Barnes v. Orthofix International NV et al

Filing 79

ORDER by Judge John C Coughenour; Plaintiff's 46 motion to amend is GRANTED. Defendant's motions to strike and exclude and motion for summary judgment are DENIED. (Dkt. Nos. 54 , 56 & 59 ). Plaintiff's 71 motion to seal is GRANTED. (TF)

THE HONORABLE JOHN C. COUGHENOUR

1
2
3
4
5
6

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF WASHINGTON
AT SEATTLE

7
8
9

JANELLE ELIZABETH BARNES,

10
Plaintiff,
11

CASE NO. C11-402 JCC
ORDER

v.
12
ORTHOFIX INTERNATIONAL NV,
13
Defendant.
14
This matter comes before the Court on Plaintiff’s motion to amend (Dkt. No. 46). The

15

16 Court also considers Defendant’s motion to strike (Dkt. No. 54), Defendant’s motion to exclude
17 (Dkt. No. 56), and Defendant’s motion to exclude consolidated with the motion for summary
18 judgment (Dkt. No. 59). Having thoroughly considered the parties’ briefing and the relevant
19 record, the Court finds oral argument unnecessary and hereby rules as follows.
20 I.

BACKGROUND

21

This is a product liability case involving the Pain Care Pump 3000, a device that infuses

22 anesthetic into a patient’s shoulder after surgery. The device is manufactured by BREG
23 Corporation, a division of Orthofix International NV. On December 12, 2006, orthopedic
24 surgeon Dr. Ronald Wobig performed shoulder surgery on Plaintiff Janelle Barnes in Corvallis,
25 Oregon. During the surgery, a catheter for the pain pump was inserted and a mixture of Marcaine
26 and epinephrine was injected through the catheter. The pain pump remained in place and a

ORDER
PAGE - 1

1 mixture of the same anesthetic was infused under pressure over the next 50 hours.
2

Plaintiff left Oregon and moved to Utah in 2007 and then to Washington in 2008. Over

3 time, Plaintiff began to experience worsening pain. On November 24, 2008, Dr. Richard Kirby
4 examined Plaintiff’s shoulder in Seattle and diagnosed her with post-arthroscopic glenohumeral
5 chondrolysis (“PAGCL”), a condition involving permanent loss of cartilage in the shoulder joint.
6 Plaintiff alleges that the pain pump created an unreasonable risk of chondrolysis when used in
7 the type of surgery Dr. Wobig performed.
8

The exact manner in which the pump was inserted is disputed by the parties. To

9 understand the dispute, a brief overview of shoulder anatomy is necessary. The area outside the
10 shoulder joint and under the acromion is called the subacromial space. The area inside the joint is
11 called the intraarticular space. There is medical literature suggesting that a pain pump catheter
12 inserted into the intraarticular space, the area inside the joint, can cause chondrolysis. Defendant
13 alleges that there is no peer-reviewed medical literature establishing that subacromial placement
14 causes chondrolysis. Dr. Wobig has testified that he inserted the pump catheter into the
15 subacromial space of Ms. Barnes’ shoulder. But much of Ms. Barnes’ case is built on the theory
16 that anesthetic from the pain pump ended up in the intraarticular space. Although the precise
17 mechanism by which this may have happened is unknown, Plaintiff offers two main theories: the
18 “misplacement” theory, that Dr. Wobig accidentally placed the catheter in the intraarticular
19 space, and the “leakage” theory, that anesthetic leaked from the subacromial space to the
20 intraarticular space.
21

Plaintiff now seeks to amend her complaint to add a claim for punitive damages under

22 Oregon law. Also, Defendant seeks to exclude much of the testimony on which Plaintiff is
23 basing her theories of causation.
24 II.

MOTION TO AMEND

25

Pursuant to FRCP 15(a), a plaintiff may amend her complaint only with the opposing

26 party’s written consent or the court’s leave. Rule 15(a) is very liberal and leave to amend “shall

ORDER
PAGE - 2

1 be freely given when justice so requires.” AmerisourceBergen Corp. v. Dialysist West, Inc., 465
2 F.3d 946, 951 (9th Cir. 2006). But a district court need not grant leave to amend where the
3 amendment: (1) prejudices the opposing party; (2) is sought in bad faith; (3) produces an undue
4 delay in litigation; or (4) is futile. Id.
5

A.

