Turner v. Biomet Orthopedics LLC et al
OPINION AND ORDER Biomets 3388 motions for summary judgment related to the Taper, ReCap, and metal-on-polyethylene devices is DENIED on the merits; Biomets 3390 motions for summary judgment relati ng to the state-of-the-art defense is DENIED, without prejudice; If the plaintiffs in White v. Biomet (3:16cv115) and Glynn v. Biomet (3:15cv491) wish to take device-specific expert depositions, they should file a motion to that effect within 14 day s from the date of this order, and should indicate in that motion whether local counsel will conduct the deposition, with or without the assistance of the Plaintiffs Steering Committee. The plaintiffs in the Price v. Biomet (3:14cv275) and Gearon v. Biomet (3:14cv2099) shall have 14 days from the date of this order to file a motion to amend the scheduling order to allow device-specific expert depositions or, alternatively, a motion for suggestion of remand. If they elect the later, the Plain tiffs Steering Committee should address the effect, if any, remand would have on the plaintiffs obligations under the December 7,2015 Amended Holdback Order 3022 in its response. Signed by Judge Robert L Miller, Jr on 2/8/18. Associated Cases: 3:12-md-02391-RLM-MGG et al.(jld)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
SOUTH BEND DIVISION
IN RE: BIOMET M2a MAGNUM HIP
IMPLANT PRODUCTS LIABILITY
LITIGATION (MDL 2391)
This Document Relates to All Cases
CAUSE NO. 3:12-MD-2391
OPINION AND ORDER
The attorneys for Biomet and the attorneys who have served on the two
plaintiffs' steering committees have impressed me. They have cooperated wherever
possible, while firmly protecting the interests of those in the groups they
represent. They have met deadlines with remarkable regularity, and appear to
have done all they can do to move these cases forward. I have been fortunate to
work with them in this MDL docket, and to be able to see their work. That said,
Biomet has placed two head-scratching summary judgment motions before me,
and this order tries to deal with them. Because most invoke expert opinion
testimony, decision had to await the ruling on motions to exclude expert
testimony. The reader should proceed with my opening comments in mind.
First, Biomet has filed what purports to be a summary judgment motion
addressed to some of the individual claims in this docket based on a "state of the
art" theory. Biomet contends that its metal-on metal devices were "state of the art"
from the time they were first designed, manufactured, and marketed until 2013
(when Biomet stopped producing metal-on metal devices), or at least 2011 (when
the FDA issued a public notice of concern regarding metal-on metal hip implants),
and that it is entitled to judgment as a matter of law in the remaining metal-on
metal cases because the plaintiffs haven't presented any device-specific evidence
to the contrary.
Biomet argues that it marketed its second-generation metal-on metal
devices based on studies that showed few adverse effects after five years of wear,
and a clinical study showing that the products had far less wear debris and could
support larger femoral heads than metal-on-polyethylene devices, reducing
dislocation. Biomet says that reports indicating a connection between
metal-on-metal devices and elevated metal ion levels only surfaced after the
products were being marketed. Dr. St. John and Dr. Schroeder, Biomet's experts,
opined that: Biomet's knowledge of the impact of metal ions was consistent with
the knowledge available at the time; Biomet incorporated new knowledge into its
instructions for use as it became available; and testing complied with ASTM
standards and all other applicable codes and standards. Biomet thus claims its
metal-on metal devices were designed, labeled, and sold based on the best data
reasonably available at the time, and that concerns about metallosis weren't
"generally recognized" or even known at the time.
Biomet argues that plaintiffs' expert Mari Truman's opinion doesn't create
a genuine issue of material fact on these points. She says that Biomet's testing
was deficient because it didn't involve more extreme testing designed to mimic
more active patients. Even if her opinion is admissible (and I have determined that
it is), Biomet says that the testing it applied was the state of the art when the M2a
implants were developed.
Ms. Truman's report argues that all metal-on metal implants were defective
because the metal-on-polyethylene designs offered safer alternatives. Biomet
argues that her opinion ignores the potential benefits from metal-on metal
implants, especially as they were perceived during the 1990s through mid-2000s.
Biomet also says that the kinds of metal-on-polyethylene devices on which Ms.
