For at least forty years we’ve been hearing that soccer is going to supplant baseball, basketball, or football among America’s top three sports.  It hasn’t happened.  Maybe we heirs of Washington, Jefferson, Ruth, Rice, and Chamberlain have limited enthusiasm for one-nil scores and players diving and mimicking death throes in a cheap effort to extract a penalty kick.


Meanwhile, we have seen boxing subside in the country’s consciousness, bullied out of the way by mixed martial arts (MMA). It’s hard to believe one of those M’s does not stand for mayhem.  Forget about the Marquis of Queensbury’s niceties.  In MMA, the contestants are free to kick, choke, and elbow each other.  Hit a man when he’s down?  That’s not forbidden in MMA. Nope, that’s when the action is just getting started.  Pretty much anything goes in MMA.  
But you cannot use anabolic steroids.  If you test positive, you get suspended.  Rules are rules.  

The plaintiff in In re Lyman Good Dietary Supplements Litigation, 2018 U.S. Dist. LEXIS 131668 (SDNY Aug. 6, 2018), was an MMA fighter who was suspended because he tested positive for a banned substance.  The court employs the short-hand reference “andro” for the banned substance, and so shall we.  The plaintiff claimed that he had unknowingly ingested andro that was present in two dietary supplements that had been labeled to be free of any banned substances. The plaintiff alleged that the manufacturers and sellers of the dietary supplements promised that the products were “safe,” “without the use of banned substances,” “banned substance free,” and in compliance with “strict quality assurance procedures.”  The presence of andro broke such promises, and the plaintiff’s career had suffered a serious bruise. The plaintiff sued the manufacturers, high ranking executives at the manufacturers, and the retailer. The causes of action were interesting, including some you’d expect (breach of warranties, fraud, deceptive practices, false advertising, negligence, and strict liability) and some you wouldn’t (intentional infliction of emotional distress, assault and battery).  The defendants moved to dismiss and ended up winning more than they lost.

The court dismissed the claims for fraud, assault and battery, and intentional infliction of emotional distress.  Fraud claims are subject to heightened pleading requirements, which the complaint didn’t come within a puncher’s chance of satisfying. All we get are general allegations of fraudulent intent, along with generalized motive to earn profits.  That isn’t nearly enough.  The court applied a rear naked choke to the fraud claim and counted it out.  The assault and battery claim was a wild swing and miss.  The plaintiff’s theory was that putting a substance in someone’s body without consent is battery, but there was no case support for that, plus the plaintiff never alleged the requisite intention to inflict injury.  Here comes a reverse guillotine, and watch the court slice off the assault and battery claims.  Lack of intent is also what doomed the claim for intentional (or reckless) infliction of emotional distress.  The court also could identify no alleged outrageous conduct that went “beyond all possible bounds of decency.”  (To be sure, when one is dealing with MMA, it might seem difficult to meet that standard.) 

The court dismissed the claims against the executives, both on the merits and for want of personal jurisdiction.  Suing executives is fairly rare, and there are reasons for that.  Piercing the corporate veil requires a showing that the executives exercised compete domination and disregarded corporate formalities, including use of corporate funds for personal purposes.  At most, the complaint alleged that the individual defendants were high-level officers with wide-ranging authority, but an officer or director is not personally liable for the torts of a corporation merely by reason of occupying an important office.  The complaint utterly failed to allege that the executives used corporate domination to perpetrate a fraud.  In any event, there was no personal jurisdiction over the individuals.  They all had general authority over their corporations, but were not the primary drivers of the particular transactions in New York that gave rise to the litigation.  Hello sleeper hold, and good-bye claims against the individual defendants.  

The retailer prevailed on most of its motions to dismiss.  The claims for implied warranty of fitness for particular purpose, express warranty, and false advertising were carried out of the ring, but the claim of implied warranty of merchantability emerged unscathed.   The only express warranty by the retailer listed in the complaint was a statement in its 10-K annual report that the company used quality control procedures and that it refused to sell products that did not comply with law or were unsafe.  Those representations are pretty general, and the plaintiff did not even claim to have read them or relied upon them prior to purchase.  Nor did the annual report constitute a form of advertisement.  The court granted the plaintiff leave to amend the claim for implied warranty of fitness for particular purpose because, even though the complaint was bereft of any assertions that the plaintiff and the store had any conversations about how the plaintiff would use the supplements to prepare for MMA combat, the plaintiff wanted to add six paragraphs alleging precisely such conversations.  If such conversations did take place, it would not be “outside the realm of reasonable knowledge” that professional competitions require drug testing.   Thus, the particular purpose warranty claim might live to fight again.

The opinion in Lyman Good is solid and clear.  It goes through the different causes of action and defendants one-by one, jab by jab.  It reminds us that MMA is not the only place where rules are rules.

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of the devices’ 510(k) regulatory pathway.  Most or all of these orders rely on the Supreme Court’s 1996 opinion in Medtronic, Inc. v. Lohr, where the Court held that federal law did not preempt certain medical device warnings claims involving 510(k) devices.  In so holding, the Court distinguished the pre-1990 510(k) clearance process from the more involved and “rigorous” premarket approval (“PMA”) process and observed that the old 510(k) process was “focused on equivalence, not safety.”  518 U.S. 470, 493 (1996).

The Supreme Court did not hold that 510(k) clearance has no bearing on safety and efficacy, but the language quoted above provides a foothold for those inclined to marginalize the FDA’s role.  Indeed, we believe the Supreme Court’s view of the 510(k) process was already outdated in 1996.  As we have explained multiple times (including here), the 510(k) clearance process is keyed directly to safety and efficacy, and the Supreme Court has been retreating from Medtronic v. Lohr almost since the day the opinion was filed.

