South Carolina Woman Files GranuFlo Wrongful Death Lawsuit

South Carolina Woman Files GranuFlo Wrongful Death Lawsuit

By Amanda Antell

South Carolina plaintiff Betty Sims is suing Fresenius Medical Care for the wrongful death of her husband, Charles A. Sims. According to her GranuFlo lawsuit, the decedent had suffered a sudden cardiac death in direct result of his GranuFlo dialysis treatment. The decedent was prescribed GranuFlo and NaturaLyte sometime in 2007, and died on August 13, 2010. He suffered sudden GranuFlo cardiac death, even though he received immediate medical attention.

Betty Sims is bringing charges against Fresenius for negligence, false advertising, and concealing information. She claims that, if she or her husband had known about the possibility of sudden GranuFlo cardiac death, they never would have used the dialysis product. In her GranuFlo lawsuit, Betty Sims accuses Fresenius of manufacturing, distributing, selling, and marketing a dangerous product that led to the wrongful death of her husband.

Overview of GranuFlo and NaturaLyte Complications

GranuFlo is a dry dialysis acid concentrate that is manufactured by Fresenius Medical Company. Its liquid concentrate cousin, NaturaLyte, is also manufactured by Fresenius. GranuFlo was approved by the U.S. Food & Drug Administration (FDA) in 2003, and is one of the most popular dialysis elixirs in the world.

GranuFlo and NaturaLyte are composed of bicarbonate concentrates, which alleviate the body’s suffering from alkalosis. Essentially, alkalosis occurs when the body’s kidneys start to fail, which leads to a variety of medical complications. While many have claimed that GranuFlo and NaturaLyte have worked miracles, it has been discovered that there may be a darker side to these products as well.

Fresenius has more than 1,000 dialysis centers in the United States. In 2012, it was estimated that GranuFlo and NaturaLyte were used by the majority of 400,000 hemodialysis patients in the United States. On November 4, 2011, Fresenius sent out an internal memo to their clinics and employed physicians, warning them that GranuFlo and NaturaLyte significantly increase the patient’s chances of suffering from sudden GranuFlo cardiac arrest and other cardiac complications. Some incidents even occurred during the hemodialysis procedure.

Fresenius had conducted its own clinical studies of GranuFlo and NaturaLyte, and did not disclose their results. While Fresenius warned of the significant increase to their physicians and clinics, they did not disclose the full severity of study’s results. Fresenius also did not send this memo out to the public, FDA, or the rest of the medical community, leaving thousands vulnerable. Sometime later, the memo was leaked to the FDA, which started a massive investigation into Fresenius, leading to the discovery that hundreds of patients had died after receiving GranuFlo or NaturaLyte.

On June 27, 2012, the FDA issued a Class 1 recall of GranuFlo and NaturaLyte. The FDA advisory stated that these products had insufficient warning labels, and that they increase the likelihood of sudden GranuFlo cardiac death in patients quite significantly.

GranuFlo and NaturaLyte Litigation Movement

The 2011 memo indicated that the company had been observing patients from 2004 to 2011, and had known about this problem for a number of years. Despite the knowledge Fresenius had, the company continues to aggressively market GranuFlo and NaturaLyte without properly warning patients or their physicians about the possible GranuFlo side effects. Patients across the country are seeking justice for the damages they suffered from these products. Betty Sims is suing Fresenius for over $75,000, seeking medical compensation and punitive damages.

The GranuFlo lawsuit is Betty Sims v. Fresenius GranuFlo/NaturaLyte Litigation, MDL No. 1:13-md-02428-DPW, in the U.S. District Court for the District of Massachusetts.

File a GranuFlo & NaturaLyte Lawsuit Today

If you believe that you or a loved one have been the victim of a GranuFlo or NaturaLyte Injury, you have legal options. Please visit the Kidney Dialysis Heart Attack GranuFlo and NaturaLyte Recall Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned GranuFlo or NaturaLyte lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The sudden GranuFlo cardiac death attorneys working this investigation do not get paid until you do.