In re Prempro Products Liability Litigation

• Court: U.S. Court of Appeals — Eighth Circuit
• Writing for the Court: Wollman
• Citation: In re Prempro Products Liability Litigation, 586 F.3d 547 (8th Cir. 2009)
• Decision Date: 02 November 2009
• Docket Number: No. 08-2713.,No. 08-2555.,No. 08-2711.,08-2555.,08-2711.,08-2713.
• Parties: In re PREMPRO PRODUCTS LIABILITY LITIGATION. Donna Scroggin, Plaintiff/Appellant, v. Wyeth, and its divisions; Pharmacia & Upjohn Company, L.L.C., Defendants/Appellees. Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellee, State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma; State of Oregon; State of South Carolina; State of South Dakota; State of Utah; Trial Lawyers Association, Amici on behalf of Appellant. In re Prempro Products Liability Litigation. Donna Scroggin, Plaintiff/Appellee, v. Wyeth, and its divisions, Defendant/Appellant, Pharmacia & Upjohn Company, L.L.C., Defendant. Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellant, State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma; State of Oregon; State of South Carolina; State of South Dakota; State of Utah, Amici on behalf of Appellee. In re Prempro Products Liability Litigation. Donna Scroggin, Appellee, v. Wyeth, and its divisions, Defendant, Pharmacia & Upjohn Company, L.L.C., Defendant/Appellant. Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellant, State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma; State of Oregon; State of South Carolina; State of South Dakota; State of Utah, Amici on behalf of Appellee.

586 F.3d 547

In re PREMPRO PRODUCTS LIABILITY LITIGATION Donna Scroggin, Plaintiff/Appellant, v. Wyeth, and its divisions; Pharmacia & Upjohn Company, L.L.C., Defendants/Appellees Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellee State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma;

State of Oregon; State of South Carolina; State of South Dakota; State of Utah; Trial Lawyers Association, Amici on behalf of Appellant.

In re Prempro Products Liability Litigation.

Donna Scroggin, Plaintiff/Appellee, v. Wyeth, and its divisions, Defendant/Appellant, Pharmacia & Upjohn Company, L.L.C., Defendant.

Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellant,

State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma; State of Oregon; State of South Carolina; State of South Dakota; State of Utah, Amici on behalf of Appellee.

In re Prempro Products Liability Litigation.

Donna Scroggin, Appellee, v. Wyeth, and its divisions, Defendant, Pharmacia & Upjohn Company, L.L.C., Defendant/Appellant.

Barr Laboratories, Inc.; Duramed Pharmaceuticals, Amici on Behalf of Appellant,

State of Arkansas; State of Florida; State of Idaho; State of Iowa; State of Kentucky; State of Maine; State of Minnesota; State of Missouri; State of Montana; State of Nebraska; State of New Hampshire; State of New Jersey; State of New Mexico; State of North Dakota; State of Oklahoma; State of Oregon; State of South Carolina; State of South Dakota; State of Utah, Amici on behalf of Appellee.

No. 08-2555.

No. 08-2711.

No. 08-2713.

United States Court of Appeals, Eighth Circuit.

Submitted: May 13, 2009.

Filed: November 2, 2009.

Eric B. Walker, argued, Houston, TX, James A. Morris, Jr., on the brief, Austin, TX, for Appellant.

William Hoffman, F. Lane Heard III, argued, Washington, DC, Lyn Peoples Pruitt, Little Rock, AR, Stephen L. Urbanczyk, John W. Vardaman, Jr., Washington, DC, Steven J. Glickstein, Wendy S. Dowse, on the brief, New York, NY, for Appellees.

Before WOLLMAN, JOHN R. GIBSON, and MURPHY, Circuit Judges.

WOLLMAN, Circuit Judge.

Donna Scroggin was diagnosed with breast cancer eleven years after she began taking estrogen and progestin drugs manufactured by Wyeth Pharmaceuticals Inc. (Wyeth) and Pharmacia & Upjohn Co. (Upjohn).¹ She sued the companies in 2004 for failure to warn of the risk of breast cancer from combination hormone therapy. The trial was bifurcated, with liability determined first and punitive damages determined second.

A jury returned a verdict finding Wyeth and Upjohn liable and awarding Scroggin compensatory damages. The district court denied Wyeth's and Upjohn's motions for judgment as a matter of law on liability. Following the second phase of the trial, the jury awarded Scroggin punitive damages. Wyeth and Upjohn moved to strike Scroggin's expert witness's testimony and for judgment as a matter of law. The district court granted the motions, vacating the punitive damages award. The district court ruled in the alternative that, had it denied the motions, it would have granted a new trial to determine punitive damages.

Wyeth and Upjohn appeal from the entry of judgment against them on liability, arguing that Scroggin's claim was preempted, that the statute of limitations barred her claim, and that she failed to prove causation. Wyeth and Upjohn also contend that the district court erred in admitting Scroggin's expert evidence on specific causation and in instructing the jury on proximate causation. Scroggin appeals from the district court's order striking her expert evidence during the punitive damages phase of the trial, granting Wyeth's and Upjohn's motions for judgment as a matter of law, and vacating the jury's punitive damages award.

