# Hill v. Biomet, Inc.

> District Court, E.D. North Carolina · March 9, 2022

URL: https://www.frixlaw.com/law-library/cases/10653200

## Case

- **Court:** District Court, E.D. North Carolina
- **Decided:** March 9, 2022
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

IN THEUNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
WESTERN DIVISION
No. 5:20-CV-162-D

CATHY HILL, )
Plaintiff, )
)
v. ) ORDER
)
BIOMET, INC.; BIOMET, INC. dba )
ZIMMER BIOMET; ZIMMER BIOMET )
HOLDINGS, INC.; ZIMMER BIOMET )
HOLDINGS, INC. dba ZIMMER BIOMET; __)
ZIMMER, INC.; ZIMMER, INC. dba )
ZIMMER BIOMET; ZIMMER US, INC., - )
BIOMET ORTHOPEDICS, LLC; BIOMET i+)
U.S. RECONSTRUCTION, LLC; BIOMET )
MANUFACTURING, LLC; and DOES 1-20, )
Inclusive, )
)
Defendants. )

On April 17, 2020, Cathy Hill (“Hill” or “plaintiff”) filed a complaint against Biomet, Inc.;
Biomet, Inc. doing business as Zimmer Biomet; Zimmer Biomet Holdings, Inc.; Zimmer Biomet
Holdings, Inc. doing business as Zimmer Biomet; Zimmer, Inc.; Zimmer, Inc. doing business as
Zimmer Biomet; Zimmer Biomet US, Inc.; Biomet Orthopedics, LLC; Biomet U.S. Reconstruction,
LLC; Biomet Manufacturing, LLC (collectively “Biomet,” “Biomet defendants,” or “defendants”)
for North Carolina law claims related to an allegedly defective medical device [D.E. 1]. On October
19, 2020, the court entered a scheduling order setting May 7, 2021, as the deadline for expert reports
- [D.E. 19]. Hill did not submit any expert reports. On May 17, 2021, Biomet moved for summary
judgment [D.E. 27] and filed documents in support [D.E. 28-30]. On June 28, 2021, Hill responded
in opposition [D.E. 36-38]. On June 29, 2021, Hill moved for the court to take judicial notice of
_certain public records related to Biomet products [D.E. 39]. On August 2, 2021, Biomet replied
[D.E. 41 , 43, 44], and responded opposing Hill’s motion for judicial notice [D.E. 42]. As explained

below, the court grants Biomet’s motion for summary judgment and denies as moot Hill’s motion

. to take judicial notice.
, I.
In 2012, Hill, a North Carolina citizen, underwent a total right hip replacement. See Compl.
IDE. 1] Tf 1, 15. The Biomet defendants are Indiana and Delaware Cepeenoney and Hill alleges .
that her implant was a “Biomet orthopedic [i]mplant with ring lock plus Acetabular Shell.” Id. { 15;
[D.E. 14] f] 3-11. Hill claims that she subsequently had numerous revision surgeries and that
during one of those procedures, doctors discovered that a flange from the acetabular cup cage in her
orthopedic implant broke and was “free floating” in her leg. Compl. {J 16-25. Hill alleges that the
acetabular cup was defective. See id. J 26.
The court exercises diversity jurisdiction, and the parties agree that North Carolina
., Substantive law applies. In applying North Carolina substantive law, the court “must determine how
the Supreme Court of [North] Carolina would rule.” Twin City Fire Ins. Co. v. Ben Amold-Sunbelt
Beverage Co. of S.C., 433 F.3d 365, 369 (4th Cir. 2005). In doing so, the court must look first to
opinions of the Supreme Court of North Carolina. See id.; Parkway 1046, LLC v. U.S. Home Corp.,
961 F.3d 301, 306 (4th Cir. 2020); Stahle v. CTS Corp., 817 F.3d 96, 100 (4th Cir. 2016). If there
are no governing opinions from the Supreme Court of North Carolina, this court may consider the
opinions of the North Carolina Court of Appeals, treatises, and “the practices of other states.” Twin
City Fire Ins. Co., 433 F.3d at 369 (quotation omitted).!
Summary judgment is appropriate when, after reviewing the record taken as a whole, no
genuine issue of material fact exists and the moving party is entitled to judgment as a matter of law.
See Fed. R. Civ. P, 56(a); Scott v. Harris, 550 U.S. 372, 378 (2007); Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 247-48 (1 986). The party seeking summary judgment must initially demonstrate

