Bonander v. Breg, Inc. et al
Filing
145
MEMORANDUM OPINION AND ORDER (1) Granting in part and denying in part defendant's 123 Motion for Summary Judgment. Motion is granted as to the design defect claim. The claim for design defect i s dismissed. Motion is denied in all other respects. (2) Granting in part and denying in part defendant's 128 Motion to Exclude Expert Testimony. Motion is granted as to testimony regarding the Neurontin prosecution. Testimony regarding the Neurontin prosecution is excluded. Motion is denied without prejudice in all other respects (Written Opinion). Signed by Judge John R. Tunheim on September 18, 2012. (DML)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
MICHAEL B. BONANDER,
Civil No. 09-2795 (JRT/JJK)
Plaintiff,
v.
MEMORANDUM OPINION
AND ORDER
BREG, INC.,
Defendant.
Steven B. Seal, Leslie W. O’Leary, Thomas B. Powers, and Michael L.
Williams, WILLIAMS LOVE O’LEARY & POWERS PC, 9755 S.W.
Barnes Road, Suite 450, Portland, OR 97225-6681; Matthew E. Munson,
BEASLEY ALLEN CROW METHVIN PORTIS & MILES, PC, P.O.
Box 4160, Montgomery, AL 36103-4160; Laura B. Kalur, KALUR LAW
OFFICE, 9755 S.W. Barnes Road, Suite 450, Portland, OR 97225-6681;
and Yvonne M. Flaherty, LOCKRIDGE GRINDAL NAUEN PLLP, 100
Washington Ave South, Suite 2200, Minneapolis, MN 55401-2179, for
plaintiff.
John D. Sear, Molly J. Given, and William N.G. Barron, IV, BOWMAN &
BROOKE LLP, 150 South Fifth Street, Suite 3000, Minneapolis, MN
55402, for defendant.
Plaintiff Michael B. Bonander brings negligence and strict products liability
failure to warn claims against Breg, Inc. (“Breg”) for injuries he alleges that he suffered
from a pain pump that Breg manufactured. Bonander claims that the Breg pain pump
used on his shoulder was unreasonably and dangerously defective because of Breg’s
failure to warn. The matter before the Court is Breg’s motion for summary judgment.
Breg argues that Bonander cannot show causation as a matter of law because an adequate
23
warning from Breg to Bonander’s doctor would not have prevented Bonander’s injuries.
The Court will deny Breg’s motion because Bonander has raised a genuine issue of
material fact regarding whether an adequate warning might have prevented his injuries.1
Also before the Court is Breg’s motion to exclude allegedly improper regulatory
opinion testimony of Bonander’s regulatory expert, Dr. Peggy Pence.2 The Court will
deny the majority of the motion to exclude testimony, without prejudice, because the
issues it raises are best dealt with closer to or during trial. However, the Court will
exclude testimony about the Neurontin criminal prosecution because it is irrelevant and
prejudicial.
BACKGROUND
I.
BONANDER’S SHOULDER SURGERY AND CHONDROLYSIS
Bonander underwent shoulder surgery on December 19, 2003, in Sioux Falls,
South Dakota. (Second Am. Compl. ¶ 4, Dec. 22, 2010, Docket No. 110; Decl. of
John D. Sear, Ex. 1 (Dep. of Dr. Peter A. Looby (“Looby Dep.”) 23:16-20, May 1, 2012,
Docket No. 126.) Bonander’s orthopedic surgeon was Dr. Peter A. Looby. (Looby Dep.
22:19-25, 23:1-20.) During Bonander’s surgery, Dr. Looby inserted a Breg PainCare
1
Breg also seeks summary judgment on Bonander’s design defect claim. Bonander has
abandoned this claim; accordingly, the Court will grant this aspect of Breg’s motion.
