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In re Lipitor (Atorvastatin Calcium) Marketing

United States Court of Appeals, Fourth Circuit

June 12, 2018

In Re: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502,
v.
PFIZER, INCORPORATED; MCKESSON CORPORATION; GREENSTONE, LLC; PFIZER INTERNATIONAL LLC, Defendants - Appellees, PLAINTIFFS APPEALING CASE MANAGEMENT ORDER 100, Plaintiffs - Appellants, JONAH B. GELBACH; CARL CRANOR; DIERDRE N. MCCLOSKEY; STEPHEN T. ZILIAK, Amici Supporting Appellants, PRODUCT LIABILITY ADVISORY COUNCIL, INCORPORATED; WASHINGTON LEGAL FOUNDATION; CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; AMERICAN TORT REFORM ASSOCIATION, Amici Supporting Appellees. In Re: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502, JUANITA HEMPSTEAD, Plaintiff - Appellant,
v.
PFIZER, INCORPORATED; PFIZER INTERNATIONAL LLC; GREENSTONE, LLC, Defendants - Appellees, JONAH B. GELBACH; CARL CRANOR; DIERDRE N. MCCLOSKEY; STEPHEN T. ZILIAK, Amici Supporting Appellants, PRODUCT LIABILITY ADVISORY COUNCIL, INCORPORATED; WASHINGTON LEGAL FOUNDATION; CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; AMERICAN TORT REFORM ASSOCIATION, Amici Supporting Appellees. In Re: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502, PLAINTIFFS APPEALING CASE MANAGEMENT ORDER 99, Plaintiffs - Appellants,
v.
PFIZER, INCORPORATED; MCKESSON CORPORATION; GREENSTONE, LLC; PFIZER INTERNATIONAL LLC, Defendants - Appellees, JONAH B. GELBACH; CARL CRANOR; DIERDRE N. MCCLOSKEY; STEPHEN T. ZILIAK, Amici Supporting Appellants, PRODUCT LIABILITY ADVISORY COUNCIL, INCORPORATED; WASHINGTON LEGAL FOUNDATION; CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; AMERICAN TORT REFORM ASSOCIATION, Amici Supporting Appellees. In Re: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502, PLAINTIFFS APPEALING CASE MANAGEMENT ORDER 109, Plaintiffs - Appellants,
v.
PFIZER, INCORPORATED; GREENSTONE, LLC; PFIZER INTERNATIONAL LLC; MCKESSON CORPORATION, Defendants - Appellees, JONAH B. GELBACH; CARL CRANOR; DIERDRE N. MCCLOSKEY, STEPHEN T. ZILIAK, Amici Supporting Appellants, PRODUCT LIABILITY ADVISORY COUNCIL, INCORPORATED; WASHINGTON LEGAL FOUNDATION; CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; AMERICAN TORT REFORM ASSOCIATION, Amici Supporting Appellees.

          Argued: January 23, 2018

          Appeal from the United States District Court for the District of South Carolina, at Charleston. Richard Mark Gergel, District Judge. (2:14-mn-02502-RMG)

         ARGUED:

          Derek T. Ho, KELLOGG, HANSEN, TODD, FIGEL & FREDERICK, P.L.L.C., Washington, D.C., for Appellants.

          Mark Cheffo, QUINN EMANUEL URQUHART & SULLIVAN LLP, New York, New York, for Appellees.

         ON BRIEF:

          H. Blair Hahn, Christiaan A. Marcum, RICHARDSON, PATRICK, WESTBROOK & BRICKMAN, LLC, Mt. Pleasant, South Carolina; Silvija A. Strikis, Hilary P. Gerzhoy, KELLOGG, HANSEN, TODD, FIGEL & FREDERICK, P.L.L.C., Washington, D.C., for Appellants.

          Sheila L. Birnbaum, Bert L. Wolff, Mara Cusker Gonzalez, Lincoln Davis Wilson, Jonathan S. Tam, QUINN EMANUEL URQUHART & SULLIVAN LLP, New York, New York; Michael T. Cole, Charleston, South Carolina, David E. Dukes, NELSON MULLINS RILEY & SCARBOROUGH LLP, Columbia, South Carolina, for Appellees Pfizer Incorporated, Pfizer International LLC, and Greenstone LLC.

