Robinson V 3m Company
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
TINA ROBINSON,
Plaintiff,
v. Case No. 8:24-cv-00828-WFJ-AAS
3M COMPANY,
and ARIZANT HEALTHCARE, INC.,
Defendants.
________________________________/
ORDER
Before the Court are Defendants 3M Company and Arizant Healthcare,
Inc.’s (collectively “3M” or “Defendants”) Motion to Exclude Plaintiff’s General
Causation Experts, Motion to Exclude Specific Causation Opinions of Plaintiff’s
Expert Dr. Yoav Golan, and Motion for Summary Judgment. Dkts. 73, 74, & 76.
Plaintiff Tina Robinson has responded to all three motions, Dkts. 79, 80, & 81, and
Defendant 3M replied. Dkts. 88, 85, & 87. Upon careful consideration, the Court
denies Defendants’ Motion to Exclude Plaintiff’s General Causation Experts,
denies Defendants’ Motion to Exclude Specific Causation Opinions of Plaintiff’s
Expert Dr. Yoav Golan, and denies in part and grants in part Defendants’ Motion
for Summary Judgment.
BACKGROUND
This case was transferred to this Court from the District of Minnesota as part
of the larger MDL proceeding In re: Bair Hugger Forced Air Warming Devices
Products Liability Litigation, MDL 15-2666-JNE (D. Minn. Apr. 19, 2016).
Plaintiff’s case was transferred to the Middle District of Florida and assigned to the
undersigned on April 1, 2024. Dkt. 10 at 8.
On April 23, 2021, Plaintiff Robinson presented to the emergency
department at HCA Florida Brandon Hospital (“Brandon Hospital”) in Brandon,
Florida, after a dog ran into the lateral aspect of her right knee, knocking her down.
Dkt. 75 ¶ 23. A subsequent radiology scan revealed an unstable fracture to her
right tibia, and surgery was recommended. Id. ¶ 24. Two weeks later, on May 6,
2021, Robinson underwent an open reduction and internal fixation (“ORIF”)
procedure to repair her tibial plateau split depressed fracture,1 performed by Dr.
Anjan Shah at Brandon Hospital. Id. ¶ 25. During the ORIF surgery, the surgeon
and anesthesiologist used the Bair Hugger Force Air Warming System (the “Bair
Hugger”). Id. ¶ 26. The Bair Hugger is a forced-air warming device used during
surgical procedures to prevent a patient’s core body temperature from dropping,
thereby mitigating the risk of hypothermia. Id. ¶¶ 4–5, 9. The product works by
1 A tibial plateau fracture is an injury where the patient breaks the bone and damages the cartilage on top of the tibia
(the bottom part of their knee).
warming ambient air in the heating unit, and then a blower pushes the air through a
hose into a perforated blanket placed over the patient’s chest and arms. Id. ¶¶ 4–5.
Plaintiff claims that the Bair Hugger injured her by introducing
contaminants into her open surgical wound, leading to a Staphylococcus aureus
(“S. aureus”) infection that required intervention, management, and two additional
surgeries. Id. ¶ 26; Dkt. 53 ¶¶ 90–95. Ms. Robinson was not involved in the
decision to use the Bair Hugger system during her surgery and was not aware that
the product had been used until months later. Dkt. 75 ¶ 27. The initial decision to
use the Bair Hugger system in Ms. Robinson’s surgery was the responsibility of
her anesthesiologist, Dr. Calvin Kim. Id. ¶ 28. However, Dr. Shah, as the surgeon,
was the ultimate decision-maker with the authority to overrule the decisions of
other operating room (“OR”) staff. Dkt. 83 ¶ 35. Dr. Kim has worked with Dr.
Shah in prior surgeries and was never ordered to stop using the Bair Hugger in
Plaintiff’s ORIF surgery. Dkt. 75 ¶ 33. Nor has Dr. Kim ever experienced a
scenario in which Dr. Shah was involved in the anesthesiologist’s decision
regarding the use of a warming device. Id. ¶ 34.
Plaintiff filed suit in the Bair Hugger MDL on August 7, 2023. Id. ¶ 40. On
August 1, 2024, Robinson filed an Amended Complaint alleging eight claims
against Defendant 3M: (1) negligence; (2) gross negligence; (3) failure-to-warn
under Fla. Stat. § 768.81; (4) design defect under Fla. Stat. § 768.81; (5) breach of
implied warranty of merchantability under Fla. Stat. § 672.314; (6) violation of
Florida Deceptive and Unfair Trade Practices Act (“FDUTPA”); (7) misleading
advertising under Fla. Stat. § 817.41; and (8) unjust enrichment. Dkt. 53 ¶¶ 96–
178. Plaintiff seeks compensatory and punitive damages pursuant to these claims.
Id. ¶¶ 179–195. On March 18, 2025, Defendants filed their motions to exclude
testimony from Plaintiff’s general and specific causation experts (Dkts. 73 & 74)
and a motion for summary judgment (Dkt. 76). The Court will address each one in
turn.
I. Motion(s) to Exclude under Rule 702
Defendants have moved to exclude the testimony and opinions of Plaintiff’s
one general causation medical expert (Dr. Yoav Golan), one general causation
engineering expert (Dr. Said Elghobashi), and one specific causation expert (Dr.
Golan, again) under Federal Rule of Evidence 702. The opinions of the general
causation experts are offered to establish that the Bair Hugger can cause a non-
joint infection in ORIF surgical patients. The specific causation opinion is offered
to establish that the Bair Hugger did, in fact, cause Plaintiff’s non-joint infection
following ORIF surgery in 2021. See Chapman v. Procter & Gamble Distrib.,
LLC, 766 F.3d 1296, 1316 (11th Cir. 2014).
a. Legal Standard
A qualified witness may offer an expert opinion if 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.” Fed. R. Evid.
702; see Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993). “The
party offering the expert testimony bears the burden of establishing, by a
preponderance of the evidence, the expert’s qualification, reliability, and
helpfulness.” Payne v. C.R. Bard, Inc., 606 F. App’x 940, 942 (11th Cir.
2015) (citing United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) (en
banc)). When determining the qualifications, reliability, and helpfulness/relevance
of an expert’s testimony, “the judge performs a ‘gatekeeping’ function.” Chapman,
766 F.3d at 1304 (quoting Daubert, 509 U.S. at 589 n.7).
The first requirement for the admissibility of expert testimony is
qualification. “A witness is qualified as an expert if he is the type of person who
should be testifying on the matter at hand.” Moore v. Intuitive Surgical, Inc., 995
F.3d 839, 852 (11th Cir. 2021) (citing Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK
Ltd., 326 F.3d 1333, 1341 (11th Cir. 2003)). For example, “scientific training or
education may provide possible means to qualify, [and] experience in a field may
offer another path to expert status.” Frazier, 387 F.3d at 1260–61. Importantly, the
Eleventh Circuit has warned that “the qualifications and reliability prongs of
Daubert are conceptually distinct inquiries that district courts may not collapse into
each other.” Moore, 995 F.3d at 853. In product liability cases, there is no
requirement “that an expert witness is qualified to testify regarding the cause of an
injury only if he personally has used the allegedly defective product.” Id. at 854.
Such a bright-line rule would set the qualified bar “too high” and “would bar all
expert medical testimony unless the expert has somehow recreated the same
conditions that the patient was under.” Id. (alterations accepted) (citing Adams v.
Lab. Corp. of Am., 760 F.3d 1322, 1335 (11th Cir. 2014)).
Next, “[a]n expert opinion is reliable if it was arrived at through, among
other things, a scientifically valid methodology.” Id. at 852 (citation omitted). The
Eleventh Circuit has identified four factors to guide district judges in assessing the
reliability prong of an expert’s methodology:
(1) whether the expert’s methodology has been tested or is capable of
being tested; (2) whether the theory or technique used by the expert
has been subjected to peer review and publication; (3) whether there is
a known or potential error rate of the methodology; and (4) whether
the technique has been generally accepted in the relevant scientific
community.
Chapman, 766 F.3d at 1305 (quoting United Fire & Cas. Co. v. Whirlpool
Corp., 704 F.3d 1338, 1341 (11th Cir. 2013) (per curiam)). While this inquiry is “a
flexible one,” the focus “must be solely on principles and methodology, not on the
conclusions that they generate.” Daubert, 509 U.S. at 594–95. “‘But conclusions
and methodology are not entirely distinct from one another’; neither Daubert nor
Federal Rule of Evidence 702 requires a trial judge ‘to admit opinion evidence that
is connected to existing data only by the ipse dixit of the expert.’” Chapman, 766
F.3d at 1305 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 141–43 (1997)).
“Instead, the judge is free to conclude that there is simply too great an analytical
gap between the data and the opinion proffered.” Id. at 1305 (citing Hendrix ex rel.
G.P. v. Evenflo Co., 609 F.3d 1183, 1194 (11th Cir. 2010) (internal quotations
omitted)).
Third, under the relevance prong, expert testimony must be “relevant to the
task at hand” by “logically advance[ing] a material aspect” of the case. Daubert at
591. In other words, the “relationship must be an appropriate ‘fit’ with respect to
the offered opinion and the facts of the case.” McDowell v. Brown, 392 F.3d 1283,
1299 (11th Cir. 2004) (citing Daubert, 509 U.S. at 591). “[T]here is no fit where a
large analytical leap must be made between the facts and the opinion.” Id. (citing
Gen. Elec. Co., 522 U.S. at 146). Again, the trial court “may conclude that there is
simply too great an analytical gap between the data and the opinion proffered.”
Gen. Elec. Co., 522 U.S. at 146.
Finally, the district court’s gatekeeper role is not supposed to “supplant the
adversary system or the role of the jury.” McDowell, 392 F.3d at 1299 (citing
Allison v. McGhan Med. Corp., 184 F.3d 1300, 1311 (11th Cir. 1999)). Instead,
“vigorous cross-examination, presentation of contrary evidence, and careful
instruction on the burden of proof are the traditional and appropriate means of
attacking shaky but admissible evidence.” Id. (internal quotations omitted).
b. Analysis
Defendants challenge the admissibility of testimony by Plaintiff’s general
and specific causation experts. Dkts. 73 & 74. A plaintiff seeking to establish the
causation element of a products liability claim must present admissible expert
testimony supporting both general causation and specific causation. Chapman, 766
F.3d at 1316 (stating that, to prove a product caused the plaintiff’s injury, the
plaintiff was “required to have Daubert-qualified, general and specific-causation-
expert testimony that would be admissible at trial to avoid summary judgment”
(emphasis in original)); see Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1334 n.4 (11th
Cir. 2010); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1239 (11th Cir.
