2010

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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.Continue Reading Mason Jarring, But Very Little There There

A friend recently sent us a helpful decision squelching a plaintiff’s proposal to share defendants’ confidential information with anyone who asks. Doriand v. Centocor Inc., 2010 WL 325742 (N.D. Fla. Jan 26, 2010). We noted before the relevant dearth of citable authority on this subject, and we’re glad to see another judicial vote for…

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Years ago we were often entertained by the comedic stylings of “Professor” Irwin Corey, “World’s Foremost Authority.” Authority in what? (Or so we imagine you asking.) Well, that’s the point. He was an authority on everything and nothing. His shtick was to amble on stage dressed in a collegiate gown and sneakers, and then hold forth on a variety of topics via double-talk, stream-of-consciousness, and abrupt, nonsensical topic changes. Here’s an odd bit of high-brow/low-brow trivia: Ayn Rand was a big fan of Professor Corey.
For some reason, we think of Irwin Corey when we confront plaintiff expert witnesses in drug or device cases. Plaintiff lawyers are nothing if not cheap, so they like to use the same experts again and again to cover a broad swath of scientific and technical areas, even if those areas are far away from the witness’s training and practice. More often than not, they (the plaintiff lawyers and the instant “experts”) get away with it. We remember deposing a professor of marketing who not only uttered the most inane thoughts on how certain advertisements contained Freudian themes, but also took a few stray shots at cancer causation. Like any semi-awake lawyer, we asked the witness whether he considered himself an oncologist. The witness than said something like, “I’m not board-certified as a medical doctor, but I think that I have had education, experience, and training that would permit me to share a few things that would be helpful to the jury.” And then he grinned. He grinned because he knew he had played the game well.
Too many courts let plaintiff experts play the game. Courts are supposed to act as gate-keepers. Gate-keeping must be plenty hard, because more than a few judges seem inclined to let phony experts blather. The judges would rather have the jurors sort it all out. It’s possible that we are irretrievably scarred on this issue, since we practice in a jurisdiction where a witness is qualified to testify as an expert if the witness “has any reasonable pretension to specialized knowledge on the subject under investigation.” Miller v. Brass Rail Tavern, Inc., 541 Pa. 474, 480-81 (1995). That’s right, “pretension.”Continue Reading World’s Foremost Authority

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Remember Bruesewitz v. Wyeth?  That’s the case about the Vaccine Act and express preemption.  It made our top ten list last year.  Bruesewitz and it’s evil twin, Wyeth v. Ferrari, appeared for a while to be headed for the Supreme Court together – there being a direct conflict between the two. …

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One of the interesting things about blogging is that a lot of people seem to consider us part of the “press” – whether that’s the “health” press or the “legal” press. As a result, we get sent a lot of unsolicited press releases, maybe a couple of dozen a week. Most of them are from various small medical-related companies announcing this or that medical advance. Since we’re lawyers, not doctors, we’re not competent to evaluate such things, nor would product reviews be what our chosen audience wants to read. Those emails get the “delete” button, even though they’ve occasionally offered us money for reviews.
But part of the litigation dance these days also involves the press. One thing that the other side does is try to make itself as obnoxious as possible to our clients any way they can.  There’s good reason for it.  It’s part of the game; their rationale being that anything that annoys our clients increases the settlement value of their cases.  Even if a case is lousy and has only a nuisance value – the bigger the nuisance, the bigger that value will be.  Or so a lot of folks on the other side thinks.
Among other things, plaintiffs’ lawyers pursue this annoyance function by trying to generate negative buzz about our clients in the media.  So they (or their PR flacks) send out press releases too. And they send them out to bloggers and other media types who aren’t really competent to make heads or tails of what they’re getting.  In particular, the other side throws adjectives like “illegal” and “fraudulent” around as if they’re so much confetti – or, if (like us) you’re less inclined to be charitable, a smokescreen. Toss in a few vague but dark hints about safety risks, and the other side hopes it can generate negative press. We know all about this as lawyers; it’s part of the drill, especially in the major litigation that we get called upon to defend.
But sometimes the plaintiff side’s offerings to the press find their way to us – as bloggers.Continue Reading Qui Tam Action Looks Like A Ripoff

We read lots of cases. A few are flawless and a few have no redeeming features, but most have a little bad mixed with the good, or vice versa. We tend to be curmudgeonly, even though we are down a curmudgeon, and we will fuss about a flaw in a opinion that rules in favor…

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We’ve always thought that the FDA’s close regulation of SSRI’s (selective serotonin reuptake inhibitors) and the issue of suicide was among the best fact patterns for preemption.  So did the FDA – it entered the preemption field to preserve its control over the labeling of these drugs.

If our side can’t win the preemption fight after…

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Back in April we posted about the “funky” non-manufacturer claims in Timberlake v. Synthes Spine Co., 2009 U.S. Dist. Lexis 29074 (S.D. Tex. Mar. 31, 2009).  Those claims – trying to hold people who conducted clinical trials liable in a post-approval case for alleged misconduct in how the trials were conducted – were dismissed, but…

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In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010).  There’s nothing particularly interesting about the affirmance as to the manufacturing defect claim.  But what the court had to say about plaintiff’s allegations concerning off-label promotion…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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