Davids v. Novartis Pharms. Corp.

• Citation: 977 F.Supp.2d 171
• Decision Date: 09 October 2013
• Docket Number: No. 06–CV–431 (ADS)(WDW).,06–CV–431 (ADS)(WDW).
• Parties: Barbara DAVIDS, Plaintiff, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.
• Court: U.S. District Court — Eastern District of New York

977 F.Supp.2d 171

Barbara DAVIDS, Plaintiff,
v.
NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.

No. 06–CV–431 (ADS)(WDW).

United States District Court,
E.D. New York.

Oct. 9, 2013.

[977 F.Supp.2d 172]

Valad & Vecchione, PLLC, by: Bart T. Valad, Esq., John J. Vecchione, Esq., Of Counsel, Fairfax, VA, for the Plaintiff.

[977 F.Supp.2d 173]

Terrence J. Sweeney, Esq., New York, NY, for the Plaintiff.

Lally & Misir, LLP, by: Demorah N. Misir, Esq., Of Counsel, Mineola, NY, for the Plaintiff.

Hollingsworth LLP, by: Anne Marla Friedman, Esq., Bruce J. Berger, Esq., Jared Wiesner, Esq., Katharine R. Latimer, Esq., Robert E. Johnston, Esq., Of Counsel, Washington, D.C., for the Defendant.

Rivkin Radler LLP, by: Jesse J. Graham, II, Esq., David Richman, Esq., Of Counsel, Uniondale, N.Y., for the Defendant.

MEMORANDUM OF DECISION AND ORDER
SPATT, District Judge.

On February 1, 2006, Barbara Davids (“Davids”) initiated this action against Novartis Pharmaceuticals Corporation (“Novartis” or the “Defendant”), alleging that the Defendant's drug Zometa caused her to develop a condition referred to as bisphosphonate-related osteonecrosis of the jaw (“BRONJ”). In this regard, Davids brought causes of action for (1) strict products liability; (2) breach of implied warranty; and (3) negligence. On October 4, 2012, a jury trial was commenced and approximately one month later, on November 2, 2012, the jury returned a verdict finding the Defendant liable under all three causes of action and awarding Davids (1) $350,000 in compensatory damages for Davids's injuries and her pain and suffering incurred to the present date; (2) $100,000 in compensatory damages for the Davids's injuries and her pain and suffering to be incurred in the future; and (3) punitive damages in the amount of $10,000,000.

Presently before the Court are four post-trial motions. First, the Defendant moves for a mistrial based on the allegation that the jury was provided material extrinsic to the proceedings in open court, namely a dictionary definition of the word “wanton.” Second, the Defendant moves to reduce the punitive damages award. Third, the Plaintiff moves to alter or amend the judgment under Federal Rule of Civil Procedure (“Fed. R. Civ.P.”) 59(e), or in the alternative, Fed.R.Civ.P. 58, to include appropriate interest. Lastly, the Plaintiff moves to substitute Davids's son, Ian Newman (“Newman”), as the Plaintiff in this case, as Davids died after the trial of this action. This last motion is unopposed.

As a preliminary matter, the Court grants the Plaintiff's unopposed motion to substitute Newman, in his capacity as Executor of Davids's estate, as the Plaintiff in this action. The caption is amended as follows:

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
	X
IAN NEWMAN, in his capacity as Executor of the estate
of BARBARA DAVIDS,

Plaintiff,

-against-

NOVARTIS PHARMACEUTICALS CORPORATION,

Defendant.

X

[977 F.Supp.2d 174]

The Court will now proceed to rule on the remaining motions.

I. BACKGROUND A. Factual Background

The Court assumes the parties' familiarity with the facts in this case and will thus only recount those portions of the trial relevant to the present motions.

In August of 2001, Davids was diagnosed with Stage I breast cancer. As part of her cancer treatment, in October 8, 2003, after Davids's cancer metastasized to her bones, her oncologist, Dr. Eileen Sheehy–Milano (“Dr. Sheehy–Milano”), began infusing her with Zometa, an intravenous bisphosphonate drug manufactured by the Defendant and approved by the FDA. Zometa is prescribed to patients with, among other conditions, certain kinds of cancer that have metastasized to the bones. However, Davids alleged that Zometa caused her to develop BRONJ, which is a certain type of osteonecrosis of the jaw (“ONJ”) related to bisphosphonates. ONJ is a bone disease that causes damage or death to areas in the jaw bone.

In this regard, Davids claimed that (1) the warnings for the Zometa she used were inadequate with regard to ONJ, which the Defendant knew or reasonably should have known about at the times at issue; (2) the failure to give an adequate warning was a substantial factor in bringing about Davids's ONJ; (3) the Defendant breached its implied warranty of merchantability in that the warnings on the Zometa used by Davids were not adequate for the ordinary and regular use of the product; (4) the breach of implied warranty was a substantial factor in bringing about her injuries from ONJ; (5) the Defendant was negligent in that it failed to provide an adequate warning with respect to the relationship between Zometa and ONJ; and (6) the Defendant's negligence in failing to give an adequate warning was a substantial factor in causing the injuries to Davids. At trial, the jury found that Davids proved all of these claims and awarded Davids a total of $450,000 in compensatory damages.

