Compensation for Granuflo | GranuFlo Lawsuit Alabama

Alabama Woman Claims Wrongful Death of Her Husband in Fresenius Medical Care Lawsuit

Shay Morrigan | October 24th, 2012

Alabama resident Betty Lemmond filed a new Fresenius medical care lawsuit on August 8, 2012. The case is proceeding in the U.S. District Court for the Northern District of Alabama.

Lemmond claims that her husband suffered wrongful death due to two of Fresenius’ products, NaturaLyte and GranuFlo. These products may be used during kidney dialysis procedures to help control acid buildup in the blood. An internal memo circulated by Fresenius in November 2011 indicated that these products may increase risk of bicarbonate overdose and heart attack. The company failed to notify outside medical centers that also use the products, however, until several months later.

In June 2012, the FDA alerted the public to a Class I GranuFlo recall, warning physicians that the use of these products may cause serious adverse health consequences, including death. Lemmond seeks compensation for GranuFlo wrongful death in excess of $75,000.

In her Fresenius medical care lawsuit, the plaintiff claims her husband died due to GranuFlo and NaturaLyte

According to her Fresenius medical care lawsuit, Lemmond’s husband, Dizzy Dean Lemmond, was prescribed GranuFlo and NaturaLyte three times a week beginning in June 2010. Only a few months later, on August 11, he received hemodialysis treatment where GranuFlo was used.

Both GranuFlo and NaturaLyte concentrates are made differently than other concentrate products. Others typically contain only acetic acid, whereas these two contain both acetic acid and sodium acetate. The two ingredients together can increase a patient’s risk of bicarbonate overdose if the doctor is unaware of the difference. High levels of bicarbonate can lead to a condition known as “metabolic alkalosis,” which can cause heart rhythm problems and cardiopulmonary arrest.

Mr. Lemmond had no reason to believe that the GranuFlo used during his procedure could be unsafe. On that day last when he went through hemodialysis, however, he suffered from a sudden heart attack and died.

Memo indicates the company was aware of the issues

The internal memo created by Fresenius and distributed in November 2011 indicated that they were aware of the risks associated with these products. The company had reviewed the data linked to over 900 cardiac deaths that occurred in their dialysis centers in 2010, and determined that an elevated level of bicarbonate was an independent risk factor for these deaths. They strongly recommended that physicians pay more attention to prescriptions affecting bicarbonate levels to avoid metabolic alkalosis.

They added in the memo that many facilities had converted to the GranuFlo formulation, but that some physicians had failed to adjust the prescription levels to accommodate the higher power of the product, thus exposing patients to higher bicarbonate levels.

FDA alerts the public to a GranuFlo recall

In support of her fight for compensation for GranuFlo wrongful death, Lemmond states in her complaint, “When a clinical problem finally became irrefutably evident to the Fresenius Medical Services division around 2010, top Fresenius executives chose not to properly report these complications or GranuFlo specific risks to the FDA or other government agencies.”

Indeed, it wasn’t until the FDA received an anonymous copy of the memo and started asking questions that Fresenius released a second memo March 29, 2012, to alert outside medical centers and nursing homes to the issues.

The FDA issued its own safety communication on May 25, 2012, warning healthcare providers of potential dosing errors that occurred during dialysis using concentrates like GranuFlo and NaturaLyte. They followed with a GranuFlo recall alert in June.