Thursday, October 11, 2012
Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man’s death in 2004.
Earlier this summer, a separate pharmaceutical firm with common owners was accused of failing to separate sterile and non-sterile supplies. That pharmaceutical company was shut down Wednesday for inspections, the latest example of fallout from the growing outbreak.
Officials have identified New England Compounding Center of Framingham, Mass., as the source of steroid shots suspected in the outbreak of rare fungal meningitis that has killed at least 12 people and made more than 130 others sick in 10 states.
Allegations of a shot tainted with a different form of meningitis were at the heart of a lawsuit filed against the company over the 2004 death. An 83-year-old man died about a year and a half after receiving a shot produced by the company.
Another drug company that has some of the same owners, Ameridose LLC, agreed to temporarily stop its compounding and manufacturing operations as a precaution while regulators inspect its facilities, but the measure is being done as a precaution, not because of evidence of contamination, officials said Wednesday. Ameridose, based in Westborough, Mass., was accused by a business customer this year of failing to separate sterile and non-sterile products in its warehouse.
On Wednesday, Massachusetts Gov. Deval Patrick said the New England Compounding Center may have misled regulators and done work beyond the scope of its state license. The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said.
“What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license,” he said.
A company spokesman declined comment on Patrick’s assertion beyond a statement that company officials are focused on cooperating with the investigation. The company has shut down operations and recalled the fungus-contaminated steroid.