Fraser v. Wyeth, Inc.
Decision Date | 09 March 2012 |
Docket Number | Civil No. 3:04cv1373 (JBA). |
Citation | 857 F.Supp.2d 244 |
Parties | Margaret B. FRASER and Joseph T. Fraser, Plaintiffs, v. WYETH, INC. and Wyeth Pharmaceuticals, Inc., Defendants. |
Court | U.S. District Court — District of Connecticut |
OPINION TEXT STARTS HERE
Christopher W. Goode, Bubalo Rotman, PLC, Lexington, KY, Gregory J. Bubalo, Julie Ferraro, Paula S. Bliss, Steven B. Rotman, Bubalo Rotman, PLC, Louisville, KY, Manish Indravadan Shah, Neal Lewis Moskow, Ury & Moskow LLC, Fairfield, CT, for Plaintiffs.
Adrienne D. Gonzalez, Julie B. Du Pont, Kaye Scholer, LLP, Catherine B. Stevens, Skadden, Arps, Slate, Meagher & Flom, Daniel L. Cendan, Freshfields Bruckhaus Deringer U.S. LLP, Eric M. Falkenberry, DLA Piper U.S. LLP, New York, NY, James I. Glasser, Wiggin & Dana, New Haven, CT, Jane Elizabeth Bockus, Cox Smith Matthews Incorporated, San Antonio, TX, Kathy A. Cochran, Wilson Smith Cochran Dickerson, Seattle, WA, Kelly A. Evans, Snell & Wilmer LLP, Las Vegas, NV, Matthew V. Johnson, Richmond T. Moore, William R. Murray, Jr., Williams & Connolly, Michele A. Roberts, Skadden, Arps, Slate, Meagher & Flom, Washington, DC, Michael R. Klatt, Gordon & Rees, LLP, Austin, TX, Pamela Joan Yates, Kaye, Scholer, LLP, Los Angeles, CA, Spring Catherine Potoczak, Porzio, Bromberg & Newman, PC, Morristown, NJ, Tiffany Lee Christian, DLA Piper U.S. LLP, New York, NY, for Defendants.
RULING ON MOTION FOR SUMMARY JUDGMENT
On August 18, 2004, Plaintiffs Margaret Fraser and Joseph Fraser filed a Complaint against Defendants Wyeth, Inc. and Wyeth Pharmaceuticals, Inc. (collectively “Wyeth” or “Defendants”), claiming failure to warn, strict products liability, negligence, misrepresentation, and punitive damages under the Connecticut Product Liability Act (“CPLA”), Conn. Gen.Stat. § 52–572m et seq. (Counts One–Five); breach of implied and express warranty (Counts Six–Seven); violations of the Connecticut Unfair Trade Practices Act (“CUTPA”), Conn. Gen.Stat. § 42–110a et seq. (Count Eight); and loss of consortium (Count Nine). Defendants move [Doc. # 113] for summary judgment on all counts in Plaintiffs' Complaint. For the reasons stated below, Defendants' motion for summary judgment will be granted in part and denied in part.
Prempro is a hormone therapy medication combining estrogen and progestin in a single administration. ( Ms. Fraser testified in her deposition that “to the best of her recollection” she began taking Prempro when she was 49 or 50 years old in 1995 or 1996, after it was prescribed to her by her gynecologist, Dr. Tesoro (Margaret Fraser Dep., Ex. J to Defs.' 56(a)1 Stmt. at 132:11–134:19), and that she continued taking Prempro until September, 2001 ( id. at 165:22–166:23).
The Prempro label first appearing in the 1996 Physician's Desk Reference, approved by the FDA, included the following as its first entry in the “Warnings” section:
Breast cancer. Some studies have reported a moderately increased risk of breast cancer (relative risk of 1.3 to 2.0) 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 progestins on the risk of breast cancer is unknown, although a moderately increased risk in those taking combination estrogen/ progestin therapy has been reported. Other studies have not shown this relationship. In a one year clinical trial of PREMPRO, PREMPHASE and Premarin alone, 5 new cases of breast cancer were detected among 1377 women who received the combination treatments, while no new cases were detected among 347 women who received Premarin alone. The overall incidence of breast cancer in this clinical trial does not exceed that expected in the general population.
Women on hormone replacement therapy should have regular breast examinations and should be instructed in breast self-examination, and women over the age of 50 should have regular mammograms.
Beginning in 1997, the label added the following warning under the “Breast cancer” heading:
In the three year clinical Postmenopausal Estrogen Progestin Intervention (PSPI) trial of 875 women to assess differences among placebo, unopposed Premarin, and three different combination hormone therapy regimens, one (1) new case of breast cancer was detected in the placebo group (n=174), one in the Premarin alone group (n=175), none in the continuous Premarin plus continuous medroxyprogesterone acetate group (n=174), and two (2) in the continuous Premarin plus cyclic medroxyprogesterone acetate group (n=174).
The Prempro Package Insert stated under “Risks of Estrogens and/or Progestins”:
Cancer of the breast. Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years), or who used high doses for shorter time periods. The effects of added progestin on the risk of breast cancer are unknown. Some studies have reported a somewhat increased risk, even higher than the possible risk associated with estrogens alone. Others have not. Regular breast examinations by a health professional and monthly self-examination are recommended for all women. Regular mammograms are recommended for all women over 50 years of age.
