NaturaLyte/GranuFlo Lawsuits Consolidated Into MDL

NaturaLyte/GranuFlo Lawsuits Consolidated Into MDL

By Courtney Coren

A panel of federal judges agreed to consolidate all GranuFlo and NaturaLyte lawsuits into one court in Massachusetts last week.

On March 29, 2013, the U.S. Judicial Panel on Multidistrict Litigation in San Diego, California decided that the almost 40 lawsuits filed against Fresenius Medical Care North America Inc., the maker of GranuFlo and NaturaLyte, would now be handled by the U.S. District Court of Massachusetts under Judge Douglas P. Woodlock.

There are currently 37 GranuFlo lawsuits pending in 11 states including Alabama, California, Florida, Georgia, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio, and Pennsylvania against Fresenius. But attorneys claim in the court documents filed that they have over 700 clients in 46 states ready to file additional GranuFlo and NaturaLyte lawsuits.

Multidistrict litigation (MDL) allows lawsuits making similar claims that are already pending in court to be presided over by a single judge. An MDL serves to establish the facts that will be necessary to try all the cases in the MDL when they are sent back to their districts for trial. As opposed to a class action lawsuit, all the plaintiffs will be awarded individual outcomes; although several class action lawsuits can also be consolidated into one MDL.

The GranuFlo and NaturaLyte lawsuits charge Fresenius with failure to warn the patients and the clinics where they received their dialysis treatment of how to properly dose the two drugs, which led to cardiac arrests, heart attacks, stroke, and other serious complications.

Fresenius owns and operates over 2,100 dialysis treatment centers in North America, where they also supply dialysis machines and products, such as GranuFlo and NaturaLyte that are used in the dialysis process.

GranuFlo and NaturaLyte are supposed to help filter the blood during the dialysis treatment. They serve to neutralize the acid in the blood by providing bicarbonate, the necessary alkaline substance. The problem that has been found with GranuFlo and NaturaLyte is that they provide too much of the bicarbonate, leading to a condition known as alkalosis in which the blood has become too alkaline. When this happens, the risk of cardiac arrest becomes 6 to 8 times more likely.

In November 2011, Fresenius sent out a memo to its own clinics — not all of the clinics that use the drugs — of the risks associated with GranuFlo and NaturaLyte if not properly dosed. In the memo, Fresenius claimed that GranuFlo was responsible for 941 deaths due to cardiac arrest at Fresenius clinics in 2010. They later informed the rest of the dialysis clinics using their products in March 2012, but only after the FDA forced them to.

The U.S. Food & Drug Administration received an anonymous copy of the letter that was sent out in November 2011, which caused the FDA to question Fresenius prompting the notice that was sent out in March 2012.

The FDA issued a Class I recall of GranuFlo and NaturaLyte — the most serious recall they can issue that is restricted only for products that may result in severe injury or death. Following the recall, the dosage information was updated.

One of the key questions from the FDA is how long Fresenius knew and withheld the data showing the risks of GranuFlo and NaturaLyte in their initial dosing recommendations.

In the lawsuits already filed against Fresenius, plaintiffs claim that Fresenius did not properly train the clinics on how to use GranuFlo and NaturaLyte. One lawsuit claims that the two drugs are “unreasonably dangerous.”

If you or someone you know has been injured by receiving GranuFlo or NaturaLyte during dialysis treatment, legal options are available. Learn more and get a free consultation regarding a claim’s eligibility at the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Experienced legal professionals have access to medical experts to assess whether or not these kidney dialysis products may have played a role in your complications, so act now.