McCoy v. Biomet Orthopedics, LLC
| Decision Date | 25 January 2021 |
| Docket Number | Civil Action No. ELH-12-1436 |
| Parties | JOANNA MCCOY, et al. Plaintiffs, v. BIOMET ORTHOPEDICS, LLC, et al., Defendants. |
| Court | U.S. District Court — District of Maryland |
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-Magnum™ (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 Inparticular, 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
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").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 ___, GJH-18-2440, 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 theEbert Motion; grant in part and deny in part Biomet's Summary Judgment Motion; and grant in part and deny in part Plaintiffs' Motion.
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 ceramicmaterial. 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 failureof the implant or procedure.
The section on Possible Adverse Effects lists the following, in relevant part, id.:
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