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Federal Panel Creates Massachusetts MDL for GranuFlo, NaturaLyte Lawsuits

U.S. District Judge Douglas P. Woodlock

Dozens of GranuFlo and NaturaLyte lawsuits pending in federal courts across the country will be consolidated into one court in the District of Massachusetts.

The U.S. Judicial Panel on Multidistrict Litigation heard arguments in San Diego last week about where to move a handful of federal lawsuits filed in Alabama, California, Florida, Georgia, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio and Pennsylvania.

The lawsuits all make claims against Fresenius USA and/or its subsidiaries. The Germany-based company manufactures and markets GranuFlo and NaturaLyte, two drugs commonly used in dialysis treatment.

Plaintiffs allege Fresenius failed to warn patients adequately that inappropriate dosing can lead to heart problems and other serious health complications.

Approximately 40 lawsuits are filed in 11 states, but in court documents attorneys say they have more than 700 clients in 46 states ready to file suit. Because many of those potential plaintiffs live in the South, a request for a multidistrict litigation (MDL) in Mississippi was initially suggested, with one in Alabama named as the alternative.

After weighing all factors, the panel decided an MDL proceeding in Massachusetts is the best option. The decision is favored by numerous plaintiffs, as well as Fresenius, whose North American branch is based in Waltham, Mass.

The panel appointed U.S. District Judge Douglas P. Woodlock to preside over the Fresenius GranuFlo/NaturaLyte MDL.

Fresenius Withheld Data on Safety Risks

Fresenius Medical Care is one of the world’s leading suppliers of dialysis machines and related products. It operates more than 2,100 facilities in North America.

More than 33 percent of Americans with kidney disease receive dialysis treatment at a Fresenius facility. The company’s products are also used by doctors in other medical centers.

Patients injured by Fresenius’s products allege that the company failed to adequately disclose a potentially fatal risk associated with GranuFlo and NaturaLyte, two disposable dialysate solutions used to filter the blood in dialysis treatment.

In a November 2011 internal memo, Fresenius informed its doctors that at improper dosages, GranuFlo and NaturaLyte can lead to alkalosis — a condition associated with a six to eightfold greater risk of cardiac arrest and sudden cardiac death in the dialysis facility. The memo states that 941 patients suffered cardiac arrest in Fresenius clinics in 2010.

Although the memo insists that the prescription errors should be addressed urgently, Fresenius did not hastily warn outside health centers or the U.S. Food and Drug Administration (FDA) about the elevated risk for heart complications. Other centers didn’t learn about the issue until months later, when an anonymous tip about the memo prompted the FDA to question the company. Fresenius distributed an urgent product notification to all health centers using its products shortly after.

On March 29, 2012, the FDA initiated a Class I recall of GranuFlo and NaturaLyte, which is the most serious type of FDA recall. It is reserved for products whose use is associated with a reasonable probability for serious health consequences or death. The dosing information was updated on the products. The agency is currently investigating whether Fresenius violated any federal regulations when it withheld data on its products’ risks.

Lawsuits, Need for Dialysis on the Rise

Despite the ongoing FDA investigation and the allegations from injured patients, Fresenius is confident that it acted responsibly to keep patients safe. The company has admitted no wrongdoing, and says its product labels adequately informed doctors of GranuFlo and NaturaLyte health risks.

In earlier court filings, Fresenius said plaintiffs’ claims will not show that GranuFlo and NaturaLyte are "unreasonably dangerous" or that the company did not give the proper training to providers who treated patients with dialysis involving GranuFlo and NaturaLyte.

The company is preparing for a projected rise in dialysis demand with new treatment centers. With an aging population, longer lifespans from better medical care, poor diets and ongoing issues with high blood pressure and obesity, kidney disease is a growing burden.

“We are expected to double in population in dialysis in the next 10 years nationally,” said Anita Aldridge, clinical manager of an expanded Fresenius facility in Du Quoin, Ill.

Fresenius could face many more claims related to its two dialysis drugs. One law firm representing more than a dozen plaintiffs in the case has received thousands of inquiries from people with potential claims and expects many more cases to be filed.