Searching over 5,500,000 cases.

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.

Harris v. Biomet Orthopedics, LLC

United States District Court, D. Maryland

November 18, 2019

JOHN HARRIS, Plaintiff,
BIOMET ORTHOPEDICS, LLC, et al., Defendants . STEPHEN HARBOLD, Plaintiff,
BIOMET ORTHOPEDICS, LLC, et al., Defendants . SIDNEY KANDEL, Plaintiff,
BIOMET ORTHOPEDICS, LLC, et al., Defendants . PAULETTE RINGLEY, Plaintiff,
BIOMET INC., et al., Defendants.


          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.; Biomet Manufacturing, LLC; and Biomet U.S. Reconstruction, LLC (collectively, “Biomet”) designed and manufactured the M2a Magnum Metal-on-Metal Hip System (the “Magnum”). Plaintiffs John Harris, Sidney Kandel, Stephen Harbold, and Paulette Ringley, all of whom were implanted with a Magnum between 2008 and 2010, filed suit against Biomet, alleging that the Magnum caused substantial injuries, necessitating subsequent hip replacement surgeries. See ELH-18-3924, ECF 7 (Harris Amended Complaint); ELH-18-3925, ECF 1 (Harbold Complaint); ELH-18-3926, ECF 1 (Kandel Complaint); ELH-17-747, ECF 1-3 (Ringley Complaint).[1] In particular, plaintiffs allege that the Magnum's metal-on-metal design caused the device to corrode, releasing metallic debris into the bloodstream that killed surrounding tissue and bone. Further, plaintiffs assert that Biomet advertised the Magnum as safe despite knowing that it was defective.

         Plaintiffs lodge claims exclusively under Maryland law, including strict products liability, negligence, breach of express and implied warranties, fraudulent concealment, and negligent misrepresentation. 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 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 Harbold, Kandel, and Harris matters were transferred from the MDL to the District of Maryland on December 12, 2018, as part of the second remand group. MDL-2391, MDL Dkt. No. 3738; see ELH-18-3924, ECF 181; ELH-18-3925, ECF 93; ELH-18-3926, ECF 93. The Ringley case was remanded to this District on March 11, 2019, as part of the third remand group. MDL-2391, Dkt. No. 3766; see ELH-17-747, ECF 11.[2]

         Plaintiffs filed a joint motion to consolidate on June 14, 2019, pursuant to Fed.R.Civ.P. 42(a), supported by a memorandum of law. See ELH-18-3924, ECF 196, ECF 196-1; ELH-18-3925, ECF 112, ECF 112-1; ELH-18-3926, ECF 109, ECF 109-1; ELH-17-747, ECF 22, ECF 22- 1 (collectively, the “Motion”).[3] Defendants oppose consolidation. ECF 199 (“Opposition”). Sixteen exhibits are appended to the Opposition. ECF 199-3 to ECF 199-18. Plaintiffs filed a reply (ECF 200, “Reply”), along with six exhibits. ECF 200-2 to ECF 200-8.

         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 Magnum

         The hip joint connects the thigh bone (the femur) to the pelvis. ELH-18-3924, ECF 7, ¶ 9. 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. ¶ 10. Generally, a hip implant consists of four parts, as depicted in the diagram that follows: a (1) femoral stem; (2) femoral head; (3) plastic (polyethylene) liner; and (4) acetabular shell. Id.[4]

         (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 has only three parts: a stem, femoral head, and shell. ELH 17-747, ECF 1-3, ¶ 26. The Magnum's femoral head and acetabular shell are both made out of metal. Id. This kind of hip implant is known as a metal-on-metal (MoM) system. Id.

         Plaintiffs allege that the Magnum was not sufficiently tested, and that the United States Food and Drug Administration (“FDA”) never approved the device as being safe and effective. ELH-18-3924, ECF 7, ¶ 13. Nonetheless, Biomet allegedly claimed that the Magnum would outlast a conventional hip implant with a polyethylene liner. ELH 17-747, ECF 1-3, ¶ 27. During the Magnum's initial release, Biomet promoted the device to surgeons as “‘designed specifically to address the issues of wear debris' and ‘the right choice for use in young, highly active patients.'” Id. ¶ 28. Further, Biomet hired gymnast Mary Lou Retton to promote the Magnum in direct-to-consumer print, TV, and radio advertising. Id. ¶ 29.

         According to plaintiffs, the grinding of the Magnum's metal “ball” against the metal “socket” causes tiny fragments of chromium and cobalt to slough off into the bloodstream. Id. ¶ 31; ELH 18-3924, ECF 7, ¶ 12. This metal debris kills soft tissue and bone near the hip, “prompt[ing] the body to react by rejecting the hip implant.” ELH-18-3924, ECF 7, ¶ 12. Symptoms include pain and severe inflammation. Id. This corrosion also causes the Magnum to loosen, dislocate, and fracture. Id.; ELH-17-747, ECF 1-3, ¶ 31. As a result of these complications, patients implanted with a Magnum often require “revision” surgery, whereby the Magnum is removed and replaced with a new hip implant. ELH-17-747, ECF 1-3, ¶ 38.

