Byrd v. Janssen Pharm., Inc.
Byrd v. Janssen Pharm., Inc.
Opinion of the Court
Currently before the Court, in this products liability action filed by Shaquil Byrd ("Plaintiff") against Janssen Pharmaceuticals, Inc. ("Janssen"), and Johnson & Johnson ("Defendants"), is Defendants' motion for judgment as a matter of law pursuant to Fed. R. Civ. P. 50 or, in the alternative, for a new trial pursuant to Fed. R. Civ. P. 59. (Dkt. No. 199.) For the reasons set forth below, Defendants' motion is granted.
TABLE OF CONTENTS
I. RELEVANT BACKGROUND ...115
A. Relevant Procedural History ...115
B. Parties' Briefing on Defendants' Motion Generally ...115
II. GOVERNING LEGAL STANDARDS ...116
A. Legal Standard Governing Motions for Judgment Notwithstanding the Verdict Pursuant to Fed. R. Civ. P. 50(b) ...116
B. Legal Standard Governing Motions for a New Trial Pursuant to Fed. R. Civ. P. 59(a)...116 -
C. Legal Standards Governing Grounds Asserted by Defendants ...117
III. ANALYSIS ...117
A. Whether Defendants Are Entitled to Judgment as a Matter of Law Because Plaintiff's Failure-to-Warn Claim Is Preempted ...117
1. Parties' Briefing of This Issue ...117
2. Legal Standard Governing This Issue ...120
3. Analysis of This Issue ...120
B. Whether Defendants Are Entitled to Judgment as a Matter of Law for the Alternative Reason that Plaintiff Failed to Introduce Sufficient Evidence of Proximate and Medical Causation ...125
1. Parties' Briefing of This Issue ...125
2. Legal Standard Governing This Issue ...126
3. Analysis of This Issue ...127
C. Whether, in the Alternative, Defendants Are Entitled to a New Trial Because of the Conduct of Plaintiff's Counsel ...131
1. Parties' Briefing of This Issue ...131
2. Legal Standard Governing This Issue ...132
3. Analysis of This Issue ...133
D. Remaining Issues (I.e., Whether Plaintiff Cannot Establish that Defendant Johnson & Johnson Is Liable as a Matter of Law, Whether the Jury Verdict *115Is Against the Weight of the Evidence, and Whether Plaintiff's Award Is Excessive )...135
I. RELEVANT BACKGROUND
A. Relevant Procedural History
Generally, following the issuance of the Court's Decision and Order of March 7, 2017, two claims of Plaintiff's Amended Complaint survived Defendants' motion for summary judgment: (1) Plaintiff's claim that Defendants were negligent in designing, manufacturing, and selling Risperdal as well as in failing to properly warn the general public of the risks and dangers of Risperdal ; and (2) Plaintiff's claim that Defendants are strictly liable for the injuries caused by (a) Risperdal's defective condition, (b) the failure to give appropriate warnings regarding the drug's dangers and adverse effects, and (c) their misleading representations regarding the risk of gynecomastia and hyperprolactinemia in adolescent patients. (Dkt. No. 108, at 70.)
The trial on these two claims commenced on September 18, 2017. (Dkt. No. 163.) At the conclusion of the trial on September 27, 2017, the jury reached a verdict against Plaintiff with regard to his negligent design claim but in favor of him with regard to his failure-to-work claim, awarding him $500,000 for past and/or present pain and suffering and $500,000 in future pain and suffering; and Judgment was entered accordingly. (Dkt. Nos. 179, 180.) On October 25, 2017, Defendants filed the current motion for judgment a matter of law pursuant to Fed. R. Civ. P. 50 or, in the alternative, for a new trial pursuant to Fed. R. Civ. P. 59. (Dkt. No. 199.) Plaintiff has opposed this motion. (Dkt. No. 204, 205.)
Because this Decision and Order is intended primarily for the review of the parties, who have (in their memoranda of law) demonstrated an accurate understanding of the remainder of the relevant procedural history of this action, the Court will not summarize the remainder of that procedural history in detail in this Decision and Order.
B. Parties' Briefing on Defendants' Motion Generally
Generally, in their motion, Defendants assert the following arguments: (1) as a threshold matter, Defendant Janssen is entitled to judgment as a matter of law because (a) Plaintiff's failure-to-warn claim is preempted by federal law, (b) Plaintiff failed to introduce sufficient evidence of proximate and medical causation, and (c) Plaintiff cannot establish that Defendant Johnson & Johnson is liable; and (2) in the alternative, Defendant Janssen is entitled to a new trial because (a) the jury's verdict is against the weight of the evidence, (b) the conduct of Plaintiff's counsel warrants a new trial, and (c) Plaintiff's award is excessive (warranting either remittitur or a new trial). (Dkt. No. 199, Attach. 1.)
Generally, in opposition to Defendants' motion, Plaintiff asserts the following arguments: (1) Defendants are not entitled to judgment as a matter of law because (a) their preemption arguments are meritless, unavailing and frivolous, (b) their arguments regarding causation are similarly unavailing and (c) Defendant Johnson & Johnson is liable just as Defendant Janssen is liable; and (2) there is no legal basis warranting a new trial because (a) the verdict is supported by compelling evidence, (b) there is no evidence of prejudice against Defendants created by the actions of Plaintiff's counsel, and (c) Plaintiff's award is not excessive but is comparable to awards in identical cases. (Dkt. No. 205.)
