Photo of Eric Alexander

Maybe we have been doing this too long.  Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition.  In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game.  Consider the old baseball rule that a tie goes to the runner.  That defines how an umpire is supposed to decide close plays at a base.  In legal terms, the team in the field has the burden of getting the ball to the base (possession of a player touching the base) before the runner makes contact.  People watching a game might disagree with an umpire’s call, but assigning a burden is important, even with replay review.

Plaintiffs bear the burden of proof on each element of each claim they assert.  In federal courts, the burdens on motions for summary judgment were set no later than 1986.  In that year, among the Supreme Court’s trio of landmark decisions on Fed. R. Civ. P. 56 was the holding in Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986), that summary judgment was mandated “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.”  This interplay of burdens has helped define how parties actually litigate prescription medical product cases.  For instance, plaintiffs in the vast majority of cases know that they will need evidence from a prescribing physician, testimony or affidavit for summary judgment and testimony for trial.  A body of law developed in response to the situation in a small percentage of cases where the prescribing physician is deceased or otherwise unavailable.  The idea was basically that it was not fair for a plaintiff to lose her failure to warn claims because she would not be able to get magic words from the prescribing physician to carry her burden on proximate cause.  So-called heeding presumptions and the purported “reasonable physician” standard have been urged and mostly rejected.  The diet drug cases in Philadelphia provided a number of early published decisions on these issues, but there is overwhelming acceptance of the fundamental premise that a plaintiff fails to meet her burden and loses her failure to warn claim without evidence that the prescribing physician would have altered her behavior in response to an adequate warning.

Fast forward to Thacker v. Ethicon, Inc., — F.4th –, 2022 WL 3696680 (6th Cir. 2022), a pelvic mesh case that made its way from years languishing in an MDL to summary judgment in the transferee court to an appeal to the Sixth Circuit.  As we alluded to above, this case is hardly alone at this point, with many circuit decisions and many more district decisions on recurring issues.  Thacker involved the most frequent of frequent flyer experts and two of the more common reasons for summary judgment in these cases:  lack of proof of proximate cause for failure to warn and lack of proof of a feasible alternative design.  Kentucky has the learned intermediary doctrine and a detailed product liability act modeled on section 402A of the Restatement (Second) of Torts.  The plaintiff named experts and the parties deposed the implanting surgeon.  With this record, the district court weighed the record evidence and determined plaintiff did not carry her burden on these two claims or the negligence claim that required related proof of defect.  The appeal should have been straightforward.  It was not.

First, a bit more on the facts.  Plaintiff claimed a range of injuries from two different devices, a stress urinary incontinence sling and a pelvic organ prolapse mesh, implanted at the same time by the same physician.  It did not appear that she or her experts attributed specific injuries to one or the other device.  Instead, it appears she blamed all her alleged issues on both devices collectively.  Neither she nor the court differentiated between alleged design or warnings defects of the two different devices.  That was a problem.  Logically (and legally), whether a product is defective in some respect and whether that defect caused a specific injury to a specific plaintiff are device- and injury-specific inquiries.  More precisely, it is hard to imagine a court deciding whether a plaintiff has introduced enough record evidence to carry her burden of proof on each element of her claims if the injuries, devices, warnings, and alleged defects are all lumped together.  The bigger issue, though, is “burden.”  The Thacker decision does not use the word.  It does not cite the Celotex standard.  It does not refer to the concept of a prima facie case.  It is really hard to decide an appeal of a summary judgment ruling on these issues without considering any version of the concept that the plaintiff had to come forward with evidence showing she could carry her burden.  (We checked:  the court below referenced “burden” six times in its decision.)

Thacker’s analysis had other issues.  As we said, what is required to show proximate cause for failure to warn with prescription medical products is not a novel issue, particularly in states with the learned intermediary doctrine well established.  So, we were surprised by Thacker’s characterization that “courts have struggled to pinpoint what kinds of evidence the plaintiff can or must use to support proximate causation at the summary judgment stage.”  2002 WL 3696680, *5.  A paragraph later, the court defined the inquiry as “whether Thacker has presented evidence showing that she likely would not have used the Pelvic Mesh Devices had Ethicon given adequate IFUs.”  Id. at *6 (emphasis added).  There is plenty wrong with that formulation.

We will focus just on the, well, focus on plaintiff’s “use” of the devices instead the decision of implanting physician to use the devices as he used them.  Two cases are cited in connection with the court’s definition of a novel test for proximate cause for a prescription medical device warnings claim.  The first is Larkin v. Pfizer, Inc., 153 S.W.3d 758, 769-70 (Ky. 2004), where the Kentucky Supreme Court adopted the learned intermediary doctrine.  Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry.  (Decisions to use specific prescription medical products during emergency procedures, for instance, do not involve patient choice.)  The second was the decision below.  It focused squarely on the doctor.  Its concluding paragraph on this issue is instructive:

