Over 400,000 patients receive dialysis treatments in the United States. More than thirty percent of those patients are treated by Fresenius Medical Care Group, one of the world’s largest providers of dialysis products, equipment, and treatment facilities.
In early 2012, the FDA discovered information that management at Fresenius Medical Care Group hid from the public and the FDA, regarding safety concerns and usage of GranuFlo and NaturaLyte (Fresenius products) in dialysis treatment. Specifically, this memo stated that patients receiving GranuFlo or NaturaLyte were at a four to six times increased risk for suffering from cardiac arrest due to increased serum bicarbonate levels in the blood.
Side effects from increased levels of serum bicarbonate in the blood include low blood pressure, low blood oxygen, irregular heartbeat, and cardiac arrest. Countless dialysis patients have suffered serious injuries and are filing lawsuits to obtain compensation for their damages. The following is a brief timeline of the events involving the recall of GranuFlo and NaturaLyte.
- 2003: Fresenius gains FDA approval to market GranuFlo and NaturaLyte dialysisproducts.
- 2004-2010: Fresenius’ global market share grew from 27% to 33%. Fresenius also continued to grow as a vertically integrated dialysis provider and manufacturer as it increased sales of dialyzers from 41% to 44% and machines from 39% to 55% during this period—positioning itself as a leader in the dialysis treatment industry.
- 2010: Fresenius conducted study across 667 of its U.S. clinics and found 941 cases of cardiac arrest in patients while undergoing dialysis treatment.
- Late 2011: Fresenius issued an internal memo to its facilities citing study findings that warn of a four to six times increased risk of cardiac arrest due to elevated serum bicarbonate levels in the blood.
- Early 2012: Internal Fresenius memo is leaked to FDA prompting a class I recall for GranuFlo and NaturaLyte amid concerns of an increased risk of stroke, cardiac arrest, and death.
- Mid 2012: FDA issues a general safety communication regarding all dialysate concentrates used in the treatment of hemodialysis.
- Now: Dialysis patients who suffered serious injuries are filing lawsuits against Fresenius alleging the dialysis provider and manufacturer needlessly injured by failing to warn them of an elevated risk for cardiac arrest while using GranuFlo and NaturaLyte.
If you or someone you care about has received dialysis treatments and have experienced a serious injury such as heart attack, stroke, or death—contact us. Our personal injury attorneys are experienced in product liability issues including dangerous drugs and medical devices. The initial consultation is free and we will not collect any legal fees until you receive compensation for your injuries. If you are looking for strong legal representation who will fight for your rights, call us.