MALACHY E. MANNION, District Judge.
Pending before the court are defendant Novartis Pharmaceuticals Corporation's ("NPC") motions, brought pursuant to
Throughout the country, cancer patients who have been treated with two of NPC's drugs, and who have afterwards developed osteonecrosis of the jaw, a debilitating and painful disease in which the jaw bone becomes exposed, have sued in products liability actions. In each of these cases, NPC has objected to the testimony of plaintiff's experts on varying grounds. The courts have agreed with NPC's objections to varying degrees, generally allowing the experts to testify while limiting the testimony in specific respects. This court follows the same course.
Aredia® and Zometa® are two FDA-approved drugs, called intravenous bisphosphonates ("BP"), manufactured by Novartis. The drugs are administered for treatment of advanced cancers which affect the bones. Plaintiff John Bartoli was treated with Aredia® and Zometa® for multiple myeloma.
This case is a pharmaceutical products liability action in which plaintiff brings claims for strict products liability, negligence, and breach of warranty. (Doc.
Several litigation-wide experts, whose testimony is at issue here, were retained by the various plaintiffs whose cases were consolidated in the MDL. NPC challenged their testimony during the MDL and continues to challenge the testimony in all of the MDL cases which have been remanded for trial to various districts across the country.
The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which requires an expert witness to have "specialized knowledge" regarding the area of testimony. The Third Circuit has explained, "The basis of this specialized knowledge can be practical experience as well as academic training and credentials," and "[w]e have interpreted the specialized knowledge requirement liberally."
When faced with a proffer of expert testimony, the court must determine "whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue."
In performing its gatekeeping function to determine whether an expert's report is relevant and reliable under Daubert and Rule 702, "the court is not to weigh the evidence relied upon or determine whether it agrees with the conclusions reached therein.... Determinations regarding the weight to be accorded, and the sufficiency of, the evidence relied upon by the proffered expert are within the sole province of the jury."
The court will address each disputed expert separately. Defendant's motions contain requests for Daubert hearings. The court finds that these issues have been litigated in case after case throughout the country, and does not believe that, with the abundance of case law addressing the specific questions at issue here, Daubert hearings are necessary. Because these experts' qualifications have been repeatedly discussed and accepted by various courts around the country, the court will not address in depth the education, background, and experience of the various experts in question, except insofar as it is necessary to decide the motions at issue.
At the MDL stage of these proceedings, Judge Campbell ruled that "the testimony of Dr. Skubitz concerning general causation and the scientific and medical accuracy of the warnings given by Novartis is clearly more than unsupported speculation," and that, "Dr. Skubitz's testimony concerning general causation and the accuracy of the warnings is admissible under Daubert." (Doc.
First, as to the issue of alternative dosing schemes, NPC argues that Dr. Skubitz relies on an unreliable study to opine that less frequent dosing of the drugs in question is beneficial in preventing ONJ. Novartis objects to Dr. Skubitz's reliance on this "Corso" study because it is a retrospective observational study without a control group. The court finds that the objections as to the Corso study go more to the weight of the Dr. Skubitz's testimony than its admissibility. The litigation and documents from the MDL and related cases have recognized that if a non-controlled observational study has been peer-reviewed and accepted for publication in a scientific journal, that is a good indication that it has been "taken seriously by other scientists, i.e., that it meets at least the minimal criteria of good science."
Defendant also argues that Dr. Skubitz's opinion that reduced dosing has led to decreased incidence of ONJ in his own patients is without methodological support and is prohibited ipse dixit testimony. The court agrees. There is nothing in Dr. Skubitz's rebuttal report, (Doc.
Second, defendant argues that Dr. Skubitz's opinion regarding the benefits of pre-BP-therapy dental evaluations does not satisfy Daubert's "fit" requirement, contending that there is no evidence that a warning to seek such therapy would have prevented Mr. Bartoli's jaw issues and that Mr. Bartoli had a dental examination seven months before starting BP treatment.
