Rodman v. Otsuka America Pharmaceutical, Inc.

[3] 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA [6] 7 INA ANN RODMAN, Case No. 18-cv-03732-WHO 8 Plaintiff, ORDER GRANTING DEFENDANT’S MOTION FOR SUMMARY 9 v. JUDGMENT 10 OTSUKA AMERICA Re: Dkt. No. 65, 66, 67, 68 PHARMACEUTICAL, INC., [11] Defendant. [12] 13 In this product liability suit, plaintiff Ina Rodman alleges that she suffers from a movement 14 disorder known as Tardive Dyskinesia (“TD”) as a result of ingesting the prescription 15 antipsychotic medication Abilify. She brings failure to warn and design defect claims against 16 defendant Otsuka America Pharmaceutical, Inc. (“Otsuka”). Before me are cross-motions for 17 summary judgment on the failure to warn claim, along with Otsuka’s motion for summary 18 judgment on the design defect claim. Both parties also move to exclude portions of expert 19 testimony. 20 Rodman’s case founders on a lack of proof. For the reasons set forth below, I GRANT 21 summary judgment in favor of Otsuka on all three theories of Rodman’s failure to warn claim, as 22 well as her design default claim. Along the way, I GRANT Otsuka’s motion to exclude Dr. Laura 23 M. Plunkett’s expert testimony on label inadequacy and DENY the remainder of its motion as 24 moot. And I DENY Rodman’s motion for partial summary judgment on her failure to warn claim 25 and DENY as moot her motion to exclude portions of Dr. Sara J. Polfliet’s and Dr. Christoph U. 26 Correll’s expert testimony. 27 BACKGROUND 1 was first approved by the United States Food and Drug Administration (“FDA”) for the treatment 2 of schizophrenia. See Corrected Declaration of Matthew M. Saxon in Support of Defendant’s 3 Motion for Summary Judgment (“Saxon Decl. ISO MSJ”) [Dkt. No. 73-2] ¶ 3 & Ex. B (2002 4 Abilify Label). It has since been approved by the FDA to treat several other mental health 5 conditions, including bipolar disorder and Major Depressive Disorder (“MDD”). See id. ¶ 4 & Ex. 6 C (2009 Abilify Label at 1). Since the medication was first marketed, the Abilify label has 7 included the following warning about the risks of TD: 8 5.4 Tardive Dyskinesia 9 A syndrome of potentially irreversible, involuntary, dyskinetic movements may 10 develop in patients treated with antipsychotic drugs. Although the prevalence of the 11 syndrome appears to be highest among the elderly, especially elderly women, it is 12 impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic 13 treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug 14 products differ in their potential to cause tardive dyskinesia is unknown. 15 The risk of developing tardive dyskinesia and the likelihood that it will become 16 irreversible are believed to increase as the duration of treatment and the total cumulative 17 dose of antipsychotic drugs administered to the patient increase. However, the syndrome 18 can develop, although much less commonly, after relatively brief treatment periods at low 19 doses. 20 There is no known treatment for established cases of tardive dyskinesia, although 21 the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. 22 Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and 23 symptoms of the syndrome and, thereby, may possibly mask the underlying process. The 24 effect that symptomatic suppression has upon the long-term course of the syndrome is 25 unknown. 26 Given these considerations, ABILIFY should be prescribed in a manner that is most 27 likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment 1 that (1) is known to respond to antipsychotic drugs and (2) for whom alternative, equally 2 effective, but potentially less harmful treatments are not available or appropriate. In 3 patients who do require chronic treatment, the smallest dose and the shortest duration of 4 treatment producing a satisfactory clinical response should be sought. The need for 5 continued treatment should be reassessed periodically. 6 If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, drug 7 discontinuation should be considered. However, some patients may require treatment with 8 ABILIFY despite the presence of the syndrome. 9 Id., Ex. B (2002 Abilify Label at 8-9); see also Ex. C (2009 Abilify Label at 17-18). 10 In 2010, Rodman’s prescribing physician and psychiatrist, Dr. John Hawkins, diagnosed 11 Rodman with MDD and prescribed her Abilify. Id., Ex. A, (Hawkins Dep. at 157:3-24) and Ex. 12 H, (Rodman Medical Records at 28, 32). In June 2015, after a change in medical insurance, 13 Rodman emailed Dr. Hawkins explaining that Abilify has become “quite expensive” and asking 14 for instructions about how best to discontinue the medication. Id., Ex. H (Rodman Medical 15 Records at 334). Dr. Hawkins replied with instructions for weaning her off Abilify and told her to 16 monitor her mood as she did. Id. He also instructed her to “be sure to follow-up with a new 17 psychiatrist under you[r] new medical coverage.” Id. 18 On March 30, 2016, a doctor at the University of Florida diagnosed Rodman with 19 “dyskinesia of the tongue.” Id., Ex. J (Rodman Dental Records at 9). On May 19, 2016, she 20 began seeing a neurologist, Dr. Anette Nieves, who treated her TD symptoms. Id., Ex. F (Nieves 21 Dep. at 47:11-48:23). 