2005).
General causation refers to whether the product can cause the injury in
question. Kilpatrick, 613 F.3d at 1334 n.4. Specific causation refers to whether the
product did in fact cause the plaintiff's injury. Id. General causation is proven with
expert testimony that first “rules in” possible causes of the plaintiff’s injury.
Hendrix, 609 F.3d at 1195 (“[T]he district court must ensure that, for each possible
cause the expert ‘rules in’ at the first stage of the analysis, the expert’s opinion on
general causation is derived from scientifically valid methodology.” (citation
omitted)). Then, a specific causation expert must “rule out” other potential causes
based on additional evidence, tests, or analysis, leading to a conclusion that the
remaining possible cause is (more likely than not) the actual cause. See Chapman,
766 F.3d at 1309–10; Kilpatrick, 613 F.3d at 1342–43. Specific causation can be
established by experts using a methodology known as differential etiology
(sometimes referred to as “differential diagnosis”). See Chapman, 766 F.3d at
1308–09.
i. Motion to Exclude Plaintiff’s General Causation Experts
“General causation refers to the ‘general issue of whether a substance has
the potential to cause the plaintiff’s injury.’” Chapman, 766 F.3d at 1306 (quoting
Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1248 n.1 (11th Cir. 2010)). As
discussed above, this analysis can be done with expert testimony that first “rules
in” possible causes. Thelen v. Somatics, LLC, No. 8:20-CV-1724-TPB-JSS, 2023
WL 3947945, at *3 (M.D. Fla. June 12, 2023).
In Defendants’ motion to exclude Plaintiff’s general causation experts, 3M
argues that Plaintiff has failed to meet the relevance prong of Rule 702.
Specifically, unlike the majority of cases in the Bair Hugger MDL, this case does
not involve a periprosthetic joint infection (“PJI”) following a knee or hip
prosthetic joint arthroplasty (“PJA”). Dkt. 73 at 1. As such, Plaintiff’s expert
opinions that the Bair Hugger system causes infections in tibia repair surgeries or
an ORIF procedure are not appropriate since much of the scientific evidence (from
the Bair Hugger MDL) does not “fit” this case. Id. Plaintiff has two expert
witnesses who will offer general causation testimony: Dr. Said Elghobashi and Dr.
Yoav Golan. See Dkt. 79 at 1, 3.
1. Dr. Said Elghobashi
Dr. Said Elghobashi is an engineering expert in the field of computational
fluid dynamics (“CFD”). Dkt. 73 at 2. As part of the larger Bair Hugger MDL, Dr.
Elghobashi developed a CFD simulation that used a three-dimensional design to
replicate an OR and analyze how forced-air warming devices impact the
performance of ultra-clean ventilation systems. See Dkt. 79-1 at 2, 7–11.2 The
results of this simulation showed that with the Bair Hugger’s blower on, “a large
number of squames [human skin cells large enough to carry bacteria] are lifted
upwards by the rising thermal plumes . . . [which] are lifted above the surgeons[’]
heads and are blown towards the [operating theater] by the downward moving
ventilation air. . . . Statistically significant particles do enter the imaginary boxes of
2 Dr. Elghobashi eventually published his expert report with several coauthors in a peer-reviewed journal. See X. He
et al., Effect of Heated-Air Blanket on the Dispersion of Squames in an Operating Room, 34 Int’l J. Numerical
Methods Biomedical Eng’g, May 2018 at 1.
interest above the operating table and the patient’s knee. Few particles are also
observed above the side tables [where surgical tools are located].” Id. at 61–62.3
Here, Defendants do not challenge Dr. Elghobashi’s qualifications or the
reliability of his opinions under Rule 702.4 Instead, Defendants seek to preclude
Dr. Elghobashi’s expert report on the relevance prong, arguing that his testimony
does not “fit” the facts of this case since his model does not show “how the Bair
Hugger system would impact airflow in the context of Robinson’s specific type of
surgery (ORIF).” Dkt. 73 at 2. Plaintiff responds by noting that while Dr.
Elghobashi’s study was modeled after a knee surgery, the study still “specifically
looked at four different areas within the OR[:] areas over two side tables, the entire
operating theater (including the patient’s entire body), and the surgical area in
particular (which happened to be the patients knee area in the model). The study
found that the [Bair Hugger] blew squames into all four areas.” Dkt. 79 at 8–9.
Here, the Court agrees with Plaintiff and rejects Defendants’ relevance
challenge to Dr. Elghobashi’s report. Defendants’ effort to differentiate the CFD
3 More specifically, approximately three million 10-μm-sized squames were placed on the floor of the model OR
around the operating table (on average, a person sheds about ten million squames a day). Dkt. 79-1 at 42, 60–61.
Based on mathematical equations, Dr. Elghobashi simulated whether the Bair Hugger’s thermal plumes could blow
these 10-μm-sized squames—large enough to carry bacteria—into four “regions of interest” in the OR, including the
surgical site itself. Id. at 55–59.
4 To the extent that Defendants are challenging the reliability of Dr. Elghobashi’s report, such arguments have
already been rejected In Re: Bair Hugger Forced Air Warming Products Liability Litigation, 9 F.4th 768, 783 n.6
(8th Cir. 2021). While not binding on this Court, the Eighth Circuit’s ruling on the limited admissibility of Dr.
Elghobashi’s testimony, as it relates to reliability, is persuasive and has been proven by a preponderance of the
evidence. See id. at 782–83 (“Dr. Elghobashi set out to determine whether forced-air warming ‘play[s] a role in
transporting squame particles to the surgical site’; his CFD model tested this hypothesis; and he found that forced-air
warming does play a role, at least in certain OR conditions with limited airflow disruptions from other sources. So
limited, his conclusion was tested and supported by the CFD model, and the problematic analytical gap found by the
MDL court is gone.”).
model used in Dr. Elghobashi’s study from an ORIF surgery is a distinction
without a difference, since Dr. Elghobashi’s simulation clearly examined the
distribution of squames over a significantly larger area than just the knee. The CFD
simulated the distribution of squames over four different areas: two side tables, the
area above the operating theater, and the area above the patient’s knee. See Dkt.
79-1 at 56 (showing a figure of the four zones). The study concluded that
“[s]tatistically significant particles do enter the imaginary boxes of interest above
the operating table and the patient’s knee.” Id. at 62 (emphasis added); see also id.
(“Large number of squames are seen to be above the [operating theater], several
are surrounding the surgeons[’] hands, above the side tables, and some are very
close to the patient’s knee and the surgical site.”). The Court finds Dr.
Elghobashi’s expert report sufficiently “rules in” the Bair Hugger as a possible
cause for how squames could be transported to the surgical site in ORIF surgery
for a tibial plateau fracture (only located a couple of inches from the knee). This is
not so large an analytical leap—or in this case, not so large a physical gap between
a knee PJA and ORIF surgery for a tibial plateau fracture—that would exclude Dr.
Elghobashi’s expert report under Rule 702. See McDowell, 392 F.3d at
1299 (noting “there is no fit where a large analytical leap must be made between
the facts and the opinion,” such as proffering animal studies concerning a type
of cancer in mice to establish a different cancer in humans (citing Gen. Elec.
Co., 522 U.S. at 146)); see also Rosenfeld v. Oceania Cruises, Inc., 654 F.3d 1190,
1193 (11th Cir. 2011) (“[I]n most cases, objections to the inadequacies of a study
are more appropriately considered an objection going to the weight of the evidence
rather than its admissibility.” (citation omitted)).
2. Dr. Yoav Golan
While Dr. Elghobashi’s expert testimony is reliable, Plaintiff must still
bridge the analytical gap between the airflow disruption theory5 and a surgical site
infection following ORIF surgery. Put differently, Plaintiff’s general causation
expert needs to “rule in” bacteria-carrying squames as a potential cause of
infection in an ORIF surgery. To bridge this gap, Plaintiff points to testimony from
Dr. Yoav Golan, an infectious disease expert, who opined that bacteria landing on
the hardware inserted into the tibia during an ORIF procedure can cause a S.
aureus infection. See Dkt. 79 at 11; Dkt. 73-4 at 6 (showing Dr. Golan’s expert
report). To support this opinion, Dr. Golan adopted the report of another expert
witness in the larger MDL case and referenced several studies. Dkt. 73-4 at 2, 7
(listing references and noting Dr. Golan has “reviewed the report authored by Dr.
5 In the Bair Hugger MDL, there are two general causation theories by which the Bair Hugger could introduce
bacteria into a surgical site to cause infection. Under the “dirty-machine theory,” the Bair Hugger is the source of the
infection-causing bacteria, and the hose blows the bacteria out of the perforated blanket onto the surgical site. Dkt.
73 at 3. Under the “airflow-disruption theory,” the Bair Hugger system disrupts OR airflow by blowing squames (on
the floor) up and over the operating table into the surgical site. Id. Here, Dr. Golan’s general causation opinion is
based on the air-flow disruption theory since he opines that the Bair Hugger system “was the likely cause” of
Robinson’s S. aureus infection because it “generates an uplifting of air carrying particles that are contaminated with
microbes . . . capable of causing hardware infection[,]” and “[i]t is likely that a sufficient number of these
contaminated particles landed in the surgical field and contaminated it.” Dkt. 73-4 at 6. However, as discussed in
further detail below, Dr. Golan cites studies that relate more to the dirty-machine theory. Regardless, the Court finds
Dr. Golan’s general causation opinion admissible under Rule 702.
William Jarvis from 2017 . . . [and] agree[s] with the conclusions [Dr. Jarvis]
reached concerning evidence that the Bair Hugger is capable of causing
periprosthetic joint infections. I adopt his report and supplement it with reference
to additional studies published since 2017”).
