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Louisiana Files Lawsuit against GranuFlo, NaturaLyte maker Fresenius

Arm hooked to dialysis machine

The state of Louisiana sued Fresenius Medical Care North America and nearly 100 of its clinics statewide after two of its dialysis drugs – NaturaLyte and GranuFlo – were linked to fatal heart attacks, strokes and other conditions.

Louisiana officials claim Fresenius knew that GranuFlo and NaturaLyte could elevate patients’ bicarbonate levels and therefor increase their chances of a heart attack but chose to ignore those risks. According to the lawsuit, filed in the state’s 19th Judicial District, state officials say the company knew that special instructions would have reduced those risks.

The state claims the company defrauded the state’s Medicaid program and never warned patients or roughly 1,500 non-Fresenius dialysis clinics in Louisiana about dangers of the two drugs.

The state seeks to recover $5,000 per violation for payments made to Louisiana’s Medicaid program. It also asks that Fresenius pay back profits made from the sale of GranuFlo.

FDA Recalled GranuFlo and NaturaLyte in 2012

In 2012, the U.S. Food and Drug Administration (FDA) issued an urgent Class I recall for both of the drugs, alerting consumers that the products can cause death.

Massachusetts-based Fresenius introduced GranuFlo and NaturaLyte in 2003 and 2007, respectively, for use in three-stream hemodialysis, a process that removes toxins from the blood of kidney-failure patients. GranuFlo, dry, granulated product, and NaturaLyte, a liquid, perform the same function. When used in proper measure, they help neutralize acid byproducts in the blood. But studies show that Fresenius disseminated poor directions about the use of GranuFlo and NaturaLyte during dialysis, which helped caused an excess of bicarbonate.

Excess Bicarbonate Linked to Fatal Heart Attacks, Strokes

For many patients, the additional bicarbonate led to metabolic alkalosis, which is associated with fatal heart attacks, stroke, irregular heartbeat and sudden death.

When Fresenius suspected potential problems in 2010, it ran tests on GranuFlo and found a link between heart attacks and the drug. In a 2011 internal memo, company researchers revealed that patients with excessive bicarbonate levels were six times more likely to have heart attacks than those with normal levels.

The company warned its 1,800 dialysis centers in the wake of the results, but an estimated 3,300 non-Fresenius dialysis centers were not informed until 2012, when the FDA issued its recall. Fresenius opted not to recall the drug.

About a year later, injured patients and their families filed four class-action lawsuits in Colorado federal court against DaVita Healthcare, a chain of dialysis centers. According to court filings, plaintiffs allege the medical professionals at DaVita should have monitored bicarbonate levels more carefully.

Federal MDL Already Established

At about the same time, a federal Multidistrict Litigation (MDL) was established in the U.S. District Court of Massachusetts. Victims argue that Fresenius withheld critical information and caused countless deaths. In the complaints, patients claim that Fresenius put them at risk in several ways.

They allege the company:
  • Did not properly warn health-care providers and patients about the heart attack and death risks even though the company knew about the risks.
  • Intentionally withheld the information and did not properly warn the public or the FDA.
  • Intentionally withheld information from non-Fresenius doctors and clinics.
  • Continued to market and sell both drugs despite the known risks.
  • Misled consumers and displayed a “conscious disregard for the safety of the public.”

The first MDL trial is scheduled to begin in January 2016.