Medication Error and the Role of Compounding Pharmacies

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, 2.5 million Medicare patients, along with an equal number of younger adults, sought relief with the injections and fueled a growing demand for steroids. In September 2012 an alarming number of steroid injection recipients developed meningitis, an inflammation of the membranes covering the brain and spinal cord. By December 2012, 39 people had died, and the numbers are still rising. The outbreak was caused by a drug that had been contaminated with a fungus. An estimated 14,000 people had been injected with the adulterated steroid.

Who Made the Drug?

The New England Compounding Center in Framingham, Mass. had manufactured the tainted drug, selling 17,676 vials to 75 pain clinics 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. New York City’s Beth Israel Medical Center and St. Luke’s Roosevelt Hospital were also former clients.

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. New England Compounding charged $25 per vial of the steroid injection drug while the brand-name product available from Pfizer sold for $40 to $46 per dose. 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.

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.