A federal court in Massachusetts has rekindled a lawsuit that has been dormant for nearly twelve years, targeting Sanofi for its alleged role in compromising the health of patients suffering from a rare disease treatment. The litigation accuses the pharmaceutical giant of distributing Fabrazyme (agalsidase beta)—the sole approved rare disease treatment for the disease—despite knowing it was contaminated with viruses and then limiting its availability in significantly smaller doses.
The controversy began to unfold in 2009 when it emerged that Fabrazyme was tainted with viral particles. Subsequent inspections revealed the presence of steel shavings, rubber, and glass fragments in several vials, a discovery that traced back to manufacturing flaws at Genzyme’s facility in Massachusetts, a subsidiary of the French conglomerate, Sanofi. The resulting production halt precipitated a shortage, compelling the company to distribute the drug in dosages substantially lower than what was medically prescribed, in some instances, reducing the active pharmaceutical ingredient by half.
Lawsuit Expansion Against Genzyme Highlights Severe Impact of Drug Rationing in Rare Disease Treatment
This rationing strategy had dire consequences, directly contributing to the demise of one patient in 2010 and adversely affecting the health of four others, who then became co-plaintiffs in the lawsuit. The legal action has since expanded, with over two dozen patients lodging 24 claims against Genzyme, encompassing allegations of economic and health damages as well as fraudulent practices.
The lawsuit’s revival underscores the ongoing challenges and complexities within the pharmaceutical industry, particularly concerning rare disease treatment. It also highlights the critical importance of manufacturing integrity and the potential health risks posed by contaminated medications.
Resource: Fdanews, February 22, 2024
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