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.

 

 

 

 

The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior completing a summer internship at an insanely cool company in Lower Manhattan.  We were treated to a tour of the office and to the comments that colleagues and mentors reserve for interns’ mothers.  We had perfect saltimbocca at a beloved Italian bistro.  We saw Waitress (again – we love this show).  We stayed overnight on the Climber’s couch, joined at some point by a four-pound Chihuahua.  And we relished every moment with this child-now-adult.  We were awash in happiness for the entire train ride home.

We were also happy (yet another suspect segue) with the court’s evidentiary rulings in today’s case, but decidedly not with the case’s very sad facts—an all-too-frequent dichotomy in our line of work. Because we spend vast amounts of our professional time struggling to achieve the exclusion of plaintiffs’ causation experts, we are always pleased to read a Daubert opinion that layers tidy analytical segments to reach a satisfying conclusion that correctly applies the Rules of Evidence and controlling case law.

In Smith v. Terumo Cardiovascular Systems Corp., et al., 2017 U.S. Dist. LEXIS 108205 (D. Utah July 12, 2017), the plaintiff’s decedent underwent open-heart surgery in which a heart-lung machine was used to circulate oxygenated blood through the patient’s body while his heart was being repaired.  At some point during the surgery, the machine stopped working for approximately ten minutes.  The plaintiff’s decedent never left the hospital after the surgery.  Eleven months later, he suffered a heart attack and died.

The plaintiff sued the hospital and the heart-lung machine’s manufacturer, asserting the usual claims. She hired a cardiologist as her causation expert, and he opined that the malfunction of the heart-lung machine caused the decedent to suffer physical and mental deterioration and ultimately caused his heart attack and his death.  The defendants moved to exclude the expert’s testimony, arguing that: 1) his causation opinions were unhelpful and unreliable; 2) he was not qualified to opine on neurological injuries; and 3) he should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.” Smith, 2017 U.S. Dist. LEXIS 108205 at *5 (citation omitted).

Explaining that , “to be helpful, [the expert’s] opinion . . . that the . . . surgery and related complications had any causal . . . relationship to Mr. Smith’s injuries and ultimate death must be based on a ‘valid scientific connection,’ the court held that that the expert’s own deposition testimony demonstrated that his opinion would not be helpful to a jury. To wit, in his deposition, the expert admitted that he could not testify with certainty that there was a connection “between the surgery, the ten-minute lack of flow, and the heart attack that caused” the decedent’s death. Id. at *10-11 (citations omitted).   Instead, he could only go as far as concluding that “the events that happened at the time of surgery simply made it more likely” that the decedent would die as the result of a heart attack, although the decedent’s own risk factors –hypertension, smoking, diabetes, family history – were generally considered to be “the main contributors” to the development of the plaque that narrowed the decedent’s arteries and caused his myocardial infarction.  As such, the expert concluded, “[While] I think that what happened . . . played a role in his having a heart attack and made it less likely that he would survive a heart attack, but I cannot say that it caused his heart attack.Id. at *11-12 (emphasis in original, citation omitted).

While this is refreshing (and uncommon) candor for a plaintiff’s expert, it is obviously not “helpful” to the establishment of causation. Moreover, the court held, even if the testimony had been helpful, it was not reliable, because the expert did not “provide a basis to conclude that the relationship [was] causal and not merely corollary,” leaving too large a gap between his premise and conclusion, and because he failed to account for obvious alternative explanations for the decedent’s death.   Id. at *15-16.

The expert also concluded, contrary to the results of the decedent’s autopsy, that the decedent had suffered an earlier heart attack, around the time of the surgery, before the one that ultimately killed him eleven months later. The court held that this opinion was also inadmissible because the expert’s diagnostic methods were not generally accepted.  As such, the court concluded, “To allow the jury to hear [the expert’s] opinion on this point would be to allow the jury to hear conclusions based on inferior diagnostic metrics.  This will not be permitted.” Id. at *20.

Next, the court addressed the expert’s opinion that the decedent “suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain.” Id. at *20-21.  The court held that the expert lacked the “knowledge, skill, training, or education that would qualify him to diagnose neurologic injuries.” Id. at 21 (internal punctuation and citation omitted).  Moreover, the opinion lacked any scientific basis, as the autopsy revealed no sign of hypoxic encephalopathy.   The court concluded, “[The expert] is not being as careful as he would be in his regular professional work outside his paid litigation consulting.  A jury has no use for [this type of speculation], especially from someone whose expertise lies elsewhere.” Id. at *24.

The court did not exclude the expert’s entire report, permitting him to testify that the decedent’s heart was injured during his surgery and to indicate what he relied upon to form his opinions. It held, however, that the expert would not be permitted “to give a general narrative of Mr. Smith’s health before, during, and after the surgery.” Id.

