Graw

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF MISSOURI

EASTERN DIVISION

PATTI JO GRAW, )

)

Plaintiff, )

)

v. ) No. 4:25 CV 1033 RWS

)

ELI LILLY AND COMPANY, )

)

Defendant. )

MEMORANDUM AND ORDER

Plaintiff Patti Jo Graw (“Graw”) filed this lawsuit and proceeds pro se. She

brings this action against Defendant Eli Lilly and Company (“Eli Lilly”), alleging

violations of state and federal law related to her participation in a clinical drug

trial. Eli Lilly moves to dismiss Graw’s Amended Complaint pursuant to Rules

12(b)(6) and 12(b)(5) of the Federal Rules of Civil Procedure. For the reasons set

forth below, I will grant Eli Lilly’s Motion.

Background

Taken as true for the purposes of this motion, Graw’s Amended Complaint

against Eli Lilly alleges the following facts. See ECF. No. 6 at 7. Graw

participated in a diabetic clinical trial conducted by Study Metrix, LLC (“Study

Metrix”) in St. Peters, MO, from August 2023 through December 18, 2023. Id. at

¶ 1. The clinical trial was sponsored, overseen, and funded by Eli Lilly. Id. Under

Eli Lilly’s trial protocol, Graw was repeatedly administered an investigational

drug. Id. at ¶ 2. She reported severe and worsening adverse effects, including

vomiting up to 18 times per day, extreme dehydration, critically low potassium,

and weakness. Id. Study Metrix staff, acting under Eli Lilly’s authority, instructed

Graw to continue the drug and discouraged hospital visits. Id.

According to Graw, Eli Lilly, as sponsor of the trial, failed to ensure proper

participant monitoring, ignored urgent medical warnings, and allowed its

contracted trial site to withhold necessary care. Id. at ¶ 3. She alleges that this

neglect continued even after she submitted her written resignation from the study

on December 18, 2023. Id. She alleges that at one point in time, her attempts to

reach trial staff in urgent distress went unanswered because the Study Metrix office

was preparing for a Christmas party, as allegedly admitted by Dr. Timothy Smith.

Id. at ¶ 4. She claims that being unable to reach Study Metrix staff because they

were allegedly preparing for an office Christmas party was a gross disregard for

participant safety and directly violated federal clinical trial standards. Id.

Graw further alleges that she required three emergency room visits and

hospitalization at Progress West Hospital. After these visits, she alleges she was

diagnosed with esophagitis, gallstones, chronic dry mouth and eyes, and a benign

kidney tumor. Id. at ¶ 5. She alleges that none of these conditions existed before

the trial. Id. Her primary care provider allegedly confirmed that these conditions

arose only after Graw’s exposure to Eli Lilly’s drug. Id. She alleges that her

injuries are permanent and require lifelong medical care and that they were directly

caused by Eli Lilly’s negligence and reckless conduct in overseeing the clinical

trial. Id. at ¶ 6.

In addition to reviewing the allegations of her Complaint, it is important to

identify what Graw’s Complaint does not allege. Graw does not allege that privity

of contract or some other legally binding agreement existed between Eli Lilly and

Study Metrix. She does not allege that she ever directly contacted Eli Lilly

regarding her condition. Nor does she allege that she sought medical advice and

treatment directly from Eli Lilly or any of its employees. Graw does not allege

that she had a physician-patient relationship with Eli Lilly, and nowhere does she

allege that Eli Lilly was the medical practitioner responsible for providing her with

informed consent.

Additionally, Graw does not allege that Eli Lilly engaged in extreme and

outrageous conduct that was only intended to cause her emotional distress or that

such conduct caused her physical symptoms. She does not allege that she incurred

injuries because of a defect in the drug that was administered during the clinical

trial. Nor does she allege that Eli Lilly should be held strictly liable for a defective

drug or was negligent in manufacturing it, designing it, or failing to make certain

warnings. Moreover, Graw does not allege that Eli Lilly violated any particular

FDA regulation, and she does not allege that a specific FDA regulation gives her a

private right to sue or creates a legal duty on behalf of Eli Lilly.

In her original Complaint filed in this Court, Graw brought claims against

Eli Lilly and Study Metrix, asserting diversity jurisdiction under 28 U.S.C. § 1332.

ECF. No. 1. On July 15, 2025, I entered an Order directing Graw to show cause

why her action should not be dismissed for lack of subject matter jurisdiction

because both Graw and Study Metrix are citizens of Missouri, which would defeat

diversity jurisdiction under § 1332. ECF. No. 3. Graw responded by requesting

permission to voluntarily dismiss Study Metrix and file an amended complaint.

ECF. No. 4. I granted Graw’s request, and she filed her Amended Complaint on

August 13, 2025.

In support of its motion, Eli Lilly notes that Graw filed a petition against

Study Metrix Research, LLC and Dr. Timothy Smith in the Circuit Court of St.