22 In the First Amended Complaint (“FAC”) [Dkt. No. 28], Rodman alleges three theories 23 with regard to failure to warn: (i) the Abilify label “did not accurately reflect the incidence and 24 risk of developed [TD]” with the use of Abilify (FAC ¶¶ 26, 30); (ii) the Abilify label “failed to 25 specifically discuss the fact that [TD] had been reported in patients taking Abilify, including those 26 taking lower doses for depression” (FAC ¶ 25); and (iii) the label failed to “provide[] a discussion 27 or instruction regarding specific methods for screening patient for [TD], such as AIMS (Abnormal 1 FAC ¶¶ 34-35.1 2 On March 2, 2020, Rodman filed a motion for partial summary judgment on the failure to 3 warn claim and motion to exclude or limit the expert reports of Dr. Polfliet and Dr. Correll. See 4 Plaintiff’s Motion for Partial Summary Judgment (“Rodman Partial SJ”) [Dkt. No. 66]; Plaintiff’s 5 Motion to Exclude Duplicative Expert Testimony and Motion to Exclude Inadmissible Expert 6 Testimony (“Rodman Mot. Exclude”) [Dkt. No. 65]. On the same day, Otsuka filed its motion for 7 summary judgment on both the failure to warn and design defect claims and a motion to exclude 8 the expert report of Dr. Plunkett. See Defendant’s Motion for Summary Judgment (“Otsuka 9 MSJ”) [Dkt. No. 67]; Defendant’s Motion to Exclude Testimony of Laura M. Plunkett (“Otsuka 10 Mot. Exclude”) [Dkt. No. 68].2 On May 6, 2020, I heard argument from the parties. 11 LEGAL STANDARD 12 I. MOTION FOR SUMMARY JUDGMENT 13 Summary judgment on a claim or defense is appropriate “if the movant shows that there is 14 no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of 15 law.” Fed. R. Civ. P. 56(a). In order to prevail, a party moving for summary judgment must show 16 the absence of a genuine issue of material fact with respect to an essential element of the non17 moving party’s claim, or to a defense on which the non-moving party will bear the burden of 18 persuasion at trial. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Once the movant has 19 made this showing, the burden then shifts to the party opposing summary judgment to identify 20 “specific facts showing there is a genuine issue for trial.” Id. The party opposing summary 21 judgment must present affirmative evidence from which a jury could return a verdict in that 22 party’s favor. Anderson v. Liberty Lobby, 477 U.S. 242, 257 (1986). 23 On summary judgment, the court draws all reasonable factual inferences in favor of the [25] 1 On November 6, 2018, I denied Otsuka’s motion to dismiss the FAC on grounds that it is barred by California’s two-year statute of limitations. See Order Denying Motion to Dismiss [Dkt. No. [26] 37]. [27] 2 On March 30, 2020, Otsuka filed errata for both of its motions due to clerical errors and errors in 1 non-movant. Id. at 255 . In deciding the motion, “[c]redibility determinations, the weighing of the 2 evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a 3 judge.” Id. However, conclusory and speculative testimony does not raise genuine issues of fact 4 and is insufficient to defeat summary judgment. See Thornhill Publ’g Co., Inc. v. GTE Corp., 594 5 F.2d 730, 738 (9th Cir. 1979). 6 II. MOTION TO EXCLUDE EXPERT TESTIMONY 7 Federal Rule of Evidence 702 allows a qualified expert to testify “in the form of an opinion 8 or otherwise” where: (a) the expert’s scientific, technical, or other specialized knowledge 9 will help the trier of fact to understand the evidence or to determine a fact in issue; 10 (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; 11 and (d) the expert has reliably applied the principles and methods to the 12 facts of the case. 13 Fed. R. Evid. 702. 14 To be admissible under Rule 702 expert testimony must be relevant and 15 reliable. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993). “[R]elevance 16 means that the evidence will assist the trier of fact to understand or determine a fact in 17 issue.” Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007); see also Primiano v. Cook, 598 F.3d 18 558, 564 (9th Cir. 2010) (“The requirement that the opinion testimony assist the trier of fact goes 19 primarily to relevance.”) (internal quotation marks omitted). 20 Under the reliability requirement, the expert testimony must “have] a reliable basis in the 21 knowledge and experience of the relevant discipline.” Primiano, 598 F.3d at 565. To ensure 22 reliability, the court must “assess the [expert’s] reasoning or methodology, using as appropriate 23 such criteria as testability, publication in peer reviewed literature, and general acceptance.” Id. 24 These factors are “helpful, not definitive,” and a court has discretion to decide how to test 25 reliability “based on the particular circumstances of the particular case.” Id. (internal quotations 26 marks and footnotes omitted). “When evaluating specialized or technical expert opinion 27 testimony, the relevant reliability concerns may focus upon personal knowledge or 1 DISCUSSION 2 I. MOTIONS TO EXCLUDE EXPERT TESTIMONY 3 A. Motion to Exclude Expert Testimony of Dr. Plunkett 4 Rodman retained Dr. Plunkett, a pharmacologist, toxicologist, and FDA regulatory 5 specialist, to support her failure to warn claim. See Corrected Declaration of Matthew M. Saxon 6 in Support of Defendant’s Motion to Exclude Expert Testimony (“Saxon Decl. ISO Mot. 7 Exclude”) [Dkt. No. 74-2] Ex. B (Plunkett Rep.). Otsuka moves to exclude Dr. Plunkett’s 8 testimony on two grounds: (i) she is not qualified to offer label inadequacy opinions and her 9 opinions are not reliable nor based on sufficient facts or data; (ii) she is not qualified to offer a 10 specific causation opinion. Otsuka Mot. Exclude 1. 