Fennell v. United States of America

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
ERNEST FENNELL,
Plaintiff,
v.
UNITED STATES OF AMERICA,
Defendant.
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No. 23-cv-128-JJM-AEM
MEMORANDUM AND ORDER
JOHN J. MCCONNELL, JR., United States District Court Chief Judge.
Ernest Fennell brings a medical malpractice action against the United States
(“the Government”) under the Federal Tort Claims Act (“FTCA”). 	ECF No. 1. 	He
alleges that medical staff at a federally qualified health center acted negligently in
prescribing him medication to treat his bipolar disorder and failed to properly notify
him of the risks associated with taking that medication.
	Id. 	The Government now
moves for summary judgment on Mr. Fennell’s lack of informed consent claim (Count
2), arguing that Mr. Fennell cannot prove a necessary element of that claim. 	ECF
No. 24.
For the reasons that follow, the Court DENIES the Government’s Motion for
Summary Judgment.
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I. 	BACKGROUND1
A. 	Mr. Fennell’s Initial Medical Care and Treatment
In 2003, while he was a junior in high school, Mr. Fennell was diagnosed with
bipolar disorder. 	It was around this time, during a week-long hospitalization, that
Mr. Fennell was first prescribed medication to treat his bipolar disorder.2
In or around 2006 or 2007, Mr. Fennell was hospitalized once more after he
began to have suicidal thoughts. During this second hospitalization, Mr. Fennell was
prescribed Seroquel. 3 Mr. Fennell thereafter took Seroquel until 2009 at which point
he discontinued use of the medication.
Several years later, in November 2018, Mr. Fennell sought treatment for
depression 	with 	the 	Comprehensive 	Community 	Action 	Program 	(“CCAP”), 	a
federally qualified health center in Cranston, Rhode Island. 	During this visit, Mr.
Fennell reported to medical staff that he had a history of bipolar disorder, that he
had 	previously 	been 	prescribed 	Seroquel, 	and 	that 	he 	wished 	to 	restart 	that
1 Unless otherwise noted, the following facts are undisputed and come directly
from the parties’ statements of undisputed/disputed facts and other briefing.
	See
ECF No. 25; ECF No. 52-1; ECF No. 52. 	As the non-moving party, the Court views
any undisputed facts in the light most favorable to Mr. Fennell.
Taite v. Bridgewater
State Univ., Bd. of Trs., 999 F.3d 86, 92 (1st Cir. 2021).
2 The parties dispute the precise medication that was prescribed to Mr. Fennell
during his 2003 hospital visit. 	The Government contends that, “[d]uring that 2003
hospitalization, he was prescribed . . . Seroquel for the first time.” ECF No. 25 at 4.
Mr. Fennell disputes this, asserting that he was prescribed a different medication
called Trileptal, and that he was not prescribed and did not begin taking Seroquel
until his second hospitalization in 2006 or 2007. ECF No. 52-1 at 8.
3 Seroquel is a second-generation antipsychotic medication used to treat
bipolar disorder. It is also referred to as quetiapine.
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medication. 	Mr. 	Fennell 	was 	prescribed 	Seroquel, 	along 	with 	some 	other
medications, which he filled that same day at CVS Pharmacy.
On November 29, 2018, Mr. Fennell voluntarily admitted himself to Butler
Hospital. 	At a physical examination, he reported “worsening depressive symptoms
with suicidal ideation, visual hallucinations, and intermittent general paranoia.”
Medical staff increased his Seroquel dosage and discontinued some of the other
medications he was taking. 	Mr. Fennell’s symptoms began to improve, and he was
discharged from the hospital a few days later with instructions to follow up with
CCAP for outpatient treatment.
Mr. Fennell’s next visit to CCAP came on December 14, 2018, when he
underwent a Psychiatric Diagnostic Evaluation with Cynthia Jankowski, a nurse
practitioner at CCAP. 	As part of her evaluation, Ms. Jankowski noted that Mr.
Fennell denied suicidal ideation but had reported “intermitted command AH [audio
hallucination] to hurt others.” 	Ms. Jankowski thereafter increased Mr. Fennell’s
Seroquel dosage, and Mr. Fennell continued to fill this prescription at CVS.
