Our Boston personal injury attorneys have been closely following the aftermath of the discovery of a deadly strain of fungal meningitis at a pharmaceutical compounding center in Framingham.
Now, new reports indicate that even more people have been sickened or died as a result of exposure to this deadly strain. This was a company that was making and distributing drugs in massive quantities across the country, even though it reportedly had no license to do so. What’s more, the state’s pharmacy board director has been fired, while the board’s attorney has been placed on leave, for not alerting state officials to the issue when they first learned of it.
Federal health officials, who have been monitoring the situation, says that the deadly strains of meningitis is the confirmed culprit for 31 deaths (as of Nov. 7) and 424 severe illnesses. This is throughout 19 states. Additionally, there are 10 more who haven’t tested positive for the meningitis, but did receive the steroid injections believed responsible, and have reported infections in joints, such as their shoulders and ankles.
The situation has gotten so bad that two separate congressional committees are expected to soon hold hearings on the outbreak, forcing the facility’s chief pharmacist to testify. (Ironically, it is in part the inaction of Congress that has allowed these pharmaceutical mixing facilities to continue to operate virtually unsupervised — a fact the late Senator Ted Kennedy tried to prevent with legislation before his death).
However, we should at last begin to get some valuable insight into how these events unfolded. We do know that in Tennessee, where the outbreak was first discovered, a rigorous investigation is also well under way.
Meanwhile, Massachusetts State Pharmacy Board Director James Coffey was fired, according to sources cited by The Boston Globe. The Tennessee investigation indicated that the Colorado Board of Pharmacy told both the Massachusetts Pharmacy Board and the Food and Drug Administration that the New England Compounding Center was responsible for handing out drugs in bulk. This was before they knew any of the drugs were problematic. But the issue was that compounding centers such as this are intended only to mix certain drugs for specific prescriptions – not be mass producers.
But officials with the Massachusetts pharmacy board and the FDA are trying to pass the buck, each saying they did not hold the authority to shut the center down. The FDA said that while it can conduct inspections on the facilities for cleanliness, it can’t close them down. It cited legislation 10 years ago that would have given the agency more authority, however the U.S. Supreme Court struck the measure down after finding it partially unconstitutional.
Since the meningitis outbreak was discovered and traced, the Framingham facility has shut down on its own, and all of its drugs have been recalled.
The hearings scheduled by Congress should happen soon – with one held by the Senate and another by the House. The head of the Framingham pharmacy had told a committee representative he would not testify voluntarily. As such, both entities have issued subpoenas to force him to testify.
In addition to his account, the legislators want to review FDA documents from previous inspections of this and other compounding pharmacies. Specifically, the committees are seeking information as to whether the FDA notified the states in which issues were discovered, and whether, in those instances, there was any follow-up action or sanctions.
New information from the Centers for Disease Control indicates that the outbreak can be directly traced to three batches of a steroid that were contaminated at the Framingham compounding facility. One of those batches was more contaminated than the others.
Subsequent inspections of the facility have indicated other drugs made there were also contaminated, but so far no illnesses have been reported as a result.
Jeffrey Glassman Injury Lawyers handles personal injury and wrongful death litigation in Massachusetts, including cases involving the meningitis outbreak. Call (617) 777-7777.
Additional Resources:
More die in fungal meningitis outbreak; state pharmacy chief fired, Nov. 7, 2012, By Maggie Fox, NBC News
More Blog Entries:
More Tainted Drugs Found at Framingham Pharmacy, Nov. 3, 2012, Boston Personal Injury Lawyer Blog