We like this opinion. It draws the correct lines, and it does so in clear and logical fashion.  It also reinforces the oft-apparent conclusion that plaintiffs’ lawyers disserve their clients when they hire the wrong people, and pay them to say the wrong things, in their quests for big settlement paychecks.   We will continue to keep you posted on judges who properly bar the courtroom doors against such experts, and those who don’t.

This post is from the non-Reed Smith side of the blog.

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and oh-so-creative imagining of the backstory of “the Witches of Oz” – Galinda (later, without the first “a,” the “Good Witch of the North”) and Elphaba, the viridescent lass who, in Baum’s classics, grew up to achieve infamy as the “Wicked Witch of the West” – beginning with their days as schoolgirls and reluctant roommates.  We are eternally charmed by the subtle scarecrow-Toto-Dorothy references woven throughout (we notice at least one new one every time we see the show) and we never tire of the score (“Defying Gravity,” “For Good”).  We also don’t think it puts too fine a point on it to appreciate the resonance of a character whose life is shaped by a childhood in which she never “fit” and to be gratified by her unlikely happy ending.

 

And in this manner (wait ‘til you see this tie-in), the lesson diverges from unhappy ending of the plaintiff’s expert metallurgist in today’s case, whose conclusions were excluded, in part, because they did not “fit” the facts of the case and the issues the expert had considered. In its (regrettably) unpublished and (not regrettably) short decision in Redd v. DePuy Orthopedics, Inc., 2017 WL 2859536 (8th Cir. June 6 2017), which features an appearance by our beloved “sham affidavit doctrine,” the United States Court of Appeals for the Eighth Circuit reviewed the Eastern District of Missouri’s decision excluding the plaintiff’s expert’s “defect” and “causation” testimony and granting summary judgment for the defendant.

 

In Redd, the plaintiff – five feet tall, 302 pounds, and taking immunosuppressant drugs – received a total hip replacement using the defendant’s artificial hip.  Four years later, the hip stem fractured.  When it was removed, “doctors learned that it had not properly grown into the bone at the top of [the plaintiff’s] hip,” 2017 WL 2859536 at *1.  Plaintiff’s doctors were aware of this risk, heightened by the plaintiff’s marked obesity and her medications.  The plaintiff was implanted with a second hip stem, which similarly fractured less than two years later.

 

The plaintiff filed suit, asserting the usual negligence, strict liability, and manufacturing defect claims. She retained her metallurgy expert to opine about the cause of the hip stems’ fractures.  The expert “had done research in fatigue fracture initiation in metal objects but not in metal objects implanted in the human body.  His analysis considered metallurgical factors but not any biomechanical factors (such as a hip stem’s failure to grow into the hip bone . . .).” Id. He also “did not review any records related to the manufacturing process . . . .” Id. He opined that the fracture of the plaintiff’s hip stem was caused by the improper “phase” of the metal along with the “grain size” of the metal alloy (metallurgical terms of art, we assume).  He “acknowledged that environmental factors could have also contributed to the failure of the hip implant, but said that any small variation in the biomechanical forces would have been secondary in nature to the hip stem’s . . . state” in causing the failure. Id. (internal punctuation omitted).

 

The defendant moved for exclusion of the expert’s testimony and for summary judgment. In response, the plaintiff submitted an affidavit in which the expert testified, for the first time, that the “phase” of the metal in the hip stem violated the defendant’s own specifications, and that “environmental factors would be secondary in the cause of the fracture when the material is inherently defective to begin with.” Id. (internal punctuation omitted).  The defendant moved to strike the affidavit on the grounds that it impermissibly supplemented or changed the expert’s opinion after the close of discovery.

 

Throw a little Daubert on this expert, and his opinions melt away.

 

The district court held that the expert, while qualified to testify about metallurgy, lacked a scientific or factual basis for his “manufacturing defect” or “causation” testimony. The court further found that the expert had failed to consider the issue of the forces that were exerted on the implant inside the plaintiff’s body.  Finally, the court granted the defendant’s motion to strike the expert’s affidavit, noting that statements in the affidavit contradicted the expert’s earlier testimony and “a party cannot change testimony,” by submitting an affidavit, “just to avoid summary judgment or a Daubert motion.” Id. at *2.  (This is the “sham affidavit doctrine,” which we have used with glee and success in our own appeals.)  With the expert’s “defect” and “causation” testimony excluded, the plaintiff could not meet her burden of proving those claims, and the court granted summary judgment for the defendant.

