ALAMEDA, Calif. (CN) - A patient died because Kaiser used recalled dialysis fluid, her distraught daughter claims in an Alameda County Superior Court complaint.
The fluid, made by Fresenius Medical Care, was recalled "after it was found that the products could put patients at risk for cardiac arrest," the complaint states.
Janal Watkins, individually and as personal representative of the Estate of Janice Rose Watkins sued Kaiser Foundation Health Plan Inc.; Kaiser Foundation Hospitals; Northern California Permanente Medical Group; Fresenius Medical Care; DaVita; Wesley Lesker; Kim Hadley and Satellite Healthcare.
Defendants used Fresenius' GranuFlo and Naturalyte products when they put Janal's mother on dialysis.
After several treatments, Janice had a cardiac arrest due to a condition caused by the high acid concentrates in the products, and died the same day.
The Food and Drug Administration had issued a Class 1 recall on dialysis concentrates GranuFlo and Naturalyte but did not warn outside clinics, which used the products, until an internal memo was leaked, according to the complaint.
A Class I recall indicates that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the complaint.
Janice was not warned of the risks, the complaint states.
Defendants "knew or should have known of the recall or inherent dangers of using the Fresenius Medical Products. Defendants collectively continued to administer such products to decedent, which placed her at increased and greater risk for cardiac arrest. Defendants also used unsafe doses" of the products," according to the complaint.
Prior to Janice's hospitalization, she had "lived at her own home, drove her own vehicle, and performed her own activities of daily living. She controlled her own finances. She functioned independent of others. She was in no way nearing death, an irreversible coma, or a persistent vegetative state," according to the complaint.
Mother and daughter had had an extremely close relationship, spending much of their time with each other and seeing or speaking to each other each day, as they have most of their lives, the complaint states.
Janal seeks punitive damages for negligence, medical negligence failure to warn, willful misconduct and wrongful death.
She is represented by Stephen M. Sirota of the Law Offices of Allan R Frumkin in San Ramon.