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limiting Dr. Parisian's testimony to “FDA labeling”
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CASE NO.: 06-61337-CIV-COHN/SELTZER
04-22-2013
KEITH TAYLOR, Plaintiff, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.
ORDER DENYING IN PART AND DENYING AS MOOT IN PART DEFENDANT'S DAUBERT MOTION TO EXCLUDE PLAINTIFF'S EXPERT DR. JAMES VOGEL AND GRANTING IN PART , DENYING IN PART, AND DENYING AS MOOT IN PART DEFENDANT'S DAUBERT MOTION TO EXCLUDE PLAINTIFF'S EXPERT DR. SUZANNE PARISIAN
THIS CAUSE is before the Court upon Defendant Novartis Pharmaceutical Corporation's Daubert Motion to Exclude Plaintiff's Expert Dr. James Vogel [DE 43] ("Vogel Motion") and Novartis Pharmaceutical Corporation's Daubert Motion to Exclude Plaintiff's Expert Dr. Suzanne Parisian [DE 44] ("Parisian Motion") (collectively "Motions"). The Court has carefully considered the Motions, Plaintiff's Response [DE 49] ("Response"), Defendant's Reply [DE 54], the testimony and argument presented at the April 19, 2013 Daubert hearing, and is otherwise advised in the premises.
I. BACKGROUND
Plaintiff Keith Taylor ("Plaintiff") originally filed a complaint in this Court against Defendant Novartis Pharmaceuticals Corporation ("Defendant") on September 1, 2006. Complaint [DE 1]. The Judicial Panel on Multidistrict Litigation ("JPML") subsequently removed the case to the Middle District of Tennessee for consolidated pretrial proceedings with similar actions brought against Defendant by other plaintiffs. See Conditional Transfer Order [DE 9, 10]. On September 5, 2012, the JPML signed a conditional remand order which remanded this case to this Court. Conditional Remand Order [DE 11].
In the Complaint, Plaintiff alleges that after treatment with Aredia and Zometa, drugs produced and marketed by Defendant, he suffered osteonecrosis, or bone death, of the jaw. Compl. ¶ 1. Plaintiff received Aredia and Zometa, Food and Drug Administration ("FDA") approved bisphosphonates, as part of his treatment for multiple myeloma. Id. ¶¶ 2, 6. Plaintiff contends that despite its knowledge regarding jaw problems with patients who had taken Aredia and/or Zometa, Defendant failed to warn doctors until September 2004, and dentists until May 2005, about the risk of osteonecrosis of the jaw ("ONJ"). Id. ¶ 8. Plaintiff also alleges that Defendant failed to initiate studies regarding risks associated with Aredia and Zometa, id. ¶ 9, fully test the products to ensure they were safe for their intended purpose, id. ¶ 10, and conduct dosing studies to establish minimum effective doses. Id. ¶ 11. Plaintiff brings claims against Defendant for strict liability and negligence-failure to warn.
Additional claims for negligent manufacture, strict liability based on manufacturing defect, and breach of express warranty were dismissed pursuant to the parties' stipulation on June 18, 2012. See June 18, 2012 Order [DE 28-71] at 89. This Court dismissed Plaintiff's claim for breach of implied warranty on January 7, 2013. See Order Granting in Part and Denying in Part Defendant's Motion for Summary Judgment [DE 42].
In the Motions, Defendant seeks to exclude certain testimony from Plaintiff's retained experts Dr. James Vogel and Dr. Suzanne Parisian on the grounds that the challenged testimony is inadmissible pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993) and Federal Rule of Evidence 702. Plaintiff opposes the Motions.
II. DISCUSSION
A. Legal Standard.
Under Federal Rule of Evidence 702:
[i]f scientific ... knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.Fed. R. Evid. 702. The Supreme Court has stated that district court judges perform "a gatekeeping role" regarding admissibility of expert testimony. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993).
