Horne v. Zimmer Biomet Spine, Inc.

1
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
Case No.: 23-cv-62102-JB
LANA HORNE,
Plaintiff,
v.
ZIMMER BIOMET SPINE, INC.,
Defendant.
/
ORDER ON CROSS MOTIONS FOR SUMMARY JUDGMENT
THIS CAUSE comes before the Court on Plaintiff’s Motion for Summary
Judgment, ECF No. [101], and accompanying Statement of Material Facts, ECF No.
[102] 	and 	Defendant’s 	Motion 	for 	Summary 	Judgment, 	ECF 	No. 	[104], 	and
accompanying Statement of Material Facts, ECF No. [103] (the “Motions”). 	Each
party filed their Responses in Opposition to the Motions, as well as Replies. 	ECF
Nos. [117], [119], [121], [122]. On March 19, 2026, the Court heard oral argument on
the Motions. ECF No. [190].
Upon due consideration of the Motions, the arguments of the parties, the
relevant legal authorities, and for the reasons explained below and stated at the oral
argument which are incorporated herein, Plaintiff’s Motion for Summary Judgment
is DENIED, and Defendant’s Motion for Summary Judgment is DENIED.
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 1 of 19

2
I. 	BACKGROUND
Plaintiff Lana Horne (“Plaintiff”) filed this action alleging that she sustained
damages from a defective Mobi-C artificial disc (“Device”) manufactured by Zimmer
Biomet Spine, Inc., (“Zimmer” or “Defendant”). ECF No. [65]. Plaintiff alleges that
the Device’s defect caused it to slip out of place after it was inserted in her spine
resulting in an additional surgery to remove the Device. Id.
A. The Mobi-C Implant
The Device, manufactured by Defendant ZB Spine, is a multi-component device
primarily featuring two metal endplates (i.e., an inferior and a superior endplate) and
a polyethylene mobile insert located between the endplates. 	See Defendant’s
Statement of Material Facts, ECF No. [103] ¶¶ 18, 21; Plaintiff’s Counter-Statement
of Material Facts,1 ECF No. [159] ¶¶ 18, 21. The Device’s superior and inferior sides
feature two rows of serrated edges which are referred to as “teeth.” Id. After being
developed in Europe, the U.S. Food and Drug Administration granted premarket
approval for the two-level indication of the Mobi-C implant on August 23, 2013, as a
Class III medical device. ECF Nos. [103] ¶ 19, [159] ¶ 19.
The Medical Device Amendments (“MDA”) regulate medical devices and
categorizes medical devices into three classes – Class I, Class II, and Class III – based
on the risk posed to the public. Riegel v. Medtronic, Inc., 552 U.S. 312, 315–17 (2008).
Class III devices receive the most federal oversight and must receive “premarket
approval” which is granted only if the Food and Drug Administration (“FDA”) finds
1 On February 23, 2026, the Court granted Plaintiff’s motion to clarify and amend her
Counter-Statement of Material Fact. ECF Nos. [159], [184].
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 2 of 19

3
that there is a “‘reasonable assurance’ of the device’s ‘safety and effectiveness[.]’” Id.
at 318; 21 U.S.C. § 360c (a)(1)(C). 	Premarket approval (“PMA”) is an extensive
process. Id. § 360e; Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996) ( “‘PMA’ process
is a rigorous one. Manufacturers must submit detailed information regarding the
safety and efficacy of their devices, which the FDA then reviews, spending an average
of 1,200 hours on each submission.”). 	After a device has been approved, the
manufacturer is forbidden to change design specifications that affect safety or
effectiveness without FDA permission. See Riegel, 552 U.S. at 319 (citing 21 U.S.C.
§ 360e(d)(6)(A)(i)).
B. Plaintiff’s Surgery
In August 2016, Plaintiff was injured in a car accident that aggravated her
preexisting neck issues. 	ECF Nos. [103] ¶ 2, [159] ¶ 2. 	After being told that her
condition was life threatening and that she risked paralysis if she did not undergo
surgery to treat her neck injury, Plaintiff explored her surgery options. 	ECF Nos.
[103] ¶ 4, [159] ¶ 4.
On January 18, 2019, in Orlando, Florida, Plaintiff underwent surgery, and
the Device was implanted as part of a two-level disc replacement at her C5-C6 and
C6-C7. See ECF Nos. [103] ¶¶ 4, 6; [159] ¶¶ 4, 6. Plaintiff attended a follow-up visit
with the implanting physician in April 2019. ECF Nos. [103] ¶ 7−8; [159] ¶ 7−8.
In early 2020, while Plaintiff was visiting family in Texas, she visited a sports
medicine clinic for examination. 	ECF Nos. [103] ¶ 9, [159] ¶9. 	The Texas clinic
recommended that she visit a spine and neck specialist who recommended that
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 3 of 19

