Jeffrey Thelen v. Somatics, LLC

11th Cir.9/29/2025

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USCA11 Case: 23-13892 Document: 53-1 Date Filed: 09/29/2025 Page: 1 of 31

[PUBLISH]
In the
United States Court of Appeals
For the Eleventh Circuit
____________________

No. 23-13892
____________________

JEFFREY THELEN,
Plaintiﬀ-Appellant,
versus
SOMATICS, LLC,

Defendant-Appellee,
ELEKTRIKA, INC.,

Defendant.
____________________

Appeal from the United States District Court
for the Middle District of Florida
D.C. Docket No. 8:20-cv-01724-TPB-JSS
____________________
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2 Opinion of the Court 23-13892

Before ROSENBAUM, NEWSOM, and MARCUS, Circuit Judges.
MARCUS, Circuit Judge:
Jeﬀrey Thelen received 95 electroconvulsive therapy
(“ECT”) treatments between 2014 and 2016 at a CHI Health hospi-
tal in Omaha, Nebraska in order to treat his severe depression.
Thereafter, Thelen suﬀered severe memory loss, and in 2017, was
diagnosed with neurocognitive disorder.
In 2020, Thelen sued Somatics, the manufacturer of the
Thymatron IV device used to administer the ECT treatments, in
the United States District Court for the Middle District of Florida.
He alleged negligence, strict product liability, breach of express and
implied warranties, violation of Nebraska’s Consumer Protection
Act, and fraudulent misrepresentation. At its core, Thelen claimed
that the company failed to adequately warn him of the risks asso-
ciated with electroconvulsive therapy. The district court disposed
of most of his claims before trial, dismissing Thelen’s claims for
violation of Nebraska’s Consumer Protection Act and fraudulent
misrepresentation, merging the strict liability and breach of im-
plied warranty claims, and entering summary judgment for Somat-
ics on the plaintiﬀ’s design defect and manufacturing defect theo-
ries and on his claim for breach of express warranty.
Thereafter, the case was tried by a jury on the negligence
and strict liability claims, which the district court merged in order
to simplify the case for the jury, since both claims were rooted in
the same alleged warning defect. Ultimately, the jury found that
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23-13892 Opinion of the Court 3

while there was a failure to adequately warn, this failure was not
the proximate cause of any injuries sustained by the plaintiﬀ.
On appeal, Thelen alleges that the district court erroneously
granted summary judgment for Somatics on the design defect
claim. He also says that the district court erroneously merged his
negligence and strict liability claims, that the district court’s jury
instructions on proximate cause were erroneous, and that the dis-
trict court abused its discretion in excluding some pieces of evi-
dence he had oﬀered.
After thorough review, and with the beneﬁt of oral argu-
ment, we ﬁnd none of these claims persuasive and, accordingly, af-
ﬁrm the judgment of the district court.
I.
A.
Jeﬀrey Thelen suﬀered from severe depression and other
mental health issues for many years, which resulted in his hospital-
ization on several occasions. Thelen attempted suicide a number
of times and had a long history of inﬂicting self-harm, including
incidents in which he slit his wrists, jumped into traﬃc, and
stabbed, starved, and shot himself. He also had a record of serious
substance abuse, including drinking excessively and abusing opi-
oids and cocaine.
In 2013, Thelen’s physician recommended that he try elec-
troconvulsive therapy (“ECT”) to treat his severe depression. Be-
tween May 2014 and July 2016, Thelen received 95 ECT treatments
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4 Opinion of the Court 23-13892

at a CHI Health hospital in Omaha, Nebraska. This therapy was
administered by a number of physicians including his psychiatrist,
Dr. Arun Sharma, utilizing a Thymatron IV ECT device that is
manufactured and sold by Somatics. Before each treatment, The-
len signed a consent form which expressly warned him that ECT
could cause, among other things, “short term memory loss,” “per-
manent memory loss,” “prolonged seizures,” “temporary or per-
manent heart abnormalities,” or “mortality”; the form did not use
the term “brain damage.”
After completing his ECT treatments over two years, Thelen
was diagnosed in 2017 by a neuropsychologist, Mark Hannappel,
with a neurocognitive disorder that caused severe memory loss.
According to Thelen’s mother, he suﬀered from both short-term
and long-term memory loss after receiving ECT. She testiﬁed that
Thelen could not remember many of his family members or his
high school years. Thelen’s mother also said that her son forgot
how to perform such basic tasks as doing laundry or unloading the
dishwasher. For this reason, she added, Thelen now writes every-
thing down in a “little black book” to avoid forgetting things. Ac-
cording to Dr. Hannappel’s 2021 progress report, Thelen said he
even forgot where his parents’ home was located, the very home
he had grown up in since he was six years old.
B.
On July 24, 2020, Thelen commenced this product liability
lawsuit against Somatics, alleging that the company had failed to
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23-13892 Opinion of the Court 5

warn him of the many substantial risks associated with ECT.1 The
complaint asserted that the electroconvulsive therapy treatment
had caused him to suﬀer neurocognitive injuries, including perma-
nent memory loss and brain damage. It also claimed that Somatics
had failed to comply with the FDA’s pharmacovigilance require-
ments by not adequately testing and investigating its device or re-
porting safety risks and adverse events caused by its device. See 21
C.F.R. §§ 803 et seq. Thelen asserted claims for: (1) negligence; (2)
strict liability; (3) breach of implied warranty of merchantability;
(4) breach of implied warranty of ﬁtness for a particular purpose;
(5) breach of express warranty; (6) violation of Nebraska’s Con-
sumer Protection Act, Neb. Rev. Stat. §§ 59-1601 et seq.; and (7)
fraudulent misrepresentation.
The district court disposed of most of these claims, dismiss-
ing some of them, merging some, and granting summary judg-
ment on some others. First, in February 2021, the district court
granted Somatics’s motion to dismiss Thelen’s claims for violation
of Nebraska’s Consumer Protection Act and fraudulent misrepre-
sentation, determining that the Nebraska statute did not provide
for a private right of action, and that the fraudulent misrepresen-
tation claim had not been pleaded with the particularity required

