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If not yet dead, the medical monitoring claim itself is hooked up to monitors and the prognosis is not good. It’s dying from a self-inflicted injury, which paradoxically is its lack of injury. Class action plaintiffs’ lawyers, the lawyers who have largely filed these claims, despise physical injuries. Physical injuries come with differences, and differences defeat class certification. On the other hand, they love financial damages, like those needed to implement a medical monitoring program. Financial damages come with sameness, and sameness increases the chances of class certification. This is the conundrum for medical-monitoring class action plaintiffs’ lawyers. They have struggled mightily to allege the financial damages that they so want while trying not to allege the physical injury that will kill their chances of certifying a class.

Cure v. Intuitive Surgical Inc., 2017 WL 3381848 (11th Cir. 2017), illustrates how this struggle is killing medical monitoring claims. In Cure, the plaintiffs claimed that, during heart surgery, instruments manufactured by the defendants shed small metallic particles that were later found in plaintiffs’ brains. Plaintiffs’ lawyers brought a medical monitoring claim, asking the court to set aside funds for monitoring plaintiffs, and those similarly situated, so that doctors could identify anything bad that might happen in the future.

But that’s where things go wrong. Plaintiffs could not allege that anything had actually gone bad. Not yet. So they hoped that the presence of small metal particles in their bodies would qualify. It doesn’t. The mere “presence of metal shavings in the plaintiffs’ brains does not, under Georgia law [applicable here], constitute a legally recognizable injury in itself.” Id. at *2. The metal particles had to have “caused or would eventually cause actual disease, pain, or impairment of some kind to support a finding that they suffered an injury.” Id. (quoting Boyd v. Orkin Exterminating Co., 381 S.E.2d 295 (Ga. Ct. App. 1989) (applying Georgia law), overruled on other grounds by Hanna v. McWilliams, 446 S.E.2d 741 (Ga. Ct. App. 1994)).

But the plaintiffs’ lawyers didn’t want to allege anything of the sort. Once they allege a disease, pain or impairment, they have entered the world of physical injury, which brings with it issues of causation, alternative causes, risk factors, predisposition and so many other things that wreck sameness and defeat class certification.

And so plaintiffs struggled mightily to avoid these class-killing problems by piecing together purported injuries that weren’t really injuries. They claimed that they “suffered and will continue to suffer physical, neurological, and mental effects.” Id. But those “vague, conclusory statements” weren’t nearly enough to satisfy the TwIqbal pleading standard. Id. They alleged that they would suffer future medical costs and lost wages. But, again, they were unable to tether these allegations to any explicit symptoms or conditions or how they would interfere with the plaintiffs’ work. Id.

In effect, plaintiffs’ claims had achieved sameness. They all had the same lack of injury. And, for that very reason, the district court dismissed plaintiffs’ medical monitoring claims, as had so many courts before it.  And, with its decision in Cure, the Eleventh Circuit upheld that dismissal. Id. at *3.

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Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when compared to the consequences of the conditions Risperdal is indicated to treat, that seems like a relatively minor risk.  It isn’t fatal.  It isn’t a long-term disability.  It doesn’t prevent one from making a living.  Thus, Risperdal litigation is a prime example of low-value cases that only exist because of the mass-tort system that has saddled the country for so long.

Thus, it is hardly surprising that Risperdal cases are on the front lines of the battle to rein in our long national mass-tort nightmare.

Just last week we learned of these two decisions:

(1) Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611 (E.D. Mo. Aug. 10, 2017).  Covington was one of the ridiculously misjoined multi-plaintiff complaints that mashed together residents from all over the country.  Before Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), Missouri federal courts routinely remanded these atrocities to the St. Louis litigation cesspool because there was always at least one diversity-destroying non-Missouri plaintiff, as well as one jurisdiction establishing Missouri plaintiff in the bunch.  Covington, 2017 WL 3433611, at *2 (“Historically − and especially in this district − courts generally have addressed subject matter jurisdiction first”).

Not anymore.

Covington is typical of the multi-plaintiff complaint genre – 54 plaintiffs from 26 different states.  2017 WL 3433611, at *1.  “Only one plaintiff” alleged injury from use of the drug “in the state of Missouri.  Id.  As for the rest:

The Non-Missouri plaintiffs, or those who do not have any connection to the state of Missouri, do not allege that they were prescribed Risperdal or any of its variants in Missouri, ingested the same in Missouri, or were injured in Missouri.

Id.

With BMS, the personal jurisdiction issues involving litigation tourism of this sort were largely resolved.  With no fixed “jurisdiction hierarchy,” it was now logical to take up this “more straightforward issue first. ” Id. at *2.

However, these [contrary] cases were decided before [BMS] and State ex rel. Norfolk S. Ry. Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (en banc) [our post on Dolan is here].  These decisions make the personal jurisdiction issue in this case much easier to decide. . . .  Further, analyzing the challenge to personal jurisdiction first avoids any issues relating to fraudulent joinder.  Personal jurisdiction is now the more straightforward inquiry and should be addressed first as it is in the interests of judicial economy and expeditiousness.

Id. (citations and quotation marks omitted).

The personal jurisdiction question was easy.  There could be no general jurisdiction.  “[N]o defendant is incorporated in Missouri nor has its principal place of business in Missouri.”  Id. at *4.  ‘Nuff said.  Nor was there specific personal jurisdiction for all but one of the plaintiffs – thus removing the planted plaintiffs from the defendants’ home states.