Generally, in reply, Defendants repeat the arguments asserted in their memorandum *116of law-in chief, albeit modified to reply to Plaintiff's responses. (Dkt. No. 206.)
II. GOVERNING LEGAL STANDARDS
A. Legal Standard Governing Motions for Judgment Notwithstanding the Verdict Pursuant to Fed. R. Civ. P. 50(b)
Rule 50(b) of the Federal Rules of Civil Procedure provides as follows, in pertinent part:
If the court does not grant a motion for judgment as a matter of law made under Rule 50(a), the court is considered to have submitted the action to the jury subject to the court's later deciding the legal questions raised by the motion. No later than 28 days after the entry of judgment-or if the motion addresses a jury issue not decided by a verdict, no later than 28 days after the jury was discharged-the movant may file a renewed motion for judgment as a matter of law and may include an alternative or joint request for a new trial under Rule 59.
Fed. R. Civ. P. 50(b) (emphasis added).
As a result, a prerequisite for a motion for a post-trial motion for a judgment as a matter of law (also known as a motion for judgment notwithstanding the verdict) is a pre-verdict motion for judgment as a matter of law. See Fed. R. Civ. P. 50 Advisory Committee Note (1963) ("A motion for judgment notwithstanding the verdict will not lie unless it was preceded by a motion for a judgment as a matter of law made at the close of all the evidence.") (emphasis added); Fed. R. Civ. P. 50 Advisory Committee Note (1991) ("A post-trial motion for judgment can be granted only on grounds advanced in the pre-verdict motion."); Exxon Shipping Co. v. Baker ,
Such a post-trial motion may be granted by a district court where doing so is necessary to prevent "manifest injustice." Kirsch v. Fleet Street, Ltd. ,
B. Legal Standard Governing Motions for a New Trial Pursuant to Fed. R. Civ. P. 59(a)
Rule 59(a) of the Federal Rules of Civil Procedure provides, in pertinent part, that "[t]he court may, on motion, grant a new trial on all or some of the issues-and to any party- ... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court ...." Fed. R. Civ. P. 59(a)(1)(A). The Second Circuit has interpreted this *117standard to permit the granting of new trials when, "in the opinion of the district court, the jury has reached a seriously erroneous result or the verdict is a miscarriage of justice." DLC Mgmt. Corp. v. Town of Hyde Park ,
C. Legal Standards Governing Grounds Asserted by Defendants
For ease of analysis, the legal standards governing the grounds asserted by Defendants will be set forth below in Part III of this Decision and Order.
III. ANALYSIS
A. Whether Defendants Are Entitled to Judgment as a Matter of Law Because Plaintiff's Failure-to-Warn Claim Is Preempted by Federal Law
1. Parties' Briefing of This Issue
a. Defendants' Memorandum of Law-in Chief
In their memorandum of law-in chief, Defendants assert three arguments on the subject of preemption: (1) an argument that
More specifically, Defendants' first argument can be broken down into the following three parts: (a) while
Moreover, Defendants' second argument can be broken down into the following two parts: (a) in any event, there is "clear evidence" that FDA would not have approved the proposed labeling during the relevant time period, because (i) despite the fact that Defendant Janssen asked the FDA to include safety information regarding pediatric dosing on Risperdal's label, and the fact that the FDA knew that Risperdal was being used off-label in pediatric patients, the FDA denied Defendant Janssen's request because it believed that adding dosing information for an unapproved population would encourage use of Risperdal for off-label purposes, and (ii) subsequently the FDA repeatedly approved Risperdal's label without requesting any changes regarding pediatric use until October 2006; and (b) rather, a manufacturer of prescription medication may update a label without prior FDA approval only if it acquires new information regarding serious hazards associated with the medication, and here the relationship between antipsychotics and hyperprolactinemia was not new information because it had been discussed in basic psychiatry textbooks for decades, and the FDA does not consider gynecomastia a serious adverse event. (Id. )
Finally, Defendants' third argument can be broken down into the following three parts: (a) the FDA's statement in the 1979 Federal Register (that a manufacturer of prescription medicine may add warnings to labeling) is merely a general statement paralleling the language of
b. Plaintiff's Opposition Memorandum of Law
In his opposition memorandum of law, Plaintiff asserts the following four arguments on the subject of preemption: (1) Defendants' first argument (regarding
c. Defendants' Reply Memorandum of Law
In their reply memorandum of law, Defendants assert the following six arguments on the subject of preemption: (1) that portion of Plaintiff's first argument regarding the preclusive effect to be attributed to the state court decisions from Pennsylvania and California is unpersuasive, because (a) Plaintiff fails to meet his threshold burden of demonstrating how the doctrine of collateral estoppel applies, and (b) the issues in this case (which regard whether
2. Legal Standard Governing This Issue
"Impossibility pre[ ]emption is a demanding defense." Wyeth v. Levine ,
Expressed differently, "[p]ost-FDA approval preemption analysis proceeds in two stages." Utts v. Bristol-Myers Squibb Co. ,
With regard to the second stage, the Third Circuit has explained that the "term 'clear evidence' ... does not refer directly to the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate." In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. ,
3. Analysis of This Issue
After carefully considering the matter, the Court answers the above-described question (i.e., whether Plaintiff's failure-to-warn claim is preempted by federal law) in the affirmative for the reasons stated by Defendants in their memoranda of law. To those reasons, the Court adds the following analysis.
