Saturday, September 20, 2014

Sunsetting Cy Pres

We missed a day this week, so here's an extra post to make up for it.

This opinion, Redman v. RadioShack Corp., Nos. 141470, et al., slip op. (7th Cir. Sept. 19, 2014), doesn’t even mention cy pres, but its rationale could be saying (like we have), “cy pres, no way.”

Redman was a coupon settlement with the usual pathetic – less than one half of one percent – response rate to the settlement notice (itself sent to only 5 million of the estimated 16 million class members).  Slip op. at 7.  It involved something called the Fair and Accurate Credit Transactions Act, but that doesn’t matter for present purposes.  The settling parties claimed that this pathetic response was the same as acquiescence in the settlement’s terms, but Judge Posner saw through that easily:

The fact that the vast majority of the recipients of notice did not submit claims hardly shows “acceptance” of the proposed settlement: rather it shows oversight, indifference, rejection, or transaction costs.  The bother of submitting a claim, receiving and safeguarding the coupon, and remembering to have it with you when shopping may exceed the value of a $10 coupon to many class members.

Slip op. at 7.  But even that (although interesting for other reasons) doesn’t matter for present purposes.

What’s interesting to us is the number that Judge Posner does on the attorney fee request made by class counsel.

Wisely, class counsel (unlike some other settlements we can recall) didn’t even attempt to use the value of theoretical, but unsought coupons.  Counsel did, however, use the full face value of the coupons ($830,000), even though various factors (again not relevant to our point, but including that no change was given for less-than-face-amount uses) made them worth less than face value to the class who filled out the forms to get them.  Slip op. at 11-12.  Judge Posner pointed out, id. at 12, that the restrictions “chipping away” at the value of these coupons were “even more egregious” than in Eubank v. Pella Corp., 753 F.3d 718 (7th Cir. 2014), a settlement he had famously denounced as “scandalous.”  The nominal face value of the coupons, therefore, could not be used as part of the denominator for determining the reasonableness of class counsel’s fee request.

[W]hile we don’t know how much $830,000 of coupons would be worth to the class, we can be confident that it would be less than that nominal amount, doubtless considerably so.  And we note that were the value only $500,000 − and it may indeed be no greater – the agreedupon attorneys’ fee award would be the equivalent of a 67 percent contingency fee.

Redman, slip op. at 14.

Counsel also sought to inflate the denominator for purposes of their fee request by including “administrative costs.”  Id. at 10.  That wasn’t proper either, because those costs did not represent any “value received” by the class at all, since none of that sum went into the pockets of class members:

[T]he roughly $2.2 million in administrative costs should not have been included in calculating the division of the spoils between class counsel and class members.  Those costs are part of the settlement but not part of the value received from the settlement by the members of the class.  The costs therefore shed no light on the fairness of the division of the settlement pie between class counsel and class members.

Id. (emphasis added).  To treat “every penny” of administrative costs as “value” to the class was “perverse”:

[It] eliminated the incentive of class counsel to economize on that expense − and indeed may have created a perverse incentive; for higher administrative expenses make class counsel’s proposed fee appear smaller in relation to the total settlement than if those costs were lower.

Id. at 10-11 (emphasis added).

The only sums properly included in the denominator for purposes of determining the reasonableness of a class action fee request are “benefit to the class,” meaning “what the class members received”:

The ratio that is relevant to assessing the reasonableness of the attorneys’ fee that the parties agreed to is the ratio of (1) the fee to (2) the fee plus what the class members received.  At most they received $830,000. That translates into a ratio of attorneys’ fees to the sum of those fees plus the face value of the coupons [case-specific calculation omitted].  Computed in a responsible fashion by substituting actual for face value, the ratio would have been even higher because 83,000 $10 coupons are not worth $830,000 to the recipients.

Slip op. at 11 (emphasis added).

Cy pres?  No way!

Cy pres awards, like the “administrative costs” excluded in Redman, do not go into the pockets of class members – not one cent.  Indeed, cy pres awards are even further removed from being “benefit to the class” because, as Judge Posner acknowledged (but found insufficient), some of the costs at least were to give “notice to the class.”  Id. at 10.  Cy pres distributions, which take money supposedly belonging to class members and give it to non-class members (such as organizations devoted to fomenting more litigation, or class counsel’s law school) are the antithesis of “benefit to the class.”  Far from being sums “received by class members,” cy pres distributions take money away from the class and give it to supposedly deserving bystanders.

Whether or not courts should ever have the power to redistribute money belonging (if at all) to a class to persons not even in the class, under Judge Posner’s reasoning in Redman, there’s no way cy pres distributions can properly be considered in evaluating the reasonableness of a fee request.  The same “perverse incentive” exists, maybe even more strongly, with cy pres.  It’s an easy way to inflate the denominator artificially with sums that do not benefit the class – particularly when actually distributing the same money to class members would give rise to additional “administrative costs” that are themselves improper to include in that same denominator.

Although we would prefer to abolish cy pres outright as an abuse of judicial power, removing cy pres sums from the denominator in fee calculation strikes us as the next best alternative, since we believe that without the “perverse incentive” so aptly identified by Judge Posner, cy pres distributions would be few and far between.

