Kruszka v. Novartis Pharm. Corp.
| Decision Date | 01 July 2014 |
| Docket Number | Civil No. 07–2793 DWF/JJK. |
| Citation | 28 F.Supp.3d 920 |
| Court | U.S. District Court — District of Minnesota |
| Parties | Candice KRUSZKA and Alan Kruszka, Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant. |
John A. Girardi, Esq., Molly B. Weber, Esq., and Samuel Ranchor Harris, III, Esq., Girardi & Keese; John J. Vecchione, Esq., Valad & Vecchione PLLC; Yvonne M. Flaherty, Esq., Elizabeth R. Odette, Esq., and Robert K. Shelquist, Esq., Lockridge, Grindal, Nauen, PLLP; and John J. Beins, Esq., Beins Goldberg & Hennessey LLP, for Plaintiffs.
Donald R. McMinn, Esq., Katharine Ruth Latimer, Esq., and Peter J. Skalaban, Jr., Esq., Hollingsworth LLP; Amy R. Fiterman, Esq., Christine R.M. Kain, Esq., Demoya R. Gordon, Esq., James A. O'Neal, Esq., Joseph M. Price, Esq., Linda S. Svitak, Esq., and M. Joseph Winebrenner, Esq., Faegre Baker Daniels LLP, for Defendant.
This matter is before the Court on the following motions: (1) Plaintiffs Candice Kruszka's (“Kruszka”) and her husband Alan Kruszka's (“Mr. Kruszka”) (collectively, “Plaintiffs”) Motion In Limine to Exclude Testimony of Duplicative Defense Experts against Defendant Novartis Pharmaceuticals Corporation (“Novartis” or “Defendant”) (Doc. No. 43); (2) Plaintiffs' Motion to Exclude Expert Testimony of Dr. Carol Ann Huff (Doc. No. 72); (3) Plaintiffs' Motion to Exclude Testimony of Dr. Dale A. Baur (Doc. No. 81); (4) Plaintiffs' Motion to Exclude Expert Testimony Relating to Alleged FDA Compliance and/or Novartis's “State of Mind” (Doc. No. 97); (5) Plaintiffs' Motion to Unseal the Second Declaration of Robert G. Germany and Exhibits 1–182 (Doc. No. 109); (6) Defendant's Motion to Exclude Expert Testimony of Dr. Suzanne Parisian (Doc. No. 46); (7) Defendant's Motion to Exclude Testimony of Plaintiffs' Expert Dr. Keith Skubitz (Doc. No. 54); (8) Defendant's Motion to Exclude Expert Testimony of Plaintiffs' Expert Professor Wayne Ray (Doc. No. 56); and (9) Defendant's Motion to Exclude Expert Testimony of Dr. James Vogel (Doc. No. 79). For the reasons set forth below, the Court grants in part and denies in part the motions.
The facts of this case have been fully set forth in the Court's May 19, 2014 Amended Memorandum Opinion and Order, 19 F.Supp.3d 875, 2014 WL 1878771 addressing summary judgment and two Daubert motions (“May 2014 Order”). (Doc. No. 202, 19 F.Supp.3d at 882–90.) Thus, the Court briefly summarizes the facts of this case as follows: This case relates to claims that Kruszka suffered osteonecrosis of the jaw
(“ONJ ”)—also known as dead jaw bone—as a result of using Novartis's product Aredia ® (“Aredia ”). Aredia is a bisphosphonate drug that is used to treat multiple myeloma, a form of blood cancer from which Kruszka suffered. Plaintiffs refer to Kruszka's ONJ as bisphosphonate-induced osteonecrosis of the jaw (“BIONJ”).1
In the May 2014 Order, the Court granted in part and denied in part Defendant's motion for summary judgment. The Court also allowed at least some testimony from Plaintiffs' case-specific retained and non-retained expert witnesses Drs. Gertz, Juhlin, and Kraut, and also from Plaintiffs' expert Dr. Marx. Both parties now seek to exclude the expert testimony of a number of additional potential expert witnesses under Daubert and the relevant Federal Rules of Evidence. Plaintiffs additionally seek the unsealing of certain exhibits and a corresponding declaration and have also moved in limine to exclude the testimony of duplicative defense experts.
Before accepting the testimony of an expert witness, the trial court is charged with a “gatekeeper” function of determining whether an opinion is based on sound, reliable theory, or whether it constitutes rank speculation. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589–90, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). In Daubert, the United States Supreme Court imposed an obligation on trial court judges to ensure that scientific testimony is not only relevant, but also reliable under the Federal Rules of Evidence. Id. at 579, 113 S.Ct. 2786.