Charles County. Eli Lilly states that on October 6, 2025, the state court dismissed

Graw’s initial petition for failure to state a claim. ECF. No. 13 at 5 n.3. Eli Lilly

fails to mention, however, that the state court granted Graw leave to amend her

petition prior to December 1, 2025. The state court case is ongoing. See Case No.

2511-CC00920.

In her Amended Complaint, Graw brings seven claims against Eli Lilly:

negligence (Count I); medical malpractice (Count II); lack of informed consent

(Count III); intentional infliction of emotional distress (Count IV); reckless

infliction of emotional distress (Count V); products liability (Count VI); and

violations of FDA clinical trial regulations (Count VII). ECF. No. 6 at 5.

Graw seeks actual damages of $2,500,000 for “past current and future

medical care loss of income and diminished quality of life” and punitive damages

of $5,000,000. Id. at 7. She also seeks “compensation for emotional distress pain

and suffering.” Id. at 7-8.

On November 21, 2025, Eli Lilly moved to dismiss Graw’s Amended

Complaint for failure to state a claim pursuant to Rule 12(b)(6) and for insufficient

service of process pursuant to Rule 12(b)(5).1

Legal Standard

The purpose of a motion to dismiss under Rule 12(b)(6) is to test the legal

sufficiency of the complaint. In ruling on such a motion, I must accept all factual

allegations in the complaint as true and view them in the light most favorable to the

plaintiff. Hager v. Arkansas Dep’t. of Health, 735 F.3d 1009, 1013 (8th Cir. 2013).

But I may not “presume the truth of legal conclusions couched as factual

1 As an alternative ground for dismissal, Eli Lilly moves to dismiss pursuant to Rule 12(b)(5) for insufficient service

of process. ECF. No. 12 at 13-14. Eli Lilly states that it was not served a copy of the Amended Complaint and was

instead served only a copy of the original Complaint in this case. Because I have evaluated the merits of Eli Lilly’s

Rule 12(b)(6) motion, I will not direct the Court to re-serve Eli Lilly. “[W]hen service is improper, it is within the

district court's discretion to either (1) dismiss the suit, or (2) retain the suit, quash service, and allow the plaintiff to

re-serve the defendant.” United States ex rel. Murrill v. Midwest CES, LLC, No. 4:21-CV-00371-DGK, 2023 WL

2815863, at *3 (W.D. Mo. Apr. 6, 2023) (citing Adams v. AlliedSignal Gen. Aviation Avionics, 74 F.3d 882, 886 (8th

Cir. 1996); see also Lamb v. Bank of Am., N.A., No. 4:11-CV-819 CAS, 2012 WL 87146, at *2 (E.D. Mo. Jan. 11,

2012) (considering defendants’ arguments for insufficient service of process waived “because defendants also move

to dismiss plaintiffs’ claims on the merits”).

allegations.” Id. (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). Although I

also must generally ignore materials outside the pleadings, I may consider

“materials that are necessarily embraced by the pleadings and exhibits attached to

the complaint.” Mattes v. ABC Plastics, Inc., 323 F.3d 695, 697 n. 4 (8th Cir.

2003).

To survive a motion to dismiss under Rule 12(b)(6), a plaintiff need not

provide “detailed factual allegations” but must provide “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). A claim is plausible on its face when the plaintiff

pleads sufficient facts to allow me to draw “the reasonable inference that the

defendant is liable for the misconduct alleged.” Id. This requires a complaint to

contain enough factual allegations “to raise a right to relief above the speculative

level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). A threadbare recital

of the elements of a cause of action, supported merely by conclusory allegations, is

not sufficient. Iqbal, 556 U.S. at 678.

Pro se complaints are to be liberally construed. Estelle v. Gamble, 429 U.S.

97, 106 (1976). However, pro se pleadings must still allege facts which, if true,

state a claim for relief as a matter of law. Martin v. Aubuchon, 623 F.2d 1282,

1286 (8th Cir. 1980). A “complaint should be found to raise a claim only ‘if the

essence of an allegation is discernable, even though it is not pleaded with legal

nicety.’” Topchian v. JPMorgan Chase Bank, N.A., 760 F.3d 843, 849 (8th Cir.

2014) (quoting Stone v. Harry, 364 F.3d 912, 915 (8th Cir. 2004)). The Court must

weigh all factual allegations in favor of the plaintiff, unless the facts alleged are

clearly baseless. Denton v. Hernandez, 504 U.S. 25, 32 (1992).

