Deutsch v. Novartis Pharmaceuticals Corp..
| Decision Date | 08 March 2011 |
| Docket Number | Nos. 09–CV–4677 (ADS)(WDW),09–CV–4678 (ADS)(WDW).,s. 09–CV–4677 (ADS)(WDW) |
| Citation | 768 F.Supp.2d 420,84 Fed. R. Evid. Serv. 1227 |
| Parties | Samuel DEUTSCH, individually and as Administrator of the Estate of Helene Deutsch, Plaintiff,v.NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.Beth Forman, individually and as Executrix of the Estate of John Napolitano, Plaintiff,v.Novartis Pharmaceuticals Corporation, Defendant. |
| Court | U.S. District Court — Eastern District of New York |
OPINION TEXT STARTS HERE
Valad & Vecchione, PLLC by Bart T. Valad, Esq., John J. Vecchione, Esq., of Counsel, Fairfax, V.A., for Plaintiffs.Hollingsworth LLC by Katharine R. Latimer, Esq., Martin Calhoun, Esq., of Counsel, Washington, D.C., Rivkin Radler LLP, by Jesse J. Graham, II, Esq., of Counsel, Uniondale, N.Y., for Defendants.
Samuel Deutsch (“Plaintiff Deutsch”), individually and as an administrator of the estate of Helene Deutsch (collectively the “Deutsch case”), and Beth Forman (“Plaintiff Forman” and together with Plaintiff Deutsch “the Plaintiffs”), individually and as administrator of the estate of John Napolitano (collectively the “Forman case”), commenced these products liability actions against Novartis Pharmaceuticals Corporation (“Novartis” or “NPC”), alleging that the Novartis drugs Aredia and Zometa caused Mrs. Deutsch and Mr. Napolitano to develop a condition referred to as osteonecrosis of the jaw. Both Mrs. Deutsch and Mr. Napolitano passed away after filing the instant lawsuits. However, their respective spouses, Samuel Deutsch and Beth Forman, continue to pursue the claims against Novartis. Presently before the Court are nine Daubert motions by Novartis to exclude testimony by the Plaintiffs' retained and non-retained experts (the “treating physicians”); a Daubert motion by the Plaintiffs to exclude the causation testimony of the experts retained by Novartis; and a motion by the Plaintiffs to unseal documents. The Court now rules on all of these motions.
Although familiarity with the factual background and procedural history of this case is assumed, a brief review is in order.
This lawsuit involves two FDA-approved intravenous bisphosphonate (“IV BP”) drugs manufactured by Novartis, namely, Aredia (also known as pamidronate) and Zometa (also known as zoledronic acid). Both Aredia and Zometa are typically prescribed to patients with certain kinds of advanced cancer affecting bone.
Mrs. Deutsch received both Aredia and Zometa as treatment for metastatic breast cancer, and Mr. Napolitano received Zometa as part of his treatment for metastatic prostate cancer. After receiving the IV BP drugs, Mrs. Deutsch and Mr. Napolitano allegedly developed osteonecrosis of the jaw (“ONJ”). The Plaintiffs' allege that Mrs. Deutsch and Mr. Napolitano developed a form of ONJ that is caused by bisphosphonate drugs, referred to as bisphosphonate-related ONJ (“BRONJ”), bisphosphonate-induced ONJ (“BIONJ”) or bisphosphonate ONJ (“BONJ”). The American Association of Oral and Maxillofacial Surgeons (“AAOMS”) refers to ONJ that has allegedly resulted from bisphosphonate use as bisphosphonate-related osteonecrosis of the jaw and defined three requirements for its occurrence:
1. Current or previous treatment with a bisphosphonate
2. Exposed bone in the maxillofacial region that has persisted for more than 8 weeks
3. No history of radiation therapy to the jaws
Salvatore Ruggiero, et al., AAOMS Position Paper on Bisphosphonate–Related Osteonecrosis of the Jaws–2009 Update, J. Oral Maxillofacial Surgery, at 3 (2009) (hereinafter “ AAOMS 2009 Position Paper ”). The Plaintiffs' are primarily proceeding on strict products liability, negligence, and breach of implied warranty claims against Novartis, predicated on its alleged failure to warn of the risks associated with Aredia and Zometa.
