Scroggin v. Wyeth
Scroggin v. Wyeth
Opinion of the Court
ORDER
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.
I. BACKGROUND
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.
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.
Following the entry of the judgment,
II. STANDARD OF REVIEW
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.
When considering a Motion for JNOV, a court may reconsider evidence
Additionally, a trial judge who grants a JNOV should rule conditionally on an alternative motion for new trial.
III. DISCUSSION
A. Dr. Parisian’s Punitive Damages Stage Testimony
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.
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,
1. Pre-Trial Limitations on Testimony
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 influ*879 enced 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
2. Trial Testimony on Regulations
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.”
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.
a. December 1975 Dear Doctor Letter (Plaintiffs Ex. 22) and January 1976 Response from FDA (Plaintiffs Ex. 24)
Plaintiff questioned Dr. Parisian about the December 1975 Wyeth “Dear Doctor” letter and the FDA’s January
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?”
But, Dr. Parisian’s testimony did not align with Plaintiffs assurances at the sidebar. Instead Dr. Parisian summarized the document:
The letter shows that there has been a scientific discussion at the advisory panel meeting and the FDA anticipated that the company, since they are the primary provider of this product, would have pursued a scientific course or some kind of response about a clinical trial doing some kind of study. And that’s why the FDA referred to this as a passive position. The company instead chose to tell physicians that it was simplistic and that there was no relation to their product and rather downplayed the risk in terms of addressing it as a responsible manufacturer.31
The testimony was simply a regurgitation of an exhibit, absent any expert analysis or opinion. Also missing was any reference to FDA requirements. Despite the assurances of Plaintiffs counsel, Dr. Parisian mentioned neither guidelines nor requirements in her assessment of these two exhibits. Regarding Plaintiffs Exhibits 22 and 24, the record is devoid of any testimony that Wyeth’s actions violated FDA regulations or any other defined standard.
Next, Dr. Parisian addressed Wyeth’s internal minutes of discussions about Prempak and its Prempak Study. Again, she and Plaintiffs counsel took turns reading the document into the record. And, again, Dr. Parisian provided no testimony as a “regulatory expert.” As best I can tell, the only reason this document was introduced was to point out that someone at Wyeth wanted to “peek at the data” of the ongoing study. There was no testimony that this would violate any regulations—Dr. Parisian did not testify that this was inappropriate behavior'—she stated only that you “have to be careful peeking at the data” so as not to introduce bias.
c. Seasons Magazine Proposal (Plaintiffs Ex. 154)
Plaintiff claimed Wyeth’s proposal to the FDA regarding Seasons magazine established that “Wyeth pushed unapproved long term benefits of E and E + P” but did not study the potential risks of long-term use.
When asked about the letter’s meaning “from the FDA’s standpoint,” Dr. Parisian responded that all manufacturers are supposed to have fair and balanced labeling that’s not misleading.”
d.1993 Premarin Marketing Plan (Plaintiffs Ex. 1565)
According to Plaintiff, the 1993 Premarin marketing plan “show[ed] Wyeth’s awareness of long term use of its drugs by many consumers yet Wyeth never chose to study E or E + P long term to evaluate the risks ... which goes squarely to notice, duty to test, and subsequent failure to warn.”
e. Essner’s Prempro Launch Speeches (Plaintiffs Exs. 6776 and 6558)
Plaintiff contended that Bob Essner’s April 4, 1995 and April 2, 1995 Prempro “launch” speeches showed “Wyeth’s corporate policy to support and push E+P benefits long term without every [sic] studying E + P long term” and how Wyeth treated Prempro “from a risk and benefit perspective.”
Basically, Dr. Parisian again read selected excerpts from the documents, but provided no analysis which would require regulatory expertise — or any expertise. There was no mention of FDA regulations, nor any opinion based on her experience as an FDA medical officer. Plaintiffs primary critique of Essner’s speeches was that they do not mention short-term use, breast cancer risk, or studies
Plaintiff also asked Dr. Parisian about Wyeth’s “position with regard to how the product will be treated from a marketing standpoint.”
f. Burson-Marsteller Account Overview (Plaintiffs Ex. 8019-A)
According to Plaintiff, the June 6, 1994 “Burson-Marsteller Premarin & Wyeth-Ayerst Women’s Health: Account Overview” exemplified ‘Wyeth’s policy of dismiss and distract of the concerns about the risk of HRT and breast cancer ... [and] absolutely showfed] Wyeth was on notice of breast cancer risks but did not study E + P and breast cancer and as a result did not warn of the risk.”
Dr. Parisian testified that if a company knew there was a link between its product and breast cancer, neutralizing that information would not be fair and balanced. She continued, “[I]t’s the duty of the manufacturer to ensure that the product is safe for that indication and for those women who are using the product.”
Following this testimony, I requested a sidebar, and voiced concern that Dr. Parisian was testifying outside the scope permitted by the pretrial orders. Plaintiff responded:
[A]s to everything that I’ve put on thus far, I believe that I’ve linked it to the FDA regulations. And the concern that’s been pointed out by Wyeth even in this most recent document was FDA regulatory concerns. And she went through and described, you know, what would be improper about the approach to neutralizing that evidence. So I don’t think I’ve put in anything that doesn’t fit within her area of expertise.46
Defendants responded that Dr. Parisian had “gone beyond both her report and her designation for this case and the limits of [pre-trial] ruling[s] regarding her testimony.”
g.George Mills Email on Breast Cancer Issues (Plaintiffs Ex. 7423)
Plaintiff introduced George Mills’s (a Wyeth employee) February 25, 2000 email, which set out his idea for handling breast cancer issues. In the pretrial briefs, Plaintiff asserted that this exhibit “show[ed] Wyeth’s policy of dismiss and distract of the concerns about the risks of HRT and breast cancer,” and that Wyeth was on notice of a breast cancer risk, but neither studied nor warned of the risk.
