Gioia v. Johnson and Johnson

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
Mariafrancesca Gioia,
Plaintiff,
-v-
Johnson and Johnson,
Defendant.
2:25-cv-2810
(NJC) (SIL)
MEMORANDUM AND ORDER
NUSRAT J. CHOUDHURY, United States District Judge:
Before the Court is the tenth Complaint filed by pro se plaintiff Mariafrancesca Gioia
relating to injuries that she allegedly sustained as a result of taking Invega, a drug manufactured
by a wholly-owned subsidiary of Johnson and Johnson (“J&J”) (“Defendant”) and prescribed to
Gioia by SouthEnd Psychiatry.1 (Compl., ECF No. 1, (“Gioia X”); see also 2:24-cv-1912, Mem.
& Order, ECF No. 14 at 2 (order dismissing Gioia VIII).) Gioia has also filed a motion to
proceed in forma pauperis (“IFP”) and a motion for leave to electronically file (“ECF Motion”).
(IFP Mot., ECF No. 2; ECF Mot., ECF No. 9.) Defendant has filed a motion requesting a
premotion conference in anticipation of a motion to dismiss the Complaint under Rule 12(b)(6)
1 Gioia’s other cases are: Gioia v. Janssen Pharm., No. 2:19-cv-4629 (“Gioia I”); Gioia v.
Janssen Pharm., No. 2:19-cv-5377 (“Gioia II”) (together, the “2019 Actions”); Gioia v. Janssen
Pharm., No. 2:23-cv-1187 (“Gioia III”); Gioia v. SouthEnd Psychiatry, No. 2:23-cv-1419
(“Gioia IV”); Gioia v. Patterson, Belknap, Webb & Tyler, No. 2:23-cv-3353 (“Gioia V”); Gioia
v. Patterson, Belknap, Webb & Tyler, No. 2:23-cv-8163 (“Gioia VI”); Gioia v. SouthEnd
Psychiatry, No. 2:23-cv-8164 (“Gioia VII”); Gioia v. Johnson and Johnson, No. 2:24-cv-1912
(“Gioia VIII”); Gioia v. SouthEnd Psychiatry; No. 2:24-cv-2259 (“Gioia IX”). Notably, Gioia
has also filed an eleventh complaint, Gioia v. Teva Pharm., USA, Inc., No. 2:25-cv-4418 (“Gioia
XI”), relating to injuries allegedly sustained as a result of taking the drug Adderall (amphetamine
dextroamphetamine).
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of the Federal Rules of Civil Procedure with a request for a filing injunction. (PMC Mot. (“PMC
Letter”), ECF No. 12.) Gioia has filed an opposition to Defendant’s motion. (Gioia’s Opp., ECF
No. 14.)
Upon review of the parties’ submissions, the Court: (1) grants Gioia’s IFP motion for the
limited purpose of this Order; (2) dismisses the Complaint pursuant to 28 U.S.C. § 1915(e)(2)(B)
(i)–(ii) and Federal Rule of Civil Procedure 12(b)(6); (3) bars Gioia, under 28 U.S.C. § 1651,
from filing any further actions relating to injuries that she allegedly sustained as a result of taking
Invega without prior permission from the Court; and (4) dismisses Gioia’s ECF Motion as moot.
BACKGROUND
The litigation history between the parties relating to the drug Invega in the state and
federal courts was set forth in the Court’s Memorandum and Order dated April 19, 2024 (the
“Mem. & Order”) in the related case Gioia VIII, and that history is incorporated here. See Mem.
& Order, Gioia VIII, No. 2:24-cv-1912 (Apr. 19, 2024). In dismissing the complaints in Gioia
VI, VII, and IX, and remanding the complaint in Gioia VIII to the New York State Supreme
Court, Suffolk County, the Court made clear:
Gioia is warned that, if she files another complaint about the same subject
matter as Gioia I–IX, including allegations arising from or relating to the
medication Invega, the Court will order her to show cause why she should
not be barred under 28 U.S.C. § 1651 from filing new civil actions without
prior permission from the Court. This warning applies to any complaints
filed directly in this Court or properly removed here.
Mem. & Order, Gioia VIII, 2:24-cv-1912 at 23. Undeterred, Gioia filed the present Complaint
against Defendant relating to the drug Invega.
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I. 	The Complaint2
Invoking this Court’s diversity subject matter jurisdiction, the Complaint alleges that
Gioia, a citizen of New York, seeks a damages award “between $12-17 million” against
Defendant, a citizen of New Jersey. (Compl. ¶¶ II (B)(1)(a), (2)(b), (3).) In its entirety, the
Statement of Claim alleges:
I am the plaintiff, Mariafrancesca Gioia, in this action and on July 3, 2019 I was
seeking a lawyer to sue the makers of medication Invega for Failing to Warn
about important side effects and ultimate outcome of this medication leading to
subclinical hypothyroidism. The defendant was also widely promoting the novel
medication without regards to patient demographics and was promoting it even
for uses in which it was not FDA approved such as for ADHD and anxiety. The
defendant did not warn patients or physicians in any way (voice, pamphlet,
website) about the ultimate outcome of Subclinical hypothyroidism and how such
an outcome can affect scholastic performance prior to speaking with me on July 3,
2019 where the defendant impersonated lawyers whose phone number and
information I found online while seeking counsel for Failure to Warn about
Invega and I spoke with the impersonators on the phone about my personal
experience with Invega as well as medical knowledge (I do have a Medical
Degree). The impersonators pretended to be lawyers who would potentially
represent me in such a case and took note of all my information as I heard them
typing in the background and promised to call me back as they most likely would
be representing me in my case. The impersonators never called back, but website
Invega.com changed the following day July 4, 2025 to include the information
they failed to warn me about before speaking with me and on the top of the page
showed a header than included promissory estoppel regarding my compensation
for this information reading “Invega is now approved for children 12-15” and then
on July 5, 2019 the header read “Invega is now approved for children 12-17”
giving me a signal that I was good to sue them for between $12-15 or $12-17
million. In the process of suing as pro-se I discovered Janssen Pharmaceutical at
the time was not legally servable and I was to sue Johnson and Johnson any legal
documents. I filed a few complaints since then however have revised my
complaint beyond just the Failure to Warn about medication Invega to now
include:
1) 	Impersonation, or when one impersonates another or a business or
emeritus by communication by internet, website, or electronic means
with intent to obtain a benefit or injure or defraud another, which
2 Excerpts from the Complaint have been reproduced here exactly as they appear in the original.
Errors in spelling, punctuation, and grammar have not been corrected or noted.