Defendants, however, argue that “nothing in Dr. Golan’s report or deposition
testimony provides a valid scientific basis to extrapolate PJA/PJI-related general
causation opinions to the facts here.” Dkt. 73 at 8. Specifically, Dr. Golan’s
general causation testimony is not reliable since “he failed to identify a valid
scientific basis to extrapolate his PJA/PJI-related general causation opinions,” and
“he cannot alone analogize between the Bair Hugger system’s impact on airflow in
a PJA relative to an ORIF procedure.” Id. at 8–9.
The Eleventh Circuit has “identified some of the scientifically valid methods
for establishing general causation,” including expert opinions based on
“epidemiological studies, provided the expert explains how the findings of those
studies may be reliably connected to the facts of the particular case.” Hendrix, 609
F.3d at 1196–97 (citation omitted); see also Rider v. Sandoz Pharms. Corp., 295
F.3d 1194, 1198 (11th Cir. 2002) (“It is well-settled that while epidemiological
studies may be powerful evidence of causation, the lack thereof is not fatal to a
plaintiff’s case.”).
Here, Dr. Golan’s general causation testimony is sufficiently reliable
under Daubert to warrant admission at trial. As discussed above, epidemiological
studies are strong evidence of causation, and Dr. Golan’s opinion is based on at
least two such studies. First, Dr. Golan references P.D. McGovern et al., Forced-
Air Warming and Ultra-Clean Ventilation Do Not Mix, 93-B J. Bone & Joint
Surgery 1537 (2011) (“McGovern 2011”).6 See Dkt. 73-4 at 7 (referencing
McGovern 2011); Dkt. 73-5 (showing the McGovern 2011 study); Dkt. 79-3 at
175:15-176:19 (Dr. Golan testifying that he relied on many different studies,
including McGovern 2011). Following other federal courts, the Court finds that
McGovern 2011 is a sufficiently reliable study for Dr. Golan to base his general
causation opinion on. See e.g., Boncher v. 3M Co., No. 5:24-CV-01403-JMG, 2025
WL 511116, at *7 (E.D. Pa. Feb. 14, 2025) (finding the “limitations and potential
shortcomings in [McGovern 2011] do not make the study per se unreliable, as the
strength of the study goes to its weight, not admissibility”). Indeed, as the Eighth
Circuit In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., 9 F.4th
768 (8th Cir. 2021) already concluded, “it was not necessarily unreliable for the
6 McGovern 2011 was an observational epidemiological study that explored whether forced-air warming was
associated with an increased rate of PJIs by comparing a group of individuals warmed convectively to a group of
individuals warmed conductively. See Dkt. 73-5 at 1537. The study reviewed infection data from hip or knee
replacement surgeries performed at a single hospital for a 2.5-year period. Id. at 1537, 1540. During this period,
patients were warmed with Bair Huggers and then slowly transitioned to being warmed with conductive patient-
warming devices. Id. at 1540, 1543. The researchers found an association between the use of the Bair Hugger in
ORs and surgical site infections, but the study “[did] not establish a causal basis” for this increased risk. Id. at 1543.
The researchers also acknowledged other limitations, including the “infection control measures instituted by the
hospital” and being unable to fully examine patients’ medical histories for factors associated with PJIs. Id.
experts to rely on McGovern 2011 to draw an inference of causation just because
the study itself recognized . . . that the association did not establish causation. So
long as an expert does the work ‘to bridge the gap between association and
causation,’ a study disclaiming having proven causation may nevertheless support
such a conclusion.” 9 F.4th at 779–80 (quoting Federal Judicial Center, Reference
Manual on Scientific Evidence at 218 (3d ed. 2011)).
Second, Dr. Golan references S.H. Kim et al., Relationship Between Types
of Warming Devices and Surgical Site Infection in Patients Who Underwent
Posterior Fusion Surgery Based on National Data, 20 Neurospine 1328 (2023)
(“Kim 2023”). See Dkt. 73-4 at 7 (referencing Kim 2023); Dkt. 104-26 (showing
the Kim 2023 study). In Kim 2023, researchers in South Korea examined 5,406
patients in the Health Insurance and Review Assessment Service database who
underwent posterior lumbar fusion surgery during 2014, 2015, and 2017. Dkt. 104-
26 at 1328. The goal of the nationwide study was to examine the effects of
warming devices on surgical site infection rates during posterior fusion surgery. Id.
Kim 2023 found that “[c]ompared with those not treated with intraoperative
warming devices, those treated with forced air warming devices were 1.73-fold
more likely . . . to develop [surgical site infection] after adjusting for all
covariates.” Id. at 1331. Further, “an analysis of patients administered antibiotics
21 to 60 minutes before surgery showed that the risk of [surgical site infection]
was 5.17-fold . . . higher in patients treated with forced air than with no
intraoperative warming device.” Id. As such, the researchers concluded that “the
results of the present study showing that use of forced warming devices increases
[surgical site infection] rates are clinically meaningful[,]” and “devices using
[electric] conduction seemed to have more advantages in preventing [surgical site
infection] than forced air warming device[s].” Id. at 1334.
Critically, Defendants do not attack the reliability of Kim 2023; instead,
Defendants contend the study does not “fit” since the study did not examine ORIF
procedures and there is no evidence that the Bair Hugger was the warming device
used in South Korean hospitals. Dkt. 105 at 6. While Defendants are correct about
the limitations of Kim 2023 (examining posterior lumbar fusion surgery) to an
ORIF procedure,7 the argument does not undermine the reliability of Dr. Golan’s
overall general causation opinion, since Kim 2023 is one of several studies Dr.
Golan referenced in formulating his opinion that forced air warmers (like the Bair
Hugger) can be a potential source of surgical site infection. Indeed, the Court finds
Dr. Golan’s reliance on other medical studies beyond McGovern 2011 and Kim
2023 supports his general causation opinion that the uplifting of bacteria by the
Bair Hugger is generally capable of causing a hardware infection during an ORIF
7 Interestingly, Defendants’ “different surgery” argument also cuts the other way in Plaintiff’s favor. Kim 2023
provides empirical support that forced-air warmers may increase surgical site infection rates in a surgical procedure
different from a PJA. As such, Dr. Golan opining that the Bair Hugger can be “ruled in” as a possible infection
source in a different surgery from a PJA (i.e., an ORIF procedure) is not so large of an analytical jump as
Defendants claim.
procedure. As Dr. Golan made clear in his deposition, his causation opinions were
not based solely on McGovern 2011, but “on [a] multitude of references and
studies and not one particular study. . . . So my opinion is, based on all of those
studies together, and none of those studies by itself, is the sole support to my
opinion.” Dkt. 79-3 at 176:1-19.
These additional (non-epidemiological) studies include A.J. Legg, et. al., Do
Forced Air Patient-Warming Devices Disrupt Unidirectional Downward Airflow?,
94-B J. Bone & Joint Surgery 254 (2012), where the authors found a statistically
significant increase in particles measuring 5.0 μm in size over the surgical site
when forced-air warming was used (Dkt. 104-2 at 255–56); K.B. Dasari, et.
al., Effect of Forced-Air Warming on the Performance of Operating Theatre
Laminar Flow Ventilation, 67 Anaesthesia 244 (2012), where the researchers
investigated whether the floor-to-ceiling temperatures around a draped manikin in
a laminar-flow theatre differed when using three types of warming devices,
including the Bair Hugger, and found that forced-air warming “generates
convection current activity in the vicinity of the surgical site. . . . [and] these
currents may disrupt ventilation airflows intended to clear airborne contaminants
from the surgical site” (Dkt. 104-20 at 244, 248); A.M. Wood, et al., Infection
Control Hazards Associated with the Use of Forced-Air Warming in Operating
Theatres, 88 J. Hosp. Infection 132 (2014), where the authors concluded, after a
review of the literature, that forced-air warming “does contaminate ultra-clean air
ventilation,” though acknowledging that “current research” had not shown a
“definite link” between forced-air warming and surgical-site infections (Dkt. 83-21
at 132); V. Lange, Forced Air Contamination Risk in the OR, 73 Annals of
Medicine and Surgery 1 (2022), where the author conducted a retrospective-
research correlation on a previous 2018 study on forced air-warming
contamination and found that “[forced air warming] device-component
contamination is a real risk in the OR. . . . Based on the correlation between
pathogen and [surgical site infection] risk, it has been determined that infection
risk may be eliminated through the use of alternate patient-warming
technologies/techniques” (Dkt. 104-15 at 3); J.G. Brock-Utne, et al., Potential
Sources of Operating Room Air Contamination: A Preliminary Study, 113 J. of
Hosp. Infection 59 (2021), where the researchers specifically looked at two forced
air-warmers (Neptune Surgical Suction system and the Bair Hugger), observed
higher bacterial counts in the Bair Hugger outlet hose that blows air than in the
surrounding OR air, and concluded that “the [Bair Hugger] is likely a direct
contributor to an increased burden of airborne microbes in the OR” (Dkt. 104-16 at
61, 63); and Mark Albrecht, et al., Forced-Air Warming Blowers: An Evaluation of
Filtration Adequacy and Airborne Contamination Emissions in the Operating
Room, 39 Am. J. Infection Control 321 (2011), where the authors compared five
new Bair Hugger intake filters to 52 Bair Hugger filters currently in use at
hospitals and found “[f]ifty-eight percent of the [forced air-warming] blowers
evaluated were internally generating and emitting airborne contaminants, with
microorganisms detected on the internal air path surfaces of 92.3% of these
blowers[,]” including S. aureus (Dkt. 104-4 at 321).
Importantly, Defendants do not challenge the reliability of these studies,
some of which have been cited by Amando and another district court (involved in
Bair Hugger litigation) to support general causation under an airflow-disruption
and dirty-machine theory. See Amando, 9 F.4th at 781–87; Boncher, 2025 WL
511116, at *7–8. Instead, Defendants contend “Dr. Golan offers no scientific
support for what amounts to a series of analytical leaps” between the various
studies and an ORIF procedure. Dkt. 73 at 9. But, as the Court’s sampling of the
references show, Dr. Golan’s plausible mechanism (i.e., airflow-disruption theory
from Dr. Elghobashi) in explaining the association between the use of the Bair
Hugger in an OR and increased particle counts over the surgical site of an ORIF
surgery (which can be a source of infection) is based on reliable methodology that
draws causal inferences from associations identified in peer-reviewed scientific
literature and case studies.
