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Few things in the law are as subject to abuse as the False Claims Act, 31 USC section 3729 et seq.  (the FCA). It was originally enacted to stop massive frauds perpetrated by large contractors during the Civil War. Now it is a litigation cottage industry. 

In United States ex rel. Bennett v. Bayer Corp., 2024 U.S. Dist. LEXIS 63654 (D.N.J. April 4, 2024), the relator alleged that two defendant pharmaceutical companies violated the FCA by misleading the federal government to get approval to sell fluoroquinolone antibiotics (FQs), resulting in doctors prescribing the FQs and seeking fraudulently-induced reimbursements from federal and state healthcare payors.  To our defense-hack eyes, this action smacks of a claim of  fraud on the FDA, which we think is not an issue for courts but, rather, the FDA.  We normally see courts use preemption to swat away fraud on the FDA claims.  But the defendants here prevailed on their motions to dismiss for a non-preemption reason, and that is just fine with us. 

The relator in Bennett was a bit of a gadfly (that’s as polite a term as we can muster) who had previously filed several Citizen’s Petitions with the FDA regarding FQs with (and here we are again endeavoring to be polite) mixed results — mostly denials. The FDA did require some enhanced or clarifying warnings on FQs,  but, from what we can tell, the relator does not seem to have been the primary reason for that.  We espy a bit of opportunism here, though we confess our priors in this area, and such priors are suffused with cynicism. 

Third Circuit law controlled in Bennett, and the Third Circuit permits fraudulent inducement liability under the FCA only in the context of contracts that were induced by fraud.  The alleged inducement here occurred in the context of a non-contractual interaction with the FDA. The Bennett court saw no good reason to expand liability beyond what the Third Circuit has thus far blessed. 

In any event, the relator’s allegations were flimsy. The relator alleged “half-truths” manipulated clinical trials, and “disaggregation of adverse effects.”  But none of that suggested that the defendants failed to comply with the New Drug Application process, or that they omitted any information specifically requested by the FDA. All of that adds up to a failure to plead falsity, and given what the F in FCA stands for, that is a fatal flaw. 

Is “fatal” an overstatement?  No. Because an additional amendment would be futile, the court dismissed the FCA complaint with prejudice. 

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Remember the case we told you about last week where the court shutdown plaintiff’s attempt to use non-mutual offensive collateral estoppel?  Well, that wasn’t that plaintiff’s only loss that week.  In a companion decision, the court also rejected plaintiff’s attempt to use Federal Rule of Civil Procedure 43(a)’s remote trial testimony rule to skirt the jurisdictional limitations of Rule 45(c)(1).  Coblin v. Depuy Orthopaedics, Inc., 2024 WL 1357571 (E.D. Ken. Mar. 29, 2024). 

As we explained in our prior post, this case was remanded from the hip implant MDL.  During which numerous fact witnesses were deposed; including, the five current and former employees of defendants who plaintiff subpoenaed to testify at trial remotely.  None of the witnesses reside or work within 100 miles of the courthouse.  Therefore, none fall within the subpoena power of the court pursuant to Rule 45(c)(1).  To be clear, that means the court has no authority to compel those witnesses to appear at trial. 

Rule 43(a) provides:

For good cause in compelling circumstances and with appropriate safeguards, the court may permit testimony in open court by contemporaneous transmission from a different location.

What plaintiff asked the court to do is to read Rule 43(a) as an expansion of its subpoena power under Rule 45.  Despite an unexplainable split in district court decisions on this issue, Coblin follows the Ninth Circuit decision in In re Kirkland, 2023 WL 4777937 (9th Cir. Jul. 27, 2023), that we discussed here, which refused such an expansion. 

Coblin recognizes, as did the Ninth Circuit, that while at first glance the two rules appear in conflict, “upon closer reading, however, the rules provide two distinct and different directives.”  Coblin, at *2 (emphasis added).  Rule 45 governs whether the court can require a witness to testify at trial.  Rule 43 governs the “mechanics” of how trial testimony is presented.  Therefore, the first question the court must answer is whether the witness has been properly subpoenaed under Rule 45.  The court cannot compel how a witness will testify, “if it cannot first ensure the witness is within the Court’s reach to compel.”  Id. A “textual reading” of the rules mandates this conclusion.  Id. (citing similar decisions). 

District court’s who have used Rule 43 to expand their subpoena powers to reach the entire United States via modern remote capabilities, have done so not only by disregarding the text of the rules, but also disregarding the Advisory Committee Notes which state:

When an order under Rule 43(a) authorizes testimony from a remote location, the witness can be commanded to testify from any place described in Rule 45(c)(1).

Fed. R. Civ. P. 45 (Advisory Committee’s Note, 2013 amendment) (emphasis added).  This note leaves no room for doubt.  The geographical limits of Rule 45(c) apply to both live and remote testimony. 

The court acknowledges that cases such as Coblin, drug/device litigation, are complex; that generally courts prefer live witnesses; and that technology has advanced to the point where remote testimonyis reliable and easy.  But “practical sentiment” doesn’t mean the court can “ignore the plain edicts” of textual analysis “for the sake of convenience.”  Id. at *3.  As the court summarizes:

Rule 45(a)(2) states that a “[a] subpoena must issue from the court where the action is pending.” FED. R. CIV. P. 45(a)(2) (emphasis added). The upcoming trial is set for here in the Eastern District of Kentucky. The Court cannot issue a subpoena that compels actions by a witness well beyond its jurisdictional limits simply because technology has eased the practical burdens. Federal courts remain one of limited jurisdiction and practical concerns cannot drive the Court to ignore such fundamental principles.

Id.

As we discussed recently, in our post about remote depositions, Coblin‘s reading of the federal rules is the majority rule, with most of the exceptions being MDLs – where courts have unfortunately developed the habit of ignoring rules that they find inconvenient.

In less than a month, plaintiff is going to trial without his non-mutual offensive collateral estoppel, without his remote witnesses, and most likely in need of a new plan.

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The result for the defendant (a “distributor of ophthalmologic supplies”) in the False Claims Act decision, United States ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc., ___ F. Supp.3d ___, 2024 WL 489708 (D. Minn. Feb. 8, 2024), was so terrible that something good ended up happening.

Continue Reading FCA Verdict Slashed as Unconstitutional Excessive Fine
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Released in 1965 by the Miracles, “The Tracks of My Tears” is ranked by Rolling Stone as the “Greatest Motown Song of All Time.” Smokey Robinson’s lead vocals are pure silk, the harmonies ooze soul, and  the guitar licks and strings tie it all together.  The song and the Miracles helped spread Motown around the globe.  Today’s decision about an artificial tears product won’t stack up against Smokey and the Miracles, but it hits a few chords worth sharing.

