In 2004, Massachusetts health regulators proposed a formal reprimand for the pharmacy that is currently linked to the deadly nationwide meningitis outbreak – the New England Compounding Center (NECC) in Framingham, Massachusetts. Health officials never delivered the reprimand, however, after the company protested the reprimand could be “fatal to the business”. The NECC was shut down earlier this month amidst the fungal meningitis outbreak that has so far reached 17 states, affecting around 317 people, 24 of whom have died. The epidemic has been linked to a back pain steroid produced by the NECC.
The state of Massachusetts has now revoked the New England Compounding Center’s license to operate, but the reprimand represents a missed opportunity to scrutinously investigate on the lab operations before the current outbreak.
Nearly eight years ago, in October 2004, the Board of Registration in Pharmacy proposed a sanction which included a consent agreement that was meant to resolve complaints against the pharmacy. The NECC failed to meet accepted standards for producing the same steroid that is related to the outbreak. Additionally, the consent agreement also included a three-year probationary period for the company’s registration and NECC’s owner Barry Cadden’s license. A different consent agreement with the board was reached in 2006, which ended the case without disciplinary action.
According to Alec Loftus, a spokesman for the state’s office of health and human services, Massachusetts state has expanded its investigation of the pharmacy to include the 2006 consent agreement that was reached and why the board never issued the reprimand and whether that was related to the protest from the NECC.
Pharmaceutical companies are in the business of manufacturing and selling drugs to make a profit. Manufacturers are constantly introducing new drugs into the market and, each year, thousands of people are injured or killed due to dangerous and defective characteristics.
The FDA is the primary governmental agency involved in overseeing the introduction and performance of new drugs and medications. In certain circumstances, the FDA may recall a dangerous drug, or may require that certain warnings accompany the product. Pursuing litigation against a large drug company requires experience, persistence, and resources. Defective drug cases often involve evaluations of scientific studies and assessments of the pre-market testing and investigation performed by the drug manufacturer. Compounding companies such as NECC present particular concerns, since they are not subjected to many of the strict regulations covering large pharmaceutical companies.
Swartz & Swartz, P.C. is committed to the persistent and unrelenting pursuit of drug manufacturers who cause serious injury or death to unsuspecting consumers. If you or a loved one has been the victim of a dangerous drug and would like to speak with an attorney, please contact us; you can call us at (617) 742-1900, or if you are outside the Boston area, call toll-free at 1-800-545-3732. We are here to answer your questions and discuss how to protect your legal rights.