This post comes from the Cozen O’Connor side of the blog only. 

 

Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage and again as a part of our preemption scorecardCanary was a winner.

That decision, however, dismissed only plaintiff’s product liability claims, letting her fraud claim move forward. Last month, the court issued a summary judgment decision on that fraud claim. Canary is not such a winner anymore.

Backing up a little bit, the product was Medtronic’s PrimeAdvanced spinal cord stimulator. It was implanted in plaintiff to address her neck and back pain. Canary v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 192794, at *2 (E.D. Mich. Nov. 13, 2018). Yet, after the surgery, plaintiff complained that she was experiencing hives all over her body, abdominal pain and bowel inflammation. Id. at *3-4. Almost a month later, she had the device removed. She claimed that her problems stopped. Id. at *4.

During discovery, however, plaintiff produced no causation opinion from an expert—to be clear, no expert on either general or specific causation. Instead, she relied exclusively on the testimony of her treating doctors. Their testimony, however, was only marginally helpful to her, as it was laced with words like “possible” and “plausible” and missing any declaration that the opinions were reached to a degree of medical certainty or even probability. Yet the court allowed her fraud claim to survive summary judgment.

In particular, Plaintiff’s internal medicine doctor testified that the device was a possible cause, one of the top possibilities, and that allergy and skin testing was needed. But he offered no opinion to a reasonable degree of medical certainty:

Dr. Thammineni, the internal medicine doctor who treated Plaintiff when she was admitted to the intensive care unit on May 28, 2013, explained during his deposition that while he stated that Plaintiff had “contact dermatitis secondary to spinal cord stimulator” in his notes, he recommended that she get allergy and skin testing to ascertain exactly what caused the reaction. When Dr. Thammineni was asked if the spinal cord stimulator was more of a possibility than other causes, he responded with a “yes.” And when asked “[c]an you say to a reasonable degree of medical certainty that the hives were caused by the implantation of the spinal cord stimulator on May 16th and not some other source,” he stated that the stimulator was “one of the top possibilities.”

Id. at *6.

Plaintiff’s dermatologist testified that something at the time of the surgery triggered the hives, that the timing of the implant and removal created an “association,” but that there was no test to determine the cause of the hives:

There was something around the time of the surgery that triggered a hive-like reaction. The device was used, but other things were used at the time of the procedure, such as prep and — however, when the device was removed, her hives and itching in that area went away, so there’s an association with that. Unfortunately, there’s no test for [these types of] reactions in this situation.

Id. at *6-7. She did not testify on causation to a reasonable degree of medical certainty.

Finally, plaintiff’s allergist stated that it was “plausible” that plaintiff had an allergic reaction to the device, and later said that she “believed” the device caused the hives:

Q: You stated it was plausible that she had an allergic reaction to the device; is that correct?

A: I think everything is plausible, but, yes.

Q: Okay. The fact that she reported she had hives after the device, and her hives stopped after the device was removed, would that further support the conclusion that it was plausible that the device caused a reaction?

[Defense counsel]: Object to the form.

The witness: I would — yes.

[Plaintiff’s counsel]: And earlier you testified regarding the correlation and the difference between general hives versus local hives.

A: Yes.

Q: Do you believe the stimulator caused the local hives she reported to you?

A: Yes.

[Defense counsel]: Object to the form.

[Plaintiff’s counsel]: That was a yes?

A: Yes.

Id. at *7. Again, there is no indication that the allergist testified that her “belie[f]” was held to a reasonable degree of medical certainty, or to any degree of certainty or even probability.

The court, discussing two cases involving less complex science, one of which did actually involve a plaintiff’s general causation expert, held that this treater testimony, along with the general sequence of events, was enough. In fact, while Medtronic had two experts opine to a reasonable degree of medical certainty that the device did not cause the allergic reaction—the only two causation experts in the case—the court noted that these experts “did not eliminate the possibility that it could have done so.” Id. *15.

If the analysis comes down to this, it’s not clear that a defendant could ever win summary judgment. Almost any causation issue would be trial ready, despite what could be a lack of any real science behind it or an expert to opine on that science to a reasonable degree of medical certainty.

The Canary doesn’t look so good anymore. Time to get out of the coal mine.

A couple of weeks ago, we reported on the terrific Daubert decision in the Mirena IIH MDL in the Southern District of New York, In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), in which the court granted the defendants’ motions to dismiss all seven of the plaintiffs’ remaining general causation experts.  In that post, we explained that all seven opined that the defendants’ intrauterine contraceptive device caused idiopathic intracranial hypertension (“IIH”), a rare and potentially serious condition market by increased cerebrospinal pressure in the skull.  Only one study had ever found a causal link between Mirena and IIH.  That study was by Dr. Mahyar Etminan, who was on the plaintiffs’ payroll at the time he published the study, a fact he failed to disclose.  After a prominent scientist in the field attacked the methodology of the Etminan study because it failed to control for age and gender, Dr. Etminan repudiated much of the study’s analysis and withdrew as an expert.

Of the seven remaining experts, four drew their general causation conclusions largely by drawing on existing sources, including varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The other three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In our last post, we reported on the court’s decisions regarding two of the experts in the first group but we promised to tell you more.  Today, we focus on one more expert in that group as well as highlights of the court’s decisions about the “mechanism” experts.

The former, the plaintiffs’ ophthalmology expert, was the only one of the plaintiffs’ experts who had written about the relationship between levonorgestrel (“LNG”), the synthetic hormone in  the defendants’ contraceptive device, and IIH, and was the only one of the plaintiffs’ experts who had written an expert report on the supposed causal  link before the MDL was formed.      In a 2015 book about drug-induced ocular side effects, the expert had stated that he believed there was a “possible,” but not a “probable,” association between LNG and IIH.  In the book, he explained that he assessed causation as possible “when there is a temporal relationship, but the association could also be explained by concurrent disease or other drugs or chemicals,” and dechallenge data (information about what happens when the treatment is withdrawn) is “lacking or unclear.”  Mirena, 2018 WL 5276431 at *47 (citation omitted).   In contrast, causation is “probable” or “likely” when “there is a temporal relationship unlikely to be attributed to a concurrent disease or drugs” and there is positive dechallenge data.  Id.   The book’s conclusion that there was a “possible” causal association between LNG and IIH was based largely on case reports involving the defendants’ product and other LNG-containing products and upon two publications discussing several of those case reports.  The book did not consider the Etminan and Valenzuela studies, which had not yet been published.

Unlike the other experts in the first group, the ophthalmologist did not claim to have performed a Bradford Hill analysis.  Instead, in support of the expert’s causation conclusion, his report cited case reports, discussion of another LNG-containing product, case reports, and citations to both the Etminan and Valenzuela studies.  In addition, the report included a vague discussion of broad propositions from which he suggested that there was a biological mechanism for LNG to cause IIH.  In his deposition, however, he repudiated this “mechanism” opinion, testifying that the mechanism was “unknown” and that he was not being offered as a “mechanism” expert.

