McKay v. Novartis Pharmaceuticals Corp.
McKay v. Novartis Pharmaceuticals Corp.
Opinion of the Court
ORDER GRANTING IN PART AND DENYING IN PART NOVARTIS PHARMACEUTICALS CORPORATION’S DAUBERT MOTION TO EXCLUDE CAUSATION TESTIMONY OF PLAINTIFFS’ EXPERTS IN THE MCKAY CASE
On this day, the court considered “Novartis Pharmaceuticals Corporation’s [“NPC”] Daubert Motion to Exclude Causation Testimony of Plaintiffs’ Experts in the McKay Case” (“Motion to Exclude”), filed June 10, 2011 in the Middle District of Tennessee as part of a multi-district litigation; Thomas W. McKay (“McKay”) and Leticia McKay’s (collectively “the McKays”) “Plaintiffs’ Response in Opposition to Novartis Pharmaceuticals Corporation’s Daubert Motion to Exclude Causa
I. BACKGROUND
A Procedural History
The McKays brought suit against NPC in this court on February 15, 2006, alleging that two of NPC’s drugs — Aredia and Zometa — caused McKay osteonecrosis of the jaw (“ONJ”). The McKays brought claims for strict liability, negligence, breach of express warranty and breach of implied warranty. On May 24, 2006, this case was transferred to the Honorable Todd J. Campbell of the Middle District of Tennessee as a “tag-along” case to In Re Aredia and Zometa Products Liability Litigation, MDL No. 1760, and was individually styled therein as 3:06-cv-527. On December 22, 2006, the McKays filed an amended complaint, adding a failure to warn claim and a loss of consortium claim.
B. Factual Background
Aredia and Zometa are biphosphonates used to treat bone disorders. Aredia was first approved by the FDA in 1991 to treat hypercalcemia of malignancy, and was approved in 1996 to treat bone metastases in patients with breast cancer. In 2002 the FDA approved Zometa for a number of conditions, including bone metastases.
McKay was diagnosed with prostate cancer in 1997. The parties apparently dispute whether that cancer metastatized to McKay’s bones. In 1997 he was prescribed Aredia, to be administered intravenously for osteoporosis, although the FDA had not approved the drug for that purpose. McKay took Aredia for several years, and was later prescribed Zometa as well. At some point McKay developed severe jaw and dental problems, including non-healing tooth extraction sites and exposed bones. He was diagnosed with ONJ, a condition marked by dead and dying bone in the jaw.
C. Parties’Arguments
NPC seeks to exclude testimony by Dr. Richard A. Kraut (“Dr. Kraut”), the McKays’ retained expert, as well as testimony by McKay’s eight treating physicians in various fields, on the question of whether Aredia and Zometa caused McKay’s ONJ. As to Dr. Kraut, NPC argues that he is unqualified to offer an opinion on general causation, incorporating by reference its motion addressing that issue from the multi-district case of Hill v. Novartis Pharmaceuticals Corp., 3:08-cv-
In its Motion to Exclude presently before this court, NPC also argues that Dr. Kraut should not be allowed to testify on the issue of specific causation; that is, regarding McKay’s ONJ in particular. In support of this position, NPC argues that Dr. Kraut’s methodology in reaching the conclusion that Aredia and Zometa caused McKay’s ONJ was unreliable. NPC characterizes Dr. Kraut’s testimony on that question as ipse dixit, and further argues that Dr. Kraut failed to perform a differential diagnosis to rule out other possible causes of McKay’s ONJ.
As to McKay’s treating physicians, NPC offers a variety of reasons for their testimony on causation to be excluded. For reasons explained below, the court will focus solely on two such physicians — Drs. Michael Sitters (“Dr. Sitters”) and Robert Leibowitz (“Dr. Leibowitz”) — for the purposes of this Order. Mirroring its argument regarding Dr. Kraut, NPC argues that Dr. Sitters’s specific causation testimony is unreliable to the extent that his opinion was derived in part from reports that do not conclusively establish general causation. Additionally, NPC argues that Dr. Sitters did not perform a sufficiently reliable differential diagnosis. NPC argues that Dr. Leibowitz is unqualified to offer his opinion on causation because he has no background or training in dentistry or oral surgery and because he did not diagnose McKay with ONJ.