1 The complaint was initially filed against both Somatics and Elektrika,
which, Thelen alleged, assembled and repaired the Thymatron IV ECT de-
vices for Somatics. But after Elektrika moved for summary judgment in De-
cember 2022, Thelen and Elektrika reached a settlement agreement. Accord-
ingly, Elektrika was dismissed from the complaint in May 2023, leaving So-
matics as the only defendant.
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6 Opinion of the Court 23-13892

by Federal Rule of Civil Procedure 9(b). The court also merged
Thelen’s two claims for breach of implied warranty with his strict
liability claim, explaining that Nebraska law “unequivocally” re-
quired this result. See Freeman v. Hoﬀman-La Roche, Inc., 618 N.W.2d
827, 842–44 (Neb. 2000) (ﬁnding “persuasive” the “reasoning” of
“many courts [that] have merged theories of recovery for breach of
implied warranty and strict liability on the basis that each theory
states the same strict liability claim”).
Then, after the completion of discovery, Somatics moved for
summary judgment on the plaintiﬀ’s remaining claims for negli-
gence, strict liability, and breach of express warranty. The district
court granted the motion in part. To the extent Thelen’s negli-
gence claim was grounded in Somatics’s failure to report adverse
events to the FDA, the court concluded that this theory was im-
pliedly preempted by federal law. See 21 U.S.C. § 337(a) (providing
that actions to enforce FDA requirements “shall be by and in the
name of the United States”); Buckman Co. v. Plaintiﬀs’ Legal Comm.,
531 U.S. 341, 348 (2001) (“[P]laintiﬀs’ state-law fraud-on-the-FDA
claims conﬂict with, and are therefore impliedly pre-empted by, fed-
eral law.”); Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th
Cir. 2017) (“[I]mplied preemption prohibits state-law claims that
seek to privately enforce duties owed to the FDA.”).
As for Thelen’s claim for breach of express warranty, the dis-
trict court determined that Thelen failed to prove reliance on an
express warranty, as required by Nebraska law. See Hillcrest Country
Club v. N.D. Judds Co., 461 N.W.2d 55, 61 (Neb. 1990) (“[S]ince an
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23-13892 Opinion of the Court 7

express warranty must have been ‘made part of the basis of the
bargain,’ it is essential that the plaintiﬀs prove reliance upon the
warranty.”) (quoting Wendt v. Beardmore Suburban Chevrolet, Inc., 366
N.W.2d 424, 428 (Neb. 1985)). The court reasoned that Thelen had
not established that he relied on alleged representations found on
Somatics’s website.
Finally, the district court granted partial summary judgment
for Somatics on Thelen’s strict liability claim, ﬁnding no evidence
of a manufacturing or design defect. Under Nebraska law, a “man-
ufacturing defect exists when the product diﬀers from the plan and
speciﬁcations of the manufacturer.” Freeman, 618 N.W.2d at 841.
The district court explained that Thelen had failed to show that the
ECT device used to treat him contained a manufacturing ﬂaw that
deviated from its intended speciﬁcations. As for the strict liability
claim rooted in a design defect, the Nebraska Supreme Court has
instructed that this claim should be measured against the con-
sumer’s expectations, which asks whether a product is “dangerous
to an extent beyond that which would be contemplated by the or-
dinary consumer who purchases it, with the ordinary knowledge
common to the community as to its characteristics.” Id. at 840.
The district court agreed with Thelen that for these purposes, the
relevant “consumers” are patients, not physicians, but determined
that Thelen oﬀered no evidence to establish the expectations of an
ordinary patient about ECT devices, and instead only described his
own subjective expectations. However, the district court did not
grant summary judgment for Somatics on Thelen’s strict liability
claim under a failure to warn theory.
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8 Opinion of the Court 23-13892

Somatics argued separately on summary judgment that
Thelen had oﬀered no competent evidence that ECT causes per-
manent memory loss and brain damage. The district court rejected
this argument too. In Nebraska, in order to establish causation in
a product liability claim, a plaintiﬀ must show both general and
speciﬁc causation. See King v. Burlington N. Santa Fe Ry. Co., 762
N.W.2d 24, 34 (Neb. 2009). General causation refers to whether the
product can cause the injury in question, and is shown by expert
testimony establishing the association between the product and the
injury through epidemiological studies and the biological plausibil-
ity of a causal relationship. Id. at 34–42. In concluding that Thelen
made a suﬃcient showing to allow the issue to go to the jury, the
district court credited Thelen’s expert Dr. John Read, a clinical psy-
chologist, who oﬀered the opinion that “to a reasonable degree of
scientiﬁc certainty . . . ECT causes persistent/permanent memory
loss and brain damage in a substantial proportion of recipients,
somewhere in the range of 12% to 55%.”
Speciﬁc causation refers to whether a product in fact caused
the plaintiﬀ’s injury and is established by expert testimony employ-
ing a technique known as diﬀerential diagnosis, which involves rul-
ing in and out possible causes of the patient’s condition. Id. at 34,
50–51. While the district court excluded testimony on this matter
from Thelen’s expert psychologist, Dr. Mark Hannappel, who is
not a medical doctor, it suﬃciently credited Thelen’s expert Dr.
Bennet Omalu, a medical doctor and forensic pathologist, who
opined that ECT treatment caused brain injury in Thelen’s case. In
the course of the trial, however, the district court barred Dr.
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23-13892 Opinion of the Court 9