As for the differences between ORIF and PJA surgery, Dr. Golan testified he
was confident the literature he relied on showed “that the Bair Hugger in Ms.
Robinson’s OR in May of 2021 was capable of doing the same thing that it does in
other cases involving a total joint arthroplasty[.]” Dkt. 79-3 at 153:17-23.
Specifically, Dr. Golan articulated that:
the operation of the Bair Hugger leads to contamination of the
operating room with particles, so that there is a much, much larger
number of particles in the operating room air. It interferes with the
different measures that we use in the operating room to reduce the
number of loading particles.
And we know that many of those particles are contaminated, and it
leads to landing of contaminated particles in the sterile field, whatever
the sterile field is -- whether it’s an exposed tibia or whether it's
exposed end of the tibia -- you have to understand knee replacement
surgery. It’s the tibia that's exposed.
The only other thing that's exposed is the femur, and here the tibia is
exposed. And in addition to that, there’s hardware that's exposed. And
it doesn’t matter at all whether the hardware has this shape or that
shape.
So from my perspective, all the information that I saw that relates to
the Bair Hugger contaminating the operating room was just as
applicable to tibia fractures as it is to prosthetic joint infection
surgery.
Id. at 154:2-155:2. As such, Dr. Golan concluded that the “infection risk” and
“what affects the infection risk” in both types of surgeries are “very similar.” Id. at
247:9-248:15.
Defendants, of course, strongly dispute Dr. Golan’s finding that the type of
hardware is not a significant factor in considering the infection risk. See Dkt. 105
at 2–4. Indeed, Defendants persuasively argue that the hardware in a PJA/total
joint arthroplasty—two large metal implants: a polyethylene spacer and a patella
implant—provides a large, non-vascularized surface for bacteria to adhere to when
it lands on the exposed surgical site. Id. at 3. Conversely, the hardware in Ms.
Robinson’s ORIF surgery consists of thinner plates and screws that are buried into
vascularized bone and surrounded by vascularized tissue, resulting in a less
exposed surface area that impacts the ability of bacteria to attach. Id. at 4.
Nevertheless, the Court admits Dr. Golan’s sufficiently reliable testimony since the
“traditional and appropriate means of attacking shaky but admissible evidence” is
for Defendants to present to the jury “contrary evidence” on the different infection
risks in PJA and ORIF procedure. Allison, 184 F.3d at 1311 (citing Daubert, 509
U.S. at 596).8
At bottom, this is not a case where the gap between the scientific studies and
the general causation opinion is “simply too great.” Hendrix, 609 F.3d 1203
(noting the expert “did not even attempt to provide any evidence to support a
general causal link between traumatic brain injury and [Autism Spectrum
8 Defendants also fault Dr. Golan for simply “agree[ing]” and “adopt[ing]” the conclusion of Dr. Jarvis concerning
the Bair Hugger causing periprosthetic joint infections. Dkt. 105 at 12. While Defendant is correct that “[e]xpert
opinions ordinarily cannot be based upon the opinion of others[,]” Am. Key Corp. v. Cole Nat. Corp., 762 F.2d 1569,
1580 (11th Cir. 1985), Dr. Golan’s general causation opinion is not simply a regurgitation of Dr. Jarvis’s findings.
Dr. Golan assessed the validity of Dr. Jarvis’s report by reviewing the cited materials in the Jarvis report and then
compiled his own report (based on empirical sources) to opine that airborne microbes caused a surgical site infection
following Ms. Robinson’s surgery. See Dkt. 79-3 at 132:15-133:15 (Dr. Golan testifying he received Dr. Jarvis’s
report and “reviewed the references used for the Jarvis report, because I wouldn’t take the Jarvis report just because
it’s the Jarvis report”); Schoen v. State Farm Fire & Cas. Co., 638 F. Supp. 3d 1339, 1349 (S.D. Ala. 2022) (“Rule
703 does not permit an expert to simply repeat or adopt the findings of another expert without attempting to assess
the validity of the opinions relied upon.” (citing La Gorce Palace Condo. Ass’n, Inc. v. Blackboard Specialty Ins.
Co., 586 F. Supp. 3d 1300, 1306 (S.D. Fla. 2022)).
Disorder]. He presented no medical literature, described no relevant physiological
process, and provided no other support for his conclusion that traumatic brain
injury can cause autism”). Although the Court is to serve as a gatekeeper to ensure
the requirements of qualification, reliability, and fit are met, “[t]he judge’s role is
to [also] see that the jury hears reliable and relevant evidence[.]” McDowell, 392
F.3d at 1299. Thus, Defendants’ concerns regarding the strength of the studies that
Plaintiff’s general causation experts relied on or the conclusions they have drawn
from them as applied in the ORIF context can be challenged on cross-examination
and with the presentation of contrary evidence during their case-in-chief. Plaintiff’s
general causation opinions are reliable and admissible under Rule 702.
ii. Motion to Exclude Plaintiff’s Specific Causation Expert
Next, Defendants move to exclude the specific causation opinion of Dr.
Yoav Golan. Dkt. 74 at 3. First, 3M contends that Dr. Golan’s specific causation
theory—that the Bair Hugger can cause airflow disruptions that moved
contaminated squames into Ms. Robinson’s surgical site, causing her infection—
should be excluded since Dr. Golan is unqualified to offer an opinion on airflow
disruption, his opinions are based on unreliable methods, and there is insufficient
facts and data to support his causation theory. Id. Second, Dr. Golan’s differential
diagnosis allegedly “fails to properly ‘rule in’ the Bair Hugger system (the source
he ultimately implicates)” and “rule out” other surgical site infection sources. Id.
The Court addresses each argument in turn.
Beginning with Dr. Golan’s qualifications, the Court finds Dr. Golan is
qualified to provide expert opinion on infectious diseases. Indeed, with over three
decades of education, training, and experience in the field of infectious diseases,
Dr. Golan is undoubtedly qualified to offer expert testimony on the most likely
cause of Ms. Robinson’s infection. See Dkt. 80-2 (showing Dr. Golan’s CV). As to
Defendants’ arguments that Dr. Golan is unqualified to give opinions on how the
Bair Hugger system disrupted the airflow in Ms. Robinson’s surgery, see Dkt. 74
at 8, the Court finds such an argument is without merit. Defendants confused the
distinction between an expert’s qualifications and the reliability of the proffered
opinion.
As discussed previously, “qualifications and reliability prongs
of Daubert are conceptually distinct inquiries” that cannot be collapsed into each
other. Moore, 995 F.3d at 853. In Moore, a district court erroneously found that a
medical doctor was not qualified to testify because he had not used “the Intuitive
robotic tools at issue and because he could not describe the differences between
those tools and the traditional laparoscopic instruments.” Id. The Eleventh Circuit,
however, reversed the district court since the doctor’s familiarity with the product
at issue goes to the reliability of the opinion, not the expert’s qualification. Id. at
858. Indeed, the medical doctor was “qualified to perform a differential etiology on
a patient who suffered a thermal injury during a hysterectomy performed with a da
Vinci robot[,] not because of his familiarity with the robot, but because of his
familiarity with differential etiologies in the context of gynecological procedures.”
Id. at 853.
Here, as in Moore, Dr. Golan is qualified as an expert to perform a
differential etiology on Ms. Robinson’s infection, not because of his familiarity
with the Bair Hugger and airflow disruption in an OR, but because of his
familiarity with the (infectious disease) analysis he was tasked with performing.
While Defendants are correct that Dr. Golan has repeatedly testified he is not
qualified to opine on OR airflow disruptions, see e.g., Dkt. 80-3 at 232:3-6
(testifying he is “definitely not an expert” in airflow, “but I understand the air flow
in the operating room to some extent”), this concession does not mean Dr. Golan
should be excluded from performing the “task at hand”—i.e., performing a
differential etiology on a patient who suffered a S. aureus infection following a
ORIF surgery. See Daubert, 509 U.S. at 597.
To complete this task within his expertise, Dr. Golan relied upon Ms.
Robinson’s medical records, medical literature, and the reasonable opinions of
other experts who are qualified to opine about airflow disruption (i.e., Dr.
Elghobashi) to determine that bacteria displaced by the Bair Hugger is a potential
cause of Plaintiff’s infection. See Dkt. 74-1 at 6, 7 (“Peer-reviewed publications
confirm that Bair Hugger generates an uplifting of air carrying particles that are
contaminated with microbes that are virulent and capable of causing hardware
infection” and referencing Dr. Elghobashi’s published report in X. He et al., Effect
of Heated-Air Blanket on the Dispersion of Squames in an Operating Room, 34
Int’l J. Numerical Methods Biomedical Eng’g, May 2018 at 1); see also Dkt. 80-3
at 130:22-133:15 (discussing Dr. Jarvis’s report and the references used to
determine whether the Bair Hugger could be a plausible cause of Plaintiff’s
infection). As discussed above in the general causation section of this Order, the
Court has already found Dr. Elghobashi’s report to be admissible, and Dr. Golan
could rely on other empirical sources when “ruling in” the Bair Hugger as a
potential source of infection. Defendants’ argument about Dr. Golan’s lack of
knowledge and expertise on OR airflow, including the Bair Hugger’s impact on
OR airflow, is a credibility dispute that should be decided “within the crucible of
cross-examination,” not by this Court at the Daubert stage. Moore, 995 F.3d at
857; see also Quiet Tech., 326 F.3d at 1342 (noting that shortcomings regarding
knowledge of the specific product at issue do not bear on an expert’s
qualifications).
Defendants, however, argue that even if Dr. Golan is qualified, his airflow
disruption opinions are “based on unreliable methods and insufficient facts and
data.” Dkt. 74 at 10. Specifically, Defendants fault Dr. Golan for failing to take
“meticulous care to track and account for [the OR design, layout, and sources of air
turbulence] in Robinson’s May 2021 surgery[,]” not being an orthopedic surgeon,
and having “little understanding of the different devices that are used in any given
orthopedic procedure, let alone what happens in an OR during such procedures.”
