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.

 

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.

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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.”

This guest post is by Tom Hurney at Jackson Kelly, a genuine West Virginia lawyer who leaped at the opportunity to write about a recent favorable decision of his home state’s highest court and to give you a taste of what West Virginia is like.  We were happy to oblige.  So here’s a discussion of why plaintiffs really need expert witnesses in their West Virginia cases.  As always, our guest posters are 100% responsible for what they say – they deserve all the credit (and any blame) for their analysis.

[Sadly, on the day this Post was published, Mr. Bourdain passed away.  West Virginia was glad to host him.

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West Virginia is a great state. If you come to West Virginia, you, like Anthony Bourdain, will meet gracious and kind people, see nature’s beauty and have some great meals. In his “Parts Unknown” field notes on West Virginia, here, Bourdain said he was “intensely grateful for the kindness, hospitality, and patience the people of West Virginia showed to this ignorant rube from New York City who arrived with so many of the usual preconceptions, only to have them turned on their head.”  Bourdain tried squirrel, learning how to skin, gut and quarter, here, and had mortgage lifter tomatoes on salt-rising bread, salt trout, chow chow and vinegar pie, here.  We were glad to have him, although we would have included on his culinary tour some West Virginia hot dogs (with mustard and cole slaw and onions if you want them), beans and cornbread, pepperoni rolls and perhaps a few of our superior craft beers like Devil Anse IPA, Wild Trail Pale Ale, and Bridge Brew Ale.  We would have suggested pizza at Pies & Pints in Charleston, Morgantown or Fayetteville or DiCarlo’s in Wheeling or Lola’s in Charleston; sandwiches at the Secret Sandwich Society in Fayetteville; lunch or dinner at Stardust Café or Jim’s Drive In (great burgers) in Lewisburg; Italian at Oliverio’s in Morgantown or Bridgeport, Muriales in Fairmont, Fazio’s or Soho’s in Charleston; great steaks at the Char in Beckley or Boyd’s in Martinsburg or Chop House in Charleston; and Seafood at Tidewater Grill in Charleston, unless you just want a big fish sandwich, then go to the Fresh Seafood Co. at Capitol Market.  There are a bunch of other great places we don’t have room to mention.

We tell you all this because if you aren’t from here or haven’t visited (and many D&D Blog readers have) you might have the wrong impression of West Virginia. You should rethink that stereotype, like Anthony Bourdain, because in West Virginia it is now clear that plaintiffs need experts to prove warning cases in West Virginia.

On the heels of its 3-2 opinion rejecting “innovator liability” in McNair v. Johnson & Johnson, the Supreme Court of Appeals of West Virginia issued J.C. v. Pfizer, Inc., 2018 WL 2293297 (W. Va. May 15,
2018), where the plaintiffs appealed a summary judgment ruling from the West Virginia Mass Litigation Panel (, arguing that “the Panel’s decision was erroneously based on the absence of expert testimony to support their claims that Pfizer failed to adequately warn of the risks of a prescription medication.  The petitioners further assert that even if expert testimony were required, summary judgment was erroneous because Pfizer’s experts could supply the necessary testimony.”

Here is the new syllabus point from the case, which as West Virginia lawyers (or our National Big Law friends who come down to visit frequently) know, is the binding precedent from the opinion:

The determination of whether expert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, technology and the like is made on a case-by-case basis.  When the issues involved are beyond the common knowledge and experience of the average juror, expert testimony shall be required.

This isn’t a Daubert deal (or in West Virginia, a Wilt deal) – it doesn’t analyze the admissibility of expert testimony because there wasn’t any.  That’s right.  Basically, after losing their designated expert (detail on that below) Plaintiffs argued they could proceed without an expert in a case where they alleged “the children had suffered birth defects that were proximately caused by their mothers’ ingestion of the drug sertraline hydrochloride (brand-name ‘Zoloft’) while they were pregnant.”  Plaintiffs “alleged that Pfizer failed to adequately warn of the risks of birth defects from the use of Zoloft while pregnant and that adequate warnings would have prevented their injuries.  The petitioners do not dispute that the federal Food & Drug Administration (‘FDA’) has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.”  In furtherance of that claim, plaintiffs “designated Adam C. Urato, M.D., as their expert on the adequacy of the Zoloft label in 2003, specifically as it related to the use of Zoloft during pregnancy.”  They disclosed that “Dr. Urato would offer opinions concerning the label to a reasonable degree of medical and scientific certainty, as an expert in Maternal-Fetal Medicine and based on his education, training, experience, review of the relevant literature, and specialized knowledge[.].”  So far, so good, right?