Omalu’s testimony on general causation, but not his opinion on
speciﬁc causation.
After granting partial summary judgment on some claims
and dismissing most of the others, what remained to be tried were:
(1) plaintiﬀ’s strict liability claim on a failure to warn theory (but
not on a manufacturing or design defect theory); and (2) plaintiﬀ’s
negligence claim arising from a failure to test or investigate and a
failure to warn. The district court excluded any theory about a fail-
ure to report to the FDA.
On the ﬁrst day of trial, the district court merged the strict
liability and negligence claims because it determined that, pursuant
to Rule 16 of the Federal Rules of Civil Procedure and Nebraska
law, “sending the case to the jury under two diﬀerent warning the-
ories would lead to confusion and inconsistent results.” The trial
court also concluded that the failure to test or investigate compo-
nent of the plaintiﬀ’s negligence claim “would be redundant,” ex-
plaining that unless Somatics’s “negligent failure to test resulted in
a warning defect,” it couldn’t have caused cognizable injury and
thus was not independently actionable. The court added that there
is “no separate cause of action for failure to test,” because this the-
ory is “subsumed within a claim for failure to properly design or
properly warn.”
During the course of the trial, Thelen unsuccessfully oﬀered
a portion of a sixteen-minute patient consent video featuring The-
len’s treating physician, Dr. Sharma, that had been produced by the
CHI Health hospital. The district court excluded the video under
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10 Opinion of the Court 23-13892

Federal Rule of Evidence 403 since it determined that the video
would “end up confusing the issues because then we’re going to be
focusing on disclosures that were given to the patient from the doc-
tor as opposed to disclosures given from the manufacturer to the
patient.”
The district court instructed the jury on proximate cause this
way: “In order to prove that inadequate instructions or warnings
proximately caused Thelen’s injury, Thelen must prove that his pre-
scribing physician would have altered his conduct had adequate
warnings and instructions been provided.” During closing argu-
ment, counsel for Somatics told the jury that for Thelen to succeed,
the plaintiﬀ must show that “Dr. Sharma would not have prescribed
ECT to Mr. Thelen if the words brain damage were in the manual
instead of permanent memory loss.” Thelen’s counsel did not ob-
ject to these statements when they were made during closing.
Counsel interposed an objection only later, after the jury had com-
menced its deliberative process, and only after the jury passed a
note to the court asking a series of questions. Thelen sought a cu-
rative instruction; the district court rejected it as untimely.
At the conclusion of a seven-day trial, the jury determined
that Somatics placed its ECT device on the market without ade-
quate instructions or warnings to the physician who prescribed the
treatments to Thelen, but it found that the absence of adequate
warnings was not the proximate cause of injury to Thelen. The
jury awarded Thelen no damages, and the district court aﬃrmed
the jury verdict in its ﬁnal judgment.
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23-13892 Opinion of the Court 11

Thereafter, Thelen moved for a new trial under Federal Rule
of Civil Procedure 59. Thelen claimed that: Dr. Sharma’s patient
consent video was highly probative yet erroneously excluded; the
district court issued an erroneous jury instruction on proximate
cause under Nebraska law; a curative instruction should have been
given after Somatics’s closing argument on proximate cause; the
district court improperly excluded Dr. Hannappel’s testimony; and
the district court erroneously dismissed Thelen’s design defect
claim at summary judgment. The district court denied Thelen’s
Rule 59 motion.
This timely appeal ensued.
II.
We review a district court’s grant of summary judgment de
novo, taking “the evidence and all reasonable inferences drawn
from it in the light most favorable to the nonmoving party.” Teso-
riero v. Carnival Corp., 965 F.3d 1170, 1177 (11th Cir. 2020) (quoting
Hornsby-Culpepper v. Ware, 906 F.3d 1302, 1311 (11th Cir. 2018)).
Summary judgment is appropriate “if the movant shows that there
is no genuine dispute as to any material fact and the movant is en-
titled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “Where
the record taken as a whole could not lead a rational trier of fact to
ﬁnd for the non-moving party, there is no genuine issue for trial.”
Tesoriero, 965 F.3d at 1177 (citation omitted).
We review a district court’s denial of a motion for a new trial
for abuse of discretion. Lamonica v. Safe Hurricane Shutters, Inc., 711
F.3d 1299, 1312 (11th Cir. 2013). “The only grounds for granting [a
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12 Opinion of the Court 23-13892

Rule 59] motion are newly-discovered evidence or manifest errors
of law or fact.” Arthur v. King, 500 F.3d 1335, 1343 (11th Cir. 2007)
(quoting In re Kello, 197 F.3d 1116, 1119 (11th Cir. 1999)). A district
court’s refusal to give a requested jury instruction, including a cu-
rative instruction, is only reviewed for abuse of discretion. Lamon-
ica, 711 F.3d at 1309 (citing Pensacola Motor Sales Inc. v. E. Shore
Toyota, LLC, 684 F.3d 1211, 1224 (11th Cir. 2012)).
“We review jury instructions de novo to determine whether
they misstate the law or mislead the jury to the prejudice of the
objecting party, but the district court is given wide discretion as to
the style and wording employed in the instructions.” Goldsmith v.
Bagby Elevator Co., 513 F.3d 1261, 1276 (11th Cir. 2008) (citations
omitted). “Reversal is warranted for the failure to give a proposed
instruction only if this failure prejudiced the requesting party.” Id.
That is, “[s]o long as his jury instructions reﬂect the pertinent sub-
stantive law, the trial judge is given wide discretion as to the style
and wording that he may employ.” Andres v. Roswell-Windsor Vill.
Apartments, 777 F.2d 670, 673 (11th Cir. 1985).
Finally, we review for abuse of discretion a district court’s
decision to admit or exclude certain evidence or expert testimony.
United States v. Frazier, 387 F.3d 1244, 1258 (11th Cir. 2004) (en
banc). We will not reverse a district court’s evidentiary ruling on
expert testimony “unless the ruling is manifestly erroneous.” Id.
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 142 (1997)). Thus, a
reviewing court “will reverse only if the error may have had a sub-
stantial inﬂuence on the outcome of the proceeding.” Knight ex rel.
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23-13892 Opinion of the Court 13

