Krueger v. Wyeth, Inc.

Decision Date01 July 2019
Docket NumberCase No.: 3:03-cv-2496-JAH (MDD)
Citation396 F.Supp.3d 931
Parties April KRUEGER, Individually and on Behalf of All Others Similarly Situated, Plaintiff, v. WYETH, INC. f/k/a American Home Products, a Pennsylvania Corporation; Wyeth Pharmaceuticals f/k/a Wyeth-Ayerst Pharmaceuticals, a Pennsylvania Corporation; and Does 1 Through 100 Inclusive, Defendants.
CourtU.S. District Court — Southern District of California

Anthony D. Birchfield, Jr., P. Leigh O'Dell, Beasley, Allen, Crow, Methvin, Portis & Miles, PC, David B. Byrne, III, Montgomery, AL, Breean Walas, Walas Law Firm, PLLC, North Little Rock, AR, Eileen L. McGeever, Rushall and McGeever, Carlsbad, CA, Russell D. Marlin, Nahon, Saharovich & Trotz, Memphis, TN, William Gary Holt, Gary Holt & Associates PA, Little Rock, AR, for Plaintiff.

Alexandra Walsh, Beth A. Wilkinson, Jennifer L. Saulino, Kieran Gostin, Lori Alvino McGill, Norman H. Pentelovitch, Wilkinson Walsh + Eskovitz LLP, Jessica D. Miller, John H. Beisner, Nina Ramos Rose, Jessica D. Miller, John H. Beisner, Skadden Arps Slate Meagher & Flom LLP, Frank Lane Heard, III, Wiliiams & Connolly LLP, Washington, DC, Bert L. Slonim, Kaye Scholer LLP, Bert L. Wolff, Hayden A. Coleman, Sheila L. Birnbaum, Dechert LLP, New York, NY, Christopher M. Young, DLA Piper U.S., San Diego, CA, David C. Bonnin, DLA Piper LLP, Houston, TX, Grace Lee, Shook Hardy & Bacon LLP, Irvine, CA, Nathan E. Hoffman, Dechert, LLP, Chicago, IL, Fletcher C. Alford, SNR Denton U.S. LLP, Ryan B. Polk, Gordon & Rees LLP, San Francisco, CA, Pamela Joan Yates, Kaye Scholer LLP, Los Angeles, CA, for Defendants.




Hon. John A. Houston, United States District Judge


This matter comes before the Court on Defendants Wyeth, Inc. and Wyeth Pharmaceuticals, Inc.'s (collectively "Wyeth" or "Defendants") motion to exclude expert testimony and motion for summary judgment, or in the alternative, partial summary judgment pursuant to Rule 56(a) of the Federal Rules of Civil Procedure ("Fed. R. Civ. P.") See Doc. Nos. 317, 341. Both motions have been fully briefed by the parties. See Doc. Nos. 326, 340, 342, 350, 351, 353, 359, 360. After careful consideration of the record, pleadings and exhibits submitted by the parties, oral argument from counsel, and for the reasons set forth below, the Court DENIES Wyeth's motion to exclude Professor Rosenthal's testimony (doc. no. 317), DENIES Wyeth's motion for summary judgment and GRANTS Wyeth's motion for partial summary judgment. Doc. No. 341.


Defendants manufacture a variety of hormone replacement therapy ("HRT") products, including the drugs known as Prempro

, Premarin and Premphase. Between 1995 and 2002, Wyeth employed a standardized pervasive marketing campaign in California, and throughout the United States, aimed at "rebalancing" consumer and prescriber perceptions about the risks and benefits of Wyeth's HRT drugs. Defendants positioned themselves as the authoritative source on HRT and developed strategies, campaigns, education materials, and presentations to neutralize the global fear of breast cancer. Doc.

Nos. 351-24, 32, 35, 36. Defendants created articles discussing the myths and mis-perceptions relating to breast cancer and HRT with suggestive readings authored by hired consultants to refute negative HRT information. Doc. No. 351-62. These materials and guides were created by Defendants' home office and the information was uniformly distributed to their sales force nationwide. Doc.

Nos. 351-4, 6. It was also disseminated in advertisements using celebrities, publications targeting women, and in "Dear Doctor" letters aimed at reaching those physicians treating women with menopausal symptoms. Doc.

Nos. 351-34, 351-35 at 28, 351-48,50-52; 351-28,29. Wyeth promoted that its HRT drugs protected women from cardiovascular disease, and had other cognitive benefits, despite the Food and Drug Administration ("FDA") prohibiting "off-label" promotion prior to standardized verification. Doc. No. 351-17 at 10 (Parisian, M.D. Decl., at 10). Although Wyeth warned of a moderate risk of breast cancer on its Prempro label, it qualified the risk as being associated with higher doses and prolonged use, in excess of 10 years. Id. at 13. These representations were made despite clinical data showing an increased risk of breast cancer at any dose and several studies reporting an increased risk of breast cancer following usage significantly less than ten years. Id. (citing to various studies published before and during the relevant time frame indicating increased risk after only a short exposure) (i.e. Bergkvist, 1989: 2 years; Wyeth's Pivotal Trial, 1994: One year; Schairer, 1994: 2 years; Gapstur, 1999: Less than 5 years; Schairer, 2000: 4 years). Nonetheless, between 1995 and 2002, Defendants' label remained unchanged. Id. at 13.

