Vardouniotis v. Pfizer, Inc.

Vardouniotis v Pfizer, Inc.

2024 NY Slip Op 32322(U)

July 8, 2024

Supreme Court, New York County

Docket Number: Index No. 152029/2019

Judge: Nancy M. Bannon

Cases posted with a "30000" identifier, i.e., 2013 NY Slip

Op 30001(U), are republished from various New York

State and local government sources, including the New

York State Unified Court System's eCourts Service.

This opinion is uncorrected and not selected for official

publication.

FILED: NEW YORK COUNTY CLERK 07/09/2024 11:51 AM INDEX NO. 152029/2019

NYSCEF DOC. NO. 202 RECEIVED NYSCEF: 07/09/2024

SUPREME COURT OF THE STATE OF NEW YORK

NEW YORK COUNTY

PRESENT: HON. NANCY M. BANNON PART 61M

Justice

---------------------------------------------------------------------------------X INDEX NO. 152029/2019

VASILIKI VARDOUNIOTIS,

MOTION DATE 07/17/2023

Plaintiff,

MOTION SEQ. NO. 005 006 007

-v-

PFIZER, INC., DECISION + ORDER ON

MOTION

Defendant.

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The following e-filed documents, listed by NYSCEF document number (Motion 005) 94, 95, 96, 146, 151,

184, 188, 191, 194, 197

were read on this motion to/for SEAL .

The following e-filed documents, listed by NYSCEF document number (Motion 006) 97, 98, 99, 100, 101,

102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 144, 147, 149,

152, 153, 156, 158, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 185, 189, 192, 195, 198

were read on this motion to/for PRECLUDE .

The following e-filed documents, listed by NYSCEF document number (Motion 007) 120, 121, 122, 123,

124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 145,

148, 150, 154, 155, 157, 159, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 186, 187, 190,

193, 196, 199

were read on this motion to/for SUMMARY JUDGMENT .

I. INTRODUCTION

In this products liability action, the plaintiff seeks to recover for injuries allegedly

resulting from her use of Chantix, a smoking cessation medication manufactured by the

defendant and generically known as varenicline. The defendant now moves to exclude the

opinions of the plaintiff’s expert (MOT SEQ 006) and for summary judgment pursuant to CPLR

3212 dismissing the amended complaint (MOT SEQ 007). The plaintiff opposes these motions.

The defendant also moves, unopposed, pursuant to 22 NYCRR 216.1(a), to seal certain exhibits

and redact portions of the papers filed in support of its other two motions (MOT SEQ 005). The

motion to exclude plaintiff’s expert is granted and the motions for summary judgment and to seal

are denied.

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II. BACKGROUND

The plaintiff was prescribed Chantix for smoking cessation by her physician, Dr. Adrian

Lombardi, on May 17, 2016. At the time, in addition to her expressed desire to quit smoking, the

plaintiff complained of pre-existing back and neck pain, and had a documented history of anxiety

and depression. She started Chantix the same day and took the drug for eleven days, through

May 27, 2016. According to the plaintiff, on the night of May 27, 2016, she awoke with pain in

her torso and back and felt as though her body was “frozen.” When she saw Lombardi the next

day, although he did not think her symptoms were related to Chantix, he instructed her to

discontinue its use, which she did. At the time, the plaintiff was experiencing pain in her neck

and back but was not experiencing any tics or other abnormal movements. Lombardi prescribed

opioid medication for the pain. A few days later, after stopping Chantix, and while trying to

gradually discontinue opioid use, the plaintiff claims that she began to experience abnormal

movements of her torso and neck.

In July 2016, the plaintiff began treatment with a pain management specialist, Dr.

Philippe Vaillancourt. She reported to Vaillancourt that her abnormal torso movements had

started eight years prior. Vaillancourt prescribed the plaintiff an opioid medication for her pain,

which, according to the plaintiff, also completely resolved her abnormal movements. The

plaintiff continued to take opioid medications throughout the remainder of 2016, 2017, 2018,

2019, 2020 and 2021.

Between July 2016 and February 2019, the plaintiff saw ten neurologists, including two

at Columbia University Medical Center’s Movement Disorders Clinic, and underwent multiple

diagnostic tests to determine the cause of her abnormal movements. None of the plaintiff’s

diagnostic tests, which included MRIs, EEGs, EMGs, and nerve conduction studies,

demonstrated a neurological basis for the plaintiff’s abnormal movements. One EMG study

conducted in July 2017 did find “occasional patterns of EMG activity consistent with

stereotypies or tic-like movements,” but also noted that “[t]here were no findings of prolonged

contractions characteristic of dystonia[,]” a type of movement disorder characterized by muscle

contractions that are repetitive and may be stereotyped. The same EMG study also noted that the

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plaintiff’s “jerking movement and firing pattern were modulated by distraction,” and concluded

that, “[i]n their aggregate, the frequency range, EMG burst discharge variability, and modulation

with distraction and other movement suggest that these findings were not indicative of a

pathophysiological movement disorder[.]”

Similarly, with one exception, none of the plaintiff’s treating neurologists determined that

Chantix caused her abnormal movements, and several diagnosed her with a psychogenic or

functional movement disorder—i.e., a physical manifestation of an underlying psychological

condition, or possibly a purposeful performance for secondary gain (malingering), rather than an

organic condition caused by a neurological abnormality or chemical imbalance. For example, in

November 2016, neurologist Dr. Agha Raza noted that the plaintiff’s abnormal movements went

away with distraction and indicated his suspicion that they had a psychogenic basis. Also in

November 2016, neurologist Dr. Sulada Kanchana noted that the plaintiff’s trunk spasms were

“likely psychogenic” and “unlikely to be from Chantix.” In December 2016, neurologist Dr.

Anthony Adamo noted that the plaintiff’s abnormal movements were “intermittent” and

“random” and suspected “a conversion disorder, i.e., psychogenic etiology.” In January and

March 2017, the plaintiff consulted neurologists at the Columbia University Medical Center’s

Movement Disorders Clinic, including Dr. Miriam Sklerov and Dr. Sheng-Hen Kuo, who offered

a differential diagnosis of thoracic spinal myoclonus versus psychogenic movement disorder. In

December 2018, neurologist Dr. Marcie Rabin posited a diagnosis of “[t]ics vs psychogenic vs

tics + embellishment[.]” Also in December 2018, Dr. Marc Cohen, a pain specialist, suggested

the plaintiff’s abnormal movements were “psychogenic in nature[.]” And in February 2019,

neurologist Dr. Ronald Kanner indicated “the most likely diagnosis” to be “a psychogenic

movement disorder and possible borderline personality disorder[.]”

