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It’s opening day here in NYC.  The Nationals are in town to play the Mets.  And the sun is supposed to emerge just before game time.  A perfect day.  In fact, as all ragged and abused Mets fans know, opening day is the highlight of the year. And it’s generally downhill from there. But on opening day, the Mets are the best team in baseball.  It’s a fact: 34-18 (.654) on opening days.  And that’s after having been so bad in the 1960s that they lost their first 8 opening day contests.  Since then, they’re 34-10 (.772).  So it’s imperative to see the first game.  It’s not likely to get any better.  So this post will be quick.

Zeltiq Aesthetics, Inc. v. BTL Indus., 2014 U.S. Dist. LEXIS 40402 (N.D. Cal Mar. 25, 2014), is another business-on-business decision with favorable implications for product liability litigation, particularly cases involving off-label claims and medical devices. The plaintiff markets a medical device named CoolSculpting, which lowers the temperature of fat cells and then somehow eliminates them.  Id. at *4-5.  That’s a nice deal if it works.  The FDA cleared it under §510(k).  The defendant firm markets a device called Vanquish, which the FDA cleared under §510(k) for treating muscle aches and pain.  Id. at *5-7.  That’s nice too.

The plaintiff alleged that the defendant firm didn’t market Vanquish for treating muscle aches and pains.  Instead, it marketed Vanquish for fat reduction.  Id. at *6-7.  That’s not the use for which the FDA cleared it.  But it is the use for which the FDA cleared CoolSculpting, the plaintiff’s device.  So now you see the dispute.

Plaintiff filed for a preliminary injunction, asserting claims for false advertising under the Lanham Act and, more important, for misleading and deceptive advertising under California’s ubiquitous Unfair Competition Law (“UCL”).  Id. at *21.  After hearing evidence, the court denied the preliminary injunction.  It ruled that the plaintiff was not likely to succeed on its Lanham Act claim because it couldn’t show that the defendant’s advertising was either literally false or false by implication.  Id. at *24-34.  Since much of the plaintiff firm’s allegation concerned FDA clearance issues, we wonder whether the court might have simply barred application of the Lanham Act in favor of the FDCA, which is to be enforced solely by the United States, not private plaintiffs.  But we won’t dwell on that.

More important is the court’s treatment of the plaintiff’s two UCL claims for off-label promotion.

First, plaintiff claimed that the defendant sold Vanquish without 510(k) clearance, violating California Health and Safety Code § 111550: “No person shall sell, deliver, or give away any … new device unless … [i]t is … [a] device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)) . . . .”  The problem is that the FDA did clear Vanquish under §510(k).  Plaintiff hoped that it could side step that clearance because Vanquish was cleared for treating aches and pains, not fat reduction.  Maybe, but that doesn’t matter.  Off-label use doesn’t turn a 510(k) device into a device that wasn’t cleared.  Even if California law tried to do that, it would almost certainly be preempted.  In fact, there are a number of ways that this law, if applied as plaintiff requested, would conflict with federal regulation.  Firms don’t have the authority to create instructions for off-label uses without FDA clearance. And the FDA recognizes that cleared devices will be used off-label as part of the every-day practice of medicine.  And so disallowing off-label use or requiring distributors to use unapproved instructions would run head on into preemption.

Second, plaintiff claimed that Vanquish was unlawfully “misbranded” under California law, which requires devices to have “adequate instructions for use.”  Cal. Health & Safety Code §111375.  The plaintiff got to this claim by arguing that Vanquish was misbranded because its labeling failed to include “adequate directions for” its off-label use, fat reduction.  But Vanquish was sold with instructions on the FDA cleared uses of the device.  Id. at *37.  So plaintiff’s argument would require the defendant to add unapproved instructions on its own.  That’s preempted. Plaintiff also argued that once the defendant sold the device for an off-label use those actions rendered it misbranded because it didn’t have the required instructions for such use.  This is just a different way to make the same argument.  The labeling of the device is regulated by the FDA.  California law can’t change that.  It can’t be different.  The court rejected plaintiff’s argument:

[Plaintiff] has not cited any authority to suggest that a device may be “misbranded” by virtue of its overall promotional practices as opposed to the more obvious source of “labeling”: the Instructions for Use in the Operator’s Manual.

Id. at *38.

So we now have in the bucket a California federal court holding that the UCL cannot be used to create a misbranding claim from off-label allegations.  We’re certainly happy with that.

OK, done.  Now it’s off to the ballpark.

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The defendant in Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, 2014 U.S. Dist. LEXIS 36677 (D. Or. Mar. 20, 2014), won summary judgment on warnings causation because the alleged inadequacy in the drug warnings didn’t make a lick of a difference.  That is the right result and is why we think warnings causation is such a useful concept.  Bexis likes to remind us that preemption is the king of all defenses because it eliminates entire cases, and in some instances entire MDLs, or an entire category of claims within an MDL.  But if preemption is king, then warnings causation is a crown prince.  For one thing, warnings causation is not a defense.  Every plaintiff bringing a claim based on allegedly inadequate warnings bears the burden of proving that the alleged inadequacy proximately caused his or her injury.  That is to say, the plaintiff must prove that additional or “more adequate” warnings would have altered the physician’s decision to prescribe the drug or select the medical device.  For another thing, unlike preemption, causation is present and potentially a winning argument in most every drug and medical device case, depending on the case-specific evidence.  Sure, there are presumptions in certain states that doctors would have heeded stronger warnings if given, but presumptions can be overcome, and they often are.

In Parkinson, the patient was taking the defendant’s bisphosphonates to treat cancer. Bisphosphonates were the subject of an FDA Safety Alert explaining that osteonecrosis of the jaw (ONJ) was observed in cancer patients receiving treatment with intravenous bisphosphonates and that dental surgery may aggravate the condition in cancer patients who develop ONJ while on bisphosphonate therapy.  Although the order in Parkinson does not explain it, that seems to be the basis for the claims against the drug manufacturer.  The patient had two teeth extracted, which evidently resulted in ONJ or worsened ONJ.  At least that is what the order seems to say, and the plaintiff claimed that the defendant failed to warn adequately about that risk.

