Schoenborn et al v. Stryker Corporation et al
Filing
216
ORDER: Denying Defendant's Motion for Summary Judgment 170 ; Order Denying Defendant's Motion for Leave as moot 201 . Signed on 7/11/2011 by Chief Judge Ann L. Aiken. (lg)
':':,,""
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON
ERIC J. SCHOENBORN, and
SUZANNE G. SCHOENBORN,
Civ. No. 08-1419-AA
OPINION AND ORDER
Plaintiff,
v.
STRYKER CORPORATION, and
STRYKER SALES CORPORATION,
Defendants.
AIKEN, Chief Judge:
Plaintiffs
filed
suit
alleging
products
liability
and
negligence after a medical device known as a "pain pump" was used
to administer local anesthetics to plaintiff Eric Schoenborn's
shoulder
joint
after
arthroscopic
surgery.
economic, non-economic, and punitive damages.
Plaintiffs
seek
Defendants Stryker
Corporation and Stryker Sales Corporation (collectively Stryker)
were the alleged manufacturer and distributer of the pain pump.
Stryker now moves for summary judgment on plaintiffs' claims.
Stryker argues that it did not know and could not have known of any
I
- OPINION AND ORDER
risk associated with the use of pain pumps in the joint space prior
to Schoenborn's surgery, and therefore it had no duty to warn of
such risk.
Stryker also argues that plaintiffs cannot prove that
Stryker's alleged failure to warn of such risk caused Schoenborn's
injuries, or that plaintiffs are entitled to punitive damages.
The motion is denied.
BACKGROUND
Pain pumps are medical devices used to administer prescribed
amounts of pain medication directly to a certain area of the body.
The marketing, labeling, and sale of pain pumps are regulated by
the Food and Drug Administration (FDA).
The FDA classifies medical
devices into three types: Class I, Class II, and Class III.
U.S.C. § 360c.
Prior
21
Stryker's pain pumps are Class II devices.
to
marketing
a
new
Class
II
medical
device,
a
manufacturer must obtain Premarket Approval (PMA) for the device,
unless an exception applies.
pertinent to this case,
permits
the marketing
See 21 U.S.C. §§ 360c, 360e.
the "substantial equivalent" exception
of
a
new Class
premarket notification process,
notification process.
process,
if
the
As
II
device
II
the
commonly known as the "510 (k)"
Id. §§ 360c(f), 360(k).
Class
through
device
is
"Under the 510(k)
deemed
'substantially
equivalent' to a pre-existing device with prior clearance, 'it can
be marketed without further regulatory analysis.'"
Inc.
2
v.
Irwin,
601
F.3d
- OPINION AND ORDER
919,
925
(9th
Cir.
PhotoMedex,
2010)
(quoting
Medtronic,
Inc. v. Lohr,
518
u.s. 470, 478 (1996)).
"In other
words, that device receives '510(k) clearance' and can be put on
the market."
Id.
The 510 (k) notification process is much less
rigorous than the PMA process and requires no additional testing of
the device.
Id.; Medtronic, 518
u.s. at 478-79.
In 1999, Stryker began distributing pain pumps manufactured by
McKinley Medical, LLC, and in 2000, Stryker acquired the product.
In 2002, Stryker introduced a second version of the pain pump which
included
a
programmable
computer
administration of medication.
to
regulate
the
dosage
and
As with other brands of pain pumps,
Stryker's pain pumps are prescription devices sold to health care
providers and prescribed by licensed physicians.
The parties agree that at all relevant times, Stryker's pain
pumps were cleared through the 510 (k)
notification process for
general surgery applications and "interoperative" use.
Notably,
McKinley Medical, Stryker, and other pain pump manufacturers had
sought 510 (k)
clearance to market pain pumps for the specific
indication of orthopedic use and/or use in the joint cavity.
Decl., Ex. 4 (Petty Depo., p. 152); Exs. 29-31.
Love
Ultimately, the
FDA determined that a substantially equivalent predicate device
with this specific indication did not exist and did not give
clearance to market the pain pumps for use in the joint space.
Love Decl., Ex. 4 (Petty Depo., p. 152).
the Stryker pain pumps
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- OPINION AND ORDER
for
the general
Rather, the FDA cleared
indication of "intra-
operative" use.
Hoffman Decl., p. 2.
Plaintiffs maintain that
Stryker nonetheless continued to market and sell its pain pump for
use directly in the joint space, in violation of FDA regulations.
Stryker denies these allegations.
On November 8, 2004, Schoenborn underwent arthroscopic surgery
on his shoulder, and his surgeon used a Stryker pain pump device to
administer local anesthetics for up to 72 hours following surgery.'
Schoenborn's surgeon, Dr. Isaacson, placed the pain pump catheter
directly into Schoenborn's shoulder joint to deliver the prescribed
pain medication.
