September 2012

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How obsessed are we, you ask?  Well, when (courtesy of Mealey’s; we probably wouldn’t have seen the case at all otherwise) we read McCormack v. Hiedeman, ___ F.3d ___, 2012 WL 3932735 (9th Cir. Sept. 11, 2012), we didn’t think about pro-life. pro-choice, or even preliminary injunctions.
No, we thought about FDCA preemption.
You see, going all the way back to McDermott v. Wisconsin, 228 U.S. 115 (1913), essentially the first FDCA successful preemption case ever, it has been established that a product, labeled in compliance with FDA regulations (although in 1913, it wasn’t the FDA yet), and traveling in interstate commerce, cannot be excluded by state law.  In McDermott the Court recognized the preemption of a state statute that prohibited any product – including products labeled in accordance with the FDCA – unless they carried a state-specific label that was inconsistent with federal law.  The Supreme Court barred the state from prohibiting importation and sale of the federally-approved product:

If truly labeled within the meaning of the [predecessor of the FDCA], his goods are immune from seizure. . . . [T]he Wisconsin statute provides that they shall bear the label required by the state law and none other. . . . . In others words, it is essential to a legal exercise of possession of and traffic in such goods under the state law that labels which presumably meet with the requirements of the Federal law, and for the determination of the correctness of which Congress has provided efficient means, shall be removed from the packages before the first sale by the importer. . . . Conceding to the state the authority to make regulations consistent with the Federal law for the further protection of its citizens against impure and misbranded food and drugs, we think to permit such regulation as is embodied in this statute is to permit a state to discredit and burden legitimate Federal regulations of interstate commerce, to destroy rights arising out of the Federal statute which have accrued both to the government and the shipper, and to impair the effect of a Federal law which has been enacted under the Constitutional power of Congress over the subject.

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. . .The legislative means provided in the Federal law for its own enforcement may not be thwarted by state legislation having a direct effect to impair the efficient exercise of such means. For the reasons stated, the statute of Wisconsin, in forbidding all labels other than the one it prescribed, is invalid.

288 U.S. 133-34, 137.
So what happened in McCormack?  The state of Idaho passed a “fetal pain” statute limiting abortions to the first 20 weeks of pregnancy.  Apparently an ordinary termination was beyond this particular plaintiff’s means.  2012 WL 3932735, at *1.  However, plaintiff “learned that medications inducing abortions had been approved for use in the U.S. and could be purchased over the internet.”  Id.  That’s exactly what she did.  Somehow, the opinion doesn’t give details, the plaintiff “ingest[ed] one or more medications she reasonably believed to have been prescribed by a health care provider practicing outside” the state.  Id., see id. (plaintiff “reiterated that the medications were prescribed by a physician”).  These unidentified medications – prescribed by a physician – induced an abortion/miscarriage.  Id.Continue Reading Obsessed With FDCA Preemption

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We’re not comfortable saying much because we have tangential involvement (not on this appeal), but blog readers, particularly in California, might be interested in the recent decision in Pomona Valley Medical Center v. Superior Court, No. B241684, slip op. (Cal. App. Sept. 24, 2012) (for publication).  We haven’t researched it thoroughly, but we believe that Pomona

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We all know how easy it is to complain about bad decisions. Right now, sports pundits and fans are holding a gripeathon about the National Football League ‘s replacement referees. There has been more talk about the officiating mistakes than about the athletic performances. A sense of perspective is in order.　 The comparison baseline is

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First and foremost here at the Drug and Device Law Blog, we like good, strong defense decisions.  If those decisions contain lessons (or reminders) for our everyday practice – so much the better.  That’s why we’ve blogged about cases that let us remind you to check publicly available information about plaintiffs, make sure the plaintiff was alive when she filed suit, and search bankruptcy filings to see if plaintiff disclosed her lawsuit.  We blogged about a bankruptcy discharge case a few months ago out of state court in Massachusetts.  So, when we stumbled across a recent federal court decision on the issue, we thought we’d pass it along and take a look to see what else was going on in federal court on this issue.
The case that prompted this post is a holdout from the Vioxx MDL – In re Vioxx Products Liability Litigation, 2012 WL 4097200 (E.D. La. Sep. 17, 2012).  Plaintiff Sandra Elliott filed her Vioxx lawsuit in 2006 and later filed for bankruptcy in 2009, but did not disclose to the trustee her claims against Merck.  Id. at *1.  While the bankruptcy was still pending, Merck moved for summary judgment on the grounds of judicial estoppel.  Id.  The fact that the bankruptcy was still pending is one of the things that caught our eye about this case.  We’re sure you won’t be surprised to learn that plaintiff’s primary argument in opposition to the motion to dismiss was – I’ll just go back and amend my bankruptcy petition and then no harm, no foul.  The court didn’t see it that way.
There are three requirements for judicial estoppel to apply: “(1) [T]he party is judicially estopped only if its position is clearly inconsistent with the previous one; (2) the court must have accepted the previous position; and (3) the non-disclosure must not have been inadvertent.”  Id. at *2 (citation omitted).   It is the second two factors which are most often at issue in the bankruptcy non-disclosure context.
Let’s start with number 3.  We can imagine that almost every plaintiff when faced with this type of motion to dismiss argues inadvertence.  The definition of an inadvertent non-disclosure can vary from court to court.  In the Fifth Circuit “[a] nondisclosure is considered inadvertent only when, in general, the debtor either lacks knowledge of the undisclosed claims or has no motive for their concealment.”  Id. (emphasis added and citation omitted).  Knowledge and/or motive give “rise to an inference of intent sufficient to satisfy the [bad faith] requirements of judicial estoppel.”  In re Coastal Plains, Inc., 179 F.3d 197, 210 (5th Cir.1999).  The Third, Eighth, Tenth, and Eleventh Circuits have also adopted this reasoning.   See, e.g., Eastman v. Union Pac. R.R. Co., 493 F.3d 1151, 1157 (10th Cir.2007); Stallings v. Hussmann Corp., 447 F.3d 1041, 1048 (8th Cir.2006); Barger v. City of Cartersville, Ga., 348 F.3d 1289, 1294 (11th Cir.2003); Ryan Operations G.P. v. Santiam–Midwest Lumber Co., 81 F.3d 355, 363 (3d Cir.1996).Continue Reading Practice Pointer Follow Up

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Breaking news here.  The Ninth Circuit has upheld a preemption-based dismissal of a Vaccine Act case. See Holmes v. Merck & Co., No. 08-16557, slip op. (9th Cir. Sept. 25, 2012).  As the docket number indicates, the Holmes appeal has been pending for over about 4 years.  It was resubmitted in 2011 after Bruesewitz …

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Anything can happen. You’ve probably heard the claim that a million monkeys in front of a million typewriters would eventually type one of Shakespeare’s sonnets.  But good luck waiting for the release of “A Monkey’s Immortality Sonnet.”  In sports, old-time Dodger fans used to say, “Wait’ll next year,” and the next spring they thought, “Anything

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One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip.  The kind with a tent, sleeping bags, no electricity.  You get the idea.  This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone –…

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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.

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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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