Continue Reading Tracks of My Tears – Narrowing of Economic Loss Class Claims in Kentucky
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We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space. 

The complaints filed by such attorneys often are written as if federal preemption doesn’t exist, so our motions to dismiss start by explaining the basics of express medical device preemption, 21 U.S.C. § 360k(a) as interpreted by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and implied preemption, generally in the vein of Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  Then we detail how the plaintiffs’ causes of action seek to impose liability based on state tort law standards which are different from, or in addition to” the federal requirements imposed by the FDA through its premarket approval of the device.

The opposition briefs we receive in response tend to miss the mark.  They also generally fall into a couple of regular buckets.  The “tangent about Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)” bucket.  The “presumption against preemption” bucket.  The “but plaintiff needs discovery” bucket. 

Today, we are going to talk about the “but the device was recalled” bucket.

The theme in these plaintiffs’ briefs is that preemption cannot possibly apply, because the medical device at issue was one that was recalled.  (For the less-discerning plaintiff lawyers, heck, it doesn’t even have to be the same device that was recalled.  If the company had a recall of a different model, in a different year, involving an entirely different device issue, close enough!)

Sometimes, the analysis is no deeper than “recall = plaintiff wins”. 

Sometimes, the opposition suggests that because there was a recall, there must have been a violation of federal PMA requirements, and that means they have asserted one of the mythical “parallel claims” that thread the Scylla and Charybdis of express and implied preemption. 

Regardless, the defense position is that the fact that a recall occurred does not necessarily change things.  If the plaintiff wants to argue their tort claim involves state law duties that are not “different from, or in addition to” federal requirements imposed through the PMA process, then they must “identify some pertinent federal regulation, a violation of that specific regulation, and sufficient facts to substantiate the allegation, including a causal link to the alleged injury.”  Womack v. Nevro Corp., 2019 U.S. Dist. LEXIS 103864, at *6 (M.D. Fla. June 21, 2019) (emphasis added).  Evidence of a defect, without evidence that the defect was the result of a violation of a federal requirement for the device, is insufficient to defeat preemption. Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019) (“district court properly granted summary judgment because [plaintiff] failed to raise a genuine dispute of material fact that [defendant] violated a federal ‘requirement’ for [its medical device]”).  Stated differently, a plaintiff cannot “rely on res ipsa loquitur” “to survive MDA preemption.”  Id. at 1109; see also Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011). 

Before we go further into the preemption recall discussion, however, a few digressions.

First, remember (ha!) that the term “recall” has a specific meaning in this context that generally differs from what most lay people expect the term “recall” to mean. 

To the FDA, a “recall” is any “removal or correction”—including any “repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location”—but the term “does not include a market withdrawal or a stock recovery.”  21 CFR § 7.3(g), (h).  In other words, within the medical device space, a recall might mean the manufacturer sent an “Important Medical Advice Advisory” to physicians with updated patient management information.  It certainly does not mean that the manufacturer has demanded all implanted devices be immediately explanted from patients and returned to the company.

Also remember that, from a regulatory perspective, the existence of a recall does not mean that the FDA has withdrawn its premarket approval of the device.  Withdrawing premarket approval for a device requires specific procedures and findings.  See 21 CFR § 814.46 (specifying procedure required for FDA to withdraw a PMA).  Without those, the FDA’s premarket approval remains in place.  See In re Medtronic, Inc., 592 F. Supp. 2d 1147 (D. Minn. 2009) (rejecting plaintiff’s argument that recall “invalidated” the device’s premarket approval).

Another point to remember:  Even when a device allegedly malfunctions or allegedly causes injury, that does not automatically mean that the device has a defect.  “Medical devices, even [or especially] Class III medical devices receiving rigorous premarket approval, inherently carry risks and the potential for harm to consumers.”  Gross v. Stryker Corp., 858 F. Supp. 2d 466, 499-500 (W.D. Pa. 2012). 

Class III medical devices are “complex” and “can fail for a variety of reasons, including medical complications, body rejection phenomena, allergic reaction, and surgical techniques, all of which occur without someone acting in a negligent manner.”  Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090, 1094-95 (D. Minn. 2008).  Indeed,

the “safety and reliability” of an implanted device “cannot be guaranteed indefinitely in the ‘extremely hostile environment of the human body,’ where myriad other factors external to the device are brought to bear.”

Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012). 

Like mere evidence of malfunction or injury, evidence that a recall occurred does not amount to evidence of a defect without more.  See Christian v. Altaire Pharms., 2020 U.S. Dist. LEXIS 189231, at *13 (E.D. Ky. Oct. 13, 2020) (“Standing alone, a voluntary recall notice which fails to identify a specific contamination issue and expressly states that no product has been identified as out-of-specification does not constitute a plausible allegation of a product defect”); Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 171021, at *-9 (E.D.N.Y. July 12, 2013) (“the fact that the [device] loosened and was recalled for the same issue is merely consistent with [defendant’s] liability and stops short of the line between possibility and plausibility of entitlement to relief”) (internal citations omitted).

Now, getting back to preemption, the existence of a recall does not mean a device deviated from federal requirements.  “Many courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.”  Erickson v. Bos. Sci. Corp., 846 F. Supp. 2d 1085, 1093 (C.D. Cal. 2011). There are some good recent cases on this: 

In Wilhite v. Medtronic, Inc., 2024 U.S. Dist. LEXIS 39248, *5 (N.D. Ala. Mar. 6, 2024), despite a recall of the PMA defibrillator due to a potential risk of premature battery depletion, the plaintiff’s claims were held to be expressly preempted.  In fact, the court concluded that plaintiff did not allege a parallel claim because an “oblique suggestion” of a violation of an FDA requirement is not enough.

Likewise, in Tripolskiy v. Boston Scientific Corp., 2023 U.S. Dist. LEXIS 146689, *14 (C.D. Cal. Aug. 18, 2023), that court also held that claims regarding a premarket-approved implantable cardioverter defibrillator (“ICD”) recalled due to the potential risk of premature battery depletion were expressly preempted.  This court agreed the plaintiff did not allege a parallel claim; specifically noting that a conclusory allegation that the device “did not meet federal standards, based solely on the [product]’s failure and product recalls . . . is insufficient.” Tripolskiy, 2023 U.S. Dist. LEXIS at *14 (citing Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011)).