Finally, defendant argues that Dr. Skubitz should not be allowed to testify to incidence rates of ONJ in those undergoing BP treatment. Defendant again rests this argument on the unreliability of the underlying studies on which Dr. Skubitz relies. The methodology of the underlying studies is a matter for cross-examination, but does not preclude the testimony.
Accordingly, defendant's motion to exclude Dr. Skubitz's testimony, (Doc.
At the MDL stage of these proceedings, defendant moved to exclude Dr. Marx's testimony regarding "(1) the causal connection between Aredia and Zometa and ONJ, (2) treatment and preventative measures for ONJ, (3) alleged misconduct by NPC which he considers to be taken in "bad faith," (4) whether certain patients in the Aredia/Zometa clinical trials likely had BP-induced ONJ, and (5) criticisms of certain aspects of the clinical trials." (Doc.
Defendant's current motion seeks to exclude Dr. Marx from: (1) testifying that dental treatment measures prevent ONJ; (2) presenting his opinion that NPC engaged in "bad faith" conduct; (3) criticizing the clinical trials; (4) speculating that certain patients in the clinical trials for Zometa® and Aredia® had ONJ; (5) presenting general causation opinions based on adverse event reports; and (6) testifying about the biological mechanism by which BPs allegedly cause ONJ.
First, as to the biological mechanism by which BPs cause ONJ, the court finds that the MDL order already decided this exact issue, which was presented to the MDL Court.
Second, as to general causation opinions based on adverse event reports which Dr. Marx has not reviewed, the MDL court ruled on this very issue, and it is law of the case that Dr. Marx may testify as to general causation based on adverse events reports whether he has reviewed them or not. See id., at 450-51.
Third, as to dental treatment measures to prevent ONJ, NPC presents the same arguments as it employed in attempting to keep Dr. Skubitz from testifying on preventative dental screenings. For the same reasons as above, the court will allow Dr. Marx to opine on preventative dental screenings.
Fourth, as to whether Dr. Marx may testify as to NPC's bad faith, plaintiff argues that NPC attempted to control the conclusions of advisory boards it convened, in which Dr. Marx was personally involved, that no specialized knowledge is needed for Dr. Marx to testify about bad faith, and that he can testify to his perception of NPC's actions as they relate to how he felt NPC was dealing with him. However, "intent is not a proper subject for expert testimony" and "expert testimony that constitutes a legal opinion is inadmissible."
Fifth, as to Dr. Marx's opinion that patients in the clinical trials were suffering from ONJ, NPC informed the FDA in 2005 that a retrospective review of its data from the clinical trials for the BP drugs had identified six individuals whose symptoms were "consistent with a potential diagnosis of ONJ." (Doc.
The court agrees that Dr. Marx did not employ his own methodology, but finds that this was because the records from the clinical trials were created before there was any definition of ONJ induced by BP drugs, and so the records would not necessarily reflect the presence of exposed bone. See
Finally, NPC seeks to exclude Dr. Marx's opinion criticizing NPC's clinical trials for the drugs in question. Dr. Marx states that "[a]s a research matter, I found the records to be a serious deviation of proper research data recording and noted that jaw and mouth examinations were apparently not routinely performed as part of the trial." (Doc.
Accordingly, defendant's motion to exclude Dr. Marx's testimony, (Doc.
NPC moves to exclude aspects of the testimony of Dr. Suzanne Parisian, (Doc.
As an initial matter, Dr. Parisian has repeatedly served as a trial expert on the matters at issue here, and has significant expertise with the FDA and its practices, something about which the average layperson does not have significant knowledge. Generally, she is qualified to testify. See
As to NPC's specific objections, first, Dr. Parisian may not testify as to NPC's intent, motive, or bad faith. As discussed above, "intent is not a proper subject for expert testimony."