Kerr v. Miami-Dade County, 856 F.3d 795, 813 (11th Cir. 2017) (quot-
ing United States v. Augustin, 661 F.3d 1105, 1127 (11th Cir. 2011)).
III.
A.
First, Thelen argues that the district court erred in granting
summary judgment for Somatics on his design defect claim. Re-
viewing the evidence de novo and taking it in the light most favor-
able to Thelen, we are satisﬁed that the district court properly dis-
posed of this claim.
All parties agree that we look to the substantive law of Ne-
braska to inform the meaning of a design defect. To establish a
design defect under Nebraska law, a plaintiﬀ must show that a de-
fect renders a product “unreasonably dangerous,” meaning that it
“has a propensity for causing physical harm beyond that which
could be contemplated by the ordinary user or consumer.” Pitts v.
Genie Indus., 921 N.W.2d 597, 608 (Neb. 2019). The plaintiﬀ must
also prove by a preponderance of the evidence that the defect was
the “proximate” cause of his injury. Id. at 609. The relevant con-
sumer for design defect claims is the patient, not the physician. See
Langner v. Bos. Sci. Corp, 492 F. Supp. 3d 925, 933 (D. Neb. 2020) (“Alt-
hough not stated explicitly in Nebraska case law, it is implicit that
the consumer or user of a medical device or prescription drug is
the patient -- not the physician.”).
Thelen failed to present suﬃcient evidence to create a genu-
ine issue for trial on his design defect claim -- he has not shown that
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14 Opinion of the Court 23-13892

the product was unreasonably dangerous or that any claimed de-
fect was the proximate cause of injury.
First, Thelen oﬀers as relevant evidence of a design defect
the ECT consent form, a CHI Health hospital information pam-
phlet, Somatics’s website advertisement, and a Thymatron IV de-
vice manual. He claims that none of them warns a patient of the
risk of “brain damage.” But the various documents in fact alert the
patient to the serious, indeed potentially grievous, risks associated
with ECT, including risks to the brain. The documents conﬁrm
that ECT can cause death as well as the permanent loss of memory.
The consent form speciﬁcally warns that ECT could cause “short
term memory loss” as well as “mortality, temporary or permanent
heart abnormalities, . . . prolonged seizures and permanent
memory loss.” The CHI Health pamphlet states that potential risks
include “mortality, temporary or permanent heart abnormalities,
oral injuries, reactions to medications, injuries to muscles, bones or
other parts of body, prolonged seizures, and permanent memory
loss.” The device manual also observes: “Please note that nothing
in this manual constitutes, or should be construed as, a claim by
Somatics LLC that confusion, cognitive impairment, or memory
loss (short-term, long-term, recent, remote, transient, or persis-
tent) can not occur as the result of ECT. Many patients experience
temporary loss of recent or remote memories with ECT . . . . A
few patients have reported experiencing persisting loss of memo-
ries or memory functions after ECT.”
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23-13892 Opinion of the Court 15

While these documents do not use the term “brain dam-
age,” they unambiguously warn the patient of the potential seri-
ous, even fatal, risks associated with ECT -- including short- and
long-term memory loss, bodily injury, and even death. A reasona-
ble consumer -- the focal point of our analysis -- would readily con-
template that the risk of “brain damage” is encompassed in the risk
of permanent memory loss. It is hard to imagine an ordinary con-
sumer not understanding that “permanent memory loss” is associ-
ated with some kind of injury to the brain. Indeed, Dr. Omalu,
one of Thelen’s experts, observed at trial: “It is a fact” that “brain
damage is equivalent . . . in Mr. Thelen’s case to loss of memory.”
He also testiﬁed that: “[W]henever any human being suﬀers a sei-
zure, it is a manifestation of brain injury and brain damage.” An-
other one of Thelen’s experts, Dr. Read, said this at trial: “[P]ersis-
tent/permanent memory loss and brain damage” are used “inter-
changeably to the extent that brain damage is a term which there
is no consensus or agreement on.”
Thelen also relies on expert testimony from Dr. Kenneth
Castleman (a biomedical engineer), who is not a medical doctor.
Dr. Castleman submitted a declaration stating that: “Despite its
widespread use, ECT exposes patients to risks of brain damage that
have not been thoroughly evaluated.” After reviewing the scientiﬁc
literature, Dr. Read separately concluded in his expert report that
“ECT causes persistent/permanent memory loss and brain dam-
age in a substantial proportion of recipients, somewhere in the
range of 12% to 55%.” Thelen argues that this testimony suggests
a design defect in Somatics’s Thymatron IV device. But, as we’ve
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16 Opinion of the Court 23-13892

