We focused our blogs this past week on defective drugs and the harm they cause to consumers. When you read or hear about a drug recall, the Food and Drug Administration (FDA) is attempting to pull the drug from the market as quickly as possible. As the main regulatory body of prescription drugs, the FDA can issue a recall or request a recall through an agency order. In some cases, the drug manufacturer voluntarily takes the drug off the market.
There are three classifications for drug recalls according to the level of potential harm:
· A Class 1 recall means there is a reasonable probability that using the drug will cause serious adverse health consequences or death
· A Class 2 recall means that using the drug may cause temporary or medical reversible adverse health consequences, or the probability of serious adverse health consequences is remote
· A Class 3 recall means that using the drug is not likely to cause adverse health consequences
In lesser cases of perceived harm, the FDA issues a “market withdrawal,” which is for minor violations that do not result in manufacturing defects. If there is evidence of package tampering, the FDA can issue a market withdrawal without taking legal action against the drug maker.
Unfortunately, the FDA cannot police harm to victims until after an injury has occurred. A personal injury attorney can help people harmed by a defective drug.
Harrell & Nowak, L.L.C. – New Orleans injury lawyers