[B]esides the Missouri plaintiff, no other plaintiff allege that they, or a child or incapacitated person whom they represent as next friend, were prescribed or purchased Risperdal in this state, suffered an injury from Risperdal in this state, or received treatment for an injury from Risperdal in this state.

Id.  The “mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug in Missouri] − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.”  Id. at *4 (quoting BMS).  Thus 53 of the 54 plaintiffs were dismissed (without prejudice, and with the laws of their home states determining whether an unsuccessful litigation tourism jaunt tolled their statutes of limitations).  A single plaintiff’s low-value case thus remained in Missouri federal court.  Id. at *5.  It probably won’t last long, since the March 8, 2017 filing date was more than a dozen years after 2004, when that plaintiff admits discovering the supposed injury.  Id. at *6.

Plaintiffs mounted unsuccessful rearguard actions in Covington.  They sought a stay – claiming “prejudice” from the need to sort out a supposed jurisdictional morass that they, themselves, created.  That went nowhere.  Id. at *3 (“A motion to stay should not be abused by a party to dictate which motion is first addressed by the Court.”).  They also sought “jurisdictional discovery” – a fishing expedition to search for Risperdal/Missouri contacts.  Covington likewise saw that request for what it was:

Here, the plaintiffs do not plead any specific facts that support their contention that this Court has personal jurisdiction over all of the plaintiffs’ claims. Alleging that facts might be discovered during a jurisdictional discovery expedition will not allow plaintiffs to survive a 12(b)(2) motion to dismiss.

Id. at *5.

Summing up, Covington observed:

Unfortunately for the plaintiffs, [BMS], under the facts of this case, made personal jurisdiction the more straightforward issue and therefore more proper to be analyzed first.  Further, [BMS] held that forums, like Missouri in this action, do not have specific personal jurisdiction over non-resident corporations when the plaintiffs do not allege any specific connection between the forum and the specific claims at issue.

Neither this Court nor the state court in which this action was removed can exercise personal jurisdiction − whether general or specific − over the defendants for the claims brought by the 53 non-Missouri plaintiffs.

Id. at *6.

That’s one.

(2) West v. Janssen Pharmaceuticals, Inc., 2017 U.S. Dist. Lexis 124276 (Mag. M.D. Ala. Aug. 4, 2017).  West is something of the obverse of Covington.  In Covington the plaintiffs joined together in an attempt to manufacture jurisdiction for a horde of weak cases, whereas in West, jurisdiction already existed, so the plaintiffs were trying to join their weak cases together to prejudice the defendant at trial.  Once again, the court wasn’t buying the consolidation.  West involved two plaintiffs, Harper and West, treated at one point by the same prescribing physician, both alleging the same injury from the same drug.  Id. at *2, 11.

But that was as far as the similarities went.

The two plaintiffs were of much different ages; one a minor, the other not. One involved off-label use; the other not.  One involved innovator liability (being filed during the few Weeks window when that theory was allowed in Alabama); the other not.  There were various other differences as well, such as duration of use, and when the drug was prescribed (affecting the relevant warnings), and the age at which the risk allegedly manifested.  Id. at *13-15.

The dissimilarities in the Plaintiffs’ claims have be-come more apparent as discovery and expert testimony have developed.  Harper began taking Risperdal as a five or six-year old and was always a minor while taking the medication.  In contrast, West did not begin taking the medication until he was almost eighteen years old and was physiologically an adult.  The significance of this difference is highlighted by the expert causation testimony. . . .  Further, the consequence of Risperdal not being approved for pediatric use takes on a much different meaning in the two cases.

Id. at *12-13.

These differences precluded a joint trial under Fed. R. Civ. P. 20.  “The critical differences between the claims asserted by Plaintiffs outweigh the similarities between the cases, and the court finds trying the cases together would thus be inefficient and confusing for both the Court and the jury.”  Id. at *14.  The presence of an innovator liability claim in one of the cases demonstrated their legal as well as factual disparity.  Id. at *15-16.  Further, “West and Harper were prescribed multiple prescriptions, written at different times by different physicians and in different doses at different physiological stages of their lives.”  Id. at *16.

Thus, two disparate plaintiffs could not claim injury “from the same series of transactions” as required by Rule 20. Id. at *17.  No consolidation synergies for these two weak cases.

*          *          *          *

Two Risperdal cases; two different jurisdictions; two attempts by plaintiffs to manipulate joinder to the disadvantage of defendants defeated.  We look forward to similar rulings in the future.

 

 

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Not even three weeks ago, back on July 28,  we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.  The plaintiff had undergone a heart valve replacement surgery.  As is typical, the surgery required use of a perfusion heart/lung bypass machine.  At some point, the machine stopped working for 10-11 minutes.  The patient died of a heart attack 11 months later.    The decedent’s heirs brought suit against various defendants, including the manufacturer of the heart/lung bypass machine.

