A Boston federal judge criticized the pleadings in two unusual purported class actions against Genzyme Corp. over its rationing of the drug Fabrazyme, complaining that just one of more than 70 plaintiffs appears to have a valid claim.
The drug treats Fabry Disease, a potentially life-threatening inherited disorder stemming from the buildup of a particular type of fat in the body’s cells.
U.S. District Judge Douglas Woodlock made the remarks during a hearing on Wednesday in Adamo v. Genzyme Corp. and Hochendoner v. Genzyme Corp. The plaintiffs also named Mount Sinai School of Medicine, which invented the drug and licensed the patent to Genzyme.
The plaintiffs’ lawyers say the case is notable because Genzyme decided how to ration the drug—by cutting back on dosages—even though a government grant funded its development. “I’ve never seen a case where a corporation was choosing how to triage patients during a public health crisis,” said one of the plaintiffs’ lawyers, C. Allen Black Jr. of Allison Park, Penn.
Genzyme cut production from June 2009 through March 2012 following discovery of a viral contamination at its Allston, Mass., plant. The plaintiffs complained that European patients retained access to full dosages.
Genzyme agreed to pay a $175 million fine and accept oversight of the drug’s manufacture for at least seven years in a May 2010 consent decree with the U.S. Food and Drug Administration and the Justice Department.
Woodlock repeatedly contended that none of the plaintiffs had claimed a specific injury. “It doesn’t get better by aggregating a bunch of individuals, none of whom said they suffered a particular harm,” he said. “I guess I’m at a loss to see why you haven’t simply stumbled at the threshold of your pleadings.”
Plaintiffs attorney Matthew Kurzweg of Kurzweg Law Offices in Pittsburgh insisted: “We do allege [that] when they reduced the dosage and administered it, they knew it was harmful.”
When pressed to city any specific injuries, the plaintiffs attorneys pointed to James Mooney of Lebanon, Ohio, who they said suffered a severe allergic reaction when he resumed the full dosage because his immune system had developed a resistance.
But Woodlock responded that, if Mooney’s claim survives and the other claims do not, “it becomes an Ohio products liability claim.”
The legal claims in the cases include negligence, strict liability, breach of warranty, violation of federal law governing publicly funded inventions, violations of various states’ consumer, deceptive trade practices and products liability laws and loss of consortium.
Woodlock also challenged the plaintiffs’ lawyers to come up with a reason why he shouldn’t follow the lead of U.S. District Judge Beryl Howell in Washington, who dismissed a similar case involving the drug in November. That case, Carik v. U.S. Department of Health and Human Services, named several federal agencies and Mount Sinai, but not Genzyme, for failing to ensure an adequate supply of Fabrazyme.
Defense attorney Catherine Mondell, a partner at Boston’s Ropes & Gray, suggested Woodlock adopt the analysis in yet another action, Schubert v. Genzyme Corp. In September, U.S. District Judge Dale Kimball in Utah allowed Genzyme’s motion for judgment on the pleadings, rejecting Janet Schubert’s claim that the company had a duty to make enough of a pharmaceutical to meet demand.
Still, Kimball allowed Schubert to proceed with a claim that the reduced dosage he received caused her late husband Dr. William Schubert’s death.
“The Schubert court found it was appropriate for Genzyme to supply [Fabrazyme] to the extent it was able to do so,” Mondell said.
Following the hearing, Black promised that the plaintiffs would appeal any dismissal. “The invention was paid for by taxpayers and shipped overseas in full doses. It goes to fundamental fairness,” Black said.
Sheri Qualters can be contacted at email@example.com.