The Eleventh Circuit has established a three part test for evaluating the admissibility of expert testimony under which the district court must assess whether: "(1) the expert is qualified to testify competently regarding the matters he intends to address; (2) the methodology by which the expert reaches his conclusions is sufficiently reliable as determined by the sort of inquiry mandated in Daubert; and (3) the testimony assists the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue." Hendrix ex rel G.P. v. Evenflo Co., 609 F.3d 1183, 1994 (11th Cir. 2010) (citing United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004)). "The proponent of the expert testimony bears the burden of showing, by a preponderance of the evidence, that the testimony satisfies each prong." Id. (citing Boca Raton Cmty. Hosp., Inc. v. Tenet Health Care, 582 F.3d 1227, 1232 (11th Cir. 2009)). The Court will address the admissibility of each experts' opinions individually below.
B. Whether Challenged Testimony of Dr. Vogel is Admissible Under Daubert.
Dr. James Vogel ("Dr. Vogel") has been a hematologist and oncologist for over 35 years. Expert Report of James M. Vogel, M.D., Exhibit 6 to the Vogel Motion [DE 43-6] ("Vogel Report") ¶ 1. Dr. Vogel currently serves as a professor at the Mount Sinai School of Medicine. Id. ¶ 2. The MDL Court previously determined that Dr. Vogel's testimony regarding general causation and the adequacy of warnings was admissible under Daubert. See In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, at 3 (M.D. Tenn. Aug. 13, 2009), attached as Exhibit 1 to the Vogel Motion [DE 43-1]. The MDL court did not consider "Dr. Vogel's opinions concerning the alleged corporate behavior of Novartis, his statement that the delay and failure in transmission of certain information impacted a large number of patients, or his statements concerning the benefit of pretreatment dental screening." Id. Defendant has moved to exclude certain additional opinions of Dr. Vogel which it contends were not addressed by the MDL court.
1. Opinions Regarding Defendant's Corporate Behavior, Motives, and Intent.
Defendant first argues that any opinions Dr. Vogel seeks to offer regarding Defendant's corporate behavior and motive and intent should be excluded. Vogel Motion at 7. According to Defendant, such "opinions are ill-suited for expert testimony" because they are not based on scientific, technical or other specialized knowledge. Id. Defendant further contends that these opinions "invade[ ] the province of the jury by putting his own spin on evidence that jurors can evaluate for themselves." Id. Defendant also argues that Dr. Vogel lacks the requisite expertise to opine on Defendant's corporate conduct, id. at 8, and that these opinions are unreasonably speculative. Id. at 9. Finally, Defendant contends that any criticism of the warnings language of the Zometa package insert does not fit the facts of this particular case because ONJ was "a yet-to-be discovered adverse event" at the time Plaintiff began his Aredia and Zometa treatment. Id. at 10-11. In opposition, Plaintiff avers generally that all Defendant's objections to Dr. Vogel's testimony have been addressed by other state and federal courts and the MDL court has already ruled that Dr. Vogel "may testify about causation and the adequacy of warnings." Response at 6.
The Response contains no other substantive response regarding any of Defendant's arguments to exclude Dr. Vogel's testimony. Instead, the Response devotes itself to why additional Daubert hearings are not necessary in this matter.
First, the Court notes that whether Dr. Vogel may offer this opinion has not been previously addressed by the MDL court. See In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, at 3-4 (M.D. Tenn. Aug. 13, 2009), attached as Exhibit 1 to the Vogel Motion [DE 43-1]. Other district courts, however, have considered the admissibility of this opinion after remand from the MDL court. The Eastern District of New York, for example, in Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp. 2d 420 (E.D.N.Y. 2011), concluded that this opinion was inadmissible "to the extent Dr. Vogel seeks to opine on the intent, motive, or state of mind [of Novartis or Novartis employees], or evidence by which such state of mind may be inferred." Id. at 442 (quoting AstraZeneca LP v. Tap Pharm. Prods., Inc., 444 F. Supp. 2d 278, 293 (D. Del. 2006) (internal quotation marks omitted)). However, the court did permit Dr. Vogel to "opine on the medicine and science that was available at the time regarding the risks and benefits of Aredia and Zometa, and [to] compare that information to what was disclosed on the label or in other materials Novartis presented to the medical community." Id. at 443. Another district court addressing this same issue concluded that Dr. Vogel could not offer any opinions regarding Defendant's corporate behavior. Brodie v. Novartis Pharm. Corp., No. 4:10CV0138-HEA, at 2 (E.D. Mo. Jan. 20, 2012).