( Id. at 3.)
When asked at his deposition what recollection he had about his treatment and care of Ms. Fraser, Dr. Tesoro testified: “I can't recall very much.” (Tesoro Dep., Ex. I to Defs.' 56(a)1 Stmt. at 46:21–47:9.) However, on both direct and cross examination, Dr. Tesoro reviewed and was asked questions regarding the warning labels for Prempro. After reviewing the warning label contain in the PDR, Dr. Tesoro agreed that he was aware of the information on the warning label at the time he prescribed Prempro to Ms. Fraser, and that he was aware of “the moderate increased risk” described in the label. ( Id. at 51:15–53:20.) Dr. Tesoro also agreed that he would “[a]bsolutely” discuss with a patient the risks of hormone therapy, including “the moderate increased risk of breast cancer.” ( Id. at 55:19–56:1.) With respect to the package insert, Dr. Tesoro testified that the information contained in the “cancer of the breast” section would “[p]ossibly” indicate to a patient that she should be aware of the risk of breast cancer associated with Prempro. ( Id. at 58:22–59:16.)
Dr. Tesoro also testified that the first two sentences of the breast cancer warning in the Prempro label 1 were “a little confusing” because “in one way they're saying that there is [a risk] if you use it for excess of ten years, and it's talking about other studies but they don't outline those studies.” ( Id. at 102:21–103:11.) He then agreed that “[b]y stating that ‘the majority of studies show no risk,’ [the label] was ... reassuring that the risks were minimal if not absent.” ( Id. at 103:12–16.) Dr. Tesoro further testified that the next part of the label—which stated —was “sort of a double-edged sword, confusing,” and that it did not provide any actual warning of breast cancer. ( Id. at 103:17–104:17.) He also agreed that the sentence in the warning “The overall incidence of breast cancer in this clinical trial does not exceed that expected in the general population” reassured him that “there is not really a breast cancer risk.” ( Id. at 104:18–105:20.)
Ms. Fraser testified that in prescribing Prempro for her, Dr. Tesoro told her that it “was a safe alternative to my hot flashes, and that it would help with [vaginal] dryness.” (Margaret Fraser Dep. at 137:13–138:10.) She testified that she based her decision to take Prempro on Dr. Tesoro's advice rather than any particular advertisements for Prempro and that she continued to take it because “[i]t was working ... and because my doctor felt it was safe.” ( Id. at 140:13–145:10.) Ms. Fraser added, however, that advertisements “enhanced”her decision to continue taking Prempro. ( Id. at 145:11–13.)
Ms. Fraser did not recall having any discussion with Dr. Tesoro regarding the risks associated with Prempro but added: “Knowing Dr. Tesoro and knowing how he took care of me, he would—if it was unsafe, he would tell me.” ( Id. at 138:25–139:18.) Ms. Fraser also testified that she relied on Dr. Tesoro's knowledge in deciding to take, and continuing to take, Prempro and that she “depended on him to let me know if there was any harm that was going to come to me,” but added “[i]f there had been huge, black, bold don't take this, it's going to cause cancer or it may cause cancer, I would not have taken it.” ( Id. at 141:16–142:6.) She also stated that she “may have” read the patient insert for Prempro and explained with respect to what could have led her to read the insert:
Well, one of the things might have been what would have led me was if it was in bold letters, if there was something that said a side effect might be, that it would be harmful, or that it could cause an illness or cause cancer, I would read it. If it was bold, it was written that boldly. But I didn't read anything. I don't remember reading anything. I don't remember reading that. I would not have taken it if I thought I was going to be harmed by it. I trusted the drug maker and I...
To continue reading
Request your trial-
Ferry v. Mead Johnson & Co.
...warranty in the absence of a guarantee that the particular product is free from all harmful side effects." Fraser v. Wyeth, Inc. , 857 F. Supp. 2d 244, 257–58 (D. Conn. 2012) (citing, inter alia, Basko , 416 F.2d at 428 ).b. Implied Warranty Just as in the case of a breach of express warran......
-
Precision Trenchless, LLC v. Saertex Multicom LP
... ... commissioned the pipe repair project; (2) Ludlow Construction ... Company, Inc. (“Ludlow”), MDC's general ... contractor; (3) The Charter Oak Fire Insurance Company ... action” in product liability cases. See Fraser v ... Wyeth, Inc. , 857 F.Supp.2d 244, 252 (D. Conn. 2012) ... However, where a ... ...
-
Fraser v. Wyeth, Inc.
...Plaintiffs' breach of warranty and CUTPA claims, but leaving all other claims for adjudication. Fraser v. Wyeth (“ Fraser I ”), 857 F.Supp.2d 244 (D.Conn.2012). Following a three-and-a-half week trial, the jury returned a verdict finding Wyeth [992 F.Supp.2d 78]liable on all of Plaintiffs' ......
-
In re Chantix (Varenicline) Prods. Liab. Litig.
...that forms the basis of the plaintiff's complaint.”); Anderson v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir.1987); Fraser v. Wyeth, 857 F.Supp.2d 244, 253–54 (D.Conn.2012);Snyder v. Hoffman–LaRoche, Inc., 2008 WL 4790666, *6 (M.D.Fla.2008) (stating that in evaluating warnings, death from sui......