 

On appeal, the Eighth Circuit affirmed all of the district court’s holdings. First, it held that the expert’s affidavit, invoking, inter alia, manufacturing specifications he earlier testified that he had not been provided, “arguably crossed the line between clarifying prior testimony and changing prior testimony,” id. (citation omitted); thus, the district court had not abused its discretion in excluding the affidavit from consideration.  The court also rejected the plaintiff’s argument that the district court had erred when it required the expert to exclude biomechanical causes of the plaintiff’s fracture.  The court emphasized that, while “an expert need not rule out all possible causes of an injury, [he] nonetheless should adequately account for obvious alternative explanations.” Id. at *3 (internal punctuation and citation omitted).  In this case, the expert failed to consider the obvious alternative cause of the plaintiff’s fracture; namely “the failure of the hip stem to grow into [the plaintiff’s] hip bone and properly distribute her weight,” id, and gave no consideration to the biomechanical forces applied to the hip stem.  As such, the court concluded, the district court had acted within its discretion in excluding the expert’s testimony on causation and defect.

 

Short, tidy, and correct on all counts. Keep ‘em coming.  As for us, we are off to see the Wizard (again).

This post is from the non-Reed Smith side of the blog.

Usually when we are talking about Michigan, it’s to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.” M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b).  Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it’s somewhat rare to get to post on a Michigan law case that isn’t focused on the statute or preemption, but we found one – Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff’s surgeon in plaintiff’s hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in “Class I/Clean wounds.” Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19.   In addition, the product’s labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to “high concentrations of digestive enzymes.” Id. at *17.

Against this background, plaintiff filed suit alleging that defendant’s product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant’s insufficient testing led it to market the product as a “biologic mesh,” when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff’s injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff’s treating surgeon who performed the surgery removing the mesh. Plaintiff opted not to have Dr. Rosen prepare a full Rule 26 expert report, the consequences of which were that he would be limited to testifying as a treating physician and so only permitted to testify as to those opinions that were formed “for purposes of, and within the scope of, his care and treatment of [plaintiff].” Id. at *2. Most of Dr. Rosen’s opinions were not.

For example, Dr. Rosen’s opinion that the mesh was unsafe for use in Class I wound was excluded as not being related to his care and treatment of the plaintiff. That may have been an opinion he held at the time he treated plaintiff, but it was not formed for the purpose of or within the scope of his care and treatment of plaintiff. Id. at *23. He had no reason to form a safety opinion to care for and treat plaintiff and he didn’t include any such opinion in his medical records or in any discussion with plaintiff or any of his colleagues. Id. Moreover, Dr. Rosen did not report plaintiff’s case to the FDA as an adverse event. Id. Dr. Rosen’s opinions on the sufficiency of the testing and adequacy of the warning suffered the same fate – to even be considered potentially admissible Dr. Rosen needed to prepare a proper Rule 26 expert report “setting forth the scientific or experiential basis” of his theories. Id. at *25.

But that wasn’t the only fatal flaw for Dr. Rosen’s opinions. His opinions were also unsupported. Unlike his litigation opinion that defendant’s biologic mesh was unsafe for Class I wounds, Dr. Rosen had opined in numerous peer-reviewed articles that defendant’s product was acceptable in that precise situation. Id. at *23-24. The blatant contradiction was another ground for exclusion. Id. at *25. These same peer-reviewed publications also discussed the need for further study of the biologic mesh for treating Class II and III wounds, but nowhere suggested that further testing was needed regarding treatment of Class I wounds such as plaintiffs. So, Dr. Rosen’s opinions on adequate testing were also unsupported. Id. at *26.

As to the adequacy of the warning, plaintiff argued that the product’s labeling should have included a warning to remove the mesh in the event of a seroma (what plaintiff had) or an infection. Id. Dr. Rosen, however, could only opine that “there should be more information” about the types of cases for which the mesh should be used. Id.  That was not enough to clear plaintiff’s hurdle of proving as a matter of law that defendant had a duty to warn. Id. Moreover, as noted above, the label did warn about weakening and breakdown – the very side effects plaintiff suffered. Id.

Finally, Dr. Rosen also offered an opinion on causation. He testified that he saw the mesh “sitting on a bed of pus,” removed it, and concluded that the mesh caused the infection because the infection cleared up after removal. Id. at *29. The court didn’t question that Dr. Rosen knew an infection when he saw it.  But “the ability to diagnose medical conditions is not remotely the same … as the ability to deduce … in a scientifically reliable manner, the causes of those medical conditions.” Id. (citation omitted). Bottom line – nowhere in his opinion did Dr. Rosen rule out the other potential causes of plaintiff’s infection and failure to heal; such as his diabetes, obesity, blood pressure, and use of immunosuppressants. Id. *29-30.

But Dr. Rosen wasn’t the only problem with plaintiff’s case. Plaintiff’s failure to warn claim also failed for lack of causation. First, the learned intermediary doctrine applies to a medical device. Id. at *21-22. So any duty to warn ran to plaintiff’s surgeon. Second, there was no evidence that plaintiff’s surgeon read the product’s labeling. Id. at *29.   He had not met with the defendant’s representative, had not read the instructions for use, and had not read any of the literature about the product. Under this circumstance, no additional or different warning would have made a difference because the doctor wouldn’t have seen it. No failure to warn.