The sole exception was neurologist Dr. Roger Kurlan, whom the plaintiff sought out and

began treating with in December 2017, who diagnosed the plaintiff with a Chantix-induced

movement disorder. The plaintiff had indicated to prior treatment providers that she believed her

abnormal movements were caused by her use Chantix, and she specifically sought treatment

from Kurlan after reading an article he co-authored that reported the cases of two patients who

developed a movement disorder following Chantix use.

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During this period, multiple treatment providers also noted concerns of opioid use

disorder and malingering. During an involuntary admission to Zucker Hillside Hospital in May

2018 for suspected psychosis, the plaintiff’s abnormal movements were observed on camera only

when she was communicating with physicians or other medical providers, but not when she was

alone or socializing with peers, which contributed to diagnoses of “conversion disorder (i.e.,

psychogenic) versus factitious disorder versus malingering[.]” These same concerns were noted

six months later during a voluntary admission to Zucker Hillside for depression and pain.

Similarly, on January 2, 2019, the plaintiff presented to the emergency room at Long Island

Jewish Medical Center with suicidal ideation after Dr. Vaillancourt refused to prescribe

oxycodone. During this visit, the plaintiff’s abnormal movements were observed on camera only

when she was communicating with physicians but not when she was alone. The plaintiff was

offered a psychiatric admission but requested to be discharged home after learning she would not

receive oxycodone due to suspected opioid use disorder and malingering. The plaintiff returned

to Long Island Jewish on January 5, 2019, again seeking oxycodone, which physicians refused to

prescribe, having diagnosed her with “opioid abuse,” “personality disorder,” and “truncal

myoclonus (high suspicion for malingering vs Chantix induced [reflecting Kurlan’s diagnosis]).”

On January 7, 2019, the plaintiff returned to Zucker Hillside seeking oxycodone for her

abnormal movements. Hospital staff once again noted that her abnormal movements were

observed only when she was aware of being visible to staff, “raising concern for volitional

movement vs. functional movement disorder.” The plaintiff once again requested discharge after

being denied oxycodone. On January 14, 2019, the plaintiff presented to NYU Langone

Brooklyn and was discharged the same day with an impression of malingering. And in June

2019, Dr. Vladimir Salomon, a pain specialist, noted signs of opioid use disorder and

malingering.

The plaintiff initiated this action in February 2019 with the filing of a summons and

complaint. She alleges that her brief, eleven-day use of Chantix caused her to develop a

movement disorder characterized as dystonia and persistent dystonic tics, as well as various other

injuries, including: chronic pain in entire spine, abdomen, and hips; muscular spasms; spinal disk

bulges; arthritic changes in neck, cervical spinal stenosis, and an abnormal straightening of

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cervical spinal canal; limping upon ambulation; difficulty lifting items; persistent exhaustion;

labored breathing; depression; anxiety; and hospitalization. She alleges that the defendant failed

to properly disclose these risks, that her prescribing physician, Dr. Lombardi, was therefore not

aware of them, and that, had Lombardi known of the risks of these side effects, he would not

have prescribed Chantix.

The plaintiff’s original complaint asserted the following causes of action: (1) negligence;

(2) breach of express warranty; (3) breach of implied warranty; (4) fraudulent misrepresentation;

(5) fraudulent concealment; (6) reckless and/or negligent misrepresentation and concealment; (7)

gross negligence; (8) willful, wanton, and malicious conduct; and (9) unjust enrichment. The

defendant moved to dismiss the complaint in its entirety (MOT SEQ 001).

By decision and order dated July 7, 2020, the court dismissed the first (negligence),

seventh (gross negligence), and eighth (willful, wanton and malicious conduct) causes of action,

insofar as those causes of action were based on failure to warn allegations. It also dismissed in

their entirety the second (breach of express warranty), fourth (fraudulent misrepresentation), fifth

(fraudulent concealment), and sixth (reckless and/or negligent misrepresentation and

concealment) causes of action, as well as the plaintiff’s request for punitive damages, and

otherwise denied the motion.

In dismissing the first (negligence), seventh (gross negligence), and eighth (willful,

wanton and malicious conduct) causes of action, to the extent they were based on a failure to

warn, the court held that the plaintiff failed to sufficiently plead a failure to warn claim that is not

preempted by the Food, Drug, and Cosmetic Act of 1938 (“FDCA”), because “the complaint

fail[ed] to allege facts indicating that [there was] ‘published medical literature’ [that] ‘reveal[ed]

risks of a different type or greater severity or frequency than previously included in submissions

to FDA.’” Nonetheless, the court held the complaint adequately pleaded these three causes of

action to the extent they were based on the defendant’s alleged failures to properly test Chantix

before releasing it to the market and to conduct adequate post-market surveillance and

monitoring of the drug.

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The court denied the motion as to the ninth cause of action (unjust enrichment), holding

that the plaintiff “sufficiently allege[d] a relationship sufficient to create reliance or inducement,”

as she “allege[d] that Pfizer advertised Chantix as a safe product, and that it knew or should have

known of the dangers of the drug,” and “that Pfizer accepted payment from her, and that it would

be unjust for Pfizer to retain this money because she did not receive the product that Pfizer

represented Chantix to be.” Moreover, the court held that the “claim [was] not duplicative of any

other claim, given that [the plaintiff sought] disgorgement of Pfizer’s profits and monetary

benefits.”

Following the issuance of the July 7, 2020, decision, the plaintiff filed the amended

(operative) complaint, asserting causes of action sounding in: (1) negligence; (2) breach of

express warranty; (3) breach of implied warranty; (4) gross negligence; (5) willful, wanton, and

malicious conduct; and (6) unjust enrichment. Once again, the defendant moved to dismiss the

amended complaint in its entirety (MOT SEQ 002).

By decision and order dated January 10, 2022, the court dismissed the second cause of

action (breach of express warranty) in its entirety, as well as so much of the first (negligence),

fourth (gross negligence), and fifth (willful, wanton, and malicious conduct) causes of action as

were based on allegations of a failure to warn the plaintiff or the public of the alleged risks of

Chantix, and otherwise denied the motion.

With respect to the first (negligence), fourth (gross negligence), and fifth (willful,

wanton, and malicious conduct) causes of action, the court determined that the amended

complaint corrected the pleading deficiency in the original complaint and now stated failure to

warn claims that were not preempted. Specifically, the court found that allegations that the

Chantix label was inadequate in failing to warn of the risks of “dystonia, muscular spasm,

movement disorders and abnormal posture” were not preempted because the amended complaint

“sufficiently allege[d] the existence of newly acquired information that could have permitted a

change of the Chantix label under the CBE regulation” with respect to these risks. NYSCEF

Doc. 81 at 6, 13-14. The court based this determination on a pair of medical case reports

submitted by the plaintiff concerning three patients who developed movement disorders after

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taking varenicline. The court held that these reports satisfied the definition of “newly acquired

information” for purposes of the CBE regulation because they “draw a causal relationship

between Chantix and the side effects plaintiff claims should have been included on its label.” Id.

