In re Prempro Products Liability Litigation
| Decision Date | 08 July 2008 |
| Docket Number | MDL Docket No. 4:03CV1507-WRW.,MDL Docket No. 4:04CV01169. |
| Citation | 554 F.Supp.2d 871 |
| Parties | In re PREMPRO PRODUCTS LIABILITY LITIGATION. Donna Scroggin, Plaintiff v. Wyeth, et al., Defendants. |
| Court | U.S. District Court — Eastern District of Arkansas |
Brian Madden, Patrick Stueve, Jan P. Helder, Jr., Todd E. Hilton, Stueve Siegel Hanson LLP, Kansas City, MO, Christopher T. Kirchmer, Provost Umphrey Law Firm, L.L.P., Beaumont, TX, Clinton. A. Krislov, Krislov & Associates, Ltd., Jason P. Stiehl, Seyfarth Shaw LLP, Chicago, IL, D. Aaron Rihn, Peirce, Raimond & Coulter, Henry H. Wallace, Wallace, Barozzini, Harvey & Zimmaro, Jason P. Stiehl, Seyfarth Shaw LLP, Pittsburgh, PA, Eileen L. McGeever, Rushall & McGeever, Carlsbad, CA, Irwin B. Levin, Cohen & Malad, LLP, Indianapolis, IN, James A. Morris, Jr., Brent Coon & Associates, P.C.,| Austin, TX, Kathleen Dailey, Michael L. Williams, Williams Love O'Leary & Powers, P.C., Portland, OR, Kenneth M. Suggs, Janet, Jenner & Suggs LLC, Columbia, SC, Michel F. Mills, Pace International Union, Nashville, TN, Patricia Mitchell, Albright, Yee & Schmit, LLP, Los Angeles, CA, Paul W. Odenwald, Jr., Odenwald Law Firm, Metairie, LA, Ralph M. Cloar, Jr., Law Office of Ralph M. Cloar, Jr., Little Rock, AR, Richard S. Lewis, Cohen, Milstein, Hausfeld & Toll, P.L.L.C., Washington, DC, Robert K. Jenner, Janet, Jenner & Suggs, LLC, Baltimore, MD, Russell D. Marlin, William Gary Holt, Gary Eubanks & Associates, Little Rock, AR, Shawn F. Khorrami, Khorrami Pollard & Abir, LLP, Los Angeles, CA, Tobias L. Millrood, Pogust, Braslow
Millrood, LLC, Conshohocken, PA, W. James Singleton, Singleton Law Firm, Shreveport, LA, Zoe B. Littlepage, Littlepage Brockman, P.C., Houston, TX, James Rodney Nixon, Nixon, Luckett & Gianola PLLC, Jackson, MS, Russell G. Thornton, Stinnett Thiebaud & Remington, L.L.P., Dallas, TX, for Prempro Products Liability Litigation.
Pending are Defendants' Motion for Judgment as a Matter of Law, or for New Trial, or Remittitur of Punitive Damages Awards (Doc. Nos. 637, 642). Plaintiff has responded and Defendants have replied.2 The parties presented oral arguments on May 9, 2008.
Following a trial of nearly three weeks, the jury, on February 25, 2008, found that Plaintiff proved by the greater weight of the evidence that Wyeth and Upjohn inadequately warned about a known or knowable risk of Premarin, Prempro, and Provera, and Defendants' failure to warn resulted in Plaintiffs breast cancer.3 The jury awarded compensatory damages of $2,700,000.00.4
The punitive damages phase of the trial commenced on March 3, 2008, and lasted three days. On March 6, 2008, the jury found Defendants liable for punitive damages; Wyeth in the sum of $19,360,000.00 and Upjohn in the sum of $7,760,000.00.5
Following the entry of the judgment,6 Defendants filed Motions for Judgment as a Matter of Law or for a New Trial on both compensatory and punitive damages. As to compensatory damage issues, the motions were denied on April 10, 2008, and the parties were directed to focus their attention on the issue of punitive damages.7
A motion for judgment as a matter of law following a jury verdict—a.k.a. motion for judgment notwithstanding the verdict ("JNOV")—is governed by Federal Rule of Civil Procedure 50. Judgment as a matter of law is appropriate when the evidence, viewed in the light most favorable to the verdict, was such that no reasonable juror could have returned a verdict for the nonmoving party.8 "Judgment as a matter of law is proper when the record contains no proof beyond speculation to support the verdict."9 A court should review all of the evidence in the record, including any evidence unfavorable to the non-moving party that "the jury is required to believe."10
When considering a Motion for JNOV, a court may reconsider evidence that was erroneously admitted, strike the evidence, and then make the determination as to whether, based on the properly admitted evidence, there was sufficient evidence to support the verdict.11
Additionally, a trial judge who grants a JNOV should rule conditionally on an alternative motion for new trial.12
Plaintiff designated Dr. Parisian as her "regulatory expert," and asserted that Dr. Parisian would establish that the duty to test is part of the ordinary care required of pharmaceutical companies.13 To support her opinions, Dr. Parisian was to rely on her observations over the years as a former FDA medical officer and her understanding of the regulations referenced in her expert report, her deposition and the supplemental briefs.14
Defendants repeatedly argued that Dr. Parisian's punitive damages phase testimony should be stricken. Because a court may "satisfy its gatekeeper role" under Daubert on a post-trial motion,15 I will now consider Defendants' Motions to Strike. Incidentally, any assertion by Plaintiff that Defendants did not properly reserve their objections to Dr. Parisian's testimony is without merit. Defendants submitted motions to exclude,16 lodged numerous objections during the punitive damages stage, and requested, both orally17 and in writing,18 that Dr. Parisian's punitive damages testimony be stricken or excluded. On an occasion or two, Defendants may have failed to reassert a specific objection contemporaneously, but their specific points had been made and were well-known to me and Plaintiffs counsel.
