Published October 13, 2012
One of the 14,000 patients who was administered a potentially tainted steroid injection has filed the first lawsuit over the deadly U.S. meningitis outbreak.
The lawsuit was filed Thursday in a Minnesota federal court. The woman said she was given the steroid injection for back pain and has since suffered symptoms associated with meningitis. She is currently awaiting test results.
According to federal and state authorities, the meningitis outbreak has resulted in 14 deaths nationwide since last month, when people who received the injections began coming to hospitals in Tennessee, which has seen the most cases.
The number of cases continues to rise, reaching 184 people -- plus one additional person with a joint infection -- by Friday. Infections have occurred in Florida, Idaho, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee, Texas and Virginia
Multiple investigations have begun in response to the outbreak and lawmaker Senator Richard Blumenthal of Connecticut has publically called for a criminal probe of the company that distributed the tainted medicine, New England Compounding Center (NECC) of Massachusetts.
NECC has recalled the injections, suspended its operating license and said it is cooperating with investigations.
"We are cooperating fully with state and federal agencies whose policy it is not to comment on pending matters," Paul Cirel, the NECC's lawyer, said in a released statement. "In the spirit of our ongoing cooperation, we are honoring their policy."
The Massachusetts health regulator claims the company broke state laws for pharmacies, while federal and state regulators are being criticized for allowing compounding, a specialized sector of pharmaceuticals, to flourish with little federal oversight.
Compounders use drug ingredients to make specialized treatments for patients and have proliferated rapidly thanks to growing demand for custom drug mixtures. Compounding pharmacies produce and ship thousands of doses of medication nationwide.
According to USA Today, public records indicate compounding pharmacies have been tied to a number of fatal infections and overdoses for more than a decade.
There have been repeated calls for oversight of these companies, which are not limited by the same safety rules as large-scale drug manufacturers, since at least 2001. The pharmacies fall between the regulation of the U.S. Food and Drug Administration (FDA), the federal pharmaceutical regulator, and state boards of pharmacy.
Over the past 11 years, the FDA has sent approximately 40 warning letters to compounding pharmacies for sanitary violations and for not taking the proper steps to prevent the sale of dangerous or ineffective drugs, USA Today reported.
In addition, more than two dozen deaths have been linked to contaminated or mismeasured medications provided by compounding pharmacies since 2001. Other patients have been badly injured, and even permanently disabled.
While the meningitis outbreak is the worst recorded outbreak associated with compound pharmacies, there have been a number of others in the past, USA Today said.
In March, 33 patients in seven states developed fungal eye infections after they were injected with contaminated drugs from a compounding facility in Florida, and a year earlier – in March 2011 – nine patients in Alabama died after receiving contaminated nutritional supplements produced by a compounding pharmacy in Birmingham.
There have also been reported cases of death and illness due to taking contaminated or mismeasured drugs from compounding pharmacies in 2007 and 2005, according to USA Today.
In this current outbreak, health officials told Reuters more than 50 vials of the steroid, out of more than 17,000, had so far been confirmed as contaminated. More tests are underway.
The lawsuit is Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No.12-2605.
Reuters contributed to this report.