McCoy v. Biomet Orthopedics, LLC et al
Filing
109
MEMORANDUM OPINION. Signed by Judge Ellen L. Hollander on 1/25/2021. (hmls, Deputy Clerk)
Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 1 of 66
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
JOANNA MCCOY, et al.
Plaintiffs,
v.
Civil Action No. ELH-12-1436
BIOMET ORTHOPEDICS, LLC, et al.,
Defendants.
MEMORANDUM OPINION
This product liability case concerns an allegedly defective orthopedic device used for hip
replacements. Defendants Biomet Orthopedics, LLC; Biomet Manufacturing Corp.; and Biomet
U.S. Reconstruction, LLC (collectively, “Biomet”) designed and manufactured metal-on-metal hip
implant systems, including the M2a-MagnumTM (the “Magnum” or the “Biomet device”). Plaintiff
Joanna McCoy was implanted with the Biomet device in 2007, during an operation for a
replacement of her right hip. ECF 96-3 at 22.
In 2012, Dr. McCoy, a veterinarian, and her husband, plaintiff Kenneth Burgwin, filed suit
against Biomet. They allege that the Biomet device was defective and caused Dr. McCoy
substantial injuries, necessitating subsequent hip replacement surgeries, i.e., “revision” surgeries.
See ECF 1; ECF 96-1 at 8 n.3.
In 2019, after consolidated pretrial proceedings, discussed infra, plaintiffs filed an
amended complaint, containing multiple counts. ECF 43 (the “Amended Complaint”). 1 In
1
In the Amended Complaint, plaintiffs sued Biomet Orthopedics, LLC; Zimmer Biomet
Holdings, Inc.; Biomet Manufacturing Corp.; and Biomet U.S. Reconstruction, LLC. ECF 37.
However, during the consolidated pretrial proceedings, all Biomet corporate entities were
dismissed from suit, except Biomet, Inc.; Biomet Orthopedics, LLC; Biomet Manufacturing Corp.;
Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 2 of 66
particular, plaintiffs allege that the metal-on-metal design of these implants caused the device to
corrode, releasing metallic debris into the bloodstream that killed surrounding tissue and bone.
Further, plaintiffs assert that Biomet advertised these products as safe, despite knowing that they
were defective.
This case was one of many filed against Biomet. On October 2, 2012, pursuant to 28 U.S.C.
§ 1407, the Joint Panel on Multidistrict Litigation (“JPML”) consolidated all cases involving
Biomet’s Magnum and the M2a-38 into a Multi-District Litigation action (“MDL”) for coordinated
pretrial proceedings. See In re: Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 896 F.
Supp. 2d 1339, 1340 (J.P.M.L. 2012). MDL-2391 was assigned to Judge Robert Miller, Jr. of the
United States District Court for the Northern District of Indiana. 2 Id. On September 19, 2018,
after extensive pretrial proceedings, the McCoy matter was returned from the MDL to the District
of Maryland as part of the first remand group. MDL-2391, MDL Dkt. No. 3724; see ECF 22. 3
and Biomet U.S. Reconstruction, LLC. See MDL-2391, Dkt. No. 444. Accordingly, Zimmer
Biomet Holdings, Inc. is no longer a defendant.
In the answer to the Amended Complaint, Biomet states that Biomet Manufacturing, LLC
was “incorrectly named” in the Amended Complaint as Biomet Manufacturing Corp. ECF 48 at
1. However, the aforementioned order of the MDL court referenced Biomet Manufacturing Corp.
2
The docket for MDL-2391 can be accessed at MDL 2391, In Re: Biomet M2A Magnum
Hip Implant Products Liability Litigation, UNITED STATES DISTRICT COURT NORTHERN DISTRICT
OF INDIANA, https://www.innd.uscourts.gov/mdl-2391 (last accessed January 13, 2021).
3
Several other lawsuits against Biomet were assigned to me. Plaintiffs moved to
consolidate their suit with another case returned from the MDL court. ECF 54. I denied that
motion. ECF 79; ECF 80. However, I did consolidate other Biomet cases.
The cases of Fowler v. Biomet Orthopedics, LLC, ELH-19-2931 and Soustek v. Biomet
Mfg. Corp., ELH-15-1890 settled in 2019. Both Ringley v. Biomet, Inc., ELH-17-747 and
Laughlin v. Biomet, Inc., ELH-14-1645 settled in June 2020. On January 6, 2021, a notice of
settlement was filed in the cases of Harris v. Biomet Orthopedics, LLC, ELH-18-3924, Harbold v.
Biomet Orthopedics, LLC, ELH-18-3925, and Kandel v. Biomet Orthopedics, LLC, ELH-18-3926.
2
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Plaintiffs filed the Amended Complaint in 2019, after the suit was returned to this Court.
They lodge claims exclusively under Maryland law. In Count I, plaintiffs assert a claim for “Strict
Product Liability,” alleging, inter alia, that the Magnum contained manufacturing defects and
design defects, and that Biomet’s failure to warn McCoy of the risks posed by the Magnum caused
her harm. ECF 43 ¶ 102(a), (b), (d); see id. at 24. In Count II, plaintiffs allege negligence as to
Biomet’s “design, manufacture, testing, inspection, labeling, promotion, marketing, and sale” of
the Magnum. Id. ¶ 111. Count III lodges a claim for “Breach of Implied Warranties,” asserting
that the defendants breached the implied warranty of merchantability. See id. ¶¶ 118-24. And,
plaintiffs assert claims for “Breach of Express Warranty” (Count IV), id. ¶¶ 125-29, punitive
damages (Count V), id. ¶¶ 130-38, and loss of consortium (Count VI). Id. ¶¶ 139-40. 4 Jurisdiction
is founded on diversity of citizenship under 28 U.S.C. § 1332. It is undisputed that Maryland law
governs plaintiffs’ claims.
Pursuant to Fed. R. Civ. P. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
U.S. 579, 597 (1993), Biomet has moved to exclude the opinion evidence offered by two of
plaintiff’s expert witnesses. The motion to exclude the opinions of Jeffrey F. Shapiro, M.D. is
docketed at ECF 94, supported by a memorandum of law. ECF 94-1 (collectively, the “Shapiro
Motion”). And, defendants’ motion to exclude the opinions of Frank Ebert, M.D. is docketed at
ECF 95, supported by a memorandum of law. ECF 95-1 (collectively, the “Ebert Motion”).
As discussed, infra, Judge Hazel recently granted in part and denied in part Biomet’s
motion for summary judgment in Morris v. Biomet, Inc., ___ F. Supp. 3d ___, GJH-18-2440, 2020
WL 5849482 (D. Md. Sept. 30, 2020).
4
The Amended Complaint does not contain a Count V; it skips from Count IV to Count
VI. See ECF 43 at 29-30. And, the punitive damages claim and the loss of consortium claim are
both labeled “Count VI.” Id. at 30, 33. I shall refer to the punitive damages claim as Count V and
the loss of consortium claim as Count VI.
3
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Plaintiffs oppose both motions. ECF 100 (opposition to the Ebert Motion); ECF 101 (opposition
to the Shapiro Motion). Biomet has replied. ECF 104 (as to the Ebert Motion); ECF 105 (as to
the Shapiro Motion). All submissions, except ECF 105, are accompanied by exhibits. Neither
side has requested a hearing and no hearing is needed. Local Rule 105.6.
Biomet has also moved for summary judgment on all counts (ECF 96), supported by a
memorandum of law. ECF 96-1 (collectively, the “Summary Judgment Motion”). Plaintiffs
oppose the Summary Judgment Motion. See ECF 103. Biomet has replied. ECF 106. All
submissions are accompanied by exhibits.
In addition, plaintiffs have filed a cross-motion for partial summary judgment as to several
of the affirmative defenses that Biomet asserted in its answer to the Amended Complaint. ECF 97
(“Plaintiffs’ Motion”). Biomet’s opposition is docketed at ECF 102. Plaintiffs have not replied
and the time to do so has expired.
While the motions were pending, Biomet filed a notice of supplemental authority (ECF
107) to draw the court’s attention to a recent decision authored by Judge George Hazel of this
Court in a case returned from MDL-2391. See Morris v. Biomet, Inc., ___ F. Supp. 3d ___, GJH18-2440, 2020 WL 5849482 (D. Md. Sept. 30, 2020). Thereafter, plaintiffs filed a similar
submission, highlighting recent decisions in Fitzsimmons v. Biomet Orthopedics, Inc., No.
219CV182FTM29NPM, 2020 WL 6784236, at *1 (M.D. Fla. Nov. 18, 2020); Bayes v. Biomet,
Inc., No. 4:13-CV-00800-SRC, 2020 WL 5095346, at *13 (E.D. Mo. Aug. 28, 2020); and
Nicholson v. Biomet, Inc., 18-CV-3057-CJW-KEM, 2020 WL 3399899 (N.D. Iowa Mar. 6, 2020).
No hearing is necessary to resolve the summary judgment motions. See Local Rule 105(6).
For the reasons that follow, I shall grant in part and deny in part the Shapiro Motion; grant the
4
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Ebert Motion; grant in part and deny in part Biomet’s Summary Judgment Motion; and grant in
part and deny in part Plaintiffs’ Motion.
I. Background
A. Factual Background 5
1.
The hip joint, also referred to as the hip, connects the thigh bone (the femur) to the pelvis.
ECF 43, ¶ 13; ECF 48, ¶ 13. It operates like a ball and socket: the femoral head, a ball-like
structure that sits atop the femur bone, rotates within the cupped surface at the bottom of the pelvis,
i.e., the acetabulum, which functions as a socket. See ECF 43, ¶ 13; ECF 48, ¶ 13. The hip joint
is lined with cartilage, lubricating tissue that cushions the femur and the acetabulum as the joint
bears weight. See ECF 43, ¶ 13; ECF 48, ¶ 13. With every step taken, the hip joint moves: “It
flexes, extends, and moves out to the side.” ECF 103-6 at 10.
Over time, the cartilage in the hip joint can wear down, leaving bone to rub against bone.
Id. This process can cause swelling, inflammation, and pain, which are symptoms associated with
arthritis. Id.
Total hip replacement surgery, also known as total hip arthroplasty, entails replacing the
body’s natural joint with an artificial one. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10.
Damaged bone and cartilage from the socket of the hip joint, along with part of the femur, is
replaced with an implant. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10. A hip implant may
be made of different materials, including metal alloys, polyethylene (a type of plastic), or ceramic
5
The factual background is largely drawn from the exhibits attached to the motions, as
well as from undisputed allegations in the Amended Complaint.
5
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material. See ECF 43, ¶ 14; ECF 48, ¶ 14. Implants are designed to restore the femoral head’s
smooth rotation and natural leg movement. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10
The Biomet device at issue has three components: an acetabular cup (also referred to as a
shell), a femoral head, and a taper insert. ECF 96-1 at 11. During total hip replacement surgery
using such a device, a surgeon inserts the acetabular cup into the hip socket. ECF 103-6 at 10.
The surgeon also removes the “diseased ball part” of the femur and replaces it with the femoral
head and the taper insert, which fit into the acetabular cup. See id.; ECF 96-1. The Magnum is
affixed to a metallic femoral stem, a separate device, which is fitted into the femur. ECF 103-6;
see ECF 96-5 at 4. Thus implanted, the femoral head functions as a ball within the acetabulum,
allowing for natural leg movement. Id.
The Magnum’s acetabular cup and femoral head are made out of cobalt chrome
molybdenum, a metal alloy. ECF 96-1 at 11; ECF 96-6 at 2. The taper insert is made of a titanium
alloy. For this reason, the Magnum is known as a metal-on-metal (“MoM”) device or system. See
ECF 96-13 at 11; ECF 103-6 at 2. Devices that contain a polyethylene (plastic) liner between the
femoral head and the acetabular cup, known as metal-on-polyethylene devices (“MoP”), are a
prominent alternative to the MoM design. See ECF 43, ¶ 14; ECF 96-1 at 11; ECF 103-6 at 8.
Like all Magnum devices distributed to medical providers, the Magnum device implanted
into Dr. McCoy included “Instructions for Use” (“IFU”). ECF 96-1 at 12; ECF 96-6 at 2. The top
of the IFU reads: “Attention Operating Surgeon.” ECF 96-6 at 2. Among other things, the IFU
contains sections titled “Warnings,” “Precautions,” and “Possible Adverse Effects.” Id. The
section on Warnings states, in relevant part, id.:
Improper selection, placement, positioning, alignment and fixation of the implant
components may result in unusual stress conditions which may lead to subsequent
reduction in the service life of the prosthetic components. Malalignment of the
components or inaccurate implantation may lead to excessive wear and/or failure
6
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of the implant or procedure.
The section on Possible Adverse Effects lists the following, in relevant part, id.:
1. Material sensitivity reactions. Implantation of foreign material in tissues may
result in histological reactions involving various sizes of macrophages and
fibroblasts. The clinical significance of this effect is uncertain, as similar changes
may occur as a precursor to or during the healing process. Particulate wear debris
and discoloration from metallic and polyethylene components of joint implants may
be present in adjacent tissue or fluid. It has been reported that wear debris may
initiate a cellular response resulting in osteolysis or osteolysis may be a result of
loosening of the implant. A low incidence of metal hypersensitivity has been
reported with failed metal on metal implants. The clinical relevance of these
findings is unclear, and it is not known whether metal hypersensitivity causes
implant failure.
2. Early or late postoperative infection and allergic reaction.
***
4. Loosening or migration of the implants may occur due to loss of fixation, trauma,
malalignment, bone resorption, excessive activity.
***
10. Fretting and crevice corrosion may occur at interfaces between components.
11. Wear and/or deformation of articulating surfaces.
***
15. Elevated metal ion levels have been reported with metal-on-metal articulating
surfaces. Although mechanical testing demonstrates that metal-on-metal
articulating surfaces produce a relatively low amount of particles, the total amount
of particulate produced in vivo throughout the service life of the implants remains
undetermined. The long-term biological effects of the particulate and metal ions are
unknown.
7
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2.
Plaintiff began experiencing pain in her right hip around 2006. ECF 96-3 at 3. 6 Beginning
in October 2006, she met with multiple doctors, including orthopedic specialists. See id. at 7-8,
12-15. She was diagnosed with arthritis in both her right and left hip. Id. at 7.
Dr. McCoy first saw orthopedic surgeon Dr. Marc Brassard in Annapolis, Maryland in
April 2007. Id. at 16. At that visit, plaintiff was five feet, five inches in height and weighed 192
pounds. Id. Dr. Brassard’s notes indicate that plaintiff reported constant pain in her right hip. Id.
During a visit in October 2007, Dr. Brassard recorded an impression of plaintiff as having bilateral
hip arthritis. Id. at 17. He identified total hip replacement surgery as a treatment option for her
right hip. See id. at 9-10. A month and a half later, Dr. McCoy indicated that she wished to
proceed with surgery. Id. at 10.
According to the transcript of Dr. McCoy’s deposition (ECF 96-4, “McCoy Tr.”), plaintiff
had consulted with other surgeons about hip replacement surgery. ECF 96-4 at 4, McCoy Tr. 5455. The other surgeons recommended MoP implants. Id. Dr. Brassard, however, recommended
a MoM device. Id. Plaintiff understood from her conversation with Dr. Brassard that a MoP
device might require a revision surgery in fifteen to twenty years, whereas a MoM device would
“probably last the rest of [her] life.” Id., McCoy Tr. 55. Dr. Brassard did not specifically
recommend the MoM device of any particular manufacturer or indicate which manufacturer’s
device he planned to use. Id. at 5, McCoy Tr. 60. Plaintiff trusted Dr. Brassard to choose the right
device for her. Id.
6
Throughout the Memorandum Opinion, any reference to “plaintiff” pertains only to Dr.
McCoy, not her spouse.
8
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On December 6, 2007, Dr. Brassard performed a total right hip replacement with the
Magnum on Dr. McCoy. Id. at 22. At his deposition (ECF 96-5, “Brassard Tr.”), Dr. Brassard
could not specifically recall whether he had previously read the Magnum’s IFU. Id. at 31. But,
he testified that, in general, he would review materials like the IFU. Id. In addition, Dr. Brassard
testified that at the time of plaintiff’s surgery in 2007, he was independently aware of some of the
“Possible Adverse Effects” indicated in the IFU, including “material sensitivity reactions,”
“elevated metal ions” of cobalt and chromium, and “postoperative infection.” Id. at 37-39.
Plaintiff had a follow-up appointment with Dr. Brassard three months after the surgery.
