Foreign Regulations

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A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.

The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA.  In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule.  The Court shot that down, giving a significant win to the government.  Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).

In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).Continue Reading Can The FDA Do That?

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The MDL court in West Virginia in the pelvic mesh litigation is continuing to issue pre-trial opinions.  Amongst those issued last week was an opinion addressing 24 motions in limine filed by plaintiffs and defendant, Boston Scientific Corporation (“BSC”).  Eghnayem v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 153284 (S.D.W. Va. Oct. 28, 2014).  We won’t address all the court’s rulings.  A number of them, as is almost always the case, were denied without prejudice to re-raising them at trial.  But some are either interesting or address issues frequently raised in mass tort trials.  So we discuss them here.

Exclusion of Material Safety Data Sheets (“MSDS”).  Admissibility of MSDS is often an issue in drug and device law litigation.  BSC sought to exclude the MSDS for polyethylene because it was not used in BSC’s mesh product.  They won – for obvious reasons.  The loophole that plaintiffs apparently tried to exploit was that certain BSC employees answered questions at their depositions about the polyethylene MSDS, incorrectly believing that it was the MSDS for a different substance – polypropylene – that is contained in BSC’s mesh product.  The court figured that out and excluded the polyethylene MSDS.

BSC also tried to exclude the MSDS for polypropylene, a material that is in its product.  No luck. BSC argued that a representative from the chemical company that made the polypropylene testified that the MSDS cautionary language was not placed there for scientific concerns.  The court found that testimony to be unclear and that the witness had actually testified that he didn’t know who drafted the MSDS or why it was written.  The court denied BSC’s motion, so BSC went one for two on its attempts to exclude the MSDS.  Id. at *5-8.Continue Reading The West Virginia Pelvic Mesh Court Issues in Limine Rulings

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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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According to the Wikipedia entry (OK, maybe not the most reliable source, but it is the fastest), “American exceptionalism” is the notion “that the United States is qualitatively different from other nations.”  The first person to say so (although not in those exact words) wasn’t even American, but French – Alexis de Tocqueville.  While sometimes…

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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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Last week (we think; it was before Levine anyway) we reported on the belated and meritless recusal motion filed by the plaintiffs in the Sprint-Fidelis litigation. We were remiss in not reporting sooner, but the other day, the court denied the motion, as it well should have. The last section of the opinion discussed some…

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We reported last week that Judge Anne Conway, who’s overseeing the Seroquel MDL, had granted summary judgment in favor of AstraZeneca in the bellwether cases involving the first two plaintiffs. She had not yet issued her written decision at that time.
She still hasn’t entered that written decision. (We just couldn’t leave you hanging there.)…

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We posted last month about a Baycol ruling and noted that the one of us who wrote that post had not previously briefed the admissibility of foreign regulatory activities in American product liability trials.
It’s a left-brain/right-brain kind of thing. The other one of us pulled out a brief from a couple of years ago.…

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We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.…

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