On January 24, 2019, Mr. Fennell met with Cindy Johnson, an advanced
practice registered nurse (“APRN”) at CCAP, for the first time. 	During that
appointment, Mr. Fennell expressed concerns with his weight, and he reported
having an increased appetite while on Seroquel. 	Ms. Johnson opted to discontinue
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Mr. Fennell’s use of Seroquel and instead prescribed him Geodon. 4 Mr. Fennell filled
his Geodon prescription that same day.
Mr. Fennell returned to the CCAP office for a second appointment with Ms.
Johnson on March 20, 2019. At this appointment, Mr. Fennell reported that his mood
felt more stable, but that he continued to have trouble sleeping. 	Ms. Johnson
thereafter opted to increase Mr. Fennell’s Geodon dosage.
At a third appointment on April 7, 2020, Mr. Fennell disclosed to Ms. Johnson
that he had started taking some of his leftover Seroquel medication at the same time
that he was taking Geodon. 	It was at this point that Mr. Fennell asked that he be
prescribed Seroquel again. Ms. Johnson obliged and wrote him prescriptions for both
medications, which Mr. Fennell filled for the next year or so.
On August 19, 2021, Mr. Fennell came in for another appointment and
reported to Ms. Johnson that he had stopped taking his medications about three to
four weeks prior. He told her that he had been experiencing involuntary movements
of his neck and jaw with accompanying shortness of breath. Ms. Johnson explained
to Mr. Fennell that tardive dyskinesia5 can occur when medications are stopped and
4 Geodon, which is also referred to as ziprasidone, is another second-generation
antipsychotic medication used to treat bipolar disorder. 	The parties do not dispute
that, as compared to other antipsychotic medication (including Seroquel), Geodon has
a lower risk of weight gain. ECF No. 25 at 6; ECF No. 52-1 at 9.
5 Tardive dyskinesia is an involuntary-movement disorder that can be caused
by antipsychotic medication. 	Common symptoms of tardive dyskinesia include, but
are not limited to, involuntary movements of the lips, tongue, and jaw. ECF No. 25
at 2; ECF No. 52-1 at 3.
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suggested that his symptoms may be reduced if he restarted his medications. 	As
such, Ms. Johnson restarted Mr. Fennell on Geodon.
Mr. Fennell followed up with Ms. Johnson two weeks later. His symptoms had
failed to dissipate, and Ms. Johnson noted that Mr. Fennell’s involuntary movements
were “severe.” Ms. Johnson made the decision to wean Mr. Fennell off Geodon, and
he filled his last Geodon prescription on September 2, 2021. 	Mr. Fennell continued
to fill his CCAP prescription for Seroquel from at least September 17, 2021 through
November 13, 2022.
Around this time, Mr. Fennell sought treatment from specialists for his tardive
dyskinesia. 	He was prescribed Austedo6 to reduce the intensity of his symptoms,
which he took along with his Seroquel medication. 	Though the Austedo medication
helped to minimize the intensity of his involuntary movements, Mr. Fennell reports
that his tardive dyskinesia is likely permanent.
B. 	Mr. Fennell Files a Claim Against the Government
On September 28, 2022, Mr. Fennell filed an administrative claim against
CCAP with the U.S. Department of Health and Human Services (“HHS”),7 accusing
the federal entity of medical malpractice. Given the conflict of interest created by his
claim, CCAP terminated its patient relationship with Mr. Fennell. 	As part of its
6 Austedo is a VMAT2 inhibitor used to treat tardive dyskinesia.
7 Because Mr. Fennell brings suit under the FTCA, federal law required him
to first present his claim to the appropriate federal agency (i.e., HHS) and wait until
that agency denied his claim before he could bring a claim in federal court.
	See 28
U.S.C. §§ 2401(b), 2675;
see also Barrett ex rel. Estate of Barrett v. United States,
462 F.3d 28, 36 (1st Cir. 2006).
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discharge planning, CCAP prescribed Mr. Fennell three months’ worth of Seroquel to
be used until he could find a new provider.
