As the meningitis outbreak continues to spread around the country, one begins to question how this could happen in the first place and wonder if it could happen again. So far, as a result of this recalled steroid product there have been 368 illnesses, 29 deaths, and 19 affected states, including Illinois. As this death toll only continues to rise, we have to wonder, was this preventable?
The simple answer is yes.
Currently, state regulators are primarily responsible for the regulation of drug compounding pharmacies. The Food and Drug Administration, or FDA, performs some tests on a limited amount of drug samples that come from these pharmacies, but their regulation is quite minimal. There are an estimated 3,000 to 4,000 of these compounding pharmacies in the United States, with facilities in nearly every state, including several in Illinois. With such a large number of compounding pharmacies across the nation, it is evident that state-by-state regulation is unrealistic as certain states will have stricter regulations and others will not, leading to inefficiencies, gaps, and lax regulation. That is what we saw happen with the New England Compounding Center in Massachusetts, the drug compounding company responsible for the outbreak, which had a record of violating state law with little to no reprimand.
Our pharmaceutical climate is nationwide, with injectable medications and pills shipped nationally and available to the public at large, making state-by-state regulation difficult. The states are simply unequipped to deal with the regulation of such a large volume of pharmaceuticals. This failure to regulate affects all of us, as many compounding pharmacies ship their drugs to every corner of the country, and a single tainted batch of drugs can affect hundreds of people, as evidenced by the current meningitis outbreak.
Nationwide regulation by the FDA, the entity created to police pharmaceutical drugs, is one solution. The FDA should be granted the power by Congress to force drug compounding pharmacies to meet federal manufacturing standards and to register with the FDA. Federal regulation will help to ensure that drugs are being made in a sterile and safe environment no matter where they are produced. This way, a tainted drug like the one that caused the current meningitis outbreak, would not be so easily overlooked and carelessly shipped nationwide causing hundreds of deaths. The meningitis outbreak may have been prevented if strict federal regulation were applied to these drug compounding pharmacies across the country, including several in Illinois. Without such regulation, who knows what preventable outbreak will be next.
Legal Help for the Meningitis Outbreak
While it is clear that this outbreak was preventable, the sad truth is that it has already happened, and unfortunately has affected victims in Illinois. The attorneys at our firm are hard at work to uncover the legal issues created by this devastating event. We hope that this outbreak will send a message to drug compounding pharmacies that this type of negligent action will not go unpunished. Those affected in Illinois can send that message by seeking compensation for lost wages, pain and suffering, and emotional distress to name a few.
This recalled steroid product might have affected many in Chicago and the nearby communities. The Illinois Department of Public Health states that at least three APAC Pain Clinics gave local patients injections of the contaminated steroids. They include APAC Lincoln Park, the facility in the Thorek Hospital Building, and the Prairie Medical Building in Westchester.
If you or someone close to you may belong to the affected group, please consider giving our office a call to see how we can help you.