Plaintiffs counsel mentioned that he’d previously read the exhibit to the jury, and asked Dr. Parisian if it would “ever be appropriate ... to withhold information about breast cancer risk from users of the product....”
h. February 28, 2000 Budget Proposal (Plaintiffs Ex. 8151)
According to Plaintiff, the February 28, 2000 budget proposal “show[ed] Wyeth’s policy of funding to dismiss and distract the risk of breast cancer of E+P while expounding on the long-term benefits of E+P....”
i. Dr. Karla Kerlikowske Study
This is an August 14, 2007 article titled “Declines in Invasive Breast Cancer in Use of Postmenopausal Hormone Therapy in a Screening Mammography Population,” by Dr. Karla Kerlikowske, which was published in the Journal of the
Based on an estimated 211,300 breast cancer cases in 2003, 75 percent of these diagnosed in postmenopausal women, 85 percent of them are ER positive, and an annual decline of 13 percent in ER-positive disease. The impact of declining use of postmenopausal hormone therapy could account for an estimated 17,500 fewer ER-positive invasive breast cancer cases annually among women aged 50 to 69 years.59
This testimony on “excess breast cancers” was the subject of numerous oral and written motions. At the close of Dr. Parisian’s punitive damages phase testimony, Defendants argued that this “learned treatise” was not properly authenticated by Dr. Parisian.
“A scientist, however well credentialed he may be, is not permitted to be the mouthpiece of a scientist in a different specialty. That would not be responsible science.”
j. CME “Myths and Misperceptions” Handout (Plaintiffs Ex. 427)
This exhibit is a CME course handout titled “Myths and Misperceptions, Breast Cancer and HRT” from September, 1998. Dr. Parisian testified that the FDA would have no ability to restrict these types of CME activities. Since the FDA
Furthermore, when Plaintiff used this exhibit, Wyeth objected to “lack of foundation” because the exhibit was “not a Wyeth document.”
k. March 4, 1999 Grants Authorizations (Plaintiffs Ex. 5733)
Through Dr. Parisian, Plaintiff introduced Wyeth’s finance committee’s March 4, 1999 authorization for awards and grants, but all Plaintiffs counsel did with the exhibit was read a few of the names of the organizations on the list.
l. Ghostwriting
Dr. Parisian testified that the FDA would not be aware of ghostwriting,
m. 1970 Upjohn “Dear Doctor” Letter (Plaintiffs Ex. 5785)
This November 19, 1970 Upjohn “Dear Doctor” letter informed physicians that Upjohn’s oral contraceptive, Provest, had been shown to be connected with the “appearance of mammary nodules in beagle dogs exposed to multiples of the human dose of the progestational component for a prolonged period of time.”
n. July 21, 1992 HRT Scientific Review: Executive Session Summary (Plaintiffs Exs. 11011 and 11012)
Through Dr. Parisian, Plaintiff introduced an Upjohn internal memorandum and attachment that described the company’s desire to get indications for HRT uses and its strategy going forward. Dr. Parisian simply read a few sections from the document. Since she provided no testimony regarding FDA regulations,
In pre-trial briefs and hearings, Plaintiff argued that an expert like Dr. Parisian was necessary to review and summarize documents and “give the jury the tools they need to look at those documents, [and] understand them in the context of a regulatory background.”
Repeatedly, Plaintiff has argued that “[distilling voluminous documents is proper” for an expert — but I do not believe the 22 or so documents introduced through Dr. Parisian during the punitive damages stage can be considered “voluminous.” But more importantly, and contrary to Plaintiffs position during the Daubert hearing, and during he punitive damages stage, Dr. Parisian, generally, did not “give the jury the tools they need to look at those documents, [to] understand them in the context of a regulatory background”
I cannot accept Plaintiffs position that Dr. Parisian “didn’t just read a document,” but “tie[d] pieces of the puzzle together.”
If an expert does nothing more than read exhibits, is there really any point in her testifying as an expert? As was seen during the punitive damages stage, the use of the “regulatory expert” to deal with large volumes of documents is subject to abuse. The expert did not explain the documents, provide summaries, or tie them in to her proposed regulatory testimony. Dr. Parisian did not provide analysis, opinion, or expertise.
4. Applying FDA Regulations to the Facts
In response to Defendants’ Motion to Exclude Dr. Parisian’s testimony regarding FDA regulations — filed before Dr. Parisian testified during the punitives phase — Plaintiff asserted that Dr. Parisian “will testify further, what those [FDA] regulations require in a particular set of facts and circumstances. Dr. Parisian will also testify that the regulations were violated under this set of facts.”
5. Summary
Federal Rule of Evidence 702 permits expert testimony to assist a jury in understanding technical or scientific evidence. Dr. Parisian was designated to testify on regulations and the standards and practice in the industry based on her experience. Yet, Dr. Parisian’s punitive damages stage testimony was hardly expert in nature. The question and answer sessions merely paid Up service to Dr. Parisian testifying from an expert standpoint.
The Advisory Committee notes to Federal Rule of Evidence 702 read: “If the witness is relying ... primarily on experience, then the witness must explain how that experience is a sufficient basis for the opinion and how that experience is reliably accurate to the facts.” In pretrial hearings, Judge Jones and I both expressed concern regarding whether Dr. Parisian met this requirement (as evidenced by the repeated requests for citations and explanations
Dr. Parisian’s punitive damages stage testimony reveals “how vital it is that judges not be deceived by the assertions of experts who offer credentials rather than analysis.”
During the punitive damages stage of the trial, Dr. Parisian’s testimony tracked Plaintiffs legal arguments, and there was very little significant analysis. On numerous occasions, Dr. Parisian declared “this isn’t fair and balanced,” but she provided no explanation. Dr. Parisian, no doubt has special knowledge and skill regarding FDA operations and regulations, but she did not apply this knowledge and skill to her testimony.
When Dr. Parisian actually elaborated on documents, her testimony did “no more than counsel for plaintiff [did] in argument, i.e., propound a particular interpretation of [defendant’s conduct.”
Since Dr. Parisian testified as to the bottom line without any explanation, failed to provide expert analysis, testified beyond limitations established by pretrial orders, testified in areas beyond her expertise, and invaded areas that required no expert testimony, most of Dr. Parisian’s punitive damages testimony should have been excluded.
B. Sufficiency of Evidence During Punitive Damages Stage
Excluding the testimony I erroneously allowed in through Dr. Parisian, Plaintiff
The Arkansas Supreme Court has approached punitive damages with caution: “If punitive damages are improperly awarded, the defendant suffers far more than a plaintiff does if the jury incorrectly fails to give him a windfall.”
