In June of 2012, an article ran in The New York Times titled “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry.” The subject of this newspaper article has also become the catalyst for many dialysis death lawsuits against large German medical device manufacturer Fresenius Medical Care, which was founded in 1996 through a merger. Fresenius, which is the largest operator of dialysis centers in theUnited States, is being investigated by the US Food and Drug Administration due to allegations that the company was aware of severe risks associated with two of its acid concentrate products: GranuFlo and NaturaLyte. In addition to owning and operating thousands of dialysis centers, Fresenius is also the leading supplier of dialysis products and machines to other clinics as well.
The claims being investigated by the FDA come from an alleged internal member sent by Fresenius to the doctors and medical professionals working in its company-owned and operated dialysis centers. The memo was first reported on by an internet site focused on dialysis, called RenalWEB. Dialysis is used in place of the kidneys for ridding the blood of toxins, and in this process GranuFlo is used to provide the body with bicarbonate, which neutralizes acid. However, GranuFlo Dry Acid Concentrate contains an ingredient (not present in many similar products) that the body converts to bicarbonate once it is in the body. If administered incorrectly, GranuFlo can result in abnormally high bicarbonate levels. This bicarbonate overdose can result in cardiac injuries as well as death. In the Fresenius internal memo, these dangers were discussed and doctors were notified that improper use of dialysis products contributed to a severe increase to a patient dying of a heart attack.
The Fresenius GranuFlo Dialysis Death Memo was sent out in November of 2011 and referenced that 941 patients in company treatment centers had experienced cardiac arrest. These 941 deaths occurred in the year 2010 alone. Their data suggests that the risk of GranuFlo cardiac side effects was up to 6 times greater. Alarmingly, there are approximately 125,000 patients treated with GranuFlo that are not treated in Fresenius dialysis centers. None of these patients or the doctors treating them were warned of these potential dangers until March of 2012.
If you or a loved one was treated with GranuFlo or NaturaLyte within a Fresenius dialysis center or in another treatment center, contact the Willis Law Firm today for a free dialysis complication lawsuit evaluation. When you call, our team of gifted legal professionals will assist you in determining whether or not you and your family have a viable claim. You may be legally entitled to financial damages for your suffering. At present, we are assessing GranuFlo claims nationwide. Don’t delay; let the Willis Law Firm help you get the compensation you deserve.