Truman based her conclusions - highly cross-linked metal-on-polyethylene
implants - were in development at the same time as the metal-on metal devices,
but hadn't had significant clinical testing and weren't as widely accepted yet.
Biomet argues that the metal-on-polyethylene devices shouldn't be treated as
alternative designs for the metal-on metal devices, but as different devices entirely.
The different materials in each type of design have their advantages and
disadvantages, Biomet says, making them appropriate for some persons and
inappropriate for others.
"State of the art" can be a pertinent (possibly determinative) part of the
defense case in product liability suits in most states. But the definition varies from
state to state, as does the role the concept plays in a case. Biomet says (and the
plaintiffs only agree up to a point) that "state of the art" is an affirmative defense
in Arizona, Iowa, Louisiana, Missouri, Nebraska, New Hampshire, and New Jersey,
and that it creates a presumption of non-liability in Indiana and Kentucky. Biomet
says (without full agreement from the plaintiffs) that the following states require
a plaintiff to show an alternative design (which Biomet says the plaintiffs can't do):
Alabama, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, New York,
Ohio, South Carolina, Texas, West Virginia, and Wisconsin. Biomet appears to
believe that while the laws of those states vary somewhat, they are close enough
to fit within a single definition it offers: "Biomet defines the state of the art for this
motion as the best technology reasonably available for MoM hip implants during
the time Biomet developed and marketed the implants or, as alternatively phrased
(but with a consistent meaning), what was reasonably known an technologically
feasible regarding MoM hip implants.” [Doc. No. 3437 at 2]. But the court would
need to engage in a side-by-side comparison to see which states use a
substantially identical definition.
Biomet is correct that transferee courts often resolve summary judgment
motions before considering suggestion of remand of cases to the transferor court
or district where trial is to be held. I told counsel early on that I didn't intend to
do that in this case, because there is less delay when the judge applying the law
doesn't have to learn that law from scratch, and it was unfair to make all cases
wait here while I studied a body of law that didn't apply to those cases. As I stated
in the December 21, 2015 scheduling order: "With regard to the parties' general
experts all summary judgment motions...that are heavily dependent upon the
unique law of a specific state (other than Indiana) may be left to the transferor
court following remand." [Doc. No. 3047, 13].
While Biomet discusses the "state of the art" doctrines in nineteen states,
the Plaintiffs Steering Committee reports that, according to its review of the
pending unsettled cases, there are plaintiffs from 39 states and the District of
Columbia. I think that count might elide upcoming forum selection issues in
cases directly filed in this court, as well as looming choice of laws issues. Biomet's
motion doesn't identify which constituent cases it targets with this summary
Biomet also concedes that once I make some sort of state-of-the-art ruling,
the unique facts of the individual cases will have to be examined to see when the
device was constructed, when it was implanted, and so on. But, Biomet says,
"MDL courts often make rulings that are then applied later to individual cases,
which is what Biomet seeks with this motion," citing discovery rulings in the
Welding Fume Products Liability Litigation, MDL No. 1535, 2010 U.S. Dist. LEXIS
146067, at *31, 297 n.236 (N.D. Ohio June 4, 2010). But an enormous gulf
separates rulings on the admissibility of evidence and what Biomet might be
seeking from this ruling.
Biomet seems to be asking me to study and then articulate, or synthesize,
the state-of-the-art law of nineteen different states and make some sort of
declaration – it couldn't be a judgment or an order of the sort contemplated by
Fed. R. Civ. P. 56(g) – that might or might not apply to a case in which one of
those states provide the rule of decision, depending on the specific facts of that
case. Any such undertaking would indefensibly slow the process in this docket,
which is now in its sixth year, and includes a case that landed in the federal court
system in September 2011 and arises from a June 2008 surgery. Time in this
court is better spent on other matters, with application of state law left to the
transferor courts, which more often than not are located in the state whose law
provides the rule of decision. I am denying Biomet's state-of-the-art summary
judgment motion without prejudice to its renewal after remand to the transferor
Biomet's other summary judgment motion is directed to the Taper, ReCap,
and metal-on-polyethylene cases, which represent a very small fraction of the total
number of cases filed in this MDL docket. Although Biomet hasn't specifically
identified which cases its motion applies to, I count only four: Price v. Biomet
(3:14cv275), Gearon v. Biomet (3:14cv2099), White v. Biomet (3:16cv115), and
Glynn v. Biomet (3:15cv491). Price involves a Taper device, Gearon involves a
ReCap device, and White and Glynn are metal-on-polyethylene cases. The Judicial
Panel on Multidistrict Litigation centralized the Price case here after it expanded
the scope of the docket to include Taper devices. Although the MDL was never
officially expanded to include the ReCap and metal-on-polyethylene hip implants,
those cases were filed directly in the Northern District of Indiana, using the direct
filing method outlined in the February 15, 2013 Case Management Order [Doc.
