Case 1:14-cv-00820-GTS-DJS Document 208 Filed 09/21/18 Page 1 of 40
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF NEW YORK
`_______________________________________
`
`SHAQUIL BYRD,
`
`Plaintiff,
`
`v.
`
`JANSSEN PHARM., INC.; and JOHNSON
`& JOHNSON,
`
`Defendants.
`_______________________________________
`
`APPEARANCES:
`
`DeGRAFF, FOY & KUNZ, LLP
` Counsel for Plaintiff
`41 State Street
`Albany, NY 12207
`
`1:14-CV-0820
`(GTS/DJS)
`
`OF COUNSEL:
`
`LUKE S. MALAMOOD, ESQ.
`GEORGE J. SZARY, ESQ.
`
`PATTERSON, BELKNAP, WEBB & TYLER, LLP
` Counsel for Defendants
`1133 Avenue of the Americas
`New York, NY 10036
`
`JOHN D. WINTER, ESQ.
`THOMAS P. KURLAND, ESQ.
`JEFFREY J. HUGHES, ESQ.
`
`GLENN T. SUDDABY, Chief United States District Judge
`
`DECISION and ORDER
`
`Currently before the Court, in this products liability action filed by Shaquil Byrd
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`(“Plaintiff”) against Janssen Pharmaceuticals, Inc. (“Janssen”), and Johnson & Johnson
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`(“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
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`reasons set forth below, Defendants’ motion is granted.
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`

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`Case 1:14-cv-00820-GTS-DJS Document 208 Filed 09/21/18 Page 2 of 40
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`TABLE OF CONTENTS
`
`I.
`
`RELEVANT BACKGROUND...............................................................................................3
`
`A.
`
`B.
`
`Relevant Procedural History......................................................................................3
`
`Parties’ Briefing on Defendants’ Motion Generally................................................4
`
`II.
`
`GOVERNING LEGAL STANDARDS..................................................................................5
`
`A.
`
`B.
`
`Legal Standard Governing Motions for Judgment Notwithstanding
`the Verdict Pursuant to Fed. R. Civ. P. 50(b)...........................................................5
`
`Legal Standard Governing Motions for a New Trial Pursuant to
`Fed. R. Civ. P. 59(a)....................................................................................................6
`
`C.
`
`Legal Standards Governing Grounds Asserted by Defendants...............................7
`
`III.
`
`ANALYSIS...............................................................................................................................7
`
`A.
`
`B.
`
`C.
`
`D.
`
`Whether Defendants Are Entitled to Judgment as a Matter of Law
`Because Plaintiff’s Failure-to-Warn Claim Is Preempted.......................................7
`1.
`Parties' Briefing of This Issue.........................................................................7
`2.
`Legal Standard Governing This Issue..........................................................12
`3.
`Analysis of This Issue....................................................................................13
`
`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....................................... .............22
`1.
`Parties' Briefing of This Issue.......................................................................22
`2.
`Legal Standard Governing This Issue..........................................................24
`3.
`Analysis of This Issue....................................................................................26
`
`Whether, in the Alternative, Defendants Are Entitled to a New
`Trial Because of the Conduct of Plaintiff’s Counsel..............................................34
`1.
`Parties' Briefing of This Issue......................................................................34
`2.
`Legal Standard Governing This Issue..........................................................36
`3.
`Analysis of This Issue....................................................................................37
`
`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)................................................................40
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`I.
`
`RELEVANT BACKGROUND
`
`A.
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`Relevant Procedural History
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`Generally, following the issuance of the Court’s Decision and Order of March 7, 2017,
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`two claims of Plaintiff’s Amended Complaint survived Defendants’ motion for summary
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`judgment: (1) Plaintiff’s claim that Defendants were negligent in designing, manufacturing, and
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`selling Risperdal as well as in failing to properly warn the general public of the risks and dangers
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`of Risperdal; and (2) Plaintiff’s claim that Defendants are strictly liable for the injuries caused by
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`(a) Risperdal's defective condition, (b) the failure to give appropriate warnings regarding the
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`drug's dangers and adverse effects, and (c) their misleading representations regarding the risk of
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`gynecomastia and hyperprolactinemia in adolescent patients. (Dkt. No. 108, at 70.)