A district judge in Los Angeles recently provided what we think is the correct perspective. The case is Otero v. Zeltiq Aesthetics, Inc., No. CV 17-3994, 2018 WL 3012942 (C.D. Cal. June 11, 2018), and it is not a preemption case, or even a product liability case.  Instead, patients sued the manufacturer of a non-invasive fat-reducing system under California’s permissive consumer fraud statutes, claiming that the company made partial statements that were misleading and failed to disclose material information about the product. Id. at **1-2.

What were the misleading partial statements and omitted facts? The plaintiffs alleged that the manufacturer stated (truthfully) that the product was “FDA-cleared” and “FDA-cleared as safe and effective.” Id. at *1.  And the manufacturer failed to explain the difference between “FDA clearance” on the one hand and “FDA approval” on the other.  That’s the omission.

We have unending sympathy for individuals who fight weight gain and for whom the condescending admonition to exercise more and eat less is not helpful. Be that as it may, these claims have no arguable merit, and the district court correctly dismissed them.  With regard to the alleged “partial” representation that the device was “FDA cleared,” the district court ruled that “Plaintiffs fail to explain how that true representation—on its own—could cause reasonable consumers to erroneously believe that the system received FDA approval.” Id. at *2.  The court continued:

Plaintiffs simply point out that under California law, true statements may mislead reasonable consumers if other relevant information is omitted. Although that is an accurate legal proposition, it does not establish that “FDA-Cleared” gives rise to viable [California statutory] claims, especially because the “mere possibility” that some consumers acting unreasonably will conflate FDA-clearance and FDA-approval is insufficient.

Id. So can a true statement ever support a claim?  Under some circumstances not presented here, it appears that one could, although that would be truly exceptional case.  Can a true statement support a claim where it is merely possible that a consumer will unreasonably misconstrue it?  This court ruled that it cannot.

There is more. The plaintiffs also argued that adding the words “safe and effective” to “FDA-cleared” was misleading because that claim can only be made in connection with FDA approval, citing Medtronic v. Lohr.  (See, we were going to get back to Medtronic v. Lohr eventually, and here we are).  In the part of the order that we like the most, the district court convincingly debunked the myth that “safe and effective” is unique to the PMA process:

It appears that this argument relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which allegedly establishes that “‘[t]he § 510(k) notification process is by no means comparable to the PMA process’ and in no way warrants that the device is safe and effective.”  [quoting Plaintiffs’ brief.]  Although Medtronic observed that obtaining Section 510(k) clearance is not as onerous as the “rigorous” PMA process, the Supreme Court did not find that the former has no bearing on a device’s safety and effectiveness. In fact, Medtronic acknowledged that “the FDA may well examine § 510(k) applications . . . with a concern for the safety and effectiveness of the device . . .”  The Supreme Court later clarified “the FDA simultaneously maintains the exhaustive MPA and the more limited § 510(k) process in order to ensure . . . that the medical devices are reasonably safe and effective.

Id. at *3 (first emphasis added, second in original).  In other words, the plaintiffs (and others before them) were relying on a snippet to misread Medtronic and overstate its holding.  The district court went on to state that the FDA’s regulations connect 510(k) clearance to safety and effectiveness, too:

Indeed, the FDA regulations provide that if the agency has found that a device is substantially equivalent to—but has “technological characteristics” that are different from—a predicate device, then that means the agency has concluded that “[t]he data submitted . . . contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.”

Id. (emphasis in original).  Finally, the district court noted that compliance with general and special controls, which Class II medical devices must do, further provides “reasonable assurance of the safety and effectiveness of the device.” Id. There was no deceptive, no misleading statement.  Only true representations of a medical device’s regulatory pathway.  That is not the basis for a consumer fraud claim.

Nor is it consumer fraud when a manufacturer does not explain the difference between FDA clearance and FDA approval. The district court ruled that a manufacturer’s duty to consumers is limited to warranty obligations, absent an affirmative misrepresentation or a “safety issue.” Id. at *4.  We are not sure this is an accurate statement of a medical device manufacturer’s duty to consumers, especially considering the presence of prescribing physicians (i.e., the learned intermediaries) for many devices.  We also can’t imagine a situation where a medical device manufacturer would be under a legal obligation to explain FDA regulations to consumers.  But even taking the rule at face value, the plaintiffs alleged no safety risk. Id. at *5.  Maybe they were unsatisfied with the results (i.e., effectiveness) and wanted their money back.  Whatever their beef was, it was not about safety.

The plaintiffs walked away with their core claims dismissed without leave to amend. The district court gave them another chance to plead that they actually observed other statements that they claimed were misleading, based on counsel’s representations at argument that their clients might have seen them. Id. at **5-6.  We don’t know.  It seems to us that if those facts existed, the plaintiffs would already have pleaded them.  The takeaway for us is the reality that the 510(k) process does tie into safety and efficacy.  Don’t let anyone tell you otherwise.

We have written extensively on the travesty of the Neurontin trilogy (like here and here) and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric have not been as successful. Today’s case addresses what we understand to be some of the last few cases in the MDL.   In re Celexa & Lexapro Mktg. & Sales Practs. Litig., MDL No. 09-02067-NMG, 2018 U.S. Dist. LEXIS 13579 (D. Mass. Jan. 26, 2018).  This summary judgment decision addresses three cases, one by a third party payor on behalf of a purported class and two by parents of former pediatric users.  As always, we reserve the right to focus on the parts we want and to make gratuitous statements about how these cases exemplify much of what is wrong with civil RICO and consumer fraud cases over prescription drugs.

