Herndon v. Janssen Pharmaceuticals Incorporated

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
Coral Herndon,
Plaintiff,
v.
Janssen Pharmaceuticals Incorporated,
Defendant.
No. CV-25-01786-PHX-KML
ORDER
Plaintiff Coral Herndon filed this lawsuit against defendant Janssen
Pharmaceuticals, Inc. (“Janssen”) after suffering a pulmonary embolism and related
symptoms following her use of a Janssen medication. Herndon brought a single claim
alleging product liability under a strict liability failure-to-warn theory. This court
previously granted Janssen’s motion to dismiss because Herndon did not allege sufficient
facts showing causation. (Doc. 22.) Herndon filed an amended complaint (Doc. 23), and
Janssen once again moves to dismiss (Doc. 25). Its motion is denied.
I. Factual Background
Janssen creates and develops medications, including antipsychotic medications with
the active ingredient paliperidone (and paliperidone palmitate, an injectable version of
paliperidone). (Doc. 23 at 2-3.) Herndon’s second amended complaint (“SAC”) describes
about a decade of studies linking paliperidone to pulmonary embolisms and two related
diagnoses, deep vein thrombosis and venous thrombosis. (Doc. 23 at 3-8.) Janssen has
marketed multiple paliperidone drugs with product labels that warn about these possible
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adverse reactions. (Doc. 23 at 2-3.)
In 2009, the FDA approved for sale Janssen’s Invega Sustenna, a long-acting
injectable paliperidone palmitate antipsychotic drug. (Doc. 23 at 3.) Janssen alerted
authorities in New Zealand (Doc. 23 at 3; see Doc. 23-3 at 26) and Canada (Doc. 23 at 7-
8; see Doc. 23-11 at 21) that pulmonary embolism, deep vein thrombosis, and/or venous
thrombosis had been identified as adverse reactions to Invega Sustenna and suggested
prescribers identify risk factors and undertake measures to prevent those reactions.
Herndon alleges although Janssen knew Invega Sustenna could cause these adverse
reactions, its 2022 U.S. product label did not include warnings about them. (Doc. 23 at 8;
see Doc. 23-12.)
Herndon was prescribed Invega Sustenna on September 28, 2022, and received
monthly injections for about seven months. (Doc. 23 at 9.) At the time, Herndon had risk
factors for pulmonary embolism, deep vein thrombosis, and venous thrombosis, including
her habits of smoking and drinking alcohol; elevated blood pressure and cholesterol; and a
family history of heart attacks and other issues. (Doc. 23 at 9.) In early May 2023, Herndon
began experiencing difficulty breathing and pain in her back. (Doc. 23 at 10.) She attributed
these conditions to sleeping in an awkward position and did not immediately seek medical
care, but the pain worsened. (Doc. 23 at 10.) On May 8, 2023, Herndon was admitted to
the hospital with symptoms of “pulmonary embolism/filling defects.” (Doc. 23 at 10.)
She alleges a reasonable prescribing professional “such as [her] prescribing
professional,” given proper warning the medication may cause pulmonary embolisms,
should have prescribed an alternative treatment, monitored her blood clotting studies for
risk, and explained to her the early warning signs of pulmonary embolism and related
conditions so she knew when to seek care. (Doc. 23 at 9-10.) If Janssen had given her
prescribing professional “adequate warning of the danger of using Invega Sustenna,” the
professional “would have reduced the risk of harm” by doing some or all of these things.
(Doc. 23 at 12.) She further alleges that had her prescriber taken those steps, she would not
have suffered pulmonary embolism symptoms or would have suffered less severe
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symptoms. (Doc. 23 at 11-12.) She does not identify her prescribing physicians.1 (Doc. 23.)
This court dismissed Herndon’s first amended complaint because it did not
sufficiently plead causation. (Doc. 22 at 4.) Herndon filed a second amended complaint
(Doc. 23), which Janssen now moves to dismiss on similar grounds (Doc. 25).
II. Legal Standard
A motion to dismiss may be granted “based on the lack of a cognizable legal theory
or the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v.
Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1988). “To survive a motion to dismiss,
a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to
relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal citations omitted)). This is
not a “probability requirement,” but a requirement that the factual allegations show “more
than a sheer possibility that a defendant has acted unlawfully.” Id. “Determining whether
a complaint states a plausible claim for relief will . . . be a context-specific task that requires
the reviewing court to draw on its judicial experience and common sense.” Id. at 679.
