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Fresenius Wins Bellwether Trial Over Dialysis Treatment
Mar 3, 2017 | Law360
By Brian Amaral
A federal jury in Massachusetts delivered a verdict in favor of Fresenius Medical Care Friday in a bellwether trial over its dialysis treatments, finding that the plaintiff hadn’t proved her late husband died as a result of the clinic’s care. -
Jury clears Fresenius dialysis treatment in patient death lawsuit
Mar 3, 2017 | Modern Healthcare
By Maria Castelluci
A Massachusetts federal jury cleared dialysis provider Fresenius Medical Care of liability in a suit alleging one of its clinics caused a patient's death. The verdict marks a big win for Fresenius, as it was the first case to go to trial after the company agreed to pay $250 million to settle thousands of lawsuits from dialysis patients and their families over their care.
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Fresenius Wins Bellwether Trial Over Dialysis Treatment
Mar 3, 2017 | Law360
By Brian Amaral
A federal jury in Massachusetts delivered a verdict in favor of Fresenius Medical Care Friday in a bellwether trial over its dialysis treatments, finding that the plaintiff hadn’t proved her late husband died as a result of the clinic’s care.
Former North Carolina resident Carley Dial’s case was the first to go to trial for people who opted out of a $250 million settlement over claims that Fresenius’ dialysis treatment with Naturalyte and Granuflo caused patient deaths.
The jury, after deliberating for about a day, found that Florella Dial hadn’t established by a preponderance of the evidence that her husband Carley Dial’s treatment with Naturalyte was the proximate cause of his death.
“We’re pleased with the outcome,” Ronald Castle, a Fresenius attorney, said after the verdict.
Dial’s family said that because his doctors weren’t properly trained on how to use Naturalyte, he was given an overload of ingredients that help regulate the amount of acid in the system of someone with unhealthy kidneys. Two different chemicals, bicarbonate and acetate, can work together to increase the amount of bicarbonate in patients' systems, but the label on Naturalyte didn't even correctly describe its ingredients, Dial's family said.
For Dial, an ingredient overload administered by confused doctors caused metabolic alkalosis and Dial’s death from cardiac arrest, likened to an electric problem with the heart, Dial’s family said.
“I believe Mr. Dial unfortunately died of a sudden cardiac arrest that more likely than not was due to excess delivery of bicarbonate,” Dial’s expert, Dr. Steven Borkan, told the jury in testimony on Feb. 21.
But Fresenius’ expert testified that Dial had actually died of a heart attack, related not to his treatment at Fresenius but to underlying issues like sky-high blood pressure and a family history of heart disease.
Fresenius has sold 300 million gallons of Naturalyte since 1981, James Bennett of Dowd Bennett LLP told the jury when the trial opened on Feb. 8.
”Naturalyte is safe and effective,” Bennett said.
Senior U.S. District Judge Douglas Woodlock told the parties that the next bellwether case should be teed up soon for a trial date; a previous bellwether trial in state court, before the settlement was reached, also resulted in a verdict for Fresenius.
Fresenius’ $250 million settlement in principle would need 97 percent of plaintiffs to opt in. It’s not clear if that threshold has been reached, nor whether the company would trigger it if it fell below that total. In total, 12,000 cases in federal and state courts were filed for Naturalyte and a related product, Granuflo, though more than 1,000 were dismissed, according to court documents.
Fresenius has until May 10 to back out of the deal per the terms of the settlement.
“We have made no decision about whether to confirm or void the comprehensive settlement,” Fresenius spokesman Kent Jarrell told Law360 Friday.
Fresenius is represented by James Bennett and Megan S. Heinsz of Dowd Bennett LLP, William Kettlewell, Sara Silva and Maria Durant of Collora LLP and Juanita Brooks and Roger Denning of Fish & Richardson PC.
Dial's estate is represented by Robert Carey and Molly Booker of Hagens Berman Sobol Shapiro LLP, Craig Valentine of Norton Frickey LP and Stuart Paynter of the Paynter Law Firm PLLC.
The case is Dial v. Fresenius Medical Care Holdings Inc. et al., case number 1:14-cv-11101, in the U.S. District Court for the District of Massachusetts. -
Jury clears Fresenius dialysis treatment in patient death lawsuit
Mar 3, 2017 | Modern Healthcare
By Maria Castelluci
A Massachusetts federal jury cleared dialysis provider Fresenius Medical Care of liability in a suit alleging one of its clinics caused a patient's death.
The verdict marks a big win for Fresenius, as it was the first case to go to trial after the company agreed to pay $250 million to settle thousands of lawsuits from dialysis patients and their families over their care.The suit was filed by the family of Carley Dial, a North Carolina man who died at a Fresenius clinic in 2012. Dial's family claims he died of cardiac arrest shortly after he received GranuFlo, a treatment used in dialysis machines to cleanse patients' blood. The Dial family is barred from participating in the settlement because it opted not to join and file a suit.
The verdict may be used by the company and other plaintiffs who opted out of the settlement to gauge the value of their claims. Fresenius still faces more than 4,000 lawsuits in federal court over dialysis treatments that use Naturalyte and Granuflo. Plaintiffs claimed the treatments caused patients to suffer heart attacks and deaths because Fresenius doctors didn't know how to use the treatment ingredients.
Kent Jarrell, a spokesman for Fresenius, said the company was “gratified" by the verdict. He added that the verdict doesn't impact the $250 million settlement agreement, which is still pending. No decision has been made by Fresenius to confirm or void the settlement. The $250 million settlement must include at least 97% of all suits filed.
Fresenius initially came under fire in 2012 for its GranuFlo product when it sent a memo to its doctors warning the treatment was contributing to an increase of patients dying from cardiac arrest. The Germany-based provider failed to warn physicians not part of Fresenius of the concern. The Food and Drug Administration launched an investigation shortly afterward.
More than 10,000 lawsuits were filed as a result of the adverse treatment effects, but more than half were settled.
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