In the punitive damages stage, Plaintiffs burden was to establish, by clear and convincing evidence, that Defendants knew or should have known that their negligent failure to warn (which, based on the compensatory damages phase testimony, included a duty to test) of the risks associated with ERT/HRT use and breast cancer would result in injury, and that Defendants continued the conduct with wantonness or reckless disregard from which malice can be inferred.
During opening statements of the punitive damages stage, Plaintiffs counsel argued the evidence would establish that:
Wyeth and Upjohn failed to follow up on the red flags that showed that this product was causing breast cancer, they failed to get the proper answers by going out and studying the drugs, and they failed to give the doctors and the women accurate information. And then finally, they failed to market the product appropriately.93
Yet, the evidence Plaintiff presented was an extension of the liability arguments that amounted to no more than negligence. The record, absent erroneously admitted information, reflects insufficient evidence of wantonness, willfulness, or reckless disregard from which malice could be inferred.
1. Summary of Punitive Damages Evidence Against Wyeth.
Plaintiffs argument for punitive damages can be summarized as follows: In 1976 Wyeth was aware of the Hoover Study, which suggested a link between estrogen use and breast cancer. The endometrial cancer crisis also occurred around this time, and Wyeth should have seen it as a wake-up call to commence looking into the relationship between estrogen use and breast cancer. Wyeth
Wyeth knew more study was needed, but took a passive role in conducting studies. When Wyeth considered initiating the Prempak Study, Wyeth was concerned that the study might not be successful and could be “embarrassing.” Wyeth never completed the Prempak Study.
Wyeth responded to studies associating ERT and HRT use with breast cancer by downplaying the studies and promoting the benefits of ERT and HRT. Specifically, Wyeth used public relations firms, “friendly organizations to which it gave millions of dollars, friends who spoke favorably about its products, marketing, press manipulation or even ghostwriting” to counter studies (and media) reporting a link between HRT and breast cancer.
a. Wyeth Knew About Studies Linking Breast Cancer and Estrogen
Plaintiff argued that in 1976 Wyeth was aware that the Hoover Study
Three months later, in June of 1976, Wyeth noted that “there have been and are numerous epidemiological studies on the clinical effects of long term estrogen therapy,” but concluded that the “studies on estrogen-breast cancer relationships ... show[ed] no significant increase in the relative risk.”
In sum, Wyeth’s response to the 1976 study suggesting a link between estrogen use and breast cancer — recognition of a possible connection and follow-up research — illustrated neither a passive re
b. Endometrial Crisis Should Have Been A Wake-Up Call
In post-trial briefing, Plaintiff asserted that the “endometrial cancer crisis should have been a wake-up call to Wyeth. If E-alone eause[d] cancer in one reproductive organ, the addition of a new hormone, progestin, could cause cancer in another such organ.”
c. Wyeth Knew That Adding Proges-tin Could Increase Risk
In its post-trial brief, Plaintiff argued that ‘Wyeth knew that the addition of a progestin could increase the incidence of breast cancer”;
d.Wyeth Knew More Study Was Needed, But Took a Passive Role
Plaintiff asserted that in 1977, Wyeth knew that “more study was needed on the combination product.”
Plaintiff relied on Plaintiffs Exhibits 22 and 24 for this testimony. However, above I determined that since Dr. Parisian did not connect her testimony on these documents to FDA regulations, the testimony and exhibits should not have been admitted. That being so, there is no evidence to support Plaintiffs position.
Wyeth began studies of the estrogen and progestin combination in the early 1980s.
i. Study Results Could be Embarrassing
A September 22, 1983, Wyeth internal correspondence titled “PREM-PAK: Desired Labeling and Indications” reads, in part:
An underlying consideration concerning our overall approach to the FDA concerning PREM-PAK has been the importance of avoiding the problems which could arise if the FDA were to take the position that PREM-PAK is equivalent to a combination drug product of the type requiring demonstration that the combination does more than its components in regard to each indication for the combination product. To attempt such demonstration would be very costly, would take many years, and might in the end not prove successful. In fact, the results of the studies that would be needed could turn out to be embarrassing.112
Plaintiff asserted that this exhibit “goes to the heart of this issue of whether or not [Wyeth] had reckless disregard.”
Q: And what could be embarrassing, from your standpoint as an FDA reviewer, if they did studies?
A: Well, it would be embarrassing, perhaps, if the results weren’t positive and you didn’t get approved.114
Plaintiff argued that this exhibit established that Wyeth was aware that a study might reveal that breast cancer could result when progestin is added to estrogen;
is talking about the FDA combination drug policy, which typically when you combine two products together into a combination, the first product has a certain degree of benefit or efficacy and the second product has a certain degree of benefit or efficacy. The expectation is that the combination would have a greater benefit, more efficacy, faster efficacy, better efficacy. In this instance, we were not putting the MPA or the progestin component to estrogen to make it more efficacious, to give it better effect, to relieve vasomotor symptoms faster or better, to improve bone better. It was there to protect the en-dometrium only.
So what Dr. Perdue is saying is that if FDA or anyone were to expect that this particular combination would have better efficacy, it wouldn’t, and so if one were to have that expectation, the results of the study might be embarrassing because it didn’t provide greater efficacy. That was never the intent and was not the expectation.116
When considering the exhibit in context and based on the evidence as a whole,
ii. Someone Suggested Peeking at the Data
The Prempak Study’s goal was to show that adding progestin to an estrogen would reduce the risk of endometrial hyperpla-sia.
Objective was to demonstrate that the presence of a progestogen did not add to the detriment of the product ... Hope [the hyperplasia] is showing up in estrogen alone group. If not, can [sic] kiss the product good-bye ... Somebody should peek at the data when you reach a certain point. [Wyeth] hides the randomization code.119
Regarding testing, Plaintiffs counsel suggested that “it looks like [Wyeth] was doing the right thing, but somebody else within this system wanted to peek at the data.”
iii. The Prempak Study Was Not Completed
Plaintiff pointed out that the Prempak Study was not completed. In 1988, the Prempak Study ended because of on-going difficulty obtaining participants.
f. Refusal to Provide Drugs to ECOG (Plaintiffs Exs. 251 and 265)
During the compensatory damages stage, Plaintiff presented two internal Wyeth memos, dated December 8, 1993 and February 9, 1994, regarding Wyeth’s refusal to supply Premarin in support of a proposed study by the Eastern Cooperative Oncology Group.