And there are some older, also good cases on this:

  • Engle v. Medtronic, Inc., 2021 WL 1318322, at *14 (W.D. Ky. April 8, 2021) (“[T]he FDA’s recall of a PMA Class-III medical device does not give rise to a claim capable of surviving federal preemption.”);
  • ASEA/AFSCME Local 52 Health Benefits Tr. v. St. Jude Med., LLC, 362 F. Supp. 3d 642, 645, 650 (D. Minn. 2019) (dismissing state law claims as preempted in case involving recalled device);
  • McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193, 1201 (M.D. Fla. 2013) (granting preemption motion to dismiss in case involving recalled device);
  • Simmons v. Bos. Sci. Corp., 2013 U.S. Dist. LEXIS 45852, at *15-16 (C.D. Cal. Mar. 25, 2013) (preemption motion granted where device was the subject of a corrective action classified by FDA as a recall);
  • Franklin v. Medtronic, Inc., 2010 U.S. Dist. LEXIS 71069, at *31 (D. Colo. May 12, 2010), report and recommendation adopted, 2010 U.S. Dist. LEXIS 61889 (D. Colo. June 22, 2010) (claim that defendant failed to warn physicians and patients of purported defect with device that was later recalled was insufficient to constitute parallel claim); and
  • Gow v. Medtronic, Inc., 2010 Ky. Cir. LEXIS 4, *18-19 (Ky. Cir. Aug. 26, 2010) (a recall does not affect PMA approval; all state law claims preempted in case involving Class III device).

Claims that a manufacturer should have recalled a device sooner also are preempted by 21 U.S.C. § 360k(a).  See In re Medtronic, Inc., 592 F. Supp. 2d 1147, 1159 (D. Minn. 2009) (“claims alleging that [manufacturer] should have recalled the [device] leads sooner than it did are similarly preempted”).  They also seem to us to be a version “stop selling” claims that are subject to implied preemption.

Finally, don’t forget that recall-based theories may be improper for other reasons. “Failure to recall” claims do not exist at common law.  And evidence of a recall can be a subsequent remedial measure inadmissible pursuant to Federal Rule of Evidence 407, unless offered for another purpose like impeachment or notice

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Coblin v. Depuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 62114 (E.D. Kentucky April 4, 2024) is the ultimate dodged bullet.  It is part of a multidistrict litigation.  That’s bad enough. Then it gets worse.  It’s not just any MDL, it’s the hip implant MDL. Then it gets even worse. This Coblin decision involves a plaintiff’s motion for partial summary judgment.  Yikes.  Then it gets even even worse.  The plaintiff in Coblin moved for summary judgment based on nonmutual offensive collateral estoppel.  What is so bad – or perhaps we should say offensive – about nonmutual offensive collateral estoppel?  Collateral estoppel is a species of issue preclusion.  It means that some issue was decided in a prior litigation, and that decision carries forward to other cases.  There is no more fighting over the issue.  It is established.   Nonmutual collateral estoppel means that the party invoking issue preclusion was not a party to the prior decision. Finally, offensive nonmutual collateral estoppel means that it is a plaintiff looking to get the benefit of the prior decision. (We have written before about how nonmutual offensive collateral estoppel is systematically unfair.) 

The key case on nonmutual offensive collateral estoppel is Parklane Hosiery Co. v. Shore, 439 U.S. 322 (1979). We remember studying the Parklane case in law school, and we remember how horrifying nonmutual offensive collateral estoppel seemed to us even then, well before we became defense hacks. Parklane set forth a nightmare scenario. Imagine that a defendant gets sued by multiple plaintiffs for similar conduct and similar injuries. Got it?  You might have heard of something like that happening. Now suppose the first few plaintiffs lost.  Could the defendant then apply collateral estoppel against future plaintiffs?  Probably not.  The new plaintiffs did not have a chance to press their position in those earlier cases.  Fair enough.


But what about once a plaintiff wins?  Can a future plaintiff then apply collateral estoppel against the defendant, arguing that the defendant had a full opportunity to litigate its case, so its loss should carry forward? It’s crazy, because a defendant could win, say, 25 consecutive cases, but as soon as it loses one, all future plaintiffs could lock in a win on important issues.  (We were pleased to see the Coblin court include a parenthetical quote from Parklane that mentioned our Federal Courts professor, the great David Currie.)


In Parklane, the Supreme Court recognized that nonmutual offensive collateral estoppel could be pernicious, to say nothing of unfair, for three reasons: (1) it might encourage some plaintiffs to lay back, wait and see, and then pounce once another plaintiff won an issue; (2) courts should not clobber a defendant who did not have a reason to defend earlier actions vigorously, particularly if future consequences were not foreseeable; and (3) the doctrine should not apply if the judgment relied upon as a basis for the estoppel is itself inconsistent with one or more previous judgments. 

That third Parklane factor is why the plaintiff in Coblin lost its attempt at summary judgment on the basis of offensive non mutual collateral estoppel. The plaintiff in Coblin sought partial summary judgment to the effect that the defendant had designed and sold a defective product.  That would certainly be a nice head start for any plaintiff. In the MDL from which this case was remanded, the plaintiffs did not win all the bellwether trials, and not all their wins held up on appeal.  Specifically, the defense won the first bellwether trial. The plaintiff won the second, but it was overturned on appeal because of some serious errors by the court and some seriously shady misrepresentations by the plaintiff.  (See our post here.) The plaintiffs won the next two bellwether trials, then settled the cases while they were on appeal. 

There are several reasons why nonmutual offensive collateral estoppel would be monstrous in this situation.  As an initial matter, MDL bellwether trials are not supposed to be binding.  They are for informational purposes only.  (Never mind whether that information is useful, or even whether it qualifies as misinformation.)  Nor were any of the prior bellwether trials under the law that applies to the Coblin case (Kentucky), though that might not matter much here. But the fundamental problem here is that nonmutual offensive collateral estoppel here would be unfair.  Mindful of Parklane factor three, the court in Coblin refused to “don blinders” in the face of inconsistent judgments and defense wins.  

The plaintiff actually asked the Coblin court to don those blinders. The plaintiff suggested that the court should disregard the first trial result, where the defendant prevailed.  Why?  The verdict form in that case contained a question that combined design defect and injury. Thus, according to the Coblin plaintiff, maybe when the jurors in the earlier case answered No to the combined question, they might have been saying No to injury without addressing defect.  The Coblin plaintiff’s argument is, of course, rank speculation.  It is a pretty weak stuff to support something as outcome dispositive and one-sided as nonmutual offensive collateral estoppel.  Such speculation could not erase the simple fact that the defense verdict in that first trial was inconsistent with the later trial results that the Coblin plaintiff sought to exploit.  