The Court is especially persuaded by the second and third of Defendants' three general arguments described above in Part *121III.A.1.a. of this Decision and Order (i.e., that clear evidence exists that the FDA would not have approved a change to the drug's label, and that contrary arguments are unavailing). In particular, the Court is persuaded by not only the arguments primarily relied on by Defendants in their memorandum of law-in chief and their reply memorandum of law but an argument more-obliquely relied on by Defendants: that the updated warning must have regarded a hazard that was serious.
While the relevant regulations during the time in question permitted Defendants to "add or strengthen a ... warning" without prior FDA approval,
Rather, Plaintiff spent much time at trial adducing the testimony of experts that, in their opinion, gynecomastia is a "serious" adverse event, which Defendant attempted to rebut.
After scouring the record, the Court has found insufficient evidence upon which a jury could rationally answer that question in the affirmative. For the sake of brevity, the Court will not linger on the fact that there appears to be a dearth of evidence that, when Plaintiff underwent surgery on June 24, 2014, he received inpatient hospitalization at Ellis Hospital. The Court will also set aside the fact that any inpatient hospitalization (at a psychiatric facility) that Plaintiff may still need due to his gynecomastia has (by definition) not been prevented by his 2014 surgery,
More important is the fact that, while a November 2014 letter from a FDA senior official (stating that "Gynecomastia is a common clinical manifestation of hyperprolactinemia, regardless or cause, and does not represent a serious adverse event as defined in 21 CFR 3l2.32(a)") was not admitted into evidence because of Fed. R. Evid. 403,
Granted, Dr. Plunkett hastened to add that she personally disagrees with the FDA because hospitalization and/or surgery sometimes result from gynecomastia.
Dr. Plunkett certainly did not testify that the "investigators" or "sponsors"
In short, because it is undisputed that gynecomastia was not a "serious" hazard pursuant to the regulations in existence during the time in question, the Court finds that Defendants could not have unilaterally warned of gynecomastia pursuant to those regulations: even if Defendants had tried to do so, Plaintiff's regulatory expert conceded (as described above) that the FDA would not have approved the proposed change. See, supra, note 10 of this Decision and Order. This admission constitutes the sort of "clear evidence" required under the governing legal standard. See Risperdal & Invega Product Liability Cases , No. BC599531,
For all of these reasons, the Court grants Defendants' motion for judgment a matter of law. The Court notes that, while granting a summary judgment motion based on preemption might have been appropriate, Defendants' motion for summary judgment did not present the issue. (See generally Dkt. No. 92, Attach. 1.) Furthermore, while one of Plaintiff's pre-trial motions in limine and Defendants' response thereto presented the issue (Dkt. No. 142, at 27-29; Dkt. No. 147, at 16-17), the Court found it necessary to receive evidence, and hear additional argument, regarding the issue (Dkt. No. 152, at 17). Having now done so, the Court finds that the issue of preemption has been clarified.
The Court notes also that, in rendering the above-described findings, it does not accept any argument that Defendants could have warned of the risks of gynecomastia on the pre-2006 labeling through other means (such as sales force communica *125tions, medical education, "Dear Doctor" letters, regional advisory committee meetings, its website, or medical literature),
B. Whether Defendants Are Entitled to Judgment as a Matter of Law for the Alternative Reason that Plaintiff Failed to Introduce Sufficient Evidence of Proximate and Medical Causation
1. Parties' Briefing of This Issue
a. Defendants' Memorandum of Law-in Chief
In their memorandum of law-in chief, Defendants assert two arguments on the subject of causation: (1) no alternative warning would have affected the prescribing decisions of Plaintiff's treating doctors, because (a) no alternative label would have affected the prescribing decisions of Plaintiff's expert Dr. Suguna C. Reddy, M.D. (b) no alternative label would have affected the prescribing decisions of Plaintiff's expert Dr. Robertson B. Tucker, M.D., and (c) no alternative warning would have affected the prescribing decisions of Plaintiff's other prescribing physicians; and (2) Plaintiff has not established that his alleged gynecomastia is causally related to Risperdal as a matter of law, because (a) Plaintiff has failed to put forward a prima facie case of general or specific causation (given that [i] Plaintiff's general causation expert Dr. Plunkett conceded she is not an expert regarding causation, and the fact that her opinion is contradicted by the literature she cited, [ii] Plaintiff's expert Dr. Matthew Leinung, M.D., merely assumed that general causation had been proven, [iii] Dr. Leinung failed to properly rule out obesity as a potential cause of Plaintiff's gynecomastia, [iv] Dr. Leinung also failed to properly rule out marijuana and puberty as potential causes of Plaintiff's gynecomastia, and [v] there is undisputed testimony that elevated prolactin levels related to Risperdal cannot cause *126gynecomastia prior to puberty), and (b) Plaintiff has failed to demonstrate that any psychological suffering is linked to his use of Risperdal. (Dkt. No. 199, Attach. 1.)