Following several rounds of briefing and a hearing, an Order outlining permissible testimony from Dr. Parisian was entered:
A purely factual recitation of the history of Provera, and its progression as a drug to be used in conjunction with estrogen to treat menopausal symptoms is relevant to show the environment in which Upjohn operated. Use of the specific advertising or promotional pieces is not necessary to make this point. Plaintiff has conceded that Dr. Parisian will not give an opinion on Upjohn's intent or whether Upjohn's advertisement influenced either Plaintiff or any treating physician.
Also Dr. Parisian's testimony is relevant, because she is attempting to show that off-label promotion, without testing, is a violation of pharmaceutical company's duty to use ordinary care ... Plaintiffs attempt to use Dr. Parisian to establish that the duty to test is part of the ordinary care required from pharmaceutical companies, is relevant to the claims in this case ...
Dr. Parisian has recited her experience in the FDA and the history of Provera, but she has not set out what standards or "standards of the industry" she relies on. As Judge Wilson requested [in his] November 1, 2007 Order, Plaintiff must provide some citation to authority, whether it is legislative or historical, that Dr. Parisian relies on. I have not been able to find such a reference after reviewing her report in the record. If Plaintiff can provide a specific reference to the standards relied upon by Dr. Parisian, I will reconsider this ruling and address the remaining issues raised in Upjohn's motion.19
In response, Plaintiff submitted supplemental briefing, and this order was entered:
While I agree that Dr. Parisian's citations leave a bit to be desired, I believe she has met the Daubert threshold. Defendants' remaining criticism of Dr. Parisian's testimony and report can be addressed during cross-examination. Dr. Parisian can give her opinions on the reasonableness of a pharmaceutical company's actions based on her observations over the years and her understanding of the regulations referenced in her expert report, her deposition, and the supplemental briefs. Dr. Parisian will not be permitted to talk about or refer to what an "ethical" or "responsible" pharmaceutical company does or would do.20
Although she is Plaintiffs "regulatory expert," Dr. Parisian mentioned only three FDA regulations during the punitive damages stage of trial. At the beginning of the punitive damages stage, Plaintiff asked Dr. Parisian whether she had "run across documents that would violate rules that the FDA has regarding how information is to be handled," and she responded, "Yes, sir."21 Next, Dr. Parisian cited three C.F.R. statutes—two of which Defendants claim were cited erroneously22—and summarized the regulations:
you're supposed to have adequate instructions for use, adequate warnings ... truthful advertisement, reprints, [and] information that you would provide to your physician ... marketing information is supposed to be truthful ... and you're not allowed to have labeling that's false, not fair and balanced.23
Following this cursory review of FDA regulations, Dr. Parisian and Plaintiffs counsel commenced addressing specific exhibits.
Plaintiff questioned Dr. Parisian about the December 1975 Wyeth "Dear Doctor" letter and the FDA's January 1976 summary of a meeting between Wyeth and the FDA, which discussed this letter.24 In briefing,25 Plaintiff asserted that these documents were necessary to "show Wyeth's policy to dismiss and distract, even outright deny, that Premarin causes cancer."26
After Dr. Parisian read lengthy passages from the exhibits, Plaintiffs counsel asked "Now, from your expert standpoint, what do those two letters ... say with regard to Wyeth's knowledge of how to handle scientific data that pertains to their products?"27 Defendants objected that the question called for speculation and was beyond the scope of Dr. Parisian's report. At the sidebar, I overruled the objection after Plaintiff asserted that Dr. Parisian could "certainly opine about what information FDA requires," how Wyeth...
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