In its post-trial brief, Plaintiff asserted that since Wyeth provided no document laying out “company policy,” a jury has the right to infer that the policy was to not give drugs to breast cancer studies.
g.Prempro Pivotal Trial
In 1988, Wyeth submitted a draft to the FDA for what would become the Prempro Pivotal Trial.
h. Reaction to Adverse Studies and Media
According to Plaintiff, Wyeth’s reactions to studies that suggested a link between breast cancer and hormone replacement therapy demonstrated Wyeth’s conscious indifference. Plaintiff pointed out that Wyeth used public relations firms, “friendly organizations to which it gave millions of dollars,” marketing, press manipulation, and ghostwriting to counter studies (and press reporting on the studies) that suggested a link between HRT and breast cancer.
i. Public Relations Firms
Burson-Marsteller is a public relations firm that has worked for Wyeth since the 1980s.
According to Plaintiff, Burson-Marstel-ler’s June 6, 1994 “Premarin & Wyeth-Ayerst Women’s Health: Account Overview”
In 1997, Burson-Marsteller suggested that “[i]n the world of ERT and breast cancer, misperceptions and confusion dominate the emotional issues surrounding breast cancer,”
In the proposal, Burson-Marsteller designated the Nurses’ Health Study as one of “four primary barriers distorting reality” between breast cancer and HRT.
Plaintiff also introduced an August 22, 1997 Burson-Marsteller proposal titled “Premarin Pre-emptive Plan.”
Plaintiff presented a July 25, 1994 letter from Burson-Marsteller to Wyeth titled “Breast Cancer & ERT: Risk in Perspective Campaign — Preliminary Recommendations.”
Plaintiff introduced Wyeth’s 1991 “Pre-marin crisis preparedness plan.”
Essentially, Plaintiff used the Burson-Marsteller documents to suggest that Wyeth’s responses to negative media are inappropriate. But the evidence in the record established that Wyeth believed the “media sensationalize^] negative events,”
ii. Donations to Friendly Organizations
According to Wyeth’s finance committee’s March 4, 1999 authorization, Wyeth authorized $18,114,725 for awards and grants as part of the annual budget.
iii. Seasons Magazine (Plaintiffs Ex. 154)
Wyeth’s Seasons magazine was intended for “women taking Premarin with incentives to continue taking Premarin.”
In a February 25, 1991 letter, the FDA responded to Wyeth’s Season magazine proposal, which Wyeth “plan[ned] to use in a direct-to-consumer program....”
It was not our intent to imply to consumers that Seasons [sic] magazine is a commercially available magazine being provided by her physician or pharmacist. We have, therefore, revised all components of the program to clearly state that the program and magazine are produced and distributed by Wyeth-Ay-erst.165
Wyeth revised the Seasons magazine draft and resubmitted it to the FDA.
Dr. Parisian only testimony on this exhibit was that when pharmaceutical companies distribute information, it should be clear that the pharmaceutical company was the source of the information, rather than a doctor or pharmacist.
If this exhibit suggests malice or reckless disregard, the suggestion is weaker than a $2.00 suitcase — it is not enough standing alone or with the other admissible evidence to create a submissible issue on punitive damages. Furthermore, I unable to discern or divine how this omission (failing to show who wrote the articles) relates to a failure to warn allegation. Regardless, as discussed in Section 111(A)(2)(c) of this Order, I should have struck the exhibit and Dr. Parisian’s testimony about the exhibit.
iv. Press Manipulation
In early 1990, Wyeth discovered that Dr. Graham Colditz was going to present a study relating Premarin and increases in the risk of breast cancer. Plaintiff introduced evidence that Wyeth’s proposed strategy in response to the study was to “[b]e reactive on the cancer issue. Be prepared to take a responsive stance towards media covering the cancer story with accurate, full and balanced information on the issues presented in proper context.”
not adequately support the additional tactics needed to drive growth, particularly in light of the introduction of four new competitors ... In addition, media attention on two recent publications have [sic] raised consumer awareness about the relative risk of breast cancer ... Additional funds are needed to minimize the impact on growth or programs which focus on the role of estrogen in disease prevention and help put the small potential risk of breast cancer in perspective.175
This document does not bolster Plaintiffs claim for punitive damages. The fact that Wyeth increased the Premarin budget in an effort to “put the small potential risk of breast cancer in perspective” does not support a claim that Wyeth acted with reckless indifference. While “putting the risk of breast cancer in perspective” rather than doing an independent study may support a claim for negligence, it does not rise to the level required for punitive damages.
The record is replete with evidence that Wyeth wanted the media to present “balanced” information.
v. Ghostwriting
Plaintiff focused heavily on the fact that Wyeth, through DesignWrite, collaborated with authors to have articles written about HRT in a process called “ghostwriting.” In closing argument, Plaintiff asserted that ghostwriting is “exactly the type of conduct that necessitates punitive damages.”
Regardless of the bad inference Plaintiff placed on ghostwriting, it is apparently the norm in the industry,
Plaintiff contended that Bob Essner’s (a Wyeth executive) April 4, 1995 Prempro “launch speech”
First, Plaintiff pointed out that nowhere in these launch speeches does Mr. Essner mention short-term use, breast cancer risk, or studies;
Second, Plaintiff argued that Mr. Essner instructed the sales force to “thumb its nose at the FDA” and “improperly, if not illegally promote lifetime use for all women.”
“[Dr. Healy] made the prediction that in the very near future there is going to be a revolutionary increase in the use of hormones to prevent and treat a variety of conditions in older women ... [Dr. Healy said] that women starting on HRT at menopause and staying on it for the rest of their lives will become the rule, and that this will have a dramatic and positive effect on women’s health ... We have an opportunity to start the HRT revolution that Dr. Healy predicted. We can make real the full promise of HRT to create in the near future a world where the majority of women will start HRT at menopause and continue on it for the rest of their lives. A world where women will get the full medical benefit of replacing the estrogen lost after menopause and the full protective effect of MPA.”188
Mr. Essner was quoting Bernadine Healy, the former head of NIH, and her opinion that all women should be on HRT. Additionally, nowhere in the speech does he tell the sales force to promote Prempro in this manner; rather, he’s suggesting that things look good for Prempro in view of Dr. Healy’s predictions on the future of HRT.
Plaintiff also pointed out that Mr. Ess-ner referenced Carrie Smith-Cox’s (from Wyeth’s marketing department) comments that “for Prempro and Premphase there are no boundaries, no limits.”
