It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal. Nov. 8, 2017).  Here, we are talking about Daubert rulings.  (The court also issued good preemption rulings that might be the subject of a separate post.)  The Laux court’s Daubert order is not up on Westlaw or Lexis yet, but it will be, and that is good news for defendants and bad news for plaintiffs.

The plaintiff in Laux alleged that she suffered pain and other injuries as a result of moldy silicone breast implants.  Her allegations depended upon opinions by a three experts:  Kolb, Blais, and Brawer.  At least two of these experts are repeat players. The other might be as well, but we confess to being a little out of touch with this litigation. One plaintiff expert (Kolb) explanted the implants and concluded that they were leaking bilaterally.  Another (Blais) examined the implants and concluded that they had defective valves, causing them to leak bilaterally. The moldy saline implant theory has persisted since the turn of the century, largely propped up by a book, The Naked Truth About Breast Implants, written by – ta da! – one of these experts.  Another one of the experts testified long ago at the FDA panel hearings and raised the theory back then that breast implants contained a manufacturing defect that either (1) allowed bi-directional flow of saline and bodily fluid in and out of the valves such that the saline became contaminated by “toxic mold” that then colonized and leached “biotoxins” into plaintiff’s body; or (2) allowed the silicone shell or toxins/metals to flake off in plaintiff’s tissue.  To our moldy eyes, this theory seems driven more by litigation than science.  Is our cynicism based at all on the fact that these selfsame experts seem to be actively working with plaintiffs’ counsel to resurrect breast implant litigation, claiming breast implants cause systemic autoimmune disease despite dozens of epidemiological studies to the contrary?  Yes.  Yes, it is.

In any event, these experts’ sparkling resumes did not dazzle the Laux court. Their methodologies were even weaker than their qualifications, which, as you will see, is really saying something.

By the way, this is hardly our favorite trio.  Here are just a few we prefer:

  • Harry, Hermione, and Ron
  • Kirk, Spock, and Bones
  • The Three Musketeers (literary or candy version)
  • The Three Fates
  • Three Dog Night
  • Three’s Company
  • The Three Amigos
  • Tinkers to Evers to Chance
  • The Good, the Bad, and the Ugly
  • The Dude, Walter, and Donny
  • Willie, Mickey, and The Duke
  • ZZ Top
  • Cream
  • Emerson, Lake, and Palmer
  • The Police
  • Destiny’s Child
  • The Three Tenors
  • Workaholics
  • Moe, Larry, and Curly.  (Heck, we also prefer Moe, Larry, and Shemp to any assortment of litigation/expert stooges.).

Anyway, here, in brief, is how the Laux court concluded that the three plaintiff expert (three blind mice?) opinions could not survive a Daubert challenge:

Kolb

The court deemed Kolb to be insufficiently qualified to provide the proposed testimony. Big surprise: a plastic surgeon is not competent to testify about immunology, mycology (the study of fungi), or infectious disease. Moreover, Kolb’s methodology, such as it was, was unreliable.  Yes, the “differential diagnosis” incantation was muttered by this expert, but to no effect. Kolb’s expert report stated that the plaintiff had developed biotoxin disease from defective implants, and that “Plaintiff had no other environmental mold exposure to account for these symptoms.”  Oops. That premise was directly contradicted by the plaintiff’s earlier statement that she was exposed to mold found in her bedroom closet and mother’s home. Further, Kolb’s failure to test for TGF beta 1 also prevented her from ruling out environmental exposure from an objective perspective.  The court decried Kolb’s “[u]nexplained selective use of the facts” which failed “to satisfy the scientific method.” None of Kolb’s theories had been tested, peer reviewed, or generally accepted by the scientific community.  Her “inferential leap” from the plaintiff’s symptoms to the conclusion that the plaintiff suffered from biotoxin disease was unsupported by any peer-reviewed scientific literature or research.  Adios, litigation expert amigo #1.