Analyzing the expert’s opinion, the court stated, “[The] proposed testimony amounts to a blend of disparate items that [the expert] contents together show that Mirena causes IIH. . . . [The expert] does not purport to use the flexible Bradford Hill methodology to guide his analysis.”  Instead, he used a “non-replicable mode of analysis” consisting of “listing factors that he argues support his conclusion.”  Id. at *50.   The court held that the expert’s proposed testimony “fails to meet any of the Daubert reliability factors.”   The expert’s causation conclusion “has not been tested; it has not been subject to peer review; it has no known error rate and there are no standards controlling its operation; and it has not been generally accepted by the scientific community.”  Moreover, the expert’s “handling of virtually every one of the individual items on which he relies” was “methodologically suspect.”  Id.   This included overlooking the fatal flaws in the Etminan study, the expert’s failure “to engage with consequential evidence contrary to his outcome.”   Id.  at *51-52.  Finally, though the expert “[made] his mechanism opinion an important component of his expert report,” he “repeatedly distanced himself” from that opinion at his deposition, “repudiate[ing] any mechanism opinion as beyond his expertise.”  The court held, “”The removal of that pillar alone is fatal to [the expert’s] weight of the evidence analysis;” moreover, the “mechanism” opinion would have been inadmissible in any event because the expert was not qualified to offer it.  Id. at *52.   And so, holding that the expert’s opinions failed to satisfy Daubert’s reliability standards, the court excluded the opinions in their entirety.

The plaintiffs’ “mechanism” experts fared no better.  One, an OB/GYN and the founder of a clinical and epidemiological research organization devoted to reproductive health issues, “embrace[d] the ‘androgen theory’ by which Mirena purportedly causes IIH—specifically that androgens cause IIH and that because LNG, while a progestin, has androgenic effects, LNG in turn may cause  IIH.”  Id.  at *53.  The court held, “As a threshold consideration, [the] theory that Mirena  causes IIH through androgenic side effects does not satisfy any of the four Daubert reliability factors.”  Id. at *58.   But beyond the flaws in the opinion’s premises, the court “discern[ed] a broader overarching lapse of methodology” affecting the mechanism opinion: the expert’s report did not address the threshold issue of “what IIH is and how this condition comes about.”   Id.  In addition, the court criticized (in extensive and thorough detail that is beyond the capacity of these pages) the expert’s “scant attention to the pharmacokinetic process that must underlie the causal sequence that he postulates” and his “speculative leaps in support of his two central premises:  that androgens can cause IIH, and that LNG, a progestin with androgen receptor affinity, can cause IIH.”  Id.   The court concluded,

“In the end, while [the expert’s] credentials are sterling, the methodology underlying his opinion in this case is not.  He relies on supposition and attempts to link disconnected studies by others.   And he uses some of his source material for more than it can fairly support.  The result is a hypothesis that may or may not bear up when and if it is ultimately tested, not a reliable expert opinion admissible under the governing standards.  The Court therefore must exclude his testimony.”  Id. at *62.

The court similarly dispatched the plaintiffs’ other two mechanism experts because their methodologies were unsound and their theories failed to satisfy Daubert’s reliability standards.  Both discussions are lengthy and we cannot do justice to them here, but we again recommend that you read the whole opinion when you have time to appreciate its rigor and its unflinching confrontation and dissection of the technicalities underlying all of the experts’ opinions.  Doing justice to Daubert analysis of opinions like these is a monumental task.   All too frequently, and perhaps understandably, courts decline even to try, counting on juries (or, more likely, settlements) to do their work for them.   The Mirena court displayed rare dedication to the principle that the system can work only if courts properly discharge their duties as “gatekeepers.”  We applaud this decision, urge you to read it and cite it, and we hope that more courts will accept similar challenges.  We will keep you posted.

This will be the third consecutive week for us to discuss a favorable expert ruling out of the Cook Medical IVC filter litigation in the Southern District of Indiana. By this point, we really do expect some sort of remuneration from the Indiana Chamber of Commerce – maybe tickets for the surprisingly impressive Colts, or a reuben sandwich from fabulous Shapiro’s delicatessen. (To our palate, the Shapiro’s outpost at the Indy airport offers better corned beef than any you can find at LaGuardia, JFK, Newark, O’Hare, or even our hometown PHL. How weird is that?). Today’s Daubert ruling is In re Cook Med., Inc., IVC Filters Mktg., Sales Practices & Prod. Liab. Litig., 2018 U.S. Dist. LEXIS 196637, 2018 WL 6047018 (S.D. Indiana Nov. 19, 2018), and, as with earlier orders from this court, is clear, concise, and eminently sensible. The Daubert motion at issue here was filed by the plaintiff, who wanted to shut down a defense psychiatrist from rendering opinions that the plaintiff’s emotional injuries were not caused by the IVC filter. We won’t make a secret of the fact that we think the plaintiff’s Daubert arguments were uncommonly silly. For example, the plaintiff contended that the defense experts opinions were not offered to a reasonable degree of certainty when, in fact … they were. Still, there are commonly silly courts out there that might have given some credence to some of the plaintiff’s arguments. Thankfully, though, there is nothing silly about the In re Cook court.

The plaintiff attempted to preclude the defense expert’s differential diagnosis because it listed several alternative causes, not just one, for the plaintiff’s injuries. That position is a misfire in several respects. To begin with, the etiology of the plaintiff’s injuries was multifactorial. If reality puts more than one cause in play, why must a defense expert be forced to pick one? Further, the defense, of course, does not bear the burden of showing any cause. That burden is on the plaintiff. It is powerful stuff for a defense expert to show that there are many other plausible causes out there for the plaintiff’s injury, and those other causes exist independently of the defendant’s product. Indeed, the defense expert does not even need to exclude the product as a possible cause; it is enough if the expert can show that there is no reasonable way to put the finger on the product as opposed to one of the other possible causes. The defendant has absolutely no obligation to alight upon only one alternative cause. At a minimum, the multiplicity of alternative causes is a multiplicity of confounders that undermines the plaintiff’s false certainty.

The plaintiff also objected to the defense expert’s differential diagnosis because that expert had never physically examined the plaintiff. First, the defense expert had done plenty of work to substantiate his opinions. He had reviewed the plaintiff’s medical records, the plaintiff’s two videotaped depositions, the depositions of five treating physicians, an independent medical examination, and the reports of the plaintiff’s experts. That would be enough in pretty much any court to get to the jury. If the plaintiff wanted to make something out of the lack of a physical exam, that is fine fodder for cross-examination. But there is an additional wrinkle here. The court tells us that the defense expert “was not given the opportunity for an appropriate, direct, clinical examination” of the plaintiff. Apparently, there is a dispute between the parties as to why, exactly, that was so. Reading between the lines, we suspect that the plaintiff objected to the exam, or at least to some aspect of the exam. Obviously, then, the plaintiff cannot be heard to object to the absence of a medical examination that the plaintiff refused. Call it estoppel or fairs-fair, or whatever. (At this point, we cannot resist raising one of our chief gripes with other defense lawyers. In almost every mass tort litigation we’ve seen, there will be some defense lawyers who oppose having their defense experts perform physical examinations on the plaintiffs. Why? They are afraid of what the expert might find. Huh? Do you believe in your case or not? Plus, a good expert will be able to work with whatever the facts are. More information is better than less information. Our job is to deal with the facts, not alter or ignore them. Finally, as the In re Cook case demonstrates, you are simply in a much better position if you at least tried to perform the examination. Plaintiff lawyers often oppose these exams. Make them pay for that opposition. Anyway, the next time we hear from a plaintiff lawyer that this blog does nothing but bash plaintiff lawyers, we’ll point them to this parenthetical.)

