Critics have been known to accuse us of being too hard on product liability plaintiffs and too forgiving of defendants who develop medical products.  We all have our biases, especially after many collective decades of representing the latter group, but we do think the table is often tilted in favor of the former group.  One

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.

The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA.  In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule.  The Court shot that down, giving a significant win to the government.  Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).

In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).

Continue Reading Can The FDA Do That?

Professor Richard Epstein, of The University of Chicago Law School, has this article about Wyeth v. Levine in this week’s issue of Forbes.

Professor Epstein favors preemption, but he thinks that Wyeth’s position does not go far enough: Wyeth seeks preemption only because of a conflict between the warnings that the FDA required and the

It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it in the middle of a routine post) – but earlier this month the Supreme Court indicated interest in the certiorari petition from the

We can’t figure out how to italicize the title of a post, so we’ll repeat that title here, with our emphasis added:

“The Case for Field Preemption of State Laws in Drug Cases.”

That’s the provocative title of Richard Epstein’s piece posted yesterday at Northwestern University Law Review’s Colloquy site.

Everyone argues for conflict preemption