What gives with these compounding pharmacies? In a string of deaths, primarily back east, these pharmacies are right in the heart of it all. Just a few days ago, the operations of a Boca Raton, Florida compounding pharmacy has been ordered shut down by the Florida Department of Health. Are there more to come? What about all these wrongful death lawsuits? Who is going to pay for all of this?
Second in a String of Shutdowns
Let’s take a look at the history to understand how negligence law would apply here. This is the second compounding pharmacy whose doors have been shut recently, making you wonder if it is safe to order drugs from compounding pharmacies. The first shut down, occurred after a deadly fungal meningitis outbreak, which appears to have been caused, due to the substandard practices at the New England Compounding Center.
Rejuvi Pharmaceuticals in Boca Raton, Florida received an emergency suspension order (ESO), by the Florida Department of Health, for a number of practice violations. So clearly, we already have the defendant falling below the statutory standard of care and have a negligence per se fact pattern in these fatalities.
The Statutory Violations
Rejuvi was found in violation of statutes, related to cleanliness of the prescription department, during a routine inspection. The dispensing of medications, compounding of medications and record keeping were a few of the violations, during the October 2nd inspection, according to documents by the Florida Department of Health( DOH) records.
- Clean Room: In violations of USP 797, the sink had dirty sitting water and hoses were connected to the faucet. Open containers of products were observed near dust pans and brooms. Bugs, dead bugs and rodent fecal matter were observed.
- The Florida DOH observed one pharmacist arrive an hour after opening and presented an expired consultant license, and then indicated he did not know the strengths of the compounds made at the pharmacy. He described his duties as “checking logs” and did not elaborate on any of his additional duties.
- The incorrect pharmacist was listed on most prescriptions and Rejuvi was unable to produce dispensing records. The owner said “ he probably throws invoices and pedigrees away.”
Previous Inspections Reveal Failure to Correct Big Problems
When previous inspections were reviewed, The Florida DOH documentation shows that Rejuvi had been previously notified about many of the violations and failed to take action to correct them. Inspections in 2009, they were cited for improperly maintained medications, which were missing lot numbers and expiration dates. The pharmacist on duty was sleeping in the prescription department; the daily logs were missing signatures, dates, prescriptions, pedigrees and invoices. Compounding drugs were missing lot numbers and expiration dates. Physician’s instructions and patient information were also missing.
This is Not a Final Action
According to a Department of Health press release, the ESO is not a final action, but is “imposed when the subject’s actions pose an immediate serious danger to public health.” Rejuvi has not commented on the order to shut down and there have been no injuries or illness associated with the closure at Rejuvi.
What Do I Do And Who Can I Sue?
Many family members may have lost a significant wage earner as a result of these fatalities. Typically, the company will have insurance to cover these types of things. But here, even if there is sufficient insurance under the law, there are so many victims it is hard to see how there will be enough to pay for all of this. No word on whether or not this will be filed as a class action or not yet either.