Moreover, there are some problems with giving preclusive effect to those plaintiff wins. Obviously, a verdict vacated for plaintiff-side misconduct cannot possibly be a basis for collateral estoppel.  Further, verdicts in cases that later settled and did not produce judgments are inappropriate for collateral estoppel.  There are some aspects of the Coblin opinion we don’t love.  There are some other cases out there hinting that nonmutual offensive collateral estoppel might apply in some mass torts.  That is scary stuff.  The ultimate defense is an appeal to fairness.  Fortunately for the defendant in Coblin, the Parklane decision enshrined such fairness considerations, especially when there are inconsistent outcomes.  

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We have previously analogized that when a case is dismissed for failure to state a claim under Rule 12, that is like the plaintiff not even getting to first base.  And that when a complaint is dismissed for lack of standing, a rarer form of dismissal, the plaintiff couldn’t even get up to bat, let alone get on base.  A dismissal for lack of standing recently occurred in Gibriano v. Esai, Inc., 2024 U.S. Dist. LEXIS 59535 (D.N.J. Mar. 31, 2024).  When that kind of dismissal occurs, you can bet the complaint is really bogus.

And this wasn’t plaintiff’s first attempt.  She got benched in 2022 when her case was dismissed for lack of standing the first time.  But the court saw fit to giver her another chance.  This time the game has officially been called and plaintiff never got out of the dugout.  That’s because, plaintiff, as the would-be class representative, did not claim to be injured in the slightest.

Plaintiff was prescribed a weight loss medication that she purchased and used for about six months.  Shortly after she stopped using the drug, it was withdrawn from the market due to cancer risks.  Plaintiff alleges the drug was ineffective for her because “it did not meaningfully impact her weight.”  Id. at *4.  But her claim for damages stems from her allegation that she paid a “premium” for the drug based on her understanding that it was safe.  Id. at *4-5.  In other words, the only damages that plaintiff (and the supposed class) sought were of the existential varietal—some difference in the subjective “worth” versus the purchase price of the medication.  But that is too speculative a theory of injury to establish standing. 

To have standing, plaintiff must allege an “injury-in-fact” which requires plaintiff have sufficient evidence to demonstrate she suffered a “concrete and particularized” injury.  Id. at *10-11.  Plaintiff seems to hang her hat on her allegation that the drug was ineffective because she did not lose a meaningful amount of weight.  But that is a subjective, non-concrete assertion.  Id. at *12. 

Further plaintiff alleges that if the alleged cancer risk had been disclosed, she either would not have purchased the medication or would have paid less.  “However, Plaintiff does not allege that she suffered from cancer, is at risk of cancer, or any other health problems as a result of using [the drug].”  Id. at *14. Plaintiff was relying on an unrealized increased risk, not affecting either her actual safety or the efficacy of the drug.  That is a purely economic injury.  “Plaintiff seeks to be reimbursed for purchasing a functional product that she has already consumed without incident; this is legally insufficient to establish Article III standing.”  Id. at *15-16.  The court relied on Third Circuit precedent which requires an allegation either that the product failed to work as intended or was worth “objectively” less than one could reasonably expect for standing to exist.  See Koronthaly v. L’Oreal USA, 374 F. App’x 257, 258 (3d Cir. 2010).  Plaintiff had neither here. 

Plaintiff tried to liken her case to a case where plaintiffs were unable to use a portion of the medication they purchased.  But in that instance, plaintiffs could demonstrate an economic theory based on the value of the portion of the product that was unusable.  Gibriano, at *17.  Here plaintiff may contend she would not have purchased the drug had she known about the cancer risk, but she used all of the product and therefore has no quantifiable damages. 

Plaintiff also offered no evidence to support that the drug she purchased was unsafe for her.  In fact, the court found her allegations directly to the contrary. Plaintiff did not allege that she developed cancer or was at risk for developing cancer as a result of using the drug.  Id. at *18-19.  Plaintiff’s only evidence in support of a price difference between a “safe” and “unsafe” version of the drug was a subjective consumer survey.   Plaintiff has no evidence that she, or anyone, could have purchased an “unsafe” drug at the suggested reduced price.  Moreover, she does not allege that the economic benefits she received “were anything less than the price she paid.”  Id. at *19. 

The fact that others have suffered a concrete injury (cancer or other health conditions), does not mean plaintiff has suffered an injury-in fact.  Plaintiff’s claim is really nothing than buyer’s remorse.  She wished she had not purchased the drug but having done so and having consumed all of it, she has not suffered an economic injury that confers standing. 

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One of the blogposts that generated a lot of “Thanks, I needed that” responses from our readership was our 2022 post, “Remote Depositions in MDLs.”  For that reason, we have updated it by adding references to additional MDL orders on that subject that have been entered since early 2022.  We pay particular attention to MDL orders because, due to their stakes, every procedural jot and tittle is gone over with a fine-toothed comb.  The “litigate everything” mentality in MDLs produces the most comprehensive consideration of issues that arise in remote depositions generally.  We asked one of our crack legal assistants to look for additional MDL orders during this time frame to see what MDL transferee judges – advised by the parties – have had to say most recently about the conduct of remote deposition.

Continue Reading Remote Depositions in MDLs 2.0
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We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned intermediary case before the California Supreme Court?  For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one! 

Who will be giving thanks after the California Supreme Court decides Himes?  We don’t know, but it sure was a good show.

To recap, Himes is before the California Supreme Court on a question certified from the Ninth Circuit.  As we detailed here, the issue is how plaintiffs in prescription medical product, failure-to-warn cases can meet their burden of proving warnings causation under California law.  In a failure-to-warn claim against a prescription medical product manufacturer, is the plaintiff required to show that a stronger warning would have altered the physician’s decision to prescribe the product?  Or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment? 

Our initial take on these issues still applies: 

It’s an important question.  Time and again, we have seen cases where there is no evidence that stronger warnings would have had any impact on the physician’s prescribing physician, which should be, and often is, the basis for summary judgment under the learned intermediary doctrine.  The essence of the doctrine is that a prescription medical product manufacturer’s duty to warn runs to the physician—the learned intermediary—not the patient.  Thus, if there is no evidence that stronger warnings would have had an impact on the physician, the plaintiff cannot prove that an alleged inadequacy in the warnings caused his or her injury. . . .

But what about cases where the plaintiff says, sure a stronger warning would not have influenced my doctor, but what about me?  If my doctor had informed me, I would not have consented to the treatment.

An engaged California Supreme Court confronted the issues with aid of highly capable counsel, both of whom were swinging for the fences.  What do we mean by that?  Well, the questions certified to the California Supreme Court were couched in terms of the plaintiff’s causation burden.  So we were surprised when the plaintiff’s counsel spent most of his time arguing that the learned intermediary doctrine should not apply at all and that the duty to warn should run to the patient—and only the patient—whenever the manufacturer has not provided sufficient warnings to physicians.    

