Massachusetts Health Chief Cans Coffey Over Meningitis Outbreak

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Posted on 10th November 2012 by gjohnson in Uncategorized

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This certainly took long enough to happen: The Massachusetts Department of Health has booted James Coffey, the director of its pharmacy board.

http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/121107-statement-from-lauren-smith.pdf

Coffey’s apparent incompetency may have contributed to a meningitis outbreak that has killed more than 30 people and made hundreds of others ill. Coffey was canned Wednesday for not following up on a complaint from the Colorado Pharmacy Board against the New England Compounding Center (NECC), which is the source of the steroids that were contaminated by a fungus and proved deadly.

Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith made the announcement Wednesday.

“We have discovered a Colorado Board of Pharmacy complaint against NECC, which was forwarded to James D. Coffey, Director of the Massachusetts Board of Pharmacy, on July 26,” the press release said.

“The information shared by Colorado showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient–specific prescriptions, in violation of NECC’s Colorado and Massachusetts licenses,” the statement said.

“”The Colorado Board of Pharmacy contacted the FDA who confirmed that NECC was not a licensed manufacturer. As seen in the attached documents, this information was provided in detail by Colorado to Mr. Coffey in July, which he then forwarded to Boa rd attorney Susan Manning and Board inspectors.”

“The director of the Board is responsible for ordering investigations,” Smith said in her statement. “Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint. It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints.”

“Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at DPH,” Smith said. “As a result of these findings, we have terminated James Coffey and placed Susan Manning, a member of a bargaining unit, on administrative leave pending the final conclusions of our investigation. We have identified highly qualified individuals to fill these positions and the important work of the agency will continue with even greater resolve at this critical juncture.”

Smith didn’t mince words.

“I find the actions of NECC reprehensible,” she said. “We have the right to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here.”

Summing up, Smith said, “Since starting as interim commissioner, I have promised and delivered swift and decisive actions. This investigation and the Department’s thorough response will not stop until we have a complete understanding of what happened, assign accountability where it is warranted and can be certain the failures that led to this tragedy never happen again.”

Coffey is one of the witnesses who has been called to testify as part of an investigation into the meningitis outbreak. The U.S. House Energy and Commerce Committee has said that the Subcommittee on Oversight and Investigations will convene a hearing next week, on Nov. 14.

http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak

One of the other witnesses called to appear was Barry Cadden, Director of Pharmacy and NECC owner. He indicated that he would not appear, and was promptly subpoenaed.


Attorney Gordon Johnson
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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