4
Plaintiff undergo revision surgery. ECF Nos. [103] ¶¶ 9−10, [159] ¶¶ 9−10.
On June 18, 2020, Plaintiff underwent revision surgery whereby the Device
was removed. ECF Nos. [103] ¶ 11, [159] ¶ 11. Plaintiff recovered in Texas with her
son for close to a year and underwent various post-revision treatments including
physical therapy and at-home treatments. ECF Nos. [103] ¶ 12, [159] ¶ 12.
On September 14, 2024, Plaintiff filed this action alleging that the Device was
defective and resulted in “chronic pain, sadness, depression, anxiety and requires
chronic pain management and medication.”2 ECF No. [65] ¶ 62. Plaintiff asserts one
cause of action alleging that the Device implant at the C6-C7 level contained a
manufacturing defect, specifically stating that the Device’s “serrated teeth” were
defectively manufactured. See generally id; ECF No. [101]; see also ECF No. [103-7].
She further alleges that her injuries, and subsequent revision surgery, have not only
cost her thousands of dollars, but also post and future wage loss and pain and
suffering. ECF No. [65] ¶¶ 60−62.
II. 	THE INSTANT MOTIONS
Plaintiff argues that the Court should grant summary judgment as to liability
because the Device was 1) defective, 2) the defect was present when the product left
the manufacturing plant, and 3) the defect was the proximate cause of her damages.
ECF No. [101].
Defendant argues that it is entitled to summary judgment for the following
reasons. First, Defendant claims that because Plaintiff sought treatment, received
2 The Third Amended Complaint is the operative complaint. ECF No. [65].
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 4 of 19

5
treatment, underwent revision surgery, and recuperated in Texas, the Texas statute
of limitations applies to Plaintiff’s claims. ECF No. [104] at 8. Because Plaintiff filed
her lawsuit after the Texas two-year limitation period expired, Defendant argues that
it is entitled to judgment in its favor. Id.
Second, 	Defendant 	argues 	that 	Plaintiff 	does 	not 	have 	evidence 	of 	a
manufacturing defect or that the alleged defect existed while the Device was still in
the custody of the manufacturer. 	Id. at 9. 	Defendant asserts that the Device
inspection records show that the Device was manufactured according to the approved
FDA process and that the serrated teeth on the endplates were within the approved
specifications. 	Id. 	Defendant also asserts that Plaintiff failed to show that the
alleged defect resulted from a particular violation of a PMA requirement, a failure
that is fatal to her claims. Id. at 11.
Third, Defendant argues that Plaintiff’s claim fails for lack of expert testimony
on medical causation. 	Id. at 13. 	Defendant states that Florida law requires expert
testimony to establish that an alleged manufacturing defect was the proximate cause
of a plaintiff’s injury. 	Id. 	Specifically, Defendant argues that Mr. Drewry, an
engineer who opined on the manufacturing defect, cannot testify as to medical
causation, nor can Plaintiff’s treating physicians. 	Id. 	at 13–19. 	Without evidence
that links the Device’s alleged defect to her injury, Plaintiff cannot satisfy an
essential element, and her claim must fail as a matter of law. Id. at 17. 3
3 	Defendant 	also 	argued 	that 	Plaintiff’s 	claims 	were 	barred 	by 	a 	settlement
agreement that Plaintiff entered in connection with an accident. See ECF No. [104]
at 19−21. 	Defendant later abandoned this argument in its Reply, stating that it
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 5 of 19