"The question of intent or motive is a classic jury question and not one for experts." In re Trasylol Prods. Liab. Litig., No. 08-MD-01928, 2010 WL 4259332, at *8 (S.D. Fla. Oct. 21, 2010) (excluding expert testimony regarding FDA and corporate defendant's desire and state of mind). At the April 19, 2013 Daubert hearing, however, Plaintiff's counsel represented that Dr. Vogel will not present any testimony regarding Defendant's intent or motives. Accordingly, the Court will deny the motion as moot regarding this issue.
2. Opinions Regarding Pretreatment Dental Screening Options.
Defendant also argues that Dr. Vogel should not be permitted to opine regarding pretreatment dental screening procedures because these opinions are scientifically unreliable. Vogel Motion at 12. Defendant contends that Dr. Vogel is unqualified to offer these opinions because he is neither a dentist nor an oral surgeon. Id. Additionally, Defendant argues that this opinion is unreliable because, other than some case reports, it is premised entirely upon a single publication that Dr. Vogel reviewed. Id. at 12-13.
In Deutsch, the Eastern District of New York rejected Defendant's arguments, finding that "Dr. Vogel's extensive experience as an oncologist and hematologist including treating patients with bisphosphonate therapy provides a reliable basis for his opinions on the benefits of preventative measures such as pretreatment dental screening." 768 F. Supp. 2d at 437. The court also rejected Defendant's argument that whether pretreatment screening can prevent ONJ is speculative, holding that "Daubert does not require absolute certainty before an expert can proffer an opinion and allows for the admissibility of new theories provided they are based on a reliable methodology. . . . The fact that an expert witness speaks in probabilities, rather than certainties, does not by itself make the testimony unreliable." Id. at 437-38 (internal citations omitted). In Brodie, the Eastern District of Missouri also found the testimony admissible provided that a foundation could be laid. Brodie v. Novartis Pharm. Corp., No. 4:10CV0138-HEA, at 3 (E.D. Mo. Jan. 20, 2012). At the April 19, 2013 hearing, however, Plaintiff stated on the record that Dr. Vogel will not offer any opinion as to pretreatment dental screenings. Accordingly, the Court will also deny the motion as moot regarding this issue.
3. Opinions Regarding Incidence of ONJ.
Defendant also seeks to exclude any opinion from Dr. Vogel that Defendant minimized the incidence of ONJ in its patients in publications and correspondence because the incidence rate was five percent or above. Vogel Motion at 15. Defendant argues that this opinion impermissibly touches upon Defendant's corporate intent, does not have a valid scientific connection to the facts at issue in this case, and is unreliable because it is based on insufficient facts or data. Id. at 16. The Deutsch court addressed this precise issue and permitted Dr. Vogel to testify as to this opinion. 768 F. Supp. 2d at 441. The court found that any challenge to the factual basis of this opinion went to its weight rather than its admissibility. Id. Additionally, the court rejected Defendant's argument that a five percent or greater incidence rate was inconsistent with Dr. Vogel's professional experience because he testified at deposition that he could not produce a statistically significant incidence rate due to the small number of patients he treats. Id.
The Court finds that Dr. Vogel may opine that the incidence rate of ONJ was five percent or greater. The record establishes that Dr. Vogel has an adequate basis for this opinion. Additionally, Defendant is entitled to cross examine Dr. Vogel regarding additional studies which he did not consider when formulating this opinion. See Vogel Motion at 16; see also Primrose Operating Co. v. Nat'l Am. Ins. Co., 382 F.3d 546, 562 (5th Cir. 2004) ("[A]s a general rule, questions relating to the bases and sources of an expert's opinion affect the weight to be assigned that opinion rather than its admissibility and should be left for the jury's consideration.... It is the role of the adversarial system, not the court, to highlight weak evidence.") (emphasis in original) (internal quotations and citations omitted). However, consistent with the Court's above ruling, Dr. Vogel will not be permitted to opine that Defendant sought to minimize the incidence rate of ONJ as Defendant's motivation or intent is not a proper subject of expert testimony. See In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531 546 (S.D.N.Y. 2004) (finding that opinions related to "the intent, motives or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise" and were not proper expert testimony).
4. Opinions Regarding Alternative Dosing and Duration Regimens Not Approved by the
FDA.