Dkt. 74 at 12. But such an argument sets an evidentiary burden that is much “too
high.” Moore, 995 F.3d at 854. Rule 702 does not require Dr. Golan to be a
surgeon who has used the Bair Hugger in ORIF surgeries in order to provide a
differential etiology of Ms. Robinson’s infection. Indeed, the Eleventh Circuit has
already rejected Defendants’ way of reasoning since it would seemingly “bar all
expert medical testimony unless the expert has somehow recreated the same
conditions that the [patient] was under[,] . . . [and] Rule 702 does not impose such
a requirement.” Adams, 760 F.3d at 1335–36; see also Moore, 995 F.3d at 854
(“Our caselaw does not support a bright line rule that an expert witness is qualified
to testify regarding the cause of an injury only if he personally has used the
allegedly defective product.”).
Additionally, the list of airflow disruption sources that Dr. Golan failed to
consider in his report—Brandon Hospital’s OR and HVAC schematics, Brandon
Hospital’s protocols on sterility or infection control, the deposition transcripts of
Dr. Shah and Dr. Kim, the drape and fluoroscopy (x-ray machine) used in Ms.
Robinson’s surgery, and 3M’s expert reports (Dkt. 74 at 13)—“are of a character
that impugn the accuracy of [Dr. Golan’s] results, not the general scientific validity
of [differential etiology].” Quiet Tech, 326 F.3d 1345. Defendants’ “identification
of such flaws in generally reliable scientific evidence is precisely the role of cross-
examination.” Id. Dr. Golan’s alleged failure to consider these other variables of
airflow disruption during surgery is an argument that goes to the weight, not the
admissibility, of the evidence offered. Id. at 1345–46 (“Normally, failure to include
variables will affect the analysis’ probativeness, not its admissibility.” (quoting
Bazemore v. Friday, 478 U.S. 385, 400 (1986)) (citation modified)).
Next, Defendants challenge the reliability of Dr. Golan’s differential
diagnosis itself, as it allegedly “fails to apply reliable principles and methods to
‘rule in’ the Bair Hugger system as the source of Robinson’s S. aureus infection[,]
[and] he fails to ‘rule out’ endogenous sources of S. aureus as the cause of her
infection.” Dkt. 74 at 15. The Court disagrees.
“If properly followed, differential diagnosis can be a reliable methodology
under Daubert.” Arevalo v. Mentor Worldwide LLC, No. 21-11768, 2022 WL
16753646, at *4 (11th Cir. Nov. 8, 2022) (citing Chapman, 766 F.3d at 1309).
Differential diagnosis methodology is “a medical process of elimination whereby
the possible causes of a condition are considered and ruled out one-by-one, leaving
only one cause remaining.” Chapman, 766 F.3d at 1308 (quotation marks and
citation omitted). The methodology requires three steps: “(1) the patient’s
condition is diagnosed, (2) all potential causes of the ailment are considered, and
(3) differential etiology is determined by systematically eliminating the possible
causes.” Id. (citation omitted). To be reliable, the expert’s differential diagnosis
“need not rule out all possible alternative causes” but “must at least consider other
factors that could have been the sole cause of the plaintiff’s injury.” Id. at 1308–09
(quotation marks and citation omitted). Indeed, “an expert does not establish the
reliability of his techniques or the validity of his conclusions simply by claiming
that he performed a differential diagnosis on a patient.” McClain, 401 F.3d at 1253.
“[A] differential diagnosis that fails to take serious account of other potential
causes may be so lacking that it cannot provide a reliable basis for an opinion on
causation.” Guinn, 602 F.3d at 1253 (quotation marks and citation omitted).
As an initial matter, Defendants’ arguments about Dr. Golan failing to
reliably “rule in” the Bair Hugger as a potential source of infection are a rehashing
of Defendants’ general causation motion. See Dkt. 73 at 8; Dkt. 74 at 15; see
Thelen, 2023 WL 3947945, at *3 (“General causation addresses how the possible
causes are ‘ruled in’ in the first place, and cannot be established by differential
diagnosis.”). The Court has already previously discussed at length why Dr.
Elghobashi and Dr. Golan’s general causation opinions properly “ruled in” the Bair
Hugger as a potential source of surgical site infection.
Turning to Defendants’ argument on whether Dr. Golan properly “ruled out”
endogenous sources of S. aureus as the cause of Ms. Robinson’s infection, the
Court finds Dr. Golan has shown he “at least consider[ed] other factors that could
have been the sole cause of the plaintiff’s injury.” Chapman, 766 F.3d at 1309. Dr.
Golan does not merely declare his specific causation opinion ipse dixit without
citing other relevant medical information that establishes a causal connection
between the Bair Hugger device and Plaintiff’s infection during ORIF surgery. See
generally Dkt. 80-1. Defendants, however, articulate three “obvious” alternative
sources of Ms. Robinson’s S. aureus infection that Dr. Golan allegedly failed to
consider: the presence of S. aureus on Ms. Robinson’s skin during surgery, a post-
surgery infection, and a breach of infection control measures during surgery. Dkt.
74 at 17–20. The Court disagrees. A review of Dr. Golan’s report and deposition
demonstrates that he adequately considered these alternative sources before ruling
them out.
First, a review of Dr. Golan’s expert report demonstrates that he
acknowledged Ms. Robinson’s skin flora (during surgery) as a possible source of
infection and then properly ruled it out:
Because S. aureus, CNS, Corynebacterium and Propionibacterium are
commonly found on humans’ skin, they are common pathogens in
hardware infections. Each of these and other infecting pathogens can
arise from an endogenous or exogenous source. Endogenous sources
include the patients’ own flora- from their skin, mucous membranes,
gastrointestinal tract, or seeding from a distant focus of infection via a
bloodstream infection. In the case of hardware infection development,
endogenous causes are implicated when the surgical site never heals
and becomes infected immediately after surgery, usually due to
problems with wound healing or the development of a bloodstream
infection with secondary seeding of the hardware. . . .
In support of the development of a bone hardware infection that is the
result of contamination of the surgical field during surgery and to
decipher whether any intra-surgery factor may be responsible for such
contamination, the following questions need to be considered: . . . b)
Was the hardware infection acquired during surgery or after surgery? .
. .
Ms. Robinson underwent her first right knee surgery on 5/6/21. Prior
to the surgery, there were no local or systemic signs of infection and
there were no violations to the skin’s integrity. During the surgery, the
tissues appeared non-inflamed with no signs of infection, supporting a
decision to proceed and place a plate and screws to repair the fracture.
. . .
b) Was Ms. Robinson’s hardware infection acquired before the 5/6/21
surgery, during the 5/6/21 surgery or was it acquired after that
surgery? At the time of her 5/6/21 surgery, there were no signs of
infection and none of her care providers suspected an infection. Intra-
operative findings on 5/6/21 were inconsistent with an existing
infection at that time. It is therefore unlikely that Ms. Robinson was
already infected on 5/6/21. After the 5/6/21 surgery, up to a few days
before Ms. Robinson’s 6/16/21 follow up visit, Ms. Robinson’s
surgical wound was healing well with no documentation of wound
dehiscence or drainage. . . . Therefore, it is highly likely that Ms.
Robinson’s infection was acquired during the 5/6/21 surgery.
Dkt. 80-1 at 4–6; see also Dkt. 80-3 at 186:9-192:3 (Dr. Golan discussing
endogenous flora and concluding Ms. Robinson’s endogenous flora “is a very
unlikely cause” of her infection). Defendant, however, contends that Dr. Golan
could only rule out an “endogenous/direct-contact source” by quantifying that risk
and weighing it against the risk from airborne sources. Dkt. 74 at 17. Dr. Golan’s
failure to conduct a “quantitative assessment” of the Bair Hugger’s risk compared
to other risks in the OR does not mean his differential etiology is unreliable;
instead, it means Dr. Golan’s opinion has inadequacies that should be brought up
during cross-examination. See Quiet Tech, 326 F.3d at 1345–46. Based on the
record, the Court cannot conclude that the elimination of Ms. Robinson’s flora as a
potential cause of her infection was based on “subjective beliefs or unsupported
speculation.” Chapman, 766 F.3d at 1310 (quoting Hendrix, 609 F.3d at 1197).
Second, Dr. Golan sufficiently ruled out post-surgery inoculation from Ms.
Robinson’s skin as a source of her infection. Defendants point out that Dr. Golan
admitted that Ms. Robinson’s post-surgery wound dehiscence could have provided
a pathway for deep infection, see Dkt. 74 at 19, but Dr. Golan’s admission is taken
out of context. In Dr. Golan’s report, he fully considers Ms. Robinson’s wound
dehiscence and ruled it out as a possible cause of infection, explaining:
After the 5/6/21 surgery, up to a few days before Ms. Robinson’s
6/16/21 follow up visit, Ms. Robinson’s surgical wound was healing
well with no documentation of wound dehiscence or drainage. During
this critical period of time post-surgery, there was no potential portal
of entry of bacterial pathogens into the wound. A few days later, on
7/1/21, when Ms. Robinson underwent surgery to explore the deep
tissues, bone, and hardware, there was clear evidence of deep
infection affecting the hardware and the bone. The development of
clinical signs of bone involvement, such that can be identified by a
surgeon during surgery, requires a minimal period of 3-4 weeks to
develop. In Ms. Robinson’s case, the first signs of wound dehiscence
were observed approximately two weeks prior to the 7/1/21 surgery
and not earlier. This leading time of 2 weeks would be insufficiently
short to allow the development of clinical signs of infection in the
bone and hardware. In addition, other intra-operative findings such as
the existence of extensive fibrinous tissue is consistent with an
established infection that would have taken longer than 2 weeks to
develop. Furthermore, even when wound dehiscence was observed,
Ms. Robinson’s care providers did not express any concern regarding
a deep wound, such that can lead to the bone and hardware, or the
existence of a deep tissue infection. While the wound dehiscence
could have served as a contributing factor to the earlier diagnosis of
hardware and bone infection, in my opinion, for the reasons
mentioned above, it is unlikely that the wound dehiscence caused the
infection of hardware and bone. Therefore, it is highly likely that Ms.
Robinson’s infection was acquired during the 5/6/21 surgery.
Dkt. 80-1 at 5–6. On the topic of post-surgery infection, Dr. Golan’s deposition
further articulated that:
Q. [D]id you rule in any of Ms. Robinson’s comorbid conditions as
potential risk factors for her to develop an infection as part of your
differential diagnosis?
A. I looked at all her information. I considered any of her risk factors
as factors that may increase her risk of infection in general. And in my
differential diagnosis, I focused on the translocation of bacteria into
the sterile site and whether it happened before, during and after
surgery, because this is the question in hand.