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`The trial on these two claims commenced on September 18, 2017. (Dkt. No. 163.) At
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`the conclusion of the trial on September 27, 2017, the jury reached a verdict against Plaintiff
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`with regard to his negligent design claim but in favor of him with regard to his failure-to-work
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`claim, awardeding him $500,000 for past and/or present pain and suffering and $500,000 in
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`future pain and suffering; and Judgment was entered accordingly. (Dkt. Nos. 179, 180.) On
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`October 25, 2017, Defendants filed the current motion for judgment a matter of law pursuant to
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`Fed. R. Civ. P. 50 or, in the alternative, for a new trial pursuant to Fed. R. Civ. P. 59. (Dkt. No.
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`199.) Plaintiff has opposed this motion. (Dkt. No. 204, 205.)
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`Because this Decision and Order is intended primarily for the review of the parties, who
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`have (in their memoranda of law) demonstrated an accurate understanding of the remainder of
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`the relevant procedural history of this action, the Court will not summarize the remainder of that
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`procedural history in detail in this Decision and Order.
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`B.
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`Parties’ Briefing on Defendants’ Motion Generally
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`Generally, in their motion, Defendants assert the following arguments: (1) as a threshold
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`matter, Defendant Janssen is entitled to judgment as a matter of law because (a) Plaintiff’s
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`failure-to-warn claim is preempted by federal law, (b) Plaintiff failed to introduce sufficient
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`evidence of proximate and medical causation, and (c) Plaintiff cannot establish that Defendant
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`Johnson & Johnson is liable; and (2) in the alternative, Defendant Janssen is entitled to a new
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`trial because (a) the jury’s verdict is against the weight of the evidence, (b) the conduct of
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`Plaintiff’s counsel warrants a new trial, and (c) Plaintiff’s award is excessive (warranting either
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`remittitur or a new trial). (Dkt. No. 199, Attach. 1.)
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`Generally, in opposition to Defendants’ motion, Plaintiff asserts the following
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`arguments: (1) Defendants are not entitled to judgment as a matter of law because (a) their
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`preemption arguments are meritless, unavailing and frivolous, (b) their arguments regarding
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`causation are similarly unavailing and (c) Defendant Johnson & Johnson is liable just as
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`Defendant Janssen is liable; and (2) there is no legal basis warranting a new trial because (a) the
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`verdict is supported by compelling evidence, (b) there is no evidence of prejudice against
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`Defendants created by the actions of Plaintiff’s counsel, and (c) Plaintiff’s award is not excessive
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`but is comparable to awards in identical cases. (Dkt. No. 205.)
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`Generally, in reply, Defendants repeat the arguments asserted in their memorandum of
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`law-in chief, albeit modified to reply to Plaintiff’s responses. (Dkt. No. 206.)
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`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
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`for judgment as a matter of law. See Fed. R. Civ. P. 50 Advisory Committee Note (1963) (“A
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`motion for judgment notwithstanding the verdict will not lie unless it was preceded by a motion
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`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
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`granted only on grounds advanced in the pre-verdict motion.”); Exxon Shipping Co. v. Baker,
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`554 U.S. 471, 486, n.5, 128 S. Ct. 2605 (2008) (“A motion under Rule 50(b) is not allowed
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`unless the movant sought relief on similar grounds under Rule 50(a) before the case was
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`submitted to the jury.”).
