Congressional Testimony Highlights FDA Failure to Correct Safety Violations at Compounding Lab Responsible for Fungal Meningitis Outbreak
Congressional testimony by Dr. Margaret A. Hamburg, Food & Drug Administration (FDA) Commissioner, highlighted the FDA’s failure to pursue fines and corrective action for the continuing safety problems at 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 has sickened more than 730 people and led to 53 deaths in 20 states, and which press reports indicate has now claimed a 54th victim. Elizabeth A. Kaveny, name partner in noted Chicago plaintiffs’ law firm Burke Wise Morrissey Kaveny (BWMK), was 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.
Commissioner Hamburg’s testimony, as reported in such major newspapers as the Chicago Tribune, Los Angeles Times, New York Times and Washington Post, showed that, dating back to at least 2002, the FDA had received and largely ignored complaints from doctors, nurses and whistleblowers about safety problems at the NECC. The complaints and concerns continued even after the agency issued a warning letter to NECC in 2006. Commissioner Hamburg stated concerning the FDA, “I wish we had been more aggressive” in taking action against NECC.
Ms. Kaveny stated regarding the congressional testimony and the government’s lack of corrective action against NECC: “”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. The “F” in the agency’s name should also remind us that it is an arm of the federal government. Let’s hope that government steps up to compensate and treat the victims.”
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.