United States District Court, N.D. Indiana, South Bend Division
OPINION AND ORDER
L. Miller, Jr. United States District Judge
these plaintiffs received Biomet M2a Magnum, M2a-38 or M2a
Taper metal-on-metal hip implants, and sues Biomet for
injuries stemming from alleged defects in the product. Biomet
moves for summary judgment, arguing that because none of the
plaintiffs preserved the explanted device, each should be
sanctioned with dismissal. The court disagrees.
in the multi-district litigation related to the Biomet M2a
hip implants, I ordered “[a]ll parties [ ] to take
reasonable steps to preserve documents and other records
(including electronic documents) containing information
potentially relevant to the subject matter of this
litigation.” Pretrial Order #1 ¶ 13, Oct. 12, 2012
[3:12-md-2391, Doc. No. 3].
March 7, 2013, I issued an “Explant Preservation
Order” requiring preservation of M2a devices removed
from plaintiffs during revision surgeries, thus aiding in
proving or disproving causation of injuries. The order
imposes the following obligations:
• “A plaintiff shall make good faith efforts to
ensure that non-party medical practitioners, hospitals, and
vendors . . . preserve his or her Explanted M2a Devices . . .
.” Explant Pres. Order § VI, Mar. 7, 2013
[3:12-md-2391, Doc. No. 279].
• “With respect to M2a Devices that have not yet
been explanted or have been explanted but are not in either
party's possession, counsel for a plaintiff may elect to
obtain plaintiffs Explanted M2a Device from plaintiffs
surgeon or the hospital where the surgery occurred and send
it to a contract laboratory of plaintiffs choice or a
designated storage facility. If plaintiffs counsel does not
elect to obtain an Explanted M2a Device within 60 days of the
revision surgery, Biomet will make arrangements for it to be
sent to Malcolm Naylor of Biomet in Warsaw, Indiana.”
Id. § III(A). Each party must notify the other
if that party has the explanted device in its possession
prior to the date of the order. Id. § III(B).
• Each party must handle the explanted device in
accordance with a Retrieval Analysis Protocol described in
the order or a procedure that's consistent with methods
and practices accepted by those in the field of inspection
and testing of orthopaedic devices. Id. § II.
• Each party in possession of the explanted device shall
make the device available to the other party after inspection
and testing. Id. § III(C).
the start of the MDL, the FDA used its powers under Section
522 of the Federal Food, Drug, and Cosmetic Act to require
Biomet to conduct a postmarket surveillance study. Biomet had
to submit a plan to conduct surveillance that would identify
“the modes and causes of failure based on analysis of
[Biomet's] reasonably available explanted retrieved
George Marous, 3:14cv768
Marous was implanted with a Biomet M2a-Magnum hip implant. He
contacted a law firm in December 2012 about problems with the
implant and spoke to a paralegal there, who referred him to
his current counsel. In April 2013 Mr. Marous underwent
revision surgery. Before the surgery he signed a form
consenting to disposal “of any tissues, parts, or
organs which may be removed.” In an affidavit, he says
that he requested the explant components before going into
surgery. He and his wife say in affidavits that she spoke to
the surgeon after surgery about retrieving the explant, but
the surgeon said the request couldn't be fulfilled
because bone was attached. At his deposition, Mr. Marous says
he didn't know he could ask the hospital to preserve the
explant. Joe Richardson, Jr., an independent contractor for
“Biomet Mid Ohio, ” a Biomet distributor, was
present at the surgery. He says he was never instructed to
retrieve the explanted device and didn't do anything to
Marous hired his current counsel in May 2013. They represent
that they made an effort to contact the hospital's
Department of Pathology after the revision to retrieve the
explanted device, but the department said it never received
the device. Mr. Marous filed suit in this court in April
Yolanda Chisolm, 3:14cv1647
Chisolm was implanted with a Biomet M2a-38 hip implant. In
March 2014, her doctor told her that she needed revision
surgery, tested high for cobalt and chromium, and suffered
bone loss. Ms. Chisolm says that at this time she was aware
of lawsuits involving Biomet and metal-on-metal hip implants.
According to interrogatories, she first contemplated hiring
an attorney in February 2014, and she first contacted an
attorney at the end of March 2014.
filed suit against Biomet in North Carolina state court in
April 2014, before her revision surgery the following month.
Before revision, she signed a form authorizing her
“physician, other practitioners and the Hospital [to]
examine any organs, tissues, other body parts or foreign
bodies that are removed from [her] during the Surgery and
[to] ke[ep], use[ ] and save[ ] [them] for scientific,
educational or research purposes or dispose[ ] of [them]
according to Hospital policies.” Eric Owens, a Biomet
sales representative, was present at the revision surgery.
Ms. Chisolm says she doesn't know what happened to the
device after it was removed from her.
the revision surgery, Biomet removed the case to federal
court, and it was then transferred to this court as part of
this MDL docket.
Joseph Cecil, 3:14cv1712
Cecil was implanted with a Biomet M2a-Taper hip implant in
2005. In 2013 his doctor told him that he suffered from
metallosis and needed revision surgery. Mr. Cecil says that
at that time he wasn't aware of litigation and possible
defects in metal-on-metal hip implants. Later that year, Mr.
Cecil considered hiring an attorney. About two weeks before
his revision surgery, he learned about problems with the
DePuy and Stryker hip implants and went to a law firm. At
that point, he says, he believed his injury was the result of
his hip implant.
request of Mr. Cecil's wife, he signed a “Release
of Specimens or Other Items” form, in which he
requested that the “Left Hip Implant (Socket)”
not be destroyed after surgery, but be released into his
possession. Mr. Cecil underwent revision surgery in December
2013 and the hip implant was removed. After the revision
surgery, Mr. Cecil never heard whether the hospital actually
preserved that portion of the device, and neither he nor his
wife ever received it. Mr. Cecil didn't follow up to see
that the device was preserved or delivered to him, and he
said he only learned that the explanted component hadn't
been preserved on the day before his deposition.
filed suit in federal court in Kentucky in April 2014 and the
case was transferred to this court as part of this MDL