11 1. Dr. Plunkett’s Opinion on Label Inadequacy 12 Otsuka attacks Dr. Plunkett’s opinions supporting Rodman’s three failure to warn theories 13 that the Abilify label: 14  “failed to adequately describe the risk of [TD] associated with use of the drug” 15 because “the scientific literature [] contained discussion of the fact that the 16 occurrence rate for [TD] was much higher than 0.1 to 1%, the ‘infrequent’ 17 standard that was mentioned in the initial Abilify labeling.” Plunkett Rep. ¶ 33. 18  “failed to specifically discuss the fact that [TD] had been reported in patients 19 taking Abilify, including those taking lower doses for depression.” Plunkett 20 Rep. ¶ 33. 21  “never provided a discussion or instruction regarding specific methods for 22 screening patients for [TD], such as AIMS (Abnormal Involuntary Movement 23 Scale).” Plunkett Rep. ¶ 36. 24 In this section, I focus on whether Dr. Plunkett is qualified to render the first opinion and if it is 25 based both on reliable facts or data and is the product of reliable principles or methods. As I 26 explain later in Sections II.A.2-3, I deny Otsuka’s motion to exclude Dr. Plunkett’s second and 27 third opinions as moot because I am granting Otsuka’s motion for summary judgment on the 1 added these points would not have changed his prescribing decision. 2 Otsuka argues that Dr. Plunkett lacks the qualifications to opine on the adequacy of the 3 Abilify label because she has no special knowledge of antipsychotics like Abilify, she cannot 4 prescribe them, and she has not published articles about them. Otsuka Mot. Exclude 7. 5 While she cannot prescribe Abilify or diagnose TD, those skills are not necessary prerequisites to 6 testifying about the adequacy of Abilify’s label. Dr. Plunkett’s experience and expertise as a 7 toxicologist and pharmacologist qualify her to opine on Otsuka’s labeling practices and the 8 adequacy of its Abilify label. See In re Xarelto (Rivaroxaban) Prod. Liab. Litig., No. MDL 2592, [9] 2017 WL 1352860 , at *2 (E.D. La. Apr. 13, 2017) (denying motion to exclude Dr. Plunkett in case 10 bringing multiple product liability claims, including failure to warn, and finding that she is 11 “qualified to testify about drug pharmacology, general causation, regulatory matters and the 12 adequacy of labels for both prescription and non-prescription drugs”). 13 That said, the method she employed here is problematic. Dr. Plunkett primarily relies on a 14 survey of scientific published literature to conclude that the Abilify label “failed to adequately 15 describe the risk of [TD] associated with use of the drug.” Plunkett Rep. ¶ 33. She describes this 16 survey of scientific literature in paragraph 21 of her report. 17 It was initially reported that the risk of TD was greater with older antipsychotics compared 18 to new agents, like Abilify, but Dr. Plunkett explains that published literature starting as early as 19 2006 found that may not be the case. Id. ¶ 21 (string cite of articles). She draws attention to two 20 sources in particular. The first source is a 2011 study that calculated a 3.4% “estimate of the rate 21 of occurrence of [TD] in a clinic population.” Plunkett Rep. ¶¶ 21, 34; see Saxon Decl. ISO Mot. 22 Exclude, Ex. I (Peña, M.S., et al. 2011, Tardive dyskinesia and other movement disorders 23 secondary to aripiprazole. Mov. Disord. 26:147-152) (hereinafter “Peña study”). The second 24 source is a listing of events found in the FDA Adverse Event Reporting System known as 25 “FAERS”. TD was the second most frequent reported adverse event among Abilify users and Dr. 26 Plunkett finds that this “reporting rate (5%) was similar to the rate reported by Peña in 2011 in 27 clinic experience (3.4%).” Plunkett Rep. ¶ 34. She compares these figures to those provided on 1 observed outside of clinic studies with Abilify; infrequent was defined as an occurrence of greater 2 than 0.1% but less than 1%. Plunkett Rep. ¶ 31.3 3 From all of this she concludes that “consideration of the body of studies related to [TD] 4 and Abilify use show that [TD] is not a rare event (i.e., less than 0.1%) or even an infrequent event 5 (less than 1%) but instead may be considered a common adverse event (greater than 1%).” Id. ¶ 6 21. Her concluding paragraph reads: “Therefore, it is my opinion that the Abilify labeling on the 7 drug prescribed by Dr. Hawkins and used by Ms. Rodman failed to adequately describe the risk of 8 [TD] associated with use of the drug. Moreover, removal of the mention of [TD] from the 9 Adverse Reactions section of the label in 2014 was inconsistent with the fact that the reporting of 10 [TD] in the published literature has risen significantly and that physicians were reporting higher 11 rates of [TD] than 1% (see paragraph 21 above). Failure to provide physicians with accurate and 12 up to date information on the occurrence of [TD] put patients at risk.” Id. ¶ 33. 