observed, to establish a design defect, Thelen must show that the
product is dangerous “beyond that which could be contemplated
by the ordinary user or consumer.” Pitts, 921 N.W.2d at 608. The-
len has not presented evidence that the speciﬁc Thymatron IV de-
vice used was unreasonably dangerous relative to ordinary expec-
tations, but rather that ECT generally presents certain detailed
risks (including the most grievous ones), which were made known
to Thelen before his treatments.
Finally, Thelen oﬀered testimony from his treating physician
and parents as evidence of a design defect. Dr. Sharma testiﬁed,
when asked about whether he had seen ECT cause brain damage
in any of his patients: “No. I have not.” Thelen’s mother likewise
testiﬁed that the various physicians she spoke with, including Dr.
Sharma, said that “ECT doesn’t cause brain damage.” And The-
len’s father testiﬁed that Dr. Sharma did not “say anything about
the potential to suﬀer any sort of brain injury” from ECT. But as
the district court found, the fact that Thelen’s physician and parents
were seemingly unaware about the risks of ECT does not mean
that the ordinary patient would not have been aware of these risks.
Again, Thelen must present objective evidence of “ordinary
knowledge common to the community” concerning ECT, not sub-
jective evidence about “his own expectations.”
Moreover, to prove that a design defect rendered the product
unreasonably dangerous, the plaintiﬀ must show that the defect
was the proximate cause of the injury. See id. at 609. Thelen’s only
claim here is that the product was marketed without adequate
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23-13892 Opinion of the Court 17

warnings, which in turn caused Dr. Sharma to inadequately warn
Thelen. The problem with the argument is that the jury directly
found that while the warnings made by Somatics were inadequate,
the inadequate warnings did not cause any injury to the plaintiﬀ.
On this record, Thelen is hard-pressed to establish that he was prej-
udiced because the design defect claim was not sent to the jury.
B.
Thelen also argues that the district court erred in merging
his negligence and strict liability claims. The court sua sponte
merged the claims on the ﬁrst day of trial to “simplify issues” under
Federal Rule of Civil Procedure 16, concluding that both claims
were grounded in Somatics’s failure to warn. See Fed. R. Civ. P.
16(c)(2)(A) (“[T]he court may consider and take appropriate action
on the following matters: formulating and simplifying the issues,
and eliminating frivolous claims or defenses.”). The trial court un-
derscored the risk that “under a two-theory approach, the jury
might conclude under the negligence theory that the manufacturer
was negligent (that is, failed to act with reasonable care) with re-
spect to the warnings it provided with its product, while at the
same time concluding under the strict liability theory that the
warnings were adequate.” Thelen says, however, that the district
court erred because the negligence claim was predicated on more
than a failure to warn -- it also encompassed a failure to test and a
failure to investigate. We remain unpersuaded.
Under Nebraska law, negligence and strict liability can be in-
dependent causes of action in failure to warn cases. See Freeman,
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18 Opinion of the Court 23-13892

618 N.W.2d at 845 (“Aside from pleading theories of recovery under
strict liability for speciﬁc product defects, a plaintiﬀ may assert a
theory of recovery based on negligence.”). But the Nebraska Su-
preme Court has also recognized the “merger of doctrines” that
allows the court to “adopt[] a single theory approach”:
Instead of focusing on doctrinal tort categories such
as negligence or strict liability, the Third Restatement
functionally deﬁnes each of the three basic types of
product defect claims: design, manufacturing, and
warning defect claims. The Third Restatement
adopts the position that the deﬁnition of ‘defect’ is
the important issue and should remain the same re-
gardless of the doctrinal tort category under which it
is brought. . . . [T]wo or more factually identical de-
fective-design claims or two or more factually identi-
cal failure-to-warn claims should not be submitted to
the trier of fact in the same case under diﬀerent doc-
trinal labels. . . . To allow two or more factually iden-
tical [] claims to go to a jury under diﬀerent labels,
whether ‘strict liability,’ ‘negligence,’ or ‘implied war-
ranty of merchantability,’ would generate confusion
and may well result in inconsistent verdicts.
Id. at 843 (citing Restatement (Third) of Torts: Prod. Liab. § 2
(1997)). Since Somatics’s purported failure to warn underlay both
the plaintiﬀ’s negligence and strict liability claims, the district court
acted well within its discretion in merging the two claims. The
claims were “factually identical” -- they arose out of the same al-
leged warning defect. Id.
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23-13892 Opinion of the Court 19

Indeed, Thelen’s counsel, Mr. Bijan Esfandiari, acknowl-
edged as much in an exchange with the district court:
MR. ESFANDIARI: The negligence claim, Your
Honor, is failing to act as a reasonable manufacturer
would have done under the circumstances. . . .
THE COURT: By doing what, not having air-condi-
tioning in its factory?
MR. ESFANDIARI: No, by failing to warn, failing to
provide warnings.
THE COURT: Failure to warn, that’s our strict liabil-
ity claim. Go ahead.
MR. ESFANDIARI: Both of them, you can have one
under negligence. You can have one under strict lia-
bility. . . .
THE COURT: Wouldn’t that only cause injury if it
was -- you know, resulted from a failure to warn? Isn’t
a failure to investigate or test really an independent
cause of action? . . .
MR. ESFANDIARI: It’s part of a negligence claim
that also is -- you know, informs on the conduct of the
company and informs on whether the company was
negligent in failing to warn, because they failed to inves-
tigate properly in order to inform themselves of the
risk. And, therefore, because they failed to inform
themselves of the risk, they did not provide adequate
warnings. . . .
Pretrial Conference Proceedings Transcript at 42–43, Dkt. No. 208
(emphases added).
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20 Opinion of the Court 23-13892

Although Thelen now attempts to cast his failure to test and
failure to investigate claims as independent theories of negligent
liability, as Thelen’s counsel acknowledged, both theories require
proving a failure to warn in order to succeed. Under Nebraska’s
merger doctrine, as explicated by its high court, the district court
did not err in exercising its broad discretion under Rule 16 to merge
the two claims. See Pac. Indem. Co. v. Broward County, 465 F.2d 99,
103 (5th Cir. 1972) (holding that Rule 16 “gives the trial
court broad discretion in conducting pre-trial procedures in order
to narrow the issues, reduce the ﬁeld of fact controversy for reso-
lution, and to simplify the mechanics of the oﬀer and receipt of
evidence”).2
C.
Thelen further claims that the district court fatally erred in
its jury instruction on proximate cause. For starters, while Thelen
asked for a very broad jury instruction on proximate cause, the in-
struction the court actually gave was quite broad, especially when
compared to Somatics’s narrower request. The court told the jury:
“In order to prove that inadequate instructions or warnings proxi-
mately caused Thelen’s injury, Thelen must prove that his prescrib-
ing physician would have altered his conduct had adequate warn-
ings and instructions been provided.” Thelen argues that this in-
struction was erroneous because Nebraska law has never required

