In 2012, the New England Compounding Pharmacy sent vials of contaminated steroid injections to patients throughout the country, killing 64 people and infecting hundreds more. Both the president and pharmacist have been arrested and charged with second degree murder. Drug recall lawyers at Pintas & Mullins Law Firm explain the charges brought against employees of the New England Compounding Pharmacy, as well as the injury claims filed by injured patients.
Pharmacy compounding centers prepare medications for patients who need specialized formulas. In theory, these unique drugs are made “from scratch,” with pharmacists mixing individual ingredients to meet the needs of each unique patient. Prior to the 1950s, all medications were made this way, however, after mass drug manufacturing was invented it quickly fell out of favor with the exception of a few specialized cases.
Since the advent of mass-produced drugs, the role of pharmacists changed to dispense dosages instead of training to compound drugs. In recent years, however, compounding has become increasingly common as an alternative for patients with unique needs.
Unfortunately, these compounding pharmacies operated under little-to-no-oversight in recent decades, as the FDA gave full oversight authority to state health boards. State boards are notoriously overworked and under-resourced, so compounding pharmacies were by and large left to govern themselves.
Not surprisingly, this caused compounding pharmacies to skimp on health and safety precautions, resulting in the devastating tragedy of 2012. According to the lawsuit against New England Compounding Pharmacy, the facility operated in willful disregard of the likelihood that their actions would cause death or great bodily harm.
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The indictment stated that several NECP employees consistently failed to ensure that drugs were sterile by failing to test them, allowing grossly insufficient and unsanitary practices, and intentionally misleading regulators with false information.
This was all explicitly condoned and directed by management and senior pharmacists at NECP; in fact, the supervising pharmacist specifically instructed pharmacy technicians to prioritize production over cleaning and disinfecting, even directing them to falsify cleaning records.
Thus, the pharmacists knew that the drugs made at NECP were contaminated, that the “clean rooms” failed to comply with the most basic health standards, and sent them to patients throughout the country anyway. Federal prosecutors charged a total of fourteen NECC employees in the suit, including charges of racketeering. Racketeering charges allege that employees conspired to profit from sterile injections, despite knowing they were untested and unsterile.
The outbreak in 2012 was from epidural steroid injections that were contaminated with severely dangerous bacteria that caused fungal meningitis in patients in 23 states. As stated, more than 750 people were diagnosed with a fungal infection after taking these drugs, 64 of whom died.
One of the only positive consequences of this is a federal law change, awarding the FDA with the appropriate regulatory power over compounding pharmacies. Congress passed new legislation that will enhance the security of American drugs, and protect patients from contaminated, harmful, or counterfeit drugs. Compounding centers will now be subject to FDA inspection.
Overall, compounding pharmacies will still be primarily overseen by state boards of pharmacy. More information on the new Drug Quality and Security Act may be found here.
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The drug recall lawyers at Pintas & Mullins Law Firm are currently investigating cases of serious injury and death from dangerous, recalled, or contaminated drugs. We provide free, confidential, no-obligation legal consultations to concerned parties nationwide.