It has been said, with maybe a bit of sarcasm, that a company developing a drug hopes that its drug will become successful enough to attract frivolous lawsuits.  OK, so maybe only outside lawyers have offered such an aphorism, but bear with us.  Imagine that a drug is developed to treat a really common condition, like high cholesterol, it becomes accepted as a first-line treatment, and becomes one of the most widely used prescription drugs of the last few decades.  Imagine then that the patient population that would take this drug has lots of co-morbidities and that, while the drug is being used on a long-term basis, some predictable portion of the drug’s users will develop a new condition, like diabetes.  Imagine then that, because the drug has been widely used for so long, there are lots of studies, published and unpublished, that look at measures like blood glucose and new diagnosis of diabetes, among many other things.  It should not be hard to imagine that thousands of the patients taking the drug would develop diabetes on the drug in the absence of any relationship and that plaintiff lawyers would round many of them up to sue based on the expectation that the lawyers and their favorite experts could gin up proof of causation that would survive a Daubert challenge if the manufacture did not pay to get rid of the litigation first.  This is hardly fancy as we have posted on multiple orders from Lipitor MDL (here, here, and here) that excluded plaintiffs’ causation experts and then granted summary judgment for the manufacturer across the board.

Much like the Zoloft MDL affirmance we lauded last year, all of this went up on appeal to either revive or affirm the end of an entire litigation.  We are pleased to say that In re Lipitor (Atorvastatin Calcium) Mkt’g, Sales Pracs. & Prods. Liab. Litig. (No. II), MDL No. 2502, — F.3d —, 2018 WL 2927629 (3d Cir. June 12, 2018), did the latter.  Without repeating the history of all of the decisions below that we detailed previously, there were five basic issues on appeal, the admissibility of each of the three experts plaintiffs offered, whether plaintiffs could use other evidence to establish causation without experts, and whether plaintiffs’ responses to show cause orders were sufficient to avoid summary judgment.  Each deserves some attention.

Plaintiffs’ statistician was up first.  His approach was to re-analyze clinical trial data to suggest that there was an increase in blood glucose levels and infer that as proof of causation for diabetes.  The disconnect here is fairly obvious, but the statistician compounded the problem by including both patients with a single instances of elevated glucose levels during the trials and patients with elevated glucose levels before the study began. Id. at *4.  Plaintiffs, their statistician, and other experts had agreed that a single increased glucose level did not indicate diabetes. Id. The statistician also agreed, as the MDL court put it, that he “lacked the expertise to opine about any implications that single glucose readings might have about the possibility of new-onset diabetes.” Id. This might have been enough to exclude his opinions, but he also relied on one test of statistical significance after the standard test failed and presented calculations of average blood glucose increases in a misleading and result-driven fashion. Id. at **5-6.  He also re-analyzed a study that had found no increased in the rate of diabetes with the drug compared to placebo based on a applying a new definition of diabetes after the fact and by someone who lacked relevant expertise. Id. at **6-8.  The Fourth Circuit affirmed the exclusion of his opinion, noting that the MDL court “properly discharged its gatekeeping duty” by weighing “classic concerns regarding reliability and relevance.” Id. at *6.

Plaintiffs also offered an internist to interpret the medical literature and perform meta-analysis of select studies, which he attempted to dress up with a purported application of the Bradford Hill criteria.  Noting the importance of dose to these analyses, the MDL court asked the internist to provide an analysis specific to each commercially available dose of the drug.  The MDL court ultimately excluded his causation opinion as to all but the highest dose because he acknowledged there was not a statistically significant increased risk of diabetes for the other doses. Id. at *9.  On appeal, plaintiffs challenged that their internist could not just lump all the doses together and offer a single causation opinion.  Given the facts here—like a 10 mg low dose, a 80 mg high dose, and studies specific to each dose—we do not think this requirement should have been the least bit controversial.  The Fourth Circuit, however, while holding that the MDL court did not “abuse its discretion in asking the expert to produce a dose-by-dose analysis,” cautioned that this was not a new requirement for all cases. Id. at *10.  The more serious, and recurring, issue was whether statistical significance was required for a causation opinion based on epidemiologic evidence and the Bradford Hill criteria.  Again, we think the Fourth Circuit could have gone a little farther—like you always or almost always need epidemiologic evidence as a starting point for causation in a product liability case and epidemiologic evidence must be statistically significant (with multiple studies with an increased risk greater than 2.0) to count—but its conclusion that the MDL court had not abused its discretion on the record here was good enough.  Specifically, the internist’s purported application of the Bradford Hill criteria and failure to establish that reliance on non-statistically significant results was accepted by epidemiologists were enough for the court to find his causation opinions unreliable. Id. at *12.