Defendant also argues that Dr. Vogel's opinion that "a reduced dosing schedule has shown equal efficacy and less risk" and that Defendant improperly failed to release information regarding alternative dosing scheduling should be excluded. Vogel Motion at 18. According to Defendant, Dr. Vogel is not qualified to give this opinion because he lacks knowledge of the FDA's role in the regulation and labeling of prescription drugs. Id. Defendant also contends that Dr. Vogel's proposed dosing schedule cannot be relevant to Plaintiff's case because the article he relies upon was not published until 2007, years after Plaintiff finished his Aredia and Zometa treatment. Id. Additionally, Defendant argues that Plaintiff cannot establish that this opinion is scientifically reliable because in 2011, the American Society of Clinical Oncology "rejected as unreliable and medically inadvisable" the very dosing schedule Dr. Vogel presents as safer and effective." Id. at 19.
In Brodie, the court excluded this opinion, finding that "Dr. Vogel's opinions that NPC should have disseminated information on alternate dosing and duration of treatment are not within his expertise, nor are they based on scientifically reliable sources; therefore, he will not be allowed to opine on such." Brodie v. Novartis Pharm. Corp., No. 4:10CV0138-HEA, at 3 (E.D. Mo. Jan. 20, 2012). Defendant also points out, that another federal court, in Conklin v. Novartis Pharmaceuticals, Corp., No. 9:11CV-178, 2012 WL 4127295, at *9-10 (E.D. Tex. Sept. 18, 2012), prohibited another expert, Dr. Robert Marx from offering this same opinion. See Vogel Motion at 18. In Conklin, the court found that Dr. Marx could not offer this opinion because
[i]t is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancerrelated diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen, and he does not explain from where he draws his naked conclusion regarding efficacy—certainly, it is not in either of the articles he cites.2012 WL 4127295, at *10. The Deutsch court also considered this issue and rejected Defendant's argument that the Corso study Dr. Vogel relied upon was an unreliable basis for his opinion or that Dr. Vogel was unqualified to interpret the study. 768 F. Supp. 2d at 445. However, although the court declined to grant the Daubert motion, the Court stated that it would permit a motion in limine on this issue because the MDL court did not have before it deposition testimony where Dr. Vogel stated that he did not have an opinion as to what threshold dose of Aredia or Zometa would increase the risk of ONJ. Id.
It appears that Dr. Marx relied upon different studies than Dr. Vogel for this opinion. Dr. Marx relied upon Lacy, M.Q., et al., Mayo Clinic Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma 81(8) Mayo Clin. Proc. 1047 (2006) and Lipton, A. Toward New Horizons: The Future of Bisphosphonate Therapy 9 (Supp. 4) The Oncologist 38. Conklin, 2012 WL 4127295, at *13.
The full citation of this study is A. Corso, et al., A Different Schedule of Zoledronic Acid Can Reduce the Risk of Osteonecrosis of the Jaw in Patients with Multiple Myeloma, 21 Leukemia 1545 (2007).
Here, Dr. Vogel's expert report, relying upon the Corso study, posits that patients who received reduced dosages of Aredia and Zometa had lower incidents of ONJ while the reduction in skeletal events was "similar." Vogel Report ¶ 58. Thus, it appears that Dr. Vogel, relying on different studies than Dr. Marx in Conklin, has provided some basis for his opinion that patients who received lower doses of Aredia and Zometa had lower incidences of ONJ while experiencing a similar reduction in skeletal events. At the Daubert hearing, Dr. Vogel was unable to articulate a precise dosage where Aredia and Zometa would still be effective at treating cancer related diseases, but the risk of ONJ would decrease. Nonetheless, the Court finds that this opinion does have a factual basis, namely the Corso study, and that Dr. Vogel is qualified to interpret the results of this study and present it to the jury. Whether the results of the Corso study are sufficiently verified or whether subsequent studies have reached different results goes to the weight rather than the admissibility of the testimony and may be explored on cross examination. See Deutsch, 768 F. Supp. 2d at 437 ("However, Daubert does not require absolute certainty before an expert can proffer an opinion and allows for the admissibility of new theories provided they are based on a reliable methodology."). Accordingly, the Court will deny the motion as to this issue.
5. Opinions Regarding the Biological Mechanism by Which Bisphosphonates Affect Jaw
Bones.