6
In her Response, Plaintiff argues that she was never a resident of Texas and
was simply there to visit her son. 	ECF No. [117] at 10. 	In addition, because the
Device was implanted in Florida and had already failed while she was in Florida,
Plaintiff contends that the Texas statute of limitation does not apply. Id. As to the
evidence of defect, Plaintiff argues that the Court should deny Defendant’s Motion
because “[a] jury may take the expert testimony from Dr. Kuns, Dr. Beauregard and
Troy Drewry and conclude by looking at the X-Rays and the Zimm[e]t specifications
and determine that this is a manufacturing defect.” ECF No. [117] at 20. As to the
manufacturing defect, Plaintiff asserts that the testimony from her biomechanical
expert, Troy Drewry, has shown that the Device was defective while still within
Defendant’s control and the Device was in fact defective “to a reasonable degree of
bio-mechanical probability.” 	Id. at 14−17. 	As to medical causation, Plaintiff again
argues that a jury may come to conclusion as to medical causation by looking to the
testimony of “Dr. Kuhns or Troy Drery or both.” Id. at 18.
In its Reply, Defendant argues that Plaintiff overemphasizes this matter’s
connection to Florida and again reiterates that the Court should apply Texas law to
whether Plaintiff’s claims are time-barred. 	ECF No. [121] at 3. 	Next, Defendant
argues 	that 	Plaintiff 	has 	no 	admissible 	evidence 	showing 	the 	existence 	of 	a
manufacturing defect, or a specific violation of a PMA requirement. 	Id. at 5–8.
Lastly, Defendant points out that Plaintiff has not disclosed a medical expert, nor
have Plaintiff’s treating physicians offered to give causation opinions. Id. at 9−11.
would reserve any arguments related to the settlement release for trial. See ECF No.
[121] at 11.
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 6 of 19

7
III. 	LEGAL STANDARD
Summary judgment is proper when there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a matter of law. Celotex Corp.
v. Catrett, 477 U.S. 317, 322 (1986). A genuine issue of material fact is one with “‘a
real basis in the record,’” such that “a reasonable jury could return a verdict for the
[nonmoving party].” Mann v. Taser Int’l, Inc., 588 F.3d 1291, 1303 (11th Cir. 2009)
(quoting Hairston v. Gainesville Sun Pub. Co., 9 F.3d 913, 919 (11th Cir. 1993));
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). Speculation cannot create
a genuine issue of material fact sufficient to defeat a well-supported motion for
summary judgment. Cordoba v. Dillard's, Inc., 419 F.3d 1169, 1181 (11th Cir. 2005).
The movant has the initial burden of showing the absence of a genuine issue
of material fact. Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir. 1991). To
determine whether the movant has met this burden, courts view the movant’s
evidence and all factual inferences arising therefrom in the light most favorable to
the non-movant. 	Denney v. City of Albany, 247 F.3d 1172, 1181 (11th Cir. 2001)
(quoting Burton v. City of Belle Glade, 178 F.3d 1175, 1187 (11th Cir. 1999)). 	As to
issues on which the non-moving party would bear the burden of proof at trial, it is
sufficient for the movant to highlight a failure of proof concerning an essential
element of the non-movant’s case. Celotex, 477 U.S. at 322–23.
Once the moving party satisfies its initial burden, the burden shifts to the non-
moving party to present evidence showing a genuine issue of material fact that
precludes summary judgment. Bailey v. Allgas, Inc., 284 F.3d 1237, 1243 (11th Cir.
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 7 of 19

8
2002); see also Fed. R. Civ. P. 56(e). 	“If reasonable minds could differ on the
inferences 	arising 	from 	undisputed 	facts, 	then 	a 	court 	should 	deny 	summary
judgment.” 	Miranda v. B & B Cash Grocery Store, Inc., 975 F.2d 1518, 1534 (11th
Cir. 1992). But if 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, and granting
summary judgment is proper. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 587 (1986).
“The standard of review for cross-motions for summary judgment does not
differ from the standard applied when only one party files a motion” Torres v. Rock
River Food Inc., 244 F. Supp. 3d 1320, 1327 (S.D. Fla. 2016) (citing Am. Bankers Inc.
Grp. v. United States, 408 F.3d 1328, 1331 (11th Cir. 2005)). The Court reviews each
individual motion on its own merits, taking the facts on each motion in the light most
favorable to the respective nonmovant. See Adega v. State Farm Fire & Cas. Ins. Co.,
No. 07-cv-20696, 2009 WL 3387689, at *3 (S.D. Fla. Oct. 16, 2009). Cross-motions for
summary judgment do not, in themselves, warrant the court in granting summary
judgment “unless one of the parties is entitled to judgment as a matter of law on facts
that are not genuinely disputed.” Purcell v. City of Fort Lauderdale, 753 F. Supp. 3d
1308, 1324 (S.D. Fla. 2024) (quoting United States v. Oakley, 744 F.2d 1553, 1555
(11th Cir. 1984)).
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 8 of 19

