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We spend a large portion of our professional life preparing motions to exclude the testimony of plaintiffs’ experts in mass tort litigation.  Our pleasure in reading today’s decision is no doubt a function of the frequent futility of this effort and the consequent inflation of plaintiffs’ settlement demands.  As such, we offer an enthusiastic tip of the hat to Tarek Ismail for sending us a nearly great (we’ll explain the qualification later) opinion out of the Mirena MDL.  In a voluminous opinion in In re Mirena IUD Prods. Liab. Litig., 2016 WL 890251 (S.D.N.Y. Mar. 8, 2016), the United States District Court for the Southern District of New York considered both sides’ Daubert motions.

Defendant’s Medical Experts

Plaintiffs’ chief claims involved perforation of their uteruses by the defendant’s intrauterine device (“IUD).  Plaintiff’s “omnibus” Daubert motion sought to exclude defendants’ experts’ opinions in five subject areas:

  • Secondary perforation: – Plaintiffs’ experts opined that perforation of the uterus by the IUD could occur after, and unrelated to, insertion of the device.   Defendants’ experts opined that perforation could occur only in connection with insertion of the IUD, though it might not be detected until later.
  • Effects of Levonorgestrel on the Uterus and Uterine Contractions:  The IUD in question has a cylinder in its stem that releases a continuous stream of the synthetic progestin levonorgestrel (“LNG”).  Plaintiffs’ experts argued that the LNG weakened the endometrium (the innermost layer of the uterus) and made it more susceptible to perforation by the IUD.   They theorized that regular (non-childbirth) uterine contractions helped propel the IUD through the weakened uterine wall.   Defendant’s experts argued that the LNG did not thin or weaken “the myometrium, the middle, muscular layer of the uterus though which a migrating [IUD] would have to pass,” 2016 WL 890251 at *6, and argued that uterine contractions “could not force through that wall an IUD that has not at least partially perforated.”  Id.
  • Ultrasound imaging:  Defendant’s experts had opined that, while 2D ultrasound was still commonly used to determine whether the IUD had been properly placed (to detect any perforation or damage occurring at insertion, this type of ultrasound “cannot rule out such damage, and 3D ultrasounds producing higher quality images are capable of more detailed detection.”  Id. at *7.  Plaintiffs argued that defendants experts should not be allowed to introduce evidence of the superiority of 3D imaging “because 2D imaging is capable of detecting proper placement of an IUD, it is frequently used to ensure proper placement, and [defendant] has never instructed or recommended that physicians use 3D ultrasounds to detect [the IUDs].  Id.
  • Adequacy of the IUD’s label:  Not surprisingly, defendant’s experts argued that the label has always been adequate to warn of the IUD’s risks. Plaintiff’s ob/gyn experts argued that defendant’s “experts are not qualified to opine on the adequacy of the . . . label because they have not worked in a regulatory capacity.”  Id. at *8.
  • Epidemiological studies:  Defendant’s experts offered opinions about the scope and results of a particular study, while the plaintiffs argued that the defendant’s experts, who were not “epidemiologists, biostatisticians, or medical scientists, were not qualified to render opinions about the study.   Id.

To offer these opinions, the defendant proffered seven experts:

  • A nurse-midwife, who opined that the benefits associated with the IUD in question outweighed its risks, that the label warnings were adequate, and that there was no evidence to support the plaintiffs’ “secondary perforation” theory.
  • Five ob/gyn physicians who testified about the efficacy of IUD, refuted the plaintiffs’ “spontaneous migration” and “secondary perforation” theories, and opined that the warnings accompanying the IUD were adequate;
  • A radiologist, who opined “on the imaging of IUDs and the differences between 2D and 3D ultrasound technology. . . .[concluding] that 3D ultrasound offers advantages over 3D ultrasound with respect to localizing IUDs within the uterine cavity.” Id. at*9.

And the defendant scored a thunderous defeat of the plaintiffs’ motion:

Secondary Perforation/LNG Opinions:   The court held that all five of the defendant’s ob/gyn experts had demonstrated the requisite qualifications, reliability, and helpfulness to the trier of fact to pass muster under Rule 702 and Daubert with respect to Plaintiff’s theory of secondary perforation, uterine contractility, and the effects of LNG on the uterus.”  Id. at *13.  The court rejected the plaintiffs’ argument that the testimony should be excluded “because Defendants’ experts have not personally studied uterine activity upon exposure to LNG or pointed to studies ruling out the possibility of secondary perforation.”  Id. at *10.  The court pointed out that personal study is not necessary for an opinion to be admissible.  Further, as the court pointed out, “given that Defendants’ experts are trying to prove a negative – that secondary perforation does not exist – pointing to the absence of convincing studies or the weaknesses of the studies on which Plaintiffs’ rely, and evaluating them in light of their clinical experience, training and research, is in these circumstances a logical and valid approach.”  Id.

