MARCIA S. KRIEGER, Chief District Judge.
The Court assumes the reader's familiarity with the proceedings to date. Greatly summarized, the Plaintiffs bring a variety of product liability and other tort claims against the Defendants, arising from the Defendants' manufacture and sale of weight-loss drugs called Pondimin and Redux. The Defendants eventually withdrew the drug from the market after studies revealed that it caused harmful side effects. Ms. Heineman used Pondimin and Redux while they were being actively marketed by the Defendants and claims that she suffered permanent injuries as a result.
Both sides designated expert witnesses who they intended to call at trial and, consonant with this Court's procedures, sought a pre-trial determination as to whether certain opinions proffered by the other side's expert conformed to the foundational requirements of Fed. R. Evid. 702. The Court held a Rule 702 hearing on November 4, 2014 and ruled on the various objections to the proffered opinions. Pertinent here are the Plaintiffs' proffer of two opinions by Dr. Cheryl Blume. As denominated in the Rule 702 Motion: (i) Opinion 2, that "the risks associated with ingesting diet drugs manufactured by [the Defendants] outweighed the benefits to patients by 1995"; and (ii) Opinion 3, that "corporate documents demonstrate that [the Defendants] failed to conform to the standard of care for post-market safety surveillance of its diet drugs" (along with certain additional opinions discussed below). As explained in more detail below, the Court excluded Opinion 2 on the grounds that Dr. Blume lacked the requisite knowledge or experience to render such an opinion, and the Court excluded the second opinion on the grounds that the opinion was not the product of a reliable methodology.
The Plaintiffs have moved
The Plaintiffs' motion is considered under Fed. R. Civ. P. 59(e). Relief under that rule is appropriate where there has been an intervening change in the law, newly discovered evidence, or where necessary to correct clear error or prevent manifest injustice. Servants of the Paraclete v. Does, 204 F.3d 1005, 1012 (10
Fed. R. Evid. 702 sets out
The touchstone of the Rule 702 inquiry is whether the testimony has a "reliable basis in the knowledge and experience of [the relevant] discipline." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149 (1999). Thus, a court's focus is on the proffered expert testimony or opinion, rather than simply on the witness' credentials. It is no longer sufficient to "qualify an expert" based on his/her credentials and then to expect that the witness can express any opinion within the area of his/her expertise.
Rule 702 requires the court to focus on the expert's opinion or testimony to ensure its reliability. Such focus is not on the merits or persuasiveness of the opinion or testimony, but rather on the method by with the opinion or testimony was derived. Dodge v. Cotter Corp., 328 F.3d 1212, 1222 (10
As explained in more detail below, the Court's focus here is on two opinions by Dr. Blume.
Rule 702(a) requires the proponent of the opinion to show that "the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or determine a fact in issue". In assessing whether a proffered opinion meets this standard, courts "consider several factors, including whether the testimony is within the juror's common knowledge and experience, and whether it will usurp the juror's role of evaluating a witness's credibility." U.S. v. Gutierrez de Lopez, 761 F.3d 1123, 1136 (10
Rule 702(c) requires that "the testimony is the product of reliable principles and methods". This requirement can be satisfied in two ways. If the testimony is based on a scientific or another analytical approach, the court may consider a variety of factors set out Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), Kuhmo Tire Co., v. Carmichael, 526 U.S. 137 (1999) and their progeny. These factors include: (1) whether a theory has been or can be tested or falsified — that is, whether the expert's theory can be challenged in some objective sense or whether it is instead simply a subjective, conclusory approach that cannot reasonably be assessed for reliability; (2) whether the theory or technique has been subject to peer review and publication; (3) whether there are known or potential rates of error with regard to specific techniques; and (4) whether the theory or approach has "general acceptance" in the scientific community; (5) whether the expert employed the same degree of intellectual rigor in testifying as he would be expected to employ in his professional life; (6) whether the expert proposes to testify about matters growing naturally and directly out of research he or she conducted independent of the litigation or whether the expert developed opinions expressly for purposes of testifying; (7) whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion (i.e., whether there is too great an analytical gap between the data and the opinion proffered); (8) whether the expert adequately accounted for obvious alternative explanations; (9) whether the expert was as careful as he or she would be in regular professional work outside of paid litigation consulting; (10) whether the field of expertise claimed by the expert is known to reach reliable results for the type of opinion the expert would give; (11) the extensiveness of the expert's credentials; (12) the expert's ability to articulate a process that he or she applied; (13) whether the industry adheres to a particular practice; and (14) whether the opinion consists of summary conclusions or broad generalizations based on perfunctory analysis with no supporting specifics.
