Last week we threw up a quickie post about the preemption – or more properly no-preemption decision in Mason v. SmithKline Beecham Corp., 2010 WL 605922, slip op. (7th Cir. Feb. 23, 2010).  We promised you our thoughts when we’d had a chance to read it thoroughly.  We’ve had that chance, but there’s still not a lot to say.  That’s because the Mason opinion is almost totally bereft of legal analysis of the preemption issue.  It’s too bad – particularly since Mason is the first post-Levine SSRI preemption case – that a circuit with such legal heavyweights as Posner and Esterbrook would release such lightweight opinion.

Here’s what we mean.  For one thing, the court spends a page and a half criticizing the lawyers on both sides for being too argumentative in their statements of facts, 2010 WL 605922, at *1-2, which is about a page more than it spends on the law of preemption.

Mason involved a 23-year-old who committed suicide in 2003.  That means that at the time, it was the FDA’s position that there was insufficient scientific data to support a warning of increased risk of suicide.  The FDA had said so several times, rejecting various proposals to require such warnings over the years.

Eventually, after new SSRI studies were completed, the FDA authorized a warning for minors and young adults (that would have covered plaintiff) in 2007.  Largely because of these warnings, SSRI prescriptions in this age group have declined and – since SSRI’s treat depression, which is far more suicide-provoking than the drugs – suicide rates have increased.  We commented on this perverse (but predictable) effect here.

Rant aside, Mason states with zero reasoning that Levine “restored the preemption landscape to its pre-2001 form.”   2010 WL 605922, at *3.  Levine didn’t say that at all – and it’s not true.  While Geier v. American Honda Motor Co., 529 U.S. 861 (2000), hadn’t rippled that far yet, and 2001 was the year that Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) unanimously found conflict preemption of fraud on the FDA cases.  Note to the Seventh Circuit – Levine did not purport to overrule either Geier or Buckman – although its contortions especially with respect to Geier were somewhat painful.  What Levine said is that preemption requires “clear evidence” that the FDA wouldn’t have allowed the warning at issue (for impossibility preemption), and it recognized that there would be circumstances where preemption would frustrate what the FDA was trying to accomplish (obstacle preemption).  Wyeth v. Levine, 129 S.Ct. 1187, 1198 (for the clear evidence point), 1204 (“we recognize that some state-law claims might well frustrate the achievement of congressional objectives”) (2009).  Only Justice Thomas, a notorious disrespector of precedent, held the view that Mason seemed, without the slightest analysis, to ascribe to the Court.

We would have thought that demanding a warning where there was insufficient science to support it might have been one of these situations – or if it wasn’t, that the court would at least explain exactly why not.

No such luck in Mason.  The court simply examines the facts of the case and endeavors to compare them to the “facts” in Levine.  2010 WL 605922, at *4 (“if the evidence here is less compelling than it was in Levine, we will not find preemption”).  That might have been OK if some sort of objective framework was used.  But no, the analysis is as impressionistic as a Rorschach ink blot.

  • “the allegation is partially true,” 2010 WL 605922, at *5;
  • this “does not provide much, if any, evidence,” id.;
  • that “isn’t a great comfort,” id.;
  • “[o]verall, we do not find the FDA’s rejection of the citizen petitions or its call to do more research very compelling for either side,” id. at *6;
  • “[w]hile what [defendant] points out is true, it only tells one side of the story,” id, at *6;
  • “[t]o the extent these subsequent events have any sway….”  Id. at *7.

This strikes us as more akin to guesstimating the volume of an irregular object before Archimedes had his original “eureka moment” over 2000 years ago, than to the kind of legal analysis we’ve come to expect from an appellate court.  There’s no weighting, no test, no nothing – except the sort of “I’ll know it when I see it” subjectivity that courts use when they go for gut reactions over reproducibility of results.

And it gets worse.  Even the gut reaction in Mason is intellectually dishonest.  We discussed that a bit in the comments to our first post, and it occurs in the opinion at 2010 WL 605922, at *4.  Note the transition.  The court starts out its Levine comparison, logically enough (to the extent subjectivity can be logical) by looking at what the Levine majority had to say about the FDA’s review of the drug in that case.  But incredibly, it then adds in the facts as portrayed by the Levine dissent:  “While the opinion in Levine covers the administrative history and record, the dissent delves even deeper.”   2010 WL 605922, at *4.

Excuse us, but that’s neither logical nor honest.  The “facts” that Mason goes on to recite from the Levine dissent were ignored altogether or pooh-poohed by the majority:

“For at least the last 34 years, the FDA has focused specifically on whether IV-push administration of Phenergan is ‘safe’ and ‘effective’…. And the record contains ample evidence that the FDA specifically considered and reconsidered the strength of Phenergan’s IV-push-related warnings in light of new scientific and medical data .” Levine, at 1222. The dissent then meticulously lists the various times the FDA considered a different warning label regarding the IV-push method. It begins in 1975 when several people from Wyeth and several members of the FDA met regarding Phenergan’s label and the FDA proposed that Phenergan should not be injected via Tubex, which is a syringe system used exclusively for IV push. Instead of banning the use of IV push altogether, both parties agreed that there was instead a need for better instruction regarding the problems of intra-arterial injection. A year later, an FDA committee recommended an additional IV-push-specific warning for Phenergan’s label but decided not to prohibit using the IV-push method. In its labeling order, the FDA cited numerous sources describing the costs and benefits of IV push including published case reports from 1960 about cases of gangrene caused by the intra-arterial injection of Phenergan.

2010 WL 605922, at *4.  But what did the Levine majority have to say about those selfsame facts?   Not much.  The Levine majority held that FDA review of Phenergan was:  “sparse,” 129 S. Ct. at 1192; “intermittent,” id.; its “retain verbiage verbatim” instruction occurred “without addressing [defendant’s] submission,” id.; after the FDA was finished, the warning, it “did not differ in any material respect,” id. at  1198; “FDA “paid no more than passing attention to the issue of IV-push,” id. at 1199; and “the FDA did not consider and reject a stronger warning against IV-push,” id. at 1203.

In short, in order to find no preemption in Mason, the court relied on facts from the dissent in favor of preemption in Levine – where the anti-preemption majority in Levine either denied, disregarded or downgraded those very facts.  In Mason the vampire “facts” from the Levine dissent, were disinterred, stood on their heads, and used to establish the polar opposite of what they were intended to establish.

If an expert witness offered an opinion like that, practically no court in the country (except possibly in New Jersey) would let it into evidence.