A National City man has filed a wrongful death lawsuit against a medical center, claiming that the center’s dialysis treatments killed his 86-year-old father.
Arthur Aragon said that the Massachusetts-based Fresenius Medical Care — which has a center at 303 W. 26th St. in National City — neglected a class one Federal Drug Administration recall of the dialysate products GranuFlo and NaturaLyte.
Pedro Aragon died on July 14, 2011, of cardiac arrest, hours after receiving a dialysis treatment at Fresenius’s National City center.
Other than kidney failure —for which he was receiving dialysis — and occasional high blood pressure, Pedro did not have any other health issues, his son Arthur said.
Aragon said since his father started dialysis treatments with the use of GranuFlo and NaturaLyte his body reacted badly to it and showed signs of breaking down.
Both GranuFlo and NaturaLyte are manufactured by Fresenius, which sells the product to other clinics worldwide.
Kent Jarrell, spokesman for Fresenius Medical Care, said the products received FDA clearance and are in use today.
“GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect,” he said.
The products are used in daily kidney dialysis treatments.
According to the FDA, class one recalls are “the most serious type of recall” and involve situations where there is a reasonable probability that use of the recalled products can cause serious adverse health consequences or death.
The recall was issued in March 2012 when the FDA discovered evidence that the two products caused serious side effects such as heart attack, stroke and brain damage.
Fresenius Medical Care used the recalled products from 2008 to 2012.
“The FDA has not suggested any change in the production or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care,” Jarrell said.
He also said Fresenius has since changed its labels to remain in compliance with FDA regulations.
The suit filed by the Boston-based law firm Kreindler & Kreindler LLP alleges that Fresenius was responsible for Pedro’s death.
“Plaintiff’s decedent suffered a cardiac event and died as a result of use of defendants’ defective product during dialysis,” the suit states.