The problem for the plaintiff—the survivor of the patient, who sadly died—is that the doctor who prescribed bisphosphonates “knew of thousands of scientific articles . . . that set out and described the various risks associated with [bisphosphonates] (including ONJ).”  Id. at *11.  Moreover, the evidence was undisputed that the doctor chose to prescribe the drugs “because the benefits to Plaintiff . . . outweighed the risk of ONJ.”  Id.  The district court further noted that the prescribing physician continues to prescribe bisphosphonates despite the risk of ONJ because the benefits “greatly outweigh” the risks.  Id. at *12.

This is ironclad, and when we depose prescribing physicians, this is what we hope (and usually expect) them to say.  Such testimony cuts off causation because additional information about a risk about which the prescriber already knows cannot have had an impact on the prescribing decision.

The plaintiff had a few responses to this, but none held water.  First, the plaintiff argued that Oregon law provided a heeding presumption, but the only authority she cited was an unpublished (and thus uncitable) Ninth Circuit opinion applying Alaska law.  Maybe plaintiffs in Alaska can see Russia from their houses, but this Oregon plaintiff clearly could not see a heeding presumption in Oregon law.  Neither could the district court, because one does not exist.  Id. at **9-10.  To the contrary, “the burden is on the plaintiff ‘to establish that [the alleged inadequate warning] proximately caused [her] injures or damages.”  Id. at *10 (citing Oregon authority).

Second, the plaintiff argued that her late daughter (the patient) would not have consented to treatment with these bisphosphonates if she had known about the risk of ONJ.  But there was no competent evidence of that, and even if there were, the learned intermediary doctrine makes it beside the point.  As the district court explained,

[T]he Ninth Circuit has made clear that the relevant inquiry is not whether Plaintiff would have taken [the medicine], but whether Dr. Seligman would have prescribed [the medicine] if he had received a different warning related to the possibility of ONJ.

Id. at **12-13 (emphasis in original).  This is ironclad too, and we wish every court were as vigilant in shutting down plaintiffs who claim after the fact they would not have used the product “if they had known.”  We take with a grain of salt any plaintiff’s statement that he or she would have rejected a doctor’s advice “if they had known,” especially a cancer patient for whom rejecting treatment could have had grave consequences.  But even if crediting those self-serving statements as true, they are immaterial where the learned intermediary doctrine applies, which the district court correctly found.

Third, the plaintiff claimed that the dentists who pulled the teeth “changed their practices with regards to going over treatment with patients” since the time they treated the decedent.  Id. at *15.  We’re not sure where the plaintiff was going with this argument.  She cited no authority for the idea that these “changed practices” made any difference, and the actual facts of the case demonstrated that they would not have made any difference:  The dentists agreed that there were no alternatives to extracting the teeth, which means that even if they had known more about bisphosphonates and ONJ, they would have treated the patient the same anyway.  Id. at *17.  To remove any doubt, it was undisputed that the patient did not tell her dentists that she had cancer or that she was using bisphosphonates until after they pulled her teeth.  Id. at **18-19.  Unless the plaintiff had a time machine, what impact could additional information regarding bisphosphonates have had on her treatment when her dentists were unaware?

We have to admit, we have always considered warnings causation mainly in the context of the impact of warnings on prescribing physicians.  (See for example Bexis’s recent “little list” of authorities dismissing warning claims for lack of causation where the prescribers were unavailable.)  This plaintiff questioned the warnings and their impact (or lack thereof) both on prescribing physicians and treating physicians.  Hmm.  Maybe the next time we depose a treating physician, we will give that line of questioning some additional thought.

So, we like warnings causation.  The argument may not always be there, and it may require marshaling evidence for a defendant to assert it (or perhaps not since, after all, proving causation is the plaintiff’s burden).  Parkinson is a good example of a defendant presenting the argument, the court understanding it, and the correct resulting following.

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If you even dally in one or more of the most popular social media sites (Facebook, Twitter, instagram), then you’ve probably heard about Throwback Thursday — or if you are super cool, #tbt.  Nobody is exactly sure when it started, but by 2013 it was thoroughly ensconced in our social media habits.  Purportedly there are somewhere around 23 million pictures tagged #throwbackthursday on Twitter alone.

What is Throwback Thursday?  Some say it’s an excuse to post your most angelic baby picture or a photo of yourself from anytime in the past when you were thinner than you are now. Or, perhaps post an embarrassing old photo of a friend.  All are legitimate throwbacks.  The only real requirement seems to be a picture so old you actually had to snap a photo of a physical picture to be able to post it.  So, that means you probably need to reach back at least 5 years.

Well, this post reaches back almost 20 years for some of us (Bexis and Yeary).  A time when not only were photos in hard copy, but so were our filings. Mad dashes to the courthouse to beat the 4:00 pm closing rather than hitting the submit button at 11:59 pm. Making dozens of copies to serve on all the parties rather than sending a pdf by email.   Ahh, the feel of warm pages fresh off the printer and the frenzy of cab rides to the airport to make the last Federal Express flight of the night. Sweet memories.

Continue Reading It’s Throwback Thursday

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Last week brought another example of the chaos being caused in preemption jurisprudence by the Supreme Court’s sloppily reasoned decision in Wyeth v. Levine, 555 U.S. 555 (2009).  Prior to Levine, the Court had repeatedly held that the doctrines of express (that is, where there’s an on-point statutory provision) preemption and implied (where no statute is dispositive, but state law conflicts in some way with federal law) preemption operate independently of each other. That is, regardless of what any statute does or doesn’t say, implied preemption is still available to resolve conflicts between state and federal law.

