Lipitor (Atorvastatin Calcium) Mktg. v. Pfizer, Inc.
| Decision Date | 12 June 2018 |
| Docket Number | No. 17-1189, No. 17-1137,No. 17-1140, No. 17-1136,17-1140 |
| Parties | IN RE: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION (NO II) MDL 2502, Plaintiffs Appealing Case Management Order 100, 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, 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. |
| Court | U.S. Court of Appeals — Fourth Circuit |
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.
Affirmed by published opinion. Judge Diaz wrote the opinion, in which Judge Niemeyer and Judge King joined.
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 Daubert1 ; 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.
Pfizer manufactures Lipitor
(atorvastatincalcium ), 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
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...
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