Rowland v. Novartis Pharms. Corp.

• Decision Date: 31 March 2014
• Docket Number: Civil Action Nos. 2:12–CV–01474,2:12–CV–01476,2:12–CV–01715.
• Citation: 9 F.Supp.3d 553
• Parties: Karen ROWLAND, Plaintiff, v. NOVARTIS PHARMACEUTICALS CORP., Defendant. George Machen and Stacy Machen, Plaintiffs, v. Novartis Pharmaceuticals Corp., Defendant. Michelle Pratt Orr, Plaintiff, v. Novartis Pharmaceuticals Corp., Defendant.
• Court: U.S. District Court — Western District of Pennsylvania

9 F.Supp.3d 553

Karen ROWLAND, Plaintiff,

v.NOVARTIS PHARMACEUTICALS CORP., Defendant.

George Machen and Stacy Machen, Plaintiffs,

v.Novartis Pharmaceuticals Corp., Defendant.

Michelle Pratt Orr, Plaintiff,

v.Novartis Pharmaceuticals Corp., Defendant.

Civil Action Nos. 2:12–CV–01474, 2:12–CV–01476, 2:12–CV–01715.

United States District Court, W.D. Pennsylvania.

Signed March 31, 2014.

John J. Vecchione, Valad & Vecchione, PLLC, Fairfax, VA, David K. Lietz, Washington, DC, Joseph F. Butcher, Samantha Quinn, Daniel E. Krauth, Zimmer Kunz, Pittsburgh, PA, Philip Jeremy Miller, Daniel A. Osborn, Osborn Law, P.C., Russel Harrison Beatie, Jr., Russel Harrison Beatie, LLP, New York, NY, for Plaintiff.

Ethan D. Stein, Diane E. Lifton, Gibbons P.C., New York, NY, Jacqueline Mecchella Bushwack, Rivkin Radler, LLP, Uniondale, NY, Constantine J. Passodelis, Jeffrey Cohen, Michael R. Lettrich, Jonespassodelis PLLC, Pittsburgh, PA, Joe Gregory Hollingsworth, Spriggs & Hollingsworth, Robert E. Johnston, Donald W. Fowler, Neil S. Bromberg, Hollingsworth, L.L.P., Katharine Ruth Latimer, Washington, DC, for Defendant.

OPINION

MARK R. HORNAK, District Judge.

Plaintiffs Karen Rowland (“Ms. Rowland”), George Machen (“Mr. Machen”), Stacy Machen (“Mrs. Machen”), and Michelle Pratt Orr (“Mrs. Orr”) bring strict liability, negligence, and breach of warranty claims against the Defendant, Novartis Pharmaceuticals Corporation (“NPC”), alleging that they or their spouse developed a painful and permanently disfiguring condition as a result of using NPC's prescription medication for the purpose of managing metastatic bone cancer. Pending before the Court is a deluge of Daubert motions filed by NPC to exclude opinion testimony from Plaintiffs' retained experts and to exclude causation testimony from Plaintiffs' case-specific retained and non-retained experts (their “treating physicians”) under Federal Rule of Evidence 702 (“Rule 702”). Mrs. Orr has also filed a pending Daubert motion to exclude certain expert testimony from two of NPC's case-specific experts. The Court has carefully considered all of the parties' voluminous motions, briefs in support, responses, and reply briefs. It has the benefit of a multitude of rulings from its sister federal and state courts on virtually identical motions. All counsel are well-familiar with them. The Court has no independent reason to reinvent the wheel as to commonly raised, litigated, and decided issues in those regards, except as specifically stated herein. In attempting to avoid comparisons to Tolstoy ¹, the Court will now seek to rule succinctly on each of these motions.

I. BACKGROUND AND FACTS

The Court assumes the parties' familiarity with the factual background and wending procedural history of this case but will provide a brief review. These lawsuits involve Zometa, a Food and Drug Administration (“FDA”) approved intravenous bisphosphonate (“IV BP”) prescription drug designed, manufactured, marketed, distributed, and sold by NPC for patients with cancer that has metastasized to their bones. Rowland Compl. ¶ 6 (“RC”). Ms. Rowland received Zometa in conjunction with her treatment for metastatic breast cancer, Mr. Machen was prescribed Zometa in relation to his metastatic Stage IV–B Hodgkin's disease, and John Orr (“Mr. Orr”), Mrs. Orr's late husband ², received it relative to his treatment for metastatic Stage II multiple myeloma. Rowland v. Novartis Pharm. Corp., 983 F.Supp.2d 615, 2013 WL 6145119, at *1 (W.D.Pa. Nov. 22, 2013) (ECF No. 107 at 2–3). Plaintiffs allege that they developed osteonecrosis of the jaw (“ONJ”), a permanently disfiguring and painful condition that may result in complete loss of the jaw bone. RC ¶ 1. More specifically, they claim they developed a form of ONJ caused by IV BPs, interchangeably referred to by the parties as bisphosphonate-related ONJ (“BRONJ”), bisphosphonate-induced ONJ (“BIONJ”), or bisphosphonate ONJ (“BONJ”) ³, as a result of their Zometa use. Id. They bring claims for strict products liability, negligence, and breach of express and implied warranty against NPC on the basis that it failed to adequately warn of the risks associated with Zometa.