The question whether express preemption language in a statute foreclosed the operation of implied conflict preemption arose in Freightliner Corp. v. Myrick, 514 U.S. 280 (1995), based on an express preemption clause in the National Traffic and Motor Vehicle Safety Act.  The Court rejected an argument that express preemption necessarily precluded implied preemption:

[W]e must address the argument that we need not reach the conflict pre-emption issue at all. According to respondents and the Court of Appeals . . . implied pre-emption cannot exist when Congress has chosen to include an express pre-emption clause in a statute.  This argument is without merit.  . . .  The fact that an express definition of the pre-emptive reach of a statute “implies” − i.e., supports a reasonable inference − that Congress did not intend to pre-empt other matters does not mean that the express clause entirely forecloses any possibility of implied pre-emption.

Id. at 287-88 (citations omitted).

The court followed Myrick in Geier v. American Honda Motor Co., 529 U.S. 861 (2000).  In Geier, also an automobile preemption case, the relevant statute contained both an express preemption clause and an express savings clause.  Discussing this issue at some length, the Court held that, whatever might be the effect of those arguably conflicting provisions on express preemption, neither statutory provision had any effect on the workings of implied preemption:

We have just said that the saving clause at least removes tort actions from the scope of the express pre-emption clause.  Does it do more?  In particular, does it foreclose or limit the operation of ordinary pre-emption principles insofar as those principles instruct us to read statutes as pre-empting state laws (including common-law rules) that “actually conflict” with the statute or federal standards promulgated thereunder?  Petitioners concede, as they must in light of [Myrick], that the pre-emption provision, by itself, does not foreclose (through negative implication) any possibility of implied conflict pre-emption. But they argue that the saving clause has that very effect.

Id. at 869 (Myrick citation and quotation marks omitted).  The Court then explicitly extended the Myrick principle (which had focused only on the statute’s preemption clause) to saving clauses:

We now conclude that the saving clause (like the express pre-emption provision) does not bar the ordinary working of conflict pre-emption principles.  Nothing in the language of the saving clause suggests an intent to save state-law tort actions that conflict with federal regulations. . . .  Moreover, this Court has repeatedly declined to give broad effect to saving clauses where doing so would upset the careful regulatory scheme established by federal law. We find this concern applicable in the present case.

529 U.S. at 869-70 (citations and quotation marks omitted).  Finally, Geier went on to base its holding – that neither savings nor preemption clauses affected implied preemption – firmly on policy grounds:

Neither do we believe that the pre-emption provision, the saving provision, or both together, create some kind of “special burden” beyond that inherent in ordinary pre-emption principles − which “special burden” would specially disfavor pre-emption here  . . .  [W]e can find nothing in any natural reading of the two provisions that would favor one set of policies over the other where a jury-imposed safety standard actually conflicts with a federal safety standard.  Why, in any event, would Congress not have wanted ordinary pre-emption principles to apply where an actual conflict with a federal objective is at stake?  Some such principle is needed. In its absence, state law could impose legal duties that would conflict directly with federal regulatory mandates.

Id. at 870-71 (citations and quotation marks omitted).

These decisions were in turn applied to the FDCA by a unanimous court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), a medical device case that, of course, was also governed by 21 U.S.C. §306k.  The Court in Buckman did not address express preemption, 531 U.S. at 348 n.2, and instead based its decision on implied preemption, finding that nothing about the former could preclude the latter:

Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA.  To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion . . . that neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles.

Id. at 352 (citations and quotation marks omitted).  See also Sprietsma v. Mercury Marine, 537 U.S. 51, 65 (2002) (“Congress’ inclusion of an express pre-emption clause does not bar the ordinary working of conflict pre-emption principles that find implied pre-emption”; finding no implied preemption either) (citing Buckman); Medtronic, Inc. v. Lohr, 518 U.S. 470, 503 (1996) (“Until such a case arises, we see no need to determine whether the statute explicitly pre-empts such a claim.  Even then, the issue may not need to be resolved if the claim would also be pre-empted under conflict pre-emption analysis”) (citing Myrick).

Then along came Levine.  Without even mentioning the rule that express and implied preemption operate independently (even though the Court in Levine elsewhere addressed other aspects of Geier and Buckman), Levine used the absence of any express preemption provision in the (drug portion of the) FDCA as a basis for holding that implied preemption did not exist either:

If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history.  But despite its 1976 enactment of an express pre-emption provision for medical devices . . . Congress has not enacted such a provision for prescription drugs.  Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

555 U.S. at 574-75 (citations omitted).  So in Levine we have an absence of affirmative Congressional action being used to establish a negative – that the absence of express preemption means no implied preemption either.  This result doesn’t fit with Myrick, Geier, and Buckman, all of which held that even affirmative congressional action, whether a preemption clause or a savings clause, did not preclude the operation of implied preemption.

But after Levine, the Court appears to have reverted to the prior rule that express and implied preemption operate independently.  See Arizona v. United States, 132 S. Ct. 2492, 2504-05 (2012) (“the existence of an express pre-emption provision does not bar the ordinary working of conflict pre-emption principles or impose a special burden that would make it more difficult to establish the preemption of laws falling outside the clause”); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011) (“the absence of express pre-emption is not a reason to find no conflict pre-emption”); AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740, 1748 (2011) (“Although [the] saving clause preserves generally applicable contract defenses, nothing in it suggests an intent to preserve state-law rules that stand as an obstacle to the accomplishment of the [statute’s] objectives”); Williamson v. Mazda Motor, Inc., 131 S. Ct. 1131, 1136 (2011) (“neither can the statute’s saving clause foreclose or limit the operation of ordinary conflict pre-emption principles”).

Due to the aberrant result in Levine, uniquely in the drug area courts are encouraged to disregard the general rule, followed both before and after by the Supreme Court, that express and implied preemption stand or fall on their own merits, and that the absence of express preemption does not impede the operation of implied preemption.  Such is the case with Hunt v. McNeil Consumer Healthcare, 2014 WL 1116358 (E.D. La. Mar. 11, 2014), which is what got us thinking about this issue once again.  Hunt involves allegations that an over-the-counter (“OTC”) drug causes SJS/TENS (the same nasty condition at issue in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013)).  The defendant in Hunt sought to apply Mensing/Bartlett to preempt a design defect claim.  Mensing/Bartlett, of course, is based on a form of implied preemption – “impossibility” – positing that where federal law prohibits “unilateral[] alter[ation]” of a particular product attribute, state law cannot require such conduct.  Hunt, 2014 WL 1116358, at *6.

