The Food and Drug Administration (FDA) is the federal agency responsible for regulating and approving the sale of pharmaceuticals in the United States. While not always the case, FDA investigations, warnings and recalls frequently precipitate widespread litigation directed at the drugs they concern. Such was the case with Actos®, Pelvic Mesh and Pradaxa®, for whom lawsuits spiked following actions by the FDA.
The FDA may issue recalls and warnings for a variety of reasons, including contamination, defective manufacturing, deficient labeling or other statutory and regulatory violations and safety concerns. These recalls also cover more than just pharmaceutical drugs. They can also affect food, cosmetics, durable medical equipment and surgical implants. Since August 24, the FDA has issued eight drug recalls, ranging from contaminated and mislabeled drugs to unapproved dietary supplements.
Recalls are an extreme step the FDA can take. Safety alerts are much more common and are intended to educate the medical community and the public regarding previously undisclosed dangers of a drug or product. If FDA regulators believe that the benefits of a particular product still outweigh its risks, it will issue such a safety alert rather than a general recall. Safety alerts are, nevertheless, frequently a bellwether of common litigation, as it was when the FDA issued a safety alert regarding Actos in August and Pradaxa in December of 2011. While both drugs are still on the market today, FDA safety warnings triggered mass litigation by those harmed by the product.
Posted in Personal Injury
Tagged drug recalls, FDA, Food Drug Administration, litigation