Brown v. Novartis Pharmaceuticals Corporation

Filing 223

ORDER granting in remaining part and denying in remaining part 51 Motion to Exclude Testimony of Plaintiffs' Expert Dr. Suzanne Parisian - Signed by District Judge Louise Wood Flanagan on 9/20/2012. (Baker, C.)

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~OPENCOURT C\ -8-0- dO Jd- Julie A. RJchan:Is, Clertc: us District Court Eastern District of NC IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NORTH CAROLn~A SOUTHERN DIVISION NO.7:08-CV-130-FL VICTOR BROWN Plaintiff, v. NOV ARTIS PHARMACEUTICALS CORPORATION, Defendant. ) ) ) ) ) ) ) ) ) ) ) ORDER With reference to matters still at issue concerning the testimony ofDr. Suzanne Parisian, anticipated to be presented by plaintiff this date, after extensive briefing and hearing, the court makes the following determinations: 1. At the outset, where plaintiffhas not presented to the court an applicable regulation that uses the terminology "causal association," Dr. Parisian shall not use such terminology. It would only confuse the jury. 2. Dr. Parisian may not testify as to general or specific causation. 3. Dr. Parisian may testify as to what the applicable Federal Regulations required of drug manufacturers at various stages of the drug approval process. 4. Dr. Parisian may testify as to what constitutes "reasonable evidence of an association of a serious hazard with a drug," 21 C.F.R. § 201.57(e) (2005); see also 21 C.F.R. § 201.80(e); and more specifically as to whether there was such reasonable evidence in this case, subject to further limitations set forth below. 5. Dr. Parisian may testifY that the applicable Federal Regulations required defendant to take particular action when it received particular material or information, only to the extent she is qualified by her training as a doctor of medicine, her FDA experience, consulting experience, and her review of materials in this litigation, to give such an opinion. Fed. R. Evid.702. 6. Dr. Parisian may not attempt to provide opinion that requires expertise she does not possess, such as in the areas of oncology, dentistry, oral surgery, or bone disorders. 7. Specific examples raised at the 9114112 Daubert hearing and elsewhere in the record: a. "Summary ofONJ Cases in Zometa and Aredia Clinical Trials" (chart of6 cases)1 1. Dr. Parisian may testifY as to what action, if any, the Federal Regulations required defendant to take when each diagnosis in the chart was made; n. Dr. Parisian may testifY as to what action, if any, the Federal Regulations required defendant to take in or around January 2005, when defendant in conducting its review of the Zometa and Aredia clinical trials recognized these 6 clinical trial results as possible cases of ONJ; but 111. Dr. Parisian may not testifY that the six cases listed in this chart were actually cases of ONJ, where she testified at her Daubert hearing that it is not her testimony that any of these cases on the table are actual ONJ cases. 2 b. Gotcher & Jee, "The progress of the periodontal syndrome in the rice rat" (1981). 1 See 9114112 Hr. Tr. 50:13. 2 9114112 Hr. Tr. 51:9 - 17 ("Q. Doctor, is it your testimony that any of these -- any ofthese cases on the table that's in front of you are actual osteonecrosis ofthe jaw cases. A. No, it hasn't been."). 2 1. Dr. Parisian may testifY as to what action defendant should have taken, under the applicable Federal Regulations, due to the existence ofthe Gotcher & Jee article. SO ORDERED, this the 20th day of September, 2012. Cii:¢ -,~.&: QUE W. FLANAGAN United States District Judge 3

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