2 In Bonner v. City of Prichard, 661 F.2d 1206 (11th Cir. 1981) (en banc),
we adopted as binding precedent all Fifth Circuit decisions issued before Oc-
tober 1, 1981. Id. at 1209.
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23-13892 Opinion of the Court 21

a plaintiﬀ to establish that his physician would have altered his con-
duct had adequate instructions been provided. Thelen maintains
that the instruction erroneously applied the learned intermediary
doctrine -- which applies to the element of duty -- to the element
of causation. Thelen’s proposed jury instruction read more gener-
ally: “A proximate cause is a cause that produces a result in a natural
and continuous sequence, and without which the result would not
have occurred.”
However, as the district court noted in its Rule 59 order,
“Thelen cites no contrary Nebraska authority” to support his view
that the learned intermediary doctrine does not apply to causation.
While there is “no controlling Nebraska authority on this principle
of causation,” several federal district courts interpreting Nebraska
law have applied the learned intermediary doctrine to the causation
inquiry too. See, e.g., Langner, 492 F. Supp. 3d at 933 (“Under the
learned intermediary doctrine, the failure of a manufacturer to
provide the physician with adequate warnings must be the cause in
fact and proximate cause of the plaintiﬀ’s injuries. . . . In other
words, the plaintiﬀ must demonstrate that the treating physician
would not have prescribed the medical device if the manufacturer
had given a diﬀerent warning.”) (citing Ideus v. Teva Pharms. USA,
Inc., 361 F. Supp. 3d 938, 946 (D. Neb. 2019) (“[T]o avoid summary
judgment, Ideus must demonstrate that had the package insert
contained a diﬀerent warning, the treating physician would not
have used or prescribed [the product].”)).
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22 Opinion of the Court 23-13892

Inasmuch as Thelen has not shown that the district court
“misstate[d] the law or misle[]d the jury to the prejudice of the ob-
jecting party,” his argument on appeal fails. Goldsmith, 513 F.3d at
1276. Additionally, Thelen’s counsel conceded at several points
during the charge conference that the proximate cause instruction
as given was correct. When asked if Thelen had to “prove that his
treating physicians would have altered their conduct had adequate
warnings been given,” his counsel said, “Yes. Your Honor has it
correct.” Thelen’s counsel also said that “whoever wrote these jury
instructions knew the law, and it’s the conduct of the physician that
matters,” and “I think the instructions on this point are accurate as
written.” At another point in the proceedings, counsel argued “for
the appellate record” that “when Somatics or any manufacturer
fails to warn the physician, then it no longer can seek shelter behind
the learned intermediary defense.” While Thelen may have pre-
served his argument for appeal, his counsel’s concessions also sug-
gest that the district court was not mistaken in giving this jury in-
struction, and regardless, that he would not be prejudiced by it.
Moreover, even if the instruction were erroneous -- and we
do not believe that it was -- Thelen does not explain how he suﬀered
“prejudicial harm” warranting reversal. McElroy ex rel. McElroy v.
Firestone Tire & Rubber Co., 894 F.2d 1504, 1509 (11th Cir. 1990). He
has not shown (as he must) that he would have succeeded on prox-
imate cause if the court had provided a slightly broader jury in-
struction.
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23-13892 Opinion of the Court 23

Ultimately, “the trial judge is entitled to wide discretion over
the style and wording employed as long as the instructions accu-
rately reﬂect the law.” Schafer v. Time, Inc., 142 F.3d 1361, 1368 (11th
Cir. 1998). Thelen cannot fairly claim that the trial court abused
this wide discretion in its jury instruction on proximate cause.
D.
Thelen also raises a related claim that Somatics’s counsel of-
fered the wrong legal standard for proximate cause during his clos-
ing argument and that the district court abused its discretion in fail-
ing to give a curative instruction. This error, he asserts, required
the district court to set aside the verdict. Again, we are unper-
suaded.
During closing, Somatics’s counsel said that in order for The-
len to succeed on his claim, “Dr. Sharma would not have prescribed
ECT to Mr. Thelen if the words brain damage were in the manual
instead of permanent memory loss.” Jury Trial Proceedings Tran-
script at 54, Dkt. No. 264 (emphasis added). Defense counsel’s em-
phasis on prescription was more speciﬁc than the court’s jury in-
struction, which, again, required that the “prescribing physician
would have altered his conduct.” Thelen protested that Somatics
“used the word prescribed when the instructions are the conduct
of the physician,” and asked the court for a curative instruction.
The court denied the request, ﬁnding that the objection had been
lodged too late.
The district court did not abuse its discretion in failing to
give a curative instruction or in failing to reread its jury instruction
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24 Opinion of the Court 23-13892