ECF 96-3 at 12. According to Dr. Brassard’s notes, plaintiff was doing well. Id. Her right hip
showed “good alignment with no evidence of loosening” of the implant. Id.
In May 2008, Dr. McCoy saw Dr. Brassard a few days after experiencing a fall. Id. at 20.
Dr. McCoy had “landed directly on her knee,” which “pushed up on her hip.” Id. She was
experiencing pain in her right hip. Id. Dr. Brassard observed that her right hip still showed “good
alignment.” Id.
Plaintiff attended a scheduled check-up with Dr. Brassard on October 22, 2008, over ten
months after her surgery. Id. at 24. According to Dr. Brassard, x-rays showed that the Magnum
continued to demonstrate “good alignment,” with “no evidence of loosening.” Id.
Over the following two years, Dr. McCoy met with several doctors regarding a range of
issues related to musculoskeletal pain, including but not limited to pain in both of her hips, back
pain, sciatic joint pain, fibromyalgia, and psoriatic arthritis. See id. at 3-5, 27-31. At an
appointment on July 10, 2009, plaintiff reported that the pain for which she was seeking treatment
was distinct from the pain that led her right hip replacement. Id. at 4.
9
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Plaintiff met with Dr. Brassard again on March 22, 2010, and reported renewed right hip
pain among various other issues. Id. at 21. The medical record from that visit is incomplete; it
indicates that Dr. Brassard recorded his observations about the alignment of her right hip, but cuts
off before the completion of that portion of the record. See id.
Dr. Ebert, an orthopedic surgeon at MedStar Union Memorial Hospital in Baltimore,
examined plaintiff for the first time on April 17, 2010. See ECF 96-3 at 10; ECF 95-2. Dr. Ebert
observed that plaintiff had “tremendous restriction of motion about the right hip” and that her right
leg was three-quarters of an inch shorter than her left. ECF 96-3 at 10. He also noted: “[Plaintiff]
is followed by Dr. Brassard and he has evaluated her from the infection stand point and this has
been entirely negative.” Id.
According to Dr. Ebert’s notes, radiographs taken of plaintiff’s right hip showed, in
relevant part, ECF 96-3 at 10:
[A] vertical orientation of the acetabular component consistent with loosening
when compared to the immediate post-operative x-ray . . . . The cup is now changed
in its position . . . . There also is radio lucency consistent with loosening around
the acetabular component and in fact the patient has osteolysis of the medial calcar
of the femur suggestive of the fact that she may also have a granulomatous reaction
about her hip related to the metal on metal implant.
Based on his observations, Dr. Ebert recommended revision surgery on plaintiff’s right
hip. Id. He performed the revision surgery on May 10, 2010. Id. at 36. During the surgery, Dr.
Ebert found purulence, i.e., purulent fluid or pus, in plaintiff’s right hip, which indicated the
possible presence of infection. Id. at 34. The femoral stem was intact. Id. He removed the
acetabular cup of the Magnum implant and replaced it with “an antibiotic-impregnated cement and
a liner for an acetabular shell.” Id.
Tests were conducted on the purulent fluid from plaintiff’s right hip, which “showed no
evidence of any growth.” Id. Tests conducted on fluid drawn from plaintiff’s hip six weeks after
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the surgery similarly “showed no evidence of any growth.” Id. Dr. Ebert’s notes state, in relevant
part: “[I]n light of this it was felt that the debris that was found that was purulent material was
most likely debris from the metal-on-metal prosthetic device and not gross purulence.” Id.
On March 1, 2011, Dr. Ebert performed a second revision surgery on plaintiff’s right hip.
Id.
He replaced the Magnum’s acetabular cup with a different product that contained a
polyethylene liner. Id. Thereafter, plaintiff also underwent surgery for total left hip replacement,
during which Dr. Ebert implanted an MPE device. Id. at 33.
Additional facts are discussed, infra.
B. Procedural History
As noted, on October 2, 2012, the JPML created MDL No. 2391 in the Northern District
of Indiana, assigning Judge Miller to coordinate pretrial proceedings for all lawsuits alleging
defects with Biomet’s Magnum and a predecessor product. See In re: Biomet, 896 F. Supp. 2d at
1340 n.2, 1341. At the time, Biomet opposed centralization, arguing that “individualized, plaintiffspecific issues will predominate among the actions.” Id. at 1339-40. But, the JPML rejected that
contention. It observed that “‘almost all injury litigation involves questions of causation that are
case- and plaintiff-specific. Such differences have not been an impediment to centralization in the
past.’” Id. at 1340 (quoting In re Wright Med. Tech., Inc., Conserve Hip Implant Prods. Liab.
Litig., 844 F. Supp. 3d 1371, 1372 (J.P.M.L. 2012)). And, it found that the “central issues in these
cases may well be whether a common defect has led to the injuries alleged.” Id. Thus, because
the lawsuits “share factual questions concerning design, manufacture, marketing and performance
of Biomet’s M2A Magnum system,” the JPML concluded that “centralization will serve the
convenience of the parties and witnesses and promote the just and efficient conduct of the
litigation[.]” Id.
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By order of March 14, 2016, Judge Miller permitted any plaintiff whose case would have
been subject to transfer to MDL No. 2391 to file his or her case directly in the Northern District
of Indiana. MDL-2391, Dkt. No. 3096. As Judge Miller explained, permitting eligible plaintiffs
to do so was intended to “eliminate delays associated with the transfer cases from other federal
district courts to [the MDL] and to promote judicial efficiency.” Id. at 2. However, direct filing
was “contingent on the understanding that upon completion of all pretrial proceedings . . . th[e]
court w[ould], pursuant to 28 U.S.C. § 1404(a), transfer the case to a federal district of proper
venue, as defined by 28 U.S.C. § 1391, unless the parties expressly agree to an alternate venue.”
Id.
As mentioned, plaintiffs filed suit in this Court in 2012. ECF 1. The case was transferred
to the MDL on October 23, 2012. ECF 21.
In the consolidated pretrial proceedings, the Plaintiffs’ Executive Committee and Biomet
each submitted expert opinion testimony. In re Biomet M2a Magnum Hip Implant Prod. Liab.
Litig., No. 3:12-MD-2391, 2017 WL 10845178, at *1 (N.D. Ind. Dec. 21, 2017). The expert
evidence that the Executive Committee sought to admit included the opinions of Mari Truman, a
biomedical engineer, and George S. Kantor, M.D., an orthopedic surgeon. Id. at *1, 10, 15.
Plaintiffs designated Ms. Truman and Dr. Kantor as “general causation” experts pursuant to Fed.
R. Civ. P. 26, as discussed infra.
According to Judge Miller, Ms. Truman opined, id. at 11:
(1) [A]ll metal-on-metal devices are defectively designed; (2) metal-onpolyethylene devices are a reasonably safe alternative to metal-on-metal devices;
(3) Biomet should have conducted additional testing of its metal-on-metal devices;
(4) Biomet should have provided additional and more aggressive warnings to
surgeons about the risks associated with its metal-on-metal devices; (5) Biomet
downplayed the risks of its metal-on-metal devices; and (6) excessive metal ions
cause certain clinical effects in patients with metal-on-metal devices.
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Specifically, Ms. Truman’s sixth opinion was that “Biomet’s metal-on-metal devices can
cause ‘elevated metal ions with immune response complications ... and tissue necrosis.’” Id. at 14
(quoting MDL 2391, Dkt. No. 3387-2 at 86). In other words, Ms. Truman’s proffered report
described Biomet’s MoM hip implants, including the Magnum, as prone to “excessive wear,”
which “produces elevated metal ions, which cause immune response complications and tissue
necrosis.” 2017 WL 10845178, at *14.
Biomet sought to exclude Ms. Truman’s opinions under Rule 702 and Daubert, contending
that they were not reliable and that Ms. Truman was not qualified to render them. Id. at 11. Judge
Miller rejected Biomet’s arguments and determined that all of Ms. Truman’s opinions were
admissible, noting that several of Biomet’s challenges were directed to the weight, not the
admissibility, of the evidence. Id. at 11-15. As to Ms. Truman’s sixth opinion, Judge Miller ruled:
“Ms. Truman can't testify as an expert on the clinical effects of metal ions, but she can permissibly
rely on other experts’ opinions that metal ions cause clinical effects to support her opinion that
metal-on-metal devices are unreasonably dangerous. . . . That’s what she did in her report, so her
opinion is admissible.” Id. at 15.
Biomet also filed a Daubert motion to exclude Dr. Kantor’s opinions. Id. Dr. Kantor
opined in his report, id.:
(1) [M]etal-on-metal devices generally, and Biomet’s metal-on-metal devices
specifically, are defectively designed and their risks outweigh their benefits; (2)
Biomet didn’t conduct sufficient testing and monitoring of its devices; (3) Biomet’s
instructions for use were inadequate; and (4) elevated metal ions might cause
cancer.
Judge Miller ruled that Dr. Kantor’s opinions as to the design defects and associated risks
of Biomet devices specifically were inadmissible, but that Dr. Kantor’s opinions as to the design
defects and associated risks of MoM devices generally were admissible. Id. at 19. Judge Miller
also excluded the opinion “about the sufficiency of Biomet’s testing and clinical studies.” Id. But,
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he allowed Dr. Kantor’s opinions regarding the Biomet devices’ IFUs and the effects of elevated
metal ions. Id.
In the MDL, Biomet also moved for summary judgment as to some of the product liability
claims, on the basis of a “‘state of the art’ theory.’” In re Biomet M2A Magnum Hip Implant Prod.
Liab. Litig., No. 3:12-MD-2391, 2018 WL 776776, at *1 (N.D. Ind. Feb. 8, 2018). According to
Biomet, there were no genuine disputes of material fact regarding its state-of-the-art assertions.
Id. Biomet contended, id.:
[I]ts metal-on metal devices were ‘state of the art’ from the time they were first
designed, manufactured, and marketed until 2013 (when Biomet stopped producing
metal-on metal devices), or at least 2011 (when the FDA issued a public notice of
concern regarding metal-on metal hip implants)[.]
Judge Miller denied defendants’ motion but declined to reach the merits. He reasoned that
a ruling on the merits would require synthesizing “the state-of-the-art law of nineteen different
states,” which would “indefensibly slow the process in this docket.” Id. at 3.
Therefore, Judge Miller transferred plaintiffs’ suit back to this Court on September 19,
2018. MDL-2391, Dkt. No. 3724; see ECF 22. In the transfer order, Judge Miller explained that
of the approximately 3,000 cases that were part of the MDL, 90% had settled as part of a master
settlement agreement reached in 2014. See MDL-2391, Dkt. No. 3738 at 2-3, 6; see also MDL2391, Dkt. No. 1317 (Master Settlement Agreement). The remaining cases were being sent to
their proper districts for trial. MDL-2391, Dkt. No. 3738 at 13. Further, Judge Miller observed,
id.:
Any case might present its own atypical need, but for the most part, here is what
will be left to do after remand: (1) additional, non-duplicative, case-specific
depositions; (2) disclosure of case-specific experts, service of case-specific expert
reports, and case-specific expert depositions; (3) any motions addressing the
testimony of case-specific experts; (4) any motions (or, perhaps, trial objections)
directed to the recorded trial testimony of the plaintiffs’ generic experts; (5) any
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other motions addressing the testimony of generic or case-specific experts; and (6)
any summary judgment motions.
Since the case was returned to this Court, both sides have gathered opinion evidence from
expert witnesses. As noted, plaintiffs seek to present expert testimony from Dr. Ebert and Dr.
Shapiro.
Biomet has also retained three experts in this litigation: Steven Kurtz, PH.D., a
biomedical engineer; Thomas Fleeter, M.D.; and Thomas W. Bauer, M.D., PH.D., a pathologist.
The reports produced by Dr. Kurtz and Dr. Bauer have each been submitted as exhibits. See ECF
96-13 (Dr. Kurtz’s report); ECF 96-15 (Dr. Bauer’s report). Dr. Fleeter’s report appears not to
have been successfully appended as an exhibit. ECF 96-14 contains a Declaration of Thomas
Fleeter, M.D., which references an expert report. But, there is no such report among the exhibits.
The pending motions followed. Thereafter, Biomet filed a notice of supplemental authority
to draw the court’s attention to Morris, 2020 WL 5849482. ECF 107. Plaintiffs filed a similar
submission, highlighting recent decisions in Fitzsimmons v. Biomet Orthopedics, Inc., No.
219CV182FTM29NPM, 2020 WL 6784236, at *1 (M.D. Fla. Nov. 18, 2020), Bayes v. Biomet,
Inc., No. 4:13-CV-00800-SRC, 2020 WL 5095346, at *13 (E.D. Mo. Aug. 28, 2020), Nicholson
v. Biomet, Inc., 18-CV-3057-CJW-KEM, 2020 WL 3399899 (N.D. Iowa Mar. 6, 2020). Each case
involves distinct fact patterns.
II. The Daubert Motions
According to plaintiffs’ Rule 26 disclosures, which Biomet has submitted as an exhibit to
its Summary Judgment Motion (ECF 96-9), plaintiffs seek to introduce evidence from five experts.
Id. Plaintiffs have designated three of their experts as “general causation” experts and two as
“specific causation” experts. Id.
“For specific causation, the plaintiff must ‘demonstrate that the substance actually caused
injury in her particular case.’” In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod.
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Liab. Litig. (No II) MDL 2502, 892 F.3d 624, 642–43 (4th Cir. 2018) (citation omitted). “Specific
causation is often distinguished from general causation, which refers to the more general issue of
whether a substance has the potential to cause the plaintiff's injury.” Guinn v. AstraZeneca Pharm.
LP, 602 F.3d 1245, 1249 n.1 (11th Cir. 2010) (emphasis added); see In re Lipitor, 892 F.3d at 65859 (discussing Guinn).
The three general causation experts identified by plaintiffs are Mari Truman; George
Kantor, M.D.; and Francis H. Gannon, M.D., a Professor of Pathology & Immunology and
Orthopedic Surgery. Id. Each expert has produced a written report and is expected to testify via
previously recorded deposition testimony. Id.
In addition, plaintiffs have designated Dr. Shapiro and Dr. Ebert, both of whom are
orthopedic surgeons, as “specific causation experts.” Id. Dr. Shapiro’s opinion evidence is
contained in a four-page report dated May 12, 2019 (ECF 94-2), and in the transcript of his
deposition, which took place on February 27, 2020. ECF 94-3 (“Shapiro Tr.”). In his report,
which is described further below, Dr. Shapiro opines that Dr. McCoy experienced “‘[a]dverse
tissue reaction’ to metal debris,’” which was “the result of the breakdown and failure of the metalon-metal [Magnum].” ECF 94-2 at 5. According to Dr. Shapiro, Dr. McCoy’s revision surgeries
“were required as a result of the failure of” her Magnum implant. Id. And, the report states: “There
is no other explanation.” Id.
As indicated, Dr. Ebert was plaintiff’s treating physician; he performed two revision
surgeries on plaintiff’s right hip. Dr. Ebert’s opinion evidence is contained in a one-page affidavit,
dated February 9, 2015 (ECF 95-2), and in the transcript of his deposition, which took place on
September 15, 2016. ECF 95-3 (“Ebert Tr.”). In his affidavit, Dr. Ebert opines that Dr. McCoy’s
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revision surgery of May 10, 2010, “was more likely than not due to symptoms linked to the metalon-metal design of [her] Biomet device.” ECF 95-2.
As noted, Biomet has moved to exclude the opinions of both doctors, pursuant to Rule 702
and Daubert, 509 U.S. 579.
A. Legal Standard
1.
Pursuant to Rule 104(a) of the Federal Rules of Evidence (“F.R.E.”), the court is
responsible for determining “preliminary questions concerning the qualification of a person to be
a witness” and “the admissibility of evidence.” This includes the admissibility of expert testimony
under F.R.E. 702.
In Daubert, 509 U.S. at 597, the Supreme Court made clear that scientific evidence is
admissible under F.R.E. 702 if “it rests on a reliable foundation and is relevant.” In Kumho Tire
Co., Ltd. v. Carmichael, 526 U.S. 137, 141 (1999), the Supreme Court extended the principles
pertaining to scientific expert testimony to all expert testimony requiring technical or specialized
knowledge. Notably, the party seeking to present expert testimony must establish its admissibility
by a preponderance of the evidence. See Cady v. Ride-Away Handicap Equipment Corp., 702 Fed.