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includes Breach of Confidential Relationships under New York Penal
Law S 190.25.
And
2) 	Transparency and Purpose Specification were not disclosed/followed
to consumer (myself, plaintiff) as per New York Privacy Act.
“Individuals have a Private Right of Action that empowers them to
take legal action against companies that violate specific provisions of
such data privacy law. Privacy Laws hold accountable those who steal
or misuse data and are necessary to protect Privacy Rights. The 2023
Senate Bill 365A includes Mandatory Consent which means
Companies would be obligated to obtain explicit consent from
consumers before processing their personal data. This requirement
ensures that individuals have the choice and awareness regarding the
use of their information as well as Transparency and Accountability
which is where the legislation would establish robust transparency and
accountability standards for businesses and this ensures that companies
are transparent about their data collection and processing practices and
are accountable for how they handle consume information…”
www.centraletes.com/everthing-you-need-to-know-about-the-new-
york-privacy-act-2021/
And
3) 	5.40C Failure to Warn 564 U.S. 605 about medication Invega side
effect and ultimate outcome of Subclinical Hypothyroidism in
particularly for my case how it affects scholastic performance. The
defendant Failed to Warn about this information because it
misprescribed without regards to patient population and at times even
for reasons not approved by the FDA. Invega was widely promoted at
that time meaning that they did not have knowledge about this
outcome of Subclinical hypothyroidism and did not have concern for
FDA protocol of avoiding such heavy promotion among a novel drug.
In addition, my physician that prescribed it to me knew that I was
studying medicine and that I had board exams coming up and if there
was knowledge about such affects my physician would not have
prescribed it to me. Additionally, as can be seen from the website
Invega.com before and after speaking with me on July 3, 2024 while
Impersonating Lawyers, if the defendant (owners of Invega and
Invega.com) took my information of personal experience and medical
knowledge without my consent to update their database and website,
that means they had failed to warn about this information prior to
speaking with me.
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(Compl. at 6–9.)3 For relief, Gioia seeks
$16,000,999.00 from defendant Johnson & Johnson because this was within the
original Promissory Estoppel amount the defendant indicated with the abrupt
website changes after collecting my valuable information I provided without
consent for such purposes that they had priorly failed to know about or warn
about.
In addition, taking the medication Invega without proper warning of ultimate
outcome and side effects of subclinical hypothyroidism and effects on scholastic
performance made me perform poorly on my second USMLE board exam in that
I did not pass on the first attempt. Not passing a USMLE board exam on first
attempt eliminates the chance of getting into any United States Medical
Residency Programs through the Residency Match system and this is why I was
not able to pursue a career in medicine even though all my other credentials
would not have eliminated me from the Medical Residency Match. As can be seen
in my financial analysis, the amount made would have been around that much
plus expenses for school (Ivy League Undergraduate University and Medical
School).
Lastly, the promissory estoppel of the compensation promised for providing this
information did not realize as expected. Court filings and trying to navigate the
legal system on my own was very stressful and added to the financial and
personal setbacks and obstacles presented from Failing to Warn about Invega to
begin with.. The promised amount put stress on my family as well as they also
personally witnessed the ordeal from when Invega was first misprescribed on
account of the Failure to Warn to the Impersonation and taking my information
(personal experience and medical knowledge) without consent for such purposes
violating Privacy Act Transparency and Purpose Specification Regulations which
give me Statutes, Nexus, Cause of Action, and Proof of Failure to Warn I need to
bring suit on Johnson & Johnson for the damages caused of my career loss as a
physician, Subclinical Hypothyroidism, and emotional distress from the wild
goose chase after the Promissary Estoppel.
The impersonation of lawyers and Promissory Estoppel after collecting my
information without consent for purposes to update their database about what they
had failed to warn about that I was suing for also obstructed me from further
seeking another lawyer to sue them about Failing to Warn about Invega, adding to
potential money/financial loss from that suit alone on account of the
3 Gioia has annexed an additional 39 pages of exhibits to her Complaint including a duplicate of
her Complaint, various exhibits from other litigation, and printed webpages pertaining to Invega.
(ECF No. 1 at 12–51.)
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Impersonation and Privacy Act Transparency and Purpose Specification
Violations.
(Id. at 10–11.)
II. 	Defendant’s Motion
On June 18, 2025, Defendant filed a pre-motion conference letter in support of its
anticipated motion to dismiss the Complaint pursuant to Rule 12(b)(6), and for an order
enjoining Gioia from filing any further action against Defendant arising out of the same subject
matter without leave of Court. Citing the dismissals of Gioia’s “eleven harassing and meritless
lawsuits against Johnson & Johnson, its subsidiaries (i.e., Janssen Pharmaceutical), and its
attorneys, asserting baseless claims regarding certain ‘side effects’ [Gioia] purportedly
experienced as a result of her use of prescription antipsychotic medication, Invega,” Defendant
urges dismissal of the present Complaint “for a myriad of reasons.” (PMC Letter at 1–2 (citing
Gioia I, No. 2:19-cv-4629, 2021 WL 5447330 (E.D.N.Y. Nov. 22, 2021), appeal dismissed, No.
22-53 (2d Cir. July 20, 2022), ECF No. 60; Gioia V, 2:23-cv-3353, ECF No. 17 at 12 (E.D.N.Y.