Against the operation of implied preemption, Hunt interposed solely express preemption – doing what the Supreme Court implicitly allowed in Levine, but has expressly rejected (as already discussed) in more than a half-dozen decisions both pre- and post-dating that opinion.  As in Geier, the OTC drug statute contains an express savings clause (which Hunt also called a “non-preemption clause”).  That provision, 21 U.S.C. §379(e), exempts “action[s] . . . under the product liability law of any State”) from express preemption.  The court in Hunt held that this savings clause, precluding express preemption, also barred implied preemption under the impossibility rationale of Mensing/Bartlett:

Because the statute governing non-prescription drugs contains a non-preemption clause, Plaintiff’s design-defect claim is not preempted under Bartlett.  This result makes perfect sense, given that Congressional intent is the “ultimate touchstone” of any preemption analysis. There are equally compelling policy justifications for reading Bartlett and Mensing narrowly so as to preserve the viability of products liability actions.  As the Court recognized in [Levine], statelaw [sic] tort suits play an important “complementary” role to federal drug regulation.

Hunt, 2014 WL 1116358, at *7 (citations omitted).  Hunt also read Bartlett – at least the part of it that bemoaned lack of Congressional guidance – as supporting a finding of no preemption.  Id. (pointing out that Bartlett had “lamented the fact that Congress had not expressly addressed . . . difficult pre-emption questions” and “noted that Congress had ‘explicit[ly]’ addressed preemption in other drug laws” including OTC drugs).  However, absent from the analysis in Hunt was how Bartlett actually resolved the preemption question before it:

[W]e are left to divine Congress’ will from the duties the statute imposes.  That federal law forbids [defendant] to take actions required of it by state tort law evinces an intent to pre-empt.

Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2480 (2013) (citation and quotation marks omitted).

We think Bartlett was right on that point – the fact that federal law prohibits something is, in and of itself, indicative of “intent to pre-empt.”  We think that Hunt should not have ignored (to the point of never mentioning) the contrary Supreme Court rule about express vs. implied preemption.  So Hunt seems to us yet another example of anti-preemption wishful thinking – of courts doing strange things in tort preemption cases.  There is nothing in Bartlett stating that the Court was reversing, or even questioning, the holdings in Myrick, Geier, Buckman, Sprietsma, Arizona, Mensing, Concepcion, and Williamson that express and implied preemption operate independently. Indeed, the majority in Bartlett expressly reaffirmed that implied preemption does operate where there is no express preemption.

Even in the absence of an express pre-emption provision, the Court has found state law to be impliedly pre-empted where it is impossible for a private party to comply with both state and federal requirements.

Id. at 2483. And the dissent?  It understood that “[u]nder the majority’s approach, . . . design-defect claims are categorically displaced.”  Id. at 2595.

Maybe, at some point, the Supreme Court will decide to overturn almost two decades of preemption jurisprudence (except for Levine) and hold that lack of express preemption is dispositive of implied preemption as well.  But it certainly hasn’t done so yet.  Until then, we’ll be of the view that Hunt was wrongly decided.

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Last July we discussed a rare event, a preemption win for an innovator drug under the  Wyeth v. Levine, 555 U.S. 555 (2009), “clear evidence” standard.  However, that case, In re Fosamax Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. June 27, 2013), occurred in the peculiar context of a preemption motion granted after the defendant won a trial of the same case.  Given that the plaintiff was extremely likely to lose anyway, given the verdict, that case was never appealed.

Now the Fosamax preemption ruling has been extended to other, similarly situated cases in the MDL.  See In re Fosamax (Alendronate Sodium) Products Liability Litigation, No. 3:08-cv-00008-JAP-LHG, slip op. (D.N.J. March 26, 2014).  The court disposed of the MDL plaintiffs (mostly) procedural arguments against preemption and applied its earlier ruling to all cases in the MDL with injury dates before Sept. 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change. Slip op. at 7.

The court found no reason not to apply its preemption ruling to other similarly situated plaintiffs because: (1) the case in question had been selected as a bellwether; (2) preemption had been thoroughly briefed; and (3) plaintiffs had been repeatedly instructed to come forward with all their preemption related evidence.  Slip op. at 9-13.  The “newly discovered” evidence that the plaintiffs predictably asserted after they lost didn’t change anything.  It was an expert opinion based on the same facts that existed when the court decided the original bellwether preemption motion.  Slip op. at 15.  Further, all the expert testimony in the world about what might have happened, did not change the undisputed regulatory facts about what actually did happen. Slip op. at 19-20.  The court pointed out (with a useful collection of cases) that preemption had repeatedly been addressed in similar fashion in other MDLs.  Slip op. at 16-17.

Plaintiffs attempted to claim that design defect claims were different and couldn’t be preempted.  The court again disagreed.  There was no way to change the chemical composition of Fosamax, so the “design” claims were merely warning claims in disguise.  Slip op. at 21-22.

After disposing of various arguments rehashing what had already been decided, the court disposed of the plaintiffs’ final argument that “if fully informed” the FDA might have acted differently.  That claim was merely warmed over fraud on the FDA:

[T]o the extent that Plaintiffs claim that [defendant] withheld information from the FDA and clear evidence does not exist as to whether the FDA, if fully informed, would have rejected a stronger label, this does not defeat Defendant’s showing that it is entitled to judgment as a matter of law on preemption grounds. . . .  [E]ven assuming [defendant withheld information], Plaintiffs have failed to show that providing such information to the FDA would have changed the FDA’s conclusion that a Precaution was not warranted.  Instead, Plaintiffs’ contention appears to be a fraud-on-the-FDA theory which was rejected by the Supreme Court in [Buckman], or alternatively, is based largely on speculation and cannot defeat summary judgment.