On May 24, 2006, the Plaintiffs' cases against Novartis were consolidated with similar cases pursuant to the Multi–District Litigation Act and transferred to United States District Judge Todd J. Campbell in the Middle District of Tennessee (“the MDL court”). In the MDL court, Novartis filed two general summary judgment motions: (1) Motion for Summary Judgment Based upon a Failure of General Causation Proof under Daubert (“Causation Summary Judgment Motion”) and (2) Motion for Summary Judgment on the Adequacy of its Aredia and Zometa Warnings (“Warnings Summary Judgment Motion”). In conjunction with the summary judgment motions, Novartis filed Daubert motions to exclude the expert testimony of Dr. Keith Skubitz, Dr. James Vogel, Professor Wayne Ray, Ph.D. (“Prof. Ray”), Dr. Talib Najjar, Dr. Robert Marx (consisting of two separate motions, one to exclude his litigation-wide testimony and one to exclude his case-specific testimony in the Forman case), Dr. Suzanne Parisian, Dr. Robert Fletcher, Dr. Paul Hanson, Dr. John Hellstein, and the Plaintiffs' non-retained experts. The Plaintiffs' also filed Daubert motions, including one to exclude the testimony on the causation of BONJ by Novartis' oncologic experts.
By orders dated August 13, 2009, the MDL court denied both the Causation Summary Judgment Motion, In re Aredia and Zometa Prods. Liab. Litig. (“MDL Causation Order”), No. 06–MD–1760, 2009 WL 2497536 (M.D.Tenn. Aug. 13, 2009) and the Warnings Summary Judgment Motion, In re Aredia and Zometa Prods. Liab. Litig., No. 06–MD–1760, Docket # s 2766, 2767 (“ MDL Warnings Order ”). In addition, the MDL court either denied or denied in part and mooted in part Novartis' Daubert motions to exclude the expert testimony of Dr. Skubitz, Dr. Vogel, Dr. Najjar, and the litigation-wide and case specific testimony of Dr. Marx. Finally, the MDL court mooted in their entirety Novartis' motions to exclude the expert testimony of Dr. Hanson, Dr. Hellstein, Prof. Ray, Dr. Fletcher, Dr. Parisian, as well as the Plaintiffs' non-retained experts, and the Plaintiffs' motions to exclude the expert testimony on the causation of BONJ by Novartis' oncologic experts.
Following the resolution of these motions, on September 25, 2009, the MDL court remanded the Deutsch case and the Forman case back to this Court for trial. On December 16, 2009, the Court held a case management conference where it granted the parties' request to file Daubert motions on issues not previously decided by the MDL court. Subsequently, the parties filed the motions that are the subject of this decision. Specifically, Novartis filed Daubert motions to exclude the expert testimony of (1) Dr. Skubitz, (2) Dr. Vogel, (3) Dr. Marx, (4) Prof. Ray, (5) Dr. Fletcher, (6) Dr. Parisian, (7) Plaintiffs' non-retained experts with regard to causation, (8) Dr. Hanson, and (9) Dr. Hellstein. The Plaintiffs' filed (10) a Daubert motion to exclude testimony on causation of BONJ by Novartis' oncologic experts and (11) a motion to unseal documents.
As an initial matter, the Plaintiffs' have stipulated that Drs. Hanson and Hellstein will not testify at trial and therefore the Court will not address those motions. In addition, Novartis has stipulated to unseal certain documents (Calhoun Decl. Unseal Motion, Ex. 1), and to resubmit redacted versions of certain documents ( Id., Ex. 3) and therefore the motion to unseal with respect to those documents is moot. With regard to the remaining documents subject to the motion to unseal that the Plaintiffs' contend were improperly designated pursuant to the parties' protective order, the Court denies the Plaintiffs' request without prejudice to file the motion before United States Magistrate Judge William D. Wall.
The present motions seek to either exclude certain experts entirely or certain lines of expert testimony for failing to satisfy the requirements of Federal Rule of Evidence 702 (“Rule 702”). Rule 702 provides that:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
Fed.R.Evid. 702. As articulated by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), Rule 702 “clearly contemplates some degree of regulation of the subjects and theories about which an expert may testify” and “assign[s] to the trial judge the task of ensuring that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand.” As the Supreme Court further explained in Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999), Rule 702 requires that a court fulfill this “gatekeeping” function by “mak[ing] 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.”
To determine whether expert testimony is admissible, the court must consider whether (1) the witness is qualified as an expert to testify as to a particular matter; (2) the witness has based his opinion upon reliable data and methodology; (3) the expert's testimony on the particular subject is relevant because it will assist the trier of fact; and (4) pursuant to Rule 403 the testimony's “probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.” Nimely v. City of New York, 414 F.3d 381, 397 (2d Cir.2005) (quoting Fed.R.Evid. 403).
To be qualified to testify as an expert under Rule 702, the Court must be satisfied that “the expert's...
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