Q. Did you rule out the possibility that the bacteria that caused Ms.
Robinson's infection got into the joint after her surgery?
A. To a -- an extent of high likelihood, I did.
Q. And how did you do that?
A. I looked at her wound healing, particularly her immediate wound
healing, as reflected in the medical chart, to make sure that there were
no issues with the wound healing, particularly not over the first week
or two, that there were no dehiscence during this period of time; that
there were no -- no drainage during this period of time. During this
period of time, it takes time for the deeper tissues to seal from the
outside world. And during this period of time, if the wound wouldn't
heal, bacteria could have penetrated the wound from the outside. I
also looked at the way she developed her infection. I also looked at
the operative report and what they actually observed during surgery in
terms of the infected tissues and where was most of the infection. It
was deeply within the deep tissues. And when I looked at all of this
information and the totality of data, it appeared like the likelihood that
she developed the infection after surgery is very low.
Dkt. 80-3 at 211:23-213:13.
But Dr. Golan’s differential diagnosis did not stop there. Contrary to
Defendants’ assertion that Dr. Golan “ignore[d] Robinson’s multiple risk factors
for delayed wound healing” that could have “extended the opportunity for wound
inoculation” post-surgery, see Dkt. 74 at 19, Dr. Golan’s deposition shows he
considered Ms. Robinson’s post-surgery “noncompliance with physician orders,”
including her “weight bearing [as] a risk factor for wound non-healing,” but
dismissed it as a cause of her infection “because her weight bearing did not lead to
wound-healing issues, particularly not during the first two or three weeks after
surgery, [so Dr. Golan] didn’t consider the wound non-healing to be an important
or likely factor contributing to infection in her case.” Dkt. 80-3 at 214:20-218:10
(showing Dr. Golan being questioned on Ms. Robinson’s weight bearing as a risk
factor for infection and concluding “for weight bearing to serve as a risk factor for
infection is through wound dehiscence and wound non-healing [which] happens
early. And this hasn’t happened in this case”); see also id. at 203:13-211:2 (Dr.
Golan also considering Ms. Robinson’s smoking and malnutrition as risk factors
for infection). Again, Dr. Golan properly ruled out a post-surgery infection based
on relevant medical information and his expertise as an infectious disease expert.
Third, Dr. Golan addressed a possible breach of infection control measures
during surgery and explained why it was excluded as a potential source of
infection. As described in his expert report, Dr. Golan opined that:
During the 5/6/21 surgery, [were] there any factors that are known to
increase the risk of intra-surgery contamination? A careful review of
all medical records revealed no evidence of a breach of any of the
infection control measures which are practiced in the operating room
during surgery to prevent hardware infections. Specifically, there was
no prolonged pre-surgery hospital stay, the surgery was not
complicated, there were no documented problems with the sterility of
instruments or solutions which were used during surgery, and there
was no documented breach of sterile technique by the surgeons and
those present at surgery.
Dkt. 80-1 at 6.9 In the absence of any evidence of a breach of sterile treatment of
instruments and hardware, there is sufficient evidence to support Dr. Golan’s
opinion that the hardware was the likely source of the S. aureus infection after
being contaminated by bacteria blown by the Bair Hugger. Defendants’ argument
that “infection prevention measures” at the hospital only “reduce the risk of
infection, [but] they do not eliminate it” is an issue that can be raised at trial, not at
the Daubert stage. Dkt. 74 at 19.
9 Additionally, Dr. Kim and Dr. Shah both testified that neither doctor recalled a breach of sterility protocol, and if
there were a breach during Ms. Robinson’s surgery, they would have documented it in a report. See Dkt. 83-34 at
95:3-12; Dkt. 83-38 at 149:5-19.
In sum, Dr. Golan’s differential diagnosis sufficiently enumerates a
comprehensive list of alternative causes and then systematically eliminates those
potential causes. See Guinn, 602 F.3d at 1254. The Court finds Dr. Golan offered a
sufficient explanation as to why his specific causation opinion—that Ms.
Robinson’s infection was acquired during her ORIF surgery, and that the Bair
Hugger was the most likely cause of this infection—is reliable under Rule 702.
II. Defendants’ Motion for Summary Judgment
In addition to the motions to exclude, Defendants bring a motion for
summary judgment on all of Plaintiff’s claims. Defendants argue that “[a]part from
causation, many of Robinson’s claims (including gross negligence, failure-to-warn,
implied warranty, violation of [FDUTPA], misleading advertising, unjust
enrichment, and punitive damages) fail for additional reasons.” Dkt. 76 at 2.
Plaintiff responds, contending she has “proffered sufficient evidence to create a
genuine issue of material fact in favor of negligence (Count I), gross negligence
(Count II), failure to warn (Count III), defective design (Count IV) and misleading
advertising (Count VII), as well as her prayer for punitive damages.” Dkt. 81 at
4.10
10 As for the other counts not listed, Plaintiff states that “Ms. Robinson does not intend to pursue her claims for
unjust enrichment, violation of FDUTPA, and breach of implied warranty at trial and therefore does not respond to
Defendants’ arguments on these claims.” Dkt. 81 at 4 n.2. As such, the Court grants Defendants’ motion for
summary judgment as to Counts V, VI, and VIII.
a. Legal Standard
Summary judgment is only appropriate when there is “no genuine issue as to
any material fact [such] that the moving party is entitled to a judgment as a matter
of law.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Fed R. Civ. P. 56(a).
An issue of fact is “material” if it might affect the outcome of the case under the
governing law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). It is
“genuine” if the evidence could lead a reasonable jury to find for the non-moving
party. See id.; see also Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S.
574, 587 (1986).
The moving party has the burden of proving the absence of a genuine issue
of material fact, and all factual inferences are drawn in favor of the non-moving
party. See Allen v. Tyson Foods Inc., 121 F.3d 642, 646 (11th Cir. 1997);
Pennington v. City of Huntsville, 261 F.3d 1262, 1265 (11th Cir. 2001) (noting a
court must “review the facts and all reasonable inferences in the light most
favorable to the non-moving party”). Once the moving party satisfies its initial
burden, it shifts to the non-moving party to come forward with evidence showing a
genuine issue of material fact that precludes summary judgment. Bailey v. Allgas,
Inc., 284 F.3d 1237, 1243 (11th Cir. 2002); Celotex, 477 U.S. at 324; Fed. R. Civ.
P. 56(e), (c). Speculation or conjecture cannot create a genuine issue of material
fact. Cordoba v. Dillard’s, Inc., 419 F.3d 1169, 1181 (11th Cir. 2005).
The court may not weigh evidence to resolve a factual dispute; if a genuine
issue of material fact is present, the court must deny summary
judgment. Hutcherson v. Progressive Corp., 984 F.2d 1152, 1155 (11th Cir. 1993).
Likewise, the court should deny summary judgment if reasonable minds could
differ on the inferences arising from undisputed facts. Miranda v. B & B Cash
Grocery Store, Inc., 975 F.2d 1518, 1534 (11th Cir. 1992).
Importantly, a district court is only required to consider “the cited materials”
when deciding a summary judgment motion, Fed. R. Civ. P. 56(c)(3), and
“[m]aking district courts dig through volumes of documents and transcripts would
shift the burden of sifting from petitioners to the courts . . . [D]istrict court judges
are not required to ferret out delectable facts buried in a massive record.” Chavez v.
Sec’y Fla. Dep’t of Corr., 647 F.3d 1057, 1061 (11th Cir. 2011). “[T]here is no
burden upon the district court to distill every potential argument that could be
made based on the materials before it on summary judgment. Rather, the onus is
upon the parties to formulate arguments; grounds alleged in the complaint but not
relied upon in summary judgment are deemed abandoned.” Solutia, Inc. v.
McWane, Inc., 672 F.3d 1230, 1239 (11th Cir. 2012) (per curiam) (citing Resol. Tr.
Corp. v. Dunmar Corp., 43 F.3d 587, 599 (11th Cir. 1995) (en banc)).
b. Discussion
Defendants moves for summary judgment on several grounds, arguing all of
Ms. Robinson’s claims fail because she lacks admissible evidence of causation
(Counts I–VIII); Florida does not recognize a stand-alone cause of action for gross
negligence (Count II); Ms. Robinson’s failure-to-warn claim fails for lack of a duty
to warn and lack of causation (Count III); Ms. Robinson’s misleading advertising
claim fails because Fla. Stat. § 817.41 does not apply to personal injury cases in
the absence of a direct transaction between the parties (Count VII); and Plaintiff’s
prayer for punitive damages fails. Dkt. 76 at 9, 11, 16, 21. The Court will address
each argument in turn.
i. General and Specific Causation
To prove causation under Florida law, which applies to Ms. Robinson’s tort
claims,11 the plaintiff must introduce evidence that “it is more likely than not that
the conduct of the defendant was a substantial factor in bringing about the result.”
Guinn, 602 F.3d at 1256 (quoting Gooding v. Univ. Hosp. Bldg., Inc., 445 So. 2d
1015, 1018 (Fla. 1984)). To avoid summary judgment in this products liability
case, Ms. Robinson must have “Daubert-qualified, general and specific-causation-
11 In diversity cases, federal courts apply the substantive law of the state in which the case arose—here, Florida law.
Pendergast v. Sprint Nextel Corp., 592 F.3d 1119, 1132–33 (11th Cir. 2010).
expert testimony that would be admissible at trial.” Chapman, 766 F.3d at 1316;
see also Shepard v. Barnard, 949 So. 2d 232, 233 (Fla. 5th DCA 2007) (approving
trial court’s grant of summary judgment against plaintiff after excluding plaintiff's
medical experts’ testimony, because the doctors were needed “to provide opinions
regarding any causal link between the alleged injury and the medical treatment”).
Here, for the reasons discussed above, and in light of the Court’s decision to
deny Defendants’ motions to exclude Plaintiff’s general and specific causation
experts, the Court finds there is sufficient evidence of the required element of
causation for a reasonable juror to find in Plaintiff’s favor on her tort claims. As
such, the Court rejects Defendants’ causation arguments as to all counts.
ii. Gross Negligence (Count II)
Defendants argue that Florida law does not allow for a “stand-alone” cause
of action for gross negligence. Dkt. 76 at 11. Plaintiff appears to concede that her
stand-alone gross negligence claim may not be a permitted cause of action under
Florida law, but still asserts that Florida jurisprudence acknowledges it as a distinct
claim. Dkt. 81 at 10 n.5 (“Plaintiff acknowledges that some courts, primarily in the
Northern District of Florida, have held that gross negligence is not a stand-alone
claim.”).