Prejudice

6

Defendant argues that it would be prejudiced by the amendment because it would have

7 conducted depositions and other trial preparations differently if it had known the complaint
8 would be amended. Defendant cites to Morongo Band of Mission Indians v. Rose, 893 F.2d 1074
9 (9th Cir. 1990), in which the Ninth Circuit affirmed the district court’s denial of an amendment
10 where the amendment would have greatly altered the nature of the litigation. The Morongo court
11 did not hold that the altered nature of the litigation was fatal to amendment, merely that it entered
12 into the balance. Id. at 1079. Defendant fails to show that the balance tips in its favor. In
13 Morongo, after the dismissal of a complaint relating to enforcement of a tribal ordinance on non14 tribal members, the plaintiffs sought to amend the complaint to add RICO and civil rights
15 claims—a dramatic shift. Here, Plaintiff seeks only to add a damage claim, but leaves the
16 remaining claims unchanged. Defendant has failed to show that a minor amendment of this
17 nature would amount to prejudice.
18

B.

Choice of Law

19

Washington law is presumptively the law of this case unless there is a conflict with the

20 laws and interests of another state. Rice v. Dow Chem. Co., 875 P.2d 1213, 1216 (Wash. 1994).
21 With respect to punitive damages, the law of Washington, which does not allow them, is in
22 conflict with the law of Oregon, which does. To determine the proper law to apply, Washington
23 uses the “most significant relationship” test as set out in the Restatement (Second) of Conflict of
24 Laws § 145 (1971). Johnson v. Spider Staging Corp., 555 P.2d 997 (1976). Section 145 provides
25 that when evaluating those relationships, contacts to be taken into account include: (a) the place
26 where the injury occurred; (b) the place where the conduct causing the injury occurred; (c) the

ORDER
PAGE - 3

1 domicil, residence, nationality, place of incorporation and place of business of the parties; and
2 (d) the place where the relationship, if any, between the parties is centered.
3

Plaintiff argues that Oregon has the most significant relationship because that is where

4 the operation was performed and where Plaintiff suffered the injury. Plaintiff cites to Rice v.
5 Dow Chem. Co. for comparison. In that case, a forest service employee was exposed to
6 significant doses of herbicides while living in Oregon and later moved to Washington where he
7 developed leukemia. The court found:
8
9
10
11

The relationship between the parties occurred in Oregon, the damaging product
was placed in the stream of commerce and sent to Oregon, at the time of the
injurious contact Plaintiff lived in Oregon, and Plaintiff was exposed to the
chemicals at work while employed in Oregon. Virtually the only connection with
Washington is that the disease allegedly caused by the chemicals manifested itself
in this state.

12
13 Rice, 875 P.2d at 1218.
14

Defendant counters that because Plaintiff did not experience pain until well after her

15 surgery, the state with the most significant relationship would be either Utah or Washington,
16 depending on where she was residing when the PACGL developed. Alternatively, Plaintiff
17 argues, California, the state in which the corporate conduct that allegedly resulted in insufficient
18 warnings occurred, may have the most significant relationship.
19

Although there is some basis for applying California’s punitive damages law, and

20 Plaintiff indicates that she does not object, Oregon is the state with the most significant
21 relationship. All but one of the reasons mentioned by the court in Rice applies in this case. The
22 relationship between Plaintiff and Defendant occurred in Oregon, the pain pump was sent to
23 Oregon, and at the time of the surgery Plaintiff lived in Oregon. The only difference is that
24 Plaintiff has not alleged that she was employed in Oregon at the time of the surgery, a negligible
25 distinction. The Rice court specifically held that these factors outweighed the fact that the
26 “Defendant’s main headquarters, state of incorporation, place where the product was designed or

ORDER
PAGE - 4

1 tested, place where appropriate warnings for the label were determined or place where the
2 product was labeled” was not in Oregon. Id.
3

Defendant also argues that in a case involving punitive damages, § 145 comment c states

4 that if the purpose of the tort rule is to punish misconduct, the state where the conduct took place
5 may be that of the most significant relationship. However, comment c goes on to say that if the
6 tort rule is designed to compensate victims, then the state where the injury occurred may have
7 the greater interest in the matter. Defendant does not argue which of these two categories
8 California’s law of punitive damages falls in to, so the argument is unilluminating.
9

In the event of a conflict with Washington law, Oregon substantive law governs this case.