9
IV. 	ANALYSIS
A. 	Texas’ Statute of Limitations Does Not Apply.
Texas applies a two-year statute of limitations in medical device tort cases such
as this one, whereas Florida courts apply a four-year statute of limitations. 	See
Shepherd v. Danek Med., 1999 WL 1129705, at *1 (S.D. Tex. Aug. 13, 1999); Compare
Tex. Code Civ. Prac. & Remedies, § 16.003, with Fla. Stat. § 95.11(3)(a) (before
amendment).4 	Defendant contends that Texas’ statute of limitations applies, and
because this action was filed after the two-year period, it is barred. 	Id. at 3. 	This
Court disagrees.
“When it exercises jurisdiction based on diversity of citizenship, 28 U.S.C. §
1332, a federal court must apply the choice of law rules of the forum state to
determine which substantive law governs the action.” 	U.S. Fid. & Guar. Co. v.
Liberty Surplus Ins. Corp., 550 F.3d 1031, 1033 (11th Cir.2008). Any conflict-of-laws
analysis must first address if “a conflict actually exists.” Cooper v. Meridian Yachts,
Ltd., 575 F.3d 1151, 1171 (11th Cir. 2009). 	A “true conflict” (as opposed to a “false
conflict”) exists if two states possess conflicting policy interests in the outcome of the
litigation. Tune v. Philip Morris Inc., 766 So. 2d 350, 352 (Fla. 2d DCA 2000). Here,
both Florida and Texas have a conflicting interest. As a result, a true conflict exists.
4 Florida recently changed its statute of limitations for negligence claims to two years,
Fla. Stat. § 95.11(5)(a). Because the new statute only applies to claims accruing on or
after March 24, 2023, it does not apply to this case, which was filed on March 21,
2023. 	See Williams v. Home Advantage Humana, No. 8:23-CV-980-CEH-AAS, 2023
WL 4104520, at *1, n. 3 (M.D. Fla. May 31, 2023) (“Effective March 24, 2023, Fla.
Stat. § 95.11, was amended to reduce the statute of limitations for negligence claims
from four years down to only two years.” (citing Fla. Stat. § 95.11(4)(a)).
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 9 of 19

10
To determine which state’s statute of limitations apply, this Court looks to
Florida’s choice-of-law rules. 	See Adolfo House Distrib. Corp. v. Travelers Prop. &
Cas. Ins., 165 F. Supp.2d 1332, 1335 (S.D. Fla. 2001) (citing LaFarge Corp. v.
Travelers Indem., 118 F.3d 1511, 1515 (11th Cir.1997)) (“This case is before the court
under exercise of its diversity jurisdiction. Therefore, the court must look to [ ]
Florida’s choice of law rules to determine the law applicable to this action.”). Florida
applies the “most significant relationship” test in tort cases as delineated in § 145 of
the Restatement (Second) of Conflicts of Laws. 	Grupo Televisa, S.A. v. Telemundo
Communs. Group, Inc., 485 F.3d 1233, 1240 (11th Cir.2007) (citing Bishop v. Fla.
Specialty Paint Co., 389 So.2d 999, 1001 (Fla.1980)). 	Under the most significant
relationship test, the law of the state where the injury occurred applies “unless, with
respect to the particular issue, some other state has a more significant relationship.
. . to the occurrence and the parties.” 	Restatement (Second) of Conflict of L. § 146;
see also Bishop, 389 So.2d at 1001 (“The state where the injury occurred would, under
most circumstances, be the decisive consideration in determining the applicable
choice of law.”); Schenone v. Zimmer Holdings, Inc., No. 3:12-CV-1046-J-39MCR,
2014 WL 12619899, at *3 (M.D. Fla. Mar. 5, 2014) (“Because the device failed in
Florida, Plaintiff’s injury occurred in Florida and the law of Florida should control
this case.”).
The most significant relationship test examines four contacts to determine
whether a state indeed has a significant relationship: a) “the place where the injury
occurred b) the place where the conduct causing the injury occurred, c) the domicile,
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 10 of 19