App’x 120, 124 (4th Cir. 2017) (citing Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199 (4th
Cir. 2001)); Maryland Casualty Co. v. Therm-O-Disc., Inc., 137 F.3d 780, 783 (4th Cir. 1998);
Fireman’s Fund Ins. Co. v. Tecumseh Prods. Co., 767 F. Supp. 2d 549, 553 (D. Md. 2011); Casey
v. Geek Squad ® Subsidiary Best Buy Stores, L.P., 823 F. Supp. 2d 334, 340 (D. Md. 2011).
Rule 702 of the F.R.E. governs expert testimony. It provides:
A witness who is qualified as an expert by knowledge, skill, experience, training,
or education may testify in the form of an opinion or otherwise if:
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(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 has reliably applied the principles and methods to the facts of
the case.
Pursuant to Rule 702, a properly qualified expert witness may testify regarding technical,
scientific, or other specialized knowledge in a given field if the testimony would assist the trier of
fact in understanding the evidence or to determine a fact in issue, and the testimony is both reliable
and relevant. United States v. Young, 916 F.3d 368, 379 (4th Cir. 2019). The rule “was intended
to liberalize the introduction of relevant expert evidence.” Westberry v. Gislaved Gummi AB, 178
F. 3d 257, 261 (4th Cir. 1999).
Under Rule 702, the district judge “must ensure that the expert is qualified and that the
expert’s testimony is both relevant and reliable.” United States v. Smith, 919 F.3d 825, 835 (4th
Cir. 2019) (citing Daubert, 509 U.S. at 589). The trial court serves a “gatekeeping role” by making
pretrial determinations “of whether the reasoning or methodology underlying the testimony is
scientifically valid and of whether that reasoning or methodology properly can be applied to the
facts in issue.” Daubert, 509 U.S. at 592–93. This gatekeeper role helps to ensure that the expert’s
testimony “rests on a reliable foundation and is relevant to the task at hand.” Id. at 597; see Lord
& Taylor, LLC v. White Flint, L.P., 849 F.3d 567, 577 (4th Cir. 2017).
However, the Supreme Court did not intend the gatekeeper role to “supplant the adversary
system or the role of the jury: ‘[v]igorous 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.’” Allison v. McGhan Medical Corp., 184 F.3d 1300, 1311–12
(11th Cir. 1999) (quoting Daubert, 509 U.S. at 596); see United States v. Moreland, 437 F. 3d 424,
431 (4th Cir. 2006) (recognizing that “expert testimony is subject to testing by vigorous cross18
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examination, presentation of contrary evidence, and careful instruction on the burden of proof”).
Thus, the district court “is not intended to serve as a replacement for the adversary system, and
consequently, the rejection of expert testimony is the exception rather then the rule.” In re Lipitor
(Atorvastatin Calcium) Mktg., Sales Practices & Production Liab. Litig. (No. II), 892 F.3d 624,
631 (4th Cir. 2018) (citation and quotation marks omitted).
As noted, to be admissible, scientific evidence must be both reliable and relevant. Daubert,
509 U.S. at 597. To be reliable, the testimony must be grounded “in the methods and procedures
of science,” and it must be something more than subjective belief or unsupported assumptions. Id.
at 589–90; see Belville v. Ford Motor Co., 919 F.3d 224, 232 (4th Cir. 2019); Oglesby v. Gen.
Motors Corp., 190 F.3d 244, 250 (4th Cir. 1999). Moreover, the evidence or testimony must be
relevant to the extent that it will “assist the trier of fact to understand the evidence or to determine
a fact in issue.” Daubert 509 U.S. at 591; see also In re Lipitor (Atorvastatin Calcium) Mktg.,
Sales Practices & Prod. Liab. Litig. (No II) MDL 2502, 892 F.3d 624, 631 (4th Cir. 2018); Nease
v. Ford Motor Co., 848 F.3d 219, 229 (4th Cir. 2017); United States v. Forrest, 429 F.3d 73, 80–
81 (4th Cir. 2005). An expert’s testimony is relevant if it has “‘a valid scientific connection to the
pertinent inquiry.’” Belville, 919 F.3d at 232 (citation omitted).
Daubert articulated five factors that the trial court should consider in evaluating the
reliability of an expert’s reasoning or methodology: (1) whether the particular scientific theory has
been or can be tested; (2) whether the theory has been subjected to peer review and publication;
(3) the known or potential rate of error; (4) whether there are standards controlling the method;
and (5) whether the technique has gained general acceptance in the relevant scientific community.
Daubert, 509 U.S. at 593–94; see Belville, 919 F.3d at 233; United States v. Crisp, 324 F.3d 261,
265–66 (4th Cir. 2003).
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Notably, the factors are “‘not exhaustive.’” Belville, 919 F.3d at 233 (citation omitted).
Moreover, the evaluation “is always a flexible one . . . .” Oglesby, 190 F.3d at 250. As a whole,
the factors are meant to ensure that “an expert, whether basing his testimony upon professional
studies or personal experience, employs in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.” Kumho Tire Co., 526 U.S. at 152.
Thus, the factors are meant to be “helpful, not definitive,” and not all factors necessarily apply in
a given case. Id. at 151; see Nease, 848 F.3d at 229. Indeed, the Supreme Court has said that the
factors are not a “checklist.” Kumho Tire Co., 526 U.S. at 150.
With regard to an expert’s qualifications, the Advisory Committee’s notes to Rule 702
provide that experience alone, or in conjunction with “other knowledge, skill, training or
education,” can provide sufficient foundation for expert testimony. See Kumho Tire Co., 526 U.S.
at 156 (stating that “no one denies that an expert might draw a conclusion from a set of observations
based on extensive and specialized experience.”). On the other hand, an expert witness may not
offer an opinion where the subject matter goes beyond the witness’s area of expertise. See Berry
v. City of Detroit, 25 F.3d 1342, 1351 (6th Cir. 1994); see also Smith v. Central Admixture Pharm.
Servs., Inc., AW–07–3196, 2010 WL 1137507, at *3 (D. Md. Mar. 19, 2010) (“It is well
established that ‘general expertise is not sufficient to qualify [an expert] to testify on a matter that
requires particularized knowledge, training, education, or experience.’” (quoting Fitzgerald v.
Smith & Nephew Richards, Inc., JFM-95-3870, 1999 WL 1489199, at *3 (D. Md. Dec. 30, 1999),
aff'd sub nom. Fitzgerald v. Smith & Nephew, Inc., 11 F. App’x 335 (4th Cir. 2001))).
The trial court “should meticulously focus on the expert’s principles and methodology, and
not on the conclusions that they generate.” McDowell v. Brown, 392 F.3d 1283, 1298 (11th Cir.
2004); see Bresler, 855 F.3d at 195. Moreover, expert testimony need not be “‘irrefutable or
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certainly correct’” in order to be admissible. Moreland, 437 F. 3d at 431 (citation omitted); see
Daubert, 509 U.S. at 596; Bresler v. Wilmington Trust Co., 855 F.3d 178, 195 (4th Cir. 2017);
Westberry, 178 F.3d at 261. Therefore, “‘questions regarding the factual underpinnings of the
[expert witness’] opinion affect the weight and credibility’ of the witness’ assessment, ‘not its
admissibility.” Bresler, 855 F.3d at 195 (citation omitted).
But, a court should exclude testimony based on “belief or speculation,” Oglesby, 190 F.3d
at 250, or when not supported by the record. See Bryte ex rel. Bryte v. Am. Household, Inc., 429
F.3d 469, 477 (4th Cir. 2005); Tyger Const. Co. v. Pensacola Const. Co., 29 F.3d 137, 142 (4th
Cir. 1994); Casey, 823 F. Supp. 2d at 340. Moreover, “nothing in either Daubert or the Federal
Rules of Evidence requires a district court to admit opinion evidence that is connected to existing
data only by the ipse dixit of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).
Similarly, a court may exercise its “discretion to find that there is ‘simply too great an analytical
gap between the data and the opinion proffered.’” Pugh v. Louisville Ladder, Inc., 361 F. App’x
448, 454 n.4 (4th Cir. 2010) (quoting Joiner, 522 U.S. at 146).
Further, proposed testimony that concerns matters within the common knowledge and
experience of a lay juror does not pass muster. United States v. Dorsey, 45 F.3d 809, 814 (4th Cir.
1995); Kopf v. Skyrm, 993 F.2d 374, 377 (4th Cir. 1993). “While the fit between an expert’s
specialized knowledge and experience and the issues before the court need not be exact . . . an
expert’s opinion is helpful to the trier of fact, and therefore relevant under Rule 702, ‘only to the
extent the expert draws on some special skill, knowledge or experience to formulate that opinion.’”
Shreve v. Sears, Roebuck & Co., 166 F. Supp. 2d 378, 392–393 (D. Md. 2001) (quoting Ancho v.
Pentek Corp., 157 F.3d 512, 518 (7th Cir. 1998)).
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In addition, Rule 702 does not relieve the party seeking admission of meeting the
requirements of other applicable rules. This includes Rule 403’s instruction that evidence may be
excluded for undue prejudice, confusion of the issues, or a potential to mislead the jury. Casey,
823 F. Supp. 2d at 341; see Westberry, 178 F.3d at 261 (“[G]iven the potential persuasiveness of
expert testimony, proffered evidence that has a greater potential to mislead than to enlighten should
be excluded.”).
2.
Of relevance here, Fourth Circuit case law establishes particular rules for assessing the
reliability of expert testimony regarding medical causation under Rule 702. The method, or
technique, for rendering an opinion regarding the cause of a medical problem is commonly referred
to as a “differential diagnosis.” See Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir.
1999). This “standard scientific technique” involves “identifying the cause of a medical problem
by eliminating the likely causes until the most probable one is isolated.” Id. (citing Baker v. Dalkon
Shield Claimants Trust, 156 F.3d 248, 252–53 (1st Cir.1998)); see Cooper v. Smith & Nephew,
Inc., 259 F.3d 194, 200 (4th Cir. 2001) (discussing Westberry).
In Westberry, 178 F.3d 257, the Court “held that a reliable differential diagnosis provides
a valid foundation for an expert opinion under Rule 702.” Cooper, 259 F.3d at 200 (emphasis in
original). The Westberry Court said, 178 F.3d at 262: “[T]ypically, though not invariably,” a
reliable differential diagnosis “is performed ‘after physical examinations, the taking of medical
histories, and the review of clinical tests, including laboratory tests . . . .’” (citation omitted).
Generally, a reliable differential diagnosis “is accomplished by determining the possible
causes for the patient’s symptoms and then eliminating each of these potential causes until
reaching one that cannot be ruled out or determining which of those that cannot be excluded is the
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most likely.” Id. (collecting cases). “‘Although a reliable differential diagnosis need not rule out
all possible alternative causes, it must at least consider other factors that could have been the sole
cause of the plaintiff's injury.’” In re Lipitor, 892 F.3d at 644 (quoting Guinn, 602 F.3d at 1253).
Moreover, an expert offering a differential diagnosis “‘must provide a reasonable explanation as
to why he or she has concluded that any alternative cause suggested by the defense was not the
sole cause.’” In re Lipitor, 892 F.3d at 644 (quoting Best v. Lowe’s Home Centers, Inc., 563 F.3d
171, 179 (6th Cir. 2009)).
B. The Ebert Motion
During discovery plaintiffs identified Dr. Ebert, one of Dr. McCoy’s treating physicians,
as an expert, pursuant to Rule 26(a)(2). ECF 96-9 at 3. The disclosure states, in relevant part:
“Dr. Ebert is expected to testify as a specific causation expert consistent with the diagnosis, care,
and treatment contained in Plaintiff’s medical records and consistent with his July 28, 2016
deposition testimony.” Id. at 3-4. 7 Dr. Ebert did not provide a written report.
During discovery, however, plaintiffs produced a one-page affidavit prepared by Dr. Ebert
for purposes of this litigation. See ECF 95-2. The affidavit, dated February 9, 2015, contains the
caption for this case while part of the MDL. Id. The affidavit provides, in full, id:
1. I am an orthopedic surgeon based in Baltimore, Maryland.
2. On or about May 10, 2010, I performed a right-side hip revision surgery on my
patient Joanna McCoy, who also is the plaintiff in the above legal proceeding.
3. In the revision operative report where I removed the patient’s failed Biomet
Magnum hip device, I described encountering a “large amount of purulent fluid”
from the hip joint.
7
As noted, the transcript of Dr. Ebert’s deposition is dated September 15, 2016. See ECF
100-3. Thus, it appears that plaintiffs erred in their Rule 26 disclosure by referencing “July 28,
2016 deposition testimony.”
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4. Furthermore, the pathology report for the revision surgery describes bone and
tissue with “necrosis, granulation, acute and chronic inflammation.” I also
examined the patient prior to revision on April 17, 2010, and found no evidence of
infection.
5. Based upon my professional training and experience as an orthopedic surgeon,
it is within a reasonable degree of medical certainty that the above revision surgery
was more likely than not necessary due to symptoms linked to the metal-on-metal
design of my patient’s Biomet device.[8]
Dr. Ebert was questioned by defense counsel about this affidavit at his 2016 deposition.
Biomet seeks to exclude Dr. Ebert’s “later-formed causation opinions,” expressed in his
affidavit and in his deposition testimony, for two reasons. ECF 95-1 at 1. First, Biomet contends
that Dr. Ebert’s opinions are inadmissible because they were not included in plaintiffs’ Rule 26
disclosure as to expert witnesses. And, defendants argue that Dr. Ebert’s opinions, as expressed
both in his affidavit and in his deposition testimony, are unreliable and, thus, inadmissible under
Rule 702.
8
As indicated, Dr. Ebert’s affidavit sets forth his opinion “within a reasonable degree of
medical certainty.” ECF 95-2. However, Rule 702 and Rule 703 “require a reliable methodology
and reliable data but nowhere require a reasonable degree of medical certainty.” In re Paoli R.R.
Yard PCB Litig., 35 F.3d 717, 751 (3d Cir. 1994) (citing, inter alia, Daubert, 509 U.S 587-88;
United States v. Cyphers, 553 F.2d 1064, 1072 (7th Cir. 1977), cert. denied 434 U.S. 843 (1977));
see also Samuel v. Ford Motor Co., 112 F. Supp. 2d 460, 470 (D. Md. 2000) (stating that the
Federal Rules of Evidence do not require an expert to “affirmatively state that the opinion is held
to a ‘reasonable degree of certainty or probability’”), aff’d sub nom. Berger v. Ford Motor Co., 95
F. App’x 520 (4th Cir. 2004).
Federal law controls the determination of admissibility. But, it bears mentioning that,
under Maryland law, an expert’s opinion must be held to a “‘reasonable degree of medical
probability . . . .’” Am. Radiology Servs., LLC v. Reiss, 470 Md. 555, 580, 236 A.3d 518, 532
(2020) (citation omitted). An expert witness is not required to base his opinion upon a reasonable
degree of medical certainty. Id.; see Rite Aid Corp. v. Levy-Gray, 162 Md. App. 673, 711, 876
A.2d 115, 138 (2005) (“An opinion held to a reasonable degree of medical probability is
sufficient.”), aff’d, 391 Md. 608, 894 A.2d 563 (2006).
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As to Biomet’s first argument, defendants assert that Dr. Ebert “‘formulated opinions going
beyond what was necessary to provide appropriate care for the injured party [and] step[ped] into
the shoes of a retained expert for purposes of Rule 26(a)(2).’” ECF 95-1 at 5 (quoting Thomas v.
Consol. Rail Corp., 169 F.R.D. 1, 2 (D. Mass. 1996)). According to defendants, Dr. Ebert did not
formulate the opinion that the Magnum was the cause of plaintiff’s revision surgeries during the
course of his treatment of Dr. McCoy. Rather, he developed and articulated the opinion for the
first time in response to this litigation, several years after performing surgery on plaintiff. ECF
95-1 at 5. Therefore, Biomet asserts that the opinion “exceeds the scope of treating physician
testimony and is inadmissible without an expert report.” Id. at 6.
Biomet principally relies on the reasoning of Judge Paul Grimm in Sullivan v. Glock, Inc.,
175 F.R.D. 497, 501 (D. Md. 1997). 9 That decision states, in pertinent part, id.:
To the extent that the source of the facts which form the basis for a treating
physician’s opinions derive from information learned during the actual treatment
of the patient—as opposed to being subsequently supplied by an attorney involved
in litigating a case involving the condition or injury—then no Rule 26(a)(2)(B)
statement should be required.