Discussion

Eli Lilly argues that Graw’s Amended Complaint should be dismissed because

it contains sparse, conclusory allegations that fail to state a plausible claim for

relief against Eli Lilly. Eli Lilly suggests that I may not consider new factual

allegations raised in Graw’s Response to its motion to dismiss. ECF. No. 21 at 8

(citing Al-Saadoon v. Barr, 973 F.3d 794, 805 (8th Cir. 2020); Marin v. TVS Supply

Chain Sols. N. Am., Inc., No. 4:24-CV-00901-JAR, 2024 WL 4826792, at *6 n.5

(E.D. Mo. Nov. 19, 2024)).

However, the Eighth Circuit held that when a plaintiff is proceeding pro se, the

district court must consider not only allegations made in the operative complaint,

but also new allegations made in a plaintiff’s response to a motion to dismiss. See,

e.g., Neudecker v. Boisclair Corp., 351 F.3d 361, 362 (8th Cir. 2003) (noting the

“district court must consider allegations made in response to motion to dismiss”);

Anthony v. Runyon, 76 F.3d 210, 214 (8th Cir. 1996) (finding the district court

“should have considered the new allegations contained in the response to the

motion to substitute and dismiss”); Pratt v. Corr. Corp. of Am., 124 F. App'x 465,

466 (8th Cir. 2005) (“[T]he district court was required to consider the allegations

not only in [plaintiff’s] pro se complaint, but also in…his response to defendants'

motion to dismiss”); Alexander v. Dep't of the Army - Army Bd. for Correction of

Mil. Recs., No. 4:23-CV-1468-RHH, 2025 WL 2780908, at *4 (E.D. Mo. Sept. 30,

2025) (“[W]hen evaluating a motion to dismiss a pro se plaintiff's complaint, the

Eighth Circuit requires district courts to consider both the allegations made in a

complaint and the allegations in the plaintiff's response to the motion to dismiss.”).

A. Count I: Negligence

Count I will be dismissed with prejudice.

Both Graw’s Amended Complaint and her Response to Eli Lilly’s motion are

devoid of any allegations attempting to show that privity of contract or some other

legally binding agreement existed between Eli Lilly and Study Metrix. She makes

no allegations that she ever directly contacted Eli Lilly regarding her condition.

Nor does she allege that she sought medical advice and treatment directly from Eli

Lilly or any of its employees. The lack of these allegations is fatal to Graw’s

negligence claim.

To plead a claim for negligence under Missouri law, a plaintiff must plausibly

allege “(1) a legal duty owed to the plaintiff by the defendant; (2) a breach of that

duty by the defendant; (3) proximate cause; and (4) injury to the plaintiff.”

Campbell v. Baxter Int'l, Inc., 697 S.W.3d 36, 42 (Mo. Ct. App. 2024) (citing

Thornburg v. Federal Express Corp., 62 S.W.3d 421, 427 (Mo. App. W.D. 2001)).

First, I find that Graw fails to plausibly allege that Eli Lilly owed her a legal

duty. Graw attempts to show that Eli Lilly owed her a duty of care as the sponsor

of the clinical trial. Under Missouri law, “foreseeability alone is not enough to

establish a duty…there must also be some right or obligation to control the activity

which presents the danger of injury.” Stitt by Stitt v. Raytown Sports Ass'n, Inc.,

961 S.W.2d 927, 930 (Mo. Ct. App. 1998). Graw alleges that Eli Lilly

“sponsored,” “oversaw,” and “funded” the trial and “failed to ensure proper

participant monitoring.” ECF. No. 6 at 7. She further alleges that Study Metrix

staff were acting “under Eli Lilly’s authority” and in accordance with “Eli Lilly’s

trial protocol” in administering the drug and responding to her requests for medical

advice and treatment. Id. These allegations are merely conclusory statements

about Eli Lilly’s alleged oversight role. Graw fails to plead any facts supporting

the claim that Eli Lilly had the right or obligation to direct her medical care solely

because she participated in one of its clinical trials. Graw does not cite any

authority that recognizes such a duty owed under Missouri law. See, e.g., Turner v.

ILG Techs., LLC, No. 2:21-CV-04192-NKL, 2022 WL 4543209, at *11 (W.D. Mo.

Sept. 28, 2022) (dismissing pro se plaintiff’s complaint where she “failed to

sufficiently allege, beyond mere conclusory statements, that [defendant] owed a

duty” under Missouri law).

Second, Graw’s Amended Complaint does not contain sufficient facts to plead

that an agency relationship existed between Eli Lilly and Study Metrix regarding

the clinical trial. Eli Lilly notes that Study Metrix is an “independent trial site” by

design, which “ensure[s] the integrity and reliability of research results.” ECF. No.

13 at 3 n.2 (citing Suthers v. Amgen Inc., 441 F. Supp. 2d 478, 487-88 (S.D.N.Y.