Proposed expert testimony must meet three prerequisites to be admissible under Federal Rule of Evidence 702. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001). “First, evidence based on scientific, technical, or other specialized knowledge must be useful to the finder of fact in deciding the ultimate issue of fact.” Id. “[I]t is the responsibility of the trial judge to determine whether a particular expert has sufficient specialized knowledge to assist jurors in deciding the specific issues in the case.” Wheeling Pittsburgh Steel Corp. v. Beelman River Terminals, Inc., 254 F.3d 706, 715 (8th Cir.2001). Second, the proposed expert must be qualified. Lauzon, 270 F.3d at 686. Third, the proposed evidence must be reliable. Id. The proponent of the expert testimony bears the burden to prove its admissibility by a preponderance of the evidence. Daubert, 509 U.S. at 592 n. 10, 113 S.Ct. 2786.
In determining whether the proposed expert testimony is reliable, the Court considers: (1) whether the theory or technique can be and has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known rate of potential error; and (4) whether the theory has been generally accepted. Id. at 593–94, 113 S.Ct. 2786. The purpose of these requirements “is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).
In Kumho Tire, the Supreme Court concluded that “the trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable.” Id. In other words, “a trial court should consider the specific factors identified in Daubert where they are reasonable measures of the reliability of expert testimony.” Id. “The objective of that requirement is to ensure the reliability and relevance of expert testimony.”Id.
The Court's focus should be on whether the testimony is grounded in scientifically valid reasoning or methodology. United States v. Dico, Inc., 266 F.3d 864, 869 (8th Cir.2001). Bonner v. ISP Techs., Inc., 259 F.3d 924, 929–30 (8th Cir.2001) (internal citation omitted).
Dr. Carol Ann Huff (“Dr. Huff”) is an oncologist who is certified in internal medicine and oncology. (Doc. No. 150 (“Huff Exs. Index”) ¶ 1, Ex. 1 (“Huff Report”).) She is a faculty member at Johns Hopkins University where she began working in 1997 and where she has been in the Department of Oncology as an Associate Professor of Medicine and Director of the Department's multiple myeloma
program since 2001. (Id. ) She is a member of a number of cancer-related associations and committees. (Id. ) Dr. Huff has worked with a number of multiple myeloma patients over the years. (Id. ) Dr. Huff is involved in clinic research in the multiple myeloma field and has authored or co-authored several book chapters, as well as more than twenty peer-reviewed scientific articles and eighteen abstracts. (Id. ) Novartis proffers Dr. Huff to opine on issues relating to myeloma
and its treatment, including the effects of its treatments and therapies. In part, Dr. Huff's expert report opines that osteomyelitis cannot be ruled out as a cause of Kruszka's jaw problems, and that Kruszka benefitted from her Aredia therapy.
Plaintiffs seek to exclude Dr. Huff's specific causation testimony. Plaintiffs make two main arguments. First, Plaintiffs argue that Dr. Huff is unqualified to render the opinions she proffers, particularly any opinion regarding the specific cause of Kruszka's jaw problems, because she is an oncologist and is not an oral maxillofacial surgeon or dentist who works with osteomyelitis
or ONJ. Second, Plaintiffs argue that Dr. Huff cannot proffer opinions on quality-of-life improvements and special benefits associated with Aredia. Separately, Plaintiff seeks to exclude Dr. Huff's declaration that Novartis included as an attachment to its opposition to Plaintiffs' Daubert motion on Dr. Huff (“Huff Decl.”). The Court addresses each issue below.
As an initial matter, the Court concludes that Dr. Huff is qualified to opine on myeloma
treatment and therapies and their impact. A medical doctor need not have treated the specific disease at issue to opine on medical matters relating to that condition. Dittrich–Bigley v. Gen–Probe, Inc., Civil No. 11–1762, 2013 WL 3974107, at *7 (D.Minn. July 31, 2013) (). Dr. Huff is highly qualified as an oncologist and can therefore opine on issues relating to her oncological work, including treating myeloma, prescribing Aredia and Zometa ®2 (“Zometa ”) to treat myeloma, the immunosuppressive effect of myeloma-related treatments, and the specific effects of Aredia treatment. This also includes opining on Kruszka's clinical course of treatment. Dr. Huff regularly treats the cancer at issue here through a number of different methods and therapies, one of which is by regularly prescribing Aredia and Zometa. Dr. Huff has also written on and...
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