Friday, September 19, 2014

Eleventh Circuit Says Forget It to Fixodent Daubert Appeal


We admit that we never gave much thought to denture adhesive, and until recently our knowledge of denture adhesive products was gained mainly from watching commercials that tend to run during daytime television or reruns of Murder, She Wrote.  But as Bexis says, useful precedent can come from unexpected places, and litigation over the denture adhesive known as Fixodent resulted in a good Daubert ruling in the district court that we reported on here more than three years ago.  The Eleventh Circuit has now affirmed the order in a published decision, so we will again wade into the sticky goo that was the plaintiffs’ experts’ opinions. 
Numerous plaintiffs sued the manufacturer of Fixodent alleging that zinc in the product caused them neurological disorders.  One of the cases was Chapman v. Procter & Gamble Distributing, LLC, 2014 WL4454979 (11th Cir. Sept. 11, 2014), where the plaintiff alleged that she used Fixodent to place her dentures for eight years and experienced a neurological condition known as copper-deficiency myelopathy as a result.  Id. at *1.  The problem for the plaintiffs was that there was no reliable scientific evidence that use of zinc-containing denture adhesive caused the plaintiff’s condition, even assuming that “copper-deficiency myelopathy” even exists.  Sure, the plaintiffs had experts who were willing to offer such opinions as “zinc containing Fixodent denture adhesives are a health hazard and capable of causing severe hematological and neurological injury” and “long-term use of Fixodent (containing 1.69% zinc) will result in . . . neurotoxic, neurologic, and hematologic consequences.”  Id. at *6.  But as we tend to say, just because an expert says something does not make it so.  The plaintiffs’ experts, it turns out, could not connect the dots, resulting in their opinions being excluded and summary judgment being granted for the defendants.  We described it all in some detail in our prior post, and the analysis in the Eleventh Circuit is similar. 
So why then is the Eleventh Circuit’s opinion interesting?  Well, for a number of reasons.
First, the Eleventh Circuit (and the district court before it) applied the “McClain categories.”  Citing McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005), the Eleventh Circuit stated that in cases where cause and effect has been proved and accepted by the medical community, federal judges “need not undertake an extensive Daubert analysis on the general toxicity question” for the sake of “judicial economy.”  Id. at *3.  In other cases—the “second category”—federal court must undertake a full Daubert analysis before admitting expert opinions into evidence.  Id.  We understand that district judges sometimes express frustration with long and complicated Daubert motions.  We also believe generally that the Eleventh Circuit is about as good a place as any to challenge the admissibility of experts’ opinions, largely because of the McClain opinion.  We are uneasy, however, with dividing cases into categories that offer one side a potential pass when introducing expert opinions on causation. 
Fortunately, the Eleventh Circuit (and the district court before it) placed the expert opinions at issue into “category two” (noting that “[m]illions of consumers have regularly used Fixodent for decades without complaint”) and undertook a full Daubert analysis. 
Which leads us to the second reason why we think this opinion is interesting:  In affirming the exclusion of the plaintiffs’ experts on general causation, i.e., whether the subject denture adhesive could cause copper-deficiency myelopathy, the Eleventh Circuit approved of the district court’s treatment of three concepts that we write on a lot—dose-response relationship, background rate of disease, and epidemiology.  The plaintiff alleged that she swallowed denture adhesive when she used the product to affix her dentures and that it caused an illness-inducing copper deficiency.  That argument begs the question of dose response—i.e., how much adhesive do you have to swallow to get sick?  The Eleventh Circuit put it this way:

Recognizing all substances potentially can be toxic, the judge noted “‘the relationship between the dose and effect (dose-response relationship) is the hallmark of basic toxicology’” and “‘is the single most important factor to consider in evaluating whether an alleged exposure caused a specific adverse effect.’” 

Id. at *6.  The Eleventh Circuit agreed with the district court and its finding that the plaintiffs’ experts could not say (1) how much adhesive must be used for how long to increase the risk of copper deficiency or (2) for how long a person much experience copper deficiency before being at an increased risk of myelopathy.  Id.  The lack of evidence on dose-response drove a truck-size hole through the experts’ opinions. 

The Eleventh Circuit similarly approved of the district court’s handling of the background rate of disease and its observation that

[s]ome people use denture cream and some people have a myelopathy; it is possible (and depending on the incidence of myelopathies, likely) that some denture-cream users have an idiopathic myelopathy simply due to the background distribution of that disease.  Without a baseline, any incidence may be coincidence. 

Id. at *7 (emphasis added).  In other words, just because two events coincide does not mean that one caused the other because the other could have been caused by something else or by nothing at all.  The plaintiffs’ experts did not know the background rate of copper-deficiency myelopathy, which was another “serious methodological deficiency.”  Id. 
So too was the lack of any epidemiological evidence, which is “the best evidence of causation in cases involving toxic substances.”  Id. at *6 (internal quotations omitted).  The plaintiffs’ experts offered lesser forms of evidence—case reports and animal studies—but such information cannot support a causation opinion.  Id.  Case reports are mere anecdotes, which can be useful in generating hypotheses for future study, but cannot prove a cause-and-effect relationship.  Animal studies can similarly provide useful research information, but their results cannot be validly extrapolated to prove causation in humans.  The experts also offered “hypotheses” and “plausible explanations,” which are not scientific data on any level.  Id. 
Third, we found interesting the Eleventh Circuit’s treatment of specific causation—whether the product “actually caused injury in [the plaintiff’s] particular case.”  Id.  As it turns out, no doctor ever diagnosed the plaintiff with copper-deficiency myelopathy or told her that denture adhesive was at fault, until her retained expert examined her in the course of litigation.  Id. at *8.  Prior to that litigation-driven point, who diagnosed the plaintiff?  Her husband diagnosed her, after conducting research on the Internet.  Id. at *8 n.13.  Hmm.  Do you suppose his Internet search results included attorney advertising?  We don’t know.  Just saying. 
In any event, the plaintiffs’ specific causation expert fell back on what we have called either the “real last refuge of a scoundrel” or “that most-abused method for determining medical causation,” depending on when you read and who was writing:  the differential diagnosis.  But the differential diagnosis that the plaintiffs’ expert performed was unreliable for the usual reasons—he could not “rule in” the denture cream because it had not been established that the product could cause the plaintiff’s alleged disease and there were numerous potential causes that he did not consider and could not reliably “rule out.”  Id. at **8-9. 
We especially like that the Eleventh Circuit faulted the expert for failing to consider “the possibility of an idiopathic cause.”  Id. at *9.  Many diseases can occur spontaneously without any identifiable cause, and we agree that it is essential to take that into account when determining whether causation can be attributed to any particular factor.  As a practical matter, it is fair to ask whether a plaintiff could ever prove causation through a differential diagnosis when idiopathic disease is on the differential.  After all, how can someone “rule out” a cause that cannot be identified in the first place?  Maybe it’s not possible, but if that reduces the reliance on differential diagnoses in litigation, that would be a change for the better. 
Fourth, we like that the Eleventh Circuit affirmed the exclusion of the Plaintiffs’ final two experts, who intended to opine that the denture cream was toxic.  The Eleventh Circuit cited the following passage with approval:

In short, taking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.  Hypotheses are verified by testing, not by submitting them to lay juries for a vote.  It may very well be that Fixodent in extremely large doses over many years can cause copper deficiency and neurological problems, but the methodology [the plaintiffs’] experts have used in reaching that conclusion will not reliably produce correct determinations of causation.