2
Breg moved to exclude testimony from two of Bonander’s experts, Dr. Peggy Pence and
Dr. Suzanne Parisian. Bonander informed the Court at oral argument on August 6, 2012, that
only Dr. Peggy Pence would testify in this case. Therefore, the Court only considers the motion
to exclude the testimony of Dr. Pence.
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3200 pain pump into Bonander’s shoulder joint to infuse 200cc of Marcaine continuously
into the inside of Bonander’s shoulder joint (i.e., the intra-articular glenohumeral space).
(Id. 26:22-27:8, 42:1-3.) Dr. Looby often used pain pumps to continuously inject pain
relief drugs directly into patients’ shoulders for the first forty-eight hours after surgery to
increase patient comfort and facilitate rehabilitation. (Id. 9:11-16.)
Bonander claims that the pain pump caused a condition in his shoulder called
chondrolysis. (Second Am. Compl. ¶ 1.) Chondrolysis is defined by one source as the
“[d]isappearance of articular cartilage as the result of disintegration or dissolution of the
cartilage matrix and cells.”
Stedman’s Medical Dictionary 369 (28th ed. 2006).3
Dr. Looby diagnosed Bonander with chondrolysis on or around April 19, 2004, the date
when he performed a procedure to debride Bonander’s shoulder. (Second Am. Compl.
¶ 4; Looby Dep. 28:3-12.)
Bonander contends that he has suffered permanent
impairment of the use and function of his affected upper extremity and that he may
require future medical care as he ages, including possible future shoulder replacements,
because of the insertion of the pain pump. (Second Am. Compl. ¶ 13.)
II.
DR. LOOBY AND CAUSATION
The parties dispute whether Breg’s alleged failure to warn caused Dr. Looby to insert
the pain pump into Bonander’s shoulder. The facts outlined below are relevant to this
issue.
3
Another source defines chondrolysis as “the degeneration of cartilage cells that occurs
in the process of intracartilaginous ossification.” Dorland’s Illustrated Medical Dictionary 358
(31st ed. 2007).
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A.
Dr. Looby’s Initial Use of Pain Pumps
Dr. Looby stated that he first used pain pumps intra-articularly in 2000 or 2001
after seeing a presentation by another doctor. (Looby Dep. 12:1-9.) In 2003, he began
to use pain pumps to treat post-operative shoulder pain. (Id. 12:10-13.) He testified that
he was not worried about injecting anesthetic directly into a shoulder, stating, “I’ve been
injecting marcaine intra-articularly into shoulder joints since the first day of my training
in orthopedics. . . . And I had been using [pain pumps] in the knee for years without a
single problem.” (Id. 20:18-25.)
B.
Dr. Looby and Communications from Breg
Dr. Looby had limited communications with Breg about its pain pump. In his
deposition, Dr. Looby testified that he had never read the instructions of the pain pump
“until the night before the last time I was deposed[.]” (Id. 19:24-20:7.) Dr. Looby
further testified that his decision to use pain pumps was the result of his “clinical
experience and discussions with other orthopedic surgeons” and not “based upon any
sales pitch by the Breg representative.” (Id. 46:7-14.) He did not expect medical device
companies and their sales representatives to inform him of the risks or benefits of their
product. As he stated, “I don’t expect those sales people to do anything except be sales
people for their devices and their companies.” (Id. 11:11-18.)
Dr. Looby further claimed that his knowledge of how to use the pumps and where
to place the catheter did not come from a Breg sales representative. (Id. 47:7-15.) Breg’s
sales representative, Kyle Jellema, similarly testified that he “can’t say” that he met with
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Dr. Looby about pain pumps before 2003. (Powers Decl., Ex. AX at 4 (Dep. of Kyle
Jellema 12:15-19), May 22, 2012, Docket No. 136.) When Dr. Looby was asked if he
would have used the pain pumps intra-articularly if Breg or anyone else had told him that
the device had not been tested for intra-articular use, he responded in the affirmative.
(Looby Dep. 14:19-15:5.)
