Boston Personal Injury Attorney Blog

Facing some measure of accountability for the 32 people who have died and more than 460 who have been sickened, the owner of the New England Compounding Center raised his right hand before the House of Representatives, swore to tell the truth and then refused to answer any questions.

Our Boston meningitis attorneys are not surprised that the head of a company that has shown so little regard for the well-being of others would fail to take responsibility and provide answers to the families who have lost loved ones.

He will be called again to testify soon before a Senate committee, though it’s likely we can expect more of the same.

Perhaps even more troubling is that while Congress presses forward with efforts to obtain some insight, legislators had the opportunity nearly a decade ago to approve measures that might have prevented this in the first place – and shut down this dangerous operation.

Back in 2003, Dr. Steven Galson was a top official at the U.S. Food and Drug Administration. At the time, he testified before the Senate Health, Education, Labor and Pensions Committee, telling them that his agency had conducted a small survey on about a dozen compounding pharmacies.

If you recall, these are facilities where the intent is to make custom drugs at the request of physicians for certain patients. Instead, what we are finding is that they have been mass-producing medication without a license, which is partly what officials believe led to the contamination issues that spurred the nationwide fungal meningitis outbreak.

Galson at the time told the committee that of the 29 drugs tested, including steroids, hormones, antibiotics and drugs to treat asthma, erectile dysfunction and glaucoma, 10 failed quality testing. Nine of those failed potency tests, in some cases showing a potency of less than 70 percent.

When people are counting on these drugs to aid them in meeting critical medical needs, this is absolutely unacceptable.

Now compare those results to the tests conducted around the same time on products directly from drug manufacturers. Of 3,000 samples tested, only four failed quality control.

FDA officials say the government had ample warning of serious problems in the compounding industry, and yet chose not to act.

Shortly after Galson delivered his testimony, Congress shot down an effort to establish an FDA oversight committee specifically for compounding pharmacies. And there have been multiple efforts since then to establish a greater level of oversight – and legislators have continued to shoot them down. Before his death, Massachusetts Senator Ted Kennedy sponsored a bill that would have created better oversight, however lawmakers failed to pass it amid heavy lobbying by the pharmaceutical industry.

Lobbyists continue to stress the great need for compounding facilities. We could concede that, when operated as intended and according to the high standards set for other drug makers, these facilities serve a purpose. However, the problems began when Congress repeatedly denied oversight authority to the FDA.

Now, legislators are demanding answers from the NECC (and the Ameridose facility, also in Massachusetts). But the fact is, these problems were nothing new. Too bad that it took a tragedy of this scale for Congress to take action.
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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.
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