Fatal Car Accident Cited in GranuFlo Heart Attack Lawsuit

In a lawsuit filed on June 3rd, 2013, an Iowa man is seeking damages from Fresenius Medical Care, manufacturers of the dialysate GranuFlo. The plaintiff suffered a heart attack – allegedly as a result of using GranuFlo – that led to a fatal car accident. The GranuFlo heart attack lawsuit was filed at the U.S. District Court for the Southern District of Iowa (Davenport Division).

The plaintiff suffers from kidney problems which require dialysis treatment three times a week. About an hour after his appointment at the University of Iowa Hospital on March 7, 2011, he reported feeling sick and light-headed. Whilst driving to work later that day, the plaintiff suffered a heart attack and lost consciousness. His truck veered into oncoming traffic and collided with a passenger van containing a family of three. The driver of the van died as a result of the accident, and the wife and small child required hospital treatment. The plaintiff was severely injured, suffering a broken hip, broken femur, and a shattered pelvis.

According to the GranuFlo heart attack lawsuit, Fresenius is liable for the accident and the subsequent suffering caused to all parties involved in the accident. The company is accused of negligence and a failure to provide adequate warnings about GranuFlo side effects.

Thousands of dialysis centers used GranuFlo

GranuFlo is used during hemodialysis to offset the acid produced by kidney malfunction. The latest GranuFlo heart attack lawsuit states that the sodium acetate contained in the dialysate converts to sodium bicarbonate at an unusally high level. Thousands of patients are thought to have been unwittingly overdosed with sodium as a result of receiving the treatment.

There are around 5,700 dialysis centers in the U.S. Around 3,300 of them have used GranuFlo. Some clinics are operated by Fresenius directly, and many others buy the firm’s dialysates. An estimated quarter of a million patients were treated with GranuFlo  before it was recalled by the FDA.

Fresenius allegedly knew of risks

On March 29th, 2012, the FDA issued a Class 1 recall of the product, after it emerged that Fresenius was aware of the risk of serious GranuFlo side effects – including heart attacks – but did nothing to warn the clinics they supply it to.

At the center of the allegations is an internal memo dated November 2011. The memo, sent to all Fresenius-owned clinics in the country – clearly stated that the risk of cardiac arrest was up to eight times higher with GranuFlo compared to other dialysates. The memo was not issued to non-Fresenius clinics, which account for nearly half of all clinics that used GranuFlo.

More GranuFlo heart attack lawsuits anticipated

There are multiple GranuFlo lawsuits pending against Fresenius, spread across eight different U.S. District Courts. Because of the large number of patients who have been treated with GranuFlo, that number is expected to rise as more people become aware of the seriousness of undisclosed GranuFlo side effects.

On December 12, 2012, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all cases to the District of Massachusetts. The petition was signed by Fresenius in January, 2013. Plaintiffs whose cases have been joined to the GranuFlo multidistrict litigation (MDL 2428) allege Fresenius knew or should have known of the risks, but failed to provide patients or physicians with adequate warnings.