Oct. 12, 2023) (Order explicitly warning Gioia “that her continued filing of new complaints
arising from or relating to her prior litigation involving Janssen Pharmaceutical will not be
tolerated. Should Plaintiff file another complaint arising from or relating to her prior litigation
involving Janssen Pharmaceutical, the Court will order Plaintiff to show cause why a litigation
bar should not be entered.”); Gioia VI, 2:23-cv-8163, Elec. Order. Nov. 7, 2023 (E.D.N.Y Nov.
7, 2023) (Order requiring Gioia to submit an affidavit explaining why a filing injunction should
not be entered against her, to which Gioia did not respond)).
Defendant asserts that the Complaint fails to plead any claim upon which relief may be
granted because Gioia’s: (1) allegations that Defendant “impersonated lawyers” and “took [her]
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information of personal experience and medical knowledge without [] consent” do not give rise
to any cognizable claim; (2) claims pursuant to the “Transparency and Purpose Specification”
and the “New York Privacy Act” are not plausible because these are not enacted laws and
provide no right of action; (3) claims under New York Penal Law § 190.25 fail as there is no
private right of action under a criminal statute4; and (4) failure to warn claim fails because “this
Court has already determined that the side effects [Gioia] claims to have experienced were
included on the Invega label.” (PMC Letter at 2 (emphasis in original) (citing Gioia I, 2:19-cv-
4629, ECF No. 58 at 5–6 (E.D.N.Y. Nov. 22, 2021) (finding that “nearly all of the alleged side
effects [Gioia] experienced are identified in Invega’s FDA-approved package insert” of which
the Court took judicial notice, and reasoned that “[Gioia]’s allegations of suffering from the very
side effects of which defendant warns, requires dismissal”)).
Moreover, even if Gioia had plausibly alleged some claim relating to her use of
the drug Invega, Defendant asserts that such claims should be dismissed with prejudice as
they would be barred by the doctrines of collateral estoppel and res judicata. (PMC Letter
at 3.) Because Gioia “had a full and fair opportunity to litigate her claims in her myriad
prior proceedings,” Defendant seeks dismissal of the Complaint with prejudice. (Id.)
Further, Defendant urges this Court to order Gioia “to show cause as to why a litigation
4 “A person is guilty under § 190.25(1) if he or she ‘[i]mpersonates another and does an act in
such assumed character with intent to obtain a benefit or to injure or defraud another.’ A person
is guilty under § 190.25(4) if he or she ‘[i]mpersonates another by communication by internet
website or electronic means with intent to obtain a benefit or injure or defraud another, or by
such communication pretends to be a public servant in order to induce another to submit to such
authority or act in reliance on such pretense.’” Sims v. Monaghan, No. 13-cv-6496, 2015 WL
9307350, at *7 (W.D.N.Y. Dec. 21, 2015); see also People v. Mohammad Rafikian, also known
as Mo Kian, No. 2014–11351, 2026 WL 602747, at *2 (N.Y.AD.2d. Mar. 4, 2026).
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injunction should not be issued against her once and for all. Without an express bar, there
is no end in sight to [Gioia’s] vexatious conduct.” (Id.)
III. 	Gioia’s Response
Gioia responded to Defendant’s letter by filing an unsigned, fifteen-page letter
dated June 21, 2025, entitled: “Answer to Pre-Conference Letter And Opposition to Pre-
Motion to Dismiss and Injunction.” (Opp. Ltr (“Opposition”), ECF No 14.) There, Gioia
largely repeats the allegations in the Complaint and provides a litigation history that is
belied by her history with this Court as detailed above. Gioia asserts:
The defense is wrong in stating that so many cases have been filed
against Janssen/J&J on my behalf about this matter. This matter happened in
July 2019 and then Covid happened and that delayed my first filing a couple
of years. My first filing was dismissed without prejudice as it did have merit
however I didn’t know about legal proceedings or what a cause of action or a
statute was. Since then, I have filed other cases on this matter; however,
most of them were withdrawn because I was not sure about how the
lawyers were not following the laws of legally servable entity and also
because it was unclear to me why some cases would be moved to Federal
Court. I understand these principles now except for the legally servable
entity violations that the lawyers did in the beginning but that ship has
passed since J&J is answering to Complaints as well now. Before, J&J (the
only legally servable entity for Janssen) would not answer my complaint as in
accordance to Promissory Estoppel they promised me when collecting my
information while pretending to be lawyers in July 2019. Janssen lawyers
whom may have not been aware of this in the beginning and learned about my
case by me sending a “Notice of Intent to File” before I knew J&J were
their owners acquired a personal aspect to this case and would subsequently
answer even if not served and were not following the legally servable entity
laws. This is what took so many filings and so much time was this improper
behavior and confusion, until eventually even J&J got fed up and now
answers the complaint as well. That is why my Complaint has since then
changed in its entirety and cannot be judged by Res Judicata.
Any subsequent cases I filed on this matter while moving between NY
and NJ were briefly looked at and even they had completely different causes
of actions and statutes. Res Judicata can not apply to a case that now
includes new statutes and causes of action. I was not able to include these in
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the second judgement by EDNY because I was not aware of these statutes
and also because I was still expecting a default judgement at that time and
was not sure why J&J would sign for and then not answer and only when
Janssen heard about would this non legally servable entity answer on behalf
of the legally servable entity that would remain silent as if in accordance
with the Promissory Estoppel. It was a good thing I did withdraw this case
that was supposed to be judged a second time by judge Azrack because at
that time I was not aware of these new statutes and causes of action thereby
could not have Included them but little to my knowledge at that time the
case was judged anyway even though I had asked for it to be withdrawn. I
did not receive announcement of the case being judged anyway because I
was in the middle of moving at the time and I had asked for it to be
electronically uploaded however it never was electronically uploaded so I
had no idea that the second judgement happened. This second judgement
did not include the statutes and new causes of action because I was not
aware of them and I was not aware that the case was still being judged. I did
not even include the screenshot evidence nor the letter of Right to Sue from
the Federal EEOC. There were many things missing from the second
judgement at Eastern District court of New York. Nevertheless ever since the
second judgement, that happened without my knowing about the judgement and
also without my knowing of these new statutes and causes of action, ever since
this second judgement every case that I have filed has been dismissed with
prejudice on account of Res Judicata even though the second time it was judged
and dismissed with prejudice, I had not included the statutes and causes of action
I was not aware of at that time and I also had not included evidence and other
important documents such as letter from Federal Equal Employment Opportunity
Commission granting me the Right To Sue the individual pharmaceutical
company. It has been the lawyers that were not following the legally servable
entity laws that have been giving me the run around and also this
misunderstanding of the second judgement actually being judged without my
awareness thereby lacking important documents to judge the case in full. Most
importantly, the meritful case now has the missing Legal Statutes and Causes of
Action that I was not aware about before that their lack was the reason why it was
dismissed the first two times before being judged now due to res Judicata.