But, as discussed earlier in detail, I should have struck these two exhibits and Dr. Parisian’s testimony about the exhibits.
vii. IARC Document (Plaintiffs Ex. 146)
Plaintiff contended that Wyeth wanted to “ensure that IARC [did] not develop a position on a definitive relationship between breast cancer and estrogen replacement therapy....”
There is no testimony that Wyeth’s forming a task force to “provide the necessary information to IARC”
2. Summary of Punitive Damages Evidence Against Upjohn
Plaintiff contended that Upjohn was liable for punitive damages because it conducted no studies and proposed no warnings to the FDA regarding the possible connection between Provera use and breast cancer. Plaintiffs position was:
As early as 1963, Upjohn should have been aware of the breast cancer risk related to Premarin, based on an abstract that was released. In 1966, the FDA rejected Upjohn’s supplemental new drug application for “revised labeling to include the adjunctive use of [Provera] in hypoestro-genic states.”
Plaintiff asserted that “Upjohn knew of the potential breast cancer risk at least by 1963,”
b. “The Other Half of Estrogen Replacement Therapy”
During the punitives stage, Plaintiffs punitive damages evidence against Upjohn focused primarily on correspondence between the FDA and Upjohn regarding advertising campaigns for Provera. Plaintiff argued that this evidence established a duty to test — e.g., “If a drug company advertises its products to be used in combination with another product, the company has a duty to study the two drugs in operation together.”
• January 5, 1984 FDA Letter — The FDA requested “immediate cancellation” of an advertisement that “impl[ied] the use of Provera with estrogen replacement therapy except in those situations as described in [the] approved package insert.”203 The FDA also informed Upjohn that it recognized that the concurrent use of estrogen and progestin was becoming a more common practice, but that Upjohn needed to update its package insert before promoting Provera for such a use.204
• September 10, 1985 FDA Letter — The FDA wanted ads titled “The other half of estrogen replacement therapy” removed from circulation, because the ads “presented] Provera as being safe and effective for the treatment and reversal of endometrial hyperplasia which [was] not an approved indication ....”205 Plaintiff argued that this exhibit establishes that in 1985 Upjohn was aware that its product was being used with estrogen and was under a duty to test.
• July 10, 1986 Letter — Upjohn informed the FDA that it planned to submit a proposal for a “convenience pack” for concomitant estrogen and progestin administration.206 The FDA informed Upjohn that “there [was] not yet an indication for such combinations and the potential risks [were] not yet resolved.”207
• January 15, 1988 FDA Letter — Upjohn, wanted Provera approved to oppose the endometrial effects of estrogen in menopausal women receiving estrogen replacement therapy. The FDA informed Upjohn that it “failed to provide substantial evidence consisting of adequate well-controlled studies ...” that Provera will have this effect.208 Dr. Parisian testified only that the FDA believed that there was insufficient evidence to support the indication Upjohn wanted.
*901 • October 30, 1990 FDA Letter209 — This exhibit was admitted into evidence, but Plaintiff never discussed it with a witness.
• October 31, 1990 FDA Letter210 — The FDA informed Upjohn that it should voluntarily withdraw a promotional piece that suggested that combination estrogen and progestin therapy is indicated to reduce the risk of postmenopausal osteoporosis, because Provera was not indicated for that use.
• November 13, 1990 FDA Letter — The FDA rejected Upjohn’s proposed ads based on the ads’ “emphasis ... on ‘menopausal therapy’ rather than on an approved product indication.”211 On November 9, 1990, Upjohn informed the FDA that “the relevant promotion pieces and reprints [were] no longer being distributed by sales representatives.”212
• December 9, 1991 FDA Letter213 — In response to a proposed advertisement from Upjohn, the FDA reminded Upjohn that Provera was not “indicated for use in postmenopausal replacement therapy for the prevention of endome-trial hyperplasia.”214
• December 13, 1991 FDA Letter — The FDA informed Upjohn that referring to a postmenopausal patient as a candidate for using Provera is “potentially misleading to the reading regarding the indication for use of the product.”215
Plaintiff asserted several purposes for this evidence. In pre-trial responses to Upjohn’s objections to the exhibits, Plaintiff argued that the exhibits showed Upjohn’s policy of promoting “Provera to be used in combination with Premarin without an indication or approval to do so.”
If Plaintiffs final position is that the exhibits established a duty to test, then the exhibits are no help in determining punitive damages. First, as stated, this is a compensatory damages stage issue. Second, Plaintiff conceded that “Upjohn was
To the extent that these exhibits are intended to establish Upjohn’s alleged reckless indifference, the inference is not supported by the record. A review of the exhibits shows that the FDA’s criticisms were quite specific. Never did the FDA criticize Upjohn’s use of the phrase “the other half of estrogen replacement therapy”; rather, the FDA criticized the indications for use suggested by the advertisements. Specifically, the FDA scolded Upjohn for suggesting progestin prevented endometrial hyperplasia,
In summarizing these exhibits, Dr. Parisian testified that Upjohn was “ignoring the FDA” and “providing labeling that’s misleading, that’s false and misleading, with inadequate instruction for use.”
Dr. Parisian elaborated that “Upjohn is not doing the clinical trials. If you want that indication, you need to do the clinical trials to support that indication and get approved....”
According to Dr. Parisian, if Upjohn “wanted that indication,” it needed “to do a clinical study and submit an application to the FDA for approval.”
Finally, if these exhibits were submitted under the negligence standard, they might pass muster for jury consideration, but not under the clear and convincing standard.
c. Response to the Degge Group Findings
Plaintiff argued that Upjohn’s response to the Degge Group findings “is the most telling proof of Upjohn’s abject refusal to examine the breast cancer issue....”
Plaintiffs focus on the fact that Upjohn did not do its own breast cancer studies is of no consequence. This is argument, unsupported by the evidence — there is no evidence that Upjohn was required to conduct its own “in-house” study. Additionally, Dr. Parisian did not reference any FDA regulations that require a pharmaceutical company to conduct an “in-house” study. In fact, as the agreed-to jury instruction points out, Upjohn’s duty was “to test or otherwise discover risk about which a manufacturer should warn.”