Id. at *10 (emphasis added).  The law lags science; it does not lead it, and this is a quote that we can use in urging on district courts in their roles as gatekeepers for scientific opinion.
Without causation experts, summary judgment was a foregone conclusion.  The plaintiffs tried to argue that they could prove causation using their one remaining expert (a biochemist), treating physicians, and the defendants’ experts, but the Eleventh Circuit rejected those arguments, as had the district court, including on the basis that the defendants’ experts held the opinions that the denture adhesive did not cause copper deficiency myelopathy.  Id. at *12. 
We like Chapman because it is a good example of a district court conducting a rigorous Daubert analysis and a Court of Appeals following and affirming that analysis to come to the correct result.  The opinion certainly puts a dent in that litigation, and so be it. 

Thursday, September 18, 2014

Teleseminar by the Reed Smith Side of the Blog

This coming Wednesday, September 24th at 12:00 pm ET/9:00 am PT, three of your Reed Smith bloggers, Steve Boranian, Steve McConnell, and myself (Bexis) will be presenting a teleseminar that we've entitled, "And the Verdict Is…: Recent Trends in Drug and Device Litigation."
 
What we'll be talking about are some of the more notable trends that we have observed in drug and device litigation since the beginning of the year.  One of those topics is what the recent Supreme Court Bauman decision portends (and in some cases is already doing) to mass tort personal jurisdiction.  We'll also discuss what types of claims plaintiffs seeking refuge from preemption are bringing and how those have fared.  These include innovator liability, driven by generic preemption, and a variety of claims driven by PMA medical device preemption.  Attendees will also hear about  recent developments in liltigation involving off-label use, developments regarding the learned intermediary rule, and the "Third Man" - that is, claims brought by unusual plaintiffs or against unusual categories of defendants.  Join us for a one-hour presentation during which we will discuss these trends, their effects (or possible future effects) on litigation involving the pharmaceutical and medical device industries, and how these industries should prepare themselves for future litigation.

 To register for this free program, click here.
Talk to you then.

Shootout at the First Amendment Corral

Ever since the FDA decided that discretion was the better part of valor – or read the handwriting on the wall – and decided not to appeal United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), to the United States Supreme Court, we’ve been wondering where the next First Amendment opportunity is going to come from.  We doubted that the government would ever again be so stupid as to prosecute off-label promotion without a large dollop of fraud and/or falsity thrown in.  Likewise, in private product liability actions, plaintiffs invariably allege (as opposed to prove) that any off-label promotion is false/fraudulent in one way or another.

The most promising spawning ground for future Caronias seems likely to be in False Claims Act (“FCA”) litigation.  While FCA claims are ostensibly brought in the name of the government, agencies like the FDA have relatively little control over the allegations that FCA plaintiffs (called “relators”) make.  Also, to increase their own take, such relators have the incentive to make the broadest allegations, which means they would like to avoid having to prove reliance on false information on a one-by-one basis.  In pursuit of that objective, FCA relators have been trying for years to bring FCA claims over activities that aren’t really “false” at all in the dictionary sense of the word – but rather are allegedly illegal.  Enter off-label promotion.

United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., No. 2:09-cv-03010 (E.D. Cal.), is such a case.  The allegations, as discussed in United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., 2014 WL 1270581 (E.D. Cal. Mar. 26, 2014), are that the defendant drug manufacturer “caused” false claims to be submitted for federal reimbursement through off-label promotion that purportedly did not “properly disclose the dangers.”  Id. at *2.  The government declined to intervene, id. at *1, meaning:  (1) that it thought the suit not worth pursuing, and (2) the relator was free to pursue whatever allegations he wanted.  In Solis that turned out to be alleging promotion of off-label use through the dissemination of published articles in the medical literature.  That may be “illegal” under the FDA’s constitutionally-suspect interpretation of the FDCA to ban off-label promotion categorically, but it’s damn hard to conceive of the distribution of peer-reviewed scientific articles as “false” in any sense that the First Amendment would recognize.

We’re not the only ones with an eye open for promising First Amendment openings to challenge the FDA’s ban on truthful scientific speech whenever it happens to involve off-label uses of the speaker’s FDA-regulated product.  The Pharmaceutical Research & Manufacturers of America (“PhRMA”) is sick and tired of its members being shaken down for many millions of dollars by government “enforcement” actions seeking to monetize the FDA’s questionable interpretation.  The risks are so great, due to penalties like debarment and the specter of FDA regulatory retaliation, that individual manufacturers can’t go to the mat with the FDA on First Amendment issues in government enforcement actions, and are forced to settle for ridiculous sums.

That’s not true in a private FCA action – particularly one that the government doesn’t think is worth the time and effort to pursue.  Thus, on August 15, 2014, PhRMA filed an amicus curiae brief in Solis in support of the defendant’s motion to dismiss, arguing that the conduct in question was protected by the First Amendment, and therefore could not be the subject of an FCA (or any other type of) action.

PhRMA first placed Solis solely in the constitutional cross-hairs as a case alleging that the distribution of published, peer-reviewed scientific arguments could not possibly involve anything “false” under the First Amendment:

[N]either relator nor the government alleges that the speech at issue here − relaying reprinted articles about unapproved uses of the drug [in question] from peer-reviewed journals, and summarizing the results of clinical trials − was false or misleading.  Relator and the United States do not even agree on why the FCA proscribes this speech, or how this speech somehow causes others to submit false claims.  But their interpretations of the FCA share a critical flaw: both threaten core First Amendment rights and should be rejected under principles of constitutional avoidance.


The relator was interpreting the FCA as deeming claims for reimbursement of off-label prescriptions “false” solely because the FDA interprets the FDCA as banning all off-label promotion.  That interpretation had several steps:  (1) truthful off-label promotion can “knowingly cause” submission of false claims, because (2) it is “reasonably foreseeable” that doctors would be influenced by such promotion to prescribe off-label; and (3) then submit claims for reimbursement of such off-label use to the government; therefore (4) the off-label promotion has “incited” the “illegal conduct” of submitting false claims.  Id. at 5.  Under this rationale it is “always foreseeable” that off-label promotion of any sort prompts “false” claims, because the whole point of promotion is to induce doctors to use drugs in the off-label manner being promoted.  Id.  PhRMA calls this approach unconstitutional.  We would add “Orwellian” to the description, since inherent in this reasoning is calling the truth “false.”