The case having entirely different Statutes and Causes of Action needs
proper judgement in its entirety also now including the missing evidence and
documents such as Federal EEOC granting me the Right to Sue the individual
pharmaceutical company and my Financial Analysis, and evidence of taking
my information reflecting my story almost verbatim while now including the
valuable medical information I provided them that they had priorly failed to
warn about to patients and physicians of Subclinical hypothyroidism which
has severe impact on scholastic performance.
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Clear evidence of the defendant Failing to Warn is most easily proven by
how if the company scrambled to seek this information they failed to warn
about to the point they were impersonating lawyers while trying to stop or
prevent a potential plaintiff from suing them while collecting this information
they indeed had failed to warn about, that most easily and most conveniently
proves that they had priorly failed to warn about this information. They were
literally trying to obstruct justice from those seeking to sue them about
information they failed to warn about that had harmed them. My information
proved very valuable to them as I have a Medical Degree and also know the
pathophysiology of what they had priorly failed to warn about. They collected this
information they had priorly failed to warn about to both patients and physicians
and I am lucky to have that proof even if it meant taking my information in an
illegal and deceitful manner. These manners not o Lyn provide proof of failing to
warn but in addition provide further means of me to sue them because I was never
compensated nor gave consent for my information to be used for such purposes. I
certainly did not consent to be given the run around by lawyers not following
legally servable entity laws and taking things personally rather than giving my
case a fair chance to be judged in its entirety.
If the defense is still in denial and wants to prove that that J&J/Janssen
did this form of racketeering to collect information from potential plaintiffs
that they had priorly failed to warn about to patients and physicians,
J&J/Janssen are the sole owners of the website lnvega.com so there is no
question that J&J/Janssen did this and in order to collect information from
potential plaintiffs like myself that were harmed by information they failed
to warn about. There are no other persons that had access to this website
and there are no other persons that would have had other motives or
interests in sneakingly obtaining this information they had failed to warn
about to then update their database and website. There is no way the doctor
who prescribed me the medicine was aware of this information either
because at the time lnvega was being overly prescribed and misprescribed
even for ADHD and for Anxiety, which the FDA did not approve it for but the
defendant was pushing anyway. In addition, my doctor knew that I was
studying to become a physician. He would not have prescribed this medication if
he was aware of the effects it would have on scholastic performance through the
ultimate outcome of subclinical hypothyroidism. It was only once speaking to me
about my medical knowledge and personal experience did J&J/Janssen first obtain
this information they had failed to warn about to patients and physicians.
My first case against Janssen in July 2029 was solely a Failure to Warn case that
was dismissed because I did not include evidence or statutes in that one as I was
expecting a default judgement following the legally servable entity laws as well as
the promissory estoppel. The second time this case was judged in EDNY it was
judged after I had withdrawn the case and it did not include evidence and
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important supporting documents. I was still convinced the legally servable entity
was in accordance with the promissory estoppel and would follow a default
judgement because that was the behavior J&J versus Janssen was exhibiting at
this time. In addition, I had not researched the Statutes and Causes of Action
needed to win the case without a Default Judgement therefor was not aware of
them and could not have included them. I was not aware that this second
judgement in EDNY happened and every case following this judgement was
dismissed solely based upon Res Judicata of that incomplete case. Additionally,
this new Complaint includes different causes of action that were not included in
any other filed Complaints. With regards to the Privacy Act not being illegal it is
still actionable within context of my causes of action included in the Complaint
because they prove the Failure to Warn and provide further grounds to collect the
money defendant owes and promised me for Failing to Warn. In addition, other
elements of the Claim are indeed actionable. You can refer to my Legal Data
document to see how the Privacy Act also applies in NY.
My Claim can be plausibly asserted because the website lnvega.com is
owned only by Janssen/Johnson & Johnson and they are the only ones who
could have taken my information unlawfully to update this website with the
attempts to Obstruct Justice from potential plaintiffs seeking suit against
them. My information happened to be valuable to them and they promised
me compensation for it. I have not received that compensation yet but I do
have proof of the website Invega.com, which only the defendant has
ownership and access to change, thereby proving only the defendant could
have committed these acts with the intent to prevent suit against them and
to collect information without consent for such purposes. In fact it was for
the exact opposite purposes. I have a medical degree and provided not only
my personal experience but most importantly I provided them thorough
medical pathophysiology that proved Subclinical Hypothyroidism as an
ultimate outcome of medication Invega the defendant had priorly failed to
warn about as they were atypically broadly and hastingly promoting it
without regards to patient population and without warning the physicians
about this consequence either.
It is very obvious when reading the screen shots of the before and after
websites that the defendant had priorly failed to warn about Subclinical
Hypothyroidism and how it related to scholastic and academic performance.
In the after screen shot, you can see specifically where the defendant updates their
website Invega.com to now include Subclinical hypothyroidism and in
particularly how it relates to scholastic multiple choice questions. This proved
they had priorly failed to warn about this and that the information came
specifically from me while they were pretending to be lawyers as I was seeking
lawyers back in July 2019 for failing to warn about this to patients and physicians.