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`Such a post-trial motion may be granted by a district court where doing so is necessary to
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`prevent “manifest injustice.” Kirsch v. Fleet Street, Ltd., 148 F.3d 149, 164 (2d Cir. 1998) (“As
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`to any issue on which proper Rule 50 motions were not made, [a judgment as a matter of law]
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`may not properly be granted by the district court, or upheld on appeal, or ordered by the
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`appellate court unless that action is required in order to prevent manifest injustice.”); accord,
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`Lore v. City of Syracuse, 670 F.3d 127, 153 (2d Cir. 2012); Cordius Trust v. Kummerfeld, 331 F.
`
`App’x 810, 811 (2d Cir. 2009). “[M]anifest justice” exists only when a jury’s verdict is “wholly
`
`without legal support.” Pahuta v. Massey-Ferguson, Inc., 170 F.3d 125, 129 (2d Cir. 1999) (“We
`
`may overlook such a default in order to ‘prevent a manifest injustice’ in cases where a jury’s
`
`verdict is wholly without legal support.”) (internal quotation marks omitted); accord, U.S. S.E.C.
`
`v. Stamoulis, 350 F. App’x 499, 500 (2d Cir. 2009); Clergeau v. Local 1181, Amalgamated
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`Transit Union, AFL-CIO, 162 F. App’x 32, 34 (2d Cir. 2005); Rothstein v. Carriere, 373 F.3d
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`275, 291 (2nd Cir. 2004).
`
`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
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`jury trial, for any reason for which a new trial has heretofore been granted in an action at law in
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`federal court . . . .” Fed. R. Civ. P. 59(a)(1)(A). The Second Circuit has interpreted this standard
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`to permit the granting of new trials when, “in the opinion of the district court, the jury has
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`reached a seriously erroneous result or the verdict is a miscarriage of justice.” DLC Mgmt. Corp.
`
`v. Town of Hyde Park, 163 F.3d 124, 133 (2d Cir. 1998) (internal quotation marks omitted);
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`Lightfoot v. Union Carbide Corp., 110 F.3d 898, 911 (2d Cir. 1997). Examples of such a serious
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`error or a miscarriage of justice include when “the verdict is against the weight of the evidence,”
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`or when “for the reasons stated the trial was not fair to the moving party.” Mallis v. Bankers
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`Trust Co., 717 F.2d 683, 691 (2d Cir. 1983). However, “the court should only grant a motion for
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`a new trial when the jury’s verdict is ‘egregious.’” DLC Mgmt. Corp., 163 F.3d at 134 (internal
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`quotation marks omitted); Dunlap-McCuller v. Riese Org., 980 F.2d 153, 158 (2d Cir. 1992),
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`cert. denied, 510 U.S. 908, 114 S. Ct. 290 (1993).
`
`C.
`
`Legal Standards Governing Grounds Asserted by Defendants
`
`For ease of analysis, the legal standards governing the grounds asserted by Defendants
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`will be set forth below in Part III of this Decision and Order.
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`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
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`of preemption: (1) an argument that 21 C.F.R. § 201.57(e) (2004) (which governed the content of
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`the “Warnings” section on Risperdal’s label because it was the regulation in effect at the time
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`Plaintiff started taking Risperdal) should be interpreted to mean that Defendants were precluded
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`from using the “Changes Being Effected” (or “CBE”) process to update Risperdal’s warning
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`label; (2) an argument that, in any event, there is “clear evidence” that the FDA would not have
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`approved the proposed labeling during the relevant time period; and (3) an argument that
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`contrary arguments by Plaintiff are unavailing. (Dkt. No. 199, Attach. 1.)
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`More specifically, Defendants’ first argument can be broken down into the following
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`three parts: (a) while 21 C.F.R. § 314.70(c)(2)(i) permits a manufacturer to “add or strengthen a .
