Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Barbara Davids v. Novartis Pharmaceuticals Corporation

April 19, 2012

BARBARA DAVIDS PLAINTIFF,
v.
NOVARTIS PHARMACEUTICALS CORPORATION, DEFENDANT.



The opinion of the court was delivered by: Spatt, District Judge.

MEMORANDUM OF DECISION AND ORDER

Barbara Davids ("Ms. Davids" or "the Plaintiff") commenced this products liability action against Novartis Pharmaceuticals Corporation ("Novartis", "NPC", or "the Defendant"), alleging that the Novartis drug Zometa caused her to develop a condition referred to as bisphosphonate-related osteonecrosis of the jaw. Presently before the Court are seven Daubert motions by Novartis to exclude testimony by the Plaintiffs' retained and non-retained experts and a motion by Novartis for summary judgment dismissing the Plaintiff's complaint pursuant to Federal Rule of Civil Procedure 56. The Court now rules on all of these motions.

I. BACKGROUND

A. Factual Background

In August of 2001, Barbara Davids was diagnosed with Stage I breast cancer. Initially, Dr. Sheehy-Milano, Ms. Davids's oncologist, prescribed a number of treatments, including Cytoxan, Methotrexate, chemotherapy, radiation therapy, cortiscosteroids, and hormonal therapy. In 2001, Dr. Anthony Ardito, Ms. Davids's primary care physician, prescribed weekly Fosamax to treat Ms. Davids's osteoporosis. Fosamax is an oral bisphosphonate drug manufactured by Merck, which is also alleged to be linked to the development of osteonecrosis of the jaw.

In September of 2003, Ms. Davids's cancer metastasized to her bones and Dr. SheehyMilano prescribed a drug called Femara. Subsequently, beginning on October 8, 2003, Dr. Sheehy-Milano began infusing Ms. Davids with Zometa, an intravenous bisphosphonate drug manufactured by the defendant Novartis Pharmaceuticals Corporation.

Zometa is a bisphosphonate prescribed to patients with, among other conditions, certain kinds of cancer that have metastasized to the bones. Zometa may reduce or delay bone fractures or pressure on the spinal cord that can result from bone damages from these advanced cancers. It is prescribed by oncologists to limit and, according to Novartis, prevent, the harmful effects of disease induced bone loss, including debilitating skeletal events such as bone fractures or spinal cord compression. The parties greatly dispute whether Zometa is the "standard of care" in medicine to treat bone cancers, and whether Zometa has been shown to slow the spread of the underlying cancer itself.

In February 2002, the Food and Drug Administration ("FDA") approved Zometa as safe and effective to treat multiple myeloma and bone metastases from solid tumors. Although the FDA also approved the label information for Zometa, the parties dispute whether Novartis knew of and withheld information from the FDA, namely, that certain users of Zometa were at risk of developing a condition called osteonecrosis of the jaw ("ONJ"). Osteonecrosis of the jaw is a type of bone disease that causes damage or death to areas in the jaw bone. Ms. Davids alleges that she has developed a type of ONJ referred to as bisphosphonate-related osteonecrosis of the jaw ("BRONJ").

It is undisputed that Zometa remains on the market as an FDA-approved drug, with labeling approved by the FDA. However, the Plaintiff argues that this is only true to the extent that the FDA has required stronger safety information regarding ONJ, and the removal of false language placed on the label by Novartis regarding "well documented" risk factors.

Ms. Davids received Zometa infusions from Dr. Sheehy-Milano approximately once a month between October of 2003 and January 2005. Her last infusion was on January 6, 2005. During this time, Dr. Sheehy-Milano also treated Ms. Davids for anemia; took her off Femara; prescribed Faslodex; and Ms. Davids underwent additional radiation therapy.

Relevant to the instant case is Ms. Davids's dental history, and the extent to which her pre-existing dental problems contributed to her development of osteonecrosis of the jaw and/or the decisions by her doctors to prescribe Zometa. Dr. Perry Perzov has been Ms. Davids's general dentist since 1989, although Ms. Davids admits to having a history of periodontal disease in the five years preceding her treatment by Dr. Perzov. On November 11, 1995, Dr. Perzov extracted Ms. Davids's tooth # 17. In addition, prior to Ms. Davids's diagnosis of breast cancer in 2001, Dr. Perzov treated Ms. Davids for symptoms relating to the lower right mandible and upper right maxilla with periapical pathology associated with tooth #5; food trapping between teeth # 18, #19, and #20; and a loose tooth, #29 with complete bone loss.