Interestingly, Plaintiff fails to cite a single Florida Supreme Court or Florida
District Court of Appeal case that demonstrates gross negligence can be pled as a
standalone count. Conversely, there is ample case law indicating that gross
negligence is not a standalone count, but rather a legal standard that must be met
when seeking punitive damages under Fla. Stat. § 768.72(2). See Geery v. Ethicon,
Inc., No. 6:20-CV-1975-RBD-LRH, 2021 WL 2580167, at *3 (M.D. Fla. Apr. 20,
2021) (granting summary judgment to the Defendant on a gross negligence claim
in light of the parties’ agreement that gross negligence “is not a standalone cause
of action under Florida law” and noting that “[t]his does not preclude Plaintiff from
seeking punitive damages in her surviving claims under the gross negligence
standard”); Hughes-Payne v. Argon Med. Devices, Inc., No. 3:22-CV-1944-TKW-
ZCB, 2022 WL 19408078, at *2 (N.D. Fla. July 29, 2022) (“[The plaintiff] should
also consider whether it is necessary or proper to plead ‘gross negligence’ as
a separate stand-alone count.”); Smith v. Ethicon, Inc., No. 4:20-CV-394-
MW/MAF, 2020 WL 9071685, at *3 (N.D. Fla. Dec. 28, 2020) (“[G]ross
negligence is a heightened standard of proof to receive punitive damages under
Florida law and not a stand-alone claim.”); Duff v. Racine, --- So.3d ----, 2025 WL
1646730, at *2, 4 (Fla. 4th DCA June 11, 2025) (reversing trial court order
granting the plaintiff’s motion for leave to assert a punitive damages claim since
the trial court failed to determine if there was sufficient showing of gross
negligence); Cleveland Clinic Fla. Health Sys. Nonprofit Corp. v. Oriolo, 357 So.
3d 703, 706 (Fla. 4th DCA 2023) (noting a claim for punitive damages can only be
brought when the proffered evidence meets a gross negligence standard under Fla.
Stat. § 768.72(2)); Brady v. SCI Funeral Servs. of Fla., Inc., 948 So. 2d 976, 978–
79 (Fla. 1st DCA 2007) (declining to require the plaintiffs to plead a gross
negligence count separate from their ordinary negligence count).
As such, the Court enters summary judgment for Defendants on Count II.
However, this does not preclude Plaintiff from seeking punitive damages in her
surviving claims under the gross negligence standard of Fla. Stat. § 768.72(2)(b).
iii. Failure-to-Warn (Count III)
Defendants contend that Plaintiff’s failure-to-warn claim fails since Ms.
Robinson “cannot establish that 3M owed a duty to warn of an increased risk of
surgical site infections with the Bair Hugger system; and [] because Robinson has
no evidence that any purported failure to warn by 3M caused her injuries.” Dkt. 76
at 16.
To succeed on a failure-to-warn claim, the “plaintiff must show (1) that the
product warning was inadequate; (2) that the inadequacy proximately caused her
injury; and (3) that she in fact suffered an injury from using the product.” Salinero
v. Johnson & Johnson, 995 F.3d 959, 964 (11th Cir. 2021) (first citing Eghnayem
v. Bos. Sci. Corp., 873 F.3d 1304, 1321 (11th Cir. 2017), then citing Hoffmann-La
Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla. 1st DCA 2009)).
However, in cases involving medical products like the Bair Hugger, “the
duty of a device manufacturer to warn of dangers involved in the use of a device is
satisfied if it gives adequate warning to the physician who prescribes the device.”
Salinero, 995 F.3d at 965 (citing Buckner v. Allergan Pharms., Inc., 400 So. 2d
820, 823 (Fla. 5th DCA 1981) (alterations accepted)); see also Eghnayem, 873
F.3d at 1321. “The physician acts as a ‘learned intermediary’ between the
manufacturer and the patient, ‘weighing the potential benefits of a device against
the dangers in deciding whether to recommend it to meet the patient’s needs.’”
Salinero, 995 F.3d at 965 (quoting Eghnayem, 873 F.3d at 1321). As such, to meet
the causation element in a medical device failure-to-warn claim, “a plaintiff must
show that her treating physician would not have used the product had adequate
warnings been provided.” Id. Moreover, “[t]he causal chain may still be broken
even if the manufacturer provides an inadequate warning so long as the physician
is aware of the risks or would still recommend the device despite those risks.” Id.
Here, Defendants argue they had no duty to warn because there were no
risks known to them from the scientific and medical data available at the time of
Plaintiff's surgery. Dkt. 76 at 12. To support this argument, Defendants point to a
2017 “Safety Alert” from the FDA that reminded “health care providers that using
thermoregulation devices during surgery, including forced air thermoregulating
systems, ha[s] been demonstrated to result in less bleeding, faster recovery times,
and decreased risk of infection for patients.” Dkt. 83-37 at 1 (showing FDA Safety
Alert); see Dkt. 76 at 12.
However, Plaintiff points to various types of rebuttal evidence in support of
her argument that 3M knew (or should have known) of the risk of infections from
the use of the Bair Hugger. First, as discussed above, some of the scientific studies
Plaintiff’s experts relied on in reaching their general causation opinions were
published before Plaintiff’s 2021 ORIF surgery and identified an association
between the use of the Bair Hugger and an increased risk of airborne
contamination. See e.g., Dkt. 73-5 at 1537 (showing the McGovern 2011 study).
Second, Plaintiff has provided a sworn filing submitted to the FDA in January
1996 where 3M admitted that “[a]irborne contamination from air blown intra-
operatively across the surgical wound may result in airborne contamination.” S-
Dkt. 82-1 at 3. Third, Defendants’ own Clinical Research Director acknowledged
in 2010 that “[a]ctually, there is evidence that [forced-air warming] increases risk”
of surgical site infections. S-Dkt. 82-4 at 2. Lastly, Plaintiff has provided evidence
that Defendants included warning labels on the original Bair Hugger model, which
warned of the possibility of airborne contamination and against the use of the
machine in an OR. Dkt. 104-29 at 3–5. Construing the facts in the light most
favorable to Plaintiff, the Court finds a reasonable jury could conclude Defendants
had knowledge of the risk of surgical site infection from use of the Bair Hugger.
Nevertheless, Defendant argues that even if Plaintiff is correct about an
inadequate warning, Dr. Kim’s testimony severs the causal chain since he stated
that he would not have changed his decision to use the Bair Hugger system during
Ms. Robinson’s May 2021 surgery and would even use the Bair Hugger again if he
had to redo Ms. Robinson’s surgery. Dkt. 76 at 15; see Dkt. 83-34 at 82:18-84:21,
119:24-120:5. The Court disagrees. Setting aside the fact that Dr. Shah indicated
he had ultimate decision-making authority as the surgeon, Dkt. 83-38 at 152:24-
153:3, it is undisputed that Dr. Kim (and the anesthesiology department) never
received any warning from 3M regarding the Bair Hugger. Dkt. 83-34 at 96:10-13
(“But at this point, there was -- there has been no warnings about using the Bair
Hugger as a warming device to prevent infection, so that’s not one of the
guidelines that’s been proposed by our department.”); id. at 98:16-19 (“When was
the last time that you looked at the instructions to see if there were any warnings or
contraindications related to the use of the Bair Hugger? Well, I can’t say I
remember any of those times.”). Indeed, the deposition questions directed at Dr.
Kim primarily focused on what he would do if 3M provided a hypothetical
warning to him about the risks associated with the Bair Hugger. See e.g., id. at
95:25-96:4, 98:20-22. As such, the Court cannot even apply the learned
intermediary doctrine to determine if the warning was adequate because there was
no warning to the physicians in this case.
Nor is this a case where, even if 3M provided an inadequate warning, the
causal chain is still broken because the physician was actually aware of the risks or
would continue using the Bair Hugger despite those risks. See Small v. Amgen,
Inc., 723 F. App’x 722, 725 (11th Cir. 2018) (explaining that the learned
intermediary doctrine applies, “regardless of the sufficiency of the warning, where
a learned intermediary has actual knowledge of the substance of the alleged
warning and would have taken the same course of action even with the information
the plaintiff contends should have been provided” to the physician (emphasis
added) (citation and quotations omitted)). Dr. Kim’s testimony forecloses any
argument that he had actual knowledge of any alleged risks with the Bair Hugger,
see Dkt. 83-34 at 72:6-75:7 (Dr. Kim testifying he is unaware of the alleged risks
with the Bair Hugger and surgical site infections), and affirms he would no longer
use the Bair Hugger if warned by 3M about alleged risks. Id. at 99:1-5 (“If 3M had
warned you that the Bair Hugger was contraindicated in orthopedic procedures,
you would no longer use it for orthopedic procedures. Would you agree with that?
Yes, correct. Yes.”); see also id. at 95:25-96:14, 100:16-25. Dr. Shah also testified
that he was not aware of the risks associated with the Bair Hugger and would have
stopped using it in orthopedic surgeries if he had been warned by 3M. See Dkt. 83-
38 at 155:7-156:18. Thus, the Court finds Plaintiff has demonstrated a genuine
dispute of material fact over her failure-to-warn claim. Defendants’ motion for
summary judgment as to Count III is denied.
iv. Misleading Advertising Claim (Count VII)
Florida law prohibits any person from making or disseminating before the
general public of the State any misleading advertisement. See Fla. Stat. §
817.41(1). A “misleading advertisement” is defined by statute as:
[A]ny statements made, or disseminated, in oral, written, electronic, or
printed form or otherwise, to or before the public, or any portion
thereof, which are known, or through the exercise of reasonable care
or investigation could or might have been ascertained, to be untrue or
misleading, and which are or were so made or disseminated with the
intent or purpose, either directly or indirectly, of selling or disposing
of real or personal property, services of any nature whatever,
professional or otherwise, or to induce the public to enter into any
obligation relating to such property or services.