Alternatively, if the testimony is the product of the only the witness' experience, the Comments following Rule 702 instruct that "the witness must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts". The trial court's gatekeeping function requires "more than simply taking the expert's word for it." Daubert, 43 F.3d 1311, 1319 (9
Dr. Blume's Opinion 2 is that "[t]he risks associated with ingesting diet drugs manufactured by [the Defendants] outweighed the benefits to patients by 1995."
Dr. Blume is a pharmacologist. She worked with pharmaceutical corporations from 1977 to 1998, focusing her efforts on regulatory affairs. Since that time, she has assisted various clients applying for FDA approval of drug products, including preparing New Drug Applications, developing product labeling (including identification of the risks and benefits of drugs), and post-marketing evaluation of a drug's safety. She explained that the first "risk-benefit" examination of a drug occurs prior to FDA approval, during "Phase II" testing of a drug. At that point in time "you must demonstrate [to the FDA] that the product has clinical effect, and that the benefit of the product exceeds the risk." Once a drug is approved by the FDA (as Pondimin was), drug makers continue to look for "signals" of new or enhanced adverse effects. If such signals appear, drug makers may conduct "Phase IV" studies to further assess the situation or otherwise examine the additional data. The drug maker must then determine "whether the benefit of their product is such that it can justify all of the new risks that were observed following the launch of the product." If not, the drug maker might attempt to fix the situation with additional label warnings, but "if your post-marketing experiences demonstrate that the benefit of the drug can never justify the new adverse effects that you're seeing, that the benefit-risk relationship can never be positive, then the product is to be removed from the marketplace." Much of Dr. Blume's testimony focused on the "risk" side of that calculation — that is, the drug maker's duties of "pharmacovigilance" or "scientific and data-gathering activities relating to detection, assessment, and understanding of adverse effects."
After several hours of general direct examination of Dr. Blume, the Court called counsel to the bench and observed that, thus far, the Plaintiffs' questioning of Dr. Blume, though extensive, had not begun to approach the Defendant's foundational challenges to the recited opinions. With the consent of counsel, the Court took over the examination of Dr. Blume.
The Court began by clarifying that Dr. Blume's opinion was that "the risks associated with ingesting diet drugs manufactured by [the Defendants'] outweighed the benefits to patients" during a time frame that Dr. Blume defined as "by the first half of 1995" until the drugs were withdrawn from the market in 1997. The Court then asked how Dr. Blume formulated that opinion.
Dr. Blume responded that she "asked for all the same documents . . . for which I would do it if I were conducting a new product review or safety assessment for a drug company." She assembled the documents she obtained chronologically, reviewed them, reviewed the relevant FDA regulations, and then reviewed "internal databases" maintained by the Defendants "to get a handle on how many [adverse] events were coming in." She then looked at benefit side of the risk-benefit equation:
Dr. Blume testified that she balanced this benefit against evidence that, by 1995, indicated the potential for side effects causing heart disease or preliminary pulmonary hypertension. She stated that "in my mind for that de minimis and temporary and transitory weight loss, that is confirmed in the literature and in their own FDA regulations files for Pondimin alone and although not approved for Pondimin plus [unknown], that combination, that weight loss, that benefit cannot justify two very serious cardiovascular events . . ., one of which is always fatal. So that formed my opinion."
Dr. Blume then performed a similar task with the drug Redux (which the Defendants also manufactured and which Ms. Heineman used). Although "the weight loss with Redux was somewhat better than with Pondimin, [it] was of the same magnitude I mentioned earlier," and the same side effects were present, leading Dr. Blume to reach the same opinion regarding it. Simply put, Dr. Blume concluded that "I felt the weight loss that was seen, you couldn't justify marketing it . . . in lieu of those adverse events."
The Court inquired whether this retrospective risk-benefit review was something that Dr. Blume typically did. Dr. Blume responded that this was the first time she had done such a review in order to testify as an expert witness, but that in corporate practice, she would occasionally conduct retrospective risk-benefit reviews for existing drugs, such as when her company purchased the rights to domestically distribute a drug that was already in use overseas. She explained that "we would be given opportunities to license products, the same drill that I gave you in such detail was also undertaken, and at the end of it, the pencil went down and we said `we can't take the risk.' The benefits sometimes were great, but for our size company and the goals of our company, we couldn't take the risk of what we saw lurking in there."
The Court then asked whether "there [was] a regulation or policy or a standard of care or an industry standard that compels your conclusion". As to the benefit side of the equation, Dr. Blume explained "the efficacy component of it — I would assess the efficacy . . . For most products that are approved in the United States, it did not require [consultation with specialists]. I conducted it." Exploring that issue further, the following exchange occurred:
Both parties were offered the opportunity to ask additional questions. The Defendants' cross-examination of Dr. Blume focused, in part, on the fact that Dr. Blume is not a medical doctor and had no particular knowledge or experience regarding the care of obese patients or the risks and benefits of bariatric surgery or other non-pharmaceutical treatments for obesity.
