Legislation Introduced for Federal Regulation of Large Compounding Labs Similar to NECC, Which Was Responsible for Fungal Meningitis Outbreak Targeted by BWMK Lawsuits
Legislation introduced in the U.S. Senate is the first bipartisan bill in Congress aimed at implementing direct federal oversight of large specialty compounding laboratories similar to New England Compounding Center (NECC). NECC was the source of tainted pain medication that caused a fungal meningitis outbreak which according to the Centers for Disease Control and Prevention and press reports has sickened more than 730 people and led to 54 deaths in 20 states.
The new legislation would subject large compounding operations such as NECC to direct federal regulation by the Food and Drug Administration (FDA), rather than by state pharmacy boards that have previously overseen these companies. It also sets minimum standards for ingredients used by all compounding pharmacies. Elizabeth A. Kaveny, name partner in noted Chicago plaintiffs’ law firm Burke Wise Morrissey Kaveny (BWMK) and one of the first attorneys in the country to file suit against NECC in Massachusetts on behalf of a number of individuals who were victims in the fungal meningitis outbreak, has spoken out strongly in favor of such FDA regulation of large compounding pharmacies. “We should not forget that sadly it is only on the death and suffering of my clients that we all will benefit from higher scrutiny forced upon the FDA,” Ms Kaveny has stated. She has also emphasized why such regulation is necessary, pointing out that NECC “intentionally allowed filthy conditions and contamination to occur, creating a danger that NECC chose to expose to innocent people.”
In her pioneering cases, now assigned to federal court in Massachusetts, Ms. Kaveny is seeking monetary damages and criminal penalties against the company and its agents on behalf of her clients contracted fungal meningitis as a direct result of the steroid produced by NECC. More information on Ms. Kaveny’s fungal meningitis representation is available here.