Finally, the plaintiff tendered a back-up position that, if the defense expert would be permitted to opine on alternative causes, then that expert should not mention opioid use disorder. Nice try. The court observed that the defense expert had found “ample evidence in the record” to suggest that the plaintiff met the criteria for opioid use disorder, and such condition could be a cause of the mental health injuries of which the plaintiff complained. As much as the plaintiff was trying to keep out evidence of alternative causes, this was the alternative cause that the plaintiff most feared. And with good reason. It is, no doubt, powerful evidence. It reminds us of the old prosecutor’s joke about criminal defense lawyers objecting “Prejudicial, your Honor – tends to show guilt.” The In re Cook court held that the evidence of opioid abuse was part of the plaintiff’s medical record and was “essential” to the defense expert’s differential diagnosis. It was, therefore, admissible.

Last week we praised the S.D Indiana court’s Daubert decision in the Cook IVC filters litigation. Apparently the court is an expert on experts, because it came out with another sensible decision on experts, this time on the use of treating physicians to offer causation opinions. In re Cook Medical IVC Filters Mktg., Sales Practices, & Prod. Liab. Litigation, 2018 WL 5926510 (S.D. Indiana Nov. 13, 2018).

We all know how the expert game works. Each side hires experts (sometimes through an ever-so-helpful expert service), spoon-feeds them the friendliest supporting materials, and plops these walking jukeboxes down in front of a jury to play a catchy tune. Expert testimony, done properly, ends up being a well-rehearsed preview of the closing argument. These experts are usually experienced story-tellers and can parry with the most cunning cross-examiners. The problem is that jurors have a pretty good sense of how this process works. And if they had any doubts that the expert witness is an advocate, such doubts are erased when they learn the expert is making more money that day in court than any juror makes in a month. Thus, it is not surprising to hear from jurors after a case is over that they discounted the expert testimony. (Yes, we acknowledge that the discount might not be as much as the jurors say. It is kind of like how everyone claims that advertising does not affect them.)

Enter the treating physician. Both sides try to enlist the treating physicians as oath-helpers. If a party does manage to get the treater on its side, you can bet that will be a huge point in the closing. E.g., “Throw out all the experts if you want, but you cannot throw out the treater’s opinion. Nobody paid the treater to testify. The only side the greater is on is the patient’s health.” Etc. That is why the depositions of the treating physician is one of the most important moments in a case. That is why we defense hacks hate being in jurisdictions where the defense is forbidden from contacting treaters, but plaintiff lawyers are free to meet with them, shower them with bad company documents, woodshed them, perhaps dangle threats or promises, and, in general, do their best to line up the treaters with their paid experts on crucial issues such as warnings, injuries, and, most of all, causation. The treater’s testimony seems credible precisely because the treater is not retained by either party.

Most of you are familiar with the concept of non-retained experts. But there is probably a non-trivial subset of lawyers unfamiliar with the 2010 amendment to Fed. R. Civ. P. 26(a)(2). That amendment added requirements for disclosing non-retained experts. More specifically, the 2010 amendment added 26(a)(2)(C), providing that a party designating a non-retained experts must issue a summary disclosure stating the subject matter and summary of the facts and opinions to which the witness will testify. Rule 26(a)(2)(C), eight years after its adoption, is still a trap for the unwary. There is a 50% chance that a plaintiff lawyer naming nonretained experts will fail to supply the summary disclosure required by Rule 26(a)(2)(C).

But that is not what happened in In re Cook. The plaintiff did, in fact, make a summary disclosure. That summary disclosure proffered the treating physicians’ opinions that several possible alternative causes did not play a role in the plaintiff’s injury. Those opinions would have been, of course, quite useful for the plaintiff. If the jury is persuaded to rule out alternate causes, the defendant’s product would look more and more like the culprit. So what’s the problem? The plaintiff followed all the rules, right? Wrong. There is an even more fundamental rule, antedating Rule 26(a)(2)(C): non-retained expert treating physicians are limited to opinions formed during the course of providing treatment. The In re Cook court cited a Seventh Circuit opinion, Meyers v. Nat’l R.R. Passenger Corp., 619 F.3d 729, 734-35 (7th Cir. 2010). You won’t have to look too hard to find a similar opinion in whatever jurisdiction houses your litigation. The plaintiff in Cook argued that the treaters were basing their causation opinions on “their training, expertise, and observations during treatment,” but that last bit rang untrue. As the Cook court put it, “The first time these opinions were introduced was during their deposition testimony for purposes of this litigation. It is, therefore, inadmissible.”

Perhaps the plaintiffs could have gotten around this problem by submitting the treaters’ opinions pursuant to the standard expert disclosure process in Rule 26(a)(2)(B) rather than the summary disclosure in 26(a)(2)(C), but that would mean that the plaintiffs would have had to retain the treaters. That probably also means that those treaters would be paid. Bye-bye neutrality/purity. Plus, most plaintiff lawyers are cheap. For that reason, and for the S.D. Indiana’s persistent reasonableness, we are thankful.

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We are also thankful for your attention, comments, and suggestions. We are thankful for another year of smart, supportive clients. We are thankful for judges who work hard, read all the papers, do their utmost to be fair, and, consequently, tell us that we won. Mostly, though, we are thankful for the mashed potatoes on our plate tomorrow. Sure, we adore the Drug and Device Law Family gathered around the table, but there is zero chance that the potatoes will start a political argument. Happy Holiday to you all.

A couple of years ago we penned a paean to Indiana and its cultural and legal triumphs. Now that another chunk of our family has decided to relocate to that happy state, our thoughts returned to Indiana’s many virtues. Sure, there’s the Indy 500, the fabulous covered bridges of Parke County, the Benjamin Harrison home, and a couple of our favorite in-house lawyers. And now there’s In re Cook Medical, Inc., IVC Filters Mktng., Sales Practices & Prod. Liab. Lit., 2018 U.S. Dist. LEXIS 190177 (S.D. Ind. Nov. 7, 2018).

Maybe plaintiff-files-Daubert-motion isn’t quite man-bites-dog, but it’s still pretty rare. Plaintiffs are usually all about getting to the jury, no matter how raggedy the case. In fact, the more raggedy, the better. Consequently, plaintiffs devote considerably more time fending off Daubert challenges than mounting their own. Maybe there’s a reason for that. Maybe plaintiffs tend to put up hack experts, while defendants put up good ones. Maybe we’re biased. Okay, definitely we’re biased. But take a look at what happened in In re Cook.

