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IN RE PREMPRO PRODUCTS LIABILITY LITIGATION

August 30, 2005.

IN RE: PREMPRO PRODUCTS LIABILITY LITIGATION.


The opinion of the court was delivered by: WILLIAM WILSON, District Judge

ORDER DENYING PLAINTIFFS' MOTION FOR CLASS CERTIFICATION

Pending is Plaintiffs' Motion for Class Certification (Doc. No. 80). Defendants have responded (Doc. No. 630). A Class Certification Hearing was held June 1-3, 2005. After the hearing, I sent a letter posing several questions. The parties responded with briefs, and another hearing was held on June 24, 2005. For the reasons set forth below, Plaintiffs' Motion for Class Certification is denied.

I. BACKGROUND

  Wyeth and Wyeth Pharmaceuticals ("Wyeth") are Delaware corporations with principal places of business in New Jersey and Pennsylvania, respectively. Wyeth manufactures and distributes pharmaceuticals, including the prescription drugs Prempro, Premarin, Premphase, and Cycrin.

  A. Premarin and Prempro

  Premarin is an unopposed conjugated*fn1 estrogen prescription drug, which has been approved by the Food and Drug Administration ("FDA") for the treatment of moderate to severe vasomotor symptoms — such as hot flashes and night sweats — associated with menopause; it has also been approved for the prevention of postmenopausal osteoporosis and the treatment of vaginal dryness.*fn2 Before Prempro, physicians often prescribed estrogen — such as Premarin — in combination with progestin to treat symptoms of menopause. All of this is commonly known as hormone replacement therapy ("HRT"). In 1994, the FDA approved the marketing of Prempro as separate tablets of Premarin and Cycrin,*fn3 blister packaged together so they could be taken at the same time. The FDA authorized Prempro for post-menopausal women with uteri for the treatment of vasomotor symptoms associated with menopause, including hot flashes, night sweats, and vaginal atrophy.*fn4 In 1995, the FDA approved the marketing of Prempro as a single tablet.*fn5

  Plaintiffs allege that, for decades, Wyeth has used general advertising, "direct-to-consumer" advertising, and other marketing tools to "orchestrate widespread misunderstanding among the general public and the medical community" on the benefits and risks of HRT.*fn6 According to Plaintiffs, Wyeth also promoted Prempro and HRT for off-label uses, i.e., uses not approved by the FDA.*fn7 B. Women's Health Initiative ("WHI")

  The WHI is a long-term national health study focused on "defining the risks and benefits of strategies that could potentially reduce the incidence of heart disease, breast and colorectal cancer, and fractures in postmenopausal women."*fn8 The WHI Clinical Trial and Observational Study began in 1993 and has involved over 161,000 postmenopausal women.*fn9

  The estrogen plus progestin part of the WHI study involved 16,608 women ages 50-79 who had not had hysterectomies. Prempro was the only estrogen/progestin combination drug tested in this initial study. The study's objective was to examine the effectiveness of estrogen and progestin in heart disease and hip fracture prevention; and to examine any association between Prempro and the risks of breast and colon cancer.*fn10

  On May 31, 2002, the independent data and safety monitoring board ("DSMD") "concluded that the evidence for breast cancer harm, along with evidence for some increase in coronary heart disease, stroke, and pulmonary embolism, outweighed the evidence of a benefit for fracture and possible benefit for colon cancer,"*fn11 and recommended stopping the estrogen plus progestin component of the WHI trial early. On July 9, 2002, the National Heart, Lung and Blood Institute ("NHLB"), a division of the National Institutes of Health ("NIH"), stopped its major clinical trial for Prempro early. Plaintiffs allege that the study was stopped because "its evidence proved the drug dangerously increased women's risk of invasive breast cancer, cardiovascular disease, stroke, venous thromboembolism, and pulmonary embolism . . . [and] Alzheimer's disease and dementia."*fn12

