Medical procedures already carry with them dangers and risks, and this is worsened when medical products are defective. Our Atlanta product liability lawyers have been following a story about dialysis solutions and the lawsuits being filed around the country, including those in Georgia. Last year, the Food and Drug Administration (FDA) issued a recall for the particular solutions in question, Naturalyte Liquid Acid Concentrate and GranuFlo (powder) Acid Concentrate. The products were manufactured, distributed, and used by Fresenius Medical Care during dialysis. The company is the largest operator of dialysis clinics in the U.S. and also manufactures dialysis solutions and equipment. The FDA recall notice reads, "This product may cause serious adverse health consequences, including death.
Lawsuits have been filed in 37 cases in federal courts, including one involving a patient in Georgia. The plaintiffs claim that the aforementioned dialysis products caused the patients to suffer a cardiac arrest, heart attack, or sudden death, either during the dialysis treatment or within 48 hours thereafter. The various lawsuits allege that Fresenius failed to provide warnings to doctors about the importance of monitoring bicarbonate levels among patients during dialysis. The solutions contain an element that transforms into bicarbonate at levels that are often too high, leading to cardiac arrest or sudden death. The lawsuits claim that Fresenius knew as early as 2010 that their GranuFlo patients died at rates six times higher than those occurring with competing products. In 2011, the company clarified to doctors at their own dialysis centers about the problems, but didn't issue any information or instructions outside their centers until March 2012. This led the lawsuits to claim the company knew, or should have known, about these fatal consequences of the dialysis solutions.
The deaths allegedly connected to the products occurred between 2010 and 2012. These cases involve patients from across the age spectrum, from 23 years old to 89 years old. An internal review by Fresenius found that at 667 of their dialysis centers, there were at least 941 cases of patients suffering cardiac arrest during dialysis in 2010 alone. This information is what prompted the FDA recall last year.
The Fresenius dialysis solution litigation has been centralized into a multidistrict legislation case, consolidating cases filed in Georgia, Alabama, California, Florida, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio and Pennsylvania, in the District of Massachusetts, where Fresenius has its headquarters. Fresenius agreed to this approach earlier this year.
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