Compounding Pharmacy Update

According to the Boston Globe, on at least two occasions in the past decade, Massachusetts pharmacy officials have displayed indifference in their supervision of a concerning Framingham compounding pharmacy (The New England Compounding Center) that is linked to the nationwide meningitis outbreak that has killed 32 and sickened more than 400 victims.

Barry Cadden, co-owner of the New England Compounding Center (NECC), is currently going under investigation by state and federal regulators, as he was chosen to serve on a state pharmacy board to write new rules for compounding pharmacies. Cadden was appointed in June 2002, two months after the Food and Drug Administration (FDA) and the pharmacy board began investigating into complaints about the NECC mass-producing drugs and operations like a manufacturer, which violated its state license.

The FDA started investigating the NECC in April 2002, in response to 5 reports of dizziness, shortness of breath, and an abrupt drop in blood pressure after patients were injected with a steroid produced by the New England Compounding Center. Investigations of the causes of the meningitis outbreak and whether it could have been prevented are currently going on. Cadden has been subpoenaed to testify before the U.S. House Committee on Energy and Commerce, Oversight and Investigations Subcommittee.

In 2006, three top pharmacy board administrators learned that an Illinois company (Pharmacy Support Inc.) that was going to monitor the NECC was led by Ross Caputo, a man convicted of fraud, which involved a product that blinded people. Allegedly, the board officials failed to inform other board members before they voted the upcoming month. As a result, board members accepted that the Illinois firm found the NECC to have made satisfactory improvements. Who chose Cadden specifically is unclear.

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.

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