Caronia shows up, for the first of many citations, squarely for the proposition that the FDCA does not – and cannot – ban all off-label promotion, specifically not information that is objectively true.  PhRMA amicus br. at 3.  PhRMA makes the same argument accepted in Caronia, and that readers have seen on this blog for years – the First Amendment does not permit the criminalizing (here through the FCA) of truthful off-label promotion:

These constitutional concerns are well-founded: “Speech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.” Sorrell [v. IMS Health Inc.], 2653 (2011) 131 S. Ct. [2653,] 2659 [(2011)].  Interpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and the identity of the speaker, and thus triggers heightened scrutiny.  Caronia, 703 F.3d at 164-65.  The restriction is speaker-based because other individuals and entities − such as insurance companies, other doctors, and the government itself, among others − can and do speak to the same audiences about unapproved uses without running afoul of the law. Id. at 165 (“the FDCA permits physicians and academics, for example, to speak about off-label use without consequence”).  The restriction thus “has the effect of preventing [pharmaceutical manufacturers] − and only [pharmaceutical manufacturers] − from communicating with physicians in an effective and informative manner.” Id. (quoting Sorrell, 131 S. Ct. at 2663). And the restriction is content-based because it penalizes companies for disseminating information only about unapproved uses.

PhRMA amicus br. at 3 (footnotes omitted).

The particular speech involved in Solis, distribution of scientific articles and summarization of clinical trial results, is particularly protected as scientific speech.  Everyone involved in such research, except the manufacturer of the drug being studied, “can speak about the reprints and trial results as much as they wish.”  Id. at 4.  The government has had its biggest problems when it’s tried to ban this kind of scientific speech as “off-label promotion.”

If that is what the FDCA means, it is hard to imagine a more discriminatory restriction on speech that performs a vital role in the practice of medicine.  The government long ago “admit[ted] to the importance of ensuring the availability of [peer-reviewed medical journal articles discussing unapproved uses] to physicians and health care providers making prescription and treatment decisions.”   Washington Legal Foundation v. Henney, 56 F. Supp.2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  And “the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”  Sorrell, 131 S. Ct. at 2670-71 (internal quotation marks omitted).


To avoid constitutional problems PhRMA advocates that the court emulate the judicial restraint taken in Caronia and take one of two steps to reconcile the FDCA with the constitution:

  • Construe the FDCA as prohibiting, at most, only false speech (that’s what Caronia did, as we discussed here).
  • Construe the meaning of “false” in the FCA as excluding off-label promotion.


The “reasonably foreseeable” incitement rationale for truthful off-label promotion supposedly creating “false” claims can’t fly because foreseeability isn’t enough for “incitement” – the unlawful conduct must be “imminent.”  Id. at 5-6.  No way that happens where the speech identified the use as off-label and did not say “boo” about government reimbursement.  Id. at 6.  There is no “imminence” where scientific speech promotes an off-label use (which is itself legal and often the medical standard of care) to a doctor.  Rather any connection to submission of a “false” claim is “remote and attenuated”:

Physicians who received the reprints or other information from the manufacturer in this case received precisely the type of educational information that a trained physician would wish to receive about his patients.  Physicians were not only free to disregard these reprints; their Hippocratic Oath obligated them to use their own, independent medical judgment as to whether a given prescription was warranted.  And after those physicians prescribed the FDA-approved drug for an unapproved use, hospitals then made additional, independent determinations whether the prescriptions were reimbursable.

PhRMA amicus br. at 6.  “Foreseeability” is a tort concept, not a First Amendment concept.

PhRMA then addresses the “evidence” excuse that the government likes to trot out to argue that it’s ban isn’t really a ban because the government has discretion when to prosecute (and which Caronia rejected).  This “evidence” rationale is particularly inapposite to the FCA context because of the additional step of somebody else seeking federal reimbursement.  The relator “does not − and cannot − point to any act (other than truthful speech) by the manufacturer that allegedly ‘caused physicians to submit false claims.’  The only basis for liability identified in the Complaint is the manufacturer’s speech itself—as relator repeatedly acknowledges.”  Id. at 7.

The only cases advanced for the contrary proposition, involving an assault combined with racist speech and speech promoting an entirely unapproved drug, were just that – combination cases.  In both situations the speaker was also engaged in other criminal activity.  That’s not the case when the speech is solely off-label promotion.  Somebody else must make an independent medical judgment that the off-label use is therapeutically proper in a given patient.  Then another somebody else must come to an independent conclusion that the doctor’s use is also reimbursable under some relevant federal program.  That’s not “evidence” of action – or of anything.  It’s speech only, and at best an “incitement” of other persons that fails under the First Amendment’s “imminence” prong.  Beyond that, it’s truthful, and independently protected as scientific speech.

When PhRMA’s brief came in, the government went bonkers.  It filed a responsive brief on August 28, characterizing PhRMA’s relatively straightforward First Amendment argument as seeking “a constitutional right to knowingly cause other parties to submit false claims to the government, as long as a party does so by its speech.”  United States’ Statement Of Interest In Opposition To Amicus Curiae Brief Submitted By [PhRMA], copy here, at 2.  Yet it didn’t point to anything in the promotion that went beyond an off-label use (entirely legal) or that even mentioned reimbursement.

Interestingly the government made what – for it – is a huge concession right at the beginning:

[O]ff-label promotion by a manufacturer is not by itself a violation of federal law. The promotion of an approved drug for an unapproved use, without more, does not violate the False Claims Act, nor is it among the comprehensive list of prohibited acts in the Food, Drug, and Cosmetics Act (FDCA).

Government br. at 2 (emphasis added).  We’ve seen all too many courts make overbroad statements like “the FDCA prohibits off-label promotion.”  E.g., Mendez v. Shah, 2014 WL 2921023, at *6 (D.N.J. June 27, 2014); Blankenship v. Medtronic, Inc., 2014 WL 1226491, at *4-5 (E.D. Mo. March 25, 2014); Eidson v. Medtronic, Inc., 981 F. Supp.2d 868, 884 (N.D. Cal. 2013); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (taking one from each circuit).  Well, you know what?  So that it could make its “evidence” argument, the Department of Justice just agreed with us that every one of these cases is flat wrong.

After Caronia the government has been knocked off its prior absolutist rhetoric and now claims only that off-label promotion can be “evidence” of [fill in the blank of whatever illegal activity is at issue].  So the government stated in Solis that “promotional speech may be used as evidence to prove that a manufacturer knowingly caused the drug to be put to a certain use and billed to a Government health care program for such use, under circumstances in which the use is not covered and the claim is not eligible for reimbursement.”  Government br. at 2.

