'I Wonder If You Want To Give A Fuller Exposition': Roberts Asks Attorney To Explain His Argument

Added: 2026-05-07

[00:00:00]Your friends on the other side, rely heavily on Regal and they did in their opening briefs and in their reply brief they say, well, you just mentioned it, you know, pages 49 and 50 of your brief kind of in passing. I wonder if you want to give a fuller exposition about why your case is different than Regal. Of course, Mr. Chief Justice. I thought our three paragraphs at the end of the brief were persuasive, but let me hum a few more bars on that score. So, first, there's nothing like 136 AF2 in the Medical Device Amendments. So, that's a huge distinction. 136 AF2 again, I think is making very clear that registration doesn't have the effect that the Medical Device Amendments do.

[00:00:38]Second, in Regal, you found as a matter of the statute, not as a matter of regulation, we didn't have to ask a Loper Bright question, as a matter of the statute, that once the FDA approved the medical device, you couldn't depart from the label. So, that's an obvious distinction. And then finally, even then, you preserved the option of a parallel claim. In the penultimate paragraph of the opinion, you said, we're not going to address whether a misbranding claim could proceed here because there is an obligation under the Federal Food, Drug, and Cosmetic Act to not sell a misbranded device. Stop selling is the duty. Ms. Regal might have been able to pursue that sort of claim, but she raised it too late. We're a court of review, not first view, as you said many times, so you're not going to address it. So, you left open the question that's not open in FIFRA because you have Bates and Regal didn't overrule Bates sub silentio.