3. Summary of Evidence During Punitive Damages Stage
In Arkansas, a punitive damages claim “is properly submitted to the jury ... where the claim is supported by ‘substantial evidence.’ ”
Plaintiffs burden was to show, by clear and convincing evidence, that Defendants knew or should have known of the consequences of their actions, and in the face of this knowledge continued a course with such abhorrent indifference to the consequences that malice can be inferred. But the evidence in this' case establishes, at most, negligence. Defendants were aware
Plaintiff conceded that the breast cancer risk associated with estrogen plus proges-tin had not been accepted when she ingested the drugs, but argued that this “has no bearing on [Defendants’] failure to study.”
Plaintiff asserted that had Defendants done the “right” studies, they would have uncovered the breast cancer risk long ago.
Upjohn repeatedly attempted to get advertisements approved that suggested indications that had not been approved for Provera. Upjohn submitted the ads, the FDA reviewed the ads, and the FDA rejected them; this appears to be how the process works between the FDA and pharmaceutical companies. Evidence that the FDA scolded Upjohn four or five times, over 20 years, because its proposed advertisements were overly broad, does not establish reckless indifference — this might be different had Upjohn acted contrary to the FDA’s criticisms.
Wyeth used advertising to promote estrogen and progestin products. Wyeth also considered suggestion from a public relations firm on how to respond to studies that reflected poorly on its products and present the media with balanced report of the facts. These actions, standing alone or when considered with the other evidence in this case, do not establish reckless disregard.
Once again, to warrant punitive damages, Plaintiffs burden was to prove, by clear and convincing evidence, that: (1) Defendants knew or should have known, in light of the circumstances at the time, that
CONCLUSION
Based on the findings of fact and conclusions of law above, Defendants’ Motions to Strike Dr. Parisian’s testimony from the punitive damages phase is GRANTED in PART, and her testimony is STRUCK, as outlined above. Absent the improperly admitted testimony, there is insufficient evidence for a punitive damages award.
Because Plaintiff failed to present clear and convincing evidence warranting punitive damages, Defendants’ Motions for Judgment as a Matter of Law (Doc. Nos. 637, 642) are GRANTED as to punitive damages, and the punitive damages awards are VACATED.
If Defendants’ Motion for Judgment as a Matter of Law had not been granted, they, at least, would be entitled to a new trial on punitive damages. Accordingly, in the alternative, Defendants’ Motion for New Trial is GRANTED.
Plaintiffs Motions for Taxation of Costs (Doc. No. 631) is DENIED without prejudice. The motion should forthwith be modified in consideration of this Order as well as the concessions Plaintiff made in her May 5, 2008 reply.
Since I have a deep and abiding faith in randomly selected juries, I am always reluctant to set aside a jury finding. This jury was very attentive throughout. I admitted much evidence that should not have been admitted. The fault is mine alone.
IT IS SO ORDERED.
. United States Magistrate Judge Henry L. Jones, Jr. is also assigned to this case and entered some of the orders referenced in this Order.
. Doc. Nos. 651, 652, 654, 655.
. Doc. No. 552.
. Id.
. Doc. No. 616.
. Doc. Nos. 629, 636 (correcting the post-judgment interest rate).
. Doc. No. 647.
. Minnesota Supply Co. v. Raymond Corp., 472 F.3d 524, 536 (8th Cir. 2006).
. Larson by Larson v. Miller, 76 F.3d 1446, 1452 (8th Cir. 1996).
. 9B Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 2529 (3d ed. 2008) (citing Reeves v. Sanderson Plumbing Products, 530 U.S. 133, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000)).
.Weisgram v. Marley Co., 528 U.S. 440, 455-456, 120 S.Ct. 1011, 145 L.Ed.2d 958 (2000) (Finding no abuse of discretion when the appellate court found expert testimony inadmissible and instructed that judgment be entered as a matter of law, since, without the erroneously admitted testimony, there was insufficient evidence to support the jury verdict. The Supreme Court rejected Plaintiffs assertion "that allowing courts of appeals to direct the entry of judgment for defendants will punish plaintiffs who could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” The Court recognized that "although [Plaintiff] was on notice every step of the way that [Defendant] was challenging his experts, he made no attempt to add or substitute other evidence.”).
. Montgomery Ward & Co. v. Duncan, 311 U.S. 243, 253-54, 61 S.Ct. 189, 85 L.Ed. 147 (1940).
. Doc. No. 175.
. Doc. No. 389.
. Goebel v. Denver and Rio Grande Western R.R. Co., 215 F.3d 1083, 1087 (10th Cir. 2000).
. Doc. Nos. 66, 101, 577, 594.
. See March 3, 2008, Tr. at 2714; March 3, 2008, Tr. at 2740-41; March 5, 2008, Tr. at 2835; March 6, 2008, Tr. at 2974.
. Doc. Nos. 605, 607, 610, 611, 643.
. Doc. No. 340 (The Order was entered by Judge Jones).
. Doc. No. 389.
. March 3, 2008, Tr. at 2678.
. See Doc. No. 643 ("But section 201.105 has to do with veterinary drugs, and section 203 with the reimportation and wholesale distribution of prescription drugs.”).
. March 3, 2008, Tr. at 2679.
. Id. at 2681-2685; Plaintiff's Exs. 22 and 24.
. Before the punitive damages stage commenced, the parties filed several motions and responses regarding witness, exhibits, etc.
. Doc. No. 588.
. March 3, 2008, Tr. at 2683.
. Id. at 2684.
.Id.
. Id. at 2685.
. Id. at 2684.
. Notably, Dr. Parisian could hardly testify that Wyeth’s action violated FDA regulations, because this position would have been contrary to the exhibit. The exhibit reads: "This letter is borderline in terms of violating the Food, Drug and Cosmetic Act.” The FDA disagreed with Wyeth’s actions, but believed only that Wyeth’s actions had come close to crossing the line.
. March 3, 2008, Tr. at 2688.
. Doc. No. 588.
. Id.
. March 3, 2008, Tr. at 2693 (emphasis added).
. Id. at 2693.
. Doc. No. 588.
. Doc. No. 2703-2704.
. March 3, 2008, Tr. at 2704.
. Doc. No. 588.
. March 3, 2008, Tr. at 2707.
. Id. at 2708.
. Doc. No. 588.
. March 3, 2008, Tr. at 2712-2713.
. Mat 2713.
. Id. at 2714.
. Id.
