Lawsuits can be filed by individuals who are injured by dangerous drugs. But they can also be filed by the federal government for violation of the Federal Food, Drug and Cosmetic Act (FDCA). This was the case recently when Sage Pharmaceuticals Inc. of Louisiana was accused of manufacturing and distributing drugs that were not approved and incorrectly branded.
There is a process that manufacturers must go through before selling a drug. Approval must be granted by the U.S. Food and Drug Administration (FDA), to ensure that it’s effective for its intended use and is safe to use. Yet Sage Pharmaceuticals skipped this critical step, according to the complaint filed by the Department of Justice on behalf of the FDA.
Additionally, the FDA requires that all drugs be correctly and accurately labeled. This means including risks, warnings and directions for use. This was also allegedly not done by the manufacturer.
Sage Pharmaceuticals is no stranger to this type of litigation; it faced similar charges in 2000. It was another case involving the distribution of unapproved drugs. Although the FDA issued several warnings, the manufacturer failed to comply. The newest lawsuit is intended to stop any further activities until all regulations have been met.
Dangers of Unapproved Drugs
Despite laws in place to protect consumers, unapproved drugs continue to be manufactured and distributed. These include over-the-counter cold medicines, prescription pain pills and an assortment of other drugs.
One danger is that the unapproved drug could be ineffective in treating a medical condition, causing it to worsen. Or it may produce side effects that are severe or life-threatening. Inaccurate or incomplete labeling is another issue. It could result in a consumer taking the drug incorrectly, resulting in harm.
If it’s believed that an unapproved drug has resulted in serious or fatal injury, contact an attorney at Gacovino, Lake & Associates. We can help collect the necessary information and documentation to hold the responsible parties liable.