As Biomet notes, however, Fed. R. Civ. P. 37(c)(1) provides a limited exception to the
requirement of Rule 26(a)(2)(B). Rule 37(c)(1) states (emphasis added):
If a party fails to provide information or identify a witness as required by Rule 26(a)
or (e), the party is not allowed to use that information or witness to supply evidence
on a motion, at a hearing, or at a trial, unless the failure was substantially justified
or harmless.
See Sullivan, 175 F.R.D. at 503-04 (discussing the rule); see also Benjamin v. Sparks, ___ F.3d
___, 2021 WL 161981, at *6 (4th Cir. Jan. 19, 2021) (addressing the “five factors that should
9
In 1997, Judge Grimm was a U.S. magistrate judge. He is now a federal district judge in
Maryland.
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guide a district’ court’s analysis” of “substantial justification or harmlessness” under Rule
37(c)(1)).
Biomet also contends that Dr. Ebert’s causation opinions are “based solely on his own-sayso,” i.e., ipse dixit, rather than on “any scientific knowledge.” ECF 95-1 at 7. The gist of Biomet’s
argument is that Dr. Ebert’s opinion lack both foundation and a reliable methodology. Even if Dr.
Ebert’s opinions survive challenge under Rule 26(a)(2)(B), or are subject to the Rule 37(c)(1)
exception, they would nevertheless remain inadmissible under 702. Because I agree that the
opinion concerning the defective design of the device is not reliable, I need not resolve the dispute
regarding Rule 26. I turn to the issue of reliability under Rule 702 and Daubert.
Defendant emphasizes that at Dr. Ebert’s deposition, he stated that the revision surgery he
performed on Dr. McCoy in 2010 was his only experience with hip revision surgery involving the
Magnum. Id. (citing ECF 95-3 at 17, Ebert Tr. 61-62). Moreover, defendants note that Dr. Ebert
conceded that he has not conducted studies on “ingrowth of the Magnum” as compared to other
hip implant devices. ECF 95-1 (citing ECF 95-3, Ebert Tr. 62). And, Dr. Ebert could not identify
any medical or scientific publications that support his opinion regarding Dr. McCoy. ECF 95-1
(citing ECF 95-3, Ebert Tr. 62-63).
Plaintiffs counter that Dr. Ebert conducted a reliable differential diagnosis. They invoke
the Fourth Circuit’s statement that an admissible opinion of a medical expert regarding causation
need not “‘rule out every possible alternative cause of a plaintiff’s illness.’” ECF 100 at 7 (quoting
Westberry, 178 F.3d at 265). Plaintiffs cite Dr. Ebert’s statements in his deposition testimony that
elaborate on the opinion expressed in his affidavit.
In particular, plaintiffs note that Dr. Ebert expressly ruled out Rheumatoid arthritis as a
cause of Dr. McCoy’s revision surgeries. ECF 100 at 7-8 (citing ECF 95-3 at 7, Ebert Tr. 21).
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Plaintiffs also highlight that Dr. Ebert testified that during his treatment of Dr. McCoy he found
x-ray evidence of the loosening of her Magnum’s acetabular cup. ECF 100 at 8 (citing ECF 95-3
at 10-11, Ebert Tr. 36-37). Further, Dr. Ebert testified that he ordered a pathology analysis of
tissue samples (i.e., cultures) taken from plaintiff’s hip during her 2010 revision surgery, and that
the analysis indicated that there was no bacterial growth in the cultures. ECF 100 at 8 (citing ECF
95-3 at 12, 14, Ebert Tr. 42-43, 49, 52). According to plaintiffs, the negative results as to bacterial
growth support Dr. Ebert’s conclusion that the purulence and debris found in plaintiff’s hip were
the results of an inflammatory response caused by the Magnum. ECF 100 at 8. Finally, plaintiffs
characterize Dr. Ebert’s treatment of Dr. McCoy as a sufficiently reliable methodology to support
his opinions. ECF 100 at 9.
Multiple federal appellate courts have stated plainly that expert testimony from treating
physicians is subject to the same admissibility requirements as the testimony of other expert
witnesses. See, e.g., Musser v. Gentiva Health Servs., 356 F.3d 751, 757 (7th Cir. 2004) (“‘[W]e
do not distinguish the treating physician from other experts when the treating physician is offering
expert testimony regarding causation.’”) (citation omitted); Turner v. Iowa Fire Equip. Co., 229
F.3d 1202, 1207 (8th Cir. 2000). Standing alone, Dr. Ebert’s affidavit clearly fails to pass muster
under Rule 702 and Daubert. It contains a single, conclusory sentence of analysis, which states
that Dr. McCoy’s 2010 revision surgery “was more likely than not necessary due to symptoms
linked to” the MoM design of her Magnum implant. ECF 95-2. The affidavit does not address
alternative causes of the revision surgery, let alone eliminate them, as required by Westberry, 178
F.3d at 262.
Dr. Ebert avers in his affidavit that he did not find evidence of infection during his
examination of plaintiff on April 17, 2010, prior to the first revision surgery. The affidavit thus
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alludes to the basis for eliminating infection as an alternative cause. But, the document does not
“‘provide a reasonable explanation,’” reflecting thorough attention and care to the details, as to
why infection was not the sole cause of the revision surgery. In re Lipitor, 892 F.3d at 644 (citation
omitted) (emphasis added). And, when pressed on the issue of infection at his deposition, Dr.
Ebert failed clearly to rule it out as a cause of the revision surgery.
Defense counsel questioned Dr. Ebert about the medical records pertaining to Dr. McCoy’s
May 2010 revision surgery and the subsequent pathology report on tissue samples from her hip.
The exchange established that during the surgery Dr. Ebert found and removed approximately
forty to fifty milliliters of pus from plaintiff’s hip joint, which Dr. Ebert thought might have been
caused by an infection. ECF 95-3 at 11, Ebert Tr. 40. Dr. Ebert testified that after the surgery, he
ordered a pathology report on tissue samples from plaintiff’s hip. Id. at 43-44. Among other
things, the pathology report found “granulation tissue,” which Dr. Ebert defined as “inflammatory
tissue” generated in response to “chronic irritation or inflammation,” which might be caused by
infection. Id. at 44.
To assess whether an infection was at play, Dr. Ebert had cultures taken of plaintiff’s hip
tissue and withdrew and tested additional purulent fluid. Id.at 49-50. Neither the cultures nor the
tests on the aspirated fluid conducted under Dr. Ebert’s supervision revealed evidence of bacterial
growth. Id. at 50. However, defense counsel pressed Dr. Ebert on the probative value of bacterial
cultures. He asked: “Is it possible that a patient can have an infection, even though operative
cultures don’t grow out any bacteria?” Id. at 50. Dr. Ebert responded: “Yes, it is possible.” Id.
Moreover, later in the deposition Dr. Ebert again conceded that “some aspects” of Dr. McCoy’s
“presentations . . . suggested that there was” an infection. Id. 54. Rather than eliminate infection
as an alternative cause, Dr. Ebert opened the door to the possibility that a bacterial infection
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contributed to the inflammation in and condition of Dr. McCoy’s hip tissue. See In re Lipitor, 892
F.3d at 644; Westberry, 178 F.3d at 262. And, neither side has asserted that the Magnum could
have caused the bacterial infection, if such infection existed, or identified evidence that would
support such an assertion.
Dr. Ebert’s explanation of the basis for his conclusion as to the Magnum’s design fares no
better. Defense counsel asked him, point blank: “Do you have an opinion as to why the acetabular
component [of the Magnum implanted in Dr. McCoy] failed?” Id. 59. Dr. Ebert responded: “It
didn’t ingrow.” Id. He then elaborated: “I think the metal-on-metal design -- the acetabular
component is a poor design and it didn’t ingrow.” Id. at 60. The exchange established that the
“sole basis” for this conclusion was Dr. Ebert’s finding during the first revision surgery that he
“found no bone ingrowth on the back of that cup.” Id. As Biomet emphasizes, Dr. Ebert lacks
clinical and research experience with the Biomet device. Moreover, he could not draw on any
academic literature to support his conclusion. Id. at 62-63. His observation that plaintiff’s
Magnum did not ingrow, standing alone, does not rise to the level of reliable methodology under
Rule 702. There is “simply too great an analytical gap between the data and the opinion proffered.”
Joiner, 522 U.S. at 146.
Accordingly, I shall grant the Ebert Motion, barring Dr. Ebert’s proffered expert testimony
as to the causation of plaintiff’s revision surgeries and as to the alleged defective design of the
Biomet device. However, my ruling does not bar Dr. Ebert from offering expert testimony as
plaintiff’s treating physician, consistent with ¶¶ 2, 3, and 4 of his affidavit (ECF 95-2).
C. The Shapiro Motion
Dr. Shapiro is a practicing, board-certified orthopedic surgeon. ECF 101-1 at 3; ECF 943 at 7, Shapiro Tr. 28. His practice is based at NYU Langone Orthopaedic Associates in New
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York. ECF 101-1 at 3. He has appointments at four hospitals as well as an academic appointment.
Id. His C.V. lists four publications on issues related to surgery and orthopedics. Id. at 5. His
practice has, over time, focused on both hip surgery and knee surgery. ECF 94-3 at 7, Shapiro Tr.
28.
As of the time of Dr. Shapiro’s deposition in February 2020, he was seeing patients with
hip problems. Id. Dr. Shapiro has treated patients with MoM hip implants for approximately
thirteen years. Id. at 29.
Dr. Shapiro’s report is based on his review of the “[o]ffice notes” of Dr. Brassard; records
from the Anne Arundel Medical Center, where Dr. Brassard practiced; the “[o]ffice notes” of Dr.
Ebert; and Dr. Ebert’s affidavit. ECF 94-2; see ECF 96-3 at 22-23. Dr. Shapiro summarized facts
gleaned from his sources. ECF 94-2 at 3-5. His report set forth the following “Impression,” id. at
5:
“Adverse tissue” reaction to metal debris in a failed metal on metal prosthesis is
documented clearly and classically in the records that I have reviewed on Joanna
McCoy. She had a premature failure of her right total hip replacement. The classic
findings on radiographs, as well as the findings at the timing of the operative
procedures, are consistent with failure due to metal-on-metal breakdown, with
adverse tissue reaction resulting in a failed hip replacement. There is no other
explanation for the failure of her hip, such as implant malposition, trauma,
infection, etc. It is my opinion, within a reasonable degree of medical certainty,
that the destructive findings from the Biomet Magnum right total hip replacement
inserted into Joanna McCoy are the result of the breakdown and failure of the metalon-metal prosthesis in question (Biomet M2A total hip replacement). The multiple
procedures that were performed were required as a result of the failure of that
implant. There is no other explanation.
At his deposition, Dr. Shapiro was questioned by defense counsel as to his opinion.
In addition, defense counsel asked Dr. Shapiro whether he would “be offering any
testimony” as to plaintiffs’ allegations that Biomet failed to warn Dr. McCoy about the
risks associated with the Magnum. ECF 94-3 at 19, Shapiro Tr. at 76. Dr. Shapiro
responded: “Well, based upon the report, I’m not giving an opinion. Okay? However, if
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I’m asked, then I will give my opinion.” Id. An exchange followed concerning the
Magnum’s IFU, described supra. See id. at 76-84.
Biomet seeks to exclude Dr. Shapiro’s opinion as to causation as well as his opinion
as to Biomet’s alleged failure to warn. I address each argument, in turn.
1.
Biomet contends that Dr. Shapiro’s causation opinion is unreliable for three main reasons.
ECF 94-1 at 1. First, defendants argue that Dr. Shapiro did not review various materials that are
critical to this case. In particular, Dr. Shapiro did not review radiographs taken of Dr. McCoy’s
right hip in 2008, after her total right hip replacement surgery, or the transcript from Dr. Ebert’s
deposition. Id. at 7. Second, defendants observe that, despite purporting to rely in part on Dr.
Ebert’s affidavit, Dr. Shapiro reached a different conclusion regarding the ingrowth of plaintiff’s
Magnum. And, according to Biomet, Dr. Shapiro’s opinion as to ingrowth was riddled with other
problems. Id. at 8. Third, Biomet asserts that Dr. Shapiro did not adequately rule out alternative
causes of the failure of plaintiff’s implant, and thus failed to produce a reliable differential
diagnosis. Id.
As to the first of these three arguments, I do not share Biomet’s view that, in essence, Dr.
Shapiro’s proffered testimony “is not based on sufficient facts or data.” Rule 702(b). Biomet does
not explain why the 2008 radiographs or the transcript of Dr. Ebert’s deposition amount to
smoking-gun-type evidence that would have compelled a different conclusion from Dr. Shapiro.
To be sure, the 2008 radiographs have probative value. The first images of plaintiff’s hip
that Dr. Shapiro personally reviewed date to April 17, 2010, by which point the acetabular cup in
plaintiff’s implant “was already loose.” ECF 94-3 at 11, Shapiro Tr. 43. Images from 2008 are
relevant to the question of when the acetabular cup began to loosen, which in turn is connected to
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the task of determining the cause of the implant’s failure. But, Dr. Shapiro relied on notes and
records generated during Dr. Brassard’s treatment of plaintiff between 2007 and 2010. ECF 94-2
at 2-3. As mentioned, Dr. Brassard’s notes indicate that as of October 2008, nearly eleven months
after plaintiff’s hip replacement surgery, radiographs did not show any evidence of the loosening
of the implant. See ECF 96-3 at 24. At trial, the defense may subject Dr. Shapiro to “[v]igorous
cross-examination” as to the foundation for his opinion. Daubert, 509 U.S. at 596. But, at this
juncture, the foundation for Dr. Shapiro’s causation opinion is sufficient for purposes of
admissibility.
That Dr. Shapiro did not review Dr. Ebert’s deposition transcript does not alter the analysis.
Nor does the fact that Dr. Shapiro relied in part on Dr. Ebert’s affidavit, which I have excluded, as
discussed, supra. Dr. Shapiro’s opinion has a solid factual foundation for purposes of the Daubert
inquiry. As plaintiffs put it, in the process of formulating his opinion Dr. Shapiro reviewed “six
different sets of diagnostic imaging, and hundreds of pages of medical records from multiple
treating physicians.” ECF 101 at 3 (citing Dr. Shapiro’s report, ECF 94-2). 10
In addition, Dr. Shapiro testified that, prior to preparing his report, he also read the
transcript of Dr. Brassard’s deposition. ECF 94-3 at 4, Shapiro Tr. 14. And, before testifying, Dr.
Shapiro spoke with Dr. McCoy for approximately one hour and reviewed the report produced by
Dr. Bauer, one of the defense’s expert witnesses, along with certain materials on which Dr. Bauer
relied. ECF 94-3 at 3, 14, Shapiro Tr. 12, 56-57.
Therefore, Dr. Shapiro’s opinions are based on sufficient facts or data, notwithstanding his
consideration of Dr. Ebert’s affidavit and his failure to review Dr. Ebert’s deposition transcript.
10
Although while Biomet takes issue with some of plaintiffs’ factual assertions, it does not
challenge this one.
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Biomet also insists that Dr. Shapiro’s opinion is unreliable because he concluded that
plaintiff’s implant experienced ingrowth, but “failed to determine what type of ingrowth
occurred.” ECF 105 at 3. At his deposition, Dr. Shapiro offered his view that Dr. McCoy’s
Magnum implant initially “gr[e]w in” to the adjoining bone through a combination of bone and
“fibrous” connection. ECF 94-3 at 10, Shapiro Tr. 41. Then, according to Dr. Shapiro, “[a]t some
point in time” Dr. McCoy experienced a “biologic response” and an “inflammatory response” to
the metal of the Magnum. Id. Defense counsel repeatedly pressed Dr. Shapiro as to whether the
ingrowth was “bony” or “fibrous,” and whether one is stronger than the other. See id. at 46-47,
54, 60-61. In response, Dr. Shapiro maintained that there was ingrowth but that he could not
specify the extent to which it was bony or fibrous. See id. at 46-47, 60-61. However, Dr. Shapiro
also clearly asserted that ingrowth of a hip implant is not “an all-or-nothing phenomenon,” contrary
to defense counsel’s characterization. Id. at 47. Moreover, he stated: “I don’t believe that literature
supports that all successful hip replacements have 100% ingrowth.” Id. at 62.
Therefore, Biomet has not demonstrated that Dr. Shapiro’s opinion is internally
inconsistent or plagued by lacuna so great as to render his opinion inadmissible.
