In the wake of a meningitis outbreak that has killed 28 people and sickened hundreds more, there are many calls for greater regulatory oversight of so-called ‘compounding pharmacies.’ Facilities such as the one responsible for the tainted steroid shots at the heart of the current outbreak face less stringent regulation that the producers of medications. Compounding pharmacies mix already created ingredients to serve patients with allergies or unusual dose needs. Unlike a drug maker, they are generally overseen by state regulatory bodies as opposed to the Food and Drug Administration. According to a review of cases involving tainted compound products, the companies responsible often escape any serious punishment from regulators.
Rather than rely on increased regulation to get justice, it is generally necessary for the victims of tainted compound products to pursue personal injury litigation to hold the compounder responsible. Compounding pharmacies are unlikely to receive punishment that will force them out of business, even in cases where the safety conditions at a facility are deplorable. It is up to victims to seek compensation that will, if the problems are large or persistent enough, drive a substandard facility into bankruptcy. The Massachusetts Board of Pharmacy does not even have the authority to fine the compounding pharmacy at the heart of this latest outbreak.
When the makers of a product act negligently, the lives of those who purchase or receive that product can be endangered. In this case, hundreds of people have become ill and more than two dozen have died because of the unsafe practices of a compound pharmacy. The best, and perhaps only recourse for those affected by such products is to contact a lawyer and pursue a civil lawsuit for damages.
Source: USA Today, “Harsh punishments rare for drug compounding mistakes,” by Peter Eisler, 1 November 2012