. Doc. No. 588.
. March 3, 2008, Tr. at 2720.
. Doc. No. 566.
. Doc. No. 588.
. March 3, 2008, Tr. at 2721-2722.
. Id. at 2722.
. Id.
. Doc. No. 566.
. Karla Kerlikowske, et al., Declines in Invasive Breast Cancer and Use of Postmenopausal Hormone Therapy in a Screening Mammography Population, 100 J. of the Nat’l Cancer Inst. 599 (2008).
. March 3, 2008, Tr. at 2722.
. March 3, 2008, Tr. at 2722.
. March 5, 2008, Tr. at 2837-2838.
. Doc. No. 652.
. During a sidebar, I responded that Defendants' objections made me very uncomfortable and made me think I had made pretty clear error. I concluded "I’m going to overrule your motion at this time. I’ve got it under advisement still.” See March 5, 2008, Tr. at 2838.
. An expert must establish the trustworthiness of a treatise as viewed by professionals in that field.
. Dura Automotive Systems of Indiana v. CTS Corp., 285 F.3d 609, 613 (7th Cir. 2002).
. Fed.R.Evid. 803(18).
. March 3, 2008, Tr. at 2726.
. Id. at 2728.
. Feb. 20, 2008, Tr. at 2345.
. March 3, 2008, Tr. at 2729.
. Plaintiff's Ex. 5785.
. Id.
. March 3, 2008, Tr. at 2731-2732.
. March 3, 2008, Tr. at 2736-2739.
. Nov. 5, 2007, Tr. at 113.
. Doc. No. 175.
. Nov. 5, 2007, Tr. at 113 and Doc. No. 175.
. I say “the Court,” because this Order was entered by Judge Jones.
. Doc. No. 340.
. Nov. 5, 2007, Tr. at 113.
. May 9, 2008, Tr. at 41.
. March 3, 2008, Tr. at 2794.
. Doc. No. 589 (emphasis in original).
. Doc. Nos. 340, 389, and Nov. 14, 2008 email Correspondence from the Court.
. Minasian v. Standard Chartered Bank, PLC, 109 F.3d 1212, 1216 (7th Cir. 1997) (citations omitted).
. Id.
. In re Rezulin, 309 F.Supp.2d 531, 551 (S.D.N.Y. 2004) ("[E]xperts should not be permitted to 'supplant the role of counsel in making argument at trial, and the role of the jury in interpreting the evidence.’ ”).
. Id. at 541.
. Nat'l Bank of Commerce v. McNeill Trucking Co., Inc., 309 Ark. 80, 828 S.W.2d 584, 589 (1992) (Dudley, J., concurring).
. Union Pacific R.R. Co. v. Barber, 356 Ark. 268, 149 S.W.3d 325, 343 (2004) (citing cases).
. Id.
. Id.
. Orsini v. Larry Moyer Trucking, Inc., 310 Ark. 179, 833 S.W.2d 366, 368 (1992); see also Alpha Zeta Chapter of Pi Kappa Alpha Fraternity by Damron v. Sullivan, 293 Ark. 576, 740 S.W.2d 127, 132 (1987) ("Negligence alone, however gross, is not enough to sustain punitive damages.”).
. March 3, 2008, Tr. at 2649.
. Doc. No. 652.
. Dr. Hoover wrote a letter to Wyeth that reads:
Enclosed is a confidential copy of a manuscript which will be published ... This study forms the basis for my ... statement that I had evidence which I interpreted as indicating that menopausal estrogens may be a risk factor for breast cancer as well as for endometrial cancer. As you can see, the findings for breast cancer are certainly not as clear-cut as those for endometrial cancer ... I believe it does indicate that there may be a problem, that certainly needs more intensive study.
Plaintiff’s Ex. 31.
. Doc. No. 652.
. Feb. 7, 2008, Tr. at 504.
. Plaintiff's Ex. 26.
. Id.
. Plaintiff's Ex. 28.
. Plaintiff's Ex. 28 (emphasis in original).
. Doc. No. 652.
. Plaintiff's Exs. 28, 117, and 1057.
. Doc. No. 652.
. Plaintiff's Ex. 28.
. Feb. 6, 2008, Tr. at 458-459; Feb. 8, 2008, Tr. at 850-852; Feb. 15, 2008 Tr. at 1811-1812.
. Doc. No. 652.
. March 3, 2008, Tr. at 2685.
. Id.
. Id. at 2684-2685.
.Feb. 6, 2008, Tr. at 441-442.
. Plaintiff's Ex. 69.
. March 3, 2008, Tr. at 2649.
. Feb. 12, 2008, Tr. at 1286.
. May 9, 2008, Tr. at 44.
. Feb. 7, 2008, Tr. at 641.
. March 3, 2008, Tr. at 2687.
. The document is not dated, but the following is included: "No meeting on this project has been held in the last 12 months (May 1986).” Plaintiff's Ex. 95.
. Plaintiff's Ex. 95.
. March 3, 2008, Tr. at 2688.
.Id.
. Feb. 15, 2008, Tr. at 1864.
. Plaintiff’s Exs. 251 and 265.
. Plaintiff's Ex. 251.
. Feb. 7, 2008, Tr. at 552.
. Id. at 553.
. Id. at 554.
. According to the Merriam-Webster online dictionary, in medicine, a contraindication is a condition or factor "that makes a particular treatment or procedure inadvisable.” Available at: http://www.merriam-webster.com/dictionary/contraindication.
. Feb. 7, 2008, Tr. at 625.
. May 9, 2008, Tr. at 45.
. Feb. 7, 2008, Tr. at 642. This study was a one-year, randomized controlled trial designed to "assess the impact on endometrial hyperplasia of the combination product.” Feb. 7, 2008, Tr. at 644.
. Id. at 644.
. Feb. 7, 2008, Tr. at 590.
. Doc. No. 652.
. March 5, 2008, Tr. at 2897-2898.
. Plaintiff’s Ex. 8019-A.
. Plaintiff's Ex. 8019-A; March 3, 2008, Tr. at 2928.
. Plaintiff's Ex. 8019-A.
. March 3, 2008, Tr. at 2711-2712.
. Plaintiff's Ex. 5677.
. Id.
. Id.
. Id.
. March 3, 2008, Tr. at 2715.
. Id.
. Plaintiff's Ex. 5677.