As noted, Biomet’s third argument is that Dr. Shapiro has failed to eliminate alternative
causes of Dr. McCoy’s revision surgery, as required for a reliable differential diagnosis. In this
regard, I am mindful of the Fourth Circuit’s statement that while “‘a reliable differential diagnosis
need not rule out all possible alternative causes, it must at least consider other factors that could
have been the sole cause of the plaintiff's injury.’” In re Lipitor, 892 F.3d at 644 (quoting Guinn,
602 F.3d at 1253). Moreover, the expert’s burden is “‘to provide a reasonable explanation as to . . .
any alternative cause suggested by the defense . . . .’” In re Lipitor, 892 F.3d at 644 (citation
omitted) (emphasis added).
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Dr. Shapiro reasonably addressed and eliminated alternative causes suggested to him by
the defense. On its face, Dr. Shapiro’s report may seem conclusory. But, he was questioned
repeatedly at his deposition about alternative causes. For instance, defense counsel asked him
whether Dr. McCoy’s “obesity impact[ed] her need for revision?” ECF 94-3 at 7, Shapiro Tr. 26.
Dr. Shapiro replied: “I believe it is not directly related to the failure.” There were no follow-up
questions. Id. A similar exchange occurred regarding the possibility that the revision surgery
“was due to infection.” Id. at 65. Defense counsel also asked Dr. Shapiro about the impact of Dr.
McCoy’s fall on her Magnum implant. Dr. Shapiro responded that, based on his review of the
relevant medical records from the time, there was “no impact from the fall” on the fixation of the
Magnum. Id. at 60. Again, defense counsel did not press the matter further.
Biomet asserts that Dr. Shapiro failed to rule out Dr. McCoy’s medical history and other
health conditions as factors in the failure of her Magnum implant. ECF 105 at 4. Defendant
highlights that when Dr. Shapiro was asked whether he had “assess[ed] Dr. McCoy’s past medical
history and co-morbidities,” he answered that he had not. ECF 94-3 at 14, Shapiro Tr. 54.
However, defense counsel did not ask any follow-up questions about whether any particular comorbidities or elements of plaintiff’s medical history could have factored into the need for revision
surgery. Likewise, Dr. Shapiro was not questioned about whether the reports produced by any of
Biomet’s expert witnesses challenged or contradicted his own opinions. Defense counsel had
ample opportunity to present Dr. Shapiro with competing facts or data with which to question him
at his deposition. Under the circumstances here, Dr. Shapiro has provided reasonable explanations
to possible alternative causes “suggested by the defense . . . .’” In re Lipitor, 892 F.3d at 644
(citation omitted).
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2.
As indicated, in his report Dr. Shapiro did not opine as to Biomet’s warnings regarding the
Magnum. But, at his deposition, Dr. Shapiro was questioned about Biomet’s warnings, and
specifically about the IFU. See ECF 94-3 at 19-21, Shapiro Tr. 76-83.
Defense counsel asked Dr. Shapiro why he did not opine on warnings in his report. Id. at
76. In addition, defense counsel observed that, in other cases in which Dr. Shapiro offered opinions
as an expert witness, he had addressed warning claims. Id. Dr. Shapiro answered: “There is
nothing in this specific case that brought up the issue of failure to warn the surgeon or failure to
let the patient know, but there are issues out there.” Id.
Significantly, defense counsel asked: “Generally, not specific to Dr. McCoy, what are your
opinions regarding the sufficiency of the IFU . . . to identify adverse effects associated with the
[Magnum]?” Id. at 80. Dr. Shapiro prefaced his response by stating that “the overwhelming
majority of surgeons . . . never read” documents like the IFU prior to performing surgery. Id.
According to Dr. Shapiro, packaging inserts like the IFU are “not where we get our knowledge
from.” Id.
Dr. Shapiro proceeded to address the content of the IFU. He asserted “that the majority of
surgeons, if they were to read [the IFU], would focus on” the section titled “Warnings,” rather than
the section titled “Possible Adverse Effects.” Id. at 81. He then addressed the tenth possible
adverse effect listed in the IFU, which states: “Fretting and crevice corrosion may occur at
interfaces between components.” ECF 96-6. Dr. Shapiro opined that “if this issue of these
implants had been placed under warnings,” rather than Possible Adverse Effects, “[i]t may have
drawn more attention to those who would have read it, even though, in my opinion, most surgeons
do not or have not read this.” ECF 94-3 at 21, Shapiro Tr. 82.
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Dr. Shapiro was asked whether there is “anything materially false” in the IFU, and he
answered: “Not that I’m aware of.” Id. He was not asked about any other component of the IFU,
nor did he specifically address any other component.
Biomet seeks to exclude Dr. Shapiro’s opinion about the IFU on the grounds that Dr.
Shapiro is not qualified to offer it and failed to employ a reliable methodology. See ECF 94-1 at
10-12. As to qualifications, Biomet asserts that Dr. Shapiro “has no regulatory expertise and does
not consider himself to be an expert in FDA regulations that apply to orthopedic medical devices.”
Id. at 11 (citing ECF 94-3 at 18, Shapiro Tr. 70). As to reliability, defendants contend that Dr.
Shapiro’s opinion is directed to the IFU’s “formatting” rather than its substance. ECF 94-1 at 11.
Moreover, in defendants’ view Dr. Shapiro’s assertion that most surgeons do not read documents
like the IFU undermines whatever opinion he has about the IFU’s deficiencies. Id.
Plaintiffs maintain that Dr. Shapiro is qualified to opine about the IFU. ECF 101 at 4-5.
And, they contend that Dr. Shapiro’s conclusion is similar to that of Ms. Truman and Dr. Kantor,
the MDL plaintiffs’ general causation experts, which “underscor[es] the reliability of [Dr.
Shapiro’s] opinion based on his medical training and experience.” Id. at 5.
Both Biomet and plaintiffs rely on Hardison v. Biomet, Inc., 5:19-CV-00069-TES, 2020
WL 4334108 (M.D. Ga. July 27, 2020), which was part of the same MDL as this case and also
involved Dr. Shapiro’s proffered expert testimony. There, plaintiffs offered the following opinion
evidence from Dr. Shapiro, id. at 5:
Dr. Shapiro seeks to opine that Biomet's IFU and marketing activities failed to
provide proper warnings of the risks associated with the M2a Magnum and the
resulting generation of metal debris. . . . Further, Dr. Shapiro stated that “[h]ad Mr.
Hardison and his implanting surgeon been aware of the true risks associated with
Biomet’s product, they likely would have selected a safer alternative implant.”
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In Hardison, Biomet moved to exclude Dr. Shapiro’s failure-to-warn opinion under Rule
702. Hardison does not describe the basis for Dr. Shapiro’s failure-to-warn opinions. Nor does
Hardison indicate whether Dr. Shapiro was questioned about these opinions at a deposition.
The court concluded that Dr. Shapiro was not qualified to opine on “the communication of
the warnings” through the IFU. Id. at 6. However, the court also ruled that Dr. Shapiro was
“qualified to testify as to how a surgeon would react to a properly-communicated warning and
whether that would affect a surgeon’s willingness to use the device.” Id.
In light of the opinion evidence presented in this case, I am of the view that plaintiffs have
not established the admissibility of Dr. Shapiro’s failure-to-warn opinion. Plaintiffs appear to seek
a ruling similar to that of Hardison, namely, that Dr. Shapiro, as an experienced orthopedic
surgeon, is qualified to opine as to how an orthopedic surgeon would use or respond to the content
of the IFU. Yet, Dr. Shapiro testified, on the basis his experience, that most surgeons do not read
documents like the IFU. Thus, it is unclear what aspect of Dr. Shapiro’s experience plaintiffs
believe qualifies him to opine about how the content of the IFU might have affected the behavior
of Dr. Brassard in this case, or more generally, of orthopedic surgeons working with the Magnum.
See Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 970 (10th Cir. 2001) (determining
that board-certified orthopedic surgeon with no experience drafting instructional documents or
warnings for medical devices was not qualified to opine on the adequacy of a warning, reasoning
that such a warning would stray beyond the “reasonable confines” of the expert’s “subject area”);
Avila v. Willits Envtl. Remediation Tr., 633 F.3d 828, 839 (9th Cir. 2011) (affirming the exclusion
of proffered testimony and relying on Ralston).
Moreover, Dr. Shapiro’s opinion, as expressed in his deposition testimony, is conclusory.
He asserts that one of the cautionary statements listed in the IFU under “Possible Adverse Effects”
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might “have may have drawn more attention to those who would have read it” if it were listed
under “Warnings.” ECF 94-3 at 20, Shapiro Tr. 82. But, no explanation or basis was provided for
this opinion. And, I agree with Biomet that Dr. Shapiro’s testimony that most surgeons would not
have read the IFU undermines his barebones opinion about the IFU’s deficiency. In short, Dr.
Shapiro’s failure-to-warn opinion is merely ipse dixit. Therefore, it is inadmissible. See Joiner,
522 U.S. at 146; see also Oglesby, 190 F.3d at 250 (stating that expert testimony based on “belief
or speculation” is inadmissible); In re Zimmer Nexgen Knee Implant Prod. Liab. Litig., No. 11 C
5468, 2015 WL 3669933, at *32 (N.D. Ill. June 12, 2015) (“‘[A]n expert who supplies nothing but
a bottom line supplies nothing of value to the judicial process.’”) (quoting Wendler & Ezra, P.C.
v. Am. Int’l Grp., Inc., 521 F.3d 790, 791 (7th Cir. 2008)). Accordingly, I shall grant Biomet’s
Shapiro Motion as to Dr. Shapiro’s failure-to-warn testimony.
III. Summary Judgment Motions
A. Legal Standard
Under Rule 56(a) of the Federal Rules of Civil Procedure, summary judgment is appropriate
only “if the movant shows that there is no genuine dispute as to any material fact and the movant
is entitled to judgment as a matter of law.” See Celotex Corp. v. Catrett, 477 U.S. 317, 322-24
(1986); see also Cybernet, LLC v. David, 954 F.3d 162, 168 (4th Cir. 2020); Variety Stores, Inc.
Wal-Mart Stores, Inc., 888 F.3d 651, 659 (4th Cir. 2018); Iraq Middle Mkt. Dev. Found v.
Harmoosh, 848 F.3d 235, 238 (4th Cir. 2017). To avoid summary judgment, the nonmoving party
must demonstrate that there is a genuine dispute of material fact so as to preclude the award of
summary judgment as a matter of law. Ricci v. DeStefano, 557 U.S. 557, 585-86 (2009);
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986); see also
Gordon v. CIGNA Corp., 890 F.3d 463, 470 (4th Cir. 2018).
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The Supreme Court has clarified that not every factual dispute will defeat a summary
judgment motion. “By its very terms, this standard provides that the mere existence of some
alleged factual dispute between the parties will not defeat an otherwise properly supported motion
for summary judgment; the requirement is that there be no genuine issue of material fact.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986) (emphasis in original). A fact is
“material” if it “might affect the outcome of the suit under the governing law.” Id. at 248.
There is a genuine issue as to material fact “if the evidence is such that a reasonable jury
could return a verdict for the nonmoving party.” Id.; see CTB, Inc. v. Hog Slat, Inc., 954 F.3d 647,
658 (4th Cir. 2020); Variety Stores, Inc., 888 F.3d at 659; Sharif v. United Airlines, Inc., 841 F.3d
199, 2014 (4th Cir. 2016); Libertarian Party of Va. v. Judd, 718 F.3d 308, 313 (4th Cir. 2013). On
the other hand, summary judgment is appropriate if the evidence “is so one-sided that one party
must prevail as a matter of law.” Anderson, 477 U.S. at 252. But, “the mere existence of a scintilla
of evidence in support of the plaintiff’s position will be insufficient; there must be evidence on
which the jury could reasonably find for the plaintiff.” Id.
“A party opposing a properly supported motion for summary judgment ‘may not rest upon
the mere allegations or denials of [its] pleadings,’ but rather must ‘set forth specific facts showing
that there is a genuine issue for trial.’” Bouchat v. Balt. Ravens Football Club, Inc., 346 F.3d 514,
522 (4th Cir. 2003) (quoting former Fed. R. Civ. P. 56(e)), cert. denied, 541 U.S. 1042 (2004); see
Celotex, 477 U.S. at 322-24. And, the court must view all of the facts, including reasonable
inferences to be drawn from them, in the light most favorable to the nonmoving party. Ricci, 557
U.S. at 585-86; Matsushita Elec. Indus. Co., 475 U.S. at 587; accord Hannah P. v. Coats, 916 F.3d
327, 336 (4th Cir. 2019); Variety Stores, Inc., 888 F.3d at 659; Gordon, 890 F.3d at 470; Lee v.
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Town of Seaboard, 863 F.3d 323, 327 (4th Cir. 2017); FDIC v. Cashion, 720 F.3d 169, 173 (4th
Cir. 2013).
The district court’s “function” is not “to weigh the evidence and determine the truth of the
matter but to determine whether there is a genuine issue for trial.” Anderson, 477 U.S. at 249;
accord Guessous v. Fairview Prop. Invs., LLC, 828 F.3d 208, 216 (4th Cir. 2016). Thus, in
considering a summary judgment motion, the court may not make credibility determinations.
Wilson v. Prince George’s Cty., 893 F.3d 213, 218-19 (4th Cir. 2018); Jacobs v. N.C.
Administrative Office of the Courts, 780 F.3d 562, 569 (4th Cir. 2015); Mercantile Peninsula Bank
v. French, 499 F.3d 345, 352 (4th Cir. 2007). Therefore, in the face of conflicting evidence, such
as competing affidavits, summary judgment ordinarily is not appropriate, because it is the function
of the fact-finder to resolve factual disputes, including matters of witness credibility. See Black &
Decker Corp. v. United States, 436 F.3d 431, 442 (4th Cir. 2006); Dennis v. Columbia Colleton
Med. Ctr., Inc., 290 F.3d 639, 644-45 (4th Cir. 2002). That said, “a party’s ‘self-serving opinion
... cannot, absent objective corroboration, defeat summary judgment.’” CTB, Inc., 954 F.3d at
658-59 (quoting Williams v. Giant Food Inc., 370 F.3d 423, 433 (4th Cir. 2004)). In other words,
“[u]nsupported speculation is not sufficient to defeat a summary judgment motion.” Felty v.
Graves-Humphreys Co., 818 F.2d 1126, 1128 (4th Cir. 1987); Harris v. Home Sales Co., 499 F.
App’x 285, 294 (4th Cir. 2012).
When, as here, the parties have filed cross-motions for summary judgment, the court
“‘consider[s] each motion separately on its own merits to determine whether either of the parties
deserves judgment as a matter of law.’” Def. of Wildlife v. N.C. Dep’t of Transp., 762 F.3d 374,
392 (4th Cir. 2014) (citation omitted). In doing so, the court “‘resolve[s] all factual disputes and
any competing, rational inferences in the light most favorable to the party opposing that motion.’”
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Id. at 393 (quoting Rossignol v. Voorhaar, 316 F.3d 516, 523 (4th Cir. 2003), cert. denied, 540
U.S. 822 (2003)); see Mellen v. Bunting, 327 F.3d 355, 363 (4th Cir. 2003).
Simply because both parties have filed for summary judgment does not mean that summary
judgment to one party or another is necessarily appropriate. Rather, “[b]oth motions must be
denied if the court finds that there is a genuine issue of material fact.” 10A C. WRIGHT, A. MILLER,
& M. KANE, FEDERAL PRACTICE & PROCEDURE § 2720 (4th ed. Suppl. 2020) (WRIGHT & MILLER).
B. Biomet’s Summary Judgment Motion
1. Strict Liability (Count 1) & Negligence (Count 2)
a.
As noted, in Count I plaintiffs allege strict product liability under Maryland law. Count II
lodges a claim for negligence under Maryland law. In a product liability case, “‘the elements of
proof are the same whether the claim [is] characterized as one for strict liability or negligence[.]’”
Heckman v. Ryder Truck Rental, Inc., 962 F. Supp. 2d 792, 802 (D. Md. 2013) (quoting Shreve,
166 F. Supp. 2d at 407).
“A product defect may arise from the design of the product, a deficiency in its manufacture,
or from the absence or inadequacy of instructions or warnings as to its safe and appropriate use.”
Shreve, 166 F. Supp. 2d at 407 (citing Simpson v. Standard Container Co., 72 Md. App. 199, 203,
527 A.2d 1337, 1339–40 (1987)); see Phipps v. Gen Motors Corp., 278 Md. 337, 345, 363 A.2d
955, 960 (Md. 1976); Kelley v. R.G. Indus., Inc., 304 Md. 124, 135, 497 A.2d 1143, 1148 (1985);
Owens–Illinois, Inc. v. Zenobia, 325 Md. 420, 601 A.2d 633, 639 (1992). In Nissan Motor Co. v.