III. Analysis
A. Causation is Adequately Pleaded
Plaintiffs alleging strict liability for pharmaceutical products must show “[1] the
product is in a defective condition and unreasonably dangerous, [2] the defective condition
existed at the time the product left the defendant’s control, and [3] the defective condition
is the proximate cause of the plaintiff’s injury.” Gosewisch v. Am. Honda Motor Co., 737
P.2d 376, 379 (Ariz. 1987), superseded by statute on other grounds as recognized by
Jimenez v. Sears, Roebuck and Co., 904 P.2d 861, 864 (Ariz. 1995). Warning label defects
1 Without identifying any mechanism that would allow the court to consider it, Herndon
attached to her opposition to the motion to dismiss a declaration identifying multiple
possible prescribing physicians and arguing the hospital refused to provide further
information. (Docs. 26 at 4; 26-1 at 2-3.) But courts in this district “regularly decline to
consider declarations and exhibits submitted in opposition to a motion to dismiss” if the
information is not incorporated by reference. Laws. for Fair Reciprocal Admission v.
Timmer, 788 F. Supp. 3d 1000, 1011 (D. Ariz. 2025), reconsideration denied, No. 24-CV-
02175-PHX-GPC, 2025 WL 1625412 (D. Ariz. May 30, 2025). The information is not
mentioned in the SAC and cannot be considered here.
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can make a product defective and unreasonably dangerous: because manufacturers have a
general duty to “warn consumers of foreseeable risks of harm from using their products,”
their failure to warn may give rise to a strict liability claim. Paseka v. Ethicon Inc., No.
CV-20-00100-PHX-SRB, 2020 WL 8175427, at *3 (D. Ariz. Nov. 9, 2020) (citing Watts
v. Medicis Pharm. Corp., 365 P.3d 944, 949 (Ariz. 2016)). Arizona cases use the “learned
intermediary doctrine” in this context, under which a drug manufacturer fulfills its duty to
warn consumers when it provides “reasonable instructions or warnings regarding
foreseeable risks of harm” to a health-care provider like a prescribing physician (rather
than directly to a patient). Watts, 365 P.3d at 949.
As was true previously, the learned intermediary doctrine creates causation issues
for Herndon. Because the doctrine analyzes primarily the prescriber’s behavior, causation
turns on the impact a proper warning would have had on the physician(s) who prescribed
the drug. Id. at 948. So, to establish proximate cause, Herndon must allege facts showing
her prescribing physician “would have acted differently if a warning had been given.”
Welch v. Wright Med. Tech., Inc., No. CV-11-2113-PHX-DGC, 2012 WL 4711899, at *2
(D. Ariz. Oct. 3, 2012). This court previously held this standard requires facts suggesting
the physician “would have given different instructions to the plaintiff or prescribed a
different drug . . . [or] at a minimum, some facts ‘regarding what doctor prescribed the
medications, what information [the plaintiff] or her doctor relied on at the time, or whether
they may have considered alternative remedies.’” (Doc. 22 at 4 (citing Murrell v. Wyeth
Inc., No. CV-13-0290-PHX-DGC, 2013 WL 1882193, at *6 (D. Ariz. May 3, 2013)).)
The court dismissed Herndon’s first amended complaint because she did not allege
facts about her doctor, what information her doctor may have relied on in prescribing
Invega Sustenna, or why she or her doctor would have avoided Invega Sustenna if given a
proper warning (for instance, because of comorbidities). (Doc. 22 at 5.) The SAC adds
relevant allegations, including that Herndon presented risk factors for pulmonary embolism
based on her family history and because she smoked, drank, and had “borderline high”
cholesterol. (Doc. 23 at 9.) Despite these risk factors, Herndon’s prescriber did not explain
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to her the early warning signs of pulmonary embolism, a warning she alleges would have
prompted her to seek medical treatment for her symptoms sooner and thereby suffer fewer
injuries. (Doc. 23 at 10-12.) Herndon further alleges a “reasonable prescribing
professional,” knowing her risk factors and properly warned about Invega Sustenna’s
pulmonary embolism risk, would have prescribed an alternative medication at the outset or
eventually switched Herndon’s medication after monitoring her blood pressure and seeing
an increasing risk of pulmonary embolism. (Doc. 23 at 9-11.) Herndon’s complaint again
does not allege facts which shed light on her specific physician’s decision-making. She
concedes she cannot identify the prescribing physician. (Doc. 26 at 4.)