I have sworn under oath and will continue doing so and I have provided ample
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evidence and information about the occurrence and I have witnesses also. I am
sure the phone records can also be found and possibly the fake impersonator
lawyer website as well but the evidence provided of the screen shots of website
lnvega.com is ample evidence to prove this undeniable occurrence and also that
the defendant had failed to warn. In addition, the Federal Equal Employment
Opportunity Commission also specifically gave me a "Right To Sue" the
pharmaceutical company right after this occurrence. I also explained how Johnson
and Johnson had actually promised me a granted amount yet that I have not been
able to collect it because the lawyers did not follow the Legally Servable Entity
Rules in the beginning and then things got hostile. This case is extremely meritful
and shows ample evidence. The Complaint now includes the proper proof,
Statutes, and Cause of Action that were not included in prior Complaint. It is
wrong for the lawyers to try to prevent this meritful case from getting judged in
its entirety when they should be aware of the fact that the second time it was
judged in EDNY it did not include evidence or Statutes or Causes of Action
because I had asked for the case to be withdrawn and because I was not aware of
them at that time. The defense should also know that since then the case was
never given any consideration anywhere else because they did a run around with
the legally servable entity laws. The defense should thirdly know that since then
the case was never judged in its entirety because of Res Judicata based on the
second EDNY judgement that did not include Statutes, Causes of Action,
Evidence, and Supporting Documents. With regards to counsel's question about
my current Complaint including the claim violating business consumer
information Privacy Laws, please see below that it does apply in NY also and
includes informed consent about purposes of collected information:
“NYPA is a comprehensive consumer privacy law that aims to protect the privacy
of the citizens of New York by empowering them to exercise greater control over
their personal information and by holding businesses accountable. The New York
Privacy Act, advocated by Senator Kevin Thomas (D-Nassau County), passed in
the New York State Senate after its third reading on June 8, 2023, and was
delivered to the New York State Assembly. The 2023 bill is titled Senate Bill
365A The proposed measures aim to empower consumers with greater control
over their privacy and enhance accountability in data processing practices. The
key provisions include: 1. Mandatory Consent: Companies would be obligated to
obtain explicit consent from consumers before processing their personal data.
This requirement ensures that individuals have the choice and awareness
regarding the use of their information. 2. Transparency and Accountability: The
legislation would establish robust transparency and accountability standards for
businesses that handle substantial amounts of personal data. This ensures that
companies are transparent about their data collection and processing practices,
and are accountable for how they handle consumer information. 3. Oversight of
Data Brokers: The Office of the Attorney General would be granted authority to
conduct oversight of data brokers. These are entities that collect personal
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information about consumers and sell that data to other controllers or third parties.
This oversight ensures that data brokers adhere to privacy regulations and
responsibly handle consumers’ personal information.”
https://www.centraleyes.com/everything-you-need-to-know-about-the-new-
yorkprivacy-act-2021
(ECF No. 14.)
LEGAL STANDARDS
I. 	In Forma Pauperis
Upon review of the IFP motion, although the financial information reported is sparse, the
Court finds that Gioia is qualified by her financial status to commence this action without the
prepayment of the filing fee. Therefore, the IFP motion (IFP Mot., ECF No. 2) is granted for the
limited purpose of this Order.
II. 	Sufficiency of the Pleadings
Where a plaintiff is proceeding IFP, 28 U.S.C. § 1915 instructs that “the court shall
dismiss the case at any time if the court determines that . . . the action or appeal (i) is frivolous or
malicious; (ii) fails to state a claim on which relief may be granted; or (iii) seeks monetary relief
against a defendant who is immune from such relief.” 28 U.S.C. § 1915(e)(2)(B). At the pleading
stage, the court must assume the truth of “all well-pleaded, nonconclusory factual allegations” in
the complaint. Kiobel v. Royal Dutch Petroleum Co., 621 F.3d 111, 124 (2d Cir. 2010) (citing
Ashcroft v. Iqbal, 556 U.S. 662, 678–80 (2009)), aff’d, 569 U.S. 108 (2013).
This Court construes pleadings “filed by pro se litigants liberally and interpret[s] them to
raise the strongest arguments that they suggest.” Hunter v. McMahon, 75 F.4th 62, 67 (2d Cir.
2023) (quotation marks omitted). “[A] pro se complaint, however inartfully pleaded, must be
held to less stringent standards than formal pleadings drafted by lawyers.” Ceara v. Deacon, 916
F.3d 208, 213 (2d Cir. 2019) (citing Erickson v. Pardus, 551 U.S. 89, 94 (2007)) (quotation
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marks omitted). Nevertheless, pro se status “does not exempt a party from compliance with
relevant rules of procedural and substantive law.” Lomax v. Aegis Funding Corp., No. 09-cv-
2321, 2010 WL 1633440, at *2 (E.D.N.Y. Apr. 19, 2010); see also Triestman v. Fed. Bureau of
Prisons, 470 F.3d 471, 477 (2d Cir. 2006) (per curiam).
A complaint must plead sufficient facts to “state a claim to relief that is plausible on its
face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “A claim has facial plausibility
when the plaintiff pleads factual content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. The plausibility
standard requires “more than a sheer possibility that a defendant has acted unlawfully.” Id.;
accord We The Patriots USA, Inc. v. Conn. Off. of Early Childhood Dev., 76 F.4th 130, 144 (2d
Cir. 2023), cert. denied, 144 S. Ct. 2682 (2024). “Threadbare recitals of the elements of a cause
of action, supported by mere conclusory statements . . . are not entitled to the assumption of
truth.” Iqbal, 556 U.S. at 678–79. While “detailed factual allegations” are not required, “[a]
pleading that offers ‘labels and conclusions’ or ‘a formulaic recitation of the elements of a cause
of action will not do.’” Id. at 678 (quoting Twombly, 550 U.S. at 555). The factual allegations of
a complaint must be sufficient to give the defendant “fair notice of what the . . . claim is and the
grounds upon which it rests.” Twombly, 550 U.S. at 555.