Finally, Defendant argues that Dr. Vogel's opinion that bisphosphonates are more likely to accumulate in the jaw than in other bones due to a high remodeling rate and higher uptake of bisphosphonates should be excluded. Vogel Motion at 20. Defendant contends that Dr. Vogel is not qualified to offer ths opinion because he admits that he is not an expert on bone physiology. Id. In Brodie, the court excluded this opinion because "Dr. Vogel has admitted that he is not an expert on bone biology and, therefore, he is unqualified to opine on how bisphosphonates affect bone." Brodie v. Novartis Pharm. Corp., No. 4:10CV0138-HEA, at 3 (E.D. Mo. Jan. 20, 2012). However, in Deutsch, the court rejected this very argument, finding that Dr. Vogel's lack of experience as a bone biologist or pathologist did not disqualify him from opining on the mechanism through which bisphophonates affected jaw bones. 768 F. Supp. 2d at 439. Instead, the court found that because the opinion was based on articles he had reviewed and he had experience treating patients with bone metastases, he could offer this opinion. Id.
Although a proposed expert's own assertion that he is not an expert, standing alone, will not per se disqualify an individual as an expert, Harvey v. Novartis Pharm. Corp., No. 2:06-CV-114-VEH, 2012 WL 4713097, at *4 (N.D. Ala. Oct. 4, 2012), where the record demonstrates that a particular expert is not qualified to opine in a particular area, the testimony should be excluded under Daubert. Parmentier v. Novartis Pharm. Corp., No. 1:12-CV-45 SNLJ, 2012 WL 2326047, at *4 (E.D. Mo. June 19, 2012). Here, the Court finds the logic of the Deutsch court persuasive: Dr. Vogel's work as an oncologist and hematologist with experience treating patients with bone metastases qualifies him to opine on the biological mechanism through which bisphosphonates affect jaw bones. Accordingly, the Court will deny the motion as to this issue.
The Sixth Circuit has stated that "while a putative expert's self-assessment is not dispositive as to whether he or she meets the requirements of Rule 702, it is one factor that district court's may consider when determining if his or her testimony is sufficiently reliable." Thomas v. Novartis Pharm. Corp., 443 F. App'x 58, 61 (6th Cir. 2011). --------
C. Whether Challenged Testimony of Dr. Parisian is Admissible Under Daubert.
Dr. Suzanne Parisian ("Dr. Parisian") is an M.D. and a board-certified pathologist. She worked for the FDA for four years in the area of regulation of medical devices. She is a founder of a regulatory and medical consulting firm that specializes in matters involving FDA regulations. Defendant makes a number of challenges to the admissibility of her testimony in this matter. In response, Plaintiff generally avers that Dr. Parisian is qualified and that because other courts have admitted her testimony, this Court should too. See Response at 4-5.
1. Whether Dr. Parisian is Qualified to Offer Any Testimony in this Case.
First, Defendant generally argues that Dr. Parisian is not qualified to testify in this case because her experience in the FDA involved medical devices, not drugs. Parisian Motion at 10. The Court is unwilling to conclude that Dr. Parisian may not testify at all in this case simply because her FDA experience centered around medical devices. Defendant has failed to articulate precisely why Dr. Parisian is unqualified to render any opinions in this case. Accordingly, while the Court will consider challenges to Dr. Parisian's qualifications to render specific opinions, the Court will not sustain Defendant's blanket Daubert challenge to her testimony. See Guenther v. Novartis Pharm. Corp., No. 6:080cv04560Orl-31DAB, 2013 WL 1278089, at *2 (M.D. Fla. Mar. 28, 2013) ("Although Novartis asserts in its motion that the entirety of Parisian's testimony should be excluded for failure to meet the Daubert standard, . . . it never squarely addresses the topic. Insofar as Novartis truly intended to question Parisian's qualifications to offer any testimony whatsoever, the Court finds that Parisian is generally qualified by virtue of, inter alia, her tenure with the FDA and her professional experience in the field of regulatory approval[.]"); Chiles v. Novartis Pharm. Corp., No. 3:06-cv-96-J-25-JBT, 2013 WL 539891, at *3 (M.D. Fla. Feb. 7, 2013) ("As other Zometa ® courts have found, Dr. Parisian generally meets the Daubert standard regarding her qualifications to testify on some of the relevant matters in this case.").