We digress for a moment to point out that before you go off on West Virginia and the rejection of learned intermediary in State ex rel Johnson & Johnson v Karl, let’s take a moment and note the
action by the Legislature in 2016 to adopt the doctrine, as noted in footnote 9 of the opinion:

In 2016, the Legislature enacted West Virginia Code § 55-7-30, which provides, in part, that it is the “intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or medical devices.”  This Court had previously declined to adopt the doctrine. See Syl. Pt. 3, State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007) (“Under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers. We decline to adopt the learned intermediary exception to this general rule.”).  Because the case at bar was filed in 2012, the doctrine has no application here.

So, consistent with the separation of powers in the Mountain State, the Legislature stepped in to change a substantive opinion of the Court, which is how checks and balances are supposed to work.
Anywhoo, back to our discussion of J.C. v. Pfizer, which includes the Supreme Court’s careful recitation of the thorough analyses of the case by the Mass Litigation Panel.

Plaintiffs’ first expert, Dr. Urato was unable to appear for deposition “due to unspecified health reasons.”  With Urato a no-show, Pfizer moved to exclude him.  Plaintiffs’ opposition (which would come back to haunt them) “their labeling expert was a critical witness and their ‘key liability expert’ without whom they would be severely prejudiced.”  After noting the “great deal of work” he had done, plaintiffs “advised the Panel that should Dr. Urato’s medical situation prevent him from testifying, they would ‘seek to designate a new expert in his place, considering the importance of the liability topics on which he is designated to opine.’”  They argued at the hearing on the motion, ““Doctor Urato is a key liability expert of ours . . . We also want a trial to go forward with our key liability expert.  We shouldn’t be hamstrung and not have our key liability expert.”  Although the MLP ordered the deposition to proceed by a date certain, the plaintiffs “remained unable to produce him,” and instead moved for leave to designate a replacement again describing Dr. Urato as their “key” liability expert without whom the plaintiffs would be prejudiced.  The MLP directed plaintiffs to provide an affidavit under seal containing “a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition.”  But, plaintiffs advised the Panel “we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor.”

Even though the MLP found plaintiffs, knew by June 9 the expert could not be deposed, did not provide an affidavit and did not timely determine Dr. Urato’s medical condition, whether he was able to testify in these cases, or request a replacement in a timely manner[,]” the MLP found good cause to name a new expert finding it “would be unfair to punish the litigants for their counsel’s lack of diligence.”  Plaintiffs named their new expert, David A. Kessler, M.D., purportedly “a nationally known expert and former Commissioner of the FDA.”  They then moved to limit Dr. Kessler’s deposition “to no more than three hours” arguing that Pfizer was already “well aware of his opinions,” because he issued a “116-page report detailing his opinions [gave a] deposition … in 2015 in a federal Zoloft multi-district litigation case….”  The Panel denied the motion to limit the length of the deposition and ordered plaintiffs to produce him.  “Two days before the deposition was to be taken, the petitioners filed a supplemental expert disclosure in which they withdrew Dr. Kessler.”

Pfizer moved for summary judgment “arguing that the petitioners could not meet their evidentiary burden on the alleged inadequacy of the 2003 Zoloft label.”  Plaintiffs responded that they could meet their evidentiary burden with Pfizer documents and, if expert testimony was necessary, they could get it from Pfizer’s witnesses.  The MLP granted summary judgment.

