Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 1 of 66
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MARYLAND
`
`
`JOANNA MCCOY, et al.
`Plaintiffs,
`
` v.
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`BIOMET ORTHOPEDICS, LLC, et al.,
`Defendants.
`
`
` Civil Action No. ELH-12-1436
`
`
`MEMORANDUM OPINION
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`This product liability case concerns an allegedly defective orthopedic device used for hip
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`replacements. Defendants Biomet Orthopedics, LLC; Biomet Manufacturing Corp.; and Biomet
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`U.S. Reconstruction, LLC (collectively, “Biomet”) designed and manufactured metal-on-metal hip
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`implant systems, including the M2a-MagnumTM (the “Magnum” or the “Biomet device”). Plaintiff
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`Joanna McCoy was implanted with the Biomet device in 2007, during an operation for a
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`replacement of her right hip. ECF 96-3 at 22.
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`In 2012, Dr. McCoy, a veterinarian, and her husband, plaintiff Kenneth Burgwin, filed suit
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`against Biomet. They allege that the Biomet device was defective and caused Dr. McCoy
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`substantial injuries, necessitating subsequent hip replacement surgeries, i.e., “revision” surgeries.
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`See ECF 1; ECF 96-1 at 8 n.3.
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`In 2019, after consolidated pretrial proceedings, discussed infra, plaintiffs filed an
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`amended complaint, containing multiple counts. ECF 43 (the “Amended Complaint”).1 In
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`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.;
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 2 of 66
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`particular, plaintiffs allege that the metal-on-metal design of these implants caused the device to
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`corrode, releasing metallic debris into the bloodstream that killed surrounding tissue and bone.
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`Further, plaintiffs assert that Biomet advertised these products as safe, despite knowing that they
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`were defective.
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`
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`This case was one of many filed against Biomet. On October 2, 2012, pursuant to 28 U.S.C.
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`§ 1407, the Joint Panel on Multidistrict Litigation (“JPML”) consolidated all cases involving
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`Biomet’s Magnum and the M2a-38 into a Multi-District Litigation action (“MDL”) for coordinated
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`pretrial proceedings. See In re: Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 896 F.
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`Supp. 2d 1339, 1340 (J.P.M.L. 2012). MDL-2391 was assigned to Judge Robert Miller, Jr. of the
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`United States District Court for the Northern District of Indiana.2 Id. On September 19, 2018,
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`after extensive pretrial proceedings, the McCoy matter was returned from the MDL to the District
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`of Maryland as part of the first remand group. MDL-2391, MDL Dkt. No. 3724; see ECF 22.3
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`and Biomet U.S. Reconstruction, LLC. See MDL-2391, Dkt. No. 444. Accordingly, Zimmer
`Biomet Holdings, Inc. is no longer a defendant.
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`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.
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`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).
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`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.
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`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.
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 3 of 66
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`Plaintiffs filed the Amended Complaint in 2019, after the suit was returned to this Court.
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`They lodge claims exclusively under Maryland law. In Count I, plaintiffs assert a claim for “Strict
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`Product Liability,” alleging, inter alia, that the Magnum contained manufacturing defects and
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`design defects, and that Biomet’s failure to warn McCoy of the risks posed by the Magnum caused
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`her harm. ECF 43 ¶ 102(a), (b), (d); see id. at 24. In Count II, plaintiffs allege negligence as to
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`Biomet’s “design, manufacture, testing, inspection, labeling, promotion, marketing, and sale” of
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`the Magnum. Id. ¶ 111. Count III lodges a claim for “Breach of Implied Warranties,” asserting
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`that the defendants breached the implied warranty of merchantability. See id. ¶¶ 118-24. And,
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`plaintiffs assert claims for “Breach of Express Warranty” (Count IV), id. ¶¶ 125-29, punitive
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`damages (Count V), id. ¶¶ 130-38, and loss of consortium (Count VI). Id. ¶¶ 139-40.4 Jurisdiction
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`is founded on diversity of citizenship under 28 U.S.C. § 1332. It is undisputed that Maryland law
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`governs plaintiffs’ claims.
