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Regulators Ban NECC's Pharmacists From Working

We've talked before on this blog about the claim of negligent hiring. We've also talked about the Framingham pharmacy and the meningitis outbreak.

But we've never talked about the two together.

First off, we'd like to make it clear that the New England Compounding Center (NECC) is not being sued for negligent hiring or negligent supervision of employees. At least not that we're aware of.

However, such a claim might not be far off, especially now that Massachusetts regulators have come down on the NECC and ordered all of its pharmacists and pharmacy technicians to stop working.

And not just at the NECC. They've been banned from working in drug compounding altogether, reports UPI.

From available reports, The Boston Globe obtained a letter, dated October 31. The letter, from the Massachusetts Board of Registration in Pharmacy, indicates that the investigation pointed to some of the employees at the NECC in regards to the recent meningitis outbreak.

That's harsh. And problematic, for NECC.

As you may recall, last month NECC was forced to recall all of its products after reports of meningitis came to light. There were 419 reported cases of fungal meningitis and 30 deaths.

According to The Globe, the MBRP's letter stated that the pharmacists and pharmacy technicians may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease."

In legalese, that's language heading towards a negligent retention lawsuit. But that's not NECC's only concern. The US Food and Drug Administration also investigated. The FDA's investigation showed that the NECC's clean rooms weren't as "clean" as one would imagine.

These rooms, where the drugs were produced, had widespread contamination. And that's a claim for strict liability right there. The manufacturer of the product was essentially releasing a hazardous product, with a defect in manufacture, into the stream of commerce.

Finally, there's a potential claim for negligence per se, which arises when a law is violated and injury is caused. There were state laws in place that mandated a compounding pharmacy (which is what the NECC is) from mass producing drugs, without oversight from the FDA.

Oops.

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