Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

McCoy v. Biomet Orthopedics, LLC

United States District Court, D. Maryland

November 25, 2019

JOANNA MCCOY, Plaintiff,
v.
BIOMET ORTHOPEDICS, LLC, et al., Defendants. JOSEPH OSWALD, Plaintiff,
v.
BIOMET ORTHOPEDICS, LLC, et al., Defendants.

          MEMORANDUM OPINION

          ELLEN L. HOLLANDER, UNITED STATES DISTRICT JUDGE

         These product liability cases are rooted in an allegedly defective orthopedic device used for hip replacements. Defendants Biomet Orthopedics, LLC; Biomet, Inc.; and Biomet U.S. Reconstruction, LLC (collectively, “Biomet”) designed and manufactured metal-on-metal hip implant systems, including the M2a-MagnumTM (the “Magnum”) and its predecessor, the M2a-38TM. Plaintiffs Joanna McCoy and Joseph Oswald, both of whom were implanted with Biomet devices between 2005 and 2007, filed suit against Biomet, alleging that the implants caused substantial injuries, necessitating subsequent hip replacement surgeries. See ELH-12-1436, ECF 43 (McCoy Amended Complaint); ELH-19-607, ECF 1 (Oswald Complaint).[1] In 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.

         Plaintiffs lodge claims exclusively under Maryland law. These include strict liability, negligence, breach of express and implied warranties, and fraudulent concealment. Jurisdiction is founded on diversity of citizenship under 28 U.S.C. § 1332.

         These cases were among 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). The MDL was assigned to Judge Robert Miller, Jr. of the United States District Court for the Northern District of Indiana. Id. After extensive pretrial proceedings, the McCoy matter was returned from the MDL to the District of Maryland on September 19, 2018, as part of the first remand group. MDL-2391, MDL Dkt. No. 3724; see ELH-12-1436, ECF 22. The Oswald case was remanded to this District on February 22, 2019, as part of the third remand group. MDL-2391, Dkt. No. 3756; see ELH-19-607, ECF 235.[2]

         Plaintiffs have filed a joint motion to consolidate, pursuant to Fed.R.Civ.P. 42(a), supported by a memorandum of law. See ELH-12-1436, ECF 54; ELH-19-607, ECF 241 (collectively, the “Motion”).[3] They submitted four exhibits with the Motion. ECF 54-1 to ECF 54-5. Defendants filed an Opposition (ELH-12-1436, ECF 65), supported by ten exhibits. ECF 65-1 to ECF 65-10.[4] Plaintiffs have replied. ELH-12-1436, ECF 66.

         No hearing is necessary to resolve the Motion. See Local Rule 105(6). For the reasons that follow, I shall grant plaintiffs' Motion.

         I. Factual and Procedural Background

         A. Biomet's Metal-on-metal Hip Implant Systems

         The hip joint connects the thigh bone (the femur) to the pelvis. ELH-12-1436, ECF 43, ¶ 13. It operates like a ball and socket: the femoral head, a ball-like structure that sits at the top of the femur bone, rotates within the cupped surface of the pelvis, or acetabulum. Id. In a healthy hip, the femoral head and acetabulum are cushioned and lubricated by cartilage and fluid. Id.

         A total hip implant replaces the body's natural joint with an artificial one. Id. ¶ 14. Generally, these implants consist of four parts, as depicted in the diagram below: a (1) femoral stem; (2) femoral head; (3) plastic (polyethylene) liner; and (4) acetabular shell. Id.[5]

         (Image Omitted)

         During the operation, the surgeon first hollows out the patient's femur bone and inserts the femoral stem. Next, the surgeon attaches the femoral head to the stem. Finally, the surgeon inserts the liner and acetabular shell to separate the metal femoral head from the acetabulum. Id.

         Biomet's Magnum and M2a-38 devices have only three parts: a stem, femoral head, and shell. Id. ¶ 16; ELH-19-607, ECF 1, ¶ 14. In both devices, the femoral head and acetabular shell are made out of metal. Id. For that reason, these devices are known as metal-on-metal (MoM) systems. ELH-12-1436, ECF 43, ¶ 16.

