United States District Court, D. Maryland
L. HOLLANDER, UNITED STATES DISTRICT JUDGE
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). 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.
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. §
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
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”). 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. Plaintiffs have replied. ELH-12-1436, ECF
hearing is necessary to resolve the Motion. See
Local Rule 105(6). For the reasons that follow, I shall grant
Factual and Procedural Background
Biomet's Metal-on-metal Hip Implant Systems
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.
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.
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.
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.
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.
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.
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.
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.
Plaintiffs' Medical Histories
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.
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.
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.