Defendant also had no duty to conduct a randomized prospective clinical trial before marketing the product. There was no evidence that such a clinical trial was the standard of care for 510k mesh products at the time defendant’s product was approved. Id. at *27.

Plaintiff paid dearly for failing to serve a Rule 26 expert report for their sole medical expert, although it appears that even with a report very little of what their expert was offered to opine on would have been admissible under Daubert anyway. And with no causal nexus between the doctor and the warning, plaintiff’s failure to warn claim was dubious regardless of whether the expert testimony was admissible or not. While any one of these things would have sunk the case, we’re glad the court explored them all. The opinion is loaded with good precedent.

Earlier this week, we posted on the Ninth Circuit’s conversion of the Daubert’s gate (that the trial court should keep) into more of a swinging saloon door.  A week before the Ninth Circuit ruled that a trial court had erred in excluding unreliable causation testimony (and granting summary judgment as a result), the Third Circuit had affirmed a trial court’s exclusion of unreliable causation testimony (and grant of summary judgment as a result).  Even though we are discussing In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., __ F.3d __, 2017 WL 2385279 (3d Cir. 2017), second, it really is a bigger deal because it reaffirmed the end of an entire MDL.

We followed the district court’s Daubert rulings on the epidemiology and mechanism experts offered for all the plaintiffs.  We watched in amazement as the plaintiffs got to try again and still could not offer reliable expert testimony on general causation.   With our typical restraint, we applauded the court’s subsequent decision that no plaintiff could make out a case for general causation between maternal use of the drug and the cardiac birth defects claimed without the excluded experts and that was fatal to their claims.  We found that the plaintiffs, maybe because of the sympathy associated with their claimed injuries, got plenty of leeway before the court determined that there was simply no there (i.e., good science) there.  (Along the way, we saw that Pennsylvania and West Virginia state courts came to similar conclusions.)

The appeal to the Third Circuit focused on whether the biostatistician offered as a back-up expert on epidemiology was properly excluded, with plaintiffs conceding that they should have lost if he was.  Plaintiffs’ central contention was that the district court created a standard that requires general causation opinions to be “supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect.”  We think that standard, similar to Havner and Daubert II, is a fine standard, but the district court did not create or apply such a standard in knocking out the biostatistician.  Likewise, the Third Circuit declined to “state a bright-line rule” that “statistical significance is necessary to prove causality.”  (We think it is, because the Bradford Hill Criteria, which the biostatistician purported to apply, starts with an association demonstrated through epidemiologic studies.  We will try to resist arguing for the tighter standard given the result.)  The district court considered the lack of multiple statistically significant studies supporting an association to be contrary to what teratologists generally require and thus relevant to whether an opinion without such support was unreliable.  A flexible approach to evaluating the reliability of a general causation opinion was fine with the Third Circuit and its reading of the Bradford Hill Criteria.  (There is flexibility, but only when there is an association from epidemiologic studies as a predicate.  OK, we will have to try harder.)

The Third Circuit “accept[ed] that the Bradford Hill and weight of the evidence analyses are generally reliable.  We also assume that the ‘techniques’ used to implement the analysis (here, meta-analysis, trend analysis, and reanalysis) are themselves reliable.”  That assumption is dicta—which is a good thing—because the court concluded that the biostatistician did not reliably apply the methodology or techniques that he claimed to be applying.  First, he gave lip service to analyzing “multiple positive, insignificant results,” but he really just eyeballed trends.  Second, his trend analysis was based on cherry picking and inconsistent application of basic statistics principles.  Third, his meta-analysis was also result-driven, as he could not justify why he included some studies and excluded others.  Fourth, his reanalysis was done for no reason but to conclude that a published study reporting no association should have found one.  Altogether, “the fact that Dr. Jewell applied these techniques inconsistently, without explanation, to different subsets of the body of evidence raises real issues of reliability.  Conclusions drawn from such unreliable application are themselves questionable.”

The court probably could have stopped there.  It went on to detail how the biostatistician’s purported application of Bradford Hill was riddled with errors that he could not explain.  This was more than enough to conclude that the district court had not abused its discretion in excluding the expert.

