In Re: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502,
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,
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,
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,
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
from the United States District Court for the District of
South Carolina, at Charleston. Richard Mark Gergel, District
T. Ho, KELLOGG, HANSEN, TODD, FIGEL & FREDERICK,
P.L.L.C., Washington, D.C., for Appellants.
Cheffo, QUINN EMANUEL URQUHART & SULLIVAN LLP, New York,
New York, for Appellees.
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
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
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.
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.
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.
L. Andrews, Richard A. Samp, Mark S. Chenoweth, WASHINGTON
LEGAL FOUNDATION, Washington, D.C., for Amicus Washington
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.
NIEMEYER, KING, and DIAZ, Circuit Judges.
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; 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
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.
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
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
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.
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.
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
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
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"). The district
court determined that neither of these submissions were
sufficient to show causation. See id. at 582.
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.
lion's share of this appeal centers upon the district
court's decision to exclude the testimony of three of the
plaintiffs' expert witnesses.
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.
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.
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").
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
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).
then to consider the district court's decision to latch
Daubert's gate and exclude the testimony of
three of the plaintiffs' expert witnesses.
Dr. Jewell (Statistics)
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,  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.
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.
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.
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.
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
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).
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 ...