The MLP observed that whether the failure to adequately warn claim is based in strict liability or negligence, “the question is whether [Pfizer] acted reasonably under the circumstances.”  Relying on West Virginia precedent, the MLP noted the importance of having an expert witness in failure to warn cases, particularly when there are “complex technical, scientific, and medical issues beyond the common knowledge and experience of the average person.”  The MLP found that “[w]hether Pfizer behaved as a reasonably prudent manufacturer would when warning about the use of Zoloft during pregnancy involves complex issues of science and medicine”; that “this is not a case where the label is silent regarding the alleged risk” because the label during the relevant time carried the Category C pregnancy warning; that “the FDA has repeatedly approved Zoloft’s label”; that “numerous independent organizations have concluded that the evidence does not support a causal link between Zoloft and birth defects”; that the “inclusion of warnings that are not supported by the science can lead to unintended and adverse consequences for the patient”; and that the petitioners’ “prior statements regarding the importance of their labeling expert and the prejudice to their case without such an expert are inconsistent with any assertion that they do not need such an expert because the alleged inadequacy of the Zoloft label is “obvious.”

The MLP also found that the documents plaintiffs claimed proved their warning case – “animal studies, epidemiology, adverse event reports, Core Data Sheets, and FDA regulations” – were “not within the common knowledge and experience of the average juror…[and that] such evidence cannot substitute for expert testimony on the adequacy of the Zoloft label.  Further, “[n]either the interpretation of such studies nor the appropriate method for distilling such lengthy and complex information into a prescription drug label is within the ordinary knowledge and experience of the average juror.”  The MLP concluded “the adequacy of Zoloft’s label required expert testimony.  Because the petitioners had withdrawn their warning/label expert, the Panel concluded they could not meet the burden of proof on an essential element of their claim.”

After detailing plaintiffs’ argument – essentially, they didn’t need an expert because evaluation of the warning was an issue within its common knowledge of the jury – and Pfizer’s argument – you need an expert to prove a warning claim – the Supreme Court of Appeals of West Virginia stated it was plaintiffs’ burden to prove an inadequate warning or “to prove that Pfizer acted unreasonably regarding the pregnancy warning on its 2003 Zoloft label, i.e., the Category C warning mandated by the FDA, as well as the additional warning that patients should ‘notify their physician if they become pregnant or intend to become pregnant during therapy[,]’ and that the failure to adequately warn proximately caused their alleged injuries.”  Recognizing that the FDA approval of the label was evidence of reasonableness, the Court stated “our precedent reflects that expert testimony will be necessary to sustain an evidentiary burden when the matters involved are beyond the common knowledge and experience of the average juror.”

The Court noted particularly that plaintiffs resisted Pfizer’s motion to disqualify their first expert, arguing that his testimony “was critical to their claim,” and explaining in detail why.  The Court expressed some amazement at the withdrawal of the second expert and stated “[n]otwithstanding the petitioners’ u-turn after they voluntarily withdrew their key liability expert, evaluating whether the language in the 2003 Zoloft label was adequate based upon the scientific and medical information that was available at that time, including the science related to the risks of untreated depression during pregnancy, is well beyond the ken and experience of the average juror.”  After a detailed discussion of West Virginia precedent on the need for expert testimony and the common knowledge exception, the Court concluded “[o]ur consideration of the complex issues in the case at bar concerning what should and should not be included in a drug label demonstrates that this is a case where expert testimony is necessary…,” and “[t]o find otherwise, following our consideration of the facts, claims, and circumstances of this case, would be to invite an unsound, unintelligent, and speculative verdict based upon matters beyond the cognition and experience of the average juror.”  (Here, we just have to interject Justice Neely’s separate opinion in Totten v. Adongay, 337 S.E.2d 2 (1985) (Neely, J., concurring), West Virginia’s seminal case on the “common knowledge” exception to the requirement of expert testimony:  “The reason that I have taken the time to concur in part and dissent in part in a case that appears to be of little moment is simply to point out that it is stupid to try any malpractice case, no matter how outrageous, without the help of an expert witness.”).