A little background on the litigation and these cases should help.  The allegations centered on the claim that the manufacturer of these drugs had caused economic injury to the plaintiffs by promoting the use of the drugs for pediatric patients when they were only approved for adult use.  To dispose of the plaintiffs’ cases, the court did not have to resolve whether the manufacturer engaged in such promotion, let alone whether any promotion was untruthful—which we think it would need to be to impose liability consistent with the First Amendment.  Celexa was approved to treat depression in adults in 1998 and an application to treat depression in adolescents was filed in 2002.  FDA denied that application based on a lack of efficacy in one of the two clinical studies.  Lexapro was approved to treat depression in adults in 2002 and an application to treat depression in adolescents was filed in 2008 and approved a year later.  The Celexa label always stated that “safety and effectiveness in pediatric patients have not been established” and, starting in 2005, described the results of certain pediatric trials.  The Lexapro label had similar language until the pediatric indication was added.  The first individual plaintiff sued over the prescription, purchase, and intermittent use of Celexa by a thirteen year old depressed patient in 2002-2003.  The second individual plaintiff sued over the prescription, purchase, and use of Celexa and later Lexapro by an eight to fifteen year old autistic patient from 2003 to 2010.  The TPP plaintiff sued over prescriptions paid for a relatively small number of Celexa prescriptions for pediatric beneficiaries from 1999 to 2004 and for a somewhat larger number of Lexapro prescriptions for pediatric beneficiaries between 2012 and 2015, but also claimed to represent a nationwide class of payors.  The plaintiffs asserted a mix of federal civil RICO and state consumer fraud claims and, skipping some procedural history, the court entertained summary judgment motions.

The consideration of the RICO requirements of injury and causation resolved all issues. For those of you who know RICO or have just followed along with some of our posts, RICO requires an injury to “business or property” as a matter of standing.  Relying on the Neurontin cases, these plaintiffs claimed that they had been injured because they paid for drugs that were not effective for the indications for which they were prescribed.  They claimed, however, that any payment for an off-label prescription was an injury because they contended that FDA had somehow been defrauded in connection with the applications for pediatric indications.  2018 U.S. Dist. LEXIS 13579, *19.  If you are following along, then you might wonder how this theory could apply to Celexa prescriptions or the earlier prescriptions of either drug.  First things first, though, as the Celexa court had to unpack the Neurontin rulings to see if they supported plaintiffs’ relaxed standard.  They did not, so plaintiffs had to prove lack of efficacy.  The TPP and second plaintiff could not:  “[T]he FDA in this case approved the drug for use in adolescents.  There is no conclusive or even strongly suggestive evidence of inefficacy in this case and plaintiff have presented no evidence as to the inefficacy for [the second plaintiff] or for any of [the TPP’s] plan members.” Id. at *22.  As one might expect with prescriptions over the eight years, the second individual plaintiff’s prescribing physician testified that the drugs had been effective with the patient’s autism.  The TPP’s evidence resembled what we have seen in other cases—no proof from physicians for the plan beneficiaries and the plan still pays for pediatric prescriptions for both drugs, contrary to the allegations in the case.

Plaintiffs’ attempted end run was that they had experts who would say FDA was somehow defrauded about efficacy for pediatric use—presumably just for Lexapro, as FDA rejected the only application for a pediatric indication for Celexa, and not for autism, as that was not an indication for either drug.  As the court noted, and we will let the Neurontin characterizations lie, plaintiffs’ “fraud theory is a tenuous attempt to shoehorn the facts of this case into the facts of Neurontin, where there were no positive, or even equivocal, clinical trials for the indications at issue.” Id. at *25.  Here, FDA “determined that two clinical studies were positive” and “FDA is the exclusive judge of safety and efficacy and a court should not question that judgment unless new information not considered by the FDA develops.” Id. (internal quotes and citation omitted).  Keep in mind that RICO is federal, so there is no preemption.  Not too shabby.  And summary judgment for the manufacturer on two of the plaintiffs.

On the remaining plaintiff, the first individual, the manufacturer challenged causation.  In part because we think the analysis was somewhat confused, we will skip to what mattered and probably applies to other plaintiffs with similar claims.  The prescribing physician’s testimony did not support reliance on a sales representative’s discussion of Celexa at all. Id. at *30.  While he did acknowledge a possibility of some unrecalled exposure to off-label promotion, this is not enough to avoid summary judgment on an issue for which the plaintiff bears the burden of proof.  “A mere possibility that the doctor could have, at some point, encountered off-label promotion, although he has no memory of it, does not rise to the level of a disputed material fact.” Id. at **30-31.  That sounds like what courts are supposed to say when evaluating a summary judgment motion on proximate cause for failure to warn with a prescription medical product.  The court here called this “but-for causation,” but we will not quibble. Summary judgment was awarded to the manufacturer on the last plaintiff’s RICO claim and the analysis on RICO determined the result of the various consumer fraud claims.  Like we said up front, this was all without reaching whether the manufacturer did anything wrong with its promotion.

 

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.

Larry Klaman could, and thus brought the lawsuit that recently resulted in Aston v. Johnson & Johnson, ___ F. Supp.3d ___, 2017 WL 1214399 (D.D.C. March 31, 2017).

Nobody else did, though.

In particular, and fortunately for everyone on the defense side, the judge in Aston could not.  Reading the Aston opinion, it is evident that the court is beyond skeptical of the vast, or even half-vast, conspiracy claims.  In a nutshell, five plaintiffs who claimed a great many personal injuries (the opinion lists 74 separate alleged injuries, 2017 WL 1214399, at *1) from their use of the drug Levaquin, brought suit alleging that the drug’s manufacturer and the FDA were in cahoots to cover up the drug’s risks, in order to increase the value of the manufacturer’s stock, to the advantage of various investors.  As for the political officials, according to the opinion:

Amazingly, former presidents Barack Obama and Bill Clinton also make cameo appearances in plaintiffs’ alleged scheme, together with former Secretary of State Hillary Clinton, and the Clinton Foundation; these actors are alleged to have solicited, or received, “gratuities” from defendants in exchange for securing [another alleged conspirator’s] appointment as FDA Commissioner.

Id. at *2.  We admit, this is an extreme oversimplification – the opinion took two Westlaw pages just to sort through the Aston plaintiffs’ labyrinthine conspiracy allegations.