In so ruling, the court necessarily determined that the only failure to warn claims that were not

preempted were those based on allegations of a failure to warn of the risks of “dystonia,

muscular spasm, movement disorders and abnormal posture”—in effect, the risk of a Chantix-

induced movement disorder. The court further held that the informed intermediary doctrine did

not preclude the failure to warn claims in their entirety, as, in addition to a failure to warn the

plaintiff and the public, the amended complaint also alleged a failure to warn the plaintiff’s

physician.

The court found that the plaintiff had not amended its allegations with respect to the first

(negligence), fourth (gross negligence), and fifth (willful, wanton, and malicious conduct) causes

of action insofar as they were based on alleged failures to properly test Chantix and to conduct

adequate post-market surveillance, nor had she amended her allegations with respect to the third

(breach of implied warranty) and sixth (unjust enrichment) causes of action. Accordingly, the

court held that the sufficiency of these allegations had already been fully litigated and denied the

defendant’s motion with respect to these claims based on the law of the case.

Thus, the claims presently remaining in the case are the first (negligence), fourth (gross

negligence), and fifth (willful, wanton, and malicious conduct) causes of action to the extent they

are based on an alleged failure to warn the plaintiff’s prescribing physician of the risk of a

Chantix-induced movement disorder, as well as a failure to properly test Chantix before releasing

it to the market and a failure to conduct adequate post-market surveillance and monitoring of the

drug; the third (breach of implied warranty) cause of action; and the sixth (unjust enrichment)

cause of action.

Discovery thereafter commenced, during which the plaintiff produced her voluminous

medical records, the plaintiff and certain of her treating physicians were deposed, and the parties’

exchanged expert reports. The Note of Issue was filed on April 28, 2022.

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The defendant now moves to exclude the opinions of the plaintiff’s treating physician and

expert, Roger Kurlan, MD, and for summary judgment dismissing the amended complaint in its

entirety. In support of these motions the defendant submits, inter alia: two unsworn reports

prepared by its experts; hundreds of pages of the plaintiff’s medical records; a copy of the

Chantix label in effect when the plaintiff was prescribed Chantix; excerpts from the deposition

transcript of the plaintiff’s prescribing physician, Dr. Lombardi; and Kurlan’s expert report,

together with copies of the medical literature cited therein.

With respect to the motion to exclude, the defendant argues that Kurlan’s general

causation opinion is inadmissible because it is based solely on case reports and adverse event

reporting, which are not generally accepted in the scientific community as a reliable basis for

establishing causation. The defendant further argues that Kurlan’s specific causation opinion is

fatally unreliable because it disregards material facts and medical evidence in the record and fails

to address and rule out the adverse findings of the plaintiff’s nine other treating neurologists.

With respect to the summary judgment motion, the defendant argues all causes of action

should be dismissed because, if Kurlan’s opinions are excluded, the plaintiff cannot establish

causation as to any of her alleged injuries, and even if Kurlan’s opinions are not excluded, he

fails to opine that Chantix is defective with respect to its warning label, pre-market testing, or

post-market surveillance and monitoring. The defendant further contends that the first

(negligence), fourth (gross negligence), and fifth (willful, wanton, and malicious conduct) causes

of action, insofar as they are premised on allegations of a failure to warn, should be dismissed for

lack of proximate cause based on the deposition testimony of the plaintiff’s treating physician,

and because they are preempted by the FDCA. Additionally, despite the court’s prior decisions

having limited the failure to warn claims to the alleged absence of a warning regarding the risk

of a movement disorder, the defendant argues that, to the extent these claims are based on an

alleged failure to warn of the risks of anxiety and depression, they must be dismissed because the

Chantix label adequately warned of those risks.

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III. DISCUSSION

1. Plaintiff’s Summary Judgment Motion (MOT SEQ 007)

The proponent of a motion for summary judgment pursuant to CPLR 3212 must establish

prima facie entitlement to judgment as a matter of law by submitting proof in admissible form

demonstrating the absence of triable issues of fact. See Winegrad v New York Univ. Med. Ctr.,

64 NY2d 851 (1985); Zuckerman v City of New York, 49 NY2d 557 (1980). Should the movant

meet that burden, it then becomes incumbent upon the party opposing the motion to come

forward with proof in admissible form sufficient to raise a triable issue of fact. See Alvarez v

Prospect Hosp., 68 NY2d 320 (1986); Winegrad v New York Univ. Med. Ctr., supra; Zuckerman

v City of New York, supra; O’Halloran v City of New York, 78 AD3d 536 (1st Dept. 2010). If

the movant fails to meet the burden and establish a claim or defense sufficiently to warrant a

court’s directing judgment in the movant’s favor as a matter of law, the motion must be denied

regardless of the sufficiency of the opposing papers. See Alvarez v Prospect Hosp., supra.

A. Causation

To prevail on any of her claims the plaintiff must tender evidence demonstrating “general

causation,” i.e., that Chantix can cause the particular movement disorder and other medical

conditions she alleges, and also “specific causation,” i.e., that her ingestion of Chantix at the

prescribed dosage for only eleven days created or aggravated her movement disorder and other

alleged conditions. See Parker v Mobil Oil Corp., 7 NY3d 434, 448 (2006); Heckstall v Pincus,

19 AD3d 203, 204 (1st Dept. 2005). Given that this is a complex products liability action against

a pharmaceuticals manufacturer, expert testimony will likely be required for this purpose. See

Parker v Mobil Oil Corp., supra; Heckstall v Pincus, supra; In re Mirena IUS Levonorgestrel-

Related Prod. Liab. Litig. (No. II), 387 F. Supp. 3d 323, 342-43 (SDNY 2019) (“[G]enerally in

products liability cases involving complex causation issues, including cases involving

pharmaceuticals or medical devices, to establish causation, plaintiffs must offer admissible

expert testimony regarding both general causation and specific causation.”).

The defendant contends it is entitled to summary judgment on all causes of action

because the plaintiff requires Kurlan’s expert opinions to establish causation, and Kurlan’s

opinions should be excluded as inadmissible. As discussed further below, the court finds that

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Kurlan’s causation opinions are speculative and fundamentally unreliable. However, although

the defendant asserts in its moving papers that Kurlan is the plaintiff’s only expert, this is neither

admitted by the plaintiff nor established by any evidentiary submission. As such, summary

judgment cannot be based on the exclusion of Kurlan’s opinions alone, and it remains incumbent

upon the defendant to submit proof in admissible form demonstrating the absence of triable

issues of fact and its prima facie entitlement to judgment as a matter of law. The defendant fails

to meet this burden.

