The first lawsuits have been filed against New England Compounding Center (NECC), the Massachusetts pharmacy that supplied nearly 18,000 vials of contaminated steroid medication to 76 healthcare facilities in 24 states. The CDC estimates that 14,000 patients in 19 states may have received injections from three lots of drugs tainted with fungus. At press time, the CDC reported 377 cases and 28 deaths linked to fungal meningitis following injections of the tainted medication.
Federal investigators confirmed the presence of exserohilum rostratum, a fungus found in soil and vegetation, in unopened vials of methylprednisone acetate from one of the suspect NECC lots, and the company has voluntarily recalled all of its products shipped in 2012.
According to preliminary findings of the Massachusetts Department of Public Health, investigators found “serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health and safety at risk” at the NECC facility in Framingham. These included failure to use proper sterilization procedures, “visible black particulate matter” in sealed medication vials, and “unsanitary” conditions.
Fungal meningitis is a rare, noncontagious infection of the lining of the brain and spinal cord. It is caused when fungi enter the central nervous system from elsewhere in the body or through an infected wound near the central nervous system. Symptoms generally occur from one to four weeks after exposure. The disease can be life threatening, especially to people with weakened immune systems.
The first federal lawsuit by a patient treated with the tainted drug was filed in Minnesota on Oct. 11. Barbe Puro received epidural steroid injections for back pain on Sept. 17 at a clinic in Shakopee, Minn. The putative class action alleges that she suffered headaches and nausea after the injections. She was informed by health officials that she had received the tainted steroid. (Puro v. New England Compounding Pharmacy, Inc., No. 0:12-cv-02605 (D. Minn. filed Oct. 11, 2012).)
That action was followed by two lawsuits filed in federal court in Michigan. The first alleges that Brenda Bansale received a contaminated steroid injection on Aug. 28, 2012, at a pain clinic in Brighton, Mich. She developed headaches and nausea and was later diagnosed with fungal meningitis. (Bansale v. New England Compounding Pharmacy, Inc., No. 2:12-cv-14559 (E.D. Mich. filed Oct. 15, 2012).)
Bansale moved on Oct. 16 for the creation of an MDL to consolidate all of the federal cases against NECC in the district of Minnesota. That motion is pending. The suit was followed by another suit filed by a Michigan man who was hospitalized when the action was filed. (Laperriere v. New England Compounding Pharmacy, Inc., No. 1:12-cv-14581 (E.D. Mich. filed Oct. 16, 2012).)
State court lawsuits against NECC were also filed in a growing list of states, including Florida, New Jersey, and Virginia. A plaintiff in Tennessee, Thomas Rybinski, was reported to be the first person diagnosed with fungal meningitis—and the first to die—after receiving an injection of a steroid compounded by NECC.
Most, but not all, of the meningitis cases followed spinal injections for back pain. The FDA said it also investigated fungal meningitis in a heart transplant patient who was treated with an injectable cardiac medication supplied by NECC. The agency cautioned that its investigation was “ongoing” and that “there may be other explanations” for that infection, but advised doctors to contact patients who received any injectable NECC medication after May 21, 2012.
The outbreak has raised concerns about the pharmaceutical compounding industry as a whole. Thousands of such pharmacies across the nation prepare medications for specific patients who need discontinued, preservative-free, mixed, and flavored medicines. The pharmacies are largely exempt from FDA regulation if they prepare a medication for a specific patient on the prescription of a licensed health care provider.
According to its website, the International Academy of Compounding Pharmacists (IACP) represents “more than 2,700 pharmacists, technicians, students, and members of the compounding community who focus on the specialty practice of pharmacy compounding.” The Pharmacy Compounding Accreditation Board (PCAB) conducts onsite inspections of compounders, but according to a recent Washington Post article, only 162 compounding pharmacies—about 2 percent of the 7,500 total—have been accredited. The PCAB website does not list NECC as an accredited compounding pharmacy.
Anne Andrews, an attorney in Irvine, Calif., who represents plaintiffs in mass tort cases, said that the regulation of compounding pharmacies has been left to the states for decades, even though the FDA voiced its concerns about the industry as early as the 1990s. “The confrontations between lawmakers and compounding dollars, marshaled mostly by IACP, have continued since then,” said Andrews. “In 2007, an attempt to set stricter manufacturing requirements by consumer rights champion Sen. Edward Kennedy related to sanitary conditions—the Safe Drug Compounding Act—was again defeated with the help of special interests,” she added.
The recent outbreak drew renewed attention on Capitol Hill. In a letter to U.S. Attorney General Eric Holder, Rep. Edward Markey (D-Mass.) called for an investigation into whether NECC was illegally manufacturing a controlled substance without requiring individual patient prescriptions and without registering with the DEA as a manufacturer. Leaders of the House Energy and Commerce Committee also pressed for a congressional investigation by the full committee. Ranking members Henry Waxman (D-Calif.), Frank Pallone, Jr. (D-N.J.), and Diana DeGette (D-Colo.) noted in a letter that NECC was able to produce and ship large quantities of the drug “all with no oversight from the FDA.”
Attorney Alyson Oliver of Rochester, Mich., represents the plaintiff in the Bansale case. She said the meningitis cases demonstrate the dangers posed to patients when health care is unregulated. “Cases like this go to show that the lives of innocent and unknowing consumers can be completely turned upside down when the FDA and other regulatory bodies fail to catch pharmaceutical and other companies for practices that place our consumers in danger,” Oliver said.