 

In the opinion we discussed on July 28, the court excluded most of the opinions of a cardiologist tendered by plaintiffs as an expert on causation.  That expert was refreshingly candid in acknowledging that he could not say for sure that the heart attack was caused by any machine malfunction, though he thought the malfunction probably played some role.  Because the cardiology expert himself acknowledged an “analytical gap,” because he was plainly unqualified to render opinions on neurologic issues, and because he relied on diagnostic methods that were not generally accepted, the court limited the cardiologist expert’s testimony to an opinion that the decedent’s heart was injured during the valve replacement surgery.  Not nothing, but not much, either. 

 

Today, we discuss the same litigation with the same Daubert issue with a different expert but a similar result.  Smith v. Terumo Cardiovascular Sys. Corp., 2017 U.S. Dist. LEXIS 124866 (D. Utah August 7, 2017), involves a different plaintiff expert proffered to opine on medical causation.  This expert was a licensed perfusionist.  No one disputed that this expert could opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.  What was disputed was whether the expert could testify about a potential defect in the heart/lung bypass machine that may or may not have exhibited during the surgery in question.  The expert was going to testify that a defect in the machine’s air bubble detection system led to the inadvertent 10-11 minute shutdown during the surgery.  The expert primarily relied upon a recall of the heart/lung bypass machine that occurred almost two years after the decedent’s surgery.

 

The court begins its analysis in the right place with Federal Rule of Evidence 702.  Then we get a paragraph on how the law favors admissibility of expert testimony.  We wince whenever we read about such a presumption, anticipating judicial abdication of the gatekeeping function.  But that was not the case here.  Rather, the court carefully assessed the expert’s qualifications and found them wanting.  The expert knew all about perfusion and how to operate the heart/lung bypass machine, but that does mean he possessed the requisite expertise to analyze the design and technical functionality of the machine.  The defense deposed the expert, and did a nice job of bringing out the expert’s lack of expertise in mechanical engineering or design.  The existence of the product recall might have been suggestive, but to explain why the recall was issued, and why the reason for the recall also accounted for the device’s stoppage during the surgery, required precisely the sort of engineering or design expertise that was lacking.

 

Even aside from the threshold issue of qualifications, the court concluded that the expert’s opinions were unreliable.  The expert’s report disclosed reliance on depositions, reports, system logs, and medical records.  That sounds pretty good.  But the expert never explained how the facts he reviewed, including the device recall, added up to a defect in the device that prompted the stoppage during the surgery. The expert theorized that the perfusion system might have issued a false alarm, which then resulted in the stoppage, but nothing concrete supported that theory.  Indeed, the expert admitted in deposition that no one could explain exactly how the alleged malfunction occurred.   (More refreshing candor!) The court seized upon something that plaintiffs usually emphasize: the failure to test.  The plaintiff’s expert had never attempted to test his defect theory.  Testing, of course, is one of the key Daubert factors.  In this case, the expert’s failure to test his theory kept him in the realm of speculation, and kept his opinions away from the jury.

 

 

 

 

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We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts).  Last week, we saw the wonderful new musical Come From Away.   It is a true story, and it begins in the tiny town of Gander, Newfoundland on September 11, 2001.  On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks.  Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit.  On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent.   Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects.  At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages.  (The jury found that the evidence did not support an award of punitive damages.)  The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision.  In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant.  It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision.  The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate.  Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.”  In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark.  We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3.  The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id. 

            Warnings Causation 

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here.  One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it.  The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4.   We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion.   She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription.  [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted).   Have trouble following that?  Can’t figure out what it has to do with warnings causation?  Neither can we.  Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway.  And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it.  We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

  1.  Motion for New Trial 

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live.   When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition.  The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial.  The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion 

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument 

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial.   These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted).  The judge, predictably, held that none of the comments was “overly prejudicial.” Id.  

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards.   As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre.  This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description.  And we will have to find a case that makes us queasy so we can easily tie it in.  Based on today’s decision, we suspect this will not be too difficult.  We’ll keep you posted.

Photo of Michelle Yeary

The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

Photo of Eric Alexander

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

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Posts on personal jurisdiction, or the lack of it, have been all over this blog ever since the Supreme Court decided Bristol-Myers Squibb Co. v. Superior Court. Something similar happened three years ago after the Supreme Court decided Daimler AG v. Bauman. Together, these two decisions establish that federal courts are not empowered to find a reason to assert personal jurisdiction simply because the defendant is a large company doing business nationally. General jurisdiction requires the state in which the federal court sits to be the defendant’s “home,” meaning that it was incorporated there or has its principle place of business there. Specific jurisdiction requires that the very transaction from which the plaintiff’s claims arose involve the state in which the federal court sits. Otherwise, the court should dismiss the case. These decisions hold the promise of virtually eliminating litigation tourism.

But the plaintiffs in the Pinnacle Hip Implant MDL are trying to resurrect it, if only in their own litigation. The MDL is pending in federal court in Dallas. And yet the MDL court recently held, seemingly, that it can exert personal jurisdiction against the defendants and conduct trials in every case before it, even those that have no connection to Texas.

As many of us know, MDL courts have jurisdiction over the many cases that are transferred to them, but only for pretrial purposes. The transfer does not create personal jurisdiction for trial. Cases over which the MDL court does not have such personal jurisdiction must be transferred for trial back to the originating district court—or an appropriate district court that can exert personal jurisdiction. 28 U.S.C. 1407(a).

