Warner et al v. Stryker Corporation et al

Filing 153

ORDER: Denying Defendant's Motion for Summary Judgment 127 . Signed on 11/28/2011 by Chief Judge Ann L. Aiken. (lg)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON

Civ. No. 08-6368-AA
OPINION AND ORDER

SCOTT WARNER, et al.,
Plaintiffs,
v.

STRYKER CORPORATION, a Michigan
corporation and STRYKER SALES
CORPORATION, a Michigan
corporation, et al.,
Defendants.
AIKEN, Chief Judge:
Plaintiff Scott Warner filed suit alleging products liability
and negligence after a medical device known as a "pain pump" was
used to administer local anesthetics into Warner's shoulder joint
after arthroscopic surgery.
and punitive damages.
sales

Corporation

Warner seeks economic, non-economic,

Defendants Stryker Corporation and Stryker
(collectively

Stryker)

were

the

alleged

manufacturer and distributer of the pain pump.
Stryker now moves for summary judgment on Warner's claims.
1

- OPINION AND ORDER

Stryker argues that it did not know and could not have known of any
risk associated with pain pump use in the joint space prior to
Warner's surgery ,and therefore it had no duty to warn of such
risk.

Stryker also argues that Warner cannot prove that Stryker's

alleged failure to warn of such risk caused Warner's injuries, or
that Warner is 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.

See id.

360c, 360e.

§§

As pertinent

to this case, the Msubstantial equivalentH exception permits the
marketing

of

a

new

Class

II

device

through

the

premarket

notification process, commonly known as the "510(k)H notification
process.

l.!;i,.. §§ 360c(f), 360(k).

the Class I I device is deemed

MUnder the 510(k) process, i f

'substantially equivalent'

pre-existing device with prior clearance,
without further regulatory ana1ysis.,H

2

- OPINION AND ORDER

to a

'it can be marketed

PhotoMedex. Inc. v. Irwin,

601 F.3d 919, 925 (9th Cir. 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.
Decl.

at 2; Young Decl.

Ex.

19

(filed under seal).

Hoffman
Notably,

McKinley Medical and Stryker had sought 510(k) clearance to market
pain pumps for the specific indication of orthopedic use and/or use
in the joint cavity.
seal),

6

Ultimately,

(Petty

See. e.g., Young Decl. Exs. 5 (filed under

Dep.

at

17),

10

(Petty

Dep.

at

198-99).

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

3

- OPINION AND ORDER

j oint space.

Young Decl. Exs.

(Petty Dep. at 199).

5,

6 (Petty Dep. at 43-44),

10

Warner maintains 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 July 15, 2004, Warner underwent arthroscopic surgery on his
shoulder,

and his surgeon used a Stryker pain pump device to

administer local anesthetics for up to seventy-two hours following
surgery.

Warner's surgeon, Dr. Benz, placed the pain pump catheter

directly into Warner's shoulder joint to deliver the prescribed
pain medication.

Warner later developed glenohumeral chondrolysis,

a rare and painful condition involving the rapid and permanent
destruction of articular cartilage in the shoulder joint.
On November 13, 2008, Warner filed suit.

Warner maintains

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 Warner
fails to present any evidence that, at the time of his surgery, the
scientific or medical

community had reason to

know of

risks

associated with using pain pumps to administer local anesthetics

4

- OPINION AND ORDER

directly to the joint space.

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. Corp., 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 know or have reason to
know of any association between pain pump use and chondrolysis as
of July 2004, Warner cannot prevail on his products liability or
negligence claims. 1

I disagree and find that genuine issues of

material fact preclude summary judgment.
Though not overwhelming, Warner presents some evidence that
Stryker knew or should have known of toxicity concerns associated
wi th the administration of local anesthetics directly into the
j oint

area.

Warner submits the declaration of an orthopedic

surgeon who asserts that prior to 2000,

existing medical and

scientific knowledge indicated that "continuous exposure to foreign
solutions could be harmful" to articular cartilage and would have
put a medical device manufacture on notice that the continuous

'Warner's counsel maintains that a strict products liability
claim based on failure to warn does not require that the
manufacturer knew or should have known of the alleged risk of
harm but only that the device was unreasonably dangerous without
an adequate warning. Given that I find questions of fact
regarding Stryker's actual or constructive knowledge, I need not
address this issue.
5

- OPINION AND ORDER

infusion of anesthetics for one to two days
inj ury to the cartilage."
attached articles).