Some courts in this circuit have held it is not sufficient for plaintiffs to allege
physicians “would take efforts to prevent the harm caused by the [product] if they were
warned of the potential harm”—the plaintiff must actually allege “facts regarding [her]
own prescribing physician’s decision-making process.” Dreifort v. DJO Glob. Inc., No.
318CV02393BTMKSC, 2019 WL 5578240, at *9 (S.D. Cal. Oct. 28, 2019) (emphasis
added). Courts in this district have hinted that a plaintiff may need to know the identity of
the prescribing provider. See Baca v. Johnson & Johnson, No. CV-20-01036-PHX-DJH,
2020 WL 6450294, at *3 (D. Ariz. Nov. 2, 2020) (dismissing where complaint “d[id] not
name the treating physicians who received the allegedly inadequate warning” or state they
would have acted differently if properly warned); Mills v. Bristol-Myers Squibb Co., No.
CV 11-00968-PHX-FJM, 2011 WL 4708850, at *3 (D. Ariz. Oct. 7, 2011) (dismissing
claim where plaintiff alleged what her treating physician would have done “on information
and belief” instead of contacting that physician for facts).
But other courts have found that allegations about how prescribers would have acted
differently if properly warned can survive the pleadings stage so long as the plaintiff also
alleges how that different behavior would have prevented harm (as Herndon does). This
includes cases where the physician may not have been identified but the complaint
nonetheless specifies what a provider would have done differently. See Colbath v. Merck
& Co., No. 3:21-CV-120-W (DEB), 2022 WL 935195, at *4 (S.D. Cal. Mar. 29, 2022)
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(denying motion to dismiss where plaintiff alleged “upon information and belief, Plaintiff’s
medical providers would not have offered or recommended [medication] to Plaintiff.”);
Broge v. ALN Int’l, Inc., No. 17-CV-07131-BLF, 2019 WL 2088420, at *2 (N.D. Cal. May
13, 2019) (denying motion to dismiss despite “conclusory” allegations warning would have
altered physician’s decision); Baker v. Bayer Healthcare Pharms., Inc., No. C13-0490
TEH, 2013 WL 6698653, at *5 (N.D. Cal. Dec. 19, 2013) (denying motion to dismiss
where plaintiff alleged “Plaintiff did not have the same knowledge as Defendant and no
adequate warning was communicated to her or her physician(s)”). These opinions
sometimes point out that before discovery, it can be difficult for a plaintiff to allege non-
conclusory facts about a specific doctor’s decision-making. See Colbath, 2022 WL 935195,
at *4 (S.D. Cal. Mar. 29, 2022); see also Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d
711, 718-20 (C.D. Ill. 2010) (“It is difficult to know, prior to discovery, whether
[plaintiff’s] physician would have prescribed [the drug] if there were additional
warnings.”).
Ultimately, the identity of the prescribing physician is not a required element to
show causation. Plaintiffs must allege facts showing that had a proper warning been given,
the patient or doctor would have acted differently and the injury would not have happened.
Murrell, 2013 WL 1882193, at *6 (citing Mills, 2011 WL 4708850, at *3). Including facts
directly from the specific provider is one way to plausibly make that showing, but so may
be facts about information the prescriber relied on, whether the prescriber would have
considered alternatives, and other precautions the prescriber would have taken. Id.; Welch,
2012 WL 4711899, at *1. In cases dismissing failure-to-warn claims because of silence on
the prescriber’s identity, the complaint also lacks other facts plausibly supporting the
causation allegation. Murrell, 2013 WL 1882193, at *6 (dismissing claim because “simply
alleging that a failure to warn was one of the causes of injury is insufficient as a matter of
law”); see also Baca, 2020 WL 6450294, at *3 (dismissing claim in part because complaint
did not allege “physicians would have acted differently had they received a different
warning”).
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Herndon has clearly alleged which warnings were missing; that given a proper
warning, her physicians would have noticed her risk factors and prescribed an alternative
drug, monitored her more closely, or told her to watch for symptoms; and their changed
behavior would have prevented harm. Based on these facts about the providers’ decision-
making, she has properly alleged failure-to-warn at this stage. The motion to dismiss is
denied.
Accordingly,
IT IS ORDERED the second Motion to Dismiss (Doc. 25) is DENIED.
IT IS FURTHER ORDERED as follows:
The parties are directed to meet, confer, and develop a Rule 26(f) Joint Case
Management Report, which must be filed within 4 weeks of the date of this order. It is
the responsibility of plaintiff(s) to initiate the Rule 26(f) meeting and prepare the Joint Case
Management Report. Defendant(s) shall promptly and cooperatively participate in the Rule
26(f) meeting and assist in preparation of the Joint Case Management Report.