13 Otsuka’s motion focuses on the inaccuracies of comparing data collected from Dr. 14 Plunkett’s cited sources to data reflected on the Abilify label. The “infrequent” figure of 0.1 to 15 1% that Dr. Plunkett identifies in the Abilify label was a calculated incidence rate of TD among 16 Abilify users; the 5% (from FAERS) and 3.4% (from Peña study) figures she compares it with 17 were not true incidence rates. A true incidence rate is one that looks at a pool of Abilify users to 18 identify how many patients developed TD. The studies Dr. Plunkett cites looked at a pool of those 19 with TD and identified how many of them used Abilify, which does not result in a true incidence [21] 3 Dr. Plunkett also points out that this specific “infrequent” warning was located on the Abilify label when it was first approved by the FDA in 2002. Abilify continued to carry it in 2007, when [22] it was approved for use in MDD. Plunkett Rep. ¶ 31. But in December 2014, the specific mention of “infrequent” occurrence of TD was dropped from that particular “Adverse Reaction” section of [23] the label. Id. She finds it “difficult to understand why the term was removed altogether from this section” given that “by 2014 there were numerous reports of [TD] in the published medical [24] literature (see discussion in above paragraph 21).” Id. ¶ 33. [25] As Otsuka points out, the December 2014 label still mentioned TD under the “Adverse Reaction” section by cross-referencing the reader to the “Warnings and Precautions” section of the label, [26] which contained the warning reproduced in the Background section of this Order. What Dr. Plunkett referred to was the removal of information about the frequency of the TD from a [27] particular portion of the “Adverse Reaction” section of the label. See Declaration of Matthew M. 1 rate. 2 Both the FAERS and Peña study cautioned that their sources cannot be used to calculate an 3 incidence rate. In the cover letter accompanying the FAERS data, which Rodman’s counsel 4 obtained via Freedom of Information Act (“FOIA”) request and on which Dr. Plunkett relied, the 5 FDA expressly stated that the FAERS data cannot be used to calculate an incidence rate. See 6 Saxon Decl. ISO Mot. Exclude, Ex. F (FOIA Request and Response at 5) (“The information in 7 these reports has not been scientifically or otherwise verified as to a cause and effect relationship 8 and cannot be used to estimate the incidence of these events.”) (emphasis added). The Peña study 9 had a similar disclaimer. See id., Ex. I (Peña study at 150) (“[T]he true prevalence and incidence 10 of TD and other drug-induced movement disorders associated with TGAs, such as aripiprazole 11 [Abilify], are not known.”). Dr. Plunkett also conceded in her deposition that the FAERS data and 12 the Peña study did not give her an incidence rate of TD. See id., Ex. C (Plunkett Dep. at 126:1213 15); id., Ex. H (copy of Dr. Plunkett Dep. in Crochet v. Bristol-Myers Squibb Co., Case No. 3:1614 cv-00036 (M.D. La.), at 56:3-6; 324:11-19; 284:4-23). 15 Dr. Plunkett may not “analyze[] data that was not [her] own and reinterpret[] it in a manner 16 inconsistent with the conclusions of those who originally generated it.” Carnegie Mellon Univ. v. 17 Hoffmann-LaRoche, Inc., 55 F. Supp. 2d 1024, 1040 (N.D. Cal. 1999); In re Accutane Prod. Liab., 18 No. 804-MD-2523-T-30TBM, 2009 WL 2496444 , at *2 (M.D. Fla. Aug. 11, 2009), aff’d, 378 F. 19 App’x 929 (11th Cir. 2010) (“[W]hen an expert relies on the studies of others, he must not exceed 20 the limitations the authors themselves place on the study.”). Indeed, “experts are properly 21 disqualified if the studies on which they rely merely suggest, without definitely concluding, the 22 truth of a particular assertion.” Haynes ex rel. Haynes v. Nat’l R.R. Passenger Corp., 319 F. 23 App’x 541, 543 (9th Cir. 2009) (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136 , 144–47 (1997)). 24 Notably, Dr. Plunkett’s testimony has been previously excluded in another drug product 25 liability case on analogous grounds. The court in In re Mirena Ius Levonorgestrel-Related Prod. 26 Liab. Litig. (No. II), 341 F. Supp. 3d 213, 260 (S.D.N.Y. 2018) concluded “there [was] too great 27 an analytic gap between the available data and the conclusion” that Dr. Plunkett drew. In that 1 hypertension. In making her conclusion, she found that the temporality factor was satisfied based 2 on her reliance on “three studies which, she stated, had ‘addressed’ temporality (by Valenzuela, 3 Rai, and Alder) and on three case reports drawn from the Bayer database.” Id. at 255 . “Beyond 4 identifying these materials, however, Dr. Plunkett [did] not address their contents. The 5 Valenzuela authors, for instance, specifically noted in their publication that they lacked temporal 6 data.” Id. The court found that “Dr. Plunkett’s handling of the Valenzuela study is [] 7 problematic” and ultimately excluded her proposed testimony because it was “beset by 8 methodological deficiencies.” Id. at 261 , 263 9 Similarly, in this case Dr. Plunkett exceeds the boundaries of the sources she relies on by 10 going beyond what the sources concluded. Without explanation, she compares figures that authors 11 explicitly cautioned are not true incidence rates with the true incidence rate provided in Abilify’s 12 label. Rodman argues that only Otsuka has the capability to calculate the true incidence rates, but 13 this assertion is rebutted by Otsuka’s expert, Dr. Correll, who was able to conduct a true incidence 14 rate study of