That’s just crazy talk.  Plaintiffs in failure-to-warn cases always allege that the manufacturer’s warnings were not sufficient.  The plaintiff’s argument therefore would essentially read the learned intermediary doctrine out of the law.  Or, as the Ninth Circuit held when it certified the questions, “Because the adequacy of warnings is always challenged in failure-to-warn claims, ‘[i]f the learned intermediary rule became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.’” Himes v. Somatics, LLC, No. 21-55517, 2022 WL 989469, at *4 (9th Cir. Apr. 1, 2022) (quoting Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727, 734 (S.D. W. Va. 2014) (applying California law)).

That, however, is where counsel placed his marker, with emphasis on respecting and preserving patient autonomy.  Counsel even went so far as to assert that the California Supreme Court had endorsed this view in TH v. Novartis, the California case that adopted innovator liability.  Justice Kruger interrupted at this point to assert that TH v. Novartis did not really hold that and did not decide that issue.  She posited instead that there are different kinds of duties, and that a prescription medical product manufacturer can discharge its duty to warn by warning physicians—the learned intermediaries—who are best positioned to communicate warnings to patients.  Is there not an intermediate step that should consider what a reasonably prudent doctor would tell his or her patient? 

Counsel replied no, the consumer has the right to know the risks.  Justice Corrigan agreed, but asked how the Court should ensure as a matter of policy that the patient actually would know if not through a learned intermediary.  How would a duty running directly to the patient work?  Counsel replied that the manufacturer could fulfill its duty with direct-to-consumer advertising, which provoked some skepticism.  Justice Corrigan noted that the fulfillment of a medical product manufacturer’s duty to warn should not depend on what she watches on TV.  Justice Jenkins observed that counsel was suggesting a solution that was “antithetical” to the learned intermediary doctrine, which acknowledges that physicians are in the best position to advise their patients regarding the risks of treatment.  The plaintiff wanted the manufacturer to take on that duty.

Counsel argued that a manufacturer would take on that duty only if it were negligent in warning physicians.  There is that crazy talk again.  If a manufacturer provides adequate warnings, there is no liability and no need for any learned intermediary rule in the first place.  In other words, the plaintiff’s argument would render the learned intermediary rule superfluous—if the manufacturer failed to provide adequate warnings, it owes a duty directly to the patient; but if it gave adequate warnings, there is no need for the doctrine at all.  Either way, the learned intermediaries may as well go for a cup of coffee, because they don’t matter anymore.   

Justice Groban picked up on this apparent inconsistency:  The plaintiff was arguing that the physician should be part of the equation through informed consent, but that when it came to warnings causation, only the plaintiff’s decision-making process mattered.  Finally, we get to causation, and counsel argued that it was a decision for the jury.  The jury could hear from the physician and hear from the plaintiff, and then decide for itself whether the plaintiff would have consented to the treatment if the manufacturer had given the physician a stronger warning.  Justice Groban observed (as we have in multiple blogposts on this topic) that the plaintiff would win 100 percent of the time, because plaintiffs will always say that, “had they known” of the risk, they would not have granted consent. 

The balance of the plaintiff’s time was spent on whether the standard should be an objective standard or a subjective standard.  Should the plaintiff have to prove that a stronger warning would have altered the decision of a reasonably prudent patient under similar circumstances?  Or can plaintiffs meet their burden with their own subjective, 20/20 hindsight testimony that they would have declined treatment had the manufacturer provided a stronger warning? 

Counsel argued that the standard should always be subjective, subject only to the jury’s right to not believe the plaintiff.  Multiple justices tested this, asking for example whether an objective, reasonably prudent standard would adequately preserve the plaintiff’s remedy, as it does in medical malpractice cases.  Justice Evans asked how it would work with exceedingly rare side effects that physicians would not reasonably be expected to communicate to patients.  Counsel answered that it was all for the trier of fact, with the patient’s testimony subject to cross examination, just like in any other product liability case. 

That led to probably the most on-point observation of the day:  Justice Kruger noted that consumers purchasing the “average consumer product” are in a different position from patients seeking medical treatment from physicians—i.e., learned intermediaries. 

Defense counsel started by asking the Court to hold that a plaintiff in a failure-to-warn claim must offer evidence that a stronger warning would have altered the physician’s prescribing decision.  Remember how we said that both sides swung for the fences?  This is the defense version.  It is the traditional and most analytically sound restatement of the learned intermediary rule, under which the warnings causation inquiry begins and ends with the prescribing physician.  We happen to agree with this rule, since it is most faithful to how prescription medical care is actually provided, and it is the only way to invest responsibility for warning patients with the party in the best position (or even the only position) to do so—the prescribing physician.  It also happens to be the rule followed in the vast majority of jurisdictions. 

The California Supreme Court tested this argument, too.  Justice Kruger asked, in a couple of different ways, whether a rule that focuses on physicians needs also to leave room for patient autonomy.  Counsel acknowledged the importance of patient autonomy, but emphasized that there are multiple competing concerns.  These are prescription drugs that patients cannot decide to take on their own.  They need prescriptions, and physicians are not mere gatekeepers—they are learned intermediaries.  The warnings are directed to them, and they apply their experience and training to interpret those warnings for patients.  It would be speculation under these circumstances to allow patients to prove causation with their own subjective, hindsight testimony that they would not have consented to the treatment had they known all the risks.  Counsel also emphasized that the Court should presume that physicians will listen to their patients when making prescribing decisions, which further protects patient autonomy. 

The core of the defense argument was this:  Allowing plaintiffs to prove warnings causation with evidence of a stronger warning’s purported impact on patients, as opposed to physicians, comes at a cost.  Liability for prescription medical device manufacturers will be subject to significant hindsight bias, under which plaintiffs who have already suffered injuries will always say that they would not do it again.  Extending the duty to warn to patients, even indirectly, will also result in overwarning, which will not improve outcomes and threatens real harm to patients who will forego treatment.  Liability will rely on speculation—instead of looking at a prescribing physician’s actual practices, we will instead base liability on the speculative impact of a hypothetical stronger warning on a patient’s conduct years after the fact. 

Justice Corrigan noted that the Court understood all that, but would it not be sufficient to instruct a jury that it should decide causation under a reasonably prudent standard.  Counsel replied no, because that would build a house of cards.  The jury would have to consider what a reasonably prudent physician would have told a patient if the manufacturer had provided a stronger warning.  Then, it would have to consider the impact of that hypothetical conversation on the patient in a but for world.  And a jury is susceptible to same hindsight bias as the plaintiff.  The Court should instead do what other courts have done and look at what the prescribing physician actually did with knowledge of the risk.  That is not speculation. 