2006). Even if Graw plausibly alleged that Eli Lilly “controlled” Study Metrix and

its administration of the clinical trial, [“t]he right to control the alleged agent is not

sufficient to establish an agency relationship.” Wallace v. Pharma Medica Rsch.,

Inc., No. 4:18-CV-1859 PLC, 2021 WL 516768, at *5 (E.D. Mo. Feb. 11, 2021)

(citing State ex rel. Ford Motor Co. v. Bacon, 63 S.W.3d 641, 642 (Mo. 2002)). To

plead the existence of an agency relationship under Missouri law, a plaintiff must

plausibly allege “(1) the agent had the authority to alter legal relations between the

principal and a third party; (2) the agent was a fiduciary with respect to matters

within the scope of the agency; and (3) the principal had the right to control the

conduct of the agent with respect to matters entrusted to the agent.” Id. at *4.

Here, Graw does not sufficiently plead any of the essential elements of an

agency relationship. Graw’s allegations that Study Metrix was a “contracted trial

site” and Eli Lilly had “oversight authority” are vague and unsupported legal

conclusions. See, e.g., Affordable Communities of Missouri v. Fed. Nat. Mortg.

Ass'n, 714 F.3d 1069, 1074 (8th Cir. 2013) (“We are also unpersuaded by

Affordable's ‘labels and conclusions,’ that ‘[a]t all relevant times, ... EFA acted as

an agent of Fannie Mae.’”) (quoting Twombly, 550 U.S. at 555); Philadephia

Indem. Ins. Co. v. Angi Inc., 642 F. Supp. 3d 899, 905 (E.D. Mo. 2022) (finding

plaintiff’s bare assertions that defendant “directed and controlled [alleged agent] in

all aspects of the…work” could not survive a Rule 12(b)(6) motion). Graw’s

allegations that Study Metrix and its staff “acted under Eli Lilly’s authority” and

Eli Lilly “allowed” Study Metrix to withhold care constitute “threadbare recitals”

of only one of the elements required to establish an agency relationship under

Missouri law. Twombly, 550 U.S. at 555. Without more, I may not presume any

liability would attach to Eli Lilly for Study Metrix or its staff’s alleged misconduct.

Third, after carefully considering the new allegations made in Graw’s Response

to Eli Lilly’s motion to dismiss, I find that Graw still fails to raise the right to relief

above a speculative level. Accepting as true that Graw reported her worsening

condition to Study Metrix and its staff physician, Graw has not provided any facts

in her Amended Complaint or Response connecting Eli Lilly to the allegedly

negligent treatment she received. In her Response, Graw claims that Eli Lilly

owed her a duty under the “law governing clinical trials.” ECF. No. 18 at 4. But

she fails to cite any federal regulations or a duty arising under the Missouri

common law of torts. See Zeman v. Williams, No. CIV.A. 11-10204-GAO, 2014

WL 3058298, at *3 (D. Mass. July 7, 2014) (concluding that “federal regulations

do not themselves authorize a cause of action by a [clinical trial participant] against

a sponsor”).2 Graw’s reference to unspecified “federal regulations” is not

sufficient to plead that Eli Lilly either directly owed her a duty or was somehow

vicariously liable for the actions of Study Metrix and its staff.

Graw’s Response also asserts that she does not have to “prove the precise

contours of Lilly’s internal control mechanisms or contractual arrangements with

Study Metrix,” and she claims “[d]iscovery is required to determine the extent of

Lilly’s control, knowledge, and failure to act.” ECF. No. 18 at 4. Graw is still

required, however, to “[plead] enough fact[s] to raise a reasonable expectation that

discovery will reveal evidence of [the claim or element].” Twombly, 550 U.S. at

556; see also Raineri Constr., LLC v. Taylor, No. 4:12-CV-2297 CEJ, 2015 WL

1526145, at *2 (E.D. Mo. Apr. 2, 2015) (stating “the purpose of discovery is not to

assist a plaintiff in articulating a plausible claim in drafting the complaint”) (citing

Kaylor v. Fields, 661 F.2d 1177, 1184 (8th Cir.1981)).

2 The FDA regulations governing clinical trials outline the responsibilities of clinical trial investigators and sponsors.

See 21 C.F.R § 312.50-.70. Although not specifically cited in Graw’s Amended Complaint or Response, these

regulations hold that investigators are responsible “for protecting the rights, safety, and welfare of subjects under the

investigator’s care.” 21 C.F.R. § 312.60; see also Kernke v. The Menninger Clinic, Inc., 173 F. Supp. 2d 1117, 1124

(D. Kan. 2001) (“All of the duties alleged by plaintiffs in this case fall within the purview of the [] defendants as the

investigator conducting the [clinical study]; the duties do not rest with [the sponsor].”) (citing 21 C.F.R. § 312.60).

However, I find that Graw offers no well-pleaded facts raising a reasonable

expectation that discovery would reveal a contract between Eli Lilly and Study

Metrix. She claims Eli Lilly was responsible for “protocol design, safety

monitoring, adverse event reporting, and ensuring that investigators comply with

regulatory and ethical obligations to protect human subjects.” ECF. No. 18 at 4.

