Expert Witness Opinion On Law

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Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.”  In that post, we mentioned that this research is a subset of a “general” precedent “precluding expert opinions on questions of law,” which we didn’t get into because Bexis’ book addressed it. 

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We spend a large portion of our professional life preparing motions to exclude the testimony of plaintiffs’ experts in mass tort litigation.  Our pleasure in reading today’s decision is no doubt a function of the frequent futility of this effort and the consequent inflation of plaintiffs’ settlement demands.  As such, we offer an enthusiastic tip of the hat to Tarek Ismail for sending us a nearly great (we’ll explain the qualification later) opinion out of the Mirena MDL.  In a voluminous opinion in In re Mirena IUD Prods. Liab. Litig., 2016 WL 890251 (S.D.N.Y. Mar. 8, 2016), the United States District Court for the Southern District of New York considered both sides’ Daubert motions.

Defendant’s Medical Experts

Continue Reading Good Things Sometimes Come in Big Packages: Mirena Rule 702 Rulings Favor the Defense — Big Time

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Although Czimmer v. Janssen Pharmaceuticals, Inc., 2014 WL 1335511 (Pa. C.P. Philadelphia Co. Jan. 2, 2014), was decided several months ago, we only became aware of it (because of our ongoing automatic searches) the other day.  While there are a number of grounds for feeling uneasy about what went on in Czimmer, we’re

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Here’s another guest post from Reed Smith‘s Eric Alexander.  Maybe we’ll get him his own account next time.


After the overwhelming response to our first post last week – the list of the recipients of those firm holiday cards we never actually send got a bit longer – we agreed to do

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With our focus on prescription drug and medical device product liability litigation, we sometimes overlook developments that occur outside the boundaries of our own little sandbox.  While that’s necessary to restrict the blog’s scope to something manageable, nonetheless it’s somewhat artificial.  Drug and device law doesn’t exist in some kind of vacuum, cut off from the rest of tort law.  What we do here sometimes affects other types of cases, and what goes on in other types of cases certainly can have significant impact on our clients.
One of the other things that Bexis does around here to make himself useful is to prepare monthly memoranda that summarize newly decided cases involving Pennsylvania tort and product liability law generally (he’s a glutton for punishment).  In that capacity, he came across Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011), which on its face has nothing to do with prescription drugs or devices.  Instead, it has to do with injury allegedly suffered from a child car seat.
The accident apparently happened when, for unknown reasons, the child’s mother plowed her minivan headlong into a tree.  The father originally brought the suit, but also for unknown reasons – possibly due to the parents’ questionable actions – a bank ended up as guardian ad litem.  See Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 2789336 (E.D. Pa. July 18, 2011) (parents sanctioned for recklessly spoliating the product); Waltman v. Dorel Juvenile Group, Inc., 2009 WL 2877153 (E.D. Pa. Aug. 28, 2009) (parents entered into secret release, and then hid it during discovery).
The Dorel opinion at No. 3740472 addressed with a plethora of “in limine” (that means evidentiary matters presented before trial) motions.  We’re old enough to remember when in limine motions were thought of as unusual; but they’ve propagated faster than rabbits since we’ve been practicing – but back to the point.

