Albertson v. Wyeth Inc.

63 Pa. D. & C.4th 514, 2003 Pa. Dist. & Cnty. Dec. LEXIS 135
CourtPennsylvania Court of Common Pleas, Philadelphia County
DecidedJuly 8, 2003
Docketno. 0007; no. 0935
StatusPublished
Cited by2 cases

This text of 63 Pa. D. & C.4th 514 (Albertson v. Wyeth Inc.) is published on Counsel Stack Legal Research, covering Pennsylvania Court of Common Pleas, Philadelphia County primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Albertson v. Wyeth Inc., 63 Pa. D. & C.4th 514, 2003 Pa. Dist. & Cnty. Dec. LEXIS 135 (Pa. Super. Ct. 2003).

Opinion

SHEPPARD JR., J.,

Presently before the court are the preliminary objections of Wyeth Inc. and Wyeth Pharmaceuticals Inc. a/k/a Wyeth-Ayerst Pharmaceutical. These objections present a demurrer to plaintiffs’ consolidated amended complaint and a motion to strike plaintiffs’ request for attorney fees.

[516]*516FACTUAL BACKGROUND

The consolidated, amended complaint sets forth the following factual allegations.1

Wyeth manufactures, promotes and distributes three estrogen or hormone replacement drugs known as “Premarin,” “Prempro” and “Premphase.” Compl. ¶13. Premarin is a conjugated estrogen that was first manufactured and marketed by Wyeth in 1942. Compl. ¶15. It is prescribed for women suffering from severe menopausal symptoms. Compl. ¶15. When taken alone (or “unopposed”), conjugated estrogen increases the risk of uterine cancer in post-menopausal women with intact uteri. The use of estrogen alone is referred to as estrogen replacement therapy (ERT).

Prempro consists of two types of hormones: conjugated equine estrogens and progestins. Compl. ¶¶15-16. Because it combines estrogen and progestin, Prempro is often abbreviated as “E & P.” The risk of uterine cancer is decreased when estrogen is combined with progestin. The use of estrogen and progestin in the treatment of menopausal symptoms is referred to as hormone replacement therapy (HRT).

In December 1994, the United States Food and Drug Administration (FDA) granted Wyeth’s petition for approval to market Prempro as separate tablets of Premarin (0.625 mg) and medroxyprogestrone acetate (MPA) called Cyrcrin (2.5 mg). Compl. ¶18. Prempro was to be prescribed for post-menopausal women with uteri for the [517]*517treatment of moderate severe vasomotor symptoms associated with menopause, vulvar and vaginal atrophy and the prevention of osteoporosis. Compl. ¶18.

According to plaintiffs, there are an estimated 50 million post-menopausal women in the United States. Compl. ¶20. In July 2002, approximately 38 percent of post-menopausal women in the United States used estrogen or HRT. Compl. ¶21. At that time, about six million American women were taking Prempro. Compl. ¶22. Prempro is the best-selling HRT or estrogen-progestin combination drug in the United States. Compl. ¶23.

Wyeth has promoted Prempro and Premarin by marketing efforts directed to doctors and by direct-to-consumer efforts. According to plaintiffs, Wyeth utilized marketing techniques with the intention and effect of creating a lifelong demand for its estrogen replacement drugs on the part of post-menopausal women. Compl. ¶24. Wyeth’s direct-to-consumer efforts have included print advertisements, videotapes and brochures directed to consumers, as well as “product placement” efforts in which estrogen products are favorably positioned in entertainment vehicles or favorably described in the popular press by hired spokespersons. Compl. ¶25.

In 1999, Wyeth spent $34.7 million and in 2000, $37.9 million, on direct-to-consumer advertising for Prempro. Compl. ¶26. In 2001, Premarin became the first Wyeth brand to surpass $2 billion in annual sales. Compl. ¶27. According to plaintiffs, Wyeth’s marketing of Prempro and Premarin present menopause symptoms in dire and detailed fashion, describe purported benefits of ERT/HRT that have never been proven and minimize and distort the risks associated with ERT/HRT. Compl. ¶30.

