GranuFlo Lawsuits Consolidated in Massachusetts Federal Court

The mounting numbers of NaturaLyte and GranuFlo lawsuits will be consolidated into a federal court hearing, a judicial panel has decided. Pre-trial proceedings for all federal lawsuits related to the controversial dialysis products will be overseen by Judge Douglas P. Woodlock. The Judicial Panel on Multidistrict Litigation (JPML) made the announcement on March 29.

Fresenius Medical Care, the firm responsible for producing and marketing the products, faces hundreds of claims from dialysis patients who allege serious injuries including heart attacks, strokes and even death.

The panel considered Illinois, Mississippi, New Jersey and California as possible venues for the multidistrict litigation, before settling on Massachusetts, which is in close proximity to a number of plaintiffs and witnesses, and the Fresenius headquarters in Waltham.

Plaintiffs filed the motion to consolidate in December 2012. It was accepted after the judicial panel ruled there were enough similarities between cases for NaturaLyte and GranuFlo lawsuits to benefit from an MDL.

Fresenius, a German company, has been manufacturing and marketing the two dialysates, which are designed to filter toxins from the blood during hemodialysis since 2003, when they first got FDA approval. The company describes itself as ‘the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure.’ According to their website, Fresenius defines the ‘highest standards’ for dialysis treatment. In addition to operating the biggest network of treatment centers in the United States, Fresenius provides dialysates, dialysis machines and other dialysis products to hundreds of treatment centers around the country.

The NaturaLyte and GranuFlo lawsuits allege the two products contain dangerously high levels of bicarbonate, which can lead to heart attacks, strokes and death. A number of plaintiffs are representing deceased spouses or family members, and claim the dialysates were the direct cause of death. Fresenius’ own staff have determined that high levels of bicarbonate in the blood results in a risk of adverse effects six times greater than ordinary levels.

GranuFlo recall conducted in 2012

The court documents alluded to the 2012 Class I GranuFlo recall conducted by the FDA. A Class I recall denotes a serious risk of adverse reactions, but does not require the product to be removed from clinics and treatment centers. It does require Fresenius to provide physicians with dosing protocols and to add warnings to the labeling.

Central to the controversy was Fresenius’ failure to warn clinics – other than its own – of the dangers posed by the dialysates. Despite issuing an internal memo which proved the company’s awareness of the risks, Fresenius did not inform other clinics around the country. The FDA ultimately issued an Urgent Product Notification, alerting other clinics to the risks.

Litigation against Fresenius continues to grow

Because of the number of dialysis patients who have used the products, and the increased publicity surrounding the case, there may be thousands more GranuFlo lawsuits to come. A New York Times stated that the internal memo issued by Fresenius advised that at least 941 people have suffered sudden cardiac arrest while undergoing dialysis. More GranuFlo patients are consulting a dialysis injury lawyer to determine their options for legal recourse.

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