Along the way, however, it noted that it may be possible to have a reliable reanalysis that draws a different conclusion than the original published study and that an expert can make unsupported assumptions in connection with doing an “informational” reanalysis.  It offered that “[t]hese inquiries are more appropriately left to the jury.”  We disagree and think the broader context has to be considered.  A plaintiff’s expert offered on the epidemiologic evidence who cannot offer a reliable opinion that there is an association between the exposure and the type of injury the plaintiff claims, let alone that there is a causal relationship, should not be talking to the jury about anything.  A plaintiff’s expert offered on the epidemiologic evidence who can offer a reliable opinion that there is a causal relationship between the exposure and the type of injury the plaintiff claims can be allowed to discuss the various analyses she did to form that opinion.  And the defense can cross-examine her on whether some of her analysis was result-driven for-litigation drivel or based on unsupported assumptions.  A jury can hear that sort of back and forth and decide what weight to give to the expert’s testimony on general causation.  However, no trial court should abrogate its gatekeeping role and let juries hear about reanalysis of published studies unless plaintiffs have reliable evidence of general causation in the first place.  I guess we prefer the opinions of the district court, which took its gatekeeping seriously, even if it let plaintiffs take a few shots at entry.

Let’s start with a shameless plug: the author of this post, along with Sean Wajert (Shook Hardy & Bacon), will present a Strafford webinar on June 21 entitled, “Daubert/Frye Motions in Product Liability Litigation: Bringing or Defending Challenges to Expert Witness Evidence.”  Here is the link.  We will cover a lot of areas and a lot of cases.  Odds are good that the most recent case covered will be Wendell v. GlaxoSmithKline, LLC, 2017 WL 2381122 (9th Cir. June 2, 2017).  That’s too bad, because it is not a well-reasoned case.  It is a backwards step in Daubert analysis. For people who favor rigorous application of Daubert to keep junk science out of the courtroom, the Ninth Circuit’s Wendell decision is the worst sort, because it reverses a district court’s exclusion of expert opinions lacking support in epidemiology, animal studies or biologicals plausibility — meaning Wendell said it was an abuse of discretion for the district court to exclude the opinions.  That is the kind of precedent that can turn nervous judges from gatekeepers to matadors who grimly wave junk science along to the jury.

The plaintiffs in Wendell alleged that their son died because medicines used to treat inflammatory bowel disease (IBD) caused him to develop cancer.  The plaintiffs proffered two causation experts, but the district court found their opinions unreliable and, therefore, inadmissible under Federal Rule of Evidence 702.  The court subsequently granted summary judgment in favor of the defendants.  A key issue on appeal was the district court’s exclusion of the plaintiff experts’ opinions.  The district court had identified several problems with those opinions.  Here are some:

– The opinions were litigation-driven, were based on no independent research, and would not satisfy the standards for peer-reviewed journals.
– No animal or epidemiological studies showed a causal link.
– The studies cited by the experts did not show that the specific combination of drugs prescribed to the plaintiffs’ decedent actually caused the injury at issue.
– The experts did not present any scientific evidence excluding IBD itself as a risk factor for the injury.

The Ninth Circuit called it “a close question” in concluding that the district court erred in excluding the expert testimony. In the eyes of the appellate court, the litigation-driven, non-study-supported, non-alternate-cause-excluding nature of the expert opinions should not overcome the facts that the experts were “highly qualified doctors” who had performed a “differential diagnosis” in arriving at their opinions.  The Ninth Circuit’s analysis is unsatisfactory.  First, the qualifications of the experts is a different issue from reliability of their methodologies.  Under Rule 702, a qualified expert may testify if her testimony would be helpful to the jury, if she relied upon the appropriate facts/data, if she employed reliable methods, and if she reasonably applied those methods to the facts of the case.  That is, qualifications are a precursor to reliability, not a substitute for it.  If a Nobel prize winner renders an opinion based on astrology or phrenology, that opinion should be excluded no matter how impressed we are to be in the presence of such a luminary.  Second, the Ninth Circuit looks at each of the methodological problems identified by the district court one-by-one, and repeatedly holds that the deficiency by itself (e.g., lack of animal studies), cannot exclude expert testimony.  Maybe so, but when the opinions of an expert (no matter how well qualified) are beset by so many deficiencies, how can it be an abuse of discretion for a diligent district court to decide that the opinions do not pass muster?  In truth, the Ninth Circuit did not apply anything close to an abuse of discretion standard of review.  Rather, it engaged in a de novo review of the expert opinion issue, and did so in a remarkably wrong-headed fashion.  The results of this precedent could be seriously damaging.  If sparkling CV’s and invocations of “differential diagnosis” (and that’s not what was done by the experts by the way, but that’s a different point) can get causation opinions and a case to a jury, then Daubert has been diluted to the point of meaninglessness.

We will mimic the style of the great television critic Alan Sepinwall and end with some random observations:

– Along with two Ninth Circuit judges, the Wendell panel included a Vermont district judge who had authored an outlier opinion predicting that Vermont would adopt innovator liability.

– The Wendell opinion cites the Ferebee opinion from the D.C. Circuit.  Ferebee is seldom a harbinger of anything good for defendants.

