Fabryzyme Shortage Case Revived in Massachusetts

BOSTON (CN) — The sole producer of the only approved Fabry disease enzyme-replacement therapy suffered a blow as First Circuit revived one couple's claims and made it possible for other patients to amend their pleadings.

Litigation against Genzyme sprang out of a three-year shortage of the treatment Frabrazyme from 2009 to 2012.

Patients suffering from the rare genetic disorder Fabry disease need the enzyme-replacement therapy Fabrazyme to break down fats and forestall various symptoms, from gastrointestinal issues to kidney failure and eventually premature death.

They argued that Genzyme was obligated to maintain its supply of Fabrazyme because cutting back on the supply would exacerbate their symptoms.

A federal judge in Massachusetts dismissed the consolidated actions with prejudice, however, after finding no showing that the plaintiffs' conditions had been worsened.

Though the First Circuit largely upheld dismissal of the cases last week, it did so on the basis of standing, thus making it possible for the plaintiffs to file an amended complaint.

The three-judge panel also revived the claims of James Mooney and his wife.

Unlike the other plaintiffs, the court said "specific and unique details about Mooney's alleged injury" satisfied the couple's prerequisites for standing.

Quoting the complaint, the May 23 ruling says Mooney "experienced anaphylactic treatment reactions from the development of antibodies to the diluted Fabrazyme" Genzyme resumed providing in 2012.

"This statement, combined with the other information in the complaint, establishes Mooney's standing: he alleges that he was injured through an allergic reaction attributable to his exposure to a reduced dose of Fabrazyme at Genzyme's behest," U.S. Circuit Judge Bruce Selya wrote for the court. "Monetary damages would redress this injury, even if imperfectly."

Selya added that Genzyme could "be responsible for taking care to make sure that any drug it did supply was safe for use."

Researchers at the Mt. Sinai School of Medicine developed the treatment that became Fabrazyme.

Genzyme first cut back its supply of the treatment in 2009 when a virus was discovered on improperly cleaned equipment in the company's facility in Allston, Massachusetts.

Subsequent attempts to rejuvenate the supply of Fabrazyme was stymied by the discovery of steel, glass and rubber particles in a batch, followed the discovery a second tainted batch that had to be destroyed, according to the opinion.

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