`
`. . warning” without prior FDA approval, during the time in question the content of that warning
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`was governed by 21 C.F.R. § 201.57(e) (2004), which stated that “[a] specific warning relating
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`to . . . [an off-label use] may be required by the [FDA] if the drug is commonly prescribed for a
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`disease or condition, and there is lack of substantial evidence of effectiveness for that disease or
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`condition, and such usage is associated with serious risk or hazard,” and which thus prohibited
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`Defendants from unilaterally updating Risperdal’s label regarding pediatric use; (b) this
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`common-sense interpretation of 21 C.F.R. § 201.57(e) (2004) (as conferring on the FDA the sole
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`authority to add safety information regarding an off-label use of a medication) is supported by
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`the structure of the FDA’s regulations, which treat labels as containing adequate directions for
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`intended use (i.e., the use for which the medication had been approved), which is why in 1996
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`the FDA rejected as promotional Defendants’ request for permission to add safety information to
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`the Risperdal label regarding use in children and adolescents; and (c) this interpretation is also
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`supported by the FDA’s interpretation of identical language in 21 C.F.R. § 201.57(e)
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`(2004)–regarding boxed warnings–which (according to the FDA’s statement during the
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`regulation’s notice-and-comment period in 1979) permits a boxed warning in labeling only when
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`specifically required by the FDA, and which should be interpreted in the same manner as the
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`language regarding off-label uses. (Id.)
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`Moreover, Defendants’ second argument can be broken down into the following two
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`parts: (a) in any event, there is “clear evidence” that FDA would not have approved the proposed
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`labeling during the relevant time period, because (i) despite the fact that Defendant Janssen
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`asked the FDA to include safety information regarding pediatric dosing on Risperdal’s label, and
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`the fact that the FDA knew that Risperdal was being used off-label in pediatric patients, the FDA
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`denied Defendant Janssen’s request because it believed that adding dosing information for an
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`unapproved population would encourage use of Risperdal for off-label purposes, and (ii)
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`subsequently the FDA repeatedly approved Risperdal’s label without requesting any changes
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`regarding pediatric use until October 2006; and (b) rather, a manufacturer of prescription
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`medication may update a label without prior FDA approval only if it acquires new information
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`regarding serious hazards associated with the medication, and here the relationship between
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`antipsychotics and hyperprolactinemia was not new information because it had been discussed in
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`basic psychiatry textbooks for decades, and the FDA does not consider gynecomastia a serious
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`adverse event. (Id.)
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`Finally, Defendants’ third argument can be broken down into the following three parts:
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`(a) the FDA’s statement in the 1979 Federal Register (that a manufacturer of prescription
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`medicine may add warnings to labeling) is merely a general statement paralleling the language of
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`21 C.F.R. § 201.57(e), which again, inter alia, requires a serious adverse reaction; (b) 21 C.F.R.
`
`§ 201.57(f)(9)(vi) did not allow Defendants to unilaterally add to the Risperdal labeling
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`information regarding Risperdal use in children because the section required a hazard to be
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`described in the Precautions subsection of the labeling only if it was specific to children and
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`gynecomastia was not specific to children; and (c) the ipse dixit conclusion of Plaintiff’s
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`regulatory expert, Dr. Laura M. Plunkett, Ph.D., that manufacturers of prescription medicine can
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`unilaterally add safety information regarding off-label is contrary to both the plain language of
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`the regulations and her own concession that Defendants could not unilaterally add safety
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`information relative to unapproved populations. (Id.)
`
`b.
