JANE TRICHE MILAZZO, District Judge.
Before the Court are three Motions filed by Defendants Sanofi-Aventis U.S. LLC and Sanofi U.S. Services, Inc. (collectively, "Sanofi" or "Defendants"). The Motions are a Motion to Exclude Expert Testimony on General Causation (Doc. 6163); a Motion to Exclude Expert Testimony of David Madigan, PhD (Doc. 6144); and a Motion to Exclude Expert Testimony of Ellen Feigal, M.D. (Doc. 6149). On July 25, 2019, the Court heard oral argument on two of these Motions — the Motion to Exclude Expert Testimony on General Causation and the Motion to Exclude Expert Testimony of David Madigan. For the following reasons, the Motion to Exclude Expert Testimony on General Causation (Doc. 6163) and the Motion to Exclude Expert Testimony of David Madigan, PhD (Doc. 6144) are
Plaintiffs in this multidistrict litigation ("MDL") are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel,
The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which provides as follows:
The current version of Rule 702 reflects the Supreme Court's decisions in Daubert v. Merrell Dow Pharms., Inc.
First, to assess reliability, a court considers whether the reasoning or methodology underlying the expert's testimony is valid.
Federal Rule of Evidence 703 further provides that an expert may offer opinions based on otherwise inadmissible facts or data but only if (1) they are of the kind reasonably relied upon by experts in the particular field; and (2) the testimony's probative value substantially outweighs its prejudicial effect.
The three Motions before the Court are related. In the Motion to Exclude Expert Testimony on General Causation, Sanofi argues that Plaintiff fails to put forward one expert who conducts both parts of the required two-part test for demonstrating causation. Sanofi argues that instead Plaintiff improperly pieces together testimony from two experts — Dr. Madigan and Dr. Feigal. In this Motion, Sanofi also disputes that these experts are qualified to opine on causation, and Sanofi further avers that the experts did not use reliable methodologies in forming their opinions.
In the Motion to Exclude Expert Testimony of David Madigan, Defendants argue that the three analyses upon which Dr. Madigan bases his opinions are unreliable. In the Motion to Exclude Expert Testimony of Ellen Feigal, Defendants argue that Dr. Feigal is unqualified to render her opinions and that her opinions are irrelevant and unreliable.
Defendants argue that Plaintiff is unable to prove general causation with relevant and reliable expert testimony. The crux of Sanofi's argument is that Plaintiff failed to task one expert with addressing both prongs of the general causation analysis. Sanofi further argues that these experts' causation opinions were not adequately disclosed. According to Sanofi, the experts did not properly articulate their causation opinions in their reports. Sanofi argues that Dr. Madigan, a statistician, failed to state in his report that Taxotere in fact causes permanent alopecia. Regarding Dr. Feigal, Sanofi similarly argues that she failed to state that Taxotere causes permanent alopecia. Lastly, Sanofi argues that the opinions of each expert are independently unreliable. Because these arguments overlap with the arguments Sanofi brings in the individual motions against these experts, the Court will address these in the following sections regarding the individual experts.
To prevail in a pharmaceutical products liability case, a plaintiff must establish both general and specific causation through reliable expert testimony.
Plaintiff relied on Dr. Madigan to identify a statistically significant association. Plaintiff relied on Dr. Feigal to then analyze the association using the Bradford Hill criteria. Plaintiff, therefore, provides evidence on both prongs of the causation analysis. Sanofi fails to cite any law stating that the same expert who identifies the association must also be the one who applies the Bradford Hill criteria. Accordingly, the Court rejects the notion that the law requires one expert to conduct the entire causation inquiry.
The Court further rejects Sanofi's argument that Dr. Madigan is not qualified to testify regarding the second prong. He does not purport to be an epidemiologist, nor does he purport to be qualified to testify on the second prong. Instead, he appropriately limits his opinion to statistics and does not opine on medical causation. He provides only the statistical analysis, which serves as a foundation for Dr. Feigal to testify on the second prong. Insofar as Sanofi argues that Dr. Madigan's opinions are unreliable because they do not show causation, the Court rejects the premise that his opinions had to show causation, as opposed to only a statistically significant association, to be reliable. The law does not require this.
The Court further finds that the opinions of these experts were adequately disclosed. The Court sees no issues with Dr. Madigan's report, which plainly demonstrates that he conducted the first prong of the general causation test. He explains the statistical analysis he conducted and expressly states that he agrees with Sanofi's 2015 conclusion that the evidence supports a causal association between docetaxel and permanent alopecia. Further, deposition testimony shows that Defendants explored Dr. Madigan's work and understood his opinion:
Dr. Madigan's report, supplemented by his deposition testimony, leaves no guesswork for Defendants. The Court therefore rejects Sanofi's argument that Dr. Madigan's opinions were not adequately disclosed.