No. 242], and neither the PSC nor Biomet objected to their inclusion.
The December 2015 scheduling order stayed all metal-on-polyethylene cases
until they were activated for case specific discovery, and established a time line
for expert reports and deposition that were "not case-specific." [Doc. No. 3047].
Under that order, case-specific discovery was limited to:
interrogatories, requests for production, requests for admission, and
depositions of (a) the plaintiffs, (b) the implanting surgeon, (c) the
revising surgeon, (d) the Biomet representative who processed the
request for the product used during the implant surgery, (e) any
separate Biomet representatives who were present in the operating
room during the implant or revision surgery, and (f) one additional
fact witness per side.
[Doc. No. 3047 at p. 6-8]. The order indicated that plaintiffs' originating counsel
(not the PSC) would conduct those depositions, but it made no provision for any
other case- or device- specific expert discovery, and neither the Plaintiffs Steering
Committee nor Biomet ever sought to amend the scheduling order to include
metal-on-polyethylene cases. When the Plaintiffs Steering Committee elected to
focus its efforts and limited resources on the metal-on-metal cases that make up
the majority of the MDL docket, the Taper, ReCap, and metal-on-polyethylene
plaintiffs were pretty much left to fend for themselves. Their efforts to take expert
depositions (other than those identified in the scheduling order) during
case-specific discovery met with resistance, and, for reasons which aren't
altogether clear, these plaintiffs and the Plaintiffs Steering Committee elected not
to seek my assistance in resolving their discovery disputes until Biomet filed its
summary judgment motion.
In support of its motion, Biomet asserts that most jurisdictions require
plaintiffs to present design-specific expert testimony regarding defect and
causation to survive summary judgment, and that the plaintiffs in the Taper,
ReCap and metal-on-polyethylene cases haven't met that burden because the
testimony of their expert on design defect, Mari Truman, was generic (not design
specific) and unreliable for the reasons stated in its Daubert motion.
The plaintiffs respond that summary judgment is inappropriate because:
(1) State laws differ significantly as to the prima facie case that must be
presented to prove that a product is defective.
(2) Ms. Truman's testimony is reliable, admissible, and creates a genuine
issue of fact as to whether the Taper and ReCap devices are defective.
(3) The Declarations of Causation submitted by Dr. Paul Dimond and Dr.
B. Sonny Bal in White v. Biomet (3:16cv115) and Glynn v. Biomet (3:15cv491)
create a genuine issue as to whether the metal-on-polyethylene hip implant is
(4) Given the limitations on case-specific discovery, the plaintiffs haven't had
an opportunity to conduct the kind of device-specific expert discovery needed to
justify its opposition to Biomet's motion for summary judgment.
Biomet is correct that in many states, expert testimony is required to prove
design defects. See, e.g., Show v. Ford Motor Co., 659 F.3d 584 (7th Cir. 2011)
(holding that design-defect litigation under Illinois law requires expert evidence);
Lara v. Delta Int'l Mach. Corp., 174 F. Supp. 3d 719, 740 (E.D.N.Y. 2016) ("New
York law requires plaintiffs to proffer expert testimony as to the feasibility and
efficacy of alternative designs."). Without expert testimony that the Taper or ReCap
designs were defective, and with testimony in the record favorable to the
metal-on-polyethylene design, Biomet argues that the cases involving those
designs must be decided in Biomet's favor. I disagree.
