In the wake of a deadly meningitis outbreak that has killed over 30 people, it is clear that the U.S. Food and Drug Administration (FDA) failed the public when the agency allowed the New England Compounding Center (NECC) to continue selling drugs in bulk to clinics and hospitals throughout the U.S. The outbreak has been solidly linked to NECC methylprednisolone acetate contaminated with fungus, primarily Exserohilum, but also Aspergillus (one of our clients has Aspergillus meningitis).
You can contact Attorney Fred Pritzker for a free consultation here.
As far back as 2002 the FDA knew that unsafe practices at the company were putting patients at risk. Possible contamination of methylprednisolone acetate (the same drug that caused this 2012 outbreak) led the FDA to investigate NECC in 2002, but nothing was done. Now over 30 families are grieving the loss of loved ones, hundreds of people have been severely sickened and thousands of people have had painful spinal taps to test for meningitis.
NECC is licensed as a compounding pharmacy in Massachusetts. Although pharmacies are not regulated or inspected by the FDA, NECC had been selling drugs in bulk to throughout the U.S., and was obviously a pharmacy in name only. The FDA has know for years that NECC has been doing this and its inspectors also knew that the NECC facility in MA had sanitation problems. NECC claimed the FDA had no authority to do anything, and the FDA capitulated. According to Dr. Margaret A. Hamburg, the FDA commissioner, the agency backed down because NECC could have filed a lawsuit. Really? The FDA was not willing to go to court to stop the illegal sale of drugs made in a filthy facility but marketed as being sterile.
Dr. Hamburg argued that new laws need to be put in place to give the FDA authority over compounding pharmacies. We agree, but some administrative changes need to be done at the FDA so that someone with a backbone is in charge. And the legal department probably needs a shake up, too, if one of the FDA attorneys advised against taking action against NECC. The problem with just saying more legislation is the answer is twofold:
- There is a high likelihood that Congress will do nothing;
- Even if they do, the FDA is still a cowering agency afraid to take on a little company in Massachusetts.
Unlike the FDA, our law firm is taking on the little company in Massachusetts and others on behalf of over 40 patients harmed by the tainted NECC drug. Every patient who suffered harm should be compensated in full, this included those who contracted fungal meningitis, osteomylitis, epidural abscess or septic arthritis and every patient who had to have a spinal tap (lumbar puncture) to test for meningitis.
Attorney Fred Pritzker and his Bad Bug Law Team recently won over $40,000,000 for clients injured by another unsafe medical product. They have filed a lawsuit against NECC and are preparing to file several others. You can contact them for a free consultation here about a lawsuit against NECC and others for compensation, which can include amounts for medical expenses, lost income, pain and suffering, emotional distress, disability and wrongful death.
Three lots of NECC methylprednisolne acetate have been linked to the meningitis (fungal infection) outbreak.