US judge allows civil suits in meningitis outbreak to proceed

Wed Nov 28, 2012 1:50pm EST

* Judge sees "potential criminal investigation" into pharmacy

* Some 70 suits now target New England Compounding Pharmacy

By Scott Malone

BOSTON, Nov. 28 (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.

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Comments (1)
tyg wrote:
This decision comes a bit late. The Caddens and Conigliaros have probably already transferred much of their, Ameridose, and their recycling business assets. Please do not forget we are dealing with doctors, lawyers, members of boards of pharmacy, and stealthy business people. The FDA and Mass Board of Pharmacy should also be scrutinized by the courts to find out if there is any criminal prosecution that should go their way, when their very well paid professionals do not protect the public health because their commissioner, director of drugs, and other senior executive officers did not know what the public health agency’s authorities were until people die. Dr. Autor, Dr. Woodcock, Dr. Hamburg are you still unsure of your authority like Dr. Autor said to the NY Times: “There is some legal dispute about our ability to look at records and pharmacies and it is the records that help us determine whether a pharmacy is acting as a pharmacy or as a manufacturer,” Deborah M. Autor, the F.D.A.’s deputy commissioner for global regulatory operations and policy. Do you need more bodies? Who in FDA and Mass Board of Pharmacy are responsible? It seems that congress will not get their responses soon enough or that anyone in the government will be held accountable for allowing these huge compounding pharmacies develop into manufacturers of deadly drugs made in worse conditions than unregulated industries. So why is it that the top FDA and Boards of Pharmacy brass are not liable for not doing their job? How could it take over two years for lawyers, doctors, and public health professionals to figure out what to do to protect patients from people like the Caddens and Cogniliaros?

Nov 29, 2012 12:24am EST  --  Report as abuse
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