Private Right Of Action

FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  21 U.S.C. §337(a).  That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must

Almost on this date in 1901 (tomorrow actually), Teddy Roosevelt for the first time uttered in public the immortal phrase, “Speak softly and carry a big stick”. It is hard to find people who do not admire that statement.  It is harder to find people who actually practice it. These days we are accustomed to wimpy parents and blowhard politicians who talk tough but do nothing.   As a result, you get teenagers gobbling up the cheese-of-the-month delivery and Russia gobbling up Crimea.  We also encounter some soft-hearted and -headed judges who speak loudly and wield no stick – at least when it comes to clamping down on bogus lawsuits.  Corporate defendants hauled/haled/but-definitely-not-hailed into court are held to ludicrously high standards, while plaintiffs dwell in a world of do-overs and feckless flexibility.

A couple of weeks ago we discussed CD Cal Judge Wilson, who is as demanding as he is smart.  One could say (and we have said) the same about Judges Posner, Boggs, Kozinski, and Rakoff.  One could also say that about D NJ Judge Irenas who sits in the Camden federal courthouse, which we can see out our window if we crane our heads just so.  If you read the Robing Room evaluations of Judge Irenas (which you must necessarily take with a grain of salt, since they are peppered with the comments of sore losers) a picture emerges of intelligence and rigor.

We can be an oath-helper on that fact.  After our first year of law school, we summered at McCarter & English in Newark, NJ. Irenas was a partner there, and was universally acknowledged to be the smartest lawyer in the building.  In our second or third week as a summer associate, we received an assignment from Irenas.  The other summer associates cackled with glee. That is because in addition to having a reputation for being smart, Irenas had a reputation for not suffering fools gladly.  And all of the summer associates were fools.  An Irenas assignment was an opportunity, but a frightening one.

The assignment involved the inevitable research memo.  After we turned it in to him and were grilled to a nice medium-well, we got on a conference call.  At one point, the party on the phone voiced some trepidation and reservations, whereupon Irenas thundered a withering critique of said reservations. Loud dysphemisms filled the air.  He must have seen us shaking with terror, because he smiled and gestured to show us that his finger, which was resting on the microphone (back then speakerphones were separate from the actual telephone, and were connected by a wire) was also pushing down on something we did not know existed – a mute button.  He then released the button and rendered a much more temperate, but still piercing, dissection of the reservations.  What he said was about a hundred times more insightful and felicitously expressed than our pathetic research memo.  Lesson learned.

Continue Reading New Jersey Federal Baked Goods Fraud Class Actions Are Toast

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.

Continue Reading Still No Duty To Supply Drugs – In 22 States

The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic manufacturers on the basis of preemption and other defenses we like.  It certainly does those things, and that’s good.  But we see decisions like that almost every week.  What Wagner does, however, is add to the quality of those decisions, not just their quantify.  Its opinion is clear and unhesitating.  It takes on Mensing and Bartlett preemption and the non-existence of failure-to-update claims in barely more than three crisp pages.  And, along the way, it provides uncomplicated and convincing passages that all of us can use in our future briefing.

Continue Reading Preemption Made Easy

This post is from the Dechert side of the blog only.

When product-liability plaintiffs suing drug or medical device manufacturers assert California’s Unfair Competition Law (“UCL”) using a purported “violation” of the Food, Drug and Cosmetic Act (“FDCA”) as the hook for the “unlawful” prong of the claim, courts have not clearly addressed how such a claim could be reconciled with the no private right of action clause in the FDCA, 21 U.S.C. §337(a).

Earlier this month, the California Supreme Court provided some guidance on the issue in Rose v. Bank of America, N.A., S199074, slip op. (Cal. Aug. 1, 2013), in a case involving a different federal statute, the Truth in Savings Act (“TISA”).  The court allowed a UCL claim to “borrow” from” TISA because “Congress expressly left the door open for the operation of state laws that hold banks to standards equivalent to those of TISA,” even though it had repealed a federal private statutory right of action.  Slip op. at 7.  Why? Because Congress left alone a savings clause that preserved the authority of states to regulate the same subject so long as state law is consistent with TISA:

[C]onsiderations of congressional intent favor plaintiffs.  By leaving TISA’s savings clause in place, Congress explicitly approved the enforcement of state laws [within the express terms of the savings clause].  The UCL is such a state law.

Id. at 4

(TISA-specific savings language omitted).

Why does that interest us – particularly since the result was adverse to the defendant?

Continue Reading Rose Presents Thorny Issues for UCL Drug and Device Plaintiffs

“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

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