b. Plaintiff's Opposition Memorandum of Law
In his opposition memorandum of law, Plaintiff asserts the following two arguments on the subject of causation: (1) Plaintiff put forward more than sufficient evidence that Defendants' failure to adequately warn of the frequency of the risk of gynecomastia in children/adolescents proximately caused Plaintiff's injuries, because (a) Plaintiff's prescribing physician Dr. Reddy testified that she would have disclosed any frequent risks (e.g., those of gynecomastia ) had they been contained in the Physicians' Desk Reference , (b) Plaintiff's prescribing physician Dr. Tucker testified that he would have disclosed gynecomastia as a risk of Risperdal if the manufacturers had shared information indicating that it was a frequent risk during the relevant time period, and (c) Plaintiff's mother testified that she never would have consented to Plaintiff taking Risperdal had she been told during the relevant time period that there was even a chance he could develop gynecomastia ; and (2) Plaintiff put forward more than sufficient evidence for a reasonable jury to conclude that Defendants' failure to warn proximately caused Plaintiff's injuries, because (a) Dr. Plunkett testified within a reasonable degree of medical/scientific certainty that Risperdal can cause gynecomastia, (b) Dr. Leinung testified within a reasonable degree of medical/scientific certainty that Risperdal caused Plaintiff's bilateral gynecomastia ; and (c) Plaintiff's expert Dr. George S. Glass, M.D., Plaintiff's mother and Plaintiff's sister all testified in a manner that gave the jury more than sufficient evidence from which to reasonably find that Risperdal was a substantial factor in causing/exacerbating Plaintiff's psychological suffering. (Dkt. No. 205.)
c. Defendants' Reply Memorandum of Law
In their reply memorandum of law, Defendants assert the following two arguments on the subject of causation: (1) Plaintiff has not shown how an alternative label would have affected the prescribing decisions of Plaintiff's treating physicians because (a) Plaintiff does not address Defendants' argument that Plaintiff failed to introduce any evidence that an alternative warning would have affected the prescribing decisions of Plaintiff's physicians who did not testify at trial, (b) Plaintiff's reliance on Dr. Reddy's testimony is insufficient given that, in fact, she testified that she warned Plaintiff and his mother of the risk of gynecomastia, and (c) Plaintiff's reliance on Dr. Tucker's testimony is insufficient given that he testified (and Plaintiff's counsel conceded) that, even with an alternative warning, he would have prescribed Risperdal for Plaintiff; and (2) in his response, Plaintiff addresses none of the numerous flaws identified by Defendants in Plaintiff's arguments regarding the relationship between Risperdal and Plaintiff's injuries, such as (a) the fact that Dr. Plunkett conceded that she was not a causation expert and the fact that her opinion was contradicted by the literature she cited, (b) the fact that Dr. Leinung offered insufficient support for his general causation opinion and filed to properly rule out other likely causes of Plaintiff's gynecomastia, and (c) the fact that undisputed testimony demonstrated that elevated prolactin levels related to Risperdal cannot cause gynecomastia prior to puberty. (Dkt. No. 206.)
2. Legal Standards Governing This Issue
To prevail on a failure-to-warn claim involving prescription medications *127under New York law where the warnings are directed to prescribing physicians, a plaintiff must prove that, "had a different, more accurate warnings been given, his physician would not have prescribed the drug in the same manner." Alston v. Caraco Pharm., Inc. ,
Moreover, with regard to the element of causation, a plaintiff must prove both general causation and specific causation. See DeVito v. Smithkline Beecham Corp. , 02-CV-0745,
3. Analysis of This Issue
After carefully considering the matter, the Court answers the above-described question (i.e., whether Plaintiff failed to introduce sufficient evidence of proximate and medical causation) in the affirmative for the reasons stated by Defendants in their memoranda of law. To those reasons, the Court adds the following analysis.
The Court is especially persuaded that Plaintiff has failed to establish general causation for the second reason described above in Part III.B.1.a. of this Decision and Order (that, as a threshold matter, Dr. Plunkett admitted to not being a causation expert, that, in any event, her opinion is unsupported by the literature she cited, and that Dr. Leinung's opinion was unreliable in that it only assumed general causation).
With regard to the testimony of Dr. Plunkett, in response to the question, "[H]ave you come here today to offer opinion to this jury with respect to whether or not Risperdal can cause gynecomastia ?" Dr. Plunkett responded as follows:
I'm not a causation expert, as a physician but certainly as a pharmacologist and a toxicologist, yes, I have done a review of the scientific information, the clinical information and come to an opinion that indeed Risperdal can cause gynecomastia.
(Dkt. No. 181, at 59 [attaching page "129" of Trial Transcript].) Given the importance of causation in light of the facts of this *128case, Defendants' reliance on Dr. Plunkett's admission to not being a causation expert is well placed.
In any event, even if the Court were to look past this significant admission to the review of literature on which Dr. Plunkett's opinion is based, the fact remains that, while scientific literature may certainly constitute the sort of "sufficient facts or date" required by Fed. R. Evid. 702(b), the purported expert must demonstrate that the literature in question sufficiently supports her opinion.
Dr. Plunkett specifically identified only three pieces of scientific literature as the bases for her opinion: (1) Dr. Robert L. Findling's 2003 paper "Prolactin Levels During Long-Term Risperidone Treatment in Children and Adolescents"; (2) Dr. Jan Croonenberghs' 2005 paper "Risperidone in Children With Disruptive Behavior Disorders and Subaverage Intelligence"; and (3) Dr. Magali Reyes' 2006 paper "Long-Term Use of Risperidone in Children with Disruptive Behavior Disorders and Subaverage Intelligence."