So, how is the MDL court doing this? Well, the lack of personal jurisdiction defense is waivable. And that’s where the MDL court is hanging its robe. It ruled in its June 28, 2017 decision that the defendants waived their defense of lack of personal jurisdiction—and not just for cases already tried, but (seemingly) for every Pinnacle hip implant case that has been filed and will be filed and that makes its way to the MDL. The defendants made this perpetual waiver, according to the MDL court, during proceedings before the special master, who at the time was working to arrange the first and second bellwether trials.

The defendants vehemently disagree. They say that their waiver, given the setting and the very language that they used, was limited only to personal jurisdiction as to the cases involved in the first and second bellwether trials, not all cases and forever. They believe this so strongly that they have filed a petition for a writ of mandamus to the Court of Appeals for the Fifth Circuit, asking that court to order that the MDL Judge cannot exercise personal jurisdiction in any of the eight cases with New York plaintiffs that the MDL court scheduled for the next bellwether trial, which starts in September.

It’s a petition for a writ of mandamus, so from the start defendants’ chances of victory are slim. But, last year, even in losing a petition for a writ of mandamus on another issue, the defendants got one of the Circuit Court judges (in a concurring opinion) to say that the MDL judge got it wrong. We’ll see what happens here. Plaintiffs must respond by the 14th. And the Fifth Circuit will almost certainly rule before September 5, when this next multi-plaintiff bellwether trial is set to begin.

The Pinnacle hip implant litigation is never without intrigue.

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We’re on vacation. The dog days of Summer are upon us. Time for our annual (okay – monthly) (okay- weekly) substance-less post. Our vacation began just a couple of days ago, yet we already rue its passing. Good times go by in the blink of an eye. We want to get away from the keyboard and back to the beach, so today we aim to keep this blogpost short. And that’s the point: short is good.

Short and sweet. Short and memorable. The Drug and Device Law Son, who recently earned a degree in marketing, reminds us that the best ad slogans are short. Just do it. Think. Coke is it. Think different. The same is true with art. It’s easier to watch half-hour sitcoms than hour-long dramas. We miss the early Woody Allen movies, which seldom lingered beyond 90 minutes. (We are not completely discounting the possibility that our recent obsession with short-form has something to do with bathroom breaks.). Our high school junior year English teacher told us that the two greatest American novels were Moby Dick and The Great Gatsby. We’ve read Gatsby seven or eight times. Moby Dick? Once. Shorter is more user-friendly.

In the law, too, short is good. The best bits of legal instruction ever done were the late Irving Younger’s lectures on cross-examination and evidence. You can find those lectures on YouTube. Younger announces the first rule of cross-examination by looking down to the ground, gathering his forces, then roaring, “Be brief!” Make no more than three points in your cross. Two is better. One is best of all. More than that, and you’re just flopping around. The jury will be bored and/or confused. Then they will punish you.

Think of the closing arguments you’ve seen in television shows (LA Law, Boston Legal, Goliath) or movies (To Kill a Mockingbird, The Verdict, The Client). They last under five minutes and are utterly compelling. Why don’t we see those short, snappy oral arguments in real life? We’re afraid of not making all the points we need, and not responding to all our opponent’s points. Whenever we walk out of an oral argument, what obsesses us are the arguments we did not make. But maybe we’ve got it all wrong. Maybe Irving Younger’s recommendation of brevity applies to oral arguments just as much as to cross-examinations. (It is amazing that this insight arrives as any sort of surprise to us. When we represented the United States of America in criminal cases, our best oral arguments went something like this: “No doubt your Honor has read the briefs. (Wait for a judicial nod.). Unless your Honor has any questions, the government submits on the papers.”).

Shortly before we embarked on our vacation, we attended an oral argument before the Joint Panel on Multidistrict Litigation, If you haven’t been to one of these arguments, you need to know they are unlike any other. The cases are huge but the arguments aren’t. The Panel typically affords a total of 20 minutes for argument. That’s 10 minutes per side – at most. In our case, there were multiple parties on each side, taking a variety of positions as to whether there should be an MDL at all, or who should be included, or where it should be located. Most parties were allocated one or two minutes to argue. One party, which apparently was taking the position that most interested the Panel, got a whopping four minutes.

Here’s the revelation: it worked. The arguments were all really good. One could assume the Panel had read the briefs carefully. The questioning by the judges proved as much. So the goal of argument was to update if need be, emphasize one or two crucial points, and, most important of all, answer the judges’ questions. Each and every lawyer was able to do that quite well. One plaintiff lawyer even used blow-up boards and effectively melded them into a two-minute argument. Sometimes the judges asked questions that took the speaker beyond the allocated time, but never by much. When it was over, no one felt cheated. It was a rebuke to the long-winded ness that too often prevails in our profession.

Right now we have a case set for trial in front of a judge who imposes mightily compressed time limits. The lawyers all chafe under the trial chess-clock, but there is reason to believe that the more concise the witness examinations are, the more they make an impact with the jury. The judge is probably correct that lawyers ramble on, perfectly oblivious to the law of diminishing returns. Still, we will probably grind our teeth and steam over the poor jury’s misfortune in being denied an extra hour or two of our eloquence.