Plaintiffs also offered another internist to opine on specific causation for one of the bellwether plaintiffs.  While the plaintiffs touted that this expert had used a differential diagnosis to come to her opinion, the expert herself did not say that she did and claimed to use a methodology for her opinion in litigation that she had never used in her own practice. Id. at *13.  She also could not rule out other causes like the plaintiff’s weight and weight gain and relied too heavily on the post hoc ergo prompter hac fallacy. Id. at *15.  Again, this exclusion was within the MDL judge’s discretion.

Like the MDL court, the Fourth Circuit did not a bright line rule on whether general medical causation for product liability cases involving a pharmaceutical could ever be established without any expert testimony from the plaintiff.  We think the better approach, as spelled out in some state’s law, is to require expert testimony on these issues.  However, the Fourth Circuit’s conclusion that the specific non-expert evidence offered by plaintiffs—principally snippets from U.S. and foreign labeling—was not enough to establish causation is fine by us.  The causation issues are “complex and manifold” and the non-expert evidence from plaintiffs “isn’t especially strong.” Id. at *17 (contraction in the original).  So, the bottom line was more than fine by us:  “To hand to the jury the evidence here and ask it to reach a conclusion as to causation with any amount of certainty would be farcical and would likely result in a verdict steeped in speculation.” Id. Put another way, if a court is supposed to be the gatekeeper for expert evidence on key issues, it cannot just allow dubious non-expert evidence to suffice on an issue that would require an expert under Rule 702.

The last issue for the Fourth Circuit to address was whether the MDL court could require the remaining plaintiffs to come forward with evidence showing they could prove specific causation after the Daubert and summary judgment orders.  Plaintiffs’ argument on this was essentially that the MDL should have remanded all the cases rather than fulfilling the mission of the MDL court to decide common pretrial issues.  This argument was a bit disingenuous, because the plaintiffs surely would have been comfortable with summary judgment or Daubert motions being denied across the board had the rulings on the bellwether cases gone their way.  “Here, it was the district court’s prerogative to determine whether it could dispose of the cases before it on the merits.” Id. at *18.  We may not always be a fan of the direction MDL courts have taken in the last decade or so, but they are supposed to do what the MDL court did here.  At the end of the day, this MDL court “discharged [its] duties meticulously and thoughtfully” an ended a litigation as it should have been – with the manufacturer winning without facing the uncertainty of jury trials or succumbing to the pressure of a large number of pending cases.

Today we have a guest post from Reed Smith associate Curtis Waldo.  It describes a farce of a Daubert decision where a plaintiff’s expert opinion was allowed to proceed even though the court conceded the evidence was inconclusive.  We don’t like that, and neither does Curt.  As always our guest posters are responsible for their writings, deserving 100% of the credit, and any blame.  Tee time, Curt.

*********

Even the casual golf fan is likely familiar with gaudy stories involving John Daly.  On his way to winning the 1995 British Open at St. Andrews, John Daly wolfed down Otis Spunkmeyer chocolate chip muffins to offset sugar cravings induced by alcohol withdrawal.  Upon finishing second place at the World Golf Championship, Daly lost $1.65 million in Vegas, mostly at slots.  Suffering a collapsed lung in the middle of a tournament, Daly quipped, “I only smoke two packs of cigarettes a day, not three, so I’ll be alright.”  Daly self-diagnosed:  “Everyone has addictions and my problem is that I have 5,000 of them.  If it’s not drinking, it’s gambling; if it’s not gambling, it’s eating anything from burgers, doughnuts to M&Ms. The only addiction I don’t suffer from is chasing women.”

To that, Tiger Woods might say, “Hold my beer and watch this.”  Two years after Daly’s last major win at the 1995 British, young gun Tiger Woods burst on the scene and won the Master’s by 12 strokes.  In contrast to Daly, through his years atop the PGA Tour, Tiger projected nothing but the utmost discipline and confidence.  Tiger was manic about his fitness, and you would certainly never see him smoking or drinking on a golf course.  Of course, the façade came crumbling down, and Tiger was eventually exposed as a “sex addict,” subject to the same demons that haunted Daly.