. March 3, 2008, Tr. at 2716-2717.
. Plaintiff's Ex. 1448.
. March 5, 2008, Tr. at 2829.
. Plaintiff's Ex. 1030.
. See March 5, 2008, Tr. at 2816-2820.
. Plaintiffs Exs. 1187, 1188, 1190. See March 5, 2008, Tr. at 2898-2903, 2924-2925.
. March 5, 2008, Tr. at 2924.
. Plaintiff's Ex. 8019-A.
. Plaintiff’s Ex. 5733.
. Feb. 13, 2008, Tr. at 1534-1535.
. Plaintiff's Ex. 154.
. Doc. No. 588.
. May 9, 2008, Tr. at 32.
. Plaintiff's Ex. 154.
. March 3, 2008, Tr. at 2749.
. March 3, 2008, Tr. at 2690.
. Plaintiff's Ex. 154.
. March 3, 2008, Tr. at 2693.
. Wyeth’s Ex. 368.
. March 3, 2008, Tr. at 2750.
. Wyeth’s Ex. 700; March 3, 2008, Tr. at 2750.
. March 3, 2008, Tr. at 2750-2751.
. Id. at 2692.
. Wyeth's Ex. 368.
. Id.
. Plaintiffs Ex. 1265.
. Id.
. Doc. No. 588.
. Plaintiffs Ex. 8151.
. Plaintiffs Ex. 1265; Feb. 7, 2008, Tr. at 619, 625; Feb. 12, 2008, Tr. at 1294, 1305; Feb. 20, 2008, Tr. at 2323, 2340; March 3, 2008, Tr. at 2711; March 5, 2008, Tr. at 2928, 2932, 2935, 2956-2957.
. March 6, 2008, Tr. at 3025.
. Feb. 20, 2008, Tr. at 2343.
. Feb. 13, 2008, Tr. at 1533-1534.
. "[Hjiring third-parly professional writers and asking authors to sign those and asking those authors to be responsible for their content is very common practice.” Feb. 20, 2008, Tr. at 2343.
. Plaintiff's Ex. 6776.
. Plaintiff’s Ex. 6558.
. Doc. No. 588.
. Doc. No. 652.
. March 3, 2008, Tr. at 2707.
. March 5, 2008, Tr. at 2888.
. Doc. No. 652.
. Plaintiff's Ex. 6558.
. March 3, 2008, Tr. at 2707.
. March 5, 2008, Tr. at 2887.
. Plaintiffs Ex. 6776.
. Plaintiff's Ex. 146 (emphasis in original).
. March 3, 2008, Tr. at 2650.
. Feb. 7. 2008, Tr. at 547-548.
. Plaintiffs Ex. 10388.
. Id.
. Plaintiff’s Ex. 5785.
. March 3, 2008, Tr. at 2738-2739; March 5. 2008, Tr. at 2813.
. Doc. No. 651.
. Plaintiff's Ex. 10910.
. Feb. 19, 2008, Tr. at 2199-2201 and 2226.
. Doc. No. 651.
. Plaintiff's Ex. 10154.
. Id.
. Plaintiff’s Exs. 10178 and 10155 (same document).
. Plaintiff's Ex. 10342.
. Id.
. Plaintiff's Ex. 10166.
. Plaintiff's Ex. 10180.
. Plaintiff's Ex. 10179.
. Plaintiff’s Ex. 3401.
. Upjohn’s Ex. 928.
. Plaintiff's Ex. 10189.
. Plaintiff’s Ex. 10189.
. Plaintiff’s Ex. 10189.
. Doc. No. 588.
. Doc. No. 588.
. Feb. 19, 2008, Tr. at 2216; Feb. 14, 2008, Tr. at 1604-1605.
. May 9, 2008, Tr. at 55.
. Doc. No. 651.
. March 3, 2008, Tr. at 2734.
. Plaintiffs Ex. 10189.
. Plaintiff's Ex. 10179.
. Plaintiff's Exs. 10178 and 10155.
. March 3, 2008, Tr. at 2736.
. March 3, 2008, Tr. at 2736.
. Id. at 2790.
. Id. at 2791.
. Id. at 2733.
. Id.
. Doc. No. 651.
. Dr. Parisian testified that the first study that she could recall showing an increased risk of breast cancer when progestins and estrogens are used — as opposed to estrogen alone — was the Bergkvist Study, which was published in 1989. However, Dr. Parisian admitted that Bergkvist was not statistically significant. Feb. 13, 2008, Tr. at 1449.
. Feb. 15, 2008, Tr. at 1455; Feb. 19, 2008, Tr. at 2167.
. Plaintiff's Ex. 10116.
. Feb. 19, 2008, Tr. at 2168; Plaintiff’s Ex. 10116.
. Feb. 19, 2008, Tr. at 2167-2168.
. Doc. Nos. 166, 651.
. March 3, 2008, Tr. at 2738-2740; March 5, 2008, Tr. at 2986-2987, 2993.
. March 3, 2008, Tr. at 2738.
. Doc. No. 554 (emphasis added).
. Feb. 19, 2008, Tr. at 2214.
. Morris v. Union Pacific R.R., 373 F.3d 896, 903 (8th Cir. 2004).
. Feb. 19, 2008, Tr. at 2136.
. March 3, 2008, Tr. at 2789.
. See Feb. 13, 2008, Tr. at 1461 (Dr. Parisian agreed that up until 1995, "there was still an operating assumption and belief that progestins would reduce the risk of breast cancer posed by estrogen alone.... ”).
. Feb. 19, 2008, Tr. at 2165, 2230. Dr. Gambrell published an article in 1983 that suggested a reduced risk of breast cancer in women who were on the combination of estrogen and progestins. Feb. 19, 2008, Tr. at 2210. Also, Dr. Dey testified that Wyeth conducted internal research, that it shared with the FDA, that "found that some of the components in Premarin protected against breast cancer.” March 5, 2008, Tr. at 2896. This testimony was unimpeached.
. Doc. No. 651.
. Id.
. D’Arbonne Const. Co., Inc. v. Foster, 354 Ark. 304, 123 S.W.3d 894 (2003).
. Doc. No. 653.
Reference
- Full Case Name
- In re PREMPRO PRODUCTS LIABILITY LITIGATION. Donna Scroggin v. Wyeth
- Cited By
- 1 case
- Status
- Published