  The findings from the estrogen plus progestin component of the trial were published in the Journal of the American Medical Association ("JAMA") on July 17, 2002.*fn13 The article stated that, in the estrogen plus progestin component of the study, the "[o]verall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2 year follow-up among healthy postmenopausal U.S. women."*fn14 In May 2003 an article appeared in JAMA that analyzed the incidence of dementia and mild cognitive impairment in the HRT component of the WHI study.*fn15 The article concluded:
Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risk of estrogen plus progestin outweigh the benefits.*fn16
  Over the next couple of months, several other articles were printed in various medical journals involving analyses of the WHI study results.*fn17 II. ALLEGATIONS
  Plaintiffs assert that they have been "significantly exposed to proven hazardous substances through the intentional, negligent, or wrongful actions" of Wyeth.*fn18 They state:
As a direct and proximate result of Defendant's manufacturing, creating, designing, testing, labeling, sterilizing, packaging, supplying, marketing, selling, advertising, warning, and otherwise distributing Prempro in interstate commerce, Plaintiffs and class members are at a significantly increased risk of developing serious latent diseases and conditions including, inter alia, breast cancer, strokes, heart attacks, ovarian cancer, Alzheimer's disease, dementia, and blood clots.
That increased risk makes periodic diagnostic medical examinations reasonably necessary. Medical surveillance, monitoring and testing procedures exist which make the early detection and treatment of disease possible and beneficial.
Wyeth's actions render it liable to pay all costs of medical monitoring in the form of a comprehensive court-supervised medical monitoring program, to provide diagnostic and treatment services for the benefit of the class.*fn19
  Plaintiffs argue that class certification is appropriate here and propose two classes: (1) a consumer protection class under Federal Rule of Civil Procedure ("FRCP") 23(b)(3), which will include consumer fraud and unfair competition subclasses, and (2) a medical monitoring class under FRCP 23(b)(2), which will have breast cancer and dementia subclasses.*fn20

  Plaintiffs bottom their claims upon two facts they consider salient: (1) Wyeth falsely advertised and marketed HRT and Prempro; and (2) women face significantly increased risk of serious disease because they took Prempro.*fn21 A. Consumer Protection Class

  1. Consumer Fraud

  Seeking relief under FRCP 23(b)(3), Plaintiffs include in their consumer fraud subclass:
All women within Alabama, Alaska, Arkansas, California, Colorado, Delaware, Georgia, Idaho, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, and Wyoming respectively, who purchased the prescription medication Prempro between its introduction in 1994 and July 2002.*fn22
  Plaintiffs allege: that Wyeth, through its direct to consumer advertisements, "falsely represented health benefits of [Prempro] and did not provide and deceptively concealed both the seriousness and the likelihood of known adverse reactions";*fn23 that Wyeth, grossly exaggerated the beneficial characteristics, uses, and benefits of Prempro; that Wyeth commenced a marketing campaign which contended that Prempro (1) would reduce the risk of heart disease, stroke, Alzheimer's disease, dementia, and depression; (2) would improve a consumer's mental acuity, help with incontinence, reduce wrinkles, and provide a "youthful glow"; and (3) was safe and approved for long-term use; that all of these benefits were unfounded; and that, at the same time that Wyeth embellished the benefits of Prempro, it simultaneously "concealed, obscured, and trivialized" the fact that Prempro increased the risks of breast cancer, stroke, heart attack, cardiovascular disease, Alzheimer's disease, dementia, and venous thromboembolism."*fn24 Plaintiffs submit that, as a result of Wyeth's actions, they have "suffered injuries in fact, ascertainable loss, and compensable damages," and are entitled to "equitable relief, including restitution of all monies paid for Prempro" and the creation of a medical monitoring program.*fn25 Plaintiffs further allege that they are entitled to "actual damages, disgorgement of Wyeth's profits accrued from their unfair, fraudulent, and unlawful practices, attorney's fees and costs," and punitive damages.

  Plaintiffs claim that Wyeth's conduct constituted consumer fraud in violation of numerous state statutes.*fn26

  2. Unfair Competition

  Seeking relief under FRCP 23(b)(3), Plaintiffs include in their unfair competition subclass:
All women within Arizona, Arkansas, California, Connecticut, Delaware, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Rhode Island, Tennessee, Texas, Vermont, Washington, and Wisconsin respectively, who purchased the prescription medication Prempro between its introduction in 1994 and July 2002.*fn27
  For their unfair competition claim, Plaintiffs reassert the facts asserted in their consumer fraud claim, and add that "Wyeth derived profits and material gains as a direct and proximate result of [its] unlawful, deceptive, and fraudulent representations."*fn28 They allege Wyeth, as a result of its conduct, continues to be "unjustly enriched in profits, income, and ill-gotten gains at the expense of the plaintiffs and the general public who purchased and consumed Prempro in reliance upon Wyeth's false, deceptive, and fraudulent business practices."*fn29

  Plaintiffs claim that Wyeth's unfair competition violated numerous state statutes.*fn30 They seek the same relief as in their consumer fraud claim, with the addition of actual damages where permitted by statute.