Plaintiffs’ legal theories were almost as numerous as their injury allegations – twenty-two counts, including RICO, state-law (Arizona (?)) RICO, strict product liability, negligence, fraud, express and implied warranty, unjust enrichment, Lanham Act, and a bunch of state consumer fraud claims (D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California). Id. at *3.

Aston threw everything out on the many defendants’ motions to dismiss. The half-vast conspiracy, and all its subsidiary theories of liability went down in a hail of defense-friendly rulings, and that’s why – aside from its humor value – the Aston opinion is well worth reading.  We’ll list the rulings so our readers will have an idea of what this goodie basket contains.

RICO – The deficiency in the RICO counts was rather basic. RICO does not allow recovery for personal injuries.  “The overwhelming weight of authority discussing the RICO standing issue holds that the ‘business or property’ language of Section 1964(c) does not encompass personal injuries.” Aston, 2017 WL 1214399, at *4 (citation and quotation marks omitted).  For a compilation of that authority, see Bexis’ Book, §2.15, footnote 3.  Further, “as plaintiffs’ counsel is well aware, courts in this District and elsewhere have consistently rejected the argument that pecuniary losses derivative of personal injuries are injuries to ‘business or property’ cognizable under RICO.”  Aston, 2017 WL 1214399, at *4 (citing, inter alia, Klayman v. Obama, 125 F. Supp.3d 67, 88 (D.D.C. 2015)).  Aston also distinguishes “tobacco litigation [RICO] precedents” because those cases arose from a federal prosecution that was not limited by the “business or property” requirements of RICO’s private cause of action.  2017 WL 1214399, at *5.

Nor did the Aston plaintiffs satisfy RICO’s causation requirements – for another very basic reason.  Even the most recent of the five plaintiffs’ injuries arose before the conspirators allegedly acted:

Barring some sort of temporal paradox, there is no way that suppression of an FDA report in 2013 could have caused plaintiffs to be injured in 2012 or earlier.  Because plaintiffs’ allegations, taken as true, are insufficient to establish proximate causation, their federal RICO counts must be dismissed.

Id. (citing H.G. Wells, The Time Machine, 22–23 (1895)) (other citation omitted).  On this basis alone, we’re rooting for the defendants to obtain recovery of their counsel fees, since the underlying premise of the entire litigation was physically impossible.

Arizona RICO – Same basis:  “[P]laintiffs have failed to plead facts that make possible − let alone plausible − the conclusion that the alleged cover up by defendants was the proximate cause of plaintiffs’ injuries.”  Id. at *6.  Unfortunately, the relatively terse dismissal of does not answer the burning question − Why Arizona?

Lanham Act – Another fundamental basis for dismissal.  “[T]o come within the zone of interests in a suit for false advertising under [the Lanham Act], a plaintiff must allege an injury to a commercial interest in reputation or sales.”  Id. (quoting Lexmark International, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014) (emphasis original in Aston).

Now comes the most useful stuff – dismissal of the common-law claims.  For the record, Aston applies the law of the District of Columbia rather than the law of the plaintiffs’ (Maryland, Pennsylvania, Arizona, Illinois, California) or defendants’ (New Jersey) domiciles.  Aston, 2017 WL 1214399, at *6.

Product Liability (both strict liability and negligence) – Manufacturing defect is TwIqballed.  For all its factual prolixity, the Aston complaint was utterly devoid of any allegations that the drug wasn’t made precisely as intended.  Id. at *7 (“for all these recitals of the term ‘manufacture’ and its derivatives, plaintiffs plead no facts that would appear to relate to manufacturing defects”) (citation and quotation marks omitted).

Warning related claims were also dismissed, in a usefully rigorous application of TwIqbal.  Dismissal in Aston occurred because plaintiffs failed to plead:  (1) “the contents of the warning label” when the drug was taken (2) “how the contents of the label were inadequate,” (3) “the timing of each plaintiffs use of” the drug, including “when each individual plaintiff was prescribed,” (4) “the onset of [plaintiffs’] injuries,” (5) “how the alleged distinctions in the warnings would have had a causal effect,” (6) “what injuries each individual plaintiff experienced,” (7) “why [plaintiffs] think [the drug] was the cause of the[ir] injuries,” and (8) “why [plaintiffs] think inadequate warnings contributed to their injuries.”  Id. (various quotations omitted).  That’s a spicy TwIqbal – without even having to get into the learned intermediary rule.

As to warnings, we also note that the court held that all warnings publicly available on the FDA’s website are subject to judicial notice.  Id. at *2 n.1.

Design defect claims were preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and Aston rejected the well-worn plaintiff argument that, for some reason, implied preemption is different in generic, as opposed to branded (as in Aston) drugs:

Plaintiffs are mistaken.  [Bartlett] expressly found that “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to [its formulation]” by federal law.  133 S. Ct. at 2471.  Thus, even though [Bartlett] arose from a state-law design-defect claim against a manufacturer of a generic drug, its holding applies to both types of drugs, and plaintiffs’ design-defect claim must be dismissed.

Aston, 2017 WL 1214399, at *8. Preemption is “fully consistent with the well-established tort law principle, ‘especially common in the field of drugs,’ that an unavoidably unsafe product is ‘not defective, nor is it unreasonably dangerous’ where it is ‘properly prepared, and accompanied by proper directions and warning.’”  Id. at *8 n.7 (quoting Restatement (Second) of Torts §402A, comment k (1965)).

Fraud/Misrepresentation – Perhaps predictably, plaintiffs’ fraud-based claims failed under Fed. R. Civ. P. 9(b).  Id.  Allegations broadly “span[ning] the more than twenty-year period” alleged could not possibly allow defendants to file a response.  Id.  Plaintiffs “do not even specify which corporate entity they believe was responsible.”  Id.  Nor did any of the five plaintiffs allege their own circumstances with the required specificity.  Id.  “In sum, plaintiffs fall woefully short of pleading any specific allegations that would support a claim of fraud or misrepresentation.”  Id.

