Eddie C. Lovelace was a circuit judge in Kentucky. His wife, Joyce, described him as very healthy until he was in a traffic accident last March that damaged his spine. The 78-year-old did physical therapy and everything else the doctors ordered so he could return to the bench, she said.
On Sept. 11, he had numbness in his hand, a bad headache, he fell twice and when he said his legs didn't work he went to the emergency room. Several days later he died.
"We will be living this nightmare for ages to come," Joyce Lovelace told a public hearing of the House Energy and Commerce Committee in November. "It's something probably we will never really be able to get closure [on] because it was just such a useless thing that happened to my husband.
"I want them to know -- whoever is responsible -- their lack of attention to their duties cost my husband his life, cost my family, cost them a loss that we'll never recover from."
Tennessee was the first state to report a case of fungal meningitis -- a non-contagious form of meningitis caused by a mold spores, while other kinds of meningitis, which are contagious, are usually caused by bacteria or viruses.
A patient treated at the the St. Thomas Outpatient Neurosurgery Center in Nashville developed an infection after receiving methylprednisolone acetate steroid injections for back pain. The center had 2,000 vials from the suspect lots of steroid.
After Nashville reported a high number of similar infections, the Tennessee Department of Health identified a methylprednisolone acetate -- an epidural steroid injection administered June 27 to Sept. 20 -- as a prime suspect in this outbreak and alerted the Centers for Disease Control and Prevention. The CDC coordinated a multistate investigation.
The CDC confirmed the fungus Exserohilum rostratum was detected in unopened vials of the preservative-free steroid produced at the New England Compounding Center. The NECC produced about 17,000 doses of the injectable steroid, which was shipped to 23 states and an estimated 14,000 doses were used to treat back and joint pain. By mid-December, the CDC reported nearly 600 sickened from the steroid, 37 dead.
NECC voluntarily recalled three lots of the steroid Sept. 26, but on Oct. 6, the recall was expanded to all products compounded at and distributed from the Framingham, Mass., facility. The pharmacy voluntarily closed and surrendered its pharmacy license.
The U.S. Food and Drug Administration advised physicians to follow up with patients who were administered NECC injectable products and told them to watch for symptoms including headache, fever, nausea, dizziness/unsteadiness, worsening lower back pain, weakness or numbness, slurred speech, sensitivity to light, difficulty walking and stiff neck.
Most patients became ill within four weeks following the injection, but health officials said infections, meningitis and stroke could wait 42 days to manifest. They estimated the peak of the illnesses around Nov. 6, but spinal infections and other complications -- paraspinal/spinal infections, or epidural abscesses -- continue to arise.
In October, the FDA investigation found a quarter of the steroid vials in a NECC bin contained greenish black foreign matter, and several clean rooms -- where sterile products are produced -- had either mold or bacterial overgrowths.
The FDA conducted several inspections of NECC, each based on a separate set of allegations in 2002 and 2003 and one warning letter in 2006. The Massachusetts Board of Pharmacy -- responsible for regulating compounding pharmacies -- has an even more extensive history with NECC.
The U.S. House of Representatives' Energy and Commerce Committee's Subcommittee on Oversight and Investigations released a 25-page report on the history of NECC's regulatory issues in advance of a public hearing Nov. 13-14.
In 2011, the Colorado State Board of Pharmacy determined NECC was distributing unlicensed and unregistered drugs in the state and issued a cease-and-desist order. In addition, on April 18, 2002, the Massachusetts board received a letter from the Nevada Board of Pharmacy describing allegations of NECC selling non-FDA-approved products to physicians in Nevada, the report said.
At the hearing, Rep. Diana DeGette, D-Colo., said Colorado officials notified the Massachusetts Board of Pharmacy and it did nothing.
FDA inspectors and officials were repeatedly informed of problems at NECC, but the strongest action taken by the FDA was a warning letter sent to the company in 2006, a letter that appeared to have very little effect, DeGette said.
"The FDA tells us that they were hobbled by questions about whether they had the legal authority to address the problems," DeGette said.
In an article published in the Nov. 22 issue of the New England Journal of Medicine, Kevin Outterson of the Boston University School of Law wrote since 1938, the FDA has had clear authority to regulate drug manufacturing but compounding fell into a gray area between state and federal oversight.
Traditional compounding pharmacies -- which make individual medications ordered by a doctor -- are not registered with the FDA and related adverse events need not be reported to the FDA.
For more than two decades, the FDA struggled to regulate industrial-scale compounding. In 1992, it issued a Compliance Policy Guide, attempting to police the line between traditional compounding and drug manufacturing. This guide attracted enough criticism that Congress created a statute in 1997, amending the Food, Drug and Cosmetics Act with a new section, 503A.
But two days before this law was to take effect, seven compounding pharmacies sued. Section 503A(c) banned the advertising and promotion of compounded drugs. The theory was since traditional compounding occurred in response to individual prescriptions, advertising was unnecessary, the article said.
In 2002, in a 5-4 decision in Thompson vs. Western States Medical Center -- an early example of the use of free speech against public health regulation -- the Supreme Court ruled compounders have a constitutional right to advertise their drugs, Outterson wrote.
Outterson noted, some observers chastised the FDA for not acting sooner against NECC, but this critique ignored the complex regulatory history. Although the agency could react once a problem was obvious, it was unclear how it should proactively gather information before a crisis erupted.
Thousands of U.S. compounding pharmacies are not registered with the FDA or subject to reporting rules for drug manufacturers, so the FDA could be blocked for many months from visiting them. Without information about the actual conditions in compounding pharmacies, regulators cannot address violations, the article said.
"It's possible that if the Supreme Court hadn't struck down Section 503A, the tragedy at NECC could have been averted. Several features of that law are relevant," Outterson wrote.
As the year came to a close, there are some 50 federal lawsuits in nine states filed against NECC, and more are being filed in state courts alleging NECC negligently produced a defective and dangerous product. The civil lawsuits seek millions to repay families for the death of spouses, physically painful recoveries, lost wages and mental and emotional suffering.
John Day, a Nashville attorney who represents several fungal meningitis patients, told KVUE-TV, Austin, Texas, the lawsuits might take years and the chance of recovering damages from NECC was extremely low.
NECC laid off its workers and surrendered all pharmacy licenses, and it's unclear whether it had adequate liability insurance, Day said.
"It's clear to me that at the end of the day, NECC is not going to have sufficient assets to compensate any of these people, not even 1 percent," Day told KVUE.
Many attorneys are seeking compensation from other parties including NECC pharmacist and co-founder Barry Cadden; co-founder Greg Conigliaro; sister company Ameridose and its related Medical Sales Management; pharmaceutical distributors, and perhaps even doctors, hospitals, pain clinics, those who actually injected the drugs and people who bought the drugs.
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