~would

likely risk

Trippel Declo Ex. A at 5-13 (citing

Warner also presents internal documents of

Stryker discussing the lack of FDA clearance or approval
~inter-articular

injection"

referencing anesthetic

of

a

~toxicity"

certain

pain medication

Young Decl. Exs. 13, 62-63 (filed under seal).

maintains

that

documents

and

concerns associated with pain

pump use.

these

for

are

not

relevant

Stryker

because

no

competent evidence establishes that the toxicity referred to was
chondrotoxicity and objects to the consideration of such evidence
on this and hearsay grounds.
Material Facts at 16.
documents relevant.

Stryker's Reply to Pl.'s Statement of

I overrule Stryker's objection and find the
The type of toxicity to which the documents

refer is a factual finding not appropriate for this court to make
on summary judgment, and the documents are submitted to establish
notice.
Finally, Warner's evidence must be considered in the context
of Stryker's regulatory and marketing efforts and the lack of a
specific indication for the use of pain pumps 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 without a specific
indication cleared by the FDA.

David Decl. Ex. A at 5-6; Young

Decl. Exs. 20, 64 (filed under seal).

6

- OPINION AND ORDER

Construing all inferences in

favor of Warner,

he presents 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 otherwise harmful.
Monroe v. Zimmer U.S. Inc., 766 F. Supp. 2d 10l2, 1036-38

(E.D.

Cal. 2011); Hackett v. Breg, Inc., 2011 WL 4550186, at *2-3 (D.
Colo. Oct. 03, 2011); Hamilton v. Breg, Inc., 2011 WL 780541, at
*3-5 (D. Ohio Jan. 20, 2011); Koch v. Breg. Inc., 2010 WL 5301047,
at *2-4 (D. S.D. Dec. 20, 2010).

It is not incumbent on Warner 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.
Breg, Inc., 759 F. Supp. 2d 958, 974 (S.D. Ohio 2010); Pavelko v.
Breg,

Inc.,

2011 WL 782664,

at *5-6

(D. Colo.

Feb.

28,

2011);

Phillippi v. Stryker Corp., 2010 WL 2650596, at *2-3 (E.D. Cal.
July 1,2010); Meharg v. I-Flow Corp., 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 Warner's evidence at trial will fail

to show by a preponderance that Stryker had reason to know of the

7

- OPINION AND ORDER

risks associated with intra-articular pain pump use.

As noted by

one district judge, "[tJhe medical evidence that pain pumps could
cause chondrolysis was at best fragmentary at the time" of Warner's
surgery.

Hamilton, 2011 WL 780541, at *3.

On a motion for summary

judgment, however, all inferences must be construed in favor of
Warner.

So construed, genuine issues of material fact remain.

Stryker also contends that Warner cannot show any alleged
failure to warn by Stryker caused Warner's injury.
Searle

&

Co., 272 Or. 367, 369, 536 P.2d 1247

Vaughn v. G.D.

(1975).

Stryker

emphasizes Dr. Benz's deposition testimony stating that he did not
read the Instructions for Use accompanying the Stryker pain pump
prior to Warner's surgery or rely on statements from Stryker's
sales representatives,

placing into question whether Stryker's

alleged failure to warn could have caused Warner's injury.
Decl. Ex. W.

Horwitz

However, Dr. Benz's testimony must be considered in

the context of Stryker's marketing strategies, along with his sworn
testimony that he would not have used pain pumps to administer
anesthetics directly to the joint space if he had known the FDA had
not cleared the pain pumps for such use.

Young Decl. Ex. 74.

Although Stryker objects to Dr. Benz's statement as "speculative,"
given the circumstances as a whole, I do not find it so speculative
as to warrant its exclusion.
Finally, Stryker moves for summary judgment regarding Warner's
prayer for punitive damages.

8

- OPINION AND ORDER

As with other pain pump cases, Warner

here presents little evidence that Stryker had actual knowledge of
the risk of harm allegedly caused by pain pumps at the time of
Warner's

surgery,

such that Stryker acted with "malice" or a

"reckless and outrageous indifference to a highly unreasonable risk
of harm" and with "conscious indifference to the health, safety and
welfare of others" by marketing its pain pumps for intra-articular
uses.

Or. Rev. Stat.

303 Or.

505,

517,

§

31.730(1);

739 P.2d 18

(1987)

(punitive damages "are a

penalty for conduct that is culpable by reason of motive, intent,
or extraordinary disregard of or indifference to known or highly
probable 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. 127) is DENIED.
IT IS SO ORDERED.
DATED this

~ay

of November, 2011.

Ann Aiken
United States District Judge

9

- OPINION AND ORDER