Meningitis victims allowed to conduct inspection of compounding lab during wait for jurisdiction decision

By Martine Powers

 |  GLOBE STAFF   

  NOVEMBER 29, 2012

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.

The Judicial Panel on Multi­district Litigation in Washington will hold a hearing Jan. 31 and will issue its decision in February.

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.

Saylor deferred decisions on guidelines and the timing of the inspections to Magistrate Judge Marianne B. ­Bowler. He called for attorneys to coordinate with state and federal investigators who have been conducting inspections of the lab since October.

“I don’t want counsel showing up and tripping over public health authorities,” Saylor said.

Wednesday’s hearing also examined a slew of other decisions that will have to be made in the complex court cases.

Attorneys will meet again Dec. 10 for a status conference.

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Michigan Cases Tied To Meningitis Outbreak Hit 181 « CBS Detroit

Michigan Cases Tied To Meningitis Outbreak Hit 181 « CBS Detroit

Judge allows civil suits in meningitis outbreak to proceed

By Scott Malone | Reuters – 11 hrs ago

BOSTON (Reuters) - A federal judge in Boston on Wednesday allowed civil suits against the pharmacy at the heart of the deadly U.S. meningitis outbreak to proceed and noted that any criminal case would have priority in gathering evidence.

U.S. District Judge Dennis Saylor rejected arguments by attorneys for the pharmacy, its owners and an affiliate company to delay the start of civil proceedings until a panel of judges in Washington meets early next year to determine how to handle the roughly 70 suits filed in Massachusetts, Minnesota, Tennessee and Michigan.

"I don't want two or three or four months to go by with nothing happening," said U.S. District Court Judge Dennis Saylor at a hearing in Boston.

The needs of lawyers in the civil cases would fall behind those of federal and state health authorities and any criminal investigators, he added.

"There may be a grand jury investigation, I don't know, but there is certainly a potential criminal investigation overlaid on this," Saylor said.

After federal authorities in October raided the New England Compounding Center's facilities in Framingham, Massachusetts, U.S. Attorney Carmen Ortiz confirmed that her office was investigating the company.

A spokeswoman for Ortiz declined to comment on whether a grand jury had been convened to hear potential criminal charges linked to the outbreak, citing secrecy rules surrounding grand juries.

More than 500 people in 19 states have been infected with meningitis and 36 have died in the outbreak linked to an injectible steroid used to treat back pain produced by the New England Compounding Center, according to the Centers for Disease Control and Prevention.

Saylor said he would consider ordering NECC and its affiliates to preserve all evidence related to the outbreak, but noted that the needs of federal investigators from the Food and Drug Administration and Drug Enforcement Agency and state officials would come first when it came to accessing evidence.

One of NECC's attorneys, Frederick Fern of the New York law firm Harris & Beach, argued it was unnecessary to order the company to preserve its records.

"There has to be a showing of actual risk that evidence is being exfoliated," Fern said in court. "All we have is speculation."

Saylor last week denied a motion in one of the civil suits that had sought to freeze the assets of NECC's owners, though he ordered the company not to make extraordinary cash transfers or to pay dividends or bonuses to its owners.

NECC suspended its operations and recalled all its products after its role in the outbreak became clear. Ameridose, a firm owned by the same people who own NECC, has also shut down temporarily as investigators review its sterility practices.

A report by the U.S. Food and Drug Administration released earlier this month said investigators found bugs and other unsterile conditions when they inspected Ameridose's Westborough, Massachusetts facility.

(Editing by Cynthia Osterman)\

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