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`
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`Pursuant to Fed. R. Civ. P. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
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`U.S. 579, 597 (1993), Biomet has moved to exclude the opinion evidence offered by two of
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`plaintiff’s expert witnesses. The motion to exclude the opinions of Jeffrey F. Shapiro, M.D. is
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`docketed at ECF 94, supported by a memorandum of law. ECF 94-1 (collectively, the “Shapiro
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`Motion”). And, defendants’ motion to exclude the opinions of Frank Ebert, M.D. is docketed at
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`ECF 95, supported by a memorandum of law. ECF 95-1 (collectively, the “Ebert Motion”).
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`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).
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`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.
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`3
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 4 of 66
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`Plaintiffs oppose both motions. ECF 100 (opposition to the Ebert Motion); ECF 101 (opposition
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`to the Shapiro Motion). Biomet has replied. ECF 104 (as to the Ebert Motion); ECF 105 (as to
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`the Shapiro Motion). All submissions, except ECF 105, are accompanied by exhibits. Neither
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`side has requested a hearing and no hearing is needed. Local Rule 105.6.
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`
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`Biomet has also moved for summary judgment on all counts (ECF 96), supported by a
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`memorandum of law. ECF 96-1 (collectively, the “Summary Judgment Motion”). Plaintiffs
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`oppose the Summary Judgment Motion. See ECF 103. Biomet has replied. ECF 106. All
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`submissions are accompanied by exhibits.
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`
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`In addition, plaintiffs have filed a cross-motion for partial summary judgment as to several
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`of the affirmative defenses that Biomet asserted in its answer to the Amended Complaint. ECF 97
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`(“Plaintiffs’ Motion”). Biomet’s opposition is docketed at ECF 102. Plaintiffs have not replied
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`and the time to do so has expired.
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`While the motions were pending, Biomet filed a notice of supplemental authority (ECF
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`107) to draw the court’s attention to a recent decision authored by Judge George Hazel of this
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`Court in a case returned from MDL-2391. See Morris v. Biomet, Inc., ___ F. Supp. 3d ___, GJH-
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`18-2440, 2020 WL 5849482 (D. Md. Sept. 30, 2020). Thereafter, plaintiffs filed a similar
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`submission, highlighting recent decisions in Fitzsimmons v. Biomet Orthopedics, Inc., No.
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`219CV182FTM29NPM, 2020 WL 6784236, at *1 (M.D. Fla. Nov. 18, 2020); Bayes v. Biomet,
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`Inc., No. 4:13-CV-00800-SRC, 2020 WL 5095346, at *13 (E.D. Mo. Aug. 28, 2020); and
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`Nicholson v. Biomet, Inc., 18-CV-3057-CJW-KEM, 2020 WL 3399899 (N.D. Iowa Mar. 6, 2020).
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`No hearing is necessary to resolve the summary judgment motions. See Local Rule 105(6).
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`For the reasons that follow, I shall grant in part and deny in part the Shapiro Motion; grant the
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 5 of 66
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`Ebert Motion; grant in part and deny in part Biomet’s Summary Judgment Motion; and grant in
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`part and deny in part Plaintiffs’ Motion.
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`I. Background
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`A. Factual Background5
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`1.
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`The hip joint, also referred to as the hip, connects the thigh bone (the femur) to the pelvis.
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`ECF 43, ¶ 13; ECF 48, ¶ 13. It operates like a ball and socket: the femoral head, a ball-like
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`structure that sits atop the femur bone, rotates within the cupped surface at the bottom of the pelvis,
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`i.e., the acetabulum, which functions as a socket. See ECF 43, ¶ 13; ECF 48, ¶ 13. The hip joint
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`is lined with cartilage, lubricating tissue that cushions the femur and the acetabulum as the joint
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`bears weight. See ECF 43, ¶ 13; ECF 48, ¶ 13. With every step taken, the hip joint moves: “It
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`flexes, extends, and moves out to the side.” ECF 103-6 at 10.