Subsequently, Schoenborn developed glenohumeral
chondrolysis, a very rare and painful condition involving the rapid
and permanent destruction of articular cartilage in the shoulder
joint.
On December 5,
2008,
plaintiffs
filed
suit.
Plaintiffs
maintain that Stryker was on notice that the use of pain pumps to
deliver pain medication directly to the shoulder joint could cause
harm, and that Stryker nonetheless marketed its pain pumps for such
use and failed to warn physicians that pain pumps had not been
cleared for such use by the FDA.
DISCUSSION
Stryker moves for summary judgment on grounds that plaintiffs
'Stryker contends that no evidence establishes the use of
Stryker's pain pump during Schoenborn's surgery. However,
plaintiff presents evidence that identifies Stryker's pain pump.
Love Decl., Ex. 2, p. 1.
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- OPINION AND ORDER
fail to present any evidence that, at the time of Schoenborn's
surgery, the scientific or medical community had reason to know of
risks
associated
with
using
pain
pumps
anesthetics directly to the joint space.
to
administer
local
Stryker emphasizes that
under Oregon law, a manufacturer's duty to warn is limited to the
dangers of which it knew or reasonably should have known.
See
McEwen v. Ortho. Pharm. Corg., 270 Or. 375, 385-86, 528 P.2d 522
(1974)
(drug manufacturer has duty ·of making timely and adequate
warnings to the medical profession of any dangerous side effects
produced by its drugs of which it knows, or has reason to know").
Thus, Stryker maintains that because it did not have reason to know
of any association between pain pump use and chondrolysis as of
November
2004,
plaintiffs
cannot
liability or negligence claims. 2
prevail
on
their
products
I disagree and find material
issues of fact preclude summary judgment.
Though not overwhelming, plaintiffs present some evidence that
Stryker knew or should have known of toxicity concerns associated
wi th the administration of local anesthetics directly into the
joint area.
Plaintiffs cite to an article published in 1985 that
2As Stryker notes in its Motion to Submit Supplemental
Briefing, plaintiffs' counsel has taken the position in other
pain pump litigation that a strict products liability claim based
on a failure to warn does not require that the manufacturer knew
or should have known of the alleged risk of harm. Given that I
find questions of fact regarding Stryker's actual or constructive
knowledge, I need not address this issue and find Stryker's
motion moot.
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- OPINION AND ORDER
discusses the toxicity of local anesthetics to articular cartilage.
See Love Declo,
Ex.
20
(Nole,
Effects on Articular Cartilage,
SURG. (1985)).
et al.,
Bupivacaine and Saline
ARTHROSCOPY:
J.
ARTHROSCOPIC
& RELATED
Stryker emphasizes that plaintiffs fail to present
expert testimony or opinion regarding the significance of the Nole
article
and
argues
that
the
court
should
not
rely
on
the
interpretation of plaintiffs' counsel when they are not qualified
to render expert opinion.
See Monroe
V.
Zimmer U.S. Inc.,
F.
Supp. 2d _ , 2011 WL 534037, at *19 (E. D. Cal. Feb. 14, 2011)
("The court cannot accept counsel's interpretation of the medical
Ii terature, counsel's unsupported determination that defendants had
a
duty
to
investigate
the
medical
literature,
nor
counsel's
unsupported determination that the medical literature triggered
defendants' alleged duty to 'further investigate [the] risk or at
least warn of [the] risk.''') (quoting the plaintiff's memorandum in
opposition to summary judgment) .
If plaintiffs relied solely on the Nole article to establish
Stryker's actual or constructive knowledge, I might find Stryker's
argument
more
persuasive. 3
However,
plaintiffs
also
present
internal documents of Stryker discussing the lack of FDA clearance
or approval for·" inter-articular inj ection" of a
certain pain
3r also note that while Styker's objection is well-founded,
the record contains expert reports that cite the Nole article to
support opinions of causation. See. e.g., doc. 108; COX V. DJO.
LLC, Civ. No. 07-1310-AA, doc. 418 (Ex. 1, pp. 5-12), doc. 492
(Exs. 66, 67).
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- OPINION AND ORDER
medication
and
referencing
associated with pain pump use.
193; filed under seal).
anesthetic
"toxicity"
concerns
Love Decl., Exs. 8, 10, 11 (doc.
Stryker maintains that these documents are
not relevant and "say nothing about the only form of toxicity
relevant here - chondrotoxicity" and objects to the consideration
of such evidence on that ground.
Stryker's Reply to P1s.'s Concise
Statement of Material Facts, p. 2 (reply to SMO 4e, 4f); Styker's
Evid.
Obj.
to Pls.'s Response,
pp.
4-5
(Objections 7,
8).
overrule Stryker's objection and find the documents relevant.