The rabbit goes into the hat with “knowingly causes.”  The promoter doesn’t do anything illegal.  It doesn’t tell anybody else to do anything illegal.  The government conveniently forgets that off-label use is legal.  The government cites (br. at 3) Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993).  The speech in that case was racial epithets that increased an assault into a hate crime.  The government cites (br. at 4) United States v. Barnett, 667 F.2d 835 (9th Cir. 1982).  The speech at issue in Barnett was how to manufacture an illegal drug – an illegal act in and of itself.  The government also cites (br. at 4) Rice v. Paladin Enterprises, Inc., 128 F.3d 233 (4th Cir. 1997), often described as the “hitman case.”  The speech in Rice was advertisements soliciting murder for hire – another illegal act.

Repeat:  off-label use is legal.  Murder, assault, and making illegal drugs are not.

Based on this false analogy of speech about legal acts with speech about illegality, the government claims that the sky (or at least the Republic) will fall if it can’t use “foreseeability,” as opposed to the First Amendment’s incitement standard, as the test for “knowingly causes”:

If a course of conduct were constitutionally protected as long as it was effectuated through the use of speech, vast areas of federal and state law would be invalidated.  For example, the Sherman Act’s basic criminal prohibition against “contact[]s, combination[s] ..., and conspirac[ies] in restraint of trade” (15 U.S.C. § 1) would become largely uneforceable [sic], because anti-competitive agreements are normally carried out through and embodied in speech among the participants.  Similarly, criminal conspiracy law would fall by the wayside, if statements by two parties agreeing to a criminal course of action were to be treated as protected speech.

Government br. at 3.  This would happen because, the government argues, “the types of statements that underlie anti-competitive agreements and criminal conspiracies may all be perfectly truthful.”  Id.  Wow.  That’s pretty scary.  But the analogy only works if the speech is about something illegal, which off-label promotion simply isn’t.

Repeat:  off-label use is legal.  Restraint of trade and whatever is the object of a “criminal” conspiracy are not – the former by statute and the latter by the definition of the offense.  The only way to make the huge logical leap from legality to illegality in Solis is by jumping to something that’s not mentioned in most (if not all) off-label promotion at all – reimbursement of the prescription sought by yet another person.  This Tinker-to-Evers-to-Chance form of “causation” requires use of foreseeability.  There’s no way that meets the imminence test.  It would be like banning advertisements for rifle ranges, karate, or maybe the movie Scarface, because someone might decide to do something illegal with the knowledge (truthful) so obtained.

PhRMA recently replied to the government’s brief in Solis, see here.  Not without reason it contends that the government “grossly misstated” its argument.  PhRMA Reply br. at 1.  Where speech is sought to be banned due to its effects (here “knowingly cause”) on the actions of third persons, “the First Amendment demands a direct causal nexus between the speech and the claim.”  Id.

Rather than respond to this argument, the government attacks a straw man: it accuses PhRMA of advocating a First Amendment right to shield all speech from sanction, no matter how closely connected to unlawful conduct.  But there is an obvious distinction between speech (even truthful speech) that incites illicit conduct − which is unprotected − and speech that encourages lawful conduct in the form of medically appropriate treatment − which the First Amendment plainly protects.

Id.

Thus, the government’s argument “is at least as radical as the position [it] invents for PhRMA.”  Id.  Why is that?  Because the scope of the government’s foreseeability-based causation test for a “false claim,” which ignores truthfulness, would turn anybody’s speech about off-label use into a FCA action:

[T]he government’s interpretation has no rational stopping point.  FCA liability would attach to any speech to doctors about any unapproved use of any FDA-approved medicine. Fellow doctors, patient advocacy groups, insurance companies, and the medical journals themselves all foreseeably distribute the same information to doctors as manufacturers do.  They all would be just as liable for inciting false claims under the government’s stated theory.

Id. at 1-2 (emphasis original).  Only the applicability of the First Amendment’s imminence test for incitement prevents the government (or FCA relators) from suing into silence anybody saying anything about off-label use.

PhRMA’s position in Solis thus came down to this:  all the defendant did was speak truthfully.  It didn’t break the law (the government having admitted that off-label promotion isn’t per se illegal).  It didn’t tell anybody else to break the law (off-label use being 100% legal).  Nothing was being prosecuted except the defendant’s speech.  Absent evidence satisfying the “imminence” standard for incitement, a truthful speaker cannot be punished for the illegal acts of others, even if those acts were “influenced” in some tort-foreseeable way by the speech.

If that isn’t the law, then free speech isn’t nearly as free as almost everybody in the country thinks it is.
 
Solis might well be the next Caronia.  Despite the government’s best efforts to avoid scrutiny, because it couldn’t control the FCA relator’s allegations in Solis, the question of liability for truthful off-label promotion is once again squarely presented.  PhRMA hopes, and the government fears, that the constitutional infirmities in the FDA’s ban on all off-label promotion will again be litigated and more importantly appealed.  We’re on the next bench behind.  We think that, under the Supreme Court’s decisions in Sorrell and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the FDA’s goose is already cooked, as Caronia demonstrates.  The First Amendment protection of truthful off-label promotion is bound to be recognized, sooner or later.  Once that is settled, assuming it ever is, then under New York Times Co. v. Sullivan, 376 U.S. 254 (1964), tort plaintiffs will have no more ability to predicate liability on such truthful speech than the government does.

Tuesday, September 16, 2014

Who is the Prescriber?


You’ve no doubt heard that hard cases make bad law.  But sometimes hard cases make no law.  That is, the judge decides not to decide, because deciding seems too difficult.  We would have thought that ‘deciding stuff’ would have been way up there in the job description of judges, certainly above “managing litigation,” strong-arming settlements, and grousing about litigators who have the temerity to … litigate.  But not to decide is to decide.  For example, when a state court judge rules that she cannot determine whether a claim is preempted because preemption issues are too darn complicated, then she has essentially ruled that the claims are not preempted.  She has also essentially lifted the curtain to commence the discovery festival and  extortion melodrama.  (That is not a hypothetical.  That happened.)

 

The facts in Heineman v. American Home Products Corp., 2014 U.S. Dist. LEXIS 124987 (D. Colorado Sept. 8, 2014), are passing strange, but they are no basis for the court to refuse to apply well-established law.   The plaintiff alleged that her use of diet drugs in 1996-97 caused her to suffer from primary pulmonary hypertension (PPH), a very nasty disease.   The key legal theory was that the drug label failed to warn of PPH.  But the prescriber never read the label, and that fact should be enough to foreclose the claim.  After all, a better warning would have made no difference.  So why did the court deny the defendant’s motion for summary judgment?