Warranty – Again, perhaps predictably, plaintiffs’ express warranty claims failed for not “plead[ing] any express promises.”  Id. at *9.  Here, Aston made another good TwIqbal ruling:

[T]o state a claim for breach of express warranty in cases involving prescription drugs, Plaintiffs must allege facts demonstrating that Defendants’ affirmations formed the basis of the bargain, i.e., facts regarding how the warranties were made to Plaintiff’s physician, and that Plaintiff’s specific physician relied on them.

Id. (citations and quotation marks omitted).  Implied warranty claims “cannot be independently maintained in a case involving prescription drugs.”  Id.

Unjust Enrichment – As against the investor defendants, merely “earn[ing] profits” from allegedly more valuable stock was “far too remote and speculative to support an unjust enrichment claim.”  Id. at *9.  As against the drug manufacturer defendants, the plaintiffs did not allege “that they conferred a benefit” on those defendants.  Id. at *10 (emphasis original).

[Plaintiffs] do[] not allege that [they] paid any money for [the drug], rather than relying on an insurer, as most patients do.  This omission is significant because there is no authority demonstrating that benefits received from third-parties can be the proper subject of an unjust enrichment claim.

Id. “Because plaintiffs have not pleaded any facts showing that they paid for [the drug], I must dismiss their unjust enrichment claim.”  Id.

Obamacare to the rescue.

Readers should remember this point; we don’t remember ever seeing an individual (as opposed to TPP) unjust enrichment claim that contains the allegations – personal, as opposed to third party payer – required by Aston and the precedent it follows.

Consumer Fraud Claims

Seven states’ laws were implicated − D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California. “Each count fails to state a claim.” Id.

Six of the states (all but Arizona) did not recognize consumer fraud claims involving prescription drugs.  Some states’ statutes did not allow personal injury damages (Pennsylvania, California, D.C.).  Others did not consider prescription drugs to be “consumer” goods (Maryland, New York).  Still other statutes simply had been held inapplicable to prescription drugs (California, Pennsylvania, Illinois).  Id.  Beyond that, all of the consumer fraud claims were dismissed as inadequately pleaded under Rule 9(b), which Aston applied to all consumer fraud claims.  Id. at *11.  In prescription drug cases, Rule 9(b) required specific pleading of prescriber reliance:

[T]he circumstances of those prescription decisions, and plaintiffs’ reliance on them, are particularly important − yet plaintiffs allege no information about them. The absence of detail about Plaintiffs experiences leads to the conclusion that Plaintiffs have not pleaded these claims with the requisite particularity.

Id. (citations and quotation marks omitted).

Finally, none of the plaintiffs resided in D.C. or New York.  Thus, claims under those two states’ consumer fraud statutes were also “dismissed because neither statute applies extraterritorially.”  Id. at *10 n.9.  We’ve always been interested in extraterritoriality.

So that’s Aston for you – an example of really poor facts (for the plaintiffs) making some quite excellent law for our side of the “v.”  Our only quibble with Aston is grammatical – in a couple of places, “principle” is used where “principal” is meant.  Id. at *2 (“principle role”); *6 (“principle place of business”).  But apart from a law clerk needing to repeat fifth grade English, the legal rulings in Aston are truly vast, and not half-vast at all.  In Ashton all too many defendants were made to spend all too much money to hire all too many of us lawyers.  With Aston now dismissed in its entirety, we certainly hope that all the defendants so inconvenienced seek to recover their fees as a sanction against such frivolous litigation.

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes.  See Andren v. Alere, Inc., 2016 WL 4761806, at *9 (S.D. Cal. Sept. 13, 2016) (where “misrepresentations and omissions claims are based on a failure to warn” the learned intermediary rule applies” to claims under the two major California consumer protection statutes (CLRA & UCL)).  Since we haven’t addressed this issue recently (one guest post from 2007), we thought it would be a good idea to examine more generally decisions that also apply the learned intermediary rule to consumer fraud claims. Andren is definitely not an outlier, although in a lot of states precedent is not extensive.

We’ll start with California.  We know of several other cases reaching essentially the same result.  One of them, Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013), is mentioned in Andren. Saavedra, a multi-plaintiff case also applying the laws of Massachusetts and Missouri (in addition to California), found the learned intermediary rule applicable to all three states’ consumer protection statutes, based on uniform precedent:

Every case that this Court has found, and that the parties have identified, that has specifically addressed the questions has found that the learned intermediary doctrine applies to consumer protection claims predicated on a failure to warn.

Id. at *3.  Thus, Saavedra “concur[ed] with the great weight of authority and conclude[d] that the learned intermediary doctrine applies to the consumer protection claims at issue.”

Another relevant California case was not cited in Andren − the appellate decision in In re Vioxx Class Cases, 103 Cal. Rptr. 3d 83 (Cal. App. 2009). Vioxx held that the individual actions of learned intermediary prescribers physicians precluded class certification in cases under the same statutes:

[A]ll physicians are different and obtain their information about prescriptions from myriad sources. . . . [P]hysicians consider many patient-specific factors in determining which drug to prescribe, including the patient’s history and drug allergies, the condition being treated, and the potential for adverse reactions with the patient’s other medications − in addition to the risks and benefits associated with the drug.  When all of these patient-specific factors are a part of the prescribing decision, the materiality of any statements made by [defendant] to any particular prescribing decision cannot be presumed.