[518]*518Premarin and Prempro were designed and have been approved by the FDA to relieve only menopausal symptoms, such as hot flashes, vaginal atrophy and osteoporosis. Compl. ¶32. However, according to plaintiffs, Wyeth has long touted its estrogen products as having additional benefits. Compl. ¶32. Thus, in print advertisements, brochures and magazine advertisements, Wyeth claimed that Premarin could be used to relieve various ills including tension, irritability, headaches, undue fatigue, depression and insomnia when caused by declining menopausal estrogen levels. Compl. ¶33. Additionally, Wyeth claimed that Alzheimer’s disease, vision problems, tooth loss, heart disease and colon cancer could be treated with Premarin or Prempro. Compl. ¶35. Wyeth also suggested that its conjugated equine estrogen was appropriate for treating or preventing, among other things, memory loss, colon cancer and age-related vision loss. Compl. ¶36.

In 1993, Wyeth distributed a videotape to consumers entitled “What every woman should know about estrogen.” The videotape claimed to be a seminar for women and depicted a female doctor advising women about menopause, conjugated equine estrogen (CEE) and progestin. Wyeth’s video seminar warned of a wide variety of illnesses and ailments purportedly associated with menopause. Among other things, Wyeth represented that estrogen loss causes bone to become brittle, skin to become dryer and sexual intercourse to become “painful and irritating.” Plaintiffs allege that while the videotape was exhaustive in its warnings about menopause, it glossed over the dangers and risks associated with ERT. Compl. ¶43. Additionally, the video “seminar” recommended that estrogen should be combined with proges[519]*519tin when taken by women who have not had hysterectomies. Compl. ¶45. The video seminar also represented that estrogen provided “long-term health protection” and should be continued indefinitely, even after short-term menopausal symptoms, such as hot flashes, had subsided. When a purported consumer inquired how long Premarin should be taken, Wyeth’s doctor spokesperson responded “anywhere from five to 10 years in order to get protection from long-term problems.” Compl. ¶46.

With regard to breast cancer risks, Wyeth represented in its video seminar that the benefits of taking estrogen “far outweigh the risks for women unless they faced a particularly high risk of breast cancer.” Plaintiffs allege that the opposite is true: the risks of taking Prempro far outweigh the benefits. Compl. ¶47. Wyeth also allegedly misrepresented that most studies showed no increased risk of breast cancer associated with taking estrogen at usual doses, and that breast cancer risks were only elevated when estrogen was taken at higher doses “for more than 10 years.”

At least until mid-2002, Wyeth distributed a Prempro promotional brochure targeted for women consumers that had the words “Starting your Hormone Replacement Therapy” at the top of the front cover. At the bottom of the cover of this brochure and at the bottom of nine of its 17 pages of text, the following words appear: “Say yes to PREMPRO.” Compl. ¶49. Wyeth’s “Say yes to PREMPRO” brochure contains testimonials from six women who claim to have used estrogen or Prempro for an average of 12.2 years. Each of these women is reported to have used Prempro and/or Wyeth’s estrogen-only therapy, Premarin, for at least seven years. Compl. [520]*520¶50. Wyeth’s annual report contains a similar testimonial from a woman. Compl. ¶52.

According to plaintiffs, Wyeth’s “Say yes to PREMPRO” brochure does not warn about, among other things, breast cancer even though its profiles all have used estrogen or Prempro for more than five years. Compl. ¶53. In the section of Wyeth’s “Say yes to PREMPRO” brochure devoted to “side effects,” Wyeth warns about uterine cancer (associated with estrogen-only therapy), worsening diabetes, blood clots, nausea, abdominal pain, irregular bleeding, headache, hair loss, and breast tenderness, but does not warn about breast cancer. Compl. ¶54.

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Bluebook (online)
63 Pa. D. & C.4th 514, 2003 Pa. Dist. & Cnty. Dec. LEXIS 135, Counsel Stack Legal Research, https://law.counselstack.com/opinion/albertson-v-wyeth-inc-pactcomplphilad-2003.