Bailey v. Wyeth, Inc.

• Decision Date: 11 July 2008
• Citation: 37 A.3d 549,424 N.J.Super. 278
• Parties: Dora BAILEY and Carol Bailey, w/h, plaintiffs v. WYETH, INC., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.Loretta DeBoard, Plaintiffs, v. Wyeth, Inc., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.Bette Kositsky and Mark Kositsky, Plaintiffs v. Wyeth, Inc., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.
• Court: New Jersey Court of Chancery

37 A.3d 549

424 N.J.Super. 278

Dora BAILEY and Carol Bailey, w/h, plaintiffs

v.WYETH, INC., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.Loretta DeBoard, Plaintiffs,

v.Wyeth, Inc., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.Bette Kositsky and Mark Kositsky, Plaintiffs

v.Wyeth, Inc., Wyeth Pharmaceuticals, Inc., Pfizer, Inc., and Pharmacia & Upjohn Co., Defendants.

Superior Court of New Jersey,Law Division,Middlesex County.

Argued June 17, 2008.Decided July 11, 2008.

Esther E. Berezofsky, Cherry Hill, and Kevin Haverty (Williams, Cuker & Berezofsky, attorneys) and Richard S. Lewis (Cohen, Milstein, Hausfeld & Toll, PLLC) of the Washington, D.C. bar, admitted pro hac vice, for plaintiffs.

Lauren E. Handler, Morristown (Porzio Bromberg & Newman, P.C.), George E. McDavid, Princeton, Michael T. Scott, and Daniel K. Winters (Reed Smith LLP), and William R. Murray (Williams & Connolly LLP) of the Washington, D.C. bar, admitted pro hac vice, attorney for defendant Wyeth, Inc. and Wyeth Pharmaceuticals, Inc.

David J. Cooner and Gita F. Rothschild, Newark (McCarter & English LLP, attorneys) and Jay P. Mayesh (Kaye Scholer LLP) of the New York bar, admitted pro hac vice, for defendant Pfizer and Pharmacia & Upjohn Co.HAPPAS, J.S.C.

I. Introduction

This opinion addresses the motions for summary judgment by defendants Wyeth, Inc., Wyeth Pharmaceuticals, Inc. (collectively “Wyeth”), Pfizer Inc., ¹ and Pharmacia & Upjohn Co. (“Upjohn”), as to plaintiffs Dora and Carol Bailey's claims for (1) violations of the New Jersey Products Liability Act (“PLA”), N.J.S.A. 2A:58C–1 to –11, including (a) failure to warn, (b) design defect,² (2) fraud and misrepresentation, (3) negligent misrepresentation and (4) violations of the New Jersey Consumer Fraud Act (“CFA”), N.J.S.A. 56:8–1 to –156. Plaintiffs' claims arise out of breast cancer injuries allegedly suffered by Dora as a result of her ingestion of Provera®, Premarin®, and Prempro™, the three hormone replacement therapy (“HRT”) products involved in this litigation.³

II. Factual Background

Premarin, Prempro, and Provera are FDA-approved prescription drugs. Studies in the 1970s and 1980s suggested that long term use of estrogen alone could increase the risk of endometrial hyperplasia . Scientists then studied and published articles indicating progestin to be effective in reducing the risk of endometrial hyperplasia associated with taking estrogen alone. Thereafter, medical associations began recommending the addition of a progestin when a physician prescribed estrogen to a nonhysterectomized woman.⁴

a) Premarin and Prempro

Premarin and Prempro are the brand names for specific FDA-approved estrogen and combination estrogen plus progestin prescription drugs produced and marketed by Wyeth. Premarin consists of conjugated equine estrogen (“CEE”) and was first approved by the FDA in 1942. Prempro consists of CEE and medroxyprogesterone acetate (“MPA”), a synthetic progestin, and was approved by the FDA on December 30, 1994. Premarin and Prempro remain on the market today and are approved by the FDA to treat menopausal symptoms and for prevention of osteoporosis.

b) Provera

Provera is the brand name for an FDA-approved progestin, specifically MPA, produced and marketed by Upjohn. The FDA approved Provera for marketing in 1959 to treat secondary amenorrhea, functional uterine bleeding, infertility, and related conditions due to hormone imbalance in the absence of organic pathology. The pregnancy-related indications were withdrawn in 1972. In 1998, after Dora stopped using Provera, the FDA approved the following indication: “to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving 0.625 mg conjugated estrogen.” Letter from FDA to Pharmacia & Upjohn (Aug. 4, 1998). Provera continues to be approved by the FDA and on the market today.