Nave, 129 Md. App. 90, 118, 740 A.2d 102, 117 (1999), the Maryland Court of Special Appeals
explained (citations omitted):
There are three situations in which a product is in a “defective condition”: (1) there
is a flaw in the product at the time of sale making it more dangerous than intended;
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(2) the manufacturer of the product fails to warn adequately of a risk or hazard
related to the way the product was designed; or (3) the product has a defective
design.
Plaintiffs’ strict product liability and negligence claims are based on each of the three
theories identified in the case law: manufacturing defect, design defect, and failure to warn.
Biomet contends that plaintiffs’ “negligence claim fails as a matter of law” to the extent that it is
based on any theory other than “negligent design, manufacture, and failure to warn.” ECF 96-1 at
37. In particular, defendants take issue with the allegation in plaintiffs’ Amended Complaint that
defendants “negligently failed to exercise ordinary care in the design, manufacture, testing,
inspection, labeling, promotion, marketing, and sale of the” Magnum. ECF 43, ¶ 112. In their
opposition, plaintiffs counter that the negligence claim “is adequate because it contains the
necessary elements for product defect and failure to warn.” Thus, both sides appear to agree that
the negligence claim is premised on theories of design defect and failure to warn. I construe the
Amended Complaint, including ¶ 112, accordingly.
In their opposition to Biomet’s Summary Judgment Motion, plaintiffs consent to the
dismissal of Count I as to manufacturing defects. ECF 103 at 2. Thus, plaintiffs’ theories of
defective design and failure to warn remain.
b.
Biomet argues that Count I and Count II must be dismissed because plaintiffs have failed
to identify any triable issues as to “medical causation” with respect to Dr. McCoy’s hip revision
surgeries. ECF 96-1 at 18-19. First, Biomet reiterates its position that the opinion evidence of Dr.
Shapiro and Dr. Ebert is inadmissible. Id. at 20-23. Next, defendants assert that the opinion
evidence from its three expert witnesses “affirmatively establishes that Dr. McCoy’s need for
revision surgery was related to biomechanical, clinical, and patient factors, not the . . . Magnum
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device itself.” Id. at 23-24. According to defendants, the opinions from its three expert witnesses
compel the following findings, id. at 26-27:
Dr. McCoy’s M2a Magnum cup was implanted in a suboptimal position and had a
less tight fit into her acetabulum due to line-to-line reaming, which resulted in the
Magnum cup’s loosening and migration and her need for revision surgery. Various
patient factors and a periprosthetic infection also likely impacted the functioning of
Dr. McCoy’s right hip implant and her need for revision surgery. Put simply, a
combination of biomechanical, clinical, and patient factors caused Dr. McCoy’s
need for revision surgery, not any alleged defect in the M2a Magnum.
And, defendants contend: “Even if Dr. Ebert and Dr. Shapiro’s case-specific opinions were
admissible, all of Plaintiffs’ claims still fail because their testimony does not link a specific product
defect to Dr. McCoy’s claimed injuries.” Id. at 27. In other words, defendants’ view is that
plaintiffs have failed to present any genuine issues of material fact as to causation, and that
defendants are, accordingly, entitled to judgment as a matter of law with respect to Counts I and
II. Id. at 27, 35.
Proximate cause is a necessary element in actions for negligence and strict liability. Ford
Motor Co. v. Gen. Accident Ins. Co., 365 Md. 321, 335, 779 A.2d 362, 369–70 (2001) (identifying
the three “product litigation basics” as defect, attribution of defect to seller, and a causal
relationship between the defect and the injury) (citing Harrison v. Bill Cairns Pontiac, 77 Md.
App. 41, 50, 549 A.2d 385, 390 (1988)); Arbogast v. A.W. Chesterton Co., 197 F. Supp. 3d 807,
811 (D. Md. 2016); see Pittway Corp. v. Collins, 409 Md. 218, 255 n.17, 973 A.2d 771, 793 n.17
(2009) (noting that proximate cause is a necessary element of product liability claims based on
theories of both strict liability and negligence). A defendant’s conduct is the proximate cause of a
plaintiff's injury when it is “1) a cause in fact, and 2) a legally cognizable cause.” Pittway, 409
Md. at 243, 973 A.2d at 786; see Copsey v. Park, 453 Md. 141, 164, 160 A.3d 623, 636 (2017).
The Maryland Court of Appeals has explained, Pittway, 409 Md. at 243–44, 973 A.2d at
786:
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In other words, before liability may be imposed upon an actor, we require a certain
relationship between the defendant's conduct and the plaintiff's injuries. The first
step in the analysis to define that relationship is an examination of causation-in-fact
to determine who or what caused an action. The second step is a legal analysis to
determine who should pay for the harmful consequences of such an action.
The causation-in-fact inquiry asks “‘whether defendant’s conduct actually produced an
injury.’” Id. at 244, 973 A.2d at 786 (quoting Peterson v. Underwood, 258 Md. 9, 16–17, 264
A.2d 851, 855 (1970)). Maryland courts have developed two tests to determine whether the
requisite causation exists: the “but-for test” and the “substantial factor” test. Pittway, 409 Md. at
244, 973 A.2d at 786. 11
Under the but-for test, the requisite causation exists when the injury would not have
occurred but for the defendant's conduct. Pittway, 409 Md. at 244, 973 A.2d at 786–87 (citing
Peterson, 258 Md. at 16, 264 A.2d at 855). The but for test applies in cases where only one
negligent act is at issue. Id. at 244, 973 A.2d at 786.
The Maryland Court of Appeals has also adopted the substantial factor set forth in the
Restatement (Second) of Torts (1965). Pittway, 409 Md. at 244, 973 A.2d at 787 (citing EaglePicher Indus., Inc. v. Balbos, 326 Md. 179, 208–09, 604 A.2d 445, 459 (1992)). Under the
substantial factor test, the requisite causation may be found if it is “‘more likely than not’” that the
defendant’s conduct was a substantial factor in producing the plaintiff's injuries. Copsey, 453 Md.
at 164, 160 A.3d at 636 (quoting Pittway, 409 Md. at 244, 973 A.2d at 787); accord Balbos, 326
Md. at 209, 604 A.2d at 459. This test applies when two or more independent acts bring about an
injury. Pittway, 409 Md. at 244, 973 A.2d at 787.
11
Neither side has addressed whether Dr. Shapiro’s opinion evidence establishes
causation-in-fact under either the but-for test or the substantial factor test, as articulated in
Maryland case law.
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In determining whether the requisite connection exists under the substantial factor test, the
following considerations are relevant:
(a) the number of other factors which contribute in producing the harm and the
extent of the effect which they have in producing it;
(b) whether the actor's conduct has created a force or series of forces which are in
continuous and active operation up to the time of the harm, or has created a situation
harmless unless acted upon by other forces of which the actor is not responsible;
(c) lapse of time.
Pittway, 409 Md. at 245, 973 A.2d at 787 (quoting Restatement, § 433).
If causation in fact is established under the appropriate test, the proximate cause analysis
turns to whether the defendant's conduct was the legal cause of the plaintiff's injuries. Copsey,
453 Md. at 165, 160 A.3d at 637; Pittway, 409 Md. at 245, 973 A.2d at 787. This analysis focuses
on foreseeability; the court asks whether the “actual harm to a litigant falls within a general field
of danger that the actor should have anticipated or expected.” Pittway, 409 Md. at 245, 973 A.2d
at 787. 12
Moreover, to establish causation in product liability cases, the plaintiff must “link the
defendant to the product.” Scapa Dryer Fabrics, Inc. v. Saville, 418 Md. 496, 510, 16 A.3d 159,
167 (2011); see Reiter v. Pneumo Abex, LLC, 417 Md. 57, 69, 8 A.3d 725, 732 (2010); see also
Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156, 1162–63 (4th Cir. 1986) (“To support a
reasonable inference of substantial causation from circumstantial evidence, there must be evidence
of exposure to a specific product on a regular basis over some extended period of time in proximity
to where the plaintiff actually worked.”); Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 93 (D.
12
The defense of superseding cause “arises primarily when ‘unusual’ and ‘extraordinary’
independent intervening acts occur that could not have been anticipated by the original
tortfeasor.’” Pittway, 409 Md. at 249, 973 A.2d at 789 (citation omitted).
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Md. 1989) (“Maryland courts apply traditional products liability law which requires the plaintiff
to prove that the defendant manufactured the product which allegedly caused the injury.”); W.
Page Keeton, Prosser & Keeton on the Law of Torts § 103 at 713 (5th ed. 1984) (“It is quite clear
that an essential element of the plaintiff’s case has been the identification of the named defendant
as the manufacturer or supplier of the defective product.”).
Biomet contends that Dr. Shapiro’s opinion evidence as to the Magnum’s defective design
does not raise a genuine issue of material fact. But, Biomet’s argument merely rehashes its position
that this opinion of Dr. Shapiro is inadmissible. To illustrate, Biomet concludes the pertinent
section in its Summary Judgment Motion by asserting: “Dr. Shapiro’s opinion, based on
incomplete analysis of possible alternative reasons for Dr. McCoy’s hip failure, combined with his
disregard of Dr. Ebert’s operative findings and subsequent testimony does not provide proof of a
link between a specific product defect and Dr. McCoy’s injuries.” ECF 96-1 at 31.
As discussed, I have already explained why Dr. Shapiro’s opinion as to the Magnum’s
defective design was based on a sufficient foundation for purposes of Rule 702, despite the fact
that he did not independently review certain images of Dr. McCoy’s hip and he reached certain
subsidiary conclusions that conflicted with those of Dr. Ebert, whose proffered testimony I have
excluded as to design defect. And, I determined that Dr. Shapiro’s report and deposition testimony,
taken together, adequately explained his reasons for eliminating alternative causes suggested by
the defense. Thus, his differential diagnosis is admissible. Whatever criticisms Biomet lodges
against this evidence at this stage goes to weight, which is the province of the jury, and not to
admissibility. See Anderson, 477 U.S. at 249; Guessous, 828 F.3d at 216 (4th Cir. 2016).
Dr. Shapiro’s opinion evidence as to a design defect establishes a genuine issue of material
fact as to whether the Magnum’s design caused harm to plaintiff, which is pertinent to both Count
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I and Count II. There is no question that the evidence from both sides linked Biomet to the
Magnum implant at issue in this case. Further, through Dr. Shapiro’s opinion evidence, plaintiffs
have presented evidence that the Magnum’s MoM design caused a breakdown of metal that, in
turn, adversely affected the surrounding tissue and resulted in the Magnum’s premature failure,
requiring hip revision surgeries. According to Dr. Shapiro, “[t]here is no other explanation.” ECF
94-2 at 5. Thus, Dr. Shapiro’s opinion serves as evidence from which a jury could find that the
“breakdown and failure” of the Magnum’s MoM design was the cause-in-fact of Dr. McCoy’s
revision surgeries. See Pittway, 409 Md. at 244, 973 A.2d at 786–87.
Moreover, the report of Ms. Truman, one of the MDL plaintiffs’ general-causation experts,
establishes a factual basis on which a court could conclude that the failure of Dr. McCoy’s Biomet
implant was foreseeable and, thus, the proximate cause of her revision surgeries. In her report,
Ms. Truman found: “Biomet MoM hip systems are unreasonably dangerous and defective in
design and present an unreasonable risk of harm to patients.” ECF 103-6 at 86. Of relevance here,
Ms. Truman opined that one particular defect of the Magnum’s MoM design “was well known to
Biomet before it marketed” the device. Id. As to defendants’ testing of the Magnum, her report
states that it “was deficient, and was a substantial factor in the harms experienced by its MoM
patients.” Id. at 87. In particular, she asserts that Biomet “failed to quantify the probability of
occurrence of . . . excessive wear scenarios.” Id. In addition, Ms. Truman concluded that Biomet
knew of but “continuously downplayed the serious and unreasonable danger associated with its
MoM hip implant devices . . . compared to safer alternative devices” with an MoP design. Id. at
89. Taking the respective reports of Dr. Shapiro and Ms. Truman together, plaintiffs have
presented evidence from which a jury could reasonably find that the Magnum design was the
proximate cause of plaintiff’s injuries.
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At trial, Biomet is entitled to mount a vigorous defense in an effort to contest the strength
and credibility of the testimony of Dr. Shapiro and Ms. Truman, as well as that of plaintiffs’ other
general-causation witnesses.
Indeed, it may use the opinion evidence regarding causation
generated by its three experts to great effect. At this stage, I conclude only that on this summary
judgment record, viewed in the light most favorable to plaintiffs, they have presented questions
about causation that are properly for the jury to resolve. See Johnson v. Mead Johnson & Co.,
LLC, 754 F.3d 557, 562 (8th Cir. 2014) (“[D]istrict courts are admonished not to weigh or assess
the correctness of competing expert opinions.”); Moreland, 437 F. 3d at 431; see also Schultz v.
Akzo Nobel Paints, LLC, 721 F.3d 426, 433 (7th Cir. 2013) (“Rule 702 did not require, or even
permit, the district court to choose between . . . two studies at the gatekeeping stage. Both experts
were entitled to present their views, and the merits and demerits of each study can be explored at
trial.”)
c.
I turn to plaintiffs’ claims for strict product liability and negligence under a theory of failure
to warn.
A seller has a duty to warn of the dangers of a product “‘if the item produced has an inherent
and hidden danger that the producer knows or should know could be a substantial factor in causing
an injury.’” Shreve, 166 F. Supp. 2d at 413 (quoting Virgil v. Kash N' Karry Serv. Corp., 61 Md.
App. 23, 484 A.2d 652, 657 (1984)); see Zenobia, 325 Md. at 437, 601 A.2d at 641 (holding that
a seller “is not strictly liable for failure to warn unless the seller has ‘knowledge, or by the
application of reasonable, developed human skill and foresight should have knowledge, of the
presence of the ... danger’ ”) (quoting Restatement, § 402A cmt. j); see also May v. Air & Liquid
Systems Corp., 446 Md. 1, 9, 129 A.3d 984, 988 (2015); Georgia Pac., LLC v. Farrar, 432 Md.
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523, 530–31, 69 A.3d 1028, 1033 (2013); Moran v. Faberge, Inc., 273 Md. 538, 544–45, 332 A.2d
11, 15–16 (1975). Conversely, a seller does not have a duty to warn of an open and obvious danger
in its product. Mazda Motor of Am., Inc. v. Rogowski, 105 Md. App. 318, 326, 659 A.2d 391, 395
(1995); Virgil, 61 Md. App. at 33, 484 A.2d at 657.
“‘Whether there is a duty to warn and the adequacy of warnings given must be evaluated
in connection with the knowledge and expertise of those who may reasonably be expected to use
or otherwise come into contact with the product . . . .’” Emory v. McDonnell Douglas Corp., 148
F.3d 347, 350 (4th Cir. 1998) (quoting Mazda Motor, 105 Md. App. at 327, 659 A.2d at 395).
Notably, to be legally adequate, a “‘warning must only be reasonable, not the best possible one.’”
Morris, 2020 WL 5849482, at *9 (quoting Ames v. Apothecon, Inc., 431 F. Supp. 2d 566, 572 (D.
Md. 2006)). In other words, under Maryland law, a reasonable warning need not be “‘an
encyclopedic warning.’” Morris, 2020 WL 5849482, at *9 (quoting Hartford Mut. Ins. Co. v.
Apria Healthcare, Inc., 159 F. App’x 479, 483 (4th Cir. 2005)). Moreover, as with a claim of
strict product liability on the basis of a design defect theory, plaintiffs’ strict product liability claim
on the basis of a failure to warn requires proof of causation. See Arbogast, 197 F. Supp. 3d at 811;
Pittway, 409 Md. at 255 n.17, 973 at 793 n.17; Ford Motor Co., 365 Md. at 335, 779 A.2d at 369–
70.