Ms. Rowland and the Machens originally filed suit in federal court in the District of Columbia. See RC, at 1 and Machen Compl. (“MC”), at ¶ 1. Mr. Orr initially filed suit in federal court in the Southern District of New York. See Orr Compl. (“OC”), at ¶ 1. All three cases were conditionally transferred to the Middle District of Tennessee (“the MDL court”) for coordinated pretrial proceedings pursuant to the Multi–District Litigation Act, 28 U.S.C. § 1407. ECF No. 4. Along with the summary judgment motions it filed in the MDL court, NPC filed Daubert motions to exclude, for purposes of summary judgment, the expert testimony of Dr. Keith Skubitz (“Dr. Skubitz”), Dr. James Vogel (“Dr. Vogel”), Prof. Wayne Ray (“Prof. Ray”), Dr. Robert Marx (“Dr. Marx”), Dr. Suzanne Parisian (“Dr. Parisian”), and Dr. Robert Fletcher (“Dr. Fletcher”) ⁴, among others. The MDL court either denied or denied in part and mooted in part NPC's Daubert motions to exclude the expert testimony of Dr. Skubitz, Dr. Vogel, and Dr. Marx. ECF Nos. 73–4, 75–2, and 81–2. The MDL court also mooted NPC's motions to exclude the expert testimony of Prof. Ray and Dr. Parisian. ECF Nos. 77–2, 79–2. The MDL court then remanded these cases to this Court. ECF No, 9. The Court granted the parties' request to file Daubert motions on issues not decided by the MDL court. Those motions ⁵, as well as several that were filed with but not decided by the MDL court ⁶, are the subject of this decision.

II. LEGAL STANDARD

Rule 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

Fed.R.Evid. 702. Rule 702 reflects “a liberal policy of admissibility.” Kannankeril v. Terminix Int'l, Inc., 128 F.3d 802, 806 (3d Cir.1997), The Court acts as a gatekeeper and must screen purportedly scientific evidence to ensure that any and all such proffered evidence is both relevant and reliable. Daubert v. Merrell Dow Pharm., 509 U.S. 579, 589, 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). In determining the admissibility of expert testimony, courts have categorized the Rule 702 requirements as (1) the expert's qualifications, (2) the reliability of the expert's methods, and (3) the “fit” of the expert's methods to the facts of the case (i.e., whether the expert's methods are helpful to the fact finder).

See Schneider ex rel. Estate of Schneider v. Fried, 320 F.3d 396, 404 (3d Cir.2003) (quoting In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir.1994)).

Qualification “refers to the requirement that the witness possess specialized expertise.” Schneider, 320 F.3d at 404. “A broad range of knowledge, skills, and training qualify an expert.” Paoli, 35 F.3d at 741. An expert's opinion is reliable if it has “good grounds” in scientific methods and procedures and is not based on “subjective belief or unsupported speculation.” Id. at 742. The reliability inquiry is flexible and focuses “on principles and methodology, not on the conclusions they generate.” Daubert, 509 U.S. at 594–95, 113 S.Ct. 2786. Finally, an expert's testimony “fits” the issues in the case when it provides “a valid scientific connection to the pertinent inquiry.” Id. at 591–92, 113 S.Ct. 2786.

III. DISCUSSIONA. Dr. Robert Marx

Dr. Marx is a board certified oral and maxillofacial surgeon and a Professor of Surgery and Chief of the Division of Oral and Maxillofacial Surgery at the University of Miami Miller School of Medicine. ECF No. 73–2 at 2. Among his many qualifications listed in the record, see id., 2–93, Dr. Marx is well-known for helping to recognize BRONJ and notify NPC of its existence and for co-authoring the medical literature that first identified and described BRONJ. Id. NPC seeks to exclude Dr. Marx's opinions as to four issues: (1) whether certain patients in the Aredia/Zometa ⁷ clinical trials had BRONJ; (2) general ONJ causation based on adverse event reports that Dr. Marx did not review; (3) the biological mechanism by which IV BP drugs allegedly cause ONJ; and (4) whether pre-Zometa dental treatment measures reduce the risk of BRONJ.⁸

1. Occurrence of BRONJ in Clinical Trials

With the exception of one case ⁹, federal district courts that have ruled on Daubert motions in this Multi–District Litigation (“Zometa courts”) have consistently allowed Dr. Marx to opine that several patients in the Aredia/Zometa clinical trials likely had BRONJ.¹⁰ Additionally, the MDL court held such testimony from Dr. Marx to be admissible. ECF No. 73–4. Under the law of the case doctrine, a transferee court such as this one is prohibited from vacating the order of the MDL court except in extraordinary circumstances that are not present here. In re Pharmacy Benefit Mgrs. Antitrust Litig., 582 F.3d 432, 439 (3d Cir.2009). The Court concurs with the rulings of the Zometa courts and recognizes the MDL court's prior ruling in concluding that NPC's concerns as to the strength and accuracy of Dr. Marx's conclusions may be properly addressed on cross-examination.

2. General Causation Opinion Based on Adverse Event Reports

All Zometa courts that have ruled on Dr. Marx's general causation testimony—based on adverse event reports submitted to the FDA or NPC about patients who allegedly developed ONJ after being treated with Zometa—have held his opinion admissible.¹¹ The MDL Court also ruled that Dr. Marx's opinion on that issue was admissible, a...