There’s another part of our job that could benefit from brevity: writing. Briefs are ironically named. Lately we’ve been making a point of trying to get our briefs in under ten pages, even if the rules permit 20 or 25. We harbor a suspicion that anything longer taxes judicial patience, and perhaps even convinces the court that if we cannot make the point crisply and clearly, we don’t have much of a point. Accordingly, we put a lot of sweat equity in writing a one or two paragraph introduction that should, by itself, win the day for us. Then we will sprinkle the brief with headings and subheadings that make the merits of our position seem ineluctable. The supporting facts and law parked underneath those headings and subheadings should be just enough and no more. Anything that isn’t screamingly essential gets dropped to footnotes in the second draft. In the final draft, we will probably then delete almost all the footnotes. The life-cycle of marginal arguments and evidence is short and cruel.

The key is to know when to stop.

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About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices.  While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor’s prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff’s design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid.  As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board.  We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices.  Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn’t an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania’s broad reading of comment k.  225 F. Supp.2d at 315 & n.4.  Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here).  Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems “close enough,” since such tubes do extend inside the body, albeit quite temporarily.  OK, but there’s plenty of precedent out there about devices that don’t even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when “a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns.”  Id. at 391.  “The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site.”  Id. at 391-92.  The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that “unavoidably unsafe” products achieve protection despite their danger “when accompanied by proper directions and warning”. . . .  On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product which affords substantially increased protection against infection during surgical procedures.  Its water-repellant attributes increase these protections.  In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393.  The defendant still lost, but on warnings, id. at 395, not because comment k didn’t apply to the drape because it wasn’t implanted.

The Illinois Supreme Court applied comment k’s unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . .  [C]omment k presume[s] in their treatments that the denomination “product” has already been applied to the matter in question.  Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as “product,” “defective,” “unreasonably dangerous,” and “business of selling.”  For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser’s On Torts omitted).

Two other cases have applied comment k’s analysis to external patches that release drugs that are absorbed through the skin.  In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k (“the law regarding such products appears at Comment k”) in a case involving nicotine patches.  These were products “incapable of being made safe, but are of benefit to the public dispute the risk.  Id. at 300.  Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl “pain patch” was considered to be within the scope of comment k.  The court refused to grant summary judgment, but only because it found “genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe,” not because comment k was categorically inapplicable to non-implanted products.  Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body.  The court applied comment k analysis to the liability questions.  Id. at 526-28.  As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law.  Id. at 528 (“[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings”).  Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable.  Washington law “safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products.”  Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants.  However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine.  That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products.  But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body.  At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree.  There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

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We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers.  But while it’s illegal for anybody working for the U.S. government to accept anything of value from a “foreign state,” that doesn’t make it illegal, unethical, or even particularly noteworthy for a “learned intermediary” to accept things of value from prescription medical product manufacturers – provided, of course, that doing so doesn’t adversely affect patient care.

For example, the FDA knows and accepts that not only patients/subjects in clinical trials, but also physicians/investigators are routinely paid for their trouble. The FDA’s longstanding Guidance for Industry Financial Disclosure by Clinical Investigators does not require disclosure of “normal reimbursable expenditures” that compensate investigators for routine costs, as long as payments do not “exceed reasonable expectations.”  2001 WL 34768176, at *11.  Such expenses aren’t seen as having a “potential for bias.” Id. at *1.  Even interests that could potentially be a source of bias aren’t prohibited, or limited – they must only be disclosed:

  • Compensation the “value of which could be affected by study outcome.”
  • “A proprietary interest in the tested product”
  • An “equity interest in the [study] sponsor.”
  • “Any equity interest in a publicly held company that exceeds $50,000”
  • “Other sorts” of payments with “a cumulative monetary value of $25,000 or more made by the [study] sponsor.”

Id. at *1-2.

Thus, we don’t have much good to say about a couple of Texas district court opinions that would create an exception to the learned intermediary rule whenever the plaintiff’s prescriber has received any sort of compensation.  Not only is creating exceptions to state common-law rules none of a federal court’s business, but such a broad exception is contrary to precedent and totally unnecessary.

Anyway, the first of these cases was Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Tex. 2011).  The plaintiff was a participant in the defendant’s clinical trial, and signed the standard informed consent documents to participate. Id. at 964.  Murthy refused to apply the learned intermediary rule, “first” because the defendant “arguably directly marketed” the drug to the plaintiff “by creating a promotional video,” and “second” because the prescriber – plaintiff’s doctor – “was compensated by [defendant].” Id. at 967.

Murthy then launched into an extended discussion of the “foundations” of the learned intermediary rule under Texas law.  Id. at 967-70.  This exegesis was not necessary.  The Fifth Circuit, whose law Texas district courts are bound to follow, has repeatedly recognized that Texas applies the learned intermediary rule to all prescription medical products.  Pustejovsky v. PLIVA, Inc., 623 F.3d 271, 276 (5th Cir. 2010) (generic drug); Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355-56 (5th Cir. 2009) (branded drug); Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207-08 (5th Cir. 2008) (same); McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006) (same); Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (medical device); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 (5th Cir. 1992) (contrast medium); Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th Cir. 1988) (vaccine).  The only loophole to the learned intermediary rule ever recognized under Texas law is the so-called “mass vaccination” exception – where a nominally prescription product was dispensed with no doctor, and thus no physician-patient relationship, actually present.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277-78 (5th Cir. 1974).

