Mahaney ex rel. Estate of Kyle v. Novartis Pharms. Corp.

• Decision Date: 14 December 2011
• Docket Number: Case No. 1:06–CV–00035–R.
• Parties: Natasha Kyle MAHANEY on behalf of ESTATE OF Pamela Kay KYLE, Plaintiff v. NOVARTIS PHARMACEUTICALS CORP., Defendant.
• Court: U.S. District Court — Western District of Kentucky

835 F.Supp.2d 299

Natasha Kyle MAHANEY on behalf of ESTATE OF Pamela Kay KYLE, Plaintiff

v.NOVARTIS PHARMACEUTICALS CORP., Defendant.

Case No. 1:06–CV–00035–R.

United States District Court,

W.D. Kentucky,

Bowling Green Division.

Dec. 14, 2011.

Dandridge Bailey Walton, Lanphear & Walton, P.L.L.C., Bowling Green, KY, John A. Girardi, Lindsey A. Morgan, Girardi & Keese, Los Angeles, CA, John J. Vecchione, Valad and Vecchione, PLLC, Fairfax, VA, for Plaintiff.

Carol D. Browning, Stites & Harbison, PLLC, Louisville, KY, Sam E. Isaacs, II, Sam E. Isaacs, II, PLC, Lexington, KY, Amy Rae Fiterman, James A. O'Neal, Mark Joseph Winebrenner, Faegre & Benson LLP, Minneapolis, MN, Gregory S. Chernack, Joe G. Hollingsworth, Katharine R. Latimer, Hollingsworth LLP, Washington, DC, Regina M. Rodriguez, Faegre & Benson LLP, Denver, CO, for Defendant.

MEMORANDUM OPINION AND ORDER

THOMAS B. RUSSELL, Senior District Judge.

This matter is set for trial on January 9, 2012. In anticipation of the final pretrial conference, the parties have filed a number of motions in limine. These motions have been fully briefed and are now ripe for adjudication. Below is the Court's ruling on each of these matters.

I. BACKGROUND

Zometa and Aredia are two FDA-approved intravenous bisphosphonate (“IV BP”) drugs, manufactured by Defendant Novartis Pharmaceuticals Corporation (“NPC”). Both are used to combat a variety of advanced cancers that have presented themselves in patients' bones. Within cancer patients suffering this type of affliction,BP drugs like Zometa and Aredia are widely used.

Pamela Kay Kyle (“Kyle”) was diagnosed with breast cancer in 1997, which later metastasized to her skull. Her oncologist prescribed Zometa in October of 2003 as part of her treatment and she continued taking it until November 4, 2004. Kyle succumbed to her cancer on October 1, 2008.

Plaintiff Natasha Kyle Mahaney (“Plaintiff”) brings this action against NPC on behalf of Kyle's estate. Plaintiff alleges that prior to her death, Kyle developed osteonecrosis of the jaw (“ONJ”). ONJ is a condition that results in the necrosis (or death) of jaw bone. Plaintiff claims the type of ONJ that Kyle contracted was caused by IV BP drugs, commonly referred to as either bisphosphonate-related ONJ (“BRONJ”), bisphosphonate-induced ONJ (“BIONJ”), or bisphosphonate ONJ (“BONJ”). Plaintiff pursues this action under the state-law theories of strict liability, negligence, and breach of implied warranties. Her principal complaint is NPC failed to adequately warn Kyle of Zometa's dangers and side effects.

II. STANDARD

Motions in limine provided in advance of trial are appropriate if they eliminate evidence that has no legitimate use at trial for any purpose. Jonasson v. Lutheran Child & Family Serv., 115 F.3d 436, 440 (7th Cir.1997); Bouchard v. Am. Home Products Corp., 213 F.Supp.2d 802, 810 (N.D.Ohio 2002) (“The court has the power to exclude evidence in limine only when evidence is clearly inadmissible on all potential grounds.” (citing Luce v. United States, 469 U.S. 38, 41 n. 4, 105 S.Ct. 460, 83 L.Ed.2d 443 (1984))). Only where the evidence satisfies this high bar should the court exclude it; if not, “rulings [on evidence] should be deferred until trial so that questions of foundation, relevancy and potential prejudice may be resolved in proper context.” Gresh v. Waste Serv. of Am., Inc., 738 F.Supp.2d 702, 706 (E.D.Ky.2010) (quoting Indiana Ins. Co. v. Gen. Elec. Co., 326 F.Supp.2d 844, 846 (N.D.Ohio 2004)). Even if a motion in limine is denied, the court may revisit the decision at trial when the parties have more thoroughly presented the disputed evidence. See id. (“Denial of a motion in limine does not guarantee that the evidence will be admitted at trial, and the court will hear objections to such evidence as they arise at trial.”).

III. DISCUSSION

1. Statements by fact witnesses (DN 106)

NPC moves to exclude portions of the testimony by Kyle, Plaintiff, and Kyle's best friend, Pamela Lowe. The Court will address the relevant background, the offered objections, and its decisions.

a. Pamela Kay Kyle's testimony

Before her death, Kyle gave a videotaped deposition. Plaintiff will offer it into evidence at trial. NPC references portions of Kyle's deposition it hopes to strike. See Kyle Depo p. 118–121, DN 106–2, p. 17–20. Here, Kyle makes statements that she discontinued her use of Zometa because it made her bones “too hard.” The pertinent testimony that concerns the Court is as follows:

NPC Counsel's Question. So the reason that you asked to discontinue the Zometa is because you were concerned that your bones were getting too hard?