We affirm the jury verdict and its award of compensatory damages. We also affirm the disputed evidentiary orders and jury instruction. We affirm the judgment as a matter of law in favor of Upjohn, but reverse it as to Wyeth, adopting the district court's alternative holding and granting Wyeth a new trial on punitive damages.

I. Factual Background

In 1989, Scroggin began taking combination hormone replacement therapy drugs to relieve menopausal symptoms, including hot flashes and vaginal atrophy. Scroggin was prescribed Ogen, an estrogen product produced by Upjohn, and Provera, a progestin product produced by Upjohn. Dr. Irving Kuperman began treating Scroggin in 1989, and he continued the prescriptions. In 1992, Dr. Kuperman changed Scroggin's estrogen prescription to Premarin, a Wyeth-manufactured drug, and in 1996 he prescribed Prempro, a Wyeth-manufactured drug that combined estrogen and progestin. In 1999, Dr. Kuperman returned Scroggin to the Premarin/Provera combination. When she was diagnosed with ductal carcinoma breast cancer in both breasts in July 2000, her surgeon, Dr. Jim Hagans, discontinued hormone replacement therapy because it is contraindicated for breast cancer.

Scroggin underwent a double mastectomy that removed her breast tissue and the lymph nodes under each arm. After her incisions healed, she underwent six months of chemotherapy, experiencing intermittent nausea, anxiety, fatigue, hot flashes, difficulty sleeping, and continuing memory problems. Chemotherapy was followed by five years of medication to reduce the risk of her breast cancer returning. She remains at risk for recurrence and requires extensive annual examinations and lab work. Scroggin has chosen not to have reconstructive surgery.

In 2002, the National Institutes of Health (NIH) published the results of its Women's Health Initiative (WHI) study, linking the use of hormone replacement therapy to breast cancer. The WHI study results were widely publicized, and at some point after their publication Scroggin concluded that her breast cancer was the result of her long-term use of estrogen and progestin therapy.

A. Hormone Replacement Therapy

Hormone replacement therapy, consisting of estrogen plus progestin, is prescribed to combat the symptoms of menopause. Women's ovaries typically stop producing estrogen between the ages of forty-five and fifty-five, commencing the onset of menopause. Some women develop moderate to severe symptoms, including intense episodes of heat and sweating, known as hot flashes, as well as vaginal atrophy.

In 1942, Wyeth introduced Premarin, a conjugated equine estrogen intended to replace the estrogen naturally decreasing in women during menopause and reduce the associated symptoms. In 1959, Upjohn launched Provera, a progestin product approved for treatment of abnormal uterine bleeding. By the 1970s, studies showed a link between estrogen replacement drugs such as Premarin and endometrial cancer. It was later determined that prescribing progestin along with estrogen reduced this risk. Although the Food and Drug Administration (FDA) had not approved the combination of estrogen and progestin for treating menopausal symptoms, such combination hormone therapy became the standard of care. Provera was often lawfully prescribed for this off-label use in conjunction with Premarin. In 1994, Wyeth became the first pharmaceutical company to combine estrogen and progestin into one package with the launch of Prempro. In 1995, Prempro became the first pharmaceutical that combined the two hormones into a single tablet. As of 2008, Premarin and Provera were the most common forms of estrogen and progestin replacement drugs.

B. Wyeth

Premarin is among Wyeth's most profitable products. The company has described Premarin as "our most important asset and our most important priority" and has equated the Premarin marketing efforts with a "Holy War, a Crusade." At trial, Scroggin argued that this devotion led Wyeth to implement a policy of "dismiss and distract" when it came to the risks associated with the drug. Scroggin asserted that Wyeth intentionally ignored the breast cancer risk and avoided its study at the same time as it vigorously promoted Premarin and Prempro. According to Scroggin, Wyeth's "dismiss and distract" policy began in 1975.

1. Wyeth's Reaction to Estrogen Replacement Therapy Being Linked to Endometrial Cancer

In 1975, the FDA's Obstetrics and Gynecology Advisory Committee concluded that there was a link between endometrial cancer and estrogen replacement therapy drugs such as Premarin. The Committee held public hearings, the evidence presented at which suggested a 7.6% increased risk for endometrial cancer among women taking estrogen replacement drugs. This risk decreased to 5.6% for exposure of less than five years and increased to 13.9% for exposure greater than seven years. Following the hearings, the FDA notified Wyeth that Premarin's label would have to be changed to warn consumers of the risk of endometrial cancer

In response to these hearings and other reports of an endometrial cancer link, Wyeth penned a "Dear Doctor" letter in December 1975. The letter declared that "it would be simplistic indeed to attribute an apparent increase in the diagnosis of endometrial carcinoma, solely to estrogen therapy." The letter went on to state that Wyeth "is vitally concerned about the ultimate resolution of conflicting evidence in this area" and suggested that using the drug as described in the package's labeling would minimize any potential risk and allow for continued use.

Wyeth's letter "in[c]ensed the FDA at all levels, including the Commissioner." Within weeks, FDA officials met with Wyeth executives to discuss the FDA's position that the letter...