Compounding Pharmacy Implicated in Deaths
Meningitis is a swelling of the protective membranes of the brain and spinal cord. Problems with the injections arose when the contaminated steroid was injected near the spine. Steroid injections in knees or hips are highly unlikely to cause meningitis.
The compounding pharmacy shipped 17,676 potentially tainted vials to 75 pain clinics in 23 states. The contents of 14,000 vials were injected into patients. Five hundred and fifty people became ill and 37 of them died. The company has ceased operations, surrendered its license and recalled all of its products.
What Is a Compounding Pharmacy?
At one time, all pharmacies were compounding pharmacies, actually making or “compounding” a doctor’s specific prescription out of raw ingredients. After World War II, the modern pharmaceutical industry began to manufacture packaged drugs in dosage form. Many pharmacy chains ceased compounding and simply distributed pre-packaged drugs.
The U.S. Food and Drug Administration closely regulates the sites where these drugs are manufactured, and the processes used to manufacture them.
Today, traditional compounding pharmacies are used to create alternative versions of medicines, such as allergen-free versions of drugs or liquid forms for those who cannot swallow pills. At the same time, large scale compounders are behaving like drug companies, making or repackaging products in large qualities. In 2000, there were virtually no compounding pharmacies. Today, there are 3,000.
In spite of their size and cross-state distribution, compounding pharmacies are not currently regulated by the FDA like other drug manufacturers. Instead, they are regulated as pharmacies by the 50 state health departments, which are often unable to understand sophisticated drug manufacturing processes. As a result, compounding pharmacies are able to circumvent the regulatory process.
In 1997, Congress passed a law giving the FDA power to regulate large compounding pharmacies that advertised their products. That law was struck down by the U.S. Supreme Court in 2002.
Proposed Legislation Would Regulate Compounding Pharmacies
The rash of deaths and illnesses in 2012 has precipitated introduction of a bill in Congress that would require compounding pharmacies to meet the same sterility, manufacturing and record-keeping standards as those required of large drug makers, and would make them accountable to FDA regulation.
A Rash of Lawsuits
By the end of 2012, more than 50 federal lawsuits had been filed in nine states, alleging that the compounding pharmacy negligently produced a defective and dangerous product and seeking millions of dollars of compensation for deaths, physically painful recoveries, lost wages, and mental and emotional suffering.
More cases are being filed every day, and the situation will likely result in multi-district litigation.