On February 23, 2023, HHS sent Mr. Fennell a letter, informing him that his
claim had been denied. 	That same day, Mr. Fennell started seeing a new medical
care provider at Tri-County Community Action Agency (“TCCAA”). 	His TCCAA
provider also prescribed him Seroquel beginning on April 26, 2023 through at least
December 13, 2024. 	At Mr. Fennell’s request, these dosages of Seroquel were twice
increased after he expressed concerns that he was seeing and hearing things.
Mr. Fennell filed this suit, alleging that the medical staff at CCAP who
prescribed him Geodon failed to properly notify him of the risks associated with
taking that medication. 8 	ECF No. 1. 	The Government now moves for summary
judgment on Mr. Fennell’s lack of informed consent claim. ECF No. 24.
II. 	STANDARD OF REVIEW
Summary judgment is appropriate when “the pleadings, depositions, answers
to interrogatories and admissions on file, together with affidavits if any, show that
there is no genuine issue as to any material fact and that the moving party is entitled
to judgment as a matter of law.” 	Fed. R. Civ. P. 56(c). 	“A ‘genuine’ issue is one on
which the evidence would enable a reasonable jury to find the fact in favor of either
party.”
Perez v. Lorraine Enters., Inc., 769 F.3d 23, 29 (1st Cir. 2014). “A ‘material’
8 Mr. Fennell also brings claims of negligence, corporate liability, and vicarious
liability. ECF No. 1 at 3-8. These claims are not at issue in this motion.
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fact is one that is relevant in the sense that it has the capacity to change the outcome
of the jury’s determination.”
Id.
To prevail, the moving party must “‘affirmatively produce evidence that
negates an essential element of the non-moving party’s claim,’ or, using ‘evidentiary
materials already on file . . . demonstrate that the non-moving party will be unable
to carry its burden of persuasion at trial.’”
Ocasio-Hernández v. Fortuño-Burset, 777
F.3d 1, 4-5 (1st Cir. 2015) (quoting
Carmona v. Toledo, 215 F.3d 124, 132 (1st Cir.
2000)). 	Once the moving party has made such a showing, “the burden shifts to the
non-moving party, who ‘may not rest on mere allegations or denials of his pleading,
but must set forth specific facts showing there is a genuine issue for trial.’”
Barbour
v. Dynamics Rsch. Corp., 63 F.3d 32, 37 (1st Cir. 1995) (quoting
Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 256 (1986)). 	“[T]he plaintiff, to survive the defendant’s
motion, need only present evidence from which a jury might return a verdict in his
favor.”
Anderson, 477 U.S. at 256.
In analyzing a motion for summary judgment, a court “examine[s] the record
in the light most favorable to the nonmovant and draw[s] all reasonable inferences in
that party’s favor.”
	López-Hernández v. Terumo P.R. LLC, 64 F.4th 22, 28 (1st Cir.
2023). 	However, the court “need not credit ‘conclusory allegations, improbable
inferences, and unsupported speculation.’”
	Dixon-Tribou v. McDonough, 86 F.4th
453, 458 (1st Cir. 2023) (quoting
Lahens v. AT&T Mobility P.R., Inc., 28 F.4th 325,
333 (1st Cir. 2022)).
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III. 	DISCUSSION
As mentioned, Mr. Fennell has brought a lack of informed consent claim
against the Government under the FTCA. ECF No. 1. Federal courts generally “lack
jurisdiction over claims against the United States unless the government has waived
its sovereign immunity.”
	Sanchez v. United States, 740 F.3d 47, 50 (1st Cir. 2014)
(citing
F.D.I.C. v. Meyer, 510 U.S. 471, 475 (1994)). 	The FTCA provides “a limited
congressional waiver” of that immunity and gives courts jurisdiction over civil claims
against “the United States for tortious acts and omissions committed by federal
employees acting within the scope of their employment.”
	Díaz-Nieves v. United
States, 858 F.3d 678, 683 (1st Cir. 2017);
see also Sanchez, 740 F.3d at 50.
The “law of the place” where the alleged act or omission occurred governs
actions brought under the FTCA.
	Calderón-Ortega v. United States, 753 F.3d 250,
252 (1st Cir. 2014) (citing 28 U.S.C. § 1346(b)(1)). Here, then, the Court will look to
and apply Rhode Island tort law.