The first piece of literature stated, inter alia , that, although gynecomastia reported in some of the 592 children and adolescents studied, "[n]o correlation was found between [symptoms hypothetically attributable to prolactin] and prolactin levels, even when male gynecomastia during puberty was included." (Dkt. No. 199, Attach. 7, at 8.) The reason that the underlying study did not support such a correlation is that "[o]ne of the deficiencies of this analysis is that there was no long-term control group to show the incidences of gynecomastia, galactorrhea, or menstrual irregularities that may occur normally in such a population." (Id. )
The second piece of literature stated, inter alia , that, although gynecomastia reported in some of the 504 children and adolescents studied, "[g]ynecomastia ... is often observed in normal pubertal boys ... and girls ..., so it is not possible to assess the contribution of risperidone without a placebo control group." (Dkt. No. 199, Attach. 8, at 6, 8.)
The third piece of literature stated, inter alia , that, although gynecomastia reported in some of the 48 children and adolescents studied, "occurrence of gynecomastia was not related to increases in serum prolactin levels." (Dkt. No. 199, Attach. 9, at 8; cf. id. at 11 ["Importantly, elevated prolactin levels were not correlated with the 3 cases of gynecomastia."].) This is because, "[a]lthough there were several potentially prolactin-related [adverse events], it should be noted that some of these, such as gynecomastia in boys over the age of 10 years, often also present as a normal part of puberty." (Id. at 4.) As in the first and second pieces of the literature, this lack of a control group was expressly acknowledged as a "limitation[ ]" of the study. (Id. at 12; see also id. ["Because of its open-label nature, this study could not distinguish between improvements related directly to risperidone therapy or other factors, such as environment, better behavioral control, or simply normal development over the course of the study."].)
Moreover, while Dr. Plunkett relied on other data (e.g., a 1992 study, the RIS-INT 41 study, the RIS-INT 70 study, the 2002 label for Risperdal, and internal company documents), that reliance suffers from the same logical defect as do the above-discusses pieces of scientific literature: a disregard for the difference between an association between two things and a causal relationship between those two things. (See, e.g., Dkt. No. 181, at 59, 61, 63, 71, 87 [attaching pages "129," "131," "132," "141" and "157" of Trial Transcript, containing testimony of Dr. Plunkett]; Dkt. No. 183, at 40 [attaching page "350" of Trial Transcript, containing testimony of Dr. Plunkett].)
The closest Dr. Plunkett came to basing her opinion on sufficient facts or data under under Fed. R. Evid. 702(b) was when she relied on data referenced in an unpublished draft of the first piece of scientific literature (i.e., the paper by Dr. Findling). (Dkt. No. 182, at 18-20 [attaching pages "217" through "219" of Trial Transcript, containing testimony of Dr. Plunkett].) More specifically, Dr. Plunkett relied on data that she characterized as finding a statistically significant association between prolactin levels and adverse events related to prolactin during weeks eight to twelve of the study (which portion she states was omitted from the published paper). (Id. ) Admittedly, this reliance presents a close question for the Court. However, several problems plague this reliance: (1) Dr. Plunkett did not actually rely on data that was published in a peer-reviewed article but on a table that was not admitted into evidence and that was prepared not by the author of the paper but by a third-party company;
Simply stated, there is so great an analytical gap between the facts and/or data relied on and the general-causation opinion proffered by Dr. Plunkett as to render her opinion not "based" on them under Fed. R. Evid. 702(b). See Gen. Elec. Co. v. Joiner ,
Turning to the testimony of Dr. Leinung, Defendants argue that Dr. Leinung identified insufficient facts or data on which his opinion of general causation was based, citing pages "625" and "626" of the trial transcript. Those pages indeed reflect no such identification by Dr. Leinung. (Dkt. No. 185, at 81-82 [attaching pages "625" and "626" of Trial Transcript, containing testimony of Dr. Leinung].)
In response, Plaintiff relies on page "617" of the trial transcript, wherein Dr. Leinung testified that he previously diagnosed Plaintiff with bilateral gynecomastia"secondary at least in part to prolonged use of Risperdal." However, that page and the prior page of the transcript show that Dr. Leinung merely assumed that the cause of the gynecomastia was Risperdal. (Dkt. No. 185, at 72-73 [attaching pages "616" and "617" of Trial Transcript, containing testimony of Dr. Leinung].)
Plaintiff also relies on pages "672" and "673" of the trial transcript, wherein Dr. Leinung testified that Risperdal caused Plaintiff's bilateral gynecomastia. However, those pages of the transcript show only that Dr. Leinung's opinion of causation is based on (1) a differential diagnosis (discussed in the following paragraph), and (2) a "review of the literature," the "preponderance *131of [which]" he asserts "show[s] that Risperdal has a higher association with gynecomastia." (Dkt. No. 186, at 15-16 [attaching page "672" and "673" of Trial Transcript, containing testimony of Dr. Leinung].) Setting aside the lack of any specificity as to what "literature" Dr. Leinung relied on, to the extent he was relying on the literature and/or studies discussed above, that reliance was misplaced: it is insufficient to conclude the existence of causation from evidence of mere association, for the reasons discussed above in this Decision and Order.
Finally, Defendants argue that Dr. Leinung's opinion of general causation actually relied on a differential diagnosis.
For all of these reasons, the Court grants Defendants' motion for judgment a matter of law on this alternative ground.