In their Response, the McKays apparently concede that six of the eight treating physicians are unqualified to offer causation testimony. They argue, instead, that Dr. Kraut, Dr. Sitters, and Dr. Leibowitz should be able to offer opinions on specific causation. The multi-district litigation panel ruled several times that Dr. Kraut’s causation testimony was admissible as to other multi-district litigation plaintiffs, and the McKays urge the court to follow that path. They maintain that the alleged deficiencies in Dr. Kraut’s methodologies identified by NPC go to the weight, rather than the admissibility, of his testimony. The McKays also contend that Dr. Kraut did perform a differential diagnosis.
The McKays argue that Dr. Sitters is qualified to offer an opinion on causation because he is an oral maxillofacial surgeon who has done extensive research on ONJ, because he diagnosed McKay with ONJ, and because he ruled out other possible causes of McKay’s ONJ. Additionally, they point to Dr. Sitters’s explanation that his causation opinion is supported by radio-graphs.
In addressing the propriety of allowing Dr. Leibowitz to testify on causation, the McKays do not meet NPC’s arguments head-on. Instead, they reference many things that do not appear relevant to the present inquiry. They do, however, note Dr. Leibowitz’s extensive experience in dealing with Aredia and Zometa as an oncologist, and his familiarity with and study of ONJ and biphosphonates’ association with that condition.
II. APPLICABLE LAW
The Federal Rules of Evidence provide that a sufficiently qualified expert
III. DISCUSSION
A. Dr. Ambrose Aboud, Dr. Robert Buey, Dr. Nathan Dickerson, Dr. Luis Loweree, Dr. Jorge Ramos and Dr. Panagiotis Valilis
In addition to arguing for the exclusion of Drs. Kraut, Sitter, and Leibowitz’s causation testimony, NPC argues that the court should not allow Drs. Ambrose Aboud, Robert Buey, Nathan Dickerson, Luis Loweree, Jorge Ramos or Panagiotis Valilis to testify on the causation issue for a variety of reasons. In their Response, the McKays effectively concede the point. Of McKay’s treating physicians, they argue that “Dr. Sitters and Dr. Leibowitz should be able to testify directly as cause experts on Mr. McKay’s BRONJ[,]”
B. Dr. Kraut
1. Qualifications
NPC argues that Dr. Kraut lacks the qualifications to be an expert in this case, but the court finds otherwise. Dr. Kraut is board certified in oral medicine, oral and maxillofacial surgery, and dental anesthesia, and has practiced in those fields since 1975, holding numerous promi
2. General Causation
In order for Dr. Kraut’s causation opinions to be admissible under Federal Rule of Evidence 702 (“Rule 702”), they must be “based on sufficient facts or data;” must be derived using “reliable principles and methods;” and must apply those principles and methods to the facts in a reliable manner.
In arriving at his opinion regarding biphosphonates’ capacity to cause ONJ in general, Dr. Kraut relied on observations from his own practice, as well as “two landmark publications in the Journal of Oral and Maxillofacial Surgery” that addressed the association between biphosphonates and ONJ.
Although those materials do not definitively establish a causal connection between biphosphonate use and ONJ, Dr. Kraut may nonetheless reasonably rely on them for that proposition.
1) a positive correlation between biphosphonate potency and risk for developing*654 BRONJ; 2) a negative correlation between biphosphonate potency and duration of biphosphonate exposure prior to developing BRONJ; and 3) a positive correlation between duration of biphosphonate exposure and developing BRONJ.23
Accordingly, Dr. Kraut’s testimony on general causation undoubtedly amounts to more than “unsupported speculation.”
Further, Dr. Kraut’s methodology in using the available medical literature to derive his general causation opinion satisfies the applicable Daubert tests for reliability. Specifically, it is a commonly used technique for determining the causal relationship between biphosphonates and ONJ, and it is one both capable of and subject to peer review.