11
residence, nationality, place of incorporation and place of business of the parties, and
d) the place where the relationship, if any, between the parties is centered.” 	Grupo
Televisa, 485 F.3d at 1240 (quoting § 145). Additionally, § 145 advises that “[t]hese
contacts are to be evaluated according to their relative importance with respect to the
particular issue.” Id. That said, in determining which state has the most significant
relationship, the Court may not “simply add up the factors delineated in section
145(2).” Judge v. American Motors, Corp., 908 F.2d 1565, 1569 (11th Cir. 1990).
Here, the Device was implanted while Plaintiff, a Florida resident, was living
in Florida. ECF Nos. [103] ¶ 6, [159] ¶6. Although her revision surgery was in Texas,
that appeared to be fortuitous given that she was there only to visit her son. See, e.g.,
Restatement (Second) of Conflict of L. § 145 cmt. e (“[W]hen the place of injury ... is
fortuitous ... the place where the defendant’s conduct occurred will usually be given
particular weight ....”). Thus, this factor falls in favor of applying Florida law.
As to the second factor, the Device’s design or manufacture occurred in France.
ECF Nos. [103] ¶¶ 18−19, 26, [159] ¶¶ 18−19, 26. As such, this factor does not weigh
in favor of one forum or the other. As to the third factor, Plaintiff is a Florida resident,
and Defendant is a Colorado resident. 	This factor does not favor Texas as neither
party is from Texas. 	Finally, as to the last factor, the only relationship the parties
have here involved the Device that was implanted in Plaintiff by a procedure that
occurred in Florida.
Because Plaintiff was a Florida resident that received the Device in Florida,
the Court finds the Florida law applies. The Court also notes that issues of liability
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 11 of 19

12
and 	damages 	for 	patients 	that 	receive 	medical 	care 	in 	Florida, 	from 	Florida
physicians, and then continue to reside in Florida, gives Florida a legitimate interest
in this case and its result. Because Florida law applies and the action was filed within
the state’s statute of limitations, Defendant’s Motion on this ground is DENIED.
B. 	There Are Genuine Issues of Material Fact as to
Whether the Device Contained a Manufacturing Defect.
Defendant argues that summary judgment should be granted in its favor
because Plaintiff has failed to establish an issue of triable fact as to the existence of
a manufacturing defect. ECF Nos. [104] at 9–13, [121] at 5. 	Additionally, it argues
that Plaintiff cannot show that any alleged defect existed at the time the Device was
in the manufacturer’s control, or that a particular PMA requirement had been
violated. 	ECF Nos. [104] at 12, [121] at 8. 	As to this issue, Plaintiff argues that
summary judgment should be granted in her favor given the testimony of her doctors
and expert show that the Device was defective. ECF No. [117] at 4−8.
In order to prevail on a “manufacturing defect claim under Florida law, a
plaintiff must prove that 1) the product was defective, 2) the defect existed at the time
the product left the defendant-manufacturer’s control, and 3) the defect proximately
caused the plaintiff’s injuries.” Salinero v. Johnson & Johnson, 400 F. Supp. 3d 1334,
1344 (S.D. Fla. 2019); see also Colville v. Pharmacia & Upjohn Co., 565 F. Supp. 2d
1314, 1320 (N.D. Fla. 2008) (“In order to prevail in a products liability action brought
under a theory of either strict liability or negligence, a plaintiff must demonstrate
that the injuries complained of were caused by a defective product whose defect
existed at the time of 	injury and at the time in which the product left the
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 12 of 19