Kyle Answer. That's correct.

Q. What caused you to think that it was the Zometa that was related to that issue?

A. With Zometa being, I guess, a bone strengthener, that would imply that it would make the bones harder and less likely to injure. So I guess just common sense kind of put me to that deduction, that it was the Zometa that had made it so hard.

Q. But that was not based on any research that you had done on your own at that time—

A. No.

Q.—that was just your own assumption?

A. Correct.

Q. Was that based on anything that you had been told by any doctors?

A. Not that I can recall.

...

Q. Did you have any discussions at that point about other potential side effects of Zometa other than the possibility that it might be causing your bones to become hard?

A. Not that I can recall.

Kyle Depo. p. 119–21, DN 106–2 at 18–20. NPC moves to exclude this testimony because Kyle is unqualified to give opinions on medical causation and this is not a proper lay opinion under Federal Rule of Evidence 701. Plaintiff responds that Kyle's statements are consistent with the testimony of her physicians and that the jury is entitled to know her subjective impression of why she stopped taking the Zometa.

Under Rule 701, a lay witness may provide opinion testimony only when such opinions are “(a) rationally based on the perception of the witness, (b) helpful to a clear understanding of the witness' testimony or the determination of a fact in issue, and (c) not based on scientific, technical, or other specialized knowledge....” Fed.R.Evid. 701. “The primary purpose of Rule 701 is to allow nonexpert witnesses to give opinion testimony when, as a matter of practical necessity, events which they have personally observed cannot otherwise be fully presented to the court or the jury.” Randolph v. Collectramatic, Inc., 590 F.2d 844, 846 (10th Cir.1979) (citation omitted). Trial courts are afforded broad discretion when admitting lay opinion testimony. Heritage Mut. Ins. Co. v. Reck, 127 Fed.Appx. 194, 199 (6th Cir.2005).

Kyle's statement that Zometa “caused” her bones to harden is inadmissible opinion evidence under Rule 701. Kyle could not have perceived the changes in her bone density, and while she may have “felt” changes to her body during the Zometa treatment, the advanced stage of her cancer and the presence of other medical procedures during the same time frame substantially undermine the reliability of her statements. Ergo, the previously quoted passage on causation represents improper testimony. This ruling does not affect statements by Kyle about why she stopped taking Zometa that are not linked to medical causation.

b. Plaintiff Natasha Kyle Mahaney's testimony

Before her death, Kyle was diagnosed with trigeminal neuralgia, a condition unrelated to her ONJ. Kyle Depo. p. 18–21, DN 106–2 at 4–7. Trigeminal neuralgia is a syndrome characterized by “severe, episodic pain in the area supplied by the trigeminal nerve.” Trigeminal Neuralgia Definition, Dorlands.com, http:// www. dorlands. com/ def. jsp? id= 100071619 (last visited October 11, 2011). The trigeminal nerve is located in and around a person's jaw. Kyle testified in her deposition that this condition may have caused some of her jaw pain before the apparent onset of ONJ. Kyle Depo. p. 102–05, DN 106–2 at 12–15. She was able to differentiate, to a degree, between the pain caused by her trigeminal neuralgia and the ONJ.

NPC now moves to limit Plaintiff's direct testimony on three bases. The first two mirror the objections previously raised against Kyle's testimony: Plaintiff is not an expert on Zometa, ONJ, or medicine and is therefore unqualified to offer statements about causation or the effects of Zometa. The Court declines to answer these objections at present. Whereas Kyle's testimony is static since it has been prerecorded, Plaintiff will testify at trial and thus it is difficult to predict how these statements will present themselves. NPC may offer these objections at trial should the need arise. The Court will, however, issue a warning to Plaintiff: she is not an expert on causation and her opinions on Zometa and ONJ do not meet the requirements of Rule 701. Statements to that effect, absent a close nexus to the non-hearsay remarks of Kyle's physicians, are inadmissible.

NPC also argues that given Kyle's trigeminal neuralgia, Plaintiff cannot distinguish between the pain Kyle suffered as a result of this condition as opposed to the ONJ. NPC says Plaintiff should be precluded from offering testimony on the pain in Kyle's mouth because it invites speculation. The Court rejects such a contention—this is a legitimate basis for undermining Plaintiff's testimony on cross examination but not its exclusion. Plaintiff may also testify about personally observing Kyle's difficulty eating and brushing her teeth. Finally, regarding Kyle's statements about having pain in her mouth, this evidence might be admissible under the hearsay exception of a then-existing “state of mind, emotion, sensation, or physical condition.” Fed.R.Evid. 803(3). Since the Court has not confronted this testimony directly, the Court does not decide if it is admissible; instead, it opts to do so at trial.

Simply put, Plaintiff may testify on what she observed and the subjects about which she has personal knowledge. She may not speak...