The Court similarly finds that Dr. Feigal adequately disclosed her causation opinion. In the "Conclusions" section of her report, six conclusions are prominently listed.
Another conclusion states that the "Company's own analysis of the data led them to the conclusion that permanent chemotherapy-induced alopecia is causally related to Taxotere."
While her report was less than clear on the analysis underlying her general causation opinion, Sanofi deposed Dr. Feigal for multiple days and explored this underlying analysis. Dr. Feigal testified that she based her causation opinion on her review of the TAX 316 and GEICAM 9805 clinical studies, the pharmacovigilance referenced in Sanofi's 2015 Clinical Overview, and case study reports.
Regarding Dr. Madigan, Sanofi first takes issue with his analysis of the FDA's adverse event report database ("FAERS") and his analysis of Sanofi's internal databases. Sanofi argues that the key words Dr. Madigan used to search the databases returned irrelevant results and that Dr. Madigan failed to evaluate the results to ensure their relevancy. As Sanofi explains in its briefing, Dr. Madigan searched the FAERS database for case reports that included all three of the following: (1) "alopecia" as a listed adverse event; (2) "Taxotere" or "docetaxel" as one of the listed drugs; and (3) "disability or permanent damage" listed as an outcome. At oral argument, defense counsel explained that Dr. Madigan had to be creative in choosing these terms. In other cases, a search could be run for a specific medical condition. However, because "permanent alopecia" was not provided as an option on the case reports, Dr. Madigan could not search for "permanent alopecia" but had to select other terms that would locate pertinent results. Sanofi raises similar arguments regarding Dr. Madigan's search of Sanofi's internal database, averring that his search terms were overbroad.
The Court finds that Dr. Madigan's methodology passes muster.
Regarding Dr. Madigan's search of Sanofi's database, Sanofi further argues that this search was unreliable because Dr. Madigan relied upon another expert, Dr. Antonella Tosti, to decide the search terms. Sanofi emphasizes that Dr. Tosti is a dermatologist and not an expert in statistical analyses. Under Rule 703, however, an expert can rely on the work of another expert provided that the reliance is reasonable.
Sanofi next takes issue with Dr. Madigan's statistical analysis of Sanofi's clinical studies, TAX 316 and GEICAM 9805. Sanofi avers that Dr. Madigan's analysis of the studies is irrelevant because the studies evaluated "ongoing alopecia" not "permanent alopecia." Sanofi suggests that some of the patients who were reported as having "ongoing alopecia" during the follow-up period of the study may have since had their hair regrow. The Court finds that this distinction does not make Dr. Madigan's analysis irrelevant but instead only less persuasive. Accordingly, this is a criticism that Sanofi can highlight for the jury on cross-examination.
Sanofi further argues that Dr. Madigan relied on a flawed methodology in analyzing the two studies. Sanofi emphasizes that the results of each study individually produced no statistically significant results. Sanofi argues that Dr. Madigan cannot now combine the results of the studies to achieve statistical significance. The Court rejects Sanofi's argument and finds that Sanofi's concern goes to the weight of Dr. Madigan's testimony, not to its admissibility.
Finally, Sanofi takes issue with Dr. Madigan's opinion that a safety signal emerged "several years earlier" than 2015. As Sanofi explains, a "safety signal" is "a concern about an excess of adverse events compared to what would be expected to be associated with a product's use."
In its Motion to Exclude Expert Testimony on General Causation, Sanofi argues that Dr. Feigal improperly relied on Sanofi's "2015 Clinical Overview," cherry-picked literature, and Sanofi's clinical studies. The Court will address each argument in turn.
The "2015 Clinical Overview" was a report Sanofi created for the FDA in which Sanofi assessed the adverse event reports it had accumulated in its pharmacovigilance database. The Court does not find Dr. Feigal's reliance on the 2015 Clinical Overview improper. This was not the main foundation of Dr. Feigal's opinions as Sanofi suggests. This informed her analysis and provided insight — given that the report included information that was only available to Sanofi — but Sanofi fails to show that she placed undue reliance on the report. Sanofi further avers that Dr. Feigal's analysis of the report was only her "personal interpretation" of it, suggesting that understanding the report requires context. Given Dr. Feigal's experience and her consideration of numerous sources in forming her opinions about Taxotere, the Court sees no issues with Dr. Feigal's consideration the Sanofi's "2015 Clinical Overview." If the document makes more sense with context, Defendants can ensure that the jury has this context when Defendants cross-examine Dr. Feigal.