In addition, Rule 8 of the Federal Rules of Civil Procedure provides, in relevant part, that
a complaint “must contain . . . a short and plain statement of the grounds for the court’s
jurisdiction” and “of the claim showing that the pleader is entitled to relief,” and “[e]ach
allegation must be simple, concise, and direct.” Fed. R. Civ. P. 8(a)(1)–(2), (d)(1). Essentially,
Rule 8 ensures a complaint provides a defendant with sufficient notice of the claims against it.
See id. “When a complaint fails to comply with the Rule 8 requirements, the district court has the
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power, on motion or sua sponte, to dismiss the complaint or to strike such parts as are redundant
or immaterial.” Celli v. Cole, 699 F. App’x 88, 89 (2d Cir. 2017) (quoting Simmons v. Abruzzo,
49 F.3d 83, 86 (2d Cir. 1995)).
“Despite the liberal treatment courts are instructed to afford to pro se litigants’ papers,
‘pro se litigants generally are required to inform themselves regarding procedural rules and to
comply with them.’” Dubarry v. Annucci, No. 21-cv-5487, 2022 WL 4485359, at *2 (S.D.N.Y.
Sept. 27, 2022) (quoting Edwards v. I.N.S., 59 F.3d 5, 8 (2d Cir. 1995)); see also Dumel v.
Westchester Cnty., No. 19-cv-2161, 2021 WL 738365, at *4 (S.D.N.Y. Feb. 25, 2021) (“[T]he
liberal treatment afforded to pro se litigants does not exempt a pro se party from compliance with
relevant rules of procedural and substantive law.”); see also Caidor v. Onondaga County, 517
F.3d 601, 605 (2d Cir. 2008) (“[P]ro se litigants generally are required to inform themselves
regarding procedural rules and to comply with them.”).
III. 	Preclusion
“There are limits as to how often the Court can be asked to review the same allegations
against the same parties. That limitation is manifested in the doctrine of res judicata.” Baker v.
Supreme Ct. for N.Y., No. 12-cv-5757, 2013 WL 372005, at *1 (E.D.N.Y. Jan. 29, 2013) (citing
Salahuddin v. Jones, 992 F.2d 447, 449 (2d Cir. 1993)). In addition, collateral estoppel “bars the
relitigation of an issue that was raised, litigated, and actually decided by a judgment in a prior
proceeding, regardless of whether the two suits are based on the same cause of action.” Griffin v.
Sirva, Inc., 291 F. Supp. 3d 245, 251–52 (E.D.N.Y. 2018) (citing Postlewaite v. McGraw-Hill,
333 F.3d 42, 48 (2d Cir. 2003)).
The doctrine of res judicata bars a plaintiff from litigating claims that were already raised
or could have been raised in a prior action decided on the merits against the same defendants or
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those in privity with them. See Brown Media Corp. v. K&L Gates, LLP, 854 F.3d 150, 157 (2d
Cir. 2017). “Even claims based upon different legal theories are barred provided they arise from
the same transaction or occurrence” following the entry of a final judgment on the merits.
Cieszkowska v. Gray Line New York, 295 F.3d 204, 205 (2d Cir. 2002) (per curiam). “[R]es
judicata applies to pro se plaintiffs whose claims in a second action are based on the same factual
predicates presented in the first action.” Bey v. City of New York, 454 F.App’x 1, 5–6 (2d Cir.
2011) (citing Cieszkowska, 295 F.3d at 205–06). “A district court has not only the power but the
obligation to dismiss complaints . . . on res judicata grounds when the litigation history triggers
it.” Caldwell v. Pesce, 83 F. Supp. 3d 472, 481 (E.D.N.Y. 2015) (citing Salahuddin, 992 F.2d at
449).
B. 	Collateral Estoppel
Collateral estoppel, or issue preclusion, prevents parties from relitigating an issue of fact
or law in a subsequent action that was fully and fairly litigated in a prior one. See Boguslavsky v.
Kaplan, 159 F.3d 715, 719–20 (2d Cir. 1998). Collateral estoppel applies where “(1) the
identical issue was raised in a previous proceeding; (2) the issue was actually litigated and
decided in the previous proceeding; (3) the party had a full and fair opportunity to litigate the
issue; and (4) the resolution of the issue was necessary to support a valid and final judgment on
the merits.” Marvel Characters, Inc. v. Simon, 310 F.3d 280, 288–89 (2d Cir. 2002); see also In
re Hyman, 502 F.3d 61, 65 (2d Cir. 2007). Like res judicata, collateral estoppel also applies to
pro se litigations. See, e.g., Caldwell, 83 F. Supp.3d at 481 (“[T]he doctrines of res judicata and
collateral estoppel apply to pro se litigants.” (citing Austin v. Downs, Rachlin & Martin
Burlington St. Johnsbury, 270 F. App’x 52 (2d Cir. 2008))).
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IV. 	Litigation Injunction
The All Writs Act, 28 U.S.C. § 1651, empowers this Court to issue an injunction limiting
vexatious litigation. MLE Realty Assocs. v. Handler, 192 F.3d 259, 261 (2d Cir. 1999); see also
Matter of Hartford Textile Corp., 681 F.2d 895, 897 (2d Cir. 1982) (“The equity power of a court
to give injunctive relief against vexatious litigation is an ancient one which has been codified in
the All Writs Statute, 28 U.S.C. s. 1651(a) (1976).”); see also In re Martin-Trigona, 737 F.2d
1254, 1262 (2d Cir. 1984) (a district court has “the power and the obligation to protect the public
and the efficient administration of justice from [a vexatious litigant’s] litigious propensities”).
“[T]he traditional standards for injunctive relief, i.e. irreparable injury and inadequate remedy at
law, do not apply to the issuance of an injunction against a vexatious litigant.” In re Martin-
Trigona, 737 F.2d at 1262. Rather, the Second Circuit has identified five factors to be considered
in restricting a litigant’s access to the court system:
(1) the litigant’s history of litigation and in particular whether it entailed
vexatious, harassing or duplicative lawsuits; (2) the litigant’s motive in pursuing
the litigation, e.g., does the litigant have an objective good faith expectation of
prevailing?; (3) whether the litigant is represented by counsel; (4) whether the
litigant has caused needless expense to other parties or has posed an unnecessary
burden on the courts and their personnel; and (5) whether other sanctions would
be adequate to protect the courts and other parties.