10 Plaintiff’s motion to amend is GRANTED.
11 III.

MOTION TO STRIKE SUPPLEMENTAL WITNESS DISCLOSURES

12

On December 19, 2011, the Court entered a stipulation by the parties, stating that the

13 deadline for Plaintiff’s expert disclosures would be February 10, 2012. (Dkt. No. 32). Pursuant to
14 an agreement between the parties, Defendant disclosed its experts on March 19, 2012. Plaintiff
15 designated Dr. Gofeld as a rebuttal witness twenty-one days later. Plaintiff also alleges that
16 because it was apparent from Defendant’s expert reports that the experts “misapprehend[ed]
17 Plaintiff’s post-operative course,” she supplemented her disclosure with an additional witness,
18 Matt Swartz, to clarify the misapprehension. Defendant moves to strike both disclosures as
19 untimely.
20

A. Dr. Gofeld

21

FRCP 26(a)(2)(D)(ii) permits a party to disclose an expert witness within 30 days of the

22 other party’s disclosure if the evidence is “intended solely to contradict or rebut evidence on the
23 same subject matter identified by another party.” “Rebuttal evidence is admissible only where
24 the need for it could not have been foreseen at the time the plaintiff presented its case-in-chief.”
25 Daly v. Far Eastern Shipping Co. PLC, 238 F. Supp. 2d 1231, 1238 (W.D. Wash. 2003) (citing
26 Faigin v. Kelly, 184 F.3d 67, 85 (1st Cir. 1999)). Plaintiff summarizes Dr. Gofeld’s testimony in

ORDER
PAGE - 5

1 three points: (1) subacromial catheter placement would not provide plain relief for joint surgery;
2 (2) blind catheter placement might penetrate the rotator cuff or joint space; and (3) anesthetic
3 infused outside the joint can migrate into the joint. (Dkt. No. 63 at 2). While the Court is
4 concerned that some of these points may be duplicative of Plaintiff’s case-in-chief, particularly
5 the testimony of Dr. Hasan and Dr. Kirby (Dkt. Nos. 55-5 and 55-6), it is unwilling to grant a
6 pretrial exclusion of Dr. Gofeld’s testimony in the abstract. The Court will hear the testimony of
7 Dr. Hasan and Dr. Kirby and then decide whether Dr. Gofeld will be permitted to testify and on
8 what subjects. Defendant’s motion to strike the disclosure of Dr. Gofeld is DENIED.
9

B. Matt Swartz

10

Defendant’s primary argument for the exclusion of Matt Swartz is that his testimony is

11 not credible. Plaintiff states that Defendant’s experts assume that she did not have a “honeymoon
12 period” of improved range of motion following the surgery, an indication that she might not be
13 suffering from chondrolysis. The purpose of Matt Swartz’s testimony, Plaintiff explains, is to
14 contradict those assumptions and testify about her range of motion during the period following
15 the surgery. Defendant argues that this explanation would contradict Plaintiff’s own expert, Dr.
16 Hasan, who noted in his report that Plaintiff did not have the classic honeymoon period. (Dkt.
17 No. 70-3 at 4). Issues of credibility and inconsistency are best resolved in trial. Defendant’s
18 motion to strike the disclosure of Matt Swartz is DENIED.
19 IV.

MOTION TO EXCLUDE THE TESTIMONY OF DR. PARISIAN

20

Defendant moves under Fed. R. Evid. 401, 403, and 702 to exclude the testimony of

21 Plaintiff’s expert Suzanne Parisian, M.D. Federal Rule of Evidence 702 provides that if expert
22 testimony will “assist the trier of fact to understand the evidence or to determine a fact in issue,”
23 such testimony is admissible so long as “(1) the testimony is based on sufficient facts or data, (2)
24 the testimony is the product of reliable principles and methods, and (3) the witness has applied
25 the principles and methods reliably to the case.” Fed. R. Evid. 702. This Court must perform a
26 gatekeeping function to ensure that the expert’s proferred testimony is not only relevant but

ORDER
PAGE - 6

1 reliable. United States v. Freeman, 498 F.3d 893, 901 (9th Cir. 2007) (citing Daubert v. Merrell
2 Dow Pharms., 509 U.S. 579, 589, (1993)).
3

Plaintiff seeks to call Dr. Parisian, a former Chief Medical Officer in the FDA’s Office of

4 Device Evaluation, to testify on the FDA Section 510(k) application process, the FDA clearances
5 that were obtained regarding pain pumps, and whether Breg’s marketing, instructions, warnings
6 and testing were appropriate given the clearance it did obtain. Defendant argues that the question
7 of FDA clearances is a “sideshow” with no bearing on the issue of whether or not Defendant
8 should have known and warned about a risk of chondrolysis. These issues are not as distinct as
9 Defendant would have it. Appropriate distribution and marketing of a medical device, and the
10 accompanying warnings, can hardly be divorced from the regulatory approval of that device.
11 And the current state of FDA regulatory approval is such that a layman may have significant
12 difficulty understanding the rules and obligations it imposes. Dr. Parisian has the qualifications
13 and experience to provide the jury with informative and reliable testimony on this subject. Dr.
14 Parisian will not, of course, be permitted to instruct the jury on the law or the ultimate issue in
15 this matter. The Court is fully capable of ensuring that Dr. Parisian does not stray beyond the
16 permissible bounds of expert testimony. Defendant’s motion to exclude is DENIED.
17 V.

