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Texas Granuflo Metabolic Alkalosis Lawsuit Added to MDL

DialysisOn June 25, 2014, a Corpus Christi, Texas widow filed a federal Granuflo metabolic alkalosis lawsuit against the makers and distributors of Granuflo. The lawsuit was filed in the United States District Court for the Southern District of Texas. On September 4, 2014, the case was transferred to the ongoing multidistrict litigation (the “MDL”) in the Massachusetts District Court.

The complaint targets both Fresenius Medical Care Holdings, Inc., which manufactures, tests, markets, and sells Naturalyte and Granuflo products in North America and a number of its related companies, also branded under the name Fresenius, which operate dialysis centers across the country.

The plaintiff’s decedent underwent dialysis treatment from 2011 to 2013 and, allegedly as a result, suffered metabolic alkalosis and cardiac arrest. The emergency led to his death. The complaint alleges that the decedent was not informed of the risks associated with GranuFlo or NaturaLyte before undergoing dialysis.

Granuflo metabolic alkalosis lawsuit

There are over 2,000 lawsuits in the U.S. related to GranuFlo and NaturaLyte products used in hemodialysis. Because the lawsuits namely target the same defendants and are based on the same or very similar allegations, many of the federal cases have been transferred to the MDL pending before Judge Douglas Woodlock in the United States District Court for the District of Massachusetts.

The primary GranuFlo defendant, Fresenius Medical Care, is the largest manufacturer of dialysis products in the world. It is also the largest dialysis service provider, operating over 2,100 North American dialysis centers. In the recent complaint filed by the Texas widow, as in many of the other federal GranuFlo lawsuits, the defendants include a variety of Fresenius business entities from the manufacturing company to the operators of the dialysis centers.

Common allegations against Fresenius

To be suitable for MDL, cases must feature common allegations. In the GranuFlo MDL, those common allegations are that the manufacturer did know or should have known that the GranuFlo and/or NaturaLyte products may cause metabolic change leading to cardiac difficulties and heart attack. There is evidence that using GranuFlo may elevate the pH level in the tissues. Some of the injuries that can result include decreases in blood pressure, potassium, and blood oxygen; an increase in carbon dioxide in the blood; changes in heartbeat or rhythm, and cardiopulmonary arrest.

A number of the complaints, including the recent Texas-based one, allege that there is ample evidence that Fresenius knew that GranuFlo and/or NaturaLyte products had a propensity to lead to metabolic alkalosis but failed to inform consumers, doctors, non-Fresenius dialysis centers who also used the products, or the FDA. Among the evidence is an internal memo from late 2011 showing that Fresenius employees knew that GranuFlo was associated with an increased risk of cardiac arrest and death.

Ultimately, the FDA announced a recall of Naturalyte and GranuFlo in March 2012. The recall cited an association between the drugs and serious side effects including metabolic alkalosis. A second, voluntary recall of NaturaLyte liquid concentrate was issued throughout the U.S. and Canada in May 2014 due to bacterial contamination of specific lots of the solution.

  1. Justia Dockets & Filing, Cantu v. Fresenius Medical Care Holdings, Inc.,

  2. Fresenius Medical Care, Our Company: About Fresenius Medical Care North America,