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`Over time, the cartilage in the hip joint can wear down, leaving bone to rub against bone.
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`Id. This process can cause swelling, inflammation, and pain, which are symptoms associated with
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`arthritis. Id.
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`Total hip replacement surgery, also known as total hip arthroplasty, entails replacing the
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`body’s natural joint with an artificial one. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10.
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`Damaged bone and cartilage from the socket of the hip joint, along with part of the femur, is
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`replaced with an implant. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10. A hip implant may
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`be made of different materials, including metal alloys, polyethylene (a type of plastic), or ceramic
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`5 The factual background is largely drawn from the exhibits attached to the motions, as
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`well as from undisputed allegations in the Amended Complaint.
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`5
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 6 of 66
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`material. See ECF 43, ¶ 14; ECF 48, ¶ 14. Implants are designed to restore the femoral head’s
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`smooth rotation and natural leg movement. See ECF 43, ¶ 14; ECF 48, ¶ 14; ECF 103-6 at 10
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`The Biomet device at issue has three components: an acetabular cup (also referred to as a
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`shell), a femoral head, and a taper insert. ECF 96-1 at 11. During total hip replacement surgery
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`using such a device, a surgeon inserts the acetabular cup into the hip socket. ECF 103-6 at 10.
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`The surgeon also removes the “diseased ball part” of the femur and replaces it with the femoral
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`head and the taper insert, which fit into the acetabular cup. See id.; ECF 96-1. The Magnum is
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`affixed to a metallic femoral stem, a separate device, which is fitted into the femur. ECF 103-6;
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`see ECF 96-5 at 4. Thus implanted, the femoral head functions as a ball within the acetabulum,
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`allowing for natural leg movement. Id.
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`
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`The Magnum’s acetabular cup and femoral head are made out of cobalt chrome
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`molybdenum, a metal alloy. ECF 96-1 at 11; ECF 96-6 at 2. The taper insert is made of a titanium
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`alloy. For this reason, the Magnum is known as a metal-on-metal (“MoM”) device or system. See
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`ECF 96-13 at 11; ECF 103-6 at 2. Devices that contain a polyethylene (plastic) liner between the
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`femoral head and the acetabular cup, known as metal-on-polyethylene devices (“MoP”), are a
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`prominent alternative to the MoM design. See ECF 43, ¶ 14; ECF 96-1 at 11; ECF 103-6 at 8.
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`
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`Like all Magnum devices distributed to medical providers, the Magnum device implanted
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`into Dr. McCoy included “Instructions for Use” (“IFU”). ECF 96-1 at 12; ECF 96-6 at 2. The top
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`of the IFU reads: “Attention Operating Surgeon.” ECF 96-6 at 2. Among other things, the IFU
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`contains sections titled “Warnings,” “Precautions,” and “Possible Adverse Effects.” Id. The
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`section on Warnings states, in relevant part, id.:
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`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
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`of the implant or procedure.
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`The section on Possible Adverse Effects lists the following, in relevant part, id.:
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`
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`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.
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`2. Early or late postoperative infection and allergic reaction.
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`***
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`4. Loosening or migration of the implants may occur due to loss of fixation, trauma,
`malalignment, bone resorption, excessive activity.
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`***
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`10. Fretting and crevice corrosion may occur at interfaces between components.
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`11. Wear and/or deformation of articulating surfaces.
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`***
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`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.
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`2.
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`
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`Plaintiff began experiencing pain in her right hip around 2006. ECF 96-3 at 3.6 Beginning
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`in October 2006, she met with multiple doctors, including orthopedic specialists. See id. at 7-8,
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`12-15. She was diagnosed with arthritis in both her right and left hip. Id. at 7.
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`Dr. McCoy first saw orthopedic surgeon Dr. Marc Brassard in Annapolis, Maryland in
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`April 2007. Id. at 16. At that visit, plaintiff was five feet, five inches in height and weighed 192
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`pounds. Id. Dr. Brassard’s notes indicate that plaintiff reported constant pain in her right hip. Id.