Justice Groban was struck by the parties’ stark positions.  The plaintiff was arguing that only the patient’s decision-making process mattered and that the learned intermediary rule should not apply at all.  The defendant was arguing that only the physician’s decision-making process mattered.  Both were degrading the notion of informed consent, which is a dialogue under which the patient makes a decision.  Was defendant presenting the “physician as god” and saying that the patient is irrelevant?  Counsel replied that the plaintiff’s argument was presenting the “lawyer as god” in a world where manufacturers would rarely, if ever, win summary judgment.  (Again, counsel for both sides were high quality, but we have to say, the “lawyer as god” retort was pretty good.) 

Multiple justices questioned counsel on whether they should be cutting the patient out of the equation and whether the traditional formulation of the learned intermediary rule would leave patients without a remedy.  Justice Kruger again came back to the objective standard:  Why is an objective standard not the solution to hindsight bias, as it is in medical malpractice cases?  Counsel replied that patients would still have sufficient remedies, including potentially against their physicians. And, we don’t need an objective standard because we can look at the actual conduct of prescribing physicians and whether they continued to prescribe the product to their patients, even when aware of the risk. 

Entertaining arguments all around, and we have a few observations with which to close.  First, we will say again (as Justice Groban observed) that counsel on both sides were going for the home run.  The Court was looking more for a double, a compromise position that would acknowledge meaningful roles for both the patient and the physician in the decision making process.  We imagine the Court’s draft opinion reflects this evident, even obvious desire for a middle ground, wherever that may lie. 

Second, we will not hazard a guess at the outcome, but we would be shocked if the Court were to hold that the learned intermediary doctrine evaporates when the manufacturer fails adequately to warn the physician.  The learned intermediary doctrine exists because plaintiffs allege that manufacturers have failed adequately to warn, and it sets the standard for proving causation where the warnings are directed to the learned intermediary, not the patient.  Crazy talk.  We do not think the Court is rethinking the learned intermediary doctrine on a fundamental level.  It will likely stick to the certified questions and tell us what to do with warnings causation. 

Third, we would also be surprised if the Court embraced a subjective standard, under which a plaintiff could get to a jury, in every case, with her own hindsight testimony that she would not have consented to treatment if she had known about a risk that she has already experienced.  The Ninth Circuit rejected that view when it certified the questions to the California Supreme Court, and the Court’s multiple acknowledgements that it understands hindsight bias and such suggest that it will reject a subjective standard, too. 

We expect an opinion within 90 days.  We will keep you posted.

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The issue of the state of mind or intent of a party can play out a number of ways based on the nature of the case.  In the criminal context, proof of the mens rea of the defendant is typically an element in the statutory definition of the crime.  In a civil contract case, whether the parties had a meeting of the minds and how one party actually interpreted disputed provisions can be central issues to decide.  In an employment case, it may be the issue of whether the stated reason for taking an adverse employment action was mere pretext for the real reason.  In the product liability context, the focus can be on the plaintiff’s assumption of risk or the defendant’s alleged reckless indifference to the risk of the harm that allegedly befell the plaintiff.  Because plaintiffs in large-scale drug and device try cases to get punitive damages, the latter is a recurring issue in our cases.

Back in the day, well before The Case of Thorns gave rise to tort law and tort law eventually gave rise to product liability claims, some trials were decided based on the use of oath helpers, purportedly upstanding citizens who would swear that one party was good and honest and, thus, should prevail.  The oath helping could touch on all manners of state of mind, such as “Ruprecht is telling the truth that he thought it was his pig” or “Rolfe was not acting in self defense when he slew kind Alfred.”  In American jurisprudence, the distaste for this overtly classist practice—nobles tended to have better oath helpers than commoners—morphed into something called the “ultimate issue rule.”  Because juries decided disputed facts, no witness was supposed to stray into direct testimony on a deciding issue, which was seen as “usurping the province of the jury” with “empty rhetoric” from the stand.  This history is set out in the Advisory Committee Notes to Federal Rule of Evidence 704, which abolished the unwieldy ultimate issue rule in federal civil and criminal trials when it was adopted in 1975.

The 2011 to present version of the Rule provides:

Rule 704. Opinion on an Ultimate Issue

(a) In General — Not Automatically Objectionable. An opinion is not objectionable just because it embraces an ultimate issue.

(b) Exception. In a criminal case, an expert witness must not state an opinion about whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense. Those matters are for the trier of fact alone.

On its face, the abolition applies to opinion testimony from both lay and expert witnesses, although the exception is just for experts in criminal cases.

The Notes also contain a fairly familiar explanation that references oath helpers:

The abolition of the ultimate issue rule does not lower the bars so as to admit all opinions. Under Rules 701 and 702, opinions must be helpful to the trier of fact, and Rule 403 provides for exclusion of evidence which wastes time. These provisions afford ample assurances against the admission of opinions which would merely tell the jury what result to reach, somewhat in the manner of the oath-helpers of an earlier day. They also stand ready to exclude opinions phrased in terms of inadequately explored legal criteria. Thus the question, “Did T have capacity to make a will?” would be excluded, while the question, “Did T have sufficient mental capacity to know the nature and extent of his property and the natural objects of his bounty and to formulate a rational scheme of distribution?” would be allowed. McCormick §12.

We first ran across this language back in 2000 when posed with the issue how to prevent a plaintiff expert, qualified in some discipline relevant to at least some issues in the case, from offering what amounted to a second opening from the witness stand, replete with all manner of “opinions” on what the defendant drug manufacturer knew, why it did what it did, and how not doing what it did not do was proof of bad intent.  We used to call this “intentology” testimony and, when we first looked, the authority for excluding it was as thin as the basis for admitting it, even though many courts had admitted it over faint objection.  Although we offered a number of arguments for why the plaintiff experts should not be allowed to sprinkle in all their musings on intent in the course of their testimony, the one that has been the most impactful in helping to create a line of federal MDL decisions since 2000 is that experts should not be permitted to usurp the jury’s function with this sort of thinly veiled advocacy.  After our first two decisions on this issue from the In re Diet Drugs MDL, a number of individual decisions followed suit, but it was the published decision from the In re Rezulin MDL as part of broader Daubert challenges that really got things rolling in MDL after MDL. 

We detailed the first eleven years of this line of cases here.  With credit to Kelly McNeill, we can present a mini-survey of federal decisions since 2011, focused on MDL and MDL remand cases, which makes it clear that the exclusion of expert opinion on the state of mind of a corporate defendant is the decidedly majority position.