          Habib Nasrullah, WHEELER TRIGG O'DONNELL LLP, Denver, Colorado, for Appellee McKesson Corporation. Matthew Duncan, FINE, KAPLAN AND BLACK, R.P.C., Philadelphia, Pennsylvania, for Amicus Jonah B. Gelbach. Christopher J. McDonald, Christopher D. Barraza, LABATON SUCHAROW LLP, New York, New York, for Amici Carl Cranor, Dierdre N. McCloskey, and Stephen T. Ziliak.

          Mary A. Wells, L. Michael Brooks, Jr., Brendan L. Loy, WELLS, ANDERSON & RACE, LLC, Denver, Colorado; Terri S. Reiskin, DYKEMA GOSSETT PLLC, Washington, D.C.; Hugh F. Young, Jr., PRODUCT LIABILITY ADVISORY COUNCIL, INC., Reston, Virginia, for Amicus Product Liability Advisory Council, Incorporated.

          Warren Postman, UNITED STATES CHAMBER LITIGATION CENTER, Washington, D.C.; Brian D. Boone, Emily C. McGowan, Charlotte, North Carolina, David Venderbush, ALSTON & BIRD LLP, New York, New York, for Amicus The Chamber of Commerce.

          Cory L. Andrews, Richard A. Samp, Mark S. Chenoweth, WASHINGTON LEGAL FOUNDATION, Washington, D.C., for Amicus Washington Legal Foundation.

          Eric G. Lasker, Kirby T. Griffis, Gregory S. Chernack, HOLLINGSWORTH LLP, Washington, D.C., for Amici American Tort Reform Association and Pharmaceutical Research and Manufacturers of America.

          Before NIEMEYER, KING, and DIAZ, Circuit Judges.

          DIAZ, Circuit Judge:

         This appeal arises from a multidistrict litigation ("MDL") in which thousands of women claim that their use of the medication Lipitor caused them to develop diabetes. The women sued Pfizer, Lipitor's manufacturer, asserting various products liability claims. After protracted litigation, the district court granted summary judgment to Pfizer. Plaintiffs now ask us to consider a host of issues, including whether the district court erred in excluding certain expert testimony under Federal Rule of Evidence 702 and Daubert[1]; whether it erred in requiring expert testimony at all; and whether summary judgment was appropriately granted against all plaintiffs in the MDL. Finding no reversible error, we affirm the district court's judgments.

         I.

         Pfizer manufactures Lipitor (atorvastatin calcium), a pharmaceutical drug. Lipitor is a member of a class of drugs known as statins, which are broadly indicated to prevent the onset of cardiovascular disease. Physicians prescribe Lipitor to lower patients' low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol) and triglycerides in order to reduce the risk of heart attack or stroke. In the United States, Lipitor is commercially available in 10, 20, 40, and 80 mg tablets.

         The plaintiffs in this litigation are more than three thousand women who have sued Pfizer, claiming that they developed diabetes as a result of taking Lipitor. Their complaint sets forth various theories of liability, including that Pfizer was negligent in its design and promotion of Lipitor and that Pfizer failed to adequately warn others of the drug's known risks.

         The Judicial Panel on Multidistrict Litigation transferred these lawsuits to the District of South Carolina for consolidated or coordinated pretrial proceedings. See 28 U.S.C. § 1407. The district court and the parties then agreed on four plaintiffs whose claims would serve as bellwether cases.

         The parties engaged in extensive discovery, including the identification of expert witnesses and exchange of expert reports. The plaintiffs enlisted general causation experts, who intended to testify that there was a causal association between Lipitor and diabetes, and specific causation experts, who would testify that Lipitor proximately caused the onset of diabetes in each of the bellwether plaintiffs. The plaintiffs also retained an expert biostatistician, who performed analyses of several clinical trials and studies, and concluded that Lipitor led to a statistically significant increased risk of diabetes among those who took the drug.

         The plaintiffs offered other evidence to prove causation. Specifically, they sought to introduce internal Pfizer emails, information from the Lipitor labeling in the United States and Japan, a statement in the New Drug Application ("NDA") for Lipitor submitted by its original developer to the Food and Drug Administration ("FDA"), and information contained on the official Lipitor website. All of these, the plaintiffs contend, evince an association between Lipitor and diabetes-and Pfizer's knowledge of it.