The defendant relies on a pair of expert reports prepared by Dr. Drew Kiraly and Dr.

James Morley, respectively, to demonstrate that Chantix did not cause the plaintiff’s movement

disorder, which is the principal injury alleged. However, the reports, which are annexed to the

affirmation of defendant’s counsel, are both unsworn, and the defendant does not submit an

affidavit or affirmation from either expert. It is well-established that an unsworn expert report is

inadmissible. See Fiuzzi v Paragon Sporting Goods Co. LLC, 212 AD3d 431, 433 (1st Dept.

2023); Ulm I Holding Corp. v Antell, 155 AD3d 585, 586 (1st Dept. 2017); Frees v Frank &

Walter Eberhart L.P. No. 1, 71 AD3d 491, 492 (1st Dept. 2010). As such, the defendant fails to

meet its initial burden of establishing a prima facie case with respect to lack of causation,

rendering it unnecessary to consider the sufficiency of the plaintiff’s opposition on this issue.

See Alvarez v Prospect Hosp., supra; Winegrad v New York Univ. Med. Ctr., supra; Zuckerman

v City of New York, supra; O’Halloran v City of New York, supra.

B. Product Defect

Similarly unavailing is the defendant’s contention that it is entitled to summary judgment

on all causes of action because Kurlan’s report, even if not excluded, fails to opine that Chantix

is defective with respect to its warning label, pre-market testing, or post-market surveillance and

monitoring. Here, too, the defendant fails to meet its burden of submitting proof in admissible

form to establish, prima facie, that Chantix was not defective in these respects, rendering the

purported insufficiency of Kurlan’s report irrelevant.

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C. Failure to Warn Claims

The defendant contends that the first (negligence), fourth (gross negligence), and fifth

(willful, wanton, and malicious conduct) causes of action, insofar as they are premised on

allegations of a failure to warn, should be dismissed for lack of proximate cause based on the

deposition testimony of the plaintiff’s prescribing physician, and because they are preempted by

the FDCA. As discussed above, the court’s prior decisions on the defendant’s two motions to

dismiss have limited the failure to warn claims to the issue of the defendant’s alleged failure to

warn the plaintiff’s prescribing physician of the risk of a Chantix-induced movement disorder.

1. Proximate Cause

Under New York law, a negligence claim based on a failure to warn requires proof that

the product did not contain adequate warnings, directed to the plaintiff’s prescribing physician,

and that the inadequacy of those warnings was the proximate cause of the plaintiff’s injuries.

See Mulhall v Hannafin, 45 AD3d 55, 58 (1st Dept. 2007). The plaintiff has the burden to show

that, had a different warning been given, she would not have used the product that caused her

injury because her physician would have made a different prescribing decision. See id. at 60-61.

The defendant argues that the failure to warn claims fail for lack of proximate cause

because the deposition testimony of the plaintiff’s prescribing physician, Dr. Lombardi,

purportedly demonstrates that he did not read the product label before prescribing Chantix for the

plaintiff, nor did he rely on the label’s warnings or on post-market adverse event reports in

making his prescribing decision. As such, the defendant argues, the plaintiff cannot demonstrate

that, had a different warning been given, Lombardi would have made a different prescribing

decision. This argument is unavailing.

Lombardi’s testimony is insufficient to establish lack of proximate cause with respect to

the alleged failure to adequately warn of the risk of a Chantix-induced movement disorder.

Lombardi did not state definitively whether he read the product label prior to prescribing Chantix

for the plaintiff. While he stated that he did not have the label in front of him when prescribing

Chantix for the plaintiff, he also allowed that he may have previously read it, though he could

not specifically recall one way or the other. Moreover, while he testified that, in deciding to

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prescribe Chantix for the plaintiff, he did not “specifically” rely on the label warnings or on post-

market adverse event reports, he also stated that “the label mirrors the same concerns that I had

at the time that the prescription was issued[,]” and that he generally familiarizes himself with the

safety information for a new medication before prescribing it, using various online sources, some

of which “may be from manufacturers[.]” At no point in the testimony submitted by the

defendant did Lombardi state that a different safety warning would not have dissuaded him from

prescribing Chantix for the plaintiff. In short, Lombardi’s testimony does not definitively

establish that he would have been unaware of any changes made to the safety warnings for

Chantix, nor that he would have made the same prescribing decision had a different warning

been given. As such, Lombardi’s testimony does not establish, prima facie, lack of proximate

cause with respect to the plaintiff’s failure to warn claims.

2. Federal Preemption

The defendant argues the plaintiff’s failure to warn claims are preempted by the FDCA.

The court previously considered and rejected this same argument with respect to the surviving

failure to warn claims when it was raised by the defendant in its motion to dismiss the amended

complaint (MOT SEQ 002). See NYSCEF Doc. 81 at 6-14. Under the doctrine of law of the

case, if the parties had a “a full and fair opportunity to litigate when the initial determination was

made,” they are precluded “from relitigating an issue that has already been decided.” Chanice v

Federal Express Corp., 118 AD3d 634, 635 (1st Dept. 2014).

The defendant contends that, while the court previously found that two case reports

annexed to the amended complaint were sufficient to allege the existence of “newly acquired

information that could have permitted a change of the Chantix label under the CBE regulation”

to advise of the risk of developing a movement disorder, the court should now reverse itself and

hold that the surviving failure to warn claims are preempted. The sole basis for this contention is

the defendant’s insistence that neither of the subject case reports provide “reasonable evidence of

a causal association” between Chantix and the plaintiff’s alleged movement disorder. However,

the court specifically addressed precisely this issue in holding that the subject case reports

satisfied the definition of “newly acquired information” because they “draw a causal relationship

between Chantix and the side effects plaintiff claims should have been included on its label.”

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NYSCEF Doc. 81 at 13-14. The parties, having had a “a full and fair opportunity to litigate” the

preemption issue, and the sufficiency of the subject case reports in particular, may not relitigate

that issue now. See Chanice v Federal Express Corp., supra.

3. Anxiety and Depression

The defendant also contends that the plaintiff’s failure to warn claims should be

dismissed to the extent that they are based on an alleged failure to warn of the risks of anxiety

and depression because the product label at the time the plaintiff was prescribed Chantix

adequately warned of those risks. The defendant is correct. Indeed, that relief was previously

granted. As already discussed, the failure to warn claims survived the defendant’s motions to

dismiss only insofar as they are based on an alleged failure to warn of the risk of a Chantix-

induced movement disorder. Any claim based on an alleged failure to warn of the risk of anxiety

and depression has already been held to be preempted. As such, to the extent the defendant

seeks summary judgment dismissing such claims, its motion is denied as moot.