Eliahu v. Jewish Agency for Israel, 919 F.3d 709, 714 (2d Cir. 2019). In addition, the Court must
provide plaintiff with notice and an opportunity to be heard before imposing a filing injunction.
See Moates v. Barkley, 147 F.3d 207, 208 (2d Cir. 1998) (per curiam).
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DISCUSSION
I. 	Preclusion
The Second Circuit has repeatedly confirmed that “[u]nder both New York law and
federal law, the doctrine of res judicata, or claim preclusion, provides that [a] final judgment on
the merits of an action precludes the parties or their privies from relitigating issues that were or
could have been raised in that action.” Sikorsky v. City of Newburgh, New York, 136 F.4th 56, 62
(2d Cir. 2025); Maharaj v. Bankamerica Corp., 128 F.3d 94, 97 (2d Cir. 1997); see also
Federated Dept Stores, Inc. v. Moitie, 452 U.S. 394, 398 (1981). Thus, claim preclusion bars
relitigation if “(1) the previous action involved an adjudication on the merits; (2) the previous
action involved the [same parties] or those in privity with them; [and] (3) the claims asserted in
the subsequent action were, or could have been, raised in the prior action.” Sikorsky, 136 F.4th at
62; see also Blinkoff v. City of Torrington, No. 23-717, 2025 WL 502041, at *1 (2d Cir. Feb. 14,
2025) (same).
In Gioia I and Gioia II, the Court dismissed Gioia’s failure to warn claims with prejudice,
where the amended complaint failed to “cure the deficiencies of [Gioia’s] failure to warn claim
because the amended allegations, like the original allegations, [did] not identify what warnings
were provided to plaintiff’s physician or how the provided warnings were inadequate.” (Mem.,
Gioia I, ECF No. 58 at 4.) And because “nearly all of the alleged side effects [Gioia] experienced
are identified in Invega’s FDA-approved package insert,” the Court ruled that Gioia’s
“conclusory allegations coupled with [her] allegations of suffering from the very side effects of
which [Janssen] warns, requires dismissal of [Gioia]’s claims.” (Id. at 5–6.) The Court also
determined that further leave to amend would be futile in light of Gioia’s failure to correct the
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deficiencies noted in the order dismissing her original complaints. (Id. at 6.) Judgment was
entered in Gioia I and Gioia II on November 23, 2021 and, after receiving an extension of time
to file an appeal, Gioia appealed to the Second Circuit. (Gioia I, ECF Nos. 60–62, Elec. Order,
Jan. 19, 2022; Gioia II, ECF Nos. 51, 53–54, Elec. Order, Jan. 19, 2022.) The Second Circuit
dismissed the appeals on August 5, 2022 “because it lack[ed] an arguable basis in either law or
fact.” (Mandate, Gioia I, ECF No. 63.)
Thus, because the failure to warn claim was already litigated and decided on the merits,
further litigation is precluded by res judicata and collateral estoppel. Importantly, under New
York’s transactional approach, “[t]he res judicata bar extends to all . . . claims arising out of the
same transaction or series of transactions . . . even if based upon different legal theories or
seeking a different remedy.” Ricks v. Brown, No. 20-cv-43, 2020 WL 5628969, at *2 (W.D.N.Y.
Sept. 21, 2020) (internal quotation marks and citation omitted). Thus, any other claims that may
liberally be construed from the Complaint arising out of Gioia’s use of the drug Invega are
likewise precluded. Accordingly, the failure to warn claim is dismissed with prejudice pursuant
to 28 U.S.C. § 1915(e)(2)(B)(i)–(ii).
II. 	The Penal Law, Failure to Warn, and Privacy Act Claims Also Fail on Other
Grounds
The additional claims set forth in the Complaint fail as a matter of law. First, insofar as
the Complaint seeks relief under New York Penal Law § 190.25, there is no private right of
action. See, e.g., Parkes v. Bluemenfeld Dev. Grp., Ltd., No. 25-cv-74, 2025 WL 674149, at *1
n.1 (S.D.N.Y. Mar. 3, 2025) (dismissing claim brought under NY Penal Law and explaining that
“a plaintiff cannot enforce criminal law through a civil action”). Second, the reasoning set forth
by my colleague Judge Joan Azrack in a prior case brought by Gioia applies equally here: the
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failure to warn claim is not plausible given that the very warning that was allegedly missing was
included in the Invega labeling. See supra Discussion § I at 18–19; Gioia I, No. 19-cv-4629,
2021 WL 5447330 at *3 (“Moreover, nearly all of the alleged side effects plaintiff experienced
are identified in Invega’s FDA-approved package insert . . . Courts have routinely held as a
matter of law that a drug manufacturer will not be liable if there is evidence showing that the
warning specifically warned of the side effects which occurred.”). Third, the Complaint’s
reliance on “2023 Senate Bill 365A” or the “New York Privacy Act” is misplaced given that the
proposed legislation has yet to be enacted. See
https://www.nysenate.gov/legislation/bills/2023/S365/amendment/A#:~:text=Enacts%20the%20
New%20York%20privacy,whom%20their%20information%20is%20shared (last visited on
March 9, 2026).
Thus, the Penal Law, failure to warn, and proposed New York Privacy Act claims set
forth in the Complaint are not plausible and are dismissed pursuant to 28 U.S.C.
§ 1915(e)(2)(b)(i)–(ii) and Rule 12(b)(6).
III. 	Litigation Injunction
Gioia’s ten cases demonstrate a pattern of duplicative, vexatious, and harassing lawsuits.
