As has been widely reported, Michigan has granted a shield of immunity to drug manufacturers whose products have been approved by the Federal Food and Drug Administration (FDA). This absolute defense against liability may soon spread across the nation, putting consumers everywhere at risk. If pharmaceutical companies are not to be held accountable for their wrongdoing, who is left to bear the burden of defective drugs? The answer is simple: 1) Big Pharma’s victims and 2) the taxpayers.
Simply put, the FDA was not built to police multi-billion dollar companies. The FDA has a broad and unenviable mission. Its mandate is to “protect the public health by assuring the safety, efficacy, and security” of the nation’s drugs, medical devices, food, and cosmetics. In addition, it is directed to “speed innovations that make medicines and foods more effective, safer, and more affordable.” This one little agency is asked to regulate a one trillion dollar industry that accounts for about 25% of all consumer spending in this country.
Recent, well-pubicized failures in FDA oversight have driven home the point: pharmaceutical companies are acting recklessly and the FDA does not have the resources to stop them. If consumers are barred from asserting their rights in court by FDA immunity statutes, legislatures will have effectively put the fox in charge of the henhouse.
Drug company practices are starting to backfire. As patents on many popular drugs are set to expire, the search is on for the next billion-dollar miracle pill. Unfortunately, drug companies will undoubtedly focus on inventing and promoting drugs that sell rather than drugs that actually cure people. As Melody Peterson noted in her L.A. Times editorial, why cure the disease when you can treat the symptoms?
Legislatures enable and embolden pharmaceutical companies by granting absolute immunity for FDA approval. This policy cannot be effective if the FDA is unable to fulfill its mission. The victims of dangerous drugs deserve better.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.