Consider this scenario. A drug manufacturer develops a new product, then spends a billion dollars or more to satisfy the Food and Drug Administration that the drug is safe and effective. The FDA spends many years analyzing this data, including a review by outside experts, and finally permits the company to market the drug under a carefully formulated label describing the drug’s uses and risks. A consumer of the drug becomes ill and sues the manufacturer. She alleges that the drug is defective and its labeling inadequate and demands massive compensatory and punitive damages. Both the drug and the label comply with all of the FDA’s rules, and no new risks have come to the attention of the agency or manufacturer, yet a jury finds the company liable. A month later, another jury in a different state dismisses an essentially identical claim, upholding both the drug and its labeling.

What is wrong with this picture, legally? In almost all states, nothing. State tort law lets juries consider or ignore the FDA’s approval, substitute their own judgment that the product is unsafe and improperly labeled, and award unlimited tort damages. (Michigan is the only state where FDA approval pre-empts most tort liability; a handful of others offer limited protection to manufacturers.) Otherwise, even a drug company’s full and continuing compliance with the FDA requirements provides no safe harbor against tort liability. Instead, the law casts the manufacturer onto the stormy sea of litigation where the jury may treat the FDA’s expert judgment as entirely irrelevant.

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