The defendants in Cook offered the testimony of a mechanical and materials science engineer who opined that the IVC filter design was not defective and that its benefits outweighed its risks. The expert was well qualified. It’s not as if it was a close call. The defense expert had the appropriate degrees from Cal Berkeley. He also had been a general manager at a company that made IVC filters. Federal Rule of Evidence 702 requires that an expert be qualified by knowledge, skill, experience, training, or education. Note the “or.” This expert had it all. Not only was this expert qualified, he had done the work. He looked at MAUDE adverse event data, peer-reviewed literature, the company’s testing records, the design and engineering records, the opinions of other experts in the case, and fact depositions. That is, the defense expert in Cook did far more homework than virtually any plaintiff design expert we have encountered. We’re not sure we’ve ever deposed a plaintiff design expert who has actually read the design history file. Indeed, we’re pretty sure that most plaintiff experts do not know what a design history file is.

The plaintiff’s main beef with the defense design expert in In re Cook concerns the opinions regarding the device’s benefits and risks. The main benefit of an IVC filter is prevention of pulmonary embolisms. How can a mere engineer opine on medical issues? (Dear Engineering Nerds: Please do not write angry comments; we are using the “mere” word sarcastically. We have endless respect for engineers. We utter a prayer of thanks to them every time we drive across the Benjamin Franklin Bridge. At parties, we always get next to the engineers in case a game of Jenga breaks out.) The court has no problem answering this question: “a biomedical engineer … can testify about the benefits and ability of the Celect IVC filter to catch blood clots from a biomedical design and engineering perspective.” The plaintiffs were asking the wrong question. No surprise there.

Then the plaintiffs raised other wrong questions: (1) Why doesn’t the expert quantify the number of filters that actually prevented pulmonary embolisms? (2) Why does the engineer rely on adverse event data without knowing what percent of adverse events are reported? (3) How dare the expert rely on the defendant’s own studies? The Cook court is untroubled by these wrong questions, and supplies clear, easy, right answers: (1) Quantification goes to weight, not admissibility. (2) No one knows the true adverse event reporting rate, so it’s hard to fault the expert. Also, and again, this criticism might go to weight, but not admissibility. (3) The company’s data might not be perfect, but it looks like valid evidence. The data’s short-comings constitute yet another issue of weight, not admissibility. Finally, the expert relied on lots of other data besides the company’s. In short, tell it to the jury.

We’re still in favor of federal judges acting as stout gate-keepers when it comes to expert testimony. Junk science should be excluded. But when an expert is so well qualified and so well informed as the one in Cook, and when that expert applies reliable methods, there’s no reason to exclude anything. Rather, it’s time for Hoosier hospitality.

Kudos to the multifirm defense counsel team that brought home the decision on which we report today, a victory that may well end up on our “best” list for 2018.

In April 2017, we posted about Dr. Mahyar Etminan, then an expert in the Mirena MDL pending in the Southern District of New York.  Plaintiffs in the MDL claimed that the defendant’s product, an intrauterine contraceptive device containing the synthetic hormone levonorgestrel (“LNG”) caused them to develop idiopathic intracranial hypertension (“IIH”), also known as pseudotumor cerebri, a rare and potentially serious condition marked by increased cerebrospinal fluid pressure in the skull.   In 2015, Etminan had published a study designed to assess the risk of IIH.  Although the study did not definitively conclude that defendant’s product caused IIH, Etminan concluded that one of the two analyses, a “disproportionality analysis” of adverse events in the FDA’s FAERS database, identified an increased risk of IIH associated with LNG and that this result was statistically significant.  Etminan concluded that the results of the second analysis, a retrospective cohort study, did not find an increased risk but that this result was not statistically significant.   No other study has ever established a causal link between LNG and IIH.

Subsequently, a prominent scientist in the field attacked the methodology of Etminan’s disproportionality analysis because the study failed to control for age and gender, resulting in erroneous and misleading conclusions.  At the same time, it was revealed that Dr. Etminan was on the plaintiffs’ payroll at the time that he published his study, a conflict of interest he had not disclosed.  Ultimately, after defendants served Dr. Etminan with a notice of deposition in one of the cases in the MDL, Dr. Etminan repudiated much of his study’s analysis and withdrew as an expert.   When we reported this, we told you to “stay tuned,” commenting that plaintiffs’ other experts, all of whom relied on Etminan’s results, had not withdrawn.

The other shoe dropped a couple of weeks ago.  In In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), the court considered the defendants’ Daubert motions to exclude the plaintiffs’ seven remaining general causation experts.  And it granted them all.   The opinion is very long – seventy-two pages on Westlaw – and we commend it to your weekend reading, as we can’t begin to do justice to the court’s detailed analysis of each expert’s methodology.  But we wanted to bring this terrific decision to your attention and to focus its most important takeaways.

The court began its analysis by emphasizing, “In the face of [the] historical record, with no medical organization or regulator or peer-reviewed scientific literature having found that Mirena or any contraceptive product using LNG is a cause of IIH, an expert witness who would so opine . . . necessarily would break new ground in this litigation.”  Mirena, 2018 WL 5276431 at *20.  All seven of the plaintiffs’ general causation experts “so opined.”  Four of these experts “arrived at this result largely by drawing upon existing sources.”  These included varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The remaining three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In this post, we will focus on two of the experts in the first group, which included an epidemiologist, a toxicologist, an OB/GYN, and an ophthalmologist, but we urge you to read the court’s dissection of the second group as well.

The plaintiffs’ epidemiology expert was a professor of biostatistics with experience in conducting and analyzing large clinical trials.   He claimed that the nine Bradford-Hill criteria supported his causation conclusion.  As many of you know, the criteria are “metrics that epidemiologists use to distinguish a causal connection from a mere association.” Id. at *23 (citation omitted).  They are:  statistical association (also known as “strength of association), temporality, biological plausibility, coherence, dose-response effect, consistency, analogy, experimental evidence, and specificity.

The court first held that the epidemiologist’s opinion did not satisfy any of Daubert’s four reliability factors, because the expert “has not tested his theory.  He has not subjected it to peer review or had it published.   He has not identified an error rate for his application of the nine Bradford Hill factors. . . . And [his theory] has not been generally accepted by the scientific community.”  Id. at *27 (internal punctuation and citation omitted).  With respect to this last, the court again emphasized, “Outside of this litigation, there is a complete absence of scholarship opining that Mirena, or, for that matter, any LNG-based contraceptive, is a cause of IIH.”   Id.  As such, the court undertook to “take a hard look” at the expert’s methodology, scrutiny that was “particularly warranted” because:

 [I]t is imperative that experts who apply multi-criteria methodologies such as Bradford Hill . . . rigorously explain how they have weighted the criteria.  Otherwise, such methodologies are virtually standardless and their applications to a particular problem can prove unacceptably manipulable.  Rather than advancing the search for truth, these flexible methodologies may serve as vehicles to support a desired conclusion.

Id.  (citations omitted).    Citing four examples of how the expert’s assessment of individual Bradford Hill factors “depart[ed] repeatedly from reliable methodology,” the court held, “Measured against these standards, [the epidemiologist’s] report falls short.  Id. at *28-29.