The Joint Case Management Report shall contain the following information in
separately-numbered paragraphs.
1. The parties who attended the Rule 26(f) meeting and assisted in developing
the Joint Case Management Report;
2. A list of all parties in the case, including any parent corporations or entities
(for recusal purposes);
3. Any parties that have not been served and an explanation of why they have
not been served, and any parties that have been served but have not answered
or otherwise appeared;
4. A statement of whether any party expects to add additional parties to the case
or otherwise amend pleadings;
5. The names of any parties not subject to the court’s personal (or in rem)
jurisdiction;
6. A description of the basis for the court’s subject matter jurisdiction, citing
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specific jurisdictional statutes. If jurisdiction is based on diversity of
citizenship, the report shall include a statement of the citizenship of every
party and a description of the amount in dispute. See 28 U.S.C. §1332;
7. A short statement of the nature of the case (no more than three pages),
including a description of each claim, defense, and affirmative defense;
8. A listing of contemplated motions and a statement of the issues to be decided
by those motions;
9. Whether the case is suitable for reassignment to a United States Magistrate
Judge for all purposes or suitable for referral to a United States Magistrate
Judge for a settlement conference;
10. The status of any related cases pending before this or other courts;
11. A discussion of any issues relating to preservation, disclosure, or discovery
of electronically stored information (“ESI”), including the parties’
preservation of ESI and the form or forms in which it will be produced;
12. A discussion of any issues relating to claims of privilege or work product;
13. A discussion of necessary discovery, which should take into account the
December 1, 2015 amendments to Rule 26(b)(1) and should include:
a. The extent, nature, and location of discovery anticipated by the parties
and why it is proportional to the needs of the case;
b. Suggested changes, if any, to the discovery limitations imposed by the
Federal Rules of Civil Procedure;
c. The number of hours permitted for each deposition. The parties also
should consider whether a total number of deposition hours should be
set in the case, such as twenty total hours for plaintiffs and twenty
total hours for defendants. Such overall time limits have the advantage
of providing an incentive for each side to be as efficient as possible in
each deposition, while also allowing parties to allocate time among
witnesses depending on the importance and complexity of subjects to
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be covered with the witnesses;
14. Proposed deadlines for each of the following events. In proposing deadlines,
the parties should keep in mind the Case Management Order will contain
deadlines to govern this case and once the dates have been set the court will
vary them only upon a showing of good cause. A request by counsel for
extension of discovery deadlines in any case that has been pending more than
two years must be accompanied by a certification stating the client is aware
of and approves of the requested extension. The court does not consider
settlement talks or the scheduling of mediations to constitute good cause for
an extension. The parties must propose the following:
a. A deadline for the completion of fact discovery, which will also be
the deadline for pretrial disclosures pursuant to Rule 26(a)(3). This
deadline is the date by which all fact discovery must be completed.
Discovery requests must be served and depositions noticed
sufficiently in advance of this date to ensure reasonable completion
by the deadline, including time to resolve discovery disputes. Absent
extraordinary circumstances, the court will not entertain discovery
disputes after this deadline;
b. Dates for full and complete expert disclosures and rebuttal expert
disclosures, if any;
c. A deadline for completion of all expert depositions;
d. A date by which any Rule 35 physical or mental examination will be
noticed if such an examination is required by any issues in the case;
e. A deadline for filing dispositive motions;
f. Case-specific deadlines and dates, such as the deadline to file a motion
for class certification or a date on which the parties are available for a
Markman (patent claim construction) hearing;
g. A date by which the parties shall have engaged in face-to-face good
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faith settlement talks;
h. Whether a jury trial has been requested and whether the request for a
jury trial is contested, setting forth the reasons if the request is
contested;
i. Any other matters that will aid the court and parties in resolving this
case in a just, speedy, and inexpensive manner as required by Federal
Rule of Civil Procedure 1;
15. A statement indicating whether the parties would prefer that the court hold a
case management conference before issuing a scheduling order—and, if so,
an explanation of why the conference would be helpful.
IT IS FURTHER ORDERED the parties shall file a proposed Case Management
Order containing all the proposed dates at the same time they file the Rule 26(f) Case
Management Report. The proposed Case Management Order must also be emailed in Word
format to Lanham_Chambers@azd.uscourts.gov.
Dated this 8th day of April, 2026.
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