Continue Reading Cross-Fertilization

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Sometimes courts come out with rulings that surprise us, either pleasantly or unpleasantly. Sometimes courts are utterly predictable. There’s a little of both in the most recent chapter of the Iacangelo saga, which we’ve covered before here. Iacangelo v. Georgetown University, 2010 WL 4807082 (D.D.C Nov. 19, 2010). Plaintiffs brought suit on behalf of their daughter, who had been treated for arteriovenous malformation (AVM), an abnormal tangle of veins and arteries in her brain through which blood could not flow properly. The treating doctor used a method known as embolization, which involves using adhesives and other mechanisms to seal off the blood vessels feeding the AVM in the brain. In this case, the doctor used Histoacryl, a glue, and Lipiodol, a poppy seed-oil compound visible in X-rays. The FDA had not approved Histoacryl and Lipiodol for this treatment, either in combination or separately. Moreover, those substances could not be purchased from suppliers inside the United States. You might ask, “So what?” And you’d be pretty smart.
The treating doctor was named Watson, which accounts for the silly title of this post. In the old (1940s) Sherlock Holmes movies, Nigel Bruce played Dr. Watson as a dough-eye doofus, but in the original stories by Sir Arthur Conan Doyle, Watson was smart even if he lacked his buddy’s superhuman deductive powers. Dr. Watson was also something of a tough guy. He had been wounded in Afghanistan, and could handle a gun rather well. Perhaps most interestingly, in the first story, A Study in Scarlet, Conan Doyle wrote of Dr. Watson’s “experience of women which extends over many nations and three continents.” Hmmm. Maybe Jude Law’s recent portrayal of the good doctor wasn’t so far off the mark. And the words “good doctor” bring us back to the Iacangelo case.
The parties offered “wildly divergent accounts of what Dr. Watson told Ms. Kerris, her patients, and her husband.” 2010 WL 4807082 at *1. Since we’re at the summary judgment stage — for you non-lawyers, that means we don’t evaluate who’s telling the truth (although we have our suspicions) — we’ll go with plaintiffs’ allegations, including that Dr. Watson said that embolizations “had a 95% chance of success,” and that Dr. Watson never revealed that neither Histoacryl nor Lipiodol had been FDA approved.

Continue Reading No, er, Kidding, Sherlock

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One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery.  We haven’t looked at any facts of any case or about the device.  We know

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Fritz Zwicky, the tart-tongued scientist (discoverer of, among other things, supernovae and neutron stars) was wont to label his critics in the astrophysical world (of whom there were many) “spherical bastards.”  That was his shorthand for someone who was a “bastard, when looked at from any side.”
Hence the title of this post. We think that the recent decision in In re Gadolinium-Based Contrast Agents Products Liability Litigation, MDL No. 1909, slip op. (N.D. Ohio May 4, 2010), is a spherical error.  That is, it’s a decision that, no matter what direction we look at it, looks like error to us.
This goes beyond mere legal analysis, and encompasses a truly troubling disparity in the approach to defense and plaintiffs’ experts.  Leaving astrophysics for something less cosmic (but more interesting to us baseball fans) the plaintiffs’ experts got to pitch to a Kong Kingman strike zone.  E.g., Slip op. at 39-40. But when defense experts had to toe the same rubber, well it was Eddie Gaedel at the plate.  E.g., Id. at 52-53.
Read on, you’ll see what we mean.
That’s odd, because we looked at Judge Polster’s opinions to check his history was in product liability cases. We found nothing unusual in any past opinions. While Judge Polster doesn’t much like fraudulent misjoinder, he’s hardly alone in that.  He doesn’t have a long product liability track record, but he seemed okay in asbestos cases.
So we’re still scratching our heads at where this spherical error comes from.
We knew practically nothing about the Gadolinium MDL before the other day.  It had produced no opinions beside a few removal/remand decisions. Gadolinium itself is a “rare earth,” one of those oddballs that hang underneath the main periodic table, as Bexis found out about when his daughter told him she knew all the elements’ numbers by heart (it’s number 64, and, yes, she did know it).  Apparently, gadolinium’s magnetic properties make it a superior contrast agent when used in now ubiquitous resonance scans.

Continue Reading Gadolinium and Spherical Error

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Just so you know who to blame, this post is by Bexis only. Herrmann’s staying well away due to his representation of Wyeth.
The much-touted/much-reviled (depending upon which side of the “v” one resides) $27.12 million punitive damage award in the In re Prempro hormone replacement ltherapy litigation has been vacated. The judge admitted that

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The recent decision in Iacangelo v. Georgetown University, ___ F. Supp.2d ___, 2008 U.S. Dist. LEXIS 46416 (D.D.C. June 17, 2008), hasn’t gotten much play in the press.

For good reason.

It was written by a magistrate judge, doesn’t give too much of a sense of the underlying facts, and stands for a relatively