Regarding the argument that Dr. Feigal cherry-picked her sources, Sanofi states that Dr. Feigal testified that she used her personal judgment in deciding what articles to review and include in her analysis. The Court disagrees with Sanofi's characterization of this as cherry-picking. Dr. Feigal appropriately focused her research, using relevant search terms and carefully considering the results of her searches. To support their argument, Defendants rely on Konrick v. Exxon Mobil Corporation,
Regarding Sanofi's clinical studies, Sanofi raises the same argument against Dr. Feigal that it did against Dr. Madigan — that the studies evaluated "ongoing alopecia" not "permanent alopecia." For the same reasons the Court rejected this argument as to Dr. Madigan, the Court rejects it as to Dr. Feigal.
Sanofi further argues that Dr. Feigal's report "makes no mention" of the Bradford Hill criteria.
Dr. Feigal sufficiently addresses the Bradford Hill factors in her report. For example, she addresses the "temporal relationship" factor throughout her report. As one court explained, this factor can be summarized as followed: "A cause must precede its effect. Strength in temporality, such as when a cause immediately precedes its effect, supports an inference of causation."
As Dr. Feigal suggests in her deposition, however, this factor is somewhat amorphous in this case. She testified as follow:
Accordingly, the "effect" in this case is more difficult to identify than in cases involving an easily recognizable injury. Especially given this limitation, Dr. Feigal's consideration of this factor suffices.
Dr. Feigal also addresses the "biological plausibility" factor. As courts have explained, "[t]he concept of biological plausibility . . . asks whether the hypothesized causal link is credible in light of what is known from science and medicine about the human body and the potentially offending agent."
Dr. Feigal further explains her consideration of this factor in her deposition:
Dr. Feigal's report, bolstered by her deposition testimony, sufficiently shows her consideration of the "biological plausibility" factor.
Dr. Feigal also considers the "dose-response relationship" factor. As one court explained, this factor can be summarized as follows: "Causation is more likely if greater amounts of the putative cause are associate with corresponding increases in the occurrence of disease or harm."
Finally, Dr. Feigal also considers the "alternative explanations" factor. In discussing the Sedlacek study, for example, Dr. Feigal notes that while 7 of 112 women who were treated with a Taxotere/docetaxel-containing regimen suffered persistent significant alopecia, none of the 126 patients treated with a Taxol/paclitaxel-containing regimen, nor any of the 285 patients treated with doxorubicin without a taxane, suffered persistent alopecia.
Sanofi raises additional arguments in its Motion to Exclude Expert Testimony of Ellen Feigal. Sanofi first argues that Dr. Feigal is not qualified to opine on the "informed consent" discussion between an oncologist and his or her patient. Sanofi avers that Dr. Feigal has not treated a breast cancer patient in 28 years, and she has never counseled a breast cancer patient on the risks and benefits of Taxotere. The Court rejects the notion that Dr. Feigal is unqualified. Dr. Feigal has worked for pharmaceutical companies, and she has worked for the National Cancer Institute. She has given presentations and taught college courses that cover the topic of "informed consent." Dr. Feigal has more than enough experience to render her qualified.
Sanofi next argues that Dr. Feigal's general "informed consent" opinions are irrelevant and will be unhelpful to the jury. This argument is grounded in the learned intermediary doctrine, which provides that a manufacturer has no duty to warn a plaintiff but instead only a duty to warn the treating physician. Defendants assert that the learned intermediary doctrine turns on the testimony of a plaintiff's prescribing physician, not the testimony of a retained expert speculating about the decision-making process. Defendants argue that the jury, therefore, must hear from the prescribing physician and the patient. Based on such testimony, the jury can make inferences about whether an inadequate label caused Plaintiff's injury or whether she would have taken Taxotere regardless of whether Defendants warned of the risk of permanent hair loss associated with the drug. In response, Plaintiff avers that Dr. Feigal's opinions provide insight on how a reasonable physician should have navigated the decision-making process with her patient. Plaintiff argues that under the learned intermediary doctrine, subjective or objective evidence is appropriate.
Because Plaintiff's treating physician, Dr. James Carinder, is available to testify, Dr. Feigal will not be allowed to opine on the facts of Earnest's case. Dr. Carinder can testify about how he would have responded to an adequate warning from Defendants.
For the foregoing reasons,