         Biomet allegedly knew that the Magnum was defective. Id. ¶ 34; ELH 18-3924, ECF 1, ¶¶ 15-16. As early as 2006, the FDA and Biomet received reports of patients having adverse reactions to the Mangum, with many undergoing revision surgeries. Id. ¶ 17; ELH 17-747, ECF 1-3, ¶ 31. And, the FDA and its British counterpart had expressed concern about MoM implants. ELH-17-747, ECF 1-3, ¶ 33.

         However, despite knowing about issues with the Magnum, Biomet neither pulled the device from the market nor warned the public. Id. ¶ 32. Instead, Biomet aggressively advertised the Magnum as superior to other hip implants. Id. Biomet allegedly claimed, falsely: “‘The M2a-MagnumTM Large Metal Articulation System offers optimal joint mechanic restoration and ultra low-wear rates in vivo'” and “‘Many studies conducted over the last several decades have shown no definitive correlation of negative health issues to ion levels exhibited from metal-on-metal implants.'” Id. ¶ 34. And, Biomet published marketing brochures targeting doctors, touting the safety and durability of MoM devices. ELH-18-3924, ECF 7, ¶ 19. According to plaintiffs, Biomet intentionally concealed Magnum's defects because it was one of Biomet's most profitable products, and Biomet was seeking to be acquired. ELH-17-747, ECF 1-3, ¶ 35.

         B. Plaintiffs' Medical Histories

         1. Mr. Harris

         Mr. Harris suffers from severe osteoarthritis in both hips, hip bursitis, and degenerative disc disease. ELH-18-3924, ECF 199-12 (“Ex. I, ” Harris Medical Records) at 4-5, 11; ECF 199-18 (“Ex. O, ” Harris Deposition) at 9-10. Mr. Harris underwent a left hip replacement at Frederick Memorial Hospital in Frederick, Maryland on September 15, 2008. Ex. I at 6. Dr. Robert Fisher implanted a Magnum in Mr. Harris's left hip. Id. At the time of the surgery, Mr. Harris was 67 years old. Id. On October 28, 2009, he had a revision surgery on his left hip during which he received a new liner and femoral head. Id. at 21-22. That operation was performed by Dr. Christopher Cannova at Suburban Hospital in Bethesda, Maryland. Id. Before receiving a Magnum hip replacement, he had a right hip replacement that has not been revised. Ex. I at 2-5.

         2. Mr. Harbold

         Mr. Harbold's medical history is significant for Perthes disease, osteoarthritis, and scoliosis. ELH-18-3924, ECF 199-8 (“Ex. F-1, ” Harbold Medical Records) at 3, 10; ECF 199-19 (“Ex. F-2, ” Harbold Medical Records) at 7. He received a left hip implant in 1999. Ex. F-1 at 7. Mr. Harbold underwent a right hip replacement with a Magnum device on February 9, 2010. Ex. F-1 at 3. The surgery was performed by Dr. Daniel Bauk at MedStar St. Mary's Hospital in Leonardtown, Maryland. Id. Mr. Harbold was 46 years old at the time of this hip replacement. Id. at 7. The Magnum device in Mr. Harbold's right hip was revised on May 12, 2014, by Dr. Nitin Goyal at Inova Mount Vernon Hospital in Alexandria, Virginia. Ex. F-2 at 2-6. Mr. Harbold received a new acetabular shell with a polyethylene liner and a new femoral head that was ceramic rather than metal. Id. at 6.

         3. Mr. Kandel

         Mr. Kandel has a number of medical conditions, including osteoporosis. ELH-18-3924, ECF 199-11 (“Ex. H, ” Kandel Medical Records) at 10. On December 1, 2008, Dr. Robert Fisher implanted a Magnum device in Mr. Kandel's left hip. Id. at 2-3. The surgery occurred at Frederick Memorial Hospital in Frederick, Maryland. Id. Mr. Kandel was 60 years old at the time of this hip replacement. Id. at 2. The Magnum device in Mr. Kandel's right hip was revised on November 19, 2014, by Dr. Henry Boucher at Union Memorial Hospital in Baltimore, Maryland. Id. at 16-17. Dr. Boucher implanted a new device made of materials different from those in the Magnum. Id. at 18.

         4. Ms. Ringley

         Ms. Ringley's medical history includes a traumatic hip fracture from a car accident, posttraumatic osteoarthritis, degenerative joint disease in her right hip, right knee arthrofibrosis, severe right ankle osteoarthritis, and midfoot arthritis. ELH-18-3924, ECF 199-13 (“Ex. J, ” Ringley Medical Records”) at 2-4. On August 31, 2010, Ms. Ringley had a Magnum device implanted in her right hip. Id. at 2. She was 52 years old at the time. Id. at 6. The operation was performed by Dr. Barry Waldman at Sinai Hospital in Baltimore, Maryland. Id. at 4. Ms. Ringley underwent an operation to revise the Magnum device on June 16, 2014, id. at 20, performed by Dr. Sam Sydney at St. Agnes Hospital in Baltimore, Maryland. Id. She received a new acetabulum and femoral head. Id. at 21.

         C. ...

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.