The Court further rejected plaintiffs’ argument that the warning case could be proven with Pfizer documents and testimony.  After a detailed review of the documents and Pfizer witness testimony, the Court concluded “[t]he foregoing deposition testimony shows that the petitioners cannot sustain their evidentiary burden with Pfizer’s witnesses…,” because “rather than supporting the petitioners’ claim, these witnesses each testified that the U.S. Zoloft label adequately conveyed the essential information in the Core Data Sheet, including the benefit/risk assessment to be conducted by the prescribing physician and the patient for use during pregnancy.”  Again, the Court recounted the plaintiffs fought to keep their expert even though they had “‘significant material evidence’ that would obviate the need for expert testimony….  As the petitioners previously represented, the advanced education, experience, and expertise of Dr. Urato, and later Dr. Kessler, were necessary for an intelligent consideration and analysis of this “significant material evidence” and the myriad of factors involved in the formulation of the Zoloft label.  The petitioners’ argument that they do not need their key liability expert but can sustain their failure to adequately warn claim with Pfizer witnesses is plainly untenable.”

Last, the Court rejected plaintiffs’ argument that requiring expert testimony would be “unfair”:  “Importantly, requiring a party to meet his or her evidentiary burden with expert testimony – where necessary – ensures that a jury’s verdict has a sound evidentiary basis and has been intelligently rendered.”

The Court therefore affirmed the MLP’s order granting summary judgment.

The Nebraska Supreme Court issued a gem of a Daubert opinion in an Accutane case last week, Freeman v. Hoffman-La Roche, Inc., No. S-17-800, 2018 WL 2296772, at *2 (Neb. May 18, 2018).  We don’t write much about Nebraska, but the last time we waxed on about the beauty of the Platte River Valley, we actually received a few emails.  That was when we wrote last year about the Daubert order that the Nebraska Supreme Court has now affirmed, in an opinion that is as correct and straight-headed as the order it was reviewing.  Indeed, the current opinion might actually be the end of this case, which has been kicking around in the Nebraska state courts amazingly since the late 1990s.

Nebraska keeps a low profile. Growing up in California, we were told that Nebraska is in the Midwest.  But then we went to college in New England and learned that Nebraska is just plain “West,” unqualified by any prefix.  Sandwiched in between Colorado and Iowa, we suppose that either moniker could justifiably apply.  Nebraska has the country’s largest railyard, including a tall public viewing tower from which you feel as if you are looking down on a sprawling model train set.  We know because we have been there.  We had a few hours to kill in North Platte one day (don’t ask why) and we Googled “things to do in North Platte.”

There is a city in Nebraska named Kearney and a street in San Francisco named Kearny. They are spelled differently and pronounced differently (Nebraskans say Car-nee,” while Californians say “Ker-nee.”).  But they are named after the same guy.  Go figure.

Legalwise, Nebraska is the only state with a unicameral legislature—i.e., one chamber, with no separate house and senate.  The Nebraska state motto is “Equality Before The Law.”  We like that motto a lot, and we were even more impressed when we learned that it predates the Fourteenth Amendment by one year.  We begrudgingly admit that we prefer “Equality Before The Law” over our home state’s motto, “Eureka!”  The former echoes a bedrock principle of our post-Civil War legal tradition and is both declaratory and aspirational.  California’s motto celebrates sudden wealth.  Must have been sponsored by plaintiffs’ lawyers.

We like the Nebraska Supreme Court’s opinion in Freeman v. Hoffman-La Roche a lot, too.  The plaintiff was prescribed Accutane for chronic acne and allegedly experienced Crohn’s disease in her colon and rectum as a result.  2018 WL 2296772, at *2.  There is, however, no reliable scientific evidence showing a causal relationship between Accutane and this particular condition, so when it came time to produce the expert opinions necessary to prove her claims, the plaintiff could not come through.

She banked on a single expert, whom the trial court found to have applied an unreliable methodology and who “unabashedly cherry-picked supporting studies from an overwhelming contrary body of literature.” Id. The trial court’s 42-page order is among the more thorough orders on expert opinion that you will see, and you can review our take on it here.  It’s a strong order showing that the trial court understood who this expert was and what he was offering.

The Nebraska Supreme Court agreed, and it affirmed the exclusion of the expert’s opinions and the trial court’s order granting summary judgment. The Nebraska Supreme Court must have been as impressed with the trial court’s order as we were, because it affirmed the result in just a few pages.  Under Nebraska’s standard—known as the Daubert/Schafersman framework—the court must determine whether an expert’s methodology is reliable and whether the expert applied the methodology properly to the facts. Id. at *3.

