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Karleen Hogan, Surviving Spouse and Executor of the Estate of v. Novartis Pharmaceuticals Corporation

August 23, 2011


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


The parties have filed a significant number of motions in limine. This decision disposes of the motions that the parties have advised the Court continue to be disputed, and it grants, in part, defendant's motion to exclude the testimony of one of plaintiff's experts, while limiting the testimony of the other two.


Before the Court are the parties' motions in limine, including defendant's motion to exclude testimony of plaintiff's experts pursuant to Rule 702 of the Federal Rules of Evidence and Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Familiarity with the underlying proceeding is presumed. Although plaintiff pled other causes of action in the complaint, according to the Joint Pretrial Order (JPTO), she is now pursuing only two common law claims: breach of implied warranty and failure to warn of the risk of developing osteonecrosis of the jaw ("ONJ") from defendant's intravenous drug, Zometa.

In short, plaintiff's theory of the case, as articulated by counsel at the Final Pretrial Conference (hereinafter "Conference"), is that defendant knew or should have known about the risk of developing bisphosphonate-induced ONJ ("BONJ") before June, 3 2005 -- the date that Timothy Hogan's doctors temporarily halted the Zometa infusions because they concluded that it was contributing to his jaw condition. According to plaintiff, if a proper warning had been given any time before March 4, 2003, when Hogan began the infusions, his oncologist, Dr. Pryzgoda, would not have recommended Zometa or at least would have referred Hogan for a dental examination. The examination would have in turn obviated the need to remove teeth while receiving Zometa, thereby decreasing the risk of developing BONJ. A proper warning after March 4, 2003, goes the theory, would have led Dr. Pryzgoda to insist that the therapy be stopped. Additionally, plaintiff claims that had Hogan's dentists and oral surgeon, Dr. Brown, been on notice about ONJ, they would have prevented Dr. Brown from extracting Hogan's teeth.


I. Plaintiff's Experts

A. Dr. Suzanne Parisian

Unclear under this articulation of the case is where Dr. Suzanne Parisian's testimony fits. Plaintiff has offered Dr. Parisian as a "regulatory expert to opine on regulatory and labeling issues . . . to testify on these issues under federal law." Her 120-page report discusses: (1) the "role, process and functions" of the FDA and the responsibilities of pharmaceutical drug sponsors within the FDA's regulatory framework; (2) defendant's conduct regarding the FDA's approval process for Zometa, and its predecessor, Aredia; (3) defendant's investigation and interactions with the FDA; and (4) defendant's communication of ONJ's risks to health care providers. Describing her role in this litigation, Dr. Parisian stated that, "I'm here not as . . . the expert in Aredia and Zometa. I am here as the expert on FDA issues involving Aredia and Zometa."

As both she and plaintiff's counsel articulate it, most of her testimony is irrelevant to the present action. See Fed. R. Evid. 402; see also Daubert, 509 U.S. at 597 (holding that Rule 702 of the Rules of Evidence requires the Court to ensure that the expert's testimony is not only reliable but also "relevant to the task at hand"). Plaintiff has not asserted a federal claim for violating FDA regulations and fails to mention them anywhere in her pleading. Even her opposition to defendant's motion for summary judgment before the MDL Court failed to raise the regulations to suggest that they informed her state law claim. See Restatement (Third) of Torts: Products Liability § 4(b).

More importantly, the JPTO -- describing the claim in common law terms only -- makes no such disclosure, and at the Conference, plaintiff's counsel declined the Court's invitation to identify an FDA regulation that required certain information to have been on Zometa's label that would bear on plaintiff's common law claims. Counsel only confirmed that plaintiff is "not claiming there is some per se violation of the regulations;" that defendant's duty to warn comes exclusively from the common law; and that in fact he would prefer to keep federal law out of the case but feels compelled to include an expert on the regulations because one of the defenses seems to be compliance with the FDA.*fn1

Plaintiff cannot have her cake and eat it too; she cannot bring common law claims not grounded in FDA regulations only to present an expert to opine on whether defendant violated those regulations. By the same token, the Court will not permit defendant to litigate the case in the shadow of the FDA. This action is past the summary judgment stage where defendant appeared to have abandoned its preemption defense, and both of its defenses presented in the JPTO are based on causation rather than any contention that the FDA regulations forced defendant to discharge its common law duty in a way that made it impossible to comply with state law. See Wyeth v. Levine, 129 S. Ct. 1187, 1199-204 (2009) (holding that despite the FDA's observation that states' failure-to-warn claims threaten its role in the approval process of labeling, FDA regulations do not preempt state law); Mason v. Smithkline Beecham Corp., 596 F.3d 387, 391 (7th Cir. 2010) (observing that after Wyeth, the manufacturer must provide clear evidence that the FDA would have rejected the proposed change in the drug's label before a common law failure-to-warn claim is preempted). Nor has defendant claimed that as a matter of state law, defendant's purported compliance with FDA regulations precludes a judgment in favor of plaintiff. See In re Methyl Tertiary Butyl Ether Prods. Liab. Litig., 438 F. Supp. 2d 291, 301 (S.D.N.Y. 2006) ("In general, while Congressional regulation is relevant to tort liability, it is not dispositive."); Restatement (Third) of Torts: Products Liability § 4 cmt. e. ("most product safety statutes or regulations establish a floor of safety below which product sellers fall only at their peril, but they leave open the question of whether a higher standard of product safety should be applied"). Thus, as the parties agreed at the Conference, the FDA is mostly irrelevant to this action.