                        FIRST CIRCUIT

  • In re Zofran (Ondansetron) Prod. Liab. Litig., No. 1:15-MD-2657-FDS, 2019 WL 5685269, at *9 (D. Mass. Nov. 1, 2019) (MDL excluded plaintiff expert’s challenged opinions; “Inferences about the intent or motive of parties or others lie outside the bounds of expert testimony.”) (citing In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., 2018 WL 734655, at *2 (D. Mass. Feb. 6, 2018); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 547, 551 (S.D.N.Y. 2004); In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1337-38 (S.D. Fla. 2010)).

                        SECOND CIRCUIT

  • In re Mirena IUD Prod. Liab. Litig., 169 F. Supp. 3d 396, 479–80 (S.D.N.Y. 2016) (MDL excluded frequent flyer plaintiff expert’s opinions on the “intent, motives or states of mind of corporations, regulatory agencies and others,” but permitted testimony on “what information was in [defendant’s] possession” and the intent of defendant or FDA when “clearly indicated in public documents”).

                        THIRD CIRCUIT

  • Zimmer Surgical, Inc. v. Stryker Corp., 365 F. Supp. 3d 466, 497 (D. Del. 2019) (“Expert testimony as to intent, motive, or state of mind offers no more than the drawing of an inference from the facts of the case … and permitting expert testimony on this subject would be merely substituting the expert’s judgment for the jury’s and would not be helpful to the jury.”).
  • In re: Tylenol (Acetaminophen) Mktg., Sales Pracs., & Prod. Liab. Litig., No. 2:12-CV-07263, 2016 WL 4039271, at *8 (E.D. Pa. July 28, 2016) (MDL excluded frequent flyer plaintiff expert’s opinions; citing a number of decisions on the same expert, including Heineman v. American Home Products Corp., No. 13–cv–02070–MSK–CBS, 2015 WL 1186777, at *12 (D. Colo. Mar. 12, 2015) (excluding Dr. Blume’s opinions about defendants’ state of mind); In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 950, 964-965 (D. Minn. 2009) (“There is no indication in the record that the jury here would require special assistance to interpret the documents on which Dr. Blume bases her opinion that Pfizer was more worried about bad publicity than safety. Because the jury is equally capable of evaluating this particular evidence, Dr. Blume’s opinion on this matter must be excluded.”); Chandler v. Greenstone Ltd., No. C04–1300RSL, 2012 WL 882756, at *1 (W.D. Wash. Mar. 14, 2012) (excluding Dr. Blume’s opinions on defendants’ state of mind, intent, or knowledge); Johnson v. Wyeth LLC, No. CV 10–02690–PHX–FJM, 2012 WL 1204081, at *3 (D. Ariz. Apr. 11, 2012) (excluding Dr. Blume’s opinions on defendants’ motive, intent, knowledge, or other state of mind)).

                        FOURTH CIRCUIT

  • A number of decisions from 2013 forward by the judge overseeing multiple pelvic mesh MDLs expressed similar rulings that broadly excluded intent opinions.  For instance, in Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 670 (S.D.W. Va. 2014), aff’d 872 F.3d 1304 (11th Cir. 2017), the court stated:

First, as I have maintained throughout these MDLs, I will not permit the parties to use experts to usurp the jury’s fact-finding function by allowing an expert to testify as to a party’s state of mind or on whether a party acted reasonably. See, e.g., Huskey v. Ethicon, Inc., 29 F.Supp.3d 691, 702, 2:12–cv–05201, 2014 WL 3362264, at *3 (S.D.W. Va. July 8, 2014); Lewis, et al. v. Ethicon, Inc., 2:12–cv–4301, 2014 WL 186872, at *6, *21 (S.D.W. Va. Jan. 15, 2014); In re C.R. Bard, Inc., 948 F.Supp.2d 589, 611, 629 (S.D.W. Va.2013). Although an expert may testify about his or her review of internal corporate documents solely for the purpose of explaining the basis for his or her opinions—assuming the opinions are otherwise admissible—a party’s knowledge, state of mind, or other matters related to corporate conduct and ethics are not appropriate subjects of expert testimony because opinions on these matters will not assist the jury.

                        FIFTH CIRCUIT

  • Greger v. C.R. Bard, Inc., No. 4:19-CV-675-SDJ, 2021 WL 3855474, at *9 (E.D. Tex. Aug. 30, 2021) (remand case precluded plaintiff expert from opining on the defendant’s “subjective intent, motives, or internal decision-making involved in [product] testing,” while permitting opinions on defendant’s “objective actions or inactions with respect to [product] testing, and the sufficiency thereof”).

                        SIXTH CIRCUIT

  • In re E. I. du Pont de Nemours & Co. C-8 Pers. Inj. Litig., 345 F. Supp. 3d 897, 902–03 (S.D. Ohio 2015) (“Courts have typically barred expert opinions or testimony concerning a corporation’s state of mind, subjective motivation, or intent.”) (MDL No. 2433)

                        SEVENTH CIRCUIT

  • In re Fluidmaster, Inc., Water Connector Components Prod. Liab. Litig., No. 14-CV-5696, 2017 WL 1196990, at *24 (N.D. Ill. Mar. 31, 2017) (MDL excluded plaintiff expert on “the motivations, intent, and state of mind of a corporation,” noting “[t]he jury will not be aided by Plaintiffs’ expert speculating about why Defendant made design changes and outsourcing decisions”).

                        EIGHTH CIRCUIT

  • Clinton v. Mentor Worldwide LLC, No. 4:16-CV-00319 (CEJ), 2016 WL 7491861, at *11 (E.D. Mo. Dec. 30, 2016) (“The question of corporate motive, intent, knowledge or state of mind is one for the jury, not for an expert . . . . Recitation of defendant’s own corporate documents does not fall within the purview of expert testimony under Federal Rule of Evidence 702.”) ( remand from MDL No. 2004); Kruszka v. Novartis Pharms. Corp., 28 F. Supp. 3d 920, 937 (D. Minn. 2014) (“The Court agrees with the parties that Dr. Vogel may not proffer an opinion relating to what individuals at Novartis thought about information found in certain internal documents or about their motivations regarding those documents.”) (remand from MDL No. 1760).

                        NINTH CIRCUIT

  • Stanley v. Novartis Pharms. Corp., No. CV1103191JGBOPX, 2014 WL 12573393, at *6 (C.D. Cal. May 6, 2014) (“[T]he opinions of [expert] witnesses on the intent, motives, or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise.”) (remand from MDL No. 1760).

                        TENTH CIRCUIT

  • Fischer v. BMW of N. Am., L.L.C., No. 18-CV-00120-PAB-MEH, 2020 WL 9259705, at *6 (D. Colo. Mar. 10, 2020) (non-MDL exclusion of plaintiff expert’s opinion on defendant’s intent) (citing In re Rezulin and Wells v. Allergan, 2013 WL 7208221, at *2 (W.D. Okla. Feb. 4, 2013)), aff’d sub nom. Fischer v. BMW of N. Am., LLC, No. 20-1399, 2021 WL 5458444 (10th Cir. Nov. 23, 2021).