Courts in Maryland apply the learned intermediary doctrine to failure-to-warn claims
involving medical devices. “Under the learned intermediary doctrine, the manufacturer of medical
devices . . . has no duty to warn the patient of the risks associated with products used under the
supervision of a doctor. . . . The manufacturer’s duty to warn is limited to adequately informing
the patients’ doctor of any risks associated with the product’s use.” Miller v. Bristol-Myers Squibb
Co., 121 F. Supp. 2d 831, 838 (D. Md. 2000) (citing Doe v. Miles Laboratories, Inc., 927 F.2d
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187, 194 (4th Cir.1991); Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 94–95 (D.Md.1989),
aff’d, 898 F.2d 146 (4th Cir.1990); Fellows v. USV Pharmaceutical Corp., 502 F. Supp. 297
(D.Md.1980)); see Ames v. Apothecon, Inc., 431 F. Supp. 2d 566, 568 (D. Md. 2006) (“The
doctrine’s essence is that if the prescribing doctor (the learned intermediary) has received adequate
notice of a drug’s risks the manufacturer has no duty to warn the consumer.”).
At Ms. Truman’s deposition (ECF 103-8), she opined that some of the “Possible Adverse
Effects” listed in the IFU either understated the probability or magnitude of certain effects,
including local tissue reactions, id. at 283, or were “somewhat misleading” or poorly worded as to
others. Id. at 285; see id. at 287. Moreover, Ms. Truman found in her report: “Biomet’s failure to
calculate and communicate the probability of the new risks of MoM articulations to surgeons . . .
prevented them from making informed product selections, and deprived them of the ability to
choose safer alternative devices.” ECF 103-6 at 88 (emphasis added).
Here, the proper focus of the learned intermediary doctrine is on the duty to warn owed by
Biomet to Dr. Brassard, the surgeon who implanted the Magnum in Dr. McCoy as part of her hip
replacement surgery in 2007. In essence, Biomet contends that the failure-to-warn claims lack
merit for two main reasons: the warnings provided to Dr. Brassard “are adequate under Maryland
law,” and plaintiffs have not presented evidence that the warnings caused plaintiff harm. ECF 961 at 34-35.
As to the first of those reasons, Biomet’s argument boils down to the following assertion:
“Plaintiffs’ warning claims fail because it is undisputed that the IFU warns of the very
complications that Plaintiffs claim Dr. McCoy experienced with her hip implant — adverse tissue
reaction and cup loosening.” Id. at 35; see also ECF 106 at 8-9. In other cases that were part of
this MDL class, Biomet has mounted similar defenses to failure-to-warn claims, contending that
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such a claim cannot be actionable where a plaintiff experienced effects addressed in the Magnum’s
IFU.
Courts have reached different conclusions as to this defense. For instance, in Morris, 2020
WL 5849482, at *10 n.6, Judge Hazel reasoned:
The Court is not prepared to conclude that Biomet's warnings were adequate as a
matter of law, particularly with respect to the magnitude of the risks associated with
metallosis and pseudotumors. See In re DePuy Orthopaedics, Inc., Pinnacle Hip
Implant Prod. Liab. Litig., 888 F.3d 753, 773 (5th Cir. 2018) (denying summary
judgment to defendant where “the warning fail[ed] to put surgeons on notice as to
the distinctive risks that arise from [metal-on-metal devices]—‘metallosis,’
‘pseudotumors,’ and ‘tissue necrosis’—or the magnitude of those risks.” (emphasis
added)).
In contrast, in Nicholson, 2020 WL 3399899, at *15, the court concluded, on the basis of
Iowa law (alterations added):
[The IFU] provide[s] a reasonable warning of a foreseeable result that has occurred
in some patients who received the . . . Magnum. Thus, because the IFUs provided
information about the harm that allegedly occurred, the Court finds the warnings
were adequate.
I am persuaded by Judge Hazel’s reasoning as to the adequacy of the warnings. As noted,
Ms. Truman opined that the IFU understated the probability or magnitude of the Magnum’s
adverse effects, and that Biomet failed to communicate to surgeons the probability of risks
associated with the Magnum’s MoM design. Under the case law cited by Judge Hazel, evidence
that a manufacturer failed to inform surgeons of the magnitude of risks associated with a medical
device may create a genuine dispute of material fact as to a failure-to-warn claim. See 2020 WL
5849482, at *10 n.6. Here, Ms. Truman’s opinion evidence precludes summary judgment on
plaintiffs’ failure-to-warn claims.
Moreover, “[t]here is a presumption in strict liability cases that a plaintiff would have read
and heeded an adequate warning if it had been given.” Waterhouse v. R.J. Reynolds Tobacco Co.,
162 F. App’x 231, 234 (4th Cir. 2006) (per curiam). The question is whether Dr. Brassard, as the
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learned intermediary, would have acted differently had he received an adequate warning. To
establish causation-in-fact, plaintiffs must prove not only that Dr. Brassard “‘would have read,
understood, and remembered the warning, but also that [he] would have altered [his] conduct to
avoid the injury.’” Id. (quoting Balbos, 326 Md. at 227, 604 A.2d at 468) (brackets in Waterhouse).
“The presumption may be rebutted where there is ‘evidence that the personalities or dispositions
of the [plaintiffs] were such that they clearly would have ignored warnings.’” Id. (quoting Balbos,
326 Md. at 227, 604 A.2d at 468).
At this juncture, defendants have not identified evidence sufficient to rebut the presumption
that Dr. Brassard would have heeded an adequate warning or changed his recommendation or
course of conduct. To be sure, Dr. Brassard testified that he was independently aware of several
of the “Possible Adverse Effects” listed in the IFU when he selected the Magnum for Dr. McCoy.
See ECF 96-5 at 6, 8, Brassard Tr. 31-32, 37-39. But, defense counsel did not ask Dr. Brassard
whether he was aware of the magnitude or the probability of those risks. Nor was Dr. Brassard
asked whether he would have selected a different device had he been informed of the magnitude
and probability of the risks. Accordingly, on the basis of this summary judgment record, plaintiffs
are entitled to the presumption discussed in Balbos, 326 Md. at 227, 604 A.2d at 468. At trial,
however, Biomet may adduce evidence to rebut this presumption.
d.
For the foregoing reasons, I shall dismiss Count I and Count II to the extent that they are
based on a theory of manufacturing defect. But, I shall deny the Summary Judgment Motion to
the extent that the Motion is based on theories of design defect and failure to warn.
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2. Implied Warranties (Count III) & Express Warranty (Count IV)
Defendant seeks summary judgment as to both Count III and Count IV. ECF 96-1 at 3840. According to Biomet, plaintiffs’ claim for breach of implied warranties fails because the
Magnum was not defective and, even if it was, plaintiffs did not notify Biomet of any defect
“within a reasonable time” after the defect was discovered. Id. at 38. And, Biomet maintains that
it “never made any express warranties to Plaintiffs.” Id. at 39.
In their opposition, plaintiffs do not address these contentions. Yet, they responded to
Biomet’s arguments as to every other claim. ECF 103 at 11.
According to Biomet, plaintiffs have abandoned their claims in Count III and Count IV.
ECF 106 at 1-2. I agree.
In Canaan Christian Church v. Montgomery Cty., Maryland, ___ F. Supp. 3d ___, TDC16-3698, 2020 WL 5849479, at *10 (D. Md. Sept. 30, 2020), appeal filed, Judge Chuang quoted
Satcher v. Univ. of Ark. at Pine Bluff Bd. of Trustees, 558 F.3d 731, 735 (8th Cir. 2009), for the
proposition that “‘failure to oppose a basis for summary judgment constitutes waiver of that
argument.’” Judge Chuang also cited a decision from this district, Mentch v. E. Sav. Bank, FSB,
949 F.Supp. 1236, 1247 (D. Md. 1997), in which the court found that “the plaintiff had abandoned
a claim ‘by failing to address that claim in her opposition to [the defendant's] motion for summary
judgment, or to offer clarification in response to [the defendant's] reply brief.’”
Accordingly, I shall grant summary judgment to Biomet as to Count III and Count IV.
3. Punitive Damages (Count V)
The Fourth Circuit has said that “no matter what the theory of recovery, punitive damages
cannot be recovered absent malice.” Squal v. BL Ltd., 710 F.3d 1027, 1033 (4th Cir. 1983); see
also Darcar Motors of Silver Spring, Inc. v. Borzym, 379 Md. 249, 265, 841 A.2d 828, 837 (2004);
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Owens-Illinois, Inc. v. Zenobia, 325 Md. 420, 601 A.2d 633 (1992). Indeed, under Maryland law,
punitive damages may only be awarded in cases of “actual malice,” which means ill will, fraud,
intent to injure, or evil motive or purpose. Tierce Md., Inc. v. Williams, 381 Md. 378, 414 n.29,
849 A.2d 504, 526 n.29 (2004).
To prove actual malice in a products liability case, a plaintiff must establish: “‘(1) actual
knowledge of the defect on the part of the defendant, and (2) the defendant’s conscious or
deliberate disregard of the foreseeable harm resulting from the defect.’” Morris, 2020 WL
5849482, at *13 (quoting Zenobia, 325 Md. at 460, 601 A.2d at 653).
Punitive damages must be established by clear and convincing evidence, a “heightened
standard.” Jimenez v. DaimlerChrysler Corp., 269 F.3d 439, 450 (4th Cir. 2001) (internal
quotation marks omitted). “Clear and convincing evidence” is defined as “evidence . . . 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.” Id.
Biomet contends that plaintiffs have not carried their burden of demonstrating actual
malice by clear and convincing evidence. ECF 96-1 at 42. Defendant asserts: “There is no
evidence that Biomet had actual knowledge of a product defect with Dr. McCoy’s . . . Magnum
and of the danger of the product at the time the product left its possession or control. Furthermore,
there is no evidence that armed with actual knowledge, Biomet consciously or deliberately
disregarded the potential harm to consumers.” Id.
In response, plaintiffs do not point to any evidence of actual malice. Rather, they merely
incorporate by reference their arguments in earlier briefing about the sufficiency of Count V.
On February 21, 2019, Biomet moved to dismiss the punitive damages claim pursuant to
Fed. R. Civ. P. 12(b)(6) or to strike it pursuant to Fed. R. Civ. P. 12(f). ECF 47. Plaintiffs opposed
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the motion. ECF 53. The Court did not address the merits of Biomet’s motion. Rather, by Order
of August 8, 2019, I denied the motion because of ongoing settlement negotiations, without
prejudice to defendants’ right to refile if the case did not settle. ECF 76.
Now, plaintiffs seek to rely on their argument set forth in their opposition to Biomet’s
previous motion to dismiss.
However, that dispute was focused on the sufficiency of the
allegations in the Amended Complaint rather than on the evidence produced in discovery.
Plaintiffs do not identify any evidence that would enable them to survive Biomet’s
Summary Judgment Motion as to the punitive damages claim. Therefore, I shall grant summary
judgment to Biomet as to Count V.
4. Loss of Consortium (Count VI)
Maryland allows a plaintiff to recover for loss of consortium where a personal injury to
one’s self or one's spouse results in a “loss of society, affection, assistance, and conjugal
fellowship” in the marital unit. Oaks v. Connors, 339 Md. 24, 37-38, 660 A.2d 423, 430 (1995).
However, “[a] loss of consortium claim is derivative of the injured spouse’s claim for personal
injury.” Owens-Illinois, Inc. v. Cook, 386 Md. 468, 488, 872 A.2d 969, 981 (2005) (quoting Oaks,
339 Md. at 38, 660 A.2d at 430); see also Deems v. W. Md. Ry. Co., 247 Md. 95, 114, 231 A.2d
514, 525 (1967) (holding that a claim for loss of consortium arising from physical injury must be
asserted simultaneously with an underlying tort action).
Both sides agree that the loss of consortium claim is derivative and that, at this juncture,
its fortunes rest with those of plaintiffs’ other claims. See ECF 96-1 at 42; ECF 103 at 11. And, I
have rejected Biomet’s Summary Judgment Motion as to Count I and Count II to the extent that
the claims are premised on a theory of defective design. Thus, Biomet is not entitled to summary
judgment as to Count VI.
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C. Plaintiffs’ Motion for Partial Summary Judgment
1.
In a kitchen sink approach, Biomet asserted affirmative defenses, some of which are plainly
specious. Plaintiffs have moved for partial summary judgment on some of the affirmative defenses
that Biomet invoked in its answer to the Amended Complaint. At the outset, I address the
affirmative defenses for which the lack of merit is essentially undisputed.
In Biomet’s opposition, defendants stated that they are no longer pursuing four of the
challenged affirmative defenses and “withdraws them.” ECF 102 at 2. Those affirmative defenses
are: “statute(s) of limitations and/or repose . . . as well as . . . the applicable doctrines of laches,
waiver, estoppel, and/or illegality” (Second Affirmative Defense); res judicata (Third Affirmative
Defense); lack of standing (Fifth Affirmative Defense); “no legal relationship or privity with
Plaintiff” (Fifteenth Affirmative Defense). ECF 48 at 49, 51; see ECF 102 at 2. Therefore, I shall
grant Plaintiffs’ Motion as to these defenses.
The introduction to Plaintiffs’ Motion states that they seek summary judgment as to
Biomet’s Thirty-First Affirmative Defense. ECF 102 at 2. That defense states: “Plaintiffs’ claims
are barred by the doctrine of implied preemption to the extent that they are premised on alleged
misrepresentations or misstatements to the FDA. See Buckman Co. v. Plaintiff’s Legal Committee,
531 U.S. 341 (2001).” However, Plaintiffs’ Motion does not contain any argument as to this
affirmative defense.
And, plaintiffs have not replied to defendants’ opposition, as noted.
Accordingly, I shall deny Plaintiffs’ Motion as to the Thirty-First Affirmative Defense.
I turn to the disputed affirmative defenses.
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2. State of the Art (Ninth Affirmative Defense)
Biomet’s Ninth Affirmative Defense invoked defendants’ “compliance with the state of the
art, industry standards, and/or applicable government statutes and regulations.” ECF 48 at 50.
Although both sides offer succinct definitions of “state of the art,” neither fully explains the
function of the state of the art defense. See ECF 97 at 6-7; ECF 102 at 3-6.
Maryland case law indicates that state of the art evidence may be used to defend failureto-warn claims. ACandS, Inc. v. Asner, 344 Md. 155, 165–66, 686 A.2d 250, 255 (1996), is
instructive. There, the Maryland Court of Appeals stated, id. (first bracket added):
The role of state of the art evidence under Maryland law in strict liability, failure to
warn cases was explained in Owens–Illinois, Inc. v. Zenobia, 325 Md. 420, 432–
38, 601 A.2d 633, 638–41, reh'g denied, 325 Md. 665, 602 A.2d 1182 (1992). . . .
[W]e recognized in Zenobia that a majority of courts hold, expressly or implicitly,
“that a manufacturer of a product, which is defective only because of the lack of an
adequate warning, is not liable when the failure to warn resulted from an absence
of knowledge of the dangerous quality of that product.” Id. at 433, 601 A.2d at
639. But, “the required knowledge can be established by evidence that the
dangerous quality of the product should have been known by a manufacturer
because it was known in the scientific or expert community.” Id. “[E]vidence
concerning the presence or absence of knowledge in the expert community is called
‘state of the art’ evidence.” Id. at 435, 601 A.2d at 640 (emphasis added).
However, Asner did not discuss state of the art evidence in the context of a claim of
defective or negligent design. See id. at 165-68, 686 A.2d 254-56. Likewise, decisions of the
federal courts applying Maryland law appear to indicate that state of the art is pertinent only to
failure-to-warn claims. See Lohrmann, 782 F.2d at 1164 (“It appears that in Maryland, state of the
art can be considered in a strict liability tort case where the claimed defect is a failure to warn.”);
Shreve, 166 F. Supp. 2d at 413–14 (“There must be evidence that the defendant knew or should
have known of the danger posed by the product for there to be a duty to warn of such danger. . . .
A manufacturer is “held to the knowledge of an expert in the field” and “at a minimum, he must
keep abreast of scientific knowledge, discoveries, and advances.” . . . . “[T]he evidence concerning
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the presence or absence of knowledge in the expert community is called ‘state of the art’
evidence.”) (internal quotation marks and citations omitted).
Plaintiffs rely on Ms. Truman’s opinion that by 2004, MoP was the “gold standard” design
for hip implants. ECF 97; see ECF 103-6 at 87. Biomet counters with its own expert evidence.
ECF 102 at 5. The report of Dr. Kurtz asserts: “MOM bearings were widely used in orthopaedics
worldwide in the mid-2000s because they were recognized to substantially reduce the wear rate of
arthroplasties. In the United States, the usage of MOM bearings peaked in 2008 after reaching up
to 40% of primary hip implants used nationwide.” ECF 102-2 at 22.
The conflict between the two expert opinions establishes a genuine issue of material fact.