Given Gioia’s litigation history in this Court and the state court, her continued filing of new
complaints against Defendant or those in privity with them relating to the drug Invenga will not
be accepted. The instant case is Gioia’s tenth in this Court concerning the same subject matter,
and her litigation history suggests that she may file yet another action. The Court has an
“obligation to protect the public and the efficient administration of justice from individuals who
have a history of litigation entailing vexation, harassment and needless expense to other parties
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and an unnecessary burden on the courts and their supporting personnel.” Lau v. Meddaugh, 229
F. 3d 121, 123 (2d Cir. 2000) (internal quotation marks, citations, and alteration omitted).
Ultimately, the Court must determine “whether a litigant who has a history of vexatious litigation
is likely to continue to abuse the judicial process and harass other parties.” Eliahu, 919 F.3d at
713–14 (quoting Safir v. US Lines, Inc., 792 F.2d 19, 24 (2d Cir. 1986)). Here, four of the five
factors weigh heavily in favor of imposing such a sanction. With respect to the first and third
factors, Gioia has shown a history of filing duplicative, vexatious, and unreasonable lawsuits
against Defendant and others relating to the drug Invenga, which has consumed significant Court
resources. Gioia’s repetitive and incoherent submissions have caused an unnecessary burden on
the Court. Gioia’s continued filing of frivolous complaints relating to this subject is an abuse of
the judicial process. Indeed, “[e]very paper filed with the . . . Court, no matter how repetitious or
frivolous, requires some portion of the institution's limited resources. A part of the Court’s
responsibility is to see that these resources are allocated in a way that promotes the interests of
justice.” In re McDonald, 489 U.S. 180, 184 (1989) (per curiam).
With respect to the second factor, Gioia’s filings reveal a lack of any basis for a good
faith expectation that she will prevail, as detailed extensively in this Court’s written rulings. See
Mem. & Order, Gioia VIII, 2:24-cv-1912 at 2–8, 21 (dismissing the complaints in Gioia VI, VII,
and IX, remanding the complaint in Gioia VIII to New York State Supreme Court, Suffolk
County, detailing Plaintiff’s extensive litigation history, and warning Plaintiff that she cannot
“repeatedly file the same claims in an attempt to obtain a different result”).
Finally, this Court has repeatedly warned Gioia about the vexatious, harassing, and
duplicative nature of her litigation with no effect. The Court’s warnings to Gioia that further
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litigation about the same subject matter as Gioia I–IX, including allegations arising from or
relating to the medication Invega, may lead to the entry of a filing injunction, have not deterred
her. See, e.g., Mem. & Order, Gioia VIII, 2:24-cv-1912 at 23 (warning that litigation injunction
may be entered). Gioia’s present Complaint, together with her long history of frivolous litigation
(see supra at 1 n.1), suggest that Gioia may file a new, frivolous Complaint relating to the drug
Invega.
With respect to the second factor—whether a litigant is counseled—this Court is
particularly sensitive to Gioia’s pro se status and has considered her Complaint and Opposition
to the PMC Letter in the most positive light possible. However, Gioia was afforded notice and an
opportunity to be heard on the propriety of a litigation injunction given that the Defendant’s
PMC Letter requested entry of a litigation injunction. (See ECF No. 12.) Although Gioia filed a
lengthy opposition in response, she did not at all address Defendant’s argument pertaining a
litigation injunction. (See ECF No. 14.) Thus, there is sound basis for imposing a filing
injunction notwithstanding Gioia’s pro se status. See, e.g., Ranasinghe v. Kennell, No. 16-cv-
2170, 2017 WL 384357, at *5 (S.D.N.Y. Jan. 25, 2017) (circumstances showed that “mere
dismissal of this action will not hinder [the plaintiff] from initiating further similar proceedings”
and “that other types of sanctions would be unavailing”) (internal citation omitted), aff’d, 718 F.
App’x 82 (2d Cir. 2018).
For all of these reasons, the Court now bars Gioia from filing any new complaint
relating to same subject matter as Gioia I–X, including allegations arising from or relating
to the medication Invega, without first seeking leave of court. Any motion for leave to file
must be captioned “Application Pursuant to Court Order Seeking Leave to File.” Gioia must
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attach a copy of her proposed complaint and attach a copy of this Memorandum and Order with
any such motion. The Clerk of the Court is directed to return to Gioia, without filing, any new
complaint from her if it is received without a separate application seeking leave to file.
Further, the Court warns Gioia that Rule 11 of the Federal Rules of Civil Procedure
applies to pro se litigants. Should she file another frivolous action, it is within the Court’s
authority to consider imposing monetary sanctions upon her. See Maduakolam v. Columbia
Univ., 866 F.2d 53, 56 (2d Cir. 1989) (“Rule 11 applies both to represented and pro se
litigants . . . .”); Fed. R. Civ. P. 11.
IV. 	Leave to Amend
A pro se plaintiff should ordinarily be given the opportunity “to amend at least once
when a liberal reading of the complaint gives any indication that a valid claim might be stated.”
Shomo v. Cty. of New York, 579 F.3d 176, 183 (2d Cir. 2009) (quotation marks and citation
omitted). For the reasons set forth above, amendment would be futile and leave to amend is
denied.
CONCLUSION
For the reasons stated above, the Court grants Gioia’s motion to proceed IFP (ECF No. 2)
and dismisses the Complaint (ECF No. 1) with prejudice pursuant to 28 U.S.C.
§§ 1915(e)(2)(B)(i)–(ii) and Federal Rule of Civil Procedure 12(b)(6). Gioia is barred from filing
any further actions relating to same subject matter as Gioia I–X, including allegations arising
from or relating to the medication Invega, without prior permission from the Court. Finally,
Gioia’s ECF Motion (ECF No. 9) is dismissed as moot in light of the dismissal of the Complaint.
The Clerk of the Court shall mail a copy of this Order to Gioia at her address of record
and shall note such mailing on the docket.
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The Court certifies pursuant to 28 U.S.C. § 1915(a)(3) that any appeal from this Order
would not be taken in good faith and therefore in forma pauperis status is denied for the purpose
of any appeal. See Coppedge v. United States, 369 U.S. 438, 444–45 (1962).
Dated: Central Islip, New York
March 11, 2026
/s/ Nusrat J. Choudhury
NUSRAT J. CHOUDHURY
United States District Judge
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