Hanrahan v. Wyeth, Inc.

• Decision Date: 25 June 2012
• Docket Number: Case No. 4:04CV01255 ERW
• Parties: DOLISKA HANRAHAN, ROBERT HANRAHAN Plaintiffs, v. WYETH, INC., et al., Defendants.
• Court: U.S. District Court — Eastern District of Missouri

DOLISKA HANRAHAN, ROBERT HANRAHAN Plaintiffs,

v.WYETH, INC., et al., Defendants.

Case No. 4:04CV01255 ERW

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION

Dated: June 25, 2012

MEMORANDUM AND ORDER

This matter comes before the Court upon Defendants' Motion for Summary Judgment [ECF No. 60] and Defendants' Motion to Exclude Testimony of Plaintiffs' Experts [ECF No. 66].

I. BACKGROUND FACTS¹

Plaintiffs Doliska Hanrahan and Robert Hanrahan² filed a complaint, alleging personal injury caused by Defendants' prescription hormone replacement therapy (HRT).

HRT consists of pharmaceutical products comprised of estrogen and progestin, and is prescribed to treat symptoms of menopause. After their ovaries stop producing estrogen, somewomen develop moderate to severe menopausal symptoms, including episodes of heat and sweating referred to as "hot flashes," and vaginal atrophy.

Premarin and Prempro are prescription products containing conjugated equine estrogen that have been approved by the FDA to treat menopausal symptoms and to prevent osteoporosis. Provera is a prescription product containing medroxyprogesterone acetate ("MPA") that has been approved by the FDA to reduce the incidence of endometrial cancer in postmenopausal women who have not undergone a hysterectomy and are receiving conjugated estrogen. Prior to 1995, Wyeth began developing a combination of estrogen and progestin. Prempro and Premphase are prescription products containing this combination.

Defendants Pfizer, Inc. subsidiary Wyeth, LLC f/k/a Wyeth d/b/a Wyeth, Inc., and Wyeth Pharmaceuticals, Inc. (collectively referred to as "Wyeth") introduced Premarin in 1942. Defendant Upjohn Company launched Provera in 1959. By the 1970s, studies revealed a link between estrogen replacement drugs and endometrial cancer, and the FDA instructed Wyeth to change Premarin's label to warn consumers of the risk of endometrial cancer in 1975. After subsequent research indicated that prescribing progestin in combination with estrogen reduced the cancer risk this combination hormone therapy became the standard of care. In 1994, Wyeth introduced Prempro, the first pharmaceutical combining estrogen and progestin in a single tablet.

During the relevant time, Wyeth researched, tested, manufactured, marketed, distributed, and sold Premarin, Prempro, and Premphase. Wyeth also manufactured, distributed, marketed and sold Cycrin, a form of MPA. A predecessor of Pfizer, Inc. ("Pfizer") subsidiary Pharmacia, and Upjohn Company LLC (hereinafter referred to as "Upjohn") researched, tested, manufactured, marketed, and sold Provera.

The medical community became concerned regarding a possible connection between estrogens and breast cancer by 1976. In a June 14, 1976 internal memo, Wyeth physicians reported valid concern regarding the use of exogenous estrogen's role in increasing the incidence of breast cancer, but ultimately concluded that the use did not appear to do so. When informed that study findings indicating that estrogens might be a risk factor for breast cancer, possibly doubling the risk for women taking HRT for fifteen years or more, would be published in the New England Journal of Medicine, Wyeth circulated internal correspondence stating that it was crucial to formulate a plan "to either forestall or mitigate the possible adverse effects" of the study, and indicating concern that the study might impact Premarin's labeling requirements. Although a case-control study was considered, no such study was conducted.

Between the late 1980s and the early 1990s, additional studies linked HRT to an increased risk of breast cancer. Upjohn also was aware of the growing evidence indicating that HRT increased the risk of breast cancer, but did not pursue any studies to determine whether it did. A confidential Wyeth memorandum dated June 2, 1995, which was proposed to counter the publication of results of a recent Nurses' Health Study indicating that HRT caused breast cancer and increased mortality, stated: "Our recommended strategies are: Undermine/cast doubt on validity of data by raising concerns, via credible third party, regarding such issues as: inclusion criteria (e.g., exclusion of alcoholic beverage consumers). . .issue of statistical power . . . communicate estrogen's benefits in osteoporosis, heart disease[.]"

Between 1991 and 1996, Premarin's label and patient information sheet stated, "[t]he majority of studies have shown no association with the usual doses used for estrogen replacement therapy and breast cancer. Some studies have suggested a possible increased incidence of breastcancer in those women taking estrogens for prolonged periods of time and especially if higher doses are used."

