A defective drug is one whose potential risks outweigh its intended benefits or fail to provide adequate warning of the risks. In many cases, plaintiffs allege that drug manufacturers are aware of the dangers their products pose, but choose to conceal this information from the public. If a significant number of serious injuries or deaths are reported in relation to certain drugs, the Food and Drug Administration launches an investigation to determine whether the drug is defective. When the serious dangers of a drug are discovered, however, it is not necessarily taken off the market. Instead, a warning is added to the labeling and the drug continues to be sold and prescribed to consumers who may or may not be aware of the dangers posed by their medication.
How do defective drugs get on the market?
All pharmaceutical drugs that are introduced to the U.S. market must be preapproved by the Food and Drug Administration (FDA). There is a sense that drug manufacturers will downplay or conceal adverse side effects found in their studies to facilitate FDA approval. Furthermore, the FDA rarely performs follow-up research and lacks the time or resources to perform a rigorous screening of the product, which may lead to the approval of defective drugs. Many researchers who publish the findings of clinical drug trials are not given all the data available, which can lead to a skewed safety profile about the drug. Frequently researchers are paid to do research and write favorable journal articles.
What are the responsibilities of drug manufacturers?
Drug manufacturers must adequately test each product before seeking FDA approval. In addition, drug labels must properly disclose all information about the drug and warn consumers of potential side effects to reduce the risks of misuse and adverse events. Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects. This includes "compounding" companies.
What are my legal rights if I’ve been injured by a defective drug?
If you believe that you or a loved one has suffered serious personal injury from a defective drug, you may be eligible to seek compensation for your medical expenses, pain and suffering, loss of income, diminished earning capacity, loss of companionship, and more. Under product liabilitylaws, the manufacturer, distributor, and seller can all be held liable for your injuries.