Slip op. at 29 (citations omitted).

So this time, it appears, there is likely to be a Fosamax preemption appeal.  As we pointed out in our first post, the regulatory facts supporting preemption look quite strong.  Thus, another avenue for eventual reconsideration of Levine – or at least some of its loopier aspects – appears to be presenting itself.

Thanks to Terry Henry at Blank Rome for sending this decision along to us.

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Time travel is on our mind today.  We should hasten to add that it is not a topic that usually absorbs us – otherwise we might squander what little credibility we have with our serious-minded readers. But a trio of things prompted us to think about time-travel.  First, we will (soon, we promise) be discussing a nice TwIqbal case that came out more than a year ago and somehow managed to evade our DDL radar screen.  Second and third are a couple of things we heard from a couple of clients.  In one instance, in a litigation even more far-fetched and meritless than usual, with no science or logic to support the plaintiffs’ allegations, we commiserated with a company executive over a bushel of stupid emails written by low-level employees who stated opinions contrary to those of the company or anybody in it with knowledge or authority.  Still, those self-indulgent emails propped up the litigation and the possibility of settlement-extortion.  The executive wished he could climb into a time machine and smack four or five employees on their noggins before they authored the offending emails.  The litigation would disappear.  It would be like the fading photos in Back to the Future.  But talk about self-indulgent; it’s not as if the time machine idea helps us put together a litigation plan.  Plus, the time machine scenario has very little traction with judges and juries.

We also heard something from an in-house lawyer that made us think of time travel.  This in-house lawyer is someone who, as far as we can tell, is pretty much always the smartest person in the room and who has unerring judgment on all things legal, political, and aesthetic.  So when he told us that we ought to take a peek at the 2013 film About Time, we headed for our local Redbox to rent the movie.  As always, his recommendation was right on.  About Time did just so-so with the critics and the audience, and its marketing message was almost completely confined to the fact that it was directed by the same guy who directed Love, Actually.  But it is good, actually.  It is a funny and clever film about a family where the men, and only the men, have the capacity to travel backwards in time to times and places they actually were in their lifetimes.  (Thus: no ability to park a bullet in Hitler’s head, or to stay the hand of George Eliot and stop her from writing those boring books inflicted on generations of hapless high school students.)  As in Groundhog Day, the hero uses the great power of time travel to get a girl.  Maybe there really is no higher use for time travel.  As in The Butterfly Effect, there are unforeseen and unfortunate consequences to time-travel.  Bill Nighy, who is incapable of looking or sounding uninteresting, is in it (just as he was in Love, Actually).  Unlike most films, you won’t rue devoting two hours to watching it, muttering that you’ll never get that time back.   When we think of the best all-time time-travel movies, we must now include About Time, along with the aforementioned Back to the Future and Groundhog Day, as well as The Terminator, Time After Time, Bill and Ted’s Excellent Adventure, Twelve Monkeys, and the 28 minute French film that inspired Twelve Monkeys, La Jette.

And now on to our little time-capsule case, Swisher v. Stryker Corp., 2013 U.S. Dist. LEXIS 185998 (W.D. Okla. March 14, 2013). The plaintiff claimed injury from a hip implant.  He asserted a negligence per se claim, alleging that he sustained a cascade of health problems requiring additional surgeries, all proximately caused by the defendants’ violation of various regulations promulgated by the FDA.  The plaintiff was trying to avail himself of the “parallel claim”  exception to Riegel preemption.  The defendant filed a motion to dismiss under Rule 12(b)(6), arguing that the complaint was bereft of facts demonstrating how specific FDA regulations were violated and how such violations caused the injuries.

The court agreed with the defendant, applied TwIqbal, and dismissed the case.  The court reasoned that “more is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations.”  Swisher, 2013 U.S. Dist. LEXIS 185998 at *7. Actually, this plaintiff offered more than most parallel-claiming plaintiffs offer, but it was still not enough.  The plaintiff alleged that he was diagnosed with abnormally high levels of chromium and cobalt in his bloodstream, that the cup and cap components of the hip implant system were made of those two alloys, that microscopic metallic particles rubbed off from the metal surfaces of the cap and cup components, and that such rubbing off resulted from the defendants’ violation of PMA specifications and applicable Good Manufacturing Practices (GMPs).

The court held that the allusion to PMA specs and GMPs was “too conclusory to state a claim.” Id. at *8.  The complaint did not specify the manufacturing defect, nor did it  specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury, nor did it state how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.  In other words, the plaintiff supplied incantations, not facts.

Swisher is an important case because, as the court acknowledges, different courts sit on different points along the spectrum as to how many facts are needed to state a parallel claim.  Swisher is at the more rigorous end of the spectrum, so we like it just fine.  Going back in time to retrieve the Swisher case will not help us attain romantic love, save the life of civilization’s savior, or even permit us to put on a school presentation where Abe Lincoln tells us to “party on, dudes,” but it is another piece of ammo that helps us terminate parallel claim cases.

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This post discusses an Infuse case and therefore, is from the non-Reed Smith side of the blog only.

“Mother of mercy, is this the end of Rico?”  Those are the last words uttered by the gangster in Little Caesar.  That villain was played by Edward G. Robinson, who became well-known for playing tough-talking hoodlums, even though he was by all accounts a very sweet man.  He showed up as a hero in a couple of films, such as Double Indemnity and The Stranger, but he will always be most remembered  for his dastardly snarl.  [Ah – who are we kidding?  Today Edward G. Robinson’s voice is usually associated with the parody version mouthed by Chief Wiggum on The Simpsons.]

Those same Rico-valedictory words often dance through the heads of wishful-thinking corporate defense attorneys as they pray for the demise of the much-abused RICO statute.  A law ostensibly aimed at criminal enterprises has been tortured past any state of recognition, and is applied in all sorts of non-gangsterish contexts.  Too many courts let this abuse go, but more and more do not.  Recently, in Aaron v. Abubakar Atiq Durrani, M.D., et al., 2014 U.S. Dist. LEXIS 32693 (S.D. Ohio March 12, 2014), the court shot down an attempt to transform a garden variety med-mal and product liability case into a RICO case.