She also states her adverse reactions were “reported repeatedly” but does not

identify when or to whom she made her reports.3 As with Graw’s Amended

Complaint, these allegations are conclusory, threadbare recitals of the elements of

agency and negligence. The absence of any specific allegations regarding Eli Lilly

being in privity with Study Metrix or Graw directly communicating with Eli Lilly

is fatal here.

Because I find that the allegations in Graw’s Amended Complaint and her

Response fail to plead the essential elements of a negligence claim, Count I will be

dismissed with prejudice.

B. Count II: Medical Malpractice

Count II of Graw’s Amended Complaint will be dismissed with prejudice

because Graw does not allege that she was in a physician-patient relationship with

Eli Lilly. The fact that Graw did not file the mandatory healthcare affidavit

3 Graw’s Amended Complaint indicates these reports about her condition were only made to Study Metrix staff,

including one of its staff physicians. ECF. No. 6 at 7.

required by Missouri law is not fatal to her claim. To state a claim for medical

malpractice under Missouri law, a plaintiff must plausibly allege “(1) proof that

defendant's act or omission failed to meet the requisite standard of care; (2) proof

that the act or omission was performed negligently; and (3) proof of a causal

connection between the act or omission and the injury sustained by the plaintiff.”

Brickey v. Concerned Care of Midwest, Inc., 988 S.W.2d 592, 596 (Mo. Ct. App.

1999) (citation omitted). “For a claim based on medical negligence, a physician's

duty to a plaintiff is derived from a physician-patient relationship. Such a

relationship is essential to a claim for medical negligence.” Brown v. Bailey, 210

S.W.3d 397, 404 (Mo. Ct. App. 2006) (internal citation omitted).

Here, Graw fails to provide any facts that could support the existence of a

physician-patient relationship between Graw and Eli Lilly. Eli Lilly is a

pharmaceutical company and was not directly responsible for administering

treatment during the study. See ECF. No. 21 at 2. Graw has not plausibly alleged

that Eli Lilly took over the provision of healthcare services or took on any other

physician-patient role as sponsor of the study. Any alleged physician-patient

relationship between Graw and Study Metrix or its staff cannot be imputed to Eli

Lilly. Absent any plausible allegations about a physician-patient relationship,

Graw cannot state a claim for medical malpractice under Missouri law. See

Meekins v. St. John's Reg'l Health Ctr., Inc., 149 S.W.3d 525, 532 (Mo. Ct. App.

2004) (“[A]bsent that physician/patient relationship, a medical malpractice claim

must fail.”).

Additionally, Eli Lilly asserts that Graw failed to file the mandatory healthcare

affidavit required by Missouri law to bring a medical malpractice claim. ECF.

Nos. 13 at 14, 21 at 12. In Missouri, “[t]he legislature mandates healthcare

affidavits for all medical-malpractice claims [] as a precondition to a valid suit.”

Ferder v. Scott, 556 S.W.3d 100, 102 (Mo. Ct. App. 2018) (citing Mo. Rev. Stat. §

538.225). The affidavit must state that the plaintiff “has obtained the written

opinion of a legally qualified healthcare provider” that certifies the merit of the

claim. Mo. Rev. Stat. § 538.225. Eli Lilly argues that the 90-day statutory

deadline for Graw to file a healthcare affidavit has expired, requiring dismissal of

her claim.4 The Supreme Court recently held in Berk v. Choy that a similar law in

Delaware, which required plaintiffs to file affidavits of merit as a precondition to

bringing medical malpractice claims, does not apply in federal court. No. 24-440,

2026 WL 135974 (U.S. Jan. 20, 2026). The Court found Delaware’s affidavit of

merit requirement inconsistent with the federal pleading rules. “Under Rule 8,

factual allegations are sufficient, but under the Delaware law, the plaintiff needs

evidence too.” Id. at *4. As a result, the Court held a plaintiff’s failure to file such

4 Graw filed her Amended Complaint on August 13, 2025, so the 90-day statutory deadline to file a healthcare

affidavit passed on November 11, 2025.

an affidavit is not a ground for dismissal on a Rule 12(b)(6) motion. Id. (“[Rule

12] “provides only one ground for dismissal based on the merits: ‘failure to state a

claim upon which relief can be granted.’”) (quoting Fed. R. Civ. P. 12(b)(6)). I

therefore find Graw’s failure to file an affidavit of merit within the 90-day window

is not a proper ground for dismissal of her claim.

But because Graw’s fails to plead any facts showing a physician-patient

relationship existed between her and Eli Lilly, Graw’s medical malpractice claim

will be dismissed with prejudice.

