March 2013

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We were planning to write about the Bartlett oral argument today (we still might) when we learned about Howard v. Zimmer, Inc., ___ P.3d ___, 2013 WL 1130759 (Okla. March 19, 2013), in which the Supreme Court of one of the reddest states in the country, overruling prior precedent, held that, in general, violations of federal regulations suffice as a basis for negligence per se under Oklahoma law.  Contrary to a stiff dissent, the court reached this result notwithstanding 21 U.S.C. §337(a) in which Congress expressed its intent that claimed violations of the FDCA only be enforced by the federal government.  Id. at *6-7.

Prior Oklahoma precedent (rather like the law of Kentucky that we discussed earlier) had declined to permit state-law negligence per se to be brought on the basis of claimed violations of purely federal regulations.  E.g., Claborn v. Plains Cotton Co-op. Ass’n, 211 P.3d 915 (Okla. App. 2009) (no negligence per se for claimed OSHA violations); Christian v. First Capital Bank, 147 P.3d 908 (Okla. App. 2006) (same; federal usury regulations on agricultural loans); Rosson v. Coburn, 876 P.2d 731 (Okla. App. 1994) (same; Medicaid abortion regulations).

Howard was, of course, a case where federal preemption had wiped out the usual product liability claims plaintiffs would normally bring against the defendant.  A couple of years ago, in the same peripatetic case, the Sixth Circuit, in a non-precedential decision, allowed a “parallel claim” to escape preemption.  Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (“Howard I”).  Howard I, of course, did not purport to decide that such a parallel claim existed under state law.  Id. at 442 (not reaching “whether Oklahoma law recognizes a negligence per se action based on violations of FDA
regulations”).

That was the Oklahoma Supreme Court’s job.  Procedurally, at least, we think that the Tenth Circuit chose a better path in certifying the issue to that court.

Under Erie, certification was a proper avenue, although we have to wonder why the plaintiff didn’t do this during the prior appeal in the Sixth Circuit.  Unlike Fulgenzi v. PLIVA, Inc., ___ F.3d ___, 2013 WL 949096 (6th Cir. March 13, 2013), at least, the Tenth Circuit respected the limited authority of federal courts in diversity actions and certified the negligence per se question rather than making up novel state law claims out of whole cloth.  And “whole cloth” is the right description − there was nothing in prior Oklahoma law that remotely suggested what the happened next.

Make something up is exactly what Oklahoma Supreme Court did.  Not only did it overrule all prior precedent barring federally based negligence per se as a general matter, it decided not to follow its own prior precedents precluding private allegations of alleged violations where a particular piece of legislation “indicate[es that] . . . the law-making body concerned itself specifically with the problem of who should be able to bring an action . . .and it then resolved not to confer a remedy on private individuals.”  Holbert v. Echeverria, 744 P.2d 960, 965 (Okla. 1987); see also State ex rel. Oklahoma Bar Ass’n v. Mothershed, 264 P.3d 1197, 1227 (Okla. 2011) (where a statute “clearly places enforcement in the hands of governmental authorities the right of action is exclusively vested in such governmental authority”); Walls v. American Tobacco Co., 11 P.3d 626, 631 (Okla. 2000) (failure to make private cause of action retroactive was legislative intent not to permit earlier claims amounting to private enforcement).

Continue Reading Oklahoma Supreme Court OKs Federal Takeover of State Tort Law

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In a post Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), world – plaintiffs most often attempt to avoid preemption of products liability suits involving PMA (Premarket Approval) medical devices by alleging a parallel violation.  While they’ve had some success in getting past the pleadings stage on this theory, to the extent any PMA medical device case survives preemption, what survives is only a small slice of the usual panoply of products claims.  Further, proving a state law claim for violation of a federal regulation is far from a slam dunk.

So, what’s a better way to avoid PMA preemption?  Claim the product at issue isn’t actually a PMA medical device.  But if the device actually did go through the PMA process, how do you claim it didn’t?  By taking the device apart.  Well, at least that’s what plaintiffs have tried to make courts believe.  But so far, no takers.