Fla. Stat. § 817.40(5). To prove a misleading advertising claim, a plaintiff must
show that: “(1) the representor made a misrepresentation of a material fact; (2) the
representor knew or should have known of the falsity of the statement; (3) the
representor intended that the representation would induce another to rely and act
on it; and (4) the plaintiff suffered injury in justifiable reliance on the
representation.” Akai Custom Guns, LLC v. KKM Precision, Inc., 707 F. Supp. 3d
1273, 1286 (S.D. Fla. 2023) (citing Vance v. Indian Hammock Hunt & Riding
Club, 403 So. 2d 1367, 1370-72 (Fla. 4th DCA 1981)).
Additionally, when the plaintiff is a consumer, there must be “direct
reliance” on the misrepresentation. See Westgate Resorts, Ltd. v. Reed Hein &
Associates, LLC, No. 6:18-CV-1088-ORL-31DCI, 2018 WL 5279156, at *8 (M.D.
Fla. Oct. 24, 2018); Serv. Experts LLC v. Am. Serv. Experts, LLC, No. 5:23-CV-
199-GAP-PRL, 2023 WL 11257417, at *3 (M.D. Fla. Oct. 30, 2023) (citing Third
Party Verification, Inc. v. Signaturelink, Inc., 492 F. Supp. 2d 1314, 1322 (M.D.
Fla. 2007)); see also Joseph v. Liberty Nat’l Bank, 873 So. 2d 384, 388 (Fla. 5th
DCA 2004) (“[T]he adoption of section 817.41(1) requires one seeking to maintain
a civil action for violation of the statute to prove each of the elements of common
law fraud in the inducement, including reliance and detriment, in order to recover
damages.”).
Here, the parties dispute whether Section 817.41 even applies to personal
injury claims. See Dkt. 76 at 16; Dkt. 81 at 16. To resolve this motion for summary
judgment, the Court assumes (without holding) that Plaintiff can bring a
misleading advertising claim and that she engaged in a “commercial transaction”
with 3M. See Brown v. Oceania Cruises, Inc., No. 17-22645-CIV, 2017 WL
10379580, at *7 (S.D. Fla. Nov. 20, 2017) (rejecting the defendant’s argument that
a misleading advertising claim under Section 817.14 cannot be brought in personal
injury cases since the plaintiff’s purchase of the defendant’s cruise ticket was a
“commercial transaction”). Nevertheless, the Court grants summary judgment in
Defendants’ favor on Count VII since Plaintiff has not proven that 3M made any
misrepresentations or false statements in connection with an advertisement that
was intended to induce Ms. Robinson’s reliance and ultimate use of the Bair
Hugger in her ORIF surgery.
First, the record is unclear about which material statements are at issue. The
Amended Complaint alleges that “[t]he information distributed by Defendants to
the public, the medical community, and Plaintiff’s healthcare providers, including
reports, press releases, advertising campaigns, labeling materials, print
advertisements, and commercial media containing material representations was
false and misleading, and contained omissions and concealed facts about the
dangers of the use of the Bair Hugger device.” Dkt. 53 ¶ 156. But Plaintiff’s
response to the motion for summary judgment fails to point to any reports, press
releases, advertising campaigns, labeling materials, print advertisements, and
commercial media in the record that support this allegation. Instead, the only thing
Plaintiff cites is a single sealed exhibit to prove 3M misrepresented material facts,
see Dkt. 81 at 19 (citing Plaintiff’s exhibit 33), but Plaintiff’s exhibit 33 is a
confidential clinical trial protocol from 2007 by Defendant Arizant. See S-Dkt. 82-
2. The Court is unsure whether this (sealed) clinical trial protocol was even
disseminated to the general public, much less a study that Ms. Robinson (or her
treating physicians) relied on to use the Bair Hugger in her May 2021 surgery.
Second, even assuming the 2007 clinical trial protocol is an adequate
misrepresentation, Plaintiff has not shown she was injured acting in justifiable
reliance on that misrepresentation. There is no dispute that Ms. Robinson was not
involved in the decision to use the Bair Hugger during her May 2021 surgery and
was not aware that a Bair Hugger had been used until months later. Dkt. 75 ¶ 27;
Dkt. 83 ¶ 27. No reasonable jury could find that Ms. Robinson directly relied on
any misrepresentation to use the Bair Hugger in her surgery. Plaintiff’s confusing
citations to Dr. Golan’s expert report and deposition (without any page citations) to
prove Ms. Robinson’s reliance do not create a genuine dispute of material fact. See
Dkt. 81 at 19 (citing Plaintiff’s exhibits 34 and 37). As for Ms. Robinson’s
physicians (Dr. Kim and Dr. Shah), Plaintiff has pointed to no evidence in the
record that either of them relied on any misrepresentation from 3M in using the
Bair Hugger in the May 2021 surgery. Indeed, Plaintiff cannot show any reliance
since her failure-to-warn claim is premised on the allegation that no
statements/warnings from 3M (about the Bair Hugger’s risks) were ever made to
Dr. Shah or Dr. Kim.
Third, to the extent Plaintiff is bringing her theory of liability for misleading
advertising on a misrepresentation by omission (either to Ms. Robinson or her
physicians), Section 817.41 forecloses this argument. The statute explicitly
references “any statement” in defining and proscribing misleading advertising, but
there is no reference to a misrepresentation or false advertisement by omission.
Compare Fla. Stat. § 817.40(5) (“The phrase ‘misleading advertising’ includes any
statements made, or disseminated, in oral, written, electronic, or printed form . .
.”), with Fla Stat. § 634.436(1) (defining false advertising of insurance policies as
“[k]nowingly making, issuing, circulating, or causing to be made, issued, or
circulated, any estimate, illustration, circular, statement, sales presentation, [or]
omission . . .”). As another district court has already recognized:
[i]f the Florida Legislature had intended that liability for false
advertising under section 817.41 encompass misrepresentations by
omission, it could have so stated, as it has done in the context of false
advertising in the insurance industry. But it did not, and Plaintiffs
have not cited any case law for the proposition that false advertising
encompasses misrepresentations by omission under the applicable
Florida statute. Thus, any omission on SCI's website relating to KKM
barrels does not rise to the level of a misrepresentation of a material
fact for purposes of a misleading advertising claim.
Akai Custom Guns, 707 F. Supp. 3d at 1287–88. Because any alleged
representation by 3M did not induce Plaintiff’s reliance and use of the Bair Hugger
in her surgery, the Court grants summary judgment for Defendants on Count VII.
v. Punitive Damages
Finally, Defendants argue that Plaintiff has not shown that “3M acted with
evil motive or engaged in intentional, willful, wanton, or reckless conduct in
manufacturing the Bair Hugger system.” Dkt. 76 at 22. Plaintiff responds by
summarily stating, “[b]ecause Plaintiff proffered sufficient evidence to survive
summary judgment on gross negligence, Plaintiff survives summary judgment on
punitive damages.” Dkt. 81 at 20.
“A defendant may be held liable for punitive damages only if the trier of
fact, based on clear and convincing evidence, finds that the defendant was
personally guilty of intentional misconduct or gross negligence.” Fla. Stat. §
768.72(2). “Gross negligence” occurs when the defendant’s conduct is “so reckless
or wanting in care that it constituted a conscious disregard or indifference to the
life, safety, or rights of persons exposed to such conduct.” Id. § 768.72(2)(b). To
be “clear and convincing,” evidence “must be of such weight that it produces in the
mind of the trier of fact a firm belief or conviction, without hesitancy, as to the
truth of the allegations sought to be established.” Acevedo v. State, 787 So. 2d 127,
130 (Fla. 3d DCA 2001); Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA
1983). “To avoid summary judgment, Plaintiff must point to evidence that would
allow a reasonable jury, applying the clear and convincing standard, to find that
punitive damages are appropriate.” Thelen v. Somatics, LLC, 672 F. Supp. 3d 1216,
1227 (M.D. Fla. 2023) (citing Anderson, 477 U.S. at 255–56).
Here, while it is a close call, the Court rejects Defendants’ assertion that
there is insufficient evidence of punitive damages to survive summary judgment.
Plaintiff has at least pointed to some evidence that could allow a reasonable jury to
find by clear and convincing evidence that Defendants were grossly negligent.
Indeed, there is testimony from 3M’s representative that they had some knowledge
about the risk of surgical site infections, internal correspondences and documents
from 3M employees that suggest that 3M was aware that some orthopedic surgeons
had “amazing concern” about forced-air warmers moving particulates in the air,
the removal of warning labels in early Bair Hugger models that warned against
using the device in ORs, and all the previously discussed empirical and case
studies showing a growing concern of surgical site infection when using forced-air
warmers (like the Bair Hugger). See Dkt. 104-29; see also Boncher, 2025 WL
511116, at *17 (permitting punitive damages claim under Pennsylvania law in Bair
Hugger litigation). Taken together, this evidence amounts to more than just mere
negligence—it creates a triable issue of fact for the jury as to whether Defendants’
conduct is grossly negligent under a clear and convincing standard. Drawing all
inferences from this evidence in Plaintiff’s favor, a reasonable jury could find
Defendant acted with reckless indifference to the safety of patients. Defendants’
motion for summary judgment is denied on Plaintiff’s prayer for punitive damages.
CONCLUSION
Accordingly, it is hereby ORDERED and ADJUDGED that:
1. Defendants’ Motion to Exclude Plaintiff’s General Causation Experts,
Dkt. 73, is DENIED.
2. Defendants’ Motion to Exclude Specific Causation Opinions of
Plaintiff’s Expert Dr. Yoav Golan, Dkt. 74, is DENIED.
3. Defendants’ Motion for Summary Judgment, Dkt. 76, is GRANTED in
part and DENIED in part.
a. Summary judgment is GRANTED on Counts II, V, VI, VII, and
VIII.
b. Summary judgment is DENIED on Counts I, III, and IV.
c. Plaintiff Robinson is also permitted to bring her prayer for punitive
damages under Fla. Stat. § 768.72. See Dkt. 53 at 28.
DONE AND ORDERED at Tampa, Florida, on July 23, 2025.
/s/ William F. Jung
WILLIAM F. JUNG
UNITED STATES DISTRICT JUDGE
COPIES FURNISHED TO:
Counsel of Record