Abilify (which Rodman does not seek to exclude).4 15 Dr. Plunkett does not explain why it makes sense to compare different data sets and how 16 that necessarily leads to her conclusion that the Abilify label was inadequate. For example, she 17 does not address the contents of the Peña study that gave her the supposedly comparative figure of 18 3.4%. The Peña study was an analysis of TD patients over the span of eight years at a movement 19 disorders clinic in Houston, Texas. The review found that for 8 out of the clinic’s 236 patients 20 being treated for TD, their symptoms were either “definite[ly]” or “probabl[y]” associated with 21 Abilify. See Saxon Decl. ISO Mot. Exclude, Ex. I (Peña study at 150).5 Importantly, the study 22 analyzed a pool of TD patients and tracked whether they had taken Abilify in the past, not a pool [23] 4 As discussed in Section I.B. of this Order, Rodman’s motion to exclude other portions of Dr. [24] Correll’s expert testimony is DENIED as moot. [25] 5 A patient was categorized as “definite” Abilify-associated TD if Abilify was the only neuroleptic used prior to the onset of the movement disorder; a patient was categorized as “probable” if the [26] patient was exposed to multiple neuroleptics, but [Abilify] was the last one before the movement disorder emerged. See Saxon Decl. ISO Mot. Exclude, Ex. I (Peña study at 150). Out of the eight [27] patients identified in the study, five patients were categorized as “definite” and three were 1 of Abilify users to track whether they contracted TD, which would have led to a true incidence 2 rate. In addition to cautioning that the study did not provide a true incidence rate, the authors 3 recognized that although patients classified as “definite” were “only those patients taking [Abilify] 4 alone before the developments of TD, we cannot exclude the possibility that they were also taking 5 other neuroleptics as medication history was obtained only from the patient interview.” Id. at 151. 6 In her opposition, Rodman attempts to characterize Dr. Plunkett’s report in a different way. 7 She claims that even though the data and studies Dr. Plunkett relies upon cannot establish 8 incidence rates, they “should have alerted Otsuka to investigate and change the Abilify label.” 9 Plaintiffs’ Memorandum of Points and Authorities in Opposition to Defendant’s Motion to 10 Exclude Testimony of Dr. Laura M. Plunkett [Dkt. No. 75] 13. But the concluding paragraph in 11 question here, on which Rodman primarily relies for her failure to warn claim, reflects a different 12 conclusion: During this time, the scientific literature also contained discussion of 13 the fact that the occurrence rate for tardive dyskinesia was much higher than 0.1 to 1%, the “infrequent” standard that was mentioned 14 in the initial Abilify labeling and in the labeling in 2010 through December 2014 as well. Therefore, it is my opinion that the Abilify 15 labeling on the drug product prescribed by Dr. Hawkins and used by Ms. Rodman failed to adequately describe the risk of tardive 16 dyskinesia associated with use of the drug. 17 Plunkett Rep. ¶ 33. 18 Rodman also argues that Dr. Plunkett’s report would be helpful to the jury because her 19 expertise in FDA regulation is necessary to explain how Otsuka should have used the information 20 at its disposal to label its product correctly. But Dr. Plunkett’s report does not opine on whether 21 Otsuka met the FDA guidelines; she testifies about whether the Abilify label adequately warns 22 doctors about use of this prescription drug.6 23 Because Dr. Plunkett extrapolated conclusions beyond the scope of her sources, I find that [25] 6 Even if I take Rodman’s re-characterization of Dr. Plunkett’s report at face value, Dr. Plunkett does not explain how a failure to investigate informs her failure to warn claim. See, e.g., Latiolais [26] v. Merck & Co., Inc., 2007 WL 5861354 , at *3 n.1 (C.D. Cal. 2007) (finding a failure-to-act theory, based on pharmaceutical negligent testing of medication, “is subsumed by the [27] manufacturer’s duty to warn and it does not change the premise of Plaintiff’s claims, which is that 1 her opinion on label inadequacy is not the product of reliable principles or methods. Otsuka’s 2 motion to exclude Dr. Plunkett’s opinion on label inadequacy is GRANTED and its motion to 3 exclude other opinions by Dr. Plunkett, namely on specific causation, is DENIED as moot. As 4 explained below, this is ultimately fatal to Rodman’s failure to warn claim on the theory that the 5 Abilify label underreported the risk of contracting TD. 6 B. Motion to Exclude Expert Testimony of Dr. Polfliet and Dr. Correll 7 Rodman moves to exclude Dr. Polfliet’s expert testimony on grounds that it is duplicative 8 with testimony from Otsuka’s other expert, Dr. Correll, and to exclude certain portions of Dr. 9 Polfliet’s and Dr. Correll’s opinions because they “improperly offer legal conclusions” regarding 10 Dr. Hawkins’ testimony and speculate as to his state of mind. Rodman Mot. Exclude 3-4, 9-11. 