Id. at 99 (footnote omitted).  Thus, the Vioxx court presumed, albeit without holding, that the learned intermediary rule applied so that the physicians – rather than patients – are the recipients of information from manufacturers of prescription medical products.  For other similar California law cases, see Weiss v. Astrazeneca Pharmaceuticals, 2010 WL 3387220, at *5 (Cal. App. Aug. 30, 2010) (similar result in unpublished affirmance of UCL/CLRA class certification denial); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041, at *20 (S.D. Ill. March 13, 2012) (denying class certification under UCL “[b]ecause [the drug] is a prescription medication, [so] the question of uniformity must consider representations made to each putative class member and her prescribing physician”) (applying California law); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 751 F. Supp.2d 277, 288 (D. Mass. 2010) (applying learned intermediary prescriber-centric causation principles to UCL; denying summary judgment) (applying California law); In re Paxil Litigation, 218 F.R.D. 242, 246 (C.D. Cal. 2003) (rejecting argument that the learned intermediary rule “becomes irrelevant under [the UCL]”).

Continue Reading The Learned Intermediary Rule in Consumer Protection Claims

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to name a few.  Devices according to the FDCA also include “in vitro reagent[s] . . . intended for use in the diagnosis of disease or other conditions.”  There are a whole slew of diagnostic devices that are used to test blood, tissue, or other stuff from the body to provide useful health information.  Some of them get used directly by health care professionals, some can be purchased over-the-counter, and some need a prescription for the patient to use it at home.  We know that plaintiffs sue over just about every kind of device under a range of theories, but we do not recall seeing consumer fraud claims over prescription diagnostic devices.  That is what we have in Andren v. Alere, Inc., No. 16cv1255-GPC(NLS), 2016 U.S. Dist. LEXIS 124252 (S.D. Cal. Sept. 13, 2016), and we thought the issues were interesting enough to spend a little time sharing them with devoted readers.

Andren is a decision on a motion to dismiss a purported class action complaint brought by two plaintiffs, each of whom claimed to have suffered thrombotic events from inadequate anticoagulation as a consequence of inaccurate readings on a defendant’s test kit, which checks blood clotting times for people on anticoagulation therapy.  We have some guesses about why they did not just pursue product liability claims for personal injury and some of the hurdles that they would stumble over on the way to class certification.  None of that really mattered yet, because they tried to assert claims sounding in fraud and Fed. R. Civ. P. 9(b) requires heightened pleading for such claims.  Some background on the device is in order first.  Unlike the court, which had a discussion of what beyond the complaint it could consider—which we will omit here—we can say that the defendant recently elected to discontinue and withdraw the device that plaintiffs claim to have used, which followed the earlier recall of lots of the product made since 2008 because of issues with accuracy in certain patient populations or settings.  Plaintiffs’ allegations were not limited to the particular device they used and were predictably broad.  They alleged that the defendant and its predecessors received thousands of complaints of “malfunctions,” including some number that results with their devices differed significantly from what independent laboratories found on the same samples. Id. at **3-4.  They alleged that FDA issued warning letters about adverse event reporting and other issues after 2005 and 2006 inspections of defendant’s predecessor in 2005 and 2006—well before the device at issue was cleared or sold. Id. at **4-5.  In April 2014, the test strips portion of the test kit were recalled.  In December 2014, the monitor portion and other products in the line were recalled.  The recalls were because readings with the kits were sometimes significantly lower than they would have been if tested by laboratories. Id. at **5-6.

They way that these readings (of the International Normalized Ratio or “INR”) work is numbers that are lower than the expected range for someone on anticoagulation therapy (with the range depending on the underlying condition and other factors) should result in increased anticoagulation therapy.  Having too much anticoagulation therapy can put a patient at risk for undesired bleeding.  Each plaintiff claimed that their readings from the defendant’s test kits were incorrectly high, so they either failed to take a dose of anticoagulation on a certain day or reduced his regular dosage of anticoagulation over time—with each plaintiff apparently taking these actions without consulting health care providers. Id. at **7-9.  So, the alleged product issues here were the opposite of the reason for the recalls.  And then the plaintiffs claimed to have suffered a stroke (not specified as ischemic or hemorrhagic, but the former is about seven times more common and this one was apparently followed by transient ischemic attacks) or a transient ischemic attacks. Id. Based on the recounting of the medical allegations, then, the plaintiffs claimed the sort of injuries that were also the opposite of the risk implicit in the recall.

Continue Reading Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

Back in October, all of the Philadelphia Reed Smith bloggers participated in an in-house CLE presentation attended by colleagues and clients.  Our portion of the presentation dealt with third party litigation funding.  There are several different funding models, but all are united by a common theme: funding companies, aided by plaintiffs’ lawyers, identify vulnerable litigants and prey on them, advancing money that must be paid back upon verdict or settlement.  Some of these advances are “non-recourse” –  if insufficient funds are recovered, the plaintiff’s obligation to reimburse the funder is limited to the amount of the recovery.  Some are not – if the plaintiff doesn’t recover enough to pay back the advance, he or she is personally obligated for the balance.  And some charge interest rates so exorbitant that only those in the most desperate financial straits are tempted.  But such plaintiffs exist, and they agree to the funding companies’ usurious terms, and they are victimized.

But not, anymore, in Colorado.  In November, in the case of Oasis Legal Finance Group, LLC v. Coffman, 361 P.3d 400 (Colo. 2015), the Colorado Supreme Court held that litigation funding agreements were “loans,” subject to the terms of the Colorado Uniform Consumer Credit Code (UCCC).  This case was originally a preemptive strike by a couple of litigation finance companies against the State of Colorado, seeking a declaratory judgment that their funding agreements were not “loans” that could be regulated under the UCCC.  As the court explained, these agreements were called something other than loan agreements.  One plaintiff called its contracts with plaintiffs “Purchase Agreements,” labeling the tort plaintiff the “Seller” and the funding company the “Purchaser,” and defining the “Purchased Interest” as “the right to receive a portion of the Proceeds [of the litigation] equal to” the amount of cash advanced to the plaintiff (and some other charges).  316 P.3d at 402.  Those agreements provided that the “Purchaser shall receive nothing” if the Plaintiff does not recover on the tort claim.

