Naturalyte Lawsuit Brought After Dialysis Death

Nevada resident Anta Ealy filed a Naturalyte lawsuit against Fresenius Medical Care, alleging that side effects from the dialysate caused her mother’s untimely death. She brought her products liability/personal injury claim on behalf of the decedent, Francis Ealy, in New York district court on August 29, 2013. The plaintiff argues that as a direct and proximate result of adverse Granuflo and Naturalyte side effects, Francis Ealy developed metabolic alkalosis, and suffered cardiac arrhythmia and hypokalemia – all conditions that culminated in her premature demise on September 1, 2011.

Naturalyte lawsuit facts and allegations

Granuflo and Naturalyte are both acid concentrates administered during hemodialysis treatments for patients with acute or chronic kidney failure. Both are designed, manufactured and distributed by Fresenius Medical Care to be utilized in conjunction with a bicarbonate solution. Court documents state that Fresenius bypassed the premarket approval process by having both dialysates cleared through the FDA’s 510(K) system, a fast-track route that evades stringent clinical trials as long as the product has similarities to another, predicate drug or device already on the market.

According to her complaint, in 2002, the defendant altered the formulation of Granuflo and Naturalyte, with increased sodium diacetate, without advising the FDA that their revised formula was different than the previously cleared product. Ealy further argues that Fresenius intentionally and negligently concealed this vital information from the FDA, and also failed to inform treating physicians and health care facilities using the products of the increased diacete level, which would require adjustments in the amount of bicarbonate solution administered.

In 2004, Fresenius evaluated the findings of their Retrospective Study, which demonstrated among other complications a major increase in rates of metabolic alkalosis after Granuflo and Naturalyte use. Metabolic alkalosis is a result of elevated acids in the body, and often leads to potentially fatal reactions including:

• Low blood pressure
• Hypokalemia (low potassium levels)
• Hypoxemia (low blood oxygen)
• Hypercapnia (increased carbon dioxide in the blood)
• Cardiac arrest
• Sudden death

Dialysis injury reports trigger Granuflo & Naturalyte recall

It wasn’t until late March 2012, that the general public and medical community were made aware of Granuflo and Naturalyte heart attack risks. The FDA, acting on an anonymously leaked memo from Fresenius that detailed more than 900 incidents of dialysis deaths related to its products, issued a recall on both products based on serious health risks.  While the GranuFlo recall failed to remove Fresenius’ concentrates from the market, it did alert physicians about dosing errors and ensured product labels were properly updated.

Fresenius accused of fraudulent concealment

On behalf of her now deceased mother, Anta Ealy is now demanding exemplary, compensatory and punitive damages against Fresenius, based on the company’s alleged negligence and misconduct.

Her Naturalyte lawsuit adopts causes of action including:

• Negligence
• Strict products liability
• Fraud and deceit
• Wrongful death
• Negligent misrepresentation
• Fraudulent concealment
• Fraudulent misrepresentation
• Breach of implied and express warranty

At this time, court dockets don’t indicate if Ealy’s lawsuit qualifies as a tag-along action for federal consolidation in the district of Massachusetts, where the Granuflo MDL No. 2428 has been established. As of early September, just over 200 actions are pending in the Granuflo & Naturalyte multidistrict litigation.