11 Given my ruling on the other motions, Rodman’s motion to exclude is DENIED as moot. 12 II. MOTIONS FOR SUMMARY JUDGMENT 13 A. Failure to Warn 14 A manufacturer of a prescription drug is obligated warn physicians, not patients, of 15 potential side effects associated with its pharmaceutical products. Motus v. Pfizer Inc., 196 F. 16 Supp. 2d 984, 990 (C.D. Cal. 2001) (“Motus I”), aff’d sub nom. Motus v. Pfizer Inc. (Roerig Div.), [17] 358 F.3d 659 (9th Cir. 2004) (“Motus II”). Known as the “learned intermediary” doctrine, the 18 duty to warn the physician—rather than the patient—applies in the case of prescription drugs and 19 implants, where “the physician stands in the shoes of the ‘ordinary user’ because it is through the 20 physician that a patient learns of the properties and proper use of the drug or implant.” Valentine 21 v. Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1483 (1999). A manufacturer discharges its 22 duty to warn if it provides adequate warnings to the physician about any known or reasonably 23 knowable dangerous side effects, regardless of whether the warning reaches the patient. Motus I, 24 196 F. Supp. 2d, at 991 (citation omitted). 25 “A plaintiff asserting causes of action based on a failure to warn must prove not only that 26 no warning was provided or the warning was inadequate, but also that the inadequacy or absence 27 of the warning caused the plaintiff’s injury.” Motus I, 196 F. Supp. 2d at 991. Whether a warning 1 & Co., 2015 WL 5008263 at *7 (C.D. Cal. 2015). There can be no genuine dispute about the 2 adequacy of a warning that “directly warns in plain and explicit terms of the specific risk that has 3 caused injury to the plaintiff.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644 , 673-74 4 (S.D.N.Y. 2017) (applying California law), aff’d sub nom. Gibbons v. Bristol-Myers Squibb Co., [5] 919 F.3d 699 (2d Cir. 2019). 6 Otsuka moves for summary judgment on the failure to warn claim on grounds that Rodman 7 has failed to adduce any evidence that the Abilify label was inadequate or that an additional 8 warning would have changed how Dr. Hawkins treated her. Otsuka MSJ 10. Rodman cross9 moves for partial summary judgment on grounds that there is no genuine dispute that the Abilify 10 label was inadequate under all three of her failure to warn theories. Rodman Partial SJ 2. While 11 she does not explicitly say so in her motion, she appears to argue that there is no genuine dispute 12 on the proximate causation element of her failure to warn claim as well. Id. at 10. 13 1. Rodman’s First Theory: the label understated the incidence and risk of developing TD with use of Abilify [14] Rodman concedes that the Abilify label mentions TD as a risk; instead, she contends that [15] Otsuka “failed to disclose the actual risk of contracting [TD] adequately, that was known or [16] knowable in light of the generally recognized and prevailing scientific and medical knowledge [17] available at the time of manufacture and distribution.” Rodman Partial SJ 1. She relies on Dr. [18] Plunkett’s expert report to argue that she has met the first element (label inadequacy) of her failure [19] to warn claim under this theory. Id. at 6-7; see also id. at 8 (“Dr. Plunkett concluded her report [20] and testimony by confirming that defendant failed to properly identify the incidence rate of tardive [21] dyskinesia.”) [22] Because I exclude Dr. Plunkett’s opinion on this point and that opinion is essential to the [23] first element of Rodman’s failure to warn theory, summary judgment is GRANTED to Otsuka. [24] See, e.g., Carlucci v. CNH America LLC, No. 10–12205–DPW, 2012 WL 4094347 , at *1, *10 (D. [25] Mass. Sept.14, 2012) (noting that “[a]fter determining to grant [the defendant’s] motion to exclude [26] [the plaintiffs’ defective design and warnings expert’s] testimony, [the court] conclude[s][it] [27] should grant [the defendant’s] motion for summary judgment” since “[a]s to their negligence and 1 breach of implied warranty claims for design defects . . . the [plaintiffs’] lack of expert testimony 2 is fatal”).7 3 2. Rodman’s Second Theory: the label failed to specifically discuss the fact that TD has been reported in patients taking Abilify, including 4 those taking lower doses 5 “[I]nadequacy of the warning and causation are separate elements of Plaintiffs’ affirmative 6 burden.” Tucker v. Wright Med. Tech., Inc., No. 11-CV-03086-YGR, 2013 WL 1149717 , at *16 7 (N.D. Cal. Mar. 19, 2013). Therefore, even if a warning was inadequate, “a product defect claim 8 based on insufficient warnings cannot survive summary judgment if stronger warnings would not 9 have altered the conduct of the prescribing physician.” Motus II, 358 F.3d at 661 . In other words, 10 a defendant may prevail on summary judgment “by showing that Plaintiff lacks evidence 11 establishing that an adequate warning would have affected [the doctor’s] decision to prescribe [the 12 medication].” Motus I, 196 F. Supp. 2d at 992. A defendant “need not produce its own evidence; 13 pointing to an absence of evidence on the Plaintiff’s part is sufficient.” Id. (citation omitted). 14 Rodman argues that the label warning failed to specifically discuss the fact that TD has 15 been reported in patients taking Abilify, including those taking lower doses for depression. 16 Otsuka responds that the label already included a warning to physicians that patients taking low 17 doses of Abilify could develop TD. See Saxon Decl. ISO MSJ, Ex. B (2002 Abilify Label at 8-9) 18 (stating that TD “can develop, although much less commonly, after relatively brief treatment 19 periods at low doses”); id., Ex. C (2009 Abilify Label at 17-18) (same); Declaration of Matthew 20 M. Saxon in Support of Defendant’s Reply in Support of its Motion to Exclude Expert Testimony 21 [Dkt. No. 81-1] ¶ 6 & Ex. E (2014 Abilify Label at ECF page number 417). 