Ever since Kaiser left its Northern California patients off the list to receive kidney transplants, the evidence seems to be mounting that Kaiser is a particularly bad place for kidney patients.

Kaiser Death Blamed on Recalled Dialysis Fluid
By TISH KRAFT
Courthouse News
August 14, 2014

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.
v 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.

Amicus Therapeutics Inc. Conducts Successful Trial For Fabry Genetic Disorder (excess fat in cells) Drug

Amicus Therapeutics Inc. Conducts Successful Trial For Fabry Genetic Disorder Drug
By Rebekah Marcarelli r.marcarelli@hngn.com
HNGN
Apr 29, 2014

An Amicus Therapeutics Inc. drug that would reduce abnormal fat that accumulates in cells when a rare genetic disorder is present proved succeeded in trials. The condition can lead to "heart attack, stroke and kidney failure," Reuters reported. The company plans to file for U.S. marketing approval in the wake of these results. The drug, dubbed migalastat, could be an effective monotherapy for Fabry disease patients who have endure a year of previous treatment. Share This Story The researchers conducted a 24-month study in which for the first six months participants either received the fat-fighting drug or a placebo. All of the patients were then treated with migalastat for a six-month follow up period and 12-month extension phase, Reuters reported. The drug is administered intravenously. The drug did not show a significant reduction after six months, but the compant plans to report the results at 12 months. "It may be that (the drug) needs more time to work, as shown by today's results," Janney Montgomery Scott analyst Kimberly Lee told Reuters. The drug is also being tested as a combination treatment to be used with other common treatment methods for the condition. Fabry disease is genetic; it causes a type of fat called "globotriaosylceramide, or GL-3," to build up in cells, especially in the kidney. This lipid accumulation is accompanied by a reduction in the enzyme α-galactosidase A (α-Gal A), which can lead to "cell damage, leading to pain, hearing loss, kidney failure, heart attacks and strokes," Reuters reported. Migalastat could combat these devastating effects by binding to the α-Gal A enzyme and helping it to break down the accumulating lipids. Lee believes the new drug could generate $250 million globally if used as a monotherapy; if the drug is used as a combination therapy it could be worth up to twice as much, Reuters reported.