***

The court has considered the defendant’s remaining arguments and determined that they

are without merit.

Therefore, the defendant’s motion for summary judgment is denied.

2. Defendant s Motion to Exclude Kurlan’s Opinions (MOT SEQ 006)

The defendant seeks to exclude the opinions of the plaintiff’s expert, Roger Kurlan, MD,

as to general and specific causation with respect to the plaintiff’s alleged Chantix-induced

movement disorder.

Kurlan obtained his MD from Washington University School of Medicine in 1978 and

thereafter completed a residency in Neurology and a Fellowship in Movement Disorders at the

University of Rochester Medical Center in 1984. He then joined the faculty of the University of

Rochester Medical School, where he was a Professor of Neurology and headed the Movement

Disorders and Cognitive Neurology Units for several years. In 2009, he entered private practice,

starting a movement disorders program at Overlook Medical Center in Summit, New Jersey, and

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opening his own practice in 2017. He has authored over 250 scientific publications, including a

substantial number in the field of neurological movement disorders.

The defendant does not attack Kurlan’s expert qualifications. Rather, it argues that: (1)

Kurlan’s general causation opinion is unsupported by any clinical or epidemiological data or

peer reviewed studies, and is instead based solely on a handful of anecdotal case reports and

post-market adverse event reports, which is not a generally accepted methodology in the

scientific community for establishing causation; and (2) his specific causation opinion is also not

founded on a generally accepted methodology because he disregarded facts and medical

evidence in the record and failed to rule out alternative causes for the plaintiff’s condition.

“[W]here [as here] a plaintiff’s qualified experts offer no novel test or technique but

intend to testify about a novel theory of causation . . . it is proper to proceed directly to the

foundational inquiry of admissibility, which is whether the theory is properly founded on

generally accepted scientific methods or principles.” Ratner v McNeil-PPC, Inc., 91 AD3d 63,

73 (2nd Dept. 2011), citing Parker v Mobil Oil Corp., supra at 447 (inquiry focuses on the

“reliability of the procedures followed to generate the evidence proffered and whether they

establish a foundation for the reception of the evidence at trial”); see Marsh v Smyth, 12 AD3d

307, 312-13 (1st Dept. 2004) (Saxe, J., concurring) (where expert offers no novel test or process,

but rather a novel theory of causation, the inquiry is “whether a reasonable quantum of legitimate

support exists in the literature for the expert’s views”). Additionally, “even though the expert is

using reliable principles and methods and is extrapolating from reliable data, a court may

exclude the expert’s opinion if there is simply too great an analytical gap between the data and

the opinion proffered.” Cornell v 360 W. 51st St. Realty, LLC, 22 NY3d 762, 781 (2014); see

Ratner v McNeil-PPC, Inc., supra at 74-75.

A. General Causation

With respect to general causation, Kurlan posits that Chantix can cause “excessive

dopamine transmission” in the brain, which in turn “can result in an involuntary movement

disorder.” To demonstrate that Chantix can generally stimulate the release of dopamine in the

brain, Kurlan cites three studies: (1) “Pharmacological profile of the alpha4beta2 nicotinic

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acetylcholine receptor partial agonist varenicline, an effective smoking cessation aid,” an animal

study that found that varenicline stimulated increased dopamine release in the brains of rats; (2)

“Nicotine exposure and tardive dyskinesia,” another animal study, which not concern varenicline

at all, but speculated that increased dopamine release from smoking “may contribute to the

higher prevalence of [tardive dyskinesia, a type of movement disorder] in smokers” (emphasis

added); and (3) “Varenicline-induced elevation of dopamine in smokers: a preliminary [11C]-

(+)-PHNO PET study,” which used PET scan brain imaging to show that varenicline can cause

increased dopamine release in humans.

None of these studies draw a causal connection between varenicline use and any sort of

movement disorder. The first and third studies do not concern movement disorders at all and are

relied upon by Kurlan only to demonstrate that varenicline can cause increased dopamine

release. The second study, which is addressed to movement disorders, does not discuss

varenicline. And, while that study does suggest that increased dopamine release (caused by

smoking, not by varenicline use) may contribute to a higher risk of developing a movement

disorder, proof of a risk, even an increased risk, does not constitute proof of causation. See

Cornell v 360 W. 51st St. Realty, LLC, supra at 782-83 (reports and studies that speak only in

terms of “risk” and “linkage” and “association” do not establish causation). Indeed, “equat[ing]

association with causation . . . depart[s] from the generally accepted methodology for evaluating

epidemiologic evidence when determining whether exposure to an agent causes a harmful effect

or disease.” Id. at 783.

Kurlan cites no controlled clinical studies, epidemiological data, or peer reviewed studies

demonstrating a causal link between the use of varenicline and any movement disorder. Instead,

to (purportedly) demonstrate a causal connection between varenicline-induced excessive

dopamine transmission and the development of a movement disorder, Kurlan cites five case

reports, concerning a total of seven patients, who developed various movement disorders, or

experienced a worsening of movement disorder symptoms, after taking varenicline. Specifically,

Kurlan relies on the following: (1) “Withdrawal-Emergent Dyskinesias following Varenicline

Therapy” (the “TD Report”), an article that Kurlan co-authored which reported the cases of two

patients who developed tardive dyskinesia after discontinuing varenicline; (2) “Varenicline-

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induced acute dystonic reaction: a case report” (the “Dystonia Report”), which reported on a

single patient who developed acute dystonia after using varenicline; (3) “Acute worsening of tics

on varenicline” (the “Tourette Report”), which reported the cases of two patients with Tourette

syndrome whose symptoms worsened after taking varenicline; (4) “Possible varenicline

withdrawal-induced akathisia: a case report” (the “Akathisia Report”), which reported on a

single patient who developed akathisia after discontinuing varenicline; and (5) “Parkinsonism

related to varenicline in a patient during smoking cessation” (the “Parkinsonism Report”), which

reported on a single patient who developed Parkinsonism while taking varenicline.

