Litigation: Sanofi, Genzyme 'negligently allowed a virus contamination in the manufacturing facility'

Litigation is testing whether manufacturing problems at a pharmaceutical plant that led to a drug shortage can be considered legal negligence--as well as whether the manufacturer can be held accountable for patients' deaths.

An Idaho widow has sued Genzyme and parent Sanofi ($SNY), saying the viral contamination at a plant led to a shortage of Fabrazyme. The resulting rationing of the Fabry disease treatment killed her husband, she maintains. The Mount Sinai School of Medicine, which holds the patents for Fabrazyme, is also named in the lawsuit.

The lawsuit, which can be accessed via a link from a Pharmalot story, says that in June 2009, the defendants "negligently allowed a virus contamination in the manufacturing facility where Genzyme makes Fabrazyme [leading] to a shortage of the drug, which resulted in Genzyme not meeting demand of Fabrazyme to Fabry disease patients." The situation was made worse in November 2009 after the FDA found more contamination in Fabrazyme, resulting in a further reduction in the drug's availability. "Due to this shortage, Genyzme began arbitrarily rationing Fabrazyme toward the end of 2009. Although patients under the age of 18 continued to receive their treatment as scheduled, older patients received as much as a 70% reduction in dose," the lawsuit maintains.

The problems at the plant led Genzyme to sign a consent decree with the FDA, and it has been working to resolve the issues. It also began shipping Fabrazyme supplies from its recently FDA-approved plant in Framingham, MA. Fabrazyme supplies should double by year's end, according to Sanofi CEO Chris Viehbacher. Patients are now being returned to full dosing.

But those actions were too little too late for some patients, the suit suggests.

"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," according to the suit. The suit says the patient started the reduced dosage in late 2009 and died March 6, 2010.

The suit was brought by Janet Schubert, widow of Dr. William Schubert, an OB/GYN who practiced in Pocatello, Idaho, from 1976 until his death. According to an obituary, he received a Robert Wood Johnson National Award for helping establish a prenatal clinic and caring for "underserved pregnant women in Southeast Idaho."

A Genzyme spokeswoman told Pharmalot that the company could not comment on the litigation, but it shared the community's desire to return to full supplies.

Schubert's lawsuit, which was filed in Salt Lake County Court in Utah, follows another patient action in federal court. Two dozen patients, including a lead plaintiff who uses Fabrazyme, allege that the FDA allows drug companies to discriminate against U.S. citizens, citing Genzyme's decision to ration American Fabrazyme supplies more severely than those in Europe. Another patient group sued last year over Genzyme's handling of the shortage.

- get the Pharmalot story
- see Genzyme's release