I
The
type of toxicity to which the documents reference is a factual
finding
not
appropriate
for
this
court
to
make
on
summary
judgment. '
Finally,
plaintiff's
evidence must
be
context of Stryker's and other manufacturers'
510 (k)
considered in
the
attempts to gain
clearance to market the pain pumps for use in the joint
space, the FDA's determination that no predicate device established
the efficacy and safety of such use,
and Stryker's continued
promotion of the pain pumps for use in the joint space.
all inferences in favor of plaintiffs,
Construing
they present sufficient
evidence to create a genuine issue of material fact as to whether
Stryker should have known or anticipated that the administration of
local anesthetics directly into the shoulder joint was toxic or
'Stryker also objects to these documents on hearsay grounds.
However, the documents are not offered to prove the truth of the
matter asserted but to show notice.
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- OPINION AND ORDER
otherwise harmful.
Monroe, 2011 WL 534037, at *22-23; Hamilton v.
Brege Inc., 2011 WL 780541, at *3-5 (D. Ohio Jan. 20, 2011); Koch
v. Brege Inc., 2010 WL 5301047, at *2-4 (D.S.D. Dec. 20, 2010).
It
is not incumbent on plaintiffs to show that Stryker should have
known of the specific injury or damage - chondrolysis - allegedly
caused by the use of the pain pumps.
I recognize that several courts have held otherwise and found
that
any danger
from intra-articular pain pump
knowable" prior to 2005 or 2006.
use
was
"not
Rodriguez v. Stryker Corp., 2011
WL 31462, at *8 (M.D. Tenn. Jan. 05, 2011); see also Krumpelbeck v.
Brege Inc., 759 F. Supp. 2d 958, 974 (S.D. Ohio 2010); Pavelko v.
Brege
Inc., 2011 WL 782664,
at *5-6
(D.
Colo.
Feb.
28, 2011);
Phillippi v. Stryker Corp., 2010 WL 2650596, at *3 (E.D. Cal. July
1(2010);
2010 WL 711317, at *3-4 (S.D.
Ind. Mar. 1, 2010).
I respectfully disagree with those decisions
and instead find this question appropriate for the trier of fact.
It may well be that plaintiffs' evidence at trial will fail to show
by a preponderance that Stryker had reason to know of the risks
associated with intra-articular pain pump use.
As noted by one
district judge, "[tlhe medical evidence that pain pumps could cause
chondrolysis was at best fragmentary at the time" of Schoenborn's
surgery.
Hamilton, 2011 WL 780541, at *3.
On a motion for summary
judgment, however, all inferences must be construed in favor of
plaintiffs.
8
So construed, genuine issues of material fact remain.
- OPINION AND ORDER
Stryker also contends that plaintiffs cannot show any alleged
failure to warn by Stryker caused Schoenborn's injury.
G.D. Searle & Co., 272 Or. 367, 369, 536 P.2d 1247 (1975).
Vaughn v.
Stryker
emphasizes Dr. Isaacson's deposition testimony stating that she did
not read the Instructions for Use accompanying the Stryker pain
pump prior to Schoenborn's surgery or rely on statements from
Stryker's sales representatives,
placing into question whether
Stryker's alleged failure to warn could have caused Schoenborn's
injury.
Horwitz Decl., Ex. R (Isaacson Depo., pp. 45-48, 55).
However, Dr. Isaacson's testimony must be considered in the context
of Stryker's marketing strategies, along with her sworn statement
that she would not have used pain pumps to administer anesthetics
directly to the joint space if she had known the FDA had not
cleared the pain pumps for such use.
Love Decl., Ex. 1.
Stryker objects to Dr. Isaacson's statement as
Although
~specu1ative,"
given
the circumstances as a whole, I do not find it so speculative as to
warrant its exclusion.
Finally,
Stryker
moves
for
summary
plaintiffs' prayer for punitive damages.
judgment
regarding
As with other pain pump
cases, plaintiffs here present little evidence that Stryker had
actual knowledge of the risk of harm allegedly caused by pain pumps
at the time of Schoenborn's surgery, such that Stryker acted with
~malice"
or a
~reckless
and outrageous indifference to a highly
unreasonable risk of harm" and with
9
- OPINION AND ORDER
~conscious
indifference to the
health, safety and welfare of others" by marketing its pain pumps
for intra-articular uses.
United Air Lines.
Inc.,
Or. Rev. Stat.
303 Or.
505,
§
517,
31.730(1); Andor v.
739 P.2d 18
(1987)
(punitive damages "are a penalty for conduct that is culpable by
reason
of
motive,
intent,
or
extraordinary
indifference to known or highly probable
disregard
of
or
risks to others").
However, as explained above, the extent of Stryker's knowledge is
a question of fact, and I decline to grant summary judgment at this
time.
CONCLUSION
Stryker's Motion for Summary Judgment (doc. 170) is DENIED,
and Styker's Motion for Leave to Submit Supplemental Briefing (doc.
201) is DENIED as moot.
IT IS SO ORDERED.
DATED this
I/~ay
of July, 2011.
Ann Aiken
United States District Judge
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- OPINION AND ORDER
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