C. Count III: Lack of Informed Consent

Count III of Graw’s Amended Complaint will be dismissed with prejudice

because she does not allege that Eli Lilly was the medical practitioner responsible

for providing her with informed consent.

Under Missouri law, a claim for lack of informed consent has three elements:

“1) nondisclosure, 2) causation, and 3) injury.” Wilkerson v. Mid-Am. Cardiology,

908 S.W.2d 691, 696 (Mo. Ct. App. 1995). Graw’s Amended Complaint contains

no allegations supporting her lack of informed consent claim. In her Response,

Graw alleges that “she was not fully informed of the risks associated with the

investigational drug and that the ongoing risks were not adequately communicated

to her as her condition worsened.” ECF. No. 18 at 4. She states that “the material

risk information was withheld or minimized, impairing her ability to make

informed decisions about continued participation.” Id.

I find that these allegations are insufficient to state a claim for lack of informed

consent. To show lack of informed consent, “a plaintiff must show that the

disclosures made by the defendant do not meet the standard of what a reasonable

medical practitioner would have disclosed under the same or similar

circumstances.” Wilkerson, 908 S.W.2d at 696 (citing Aiken v. Clary, 396 S.W.2d

668, 675 (Mo.1965)). Graw fails to identify the specific information that was

allegedly not disclosed to her prior to or during her participation in the clinical

trial. She does not provide any allegations regarding the standard of what a

reasonable medical practitioner would have disclosed to her under the same

circumstances. Even if she had, Graw has not shown that Eli Lilly is a “medical

practitioner” as defined by Missouri law. To adequately plead lack of informed

consent, a plaintiff must plausibly allege “whether a reasonable person in plaintiff's

position would have consented to the procedure had the treating medical

practitioner made the proper disclosures of the risks and alternatives.” Ball v.

Allied Physicians Grp., L.L.C., 548 S.W.3d 373, 388 (Mo. Ct. App. 2018). Graw

has not done so here. Neither her Amended Complaint nor her Response allege

whether a reasonable person in her position would have consented to the treatment

had the “proper” disclosures been made.

Moreover, Graw fails to plausibly allege why Eli Lilly, as opposed to Study

Metrix or its staff physician, would have been responsible for disclosing the

information. As Eli Lilly points out, in the clinical trial context, the investigator is

typically responsible for obtaining the participants’ informed consent. See Butler v.

Juno Therapeutics, Inc., No. CV H-18-898, 2019 WL 2568477, at *5 (S.D. Tex.

June 21, 2019) (“Federal regulations require clinical trial sponsors to inform

participants of reasonably known risks through investigators, such as the

[physician responsible for administering treatments to participants].”) (emphasis

added); see also 21 C.F.R. § 312.60 (“An investigator shall obtain the informed

consent of each human subject to whom the drug is administered[.]”).5 Graw has

not sufficiently alleged why she should be able to sustain a lack of informed

consent claim against Eli Lilly.

For these reasons, I will dismiss Graw’s lack of informed consent claim with

prejudice.

5 When Graw filed her original Complaint on July 14, 2025, she attached as an exhibit a copy of the consent form

with her signature entitled “Study Participant Information and Consent Form and Authorization to Use and Disclose

Protected Health Information.” ECF. No. 1-1. She did not attach this form as an exhibit to her Amended Complaint,

which is the operative complaint in this case. See ECF. No. 6. “It is well established that an amended complaint

supersedes an original complaint in all relevant aspects.” Pearson v. Gittemeier, No. 2:19-CV-41 RLW, 2023 WL

2585957, at *2 (E.D. Mo. Mar. 21, 2023) (citing Thomas v. United Steelworkers Loc. 1938, 743 F.3d 1134, 1139 (8th

Cir. 2014)). I therefore did not consider the consent form in determining whether to dismiss Graw’s claim. See id.

(deciding on a motion for summary judgment not to consider two written statements attached to plaintiff’s First

Amended Complaint and not the operative Fourth Amended Complaint). Regardless, the consent form shows that

many of the side effects Graw allegedly reported experiencing were in fact disclosed. See ECF. No. 1-1 at 16-17

(listing feeling sick to the stomach, decreased appetite, and throwing up as “very common” side effects and noting

the risks associated with feeling sick to the stomach, such as dehydration and kidney failure).

D. Counts IV & V: Intentional Infliction of Emotional Distress and

Reckless Infliction of Emotional Distress

Counts IV & V of Graw’s Amended Complaint will be dismissed with

prejudice.

Graw does not allege that Eli Lilly engaged in extreme and outrageous conduct

that was only intended to cause her emotional distress or that such conduct caused

her physical symptoms. Nor does she allege that Eli Lilly was in privity with

Study Metrix and therefore liable for its conduct. The absence of these allegations

is fatal to her emotional distress claim.