The court was sorely irked by the plaintiffs’ attorney, calling him out by name.  What provoked this ire?  To begin with, there is the matter of the form of the complaint.  Or, rather, complaints.  At least seven complaints were filed in these consolidated cases.  A second amended complaint was erroneously labeled a first amended complaint.  The court did not like any of this, not even a little:

Despite having filed no fewer than seven complaints in these consolidated cases, Plaintiffs have never alleged facts supporting the existence of a plausible claim under RICO or Ohio RICO.  Plaintiffs’ latest clumsy attempt to repackage medical malpractice and product liability claims is without any plausible basis, notwithstanding its prolixity.

Id. at *1.

The complaint is “anything but a short and plain statement.” Id. at *9.   That is one of the nicer things the court says about the plaintiff’s pleadings.  The 159 page second amended complaint was “virtually incomprehensible,” containing “976 paragraphs of largely irrelevant factual summaries.”  Id. at *10.  The complaint also lumps the defendants together, thereby failing “to give the individual Defendants proper notice of what they have allegedly done wrong.”  Id. at *11. Further, the plaintiffs’ attempt to incorporate its Exhibits A and B, one a criminal indictment and the other a Medtronic package insert, violates the Federal Rules of Civil procedure, “as to the former because it is a pleading in another case, and as to the latter because it is not an ‘instrument’ that can be attached pursuant to Civil Rule 10(b).”  Id. at *14.

The substantive deficiencies in the complaint were even more fundamental.  The plaintiffs were seeking recovery in federal court under anti-racketeering laws for their own state law personal injury claims, a practice which the Sixth Circuit has expressly rejected because, “[s]imply stated, RICO is not a means for federalizing personal injury tort claims arising under state law.”  Id. at *1.  The court concluded that if it accepted the plaintiffs’ theory, “any hospital will have engaged in a pattern of racketeering activity when a credentialed physician of the hospital is accused of committing medical malpractice.  This is nonsense.”  Id.

In any event, the plaintiffs failed to plead the most basic elements of a RICO claim, such as injury to one’s “business or property,” the existence of an “enterprise,” and specific frauds in furtherance of the enterprise.  The plaintiffs alleged only personal injuries – which are not fair game under RICO – and “lost economic opportunities,” which are “mere expectancy interests” that cannot form the basis for damages under RICO.  Plaintiffs never alleged the “time, place and content” of any claimed fraudulent communications by any defendant.  Rather, the plaintiffs conclusorily alleged that “all named Defendants in this complaint knew” that wires and mails would be used “to further the scheme” and that the defendants used the mails and wires for their billing.  Too vague.  As for alleging an “enterprise,” the plaintiffs alleged nothing more than legal conclusions that the defendants constituted an enterprise, without any factual allegations of organization or coordinated behavior among the defendants, or that the organization was separate from the patterns of racketeering activity that the plaintiffs allege.  And – no surprise here – the plaintiffs did not actually allege any “racketeering activity.” Instead, all that the plaintiffs alleged was that the defendant “hospitals, as a whole, conducted normal hospital activities such as allowing physicians to perform surgeries, ordering materials required by physicians for surgeries, and paying physician salaries.”  Id. at *22.  Remember how the court called the complaint “nonsense”?  This is even more nonsense.  Or, to draw inspiration from those double-talking Little Caesar pizza commercials, “Nonsense nonsense.”

Most noteworthy for DDL practitioners, the court held that any failure-to-warn claims alleged against the device company defendants were preempted under 21 U.S.C. §360(k)/Riegel.  “Plaintiffs cannot avoid this preemption by recasting the failure to warn as a RICO claim.”  Id. at *24. The FDA provides no private right of action, and what the FDCA did not create directly, even the crazily distorted RICO cannot create indirectly.  (Plaintiff lawyers who try to invoke RICO in inappropriate fact scenarios remind us of another Edward G. Robinson bad guy, Johnny Rocco, who terrorizes people in a hotel in the great Key Largo.   What does Rocco want out of life?)

The court did not want any more from this particular group of plaintiffs and their attorney.  All of the plaintiffs’ claims against all named defendants were dismissed with prejudice, “as Plaintiffs have thoroughly demonstrated that any further leave to amend would be futile.” Id. at *26.  Mother of mercy, that’s the end of this RICO case.

We offer a tip of the cyber cap to Frank Woodside of Dinsmore & Shohl, who brought this case to our attention.

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In Bertini v. Smith & Nephew, Inc., 2014 U.S. Dist. LEXIS 35837 (E .D.N.Y. March 17, 2014), the Eastern District of New York applied preemption to a device case that involved off-label use, even though the device didn’t receive FDA Pre-Market Approval (“PMA”) and wasn’t really used off-label.  Confusing?  Maybe. But once untangled, it’s very, very good.

The plaintiff had a total hip replacement.  Id. at *4.  His doctor implanted the Smith & Nephew R3 System, which had received FDA §510(k) clearance.  Id.  The R3 System ultimately failed, and the plaintiff had revision surgery.  Id. The plaintiff and his wife then sued, claiming that the R3 device’s liner had loosened from the device’s acetabular shell.  Id. But §510(k) clearance of the R3 System does not trigger preemption.  Only PMA does.  So where does preemption enter the story?

Well, it enters through the approval of another Smith & Nephew device: a hip resurfacing system. Id.  Unlike the R3 System, the hip resurfacing system received PMA.  Id. More important, the liner from the R3 System also did – for use with the hip resurfacing system.  Id. at *3-4.  In other words, although the R3 System itself did not receive PMA, its liner later received PMA to be used with another system.

