Lawsuit Against Sanofi for “Low Dosing” Fabry Disease Drug Revived

Note: This story correctly names the U.S. Court of Appeals for the First Circuit as the court making the most recent decision.

Judges from the U.S. Court of Appeals for the First Circuit have revived a nearly 12-year-old lawsuit that charged Sanofi with damaging the health of patients with a rare liver disease by selling virally contaminated Fabrazyme (agalsidase beta) the only medication approved for the condition — and then rationing it at drastically reduced doses.

According to the suit, shortly after the viral contamination of Fabrazyme was discovered in 2009, steel shavings, rubber and glass particles also showed up in some vials, causing Genzyme, the U.S. subsidiary of French company Sanofi, to retool the Massachusetts manufacturing facility that produced the drug, and subsequently causing a shortage.

During that time, the company rationed the remaining drug by selling it to adult patients with Fabry disease at drastically reduced dosages, sometimes with as little as half the prescribed active pharmaceutical ingredient. The rationing scheme allegedly led to the death of one patient in 2010, and injured the health of four others, who were co-plaintiffs in the case. Eventually, more than two dozen patients signed onto the suit and filed 24 claims against Genzyme including economic harm, health harm, and fraud.

Read the decision here.

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