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`During a visit in October 2007, Dr. Brassard recorded an impression of plaintiff as having bilateral
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`hip arthritis. Id. at 17. He identified total hip replacement surgery as a treatment option for her
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`right hip. See id. at 9-10. A month and a half later, Dr. McCoy indicated that she wished to
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`proceed with surgery. Id. at 10.
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`According to the transcript of Dr. McCoy’s deposition (ECF 96-4, “McCoy Tr.”), plaintiff
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`had consulted with other surgeons about hip replacement surgery. ECF 96-4 at 4, McCoy Tr. 54-
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`55. The other surgeons recommended MoP implants. Id. Dr. Brassard, however, recommended
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`a MoM device. Id. Plaintiff understood from her conversation with Dr. Brassard that a MoP
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`device might require a revision surgery in fifteen to twenty years, whereas a MoM device would
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`“probably last the rest of [her] life.” Id., McCoy Tr. 55. Dr. Brassard did not specifically
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`recommend the MoM device of any particular manufacturer or indicate which manufacturer’s
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`device he planned to use. Id. at 5, McCoy Tr. 60. Plaintiff trusted Dr. Brassard to choose the right
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`device for her. Id.
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`6 Throughout the Memorandum Opinion, any reference to “plaintiff” pertains only to Dr.
`McCoy, not her spouse.
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`On December 6, 2007, Dr. Brassard performed a total right hip replacement with the
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`Magnum on Dr. McCoy. Id. at 22. At his deposition (ECF 96-5, “Brassard Tr.”), Dr. Brassard
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`could not specifically recall whether he had previously read the Magnum’s IFU. Id. at 31. But,
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`he testified that, in general, he would review materials like the IFU. Id. In addition, Dr. Brassard
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`testified that at the time of plaintiff’s surgery in 2007, he was independently aware of some of the
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`“Possible Adverse Effects” indicated in the IFU, including “material sensitivity reactions,”
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`“elevated metal ions” of cobalt and chromium, and “postoperative infection.” Id. at 37-39.
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`Plaintiff had a follow-up appointment with Dr. Brassard three months after the surgery.
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`ECF 96-3 at 12. According to Dr. Brassard’s notes, plaintiff was doing well. Id. Her right hip
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`showed “good alignment with no evidence of loosening” of the implant. Id.
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`In May 2008, Dr. McCoy saw Dr. Brassard a few days after experiencing a fall. Id. at 20.
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`Dr. McCoy had “landed directly on her knee,” which “pushed up on her hip.” Id. She was
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`experiencing pain in her right hip. Id. Dr. Brassard observed that her right hip still showed “good
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`alignment.” Id.
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`Plaintiff attended a scheduled check-up with Dr. Brassard on October 22, 2008, over ten
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`months after her surgery. Id. at 24. According to Dr. Brassard, x-rays showed that the Magnum
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`continued to demonstrate “good alignment,” with “no evidence of loosening.” Id.
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`Over the following two years, Dr. McCoy met with several doctors regarding a range of
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`issues related to musculoskeletal pain, including but not limited to pain in both of her hips, back
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`pain, sciatic joint pain, fibromyalgia, and psoriatic arthritis. See id. at 3-5, 27-31. At an
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`appointment on July 10, 2009, plaintiff reported that the pain for which she was seeking treatment
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`was distinct from the pain that led her right hip replacement. Id. at 4.
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`Plaintiff met with Dr. Brassard again on March 22, 2010, and reported renewed right hip
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`pain among various other issues. Id. at 21. The medical record from that visit is incomplete; it
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`indicates that Dr. Brassard recorded his observations about the alignment of her right hip, but cuts
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`off before the completion of that portion of the record. See id.