Another company called its contracts “Funding Agreements.”  As the court explained, “The agreement characterizes the transaction as an assignment of an interest in the proceeds from the resolution of a pending case – but not, it makes plain, an assignment of the lawsuit . . . itself.”  Id.  “The amount assigned is equal to the funded amount, together with the accrued use fee, compounded monthly, and other fees or costs, from the proceeds of the Lawsuit.”  Id. at 402-03 (internal punctuation and citation omitted).   Similarly, these “Funding Agreements” “acknowledge[] the possibility that [the company] might receive nothing depending on the outcome of the litigation.”  Id. at 403.

In the declaratory judgment action, the trial court held that the funding transactions created “debt,” and were thus “loans” governed by the UCCC, under the Code’s plain language, the court’s historical definition of debt, and the court’s decision in State ex rel Salazar v. CashNow Stores, Inc., 341 P.2d 161 (Colo. 2001), holding that agreements to advance tax refunds, at interest rates up to 50%, were UCCC “loans.”  Id. at 405.  The Court of Appeals affirmed, “emphasiz[ing] that courts liberally construe the UCCC to promote consumer protection . . . [and pointing] out that, in CashNow, the court rejected a ‘narrow interpretation’ of the term ‘debt’ in favor of a ‘broad reading’ of the UCCC’s definition of ‘loan,’ and made clear that a loan does not require an unconditional obligation to repay.”  Id

On appeal, the Colorado Supreme Court explained the policies and purposes underlying the UCCC:

The UCCC regulates consumer credit transactions including consumer loans, leases and credit sales. . . . For example, the Code seeks to corral what it terms “supervised loans,” consumer loans with an annual finance charge exceeding twelve percent . . . , restrict[ing] authority to make supervised loans to “supervised lenders,” those licensed by the Administrator
or otherwise exempted from the UCCC. The UCCC also, [inter alia], regulates “payday loans,” . . . limits creditors’ collection remedies, . . . and restricts what parties can agree to . . . .

Id. at 406 (citations omitted).   In this fashion, the UCCC seeks to protect consumers from unfair practices, foster competition among credit suppliers, and simplify consumer credit law.  Id. (citations omitted)

The court explained that the UCCC “defines ‘loan’ to include ‘the creation of debt by the lender’s payment of or agreement to pay money to the consumer . . . “  Id. at 407  (internal punctuation and citations omitted).  Moreover, “the word ‘debt’ also figures prominently in the Code’s definition of the more specific ‘consumer loan.’ Id.  Thus, the court continued, because “debt is a necessary, if not completely sufficient, characteristic of the consumer transaction the Code seeks to regulate . . . we start there.  Do the transactions at issue her create debt?”  Id.

The court concluded that a “litigation finance transaction creates ‘debt’ because it creates an obligation to repay,” id., notwithstanding the finance companies’ arguments that there was no “debt” – and no “loan” – because plaintiffs’ repayment obligations were limited to the amount of their recoveries. The court noted,

[The Code’s language and our CashNow decision show that the repayment obligation need not be unconditional; the debt “created” by a UCCC loan need not be recourse.  Litigation finance companies create debt because they create repayment obligations. This is so notwithstanding the litigation finance companies’ embrace of risks that, from time to time, require them to adjust or cancel some plaintiffs’ obligations.  Most of the time, plaintiffs’ repay the full amount borrowed – and more.

Id. at 409.  The court also found it “significant that the obligation increases with the passage of time, another characteristic of a loan,” id., noting that “one of the features of a ‘consumer loan’ under the UCCC is the presence of a ‘finance charge.’”  Id. (citations omitted).  Finally, “[b]ecause the agreements do not transfer ownership rights,” the court “rejec[ed] the companies’ theory that these transactions are ‘sales’ or ‘assignments.’”  Id. at 410.  Under the funding companies’ agreements, the funding companies do not “step into the tort plaintiffs’ shoes;” rather, the plaintiffs retain control of the litigation, and “the agreements provide [the funding companies] only with the rights that any creditor would have to receive payment of the amount due.”  Id

And so, at least in Colorado, a litigation funding company is making a “loan” when it advances money to a plaintiff with the expectation that that the money will be repaid with interest, and those loans are subject to all of the state’s consumer protection mechanisms.  Indeed, the Colorado Supreme Court pointed out that both after the plaintiff litigation funders lost in the lower courts, they ceased doing business in Colorado rather than accept possible UCCC regulation.   As such, desperate people are protected from themselves.  And if this is all a bit “Big Brother”-ish, we have no problem with that at all.

There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli Jerry,” the 107th episode of Seinfeld.)   In the face or fear of a hostile action against our client, this lawyer would file a declaratory judgment action in a friendly federal court.  The concept, of course, was to seize the initiative and do some forum-shopping.  Sometimes the action would be preemptive and sometimes it would be reactive. One would think that the timing would make a difference.  But as today’s case, Monster Beverage Corp., v. Herrera, 2016 U.S. App. LEXIS 9012 (9th Cir. May 17, 2016), demonstrates, that ain’t necessarily so.  We discussed the Monster case a couple of days after Labor Day in 2013, when Monster survived an attack on its preemptive preemption position.  Here it is just a couple of days after Memorial Day in 2016, and the Ninth Circuit has ended the case on grounds of Younger abstention and the Anti-Injunction Act.  That’s a long passage of time.  The judicial process, especially the appellate phase (doubly so in the Ninth Circuit), can take a while. What happened in the interim?

First, please enjoy this reminder of what the Monster case was about.   The San Francisco City Attorney wrote a letter to Monster informing it of an investigation into whether Monster’s marketing of its energy drinks was deceptive and bad in various other ways.  Needless to say, the City Attorney’s beef was really with the federal regulatory regime that already governed what Monster could and could not say about its products.  But San Francisco has been known to try to conduct its own foreign policy, so why should federal regulations stand in the way of its persistent effort to impose a nanny-state on its benighted citizens?   Monster filed a preemptive declaratory judgment action in C.D. Cal. (good idea to drag the San Francisco City Attorney down to SoCal), seeking to shut down the investigation because it was preempted by federal law.  Then the San Francisco City Attorney filed a complaint in San Francisco Superior Court, which Monster removed to federal court on grounds of federal question (preemption again), which the federal court remanded after rejecting the preemption argument. For those of you keeping score at home, that means there was a federal case in Dodger-land and a state case in Giant-land.

