The New York Times reported, “Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.” In documents, released on Nov. 20, “in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down” on the New England Compounding Center, “only to back away, citing lack of jurisdiction.” For its part, the NECC “at times cooperated with FDA inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.”
Reuters added that the documents revealed the FDA didn’t issue a warning letter until 684 days after its inspectors discovered potentially unsafe practices at the Framingham, Massachusetts-based specialty pharmacy. In response, FDA spokesperson Erica Jefferson was quoted as saying, “During the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA.”
Separately, Reuters noted that according to the Centers for Disease Control and Prevention, there are now 490 cases of meningitis in 19 states and 34 related deaths.
Judge denies motion to freeze compounders’ assets. Reuters reported Judge Dennis Saylor of the US District Court in Boston, on Nov. 21, denied a motion by lawyers in a class action suit to freeze assets held by the NECC, its owners and two related companies while lawsuits related to the meningitis outbreak are pending. However, Judge Saylor did grant a preliminary injunction barring the NECC from granting the owners bonuses, exceptional cash transfers or pay dividends. Bloomberg News also covered the story, noting that the assets freeze “covered as much as $461 million.”
FDA finds more contaminated drug lots. The Tennessean reported that testing by the Food and Drug Administration “on steroid medications produced” by the NECC has revealed “more contaminants in additional drugs.” The FDA has “updated its list of lot numbers for contaminated drugs produced by New England Compounding Center after finding unknown fungal growths and bacteria in triamcinolone and betamethasone.” Dr. William Schaffner, an “infectious disease expert with Vanderbilt University” said the “bacterial contaminants in betamethasone and triamcinolone are not recognized pathogens.”
Patients say meningitis case toll excludes their cases. The Tennessean reported, “52-year-old Bret Moody was told he has fungal meningitis. He’s infected with Aspergillus, the first contaminant found in a national outbreak of illness tied to tainted medication.” But when the CDC lists the “nearly 500 people sickened by the moldy drugs,” Moody and “others like him who fail to match the profile of most victims” are not included in the tally. Moody, who “also has been diagnosed with leukemia, is one of many patients nationwide who question whether health officials are undercounting the victims of the crisis.” Federal health officials “say they are watching closely and haven’t yet confirmed any illnesses related to other drugs” from the NECC or Ameridose, “both of which recalled all products amid sterility concerns.”
Tennessee couple files suit against NECC. The Tennessean reported, “A Maury County man and his wife have filed suit against the Massachusetts drug compounding firm being blamed for a nationwide outbreak of fungal meningitis.” The lawsuit, which was transferred on Nov. 20 to the “US District Court in Nashville, charges that Basil J. McElwee was injected with a tainted steroid” from the NECC on “Aug. 20 and Sept. 4″ at the Saint Thomas Outpatient Neurosurgery Center. The McElwee suit “is the latest of more than 50 filed in state and federal courts throughout the country”; and it the first “to land in US District Court in Nashville.”
From the American Association for Justice news release.