However, “[c]ourts have recognized that . . . observational studies or case reports are not

generally accepted in the scientific community on questions of causation.” Heckstall v Pincus,

supra at 205 (precluding expert's opinion where plaintiff presented “no clinical or

epidemiological data or peer reviews” linking the drug to the disease, and supported claim of

causation solely with case reports and adverse event reports); see Ratner v McNeil-PPC, Inc.,

supra at 76 (precluding expert’s causation opinion supported only by a pair of case reports,

“which are of a lesser caliber than controlled clinical studies from which results can be reviewed

and verified”). As explained in In re Breast Implant Litigation, which has been cited

approvingly on this point by the First Department, “[t]he generally accepted view in the

scientific community is that . . . case reports and animal studies can be used to generate

hypotheses about causation, but not causation conclusions[,]” for which “controlled clinical trials

and epidemiological studies” are necessary. 11 F.Supp.2d 1217, 1230 (D. Colo. 1998) (internal

quotation marks and brackets omitted); see Pauling v Orentreich Med. Group, 14 AD3d 357 (1st

Dept. 2005) (citing In re Breast Implant Litigation for proposition that “the plaintiff’s expert’s

own unpersuasive observational studies” were insufficient to demonstrate general acceptance in

the medical community of the expert’s novel theory of causation). “[C]ase reports are not

reliable scientific evidence of causation, because they simply described reported phenomena

without comparison to the rate at which the phenomena occur in the general population or in a

defined control group; do not isolate and exclude potentially alternative causes; and do not

investigate or explain the mechanism of causation.” In re Breast Implant Litigation, supra at

1231. Indeed, the Court of Appeals has similarly rejected reliance on case reports as a generally

accepted methodology for establishing causation, explaining that, “[a]lthough a causal

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relationship is one possible explanation for an observed association between an exposure and a

disease, an association does not necessarily mean that there is a cause-effect relationship.”

Cornell v 360 W. 51st St. Realty, LLC, supra at 783 (holding that studies showing an association

between a moldy environment and the medical conditions attributed to plaintiff’s exposure to

mold “do not establish that the relevant scientific community generally accepts that molds cause

these adverse health effects”).

Moreover, even taken at face value, the case reports Kurlan cites by-in-large do not

support his opinion. Three of the reports—the Tourette Report, the Akathisia Report, and the

Parkinsonism Report—are circumspect regarding causation, speculating only that varenicline

“may” have caused or exacerbated the movement disorders observed without unequivocally

concluding that it did so. See Cornell v 360 W. 51st St. Realty, LLC, supra at 782-83 (expert

departed from generally accepted epidemiological methodology for establishing causation by

relying on reports and studies that “speak in terms of ‘risk’ and ‘linkage’ and ‘association’—not

causation”); Ratner v McNeil-PPC, Inc., supra at 76 (“[E]ven taking the two case studies at face

value, they do not unequivocally state that acetaminophen caused the liver cirrhosis observed

therein.”). The Dystonia Report, too, though it states a more definite conclusion regarding

causation, does not support Kurlan’s general causation theory, as it attributes the patient’s

development of acute dystonia to the “dopaminergic deficiency” resulting from his varenicline-

aided smoking cessation—i.e., the report attributes the cause of the patient’s movement disorder

to his smoking cessation, not the direct neurological effects of varenicline itself, and the

mechanism proffered was decreased dopamine transmission, the exact inverse of the “excessive

dopamine transmission” mechanism that Kurlan seeks to prove.

Other than the five case reports discussed above, the only other medical literature that

Kurlan cites in support of his general causation theory is a study, “Strong Safety Seen for New

Varenicline Risks,” prepared by The Institute for Safe Medication Practices (“ISMP”), which

summarizes post-market adverse event reports concerning Chantix, including 372 reports of a

wide range of movement disorders, and an article, “Potential therapeutic application for nicotinic

receptor drugs in movement disorders,” which reviews the scientific evidence that varenicline

and other similar drugs may be helpful in the treatment of movement disorders (the “Treatment

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Article”). However, the ISMP study does not conclude that Chantix caused any of the

movement disorders reported, and expressly states that “[a]dverse event reports in themselves do

not establish a causal link to the drug.” See Heckstall v Pincus, supra at 205 (case reports and

adverse event reports not generally accepted basis for establishing causation). Similarly, the

Treatment Article, at best, provides evidence that varenicline may affect neurological systems

involved in certain movement disorders, but nowhere in the article is it suggested that varenicline

can cause movement disorders.

In sum, Kurlan’s general causation opinion, based principally on case reports and adverse

event reports, is not founded on a generally accepted methodology for establishing causation (see

Cornell v 360 W. 51st St. Realty, LLC, supra at 783; Heckstall v Pincus, supra at 205; Pauling v

Orentreich Med. Group, supra; Ratner v McNeil-PPC, Inc., supra at 76), and, even accepting that

he is extrapolating from case reports that reliably recount the association observed between

varenicline use and the development or worsening of various movement disorders in the seven

patients that were the subject of those reports, “there is simply too great an analytical gap

between the data and the opinion proffered” (Cornell v 360 W. 51st St. Realty, LLC, supra at

781; see Ratner v McNeil-PPC, Inc., supra at 74-75).

In opposition, the plaintiff contends that the lack of epidemiological studies supporting

Kurlan’s conclusions is irrelevant, and that Kurlan’s causation opinion is supported by generally

accepted scientific methods because it is based upon reasonable extrapolations from legitimate

empirical data. In this regard, the plaintiff principally relies upon Zito v Zabarsky, 28 AD3d 42

(2nd Dept. 2006), and Lugo v New York City Health and Hospitals Corp., 89 AD3d 42 (2nd Dept.

2011), which she cites for the propositions that “it is not necessary that the underlying support

for the theory of causation consist of cases or studies considering circumstances exactly parallel

to those under consideration in the litigation” (Zito v Zabarsky, supra at 44), and that “[i]t would

be unreasonable to preclude a 45-year smoker from seeking recovery if the only available

empirical data addressed 50-year smokers” (Lugo v New York City Health and Hospitals Corp.,

supra at 62). However, the issue with Kurlan’s general causation opinion is not that he relies on

empirical data that does not precisely match the plaintiff’s circumstances, but rather, that his

general causation opinion, at its core, is founded entirely on a handful of case reports and adverse

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event reports, which “are not generally accepted in the scientific community on questions of

causation.” Heckstall v Pincus, supra at 205. Indeed, the plaintiff simply ignores the controlling

and well-established caselaw cited above on this point. She does attempt to distinguish the Court

of Appeals’ decision in Cornell v 360 W. 51st St. Realty, LLC, but focuses entirely on the

portion of that opinion addressed to specific causation, and not the portions cited above that

relate to the general causation analysis.

B. Specific Causation

The court’s determination regarding Kurlan’s general causation opinion is dispositive of

his specific causation opinion as well. However, even considered on its own, Kurlan’s opinion

as to specific causation is similarly unreliable. Kurlan states that, in opining that the plaintiff has

a Chantix-induced movement disorder, he relied on his own treatment and examination of the

plaintiff, as well as the medical records and deposition testimony of Dr. Lombardi, the plaintiff’s

primary physician, and Dr. Vaillancourt, the plaintiff’s pain management physician. He does

not, however, claim to have reviewed the medical records of the plaintiff’s nine other treating

neurologists, her multiple objective diagnostic tests to determine the cause of her movement

disorder, her numerous emergency room visits and hospitalizations, or any of her other medical

providers, nor does he address any of these records in his expert report.