13
manufacturer’s 	control.”) 	(emphasis 	added). 	Since 	Plaintiff 	seeks 	to 	assert 	a
manufacturing defect claim relating to a PMA-approved device, she must also show
that “the defect resulted from a violation of a particular PMA requirement.” Marmol
v. St. Jude Med. Ctr., 132 F. Supp. 3d 1359, 1365 (M.D. Fla 2015) (citations omitted).
Here, Plaintiff’s expert, Mr. Troy Drewry5 concluded, based on a comparison of
the Device with Defendant’s design drawings, that the Device was not manufactured
according to the design’s measurement. Id. Specifically, Mr. Drewry concludes that
the Device’s “teeth” were defective in that they were not sharp and that the defect
that would prevent a device from adhering to the bone. Drewry Dep. 67:16−24, ECF
No. [97-3]. Plaintiff also puts forth evidence that Defendant’s representative brought
the 	Device 	unopened 	directly 	from 	the 	manufacturing 	plant 	to 	the 	surgery.
Beauregard Dep. 139:20−140:7, ECF No. [98-2]. 	Essentially, Plaintiff argues that
because the Device did not leave the manufacturer’s control, the defect arose while it
was in its control.
Defendant counters Plaintiff’s evidence with manufacturing records that show
that both of the “teeth” contained on the Device’s endplates were manufactured
within the required design specifications and therefore not defective. ECF Nos. [103-
4] ¶¶24−25, [104] at 12, [121] at 6. Defendant also relies on the declaration of one of
their employees, Engineering Manager, Guillaume Quetier, who asserts that the
5 Along with its Motion, Defendant also filed a Motion to Strike Mr. Drewery’s
testimony on Daubert grounds. 	ECF No. [105]. 	The Court denied the Motion to
Strike. ECF No. [184].
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 13 of 19

14
“teeth” on the Device were measured and within the specifications required by the
PMA. ECF Nos. [104] at 12, [121] at 6.
Given the conflict between the evidence presented, the Court finds that a
genuine issue of material fact exists as to whether the Device was defective. Plaintiff
has presented an expert that will testify to the alleged defect and that the defect
resulted from a particular violation of a PMA requirement. See Drewry Dep. 20:2−13,
20:24−21:14, 67:16−24, ECF No. [97-3]. That testimony is in direct conflict, of course,
with Defendant’s evidence. Decl. of G. Quetier, ECF No. [103-4]. Given the conflict,
the Court cannot grant summary judgment without weighing the evidence and
determining the credibility of these witnesses, a function it cannot undertake at this
juncture. 	Patterson v. Georgia Pac., LLC, 38 F.4th 1336, 1350 (11th Cir. 2022)
(“[W]hen determining whether there is a genuine issue of material fact that defeats
summary judgment, 	we do not weigh conflicting evidence or make credibility
determinations to resolve factual disputes”); Latimer v. Roaring Toyz, Inc., 601 F.3d
1224, 1237 (11th Cir.2010) (“Neither we nor the district court are to undertake
credibility determinations or weigh the evidence”); Mize v. Jefferson City Bd. of Educ.,
93 F.3d 739, 742 (11th Cir. 1996) (“It is not the court’s role to weigh conflicting
evidence or to make credibility determinations; the non-movant’s evidence is to be
accepted for purposes of summary judgment.”); Price v. Palm City Golf, LLC, No. 24-
14141-CIV, 2026 WL 691652 (S.D. Fla. Mar. 12, 2026) (citing Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 255 (1986)) (“The Court may not weigh evidence or make
credibility determinations at this [summary judgment] stage.”). Thus, the summary
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 14 of 19

15
judgment 	motions 	as 	to 	whether 	there 	is 	sufficient 	evidence 	to 	establish 	a
manufacturing defect are DENIED.
C. There Are Genuine Issues of Material Fact as to Medical
Causation.
The only remaining question is whether Plaintiff’s evidence of causation is
sufficient to defeat Defendant’s Motion. In order to prevail on a manufacturing defect
claim, Plaintiff must show that “the defect proximately caused [her] injuries.”
Salinero, 400 F. Supp. 3d at 1344. Defendant argues that Plaintiff’s claims must fail
as a matter of law because 1) Plaintiff has not disclosed any medical causation expert,
2) Plaintiff violated Federal Rule 26(a)(2) by not properly disclosing the non-retained
expert testimony of her treating physician, 3) Plaintiff’s treating physicians declined
to opine on medical causation, 4) Plaintiff’s expert, Mr. Drewry, is not qualified to
provide an opinion on medical causation, and 5) Plaintiff has no expert to rebut
Defendant’s medical causation expert. ECF No. [104] at 13−19. In sum, Defendant
argues that evidence in the record is not sufficient for the trier of fact to conclude that
Defendant’s Device caused her injuries.
As an initial matter, and before addressing the sufficiency of Plaintiff’s
evidence, the Court notes that Defendant did not move to strike the testimony of
Plaintiff’s treating physicians, and the Court sees no basis to do so now. Defendants
suffered no prejudice from the manner in which the testimony of the treating
physicians was disclosed given that Defendant was able to depose the doctors with
ample time.
Defendant, however, is correct on several other fronts. Plaintiff does not have
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 15 of 19