– The Wendell opinion is sufficiently bad and problematic to merit en banc or Supreme Court reversal.

With the Phillies stinking the joint out – off to their worst start since World War II – and both of Boranian’s local teams in last place, too (not as deeply buried as the Phillies), use of baseball imagery might seem a bit painful right now.  Only our DC-based blogger has had anything worth cheering about lately, and with what’s going on there recently….  Baseball must be a welcome distraction.

But a one-two-three inning was what came to mind in looking at the new decisions that turned up last week. We were struck by three relatively easy wins for defendants.  Individually, they would not warrant separate post, but under a “totality of the evidence” standard, when added together, we found them worth discussing

The first is N.K. v. Abbott Laboratories, 2017 WL 2241507 (E.D.N.Y. May 22, 2017), a Depakote/birth defects case.  There are a number of these cases around, and we have already commented on several.  But we have to say, if the other side’s experts are as poor as they were in N.K, this litigation deservedly isn’t going anywhere.  N.K. went away on summary judgment after all of the plaintiff’s “experts” – and the term deserves to be in quotes – were excluded from testifying.  The first purported expert was the minor-plaintiff’s treating pediatrician, who was totally out of her depth:

[The witness] has never conducted research on Depakote or valproic acid. Nor has she researched the effects of in utero exposure to valproic acid (“valproate exposure”).  Prior to [minor plaintiff’s] first visit, her knowledge of Depakote was limited to refilling prescriptions for epileptic patients.  Since that initial visit, she has conducted little to no additional research on Depakote, valproic acid, or valproate exposure.

2017 WL 2241507, at *2 (record citations omitted).  Unsurprisingly, the court found this witness “not qualified to testify that Depakote caused [minor-plaintiff’s] injuries.”  Id. at *3.  She possessed no applicable medical experience nor had she bothered even to review the relevant literature.  Id. (she “did not perform any research or make any additional investigation that might qualify her as an expert on valproate exposure”).  Instead, “[h]er attempts to understand the cause of [minor-plaintiff’s] injuries were limited to a single review of a single medical book, the day of his first visit.”  Id.  This is hardly the kind of expert we would expect to see in litigation where a strong causation case is present.

The second expert in N.K. “ha[d] a more substantial background” – it could hardly have been less – but was not even a medical doctor.  Id. at *4.  Again, we would not expect to see this kind of “expert” in a strong case.  Lack of a medical degree is a problem.  “[C]ourts have consistently drawn a distinction between the qualifications of medical and non-medical doctors, noting that non-medical doctors who are qualified to diagnose a medical condition may be unable to reliably determine its cause.”  Id.  This witness was a “teratologist and toxicologist,” but had no relevant diagnostic expertise.  “[B]y his own testimony he has never evaluated children, has never been called upon to diagnose dysmorphic features or autism in a child, and is not a clinician.”  Id.

Nor did these unqualified “experts” use proper methodology.  They both purported to engage in the last refuge of a Daubert scoundrel – differential diagnosis.  The pediatrician “viewed [minor plaintiff’s] condition as either genetic or the result of prenatal valproate exposure.”  Id. at *5.  Which one didn’t she investigate?

She reached this conclusion before eliminating any genetic causes. . . .  Not only did [she] fail to eliminate alternative causes before reaching her initial conclusion, she lacked the knowledge to independently rule out genetic causes.

Id.  Genetics were a serious alternative  “[A]t least four other treating physicians have recommended further genetic testing to determine the cause of [minor plaintiff’s] injuries.”  Id.  The court could hardly be faulted for wondering what these plaintiffs were hiding in not having this testing done.

The other expert – the one that wasn’t even a doctor – was, if anything worse.  He “did not conduct his own independent investigation,” rather “[h]is opinion is based entirely on reviewing existing reports provided to him by Plaintiffs.”  Id. at *7.  Having to spoon-feed an expert is another indicator of a weak case.  Beyond that, his “attempt to rule out potential alternative causes of [minor plaintiff’s] condition is plagued by the same problems as” the pediatrician’s.  Indeed, “[h]e relied on [her] flawed report in ruling out genetic causes.”  Id.

Finally, plaintiffs failed to slip the pediatrician’s opinions in the back door, as “factual” testimony by a treater.  A treater’s testimony was equally subject to Daubert:

Even if such an opinion could be read into her records, classifying [her] as a fact expert does not relieve this Court of its duty to ensure she utilized reliable methods in reaching her opinion.  Courts in this district have found that when a treating physician seeks to render an opinion on causation, that opinion is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for the purposes of litigation.

Id. at *8 (citations and quotation marks omitted).  To us, this is the most significant legal ruling in N.K.

Summary judgment granted.  One away on a dribbler to the mound.