 

Not so fast.  First, let’s enjoy a brief interlude.  The Heineman case began as an exercise in litigation tourism.  It was initially filed in 2012 in the Philadelphia Court of Common Pleas.  We can see that court out our window.  It is in Philly’s City Hall, surely one of the two or three most handsome city halls in our republic.  We like the building and the people in it very much.  As much as we like our local court, plaintiff attorneys seem to like it even more.   They like it so much that they file cases there even when it is clearly the wrong court.  In Heineman, the defendant was able to remove the case to the Eastern District of Pennsylvania, where the diet drug MDL was pending.  Then the defendant was able to transfer venue of the case to the federal court in Colorado, on the fairly compelling grounds that the plaintiff and her doctors were all in Colorado, and that is where the injuries were sustained. 

 

Now about those doctors.  The plaintiff had prevailed upon her physician parents, whom the court calls  “Dr. John” and “Dr. Joan,” to issue her a prescription for the diet drug.  When we see the name “Dr. John,” we think of the great New Orleans musician (“Right Place, Wrong Time,” “Such a Night,” etc.) and his unique ability to tease musicality out of nonsense words and phrases.  Some of that nonsense, but none of that musicality, creeps into the Heineman case.  It turns out that Dr. John signed the prescription for the diet drug.  To be more specific, Dr. John signed blank prescription forms, and Dr. Joan filled in the relevant information.   Dr. John testified that he did not review any warnings about the drug before prescribing it.  In fact, he had never heard of it.  This sort of thing probably happens more than we’d like.  As a real-life prescriber, Dr. John, worries us a bit.  But Dr. John is the perfect prescriber if you are a pharma defendant itching to get out of a case on the theory that there is no warning causation.

 

If Dr. John is the prescriber, then the plaintiff’s case is in real trouble.  But the plaintiff contended that Dr. Joan was truly the prescriber.  Unlike poor ignorant, non-reading dad, Dr. Joan testified that she had considered the allegedly incomplete warning information in the PDR before allowing her daughter to have the drug.  There was even some sliver of testimony that Dr. Joan might have written one or more prescriptions, but it was vague, uncertain, minimal evidence, and the court did not seem to consider it

 

The plaintiff argued that the defendant’s duty to warn ran not only to Dr. John as the physician technically prescribing the diet drug for the plaintiff, but also Dr. Joan, as the physician ostensibly “treating” the plaintiff and consulting with Dr. John on the suitability of the drug.  That argument leans heavily on Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 142 (3rd Cir. 1973), a case where the Third Circuit made an Erie guess that “Pennsylvania law would view it as insignificant whether the doctor is a prescribing or treating physician, the important consideration being that the warning best reach the patient.”  That guess was made in 1973.  In 1973 our favorite tv shows were “All in the Family” and “Room 222.”  The Godfather won Best Picture.  “Tie a Yellow Ribbon Round the Old Oak Tree” was the top song.  Nixon was still president, though in a private (later not-so-private) taped conversation he agreed that a “cancer” was growing on his presidency. 

 

1973 was a long time ago.  Pennsylvania state court cases later made it clear that the Hoffman guess was a bad one.  Pennsylvania, like pretty much every other jurisdiction, looks to see whether the prescriber’s decision was affected by the allegedly inadequate warning.

 

So the plaintiff’s failure to warn claims are toast, right?

 

Well …. the court finds the defendant’s argument to be “incomplete at this point, thus preventing the entry of summary judgment in its favor.”  2014 U.S. Dist. LEXIS 124987 at *15.    We are told that the defendant’s argument “elides the question of how the phrase ‘prescribing physician’ should be understood in the unusual factual scenario presented here.”  Id. at *16.  The court read the record as reflecting that “Dr. John did nothing more than sign a blank prescription form and turn it over to someone else, apparently abdicating any and all professional responsibilities that accompany the act of prescribing medicine.”  Id.  Maybe that makes Dr. John a bad prescriber, but it doesn’t make him not the prescriber.  How far now can we go behind the prescriber’s signature to pretend to find out what really animated the prescription decision?  In fact, the court admits that the defendant “may be correct that the question is answered slavishly, based solely on the signature on the bottom of the prescription, regardless of how that prescription came to be.”  Id.  “Slavishly” presumably means following a clear, black-letter rule.    

 

The court punts.  There is no other word for it.  Here is what the court says:  “The parties have failed to adequately address the means by which the court can identify this person (or perhaps persons) in the peculiar circumstances of this case.”  Id. at *19-20.   Maybe it’s a hard decision (we actually do not think it is – Dr. John signed the prescription, so he’s the prescriber) but it is still a decision by the court.  There is no genuinely disputed fact.  What more did the court need to know to be able to render its decision? Do we now always need a 360 degree inquiry into everyone who might have affected a prescriber’s decision?  Is the issue whether the prescriber actually made any decision?

 

Or is the issue that this court did not want to make a decision?  

 

Monday, September 15, 2014

Important FOIA Decision

We don’t normally follow Freedom of Information Act (“FOIA”) decisions, but Public Citizen v. U.S. Dep’t of Health and Human Services, ___ F. Supp.2d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014), falls more or less in our sweet spot.  Back in 2009, Public Citizen, an ostensible “public interest” group that regularly acts as a stalking horse for the plaintiffs’ bar, filed a FOIA request demanding disclosure of a drug manufacturer’s annual reports filed with defendant HHS pursuant to a “corporate integrity agreement.”  Such agreements are often part of settlements of claims brought by the government alleging illegal activity.  The claim in Public Citizen involved off-label promotion.

A number of issues were resolved in an earlier opinion, Public Citizen v. U.S. Dep’t of Health & Human Services, 975 F. Supp.2d 81, 88–89 (D.D.C. 2013).  The most important remaining issues involved disclosure of:
·                     Reportable event summaries
·                     Disclosure log summaries, and
·                     Records reflecting the content of detailing sessions between healthcare providers and manufacturer’s representatives disclosed to the government.

2014 WL 4388062, at *4.

The good news is that the intervening manufacturer won all of these issues – no FOIA disclosure of these materials was required.

The court ruled that these materials were:  (1) commercial in nature, even though involving possible regulatory violations, (2) legitimately confidential as capable of informing a competitor of how the defendant markets its products, i.e., what it considers “lawful” promotion; and (3) would allow competitors “to learn from [intervenor’s] mistakes at little or no cost in capital or exposure to risk.”  Id. at *8-10.

