As Meningitis Lawsuits Mount, Inspectors Find Evidence Maker of Epidural Steroid Injections Violated Sterility Standards
The Massachusetts compounding pharmacy at the center of a multistate outbreak of fungal meningitis failed repeatedly to keep its facility clean and sterile, according to The New York Times. Meanwhile, meningitis lawsuits have started piling up against the New England Compounding Center (NECC), with plaintiffs now seeking consolidation of federal claims in one jurisdiction for pretrial proceedings.
Epidural steroid injections prepared by NECC are being blamed for the multistate fungal meningitis outbreak that has sickened more than 300 people in 17 states. NECC has since issued an epidural steroid recall, as well as a recall for all of its products, and surrendered its license to operate in Massachusetts. The epidural steroid recall alone involved some 17,000 vials of preservative-free methylprednilosone, which had been shipped to 76 facilities in 23 states. At least 14,000 people are known to have been treated with the steroids for back pain. According to the U.S. Centers for Disease Control’s most recent update, of 308 infections tied to the recalled steroids, 304 involve fungal meningitis. Four others are peripheral joint infections that occurred in people who received steroid injections to treat joint pain (ankles, knees, shoulders, e.g.).
Not surprisingly, NECC is facing a growing number of meningitis lawsuits filed by people allegedly injured by the company’s recalled steroids. According to a report from The Wall Street Journal, meningitis lawsuits are known to have been filed in Indiana, Michigan, Massachusetts, Virginia, Florida, New Jersey and Minnesota. Four plaintiffs have already motioned the U.S. Judicial Panel on Multidistrict Litigation for consolidation of all federally-filed meningitis lawsuits in federal court in Minneapolis.
According to the most recent report from The New York Times, health officials who have been pouring over NECC’s facilities have discovered the company regularly flouted standards meant to keep the premises clean and its products sterile. Most disturbingly, inspectors have found that NECC shipped some orders of the epidural steroids blamed for the outbreak without waiting for the final results of sterility testing. While the tests later showed no contaminants, investigators told the Times they were skeptical of NECC’s methods for conducting those screenings.
Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department, also told the Times that NECC’s records indicate it failed to sterilize products “even the minimum amount of time necessary to ensure sterility.” Had proper procedures been followed, it is possible the scale of the meningitis outbreak may have been lessened, or it could have been averted entirely.
The Times report also detailed what it characterized as NECC’s “troubled history.” Established in 1998, it was the subject of complaints just years later. In 2004, for example, state health officials threatened to take action against the compounding pharmacy after it failed to comply with accepted standards when mixing methylprednisolone acetate, the steroid blamed for the meningitis outbreak. Despite that and other violations, none of those infractions were enough to put its license in jeopardy, the Times said.
According to a New York Times report published on Monday, compounding pharmacies, which alter or mix ingredients to create custom medications for patients, operate without much oversight from the U.S. Food & Drug Administration (FDA). While the FDA can inspect them and issue warnings, it is individual states that have ultimate jurisdiction over compounding pharmacies. Compounding pharmacies are also not bound by the FDA’s good manufacturing practices standards, which require companies to make reports to the agency when one of their drugs is suspected of harming patients.
“You can ask a question, but does a company have to answer you?” Robert Coleman, who served as an FDA investigator for three decades, told the Times. “That’s up for debate. It always made me wonder as an investigator, ‘Why don’t you want to tell me that? Is there some problem?’“