On July 1, 2003, three months before beginning Zometa, Ms. Davids visited Dr. Perzov and had a dental examination at which Dr. Perzov made adjustments to Ms. Davids's teeth numbers 19 and 20. At that time, Dr. Perzov noted that Ms. Davids was "OK" with "aesthetics" and "comfort". Ms. Davids continued to visit Dr. Perzov throughout the time she was being treated with Zometa by Dr. Sheehy-Milano and Fosamax by Dr. Ardito. In July 2004, while still being treated with Zometa and Fosamax, Dr. Perzov extracted teeth #6, #7, #8, #9, # 10, and #11 in the upper jaw ("maxilla"), which healed without incident, and he fitted Ms. Davids for a full upper denture.

In November 2004, Ms. Davids complained to Dr. Perzov of soreness and pain in her left lower jaw ("mandible"). Upon inspection, Dr. Perzov discovered a 2.5mm diameter lesion and a bony spicule on the lingual mucosa in the area of tooth #17, which he removed. After the area failed to heal, Dr. Perzov referred Ms. Davids to Dr. Leonard Hoffman, an oral and maxillofacial surgeon. According to Ms. Davids, and highly disputed by Novartis, the procedure to remove the bony spicule in 2004 triggered Ms. Davids's BRONJ.

On January 5, 2005, Ms. Davids met with Dr. Hoffman, and presented with a three month history of exposed bone from the front of her mouth to tooth #18. On January 12, 2005, Dr. Hoffman prescribed Clindamycin as treatment. It is undisputed, that at some point in 2003 and 2004, Dr. Hoffman learned anecdotally about a "possible" association between ONJ and bisphosphonate drugs such as Zometa and Fosamax from Dr. Salvatore Ruggiero. Ms. Davids disputes the characterization of "possible" as misleading. Based on the anecdotal evidence of a relationship between bisphosphonates and ONJ, as well as his examination of Ms. Davids, Dr. Hoffman diagnosed Ms. Davids with BRONJ.

On January 11, 2005, after consulting with Dr. Hoffman about the Plaintiff's jaw problems, Dr. Sheehy-Milano decided to end Ms. Davids's Zometa prescription. Although Ms. Davids discontinued her injections of Zometa, she continued to receive weekly Fosamax therapy as prescribed by Dr. Ardito until June of 2006. Following the discontinuance of Zometa, Dr. Sheehy-Milano has prescribed a number of different drugs and therapies to treat Ms. Davids's cancer, which has spread to other sites in her bones.

In addition to treatment by Dr. Hoffman, following the discontinuance of Zometa, Ms. Davids was also treated for her jaw problems by another oral and maxillofacial surgeon, Dr. Ronald Schneider. Following Dr. Schneider's retirement, beginning in October 2007, Ms. Davids began visiting with Dr. Salvatore Ruggiero to continue treatment of her jaw problems.

Dr. Ruggiero diagnosed Ms. Davids with Stage III BRONJ, which is the most advanced form of the disease.

On February 2, 2006, the Plaintiff commenced this lawsuit against Novartis, alleging that Zometa caused her to develop BRONJ. The Third Amended Complaint in this action seeks compensatory damages under the theories of: (1) strict liability; (2) negligent manufacture; (3) negligent failure to warn; (4) breach of express warranty; and (5) breach of implied warranty. The Plaintiff also seeks punitive damages. In addition to the current lawsuit, the Plaintiff has filed a lawsuit against Merck, the manufacturer of Fosamax. See Davids v. Merck & Co., Inc., No. 06-CV-13401 (S.D.N.Y. Nov. 20, 2006).