In addition, as to FOIA disclosure of the underlying records of detailing sessions (called “verbatims”), the court held:

While the plaintiff is correct that the information in the verbatims is known by both the health care provider who was surveyed and the market research firm, it is not freely or cheaply available from those sources.  A competitor wishing to obtain this information would, absent its release through the FOIA, have to pay a market research firm to conduct a similar survey, incurring the same expenses [intervenor] incurred in the first instance.  A competitor’s ability to obtain the information at virtually no cost would cause competitive harm . . ., since it could be used affirmatively by those competitors to challenge [intervenor’s] place in the market and exploit any vulnerability revealed through the verbatims’ content.

Consequently, [intervenor] has shown the underlying records reflecting the content of the detailing sessions . . . are confidential

Id. at *12 (citations and quotation marks omitted).

It is an unfortunate fact of life that, as a result of the government’s monetization of its constitutionally questionable ban on truthful off-label promotion, quite a few of our clients are forced to operate under corporate integrity agreements that require disclosure of promotion-related information to the government.  The Public Citizen litigation is a significant favorable development in determining that plaintiff’s lawyers, either directly or acting through surrogates, cannot obtain our clients’ promotion-related disclosure materials from the government through FOIA requests.

Friday, September 12, 2014

A Foregone Conclusion On A Runaway Verdict

            From our ivory tower in the kingdom of blogdom, we track cases and litigations from afar, peeking in on them from decisions rendered at specific points in time.  Sometimes, from a single decision, we venture on what will happen next, like whether claims that survived dismissal will make it past summary judgment or whether a judgment will survive appeal.  Other times, we look at multiple decisions in the same case or litigation and make a somewhat more intelligent guess as to where things are headed.  Every once in a while, we have looked at several pre-trial rulings from the same case that consistently favor one side or position that it is fairly easy to guess what the judge will do at trial.  What the jury will do is always less predictable.

            In In re Actos (Pioglitazone) Prods. Liab. Litig. (Allen v. Takeda Pharms. N. Am., Inc.), MDL No. 6:11-md-2299, No. 12-cv-000064-RFD-PJH, 2014 U.S. Dist. LEXIS 121648 (W.D. La. Aug. 28, 2014), we have the culmination of several bad decisions.  Back in January, we questioned the court’s rejection of conflict preemption for failure to warn claims in the absence of evidence that the FDA had rejected a request to strengthen a warning of an approved drug.  We also suggested that the court’s requirement of only a prima facie showing by the plaintiff allowed it five experts to stroll through the Daubert gate without any real challenge by its purported keeper.  Later, we have posted on rulings on spoliation and a request for default judgment because a witness answered “I don’t know” a number of times.  Along the way, we noted that the first MDL bellwether trial had resulted in a very high plaintiff verdict with lots of punitive damages thrown in.  After several months, the court has now ruled on the defendants’ Rule 50(b) motion made during trial and re-urged after the verdict.  In a surprise to nobody following the case, the court denied the motion in its entirety.  And nobody who follows this blog will be surprised to hear that we think that the decision was wrong and that the reasoning of the opinion was lacking.
            We start by what the reader will not find in the opinion—what the jury awarded to the plaintiff.  That was $1.5 million in compensatory damages and $9 billion (with a “b”) in punitive damages.  While there is plenty of discussion of money in the opinion, the profits from the sale of the drug and how profits allegedly motivated the NDA holder and co-marketer to take various actions concerning the drug and its bladder cancer risk, but nothing about what the jury awarded, whether it bore any relation to the evidence, or whether it provided any basis to suspect that something had gone wrong with the trial.  While the opinion did not address any challenge to the amount of the punitive award—just to whether there was sufficient evidence to support any award (particularly against a mere co-promoter)—it does seem strange to omit the amount of the award from a very long decision.  It also seems weird that the court repeatedly expressed its misgivings about having to address issues it had addressed in different procedural postures when, as it said, the “jurisprudential support” had not changed.  This is, of course, how the Federal Rules of Civil Procedure work.  A motion to dismiss may be followed by a motion for summary judgment, which may be followed by motions for judgment as a matter of law during and after trial, all of which may address the same issue (e.g., preemption) without the controlling law changing.  Much like the analysis of whether the amount of punitive damages comports with constitutional requirements involves looking at proportionality in regard to the amount of actual damages, there is some notion that very jury large awards, jury decisions involving many plaintiffs, and even defense verdicts in cases where the plaintiff had substantial injuries should receive extra scrutiny from the presiding judge.  An opinion that conveys a sense of anger at some of the parties (or their lawyers) or a reluctance to consider all the arguments at face value does not increase confidence in our civil courts.

            As we have said, the opinion is quite long, in part because it recaps the plaintiff’s version of the evidence he offered in more than two months of trial.  We are not in a position to begin to question whether the evidence was as described in the opinion, but a few things are obvious from reviewing the recap and how it is used.  First, lots of evidence came in that was focused solely on whether defendants defrauded the FDA.  Second, lots of evidence came in that blurred the lines between which defendant did what and when they did it in relation to when plaintiff was prescribed the drug.  Third, although Dr. Kessler was plaintiff’s mouthpiece for why the label should have been changed earlier and how discussions with FDA on labeling should have been different, there does not appear to have been any evidence that the label could have been changed unilaterally or that FDA would have acceded to the labeling change plaintiff urged.  Fourth, in discussions about what the co-marketer’s sales representatives did not say, there was no attention to whether the additional information that plaintiff urged could have been legally disclosed before the label had changed.  These observations tie in to the court’s ultimate rejection of the defendants’ preemption and punitive damages arguments.  There is certainly more to the opinion, but we can only address so much in one post before the Oscar wrap-it-up music starts playing in our head.
            We would be remiss if we discussed the rejection of defendants’ preemption and punitive damages challenges without noting that the opinion does not mention Buckman, which held:

[T]he plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by federal law. The conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Agency can be skewed by allowing fraud-on-the-FDA claims under state tort law.
531 U.S. 341, 348 (2001).  This ruling was not based on the express preemption provisions of the Medical Device Amendment and has been applied to drug cases fairly often.  See, e.g., Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-966 (6th Cir. 2004); Bouchard v. American Home Prods. Corp., 213 F. Supp. 2d 802, 811 (N.D. Ohio 2002).  Even from an account of the evidence that is avowedly from plaintiff’s perspective, the plaintiff’s case was about as focused on whether defendants had defrauded the FDA as any we have seen since Buckman.  Deciding issues of preemption and punitive damages without addressing whether plaintiff was advancing fraud-on-the-FDA claims, however he titled them, makes no sense to us.  Indeed, the opinion’s repeated citation of plaintiff’s evidence that allegedly showed defendants had concealed relevant information from the FDA as a justification for why there was no preemption of claims or why plaintiff could recover punitive damages against both defendants just reinforces that these were fraud-on-the-FDA claims that should have been preempted.