However, Murthy was bound and determined to change Texas law.  Rather than follow binding Fifth Circuit precedent, the decision latched onto a “recent[]” decision by a “Texas state appellate court [that] recognized an exception to the learned intermediary doctrine.”  Id. at 970.  That was the so-called “direct-to-consumer” (“DTC”) exception where, according to Murthy, “a drug manufacturer practices consumer marketing that fraudulently touts the drug’s efficacy while failing to warn of the risks.”  Id.  After a long paragraph describing the DTC exception, Murthy pointed out (accurately) that the Texas Supreme Court had yet to pass on any learned intermediary rule exception.  Id.

At this point Murthy imitated Captain Kirk – boldly going where no federal court had gone before.  In the absence of on-point Texas precedent, Murthy elected to “consider, among other sources, treatises, law review commentaries, [and] decisions from other jurisdictions.” Id. at 971 (citation and quotation marks omitted).  What followed were several pages (and long footnotes) that resembled what we saw in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1257-59 (N.J. 1999), or State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 472-75 (W. Va. 2007) – both of which were cited in Murthy – long on rhetoric and citations to law reviews, but notably lacking in precedent that actually did what Murthy was proposing.

What did Murthy propose?

First it jumped on the DTC exception bandwagon.  Id. at 971 (“the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals’ reasoning”).  “By creating and disseminating a promotional video . . ., [defendant] may have circumvented the doctor-patient relationship.” Id.

Then Murthy turned to the “gifts or compensation” that the prescriber-investigator had received for participating in the clinical trial in which plaintiff had been enrolled:

Studies have documented, however, that gifts or compensation from drug companies influence medical professionals’ treatment decisions.  Conflicts of interest also arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials. Indeed, a doctor who receives gifts or compensation from a drug company may no longer, as the prescriber, stand between the drug and the ultimate consumer, as the doctor has an incentive to prescribe a particular drug or, in this case, enroll a patient in a clinical trial. . . .  Under certain circumstances, when a physician receives compensation or gifts from drug companies, his or her role as the neutral decision-maker may be diminished.  As such, dismissal of [plaintiff’s] failure to warn claim on learned intermediary grounds would not be appropriate at this time.  Rather, the Court would have to examine the factual circumstances surrounding the compensation of [plaintiff’s] physician in order to evaluate whether application of the learned intermediary doctrine is appropriate.

Id. at 971-73 (citations, quotation marks and two gigantic footnotes to “studies” omitted).  In the end, however, all this discussion in Murthy was merely an extended exercise in obiter dictum – a judicial hit and run − as the warning claims in that case had to be dismissed for another reason.  See Id. at 975-76 (all warning claims fail under Texas statutory presumption of adequacy in FDA-approved warnings).

The second case, In re Depuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016) (“DOPHI”), purported to turn Murthy’s case-by-case evaluation into a blanket compensation exception:

Moreover, the learned intermediary doctrine does not apply when a manufacturer compensates a physician or incentivizes him or her to use its product.   Murthy v. Abbott Labs, 847 F. Supp. 2d 958, 971-73 (S.D. Texas 2012).   Because of the relationship between [defendant] and [the prescribers], a fact question exists regarding the legitimacy and objectiveness of [these prescribers] that precludes application of the learned intermediary doctrine as a basis for summary judgment.

Id. at *6.

There are a number of problems with this nascent emoluments exception to the learned intermediary rule.  First, its meager support in Texas precedent was blown away when the Texas Supreme Court unanimously reversed the “appellate court” decision that Murthy had followed and just an unanimously adopted the learned intermediary rule:

[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. . . .  Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974.

Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157-58 (Tex. 2012) (long string-cite footnote and quotation from Reyes, supra omitted).

As for exceptions to the learned intermediary rule, the Texas Supreme Court declined to recognize any.  Id. at 160 n.18 (“we need not determine whether Texas law should recognize exceptions to the learned intermediary doctrine”).  Particularly with respect to the DTC exception Centocor held:

We acknowledge that some situations may require exceptions to the learned intermediary doctrine, but without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directly to patients or prospective patients, we hold that, based on the facts of this case, no exception applies.

Id. at 162 (footnote omitted)  (emphasis added).  In the omitted footnote the Texas Supreme Court further criticized the decision that Murthy had blithely predicted it would follow, stating “[t]he court of appeals’ reasoning . . . relegates physicians to a mere dispensary role of prescriptions [and] fails to consider the important professional and ethical standards the law requires of physicians.”  Id. at n.24 (citing Texas statutes governing physician conduct).

After the Centocor reversal, the putative emoluments exception to the learned intermediary rule in Texas rests on precisely zero precedent, only the law journal articles and other studies that Murthy used to justify its prediction.

That brings us to the second point.  Perez and Karl, however wrong we believe them to be (and Karl has since been legislatively overturned), were decided by state high courts.  Those courts have the authority to change state law, even changes based entirely on academic musings, if they so decide.  Murthy and DOPHI, being federal district courts exercising diversity jurisdiction, do not have such authority.  We’ve been over this many times before on the blog.  In the words of the Supreme Court:

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  The Fifth Circuit, which as we mentioned includes Texas, agrees:

No Texas court has interpreted [the law] that way.  And we see no other sufficiently strong indication to make an Erie guess that the Supreme Court of Texas would do so.  [I]t is not for us to adopt innovative theories of Texas law, but simply to apply that law as it currently exists.