Next up, Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017). Rincon failed on a motion to dismiss, because of TwIqbal.  Rincon involved hernia mesh, and an alleged injury suffered more than six years after implantation.  Id. at *1.  Plaintiff’s complaint had a rather fundamental – and fatal – flaw.  It failed to allege that a defect caused the alleged injuries:

[Plaintiff] fails to allege any facts that plausibly establish such causation. . . .  Taken together, these facts − even liberally construed (not that there is a basis for liberal construction here) − fall far short of demonstrating that [defendant’s] mesh was a “but for” cause of [her] later injuries. . . .  Nothing in the Amended Complaint even endeavors to explain why the mesh is a more likely, let alone proximate, cause of [plaintiff’s] alleged harms.

Id.  One would have thought that, with an obvious serious timing issue, the plaintiff would have tried harder in Rincon to allege the sort of critical facts supportive of causation.  The absence of these facts is another marker of a weak case.

But not only did the plaintiff in Rincon fail to allege causation; she also failed to allege defect:

Under New York law, Rincon must prove the existence of a defect. . . .  But [plaintiff] fails to allege a defect except in the most conclusory terms:  that [defendant] manufactured the PCO mesh, that the mesh was used during her hernia surgery in 2006, that she needed subsequent medical procedures in 2012 and 2013, and thus [defendant] must not have “properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided [ ] the proper warnings” regarding the mesh.

Id. at *2.  To make matters worse, plaintiff tried to make up her pleading defects in her brief opposing dismissal.  The court was not impressed.  Those assertions “serve only to illustrate the deficiencies in her Amended Complaint − namely, that it does not identify any actual defect in the coating and says nothing about how the coating, even if defective, caused [her] specific injuries.”  Id.

On top of that, plaintiff only “suggest[ed],” but did not actually seek, leave to amend.  Id.  Plaintiff’s notably poor pleading resulted in dismissal with prejudice.   “[E]ven if [she] were to add her new ‘facts’ . . ., her claims would all still fail for the reasons discussed above.”

Called third strike.  Two down, and add one to our TwIqbal cheat sheet.

The final out was made by Merancio v. Smith & Nephew, Inc., 2017 WL 2257124 (E.D. Cal. May 23, 2017), where summary judgment was granted after the plaintiffs failed to retain the allegedly defective implant.  The complaint itself was a mess, which certainly did plaintiffs no favors.  “[N]either factual details concerning plaintiffs’ claimed injuries nor specific legal theories of liability have been alleged in any detail.”  Id. at *1.  Having lost the device that supposedly failed plaintiffs “presented no substantive evidence concerning the merits of their claims.”  Id.  Instead, they pursued another all too common “last refuge of a scoundrel” tactics – attempting to litigate the defendant’s supposed discovery lapses.

That didn’t work this time.  Whatever deficiencies (if any at all) in the defendant’s initial disclosures were irrelevant by the time summary judgment rolled around.  Even if the identity of the affiant who supported the summary judgment motion was disclosed too late, it was disclosed “well prior to the close of discovery,” and the witness “was ultimately deposed by plaintiffs.”  Id. at *4.  Like too much pine tar on a bat, the violation, if it existed at all, was harmless.  Or, to mix sports metaphors, “no harm, no foul.”  “Plaintiffs have made no showing that they were prejudiced by the timing of defendant’s disclosures.  Indeed, plaintiffs have made no allegations of any harm − not even general, vague, and conclusory ones − flowing from defendant’s allegedly belated disclosures.”  Id.

So plaintiffs tried again, arguing that the court should ignore the defendant’s affidavit, which was factually undisputed, because the affiant “failed to include a list of cases in which he has appeared as an expert.”  Id. at *5.  The court was having none of plaintiffs’ trivial pursuit.  If plaintiffs thought this deficiency was so important, they should have done something about it earlier, rather than pursue a nitpicking litigation strategy:

[P]laintiffs’ counsel never asked defense counsel or the expert for this list and never filed a motion to compel with the court seeking the information or the imposition of sanctions. . . .  Again, plaintiffs do not even generally suggest how they have been harmed as a result of these minor deficiencies in [defendant’s] expert report.  Indeed, when asked at the hearing on the pending motion, plaintiffs’ counsel suggested he purposefully did not pursue any further efforts to obtain the list of cases in which [the affiant] had appeared as an expert because, in counsel’s view, it made defendant’s expert “attackable.”

Id. (emphasis added).

