However, the article had cited an internal Fresenius memo with information suggesting otherwise. Included in the memo was not only an acknowledgement of the many Granuflo heart attacks that had taken place, but also an explicit order to Fresenius doctors to adjust dosage of Granuflo and NaturaLyte in order to avoid the side effects.
Granuflo and NaturaLyte are two additives put into dialysis treatments in order to lower the amount of acidity that is used in dialysis. Essentially, Granuflo and NaturaLyte work by pushing the pH further toward the bases. However, it is believed that when the pH is shifted too much toward any side, unexpected, harmful side effects may occur. Not enough acidity in the blood can lead to a shutdown of basic bodily functions, like the use of the heart, which may lead to a heart attack.
Currently there is a Granuflo and NaturaLyte dialysis lawsuit filed against Fresenius. Most of the claims made against Fresenius include allegations of falsely advertising their products. Right now there is a movement trying to consolidate all of the Granuflo cases into one multidistrict litigation. There is supposed to be a hearing on Thursday March 21, 2013 for the judicial panel on multidistrict litigation (JPML) to decide whether or not this will happen.
Following the negative side effects, the FDA placed a Class 1 recall on Granuflo and NaturaLyte.