2. Opinions Regarding Defendant's Compliance with Certain Regulatory Standards.
Next, Defendant argues that Dr. Parisian should be precluded from testifying that Defendant failed to comply with applicable regulatory standards. Parisian Motion at 11. According to Defendant, such testimony "usurps the function of both the trial judge in determining the law and the jury in weighing the evidence against the applicable legal standards." Id. Other courts considering this issue have found that this testimony is relevant and admissible. For example, in Forman v. Novartis Pharmaceuticals Corp., 794 F. Supp. 2d 382 (E.D.N.Y. 2011), the Eastern District of New York permitted such testimony because "both the Plaintiff and NPC have affirmatively asserted that NPC's compliance, or lack of compliance, with FDA regulations is persuasive evidence of the NPC's reasonableness and the adequacy of the Aredia and Zometa warnings. Accordingly, absent any representation by the parties to the contrary, the FDA, and NPC's compliance with FDA regulations are issues that are relevant to the instant litigation. Therefore, so is Dr. Parisian's testimony." 794 F. Supp. 2d at 385. At the Daubert hearing, Dr. Parisian stated that she would only testify regarding what FDA regulations require and what Defendant did or not do regarding these regulations. She denied, however, that she would testify regarding whether Defendant complied or failed to comply with specific FDA regulations. Based on Dr. Parisian's representation that she will not opine as to whether Defendant complied with FDA regulations, the Court will admit Dr. Parisian's testimony regarding regulatory standards.
3. Opinions About Alleged Violations of Industry Standards.
Defendant also argues that Dr. Parisian should not be permitted to offer any opinions regarding whether Defendant's conduct violates industry standards or whether Defendant failed to act ethically, reasonably, or responsibly. Parisian Motion at 12. In Deutsch, the Eastern District of New York excluded such testimony, finding that "Dr. Parisian is not qualified to opine on the ethical standards in the pharmaceutical industry, nor is she qualified to testify as to any obligations Novartis may have had to the medical community in addition to the FDA requirements." 768 F. Supp. 2d at 468. The Court agrees. While Dr. Parisian may be able to testify about the interaction of pharmaceutical companies with the FDA, her background does not reflect that she is generally aware of industry standards surrounding pharmaceutical companies. Accordingly, the motion will be granted as to this opinion.
4. Opinions Regarding Defendant's State of Mind and Intent.
Defendant next contends that Dr. Parisian should be prohibited from offering any opinions regarding Defendant's state of mind or intent. Parisian Motion at 13. As discussed above regarding Dr. Vogel, such opinions are not proper expert testimony. See Deutsch, 768 F. Supp. 2d at 467 ("In addition, the Court also notes that Dr. Parisian scatters improper personal opinions, speculation, and state of mind inferences throughout the narratives in her report. Such opinions are inadmissible insofar as 'the opinions of [expert] witnesses on the intent, motives, or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise.' . . . In addition, 'bad company' opinions that are not based on any FDA regulation or other applicable standard are similarly inadmissible."); see also Kaufman v. Pfizer Pharm., Inc., No. 1:02-CV-22692, 2011 WL 7659333, at *9 n.8 (S.D. Fla. Aug. 4, 2011) ("The Court will exclude all of Dr. Parisian's opinions about Defendants' motives and state of mind, regardless of where or how they appear in her expert report."); Hill v. Novartis Pharm. Corp., No. 1:06-cv-00939-AWI-DLB, 2012 WL 5451809, at *2 (E.D. Cal. Nov. 7, 2012) (excluding Dr. Parisian from testifying regarding the intent, motives or state of mind of Defendant or its employees). At the Daubert hearing, however, both Plaintiff's counsel and Dr. Parisian stated that Dr. Parisian would not testify regarding Defendant's state of mind or intent. Accordingly, the Court will deny the motion as moot as to this issue.