First, the expert used the “analogy” factor, basing his causation conclusion in part on an analogy to another contraceptive product.  But, the court explained, this analogy was based on an “unestablished hypothesis” about the other contraceptive product, for which a causal relationship with IIH had never been substantiated.  Id. at *29.  With regard to the “specificity” factor, the court explained that the factor “inquires into the number of causes of a disease,” id., with the difficulty of demonstrating a causal association escalating along with the number of possible alternative causes.   “In finding the specificity factor satisfied,” the expert “devote[d] two sentences to his discussion.”  Id.   He relied on a conclusory statement to the effect that alternative causes could be ruled out.   And he relied on the Valenzuela study, which had actually disclaimed a finding of causation.   The court explained that the “consistency” factor required “similar findings generated by several epidemiological studies involving various investigators” reaching the same conclusion.  Id. at *30.    Again, the epidemiologist claimed that the Valenzuela study satisfied this criterion because it considered two separate populations.  But, as the court stated, both studies were conducted by the same investigators, and neither found a causal relationship.  Finally, as to the biological plausibility factor, the epidemiologist postulated a biological mechanism by which he said LNG could cause IIH.  The court stated, “ . . . [B]y any measure, [the expert] is unqualified to give an expert opinion as to a biological mechanism of causation of IIH.”   Id. at *30.   This lack of qualifications compromised the expert’s assessment of the biological plausibility factor as well as of related factors.   The court concluded,

Each of [the expert’s] departures from settled and rigorous methodology favors the same outcome.  Each enables him to find that the Bradford Hill factor at issue support concluding that Mirena is a cause of IIH. . . . [His] unidirectional misapplication of a series of Bradford Hill factors is concerning – it is a red flag.  Rather than suggesting a scholar’s considered neutral engagement with the general causation question at hand, it suggests motivated, result-driven, reasoning. . . . Methodology aimed at achieving one result is unreliable.

Id. (internal punctuation and citation omitted.    The court went on to further eviscerate the epidemiologist’s methodology, criticizing his reliance on the Valenzuela study, his nearly-exclusive use of case reports to support three of nine Bradford Hill factors, his failure to consider evidence that undercut his opinions, and his cherry-picking of case reports that supported his desired conclusion.   The court concluded that the expert’s testimony was “compromised by a range of serious methodological flaws,” and failed to satisfy Daubert’s reliability standard.

The court voiced similar criticisms of the methodology of the plaintiffs’ toxicology expert.  Like the epidemiologist, the toxicologist failed to meet any of the four Daubert reliability standards  In applying the Bradford Hill factors, she failed to identify support for her conclusions, distorted or disregarded evidence that undercut her opinions, failed to articulate a plausible biological mechanism to support her causation conclusion, and drew an inapposite analogy to another contraceptive product.   And her opinions were plagued by additional methodological flaws.   She relied on the portion of the Etminan study that was discredited and that Etminan himself repudiated.  And she cited the Valenzuela study as her sole support for finding several Bradford Hill criteria satisfied without acknowledging the study’s methodological limitations and failure to find causation.   The court concluded, “[The toxicologist’s] proposed testimony is beset by methodological deficiencies.  It falls far short of satisfying Daubert’s standard of reliability.  Her testimony, too, must be excluded.”  Id. at *40.

And so it went with the court’s discussion of the rest of the plaintiffs’ experts.   The opinion does the best job we’ve ever seen of demonstrating how an expert can attempt to create the illusion of reliability by paying lip service to the Bradford Hill criteria and how those criteria can be manipulated to mask wholly result-driven ipse dixit opinions plagued by fatal methodological flaws.   In this case, a committed and rigorous judge stemmed the tide.  But we all know that this is not always the case.

We love this decision.  There is a lot more to say about it, and we look forward to telling you more in an upcoming post.

We’ve written about a lot of Risperdal summary judgment wins. No medical causation, no warnings causation (learned intermediaries aware of risks), no alternative design, no fraud. So, when we see an opinion that overturns a plaintiff’s verdict on the grounds of (1) impossibility preemption; (2) clear evidence preemption; and (3) no evidence of general causation, we can’t help but wonder how it got to trial in the first place. So we decided to do a little digging. From our review of the case, it appears these issues were all raised at the summary judgment stage but denied. What changed before and after trial? Not the facts that support these arguments. The regulatory history hasn’t changed. The experts’ opinions haven’t changed. Yet, defendant had to go through an amateur-hour trial (we’ll tell you more about that later) and then wait over a year for these post-trial rulings granting judgment as a matter of law. Sure, better a late win then no win at all – but it certainly feels like this could have been avoided.

The case is Byrd v. Janssen Pharm, Inc., No. 1:14-cv-0820, slip op. (N.D.N.Y. Sep. 21, 2018) and, as mentioned above, involved Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism. Plaintiff alleged that his use of Risperdal caused him to develop abnormal breast tissue growth. The two claims that went to trial were negligent design, manufacturing, and warning defect and strict liability design, warning, and misrepresentation. Id. at 3.

The opinion methodically sets out both defendant’s arguments and plaintiff’s responses, but we’re going to jump right to the conclusions. First up was preemption. Standard plaintiff argument: defendant unilaterally should have changed its warning to include gynecomastia and was able to do it via the Changes Being Effected (“CBE”) regulations. Standard impossibility preemption defense: federal law prohibited defendant from changing the FDA-approved labeling and/or there is “clear evidence” that the FDA would have rejected the proposed labeling change. Id. at 12. The court was persuaded as to both impossibility and clear evidence. Defendant presented “clear evidence” that the FDA had rejected its request to add safety and dosing information for pediatric use of Risperdal. Id.

But the court spent most of its analysis on whether a CBE label change even was permissible under federal law. A CBE labeling change can only be made on the basis of new information concerning a serious risk. “[H]ere, the relationship between antipsychotics and [abnormal breast development] was not new information because it had been discussed in basic psychiatry textbooks for decades, and the FDA does not consider gynecomastia a serious adverse event.” Id. at 9. A “serious” adverse event is defined by federal regulations to be an event that either “resulted in inpatient hospitalization or required surgical intervention to prevent inpatient hospitalization.” Id. at 15. And, both plaintiff’s and defendant’s regulatory experts agreed that gynecomastia “would not be a serious adverse event.” Id. at 16-17. Now, plaintiff’s expert was Dr. Plunkett and she was quick to voice her personal disagreement with the FDA on this point – but that’s irrelevant (both to us and to the court). Id. at 17.

The court didn’t stop there. Defendant also argued that plaintiff had failed to satisfy his burden of proof on causation. While defendant made arguments regarding both proximate and medical causation, the court focused its attention on the latter and specifically the lack of general causation evidence. Id. at 26. Starting with Dr. Plunkett who “admitted to not being a causation expert,” but opined on it anyway – the court found her opinion unsupported by the literature. Id. None of the three pieces of literature relied on by Dr. Plunkett included a control group, so at best they were evidence of an association, not a correlation. Dr. Plunkett’s reliance on this literature demonstrated a “disregard for the difference between an association between two things and a causal relationship between those two things.” Id. at 29; see id. at 30 (“a correlation between Risperdal and gynecomastia cannot be drawn without a control group”). The fact that these studies lack a control group was likely not “new” information at trial and again begs the question why this issue is only being properly addressed post-trial.

