Host Gibson Vance welcomes Beasley Allen attorney Frank Woodson on this episode of the Beasley Allen Report to discuss GranuFlo, a product used during dialysis treatment. Woodson works in the firm’s Mass Torts section, which investigates dangerous drugs and defective medical devices. GranuFlo, and a similar product called NaturaLyte, was administered in dialysis clinics operated by Fresenius Medical Care. GranuFlo is a product used to help balance chemicals in the blood during dialysis treatment. It contains an ingredient that metabolizes in the body as bicarbonate. GranuFlo has more of this ingredient in it than competitor products. Because of this, there may have been some confusion in dosing patients with GranuFlo properly to account for these higher levels. Studies have shown that elevated bicarbonate levels increases the risk of cardiac problems, including heart attack, stroke and sudden cardiac death. Woodson says in the case of GranuFlo, an internal memo indicates Fresenius knew about a number of cardiac problems and deaths possibly associated with GranuFlo but they did not release this information to doctors, patients or the FDA.
March 6, 2013