Barnett v. DynCorp International, LLC, 831 F.3d 296, 307 (5th Cir. 2016) (citations and quotation marks omitted).

[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it.  The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (citations omitted).  Accord, e.g., Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 616 (5th Cir. 2014); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 184 (5th Cir. 2012); Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002); Batts v. Tow-Motor Forklift Co., 66 F.3d 743, 749 (5th Cir. 1995); Solomon v. Walgreen Co., 975 F.2d 1086, 1089 (5th Cir. 1992); Dean v. Dean, 837 F.2d 1267, 1268 (5th Cir. 1988); United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986); Galindo v. Precision American Corp., 754 F.2d 1212, 1217 (5th Cir. 1985).

Finally, our third point is that no other state in the union has adopted any sort of emoluments exception to the learned intermediary rule.  Rather, such claims have been occasionally made, and always rejected, in other states.  That’s quite logical.  Unlike the mass vaccination exception, less accepted exceptions involving consumer choice products (contraceptives) or FDA-mandated DTC warnings – or even the New Jersey-only DTC advertisement “exception” – every other purported exception to the learned intermediary rule has at its justification some kind of communication that avoids the physician-patient relationship.  Claims about financial relationships with prescribers don’t do that.  Rather, they seek to attack an existing relationship using emoluments to claim the physician wasn’t “independent” of the drug/device company.  That’s not a proper “exception” to the learned intermediary rule; that’s a causation issue, if anything other than a smoke screen.  To the extent there is ever any evidence of actual influence over a particular patient’s prescription decision, that is more logically dealt with as tending to defeat a causation defense, but it is not a basis to require direct manufacturer-to-patient warnings where a physician/patient relationship has already been established, which is what exceptions to the learned intermediary rule require.

The first cases to assert financial relationships in opposition to the learned intermediary rule were in Ohio.  In Blatt v. Hamilton, 1986 WL 2925 (Ohio App. March 6, 1986), the plaintiff claimed that his prescriber’s receipt of free drug samples meant that the prescriber should be viewed as the defendant’s agent.  The court disagreed:

The mere fact that a salesman of the manufacturing company gives samples to a doctor and the doctor distributes these samples to a patient, without more, does not prove an agency relationship. . . .  There was no evidence that . . . the manufacturer, had control as to whom, when, in what doses, and in what form, topical or oral, the [drug] was prescribed or distributed by [the prescriber].

Id. at *3 (citation omitted).  Then, in Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875 (Ohio 1991), the Ohio Supreme Court considered facts quite like Murthy – the prescriber had treated the patient under an investigational research protocol and received a per patient payment from the manufacturer.  Id. at 879.  The receipt of routine research-related compensation did not, Tracy ruled, compromise the prescriber’s independence:

Although [defendant] paid [the prescriber] for each participant in the . . . study program, the evidence does not support a finding that [the prescriber] was an employee of [defendant] or that [the prescriber] was acting under the control of [defendant] rather than as a physician exercising his independent judgment. . . .  [Defendant] did not control [the prescriber’s] judgment, duties and responsibilities as he used [the drug] in the treatment of patients.  Accordingly, we find that [the prescriber] was acting as an independent physician in dispensing [the drug] to [plaintiff], that he was a learned intermediary and that the trial court correctly instructed the jury on the learned intermediary doctrine.

Id.

Participation in clinical trials similarly did not affect the learned intermediary rule in Little v. Depuy Motech, Inc., 2000 WL 1519962 (S.D. Cal. June 13, 2000).  “The Court [was] not persuaded by Plaintiffs argument that [the prescriber] was not an independent intermediary because he was part of an investigational team” that studied the type of product and surgery at issue.  To the contrary, such study “further support[ed] the finding that [the prescriber] knew about the risks associated with such devices,” and thus defeated causation.  Id. at *9.  Likewise, in a Texas trial court decision neither Murthy nor DOPHI cited, the plaintiff “contend[ed] that [defendant’s] alleged . . . misconduct influenced [the prescriber’s] treatment recommendations because of the fees he received.”  Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *24 (Tex. Dist. Harris Co. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000).  The court gave that allegation the back of its hand.  “This contention has been rejected.”  Id.

In In re Trasylol Products Liability Litigation, 2011 WL 2117257 (S.D. Fla. May 23, 2011) (applying Alabama law), allegations that the prescriber was “biased because he was a consultant for [defendant], and was paid to attend a Trasylol conference” failed to prevent summary judgment under the learned intermediary rule. Id. at *4.

Plaintiff’s assertions that the learned intermediary doctrine should not apply because [the prescriber] is biased and failed to exercise independent medical judgment do not persuade me. . . .  Plaintiff does not offer evidence that [the prescriber’s] choice to prescribe [the drug] for [plaintiff] was not an informed one, or that he did not exercise individualized medical judgment in making that decision.

Id.