`
`Plaintiff’s Opposition Memorandum of Law
`
`In his opposition memorandum of law, Plaintiff asserts the following four arguments on
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`the subject of preemption: (1) Defendants’ first argument (regarding 21 C.F.R. § 201.57[e]
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`[2004]) has been considered, and rejected, by state courts in Pennsylvania and California,1 which
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`have ruled that there was no FDA regulation that would have precluded Defendants from adding
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`new safety (as opposed the efficacy) information regarding the frequency of gynecomastia in
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`child and/or adolescent Risperdal patients during the relevant time period (which is why, for
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`example, Viagra contains safety information regarding its use by pregnant women even though
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`women are not the population for which the drug is indicated); (2) Defendants’ second and
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`fourth arguments (regarding their 1996 request) improperly rely on their 1996 request because
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`that request regarded efficacy (not safety) information for the pediatric population (specifically
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`pediatric dosing), which was why the request was denied as promotional; (3) Defendants’ first
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`argument (regarding the FDA’s 2014 response to a Citizen Petition) and third argument
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`(regarding the FDA’s 1979 statement regarding boxed warnings) are unpersuasive because the
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`FDA’s statements should be viewed as merely informative (given that they were given in
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`response to a request) and not applicable (given that Plaintiff has never advocated the use of a
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`black box warning); and (4) Defendants’ fifth argument is unpersuasive because the relationship
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`between Risperdal and hyperprolactinemia was, during the time in question, both “new” (or
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`“recently-learned”) and “danger[ous].” (Dkt. No. 205.)
`
`See Risperdal & Invega Product Liability Cases, Judicial Council Coordination
`1
`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 (Pa Ct. of Common Pleas, 1st Judicial Dist.. May 23, 2016) (Powell, J.).
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`c.
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`Defendants’ Reply Memorandum of Law
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`In their reply memorandum of law, Defendants assert the following six arguments on the
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`subject of preemption: (1) that portion of Plaintiff’s first argument regarding the preclusive
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`effect to be attributed to the state court decisions from Pennsylvania and California is
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`unpersuasive, because (a) Plaintiff fails to meet his threshold burden of demonstrating how the
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`doctrine of collateral estoppel applies, and (b) the issues in this case (which regard whether 21
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`C.F.R. § 201.57[e] preempts New York law, and whether a manufacturer can unilaterally add
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`safety information regarding an off-label use with respect to a condition that the FDA does not
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`consider a serious adverse event) are not identical to those addressed in the referenced state court
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`decisions (and non-mutual offensive collateral estoppel should not apply to pure questions of
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`law); (2) the remaining portion of Plaintiff’s first argument (regarding Viagra) is unpersuasive,
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`because (a) Viagra does not contain a warning regarding its use by pregnant women as Plaintiff
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`suggests, (b) 21 C.F.R. § 201.57(c)(9) requires the information that appears on the Viagra label
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`about usage during pregnancy, and (c) Plaintiff did not introduce evidence that Viagra’s
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`manufacturer added this information to its label without prior approval by the FDA; (3)
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`Plaintiff’s second argument (regarding Defendants’ 1996 request) is unpersuasive because the
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`fact that the FDA denied as promotional Defendant Janssen’s proposed addition of pediatric
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`dosing information before October 2006 actually supports the conclusion that safety information
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`regarding an off-label use would not be permitted because the FDA’s denial suggests an
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`unapproved intended use of the medicine; (4) Plaintiff’s fourth argument (regarding the
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`requirement of new information and serious hazards) is unpersuasive because Plaintiff does not
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`sufficiently dispute that the relationship between antipsychotics and hyperprolactinemia was not
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`new information in that it had been discussed in basic psychiatry textbooks for decades, and the
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`FDA does not consider gynecomastia a serious adverse event; (5) Plaintiff’s own regulatory
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`expert (Dr. Plunkett) conceded that (a) Janssen submitted a supplemental new drug application
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`(“sNDA”) in December of 2003 to obtain an indication for a pediatric population, (b) a
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`manufacturer of prescription medicine cannot update labeling information with respect to an
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`unapproved indication that is subject of a pending sNDA, (c) the FDA did not approve this
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`sNDA until October of 2006, and (d) 21 C.F.R. § 201.57(e) provided the FDA with control over
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`the addition of safety information related to off-label uses; and (6) Plaintiff takes out of context
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`the testimony of Defendants’ regulatory expert Dr. Janet B. Arrowsmith, M.D., (that “[21 C.F.R.
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`§] 314.70 offers options for adding safety information to a label without prior approval”),
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`ignoring her next statement that, “if you’re submitting an sNDA or particularly a CBE, that that
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`is information relevant to the approved indication.” (Dkt. No. 206.)
