Prescription drugs and medications are a big part of our lives, but before we take something or have something given to us it’s reasonable to assume that it is safe. If there are risks or dangers, we like to think that we’d be properly warned of potential side effects. Understandably drug companies are anxious to have new drugs approved by the Food and Drug Administration (FDA) in order to give people the drug’s intended benefit, and of course to profit from the drug. According to a Philadelphia lawsuit there was one company that stretched the parameters of an FDA approval and as a result caused the wrongful death of a patient with spinal fractures. In this case a bone cement was approved by the FDA to treat a condition called distal radius, but was not approved to treat spinal fractures. Its misuse, according to the lawsuit, led to preventable death.
An indictment came in 2009 when it was revealed that this bone cement product was mixed with another substance causing the wrongful death of several patients. But by then this was nothing new, as one woman claimed that unauthorized mixture was responsible for her mother’s death in 2003. The process of FDA approval may be tedious, but there are good reasons why those protocols are in place. Drugs and medications need to be used only with full understanding of the risks, and patients should always be informed of those risks.
If you’re being prescribed a newer drug, or having an innovative treatment, you should be able to trust the doctors and hospital staff to do whatever they can to keep you safe. Unfortunately, there are certain times when not all the bases are covered, and it’s the patients and their families that pay the ultimate price.
Source: Courthouse News Service, “Woman Calls Drug Companies Unconscionable,” Reuben Kramer, July 31, 2012