The Court found that the Plaintiffs failed to show that Dr. Blume had the necessary expertise to express Opinion 2. The Court explained as follows:
Having had the opportunity to study the entire record, as well as to reflect upon the arguments made by the Plaintiffs in their motion, the Court believes its prior ruling to be correct. To the extent it was unclear, or incomplete, the Court thus takes this opportunity to clarify and amplify that ruling.
The Court returns to the statement of Opinion 2 — "The risks associated with ingesting diet drugs manufactured by [the Defendants] outweighed the benefits to patients by 1995." Because Dr. Blume concedes that she cannot make an assessment for any particular patient, the Court understands this opinion to be an assessment for a population of patients or potential patients. In addition, the Court is satisfied that Dr. Blume has extensive experience and expertise in evaluating the
The difficulty with the opinion is with the determination of the "benefits" in the risk-benefit comparison and in the means by which Dr. Blume compared the risks and benefits. Dr. Blume testified that in the case of drugs like Pondimin and Redux, she looked at the evidence of weight loss and evaluated the benefits relying on her own knowledge. She offered no standards or referents that guided her in characterizing the weight loss as de minimis. In the case of Pondimin, she apparently consulted existing studies or material that indicated that the drug was likely to result in weight loss of "a couple of pounds" (perhaps as much as 12-15 pounds when Pondimin was used in combination with another drug) and that such results would be maintained only so long as the patient continued taking the drug. Her testimony was that Redux offered somewhat more favorable weight loss results, but she was not specific, other than observing that such results were "of the same magnitude" as Pondimin. Dr. Blume's factual basis for this assertion — that the expected weight loss for a Pondimin user was "a couple of pounds" — was unchallenged, and thus, the Court will assume it to be accurate.
The problem lies with nature of the opinion — a comparison or weighting of risks and benefits. An adequate and demonstrable method for assessment of the risks is not sufficient to address the other components of the opinion — assessment of the benefits and comparison of the risks and benefits. At the most abstract level, Dr. Blume did not identify any scientific or generally accepted measure that she and other experts in the field use to quantify the "benefit" associated with a drug, or how "benefits" and "risks" are compared. At the next level of specificity, Dr. Blume did not articulate how she quantified the particular "benefit" of using Redux and Pondimum as "de minimus" or how she compared that measure of "benefit" with her measure of "risk". And as noted, on the most specific level, Dr. Blume conceded that she could not assess the benefits and risks to Ms. Heineman.
Without a scientific methodology for the characterization of the "benefits" as de minimus, the question becomes whether Dr. Blume's relied on her experience and expertise and whether they would provide sufficient foundation to make her opinion reliable. Although it appears that Dr. Blume relied upon her experience as a pharmacologist in gathering information about the weight loss effects of the drugs, it does not appear that her expertise was used in assessing the information. For example, she did not compare the weight loss benefits offered by Pondimin or Redux to other weight loss drugs she evaluated during her career. She did not consult with other experts about the medical benefits of the weight loss in various ranges or attempt to identify the situations in which physicians might conclude that these weight loss amounts might nevertheless have beneficial medical purpose. Rather, it appears that Dr. Blume simply made her own value judgment that the benefit of "a couple of pounds" of weight loss for as long as one took the drug was "de minimis".." Characterizing the benefit of the drugs that way ensured that any risk would outweigh the benefit.
Quantification of the benefits of the drugs is a necessary component to Opinion 2 because it compares the benefits of the drugs to their risks. In determining the benefits of the drugs, it does not appear that Dr. Blume brought any more expertise to bear on the question than would any layperson (or, at least, any layperson advised of the weight loss data for the drugs). In such circumstances, Dr. Blume's evaluation of the benefits of Pondimin and Redux does not seem to be an opinion informed by Dr. Blume's specialized training, knowledge, or experience, and thus, fails to satisfy the foundational requirements of Rule 702(a).
In addition, the opinion lacks the necessary foundation under Rule 702(c). Without a methodology or use of experience, training etc. to formulate the benefit component of the risk-benefit comparison, the comparison is not a product of a reliable methodology. As note, the characterization of a de minimus benefit ensures that any risk will outweigh it.
However, absent the problem with the quantification of the benefit, there is a second deficiency — in methodology for comparing risk and benefit. As the Court's oral ruling discussed to some degree, it is not entirely clear from her testimony that the risk-benefit evaluation she performed necessarily yields a reliable opinion here. When performing her risk-benefit evaluations, it appears that Dr. Blume is engaging in a
Accordingly, although the Court has reconsidered its oral ruling in light of the Plaintiffs' motion, the Court nevertheless finds upon reconsideration that the same outcome is warranted. Opinion 2 is excluded under Rule 702(a) and (c).
