Drug safety: implications for the dermatologist and dermatopathologist.

The recent decades have seen a plethora of drugs removed from the world-wide market place over safety concerns and reported adverse events. In some cases, drugs with significant reports of adverse drugs events (ADEs) have remained on the market with either a Black Box warning, strict prescribing guidelines, or both. It has been reported that more than 2,000,000 Americans are harmed by ADEs each year. The financial costs associated with ADEs are staggering with over $170 billion spent annually in the United States as a result of ADEs. The implications for the dermatologist and dermatopathologist are daunting for the skin is the organ most frequently affected by ADEs. Many cases of drugs removed from the market are preceded by the filing of one or more product liability lawsuits. This means the dermatologist could be brought under claims of negligence, strict liability, breach of warranty, and consumer protection claims. The potential implications for the dermatologist or dermatopathologist are discussed along with an introduction to the legal process, which comes into play with the filing of the product liability lawsuit.