Plaintiff’s other causation expert likewise had no support for a general causation opinion. His conclusion was that plaintiff’s gynecomastia was “secondary at least in part to prolonged use of Risperdal.” Id. at 31. But, putting aside reliance on the same literature relied on by Plunkett, the only basis plaintiff’s second expert had for his general causation opinion was his differential diagnosis. A differential diagnosis, however, “generally does not prove general causation.” Id. at 33. It assumes general causation has already been proven. Without general causation, defendant was entitled to judgement as a matter of law.

Still, the opinion continues. The remainder of the decision addressed defendant’s alternative request for a new trial based on the inappropriate conduct of plaintiff’s counsel. The court did not need to decide this issue having already found two grounds to overturn the verdict and award judgement in defendant’s favor. Based on the description of plaintiff’s trial antics, however, we can only assume that the court wanted this opportunity to admonish plaintiff’s counsel. Defendant pointed out 23 separate incidences of plaintiff’s attorney’s misconduct in front of the jury. Id. at 34. In concluding that plaintiff’s counsel’s behavior did warrant a new trial, the court relied on:

(1) Plaintiff’s counsel’s self-deprecating tone of voice and posture when referring to his lack of professional skills and/or experience, (2) his helpless tone of voice and posture when referring to the fact that he was bullied as a child, (3) his alternating innocent and defensive tones of voice in response to an admonishment by the Court, (4) the sympathetic facial expressions of the jurors following the aforementioned acts and/or accompanying comments, (5) the credulous expressions of the jurors following Plaintiff’s counsel’s acts of asserting the truth of Plaintiff’s case and/or vouching for his witnesses, and (6) the jurors’ reactions following Plaintiff’s counsel’s acts of offering his personal opinions about the evidence and/or testifying when he could not otherwise introduce evidence.

Id. at 37-38. While this behavior more than justified a new trial – it wasn’t necessary because no childish antics could overcome the fact that plaintiff had failed to prove general causation and that defendant had clear evidence to support impossibility preemption. Both of those things were true a year ago too. But better late than never.

This post comes solely from the Cozen O’Connor side of the blog.

 

The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation involves more than just individual product liability cases. It includes a class action. In particular, a single named plaintiff, Medical Mutual of Ohio (“MMO”), seeks to represent a class of third-party payers (“TPPs”)—entities such as health benefit plans and HMOs—who will claim to have suffered economic damages when they reimbursed payments for medically inappropriate TRT prescriptions. The prescriptions were medically inappropriate, MMO argues, because they were the result of the class’s reliance on misrepresentations about the safety and efficacy of off-label uses for TRT. MMO wants the putative class to get its money back. And more. It wants treble damages and legal fees under RICO (it also asserts state-law negligent misrepresentation claims).

Now, in a class action, sameness is important. As viewed by plaintiffs’ attorneys, sameness is everything. The more sameness, the better. Differences, on the other hand, are deadly. They kill class actions. Accordingly, when a plaintiff files a motion to certify a class, like MMO did here, the briefing relentlessly focuses on sameness. And the defendants, you can be assured, focus on the differences. And then the court decides.

And in this instance, the Court saw a whole lot of differences. Med. Mut. of Ohio v. Abbvie Inc., 2018 WL 3586182 (N.D. Ill. July 26, 2018).

We’ll start with experts. MMO put up an expert to say that TPPs act the same way with regard to drugs listed on their formularies, in particular that TTPs usually make formulary changes “only once they receive notice” from FDA about safety or efficacy concerns. Id. at 11. If this sounds over-simplified and likely not true, it’s because it is. But MMO had an expert give this opinion because, if it were accepted, MMO could then argue that defendant misled the class by hiding data and risks before the FDA issued any notice. The problem for MMO, however, is that plaintiff’s expert didn’t have the data to support this opinion. He just said it:

But an opinion must be connected to the existing data by more than the ipse dixit of the expert. An expert’s opinions may be inadmissible because there is simply too great an analytical gap between the data and the opinion offered. That is the case here.

Id.

The court also rejected this expert’s opinion that the defendants interacted with all TTPs in the same way using “the same common promotional strategies.” Id. at *12. Among other deficiencies, the record showed that the expert reached his opinion before beginning his work. He relied on materials selected and gathered by the plaintiff’s attorneys and allegations in MMO’s complaint, not his own investigation. Id.

Plaintiff also put up a causation and damages expert—the well-traveled Dr. Meredith Rosenthal—who performed a regression analysis to show that the defendants’ alleged misrepresentations damaged all TPPs in the same way. The flaw in the analysis, however, was that it purported to measure the effect of the alleged misrepresentations on doctors and patients. In other words, it focused on direct-to-consumer and physician promotion, not promotion to and contact with the TPPs, the would-be class members asking for their money back. Id. at *8-9. This didn’t work. Proximate causation requirements for RICO claims are stringent. Evidence of anything less than a direct causal connection to the plaintiff’s injury fails. The court found Dr. Rosenthal’s opinion to be irrelevant and simply ignored it. Id. at *10.

The court next set its sights on the “adequacy” requirement of a class action, in particular whether MMO itself could be an adequate class representative. Anything that could subject MMO to unique or unusual defenses—differences from other class members—could render MMO an inadequate class representative. The court found two big problems for MMO. First, MMO appeared to react belatedly and ineffectively to a notice that the FDA was investigating the safety of TRT with regard to heart attack, strokes and death. In particular, MMO did not institute a prior authorization requirement for the reimbursement of TRT prescription payments until four years after the notice, and made a number of admitted missteps along the way. Id. at *14. Second, and maybe related, its formulary management practices did not include an annual clinical evaluation of safety and efficacy of the drugs on its formulary. The court found, with the help of testimony from a defense expert, that these practices did not meet industry standards and could subject MMO to unusual defenses. Id. at *15. The Court held “that MMO is an inadequate class representative and on that basis denies MMO’s motion for class certification.” Id.

Not done there, the court also held that the plaintiff did not meet the predominance requirement of a class action, concluding instead that individual issues will predominate over common questions of law or fact. Id. In other words, there wasn’t enough sameness to dominate the individuality. For instance, MMO could not “show that each TPP actually received defendants’ alleged misrepresentations. Id. at *16. The court found that this was an individualized inquiry, varying by TPP:

Namely, defendants highlight evidence demonstrating that whether a TPP receives sales calls and clinical information from defendants depends on the number of beneficiaries the TPP insures; whether the TPP permits or prohibits meetings with drug manufacturers as a matter of policy; whether the TPP prefers to hear only business information, only clinical information, or both; and whether the TPP adopts formularies without modification from a [pharmacy benefit managers].

Id.

The court rejected MMO’s argument that it should infer that all TTPs received the misrepresentations because “defendants spent millions on promotional efforts aimed at TPPs . . . including standardized promotional materials”—a kind of fraud-in-the-air theory. Id. at *17. Finding ample reason to doubt that the promotional materials were standardized, the court reasoned that “one would need to know what particular representations a TPP received in order to assess whether that TPP was exposed to half-truths.” Id. That’s “TPP-by-TPP proof,” the very antithesis of class treatment. Id.