See Johnson, 754 F.3d at 562 (“[D]istrict courts are admonished not to weigh or assess the
correctness of competing expert opinions.”). Accordingly, I shall deny Plaintiffs’ Motion with
regard to the Ninth Affirmative Defense.
3. Contributory Negligence and Misuse (Twelfth and Thirteenth Affirmative Defenses)
Biomet’s Twelfth Affirmative Defense invokes “the doctrine of comparative fault.” ECF
48 at 51. Plaintiffs do not cite any law in their discussion of this affirmative defense, perhaps
because “Maryland law does not recognize comparative negligence.” Franklin v. Morrison, 350
Md. 144, 167, 711 A.2d 177, 189 (1998).
But, Biomet discusses the doctrine of contributory negligence under Maryland law.
“Maryland law is grounded in contributory negligence principles.” Carter v. Wallace & Gale
Asbestos Settlement Tr., 439 Md. 333, 348, 96 A.3d 147, 155 (2014). Accordingly, I shall construe
the Twelfth Affirmative Defense to invoke contributory negligence.
In Maryland, “‘[c]ontributory negligence is the neglect of the duty imposed upon all
individuals to observe ordinary care for their own safety. It is the doing of something that a person
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of ordinary prudence would not do, or the failure to do something that a person of ordinary
prudence would do, under the circumstances.’” Berkenfeld v. Lenet, 921 F.3d 148, 153 (4th Cir.
2019) (quoting Baltimore Gas & Elec. Co. v. Flippo, 348 Md. 680, 705 A.2d 1144, 1155 (1998))
(brackets in Berkenfeld); see Miller v. Michalek, 13 Md. App. 16, 19, 281 A.2d 117, 118 (1971);
Campfield v. Crowther, 252 Md. 88, 93, 249 A.2d 168, 172 (1969).
Proof of a plaintiff’s contributory negligence “operates as a complete bar to recovery.”
Berkenfeld, 921 F.3d at 153; see Coleman v. Soccer Ass’n of Columbia, 432 Md. 679, 690, 69 A.3d
1149, 1155 (2013); Kassama v. Magat, 136 Md. App. 637, 657 767 A.2d 348, 359 (2001), aff'd,
368 Md. 113, 792 A.2d 1102 (2002). “The focus of the contributory negligence defense . . . ‘is
whether the plaintiff took appropriate precautions to protect his [or her] own interests.’” Kassama,
368 Md. at 127, 792 A.2d at 1110 (internal citation omitted).
The Fourth Circuit has noted, Berkfenfeld at 153 (quoting Coleman, 432 Md. at 691, 69
A.3d at 1156):
Maryland courts have recognized that the doctrine of contributory negligence
provides “harsh justice to those who may have acted negligently, in minor ways, to
contribute to their injuries, and absolve those defendants from liability who can find
any minor negligence in the plaintiffs’ behavior.”
The Thirteenth Affirmative Defense states: “Plaintiffs’ claims are barred to the extent that
the injuries alleged in the Complaint were caused by the misuse, abnormal use, or use of the device
in a manner not intended by Defendants and over which Defendants had no control.” ECF 48 at
51. With respect to the misuse defense, the Maryland Court of Special Appeals has explained:
“While misuse of a product is not an ‘affirmative defense’ to a products liability action, it is a
defense in the sense that proof of misuse negates one or more essential elements of a plaintiff’s
case.” Collins v. Li, 176 Md. App. 502, 580, 933 A.2d 528, 574 (2007), aff’d sub nom. Pittway,
409 Md. 218, 973 A.2d 771. In particular, a defendant might use evidence of misuse of a product
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to demonstrate that a plaintiff’s actions constituted an intervening or superseding cause of injury.
Id.; see also Kline v. ABCO Eng'g Corp., 991 F. Supp. 747, 750 (D. Md. 1997) (“‘[I]f the Court
can say as a matter of law that the plaintiffs’ manner of use of the product cut off the chain of
proximate causation, the defendant is entitled to summary judgment.’ . . . Misuse, which includes
failure to follow a manufacturer’s warnings, bars recovery for a products liability claim.”) (citation
omitted) (brackets in Kline).
Plaintiffs cite just two pieces of evidence to support their motion as to these two affirmative
defenses. First, plaintiffs observe that Dr. Brassard testified that, four months after Dr. McCoy’s
total right hip replacement, she was doing well and had resumed “normal activities.” ECF 97 at
7. It is unclear what significance plaintiffs attribute to this evidence. In addition, plaintiffs cite a
snippet of opinion evidence from Dr. Ebert’s deposition testimony. However, I have excluded such
evidence under Rule 702. Id. Plaintiffs also assert: “Biomet offers no evidence that Plaintiff
contributed to her injuries in any way, or misused her metal-on-metal device.” Id. at 8.
Biomet, on the other hand, cites opinion evidence from two of its expert witnesses. In Dr.
Kurtz’s report, he opined that suboptimal implantation of the Magnum, “combined with Dr.
McCoy’s history of falling, and, to a lesser extent, her body mass, are significant clinical and
patient factors that resulted in the . . . need for revision surgery.” ECF 96-13 at 11. And, Dr.
Fleeter testified at his deposition that falling could have contributed to the loosening of Dr.
McCoy’s Magnum. ECF 102-4 at 5. According to Biomet, this evidence presents genuine issues
of material fact regarding the role of Dr. McCoy’s actions in contributing to her implant’s failure.
Id. at 8.
Biomet has not presented any legal argument or evidence as to how falling might constitute
a negligent act or misuse of the Magnum. Without more, Biomet offers no reason why it should
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be entitled to pursue these defenses. Accordingly, I shall grant Plaintiffs’ Motion as to Biomet’s
Twelfth and Thirteenth Affirmative Defenses.
4. Spoliation (Thirtieth Affirmative Defense)
Biomet’s Thirtieth Affirmative Defense invokes “the doctrine of spoliation and the failure
to properly preserve evidence necessary to the determination of the alleged claims against
Defendants.” ECF 48 at 54.
Spoliation occurs when a party destroys or materially alters evidence or fails to preserve
property that could be used as evidence in a pending or reasonably foreseeable case. See Boone v.
Everett, 751 F. App'x 400, 401 (4th Cir. 2019) (per curiam); see also Silvestri v. Gen. Motors
Corp., 271 F.3d 583, 590 (4th Cir. 2001). Federal courts derive the power to sanction spoliation
from Fed. R. Civ. P. 37(e) as well as courts’ inherent authority to control the judicial process. See
Chambers v. NASCO, Inc., 501 U.S. 32, 43-46 (1991); EEOC v. Performance Food Grp., Inc.,
CCB-13-1712, 2019 WL 1057385, at *2 (D. Md. Mar. 6, 2019) (Gesner, M.J.); Steves & Sons,
Inc. v. JELD-WEN, Inc., 327 F.R.D. 96, 103-04 (E.D. Va. 2018); Victor Stanley, Inc. v. Creative
Pipe, Inc., 269 F.R.D. 497, 517 (D. Md. 2010). Because a court must exercise its inherent authority
with restraint, it will rely on statutory authority whenever applicable. See Chambers, 501 U.S. at
44; Victor Stanley, Inc., 269 F.R.D. at 518.
“[S]poliation does not result merely from the ‘negligent loss or destruction of evidence.’”
Turner v. United States, 736 F.3d 274, 282 (4th Cir. 2013) (brackets added). For spoliation to
occur, “the alleged destroyer must have known that the evidence was relevant to some issue in the
anticipated case, and thereafter willfully engaged in conduct resulting in the evidence's loss or
destruction. Although the conduct must be intentional, the party seeking sanctions need not prove
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bad faith.” see also Goodman v. Praxair Servs., Inc., 632 F.Supp.2d 494, 518 (D. Md. 2009)
(setting forth the elements that a party seeking spoliation sanctions is required to prove).
“The duty to preserve material evidence arises not only during litigation but also extends
to that period before the litigation when a party reasonably should know that the evidence may be
relevant to anticipated litigation.” Silvestri, 271 F.3d at 591. Even if a party “does not own or
control the evidence, he still has an obligation to give the opposing party notice of access to the
evidence or of the possible destruction of the evidence if the party anticipates litigation involving
that evidence.” Id.
Under the spoliation doctrine, a court may order dismissal, grant summary judgment, or
permit an adverse inference to be drawn against a party in order to “level the evidentiary playing
field and for the purpose of sanctioning improper conduct.” Vodusek v. Bayliner Marine Corp.,
71 F.3d 148, 156 (4th Cir.1995). Circumstances justifying dismissal, however, are rare. In
Silvestri, 271 F.3d at 593, the Fourth Circuit characterized dismissal as “the ultimate sanction for
spoliation” and observed that it “is usually justified only in circumstances of bad faith or other
‘like action’” (citation omitted). Further, the Court instructed, id.:
At bottom, to justify the harsh sanction of dismissal, the district court must consider
both the spoliator’s conduct and the prejudice caused and be able to conclude either
(1) that the spoliator's conduct was so egregious as to amount to a forfeiture of his
claim, or (2) that the effect of the spoliator's conduct was so prejudicial that it
substantially denied the defendant the ability to defend the claim.
See King v. Am. Power Conversion Corp., 181 F. App'x 373, 376 (4th Cir. 2006) (discussing and
applying Silvestri); Erie Ins. Exch. v. Davenport Insulation, Inc., 659 F. Supp. 2d 701, 708 (D.
Md. 2009) (concluding that there were “no feasible sanctions short of dismissal”); Sampson v. City
of Cambridge, Md., 251 F.R.D. 172, 180 (D. Md. 2008) (discussing Silvestri).
In their motion, plaintiffs do not discuss any of the foregoing case law. Rather, they appear
to assume that Biomet’s spoliation defense is concerned with plaintiffs’ compliance, or lack
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thereof, with an order issued by Judge Miller in the MDL proceedings. Plaintiffs cite the “Explant
Preservation Order” of March 13, 2013, in which Judge Miller ordered, MDL-2391, Dkt. No. 279
at 2: 13
With respect to [Magnum] Devices that have not yet been explanted or have been
explanted but are not in either party’s possession, counsel for a plaintiff may elect
to obtain plaintiff’s Explanted [Magnum] Device from plaintiff’s surgeon or the
hospital where the surgery occurred and send it to a contract laboratory of plaintiff’s
choice or a designated storage facility. If plaintiff’s counsel does not elect to obtain
an Explanted [Magnum] Device within 60 days of the revision surgery, Biomet will
make arrangements for it to be sent to Malcolm Naylor of Biomet in Warsaw,
Indiana.
It is undisputed that the implant is not in the possession of any party to this case and has
not been since the remnants of the implant were removed during Dr. McCoy’s second revision
surgery in 2011. See id.; ECF 102 at 10-14. According to plaintiffs, Judge Miller’s order did not
impose an obligation on them (or on plaintiffs’ counsel) to obtain the Biomet device explanted
from Dr. McCoy. As a result, they assert that Biomet’s spoliation defense necessarily fails.
However, Biomet’s spoliation defense is not based upon Judge Miller’s order, but rather
on the spoliation doctrine. See ECF 102 at 8-14. Biomet asserts: “Plaintiffs took no action to try
to locate and preserve [Dr. McCoy’s] right hip explant prior to retaining counsel, despite Dr.
McCoy’s personal belief that her injuries stemmed from her . . . Magnum device.” Id. at 11. Since
plaintiffs filed suit, Biomet has not been able to obtain the device. As a result, Biomet did not
have an opportunity to inspect it, which would have been relevant to the defense of this suit. Id.
at 12.
13
The Explant Preservation Order of March 7, 2013, was superseded by the “Amended
Explant Preservation Order” of November 24, 2015. MDL-2391, Dkt. No. 3008. The amended
order did not change the portion of the order pertinent to the issues here. See id.
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Biomet cites two pieces of evidence that, in its view, raise questions as to plaintiffs’
knowledge of the whereabouts of her removed implant.
In a response by plaintiffs to an
interrogatory, they stated that the device “was discarded by Union Memorial Hospital prior to
MDL formation and prior to engaging an attorney to represent her in this case.” ECF 102-6 at 5.
And, in response to a request for admission “that . . . the [Magnum] has been destroyed,” Dr.
McCoy stated: “Plaintiff neither admits nor denies this request. She does not know where the
subject device is located, and will not guess about the steps taken by the hospital, or by Biomet
and its representatives, to maintain and obtain the explanted device.” ECF 102-7 at 3.
In sum, Biomet is of the view that “the evidence and circumstances outlined above generate
genuine issues of material fact as to whether Plaintiffs failed in their duty to preserve the right hip
device under circumstances evidencing bad faith, willfulness, gross negligence, or ordinary
negligence, and whether Biomet has been prejudiced.” ECF 102 at 14.
The thrust of Biomet’s opposition on this issue is that sanctions against plaintiffs for
spoliation might be warranted. What is at issue here, however, is not a motion for sanctions, but
rather, an affirmative defense. “An affirmative defense will defeat the plaintiff's claim if it is
accepted by the district court or the jury.” 5 WRIGHT § MILLER 5, FED. PRAC. & PROC. § 1270
(citing, inter alia, Hartford Fire Ins. Co. v. Annapolis Bay Charters, Inc., 69 F. Supp. 2d 756, 758
(D. Md. 1999). In other words, the question is whether plaintiffs are entitled to a judgment that
Biomet cannot successfully dismiss some or all of plaintiffs’ claims on the basis of a spoliation
defense.
Under the circumstances here, I am of the view that Biomet cannot so prevail. In a footnote,
ECF 102 at 14 n.6, Biomet suggests that dismissal might be warranted here, and it cites to Silvestri,
271 F.3d at 594-95. But, Silvestri was a very different case. There, the plaintiff’s product liability
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suit against General Motors Corporation arose out of a car crash during which the airbags in the
plaintiff’s car “did not deploy as warranted.” Id. at 585. The plaintiff did not give General Motors
Corporation notice of his claim or an opportunity to inspect the vehicle before it was repaired. Id.
The district court dismissed the suit on spoliation grounds, concluding that the car was “‘the sole
piece of evidence’” in the case. Id. (citing the district court decision). The Fourth Circuit affirmed,
reasoning that the defendant was deprived of access to “the only evidence from which it could
develop its defenses adequately.” Id. at 594.
In contrast, Biomet has mounted a vigorous defense even without Dr. McCoy’s Magnum
implant. Biomet relies, inter alia, on extensive expert evidence as to both general causation and
specific causation, medical records, images of plaintiff’s hip, testimony from Dr. McCoy, and
testimony from her treating physicians, Dr. Brassard and Dr. Ebert. There is no basis for
concluding that, if Dr. McCoy’s conduct amounted to spoliation, the spoliation “was so prejudicial
that it substantially denied the defendant the ability to defend the claim.” Id. at 593.
Moreover, Biomet’s argument is contrary to common sense.
To be sure, the “duty to
preserve material evidence . . . extends to that period before the litigation when a party reasonably
should know that the evidence may be relevant to anticipated litigation.” Silvestri, 271 F.3d at
591. But, there is no evidence that Dr. McCoy contemplated litigation at the time of her revision
surgeries. Indeed, Biomet acknowledges that the existence of evidence suggesting that Dr. McCoy
first contemplated litigation “a few months after” her second revision surgery. ECF 102 at 11.
And, a patient preparing to undergo hip revision surgery, or recovering from such surgery, might
not be focused on ensuring recovery of a
hip implant device removed by the surgeon.
Understandably, the patient is likely to be focusing on her health and wellbeing, rather than on
future litigation.
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Therefore, I shall grant Plaintiffs’ Motion as to the Thirtieth Affirmative Defense, to the
extent that Biomet’s spoliation defense seeks dismissal of some or all of plaintiffs’ claims. At this
juncture, there is no indication that Biomet is “entitled to an adverse inference instruction related
to Plaintiff’s failure to preserve” Dr. McCoy’s Magnum implant. ECF 102 at 15 n.6. However,
this ruling does not foreclose the defense from seeking to question plaintiff at trial about the
matter. 14
IV. Conclusion
For the reasons set forth above, I shall grant in part and deny in part Biomet’s Shapiro
Motion (ECF 94); grant Biomet’s Ebert Motion (ECF 95); grant in part and deny in part Biomet’s
Summary Judgment Motion (ECF 96); and grant in part and deny in part Plaintiffs’ Motion (ECF
97).
An Order follows.
Date: January 25, 2021
14
/s/
Ellen L. Hollander
United States District Judge
Of course, the wisdom of such cross-examination is a matter for defense counsel to
consider.
66
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