Accordingly, the court finds Dr. Kraut’s expert testimony regarding general causation to be admissible under Rule 702. This holding is consistent with the multidistrict litigation panel’s repeated findings that Dr. Kraut and others may testify on causation, and with other courts’ treatment of the issue upon remand from the panel. To the extent NPC wishes to expose weaknesses in Dr. Kraut’s general causation opinion, “[vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”
3. Specific Causation
Dr. Kraut’s specific causation opinion is similarly based on a reliable
The Fifth Circuit has held that eliminating viable alternatives is a reliable method of determining causation.
C. Dr. Sitters
NPC argues for the exclusion of Dr. Sitters’s causation testimony for a variety of reasons. Primarily, NPC challenges the admissibility of his testimony because he disclaimed expertise in ONJ and because his differential diagnosis was inadequate. Neither argument is persuasive, and the court finds Dr. Sitters’s testimony to be admissible.
To be qualified as an expert under Rule 702, a witness must have “knowledge, skill, experience, training or education” that “will help the trier of fact.”
Further, Dr. Sitters’s testimony is based on a reliable foundation. Dr. Sitters’s deposition testimony makes clear that he extensively reviewed the available medical literature on ONJ and biphosphonates. Therefore, for the reasons set out in the section on Dr. Kraut, above, Dr. Sitters has a reliable basis for an opinion on general causation. Dr. Sitters also has a reliable basis to testify on the issue of specific causation. He based his diagnosis of biphosphonate-induced ONJ on the clinical course McKay followed.
Dr. Sitters did testify that he could not rule out nonsuppurative osteomyelitis without performing a biopsy, and he did not perform one.
D. Dr. Leibowitz
The McKays do not carry their burden of showing Dr. Leibowitz’s causation testimony to be admissible.
IV. CONCLUSION AND ORDERS
1. “Novartis Pharmaceuticals Corporation’s [“NPC”] Daubert Motion to Exclude Causation Testimony of Plaintiffs’ Experts in the McKay Case” is GRANTED IN PART and DENIED IN PART.
2. The court finds the causation testimony of Dr. Kraut and Dr. Sitters to be reliable, and such testimony is therefore admissible.
3. Drs. Ambrose Aboud, Robert Buey, Nathan Dickerson, Luis Loweree, Jorge Ramos, Panagiotis Valilis and Leibowitz may not testify on the issue of causation.
SO ORDERED.
. See 3:06-md-1760, ECF No. 223.
. See 3:06-cv-527, ECF No. 29.
. See id. ECF No. 62.
. Id. ECF No. 58.
. Fed.R.Evid. 702(a).
. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993).
. Fed.R.Evid. 402; Daubert, 509 U.S. at 591, 113 S.Ct. 2786.
. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 149, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) (quoting Daubert, 509 U.S. at 592, 113 S.Ct. 2786).
. Id. at 152, 119 S.Ct. 1167.
. See id. (referencing “Daubert’s specific factors”).
. Id. at 150, 119 S.Ct. 1167.
. "BRONJ” stands for biphosphonate-induced osteonecrosis of the jaw.
. Resp. at 21.
. See Dr. Kraut’s Expert Report at 1, attached to NPC’s Mot. to Exclude as Exhibit 32.
. Id. at 2.
. See, e.g., In re Aredia and Zometa Prods. Liab. Litig., 2010 WL 5071063, *2 (M.D.Tenn. Dec. 7, 2010); In re Aredia and Zometa Prods. Liab. Litig., 2010 WL 5071851, *2 (M.D.Tenn. Dec. 7, 2010).
.Fed.R.Evid. 702(b, d).
. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 595, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993).
. Dr. Kraut’s Expert Report at 1-2.
. Id. at 2.
. See Daubert, 509 U.S. at 591, 113 S.Ct. 2786 (“Of course, it would be unreasonable to conclude that the subject of scientific testimony must be 'known' to a certainty.”).
. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 147, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997).