The jury also found that Davids proved that the Defendant knowingly withheld or misrepresented information and warnings required to be submitted under the Food and Drug Administration's (“FDA”) regulations, as to the relationship between Zometa and ONJ, and that this information and warnings were material and relevant with regard to Davids's injuries. It further found that Davids proved that the injury, loss or harm she suffered was the result of the Defendant's acts or omissions with regard to inadequate warnings and that the conduct of the Defendant was in wanton and willful disregard of Davids' rights. As such, the jury awarded the Plaintiff $10,000,000 in punitive damages.

At the trial, evidence was presented indicating that in April of 2002, Dr. Salvatore Ruggiero (“Dr. Ruggiero”) contacted the Defendant concerning bisphosphonates and osteonecrosis, but the Defendant took no action. Again, in July of 2002, Dr. Ruggiero contacted the Defendant and informed it that he had patients with BRONJ. In response, the Defendant sent Dr. Ruggiero a form letter, but did not conduct a formal investigation.

On December 5, 2002, an investigator for the Defendant attended a Harrigan Society presentation with regard to Dr. Ruggiero's BRONJ patients. Also in December of 2002, Dr. Cesar Migliorati, D.D.S. (“Dr. Migliorati”), sent the Defendant three cases involving BRONJ and Zometa, which it then forwarded to the FDA. In addition, Dr. Regina Landesberg

[977 F.Supp.2d 175]

(“Dr. Landesberg”) sent the Defendant information about a number of cases involving patients that had half of their upper jaw bones removed apparently as a result of the Defendant's drugs. These cases were similar to the ones Dr. Ruggiero had filed with the FDA and had been trying to bring to the Defendant's attention since April of 2002. However, the Defendant ignored Dr. Landesberg's information for about a month.

Dr. Richard Kraut (“Dr. Kraut”), the Defendant's expert and Chairman of the Department of Dentistry at Montefiore Medical Center in the Bronx, also attended Dr. Ruggiero's Harrigan Society presentation. Following the presentation, Dr. Kraut returned to his hospital, where he informed the staff to look for ONJ caused by bisphosphonates. To that end, the hospital mailed a survey to approximately 450 patients who were on bisphosphonates to investigate the existence of any connection between bisphosphonates and ONJ. Ultimately, in response to BRONJ, the hospital altered its treatment protocols.

In January of 2003, Dr. Ruggiero filled out an Adverse Event for the Defendant and advised the Defendant that he had filled out MedWatch forms, which he submitted to the FDA. However, in February of 2003, the Defendant decided to delay investigating Dr. Ruggiero's cases due to concerns it had about the impact such a large number of cases would have on health authorities. Rather, the Defendant suggested that tooth extractions and chemotherapy, rather than bisphosphonates, may be the cause of ONJ in patients taking Zometa.

Thereafter, in March of 2003, the Defendant received pages from a 2002 textbook published by Dr. Robert Marx (“Dr. Marx”) which described how BRONJ was caused by another bisphosphonate called Aredia. According to Dr. Marx, in 2003, such a finding that ONJ could be related to bisphosphonates was new and unexpected. However, the Defendant did not attempt to contact Dr. Marx. Thereafter, on May 1, 2003, the Defendant found that Dr. Ruggiero's reports on the connection between Aredia and osteonecrosis were not an urgent emergency that required immediate action.

The next day, on May 2, 2003, Stefano Fratarcangeli, an employee of the Defendant, circulated to Senior Management his action steps to take in response to a forthcoming publication on BRONJ that was being prepared by Dr. Ruggiero. These action steps included preventing the publication of Dr. Ruggiero's article and providing a strong case demonstrating no cause/effect relationship between bisphosphonates like Aredia and Zometa and osteonecrosis. Also that day, another employee of the Defendant, Peter Tarassoff, reported on a plan to approach Dr. Ruggiero.

In June of 2003, the Defendant expressed concern regarding attention being brought to the apparent link between Zometa and BRONJ, because the Defendant had not proffered alternative explanations demonstrating that BRONJ could not be caused by drugs. In this regard, the Defendant wished to negate any causation between BRONJ and Zometa by implicating chemotherapy and systematic risk factors. About this time, Dr. Marx called the Defendant to discuss his cases. At the Defendant's request, Dr. Marx completed the Defendant's Adverse Event Form. He also invited the Defendant to his clinic to observe some of his BRONJ patients. However, even after observing three of Dr. Marx's BRONJ patients, the Defendant still insisted that Zometa was not the cause of the problem. In fact, the Defendant even criticized Dr. Marx's findings when talking to an oncologist from Florida.

[977 F.Supp.2d 176]

Dr. Marx also sent a “Letter to the Editor” concerning BRONJ that...