 

Blais

 

Blais is a chemist, not a microbiologist, pathologist, medical doctor, or engineer.  Blais has not published any of his theories on bacterial or fungal colonization of saline implants in peer-reviewed literature.  So much for qualifications.  Reliable methodology was also lacking.  Blais supplied a “Failure Analysis Report,” but the real failure was in the expert’s purported analysis, not the product. In developing his opinions for this case, Blais did not test the plaintiff’s breast implants, tissues, or blood, and did not establish a scientific basis for his conclusion that the plaintiff’s injuries were caused by the defendant’s breast implants.  The defendant argued that Blais’s “‘methodology’ essentially consists of looking at explanted breast implants, sometimes with the aid of a microscope, making a few notes and drawing pictures of what he claims to see.”  Not so impressive.  Blais took no measurements of the valves to support his opinion they contained manufacturing defects.  Rather, Blais stated that he “eyeball[ ed]” the valves to determine they were faulty.  Still not impressive. In addition (or subtraction?), Blais did not possess the defendant’s valve design specifications when he concluded that the valves on the plaintiff’s implants were defective. Instead, Blais utilized old documents and his own memory.  The Laux court concluded, as had other courts in earlier decisions, that Blais’s proffered testimony should never reach a juror’s ears. As Harry Potter might say, expulsus expertous hackus nonsensicus.

 

Brawer

 

There were some technical problems with Brawer’s expert report.  It recited “a toxicology opinion with no data in support of that opinion whatsoever.” (emphasis in original)  Brawer opines that there was “breast implant toxicity,” but neglects to state what toxic substance was at issue.  That would seem to be a problematic gap in the analysis.  The Laux court could find no support for Brawer’s “because I said so” – in lawyerese, we sometimes call it ipse dixit — conclusion regarding breast implant toxicityThus, the court held that Brawer’s report “fails to satisfy several requirements of Rule 26, and his report is so lacking of scientific principles and methods that the Court cannot find his opinions reliable or helpful in this case.”

 

Three up, three down.  It reminds us of a typical inning thrown by the late Roy Halladay.

 

Meanwhile, three cheers to Dustin Rawlin and Monee Hanna of Tucker Ellis, who brought this ruling to our attention.

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.

 

 

 

 

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.

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).

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.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play.  It was entirely dialogue-driven, so everything the audience learned came out of a character’s mouth – there was no action to speak of.  It was also perfectly cast, well-acted, and absorbing.  By the end of the first 75 minutes, we cared a lot about the characters and were anxious to learn how their story ended.  Then came the revelation (residents of our neighborhood who intend to see this play should skip this spoiler) that nothing we had seen and heard had actually happened, at least in anything like the fashion we had come to understand.  The (mostly glowing) reviews described this as a “plot twist.”  This wasn’t a plot twist.  A plot twist is when something unexpected happens, taking the story in a new direction.  This was a gimmick – a dishonest device that relieved the playwright of the burden to maintain plot integrity and create a plausible dramatic arc.  And we felt angry and betrayed, and somewhat “fool me twice” duped, as this was the second play in a single year that employed a “Bobby Ewing in the shower” ploy like this one.  (Only readers who share our dotage will understand that reference.)  We love the theatre more than almost anything, and we are sad to see this sort of trickery gain traction.  From now on, we will try to remember that we can’t rely on anything that any character says.

Of course, we already knew that about a lot of plaintiffs’ mass tort causation experts. Last month, we blogged about the exclusion of one plaintiff’s experts in a hernia mesh case.  Today’s case, like the Bowersock case that was the subject of our last post, is a case that was remanded to its transferor court when the hernia mesh MDL shut down.  In Olmo v. Davol, Inc. and C.R. Bard., Inc., Case No. 13-62260-CIV-COHN/SELTZER, United States District Court for the Southern District of Florida, the court recently decided the defendants’ motion to exclude the plaintiff’s causation expert and their Motion for Summary Judgment.   You can see the order here.

