Fresenius Medical Care and nearly 100 of its clinics in Louisiana are being targeted by the state’s Attorney General in a new GranuFlo lawsuit. The complaint, which was filed in state court on June 27th, claims that Fresenius failed to issue a public warning about cardiac risks associated with its GranuFlo and NaturaLyte dialysis concentrates prior to their 2012 recall.
According to a report published by The New Orleans Advocate, the state is accusing Fresenius and its clinics of violating Louisiana’s Unfair Trade Practices and Consumer Protection Law in order to “defraud dialysis clinics, physicians, the state and its residents.” Among other things, the complaint claims that the company was aware as early as 2004 about the risks associated with GranuFlo and NaturaLyte, but failed to issue any type of warning to patients or the roughly 1,500 non-Fresenius dialysis clinics using the drugs. Among other things, the lawsuit points out that in 2010, 941 dialysis patients at 667 Fresenius clinics suffered cardiac arrest during treatment with GranuFlo and NaturaLyte.
The state is seeking civil penalties of $5,000 per violation under Louisiana’s Unfair Trade Practices and Consumer Protection Law.
The lawsuit being pursued by the state of Louisiana is one of more than 1,860 similar cases that have been filed in U.S. courts on behalf of dialysis patients who were allegedly injured by GranuFlo or NaturaLyte. Like that GranuFlo case, all of these claims allege that improper use of the products can cause dialysis patients’ bicarbonate levels to rise and increase the risk of a heart attack. The majority of these GranuFlo and NaturaLyte claims are pending in U.S. District Court, District of Massachusetts.
Fresenius Medical Care warned in March 2012 that improper dosage of GranuFlo and NaturaLyte could put patients at risk for catastrophic heart events, including heart attacks, strokes and sudden cardiac death. The notification was eventually declared a Class I GranuFlo recall by the U.S. Food & Drug Administration. Class I is the agency’s most serious safety notice, and is only issued when a medical product poses a significant risk of serious injury or death.