Lawsuit Alleges Wrongful Death from Fresenius Granuflo Dialysis Treatment

Fresenius Medical Care, the nation’s largest dialysis provider, faces a wrongful death lawsuit filed by the widow of an Alabama man who died from a heart attack after receiving dialysis treatment using the company’s Granuflo product. 

The complaint (PDF) was filed by Betty Lemmond in the U.S. District Court for the Northern District of Alabama on August 10, naming Fresenius and its subsidiaries, as well as DaVita, Inc., as defendants.

Lemmond’s husband, Dizzy Dean Lemmond, died of a heart attack on August 11, 2010, shortly after hemodialysis treatment at a DaVita clinic. Dialysate prescriptions administered during the treatment included Fresenius’ NaturaLyte and Granuflo acid concentrates.

According to allegations raised in the Fresenius wrongful death lawsuit, side effects of Granuflo and NaturaLyte caused Dizzy Dean Lemmond’s heart attack because inadequate warnings and instructions were provided about the risks associated with the product. Lemmond suggests that Fresenius knew or should have known about the risk of the dialysis treatment problems before her husband suffered a heart attack.

Fresenius Medical Care owns and operates hundreds of dialysis centers throughout the United States. The company also manufactures and sells products used during hemodialysis treatment at other clinics, including DaVita.

In recent months, concerns have surfaced about risks associated with NaturaLyte and Granuflo, which are combined with bicarbonate buffers as part of the dialysate prescription.

Lemmond’s complaint and other Fresenius dialysis lawsuits filed by individuals throughout the United States allege that the manufacturer failed to provide adequate warnings about the rate at which the sodium acetate in Granuflo and NaturaLyte convert to bicarbonate, requiring doctors to closely monitor dialysis patient’s buffer prescriptions to avoid the risk of sudden cardiac arrest, heart attack or death, which may occur during or shortly after dialysis treatments.

An internal analysis by Fresenius has found at least 941 instances where individuals suffered a cardiopulmonary arrest within their dialysis centers between January 1, 2010 and December 31, 2010.

Fresenius issued an internal memo in November 2011 to its own facilities, warning that inappropriate prescription of the dialysis drugs NaturaLyte and Granuflo could result in a high sodium bicarbonate level, which can cause metabolic alkalosis. However, the memo did not go out to the other dialysis centers that use Fresenius products until March 2012.

The FDA has determined that the warnings constitute a Class I medical device recall for Granuflo and Naturalyte, which means the agency believes the products are likely to cause severe injury and death.

In May 2012, the FDA issued a safety communication warning about the risk of dosing problems during hemodialysis treatments with Granuflo and NaturaLyte, urging doctors to consider the impact of the acetate levels in these dialysate concentrates when ordering or administering hemodialysis treatments.

According to a June 2012 report by the New York Times, the FDA is investigating whether Fresenius may have violated federal law by failing to provide warnings about the risks associated with NaturaLyte and Granuflo as early as possible after they discovered the risks.

The lawsuit accuses the defendants of strict liability, failure to warn, breach of warranty, negligence, fraud, wrongful death, unjust enrichment, and wantonness. The lawsuit seeks both compensatory and punitive damages.