On reliance, the court held that individualized issues would also predominate over common issues, persuaded by defendants’ evidence that the formulary management process was complex, not standardized:

Defendants point to evidence tending to show that TPPs’ formulary and utilization management decisions are complex and individualized. Some TPPs do not meet with drug manufacturers at all and are thus unlikely to rely on information from them. Some TPPs use PBMs but customize the PBMs’ standardized formularies. Other TPPs, including MMO for much of the class period, adopt their PBMs’ formularies without modification but make their own utilization management decisions.

Id. at *18.

In short, the court found a lot of reasons to deny class certification. You can find even more in the court’s opinion, which we recommend for your reading list. It is a template for how to defend against these type of TPP class actions.

A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been the neighborhood fox, known to all for years (we live right next to Valley Forge National Park).  The conversation went back and forth for a while, eventually including descriptions of larger size, different coloration, and much longer legs than the fox’s.  We remained unconvinced.  Eventually, our neighborhood e-mail chain came alive with close-up photos of what was undeniably a coyote, taken a scant hundred yards away in a neighbor’s back yard.   Because we are law nerds, it occurred to us that coyotes are just like causation:  an expert can assert a causal link, and assert it again, but, ultimately, there has to be evidence to support the assertion.

As the court agreed in today’s case, a nice (albeit unreported) affirmance of a HUMIRA summary judgment victory out of Maryland’s Court of Special Appeals. In Larson v. Abbott Labs., Inc., 2018 WL 3479236 (Md. Ct. Spec. App. July 19, 2018), the plaintiff, a highly-educated space engineer who had been diagnosed as HIV-positive years before, alleged that the defendant’s psoriasis medication caused him to become sufficiently immunocompromised that he contracted progressive multifocal leukoencephaly (PML).  PML is an often-fatal viral brain disease that left the plaintiff physically disabled and cognitively impaired, and unable to care for himself.  PML is caused by a virus that that is present in the bodies of most adults in the United States but that generally remains inactive except in severely immunocompromised people. HUMIRA’s prescribing information warned that medications of its class had the potential to affect defenses against infection, and that the safety and efficacy of the medication in immunosuppressed patients had not been evaluated.  The warnings did not specifically mention HIV patients.

The plaintiff had been diagnosed as HIV-positive five years before he took HUMIRA. During that time, he treated his plaque psoriasis with home remedies.  When it worsened, he asked his treater about treatment with HUMIRA.  She sought information from the defendant, then referred the plaintiff to a physician who concluded from the information that, because the plaintiff’s HIV was well controlled and that he was not severely immunocompromised (and because a tuberculosis skin test came back negative), he was an appropriate candidate for the medication.  What was unknown to the doctor – and apparently to the plaintiff – was that recent lab results revealed progression of his HIV disease.   (The plaintiff’s infectious disease specialist had attempted to contact him with the results, but he hadn’t responded by the time he began his HUMIRA treatment.) Within three months after beginning his treatment, he began exhibiting headaches and extreme fatigue.  His condition worsened, and he was diagnosed with PML shortly thereafter.

The plaintiff filed suit, asserting the usual product liability claims. His primary causation expert was a “highly-regarded infections disease specialist with significant experience” treating HIV-positive patients. Larson, 2018 WL 3479236 at *7.  The defendant moved to exclude the expert’s opinion.  The trial court granted the motion, and, because the plaintiff was left without expert causation testimony, the court granted summary judgment for the defendant.  The plaintiff appealed.

The plaintiff presented several questions for the appellate court’s determination, including questions related to the trial court’s holdings about the adequacy of the product’s warnings. The appellate court found that it needed to consider only one question – whether the trial court erred in barring the testimony of the plaintiff’s general and specific causation experts and granting summary judgment – because a negative answer to that question obviated the need to consider any of the others.  In the process, the court rejected the plaintiff’s argument that the it needed to address the adequacy of the warnings whether or not the plaintiff could establish medical causation.  As the court explained,

Generally, the “proximate causation element” in a failure to warn case against a pharmaceutical manufacturer is established by proof that the allegedly inadequate warning was a substantial contributing factor to the plaintiff’s injury. . . . In certain product liability cases, however, such as the case before us, the parties disagree over whether sufficient evidence exists to show that the product, itself, can cause the specific injury alleged and, therefore, whether the manufacturer had a duty to provide different or additional warning to prevent the injury. . . . . What is often termed “general causation” is present “when a substance is capable of causing a given disease. . . . General causation, therefore, relates to the element of duty — i.e., whether the risk of the type of injury the plaintiff suffered was reasonably foreseeable, and therefore, whether the manufacturer had a duty to warn the prescribing physician in the first place. . . . Evidence demonstrating [medical] causation . . . must exist independent of whether the manufacturer’s allegedly defective warning label was a proximate cause of the injury. In other words, evidence of general and specific causation was necessary in this case to establish [the defendant’s] duty to warn . . . .

Id., at *9-10. And so the court proceeded to determine whether the trial court had erred in excluding the plaintiff’s causation experts. The plaintiff’s causation theory was that “the immunosuppressant effect of HUMIRA permitted the ‘unmasking’ of [the virus that causes PML], despite the fact that” the plaintiff was not as immunosuppressed as HIV-positive patients who develop PML” even in light of his most recent lab results.  Id.  Maryland is a Frye state.  Under that standard, as the court explained, an expert’s opinion is admissible only if the basis of the opinion is “shown to be generally accepted as reliable within the expert’s particular scientific field.” Id. at *12 (internal punctuation and citations omitted). The standard applies equally to new scientific techniques and to accepted methods applied to support novel theories.

With respect to plaintiff’s main causation expert, the trial court had held that his causation conclusions “[had] not been sufficiently tested and proven to qualify as reliable forensic conclusions rather than scientific hypothesis.” Id. at *13.   The expert’s primary contention was that, “in addition to general HIV disease progression, some additional functional immune deficit must be present for PML to occur,” and that HUMIRA caused that deficit in the plaintiff. Id.   The trial court held that the expert had not considered other potential contributing factors, and that he could not provide a sufficient factual basis for his opinion that HUMIRA was “the missing link.” Id. at *14.

The appellate court stated that, “to constitute a sufficient basis for his general causation opinion, Dr. Jacobson needed to provide support for his contention that” the class of drugs was “known to be associated with an increased risk of PML” at the time the plaintiff took the drug. Id. The plaintiff contended that this support was to be found in the expert’s reference to the drug’s black-box warning about opportunistic pathogens coupled with “well-documented reports of PML occurring in patients who had received” this class of drugs.” Id. But, the court pointed out, the expert did not discuss the “well-documented reports of PML” or explain how the reports helped form the basis of his opinion.   The plaintiff also asserted that the expert relied on “peer reviewed studies, reviews of other biologicals, and FDA Adverse Event Reporting data,” but, the court found, he did not explain how the existence of case reports demonstrated a causal connection, and, the one article he cited related to a drug with a different mechanism of action than HUMIRA’s.