            As we have said many times, a conflict preemption analysis should start with identifying whether there is a properly asserted and supported claim under a recognized state law theory of recovery and what the regulated defendant needed to do to comply with the state law duty.  Then, the analysis should go on to whether the defendant can comply with the state law duty while simultaneously complying with its federal duties.  (There are many in-depth discussions of preemption principles in prior posts, including this one on Bartlett, another Supreme Court preemption decision not discussed in the opinion.)  In analyzing whether the claims asserted against the co-marketer were impliedly preempted, the opinion neither cites the state law providing for such a claim nor what plaintiff contended the co-marketer was supposed to have do meet its state law duties.  2014 U.S. Dist. LEXIS 121648, **69-79.  In fairness—we do want to be fair sometimes—there are cites in two other sections to a single intermediate appellate decision “that visits liability on companies . . . that are responsible for placing a drug into the marketplace.”  Id. at **59 & 175 (citing Brumbaugh v. CEJJ, Inc., 152 A.D.2d 69, 71, 547 N.W.S.2d 699 (N.Y. Sup. Ct. – App. Div. 3d Dept. 1989)).  That is not the same thing as saying the state law imposes duties on co-marketers, the breach thereof can result in liability for failure to warn and implied warranty of merchantability, the two claims plaintiff apparently advanced at trial.  Similarly, for all the citation to plaintiff’s evidence that the co-marketer did not disclose the true risk of bladder cancer in the years before the FDA-approved label did (from plaintiff’s perspective), there is nothing in the opinion saying what an adequate warning would have been.  This matters because the opinion’s analysis of preemption boiled down to whether the co-marketer was precluded by federal law from conveying to physicians “any information or warning language beyond the actual language included on the insert label approved by the FDA.”  Id. at *70.  Concluding that the regulations afforded some leeway to present marketing materials that were different than, but still consistent with, the approved label, and pointing to evidence that the co-marketer consulted with the NDA holder on the label and did have some marketing materials that were different than the label, the court found no preemption.  This is not the right inquiry.  Did state law impose a duty on the co-marketer to provide physicians with information about the risk of the product?  If it did, then  could the co-marketer have complied with federal requirements of keeping marketing materials and statements consistent with the approved label while including whatever extra-label statements about a bladder cancer risk that the plaintiff urged?  Those are the questions that should have been answered.
            The opinion’s consideration of the broader preemption challenge made by both defendants followed a similar pattern.  The issue was whether FDA would have approved the labeling change that plaintiff urged—whatever that actually was—before plaintiff allegedly developed bladder cancer from using the drug.  This would be evaluated under the singular “clear evidence” standard from Levine, but with a free hand for plaintiff to ignore Buckman and contend that defendants kept FDA in the dark on the risk of bladder cancer.  Defendants had evidence that FDA determined, in the year plaintiff started the drug and the co-marketer stopped co-marketing it, that a bladder cancer warning belonged in the Precautions section of the label, did not request a revision upon receipt of study data three years later, and only approved a label with information on bladder cancer in the Warnings section two years after that.  Plaintiff countered with evidence that the defendants allegedly withheld information from the FDA and that defendants negotiated with FDA over the label, but nothing about whether the FDA would have approved the warning plaintiff wanted when plaintiff wanted them.

            In weighing this evidence, the court seemed to endorse the ludicrous notion, advanced by Dr. Kessler, that language in a drug label about a risk of the drug does not count as a “warning” (a state law concept) unless it is in the “Warning” section of the label.  Id. at **47-48; but see id. at *168 (“The Defendants are, however, correct that New York law does not require a warning to be located in the “Warnings” section of a medication label in order for the warning to comply with the duty to warn individuals considering taking the medication, or physicians considering prescribing the medication.  However, [plaintiff says none of the information about bladder cancer in the label should be considered a warning].”).  Setting aside how the format of drug labels changed during the time at issue in this case due to the Physician Labeling Rule so that the old “Warnings” and “Precautions” sections have been merged into one section called “Warnings and Precautions,” this is just a na├»ve view prescription drugs.  Language in other sections of drug labeling, like Contraindications, may be key to individual prescribing decisions and the focus of allegations by product liability plaintiffs.  In addition to this misimpression, the opinion ignored the possibility that the FDA would ever find a proposed warning to be excessive in light of the scientific evidence available.
Finally, in light of the evidence pointed to by Plaintiffs as presented at trial, this Court cannot find Defend-ants' argument that the FDA, had it been presented with a complete, accurate, and forthright description of the evidence, would have chosen to hide from the medical community and the general public the possibility of an increased risk of the very serious side effect of bladder cancer by not allowing the very warning they made overture to explore, persuasive.   
Id. at *85 (emphasis in original).  We could go on, but we think you get the gist.

            The rejection of all arguments as to the punitive award (amount hidden from the reader) built on the evidence of fraud-on-the-FDA and of the defendants failure to do things they may not have been permitted to do by applicable regulations.  It also looked to evidence of what you read as general alleged “bad conduct” evidence not tied to the underlying theories of recovery, which is generally frowned upon when it comes to punitive damages.  On top of this morass of evidence that the court stated (several times) showed that the defendants intentionally picked profits over safety, the jury got to hear about the alleged spoliation of records by the NDA holder, which we have already said mostly involved missing from sales representatives who left the company five or more years before the litigation started.  The NDA holder’s “conduct in destroying files of key employees involved in the development, marketing, and management of Actos® could be one fact the jury might have considered in assessing Takeda's intent.”  Id. at *179 (emphasis in original).  The jury was also, apparently, permitted to infer something about the co-marketer’s intent from this “fact.”  There was nothing wrong with that, because the co-marketer had apparently not requested a limiting instruction when the jury was informed of court’s view on spoliation.  Id. at **180-81.  The court took no responsibility for informing the jury of spoliation by one defendant without making it clear that the other defendant was not implicated.
            We will have to wait and see if the court can find some way under Rule 59 (motion still pending) to justify a punitive damages award that was 6000 times higher than the actual damages award.  We will also have to wait and see what, if anything, the Fifth Circuit has to say about all of this.  We do know its decision in Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012), embraced Buckman, so we are optimistic that a panel of cooler heads would prevail.