As detailed above, these voluminous medical records, submitted by the defendant in

support of its motion, include nearly a dozen objective diagnostic tests, such as MRIs, EEGs and

EMGs, none of which demonstrated a neurological basis for the plaintiff’s abnormal movements.

These records also demonstrate that many, if not most, of the plaintiff’s other treating

neurologists diagnosed her movement disorder as psychogenic, and none of them shared in

Kurlan’s diagnosis of a Chantix-induced movement disorder. In this regard, the records notably

include repeated findings that the plaintiff’s abnormal movements lessened or disappeared when

she was mentally distracted, a finding that directly contradicts Kurlan’s assertion, based solely

on his own examination of the plaintiff, that her abnormal movements did not display signs of

“distractibility.” These conflicting findings are notable because, according to Kurlan,

“distractibility” is one of the “core” clinical signs of a psychogenic movement disorder, and he

therefore cites its absence upon his own examination of the plaintiff as one of his principal

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reasons for discounting the possibility that she suffers from a psychogenic movement disorder.

Finally, the medical records that Kurlan disregarded further reflect numerous and repeated

notations by various treatment providers linking the plaintiff’s complaints of abnormal

movements, and her efforts to obtain opioid medication as a treatment for her purported

condition, to her suspected opioid use disorder and malingering. These notably include notes

from her several hospitalizations reflecting that her abnormal movements disappeared entirely

when she believed that she was not being observed by medical staff, suggesting that her

symptoms were potentially fictitious, or at least embellished, and linked to her persistent efforts

to obtain opioids.

Thus, Kurlan’s specific causation opinion also departs from generally accepted

methodologies by (i) failing to specifically address and rule out the findings of the plaintiff’s

other treating neurologists who diagnosed her with a psychogenic movement disorder, and,

similarly, by (ii) disregarding the numerous facts and findings inconsistent with his opinion, such

as the repeated findings that the plaintiff’s abnormal movements lessened with distraction, the

multiple objective diagnostic tests that found no neurological basis for her abnormal movements,

and the numerous provider notes linking her abnormal movements to her suspected opioid abuse.

See Cornell v 360 W. 51st St. Realty, LLC, supra at 784-85 (expert departed from accepted

methodology for differential diagnosis by, inter alia, failing to address diagnostic findings

inconsistent with his diagnosis); Akel v Gerardi, 200 AD3d 445, 446 (1st Dept. 2021) (expert’s

opinion was conclusory and speculative where it failed to specifically address opinions of

opposing expert and disregarded facts and medical evidence in the record); Heckstall v Pincus,

supra at 205 (expert failed to rule out alternative causes for plaintiff’s illness).

In opposition, the plaintiff argues that the fact that many of her other treating physicians

diagnosed her with a psychogenic movement disorder simply creates a question of fact for the

jury. This is another red herring, as the issue is not that other doctors reached a different

diagnosis, but that Kurlan ignores and fails to specifically address those inconsistent diagnoses

and the findings upon which they were based. Indeed, the plaintiff submits an affidavit from

Kurlan in which he still does not claim to have reviewed any of the medical records discussed

above, but nevertheless asserts that, in reaching his specific causation opinion, he was right to

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rely more-or-less exclusively on his own experience and treatment of the plaintiff, and to

discount the inconsistent findings of her other doctors. Kurlan explains that, “I have seen many

more patients with tic disorders, conducted many more research studies on tic disorders and

published many more scientific articles and books on tic disorders than all of the [other] treating

and expert neurologists combined[,]” and “it was clear to me that almost none of the other

neurologists had the depth of knowledge or experience with psychogenic tics to make a valid

diagnosis [and] I ‘ruled out their findings’ by my own findings and my realization that theirs

were mostly invalid.” In other words, Kurlan asserts that there was no need for him to consider

and specifically address the inconsistent findings of the plaintiff’s other doctors, or the

considerable evidence on which those findings were based, because, in his opinion, those doctors

are simply inferior physicians whose findings may be summarily discounted. Similarly, with

respect to his failure to address the results of the plaintiff’s numerous objective diagnostic tests,

Kurlan states in his affidavit that none of those tests “is able to properly diagnose psychogenic

tics,” completely ignoring that the salience of those tests is not that they demonstrated a

psychogenic basis for the plaintiff’s movement disorder, but rather that they uniformly failed to

demonstrate that her abnormal movements had any neurological basis. In short, even in his

affidavit in opposition to the defendant’s motion, Kurlan still simply refuses to engage with, and

in many instances to even acknowledge, the considerable medical evidence that is inconsistent

with his opinion.

***

Accordingly, the defendant’s motion to exclude the opinions of the plaintiff’s expert,

Roger Kurlan, MD, is granted. The exclusion of Kurlan’s opinions does not necessitate

summary judgment in favor of the defendant. As already noted above, while the defendant states

in its moving papers that the plaintiff cannot prove its case with respect to any of its claims

without Kurlan as an expert, the defendant submits no support for this conclusion.

3. Plaintiff’s Motion to Seal (MOT SEQ 005)

Pursuant to 22 NYCRR 216.1(a), “a court shall not enter an order in any action or

proceeding sealing the court records, whether in whole or in part, except upon a written finding

of good cause, which shall specify the grounds thereof. In determining whether good cause has

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been shown, the court shall consider the interests of the public as well as of the parties.” The

Appellate Division, First Department, has emphasized that “there is a broad presumption that the

public is entitled to access to judicial proceedings and court records.” Mosallem v Berenson, 76

AD3d 345, 348 (1st Dept. 2010). Because “confidentiality is clearly the exception, not the rule”

(Matter of Hofmann, 284 AD2d 92, 93–94 [1st Dept. 2001]), that Court has authorized sealing

“only in strictly limited circumstances.” Gryphon Dom. VI, LLC v APP Intl. Fin. Co., 28 AD3d

322, 325 (1st Dept. 2006); see Mosallem v Berenson, supra.

The burden is on the party seeking to seal court records to establish “good cause.”