  B. Medical Monitoring Class

  Plaintiffs propose a medical monitoring class that will consist of two subclasses, which are defined below. Plaintiffs assert that their "increased susceptibility to injuries and [the] irreparable threat" to their health resulting from taking Prempro entitles them to the "creation of a court-supervised medical monitoring trust fund" that will finance a medical monitoring program for:
. . . Locating persons who have used Prempro and notifying them of the potential harm from such use;
. . . Aiding in the early diagnosis and treatment of resulting injuries through ongoing testing and monitoring of Prempro users;
. . . Funding the design and implementation of further studies of the effects of Prempro on its users, including population-based studies of and for the benefit of the Class, including the establishment of an adverse health effects registry;
. . . Funding research into possible cures for the detrimental effects of using Prempro; and,
. . . Gathering and forwarding to treating physicians information related to the diagnosis and treatment of injuries that may result from using Prempro.*fn31
  Plaintiffs assert that "Prempro exposure justifies medical monitoring because of its toxicity, the seriousness of the conditions Prempro causes, and the relative risk of developing the conditions."*fn32

  1. Breast Cancer Monitoring

  Seeking relief under FRCP 23(b)(2), Plaintiffs include in their breast cancer medical monitoring subclass:
All women within Arizona, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Nevada, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Vermont, West Virginia, and Wyoming who used the prescription medication Prempro for at least 24 consecutive months until July 2002 and who are at increased risk of developing breast cancer (because of such exposure).*fn33
  Plaintiffs suggest that breast cancer medical monitoring will consist of four parts: (1) an initial screening questionnaire; (2) counseling to discuss the risks and benefits of Prempro and screening interventions; (3) MRIs in consenting women; and (4) additional studies, such as repeat mammography, echographic studies, or biopsies in women with suspicious lesions on their MRIs.*fn34

  2. Dementia Monitoring

  Seeking relief under FRCP 23(b)(2), Plaintiffs include in their dementia medical monitoring, subclass:
All women within Arizona, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Nevada, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Vermont, West Virginia, and Wyoming who used the prescription medication Prempro for at least 24 consecutive months until July 2002 and who are at increased risk of developing dementia (because of such exposure).*fn35
  Plaintiffs' medical monitoring of dementia would include screening and counseling regarding dementia risks associated with Prempro. In addition to initial screening and counseling regarding Alzheimer's disease and dementia risks associated with the use of Prempro, Phase I would include testing that would annually use the Functional Activities Questionnaire ("FAQ") and the Modified Mini-Mental Status Examination ("MMMSE").*fn36 Phase II would involve more testing, including an annual Neuropsychiatric Exam and a Physical Exam for patients who scored below the Phase I cut-off. Plaintiffs assert that this testing will allow physicians to discover symptoms of dementia at an early stage.*fn37 If a patient has dementia symptoms, she will participate in Phase III, which would provide information "concerning risks and benefits of further testing, preventative treatments, and other lifestyle changes."*fn38

  C. Other Causes of Action

  Plaintiffs seek medical monitoring relief and disgorgement of Wyeth's profits*fn39 under the following causes of action:*fn40 (1) unjust enrichment, (2) negligence, (3) negligence per se, (4) strict liability — failure to warn, and (5) negligent misrepresentation.

  III. STANDING

  Before addressing class certification issues, a court must determine whether the plaintiffs have standing to bring their suit.*fn41 Since a court must assume the truth of the facts alleged by the plaintiff at the class certification stage, the standard of review for standing is similar to the standard used to analyze a 12(b)(6) motion to dismiss.*fn42

  To establish standing: (1) the plaintiff must have "suffered an injury in fact"; (2) "there must be a causal connection between the injury and the conduct complained of'; and (3) "it must be likely . . . that the injury will be redressed by a favorable decision."*fn43 As to injury-in-fact, Plaintiffs allege that their consumption of Prempro increased their risk of developing serious latent diseases and conditions including breast cancer, strokes, heart attacks, ovarian cancer, Alzheimer's disease, dementia, and blood clots. Plaintiffs satisfy the injury-in-fact element since courts have repeatedly agreed that an increased risk of harm is an injury-in-fact.*fn44

  The causation element is satisfied "when the injury alleged is fairly traceable to the challenged action of the defendant."*fn45 Here, Plaintiffs assert that the increased risks of certain latent diseases and conditions are attributable to a drug manufactured by Defendant, and that this injury can be traced to Defendant because of Defendant's failure to test adequately and sufficiently warn of the dangers of the drug. Accordingly, Plaintiffs have met their burden of ...


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