Enter the Abilify MDL, where plaintiffs argue Abilify causes patients to develop “impulsive and irrepressible urges to engage in certain harmful behaviors, including gambling, eating, shopping, and sex.”  Op. (infra) at *1.  This author is not aware if John Daly or Tiger Woods ever took Abilify, but if so, based on a March 15, 2018 opinion out of the Northern District Florida, they could conceivably attempt to blame their respective struggles with impulse control on the drug.

To the court’s opinion, In re Abilify (Aripiprazole) Products Liability Litigation, 2018 WL 1357914 (N.D. Fla. March 15, 2018).  Before diving into the law, the opinion spends several paragraphs describing the brain as a “tremendously complex biochemical system.” I d. at *3.  The brain contains billions of neurons, sending and receiving information to other neurons.  Id.  Electrical impulses are constantly being sent from neuron to neuron across gaps called synapses.  Id.  The impulses are housed by molecules called neurotransmitters. Id. Dopamine is an “integral” neurotransmitter, constantly telling the brain what it likes and doesn’t like and thus playing a critical role in “pleasure, reward processing and motivation.”  Id.  This becomes important later when the decision addresses plaintiffs’ biological plausibility expert’s argument that Abilify prevents the activation of dopamine molecules, causing the brain to increase the number of dopamine receptors. Id. When dopamine activates these receptors, a “potentiated” physiological response is triggered, resulting in the complained of impulsive behavior.  Id.

Back to the law.  Most notable in the legal discussion, after discussing the types of general causation evidence the Eleventh Circuit normally requires (epidemiology, dose-response, accounting for background risk), the decision stated that “in practice” any expert must also consider the “weight of the evidence” in coming to his conclusion. Id. at *9.  Of course, “in practice,” this may lead to an expert throwing any number of theories against the wall, seeing what sticks, and saying that he is considering the “weight of the evidence.”  Where the science stops and the weighing begins is not entirely clear.  But what is clear is Eleventh Circuit law.  The sort of vague, seat of the pants expert opinions allowed in Abilify should not have been.  See Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245, 1253-57 (11th Cir. 2010) (affirming exclusion of unreliable differential diagnosis); McClain v. Metabolife International, Inc., 401 F.3d 1233, 1239-51 (11th Cir. 2005) (excluding various expert machinations ultimately based on the “post hoc ergo prompter hoc fallacy”).  This precedent strongly indicates that the Eleventh Circuit has not, and would not, embrace the “weight of the evidence” approach taken in Abilify.  Notably, Abilify cited only district courts from within the Eleventh Circuit, as well as cases from other, less rigorous courts of appeals.  2018 WL 1357914, at *9.

Moving to plaintiffs’ evidence, purportedly the most persuasive was the “Etminan Study,” a so-called epidemiological study drawn from an insurance claims database of millions of patients.  Id. at *11-12.  It just so happened that the author of the study, Dr. Etminan (an ophthalmologist from Canada) reached out to plaintiffs’ counsel before he developed the research protocol for his study.  Id. at *19.  How fortunate plaintiffs’ counsel must have felt when after they brought their Abilify cases; a doctor called to say he was about to conduct a study going to the central issue in the case, and imagine further the smile on face of plaintiffs’ counsel when the study turned out to say exactly what plaintiffs wanted it to say.  Imagine the smile on Dr. Etminan’s face when those expert fee checks started rolling in.

Anyway, Dr. Etminan examined the claims database to identify patients with diagnostic codes for a gambling or impulse control disorder. Id. at *11-12.  He identified a separate group of patients with neither diagnosis. Id. Dr. Etminan compared the two groups and found the former more likely to have been prescribed Abilify in the year prior to their gambling or impulse control diagnosis—so much more likely, according to plaintiffs’ experts, that an inference of causation could be drawn. Id. This study, and plaintiffs’ experts’ statistical analysis of the study, was plaintiffs’ primary evidence of general causation.

The court acknowledged several flaws in the study, including that Dr. Etminan never actually looked at any medical records for any of these people. Id. at *13.  Dr. Etminan didn’t know if any of the patients even ingested Abilify (as opposed to merely filling the prescription). Id. at *14.  If they did ingest the drug, Dr. Etminan didn’t know how much they took. Id. At least one of the Abilify-taking patients in the database reported a compulsive gambling disorder only after seeing a lawyer advertisement saying Abilify caused compulsive gambling, suggesting his “diagnosis” (and likely that of other patients in the database) was colored by reporting bias.  Id. at *20.