B. Procedural History and Prior Decisions

This is the third case to come before this court by a plaintiff who allegedly developed bisphosphonate-related osteonecrosis of the jaw from the use of an intravenous-bisphosphonate drug manufactured by Novartis ("the Davids case"). The other two cases were Deutsch v. Novartis Pharmaceuticals Corporation, No. 09-CV-4677 ("the Deutsch case"), and Forman v. Novartis Pharmaceuticals Corporations, No. 09-CV-4678 ("the Forman case"). All three of these cases were initially filed before this Court in 2006, and on May 24, 2006, 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").

1. The Deutsch case and the Forman case

In the MDL court, the Deutsch and Forman cases were part of what was known as "Wave I-A". In conjunction with the Wave I-A cases, the MDL court rendered decisions on : (1) Novartis's Motion for Summary Judgment Based upon a Failure of General Causation Proof under Daubert ("Causation Summary Judgment Motion"); (2) Novartis's Motion for Summary Judgment on the Adequacy of its Aredia and Zometa Warnings ("Warnings Summary Judgment Motion"); (3) the Daubert motions by Novartis 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 non-retained experts in the Deutsch and Forman cases; (4) the Daubert motions by the Deutsch and Forman plaintiffs' to exclude the testimony on the causation of BRONJ by Novartis's oncologic experts; (5) the Motion for Summary Judgment by Novartis in the Deutsch case; and (6) the Motion for Summary Judgment by Novartis in the Forman case.

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 the Daubert motions by Novartis 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 the motions by Novartis to exclude the expert testimony of Dr. Hanson, Dr. Hellstein, Prof. Ray, Dr. Fletcher, Dr. Parisian, as well as the Deutsch and Forman plaintiffs' non-retained experts, and the Deutsch and Forman plaintiffs' motions to exclude the expert testimony on the causation of BRONJ by the 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. Although the parties agreed that New York law governed the substantive causes of action, the parties disputed the applicable governing law as to the issue of punitive damages. On July 16, 2010, this Court issued a decision holding that New Jersey law applied to the issue of punitive damages. See Deutsch v. Novartis Pharms. Corp. ("Punitive Damages Order I"), 723 F. Supp. 2d 521 (E.D.N.Y. 2010).

Subsequently, 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) the Deutsch and Forman plaintiffs' non-retained experts, including Dr. Salvatore Ruggiero, with regard to causation, (8) Dr. Hanson, and (9) Dr. Hellstein. The Daubert motions with respect to Dr. Hanson and Dr. Hellstein were subsequently withdrawn on consent.

On March 8, 2011, this Court issued a fairly lengthy and detailed decision granting in part and denying in part Novartis's Daubert motions. See Deutsch v. Novartis Pharms. Corp. ("Deutsch Daubert Order"), 768 F. Supp. 2d 420 (E.D.N.Y. Mar. 8, 2011). Before addressing the substance of Novartis's motions, the Court held that it would "not decide any issues previously presented to and denied by the MDL court" and "to the extent Novartis' argue[d] that an opinion is inadmissible because it relies on a retrospective non-controlled study, the Court finds that these arguments go to the weight and not the admissibility of the opinions". 768 F. Supp. 2d at 429, 430. With respect to the motion by Novartis to exclude the testimony of Dr. Parisian, the Court held that, as to certain opinions, a Daubert hearing was necessary to determine their admissibility. The Court held the above-referenced Daubert hearing on April 11, 2011 and May 2, 2011. In a subsequent order dated June 22, 2011, the Court held that "Dr. Parisian's methodology is reliable and that there is no risk of prejudice to NPC by permitting her testimony". See Forman v. Novartis Pharms. Corp. ("Parisian Daubert Order"), 794 F. Supp. 2d 382, 383 (E.D.N.Y. 2011).

In addition, Novartis filed a motion in both the Deutsch and Forman cases seeking to prevent the plaintiffs from pursuing punitive damages on the grounds that: (1) federal law preempted the plaintiffs from obtaining punitive damages under the relevant New Jersey statutes; (2) the plaintiffs lacked standing to pursue punitive damages under the relevant New Jersey statutes; and (3) the plaintiffs' evidence was insufficient to raise a genuine issue of material fact as to whether they are entitled to punitive damages. On June 20, 2011, the parties in the Deutsch case entered into a stipulation of settlement on the record.

