According to the complaint, Johnny Williams began hemodialysis treatment on July 28, 2010, at DaVita Ensley dialysis clinic in Birmingham, Alabama. The treatment included the use of GranuFlo and NaturaLyte, acid concentrates manufactured by FMC for use during the hemodialysis process. Just one day after beginning treatment, Williams suffered a sudden heart attack and died. Arthurine Williams claims in her lawsuit that her husband’s death was caused by NautraLyte and GranuFlo side effects, and that FMC knew or should have known about the risk of heart complications associated with the treatment. The complaint alleges that FMC knew about NaturaLyte and GranuFlo heart problems for years and failed to disclose this side effect information to dialysis clinics and medical professionals using their products.
Fresenius Medical Care operates about one-third of all dialysis clinics in the United States and is also the leading provider of dialysis products to clinics across the U.S. and Europe. In November 2011, FMC issued an internal memo alerting its own facilities that inappropriate prescription of the dialysis drugs could cause a high sodium bicarbonate level, which can lead to hemodialysis metabolic alkalosis, a major risk factor for life-threatening heart side effects like cardiac arrest, heart attack, stroke and arrhythmia. According to the memo, as many as 941 GranuFlo users had suffered sudden cardiac arrest due to improper administration of the dialysis drug. FMC however, failed to warn other dialysis clinics about this GranuFlo side effect risk, putting thousands of patients at an unnecessary risk of serious side effects and death. It wasn’t until March 2012 that the FDA received a copy of the memo from an anonymous source and launched an investigation into Fresenius Medical Care and its potentially dangerous dialysis products.
In light of the risk of NaturaLyte and GranuFlo side effects, the FDA recently decided to initiate a Class I recall of the dialysis drugs, which means the agency believes the products have the potential to cause severe injury and death. According to Williams’ lawsuit, it became evident to FMC by 2010 that its GranuFlo dialysis drug may cause serious side effects, but the company chose to withhold this information in an attempt to avoid negative consequences. Arthurine Williams accuses the defendants of strict liability, breach of warranty, failure to warn, negligence, fraud, unjust enrichment, wrongful death, and also accuses FMC of wantonly and recklessly marketing and selling GranuFlo and NaturaLyte in spite of serious side effect risks. The complaint is believed to be the first dialysis treatment lawsuit filed against Fresenius since information about the risk of deadly heart side effects from GranuFlo and NaturaLyte became public. If you believe you have been adversely affected by the dialysis drug GranuFlo, contact a qualified GranuFlo lawyer to explore your compensation options. Our consumer advocates at Consumer Justice Foundation are here to protect patients like you who suffer injury at the hand of deceptive drug companies. With the help of an experienced GranuFlo attorney, you can defend your rights and pursue the financial compensation you deserve.