In less routine situations, allegations that prescriber held stock in the defendant or received large sums in compensation have not affected the applicability of the learned intermediary rule.  In one of Bexis’ Bone Screw appeals, Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) (applying Virginia law), the prescriber was a an equity holder in, and a paid consultant for, the defendant.  Id. at 164 (paid to teach surgical procedures, annual $250,000 consulting fee, travel budget, research funds, and 25,000 shares of stock).  The plaintiff argued that, because of these ties, the prescriber “cannot be considered an intermediary, learned or otherwise.”  Id.  Summary judgment under the learned intermediary rule was affirmed because that evidence was not connected to anything that occurred in the plaintiff’s treatment.  “[T]here is no evidence that the consulting relationship between [the prescriber] and [defendant] interfered with [his] independent medical judgment in treating [plaintiff].  On the contrary, the evidence suggests otherwise.”  Id.  Whether financial ties caused injury by lack of “independence” was a “complex question would depend on the nature of the relationship between the manufacturer and the physician and the extent to which the physician was in fact afforded independence in making medical judgments.”  Id. The Trasylol decision followed Talley.  2011 WL 2117257, at *4.

In In re Zyprexa Products Liability Litigation, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010) (applying Illinois law), the plaintiff “contend[ed] that summary judgment should not be granted on learned intermediary grounds” because his prescribing physician was “biased” by having “conducted paid research for at least ten pharmaceutical companies, including defendant,” having been “a paid speaker for at least six pharmaceutical companies, including [defendant],” and having “accepting $490,000 in compensation from” drug companies.  Id. at *11.  Such facts did not oust the learned intermediary rule because nothing showed any “bias specific to” the drug or towards the defendant.  Id.

Allegations of compensation of a similar magnitude did not impair California’s learned intermediary rule in In re Vioxx Cases, 2006 WL 6305292 (Cal. Super. Dec. 19, 2006).  A plaintiff argued that his prescriber could “not play the role of learned intermediary because it paid him hundreds of thousands of dollars over the years to conduct research and give lectures.”  Id.  Absent “evidence of actual bias” the compensation didn’t matter:

Payment to a physician, standing alone, does not deprive the physician of learned intermediary status. Such payment for research is a widespread practice, yet the court was unable to find a case where a physician who was paid for research was considered to have abrogated his or her role of learned intermediary.  Therefore, such payments alone do not constitute a “special circumstance” for purposes of setting aside the learned intermediary doctrine.  Indeed, if such payments alone sufficed, a manufacturer would have to obtain the patient list of every physician it pays for research in order to somehow provide direct warnings.

Id.

Nor does Murthy itself have much of a track record.  DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012), rejected Murthy’s rationale notwithstanding plaintiff’s allegation that her prescriber “may have had a direct financial relationship with [defendant].” Id. at 613.

This argument fails on both the law and the facts.  On the law, plaintiff has not cited any New York decision that adopts an exception to [learned intermediary rule] where physicians received compensation from drug manufacturers.  Murthy applied Texas law, and plaintiff has not demonstrated that Murthy is part of any trend supporting an exception . . . where drug manufacturers compensate physicians.  On the facts, moreover, plaintiff’s allegations that [defendant] compensated [the prescriber] are completely speculative, based entirely on what [defendant] allegedly did in other cases involving other physicians.

Id. at 616 (citation and footnote omitted).  Even assuming what plaintiff claimed was true, however, would not oust the learned intermediary rule, because “[i]t is not clear . . . that manufacturer-compensated physicians would in fact neglect their professional duties to an extent that would undermine” the rule.  Id. at 616 n.6.  See also Calisi v Abbott Laboratories, 2013 WL 5462274, at *3-4 (D. Mass. Feb. 25, 2013) (refusing to follow Murthy and rejecting any “physician compensation exception” to the learned intermediary rule).

Finally, similar emolument-related allegations have failed as challenges to otherwise uncontradicted prescriber testimony.  In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), summary judgment for the defendant was affirmed under the learned intermediary rule on the basis of the prescriber’s prior independent knowledge of the relevant product risks.  Id. at 1019.  Even with the benefit of a heeding presumption, the plaintiff could not successfully assert the prescriber’s “research for several pharmaceutical companies” as a basis for creating a credibility issue.  Id. at 1024.  Such pharmaceutical affiliations, “standing alone, however, merely offer speculation as to [the prescriber’s] motives for testifying and they are clearly insufficient to call into question either [her]  credibility or the veracity of her statements.”  Id.  “Absent evidence suggesting [the prescriber] was otherwise influenced by the defendants, we . . . find no reason to question her credibility or the truth of her testimony.”  Id.  See Miller v. Pfizer, Inc., 196 F. Supp.2d 1095, 1129 & n.108 (D. Kan. 2002), (“no reasonable jury” could “discredit” unrefuted prescriber testimony based on “bias . . . arising from his business relationship with [defendant], i.e., the fact that at or near the time he prescribed [the drug] for [plaintiff, he] was a paid consultant”), aff’d, 356 F.3d 1326 (10th Cir. 2004).

Based on the above, we believe there is no legal basis for an “exception” to the learned intermediary rule predicated on a prescribing physician having a pre-existing relationship, financial or otherwise, with a defendant manufacturer of prescription medical products.  Perhaps, in an extreme case, there might be actual evidence of bias affecting a particular plaintiff’s medical treatment, but we have yet to see any such case.  Even in the case of significant emoluments, see Talley, Zyprexa, Vioxx, supra, plaintiffs have been unable to establish a jury submissible case of actual, causal bias.  Murthy and DOPHI, exceeded the proper role of federal courts exercising diversity jurisdiction, and their novel predictions are belied by extensive contrary precedent.

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