The study also appears to treat a gambling diagnosis like a flu virus—something one contracts and is “diagnosed” with.  A small problem—the DSM says a gambling disorder takes up to 12 months to develop into a disease. Id. at *15.  And as many readers are likely aware from personal experience or the experience of loved ones, one does not buy a lotto ticket and then seek out treatment for a gambling disorder.  A likelier course is to wallow undiagnosed in heady indulgences for years, perhaps at a casino, golf course, seedy bar, or in the case of shopping addiction, perhaps the mall, until one hits the proverbial rock bottom (such as Tiger Woods’ infamous single-car accident), at which time it becomes apparent that a trip to the psychiatrist is in order.  Once one is on the psychiatrist’s couch, recounting tales that would make John Daly look like a model of discipline and rationality, then maybe also comes an Abilify prescription.

This gets to the most critical flaw of the Etminan study, which is that the very disorders that may lead to impulse control issues—depressive disorders, anxiety disorders, and personality disorders—are often the disorders that Abilify attempts to treat.  Claiming the same disorder being treated as a “adverse effect” of the drug used in treatment is a common plaintiff ploy. See, e.g. Colacicco v. Apotex Inc., 521 F.3d 253, 256 (3d Cir. 2008) (observing that suicide was also “inherent in depression,” the condition the drug at issue treated), vacated on other grounds, 556 U.S. 1101 (2009) (preemption).

The Abilify opinion conceded problem with causation, but found no actual evidence that anxiety and personality disorders were related to increased exposure to Abilify.  2018 WL 1357914, at *18.  While this may be true, the logical implications that follow are, well, hard to follow.  One could imagine that of all the humans in the world with anxiety and personality disorders, a very small percentage are taking Abilify.  But one could also imagine that of all those who take Abilify, a high percentage have anxiety and personality disorders, and as such, may be more inclined to have impulse control issues.  After all, that is one of the reasons the drug was likely prescribed in the first place.  Ultimately, the opinion found the medical literature to be “inconclusive on the question of whether depressive, anxiety and personality disorders are causal risk factors for pathological gambling.”  Id.  This lack of evidence of a causal relationship between these disorders and impulse control was decisive; not merely the fact that as the DSM notes, “individuals with gambling disorder have high rates of comorbidity with [depressive, anxiety and personality disorders].”  Id.  Plaintiffs received a mulligan.  One wonders where the burden of proof on the party offering the expert opinion went.

Next up was, plaintiffs’ non-epidemiological evidence of causation, including evidence of a dose-response relationship and of biological plausibility.  The analysis of this evidence is best summarized as, “maybe.”  Maybe it’s plausible; maybe there is a dose-response relationship; maybe the case studies and adverse event reports show causation.  Because the epidemiological evidence is sufficient, this is all gravy for plaintiffs, and defendants’ arguments don’t carry much weight.  None of these “bolstering” studies were sufficient proof of general causation under Daubert by themselves, but because the epidemiological evidence was sufficient to meet plaintiffs’ burden, the “bolstering” studies could come in, too.  Why rake the sand trap when you’re already on the green?  Of course, whether a future jury will draw this distinction is another matter.  One could certainly imagine a jury finding a single case study more persuasive than an epidemiological study of 6 million insurance claims.

After describing the general causation evidence, the Abilify opinion proceeded one-by-one through plaintiffs’ experts, finding faults with many, though ultimately allowing the key epidemiology testimony, based on the serendipitously timed Etminan study.  Id. at *36, et seq.  Defendants’ experts largely passed through, too.

Past the gatekeeper, and on to the jury. Good luck to each side in the second round.  As John Daly said, “The first tournament is not the hardest one to win.  It’s always the second one.”

We have an adorable, pigtailed, toddler grand-niece. We play a game with her that involves placing one building block on the table and asking her how many blocks there are.  She answers, “One.”  We take that block away and replace it with another.  Again, the answer is “one.”  Then we place both blocks on the table and ask, “How much is one plus one?”  As brilliant as she is beautiful, she answers, “Two!”   Simple, right?  But those of us who practice in the mass tort space are far too accustomed to reading opinions laying out the building blocks of an obvious holding then failing to conclude that one plus one equals two.