North Carolina has no mechanism for certifying questions of state law to the Supreme Court
of North Carolina. See Town of Nags Head v. Toloczko, 728 F.3d 391, 398 (4th Cir. 2013).
. 2 □

the absence of a genuine issue of material fact or the absence of evidence to support the nonmoving
party’s case. See Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986). Once the moving party has
met its burden, the nonmoving party may not rest on the allegations or denials in its pleading, see
Anderson, 477 U.S. at 248—49, but “must come forward with specific facts showing that there is a
genuine issue for trial.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 □
(1986) (emphasis and quotation omitted). “[T]here is no issue for trial unless there is sufficient
evidence favoring the nonmoving party for a jury to return a verdict for that party.” -Anderson, 477
US. at 249. “The mere existence ofa scintilla of evidence” is insufficient; “there must be evidence
on which the [factfinder] could reasonably find for the” nonmoving party. Id. at 252.
' In making this determination, the court must view the evidence and the inferences drawn
therefrom in the light most favorable to the nonmoving party. See Scott, 550 U.S. at 378.
Nevertheless, the court is not “required to submit a question to a jury merely because some evidence
has been introduced by the party having the burden of proof, unless the evidence be of such a
character that it would warrant the jury in finding a verdict in favor of that party.” Anderson, 477
U.S. at 251 (quotation omitted). “[C]onclusory statements, without specific evidentiary support,”

_ do not create genuine issues of material fact. Causey v. Balog , 162 F.3d795, 802 (4th Cir. 1998).
Only factual disputes that affect the outcome of the case properly preclude summary judgment. See
Anderson, 477 US. at 247-48.

. I. .
Hill asserts five North Carolina law claims, including negligence, negligent breach of implied
warranty, intentional breach of implied warranty, willful and intentional breach of duty to warn,and
negligent breach of duty to warn, all based out of the allegedly defective acetabular shell in □□□
orthopedic implant. See Compl. 31-76. Each of these claims requires Hill to prove causation.
“A products liability claim normally contemplates injury or damage caused by a defective
product ...and recovery is premised on either negligence or on the contract principles of warranty.”

Red Hill Hosiery Mill, Inc. v. MagneTek, Inc., 138 N.C. App. 70, 74-75, 530 S.E.2d 321, 325-26
(2000) (emphasis added; quotation omitted); see Moore v. Coachmen Indus., Inc., 129N.C. App. □
389, 397, 499 S.E.2d 772, 777 (1998); Crews v. W.A. Brown & Son, Inc., 106 N.C. App. 324,
328-29, 416 S.E.2d 924, 928 (1992). “Under North Carolina law, which the parties agree applies
tothe claims before us, plaintiff bringing a products liability action based on negligence must prove
_ (1) the product was defective at the time it left the control of the defendant, (2) the defect wasthe __
of defendant’s negligence, and (3) the defect proximately caused plaintiff damage.” Farrar &
Farrar Farms v. Miller-St.Nazianz, Inc., 477 F. App’x 981, 984 (4th Cir. 2012) (per curiam)
' (unpublished) (emphasis added; quotation omitted); see Red Hill Hosiery Mill, 138 NC. App. at 75,
530 S.E.2d at 326; cf Holley v. Burroughs Wellcome Co., 318 N.C. 352, 355, 348 S.E.2d 772, 774
(1986).
“In North Carolina, a failure to warn claim requires the plaintiff to prove that the defendant
unreasonably failed to provide an nents warning, such failure was the proximate cause of the
plaintiff's damages, and the product posed a substantial risk of harm without an adequate warning
either at the time of or after leaving the manufacturer’s control.” Carlson v. Bos. Sci. Corp., 856
F.3d 320, 324 (4th Cir. 2017) (emphasis added; quotation omitted); see N.C. Gen. Stat. § 99B-5(a);
Evans v. Evans, 153 N.C. App. 54, 57-58, 569 S.E.2d 303, 308 (2002); see also Teague v. Johnson
& raiment Inc., No. 5:21-CV-68-FL, 2022 WL 56526, at *5 (E.D.N.C. Jan. 5, 2022).
Finally, under North Carolina law, a plaintiff basing a products liability action on a breach
of an implied warranty of merchantability must prove: “(1) that the goods bought and sold were
subject to an, implied warranty of merchantability; (2) that the goods did not comply with the
warranty in that the goods were defective at the time of sale; (3) that his injury was due to the

