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.; 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). 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.
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.
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.
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”). 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.
hearing is necessary to resolve the Motion. See
Local Rule 105(6). For the reasons that follow, I shall grant
Factual and Procedural Background
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.
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.
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 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)
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.
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.
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,
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.
Plaintiffs' Medical Histories
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.
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.
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.
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.