Beginning in the 1990s, people with severe back and neck pain began to rely on spinal steroid injections to relieve their discomfort and help them avoid surgery. The injections, which combine a steroid with a numbing medication, seemed to quiet irritated and inflamed nerves. By 2011, more than 2.2 million epidural steroid injections were being performed each year in the Medicare population alone. In September 2012 an alarming number of steroid injection recipients developed meningitis, an inflammation of the membranes covering the brain and spinal cord. Ultimately, 64 people died and 798 were sickened in one of the largest healthcare-associated outbreaks in U.S. history. The outbreak was caused by a drug that had been contaminated with the fungus Exserohilum rostratum. An estimated 14,000 people had been injected with the adulterated steroid.

Who Made the Drug?

The New England Compounding Center (NECC) in Framingham, Mass. had manufactured the tainted drug, shipping approximately 17,000 vials to 75 medical facilities in 23 states. Patients who developed meningitis from the drug were later struck with a second illness caused by epidural abscess. Fungal infections arose at the site of the injections but, because they were internal, they could only be detected by MRI. Left untreated, the abscesses can cause meningitis and severe pain. The condition occurred in patients with or without meningitis and even in those who were taking powerful anti-fungal medications. An FDA inspection of the New England Compounding Center revealed greenish-yellow residue on sterilization equipment and work surfaces layered with mold and bacteria. The company, now closed, supplied some of the most prestigious hospitals in the country, including those affiliated with Harvard, Yale and the Mayo Clinic.

The Rise of Compounding Pharmacies

Under the law compounding companies like New England Compounding were intended as local services producing tailor-made prescriptions for patients with special needs. Brigham and Women's Hospital in Boston, for example, depended on New England Compounding for drugs that were in short supply, unavailable from major manufacturers, or which the hospital pharmacy could not readily produce. Over time, as drug shortages increased and brand-name products became too expensive, pharmacies turned to compounding companies for more cheaply made drugs. NECC was able to significantly undercut the prices charged by FDA-regulated manufacturers like Pfizer for injectable methylprednisolone. Eventually, due to high demand for less costly drugs, compounding companies came to resemble smaller scale drug manufacturers, even sending out sales representatives to solicit business from doctors.

Are the Cost Savings Worth It?

Although there are clear financial incentives to utilize compounding companies, they seem to operate in the shadows, away from government oversight. The FDA regulates drug manufacturers but compounding companies register as pharmacies. As such, they are subject to non-uniform state rules. Many hospitals that relied on compounding companies believed these pharmacies were monitored by state and federal regulators and that their products were safe. It took a dangerous, multi-state outbreak of meningitis to prove how mistaken they were. In 2013, Congress passed the Drug Quality and Security Act, granting the FDA greater authority to regulate and monitor the manufacturing of compounding drugs.

Contact The Orlow Firm Today

If you have been harmed by a drug that was negligently manufactured by a compounding company, the New York prescription error attorneys at The Orlow Firm can help you determine whether legal action is warranted.

Contact our New York City law office today by calling (646) 647-3398.

Sources

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