To plead an intentional infliction of emotional distress claim under Missouri

law, a plaintiff must plausibly allege a number of essential elements: “(1) the

defendant's conduct must be outrageous or extreme; (2) the defendant must act

intentionally or recklessly; (3) there must be extreme emotional distress that results

in bodily harm; (4) caused by the defendant's conduct; and (5) the conduct must be

intended solely to cause extreme emotional distress to the victim.” Crow v.

Crawford & Co., 259 S.W.3d 104, 119 (Mo. Ct. App. 2008). “[T]he conduct must

have been so outrageous in character, and so extreme in degree, as to go beyond all

possible bounds of decency, and to be regarded as atrocious, and utterly intolerable

in a civilized community.” Thomas v. Special Olympics Missouri, Inc., 31 S.W.3d

442, 446 (Mo. Ct. App. 2000). Moreover, “the emotional distress or mental injury

must be medically diagnosable and must be of sufficient severity so as to be

medically significant.” Bass v. Nooney Co., 646 S.W.2d 765, 772-773 (Mo. 1983).

In her Response, Graw alleges that the “extreme and outrageous conduct” by

Eli Lilly consisted of “ignoring repeated emergency calls from a suffering clinical

trial participant because staff were preparing for a holiday party, while Plaintiff

was experiencing life-threatening symptoms.” ECF. No. 18 at 4. However, in her

Amended Complaint, Graw states that her “attempts to reach [Study Metrix] trial

staff in urgent distress went unanswered because the office was preparing for a

Christmas party, as admitted by Dr. Timothy Smith.” ECF. No. 6 at 7. Graw again

fails to explain how the alleged conduct of Study Metrix and its staff physician is

attributable to Eli Lilly. For Eli Lilly to be held responsible for the alleged

intentional infliction of emotional distress by Study Metrix and its staff, Graw

would have to successfully plead that an agency relationship existed between Eli

Lilly and Study Metrix and its staff. See Maryland Cas. Co. v. Huger, 728 S.W.2d

574, 579 (Mo. Ct. App. 1987) (“[A] principal or employer is held liable to a third

person for a tort, even though not directed or commanded nor expressly authorized

by the employer, provided that the employee or agent has committed such act

while engaged in an activity falling within the scope of his authority or

employment.”) (citing 2 Mechem, Agency, § 1879 at 1461 (1914)); see also Gibson

v. Brewer, 952 S.W.2d 239, 246 (Mo. 1997) (finding “Diocese [(principal)] is not

liable under an agency theory” because “intentional infliction of emotional distress

[is] not within the scope of employment of a priest [(agent)].”).

Graw also fails to sufficiently plead the essential elements of the claim. She

pleads no facts and cites no supporting case law to demonstrate that “ignoring

repeated emergency calls” constitutes “extreme and outrageous conduct” as

defined by Missouri law. See, e.g., Hendrix v. Wainwright Indus., 755 S.W.2d 411,

412 (Mo. Ct. App. 1988) (finding that the “harassment of an employee for filing a

complaint with [OSHA] is not only undesirable but illegal…however, it is not so

outrageous as to go beyond all possible bounds of decency”) (internal quotation

omitted); Sproaps v. SSM Health St. Louis Univ. Hosp., No. 4:23-CV-01243 RLW,

2024 WL 180860, at *3 (E.D. Mo. Jan. 17, 2024) (dismissing plaintiff’s emotional

distress claim because allegations that he was physically thrown out of the hospital

did not “indicate that the conduct went beyond all possible bounds of decency”).

Graw also fails to allege anywhere in her Amended Complaint or Response that

such conduct was only intended to cause her emotional distress.

Because Graw’s allegations are conclusory and she fails to plead the essential

elements of an intentional infliction of emotional distress claim, I will dismiss

Counts IV and V with prejudice.6

6 Missouri law does not recognize a separate tort for reckless infliction of emotional distress. That the defendant

acted recklessly satisfies the second element of an intentional infliction of emotional distress claim.

E. Count VI: Products Liability

Count VI of Graw’s Amended Complaint will be dismissed with prejudice.

Although Graw lists “products liability” as one of the claims in her Amended

Complaint, she provides no allegations supporting the claim in either her Amended

Complaint or Response. Her pleadings are devoid of any allegations that she

incurred injuries because of a defect in the drug that was administered during the

clinical trial. She does not allege that Eli Lilly should be held strictly liable for a

defective drug or was negligent in manufacturing it, designing it, or failing to make

certain warnings. Because I find that these allegations were never made, Graw

cannot proceed on this claim.

“In Missouri, a plaintiff may bring a product liability claim under a theory of

strict liability (by asserting claims for defective manufacture, defective design, or

failure to warn) or a theory of negligence (by asserting claims for negligent

manufacture, negligent design, or negligent failure to warn).” Ameer v. Lyft, Inc.,

711 S.W.3d 534, 542 (Mo. Ct. App. 2025). Here, Graw fails to specify whether her

claim is being brought under a strict products liability theory or a theory of

negligence. Each products liability theory has distinct elements under Missouri

law that plaintiffs must prove. See generally id. Graw cannot sustain a products

liability claim without making factual allegations under at least one of these

theories.