Second, as to pharmaceutical industry ethical standards, ghostwriting, and undisclosed company funding of publications, Dr. Parisian may not testify. There is nothing to suggest that she is an expert in pharmaceutical company ethics — she has never worked at a pharmaceutical company, and ethical standards for such companies do not come from the FDA, which is the agency about whose operations Dr. Parisian has expertise. Likewise, her testimony regarding ghostwriting and undisclosed company funding is inadmissible because she opines, without foundation, that employing such practices does not provide "fair and balanced" information and that it must be disclosed. See
Third, as to causation, Dr. Parisian may not testify. Dr. Parisian is not an expert in ONJ, and does not currently treat patients. Plaintiff admits as much. (Doc.
Finally, Dr. Parisian may testify as to the FDA regulatory scheme and the role of the FDA and its interactions with pharmaceutical companies. NPC objects to the methodology she employed in reaching her conclusions, and her opinions in this area have been accepted by courts again and again, and her expertise in the complicated field of pharmaceutical regulation can surely be of use to a jury. Id.(collecting cases admitting Dr. Parisian's testimony on this subject). Furthermore, the Forman court determined, after a two-day Daubert hearing, that Dr. Parisian's methodology for forming her opinions regarding NPC's interactions with the FDA consisted of
The court thus determined that Dr. Parisian could testify regarding "the reasonableness of Novartis' conduct in its interactions with the FDA and compliance with FDA regulations, including Novartis' interactions with FDA with respect to labels and warnings, and FDA regulations and interactions with companies regarding clinical trials." Id; see also
Accordingly, defendant's motion to exclude the testimony of Dr. Suzanne Parisian, (Doc.
Defendant moves to exclude the testimony of Prof. Wayne Ray. (Doc.
Professor Ray is an epidemiologist, Professor of preventative medicine, director of the division of pharmacoepidemiology and director of the master of public health program at Vanderbilt University School of Medicine. He has significant experience in evaluating and designing studies to determine whether there is evidence that a medication causes bad reactions. He gives advice and does studies on adverse medication reactions and assesses whether medication use is appropriate. (Doc.
First, NPC objects to the use of the meta-analyses employed by Prof. Ray. A meta-analysis combines the results of several studies to increase precision and reduce the likelihood that any association found by the studies is due to sampling error.
Here, Prof. Ray performed two meta-analyses. The first (the "Table 5 study") addresses the relative risk of developing ONJ while using BPs. NPC argues that Prof. Ray failed to account for some confounding factors, that he used the patients as their own control groups, and that he treated BPs users who had been undergoing the treatment for 3 months or less as though they had not undergone BP therapy at all. However, Prof. Ray's report and his deposition testimony show that he has outlined the basis for the Table 5 study, addressed its potential flaws, and shown the methodology he employed and how he arrived at it. Moreover, he submitted a rebuttal report responding to many of NPC's complaints about his methodology. As someone with extensive experience in assessing epidemiological studies, Prof. Ray is qualified to conduct this analysis. This meta-analysis cannot be considered impermissible speculation. The court will allow Prof. Ray to testify about his Table 5 study. See
Prof. Ray also performed a meta-analysis (the "Table 6 study") regarding the increased risk of developing ONJ while taking Zometa® as compared to Aredia®. NPC also objects to the reliability of the methodology of this study. Here, Prof. Ray did not employ the same reliable methodology as with the Table 5 study, failing to account for duration of therapy as it relates to increased risk, a factor which he had determined was an important one in evaluating the risk of contracting ONJ. Having concluded that duration was important, he cannot reasonably have failed to account for it in his subsequent study. Prof. Ray may not, therefore, testify as to the Table 6 study. See id., at 458.
Second, NPC objects to Prof. Ray's opinion that it is biologically plausible that BP drugs increase the risk of ONJ on the grounds that he is not a medical doctor, does not prescribe BP drugs, and that he has not posited a particular biological mechanism of causation. The court disagrees. Where a "hypothesis has been deemed plausible and credible in the relevant medical literature" and where it is within an expert's "field of expertise based on training, experience, and history of publication," it is reasonable to admit that hypothesis.