Under Rhode Island law, the doctrine of informed consent “imposes a duty
upon a doctor which is completely separate and distinct from his responsibility to
skillfully diagnose and treat the patient’s ills.”
Wilkinson v. Vesey, 295 A.2d 676, 687
(R.I. 1972). A doctor also has a duty to inform their patient of “the risk involved and
the alternatives to [a proposed course of] treatment.”
	Id. Indeed, “informed consent
is not possible when a physician has failed to address both the material risks
associated 	with 	and 	the 	viable 	alternatives 	to 	a 	recommended 	[treatment].”
Flanagan v. Wesselhoeft, 712 A.2d 365, 370 (R.I. 1998) (internal citations omitted).
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A plaintiff seeking to recover under this doctrine “must also prove that if he or she
had been informed of the material risks and alternative methods of treatment, he or
she would not have consented to the [treatment].”
Kenny v. Wepman, 753 A.2d 924,
926 (R.I. 2000) (citing
Wilkinson, 295 A.2d at 628-29).
Thus, there are two basic elements that Mr. Fennell must prove to prevail on
his lack of informed consent claim: (1) that his medical provider failed to communicate
the material risks9 associated with and the viable alternatives to a recommended
treatment; and (2) that he would not have consented to such treatment had he been
informed of the material risks and alternative methods of treatment.10
	See Kenny,
753 A.2d at 926;
Flanagan, 712 A.2d at 371.
Here, Mr. Fennell alleges that CCAP, through its employee Cindy Johnson,
failed to inform him of the risks associated with the prescribed use of Geodon,
including the risk of developing tardive dyskinesia. 	ECF No. 1 at 2-6; ECF No. 52
9 “[I]n the context of informed consent in a medical malpractice case, the
question of materiality depends on the significance that a reasonable patient would
attach to the disclosed risk when deciding whether to submit to treatment.”
State v.
Breen, 767 A.2d 50, 58 (R.I. 2001) (citing
Lauro v. Knowles, 739 A.2d 1183, 1186 (R.I.
1999) (per curiam)).
10 This appears to be a “particular patient” subjective standard.
See generally
Beth Holliday,
Cause of Action Against Physician for Failure to Obtain Patient’s
Informed Consent, 49 Causes of Action 2d 573, § 23 (Mar. 2026 update). That is, the
plaintiff must show that adequate disclosure would have caused the patient at issue
to decline the treatment.
Compare Kenny, 753 A.2d at 926,
with Gorney v. Meaney,
150 P.3d 799, 804 (Ariz. Ct. App. 2007) (holding that a necessary element of lack of
informed consent claim is that “adequate disclosure would have caused the plaintiff
to decline the treatment”)
and Bowman v. Beghin, 713 N.E.2d 913, 917 (Ind. Ct. App.
1999) (“In the context of informed consent, there must be a causal relationship
between the physician’s failure to inform and the injury to the plaintiff. 	Such causal
connection arises only if it is established that had revelation been made, consent to
treatment would not have been given.”).
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at 11, 13. 	Had he known of the risks associated with taking Geodon, Mr. Fennell
claims that “he would have refused to consent to the performance of said treatment
and care.” ECF No. 1 at 5;
see also ECF No. 52 at 10-13.
In its motion, the Government attacks the second element of Mr. Fennell’s
claim by seizing on a fact that neither party disputes, which is that all antipsychotic
medications, including Geodon and Seroquel, pose some risk for tardive dyskinesia.
See ECF No. 25 at 1-2; ECF No. 52-1 at 1-2. 	This is fatal to Mr. Fennell’s claim, so
says the Government, because his continued use of Seroquel through December
2024—more than two years after he first filed his administrative claim with HHS—
undermines his contention that he never would have consented to the risk that
Geodon poses for tardive dyskinesia. 	ECF No. 24 at 15-16; ECF No. 53 at 1-2. 	Put
another way, the Government argues that Mr. Fennell has “consented to and
assumed the risks that all [these antipsychotic medications] present” because he has
taken Seroquel with the full knowledge that it too poses a risk of tardive dyskinesia.
ECF No. 53 at 1.