`
`2.
`
`Legal Standard Governing This Issue
`
`“Impossibility pre[]emption is a demanding defense.” Wyeth v. Levine, 555 U.S. 555, 573
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`(2009). “In the context of claims against drug manufacturers for allegedly inadequate warnings,
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`a drug manufacturer may show preemption in two ways: (1) by showing that it was prohibited by
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`federal law from modifying the FDA-approved labeling; or (2) by presenting clear evidence that
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`the FDA would not have approved a change to the drug’s label.” Amos v. Biogen Idec Inc., 249
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`F. Supp. 3d 690, 699 (W.D.N.Y. 2017) (citing two Supreme Court cases).
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`Expressed differently, “[p]ost-FDA approval preemption analysis proceeds in two
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`stages.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 661 (S.D.N.Y. 2017). First, the
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`plaintiff must show that “the defendants could unilaterally change the label . . . without FDA
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`approval,” such as through the “change being effected” (or “CBE”) regulation. Utts, 251 F.
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`Supp. 3d at 661. Second, “[b]ecause the FDA ‘retains the authority to reject labeling changes,’ a
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`manufacturer may still . . . establish an impossibility preemption defense through ‘clear evidence
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`that the FDA would not have approved a change’ to the label.” Id. “In sum, if the plaintiff can
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`point to the existence . . . to support a labeling change under the CBE regulation, the burden then
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`shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the
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`labeling change made on the basis of this newly acquired information.” Id.
`
`With regard to the second stage, the Third Circuit has explained that the “term ‘clear
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`evidence’ . . . does not refer directly to the type of facts that a manufacturer must show, or to the
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`circumstances in which preemption will be appropriate.” In re Fosamax (Alendronate Sodium)
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`Prods. Liab. Litig., 852 F.3d 268, 285 (3d Cir. 2017). Rather, the term “specifies how difficult it
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`will be for the manufacturer to convince the factfinder that the FDA would have rejected a
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`proposed label change. The manufacturer must prove that the FDA would have rejected a
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`warning not simply by a preponderance of the evidence, as in most civil cases, but by ‘clear
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`evidence.’” In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d at 285. The Third
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`Circuit noted that “clear evidence” is “synonymous with ‘clear and convincing evidence’” and
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`that, in order “for a defendant to establish a preemption defense under Wyeth, the factfinder must
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`conclude that it is highly probable that the FDA would not have approved a change to the drug’s
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`label.” Id. at 285-86.
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`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
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`Case 1:14-cv-00820-GTS-DJS Document 208 Filed 09/21/18 Page 14 of 40
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`the reasons stated by Defendants in their memoranda of law. To those reasons, the Court adds
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`the following analysis.
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`The Court is especially persuaded by the second and third of Defendants’ three general
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`arguments described above in Part III.A.1.a. of this Decision and Order (i.e., that clear evidence
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`exists that the FDA would not have approved a change to the drug’s label, and that contrary
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`arguments are unavailing). In particular, the Court is persuaded by not only the arguments
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`primarily relied on by Defendants in their memorandum of law-in chief and their reply
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`memorandum of law but an argument more-obliquely relied on by Defendants: that the updated
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`warning must have regarded a hazard that was serious.
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`While the relevant regulations during the time in question permitted Defendants to “add
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`or strengthen a . . . warning” without prior FDA approval,2 the Court construes those regulations
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`as requiring, as a threshold matter, that the new warning regard a hazard that was “serious.”3 The
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`parties’ regulatory experts appear to have agreed on this interpretation of the relevant
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`regulations.4
`
`See 21 C.F.R. § 314.70(c)(2)(i) (2002, 2003, 2004) (permitting a manufacturer to
`2
`“add or strengthen a . . . warning” without prior FDA approval); 21 C.F.R. § 314.70(c)(6)(iii)(A)
`(2005, 2006) (permitting a manufacturer to “add or strengthen a . . . warning” without prior FDA
`approval).