The precise content of Opinion 3 varied prior to and during the hearing. Originally, that opinion was stated as "corporate documents demonstrate [the Defendant's] misconduct and failure to act as a reasonable pharmaceutical company." Later, the Plaintiffs articulated Opinion 3 as the following:
The Court did not address the factual statements with regard to the sources and definitions of the standard of care, but understood there to be two, separate opinions: (i) that "corporate documents demonstrate that [the Defendants] failed to conform to the standard of care . . .," and (ii) that "based on a review of these documents, [the Defendants] knew or should have known . . . that the risk and benefits of the diet drugs that they were distributing were not adequately expressed. . . ."
The Court began by asking Dr. Blume how she came to the conclusion regarding the first component ("corporate documents demonstrate . . ."). She explained that her company was "given databases as part of the materials provided," and she had a biostatistician examine that database to ascertain "the total number of [adverse event] reports provided to the company over the years." She stated that she was also provided with "exhibits and depositions" that included statements from "people in their safety surveillance department" who had expressed concerns about the completeness of the drugs' labeling. She explained that she couldn't "talk to the people, go back down memory lane," so she used what she learned from these documents to "fill[ ] in that gap, what was going on inside the company as all of these events were being reported, did everybody miss it that the labeling needed to be changed or did some people see that it needed to be changed and noted, made an effort to make the change, although it was eventually blocked."
The Court rejected the two opinions, finding that the Plaintiffs had not satisfied Rule 702(c) — that there was no demonstration that Dr. Blume used a reliable methodology to formulate either opinion. As to the first component, the Court found that:
In retrospect, it may not have been necessary to address the methodology issue of Rule 702(c), because this portion of Opinion 3 is properly excluded on the more basic grounds that the Plaintiffs have not demonstrated that Dr. Blume's "specialized knowledge will help the trier of fact to understand" the corporate documents themselves. Fed. R. Evid. 702(a). In this regard, the Court again emphasizes that the opinion being proffered by Ms. Blume is not "the Defendants failed to conform to the standard of care" but instead that "
Dr. Blume describes deriving her opinion by performing two tasks (directly or with assistance): (i) culling through a database to extract instances of reports of adverse effects, and (ii) examining "exhibits and depositions" in which employees of the Defendants expressed concerns about the products' labeling. It may very well be that Dr. Blume's experience and knowledge was essential to performing the identified tasks — that only a person with Dr. Blume's expertise would be able to locate and extract the relevant information from the entirety of the databases and records she was given. But once Dr. Blume extracted those records, the Plaintiffs have not demonstrated that the extracted records themselves are so opaque or incomprehensible that the trier of fact requires Dr. Blume's assistance to parse them. (Indeed, one would assume that, for example, deposition testimony by the Defendants' employees would be rendered in language comprehensible to the non-expert attorneys taking the depositions.) Put differently, Dr. Blume's expertise was used in the
This argument is misplaced for several reasons. First, nothing in the record supports this contention as a factual matter. At no time during the Rule 702 hearing did Dr. Blume, for example, testify that adverse drug effect reports are somehow incomprehensible to non-pharmacologists.
The second part of Opinion 3 is Dr. Blume's opinion that "[the Defendants] knew or should have known . . . that the risk and benefits of the diet drugs that they were distributing were not adequately expressed." The Court asked about this opinion in three stages. First, it asked "how did you determine that [the Defendants]
Dr. Blume responded that:
The Court then inquired "How about that [the Defendants]
As to the second component of the opinion, the Court ruled:
Upon reconsideration, it is clear to the Court that it erred in addressing the part of Opinion 3 referring, instead, to the evidence supporting the
For the foregoing reasons, the Plaintiffs' Motion for Reconsideration
This statement is fallacious for several reasons. First, it suggests that this Court prohibited Dr. Blume from testifying. That simply is not the case — the Rule 702 process focuses on opinions/testimony not on the witness, and the Court focuses only on the opinions challenged. Even if the statement is understood to mean that the Court excluded all opinions by Dr. Blume, it is not accurate. The parties designated only 3 opinions by for Dr. Blume to test under Rule 702.
Traditionally, such expert testimony as to the "ultimate issue" was inadmissible. In 1972, Fed. R. Evid. 704(a) abrogated that rule, allowing such testimony if otherwise admissible. But the Advisory Committee notes to that Rule note that standards such as Rule 702's requirement that an opinion be helpful to the trier of fact "afford ample assurances against the admission of opinions which would merely tell the jury what result to reach." And, in this Court's experience, Rule 702(a) often operates to permit an expert to provide all of the testimony necessary to permit a factfinder to reach a conclusion, but precludes the expert from taking that last step of testifying as to the conclusion itself.
