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October 9, 2008

Eleventh Circuit Issues First Impression of Ephedrine Statute

With a tip of the hat to Ted McClure at Phoenix School of Law, and the FDA Law Blog, the Eleventh Circuit in Hi-Tech Pharmaceuticals, Inc. v. Crawford, __ F.3d __ (11th Cir. Oct. 7, 2008), issued an opinion of first impression concerning 21 USC 342(f)(1). Basically, after exhaustive hearings, the FDA declared in a final rule that dietary supplements with ephedrine alkaloids in them were "adulterated because they present an unreasonable risk."  When the FDA went to enforce this rule against Hi-Tech, it did not present any independent evidence that, in fact, ephedrine was unreasonably risky; instead, it simply relied on its final rule.

The defendant appealed the seizure of its products, and argued that summary judgment in favor of the FDA had been improperly granted -- no evidence supported its position -- and the final rule could not substitute for evidence because 21 USC 342(f)(1) stated that the US had the burden of proof to show that a supplement was adulterated by a preponderance of the evidence and "the court shall decide any issue... on a de novo basis."  Thus, argued the defendant, the de novo basis required evidence, not just the final rule.

The Eleventh Circuit disagreed.  It spent almost no time on the text, instead turning to the legislative history.  (The bridge to the legislative history wasn't ambiguity, but instead the lack of appellate construction!) Ultimately, the court stated:

The statute does not say that the applicability of a regulation promulgated by an executive agency, through an extensive administrative procedure cannot be sufficient proof of adulteration. And the legislative history does not so indicate. Indeed, that history suggests the opposite: that the statute empowers the FDA to settle the issue of adulteration through rulemaking and that additional proof to a court will not be necessary.

See

S. Rep. No. 103-410, at 35.

October 9, 2008 in Current Affairs | Permalink | Comments (0) | TrackBack

October 6, 2008

The Election and SCOTUS

The New York Time's op-ed on the importance of the election to SCOTUS is here. An op-ed on the same issue from the Washington Post is here. And, the LA Times' take is here.

The preemption issue -- where are the conservatives? -- that comes up in the cigarette case, to be heard this week, is discussed in the local Maine paper here (h/t to How Appealing).

October 6, 2008 in Current Affairs | Permalink | Comments (0) | TrackBack

October 5, 2008

CAFA v. Securities Exchange Act Antiremoval Provision

There's an interesting case from the Southern District of New York, unfortunately not on line but if you have westlaw, click here, New Jersey Carpenters Vacation Fund v. Harborview Mortg. Loan Trust 2006-4, 2008 WL 4369840 (S.D.N.Y. Sept. 24, 2008). It addresses whether the removal provision of the Class Action Fairness Act of 2005, Pub.L. 109-2, § 4(a), 119 Stat. 9, Feb. 18, 2005 (“CAFA”), trumps the anti-removal provision of Section 22(a) of the Securities Act of 1933, 15 U.S.C. § 77a et seq.

The court relies on the "general/specific" rule, legislative history, and some guessing, to harmonize the two.

October 5, 2008 in Current Affairs | Permalink | Comments (0) | TrackBack

28 USC 1367

Each year, I teach supplemental jurisdiction as part of my civil procedure class, and each year I run into the Supreme Court's dicta in Exxon v. Appalatah (sp). In that case, the question was if one plaintiff met the minimum amount in controversy, and another plaintiff did not, but both plaintiffs were diverse from the defendant, did supplemental jurisdiction exist? The court held that it did: under the literal terms of 1367(a), there was original jurisdiction over the first plaintiff's claim, and because the second plaintiff's claim arose out of the same case/controversy as the first, the second plaintiff's claim was within 1367(a) and, because it was not against a party joined under Rule 20 (or any rule, for that matter), the claim was not excluded by 1367(b).

And the Court was right.

The Court, though, wrote more about an issue it wasn't facing than it did about the issue it was: what if one plaintiff is diverse and meets the minimum amount in controversy, and the second plaintiff meets the amount in controversy, but was not diverse from the defendant. In extremely long opinions, the court said that 1367(a) would not even be an issue because the second plaintiff's citizenship would "pollute" or "contaminate" the first plaintiff's, and there would be no original jurisdiction at all.

Maybe under 1332 that is the right analysis, but each time I read 1367, I come to precisely the opposite conclusion: by its own terms, 1367(a) gives courts jurisdiction over joinder of parties when joinder is not within 1332.

Anyhow, it drives me nuts. I've read the cases on it, and the law review articles, and they all come up with really neat theories, all of which ignore the language of the supplemental jurisdiction statute, and none of whcih can be harmonized with the holding in Exxon, other than "pollution," which, imho, is a concept that has nothing to do with 1367.

Anyhow, you now know what I'm in the midst of teaching... again!

October 5, 2008 in Current Affairs | Permalink | Comments (0) | TrackBack