A wrongful death lawsuit against Fresenius Medical Care involving two of its dialysis products has been removed to federal court. In the lawsuit, Phillip Harris alleges that Fresenius, the world’s largest provider of dialysis products and services, failed to adequately warn, train, instruct and monitor treating physicians and health care facilities to ensure that their products were being properly administered, and as a result his wife Shirley Harris died from injuries sustained after being administered Fresenius products GranuFlo and NaturaLyte.
The lawsuit claims that the dialysis products were improperly labeled, which resulted in patients, including Shirley, suffering from significant health problems including heart attack, cardio-pulmonary arrest, stroke and/or sudden cardiac death.
GranuFlo and NaturaLyte contain an ingredient that metabolizes in the body into a substance known as bicarbonate. Howver, GranuFlo and NaturaLyte have higher levels of this ingredient that competitor products.
An internal investigation noted that patients may have been inadvertently administered too much of these products, causing toxic levels of bicarbonate to build up in the body. Elevated bicarbonate has been associated with serious heart problems including sudden cardiac death.
After Fresenius discovered the problems with its labeling instructions, the company issued an internal memo to doctors at its clinics warning them of possible dosing errors. The firm did not notify doctors at the thousands of other clinics that use its products, nor did it alert patients to the issue. At least not until months later, after the Food and Drug Administration (FDA) received a copy of the memo anonymously.
The Harris lawsuit is one of hundreds of wrongful death lawsuits filed against Fresenius over the labeling of GranuFlo and NaturaLyte, several of which have been transferred out-of-state to a Multidistrict Litigation (MDL) proceeding in Massachusetts federal court.
Source: WV Record