Third, NPC objects to an opinion that a causation conclusion regarding BPs and ONJ could have been reached in 2003. NPC argues that causation has not yet been definitively proven and that the evidence Prof. Ray relies on in his analysis was not available prior to 2003. Prof. Ray bases this conclusion on Dr. Marx's report and an increase in reports of ONJ in BP users for which he does not think there is an alternate explanation. While this may not be the strongest factual basis for an opinion, that is a matter of weight, and not admissibility. Dr. Ray may testify as to whether a conclusion could have been reached in 2003.
Finally, NPC moves to exclude Prof. Ray's testimony regarding incidence of ONJ and his statement that ONJ is not "rare" in BP patients. NPC argues that Dr. Ray relied on studies that were not controlled and randomized to reach that conclusion. As the court found in the discussion of uncontrolled studies above, that is a matter of weight, and not admissibility. Dr. Ray may opine as to incidence rate. He may not, however, testify that the incidence rate correlates to ONJ being not "rare" among BP patients. Plaintiff does not present an argument about why the term is appropriate, and the court finds that the term is undefined and could be misleading. See
Accordingly, defendant's motion to exclude Prof. Ray, (Doc.
At the MDL stage of these proceedings, NPC argued that Dr. Vogel was not qualified to give any of his opinions. (Doc.
Presently, defendant moves to exclude the testimony of Dr. James Vogel. (Doc.
Dr. Vogel has been a hematologist and medical oncologist for 35 years. He sees patients regularly, and sees patients with both "solid tumors," as well as blood cancers such as multiple myeloma. He is as Associate Professor of hematology and medical oncology at the Mount Sinai School of Medicine. He prescribes BP drugs to his patients.
First, as to testimony about NPC's corporate conduct, NPC argues that Dr. Vogel lacks any firsthand knowledge and formed his opinions from internal NPC documents presented to him during litigation. They allege that Dr. Vogel cannot testify:
As noted above, an expert may not opine as to the intent or motive of NPC. To the extent that Dr. Vogel's testimony seeks to do this, it will not be allowed. However,
Second, in accordance with the court's above rulings regarding the testimony of Dr. Marx and Dr. Skubitz on the same topic, Dr. Vogel will be permitted to testify as to the benefits of pre-treatment dental screenings.
Third, as to opinions regarding the incidence rate of ONJ in BP patients, the court has addressed this issue in discussing Dr. Skubitz and Dr. Marx. For the same reasons, the court finds that NPC's objections regarding the reliability of the underlying studies and Dr. Vogel's failure to consider studies published after his initial report go to the weight of the evidence, not to its admissibility. Dr. Vogel may testify as to incidence rate of ONJ in BP patients.
Fourth, NPC objects to Dr. Vogel's opinions regarding an alternative dosing schedule because he relies on the same Corso report as Dr. Marx, and he lacks expertise regarding FDA labeling. First, the court noted above that reliance on the Corso study is permissible. As to whether he is qualified to opine on the dosing information that NPC should have provided to the medical community, the MDL court ruled that Dr. Vogel may testify as to whether the label dosing information was false or misleading. Thus, Dr. Vogel may testify as to alternative BP dosing regimens.
Finally, as to whether Dr. Vogel may opine about the biological mechanism by which BPs affect jawbones, NPC contends that Dr. Vogel is not qualified to opine because he is not a bone pathologist or bone biologist. "While the MDL court did find that Dr. Vogel's inability to explain the mechanism did not render his opinions unreliable as to the biological mechanism generally, the MDL court did not directly address whether Dr. Vogel is qualified to offer an opinion on the particular hypothesis about bisphosphonates targeting the bone." Id., at 439. This court finds that Dr. Vogel is qualified to testify on the matter. While he admits that he is not an expert in bone pathology, he is an expert in cancers of the blood, a closely related field at the heart of this case. "Rule 702's liberal policy of admissibility extends to the substantive as well as the formal qualification of experts. We have eschewed imposing overly rigorous requirements of expertise and have been satisfied with more generalized qualifications."
Accordingly, defendant's motion to exclude the testimony of Dr. Vogel, (Doc.
For the foregoing reasons, each of defendant's motions, (Doc.