In conclusion, under Kentucky law a plaintiff does not have to present evidence showing the doctor would have changed his mind when the defendant also has not presented evidence that the doctor would not have changed their mind. Corder, 473 F.Supp.3d 749. However, when the defendant does present affirmative testamentary evidence that the doctor would not have changed his course of action with the additional warning, the plaintiff must present evidence to the contrary in order to show a genuine issue of material fact exists. Sexton, 2021 WL 4138399, at *4; Huskey, 29 F.Supp.3d 736 at 743. If the plaintiff is unable to come forward with such evidence, then causation, a necessary element in a failure-to-warn claim, cannot be proven and the moving party is entitled to judgment as a matter of law. Since here Defendants have presented clear testimony from Dr. Guiler that he stands by his decision even with the additional information [DE 159-2 at 119:10-120:8], and Plaintiff has not presented refuting testimony, Ms. Thacker will be unable to prove the element of causation. Even though there is likely a genuine issue of material fact regarding whether Dr. Guiler relied on the IFU, Ms. Thacker must still present evidence contradicting the defendants’ proof that Dr. Guiler would not have changed his mind even with the additional warning in order to establish causation. In this situation, it is a necessary element. Since Ms. Thacker has not presented conflicting evidence, she is unable to prove causation exists and her failure to warn claim must fail as a matter of law.

Thacker v. Ethicon. Inc., 571 F. Supp. 3d 691, 702 (E.D. Ky. 2021) (citations as in the original). So, where did the appellate court get its new test?  We do not know.

The Sixth Circuit’s application of the new burdenless test predictably found genuine issues on proximate cause.  It started by criticizing the court below for “focus[ing] solely on Dr. Guiler’s testimony” based on quoting part of the second sentence above.  In the context of the full paragraph around it, we do not understand this interpretation.  We certainly do not understand the list of what sort of evidence might bear on proximate cause:

Rather, plaintiffs can support their proximate cause arguments with various types of evidence. For example, plaintiffs may point to evidence suggesting that, with an adequate warning: the treating physician would not have recommended the device; a reasonable physician would not have recommended the device; the treating physician (or a reasonable physician) would have given the plaintiff more information about the severity and likelihood of the risks; or the plaintiff would not have consented to, or elected to proceed with, the treatment.

2002 WL 3696680, *6.  Where you have the testimony of the prescribing—not merely “treating”—physician that different warnings would not have changed his real-time decision to use the devices he thought had the best risk-benefit for plaintiff, then those other types of evidence are immaterial.  As the court below found, that is the only fair reading of the prescribing physician’s testimony in Thacker.  With its legal tests all mucked up, though, the appellate court in Thacker found room to quibble.  For instance, it highlighted that “there is nothing indicating that, on the day of his deposition, Dr. Guiler was given every warning that Thacker says should have been included in the IFUs.”  Id. at *7.  That sounds like a failure of proof from the plaintiff, who had her counsel at that deposition with every incentive to get the doctor to testify “if the IFU for Device A had said X in 2009, then I would not have implanted Device A in the plaintiff.”  The defendant’s counsel did not have to get the doctor to testify that he would have implanted the devices even if they were made of radioactive waste or had a 100% reoperation rate.  That is not how it works.

The reversal of the design defect claim was also impacted by the disappearance of burden.  The court correctly identified the high bar Kentucky imposes on design defect claims because it requires proof that a safer feasible alternative design “could have been practically adopted at the time” and it “would have prevented [plaintiff’s] injury.”  Id. at *8-10 (internal citations omitted).  This is where lumping together the devices, the alleged design defects, and all risks/injuries returns as a problem.  Plaintiff’s frequent flyer expert offered conclusory opinions that each device could have been made with a larger pore, lighter weight mesh construct like was used in certain hernia devices and that the use of these alternate devices would have avoided all of plaintiff’s injuries.  (Knowing this expert as we do, we know that he considers even these alternate devices defectively designed, admits no slings have ever been marketed with similar mesh, and has no idea whether alternate devices could have been developed and bought to market in the U.S. by specific dates.)  In accepting his opinions as plaintiff’s sole proof on feasibility, though, the court effectively eliminated the requirement for “could have been practically adopted at the time.”  Indeed, the date of implant is not mentioned in the section of the opinion.  In rejecting the implications of the expert’s admission that the theoretically alternate devices would not have eliminated the risk of plaintiff’s complications, the court also flipped the unmentioned concept of burden on its head.  “At most, the evidence Ethicon highlights shows that Ultrapro may not have eliminated all risks.  But that does not mean that it would not have prevented or lessened some, or even most, of Thacker’s injuries.”  Id. at *11 (emphasis in original).  Even without the double negative, that does not make sense.

There was one last bit of weirdness.  The defendant raised that the court could hold Dr. Rosenzweig’s unsupported speculation as inadmissible and affirm on that basis.  That is how we take the court’s jibe that “[p]erhaps recognizing that it had little defense against the substance of Dr. Rosenzweig’s opinions, Ethicon spent much of its brief arguing that this Court should not consider Dr. Rosenzweig’s testimony because it is inadmissible and unreliable.”  Id.  The court below had granted summary judgment assuming plaintiff’s expert evidence was admissible and the appellate court declined to consider admissibility.  When the case gets back to the district court, we would not be surprised if many of the plaintiff’s expert opinions that factored in the reversal get excluded.  Because the district court understands that burden matters, those exclusions could reverse the reversal.