DEFENDANT’S MOTION TO EXCLUDE CAUSATION OPINIONS

18

Again, Defendant seeks to limit in every way possible the information to be presented to

19 the jury. This time, Defendant seeks to exclude the testimony of Drs. Richard Kirby and Samer
20 Hasan (the “Causation Experts”) on the grounds that their causation theories, misplacement and
21 leakage, are unreliable. Neither theory, Defendant argues, is based on a reasonable degree of
22 medical certainty or on objective medical literature. Instead, they are based on speculation and
23 amount to conclusory ipse dixit. Defendant cites to United States v. Redlightning, 624 F.3d 1090,
24 1110 (9th Cir. 2010), arguing that where facts in the record do not support an expert’s theory,
25 exclusion is proper. In Redlightning, the expert’s testimony about the theory of false confessions
26 was excluded when the expert testified that he had not interviewed the defendant and that there

ORDER
PAGE - 7

1 was no evidence at all that a false confession had been given; ultimately, he concluded that there
2 was no reason to believe that his theory applied to the facts of the case. The present case is
3 distinct.
4

Rather than presenting theories with tenuous relationships to the facts of the case, the

5 Causation Experts’ theories are a direct result of their observations in this case. To begin, the two
6 doctors have a combined total of more than 40 years of medical experience, and can boast of
7 distinguished resumes in the field of orthopedics. Dr. Kirby has been board-certified in
8 orthopedics since 1984, and has focused almost exclusively on treatment of the shoulder for
9 many years. He has been treating Plaintiff since January 2009. Dr. Hasan is a member of the
10 American Shoulder & Elbow Surgeons, which is by nomination only and based on sustained
11 academic and research contributions to the field. He met with Plaintiff for an independent
12 medical examination on January 26, 2012. Both doctors performed a differential diagnosis, the
13 standard scientific technique of identifying the cause of a medical problem by eliminating the
14 likely causes until the most probable one is isolated.1 The Ninth Circuit has long recognized that
15 a reliable differential diagnosis passes muster under Daubert. Clausen v. M/V New Carissa, 339
16 F.3d 1049, 1058 (9th Cir. 2003). The result of the differential diagnoses was that both doctors
17 independently ruled out all possible causes of chondrolysis except the infusion of anesthetic
18 through the pain pump from December 12‒14, 2006. (Dkt. Nos. 74 at ¶ 8 & 75 at ¶ 21).
19

The testimony of the Causation Experts is based on valid methodology and that

20 methodology was properly applied to the facts in this case. Defendant’s remaining concerns
21
22

1

Defendant objects that the Causation experts erred in deeming the leakage and
23 misplacement theories “likely causes” and that these theories lack the appropriate support in the
medical literature to be included in the differential diagnosis calculus. . But proper documentary
24 support is not a prerequisite for an admissible differential diagnosis. The Supreme Court has
25 stated that “publication . . . is not the sine qua non of admissibility; it does not necessarily
correlate with reliability, and in some instances well-grounded but innovative theories will not
26 have been published. Some propositions . . . are too particular, too new, or of too limited interest
to be published.” Clausen, 339 F.3d 1060 (quoting Daubert, 509 U.S. at 593).
ORDER
PAGE - 8

1 pertain to the credibility and accuracy of the testimony, and as the Court has stated, these issues
2 are best resolved by the jury. Defendant’s motion to exclude is DENIED.
3

Finally, because the Court holds that Oregon substantive law applies to this case,

4 Defendant’s motion for summary judgment on Plaintiff’s design-defect claim is DENIED.
5 VI.

CONCLUSION

6

For the foregoing reasons, Plaintiff’s motion to amend is GRANTED. (Dkt. No. 46).

7 Defendant’s motions to strike and exclude and motion for summary judgment are DENIED.
8 (Dkt. Nos. 54, 56 & 59). Plaintiff’s motion to seal is GRANTED. (Dkt. No. 71).
9

DATED this 23rd day of May 2012.

10
11
12

A

13
14
15

John C. Coughenour
UNITED STATES DISTRICT JUDGE

16
17
18
19
20
21
22
23
24
25
26

ORDER
PAGE - 9