The court echoed the trial court’s holding that there “is sound scientific reasoning to suggest that [the drug’s immunosuppressive effect] could be a factor, but it falls short of showing with any degree of reliability that it is a factor, much less a substantial contributing cause” of the plaintiff’s PML. Id. at *15 (emphasis in original).   The court also reviewed the depositions of the plaintiff’s other experts, and held that, although they “believed that [the plaintiff’s] use of HUMIRA likely contributed to his immunological decline, none could provide a sufficient factual basis for that conclusion. . . . Indeed, [one] conceded that a scientifically reliable causal association” had not been established, id., and another stated “more unequivocally that he believed that [the plaintiff’s increased immunosuppression]” occurred “independent of HUMIRA, representing progression of his HIV disease.”  The same expert discussed an article establishing “the theoretical possibility” that the class of drugs was associated with PML, but explained that “it [didn’t] necessarily establish causation . . . .” Id.

The court commented that it agreed with the trial court that “it may well be that additional research will confirm some or all of [the expert’s] hypotheses. What is determinative in this case, however, is that those causal theories have not been established now nor were they established” when the plaintiff took the drug.  The court also acknowledged that there were ethical obstacles to conducting controlled studies on HIV-positive individuals, and that, because PML is a rare disease, “the amount of epidemiological data that could be useful is limited.”  But this didn’t excuse the experts’ theoretical causation opinions.  The court concluded, “We hold that [the plaintiff’s] experts’ opinions were not grounded on an adequate supply of data, and, therefore, the circuit court properly excluded their testimony.” Id. at *16,

We love a good expert exclusion. BTW, the coyote pictures are really cool.  E-mail us, and we will send them to you.

 

 

Today, in In re Accutane Litigation, No. A-25-17, slip op. (N.J. Aug. 1, 2018), the New Jersey Supreme Court unanimously upgraded the state’s standards for admission of expert testimony.  This decision, we hope, will finally break the back of the long-running – and scientifically bogus – Accutane litigation that has plagued New Jersey courts.

The gist of the opinion can be appreciated in the court’s summary:

HELD: There is little distinction between Daubert’s principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.  Accordingly, the Court now reconciles the standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases.  Analysis of the record in this case leads to a clear result:  the trial court properly excluded plaintiffs’ experts’ testimony.  Moreover, the Court reaffirms that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case.  In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts.

Accutane, slip op. at 2-3.

Specifically, after Accutane, the trial courts’ “gatekeeping role” for expert testimony must “assess both the methodology used by the expert . . . and the underlying data.”  Id. at 5.  New Jersey now is close to being a Daubert state.  Id. (“not much light between New Jersey’s standard and . . . the federal sphere under Daubert”; but “stops short of declaring New Jersey a ‘Daubert jurisdiction’”).  Non-exclusive “general factors” applicable to expert admissibility are:

(1) Whether the scientific theory can be, or at any time has been, tested; (2) Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review but is not a “sine qua non”; (3) Whether there is any known or potential rate of error and whether there exist any standards for maintaining or controlling the technique’s operation; and (4) Whether there does exist a general acceptance in the scientific community about the scientific theory.

Id. “[P]roper gatekeeping . . . requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.”  Id. Finally, the Appellate Division’s “less deferen[tial]” standard of appellate review is rejected, and the trial court’s dismissal of over 2000 cases for lack of scientific validity is affirmed under an abuse of discretion standard.  Id. at 4; id. at 6 (“we reaffirm that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case”).

Under proper Daubert-like standards, the result wasn’t even close.  The “clear result” was exclusion of the “expert” testimony purporting to link the drug to Crohn’s disease.  Id. at 6.

The opinion is 85 pages long. In the interest of brevity (and getting our other work done) we’re simply bullet pointing anything we find of particular interest.  We heartily recommend that all defense counsel with matters in New Jersey read the whole thing.

  • The court relies heavily on the federal Reference Manual on Scientific Evidence (here’s a link to the manual). Id. at 12-18, 24, 73-74, 77-78. That means that defense counsel should feel comfortable citing the Manual in New Jersey state courts.
  • “A majority of states have adopted some form of the Daubert standard, either explicitly or implicitly.” Id. at 65 (citing cases).
  • That N.J.R.E. 702 – unlike the federal rule − has not been amended to include the “Daubert factors” is not dispositive. Id. at 66-67.
  • Expert admissibility is “not credibility,” but rather a “legal determination” as to which “rigor [is] expected of the trial court.” Id. at 67.
  • “The gatekeeping role necessitates examination of a methodology espousing a new theory in medical cause-and-effect cases,” and “properly exercised,” it “prevents the jury’s exposure to unsound science through the compelling voice of an expert.” Id. at 68-69.
  • “[T]he gatekeeping role must be rigorous.” Id. at 69.
  • Anything less than “abuse of discretion” appellate review “is not appropriate in the context of a civil mass tort case.” Id. at 71.
  • “[T]his Court has continued to apply a pure abuse of discretion standard in civil matters concerning expert testimony.” Id. at 72.
  • “[C]ase reports are at the bottom of the evidence hierarchy, and other courts have been skeptical of their value in proving causation.” Id. at 73 (citations and quotation marks omitted).
  • “[A]nimal studies” are “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (citations and quotation marks omitted).
  • “[E]xperts cannot selectively choose lower forms of evidence in the face of a large body of uniform epidemiological evidence.” Id. at 77 (citations omitted).
  • Bradford-Hill criteria “are invoked only after an association between an agent and a particular disease has been determined to be present,” and “their pointed purpose . . . is not to create an association that has not already been detected through appropriate studies.” Id. at 78.
  • “It is not for a trial court to bless new ‘inspired’ science theory; the goal is to permit the jury to hear reliable science to support the expert opinion.” Id. at 80 (citation omitted).
  • “[B]oth our law and the Daubert trilogy are aligned in their general approach to a methodology-based test for reliability.” Id.
  • “[B]oth standards look to whether that reasoning or methodology properly can be applied to facts in issue. Id. at 81 (citations omitted).
  • “[A] technique with minimal support [is] to be viewed with skepticism.” Id. at 82 (citation omitted).
  • “[T]he factors identified originally in Daubert should be incorporated for use by our courts.” Id.
  • Daubert is not “adopted” because “[w]e hesitate to sweep in adherence to the various approaches taken among the circuits and state jurisdictions when applying the Daubert factors.” Id. at 83.
  • “[A] methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.” Id. at 84.
  • “When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.” Id. (citations omitted).
  • Plaintiffs’ theories “fl[y] in the face of consistent findings of no causal association as determined by higher levels of scientific proof” and were properly excluded. Id. at 85.

Given the size of New Jersey’s medical products industry, and the tightening of personal jurisdiction, the New Jersey courts are likely to be one of those jurisdictions seeing a greater number of mass torts involving injury claims against prescription medical products.  The importance of today’s Accutane decision cannot be overstated.

And to top it all off, for Roche, this huge victory occurred on Switzerland’s national day.