And, just yesterday, a New Jersey court said no to both – rejecting plaintiffs’ component theory of liability and casting serious doubt on the viability of parallel violation claims in PMA medical device cases.  The case is Smith v. Depuy Orthopaedics, Inc., No. 11-4139 (JAP), slip op. (D.N.J. Mar. 18, 2013).  To start, if you aren’t versed in the PMA process, the decision contains a thoughtful recitation of the process and of the defendant’s compliance with FDA requirements at every turn.  See slip op. at 2-9.  It also explains the difference between the rigorous PMA process, during which the FDA determines whether the device is safe and effective for its intended purpose, and the 510k premarket approval process, which has to do with a finding of substantial equivalence rather than safety and efficacy.  Id. at 7.  It was this distinction that led to Riegel and PMA preemption. And, it is what has plaintiffs attempting to strip medical devices like a mechanic disassembling a junker for its parts.  Sometimes that’s all an old car is good for.  Sometimes, the whole – say a 1967 Mustang GT 500 – even with scratches and dents, is worth significantly more than the sum of its parts.

The same is true for medical devices.  When determining whether state law claims are preempted, you look at the device as a whole.  “[A] device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption.”  Slip op. at 21 (citations omitted).    It doesn’t matter if some of its components were originally cleared through the 510k process.  Once those components are made part of a medical device that gets submitted to the FDA for PMA, then those components go through the PMA process too.  Id. Continue Reading New Jersey Court Finds No Parallel Claim and No Component Liability

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Bartlett – that is to say Mutual Pharmacy Co. v. Bartlett, No. 12-142 – is being argued in the United States Supreme Court today.  All of the briefs, and lots of other useful information on Bartlett, can be found on the invaluable SCOTUSblog.  In the early days of our blog (back during…

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Pom Wonderful continues to be so.  Last year it produced a terrific 9th Circuit opinion reinforcing that only the United States, not private plaintiffs, can enforce the FDCA and FDA regulations.  See Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012).  And so the FDCA and its regulations barred plaintiff’s Lanham…

In a departure from blog tradition (and possibly etiquette), I’m going to break the fourth wall and speak in the first-person singular for a moment. After much encouragement from my colleagues and several not-so-subtle hints from Bexis directed at having to post yet another guest post from me, today I become an official member of the DDL…

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The post that follows is from the Reed Smith side of the blog only.  The Decherts have a conflict.

We’ve been aware of a monstrous miscarriage of justice (in our opinion, of course) in Polett v. Zimmer for quite some time.  The “monstrous” aspect was a $27.6 million verdict to a person who, frankly, wasn’t…

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We don’t know whether it’s the complex nature of the product (a cochlear implant) or if it’s the erudition of defense counsel (Wheeler Trigg), but preemption decisions involving this defendant (Advanced Bionics) have recently seemed to be both interesting and generally favorable for our side.  Those include:  Purchase v. Advanced Bionics, LLC,…

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We’ve blogged several times in opposition to consolidation of individual plaintiffs’ lawsuits in product liability actions.  The only thing that plaintiffs seeking consolidation for trial have in common is that:  (1) they were allegedly injured by the same product, and (2) they are trying to salvage weak cases by attempting to prejudice the defendants’ defense.  Strong plaintiffs’ cases stand on their own, so why bother with consolidation?

One thing we know about mass torts, through years of experience, is that for lots of reasons most individual cases in any given mass tort are poor, as in weak.  So consolidation requests show up frequently in mass torts.  One of the busiest mass torts currently is Aredia/Zometa, so it’s no surprise to find consolidation attempts there.  The only question is whether the courts will throw these plaintiffs the lifeline they’re seeking.  Happily, that doesn’t seem to be happening.

The first consolidation attempt, in Guenther v. Novartis Pharmaceutical Corp., 2012 WL 5398219 (Mag. M.D. Fla. Oct. 12, 2012), adopted 2012 WL 5305995 (M.D. Fla. Oct. 29, 2012), failed because the two plaintiffs involved “filed their claims separately years apart, did not use the same [defendant’s] products, allegedly used [those] products at different times, have different medical and dental histories, were treated by different physicians, have identified different expert witnesses . . ., are pursuing different legal theories under different laws, and seek different damages.”  Id. at *1.  That’s pretty typical of attempted consolidations.Continue Reading Consolidation Fails In Aredia/Zometa

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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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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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