The Government seems to be raising an assumption of the risk defense, which
typically accompanies negligence actions. 	This is not out of place in this lack of
informed consent case, however, given that Rhode Island courts have long recognized
that this type of claim “sounds in negligence.”
	Wilkinson, 295 A.2d at 686;
see also
Medeiros v. Yashar, 588 A.2d 1038, 1044 (R.I. 1991) (Weisberger, J., concurring)
(“The 	question 	of 	informed 	consent 	bears 	upon 	the 	issues 	of 	due 	care 	and
negligence.”);
DiCristoforo v. Fertility Sols., P.C., 521 F. Supp. 3d 153, 157 (D.R.I.
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2021) (“Elements of a lack of informed consent claim mirror those of a negligence
claim.”). Indeed, in his Complaint, Mr. Fennell brings a separate negligence claim—
which is not at issue in the present motion—that alleges many of the same facts as
his lack of informed consent claim.
Compare ECF No. 1 at 3-4,
with id. at 4-6.
Under Rhode Island law, “‘the doctrine of assumption of the risk is an
affirmative defense that, if proven, absolves a defendant of liability for having created
an unreasonable risk.’”
	Walker v. Jackson, 723 A.2d 1115, 1117 (R.I. 1999) (per
curiam) (cleaned up) (quoting
Rickey v. Boden, 421 A.2d 539, 543 (R.I. 1980)). 	The
defense is typically available in run-of-the-mill negligence cases, such as products
liability claims,
see Mignone v. Fieldcrest Mills, 556 A.2d 35, 41 (R.I. 1989), and
premises liability claims,
see Walker, 723 A.2d at 1117. 	In the medical context,
however, “[i]t is axiomatic that absent express indication to the contrary, a patient
receiving medical care does not assume the risk of general negligence.”
	Picotte v.
Calenda, No. C.A. PC99–6142, 2006 WL 2243019, at *5 (R.I. Super. Ct. Aug. 2, 2006)
(citing
Owens v. Silvia, 838 A.2d 881, 903 (R.I. 2003);
Hennessey v. Pyne, 694 A.2d
691, 700 (R.I. 1997);
Ferguson v. Marshall Contractors, 644 A.2d 310, 310 (R.I. 1994)).
Where, as here, there is an absence of an express agreement between the
parties, “a defendant must prove that a plaintiff ‘knew of the existence of a danger,
appreciated its unreasonable character, and then voluntarily exposed himself to
it.’”
	Labrie v. Pace Membership Warehouse, Inc., 678 A.2d 867, 872 (R.I. 1996)
(quoting
Drew v. Wall, 495 A.2d 229, 231 (R.I. 1985)). This “is a ‘subjective standard,
keyed solely on the observations and understandings of the plaintiff at the time of
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injury.’”
	D’Allesandro v. Tarro, 842 A.2d 1063, 1067 (R.I. 2004) (quoting
Habib v.
Empire Prods., Inc., 739 A.2d 662, 664 (R.I. 1999) (per curiam)).
“Whether a plaintiff has assumed the risk of harm is generally a question for
a trier of fact.”
	D’Allesandro, 842 A.2d at 1067 (citing
Rickey, 421 A.2d at 543).
“However, if such a unique occasion arises in which the facts can suggest only one
reasonable inference, the trial justice must treat the issue as one of law.”
Iadevaia v.
Aetna Bridge Co., 389 A.2d 1246, 1249 (R.I. 1978) (citing
Kennedy v. Providence
Hockey Club, Inc., 376 A.2d 329 (R.I. 1977);
Garris v. Gloss, 303 A.2d 765 (R.I. 1973)).
In this circumstance, the defense must show that only one reasonable inference can
be drawn from the record: namely, “that the plaintiff actually knew about the risk
involved and appreciated its magnitude.”
Id. at 1249-50.
The Government contends that this issue can be decided in its favor “[a]s a
matter of law.” ECF No. 24 at 15. However, in viewing the record in the light most
favorable to Mr. Fennell, as this Court must do at the summary-judgment stage, it
would appear that more than one reasonable inference can be drawn from the record.
First, there is no dispute between the parties that Mr. Fennell did not know of the
risk that Geodon posed for tardive dyskinesia at the time that medication was first
prescribed to him back in 2019. 	Whether this moment marked the time of Mr.