The San Francisco (honestly, by this point we are tired of writing the city name out in full, but Boranian warned us that we’d be jeered if we abbreviated the city’s name in any way) City Attorney, as is the case with all Bay Area denizens forced to contemplate anything south of Big Sur, must have seen the C.D. Cal. case as a vast annoyance.  That was certainly the idea behind Monster’s maneuver.  Not surprisingly, then, the City Attorney filed a motion to dismiss the declaratory judgment action in C.D. Cal., arguing that the preemption argument stood no chance. The federal court denied that motion to dismiss.  That is the ruling we applauded back in September 2013.

Continue Reading San Francisco vs. The Monster (aka Federal Regulation)

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really should involve individualized proof. Like here, here and here. (This same dynamic plays out when governmental entities seek reimbursement for such products too.) Usually, though, the plaintiffs allege that the manufacturer’s fraud—under whatever particular statutes or headings it is pursued—was unknown to them during the time for which they seek damages for amounts paid for the product and that the damages stopped once they found out. In Teamsters Local 237 Welfare Fund v. Astra-Zeneca Pharms. LP, No. 415, 2015, 2016 Del. LEXIS 236 (Del. Apr. 12, 2016), the plaintiff payors were undone by their concession that they knew about the alleged fraud and kept paying for the drug at issue anyway. Based on its self-described common sense analysis, the Delaware Supreme Court affirmed the dismissal for lack of causation without weighing in on the Superior Court’s rejection of causation where individual physicians made individual decisions about what to prescribe. This is a good result, but we are concerned about the implications for the practices of payors who seem increasingly interested in signing up with contingency fee lawyers to sue medical product manufacturers. (In case you were wondering, that was a teaser, designed to get you to read all the way to the end of the post.)

The basic facts are that the plaintiff filed a purported nationwide class action on behalf of third-party payors in Delaware state court in 2004, alleging that the defendant violated state consumer fraud laws by falsely marketing Nexium as being more effective than Prilosec, an older product with allegedly one-half of the same active ingredient per dose. Adding some facts omitted in the opinion, the initial NDA for Prilosec had been approved in 1989 (under the name Losec) and lost exclusivity in 2001, around which time FDA approved the NDA for Nexium, which had an enantiomer (here, the left hand chiral image) of the Prilosec’s active ingredient as its active ingredient. The indications for both drugs were expanded through the years, with Prilosec going over-the-counter in 2015. These drugs together accounted for a large chunk of the prescriptions written for heartburn, gastroesophageal reflux disease, and related complaints. Plaintiffs claimed that the development of Nexium and the marketing campaign after its introduction were designed to get the defendant paid a high price for its newer branded product instead of money going to pay for cheaper generic versions of the older product. They claimed they had been harmed by paying for the Nexium prescribed by physicians for the patients participating in their plans. The same group of lawyers apparently filed other “essentially identical class actions” with different sets of named plaintiffs, including one in Delaware federal court that resulted in the dismissal of a New York consumer fraud claim. Ignoring some history and details much like the plaintiffs ignored the marketing for Prilosec over the last fifteen years and the difference between a racemic mixture and an enantiomer, the Delaware state court action woke up from a long slumber in 2014 with its second amended complaint asserting the same claims the federal court had disposed of a few years before.

The Superior Court first determined that the law of New York, where the named plaintiffs were based, applied instead of the law of Delaware, where the defendant was based, or the laws of thirteen other states. Id. at *9. The court found that plaintiffs had not alleged the causation required for a consumer fraud claim: the “purported chain of causation that runs from the allegedly deceptive advertisements that may have influenced the decisions of individual doctors to prescribe a drug to their patients to causally affect the payer unions in this case is simply too attenuated,” as the doctors would be “presumed to go beyond advertising medium and use their independent knowledge in making medical decisions.” Id. at **9-10. We certainly like this reasoning, which would apply to a bunch of these cases. We also like that the court did not give plaintiffs a fourth chance to frame a complaint that stated a claim.

Continue Reading TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

Two of our favorite themes in the drug and device world intersected a few weeks ago in the Third Circuit—class actions and “no injury” lawsuits.  We don’t see many drug and device class actions these days, which we view as one of the more notable accomplishments of the drug and device defense bar over the last 20 years.  In fact, it is difficult to understand why anyone ever thought that personal injury class actions would be a good idea in the first place.  Personal injury cases are different—everything from the patients, to the doctors, to the information available, to the products used, and the injuries alleged.  Those facts leave you with a Hobson’s choice:  Either you take all the individual factors into account, in which case you have defeated the whole point of a class action; or you gloss over it all and pretend everyone is the same, which violates the rules and is downright unfair to everyone involved.  Either way, class actions don’t work.

“No injury” lawsuits are similarly vexing.  They generally come in two forms—medical monitoring lawsuits, where the plaintiff has experienced no drug or device complication but wants the defendant to pay for future medical care anyway, and lawsuits alleging only some form of economic loss. At the risk of oversimplifying, we generally view these cases with a “no harm, no foul” attitude.  It particularly grabs our attention when “no injury” claims are brought as class actions.  You might call it a mashup of bad ideas, which adds up to a really bad idea.  Sort of like Kim Kardashian marrying Kanye West.  Or Donald Trump using Twitter.  Or the upcoming Superman v. Batman movie.  (Actually, that would be two good ideas adding up to a really bad idea, but we digress.)

Continue Reading Third Circuit Shuts Down “No Injury” Pharma Class Action