Along the way, the court rejected numerous examples of the plaintiffs’ hyperbole, For example, the plaintiffs’ argued that one defense expert “blindly state[d] that there is no evidence that secondary perforation actually occurs,” id., pointing out that the expert’s opinions were “based on her experience as a clinician who has inserted and instructed others on the insertion of IUDs, and on a review of medical literature.  Id.  Moreover, the court found no merit in the plaintiffs’ argument that the same expert ignored contradictory scientific literature, pointing out that she had specifically addressed the leading study on which the plaintiffs relied.  Id. at *11.   Over and over, throughout its discussion of the five ob/gyn experts, the court invited plaintiffs to challenge the experts’ credibility on cross-examination, emphasizing that plaintiffs’ arguments were relevant to the weight of the experts’ testimony and not to its admissibility.

Only on a single point did the court agree with the plaintiffs, holding that one expert would not be permitted to opine on the impact of “lawsuit-generated scientific misinformation.”  The court found that the expert’s “view on how lawsuits affect women’s contraceptive choice – assuming it would pass muster under Daubert (a dubious proposition)” was irrelevant, would waste time, and would unfairly prejudice the plaintiffs.” Id. at *12.

Opinions on the Adequacy of the IUD’s Label

The court rejected the plaintiff’s argument that the defendants’ experts were not qualified to offer opinions about the adequacy of the IUD’s label because they lacked “education or training with respect to FDA labeling.”  Id. at *13.  The court pointed out that the plaintiffs had not cited “any case where a prescribing physician or medical practitioner [was] excluded from opining oh how a label is perceived from a clinical medical perspective.  Id.  Plaintiffs’ second argument – that defendant’s’ experts  “should not be allowed to testify in the absence of knowledge of the risks of [the IUD],” and that “because [the defendant’s experts] ignore that secondary perforation is reality, they are not equipped to offer an opinion on the adequacy of [the IUD’s labeling], id., similarly received the back of the court’s figurative hand.  The court noted,

This argument does not withstand scrutiny.  Defendant’s experts do not ignore the argument that secondary perforation exists; rather, through their study of the literature and their own clinical experiences, they do not find the argument persuasive.  The legitimacy of this claim is obviously hotly contested, and the Court does not offer an opinion on its validity, but it does not mean that [the defendant’s] experts should not be able to opine on whether the label is adequate from a physician’s perspective.  It is precisely because Defendant’s expert believe secondary perforation is not a real phenomenon that they think the label, despite not warning against it, is adequate – in other words, that the label conveys the legitimate risks of the product.

Id. at *14.  The court concluded that the experts were qualified, their methodology was reliable, and their opinions were helpful to the trier of fact; thus the opinions were admissible under Daubert.  Id.

The court reached similar conclusion with respect to defendants’ experts “2D vs. 3D ultrasound” testimony, and their opinions on epidemiology.

Plaintiffs’ medical experts, we are happy to report, did not fare nearly so well.

Plaintiff’s Causation Experts

Defendants moved to exclude the testimony of four of the plaintiffs’ general and specific causation experts. The court excluded the testimony of all four.  While detailed descriptions of all of the court’s findings exceed the bounds of this post, this portion of the opinion includes a veritable laundry list of everything and expert shouldn’t do if he or she wants to testify at trial.  (We have boldfaced some of those in the discussion below.)  Here are some highlights:

  • The first causation expert’s proposed mechanism for “secondary perforation” failed to meet any of Daubert’s reliability factors.  It had never been tested or studied in human patients and had never undergone animal or in vivo testing, it had not been subjected to peer review and publication or scrutinized by the scientific community, it had produced no “known or potential rate of error,’ and it had not gained “general acceptance” in the scientific community.  Id. at *19 (citations to Daubert omitted).  In fact, the doctor “acknowledged that he [was] unaware of anyone in the scientific community who agrees with his mechanism of perforation.”  Id. (citation omitted).   The court pointed out that the expert’s theory had not been subject to validation and that there had been no testing of the hypothesis.  Instead, the court commented that “[t]his exercise does not seem to have involved any scientific methodology, but rather consisted of reverse-engineering a theory to fit the desired outcome.”  Id. at *20.  Concluding that “the courtroom is not the place for scientific guesswork,” id., the court excluded the expert’s general causation testimony.  In turn, in the absence of an admissible theory of general causation, the expert’s case-specific opinions were excluded as well.
  • The second expert opined that the tips of the IUD’s arms contained sharp edges, creating a propensity for perforating the uterus. The court noted that this observation was based solely on the expert looking at and touching the IUD and comparing the tips of the arms to other surfaces on the IUD, not to other IUDs. The expert could cite no support for his “sharpness” opinion, and the court found that the opinion “did not bear indicia of reliability” and would not be admitted.  Id. at *27.  The expert also opined that the IUD’s arms became “very stiff when loaded in constrained conditions.”  Id. at *28.  The expert based this opinion on mechanical testing he designed in an apparent attempt to mimic the uterus, and effort in which the court held that he failed.  Noting that the expert “held the [IUD] and pushed it against [a] pressure plate,” and that he did not provide “a convincing explanation for why his in vitro experiment [was] a suitable replica for a uterus,” the court concluded that there was “too great of an analytical gap between his mechanical testing and the environment inside a woman’s uterus, making his testimony both unreliable and unhelpful to a jury.”  Id. (citations omitted).   Finally, the expert based some of his opinions on animal studies, “without a sound basis for extrapolating these studies to human uteruses. . . .” Id. at *31.
  • The third expert opined that “contractions of the myometrium . . . can cause the transport of the [IUD] through the uterine wall into the perineal cavity and beyond. . . .”  Id. at *32.  Among its comments, the court noted that the expert stated that it was “undisputed” that secondary perforation occurs, but never confronted scientific literature that refutes this notionId. at *34.  Her proposed mechanism was untested and unvalidated; thus, it amounted to no more than a hypothesis.  Id.  The court also criticized the expert’s reliance on case reports to support her “secondary perforation” opinion.  The court noted that “case reports are generally disfavored by courts as evidence of causation because they merely describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group; they do not isolate and exclude potentially alternative causes, and they do not investigate or explain the mechanism of causation.  Id. at *35 (internal punctuation and citations omitted).  The court also commented that some of the publications on which the expert relied actually undermined her theoryId. at *36.  Finally, the court noted that the expert “had not heard of secondary perforation” before she was consulted for the litigation, “another indication that her opinions lack the reliability to be admissible.”  Id. at *38.
  • The fourth expert offered a specific causation opinion, but, as defendant argued, his testimony lacked “a required foundational predicate – a general causation opinion.”  Id. at *39.  The court agreed, and held that the expert’s opinions were inadmissible.

Defendant’s Regulatory Experts

The plaintiffs moved to exclude the testimony of the defendants’ regulatory experts, arguing that the experts lacked experience with contraception and with the IUD in question and were thus not qualified to opine on the adequacy of the IUD’s label.  The court permitted the first expert to testify about the adequacy of the warnings in the IUD’s label; however, he was not permitted to testify about medical causation or to comment on whether the FDA would have accepted or rejected a specific warning.  The second expert’s testimony was limited by her failure to disclose the basis for her key opinions, as required by the Federal Rules, and by certain testimony that was more prejudicial than probative.

Plaintiffs’ Epidemiology Expert

The court held that plaintiffs’ epidemiology expert was qualified to testify about the key study on which the plaintiffs relied (and which was also mentioned in defendants’ experts’ reports, unless neither party chose to rely on the study at trial. She was not permitted to testify about general causation or about a mechanism for secondary perforation, about the adequacy of defendant’s pharmacovigilance, about broad “ethical obligations” she opined that the defendant failed to follow, about the adequacy of the IUD’s label, or about foreign regulatory issues.

Plaintiffs’ Regulatory Expert, Dr. Suzanne Parisian

In our view, this merits its own post (and may get it!) as we  repeatedly find ourselves kneecapped by the current norms related to the admissibility of the so-called “regulatory testimony” of the ubiquitous Dr. Parisian.   (In fact, we have already devoted several posts to Dr. Parisian.  You can find them here, here, here, and here.)  The court agreed with the defendants that Dr. Parisian was not qualified to testify about medical causation, foreign regulatory issues, or potential safer, alternative designs for the IUD.  She was precluded from testifying about the defendant’s state of mind and motives.  She was not permitted to present narrative testimony that consisted of nothing more than regurgitating documents.

But, like way too many other courts, the court refused to preclude Dr. Parisian from offering opinions what we continue to believe are the ultimate legal/regulatory issues in the case; namely, the reasonableness of the defendant’s conduct and its compliance with FDA regulations. Every time we attempt to exclude Dr. Parisian, we argue that opinions like these that usurp the role of the court and/or the jury are not permissible expert testimony.  Our rate of success mirrors that of the defendants here.  We can only assume that Dr. Parisian gets away with these sorts of opinions because courts are intimidated by the complexity of the FDA regulatory scheme and abandon the field to regulatory “experts” to avoid explaining it themselves in jury charges.

In sum, a huge opinion – far too voluminous to capture adequately in the confines of a blog post.  The court “split the baby” in mostly sensible ways and was not afraid to shut down entire theories on which the plaintiffs based their claims. While work remains if “regulatory” testimony is ever to be confined to its proper parameters, we congratulate the defendant on a good day’s work.