On June 27, 2011, the Court issued a decision only in the Forman case, finding that federal law did not preempt the plaintiff's right to pursue punitive damages under the relevant New Jersey statutes, and that the plaintiff did not lack standing to seek punitive damages. See Forman v. Novartis Pharms. Corp. ("Punitive Damages Order II"), 793 F. Supp. 2d 598 (E.D.N.Y. 2011). In addition, the Court reserved decision as to whether a genuine issue of material fact existed to permit an award of punitive damages.

Following two days of jury selection, on February 29, 2012, the parties in the Forman case entered in to a stipulation of settlement.

2.The Davids Case

Unlike the Deutsch case and the Forman case, the Davids case was part of what was known as Wave I-C in the MDL court. On April 8, 2011, the MDL court remanded the Davids case back to this Court, with a number of motions pending. On April 21, 2011, this Court issued an order dismissing the pending motions without prejudice and with leave to re-file in accordance with this Court's Individual Motion Practice Rules. (Docket Entry # 66.) The Court held a status conference on August 4, 2011, at which the Court authorized the parties to engage in limited damages discovery, and stated that Novartis had until November 7, 2011 to re-file any of the motions that had been previously pending before the MDL court.

On November 7, 2011, Novartis filed a motion for summary judgment seeking to dismiss the complaint in the Davids case in its entirety. Novartis also filed Daubert motions to exclude the testimony of the following experts who had previously been challenged in the MDL Court, as well as in the Deutsch and Forman cases: (1) Dr. Keith Skubitz; (2) Professor Wayne Ray; (3) Dr. Suzanne Parisian; (4) Dr. James Vogel; and (5) Dr. Robert Marx ("the Previously Challenged Experts"). The admissibility of the testimony of the Previously Challenged Experts was addressed by the MDL court, as well as in the Deutsch Daubert Order and Parisian Daubert Order. In addition, Novartis filed Daubert motions to exclude the expert testimony of Dr. Richard Kraut and the specific causation testimony of the Plaintiff's non-retained experts- including Dr. Salvatore Ruggiero, whose testimony on specific causation as a non-retained expert in the Deutsch case was addressed in the Deutsch Daubert Order.

Finally, both parties have submitted a number of motions in limine relating to issues that had not been previously pending before the MDL court. In particular, on March 12, 2012, Novartis filed a letter motion to preclude the Plaintiff's demand for punitive damages. This decision will only address those motions filed by Novartis on November 7, 2011, and in the following order: (1) the Daubert motions to exclude the Previously Challenged Experts; (2) the Daubert motion to exclude the expert testimony of Dr. Richard Kraut; (3) the Daubert motion to exclude the Plaintiff's non-retained experts; and (4) the motion for summary judgment. For the caselaw applicable to the Daubert motions, the Court refers the parties to the law set forth in the Deutsch Daubert Order.

II. DAUBERT MOTION TO EXCLUDE THE PREVIOUSLY CHALLENGED EXPERTS

Despite the clear, definitive rulings by both this Court and the MDL court, Novartis again moves to exclude the expert testimony in whole or in part of the following case-wide experts:

(1) Dr. Keith Skubitz; (2) Professor Wayne Ray; (3) Dr. Suzanne Parisian; (4) Dr. James Vogel; and (5) Dr. Robert Marx. In response, by letter dated November 15, 2011, the Plaintiff stated:

The Deutsch Daubert Order, issued by this Court, this year, on all these same experts, should simply be adopted. That is what precedent means. No fact in Ms. Davids' case makes anything the Court stated previously different or inapplicable. These witnesses are all case-wide experts. They have presented no case-specific opinions in Davids. (Pl.'s Opp. at 1.) The Plaintiff further noted that most of the courts addressing the admissibility of the Plaintiff's case-wide experts have substantially adopted this Court's decision in the Deutsch Daubert Order. Finally, the Plaintiff emphasized that the Defendant's attempt to reargue the motion to exclude the testimony of Dr. Suzanne Parisian is particularly egregious in light of the fact that the Court held a two day Daubert hearing on the admissibility of Dr. Parisian's testimony.

In a letter response dated November 15, 2011, the Defendant argued that re-submitting the above motions was necessary in order to preserve the issues for appeal. Further, with respect to the merits of the motions and their similarity to those decided ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.