. Salvatore Ruggiero, et al., AAOMS Position Paper on Biphosphonate-Related Osteonecrosis of the Jaws — 2009 Update, J. Oral Maxillofacial Surgery, at 2 (2009).
. Paz v. Brush Engineered Materials, Inc., 555 F.3d 383, 388 (5th Cir. 2009) (“The [expert] testimony must be 'ground[ed] in the methods and procedures of science’ and 'more than subjective belief or unsupported speculation.' ”) (quoting Daubert, 509 U.S. at 590, 113 S.Ct. 2786).
. See id. (listing the Daubert factors for evaluating the reliability of methodology) (citation omitted).
. See generally, Deutsch v. Novartis Pharmaceuticals Corp., 768 F.Supp.2d- 420, 429-34 (E.D.N.Y. 2011) (evaluating, after remand from the multi-district litigation panel, the propriety of several experts' reliance on epidemiologic studies to establish causation).
. See Daubert, 509 U.S. at 594, 113 S.Ct. 2786 (recognizing that the degree to which a method is accepted in the scientific community can be helpful in evaluating the reliability of that method).
. See id. at 593, 113 S.Ct. 2786 ("Another pertinent consideration [in evaluating a method’s reliability] is whether the theory or technique has been subjected to peer review and publication.”).
. See Rebuttal Report of Wayne A. Ray, Ph. D., filed under seal in 3:06-cv-527 at ECF No. 72.
. Daubert, 509 U.S. at 596, 113 S.Ct. 2786 (citation omitted).
. Dr. Kraut's Expert Report at 5.
. Id.
. See Dr. Kraut Dep. at 108, attached to ECF No. 57 as Exhibit 10 in 3:06-cv-527.
. See id. at 67.
. Id. at 69-71.
. See Pipitone v. Biomatrix, Inc., 288 F.3d 239, 248 (5th Cir. 2002).
. See Wackman v. Rubsamen, 602 F.3d 391, 403 (5th Cir. 2010) (observing that analytical " 'gaps’ go to the weight of the evidence” as opposed to its admissibility) (citation omitted).
. Fed.R.Evid. 702(a).
. Sitters Dep. at 128; attached to ECF No. 67 as Exhibit 1 in 3:06-cv-527.
.Id. at 144-45.
. Id. at 27.
. Id. at 132.
. See Fed.R.Evid. 702(a).
. See Sitters Dep. at 97-98.
. See id. at 132-33.
. Sitters Dep. at 86; attached to ECF No. 57 as Exhibit 17 in 3:06-cv-527.
. Sitters Dep. at 135; attached to ECF No. 67 as Exhibit 1 in 3:06-cv-527.
. See Dr. Leibowitz, Biphosphonates and Osteonecrosis of the Maxilla and/or Mandible (Jaw Bones), at 8; attached to ECF No. 67 as Exhibit 16 in 3:06-cv-527.
. See Wells v. SmithKline Beecham Corp., 601 F.3d 375, 378 (5th Cir. 2010) (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999)) (internal quotation marks omitted).
. See Wackman v. Rubsamen, 602 F.3d 391, 403 (5th Cir. 2010).
. See Bocanegra v. Vicmar Servs., Inc., 320 F.3d 581, 585 (5th Cir. 2003) ("The party seeking to have the district court admit expert testimony must demonstrate that the expert's findings and conclusions are reliable....”).
. Specifically, the McKays state that Dr. Leibowitz “diagnosed ONJ in April 2005,” and cite to page 143 of the doctor's deposition. Resp. at 14. That portion of Dr. Leibowitz’s testimony actually supports the opposite conclusion, however. Dr. Leibowitz states that he does not remember who diagnosed McKay with ONJ, and notes that he referred McKay to Dr. Felsenfeld. Dr. Leibowitz Dep. at 142-43, attached to ECF No. 67 as Exhibit 14 in 3:06-cv-527.
. Id. at 147.
Reference
- Full Case Name
- Thomas W. McKAY and Leticia McKay v. NOVARTIS PHARMACEUTICALS CORPORATION
- Cited By
- 4 cases
- Status
- Published