In 1997, Premarin's warning included the following language:

Estrogens can cause development of other tumors in animals, such as tumors of the breast, cervix, vagina, or liver, when given for a long time. At present there is no good evidence that women using estrogen in menopause have an increased risk of such tumors, but there is no way yet to be sure they do not; and one study raises the possibility that use of estrogens in the menopause may increase the risk of breast cancer many years later.

Prempro's label in 1997 stated:

Some studies have reported a moderately increased risk of breast cancer (relative risk of 1.3 to 2.) in those women on estrogen replacement therapy taking higher doses, or in those taking lower doses for prolonged periods of time, especially in excess of 10 years. The majority of studies, however, have not shown an association in women who have ever used estrogen replacement therapy. The effect of added progestrins on the risk of breast cancer is unknown, although a moderately increased risk in those taking combined estrogen/progestin therapy has been reported. Other studies have not shown this relationship.

Premphase's 1998 label contained similar language, as did Premarin's and Prempro's 1999 labels. The HRT drugs' labels now carry a "black box"³ warning for breast cancer.

In 1991, the National Institute of Health's ("NIH") Women's Health Initiative Study ("WHI") was initiated, and one of its study components proposed to evaluate the use of estrogen and progestin in postmenopausal women. However, on July 9, 2002, the National Heart, Lung and Blood Institute, a division of the NIH, announced it was terminating the estrogen plus progestin study component due to an unacceptably high incidence of invasive breast cancer among the participants. The initial results of this study were published in the Journal of the American Medical Association in July 2002, and included the conclusion that the overall healthrisks exceeded cardiovascular benefits from use of combined estrogen plus progestin for an average 5.2 year follow-up among healthy postmenopausal women.

Prior to starting HRT, Plaintiff Doliska Hanrahan (hereafter, the singular designation of "Plaintiff" shall refer to Doliska Hanrahan only) suffered from hot flashes, vaginal dryness, and mood swings. Plaintiff would experience three or four hot flashes daily.

Between 1991 and February 1997, several physicians, including Dr. John Applebaum, Dr. Deborah Parks, and Dr. Bruce Bryan, prescribed Premarin and Provera for Plaintiff. Initially, Plaintiff's gynecologist, Dr. Applebaum, prescribed Premarin and Provera for Plaintiff. Plaintiff's primary care physician, rheumatologist Dr. Parks, prescribed MPA for Plaintiff between January 1995 and February 1997. In February of 1997, Dr. Parks switched Plaintiff from Premarin and Provera to Prempro. Between February 1997 and September 1999, Dr. Parks and Plaintiff's gynecologist, Dr. Bryan, prescribed Prempro for her.

Dr. Bryan testified in a deposition that the increased risk of breast cancer was not known when he was treating Plaintiff with HRT, so "that's not something that I would have told her about." Although Plaintiff's physicians continue to prescribe HRT drugs, they changed their HRT prescribing practices and patient counseling in varying degrees after the results of the WHI study were published.

On September 16, 1999, Plaintiff was diagnosed with invasive ductal carcinoma of the right breast, and pathology staining revealed that the cancer was strongly positive for estrogen receptors and progesterone receptors. Thereafter, Plaintiff underwent surgery, radiation, chemotherapy, and adjuvant anti-hormonal medication therapy; and she required additional treatment for lymphedema following her cancer treatment.

II. PROCEDURAL BACKGROUND

On or about September 15, 2004, Plaintiffs filed a complaint against Defendants Wyeth; Upjohn a/k/a Pharmacia & Upjohn, Inc.; and Pfizer for personal injury caused by Defendants' prescription HRT [ECF No. 1].

Plaintiffs' action was subsequently transferred to by the Judicial Panel on Multidistrict Litigation (JPML) to the HRT multidistrict litigation (MDL) proceeding (In Re: Prempro Products Liability Litigation) pending in the Eastern District of Arkansas before the Honorable William R. Wilson, Jr. [ECF No. 9]. In January of 2011, the MDL court advised the JPML that coordinated or consolidated pretrial proceedings in Plaintiffs' action had been completed, and that remand to this Court was appropriate [ECF Nos. 12, 13, 14].

Thereafter, Plaintiff filed an amended complaint containing fourteen claims⁴ [ECF No. 27]. Defendants filed their answers to Plaintiff's amended complaint, asserting several affirmative defenses, including the application of comment k of § 402A of the Restatement (Second) of Torts [ECF Nos. 30, 31]. Subsequently, Defendants filed their summary judgment motion, as well as several Motions to Exclude Testimony of Plaintiff's Experts, with memoranda in support of their motions [ECF Nos. 58-67].

III. SUMMARY JUDGMENT STANDARD

Pursuant to Federal Rule of Civil Procedure 56(c), a court may grant a motion for summary judgment only if all of the information before the court shows "there is no genuine issue of...