And that’s how preemption enters.  The plaintiffs’ claims targeted the R3 liner.  It had loosened.  The plaintiffs also pointed toward a locking mechanism that was intended to keep the liner in place inside the acetabular shell.  Id. at *13.  While multiple parts of the R3 System are implicated in plaintiffs’ claims – the liner, the acetabular shell and the locking mechanism – the court determined that preemption was in play because the R3 liner, which had gone through the PMA process, was integral to each of those claims:

[P]laintiffs would be unable to show that the R3 acetabular shell and its locking mechanism alone proximately caused plaintiffs’ injuries, because plaintiffs have plead that the R3 System and the R3 metal liner together were the cause of plaintiff’s injuries.  Plaintiffs would have to prove that the R3 acetabular shell did not stay attached to the R3 metal liner, without being able to argue, as they have repeatedly throughout this litigation, that this failure to attach was due in large part to the R3 metal liner improperly loosening from the R3 acetabular shell.  Therefore, if a claim involving the R3 metal liner’s alleged defect is preempted, the entire claim should be dismissed because plaintiffs will be unable to sufficiently plead the remainder of that claim.

Id. at *14 (emphasis added).

With that, plaintiffs’ design defect, warning, implied warranty, and negligence claims were preempted – not a bad result for a device that did not receive PMA.  The plaintiffs’ fraud claims were also dismissed for failure to plead sufficient facts.

And how did off-label use play a role in this decision?  Well, the plaintiffs argued that preemption shouldn’t apply because the R3 liner received PMA only for the hip resurfacing system, not the R3 System implanted in plaintiff. In other words, even though the R3 device had received §510(k) clearance, the liner’s use in the R3 System was off-label from the use for which it had received PMA.  But preemption doesn’t focus on use.  It focuses on whether the FDA approved and regulates the device.  More important, there’s simply nothing wrong with off-label use.  It’s necessary for the practice of medicine.  The FDA recognizes that and knows it when it approves a device:

Plaintiffs stress that although the R3 metal liner was approved through the PMA process, it was only approved for use with the [hip resurfacing system], but defendant nonetheless marketed the R3 metal liner to be used with the R3 System.  However, preemption analysis is not concerned with how a particular device is used or whether there are federal requirements imposed on a particular use of the device.  Rather, preemption is focused on whether there are federal requirements applicable to the device itself.  Indeed, “‘off-label’ usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA’s mission to regulate . . . without directly interfering with the practice of medicine,” Buckman Co., 531 U.S. at 350, 121 S. Ct. at 1018; see also United States v. Caronia, 703 F.3d 149, 153 (2d Cir. 2012) (“Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and – unapproved uses; the FDA generally does not regulate how physicians use approved drugs.”).  That the R3 metal liner was approved for use with the [hip resurfacing system] does not affect defendant’s preemption argument under the MDA, since the specific component at issue received PMA.

Id. at *17-18 (certain citations omitted).

So the court applied preemption to device claims that involved a device that hadn’t received PMA and off-label use that wasn’t all that off-label.  In more practical terms, the Bertini decision illustrates that claims can still be preempted, even if the device received only §510(k) clearance, so long as the alleged defect involves a part of the device that received PMA.  It’s also another opinion that forcefully states that off-label is appropriate and shouldn’t alter the preemption analysis.

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We do this blog not just to tout good results, slam bad decisions, and relay our likes and dislikes on various subjects, but to provide information that can help drug and device manufacturer defendants get better results in the litigations they face.  We do not presume, except facetiously, that our posts really do move the needle much on how courts decide the issues we tend to highlight in our posts. Courts pay attention to what other courts have done, though, so we like to do our part in passing on good decisions to use and ways to work around bad decisions.  When it comes to yesterday’s decision from the Arkansas Supreme Court in Ortho-McNeil-Janssen Pharms., Inc. v. State, 2014 Ark. 124 (Ark. 2014), slip op., there is not much need for us to publicize the result.  A verdict for $1.2 billion going away will get some attention on its own.  We look at the decision, however, with an eye or two toward what it means for other cases. While the reversal is clearly the right result and spells the end of actions against drug and device companies based on the Arkansas Medicaid Fraud False Claims Act (“MFFCA”), the bases for the decision may be too sui generis (or “sooie” generis) to have as broad of implications as we had hoped.

The case started with “outside law firms and other states’ Attorney General offices” approaching the Arkansas AG about suing the manufacturers of second-generation antipsychotics, which had been the subject of FDA-mandated labeling changes and Dear Doctor Letters about the risk of hyperglycemia and diabetes back in 2003.  Slip. Op at 2-3 & 7.  The letters that were sent out on Risperdal included language discussing how its risk of diabetes compared with the risk of diabetes with conventional psychotics and other atypical antipsychotics, which DDMAC deemed “false and misleading” in a Warning Letter it sent five months later.  Id. at 3-4.  The Warning Letter led to a correction being sent out three months later, which DDMAC accepted as fully addressing the issue.  Id. at 4-7.  Based on this basic fact pattern, the Arkansas AG sued Risperdal’s manufacturer under the theories that:  1) the MFFCA was violated by every Risperdal prescription filled in the State and submitted to Arkansas Medicaid for payment over a 43 month period when the drug’s labeling allegedly failed to comply with FDA’s prescription drug labeling requirements; and 2) the Arkansas Deceptive Trade Practices Act (“DTPA”) was violated by every copy of the first Dear Doctor Letter sent to a healthcare provider in the state.  Id. at 7-8.  Based on the plaintiff verdict at trial, the results of a civil penalties hearing, and the denial of all the expected defense motions, the result was $1,194,370,000 on the first theory ($5000 times 238,874 prescriptions) and $11,422,500 on the second theory ($2500 times 4,569 letters).  Id. at 8.

The appeal challenged both theories, but according to the court’s opinion, did not raise some of the fundamental problems with them addressed in some of our prior posts on this sort of case.  Because the court reversed on the first argument it considered as to each theory, potentially broader issues were not resolved.  For instance, we would certainly question how a link between inadequate labeling, the writing/filling of prescriptions, and the submission of false claims could be presumed.  We would also wonder how a cause of action expressly based on a violation of the FDCA and an FDA regulation could escape preemption and how the mere sending of a letter, even if misleading in the abstract, could create liability without some proof that some relevant readers of the letter were misled by it.  Those questions were not answered in O-M-J.