C. Whether, in the Alternative, Defendants Are Entitled to a New Trial Because of the Conduct of Plaintiff's Counsel
1. Parties' Briefing of This Issue
a. Defendants' Memorandum of Law-in Chief
In their memorandum of law-in chief, Defendants assert two arguments on the subject of attorney misconduct: (1) an argument that Plaintiff's counsel engaged in *132improper conduct by (a) eliciting the jury's sympathy through (i) constantly making personal remarks in both his arguments and questions (referring to his lack of professional skills and/or experience, the number of doctors in his family, and the fact that he was bullied as a child, despite the Court's directives not to do so) and (ii) recklessly or intentionally necessitating frequent admonishment from the Court (through disregarding the Court's directives), which placed the Court, in the eyes of the jury, in what amounted to an adversarial position, and (b) continually asserting the truth of Plaintiff's case, vouching for his witnesses (and seeking his witnesses to vouch for each other), offering his personal opinions about the evidence, testifying when he could not otherwise introduce evidence, and seeking to introduce evidence or elicit testimony after sustained objections; and (2) an argument that the cumulative impact of all of this improper conduct prejudiced Defendants in that it resulted an award of damages ($500,000 for past pain and suffering and $500,000 for future pain and suffering) that is excessive as compared to the awards typically given based on mere teasing and lowered self-esteem (especially when the plaintiff would have experienced those things anyway, to a certain extent, given his obesity and separately caused mental health issues). (Dkt. No. 199, Attach. 1.)
b. Plaintiff's Opposition Memorandum of Law
In his opposition memorandum of law, Plaintiff asserts the following two arguments on the subject of attorney misconduct: (1) at most, the conduct of Plaintiff's attorney amounted to zealous advocacy as required by the relevant ethical rules; and (2) when viewed in the context of the entire trial, any such misconduct did not cause unfair prejudice to Defendants because (a) the vast majority of purported misconduct occurred sidebars (when music was playing to ensure that the jury could not hear the content of the discussions), (b) with regard to the purported conduct occurring outside of sidebars, Defendants met the misconduct with frequent objections, which were sustained, (c) on one occasion, the Court gave a curative instruction to the jury, and (d) indeed, an affidavit of one of the jurors confirms that the verdict was based on the evidence, not the conduct of Plaintiff's counsel. (Dkt. No. 205.)
c. Defendants' Reply Memorandum of Law
In their reply memorandum of law, Defendants assert the following four arguments on the subject of attorney misconduct: (1) the misconduct of Plaintiff's counsel was so repeated that it rose above the level of de minimis misconduct; (2) Plaintiff's attempt to distinguish the current case from those cited by Defendants fails because, as do the cases cited by Defendants, the current case involves attorney misrepresentations of evidence; (3) Plaintiff's reliance on verdicts from other cases is inappropriate given that those cases do not apply New York law; and (4) the Court must strike the jury affidavit submitted by Plaintiff because, pursuant to Fed. R. Evid. 606(b)(1), "a juror may not testify about ... the effect of anything on that juror's or another juror's vote ... or any juror's mental processes concerning the verdict" (and, here, Plaintiff introduced a juror affidavit specifically to describe the mental processes of the jury and the motivating forces animating each juror's vote). (Dkt. No. 206.)
2. Legal Standard Governing This Issue
A court may order a new trial on the basis of attorney misconduct when, inter alia , "the conduct of counsel in argument causes prejudice to the opposing party *133and unfairly influences a jury's verdict." Pappas v. Middle Earth Condo. Ass'n ,
"[I]n evaluating a motion for a new trial based on counsel's alleged misconduct, the court must consider such a claim in the context of the trial as a whole, examining, among other things, the totality of the circumstances, including the nature of the comments, their frequency, their possible relevancy to the real issues before the jury, and the manner in which the parties and the court treated the comments." Graham v. City of New York ,
"Determining if counsel's conduct was so improper as to warrant a new trial is committed to the sound discretion of the trial judge." Graham ,
3. Analysis of This Issue
After carefully considering the matter, the Court answers the above-described question (i.e., whether, in the alternative, the conduct of Plaintiff's counsel warrants a new trial) in the affirmative for the reasons stated by Defendants in their memoranda of law. To those reasons, the Court adds the following analysis.
Contrary to Plaintiff's suggestion on page 18 of his opposition memorandum of law, each of the 23 acts of misconduct listed by Defendants on pages 21 through 23 of their memorandum of law-in chief occurred within the presence of the jury (not during a sidebar). (Compare Dkt. No. 199, Attach. 1, at 28-30 [attaching pages "21" through "23" of Defs.' Memo. of Law] with Dkt. No. 199, Attach. 3 [attaching relevant portions of Trial Transcripts].)
Furthermore, only 12 of those 23 acts met with objections by Defendants. (Dkt. No. 199, Attach. 3, at 18-19, 30-31, 29, 72, 81, 93, 126, 127, 129 [attaching pages "252," "253," "373," "394," "395," "671," "712," "856," "1298," "1313," and "1313" of Trial Transcript]; Dkt. No. 182, at 96-97 [attaching pages "295" and "296" of Trial Transcript]; Dkt. No. 188, at 63-64 [attaching pages "963" and "964" of Trial Transcript]; Dkt. No. 189, at 94-95 [attaching pages "1129" and "1130" of Trial Transcript].)
