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We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege.  Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant

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When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.”  The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost

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It seems like once every couple of weeks, we see a story about some plaintiff (such as this one) suing, or threatening to sue, a defendant product manufacturer over some product that, according to the plaintiff, “the company should have recalled sooner.”

That’s garbage.

There is no such claim.  Rather failure-to-recall theories are

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We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space. 

The complaints filed by such attorneys often are

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Recently, Bexis attended the DRI drug and device committee spring conference.  Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner.  On that same day, co-blogger Steve Boranian alerted Bexis to a new defense argument in asbestos/mesothelioma cases that also utilizes genomics – certain mutations in a gene called “BAP1” – to identify persons at greater risk of idiopathic (that is, not related to asbestos) mesothelioma.  Here’s a link to that article.  A verifiable alternative cause could  be a game-changer for asbestos litigation.  The statement we quoted back in 2009, uttered by the first person ever to have his genome individually sequenced, that “individual genes are just not very informative,” appears in the process of being disproven by ongoing scientific events.

Both items, as informative as they were on scientific facts, were rather short on the law.  That’s where we come in.  We thought we’d take a look at what law exists concerning the intersection of pharmacogenomics, personalized medicine, and prescription medical product liability litigation.  We’ve touched on these issues back in 2011, when we blogged about Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), one of the first cases in which the plaintiff made allegations about pharmacogenomically-based risks.  Back then we said:

The plaintiff is claiming that a drug is defective, not because of anything inherent in the drug itself, but solely because it is less effective (and therefore has a different risk-benefit profile) due to the plaintiff’s peculiar genetic makeup.  Essentially, the allegations seek to impose a non-FDA-approved contraindication, using state law, based upon human genetic variability.  With advances in computer technology making genetic testing exponentially cheaper and more detailed as times passes (see Moore’s law), more and more genetic variability in the efficacy of prescription drugs is bound to be discovered.  Eventually – certainly within some of our lifetimes – we’ll be able to carry our entire individual genetic code around with us on a chip, should we so choose….

The complaint in Mills is a bare genetic susceptibility claim, frankly based on an allegation of “variant” genetic characteristics shared by only a minority of the population.  In our view, unless and until – and only to the extent that – the FDA decides to assess drug approvals and contraindications on the basis of genetic subgrouping, this type of tort claim should not be recognized, because it is flatly contrary to the criteria by which the intended uses of drugs are currently determined.  Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.

It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a singularity-driven issue that needs to be addressed by the policy branches of our government, and not haphazardly in product liability litigation.

(Emphasis added).Continue Reading What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

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Perhaps you’ve seen the video of trees disappearing into a Louisiana bayou sinkhole.  It is dramatic and it reminds us of the feeling that Louisiana litigation has occasionally served up to us over the years.  Maybe it is the steamy climate (we mean the legal stuff, not the astonishing humidity), with plaintiff lawyers doing A-plus imitations of Foghorn Leghorn, that makes litigation in the Pelican state … unique.  Right now we are thinking of an especially flamboyant Louisiana lawyer who is crazily combative (we were at a deposition where he threw punches), crazily successful, and, not to put too fine a point on it, crazily crazy.  The fact that many of you out there are scratching your heads and wondering exactly which crazy Louisiana plaintiff lawyer we are talking about says something.  But meanwhile, some really smart judges down there have been sneaking up on us with really smart decisions.  Les bon temps rouler, indeed.

The case of Scianneaux v. St. Jude Medical, S.C., Inc., 2013 U.S. Dist. LEXIS 117081 (E.D. La. Aug. 19, 2013), is a gumbo bowl of tasty legal reasoning.  In just a few pages, the judge clearly and elegantly disposes of a device case that might have provoked bloviation and evasion in some other courts.  The court correctly applied the TwIqbal pleading standard to swat away the usual “parallel claim” effort to circumvent preemption.  You arrive at the inevitable conclusion before getting to the bottom of your glass of sweet tea.  Or, if you are of a certain bibulous nature, your Hurricane or sloe gin fizz.Continue Reading TwIqbal and Preemption Sink E.D. Louisiana Defibrillator Claim

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Boring title, but accurate.  Here’s the latest.
First, Medtronic won another one the other day.  Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system.  It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body.  Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.
The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption.  Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004.  The insulin delivery system predated the pump, and was PMA approved.  By PMA supplement in 2006, the FDA approved incorporation of the pump into the system.  The plaintiff was prescribed that system.  Duggan, 2012 WL 45503, at *3-4.Continue Reading Medical Device Preemption Developments

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We’ve been around the preemption block a few times – we know what happens when the mainstay claim in prescription medical product liability litigation, that being inadequate warnings, gets preempted.
We first saw it in DTP vaccine litigation.  We made a little headway with preemption and plaintiffs responded with “design’ claims based on non-FDA-approved formulations.  It took the Vaccine Act to bury those.
We saw it again in Bone Screw litigation, pre-Lohr.  Plaintiffs responded with fraud on the FDA claims.  It took Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to do those in.
We saw it yet again in prescription drug litigation, pre-Levine.  Plaintiffs responded with all manner of things – design defect claims with no alternative design at all, failure to test, illegal promotion, you name it. Some of these we’re still fighting, but with the preemption threat to warning claims removed, most of these have receded into the background.
We saw – and see – it a fourth time in PMA medical devices, especially after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  The plaintiff’s alternative has been disguised private FDCA enforcement actions presented as “parallel violation” claims.
And we expect to see it again now that PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has knocked out warning claims in generic drug cases.  So what’s the non-traditional (a/k/a weird) claim of choice there going to be?  The jury’s still out on that, but judging from the Mensing reargument petition, which we discussed here, one oddball claim under serious consideration by the other side is the notion that a defendant can have a common-law obligation simply not to sell its product at all.
In other words, the flavor du jour in generic cases could be failure to recall, resurrected from what has to date been extensive and well-deserved judicial repudiation.Continue Reading We Don’t Recall

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The plaintiffs in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (not sure why it’s all-caps, but that’s the way the Supreme Court has it), have sought reargument. Here’s a copy of their petition.

Any Supreme Court rehearing petition is a long shot, but in this case, we’d have to say it’s worse