Maxim, Inc. v Feifer, 145 AD3d 516, 517 (1st Dept. 2017). “Since there is no absolute

definition, a finding of good cause, in essence, ‘boils down to … the prudent exercise of the

court's discretion.’” Applehead Pictures, LLC v Perelman, 80 AD3d 181, 192 (1st Dept. 2010),

quoting Mancheski v Gabelli Group Capital Partners, 39 AD3d 499, 502 (2nd Dept. 2007) (some

internal quotation marks and citation omitted). “Conclusory claims of the need for

confidentiality … [are] not … sufficient bas[es] for a sealing order” (Matter of Hofmann, supra

at 93-94), and “the court will not approve wholesale sealing of [court] papers, even when both

sides to the litigation request sealing.” Applehead Pictures, LLC v Perelman, supra (citations

omitted); see Gryphon Dom. VI, LLC v APP Intl. Fin. Co., supra; Liapakis v Sullivan, 290

AD2d 393 (1st Dept. 2002); Matter of Hofmann, supra. That is, a party’s own “designation of

the materials as confidential or highly confidential is not controlling on the court’s determination

whether there is good cause to seal the record pursuant to 22 NYCRR 216.1.” Eusini v Pioneer

Electronics (USA), Inc., 29 AD3d 623, 625 (2nd Dept. 2006); see Mosallem v Berenson, supra.

Even where there is a proper basis for sealing, redaction is favored over sealing of an entire

document or record. See Vergara v Mission Capital Advisors, LLC, 187 AD3d 495 (1st Dept.

2020); Danco Laboratories, Ltd. v Chemical Works of Gedeon Richter, Ltd., 274 AD2d 1 (1st

Dept. 2000).

The defendant seeks the wholesale sealing of exhibits 1, 6, 7, 11-70, 73, and 80 to the

Affirmation of Jessica Wilson (NYSCEF Docs. 100, 105, 109 and 119), filed in support of its

own motion for summary judgment and to exclude Kurlan’s expert opinions (NYSCEF Docs.

100, 105, 109, 112, 119, 124, 129, 133, 136, 143). These voluminous exhibits include all of the

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plaintiff’s medical records submitted on the other two motions, which number in the hundreds of

pages, along with various other documents that refer to said medical records, such as deposition

transcripts, the parties’ expert reports, and the plaintiff’s interrogatory responses. Notably,

documents having nothing to do with the plaintiff are also included. The defendant seeks

wholesale sealing of these documents but provides no specific ground for any particular

document. The defendant also seeks to maintain redactions applied to portions of its papers filed

in support of its other two motions, which likewise refer to and discuss the plaintiff’s medical

records (NYSCEF Docs. 98, 121-22).

The defendant does not meet its burden of demonstrating “good cause” for

sealing/redacting the subject documents. The defendant asserts only a very general argument

that sealing these documents is necessary to comply with the defendant’s desire to protect the

plaintiff’s medical and mental health records from public disclosure. However, it offers no

explanation for its conclusory assertion that these records are “sensitive” and “confidential,” but

instead simply invokes New York’s public policy of protecting the privacy of personal medical

records and all physicians’ obligations to do so. See Chanko v Am. Broad. Companies Inc., 27

NY3d 46 (2016). The defendant pharmaceutical company, of course, is not a physician and no

such privilege applies. Notably, the defendant wholly ignores the well settled rule that where a

litigant affirmatively places his or her medical condition into issue, any such privilege is waived

and the protection falls. See Arons v Jutkowitz, 9 NY3d 393 (2007); Hoenig v Westphal, 52

NY2d 605 (1982); DiLorenzo v Toledano, 190 AD3d 941 (2nd Dept. 2021); Ava v NYP

Holdings, Inc. ,64 AD3d 407 (1st Dept. 2009). Moreover, courts have declined to seal medical

and mental health records in such circumstances. See e.g. Jose V. v Smiley & Smiley LLP, 214

AD3d 523, 524 (1st Dept. 2023) (no good cause for sealing where guardian placed incapacitated

individual’s mental condition at issue in legal malpractice action arising from personal injury

action). Further, in the instant case, which concerns a medication that had been widely

prescribed, the interests of the public weighs in favor of disclosure. See In Re East 51st Street

Crane Collapse Litigation, 106 AD3d 473 (1st Dept. 2013) (court denied sealing of settlement in

wrongful death action arising from a tower crane collapse); Guardino v Graco Children’s

Products, Inc., 50 Misc 3d 646 (Sup Ct, Suffolk County 2015) (sealing denied in wrongful death

action for product liability regarding defective baby stroller).

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In support of this motion, the defendant also relies upon the parties’ Stipulated Protective

Order in this case, in which the parties agreed to maintain the confidentiality of medical records.

However, the parties’ agreement that these records should remain confidential between them

does not, in itself, establish good cause to seal. See Applehead Pictures, LLC v Perelman, supra;

Eusini v Pioneer Electronics (USA), Inc., supra.

Therefore, the defendant’s motion to seal is denied, but without prejudice to renewal.

The court is cognizant that the hundreds of pages of the plaintiff’s medical records submitted as

exhibits on the instant motions may well include sensitive and/or potentially embarrassing

information that is not relevant to the matters at issue in this litigation. Such information, if

identified, may properly be kept confidential, should the parties seek leave to do so, via narrowly

tailored redactions.

IV. CONCLUSION

In light of the court’s rulings herein and in its prior orders, the causes of action remaining

for trial are as follows: the first (negligence), fourth (gross negligence) and fifth (willful, wanton,

and malicious conduct) insofar as they are based upon allegations of a failure to warn of the risks

of dystonia, muscular spasm, movement disorders and abnormal posture, as well as a failure to

properly test Chantix before releasing it to the market, and a failure to conduct adequate post-

market surveillance and monitoring of the drug; the third cause of action (breach of implied

warranty); and the sixth cause of action (unjust enrichment).

Accordingly, upon the foregoing papers and after oral argument, it is

ORDERED that the defendant’s motion for summary judgment dismissing the amended

complaint (MOT SEQ 007) is denied; and it is further

ORDERED that the defendant’s motion to exclude the opinions of the plaintiff’s expert,

Roger Kurlan, MD (MOT SEQ 006), is granted; and it is further

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FILED: NEW YORK COUNTY CLERK 07/09/2024 11:51 AM INDEX NO. 152029/2019

NYSCEF DOC. NO. 202 RECEIVED NYSCEF: 07/09/2024

ORDERED that the defendant’s motion to seal documents (MOT SEQ 005), is denied;

and it is further

ORDERED that the Clerk shall mark the file accordingly.

This constitutes the Decision and Order of the court.

N;Jl~

HON. NANCY M. BANNON

7/8/2024 $SIG$

DATE

CHECK ONE: CASE DISPOSED X NON-FINAL DISPOSITION

□ □

GRANTED DENIED X GRANTED IN PART OTHER

APPLICATION: SETTLE ORDER SUBMIT ORDER

□

CHECK IF APPROPRIATE: INCLUDES TRANSFER/REASSIGN FIDUCIARY APPOINTMENT REFERENCE

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