5. Opinions on the Adequacy of Warnings.
Defendant also argues that Dr. Parisian's opinion as to the adequacy of Defendant's warnings is irrelevant because she is not an oncologist and lacks expertise to opine as to the reasonableness of such warnings. Parisian Motion at 13-14. In Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp. 2d 608 (W.D.N.C. 2012), the court excluded any testimony from Dr. Parisian regarding Defendant's communication of ONJ risks to health care providers because she "does not possess the requisite experience or expertise, as an employee or insider of a pharmaceutical drug sponsor, to opine on the conduct of Novartis." Id. at 615. However, the court permitted Dr. Parisian to opine as to Defendant's interactions with the FDA regarding labeling. Id. In Chiles, the Middle District of Florida, relying on Lemons, found that Dr. Parisian was qualified to testify regarding "the complexity of the FDA's regulatory scheme and the role of a pharmaceutical drug sponsor in complying with the regulatory scheme." 2013 WL 539891, at *3 (quoting Lemons, 849 F. Supp. 2d at 614 (internal quotation marks omitted)). Here, the Court finds that Dr. Parisian may opine regarding warnings Defendant provided to doctors through the FDA regulatory scheme. However, Plaintiff has failed to establish Dr. Parisian's qualifications to more generally opine on the adequacy of warnings Defendant provides to treatment providers. Thus, her testimony must be limited solely to FDA labeling, such as Dear Doctor Letters and product inserts, as discussed at the Daubert hearing.
6. Causation Opinions.
Defendant also moves to exclude any opinions of Dr. Parisian that ONJ is caused by bisphosphonates. Parisian Motion at 14. According to Defendant, Dr. Parisian has previously attempted to give causation opinions she is not qualified to offer by labeling them as "regulatory" rather than "medical causation. Id. at 15. In Lemons, the Court excluded Dr. Parisian from offering causation testimony. 849 F. Supp. 2d at 615. Recently in Dopson-Troutt v. Novartis Pharmaceuticals Corp., No. 8:06-cv-1708-T-24EAJ, 2013 WL 1344755 (M.D. Fla. Apr. 2, 2013), the Middle District of Florida held that Dr. Parisian would not be permitted to testify regarding any "causal association" between ONJ and Aredia and Zometa because "Plaintiff's counsel offers nothing to meaningfully distinguish 'causal association' from medical causation." Id. at *3; see also Guenther, 2013 WL 1278089, at *3 (same); Chiles, 2013 WL 539891, at *3 (prohibiting Dr. Parisian from testifying regarding medical causation, but deferring ruling on whether she can testify about "regulatory causation" until trial); Jenkins v. Novartis Pharm. Corp., Nos. 3:11-CV-342, 3:11-CV-373, 2012 WL 6213494, at *7 (E.D. Tenn. Dec. 13, 2012) ("The Court finds that Dr. Parisian is not qualified to testify as to the mechanism by which Zometa and Aredia, or bisphosphonates generally, cause ONJ. While Dr. Parisian holds a doctor of medicine, she testified that the vast majority of her career has been spent in the field of medical regulation rather than the practice of even general medicine. Moreover, the Plaintiff has not presented any evidence indicating that Dr. Parisian has any special experience treating bisphosphonate-related disorders, jaw conditions, or bone conditions. Further, there is no evidence in the record to indicate that Dr. Parisian has either treated ONJ or studied ONJ in an academic setting. Finally, Dr. Parisian did not offer causation testimony at the hearing before the undersigned, and she, at least implicitly, acknowledged that ONJ causation was not her area of expertise."); Deutsch, 768 F. Supp. 2d at 469 (excluding Dr. Parisian from testifying regarding causation of ONJ because she is not qualified to diagnose ONJ).
At the Daubert hearing, Dr. Parisian stated that she would not testify regarding medical causation. She clarified that her opinion relates to "causal association" under 21 C.F.R. § 201.57. This regulation requires that a product's "labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug." 21 C.F.R. § 201.57(c)(6)(i). The Court finds that Plaintiff has failed to establish how this opinion significantly differs from medical causation. Additionally, Plaintiff has not demonstrated that Dr. Parisian is qualified to identify when a "causal association" with a drug emerges which necessitates a labeling change. Accordingly, Dr. Parisian will be prohibited from opining whether Defendant was required to update its labels for Aredia and/or Zometa based on an emerging "causal association" with ONJ.
7. Opinion that Defendant Failed to Adequately Monitor the Safety of Clinical Trial
Patients.
