5,500 Lawsuits Now Filed over GranuFlo, NaturaLyte in Mass. Litigations

Published on July 23, 2014 by Sandy Liebhard

A dialysis drug and service provider is currently “fending off a tidal wave of lawsuits” on behalf of GranuFlo patients who allegedly sustained strokes, heart attacks and other injuries that may have caused sudden cardiac death, the Boston Herald reports.

Between a pair of federal and state litigations established in Massachusetts, a report on July 17th indicates that Fresenius Medical Care has now been named in approximately 5,500 claims over the acid concentrates. A Case List updated two days earlier indicates that 1,900 NaturaLyte and GranuFlo lawsuit filings have now been centralized in a multidistrict litigation underway in the U.S. District Court, District of Massachusetts, while another 3,694 cases over the dialysis drugs have now been filed in Middlesex County Superior Court. All these lawsuits similarly accuse Fresenius of failing to adequately warn about serious heart side effects that may stem from use of GranuFlo and NaturaLyte, which they claim were designed defectively.

Speaking to the dialysis lawsuits stacked against them, Fresenius told the Boston Herald, “GranuFlo and NaturaLyte are safe and effective when used in accordance with their labels and instructions for use. Both products are essential to dialysis.”

Plaintiffs in claims involving these acid concentrates would likely disagree with these statements.

Fresenius failed to warn the public about GranuFlo and NaturaLyte’s risks until March 2012, according to lawsuits, when the company issued an Urgent Product Notification that noted their potential to result in a condition associated with elevated levels of bicarbonate. Patients with metabolic alkalosis may be increasingly susceptible to cardiovascular problems, Fresenius said on March 29th.

FDA Never Removed GranuFlo, NaturaLyte from U.S. Market, Fresenius Says

In June 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall involving GranuFlo and NaturaLyte after determining drug side effects to be serious and potentially fatal. Following this action, reports began to surface that the federal agency had begun investigating the dialysis drug manufacturer, who may have withheld vital safety information about patient deaths that occurred before March.

Federal regulators never removed GranuFlo or NaturaLyte from the market, however, which a Fresenius spokesperson pointed out to the Herald.

“The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care,” the spokesperson added.

An internal memo sent by Fresenius in November 2011 acknowledged 941 patient casualties that resulted after use of GranuFlo and NaturaLyte.