on proximate cause. For one thing, Thelen failed to make a con-
temporaneous objection and did not object until after the jury had
already begun deliberations, waiving his objection in the process.
See Oxford Furniture Cos. v. Drexel Heritage Furnishings, Inc., 984 F.2d
1118, 1129 (11th Cir. 1993) (rejecting defendants’ claims about
plaintiﬀ’s closing argument because defendants, “while now claim-
ing severe prejudice because of the argument, made no attempt to
object to the [closing] arguments when they were made”). The
whole point of interposing a timely objection, after all, is to provide
the district court with the opportunity to timely correct the error.
Moreover, and even more basic, Thelen has not established
that he was prejudiced by the district court’s decision not to pro-
vide a curative instruction. Cf. McWhorter v. City of Birmingham, 906
F.2d 674, 677 (11th Cir. 1990) (“Where the interest of substantial
justice is at stake, improper argument may be the basis for a new
trial even if no objection has been raised.”) (citation modiﬁed).
Simply put, Thelen has not shown that Somatics’s closing argu-
ment negatively aﬀected the jury’s verdict in any way. Defense
counsel’s language largely mirrors the more general jury instruc-
tion that Dr. Sharma would have needed to alter his conduct. It
reasonably follows from the jury instruction that altering the phy-
sician’s conduct in this case would mean not prescribing the ECT
treatment to his patient. Thelen has not oﬀered any other plausible
reading.
In any event, even if there was some error in Somatics’s ar-
gument about the controlling law, the judge made it crystal clear
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23-13892 Opinion of the Court 25

that the jury was required to follow the law as he explained it and
that anything the lawyers say is not evidence and is not binding on
the jury. “We generally presume that jurors follow their instruc-
tions.” United States v. Hill, 643 F.3d 807, 829 (11th Cir. 2011). In
short, Thelen has not established that he was prejudiced by the
court’s refusal to provide a curative instruction because it is exceed-
ingly remote that Somatics’s slightly narrower instruction on prox-
imate cause aﬀected the verdict.
E.
Next, Thelen argues that the district court abused its discre-
tion in excluding a 2009 patient consent video featuring Dr. Sharma
because he claims that it was relevant to Dr. Sharma’s knowledge
about the risks associated with ECT treatment. While the judge
ﬁrst said that the video would be admissible, although he would
not allow it to be published to the jury, he later changed his mind,
and excluded the video entirely, citing to Rule 403 of the Federal
Rules of Evidence. See Fed. R. Evid. 403 (“The court may exclude
relevant evidence if its probative value is substantially outweighed
by a danger of one or more of the following: unfair prejudice, con-
fusing the issues, misleading the jury, undue delay, wasting time, or
needlessly presenting cumulative evidence.”). The court’s ex-
pressed concern was that the video would confuse the jury because
it focused on “disclosures that were given to the patient from the
doctor as opposed to disclosures given from the manufacturer to
the patient,” and the heart of Thelen’s claim turned on the disclo-
sure made by the manufacturer to the physician.
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26 Opinion of the Court 23-13892

The district court did not abuse its discretion under Rule
403. For one thing, as the district court observed, the jury was al-
ready aware from Dr. Sharma’s own testimony that he did not be-
lieve ECT posed a risk of brain damage. (“That’s what the doctor
knew at the time, because that’s what he was conveying in his
video, which, of course, that’s already in evidence through his tes-
timony.”). So the admission of the video would have been wholly
cumulative about Dr. Sharma’s understanding of the risks associ-
ated with ECT treatment. Because Dr. Sharma’s views were fully
disclosed to the jury, the probative value of admitting the video ev-
idence was marginal, and the district court could readily deter-
mine, as it did, that the video’s slender evidential value was sub-
stantially outweighed by the risk of creating jury confusion about
the legal standard surrounding a failure to warn case involving a
learned intermediary. The district court’s Rule 403 determination
did not amount to an abuse of discretion.
What’s more, any evidentiary error by the district court may
compel a reversal of a jury verdict only if the “error aﬀected ‘a sub-
stantial right.’” Proctor v. Fluor Enters., Inc., 494 F.3d 1337, 1349 (11th
Cir. 2007) (quoting United States v. Stephens, 365 F.3d 967, 974 (11th
Cir. 2004)). In this case, the exclusion of Dr. Sharma’s patient con-
sent video did not (and could not) aﬀect the plaintiﬀ’s substantial
rights, because the jury ultimately determined that “Somatics
placed the ECT device on the market without adequate instruc-
tions or warnings to the physician who prescribed ECT treatment
to Thelen.” Since the jury found for Thelen on the failure to warn
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23-13892 Opinion of the Court 27

issue, it’s hard to imagine how the exclusion of the video could
have undermined Thelen’s position.
F.
Finally, Thelen argues that the district court abused its dis-
cretion in excluding Dr. Hannappel’s expert testimony on medical
causation. Dr. Hannappel is a neuropsychologist who ﬁrst saw
Thelen in August 2017, approximately one year after his ﬁnal ECT
treatment. His evaluation oﬀered that “[f ]rom a neuropsychologi-
cal perspective, testing results and [Thelen’s] history suggest mod-
erate circumscribed declines in his cerebral functioning, possibly
related to the ECT treatments as there do not appear to be other
explanations for the pattern of his neuropsychological deﬁcits.”
Dr. Hannappel also later testiﬁed that he believed Thelen’s 90 plus
ECT treatments were a “substantial factor in his diagnosis of neu-
rocognitive disorder.” Accordingly, Thelen sought to present testi-
mony from Dr. Hannappel in order to establish that the resultant
cognitive defects were caused by the ECT treatments.
The district court did not abuse its considerable discretion in
barring the admission of Dr. Hannappel’s opinion testimony, be-
cause he was not competent by background, training, or experi-
ence to render a causation opinion, and any opinion he might have
oﬀered was not methodologically sound or reliable.
We begin with Rule 702 of the Federal Rules of Evidence,
which governs the admissibility of expert testimony. See Fed. R.
Evid. 702 (“A witness who is qualiﬁed as an expert by knowledge,
skill, experience, training, or education may testify in the form of
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28 Opinion of the Court 23-13892