                        ELEVENTH CIRCUIT

  • In re 3M Combat Arms Earplug Prod. Liab. Litig., No. 3:19MD2885, 2021 WL 765019, at *42 (N.D. Fla. Feb. 28, 2021) (MDL excluded plaintiff expert on defendant’s “state of mind, including his opinion as to what 3M ‘hop[ed],’ had ‘no idea’ about, and what 3M knew or did not know.”).

  * * *

Now the issue of the admissibility of expert testimony on a defendant’s state of mind is pending before the Supreme Court in a drug case.  Not product liability, mind you, but a criminal prosecution for importing meth, Diaz v. United States. (The Ninth Circuit’s unpublished opinion is here.)  As we noted up front, Fed. R. Evid. 704(b) precludes expert opinion on “whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense.”  After conviction, Diaz appealed to the Ninth Circuit on four grounds, three of which were pretty much walkovers due to the defendant’s procedural failings below.  The fourth related to the admission of “the government expert’s modus operandi testimony on drug trafficking organizations’ use of unknowing couriers.”  Slip op. at 5-6.  Diaz had offered a “blind mule” or “unknowing courier” defense and the government responded with testimony from an expert (who had testified many times in similar cases before the same judge), whose testimony was determined to be reliable.  On appeal and we presume below, Diaz offered an additional argument under Rule 704(b):

Finally, Diaz argues that testimony that drug trafficking organizations rarely use unknowing couriers is the “functional equivalent” of a prohibited opinion on mental state. This is contrary to our precedent. Diaz is correct that the Fifth Circuit has adopted this view, see, e.g., United States v. Gutierrez-Farias, 294 F.3d 657, 663 (5th Cir. 2002), but we have allowed such testimony so long as the expert does not provide an “explicit opinion” on the defendant’s state of mind, see, e.g., United States v. Gomez, 725 F.3d 1121, 1128 (9th Cir. 2013) (citation and internal quotation marks omitted), and the expert did not do so here.

Slip op. at 6-7.

The Supreme Court accepted Diaz’s petition for cert.  It is unusual for the Supreme Court to accept cert on an issue addressed in one paragraph of an unpublished opinion, but the quote above from that opinion indicates that a circuit split has existed for at least ten years.  Coverage of the oral argument two weeks ago indicated that multiple justices questioned the relevancy of the expert’s testimony if, to avoid Rule 704(b)’s exception, the expert’s opinion did not address whether Diaz’s “did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense,” in this case whether she was an innocent dupe or a knowing courier of the meth.  Based on the questioning at oral argument, the tension is between expert opinion that does “not state an opinion about whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense” and expert opinion that is not relevant to the defendant at all.  In terms of graphic representation, does the Venn diagram of 401 and 704(b) have an area of admissible overlapping expert opinion testimony?

This made us think about the parallels to quasi-intent testimony presented in the sort of cases against our clients.  If the government’s expert in Diaz was, as advertised, testifying about the modus operandi of Mexican drug cartels in terms of their use of couriers of drugs across the U.S.-Mexico border, then the testimony was offered to show that a blind mule is as frequent as a sighted unicorn and, thus, Diaz’s contention that she did not know she was carrying meth must be bogus.  This is akin to what is sometimes referred to as pattern and practice evidence under Fed. R. Evid. 404(b)(2).  (Because we are not criminal lawyers, we can set aside a discussion of the notice requirement under 404(b)(3) when the prosecution tries to use such evidence in a criminal case.)  Yet, the pattern and practice at issue in this testimony was not that of Diaz, but of cartels and drug carriers.  Using the language of Rule 404, evidence of other acts (by others) was offered to prove “knowledge . . . absence of mistake, or lack of accident.”  For Diaz, the argument against admissibility is that the expert’s testimony indicated that an innocent carrier is a rarity, not whether Diaz knew she was transporting meth across the border.  In our cases, plaintiffs offer a few versions of expert opinion on the defendant’s intent based on the acts of others and data relating to probabilities, although the plaintiffs are not waiting for our clients to open the door to intent testimony.

For decades, plaintiff lawyers in drug and device product liability cases have beaten the “profits over safety” drum and have tried to have experts echo the phrase from the witness stand.  Of course, savvy judges see that direct expert testimony that the defendant did, in fact, put profits over safety in making some decision would be impermissible opinion on the defendant’s state of mind.  See In re Prempro Prods. Liab. Litig., 554 F. Supp. 2d 871, 881 (E.D. Ark. 2008) (discussing exclusion of plaintiff expert’s “editorial about pharmaceutical companies putting sales and marketing before science”), aff’d in pertinent part, rev’d in part on other grounds, 586 F.3d 547, 571 (8th Cir. 2009). One way to try to get around the prohibition of intent opinions is to offer expert evidence on the defendant’s conduct that, without saying what was in the heads of defendant’s decision makers, makes clear that good companies do not make the same decisions that defendant did because they put safety over profits.  This has been used, along with other antics, to get big punitive damages awards, which require an intent finding.    There is not much daylight between this testimony and the expert’s in Diaz in terms of the relationship to the defendant’s intent.  Both are framed in terms of the supposed intent of others to draw a contrast. 

Another way to try to get around the prohibition on expert opinion on the defendant’s state of mind involves statistical flim flam.  We have seen variants used in civil RICO, third party payor, and public nuisance litigation, among others, but it all follows a familiar pattern regardless of the theory of liability.  Based on analysis of data of orders, prescriptions, dispensation, reimbursement, etc., the statistician/economist/mouthpiece can opine, in essence, that it is overwhelmingly likely that the defendant’s actions were taken with the requisite intent or that it is overwhelmingly unlikely that they were taken for an innocent, non-culpable reason.  Again, regardless of how the expert comes up with the percentage (which is an issue for Rule 702), is there a fundamental difference in terms of relevance between an expert opining that 98% of drug carriers are not “blind mules” and an expert opining that 98% of off-label prescriptions result from intentional off-label promotion?  (Any opinion from an expert on why prescribing physicians, particularly physicians not in the case, prescribed specific medical products is inherently suspect anyway.)  We could go on.

We do not know what the Court will hold in Diaz in connection with the interplay between Rule 401 and Rule 704(b) in terms of expert opinion on the intent of individuals or entities other than the defendant.  We do strongly suspect, however, that the decision could provide ammunition to oppose the sort of veiled expert opinion on intent—itself a response to the twenty-plus year history of decisions prohibiting the unveiled variant.