defective nature of the goods; and (4) that damages were suffered as a result.” DeWitt v. Eveready
Battery Co., Inc., 355 N.C. 672, 683, 565 S.E.2d 140, 147 (2002) (emphasis added; quotations
omitted); see Morrison v. Sears, Roebuck & Co., 319 N.C. 298, 301, 354 S.E.2d 495, 497 (1987).
. ,

Hill’s claims require Hill to prove causation between the alleged product defect and her
injury. To prove that a defect in a medical device directly or proximately caused injury usually
requires expert medical evidence to establish the causal relationship. See Click v. Pilot Freight
Carriers, Inc., 300 N.C. 164, 167, 265 S.E.2d 389, 391 (1980) (discussing the necessary proof of
medical causation in the worker’s compensation context, which also requires showing proximate
cause); see also Hensley v. Danek Med., Inc., 32 F. Supp. 2d 345, 350 (W.D.N.C. 1998) (‘In North
Carolina, a jury award cannot be sustained in the absence of expert medical testimony on the issue
of causation.”); Hassell v. Onslow Cnty. Bd. of Educ., 362 N.C. 299, 308, 661 S.E.2d 709, 715 □
(2008); Thacker v. City of Winston-Salem, 125 N.C. App. 671, 676, 482 S.E.2d 20, 23 (1997)
(“[T]he record is devoid of any medical evidence to establish the necessary causal relationship
without conjecture and remote possibility.”).
Biomet argues that Hill cannot establish causation because she does not have an expert
medical witness or expert medical evidence. See [D.E. 30] 4-8. Hill responds that North Carolina
law does not require such expert medical evidence. See Resp. [D.E. 36] 6-8. Rather, Hill argues
that medical evidence to show causation need not be in the form of expert testimony. See id. Hill
also claims that she “identified her orthopedic surgeon Dr. Samuel Wellman as an expert witness by
identifying him in Plaintiffs Initial Disclosures.” Id. at 5. Biomet replies that Hill failed to file
either a report from Dr. Wellman or a disclosure of the subject matter and a summary of the facts and
opinions on which Dr. Wellman is expected to testify and thereby violated both Federal Rule of Civil
Procedure 26(a)(2) and this court’s scheduling order. See Fed. R. Civ. P. 26(a)(2)(A)B); [D.E. 19];
4145.
Even if the court ignored Hill’s glaring procedural failures, allowed Dr. Wellman to testify
as amedical expert, and considered Hill’s initial disclosures and Dr. Wellman’s notes in the medical
records as a summary of his testimony, Dr. Wellman’s testimony does not create a genuine issue of
‘material fact about causation. Dr. Wellman’s treatment notes state that “Hill has had progressive

sensory loss and plantarflexion weakness of her right lower extremity. This started after it was noted
that the ischial flange of her cup-cage construct had broken and moved.” [D.E. 38-2] 38; see Resp.
at 7. Dr. Wellman’s statement, however, does not show causation. See Singletary v. N.C. Baptist
Hosp., 174.N.C. App. 147, 154, 619 S.E.2d 888, 893 (2005) (“[I]fan expert’s opinion as to Causation!

