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Rush v. Wyeth: EXPERT WITNESSES - no error or abuse regarding expert witness opinion rulingsUnited States Court of AppealsFOR THE EIGHTH CIRCUIT ___________ No. 07-1822 ___________ In re: Prempro Products Liability * Litigation, * ____________________ ** Helene Rush, * * Appellant, ** Appeal from the United States v. * District Court for the * Eastern District of Arkansas. Wyeth, doing business as Wyeth, Inc., * doing business as Wyeth * Pharmaceuticals, * * Appellee. * ___________ Submitted: October 18, 2007 Filed: January 31, 2008 ___________ Before RILEY, MELLOY, and COLLOTON, Circuit Judges. ___________ RILEY, Circuit Judge. Helene Rush (Rush) was prescribed the Wyeth, Inc. (Wyeth) estrogen products Premarin and Prempro for symptoms related to menopause. Rush took the drugs for nearly ten years, beginning in August 1989. Rush was diagnosed with breast cancer in June 1999. Six years later, in March 2005, Rush filed this lawsuit alleging Wyeth’s 1The Honorable William R. Wilson, Jr., United States District Judge for the Eastern District of Arkansas. -2- products caused her breast cancer. Rush’s case is part of the multi-district litigation (MDL) on Hormone Replacement Therapy (HRT). A jury found Rush failed to prove: (1) Wyeth inadequately warned about the drugs’ risks, (2) the drugs were defective in design, and (3) Wyeth was negligent, or (4) any of these claims proximately caused her breast cancer. Rush moved for a new trial which was denied. On appeal, Rush argues the district court1 erred by (1) giving incorrect instructions to the jury, (2) allowing undisclosed and improper expert testimony, (3) disallowing Rush’s expert opinions, and (4) failing to instruct the jury on fraud. The jury also found against Wyeth on Wyeth’s statute of limitations defense, finding Wyeth failed to prove Rush either knew, or should have discovered by the exercise of reasonable diligence, the causal connection between the Wyeth estrogen products and her breast cancer. Wyeth asserts (1) Rush’s claims are time barred, and (2) her labeling claim was preempted by federal law. We affirm without reaching Wyeth’s issues. I. BACKGROUND In 1989, at age 55, Rush began taking prescribed estrogen products manufactured by Wyeth for symptoms related to menopause. Rush’s physician, Dr. Cynthia Frazier (Dr. Frazier), prescribed HRT for the treatment of vaginal atrophy. Before beginning the therapy, Dr. Frazier discussed with Rush the benefits and risks of the medications. In 1992, an abnormality was discovered in Rush’s breast. At that time, Dr. Frazier discussed with Rush the association between breast cancer and HRT and that -3- Rush “may want to stop hormones.” After another breast abnormality was found the next year, Rush stopped the HRT treatment for eight months before deciding to resume HRT. Rush took the product Premarin until 1996, when her new gynecologist, Dr. Karen Kozlowski (Dr. Kozlowski), switched Rush to Prempro. Dr. Kozlowski told Rush with HRT “there was a slight risk of cancer.” Rush took these drugs for nearly ten years until, in June 1999, she was diagnosed with breast cancer. Rush relied solely on her doctors’ advice in deciding to take HRT. Rush did not rely on any product advertisements. Rush did receive patient information sheets with her monthly Premarin and Prempro prescriptions. These information sheets explicitly warned that some studies suggested breast cancer was a possible danger or risk of the medications if taken “for prolonged periods of time and especially if higher doses are used.” While Rush admits receiving the information sheets, she denies ever reading them. During the entire time Rush was taking Premarin and Prempro, and continuing to this day, these drugs were approved by the Federal Drug Administration (FDA) as safe and effective. Before the FDA approved Prempro, the FDA specified the wording and placement of breast cancer warnings on the product labeling. On March 18, 2005, Rush filed her lawsuit alleging Wyeth’s hormone drugs caused her breast cancer. The case filing was nearly six years after Rush was diagnosed with breast cancer. -6- (internal brackets omitted). “[A]dequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly.” Id. While the Learned Intermediary Doctrine provides that adequate warning to a patient’s physician can suffice to defeat a patient’s fanh -9- testimony went beyond Dr. Rarick’s report, but was elicited in response to an opinion of Rush’s expert, Dr. Suzanne Klimberg (Dr. Klimberg), an opinion which also had not previously been disclosed. In answer to a juror’s question, Dr. Klimberg testified HRT brings estrone levels that are “not quite at the level that you would get premenopausal.” Essentially, Dr. Rarick’s testimony echoed Dr. Klimberg’s earlier testimony. Rush was not prejudiced, and the district court did not abuse its discretion in allowing this testimony. c. Dr. Michael Dey Rush asserts reversible error occurred when Dr. Michael Dey (Dr. Dey) testified by giving his definition of the word promote. Dr. Dey said, “[m]y definition of promotion is, they stimulate an existing cancer to grow in some tumors, in some women, or some tissues. But they do not cause cancer because they do not take a normal cell and make it a cancerous