         Plaintiffs allege that Biomet's MoM implants were not sufficiently tested, and that the United States Food and Drug Administration (“FDA”) never approved these devices as being safe and effective. Id. ¶ 23; ELH-19-607, ECF 1, ¶ 16. Indeed, Biomet allegedly skipped clinical testing related to metal poisoning, despite extensive scientific research warning that MoM systems pose such risks. ELH-12-1436, ECF 43, ¶¶ 24-33. According to plaintiffs, Biomet failed to perform comprehensive clinical trials, and marketed its MoM implants to surgeons and patients as being safe and longer lasting than metal-on-polyethylene implants. Id. ¶ 35; ELH-19-607, ECF 1, ¶ 17.

         Plaintiffs allege that the grinding of the implants' metal “ball” against the metal “socket” causes tiny fragments of chromium and cobalt to slough off into the bloodstream. ELH-12-1436, ECF 43, ¶ 17; ELH-19-607, ECF 1, ¶ 15. This metal debris kills soft tissue and bone near the hip and “prompt[s] the body to react by rejecting the hip implant.” ELH-12-1436, ECF 43, ¶ 18. Symptoms include pain and severe inflammation. Id. This corrosion also causes the implant to loosen, dislocate, and fracture. Id. As a result of these complications, patients implanted with Biomet's MoM implants often require “revision” surgery, by which the device is removed and replaced with a new hip implant. Id. ¶ 54.

         Biomet allegedly knew that its devices were defective. Id. ¶ 52. Beginning in 2004, Biomet and the FDA began receiving complaints reporting that the Magnum and M2a-38 had failed prematurely, requiring patients to undergo revision surgeries. Id. ¶¶ 53, 62; ELH-19-607, ECF 1, ¶ 18. To date, more than 350 adverse events associated with the Magnum have been reported to the FDA. ELH-12-1436, ECF 43, ¶ 62. Furthermore, Biomet was apprised of issues with the Magnum through its interactions with surgeons. Id. ¶ 55.

         However, despite knowing about issues with its MoM implants, Biomet neither removed these devices from the market nor warned the public about them. Id. ¶ 63. Instead, Biomet aggressively advertised its metal implants as superior to other hip implants. Id. ¶ 64; ELH-19-607, ECF 1, ¶ 22. And, Biomet allegedly omitted information regarding its implants' safety and efficacy from surgeons and patients. ELH-12-1436, ECF 43, ¶¶ 65, 90. According to plaintiffs, Biomet intentionally concealed the defects with its MoM devices because the Magnum was one of its most profitable products and Biomet was seeking to be acquired. Id. ¶ 92.

         B. Plaintiffs' Medical Histories

         1. Ms. McCoy

         Ms. McCoy has lumbar degenerative disease as well as arthritis. ELH 12-1436, ECF 65-5 (“Ex. E, ” McCoy Medical Records) at 2, 19. Ms. McCoy had a Magnum implanted in her right hip on December 6, 2007, at the age of fifty-five. Id. at 6, 8. The surgery was performed by Dr. Marc Brassard at Anne Arundel Medical Center in Annapolis, Maryland. Id. Ms. McCoy's right hip was revised on May 10, 2010, by Dr. Frank Ebert at Union Memorial Hospital in Baltimore, Maryland. Id. at 14. Dr. Ebert removed the acetabular shell and implanted a temporary spacer acetabular component. Id. Dr. Elbert performed a second right hip revision on Ms. McCoy on March 1, 2011. Id. at 17-18. This time, Dr. Ebert implanted a new hip device. Id. On November 8, 2011, Ms. McCoy had her left hip replaced by Dr. Ebert at Union Memorial Hospital. Id. at 19.

         2. Mr. Oswald

         Mr. Oswald suffers from lumbar degenerative disease and osteoarthritis. ELH-19-607, ECF 249-7 (“Ex. G, ” Oswald Medical Records) at 3. On February 16, 2005, Mr. Oswald underwent a right total hip replacement, performed by Dr. Bruce Zimmer at Inova Alexandria Hospital in Alexandria, Virginia. Id. at 5. At the time, Mr. Oswald was sixty-one. Dr. Zimmer implanted the 2004 version of Biomet's M2a-38 device in Mr. Oswald's right hip. Id. at 6.

         The M2a-38 device in Mr. Oswald's right hip was revised in two stages. Id. at 7-9. On April 26, 2006, Dr. Zimmer removed the M2a-38 device and replaced it with a temporary hip implant device. Id. at 7-9. On July 19, 2006, Dr. Zimmer implanted the 2005 version of Biomet's M2a-38 in Mr. Oswald's right hip. Id ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.