`
`See 21 C.F.R. § 201.57(e) (2002, 2003, 2004, 2005, 2006) (“Under this section
`3
`heading, the labeling shall describe serious adverse reactions and potential safety hazards,
`limitations in use imposed by them, and steps that should be taken if they occur. The labeling
`shall be revised to include a warning as soon as there is reasonable evidence of an association of
`a serious hazard with a drug . . . . A specific warning relating to . . . [an off-label use] may be
`required by the [FDA] if the drug is commonly prescribed for a disease or condition, and there is
`lack of substantial evidence of effectiveness for that disease or condition, and such usage is
`associated with serious risk or hazard.”) [emphasis added].
`
`(See, e.g., Dkt. No. 183, at 18 [attaching page “328” of Trial Transcript,
`4
`containing testimony of Plaintiff’s expert Dr. Plunkett, in which she answers, “Serious adverse
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`Case 1:14-cv-00820-GTS-DJS Document 208 Filed 09/21/18 Page 15 of 40
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`Rather, Plaintiff spent much time at trial adducing the testimony of experts that, in their
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`opinion, gynecomastia is a “serious” adverse event, which Defendant attempted to rebut.5
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`However, the issue is not whether, at the time of trial in September 2017 (or even at the time of
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`Plaintiff’s surgery in June 2014), an expert viewed gynecomastia as a “serious” adverse event.
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`Rather, the issue is whether, between February or March of 2002 (when Plaintiff started taking
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`Risperdal) and August 2006 (when Plaintiff stopped taking Risperdal), gynecomastia was a
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`“serious” adverse event under the then-governing law: i.e., that it, inter alia, either (1) resulted
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`in inpatient hospitalization or (2) required surgical intervention to prevent inpatient
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`hospitalization.6 Again, regulatory experts appear to have agreed on this definition of
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`reactions, yes,” to the question, “Now, the first line of Exhibit C [containing 21 C.F.R. §
`201.57(e)], in the warnings section, the label shall describe serious adverse events, correct?”];
`Dkt. No. 199, Attach. 3, at 101, 102 [attaching pages “911” and “914” of Trial Transcript,
`containing testimony of Defendant’s expert Dr. Arrowsmith, in which she states that, “in terms
`of warnings and so forth, it’s only serious adverse events that get into certain parts of the
`label”].)
`
`(Compare Dkt. No. 184, at 70 [attaching page “486” of Trial Transcript,
`5
`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 21 C.F.R. § 314.80 (2002, 2003, 2004, 2005, 2006) (2002, 2003, 2004, 2005,
`6
`2006) (defining “[s]erious adverse drug experience” as “[a]ny adverse drug experience occurring
`at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug
`experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or
`significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events
`that may not result in death, be life-threatening, or require hospitalization may be considered a
`serious adverse drug experience when, based upon appropriate medical judgment, they may
`jeopardize the patient or subject and may require medical or surgical intervention to prevent one
`of the outcomes listed in this definition.”) [emphasis added], accord, 21 C.F.R. § 312.32(a).
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`seriousness.7
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`After scouring the record, the Court has found insufficient evidence upon which a jury
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`could rationally answer that question in the affirmative. For the sake of brevity, the Court will
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`not linger on the fact that there appears to be a dearth of evidence that, when Plaintiff underwent
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`surgery on June 24, 2014, he received inpatient hospitalization at Ellis Hospital. The Court will
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`also set aside the fact that any inpatient hospitalization (at a psychiatric facility) that Plaintiff
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`may still need due to his gynecomastia has (by definition) not been prevented by his 2014
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`surgery,8 making it impossible to conclude that gynecomastia has required surgical intervention
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`to prevent inpatient hospitalization under 21 C.F.R. § 312.32(a) (2002, 2003, 2004, 2005, 2006).
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`More important is the fact that, while a November 2014 letter from a FDA senior offic