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We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

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Birth defects are scary.  We suspect most parents among our readers can remember their relief upon hearing the pronouncement “normal” during a sonogram and when the post-birth count of fingers and toes came up as expected.  When there is a child born with birth defects, parents search for reasons.  On possible explanation may be a drug the mother took while pregnant.  For more than fifty years, the vast majority of people in this country who have hit or passed childbearing age have understood that some drugs are associated with (or, more conventionally, “cause”) birth defects.  The FDA’s familiar regulatory framework for drugs dates to 1962, when it was revamped because of concern over birth defects with a drug approved in other countries.  Patient information for drugs, prescription and over-the-counter, is read unevenly, but the risks of use by pregnant women tends to get more attention in the real world.  Not surprisingly, there has been quite a bit of litigation involving allegations of birth defects with drugs for many years, some of which has been detailed in various posts here (not to mention Daubert itself).  Plaintiffs and their contentions have inherent jury appeal.  The child (regardless of age at trial) is faultless and juries are disinclined to hold anything the mother (or father) did against the child.  Although birth defects occur in the general population without regard to drug usage, the tendency of jurors to put themselves in the shoes of the parents of the child with birth defects can impede rationality and shift burdens to defendant drug manufacturers—after all, every knows that some drugs can cause birth defects and women are supposed to avoid taking them while pregnant for a reason.

So, it takes a brave judge and strong record to get rid of the general causation opinions of a well-qualified epidemiologist across all cases in an MDL about birth defects with a drug.  That is what came together in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2014 WL 2921648, __ F. Supp. 2d __ (E.D. Pa. June 27, 2014).  The expert, Dr. Berard, holds a Ph.D. and is a professor in a relevant discipline—Canadian schools count here—and actually had done research outside of litigation on birth defects with this the relevant class of drugs, SSRI antidepressants.  The lack of research outside of litigation can be a major Daubert attack on an expert, but Dr. Berard’s non-litigation work was inconsistent with her opinions here.  In addition, her work for plaintiffs suing over birth defects with another SSRI produced inconsistent opinions, which leads to the whole petard hoisting thing.  (We are not suggesting Dr. Berard actually injured herself with an explosive device.  A petard, given the context of the expression, sounds to us like an article of French clothing or perhaps an uncomfortable chair.)

Continue Reading Hoisted By Her Own Petard: A Qualified Epidemiologist’s Causation Opinions Get Tossed Across An MDL

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We’ve been informed by counsel that the Dobbs litigation – the case that brought us Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011), has been settled while on appeal before the Tenth Circuit.  That means that there is no longer any reasonable prospect of getting the best branded drug preemption facts

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Here are a few updates to some of our previous posts.
First, we posted about In re Aspartame Antitrust Litigation, ___ F. Supp.2d ___, 2011 WL 4793239 (E.D. Pa. Oct. 5, 2011), as we considered the case a promising development insofar as taxation of costs of production could exercise a restraining influence on

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Finally, a judge with some common sense….
We’ve always thought (and the FDA did too) that the adult suicide/SSRI warning claims were the strongest possible claims for implied preemption in the prescription drug context.  C’mon, the FDA looked and looked again at the suicide data for these drugs and found that there was no scientific

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We were expecting it, after Dobbs, but the 10th Circuit issued similar order today vacating and remanding Miller v. SmithKline – the other SSRI preemption appeal it had before it.  It’s a little odd, in that the longer (5 pages) Miller order is unpublished, whereas the single paragraph Dobbs order is to be published.

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Our recent post concerning the adverse (and we thought rather obtuse) SSRI preemption decision in Mason v. SmithKline Beecham drew a response from blog subscriber Mal Wheeler.  He was good enough to pass along the letter he recently wrote to the court in the pending Dobbs v. Wyeth SSRI preemption appeal concerning the Mason

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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