California women were prescribed HRT by their physicians for the "treatment of moderate to severe vasomotor symptoms associated with menopause (hot flashes, night sweats), vulvar and vaginal atrophy, and the prevention of osteoporosis

." See Doc. No. 317-3 at 5. Just under 47,000 HRT drug prescriptions were purchased by Californians during the class period at a cost of approximately $1.3 billion. Doc. No. 351-7 at 2 (Rosenthal, Ph.D. Decl. at 2). By 1997, Wyeth's HRT drugs were the most prescribed drugs in the United States, used by over 9 million women. Doc. Nos. 351-9, 351-35 at 3. However, in 2002, the National Health Institute removed Prempro from the Women's Health Initiative ("WHI") clinical trial due to the increased rate of disease present among participants, including breast cancer and cardiovascular complications. Doc. Nos. 351-11, 351-12, 351-15. In 2004, Premarin was also removed based on study participants experiencing a 39 % increased risk of stroke and a 47% increased risk of blood clots. Doc. No. 351-12. Subsequent reports issued by investigators showed that HRT increased risks of breast cancer, strokes, venous thromboembolic disease, heart attacks

, cardiovascular disease, Alzheimer's disease, and dementia. Id.

At the time the study was terminated, 53.8% of women had already stopped taking the HRT. Doc. No. 351-12 at 6. Although some women began hormone therapy use outside of the study through their own health clinicians, many women stopped taking hormone therapy altogether. Id. ; 351-15 at 2. Prescriptions of Prempro

declined by 66% and Premarin 33% from the first half of 2002 to the first half of 2003. Doc. No. 351-15 at 2; see also


Nos. 351-13 at 3, 351-14.

This representative action arises from Plaintiff April Krueger's ("Plaintiff" or "Krueger") allegation that, between January of 1995 and January of 2003 ("class period"), Defendants violated California consumer protection laws. The gravamen of Plaintiff's claims is that Defendants misrepresented the health risks associated with their HRT drugs during a long term, nationwide, marketing campaign, conducted in violation of (1) California's Unfair Competition Laws, Cal. Bus. & Prof. Code §§ 17200 - 17210 ("UCL"); and (2) the California Consumer Legal Remedies Act, Cal. Civ. Code §§ 1750 - 1784 ("CLRA"). See Doc. No. 1. Plaintiff, on behalf of herself and others similarly situated ("Class" or "class members"), seek both damages and restitution. Pursuant to the CLRA, Plaintiff seeks actual damages as a result of purchasing Defendants' HRT products during the class period (doc. no. 326 at 8). Plaintiff also seeks restitution of the full purchase price or restitutionary disgorgement of the net profits Defendants earned from class members as result of the allegedly unfair practices. Id. at 10.

Plaintiff retained the services of Professor Meredith Rosenthal, Ph.D. ("Dr. Rosenthal") to establish the damage of the alleged misconduct on the Class. See Doc. No. 326-2 at 2-9. Dr. Rosenthal was directed to utilize the class definition certified by this Court on March 29, 2011 (doc. nos. 108, 326-2 at 4-5) and "assume that all California consumers who purchased Premarin, Prempro

, and/or Premphase" would constitute members of the Class unless they had a personal injury claim. Id. at 5. She "calculated damages incurred by [ ] end-payer purchasers of Wyeth's [HRT] products[.]" Id. at 2. As a result, she provided the following opinions: (1) total dollar amount spent on prescriptions ($1.3 billion); (2) total out-of-pocket cost paid by class members ($590.2 million); and (3) profit earned by Wyeth as a result of sales to members of the class ($771.6 million), all of which were limited to the class period. Id. at 6. The Full Prescription Price scenario calculates the retail cost of Defendants' HRTs, as to all California consumers (excluding personal injury claimants), by multiplying "the total number of prescriptions sold in California" by "the full retail prescription price." Id. at 7. The Out-of-Pocket Payments scenario was calculated by taking the total amount paid for non-Medi-Cal prescriptions and excluding insurance payments from the total purchase price.1 Both the full prescription price and the out-of-pocket costs are referred to in the report as "refund" damages. Id. Last, the Wyeth Profit (i.e. Restitutionary Disgorgement ) scenario, based on profit and loss statements produced by Defendants, offers the "total net profits earned as a result of sales of Premarin, Premphase

and Prempro to California consumers during the class period." Id. at 9.

On March 28, 2016, Defendants filed the instant motion to exclude the opinions of Dr. Rosenthal on the grounds that her calculations fail to account for the value or benefit class members received from use of Defendants' HRT products. See Doc. No. 317. Defendants later filed the instant motion for summary judgment, arguing no genuine dispute of material fact exists as to certain elements of the alleged violations: (1) damages...

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