The family of a Georgia man who suffered a fatal heart attack following dialysis treatment has filed a wrongful death lawsuit against Fresenius Medical Care (FMC), claiming that problems with the company’s two dialysis products – GranuFlo and NaturaLyte – caused the man’s sudden death. The complaint, filed by the son of Harold Bolton, Sr. …
The family of a Georgia man who suffered a fatal heart attack following dialysis treatment has filed a wrongful death lawsuit against Fresenius Medical Care (FMC), claiming that problems with the company’s two dialysis products – GranuFlo and NaturaLyte – caused the man’s sudden death. The complaint, filed by the son of Harold Bolton, Sr. in the U.S. District Court for the District of Massachusetts on October 25, 2012, alleged that the heart attack death occurred as a result of FMC’s failure to provide adequate warnings about the potential side effects of GranuFlo and NaturaLyte. If you received the GranuFlo acid concentrate during hemodialysis and you have since experienced a serious side effect, or if you lost a loved one to a potential GranuFlo complication, contact our qualified GranuFlo lawyers at Oklahoma Legal Center today. You may have grounds to file a product liability lawsuit or wrongful death suit against Fresenius Medical Care, in order to seek fair and timely reimbursement for your losses.
GranuFlo and Potential Side Effects
GranuFlo and NaturaLyte are two acid concentrates that are commonly used during hemodialysis treatment in patients with acute and chronic kidney failure. According to this wrongful death suit, the dialysis products are unique because they use sodium diacetate, which doubles the amount of acetate in dialysate, compared to formulas made with acetic acid. When combined with the bicarbonate buffer prescriptions administered during dialysis treatment, this may increase the risk of cardiac arrest, heart attack or death.
According to allegations raised in the complaint, Bolton began receiving GranuFlo and NaturaLyte treatment three times a week beginning in 2006. On October 24, 2010, Bolton received treatment at a Fresenius dialysis center located on Clarke County, Georgia, according to the lawsuit, and two days later Bolton suffered a heart attack and died. Bolton’s son claims that FMC concealed or misrepresented information about the risks associated with its hemodialysis treatments, and failed to adequately warn patients and the medical community about the increased risk of adverse heart side effects and death.
FMC Under Investigation for Failure to Warn
Fresenius is the largest provider of dialysis services and products like GranuFlo in the world, and the company also owns approximately one-third of all dialysis clinics in the United States. In November 2011, a little over a year after Bolton’s death, Fresenius issued an internal memo to doctors at its own clinics, warning about the risk of deadly problems associated with its GranuFlo and NaturaLyte dialysis products. In the memo, the company advised physicians at FMC clinics that it was particularly important to monitor bicarbonate levels prior to dialysis treatment and adjust buffer prescriptions to reduce the risk of heart problems and death. FMC had also conducted an internal analysis and indicated that there were as many as 941 instances in which GranuFlo and NaturaLyte patients suffered cardiac arrest during dialysis between January 1, 2010 and December 31, 2010.
GranuFlo Lawyers for Side Effect and Wrongful Death Claims
Lawsuits filed against FMC for heart attack side effects and wrongful death claim that, although Fresenius knew or should have known about problems long before the internal memo was issued in November 2011, it wasn’t until March 2012 that those same side effect warnings were finally provided to non-FMC dialysis clinics. In light of the risk of fatal complications linked to GranuFlo and NaturaLyte treatments, the FDA has issued a Class I recall for the acid concentrates, which means the agency believes the products are likely to cause severe injury or death. Bolton’s lawsuit and other similar complaints filed on behalf of GranuFlo and NaturaLyte patients across the country are pursuing both compensatory and punitive damages against Fresenius for failure to warn, negligence, strict liability, fraud, wantonness, breach of warranty, wrongful death, and unjust enrichment. If you believe you have been adversely affected by FMC’s GranuFlo dialysis treatment, contact our GranuFlo attorneys at Oklahoma Legal Center to discuss your legal options.