In Olmo, the plaintiff’s abdominal hernia was repaired with the defendants’ Composix Kugel (“CK”) hernia repair patch in 2005.  In the CK patch, the mesh patch is attached to two memory recoil rings intended to stabilize the device.  Six years after her CK patch was implanted, the plaintiff experienced abdominal pain, and her CK patch was explanted and replaced with a different hernia mesh product.  The explanting physician observed that a corner of the CK patch had lost fixation and folded under, causing mesh to erode into the plaintiff’s bowel.  The explanter did not observe buckling in the explanted device, did not determine whether the rings had broken, and did not discern what had caused the mesh to fold.  The explanted patch was not preserved and was not photographed before it was discarded.

In her complaint, the plaintiff alleged that a break in one or both of the memory recoil rings in her CK patch caused the mesh to come into contact with her bowel. She submitted the report of a biomedical engineering expert who briefly chimed in with his assent to the plaintiff’s theory, stating, “The fact that the mesh had folded such that the porous polypropylene layer contacted internal organs, unequivocally leads to the conclusion that the outer and perhaps also the inner memory recoil rings did not prevent folding, which is only possible subsequent to . . . [ring] breakage . . . .”  Order, p. 7.  But, as the court noted, the remainder of the expert’s report was “devoted almost entirely to explaining why [he] believes that [the defendants’] product testing and design of the CK patch were unsatisfactory,” and did not explain “why folding necessarily leads to the conclusion that a ring break occurred.” Id. (citation omitted).  Nor did the expert clear this up at his deposition.  Instead, when asked how he reached his conclusion that a ring had broken, the expert responded that “major folding of the device,” such as that described by the plaintiff’s explanter, is only possible when a ring breaks.  The expert did no tests to confirm his theory.  He did no tests to rule out an alternative theory.  He was not aware of any scientific studies or literature supporting his conclusion.  And he could point to no evidence that “engineering or medical communities would accept the premise that the folding described by [the explanter] is only possible with a ring break.”  The expert did add that the folding of the plaintiff’s patch was greater than he had observed in cases in which a ring break was documented, but he couldn’t identify any of those cases.  Citing Joiner, the court concluded that there was “too great an analytical gap” between the data on which the expert relied and his “broken ring” conclusion, and excluded the expert’s testimony in its entirety.

With no admissible evidence of medical causation, the plaintiff could not satisfy her burden of proof of her warnings and design defect claims, and her remaining claims – punitive damages and loss of consortium – could not survive alone. So the court granted summary judgment and dismissed all of the plaintiff’s claims with prejudice.

We love this. You have heard us rant and rave enough times about mass tort plaintiffs who get money for claims they can’t prove.  It was nice to see aggressive lawyering and a brave and sensible judge lock the vault with this plaintiff’s open hand safely outside.  And, just maybe, plaintiff lawyers will someday think twice about relying on experts who skip the step of employing reliable (or any) methodology.  We can always hope.  Just as we will the next time the house lights dim, the curtain opens, and a theatrical journey begins.

We loved La La Land.   We were enchanted by the colors and the music and the dancing.  We were transported by the dreams-come-true and saddened by the could-have-beens.  We disappeared into the characters’ world for two hours and were not ready when the lights came up.   For us, it was the epitome of a movie experience, and we were thrilled – momentarily – when it was announced as Best Picture.  But, as all who witnessed Oscargate (and anyone who didn’t spend the last week in a submarine) can attest, simply saying it didn’t make it so.

Last week, in Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc., 2017 WL 711849 (S.D. Ind. Feb. 23, 2017) the United States District Court for the Southern District of Indiana reached the same conclusion, excluding the plaintiffs’ experts in a hernia mesh case.  The plaintiffs claimed that a component of the defendants’ hernia mesh patch – a polyethylene terephthalate ring – perforated the intestines of the plaintiffs’ decedent, ultimately resulting in sepsis and death.

