September 4, 2012 — Fresenius Medical Care, Inc. is now facing multiple wrongful death lawsuits, filed by family members of people who died after being treated with GranuFlo and Naturalyte dialysis products. The products have been linked to heart attack, sudden cardiac arrest, stroke, and death. The most recent GranuFlo wrongful death lawsuit was filed by Betty Lemmond on behalf of her husband, who suffered a heart attack after being treated with GranuFlo. The lawsuit was filed on August 10, 2012 in the U.S. District Court for the Northern District of Alabama.
This is not the only GranuFlo wrongful death lawsuit filed in the U.S. District Court for the Northern District of Alabama. On July 27, 2012, Arthurine Williams filed a lawsuit on behalf of her husband. He died during dialysis treatment in 2010, due to side effects of GranuFlo.
Both of these defective drug lawsuits allege that Fresenius was aware of the life-threatening side effects of GranuFlo and Naturalyte, but failed to adequately warn the FDA, doctors, and the public.
The problem with GranuFlo and Naturalyte is that doctors can easily mistake the dosage and cause their patient to suffer a bicarbonate overdose (metabolic alkalosis), which is associated with low blood pressure, heart attack, sudden cardiac arrest, and death. Bicarbonate is usually administered during dialysis, but there is an ingredient in GranuFlo and Naturalyte that also converts to bicarbonate inside the patient’s body. If the doctor does not adjust the dosage, the patient can easily develop dangerously high bicarbonate levels.
Fresenius was aware of the problem in November 2011, after staff noticed that there were 941 deaths at Fresenius dialysis clinics in 2010. They attributed many of the deaths to bicarbonate overdoses, and warned doctors to take care when measuring the dose of GranuFlo and Naturalyte. This memo was not sent to the FDA or other doctors. In fact, the FDA only received a copy of the memo in March 2012 from an anonymous source. After FDA officials questioned Fresenius, the company agreed to a Class 1 recall.
Now that GranuFlo and Naturalyte have been recalled, many people are filing wrongful death lawsuits against Fresenius. The litigation is expected to grow significantly in the coming months. Most of the lawsuits accuse Fresenius of failing to warn the public about known side effects of GranuFlo and Naturalyte. If the court agrees, Fresenius may be forced to pay damages to people who were injured — including pain and suffering, medical expenses, wrongful death of a family member, and more.
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