cell.” There was no objection to this testimony. Dr. Dey was then asked if he understood “the term ‘promotion’ is used differently by different scientists.” Dr. Dey agreed. Next, Dr. Dey was asked, “What other meanings of promotion have you heard in connection with this subject matter?” Only when Dr. Dey attempted to answer this question was an objection made. The objection was based solely on hearsay. The district court overruled this objection, telling the jury, “I’m going to allow the witness to give his understanding of the word ‘promote’ in the scientific field. I want you to keep in mind, though, that at the end of this trial, I am going to give you my understanding of the word ‘promote’ as Arkansas law applies, and that definition will be the one you’ll have to follow.” In the closing charge, the district court instructed the jury as to the definition of “promote” under Arkansas law, noting the jury was to consider the evidence in light of the definition provided by the court. A jury is presumed to follow the instructions given. See Weeks v. Angelone, 528 U.S. 225, 234 (2000). Thus, we must presume any confusion that may have existed because of differences between the definitions of “promote” given by Dr. Dey and the district court was resolved by the jury instruction 2SEER is an acronym for the Surveillance Epidemiology and End Results program of the National Cancer Institute. The SEER program “is an authoritative source of information on cancer incidence and survival in the United States.” Overview of the SEER Program, at http://seer.cancer.gov/about/ (last visited Jan. 4, 2008). 3In his deposition, Dr. Austin testified it would be fallacious to use the SEER database study to prove causation. -10- which defined “promote” for the jury and specified the evidence should be considered in light of the trial court’s definition of the term. 2. Expert Opinions Disallowed Rush asserts the district court abused its discretion when it excluded portions of the testimony of Rush’s expert, Dr. Donald F. Austin (Dr. Austin). Rush attempted to have Dr. Austin testify regarding new data garnered from the SEER2 database. The new testimony was intended to prove causation and contradicted Dr. Austin’s prior testimony.3 Rush cites to Farmland Indus. v. Morrison-Quirk Grain Corp., 54 F.3d 478, 482 (8th Cir. 1995), for the proposition that it is proper for the court to permit testimony like Dr. Austin’s where Dr. Austin previously gave the same opinions in a prior trial between the same parties. In Farmland, this court affirmed the district court’s decision allowing the causation testimony stating, “As with all discovery matters, the district court maintains broad control over Rule 26(e) issues regarding the disclosure of the substance of an expert’s testimony. We will not reverse a district court’s decision in this area absent a gross abuse of discretion resulting in fundamental unfairness in the trial of the case.” Id. (internal quotations and citations omitted). Unlike Farmland, where the district court admitted the causation expert testimony, the district court excluded Rush’s causation expert testimony. Farmland does not stand for the proposition this testimony must be admitted. Rather, Farmland simply expresses the unremarkable proposition that the district court’s decision, whether or not to allow testimony, is reviewed “in this area” for “a gross abuse of 4Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). -11- discretion resulting in fundamental unfairness.” Id. (internal quotations and citations omitted). The district court did not abuse its broad discretion when it excluded this testimony, particularly as here, where Dr. Austin previously testified such a study could not be used to prove causation. Rush also asserts the district court erred in excluding the causation testimony of her expert Dr. Graham Colditz (Dr. Colditz) based upon recent data in the SEER database. After the district court excluded the testimony of Dr. Austin regarding this new data, Rush attempted to permit Dr. Colditz to testify to the same data. The district court excluded Dr. Colditz’s testimony regarding this new data because Dr. Colditz had never referenced this data in his expert report nor testified about this data before his December 18, 2006, preservation deposition. The district court found this new testimony would be subject to Daubert4 and the deadline for raising Daubert issues was September 21, 2006. The district court noted, “this specific testimony by Dr. Colditz was not designated until after I ruled that Dr. Austin could not use the very same information.” The district court did not abuse its discretion when it excluded Dr. Colditz’s testimony regarding the new, and previously undisclosed, SEER database data. C. Wyeth Appeal Issues Having affirmed the decision of the district court on other grounds, we do not reach the issues of whether Rush’s claims are barred by the statute of limitations or whether Rush’s labeling claim is preempted by federal law. III. CONCLUSION For the foregoing reasons, we affirm the decision of the district court. ______________________________ |
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Michael E. Douglas, Attorney at Law, Saint Paul MN. All Rights
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