Fennell’s injury is a question that is yet to be decided.
	See D’Allesandro, 842 A.2d
at 1067 (holding that whether a plaintiff assumed the risk of harm is a subjective
standard to be decided “solely on the observations and understandings of the plaintiff
at the time of injury” (emphasis added));
Habib, 739 A.2d at 664 (same).
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Second, it does not follow that, just because Mr. Fennell knew of the risks
associated with taking Seroquel, that he also implicitly knew of the risks involved
with taking Geodon or, perhaps more importantly, that he appreciated the magnitude
of those risks.
Iadevaia, 389 A.2d at 1249-50. Though the parties do not dispute that
both Geodon and Seroquel pose
some risk for tardive dyskinesia, there is a genuine
dispute between the parties over whether Geodon poses a
higher risk for tardive
dyskinesia than Seroquel.11
See ECF No. 52 at 5-6, 14; ECF No. 52-1 at 1-5.
This issue is a material one because the magnitude of the risk may differ
between the two medications. By way of analogy, consider the difference between a
car and a motorcycle. 	Both vehicles come with some risk whenever they are taken
out on the road, as accidents can occur for all sorts of reasons. However, a motorcycle
undoubtedly poses a much higher risk. 	Without the structural frame, airbags, and
seatbelts of a car, even a minor collision on a motorcycle can lead to far more serious
injuries. 	As relevant here, Mr. Fennell may have been willing to take on some risk
11 The parties each rely on expert testimony that points in opposite directions
on this issue. 	Mr. Fennell relies on the testimony of Dr. Dan Kiel, a licensed
pharmacist and an Associate Professor of Pharmacology at Massachusetts College of
Pharmacy and Health Sciences. 	ECF No. 24 at 4 n.4; ECF No. 52 at 6. 	The
Government relies on the testimony of Dr. Deepak Cyril D’Souza, a board-certified
psychiatrist and the Vikram Sodhi Endowed Chair of Psychiatry at Yale University.
ECF No. 24 at 5 n.6.
Ultimately, the credibility of witnesses and the weight to give to their
testimony is a determination to be made by the trier of fact.
Sheehan v. N. Am. Mktg.
Corp., 610 F.3d 144, 149 (1st Cir. 2010). 	It is not appropriate to evaluate these
considerations at the summary-judgment stage.
	Ahmed v. Johnson, 752 F.3d 490,
495 (1st Cir. 2014) (citing
Sheehan, 610 F.3d at 149).
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in order to treat his bipolar disorder, but that does not necessarily mean that he
consented to taking on a high degree of risk.
These 	considerations 	certainly 	cast 	doubt 	on 	the 	notion 	that 	only 	one
reasonable inference can be drawn from the record. 	Whether Mr. Fennell assumed
the risks that all antipsychotic medications pose such that he cannot establish his
lack of informed consent claim therefore cannot be decided as a matter of law. Rather,
this is a question that must be decided by the trier of fact.
	D’Allesandro, 842 A.2d
at 1067;
Rickey, 421 A.2d at 543.
It would therefore be inappropriate to grant summary judgment on this basis
alone, and the Government’s motion must be denied.
	See Martins v. Omega Elec.
Co., 692 A.2d 1203, 1206 (R.I. 1997) (reversing grant of summary judgment for
defendant because “the record . . . suggest[ed] that more than one reasonable
inference” could be drawn from plaintiff’s conduct and “that, therefore, [plaintiff’s]
subjective apprehension of danger was a question to be decided by the trier of fact
and not by the motion justice as a matter of law”);
see also D’Allesandro, 842 A.2d
at 1068 (affirming trial court’s entry of summary judgment for defendant after
“hearing justice made a valiant attempt to discern a reasonable inference other than
assumption of the risk” but could not ultimately do so).
IV. 	CONCLUSION
For the reasons stated, the Court DENIES the Government’s Motion for
Summary Judgment on Mr. Fennell’s lack of informed consent claim. ECF No. 24.
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IT IS SO ORDERED.
s/John J. McConnell, Jr.
_________________________________
JOHN J. MCCONNELL, JR.,
Chief Judge
United States District Court
April 6, 2024
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