The Court notes that, in addition to relying on the transcript of Plaintiff's counsel's comments, the Court relies on (1) Plaintiff's counsel's self-deprecating tone of voice and posture when referring to his lack of professional skills and/or experience, (2) his helpless tone of voice and posture when referring to the fact that he was bullied as a child, (3) his alternating *134innocent and defensive tones of voice in response to an admonishment by the Court, (4) the sympathetic facial expressions of the jurors following the aforementioned acts and/or accompanying comments, (5) the credulous facial expressions of the jurors following Plaintiff's counsel's acts of asserting of the truth of Plaintiff's case and/or vouching for his witnesses, and (6) the jurors' reactions following Plaintiff's counsel's acts of offering his personal opinions about the evidence and/or testifying when he could not otherwise introduce evidence. (Cf. Dkt. No. 186, at 55 [attaching page "712" of Trial Transcript, referencing Plaintiff's counsel's "puzzled" facial expressions after objections by defense counsel].)
Moreover, contrary to Plaintiff's suggestion that the comments and practices in question regarded immaterial issues before the jury, the Court finds that the majority of the above-referenced comments and practices primarily concerned highly relevant issues before the jury: for example, (1) the credibility of Plaintiff's expert witnesses, (2) the competency and credibility as a witness of Plaintiff's counsel himself, (3) whether the verdict should be based on evidence or sympathy, and (4) whether Dr. Findling's decision to (purportedly) omit from final draft of his paper certain data from weeks eight to twelve of the study evidences an intent by Defendants to mislead physicians. (Dkt. No. 199, Attach. 1, at 28-30 [attaching pages "21" through "23" of Defs.' Memo. of Law]; Dkt. No. 199, Attach. 3 [attaching relevant portions of Trial Transcripts].)
Although Plaintiff argues that any errors by his counsel were ameliorated by the curative instruction given by the Court, the instruction to which he apparently refers was given only once (Dkt. No. 204, Attach. 1, at 66-67 [attaching pages "66" and "67" of Trial Transcript] ), and it clearly did not curb his counsel's misconduct (given the misconduct's continuation).
Simply stated, the Court is convinced that, absent the inappropriate conduct of Plaintiff's counsel, the ultimate outcome of the trial would have been different.
Finally, the Court finds that Defendants are correct when they argue that the juror affidavit adduced by Plaintiff may not be considered by the Court. The affidavit violated Fed. R. Evid. 606(b)(1) in the following three ways: (1) it contained testimony about a statement that had been made and/or an incident that had occurred during the jury's deliberations (Dkt. No. 204, Attach. 16, at ¶ 10; cf. id. at ¶¶ 4, 9); (2) it contained testimony about the effect of a thing or things on the affiant's vote (id. at ¶¶ 9, 10, 11); and (3) it contained testimony about a juror's or multiple jurors' mental processes concerning the verdict (id. at ¶¶ 9, 10).
Even if the affidavit were admissible, the Court would give it little weight because (1) it unreliably testifies to other jurors' mental processes concerning the verdict (Dkt. No. 204, Attach. 16, at ¶¶ 9, 10), and (2) it admits to having been prepared with the assistance of Plaintiff's counsel (id. at ¶ 14). See Munafo v. Metro. Transp. Auth. ,
*135For all of these reasons, the Court finds that, even if alternative grounds did not exist to grant Defendants' motion for judgment a matter of law, grounds exist to, at the very least, grant Defendants' motion for a new trial.
D. Three Remaining Issues (I.e., Whether Plaintiff Cannot Establish that Defendant Johnson & Johnson Is Liable as a Matter of Law, Whether the Jury Verdict Is Against the Weight of the Evidence, and Whether Plaintiff's Award Is Excessive)
Because the Court answers the three previously addressed issues in the affirmative, the Court need not, and thus does not, analyze these three remaining issues, except to note generally that the Court finds them to be the weaker of Defendants' arguments generally for the reasons stated in Plaintiff's opposition memorandum of law.
ACCORDINGLY , it is
ORDERED that Defendants' motion for judgment a matter of law pursuant to Fed. R. Civ. P. 50 or, in the alternative, for a new trial pursuant to Fed. R. Civ. P. 59 (Dkt. No. 199) is GRANTED ; and it is further
ORDERED that both the Jury Verdict (Dkt. No. 179) and Judgment for Plaintiff (Dkt. No. 180) are VACATED ; and it is further
ORDERED that the Clerk of the Court shall enter Judgment for Defendants and close this action.
See Risperdal & Invega Product Liability Cases , Judicial Council Coordination Proceeding No. 4775, Case Nos. BC562887 and BC568282, at 4-13 (Cal. Super. Ct., Los Angeles Cnty., June 22, 2016) (Highberger, J.); Stange v. Janssen Pharm. Inc. , Case No. 1304011984, at 11-14,
See
See
(See, e.g., Dkt. No. 183, at 18 [attaching page "328" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett, in which she answers, "Serious adverse reactions, yes," to the question, "Now, the first line of Exhibit C [containing
(Compare Dkt. No. 184, at 70 [attaching page "486" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Tucker that gynecomastia can require surgical correction] and Dkt. No. 185, at 71-72 [attaching pages "615" and "616" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Matthew Leinung that Plaintiff's gynecomastia would not have resolved itself without surgery] and Dkt. No. 189, at 129-30 [attaching pages "1164" and "1165" of Trial Transcript, containing testimony of Plaintiff that he needed to have surgery] with Dkt. No. 188, at 126-28 [attaching pages "1026" through "1028" of Trial Transcript, containing testimony of Defendant's expert Dr. Arrowsmith that surgery for Plaintiff's gynecomastia was not absolutely indicated but was a choice].)
