Regulatory Focus™ > News Articles > Lawsuit Against Genzyme Seeks Damages for Fabrazyme Shortages

Lawsuit Against Genzyme Seeks Damages for Fabrazyme Shortages

Posted 12 March 2012

A lawsuit filed by an Idaho woman claims negligence on the part of Genzyme, now a subsidiary of Sanofi, led to persistent drug shortages and consequently the death of her husband.

Shortages of Fabrazyme, used to treat Fabry Disease, started in 2009 when viral contamination was discovered at a Genzyme manufacturing facility. Shortages were further exacerbated when additional contamination was found by the US Food and Drug Administration later in 2009, leading to a situation in which the drug was rationed out to patients.

The lawsuit claims the suboptimal dose was insufficient to maintain her husband's health, and that Genzyme knew "many patients would suffer catastrophic health deterioration and even death."

The lawsuit further claims that Genzyme's quality problems constitute "negligence" and the shortages were carried out in pursuit of a "profit motive."

Read more:

Pharmalot - Fabrazyme Shortage Killed My Husband: Widow

Lawsuit - Janet Schubert vs. Genzyme; Sanofi


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