This expert employed a “weight of the evidence” methodology, under which he purported to form an opinion based on a variety of disparate data—animal tests, case reports, epidemiological studies, etc. Id. at *4.  That methodology, according to the Nebraska Supreme Court, is generally accepted.  But the problem was and remains that the expert did not apply the methodology in a reliable fashion. Id. He recognized that there was no study determining that Accutane use was a risk factor for Crohn’s disease, but theorized that it would be a risk factor for a particular type of Crohn’s disease—Crohn’s disease of the colon.

Where did he get that? Well, essentially from nowhere.  He disregarded all but one of the epidemiological studies finding no significant relation between Accutane use and irritable bowel syndrome, which is a disease of the colon.  He also found studies reporting no association between Accutane use and Crohn’s disease a “waste of time” because they did not account for the “different manifestations” of Crohn’s disease.  He admitted, though, that the scientific community does not agree that “different manifestations” of Crohn’s disease make any real difference.  He also admitted that Crohn’s disease has a different clinical presentation and different causes than ulcerative colitis, but then he still relied on one study on ulcerative colitis to support his causation opinion. Id. at *4.  So Crohn’s disease is different, except when it isn’t.

Most tellingly, the expert rejected epidemiological studies on Crohn’s disease that showed no association because they did not focus narrowly on Crohn’s disease of the colon.  But then he relied on anecdotal case reports of Crohn’s disease in Accutane patients whether they reported disease of the colon or not.  So the location of the disease was critical when it helped him, but was immaterial when it did not.  As we said before, this is called talking out of both sides of your mouth, and it is neither good nor scientific.

Taking its cue from the trial court, the Nebraska Supreme Court thus concluded:

The objective of the trial court’s gatekeeping responsibility is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. Clearly, cherrypicking studies from an overwhelming contrary body of literature without valid, supporting reasons for why the other studies were disregarded does not meet the standard of intellectual rigor required of expert witnesses.

Id. at *5.  Without admissible expert opinion, the plaintiff tried to fill the gap with “internal documents,” but that fell short, too.  To the extent the documents were in the record, they did not show a causal relationship.  Id.  Summary judgment affirmed.  This expert’s opinion was shallower than the Platte River itself—a mile wide at its mouth and six inches deep, as some Nebraskans like to say.  We got that saying, by the way, from Bexis.

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.

Last week at the DRI conference in New York an especially talented lawyer delivered an especially interesting address.  Everything about the speech was riveting and splendid, until she deployed the word “fulsome” in the increasingly popular, albeit wrong, fashion, as a synonym for full or complete. About twenty heads spun around to look at us with glee, knowing we had recently railed against this misuse.  How is “fulsome” superior to the simpler, correct words?  The interesting, specific meaning of fulsome is being diluted by foolish pomposity.  Still, the message conveyed to us by this event was not so much about the increasing misuse of “fulsome” but more about our increasing reputation for crankiness.  It is a curse.  When someone hands us a draft for editing, we must pass through it at least twice. Only after clearing away the grammatical wreckage can we review for substance.  It is undeniably a weakness on our part. A misplaced “only” will throw us off and make us want to drop the draft in the trash bin.  It would be wrong to say we “only threw three fits over confusions between ‘uninterested’ and ‘disinterested’ yesterday.”  That “only” belongs next to the word it is modifying, which is “three,” not “threw.” When someone writes that the court “found” something, if the reference is to a legal holding rather than a finding of fact, we reach for the red pen and mutter about the decline of the West.  The Third Circuit “held,” not “found,” that Levine preemption is a fact issue. Of course, the pernicious thing about the Third Circuit’s Fosamax ruling is that it transformed what should be a holding into a finding.  You have probably heard all this before.

 

Are we fretting too much over silly mistakes?  Maybe.  Are we being more than a bit pompous?  Maybe.  Nobody’s perfect.  There are probably no fewer than five dopey mistakes in this post. 