22 Even assuming that the label did not include an adequate warning about TD risks at low 23 doses, Rodman’s argument fails. Dr. Hawkins confirmed that he was aware that Abilify could 24 cause TD even in patients taking lower doses. See Saxon Decl. ISO MSJ, Ex. A (Hawkins Dep. at [26] 7 At the hearing, Rodman argued that she has met the second element of her failure to warn claim under this theory because Dr. Hawkins testified that if the incidence rate of TD was higher than [27] depicted on the Abilify label, then it would have impacted his prescribing decision. Even if 1 263:18-264:2) (statement that “syndrome can develop . . . after relatively brief periods at low 2 doses” was “consistent with [his] understanding while [he was] treating Ms. Rodman”). He 3 repeatedly testified that he “knew when [he was] prescribing Ms. Rodman Abilify that [TD] was 4 one of the risks of the medication,” and that “[TD] was a possibility” with the use of Abilify. See 5 id. at 121:20-122:15, 118:18-25; see also id. at 102:10-14 (admitting that “when [he] began 6 prescribing Ms. Rodman Abilify, at that time [he] understood that [TD] was one of the risks 7 associated with the use of Abilify”). He also testified that he understood that one of the risks 8 “related to discontinuing use of Abilify” was that “there can be symptoms of [TD] when an 9 antipsychotic is discontinued.” Id. at 294:14-19. Even if the label had included the warning 10 desired by Rodman, Dr. Hawkins unequivocally testified that it would not have impacted his 11 prescribing decision. 12 Otsuka’s motion for summary judgment on this failure to warn theory is GRANTED. 13 3. Rodman’s Third Theory: the label failed to provide instruction regarding specific methods for screening patients for TD, such as the 14 AIMS test 15 Rodman argues that the Abilify label failed to provide a discussion or instruction regarding 16 specific methods for screening patients for TD, such as the AIMS test. But Dr. Hawkins testified 17 that he knew how to monitor for TD symptoms, including using the AIMS test, and monitored 18 Rodman while she was in his care. See Saxon Decl. ISO MSJ, Ex. A (Hawkins Dep. at 124:21-24, 19 126:25-127:15, 270:10-271:13 (Dr. Hawkins testified that he was “familiar with the AIMS test” at 20 the time he was prescribing Abilify to Rodman, that he has been familiar with the test “for a long 21 time” having learned about it during medical school or residency training, and that he “didn’t need 22 a drug company at the time to tell [him] about the AIMS test”). A change in the label would not 23 have impacted Dr. Hawkins’s prescribing decision because he already understood ways to monitor 24 Rodman for TD symptoms, including the AIMS test. Accordingly, Otsuka’s motion for summary 25 judgment on this failure to warn theory is GRANTED. 26 In sum, summary judgment is GRANTED to Otsuka on all three theories of Rodman’s 27 failure to warn claim. B. Design Defect [1] California does not recognize strict liability for design defects in prescription drugs. See [2] Brown v. Super. Ct., 44 Cal.3d 1049, 1061 (1988) (“[A] drug manufacturer’s liability for a [3] defectively designed drug shall not be measured by the standards of strict liability.”). A plaintiff [4] alleging a design defect claim under a negligence theory must prove “that the defect in the product [5] was due to negligence of the defendant.” Tucker, 2013 WL 1149717 , at *7 (N.D. Cal. Mar. 19, [6] 2013) (quoting Chavez v. Glock, Inc., 207 Cal.App.4th 1283, 1305 (2012)). As with a general [7] negligence claim, the plaintiff must show breach of duty, causation, and damages. Id. (citation [8] omitted). Concerning the standard of care for negligence, a “[designer/manufacturer/etc.] is [9] negligent if [it] fails to use the amount of care in [designing/manufacturing/etc.] the product that a [10] reasonably careful [designer/manufacturer/etc.] would use in similar circumstances to avoid [11] exposing others to a foreseeable risk of harm. Id. (citation omitted, alteration in original). [12] Generally, “the test of negligent design involves a balancing of the likelihood of harm to [13] be expected from a [product] with a given design and the gravity of harm if it happens against the [14] burden of the precaution which would be effective to avoid the harm.” Tucker, 2013 WL 15 1149717, at * 7 (quoting Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479 (2001)). Even if a [16] manufacturer has done all it reasonably could have done to warn about a risk or hazard related to a [17] product’s design, a reasonable person could conclude that the magnitude of the reasonably [18] foreseeable harm as designed outweighed the utility of the product as designed. Id. (citation [19] omitted). “In evaluating the adequacy of a product’s design under the risk-benefit test, ‘a jury may [20] consider, among other relevant factors, the gravity of the danger posed by the challenged design, [21] the likelihood that such danger would occur, the mechanical feasibility of a safer alternative [22] design, the financial cost of an improved design, and the adverse