is wholly premised on the notion of post hoc ergo propter hoc (after it, therefore because of it), then
the expert has not provided competent record evidence of causation.”). .
Assuming without deciding that Hill could rely on medical evidence other than expert
testimony from Dr. Wellman to prove causation, Hill’s other evidence does not create a genuine
issue of material fact as to causation. For medical evidence, Hill offers her medical records. See
[D.E. 38-2]. As discussed, these medical records do not provide evidence of causation. Hill also
offers evidence of FDA and other documents related to Biomet products, other than the one
implanted in Hill, that she seeks to introduce through her motion for judicial notice. See [D-E. 39,
39-2, 39-3, 39-4]. Assuming without deciding that the court should take judicial notice of this
evidence, the records do not create a genuine issue of material fact because they do not involve the
product that Hill alleges was defective. See id.
Next, Hill suggests that she can rely on a res ipsa loquitur inference to establish causation.
See Resp. at 8-9. However, ina product-defect case, the plaintiff must establish the specific product
defect at issue caused the plaintiff's injuries. See Brittain v. Motorola Mobility, LLC, No. 5:17-CV-
00134-KDB-DSC, 2019 WL 3543688, at *5—6 (W.D.N.C. Aug. 2,2019) (unpublished) (“To survive
summary judgment on a products-liability claim under Chapter 99B-1.1 of the North Carolina
General Statutes . . . . a plaintiff is obligated to come forward with expert medical opinion that his
medical problems were caused by the defective product”); Sparks v. Oxy-Health, LLC, 134 F. Supp.
3d 961, 991 EDN.C. 2015) (concluding that even if res ipsa leat could be used to infer
negligence in a products liability action, a plaintiff still “must demonstrate a causal connection
between the product itself and the harm suffered”). Moreover, res ipsa loquitur applies when the

defendant had exclusive control over the thing causing harm. See Sparks, 134 F. Supp. 2d at 991.
Here, both Biomet and the doctors operating on Hill had control of the acetabular cup before it was
implanted in Hill’s leg. See Compl. J 15-21, 24-25.
In opposition, Hill cites Click v. Pilot Freight Carriers, Inc. and contends that the court can
infer causation. See 300 N.C. at 167, 265 S.E.2d at 391; Resp. at 8. In Click, however, medical
expert testimony was necessary to prove causation. See Click, 300 N.C. at 168-69, 265 S.E.2d at
391 (“[W]here i exact nature and probable genesis of a particular type of injury involves
complicated medical questions far removed from the ordinary experience and knowledge of laymen,
only an expert can give competent opinion evidence as to the cause of the injury.”). Moreover,
although the Click court posited in dicta that some case may exist where an injury’s cause was so

obvious that expert testimony would not be required, this is not such a case. Here, Hill alleges that
after multiple surgical procedures for hip replacement and revision, she suffered “unexplained
progressive sensory loss and Pinrerterion weakness in her right lower extremity.” Compl. § 23; □
P1.’s 56.1 Statement [D.E. 37] J 11. Thus, this case requires expert medical evidence to demonstrate
causation. Hill has not produced expert medical evidence of causation sufficient to survive summary
judgment, and res ipsa loquitur does not save her claims.
Even viewing the evidence in the light most favorable to Hill, no rational jury could find
causation on any of Hill’s claims based on the evidence in the record. Therefore, the court grants
defendants’ motion for summary judgment. .
i.

In sum, the court GRANTS defendants’ motion for summary judgment [D.E. 27] and
DENIES as moot plaintiff's motion for judicial notice [D.E. 39]. Defendants may apply for costs
in accordance with the Federal Rules of Civil Procedure and this court’s local rules.

SO ORDERED. This 9_ day of March, 2022.
ee Dever
J S C. DEVER III
United States District Judge

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10653200. Public record. Not legal advice.