The U.S. Food and Drug Administration (FDA) may now be investigating the safety of two dialysate drugs at the center of a growing number of Naturalyte and Granuflo lawsuits, but their manufacturer still insisted this month that those allegations will fail because there is no evidence linking its products to the plaintiffs’ supposed injuries.

Granuflo Lawsuits

In a response brief filed Jan. 3, 2013, Fresenius USA voiced its support for a petition that will create a multidistrict litigation (MDL) docket in Massachusetts, where it is headquartered, for Granuflo lawsuits brought against the company responsible for distributing the acid concentrates used to neutralize the acid that builds up during dialysis treatments.

Naturalyte and Granuflo Recall

A Naturalyte and Granuflo recall was announced by the U.S. Food and Drug Administration (FDA) in June 2012, and was categorized as Class I—the agency’s most serious type of recall—which are only issued when it determines there is a reasonable chance the product will lead to serious side effects or death.

Fresenius’ documents with the Judicial Panel on Multidistrict Litigation (JPML) this month were filed a month after a plaintiffs’ counsel filed a petition in December to move 11 pending Naturalyte and Granuflo lawsuits to the U.S. District Court for the District of Massachusetts. All of these cases include Granuflo heart attack claims as well as other cardiovascular injuries and/or death.

Since December, another 26 Granuflo lawsuits have been filed in federal courts around the U.S., with more than a dozen other cases pending in state courts located in Illinois, Louisiana, Massachusetts, New York and Colorado, according to Fresenius USA.

Fresenius Dismisses Granuflo Heart Attack Claims

The defendant maintains that its drugs are safe, and have been for the 20 years since they were approved by the FDA.

“Although the injuries alleged by these plaintiffs are serious, the plaintiffs will not be able to prove that those injuries were actually caused by Fresenius products or the information that Fresenius provided about those products.”

Considering a Granuflo Lawsuit? Call a Lawyer Today.

Victims of the Naturalyte and Granuflo recall may be eligible to receive compensation for lost wages, medical bills, pain, suffering and other damages. To learn more about Granuflo lawsuits, call a lawyer at Bernstein Liebhard LLP at (877) 779-1414.

Published January 15, 2013 by