16
a designated expert on medical causation. In addition, Mr. Drewery, a biomechanical
engineer, can only testify to the defect he identified in the Device. Plaintiff does not
appear to contest this. 	ECF No. [117] at 18. 	Instead, Plaintiff argues that it has
presented sufficient evidence because the testimony of Mr. Drewry in combination
with the testimony of Dr. Kuhns, one of Plaintiff’s treating physicians, is sufficient
for a jury to find that the defect in the Device caused her injury. Id.
As noted above, Defendant argues that expert testimony is required to
establish medical causation. 	See Payne v. C.R. Bard, Inc., 2014 WL 1887297, at *2
(M.D. Fla. May 12, 2014), aff’d, 606 F. App’x 940 (11th Cir. 2020)(“Causation in
medical 	device 	product 	liability 	cases 	also 	often 	requires 	expert 	evidence.”);
Kilpatrick v. Breg, Inc., 2009 WL 2058384, at *11 (S.D. Fla. June 25, 2009)(finding
that the plaintiff’s non-expert treating physicians could only testify as lay witnesses
and that they “[could not] touch upon causation”). Defendant also posits that Plaintiff
has no admissible medical causation testimony because no expert performed a
differential diagnosis in formulating their opinion. 	ECF No. [104] at 13–14. 	In
making this argument, Defendant relies on Guinn v. AstraZeneca Pharms. LP, 602
F.3d 1245, 1252−1253 (11th Cir. 2010) for the proposition that expert testimony is
required. 	Id. 	But Guinn does not address the issue here, where there is an expert
testifying as to the manufacturing defect and Plaintiff is relying on a combination of
other witnesses to prove that the defect caused her to undergo an additional surgery,
and as a result, an injury. Contra Guinn, 602 F.3d at 1252–53.
To be sure, expert testimony would be needed to show that there is a defect in
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 16 of 19

17
the Device. Alexander v. Danek Med., Inc., 37 F. Supp. 2d 1346, 1349 (M.D. Fla. 1999)
(“To prove a defective product, a defect must be proven by expert testimony.”). 	The
Court denied the Daubert challenge to Mr. Drewry, and as such, Plaintiff will be able
to advance expert testimony on the defect in the Device. Defendant, however, makes
another point that is not established in the authorities it relies upon. That an expert
is required as a matter of law to show that the alleged design defect, supported by
expert testimony, also caused the injury.6 See ECF No. [104] at 13–16.
6 Defendant’s reliance on Kilpatrick is also unavailing. 2009 WL 2058384, at *11.
There, after excluding the plaintiff’s causation expert, the court found that the
plaintiff could not rely on the testimony of his non-expert treating physicians for
causation because they could only testify to matters regarding treatment. Id. At any
rate, the court did not opine as to whether the treating physicians’ testimony could
be combined with an expert’s testimony to establish causation. Id.
Defendant’s other citations are also unpersuasive, as it confuses the requirement of
expert testimony of a design defect with expert evidence connecting that defect to the
injury. Salinero v. Johnson & Johnson, 400 F. Supp. 3d 1334, 1343 (S.D. Fla. 2019)
(noting that the defendants’ argument that the plaintiffs’ claims should be dismissed
due to lack of expert testimony fails because the court had not in fact excluded the
plaintiffs’ case-specific experts), aff'd, 995 F.3d 959 (11th Cir. 2021); Payne v. C.R.
Bard, Inc., No. 6:11-CV-1582-ORL-37, 2014 WL 1887297, at *3 (M.D. Fla. May 12,
2014), (granting the defendants’ motion for summary judgment where the plaintiff
could not point to expert testimony to establish a product defect or causation)
(emphasis added) aff'd, 606 F. App’x 940 (11th Cir. 2015); Wolicki-Gables v. Arrow
Intern., Inc., 634 F.3d 1296, 1302 (11th Cir. 2011) (finding that the district court did
not err in concluding that the plaintiffs were not entitled to a presumption that the
device was defectively manufactured) (emphasis added); Olmo v. Davol, Inc., 2017 WL
1367231, at *7 (S.D. Fla. April 10, 2017) (granting summary judgment where the
plaintiffs failed to provide any admissible evidence that the defect causes the injuries)
(emphasis added), aff’d, 710 F. App’x 861 (11th Cir. 2018); Savage v. Danek Med.,
Inc., 31 F. Supp. 2d 980, 984 (M.D. Fla. 1999), (noting that the court was not reaching
the issue of causation because the plaintiff showed no evidence of a defect) aff'd, 202
F.3d 288 (11th Cir. 1999); Ramkelawan v. Globus Med. Inc., No. 5:18-CV-100-OC-
30PRL, 2019 WL 8918551, at *3 (M.D. Fla. Dec. 10, 2019) (granting the defendant’s
motion for summary judgment after the court excluded the plaintiffs’ causation
expert and noting that the expert’s opinions were the only evidence of causation relied
on by the plaintiffs); Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353,
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 17 of 19