c) Dora's Use of Provera, Premarin, and Prempro

Dora first complained to her physician in 1989 of experiencing menopausal symptoms. She was prescribed Premarin and Provera. However, she did not fill the prescription. She first filled a prescription for Premarin and Provera in February 1991.⁵ She continued taking HRT for the next several years. On April 15, 1996, her physician switched her prescription to Prempro. She was diagnosed with breast cancer on May 28, 2002. On or about May 28, 2002, she stopped taking Prempro. She continued to suffer menopausal symptoms including vaginal atrophy, which her physician treated by prescribing a topical HRT medication.⁶

III. Authority of the FDA

The United States Food and Drug Administration (“FDA”) is responsible for “promot[ing] the public health by promptly and efficiently reviewing [drug manufacturers'] clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 21 U.S.C.A. § 393(b)(1).⁷ The FDA controls the introduction of new drugs to the American public. 21 U.S.C.A. § 355(a). The Federal Food, Drug, and Cosmetic Act (“FDCA”) enacted in 1938, required all new drugs to be tested for safety before marketing. 21 U.S.C.A. §§ 301– 399. The results of testing are submitted to the FDA as part of a New Drug Application (“NDA”). Amendments to the FDCA in 1962 strengthened the law. The FDA must ensure that the new drug is both safe ⁸ and effective prior to marketing. See 21 U.S.C.A. § 393(b)(2)(B) (The FDA shall “protect the public health by ensuring ... drugs are safe and effective”). The FDA will not grant approval of a NDA unless the drug is shown to be safe and effective. 21 U.S.C.A. § 355. Drugs approved between 1938 and 1962 were reevaluated to ensure compliance with the efficacy standard.⁹ The 1962 amendments also granted authority to the FDA over prescription drug advertising.

a) NDA

All drugs must be FDA-approved before marketing in the United States. The sponsoring pharmaceutical company must submit a NDA to the FDA. The NDA requires, among other things, reports of investigation into the safety and effectiveness of the drug, the components and production methods used in the drug's manufacturing, and copies of draft labeling proposed for the drug. See 21 C.F.R. § 314.50. Once the drug is approved, the pharmaceutical company remains obligated to report to the FDA adverse drug experiences and any “significant new information ... that might affect the safety, effectiveness, or labeling of the drug product.” 21 C.F.R. § 314.81(b)(2)(i).

A pharmaceutical company seeking approval of additional indications for a drug must submit a supplemental new drug application (“sNDA”). The FDA reviews the sNDA, including the data from clinical studies supporting the change, with the same degree of scrutiny as the original NDA. The FDA will reject the sNDA or NDA if it finds that:

(1) the investigations [of the drug's safety and effectiveness] do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;

(2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;

.... or

(7) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular.

[21 U.S.C. § 355(d).]

If after reviewing an application and all information it has about the product, the FDA determines that the available scientific evidence is inadequate to show that the product is safe or that it is not effective for its proposed use, the FDA will reject the sNDA. 21 C.F.R. § 314.125(b). Indeed, if the FDA concludes that there has not been sufficient study of the product to assure that it is safe for its proposed use, the FDA will reject the sNDA. 21 C.F.R. at § 314.125(b)(4).

b) Labeling

In the context of prescription drugs, “[t]he term ‘labeling’ means all labels and other written, printed or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 U.S.C.A. § 321(m). In 2006, the FDA codified the longstanding policy that labeling must “adequately inform[ ] users of the risks and benefits of the product and [be] truthful and not misleading.” 71 Fed.Reg. 3922 (Jan. 24, 2006).

Proposed labeling is submitted as part of the NDA and reviewed by the FDA. Prescription drug “labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug,” including, among other things, potential safety hazards associated with use of the drug. 21 C.F.R. § 201.56(a).¹⁰ Drug companies are precluded from listing conflicting opinions regarding studies showing a potential risk. 21 C.F.R. § 1.21(c)(1). In addition, the NDA must include a “summary of the benefits and risks of the drug, including a discussion of why the benefits exceed the risks under the conditions stated in the labeling.” 21 C.F.R. § 314.50(d)(5)(viii). The FDA will advise the applicant of necessary revisions to the labeling. Often several versions of the labeling are exchanged between the FDA and the pharmaceutical company before reaching the final approved labeling.

In addition to warning about risks from approved uses, the FDA has authority to impose warnings about off-label or unapproved uses when there is evidence of a clinically significant risk.¹¹ See 21 C.F.R. § 201.57 (1988) (prior to 2006 amendments) (“A specific warning relating to a use not provided for under the ‘Indications and Usage’ section may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is a lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard”).¹² Furthermore, “the labeling shall be revised to include a warning as soon as there is reasonable...