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`Dr. Ebert, an orthopedic surgeon at MedStar Union Memorial Hospital in Baltimore,
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`examined plaintiff for the first time on April 17, 2010. See ECF 96-3 at 10; ECF 95-2. Dr. Ebert
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`observed that plaintiff had “tremendous restriction of motion about the right hip” and that her right
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`leg was three-quarters of an inch shorter than her left. ECF 96-3 at 10. He also noted: “[Plaintiff]
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`is followed by Dr. Brassard and he has evaluated her from the infection stand point and this has
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`been entirely negative.” Id.
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`According to Dr. Ebert’s notes, radiographs taken of plaintiff’s right hip showed, in
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`relevant part, ECF 96-3 at 10:
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`[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.
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`Based on his observations, Dr. Ebert recommended revision surgery on plaintiff’s right
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`hip. Id. He performed the revision surgery on May 10, 2010. Id. at 36. During the surgery, Dr.
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`Ebert found purulence, i.e., purulent fluid or pus, in plaintiff’s right hip, which indicated the
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`possible presence of infection. Id. at 34. The femoral stem was intact. Id. He removed the
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`acetabular cup of the Magnum implant and replaced it with “an antibiotic-impregnated cement and
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`a liner for an acetabular shell.” Id.
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`Tests were conducted on the purulent fluid from plaintiff’s right hip, which “showed no
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`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
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`part: “[I]n light of this it was felt that the debris that was found that was purulent material was
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`most likely debris from the metal-on-metal prosthetic device and not gross purulence.” Id.
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`
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`On March 1, 2011, Dr. Ebert performed a second revision surgery on plaintiff’s right hip.
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`Id. He replaced the Magnum’s acetabular cup with a different product that contained a
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`polyethylene liner. Id. Thereafter, plaintiff also underwent surgery for total left hip replacement,
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`during which Dr. Ebert implanted an MPE device. Id. at 33.
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`
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`Additional facts are discussed, infra.
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`B. Procedural History
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`As noted, on October 2, 2012, the JPML created MDL No. 2391 in the Northern District
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`of Indiana, assigning Judge Miller to coordinate pretrial proceedings for all lawsuits alleging
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`defects with Biomet’s Magnum and a predecessor product. See In re: Biomet, 896 F. Supp. 2d at
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`1340 n.2, 1341. At the time, Biomet opposed centralization, arguing that “individualized, plaintiff-
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`specific issues will predominate among the actions.” Id. at 1339-40. But, the JPML rejected that
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`contention. It observed that “‘almost all injury litigation involves questions of causation that are
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`case- and plaintiff-specific. Such differences have not been an impediment to centralization in the
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`past.’” Id. at 1340 (quoting In re Wright Med. Tech., Inc., Conserve Hip Implant Prods. Liab.
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`Litig., 844 F. Supp. 3d 1371, 1372 (J.P.M.L. 2012)). And, it found that the “central issues in these
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`cases may well be whether a common defect has led to the injuries alleged.” Id. Thus, because
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`the lawsuits “share factual questions concerning design, manufacture, marketing and performance
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`of Biomet’s M2A Magnum system,” the JPML concluded that “centralization will serve the
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`convenience of the parties and witnesses and promote the just and efficient conduct of the
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`litigation[.]” Id.
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 12 of 66
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`By order of March 14, 2016, Judge Miller permitted any plaintiff whose case would have
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`been subject to transfer to MDL No. 2391 to file his or her case directly in the Northern District
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`of Indiana. MDL-2391, Dkt. No. 3096. As Judge Miller explained, permitting eligible plaintiffs
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`to do so was intended to “eliminate delays associated with the transfer cases from other federal
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`district courts to [the MDL] and to promote judicial efficiency.” Id. at 2. However, direct filing
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`was “contingent on the understanding that upon completion of all pretrial proceedings . . . th[e]
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`court w[ould], pursuant to 28 U.S.C. § 1404(a), transfer the case to a federal district of proper
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`venue, as defined by 28 U.S.C. § 1391, unless the parties expressly agree to an alternate venue.”
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`Id.