18
That said, the lack of expert testimony is problematic. 	See Pierre v. Intuitive
Surgical, Inc., 854 F. App’x 316, 320 (11th Cir. 2021) (“In cases where a jury is asked
to assess complex medical or scientific issues outside the scope of a layperson’s
knowledge, an expert’s testimony is required to establish causation.”); Sumner v.
Biomet, Inc., 434 F. App’x 834, 843–44 (11th Cir. 2011) (holding that district court
“properly granted summary judgment” to the defendant on medical device product
liability and negligence claims where there was no evidence of the defect); Hughes v.
Stryker Corp., 423 F. App’x 878, 881 (11th Cir. 2011) (affirming the district court’s
finding that the “interaction between a complex and technical medical device and the
unique 	physiological 	and 	medical 	circumstances 	of 	the 	patient 	in 	which 	it 	is
implanted is a subject on which no ordinary juror could rationally be expected to have
knowledge.”). That said, the Court is not convinced that as a matter of law Plaintiff
should not be allowed to move forward with its claim given that it will now be able to
present expert testimony on the defect and that the defect, the lack of sharpness, can
be linked to the medical testimony that the Device was removed because it did not
adhere to her bone 	Indeed, Plaintiff’s treating physician, Dr. Kuhns, testified that
the Device had to be removed because it had not properly adhered to Plaintiff’s bone.
Kuhns Dep. 94:14−95:9, ECF No. [98-1]. 	Unlike the cases relied upon by Plaintiff,
the defect at issue here is the same issue identified by her treating physician as the
1361 (M.D. Fla. 1999) (granting summary judgment where the plaintiff produced no
evidence that the product was defective or that the defect caused her damages)
(emphasis added).
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 18 of 19

19
reason the device failed and had to be removed. 	The Court finds that this unique
combination, although perhaps not particularly strong evidence, is sufficient to defeat
summary judgment. See Fair Hous. Ctr. of the Greater Palm Beaches, Inc. v. Sonoma
Bay Cmty. Homeowners Ass’n, Inc., No. 9:14-CV-80667-ROSENBERG, 2015 WL
5016836, at *3 (S.D. Fla. Aug. 25, 2015) (noting that expert assistance is not
necessary where the facts at issue do not require specialized knowledge). 	Indeed,
Plaintiff will not have an expert to rebut Defendant’s expert testimony that the
failure to adhere was caused by other factors. But the weighing of that evidence and
the credibility of the witnesses will be up to the jury, or in the event that the
testimony at trial is not sufficient, up to the Court at the conclusion of Plaintiff’s case
in chief. All the same, the Court is not convinced that under the facts here, Plaintiff’s
claim should be dismissed as a matter of law.
V. CONCLUSION
Accordingly, it is hereby ORDERED AND ADJUDGED that Plaintiff’s
Motion for Summary Judgment, ECF No. [101], and Defendant’s Motion for Summary
Judgment, ECF No. [104], are DENIED.
DONE AND ORDERED in Miami, Florida, this 30th day of March, 2026.
_______________________________________
JACQUELINE BECERRA
UNITED STATES DISTRICT JUDGE
Case 0:23-cv-62102-JB Document 193 Entered on FLSD Docket 03/30/2026 Page 19 of 19