An autopsy was performed and concluded that the decedent’s small bowel and colon were intact, without perforation. But the hernia mesh patch was not retrieved from the decedent’s body before she was buried, so, seven years later (!!!), the plaintiffs had the body exhumed so the patch could be retrieved and analyzed, after which they submitted the reports of two causation experts – a surgeon and a biomedical engineer – to opine that components of the mesh patch caused the decedent’s injuries.

The Surgeon

The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhumed body. He opined that the ring, though not broken, had buckled, creating a sharp edge that rubbed against the decedent’s bowel and perforated it.

Continue Reading Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

Last week three of our posts dealt with Daubert issues.  That was not intentional.  Chalk it up to coincidence.  Or was it?  We are not especially superstitious, but maybe the passing last week of the great “Professor” Irwin Corey had something to do with the Daubert eruption.  Corey was a comedian who pretended to be “the world’s foremost authority”.  As if to parody the parade of plaintiff experts in mass tort cases, Prof. Corey would enter the stage wearing an academic robe, awkwardly look around at the crowd and down at his sneakers, begin with the word “However,” and then proceed to spout gibberish and vague Big Ideas that made no sense.  (This is not the first time in this blog that we have cited the wisdom of Prof. Corey.)  Corey was 102 years old.  He was doing comedy into his 90s, and consistently made more sense than most plaintiff regulatory or causation expert witnesses.  Catch his act on Youtube.  You will find it more enlightening than any plaintiff expert, or even most court opinions discussing the Daubert test.

As if to trumpet one final honor to Prof. Corey, we have a wonderful, clear, compelling Daubert opinion.  This one, Nease v. Ford Motor Co., No. 15-1950 (4th Cir. Feb. 1, 2017), has nothing to do with drugs or devices.  However, [we normally hate starting a sentence with that word, but if it was good enough for Prof. Corey, who are we to stand on ceremony?], the Nease case contains reasoning and language you might want to cite against the next plaintiff exercise in pretentious hokum. That the opinion comes out of the Fourth Circuit is both important and, for the most part, expected.  There are a couple of mass torts in the Fourth Circuit, and the effect of the Nease opinion can only be beneficent.  The Fourth Circuit has long had a reputation for having smart judges who follow the law.  (That being said, we nearly wept over the poor reasoning in the Fourth Circuit’s Cisson decision.)  In this season of judicial nominations by a new administration, we will hear a lot about how judges should decide, rather than create, the law.  The Fourth Circuit has not had a lot of judges posing as philosopher kings.  They actually tend to follow precedent.  We have it on good authority that when the DOJ had an internal debate about where to bring the 9/11 prosecutions – whether S.D.N.Y. (World Trade Center) or E.D.Va. (Pentagon) would be better for the government – the winning argument for E.D.Va. was based not on the pluses or minuses of the district court (or jury pool), but on whether the government would rather face the inevitable appeal in the Second Circuit or the Fourth Circuit.  There was a perception that the Second Circuit was more capable of activism, lenience, and surprise, none of which was particularly welcome under such circumstances.

If you like to see the law interpreted and applied, rather than created, the Fourth Circuit is usually a good forum.  That was certainly true in Nease.   The plaintiff in Nease claimed serious injuries from an accident allegedly caused by a defect in the speed control system of the plaintiff’s pickup truck.  The plaintiff offered the testimony of an electrical engineering expert who maintained that the speed control cable in the truck was susceptible to getting stuck while the throttle was in the open position, thus preventing the driver from being able to slow the vehicle down.  The defendant filed a Daubert motion, challenging the plaintiff expert’s methodology. The district court (S.D.W.Va.) denied the Daubert motion, waved the expert’s testimony along to the jury, and the jury returned a verdict for the plaintiff on strict liability and awarded more than three million dollars.

Continue Reading Fourth Circuit Vigorously Applies Daubert