          At the close of discovery, Pfizer moved to exclude the plaintiffs' expert witnesses under Daubert and Federal Rule of Evidence 702. Following extensive hearings and an opportunity for the experts to amend their reports, Pfizer's challenge, in large part, succeeded. Relevant to this appeal, the district court excluded the opinions of the plaintiffs' statistician, Dr. Nicholas Jewell; the opinions of their general causation expert, Dr. Sonal Singh, except for his opinions relating to the 80 mg dose of Lipitor; and the specific causation opinions of Dr. Elizabeth Murphy, which related to the onset of diabetes in one of the bellwether plaintiffs.[2]

         The court's rulings left the plaintiffs without their bellwether cases, and limited to a subset of patients who had taken an 80 mg dose. Following a hearing, and with agreement of counsel, the district court issued a series of four show cause orders asking whether any plaintiff in the MDL could submit evidence (expert or otherwise) that would enable her claim to survive summary judgment given the court's prior rulings.

         In response to the show cause orders, one group of plaintiffs submitted evidence showing only that they were not diabetic before taking Lipitor, that they were diagnosed with diabetes after taking Lipitor, and that they lacked certain risk factors that might make them especially likely to develop the disease. Another group simply "dumped boxes upon boxes of documents" on the district court, including wholly irrelevant records such as "pictures from colonoscopies, EKGs, and pap smear results, " with "no discernment or suggestion as to which documents they claimed precluded summary judgment." In re Lipitor Mktg., Sales Practices and Prods. Liab. Litig., 226 F.Supp.3d 557, 566 (D.S.C. 2017) ("CMO 99").[3] The district court determined that neither of these submissions were sufficient to show causation. See id. at 582.

         After the court's deadline to submit new evidence expired, the plaintiffs argued that the cases in the MDL ought to be returned to their transferor district courts for individual resolution on the issue of specific causation. The district court, however, deemed itself competent to address the questions that remained and granted summary judgment against all plaintiffs in the MDL.

         II.

         The lion's share of this appeal centers upon the district court's decision to exclude the testimony of three of the plaintiffs' expert witnesses.

         Expert testimony in the federal courts is governed by Federal Rule of Evidence 702. That rule permits an expert to testify where the expert's "scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue, " so long as the expert's opinion is "based on sufficient facts or data, " "is the product of reliable principles and methods, " and the expert "has reliably applied the principles and methods to the facts of the case." Fed.R.Evid. 702.

          In assessing the admissibility of expert testimony, a district court assumes a "gatekeeping role" to ensure that the "testimony both rests on a reliable foundation and is relevant to the task at hand." Daubert, 509 U.S. at 597. The district court's inquiry is a "flexible one, " whose focus "must be solely on principles and methodology, not on the conclusions that they generate." Id. at 594-95. Daubert's design 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." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). A district court may consider a wide variety of factors to evaluate the reliability of expert testimony, including "testing, peer review, error rates, and 'acceptability' in the relevant scientific community." Id. at 141.

         "[T]he trial court's role as a gatekeeper is not intended to serve as a replacement for the adversary system, and consequently, the rejection of expert testimony is the exception rather than the rule." United States v. Stanley, 533 Fed.Appx. 325, 327 (4th Cir. 2013) (per curiam) (unpublished) (internal quotation marks omitted). Indeed, Daubert itself stressed the importance of the "conventional devices" of "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof" (rather than wholesale exclusion by the trial judge) as "the traditional and appropriate means of attacking shaky but admissible evidence." 509 U.S. at 596; see also id. at 601 (Rehnquist, C.J., concurring in part and dissenting in part) (cautioning that Rule 702 does not impose upon district judges "the obligation or the authority to become amateur scientists").

          When an expert brings science from the laboratory to the courthouse, we have recognized "two guiding, and sometimes competing, principles" that apply. Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999). "On the one hand . . . Rule 702 was intended to liberalize the introduction of relevant expert evidence. And, the court need not determine that the expert testimony a litigant seeks to offer into evidence is irrefutable or certainly correct." Id. (citation omitted). But courts must also recognize that "due to the difficulty of evaluating their testimony, expert witnesses have the potential to be both powerful and quite misleading. And, given the potential persuasiveness of expert testimony, proffered evidence that has a greater potential to mislead than to enlighten should be excluded." Id. (citation and internal quotation marks omitted).