Reaffirming the Court's observation at the Conference, any evidence or testimony discussing the FDA, its regulations, and upcoming meetings, will not be admitted without independent probative value; evidence that reveals nothing more than responsiveness to the FDA is irrelevant. The Court may, of course, permit evidence that tends to show the extent of defendant's knowledge (or lack thereof) of BONJ or the initial letters to the FDA proposing a labeling change, which is one way that pharmaceutical companies provide warnings.*fn2

I recognize that under Rhode Island law, in determining whether defendant exercised its duty to warn, it will be "held to an expert standard of care." Castrignano v. E.R. Squibb & Sons, 546 A.2d 775, 782 (R.I. 1988) (emphasis added). Defendant may therefore show that it "carefully monitor[ed] the new developments and research that pertain[ed]" to Zometa. Id. at 782-83. To that end, expert testimony on the topic of pharmacovigilance may help the jury understand what pharmaceutical companies generally do to anticipate and prevent adverse drug reactions.

The Court has considered whether Dr. Parisian is qualified to testify on this topic under the rather flexible standard test set out by the Second Circuit. See Stagl v. Delta Air Lines, Inc., 117 F.3d 76 (2d Cir. 1997); see also In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (Weinstein, J.) ("If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.").*fn3 Even under this test, however, Dr. Parisian is not qualified.

Dr. Parisian's curriculum vitae, as Judge Spatt observed in a case that was part of the same multidistrict litigation, is dominated by a specific type of work: "[a]lthough briefly a general practitioner, Dr. Parisian's work experience has primarily been with regulatory agencies." Deutsch v. Novartis Pharms. Corp., No. 09-CV-4677, 2011 U.S. Dist. LEXIS 22755, at *122-23 (E.D.N.Y. Mar. 8, 2011). This experience has included a stint as a Medical Officer with the FDA's Offices of Health Affairs and Device Evaluation. Since leaving the FDA in 1995, Dr. Parisian has been consulting different entities and individuals regarding FDA requirements. Yet she has never worked for a pharmaceutical company -- although she consults them regarding FDA regulations -- and while at the FDA, was never part of the Center for Drug Evaluation and Research.

Given this background, I find that she is unqualified to opine on the potentially relevant testimony she offers in her report regarding pharmaceutical companies' internal operating procedures and other standards with which she claims manufacturers voluntarily elect to comply. See Deutsch, 2011 U.S. Dist. LEXIS 22755, at *138 (excluding Dr. Parisian's testimony regarding what a "reasonable manufacturer would do" and "industry standards" because she "has never worked at a pharmaceutical company or with a pharmaceutical company outside of her interactions with companies involved in FDA processes"). The jury would be assisted by an expert who could explain how pharmaceutical companies test their drugs and collect data; as an expert, however, Dr. Parisian, could testify only to what the FDA requires. Accordingly, Dr. Parisian's testimony is excluded in its entirety.

I am mindful that without Dr. Parisian and defendant's mention of its efforts to cooperate with the FDA, the jury will be operating in a universe that is devoid of the heavy regulatory framework that affects the development and marketing of pharmaceutical products. Nevertheless, I find that the benefits of excluding this evidence outweighs its costs; the Court's review of the submitted exhibits and Dr. Parisian's report reveal that some of the battlegrounds the parties have chosen are simply not the ones pled in the complaint or stated in the JPTO. And as the parties seem to agree at the Conference, even if the FDA's role in this litigation were properly described, it would be a side show; if the Court allowed Dr. Parisian to testify, the side show would turn into the main event. Thus, the jury's task will be a narrow one and involve the application of state law only.

B. Dr. Robert Marx

Dr. Robert Marx is a board-certified oral and maxillofacial surgeon. He has particular expertise in bone diseases, was among the first to identify BONJ in one of his textbooks, and has treated dozens of patients with ONJ. Dr. Marx contacted defendant in 2003 to discuss what appeared to him to be BONJ cases. But his cooperation with defendant ended when his corroboration with defendant on an academic article went sour, and he concluded that defendant was "not taking responsibility for complications caused by [its] products." Plaintiff has offered him primarily as a causation and treatment expert, to testify whether bisphosphonate drugs like Zometa can cause a unique form of ONJ (BONJ), whether Hogan had BONJ, and what steps can be taken to prevent and treat this condition.

The MDL Court has already found Dr. Marx qualified to opine on general and specific causation as well as on treatment and preventive measures for ONJ. The objections before me are based on testimony that the MDL Court did not address. Specifically, defendant seeks to exclude Dr. Marx's opinion and supporting testimony that defendant's efforts in manipulating publication of an article discussing ONJ "demonstrated bad faith." Defendant also argues that Dr. Marx cannot reliably testify whether any patients in the Zometa clinical trials conducted by defendant had BONJ, and that he lacks expertise in designing trials to opine on whether they were flawed.

Plaintiff did not request punitive damages in her case, and after the MDL Court remanded the case, plaintiff confirmed on the record through counsel that she is not seeking them. Additionally, the Court bifurcated the trial, and the instant submissions are for the liability stage only. As a result, testimony of bad faith conduct is excluded as irrelevant. See Fed. R. Evid. 402. To minimize dispute at trial about the breadth of this exclusion, I note that aside from mentioning what literature was available to defendant on the topic -- testimony to which defendant does not appear to object -- the Court will also ...

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