Biomet's motion is largely premised on its assumption that its motion to
exclude Ms. Truman's report and testimony would be granted, but I denied the
motion to exclude Ms. Truman's opinion testimony. Ms. Truman opined that all
metal-on-metal devices) are defectively designed, thus creating a genuine issue of
fact as to those devices that cannot be resolved on summary judgment.
Ms. Truman lauded metal-on-polythene devices as the best alternative (the
alternate design in the state-of-the-art arguments), but Dr. Dimond and Dr. Bal
metal-on-polythene devices implanted in their patients were defective. Biomet
contends that opinions of Dr. Dimond and Dr. Bal about the cause of the injuries
suffered by Mr. White and Mr. Glynn are unreliable and so don't establish that
there was a defect in the metal-on-polyethylene devices. Again, I disagree. As
shown by the material submitted with their Expert Declarations of Causation, Dr.
Dimond and Dr. Bal are qualified orthopedic surgeons who performed the
surgeries in question. Their Declarations of Causation were submitted in
compliance with my December 15, 2016 order [Doc. No. 3272] entered by the
parties' agreement and at Biomet's urging, and create a genuine issue of fact as
to whether Biomet's metal-on-polythene hip implant is defective, as alleged. That
Ms. Truman might have opined that the metal-on-polyethylene device is a
reasonably safe alternative to the metal-on-metal device doesn't erase the opinions
offered by Drs. Dimond and Bal that a defect in the metal-on-polyethylene devices
implanted in Mr. White and Mr. Glynn caused their injuries.
While the evidence presented precludes summary judgment on the plaintiffs'
defective design claims, their responses to Biomet's motion raise a matter of some
concern - the status of case-specific expert discovery in the Taper, ReCap, and
metal-on-polyethylene cases. As I noted in the December 21, 2015 scheduling
order: "[I]t's my task under 28 U.S.C. § 1407 to get these cases as close to
trial-ready as is reasonable before remanding them to transferor courts, so taking
the [case-specific] depositions before remand seems more consistent with the MDL
process." [Doc. No. 3047 at p. 7, 8].
Case-specific discovery remains open in the metal-on-polyethylene cases
(White and Glynn) until September 14, 2018, so time remains to conduct
device-specific expert depositions in those cases. If the plaintiffs wish to conduct
such discovery in this court and require my assistance in resolving any discovery
disputes, they need only ask.
But all discovery has closed with respect to the remaining Taper and ReCap
cases (Price and Gearon). I denied the plaintiff's motions for voluntary dismissal
and for suggestion of remand in those cases in February 2016 and again in
November 2016, based in part on Biomet's belief that the plaintiffs would continue
to benefit from coordinated discovery. To deny those plaintiffs that benefit now
would be unduly prejudicial to Mr. White and Mr. Glynn. Accordingly, I will offer
both plaintiffs the option to file a motion to amend the scheduling order to allow
device-specific expert depositions in this court, or to file a motion for suggestion
of remand, so that they might conduct that discovery - discovery not yet
undertaken in cases in the MDL docket - in the transferor court.
For the foregoing reasons:
(1) Biomet’s motions for summary judgment related to the Taper,
ReCap, and metal-on-polyethylene devices [Doc. No. 3388] is DENIED on
(2) Biomet’s motions for summary judgment relating to the state-ofthe-art defense [Doc. No. 3390] is DENIED, without prejudice.
(3) If the plaintiffs in White v. Biomet (3:16cv115) and Glynn v. Biomet
(3:15cv491) wish to take device-specific expert depositions, they should file
a motion to that effect within 14 days from the date of this order, and
should indicate in that motion whether local counsel will conduct the
deposition, with or without the assistance of the Plaintiffs Steering
(4) The plaintiffs in the Price v. Biomet (3:14cv275) and Gearon v.
Biomet (3:14cv2099) shall have 14 days from the date of this order to file a
motion to amend the scheduling order to allow device-specific expert
depositions or, alternatively, a motion for suggestion of remand. If they elect
the later, the Plaintiffs Steering Committee should address the effect, if any,
remand would have on the plaintiffs’ obligations under the December 7,
2015 Amended Holdback Order [Doc. No. 3022] in its response.
February 8, 2018
/s/ Robert L. Miller, Jr.
Judge, United States District Court
Northern District of Indiana
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