Defendant also contends that Dr. Parisian's opinion that Defendant failed to monitor the safety of patients in its clinical trials should be excluded because the Plaintiff was not a plaintiff in such trials, Dr. Parisian is not qualified to testify about drug clinical trial safety, and she lacks any factual basis for such opinions because she failed to review the underlying data. Parisian Motion at 15-16. In Lemons, the court precluded Dr. Parisian from offering such testimony. 849 F. Supp. 2d at 615.
The Court finds that Plaintiff has failed to demonstrate Dr. Parisian's qualifications to give an opinion regarding Defendant's monitoring of clinical trials. Dr. Parisian is not a practicing physician. Nor does she have experience with designing clinical drug trials. She is also not an expert on ONJ or other diseases of the jaw. The Court finds no basis to permit Dr. Parisian to testify, with the benefit of hindsight, that Defendant's clinical trials were deficient or improperly monitored. Accordingly, the Court will grant the motion as to this opinion.
8. Opinions Regarding Ghostwriting and Company Funding of Publications.
Defendant seeks to exclude any opinions regarding Defendant's ghostwriting and company funding of publications. Parisian Motion at 16. According to Defendant, this testimony is irrelevant, not based upon reliable data, and constitutes subjective personal opinions. Id. In his Response, Plaintiff states that he does not intent to offer any opinion regarding ghostwriting. Response at 5. Other courts have found that "Dr. Parisian is not qualified to opine on the ethical standards in the pharmaceutical industry, nor is she qualified to testify as to any obligations Novartis may have had to the medical community in addition to the FDA requirements." Deutsch, 768 F. Supp. 2d at 468; see also Hill, No. 2012 WL 5451809, at *2 (excluding Dr. Parisian from testifying regarding ghostwriting and company funding of publications). Based on Plaintiff's representation both in his response and at the Daubert hearing that he does not intend to offer such testimony, the Court will deny as moot this part of the motion.
9. Additional Irrelevant and Confusing Testimony.
Finally, Defendant seeks to exclude "other irrelevant, unfairly prejudicial, and confusing testimony," such as criticisms of the FDA and pharmaceutical industry that do not relate to Aredia and Zometa and testimony about other drugs and injuries than ONJ." Parisian Motion at 17. In Chiles, the court rejected this argument as "vague and premature." 2013 WL 539891, at *3. In Dopson-Troutt, the court found that this issue could "be addressed at trial or cured by way of cross-examination." 2013 WL 1344755, at *4; see also Guenther, 2013 WL 1278089, at *3 (same). All testimony, even expert testimony, must be relevant under Federal Rule of Civil Procedure 401. United States v. Piccinonna, 885 F.2d 1529, 1536 (11th Cir. 1989). The Court doubts that testimony that does not relate Aredia, Zometa, or ONJ would be relevant in this case, however, the Court will reserve ruling on such specific objections until trial.
III. CONCLUSION
Based on the foregoing, it is ORDERED AND ADJUDGED as follows: 1. Defendant Novartis Pharmaceutical Corporation's Daubert Motion to Exclude Plaintiff's Expert Dr. James Vogel [DE 43] is DENIED IN PART AND DENIED AS MOOT IN PART as follows:
a. DENIED as to opinions regarding incidence of ONJ, alternative dosing, and biological mechanism of ONJ; and2. Novartis Pharmaceutical Corporation's Daubert Motion to Exclude Plaintiff's Expert Dr. Suzanne Parisian [DE 44] is GRANTED IN PART, DENIED IN PART, AND DENIED AS MOOT IN PART as follows:
b. DENIED as MOOT as to opinions regarding corporate behavior, motives, intent and pretreatment dental screenings; and
a. GRANTED as to alleged violations of industry standards, causation (both medical and "regulatory association"); and monitoring of clinical trials;
b. DENIED as to whether Dr. Parisian is qualified to offer any opinions in this case, opinions regarding regulatory standards, the adequacy of Defendant's warnings, and other irrelevant and confusing testimony; and
c. DENIED as MOOT as to opinions regarding Defendant's state of mind and intent and ghostwriting.
DONE AND ORDERED in Chambers at Fort Lauderdale, Broward County, Florida, this 22nd day of April, 2013.
/s/_________
JAMES I. COHN
United States District Judge Copies provided to counsel of record via CM/ECF.