an opinion or otherwise if the proponent demonstrates to the
court that it is more likely than not that: (a) the expert’s scientiﬁc,
technical, or other specialized knowledge will help the trier of fact
to understand the evidence or to determine a fact in issue; (b) the
testimony is based on suﬃcient facts or data; (c) the testimony is
the product of reliable principles and methods; and (d) the expert’s
opinion reﬂects a reliable application of the principles and methods
to the facts of the case.”). As we have long held, in determining the
admissibility of expert testimony under Rule 702, a court must con-
sider whether: “(1) the expert is qualiﬁed to testify competently re-
garding the matters he intends to address; (2) the methodology by
which the expert reaches his conclusions is suﬃciently reliable as
determined by the sort of inquiry mandated in Daubert; and (3) the
testimony assists the trier of fact, through the application of scien-
tiﬁc, technical, or specialized expertise, to understand the evidence
or to determine a fact in issue.” Frazier, 387 F.3d at 1260 (quoting
City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 562 (11th Cir.
1998)). Ultimately, a trial court has “considerable leeway” in exer-
cising its discretion to admit or exclude expert testimony. Frazier,
387 F.3d at 1258 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137,
152 (1999)).
The district court’s Daubert determination was well
founded. For one thing, Dr. Hannappel was a neuropsychologist,
not a physician. For another, as even he conceded at his deposition,
he was not “qualiﬁed to oﬀer medical causation opinions.” More-
over, he explained that “treatment with ECT is outside of my scope
of expertise.”
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23-13892 Opinion of the Court 29

What’s more, as the district court concluded, Dr. Hannap-
pel’s methodology for opining about causation was unreliable be-
cause he failed to evaluate alternative explanations for Thelen’s
cognitive decline in 2017. Thelen argues that Dr. Hannappel per-
formed a diﬀerential diagnosis to arrive at his causation opinion,
but by Dr. Hannappel’s own account, he did not do so. “A reliable
diﬀerential analysis requires an expert to ‘compile a comprehensive
list of hypotheses that might explain’ a plaintiﬀ’s condition.” Chap-
man v. Procter & Gamble Distrib., LLC, 766 F.3d 1296, 1310 (11th Cir.
2014) (quoting Hendrix ex rel. G.P. v. Evenﬂo Co., 609 F.3d 1183, 1195
(11th Cir. 2010)). But Dr. Hannappel did not consider whether the
plaintiﬀ’s serious substance abuse of alcohol, opioids, and cocaine
or prior suicide attempts might have contributed to Thelen’s men-
tal state. See e.g., Chapman, 766 F.3d at 1309 (holding that a “reliable
diﬀerential analysis . . . ‘must at least consider other factors that
could have been the sole cause of the plaintiﬀ’s injury’”) (quoting
Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1253 (11th Cir.
2010)). And in Dr. Hannappel’s own words from his 2017 evalua-
tion: “Obviously, all potential reversible conditions that might be
causing his cognitive decline should be ruled out,” something Dr.
Hannappel never did. In short, the district court did not abuse its
considerable discretion in determining that Dr. Hannappel was un-
qualiﬁed to opine on medical causation.
Thelen argues in the alternative that even if Dr. Hannappel’s
expert opinions were properly excluded, as Thelen’s treating physi-
cian, he should have been able to oﬀer them as a lay witness under
Rule 701 of the Federal Rules of Evidence. See Fed. R. Evid. 701
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30 Opinion of the Court 23-13892

(“If a witness is not testifying as an expert, testimony in the form
of an opinion is limited to one that is: (a) rationally based on the
witness’s perception; (b) helpful to clearly understanding the wit-
ness’s testimony or to determining a fact in issue; and (c) not based
on scientiﬁc, technical, or other specialized knowledge within the
scope of Rule 702.”); see, e.g., United States v. Henderson, 409 F.3d
1293, 1300 (11th Cir. 2005).
The ﬁrst problem with this argument is that the opinion Dr.
Hannappel was oﬀering on medical causation required a diagnostic
explanation far more complex than simply observing a broken jaw
or a broken arm. See, e.g., Travelers Prop. Cas. Co. of Am. v. Ocean Reef
Charters LLC, 71 F.4th 894, 907 n.9 (11th Cir. 2023) (“[W]e have not
held that any treating physician can testify as a lay witness about
any diagnosis she made while treating the patient.”). Rule 701 ex-
pressly prohibits lay opinions based on scientiﬁc, technical, and spe-
cialized knowledge. See Fed. R. Evid. 701(c). The explanation of
the cause of Thelen’s cognitive decline required a complex diagnos-
tic process, plainly calling for scientiﬁc and technical reasoning.
Any opinion Dr. Hannappel might have oﬀered on causation, even
as a treating physician, would properly be considered under Rule
702 and be subject to Daubert standards. See Chapman, 766 F.3d at
1316 n.23 (“[A] treating doctor . . . is providing expert testimony if
the testimony consists of opinions based on ‘scientiﬁc, technical, or
other specialized knowledge’ regardless of whether those opinions were
formed during the scope of interaction with a party prior to litigation.”)
(emphasis added) (citation omitted).
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23-13892 Opinion of the Court 31

Thelen’s additional argument that Dr. Hannappel should
have been allowed to testify as a lay witness because he was no
more than a treating physician fails because the fact is that Dr. Han-
nappel did not begin treating Thelen until June 2020, nearly three
years after he opined that “[t]esting results indicate that [Thelen’s]
cognitive declines could be related to his ECT treatments.” The
district court determined when it excluded this testimony that “at
the time he formed his opinions, Hannappel was consulting with
Plaintiﬀ’s treating physicians rather than treating Plaintiﬀ himself.”
The long and short of it is that the district court did not
abuse its discretion in barring Dr. Hannappel’s testimony.
We AFFIRM the judgment of the district court.

AFFIRMED.

Jeffrey Thelen v. Somatics, LLC

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