Private Right Of Action

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“Don’t leave home without it.”  “Takes a licking and keeps on ticking.”  “Just do it.”  “Tastes great, less filling.”  Iconic ad campaigns so recognizable that we don’t even need to tell you the product being advertised.  Here’s another one:  “The nighttime sniffling, sneezing, coughing, aching, stuffy head, fever, so you can rest medicine.”  For over

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Every now and then we run into a decision that we think is wrong in so many different ways that we call it an example of “spherical error” – that is, error no matter how one looks at it.  We only do that rarely.  Back in May, 2010 we first applied that description to In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334 (N.D. Ohio May 4, 2010).  Then in September of that year we likewise identified spherical error in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at least the Pennsylvania part of it, which dealt with the law we knew best.

That’s it – two cases earned that sobriquet in the blog’s six-plus years of existence.

Make that three.

The recent decision in Arters v. Sandoz Inc., 2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in so many different ways that we think it rises (falls?) to the level of spherical error.

Arters involved a question that a lot of courts have considered lately with almost (but not quite) uniformly good results – preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  As in many generic preemption cases, the defendant sought to have the case dismissed under Rule 12.

That – Rule 12 – is the first error in Arters.  The decision states:

A motion for judgment on the pleadings pursuant to Rule 12(c) should not be granted “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”  Conley v. Gibson, 355 U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).

Arters, 2013 WL 308768, at *1.

Umm….  No.

Someone must have been the second coming of Rip Van Winkle and slept through the last five years.  In a rather well-publicized decision, back in 2007, the Supreme Court expressly overruled Conley on specifically this “no set of facts” point.  See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 561-63 (2007).
Twombly?  Maybe you’ve heard of it.  If so, you’re already one up on Arters.  Anyway, the Supreme Court in Twombly explicitly “retired” the Conley standard relied upon in Arters:

On such a focused and literal reading of Conley’s “no set of facts,” a wholly conclusory statement of claim would survive a motion to dismiss whenever the pleadings left open the possibility that a plaintiff might later establish some set of undisclosed facts to support recovery. . . .  It seems fair to say that this approach to pleading would dispense with any showing of a reasonably founded hope that a plaintiff would be able to make a case; Mr. Micawber’s optimism would be enough.

Seeing this, a good many judges and commentators have balked at taking the literal terms of the Conley passage as a pleading standard.  [many citations omitted]  We could go on, but there is no need to pile up further citations to show that Conley’s “no set of facts” language has been questioned, criticized, and explained away long enough. . . .  [A]fter puzzling the profession for 50 years, this famous observation
has earned its retirement.  The phrase is best forgotten as an incomplete, negative gloss on an accepted pleading standard.

Twombly, 550 U.S. at 561-63 (emphasis added).  Then, a couple of years later, the Court made clear that Twombly’s interment of the Conley language cited in Arters applies across the board to all types of cases.  See Ashcroft v. Iqbal, 556 U.S. 662, 684 (2009).Continue Reading Spherical Error Revisited

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In the last few days it seems that we can’t stick our head out the blog’s front door in the morning without a court hitting us in the head with a bad decision like a wild-armed paperboy.   Stengel, Weeks, boom, thwack!  Well, we’ve had enough and we’re not going to take it

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While it remains true that our role in bringing about the Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), preemption decision is probably the highlight of our (read Bexis’) legal career to date, sometimes there may be reasons when we don’t want to rely upon the Buckman Court’s preemption-based analysis for why

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            As an openly defense-oriented blog, most of our posts deal with cases in which plaintiffs could not make out their claims.  They didn’t have sufficient evidence of a design defect.  They couldn’t prove proximate causation.  That type of thing.  But, what if plaintiff’s claim is that the defendant can’t prove its claim about its

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The class action lawyers must be getting desperate, if Reeves v. Pharmajet, Inc., 2012 WL 380186 (N.D. Ohio Feb. 3, 2012), is any indication.  In one fell swoop, this plaintiff sought:  (1) to take over enforcement of the Food, Drug and Cosmetic Act (“FDCA”) from the FDA, and (2) turn product liability into a

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Today is Boxing Day, when we, along with millions of other Americans, scamper off to the Mall to return those Christmas presents that just didn’t quite fit (physically or spiritually or aesthetically) our needs. So buh-bye jelly-of-the-month club (we’re diabetic), Hello Kitty lounge pants (wrong size), Three Stooges talking bottle-opener (we love hearing “nyuck, nyuck,

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Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters for injuries caused by counterfeit drugs.
We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.
Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.
The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.Continue Reading Twice Nice?

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We fingered Astra v. Santa Clara County as a potentially interesting case from the moment that the Supreme Court granted cert.  Here’s how we described the case on four days after certiorari was granted:

The statute in question is the Public Health Service Act because the case involves Medicare drug pricing issues.  But to us,

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We’re returning to the topic of implied Buckman preemption today to discuss three recent decisions, Hughes v. Boston Scientific Corp., ___ F.3d ___, 2011 WL 184554 (5th Cir. Jan. 21, 2011); LeFaivre v. KV Pharmaceutical Co., ___ F.3d ___, 2011 WL 148730 (8th Cir. Jan. 19, 2011); and Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011).  But before we get to these cases, we have to reiterate some things that we said not too long ago in our Bashing Bausch post.  These have to do with the relationship between implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and express preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Specifically, defendants need to keep in mind what implied Buckman preemption can and can’t do.
Specifically, as a matter of express preemption, Lohr created – under the rationale that remedies don’t matter – an exception for largely undefined state-law claims that are “identical” to FDA regulatory standards.  “Nothing in §360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”  518 U.S. at 495.  We have to live with that.  The Supreme Court was unanimous on the point.  Then there’s the Riegel dictum that MDA preemption “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.”  552 U.S. at 330.
Keep that in mind.  Express preemption allows “parallel” state law duties “premised on a violation of FDA regulations.”  If such a claim exists, it may well fail for other reasons, but it won’t be expressly preempted.
Now we turn to implied preemption.  We know now – even if we don’t like it – after Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008), that with implied preemption, we have a presumption against preemption to deal with.  That is, where, under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), there isn’t.
When isn’t there a presumption?
There’s no presumption when we’re concerned with the dealings between the FDA and the manufacturer in question.  “[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  531 U.S. at 348.
Keep that in mind, too.
Finally, Buckman – as a matter of implied preemption – held that preemption (akin to lack of standing) applies to bar certain types of FDCA violation claims by virtue of 21 C.F.R. §337(a), the statute’s preclusion of private enforcement.Continue Reading Buckman Preemption – The Good, The Bad, And The Ugly – And (This Just In) The Funky