The arguments increasingly boil down to the meaning of the word “requirements.” Preemptors insist that tort liability is equivalent to “requiring” companies to do something that conflicts with what they are required to do under FDA regulations. Folks on my side argue that civil liability, in itself, has nothing to do with conflicting requirements.

It is true that, as a result of what gets unearthed in court (suppressed studies, etc.), FDA has sometimes changed its own “requirements” of a company - changing label, etc.. But that is the FDA’s responsibility, and we should only be thankful to such cases for bringing the relevant safety data to light. What the FDA then does with it is their business. Meanwhile, more of the truth is known.

Happy Hanukkah to you and your family…