consequences to the product and [23] to the consumer that would result from an alternative design.’” Tucker, 2013 WL 1149717 , at * 8 [24] (citation omitted). [25] In opposing Otsuka’s summary judgment motion on this claim, Rodman argues that she [26] “has no obligation” to offer evidence at this point because she is “not required to divulge the [27] testimony of medical witnesses designated to testify at trial.” Plaintiff’s Opposition to 1 Defendant’s Motion for Summary Judgment (“Oppo. Otsuka MSJ”) [Dkt. No. 77] 15-16. This is 2 not the law. As the non-moving party with the burden of proof, Rodman “must set forth by 3 affidavit or other admissible evidence, specific facts demonstrating the existence of an actual issue 4 for trial”; she “may not merely state that [she] will discredit the moving party’s evidence at trial 5 and proceed in the hope that something can be developed at trial in the way of evidence to support 6 [her] claim.” T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors Ass’n, 809 F.2d 626 , 630 (9th Cir. 7 1987); see also Richardson v. CBS Studios Inc., No. CV 12-7925 ABC (SHX), 2013 WL 8 12120265, at *7 (C.D. Cal. Sept. 25, 2013) (“[s]ummary judgment is warranted because Plaintiffs, 9 the non-moving parties, have failed to produce enough evidence to create a genuine issue” and 10 cannot wait until trial to present that evidence); Codding v. Pearson Educ., Inc., No. 18-CV11 00817-LB, 2019 WL 5864579 , at *10 (N.D. Cal. Nov. 8, 2019) (granting summary judgement 12 after rejecting argument that plaintiff “has no obligation to offer affirmative evidence on [] issue 13 until trial”). 14 The limited evidence Rodman does identify comes short of creating a genuine dispute on 15 the design defect claim. She cites the deposition of Dr. Anette Nieves, the neurologist who 16 diagnosed her with TD, who testified that she does not prescribe Abilify to her patients and that 17 she may prescribe clonazepam and quetiapine when “a patient would come off of an antipsychotic 18 medication.” See Declaration of Perry R. Staub, Jr. in Support of Opposition to Defendant’s 19 Motion for Summary Judgment (“Staub Decl.”), Ex. 2 (Nieves Dep. at 38:3-10). Dr. Nieves never 20 suggested that these two medications were safer alternatives to Abilify, just that she would 21 recommend patients take these medications when “com[ing] off an antipsychotic medication,” like 22 Abilify. Id. at 38:5 . 23 Rodman also cites testimony from Dr. Hawkins that if he had been aware that the rate of 24 TD was higher than that reported in the label, he might have considered other alternative 25 medications. Oppo. Otsuka MSJ 15. But this testimony does not address whether there were any 26 safer alternative medications to Abilify. 27 Next, she relies on two portions of Dr. Plunkett’s expert report that discuss the different 1 16. In the first portion, Dr. Plunkett merely describes “[o]ther drugs that have been or are used 2 today in the treatment of psychotic disorders,” not that any of these are necessarily safer 3 alternatives than Abilify. Staub Decl., Ex. 3 (Plunkett Rep. ¶ 15). In the other portion, Dr. 4 Plunkett finds that “like other anti-psychotic drugs, the risk of adverse events such as [TD] would 5 be biologically plausible”; Rodman does not explain how this shows existence of a safe alternative 6 design. Id. at ¶ 20. Rodman fails to show how any of Dr. Plunkett’s concluding paragraphs relate 7 to her design defect claim. Id. ¶¶ 33-38. 8 Even if the testimony she points to could somehow create a genuine despite on the 9 existence of a safe alternative design, Rodman fails to address any other elements of a design 10 defect claim. For example, she does not point to evidence that goes to the relative costs and 11 benefits of Abilify as compared with similar drugs on the market. Nor does she provide any 12 evidence that Otsuka failed to design Abilify with the amount of care that a reasonably careful 13 designer or manufacturer would have used in similar circumstances and “presents no admissible 14 evidence regarding what a reasonably careful designer or manufacturer would have done with 15 respect to the design.” Mariscal v. Graco, Inc., 52 F. Supp. 3d 973, 991 (N.D. Cal. 2014) 16 (granting summary judgment to defendant where plaintiff “produced no other admissible evidence 17 from which a jury could deduce the appropriate standard of care, which is fatal to [plaintiff’s] 18 negligent design defect claim”). Instead, she incorrectly argues that she “has no obligation to 19 divulge the planned trial testimony of treating medical physicians disclosed as testifying experts at 20 trial.” Oppo. Otsuka MSJ 16. 21 For these reasons, Otsuka’s motion for summary judgment on the design defect claim is 22 GRANTED. 23 CONCLUSION 24 Accordingly, Otsuka’s motion for summary judgment on all three theories of Rodman’s 25 failure to warn claim and design defect claim is GRANTED. Its motion to exclude Dr. Plunkett’s 26 expert testimony on label inadequacy is GRANTED and the rest of its motion is DENIED as 27 moot. Rodman’s motion for partial summary judgment on her failure to warn claim is DENIED 1 and her motion to exclude Dr. Polfliet’s and Dr. Correll’s expert testimony is DENIED as moot. 2 IT IS SO ORDERED. 3 Dated: May 18, 2020 \ 5 ® liam H. Orrick 6 United States District Judge [11] a 12 [16] Z 18