Death by Drug Shortage, Widow Says

SALT LAKE CITY (CN) - A doctor's widow claims in state court that the "indefensible" rationing of a vital enzyme replacement drug for Fabry disease led to her husband's death.

Janet Schubert, widow of Dr. William Schubert, sued Genzyme, its corporate parent Sanofi, Sanofi-Aventis U.S., and the Mount Sinai School of Medicine, which holds the patent for the drug, Fabrazyme.

Courthouse News reported in February on a federal lawsuit in which two dozen people claimed that U.S. Food and Drug Administration and the Department of Health and Human Services give drug manufacturers carte blanche to create drug shortages that deny them the medicine that keeps them alive.

In that case, lead plaintiff Joseph Carik, who has a doctor's prescription for Fabrazyme, claimed: "By and through FDA consent, plaintiff has been banned interstate access to FDA-approved doses of Fabrazyme during a drug shortage created by Genzyme (a Sanofi company) an FDA licensee. Plaintiff is instead forcibly injected with a diluted, unregulated, unapproved dose of Fabrazyme because if the plaintiff refuses infusion of the unapproved dose, then the FDA licensee will withdraw any access and not provide future access to the drug until the shortage is over. The United States defendants have delegated all medical decisions during the shortage regarding plaintiff's disease, life, and health to the sole discretion and control of a corporation regulated by and through grant of an FDA license."

In the widow's case, in Salt Lake County Court, Janet Schubert says her husband was diagnosed with Fabry disease in 2005. Fabry disease is caused by a faulty or missing enzyme needed to metabolize lipids and results in lipid accumulation in blood vessel walls. Dr. Schubert needed the drug to treat the life-threatening condition.

Dr. Schubert, of Bannock County, Idaho, received Fabrazyme treatments about twice a month, his widow says, until a virus contamination in the drug's manufacturing facility triggered a shortage.

"Due to this shortage, Genzyme began arbitrarily rationing Fabrazyme toward the end of 2009," the complaint states. "Although patients under the age of 18 continued to receive their treatment as scheduled, older patients received as much as a 70 percent reduction in dose.

"Genzyme's rationing scheme was undertaken despite their knowledge that less than a full dosage would not be effective and many patients would suffer catastrophic health deterioration and even death.

"Shortly after he began treatment with the reduced dose in late 2009, decedent's health condition began to decline due to the reduced and ineffective dosage.

"Dr. Schubert died on March 6, 2010."

The widow says the drug makers were aware that a lower dose of Fabrazyme posed a deadly risk to patients.

Nonetheless, "Defendants each grossly, negligently, wantonly and recklessly failed to apprise the FDA, the prescribing medical professionals, and the public of the lethal risk presented due to inherent and customary manufacturing defects in the products. ...

"Defendants acted together, with a common profit motive, in failing to adequately or appropriately disclose material information relating to the production problems and ineffective lower dosages," the complaint states.

Schubert says the defendant companies approved a Fabrazyme dose "that is below the FDA approved use of 1 mg/kg body weight infused every two weeks" and sold "Fabrazyme contaminated with glass, rubber and steel particles," Janet Schubert says.

She adds: "The Fabrazyme supplied by defendants was unmerchantable in that it was unfit for its ordinary purposes, was not of even quality, and was not adequately labeled. This lack of merchantability was a legal cause of death of the decedent and the damages claimed herein."

She also claims strict liability under the Bayh-Dole Act, which prohibits unreasonable use or non-use of Bayh-Dole regulated inventions which are necessary for human health.

Schubert seeks economic, noneconomic and punitive damages for wrongful death.

She is represented by Jeffrey Eisenberg with Eisenberg Gilchrist & Cutt.

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