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Food and Drug Administration and Compliance Issues
Thursday, November 29, 2012
Meningitis victims allowed to conduct inspection of compounding lab during wait for jurisdiction decision
A federal judge ruled Wednesday that attorneys representing patients who contracted fungal meningitis will be allowed to conduct their own inspections of the New England Compounding Center while they await word from a federal judicial panel on where the cases will be heard.
Twelve federal lawsuits have been filed in Massachusetts against the drug compounding facility accused of selling tainted steroids that sparked a nationwide fungal meningitis outbreak, and it will be months before anyone knows whether the cases will be heard in Massachusetts and whether they will be consolidated with other lawsuits filed across the country.
In the meantime, US District Judge F. Dennis Saylor IV said Wednesday, attorneys for the plaintiffs will be allowed to begin time-sensitive inspections of the lab’s Framingham facilities.
“We’re either going to do it now, or we’re not going to do it at all,” Saylor said.
Kim Dougherty, an attorney for one of the 12 plaintiffs who filed federal suits in Massachusetts, said patients should not have to wait until February to start their investigation into the facts of the case. Attorneys want to bring in their own experts to conduct an inspection of the lab. By next year, she said, too much time will have elapsed for their results to be useful.
“Time is of the essence,” Dougherty said. “The further along we go to wait to get the sampling, the further it could be compromised.”
Frederick H. Fern, an attorney for the compounding center, argued that it would be premature for the plaintiffs to conduct inspections before it is determined whether their cases will be consolidated, which could lead to duplicated inspections and conflicting results.
“It is too soon, because it flies in the face of the coordination that this case cries out for,” Fern said.
Fern also questioned whether inspections would be fruitful at all, because of the time that has passed since the steroids were produced and the possible effects of heavy traffic from state and federal investigators inside the lab.
“There is no way that the premises now — in any way, shape, or form — show what things were like back in May, June, or July,” Fern said.
Saylor acknowledged he was also “highly skeptical” that attorneys for the plaintiffs will be able to glean accurate conclusions about the lab’s conditions.
But, he said, they deserved an opportunity to try.