See
(See, e.g., Dkt. No. 183, at 26 [attaching page "336" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett, in which she states, "I agree with that ... specific limitation [of seriousness] to that definition [contained in 21 C.F.R. 312.32 [a] ..."]; Dkt. No. 188, at 123 [attaching page "1023" of Trial Transcript, containing testimony of Defendant's expert Dr. Arrowsmith, in which she states that, "under the regulations a serious adverse reaction is ... [written] in 314.80" ... "[a]nd ... in 312.32"].)
(Dkt. No. 187, at 63-64 [attaching pages "859" and "860" of Trial Transcript, containing testimony of Plaintiff's expert Dr. George Glass that, as a result of gynecomastia, and despite his surgery, Plaintiff may still need six months of inpatient care at a structured long-term psychiatric facility].)
(Dkt. No. 183, at 23, 24 [attaching pages "333" and "334" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett]; Dkt. No. 152, at 18; Dkt. No. 142, at 33.)
(See, e.g., Dkt. No. 199, Attach. 3, at 100-01 [attaching pages "911" and "100" of Trial Transcript, containing testimony of Defendant's expert Dr. Arrowsmith]; Dkt. No. 183, at 20, 21, 82 [attaching pages "330," "331," and "392" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett, stating that "I agree that as it's defined in 21 CFR 312.32(a)gynecomastia would not be a regulatory defined [sic] serious adverse event"].)
(Dkt. No. 199, Attach. 3, at 23-26, 82-83 [attaching pages "326" through "331," and pages "392" and "393," of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett].)
(See generally Dkt. Nos. 181-183 [containing Dr. Plunket's trial testimony].)
(Id. )
See
See
(See generally Dkt. Nos. 181-192 [containing Trial Transcript].)
(See, e.g., Dkt. No. 181, at 86, 87, 89, 93, 106, 107, 109, 114-15 [attaching pages "156," "157," "159," "163," "176," "177," "179," "184," and "185" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett]; Dkt. No. 182, at 2 [attaching page "201" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett].)
(See, e.g., Dkt. No. 181, at 120, 121, 122, 123, 124, 128 [attaching pages "190," "191," "192," "193," "194," and "198" of Trial Transcript, containing testimony of Dr. Plunkett].)
(Dkt. No. 182, at 2-8 [attaching pages "201" through "207" of Trial Transcript, containing testimony of Plaintiff's expert Dr. Plunkett].)
While the Court need not rely on the FDA's November 2014 letter from a senior FDA senior official given the above-referenced concession by Plaintiff's regulatory expert, the Court may in fact rely on that letter (despite its decision to preclude the admission of the letter into evidence due to the letter's substantial likelihood of confusing the issues and misleading the jury under Fed. R. Evid. 403 ) because the particular preemption issue at hand presents a question of law reserved for the Court. See, e.g., In re MTBE Prods. Liability Lit. ,
Stange v. Janssen Pharm. Inc. , Case No. 1304011984, at 14 (Pa. Ct. of Common Pleas, 1st Judicial Dist. May 23, 2016) (Powell, J.).
See, e.g., Pliva, Inc. v. Mensing ,
See Buckman Co. v. Plaintiffs' Legal Comm. ,
See, e.g., In re: Mirena IUD Prods. Liab. Litig.,
See, e.g., Hall v. United Ins. Co. of Am. ,
(See, e.g., Dkt. No. 181, at 59-60, 112, 113, 115, 123 [attaching pages "129," "130," "182," "183," "185" and "193" of Trial Transcript, containing testimony of Dr. Plunkett]; Dkt. No. 182, at 2 [attaching pages "201," "205" and "206" of Trial Transcript, containing testimony of Dr. Plunkett].)
Indeed, the paper stated, "It is considered normal for males to have gynecomastia at some point in the evolution of puberty, with the frequency estimated as high as 50%." (Dkt. No. 199, Attach. 7, at 4.)
Indeed, the paper acknowledged that eight of the cases "resolved during the study without intervention." (Dkt. No. 199, Attach. 8, at 6.)
(Dkt. No. 182, at 11-17 [attaching pages "210" through "216" of Trial Transcript].)
(See, e.g., Dkt. No. 199, Attach. 7, at 1 ["With long-term resperidone treatment in children and adolescents, serum prolactin levels tended to rise and peak within the first 1 to 2 months and then steadily decline to values within or very close to the normal range by 3 to 5 months."].)
See Nimely v. City of New York ,
"A differential diagnosis is a patient-specific process of elimination that medical practitioners use to identify the most likely cause of a set of signs and symptoms from a list of possible causes." Ruggiero v. Warner-Lambert Co. ,
See, e.g., Levitant v. City of N.Y. Human Res. Admin. ,
See, e.g., Fineman v. Armstrong World Indus. ,
Reference
- Full Case Name
- Shaquil BYRD v. JANSSEN PHARM., INC. and Johnson & Johnson
- Cited By
- 4 cases
- Status
- Published