Not so the lovely opinion on which we report today. In Young v. Mentor Worldwide LLC, 2018 WL 2054591, — F. Supp. 3d — (E.D. Ark. May 1, 2018), the plaintiff was implanted with the defendant’s sub-urethral sling in 2003 to address her stress urinary incontinence.  In two subsequent surgeries, in 2006 and 2008, portions of the sling were removed.   In 2013, more than five years after the last revision surgery, the plaintiff filed suit, asserting all of the usual claims and alleging permanent injury from the defendant’s product.

Because Arkansas law, which governs the plaintiff’s claims, imposes a three-year statute of limitations on product liability lawsuits, the defendant moved for summary judgment, alleging that the plaintiff’s claims were time-barred. The court denied the motion, finding a question of fact as to when the plaintiff’s cause of action accrued under the applicable discovery rule.

Motion to Bifurcate Trial

Flash forward to the eve of trial. Arguing that resolution of the statute of limitations defense would require only a few witnesses and would likely take only two days, the defendant asked the court to bifurcate the proceedings in a novel manner, holding a preliminary trial on the statute of limitations and moving on to a full trial on the merits of the plaintiff’s claims only if necessary.  The plaintiff opposed the motion, arguing that resolution of the statute of limitations issue would require admission of evidence of the defendant’s alleged fraudulent concealment and that a single jury should resolve all of the issues at the same time.

The court disagreed, holding,

Regardless of whether the [plaintiff is] entitled to pursue a fraudulent concealment claim, [the defendant’s] statute of limitations defense is potentially dispositive, and preliminary trial will not consume the time and expense necessary for a trial on the merits.  The Court finds that a separate, initial trial on the statute of limitations question is especially warranted in this case, as it will promote judicial economy, avoid confusion of the issues, and prevent possible undue prejudice.

Young, 2018 WL 2054591 at *2.

Motions to Exclude Expert Testimony

The defendant also moved to exclude the testimony of two of the plaintiff’s experts, a biomedical engineer and a pathologist.

Biomedical Engineer

The biomedical engineer sought to testify about the mechanical structure of the defendant’s product “and to offer his opinion that the design and testing of [the product] was inadequate, that the product was defective for its intended use, and that [the defendant] failed to warn about the significant risk of complications and adverse events from the use of the product.” Id. at *3.  The defendant moved to exclude the expert’s testimony about the adequacy of the warnings, arguing that the expert was not qualified to offer such opinions.  The court agreed, holding, “The record is void of information indicating that [the expert’s] expertise in the area of biomedical engineering and product design qualifies him to opine as to the adequacy of warnings at issue or that his opinion on this ultimate issue of fact would be helpful to the jury.” Id.

The expert’s report also included statements to the effect that the defendant was “fully aware” of a high rate of complications associated with the product. The defendant moved to exclude these statements on the ground that they were inadmissible expressions of “corporate intent and legal conclusions.”  Again, the court agreed, holding, “The Court finds that a jury is capable of making its own determinations as to [the defendant’s] intent, motive, or state of mind, and that [the expert’s] opinion on these subjects does not meet the helpfulness criteria of Rule 702.” Id. (citation omitted).

Pathologist

The pathologist’s report stated that his general causation opinions were “based on his review of over 300 explanted mesh samples, which include[d] hernia meshes, pelvic organ prolapse meshes, and slings used to treat urinary incontinence.” Id. at *4.  He acknowledged that only ten of the 300 samples he examined were manufactured by the defendant, and those were samples he received from plaintiffs’ attorneys.

The defendant argued that the expert’s opinions about other types of mesh and other manufacturers’ products were irrelevant and unreliable. In deposition, the expert testified that “all of this background” was necessary to “interpret accurately case-specific material.”  The court disagreed, holding, “The Court finds that neither [the expert’s ] explanation nor [the plaintiff’s] arguments demonstrate that information about various types of polypropylene mesh products . . . is relevant in this case, which deals with a specific mesh product, used for a specific purpose.” Id. Further, the expert “admit[ted] that he [had] no knowledge as to how the mesh implants he has examined were selected, thus there is no assurance that they were randomly selected and no way of projecting the potential rate of error.” Id. The court concluded, “After careful review, the Court cannot find that [the expert’s] proposed opinion testimony is the product of reliable principles and methods, and [the defendant’s] motion to exclude will be granted.

We love this opinion – logical, correct, and elegant in its simplicity. We hope that others follow suit, and we will keep you posted.

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.