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`As mentioned, plaintiffs filed suit in this Court in 2012. ECF 1. The case was transferred
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`to the MDL on October 23, 2012. ECF 21.
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`In the consolidated pretrial proceedings, the Plaintiffs’ Executive Committee and Biomet
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`each submitted expert opinion testimony. In re Biomet M2a Magnum Hip Implant Prod. Liab.
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`Litig., No. 3:12-MD-2391, 2017 WL 10845178, at *1 (N.D. Ind. Dec. 21, 2017). The expert
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`evidence that the Executive Committee sought to admit included the opinions of Mari Truman, a
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`biomedical engineer, and George S. Kantor, M.D., an orthopedic surgeon. Id. at *1, 10, 15.
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`Plaintiffs designated Ms. Truman and Dr. Kantor as “general causation” experts pursuant to Fed.
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`R. Civ. P. 26, as discussed infra.
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`According to Judge Miller, Ms. Truman opined, id. at 11:
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`(1) [A]ll metal-on-metal devices are defectively designed; (2) metal-on-
`polyethylene 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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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 13 of 66
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`Specifically, Ms. Truman’s sixth opinion was that “Biomet’s metal-on-metal devices can
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`cause ‘elevated metal ions with immune response complications ... and tissue necrosis.’” Id. at 14
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`(quoting MDL 2391, Dkt. No. 3387-2 at 86). In other words, Ms. Truman’s proffered report
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`described Biomet’s MoM hip implants, including the Magnum, as prone to “excessive wear,”
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`which “produces elevated metal ions, which cause immune response complications and tissue
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`necrosis.” 2017 WL 10845178, at *14.
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`Biomet sought to exclude Ms. Truman’s opinions under Rule 702 and Daubert, contending
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`that they were not reliable and that Ms. Truman was not qualified to render them. Id. at 11. Judge
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`Miller rejected Biomet’s arguments and determined that all of Ms. Truman’s opinions were
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`admissible, noting that several of Biomet’s challenges were directed to the weight, not the
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`admissibility, of the evidence. Id. at 11-15. As to Ms. Truman’s sixth opinion, Judge Miller ruled:
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`“Ms. Truman can't testify as an expert on the clinical effects of metal ions, but she can permissibly
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`rely on other experts’ opinions that metal ions cause clinical effects to support her opinion that
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`metal-on-metal devices are unreasonably dangerous. . . . That’s what she did in her report, so her
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`opinion is admissible.” Id. at 15.
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`
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`Biomet also filed a Daubert motion to exclude Dr. Kantor’s opinions. Id. Dr. Kantor
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`opined in his report, id.:
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`(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.
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`Judge Miller ruled that Dr. Kantor’s opinions as to the design defects and associated risks
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`of Biomet devices specifically were inadmissible, but that Dr. Kantor’s opinions as to the design
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`defects and associated risks of MoM devices generally were admissible. Id. at 19. Judge Miller
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`also excluded the opinion “about the sufficiency of Biomet’s testing and clinical studies.” Id. But,
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 14 of 66
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`he allowed Dr. Kantor’s opinions regarding the Biomet devices’ IFUs and the effects of elevated
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`metal ions. Id.
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`
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`In the MDL, Biomet also moved for summary judgment as to some of the product liability
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`claims, on the basis of a “‘state of the art’ theory.’” In re Biomet M2A Magnum Hip Implant Prod.
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`Liab. Litig., No. 3:12-MD-2391, 2018 WL 776776, at *1 (N.D. Ind. Feb. 8, 2018). According to
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`Biomet, there were no genuine disputes of material fact regarding its state-of-the-art assertions.
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`Id. Biomet contended, id.:
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`[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)[.]
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`Judge Miller denied defendants’ motion but declined to reach the merits. He reasoned that
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`
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`a ruling on the merits would require synthesizing “the state-of-the-art law of nineteen different
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`states,” which would “indefensibly slow the process in this docket.” Id. at 3.