Regardless, Graw’s Response fails to mention nor seeks to defend the

sufficiency of her products liability claim. As several courts in the Eighth Circuit

have held, failure to respond to Eli Lilly’s arguments in its motion to dismiss

results in Graw abandoning her claim. “When a plaintiff fails to defend or pursue a

claim in response to a motion to dismiss or summary judgment, the claim is

deemed abandoned.” Fam. Dollar Stores of Missouri, LLC v. Tsai's Inv., Inc., No.

4:21-CV-572-SRW, 2022 WL 355109, at *14 (E.D. Mo. Feb. 7, 2022); see also

Little v. United States Dep't of Def., No. 4:21-CV-1309-JAR, 2022 WL 1302759

(E.D. Mo. May 2, 2022) (dismissing pro se plaintiff’s complaint for failure to

respond to defendant’s arguments on a motion to dismiss); Huskey v. Colgate-

Palmolive Co., 486 F. Supp. 3d 1339 (E.D. Mo. 2020) (“[A] plaintiff's failure to

address a defendant's arguments on a motion to dismiss operates as an

abandonment of those claims.”) (collecting cases).

Even if Graw had not abandoned her claim, she pleads no facts in her Amended

Complaint that could be construed as supporting a products liability claim under

either a strict liability or negligence theory. Therefore, I will dismiss her products

liability claim with prejudice.

F. Count VII: Violations of FDA Clinical Trial Regulations

Finally, Count VII of Graw’s Amended Complaint will be dismissed with

prejudice. Dismissal is appropriate because she cites no specific FDA regulation

which gives her a private right to sue or creates a legal duty on behalf of Eli Lilly.

Nor does she cite a particular FDA regulation that Eli Lilly violated. The failure to

cite any specific FDA regulations that authorize a suit against Eli Lilly is fatal to

Graw’s claim.

Graw alleges her “attempts to reach [Study Metrix] staff in urgent distress went

unanswered because the office was preparing for a Christmas party as admitted my

Dr. Timony Smith. This gross disregard for participant safety directly violated

federal clinical trial standards.” ECF. No. 6 at 7. The Court’s Order dated July

15th, 2025, noted, Graw “may not create a cause of action based on the Code of

Federal Regulations if Congress has not provided a private right of action.” ECF.

No. 3 at 5-6, 6 n.2 (collecting cases). In her Response, Graw argues that she “does

not assert a standalone private right of action under FDA regulations.” ECF. No.

18 at 5. Instead, Graw states that she “references FDA regulations as evidence of

the applicable duty of care and industry standards governing clinical trial

sponsors.” Id.

As previously addressed, the FDA regulations governing clinical trials do not

create an independent duty of care in Graw’s case, and she cannot base her

negligence claim against Eli Lilly on vague references to federal regulations. See,

e.g., Abney v. Amgen, Inc., 443 F.3d 540, 551 (6th Cir. 2006) (“[U]nder the FDA’s

regulatory scheme it is not the pharmaceutical companies that are charged with

ensuring trial participants’ well being.”) (citing 21 C.F.R. § 56.101); Zeman v.

Williams, No. CIV.A. 11-10204-GAO, 2014 WL 3058298, at *4 (D. Mass. July 7,

2014) (dismissing claim where plaintiff alleged violations of “the Federal Food,

Drug, and Cosmetic Act and regulations promulgated pursuant to said Act,’ but

there [were] no specifics about which provisions of the Act or regulations were

violated or how”).

Whether brought as a separate claim or part of her negligence claim, Graw fails

to sufficiently allege violations of the FDA’s clinical trial regulations or any other

federal regulations.

G. Conclusion

After careful review of the pleadings, I find that Graw has failed to state claims

for negligence, medical malpractice, lack of informed consent, intentional and

reckless infliction of emotional distress, products liability, and violations of FDA

clinical trial regulations. Graw has been granted leave to amend her complaint

once in this action, and I considered the additional allegations she raised in her

Response to Eli Lilly’s motion. Therefore, I will grant Eli Lilly’s motion and

dismiss all of the claims in Graw’s Amended Complaint with prejudice.

Accordingly,

IT IS HEREBY ORDERED that Defendant Eli Lilly and Company’s motion

to dismiss [12] is GRANTED. Plaintiff Patti Jo Graw’s Amended Complaint [6]

will be DISMISSED with prejudice.

A separate Judgment in accordance with this Memorandum and Order will be

entered on this same date.

A :

RODNEY W. siPPet

UNITED STATES DISTRICT JUDGE

Dated this 23" day of February, 2026.

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