 

Mistakes are not always a big deal.  That is the lesson of a recent Third Circuit ruling in Estate of Goldberg v. Nimoityn et al., No. 17-2870 (3d Cir. April 13, 2018) (not precedential).  The case was a wrongful death med-mal case.  The plaintiff claimed that the doctors and hospital erred in delaying placement of a feeding tube.  The defendants hired an expert witness doctor who opined that the delay in placing the feeding tube was appropriate.  But in that expert’s report there was a mistaken assumption that pneumonia was a factor prompting delay on a certain date when, in fact, the pneumonia diagnosis did not occur until a later date.  At trial, the defense counsel fronted the error with the expert and elicited the expert’s testimony that the mistake was a typo and did not, in any event, affect his ultimate opinion that the delay in placing the feeding tube made sense.  The plaintiff lawyer objected and explained at sidebar that the fronting of the mistake and the explanation by the expert should be precluded because such testimony wandered beyond the scope of the expert report.  The plaintiff lawyer had been salivating over the mistake.  He told the court that he had considered raising the issue before trial.  But surprise seemed more appetizing.  It would no doubt make for a devastating cross.  The problem was that the defense lawyer had surprised the plaintiff by ruining the surprise.  The district court permitted the defense expert to ruin the surprise, reasoning that the ultimate opinion was the same and there was no material surprise.  The case went to the jury, which returned a verdict for the defense.  The plaintiff asked for a new trial, again arguing that the defense expert should not have been allowed to fix his mistake and, furthermore, that the expert’s attribution of the mistake to a typo was perjury.  The district court agreed that the typo explanation was “disingenuous at best,” but continued to believe that there was no prejudicial surprise.  The district court denied the motion for a new trial.  The plaintiff appealed to the Third Circuit.

 

The plaintiff’s main argument on appeal was that the district court erred in failing to exclude the defense expert’s testimony under Federal Rule of Civil Procedure 37(c) (Failure to disclose, to supplement an earlier response, or to admit).  The defense expert never supplemented his expert report.  The expert’s repair of the mistake in his report landed like a sandbag on plaintiff counsel’s head.  So the argument goes.  The Third Circuit reviewed the district court’s decision to admit the expert’s testimony  under the abuse of discretion standard.  The issues were whether the plaintiff was surprised/prejudiced, whether there was an opportunity to cure any prejudice,  and whether the defense exhibited any bad faith.  The plaintiff lawyer acknowledged that he knew about the mistake, so the surprise element was frail.  He was more frustrated than surprised. Further, the plaintiff lawyer did have the opportunity to cross-examine the expert and force him to admit that one of the major bases for his original opinion was a pneumonia diagnosis that did not actually exist.  The point was scored, albeit with less drama than the plaintiff lawyer desired.  The point is that any prejudice was largely cured.  Finally, there was no evidence that the defense acted in bad faith by failing to supplement the report.  The mere passage of two years time between issuance of the expert report and the trial testimony did not, by itself, establish a nefarious plan.

 

The Third Circuit also agreed with the district court that the defense expert’s reference to a typo was implausible, but not clearly perjurious.  The plaintiff expert had, after all, admitted the key fact that the pneumonia diagnosis did not yet exist when he thought it had.  The expert got an important fact wrong and confessed as much.  The opinion does not mention whether the plaintiff lawyer had more than a little fun at cross-examination with the typo whopper.  He certainly could have.  As has been said more than once, and as we seem to be hearing every day now, the cover-up is often worse than the original offense.  Be that as it may, there was no reason to order a new trial just so that the impeachment could have played put just the way the plaintiff lawyer wanted.          

 

There is a certain amount of cleverness in the plaintiff’s argument.  But clever is not the same as right.  One additional fact that makes us sure the Third Circuit is right in Nimoityn is that the Third Circuit was affirming a decision by district court Judge McHugh.  Before he became a judge, Gerald McHugh was one of the preeminent litigators in Philadelphia.  We never were in a case with him, and that is probably a good thing, because McHugh probably would have been on the other side of the v, and even more probably would have beaten our brains out.  We’ve been in the Penn Inn of Court with Judge McHugh for many years, and his contributions during the question periods have been invariably insightful.  Judge McHugh possesses a superabundance of intelligence, integrity, and – well – judgment.  He does not make many mistakes.  (We cannot think of any.)  He did not make one here, and the Third Circuit did not make one in affirming his ruling.