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`Therefore, Judge Miller transferred plaintiffs’ suit back to this Court on September 19,
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`2018. MDL-2391, Dkt. No. 3724; see ECF 22. In the transfer order, Judge Miller explained that
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`of the approximately 3,000 cases that were part of the MDL, 90% had settled as part of a master
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`settlement agreement reached in 2014. See MDL-2391, Dkt. No. 3738 at 2-3, 6; see also MDL-
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`2391, Dkt. No. 1317 (Master Settlement Agreement). The remaining cases were being sent to
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`their proper districts for trial. MDL-2391, Dkt. No. 3738 at 13. Further, Judge Miller observed,
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`id.:
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`
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`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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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 15 of 66
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`other motions addressing the testimony of generic or case-specific experts; and (6)
`any summary judgment motions.
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`Since the case was returned to this Court, both sides have gathered opinion evidence from
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`expert witnesses. As noted, plaintiffs seek to present expert testimony from Dr. Ebert and Dr.
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`Shapiro. Biomet has also retained three experts in this litigation: Steven Kurtz, PH.D., a
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`biomedical engineer; Thomas Fleeter, M.D.; and Thomas W. Bauer, M.D., PH.D., a pathologist.
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`The reports produced by Dr. Kurtz and Dr. Bauer have each been submitted as exhibits. See ECF
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`96-13 (Dr. Kurtz’s report); ECF 96-15 (Dr. Bauer’s report). Dr. Fleeter’s report appears not to
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`have been successfully appended as an exhibit. ECF 96-14 contains a Declaration of Thomas
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`Fleeter, M.D., which references an expert report. But, there is no such report among the exhibits.
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`The pending motions followed. Thereafter, Biomet filed a notice of supplemental authority
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`to draw the court’s attention to Morris, 2020 WL 5849482. ECF 107. Plaintiffs filed a similar
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`submission, highlighting recent decisions in Fitzsimmons v. Biomet Orthopedics, Inc., No.
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`219CV182FTM29NPM, 2020 WL 6784236, at *1 (M.D. Fla. Nov. 18, 2020), Bayes v. Biomet,
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`Inc., No. 4:13-CV-00800-SRC, 2020 WL 5095346, at *13 (E.D. Mo. Aug. 28, 2020), Nicholson
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`v. Biomet, Inc., 18-CV-3057-CJW-KEM, 2020 WL 3399899 (N.D. Iowa Mar. 6, 2020). Each case
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`involves distinct fact patterns.
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`II. The Daubert Motions
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`
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`According to plaintiffs’ Rule 26 disclosures, which Biomet has submitted as an exhibit to
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`its Summary Judgment Motion (ECF 96-9), plaintiffs seek to introduce evidence from five experts.
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`Id. Plaintiffs have designated three of their experts as “general causation” experts and two as
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`“specific causation” experts. Id.
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`“For specific causation, the plaintiff must ‘demonstrate that the substance actually caused
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`injury in her particular case.’” In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod.
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`Case 1:12-cv-01436-ELH Document 109 Filed 01/25/21 Page 16 of 66
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`Liab. Litig. (No II) MDL 2502, 892 F.3d 624, 642–43 (4th Cir. 2018) (citation omitted). “Specific
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`causation is often distinguished from general causation, which refers to the more general issue of
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`whether a substance has the potential to cause the plaintiff's injury.” Guinn v. AstraZeneca Pharm.
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`LP, 602 F.3d 1245, 1249 n.1 (11th Cir. 2010) (emphasis added); see In re Lipitor, 892 F.3d at 658-
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`59 (discussing Guinn).
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`The three general causation experts identified by plaintiffs are Mari Truman; George
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`Kantor, M.D.; and Francis H. Gannon, M.D., a Professor of Pathology & Immunology and
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`Orthopedic Surgery. Id. Each expert has produced a written report and is expected to testify via
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`previously recorded deposition testimony. Id.
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`In addition, plaintiffs have designated Dr. Shapiro and Dr. Ebert, both of whom are