Double, Double, Toil and Trouble: One Compounding Pharmacy's Recipe for Steroids
This case is based on highly publicized events surrounding lethal medication manufactured and sold by a small pharmaceutical company outside Boston, Massachusetts called New England Compounding Center (NECC). Formed in 1998, NECC was owned and operated by husband and wife Barry Cadden and Lisa Conigliaro Cadden, along with other family members. In conjunction with its sister company, Ameridose, the businesses focused on preparing prefilled syringes and large vats of medication into smaller intravenous bags, ready for individual use. It also compounded medication for individual patients' specific needs. But as the business grew aggressively, taking larger and larger orders, fast production was prioritized over safety and sanitation. A fungal meningitis outbreak in the fall of 2012 was linked to steroids fabricated by NECC. Despite an immediate recall, the allegedly contaminated product had been distributed to more than 14,000 patients in 23 states. In total, the Centers for Disease Control and Prevention reported 751 cases of fungal infection that could be linked to tainted steroid injections compounded by NECC. Of these, 64 were fatal. How should the legal system respond?