         We review a district court's decision to admit or exclude expert evidence for abuse of discretion. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). "If the district court makes an error of law in deciding an evidentiary question, that error is by definition an abuse of discretion. A district court likewise abuses its discretion in deciding a Daubert challenge if its conclusion rests upon a clearly erroneous factual finding." Nease v. Ford Motor Co., 848 F.3d 219, 228 (4th Cir. 2017) (internal quotation marks and citations omitted).

         We turn then to consider the district court's decision to latch Daubert's gate and exclude the testimony of three of the plaintiffs' expert witnesses.[4]

          A. Dr. Jewell (Statistics)

         The plaintiffs offered the testimony of Dr. Nicholas Jewell to establish a statistical association between Lipitor and new-onset diabetes. To reach his conclusion, Dr. Jewell performed a reanalysis of the data used in several clinical trials involving Lipitor, including the Pfizer-sponsored ASCOT-LLA trial, [5] as well as clinical trial data submitted to the FDA in the NDA for Lipitor. The district court excluded Dr. Jewell's opinions as to the ASCOT and NDA data, and the plaintiffs challenge both exclusions on appeal.

         1. NDA Data

         Before a drug may be sold or marketed in the United States, its manufacturer must submit an NDA to the FDA for review and approval. See 21 CFR § 314.1. A typical NDA includes a clinical data selection, which contains an overview of clinical investigations of the drug. See id. § 314.50(d)(5). In his initial expert report, Dr. Jewell reviewed data underlying seven clinical trials submitted as part of the NDA for Lipitor. Dr. Jewell examined blood glucose levels of patients in the trials who had taken Lipitor as compared to those who had taken a placebo. Persistently elevated blood glucose levels may, but do not necessarily, indicate that a patient is diabetic.

         At the outset of his report, Dr. Jewell confessed that the data provided "less than optimum information about [Lipitor's] effect on glucose metabolism or new-onset diabetes, because of their short duration, relatively small sample sizes, and the unusual imbalance between the number of participants allocated to placebo and atorvastatin treatment." CMO 54, 145 F.Supp.3d 573, 577-78 (D.S.C. 2015) (quoting Dr. Jewell's report). Nevertheless, Dr. Jewell proceeded to analyze the data and concluded that it reasonably showed that Lipitor had a statistically significant effect on baseline glucose metabolism. That association, he opined, should have put Pfizer on notice of a possible association between atorvastatin and diabetes.

         The district court found Dr. Jewell's methodology and application too tainted with potential bias and error to pass Daubert muster. First, the court expressed concern about the patients whose data were included in the sample set. In particular, Dr. Jewell included patients who had only a single elevated blood glucose reading and patients who had an abnormally elevated baseline glucose level at the beginning of the trial. Including patients with only a single reading, the district court explained, was contrary to the position the plaintiffs and their experts had taken elsewhere in the litigation (including through testimony from Dr. Jewell himself) that a single elevated glucose reading was not a reliable indicator of a diabetic patient. And including patients with elevated baseline levels risked introducing confounding variables into the analysis and thereby endangered the reliability of the results.[6]

          The plaintiffs argue that Dr. Jewell was merely opining as to an increased risk of elevated glucose levels rather than a specific increase in the risk of diabetes. But that argument is at odds with Dr. Jewell's own report, which concludes that the NDA "should have alerted . . . Pfizer to the possibility of increased risk of new-onset diabetes associated with atorvastatin treatment." J.A. 2254 (emphasis added).

         Moreover, the district court believed that Dr. Jewell, a statistician, was simply not qualified to make determinations about which patients' data should have alerted Pfizer to a possible association between its drug and diabetes. Given that Dr. Jewell "readily admitted that he had no expertise in diabetes, did not 'quite know' what new-onset diabetes meant, and was unwilling to testify about the role or use of blood glucose as a surrogate marker for diabetes because he was not a clinician, " the district court found that he "by his own testimony . . . lacked the expertise to opine about any implications that single glucose readings might have about the possibility of new-onset diabetes." CMO 67, MDL No. 2:14-mn-02502-RMG, 2016 WL 827067, at *2 (D.S.C. Feb. 29, 2016).

         Also casting a specter of unreliability over Dr. Jewell's report was the manner in which he applied otherwise reliable statistical tests to the data. Statisticians rely on a range of mathematical tests to extrapolate meaning from data. Choosing the test to apply is a matter of selecting the appropriate tool for the ...


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