With plaintiffs’ discovery smokescreen blown away, summary judgment was inevitable.  “It [was] undisputed on summary judgment that, at the time the parts used in [plaintiff’s] knee replacement left the control of defendant, they had been inspected, passed quality control inspections, and were in compliance with all applicable FDA regulations.”  Id. at *7.  Defect at sale is a “necessary element” of strict liability.  Id.  Further, California simply does not recognize strict liability design defect claims involving prescription medical products.  Id.  Negligence failed because of a “complete failure of proof” that the device failed when it shouldn’t have.  Id. at *8.  Finally, plaintiffs’ warranty claim was dismissed (in addition to the above grounds) on an interesting legal ruling − that the personal injury damages were not available for alleged breach of contract:

Here, plaintiff seeks general damages for pain, suffering, and inconvenience, and special damages for medical expenses, future medical expenses, loss of earnings, [plaintiff] seeks here are generally not cognizable in claims sounding in contract in California.

Id. (citations omitted).  Finally, with no evidence “that the defendant negligently injured” her spouse, that wife-plaintiff’s consortium claim bit the dust. Id. at *9.

Side retired on a (very) foul popup.

Weak claims all in N.K., Rincon, and Merancio. Daubert, TwIqbal, and simple failure to prove the claim defeated these actions, and did so fairly expeditiously.   Which is as it should be.  Weak claims have no business being brought, and where plaintiffs are unable to hide weak claims in MDLs, these cases demonstrate that (at least in the federal courts), the civil justice system still works.

Discovery regarding expert witnesses can be tricky.  In our neck of the woods, the great Commonwealth of Pennsylvania, state courts almost never permit depositions of experts.  If you want to ask the expert questions – and you will – you must wait until trial.  The flip side of that restriction is that expert reports in Pennsylvania must really and truly and completely disclose the expert’s opinion.  If an expert at trial strays a millimeter past the four corners of the expert report, the court will shut such testimony down.  By contrast, in most court systems, including the federal system, discovery regarding expert witnesses is extensive, and the deposition of the other side’s expert is usually one of the most consequential moments in the litigation.

 

Mind you, we are talking about testifying experts.  Parties can retain experts who will testify at trial, but they can also retain experts who serve purely as consultants.  Those consulting experts work behind the scenes, furnishing facts and ideas.  They might, for example, help us prepare to depose the other side’s experts.  These consulting experts are usually not subjected to the discovery maw. 

 

But what if an expert transforms from consultant to testifier in the course of a litigation?  What and how much is discoverable?  That interesting scenario arose in In Re: Abilify (Aripiprazole) Prods. Liab. Litig.,  2017 U.S. Dist. LEXIS 73847 (N.D. Fla. May 15, 2017).  The plaintiff lawyers talked to an expert “informally,” then later retained him.  That expert had conducted research, resulting in an article, upon which the plaintiffs then relied.  The defendants sought to depose that expert about the article, including whether the plaintiff lawyers influenced the study.  The defense did not want the plaintiffs’ expert to point proudly to a peer reviewed study if the plaintiff lawyers had done as much reviewing as the peers.   

 

As you can imagine, the plaintiff lawyers resisted.  They argued that questions about the inputs into the article would have a chilling effect on scientific research.   The plaintiffs object to any discovery into communications between the expert and plaintiffs’ counsel because Fed. R. Civ. P. 26(b)(4)(D) protects informal consultation with experts: “Ordinarily, a party may not, by interrogatories or deposition discovery facts known or opinions held by an expert who has been retained or specially employed by another party in anticipation of litigation or to prepare for trial and who is not expected to be called as a witness at trial”  except on a “showing [of] exceptional circumstances under which it is impracticable for the party to obtain facts or opinions on the same subject by other means.”  The plaintiffs also objected because communications with the expert were protected opinion work product under Fed. R. Civ. P. 26(b)(3): the court “must protect against disclosure of mental impressions, conclusions, opinions, or legal theories of a party’s attorney or other representative concerning the litigation.”   

 

The court allowed some discovery, but within limits.  The court held that the defendants could question the expert about the plaintiffs’ influence on the study, as it is an aspect of bias.  Even if the influence occurred during the “informal” consultant period, it was fair game.  Thus, the defendants were permitted to inquire whether the expert “made any changes to the timing, methodology, or other relevant aspect of the study following communications with Plaintiffs’ counsel.”  Further, to the extent that the expert “initiated contact with Plaintiffs’ counsel, Defendants are free to inquire into his motive and the timing of such contact.”  But the court also held that the defendants could not inquire into work product (“regarding any opinions or case strategies shared by Plaintiffs’ counsel, or any other inquiries made by plaintiffs’ counsel that related to the preparation of their case”) unless the deposition established that the plaintiffs influenced the conduct of the study.  If evidence of the plaintiffs’ lawyers inputs into the study surfaces during the deposition, the parties would need to contact the Judge to determine whether a waiver of work product had taken place. 

 

This case is not really a ‘win’ for plaintiffs or defendants, because the court’s decision threads the needle fairly carefully, and because, considering the rule from an ex ante perspective, both plaintiffs and defendants might retain consulting experts who later become testifiers.  Rather, the case represents an unusual, but not impossible, situation where both sides must be especially careful.