The question that was answered as to the MFFCA was whether the trial court’s interpretation of it was “erroneous, overbroad, and untenable” in allowing it to be the basis of liability for claims for payment of a prescription drug with labeling allegedly in non-compliance with federal law.  In coming up with a resounding “hell yes” to that question, the court did something we do not think we have ever seen before:  it found the law had been miscodified by the Arkansas Code Revision Committee after it had been passed by the Arkansas General Assembly.  Id. at 13-15.  Essentially, a subsection of the Act the legislature passed that was clearly about statements in connection with (re)certifying hospitals and other healthcare facilities was later broken up into two subsections, with the latter reading “information required pursuant to applicable federal and state law, rules, regulations, and provider agreements” without a mention of certification. The State, represented by outside contingent fee counsel more interested in big bucks than in what Arkansas statutes really meant, sued under this subsection and claimed it could impose broad liability for claims for the cost of prescriptions of drugs with allegedly bad labeling.  Looking past the miscodification (and applying a strict construction in favor of the party to be penalized), the court interpreted the provision of the MFFCA under which the State had sued as only creating liability for false statements made in connection with (re)certification of hospitals and other healthcare facilities. Id. at 15-16.  In other words, this provision did not cover drugs or drug labeling at all.

We sometimes think of the state versions of the (federal) False Claims Act as being the same.  The False Claims Act is sometimes referred to as the Lincoln Law, because it was enacted during the Civil War to deal with contractors gouging the Union when it was busy with more important things.  Over the years, the False Claims Act has been used with regard to a range of claims for payment to the federal Government, not just the Medicare and Medicaid claims we have posted on before.  State versions of the False Claims Act do not all look the same and are not always addressed solely to preventing (and recouping for) Medicaid fraud. We do not know why the MFFCA—at least the part of it that the AG sued under here—was so focused on the part of the Medicaid world relating to certifying healthcare facilities, but it was. So, the main part of the AG’s case was never even conceivably tenable—it should have gone away on motion to dismiss—and $1,194,370,000 of the judgment for the State vanishes.  (With remand of the companion case on $480,000 attorney’s fees and costs, in light of the defendant’s win on appeal, the State may even end up in the hole.)  The result should mean that MFFCA suits against manufacturers are gone – the court did make sure the AG’s office could not do this again − but it is hard to project the highly specific nature of the decision outside of The Natural State. By contrast, the decision in Caldwell has broader implications.

The decision on the DTPA claim also involved a rarity and may not affect similar cases in other states.  The reversal was based solely the finding that the trial court abused its discretion in admitting a single document, the DDMAC Warning letter.  The ASC held that letter was inadmissible hearsay because Arkansas’s version of the public records exception, unlike Fed. R. Evid. 803(8), expressly carves out “factual findings resulting from special investigation of a particular complaint, case, or incident” from the exception to hearsay.  Id. at 19.  Thus, the inquiry under Ark. R. Evid. 803(8), which we think is fairly distinctive, was whether the DDMAC Warning Letter was the result of a “routine investigation” or “special investigation.”  As you would expect, the Warning Letter said it was because of the original Dear Doctor Letter, the AG’s expert (the pliable Laura Plunkett) testified that it was because of the original Dear Doctor Letter, and the close out letter from DDMAC said the Warning Letter was because of the original Dear Doctor Letter.  This was enough for a majority of the panel to conclude this was not sort of routine document that counts as an admissible public record under Arkansas law.  Id. at 24-27.  It is easy to see that just about every DDMAC letter that criticizes Dear Doctor Letters or promotional materials would be inadmissible hearsay under this particular standard.  So the heart of the AG’s case was inadmissible.

As an additional ground for excluding the Warning Letter, the majority of the panel also concluded that it was unduly prejudicial (and admitted in an abuse of discretion).  Id. at 26.  Part of its prejudice was because it was “referred to repeatedly throughout trial” and “was mentioned at least fifteen times” in closings.  In addition, “Reports issued by government agencies, because of their ‘official’ nature, may well carry inordinate weight in the minds of jurors.”  Id. (quoting Boude v. Union Pac. R. Co., 277 P.3d 1221, 1225 (Mont. 2012)).  This analysis, while brief, can certainly apply beyond Arkansas.  It also gives a hint about what may happen next in this case.  The remaining $11,422,500 of the verdict was knocked out, but the DTPA claim (unlike the MFFCA claim) was not dismissed.  Maybe the AG (or rather those outside law firms who started the whole thing) will re-try the case without the key piece of evidence used in the first case.  Then again, maybe the AG will look at the somewhat extraneous comments in the decision about the drug being “highly beneficial,” “a tremendous breakthrough,” and a “miracle drug”—the last is a quote from the State’s expert—as suggesting what the Arkansas Supreme Court might do if it tackles preemption or another unresolved issue on the DTPA claim down the road.

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We are still trying to get our hands on the opinion [update – here it is], but we understand that the $1.2 billion verdict for the State of Arkansas over marketing of the antipsychotic drug Risperdal has been reversed.  We told you in our summary of the top cases of 2013 that we were following this appeal. Because we cannot yet quote from the Arkansas Supreme Court, we quote from an equally august group, ourselves.  In touting the reversal of a very similar suit in Louisiana  based on the criticisms we had made about the lower court decision, including basically presuming injury and causation from an allegedly misleading communication, we said “We hope that other courts will follow the lead of the Louisiana Supreme Court in requiring that plaintiffs prove the claims they assert. Even statutes with avowed remedial purposes are not supposed to be mere vehicles for ringing up damages against deep pockets defendants.  We also hope that the state AGs who outsource their work to plaintiff lawyers, or other governmental lawyers who get in bed with plaintiff lawyers in the hopes of big settlements and verdicts, give a little more thought to the process going forward.”  It looks like the Arkansas Supreme Court did its part.  Now for the state AGs to get the message.

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