Fresenius agrees to $250 million settlement in class action lawsuits over heart attacks linked to dialysis drugs GranuFlo and NaturaLyte

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by Charles Miller

Fresenius Medical Care has agreed to a $250 million settlement in a multidistrict litigation (MDL) in Massachusetts over two dialysis drugs, GranuFlo and NaturaLyte. Multiple class action lawsuits had been filed against Fresenius over allegations that the company did not adequately warn patients about a potential increased risk of heart attack or stroke linked to GranuFlo and NaturaLyte.

According to the lawsuits against Fresenius in the MDL, a 2010 study conducted by the company found that GranuFlo and NaturaLyte could increase the risk of heart attack or stroke in dialysis patients who were treated with the drugs. A letter sent by Fresenius to its own dialysis centers confirmed that chemical compounds produced by the body after taking GranuFlo or NaturaLyte could cause the body to eliminate too much acid from the blood, leading to sudden cardiac arrest or stroke.

Lawsuits filed against the company allege that patients treated with GranuFlo or NaturaLyte were six times more likely to suffer serious cardiac injury. More than 900 patients treated at Fresenius dialysis centers suffered heart attacks after being treated with one of the two dialysis drugs.

Although Fresenius warned its own dialysis centers about the side effects of GranuFlo and NaturaLyte in November 2011, the company did not alert other dialysis centers about these health risks until March 2012, when the FDA ordered a recall of the dialysis drugs. Lawsuits filed against Fresenius allege that thousands of patients suffered heart attacks, strokes or other complications as a result of the company’s failure to warn patients about the side effects risk of GranuFlo and NaturaLyte.

Fresenius announced the class actions settlement in the GranuFlo and NaturaLyte lawsuits just one day after the first bellwether trial in the cases was scheduled to begin in Massachusetts court. According to terms of the agreement, the settlement will go into effect if 97% of plaintiffs involved in the litigation agree to the terms of the settlement before July.

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Despite the efforts of the FDA and other federal regulators, thousands patients are injured every year as a result of side effects from prescription medications. Far too often, the pharmaceutical industry puts profit ahead of patient interests, disregarding the safety concerns because of the enormous sales that “blockbuster” drugs and medical devices can generate.

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