But on the issue of “Dear Doctor” letters from a medical device company,
Dr. Looby was not as certain as to whether he had read them or would rely on them.
When asked if he had ever received anything like a “Dear Doctor” letter from Breg about
their pain pump, Dr. Looby responded, “I don’t specifically recall, but I would be the first
to admit that it could have come and I never – and I might have forgotten about it.” (Id.
21:12-19.)4 Bonander alleges – and Breg does not dispute – that Dr. Looby never
received a “Dear Doctor” letter from Breg about the risks of chondrolysis associated with
its pain pump.
C.
Responsiveness to Warnings
Dr. Looby suggested that he would have been responsive to scientific evidence
that suggested pain pumps were not safe. Specifically, when asked if he would have used
pain pumps in shoulders if he thought there was a question about their safety for that use,
he said, “Well, it would depend on how strong the evidence was that there was a problem
4
In a deposition for two other pain pump cases, Dr. Looby testified that he “doesn’t
spend a lot of time” reading “Dear Doctor” letters. (Powers Decl., Ex. AZ (Suhn and Koch Dep.
of Dr. Peter A. Looby 14:25, 15:1), May 22, 2012, Docket No. 136.)
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with it, and how severe the implications of that problem would be for the patient.” (Id.
14:8-18.)
In fact, Dr. Looby stopped using the pain pumps for shoulder surgeries once the
medical evidence supported a link between pain pump use and chondrolysis. (Id. 7:208:13.) Prior to reading an article published in 2007, Dr. Looby did not believe there was
a link between chondrolysis and pain pump use. (Id.) Later, as Dr. Looby tells it, “There
was an article published in the American Journal of Sports Medicine which, through my
reading, indicated that intra-articular placement of a marcaine pain pump was the leading
risk factor for the development of post-arthroscopic glenohumeral chondrolysis.” (Id.
7:25, 8:5.) Dr. Looby no longer uses pain pumps intra-articularly in shoulders because of
this risk. (Id. 8:11-13.) In his testimony, Dr. Looby never foreclosed the possibility that
he would have listened to a warning about pain pump use from a medical device
company such as Breg.
ANALYSIS
I.
STANDARD OF REVIEW
Summary judgment should be granted only when the defendant has shown that
“there is no genuine dispute as to any material fact” and the defendant is entitled to
judgment as a matter of law. Fed. R. Civ. P. 56(a). A fact is material if it might affect
the outcome of the suit, and a dispute is genuine if the evidence is such that it could
“reasonably be resolved in favor of either party.” Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 250 (1986). A court considering a motion for summary judgment must view
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the facts in the light most favorable to the non-moving party and must give that party the
benefit of all reasonable inferences that can be drawn from those facts. See Matsushita
Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).
II.
CHOICE OF LAW
Bonander and Breg agree that, for this motion, no choice of law analysis is
necessary because both South Dakota and Minnesota apply the law of causation in the
same way in a failure to warn claim. The Court likewise finds no conflict in the law at
this stage.5 The Court will therefore apply the law of the forum, Minnesota. See Best
Buy Stores, L.P. v. Developers Diversified Realty Corp., 715 F. Supp. 2d 871, 875-76
(D. Minn. 2010).
III.
CAUSATION
The Court analyzes strict liability and negligence in failure-to-warn cases under a
single theory of products liability. Bilotta v. Kelley Co., 346 N.W.2d 616, 622 (Minn.
1984). In general, there is a duty to warn users of a dangerous product “if it is reasonably
foreseeable that an injury could occur in its use.” Gray v. Badger Mining Corp., 676
N.W.2d 268, 274 (Minn. 2004). The Minnesota Supreme Court has described the duty to
5
In Minnesota, the Court can decide causation as a matter of law when “an adequate
warning could not have prevented a plaintiff’s injuries.” Johnson v. Zimmer, Inc., No. 02-1328,
2004 WL 742038, at *9 (D. Minn. Mar. 31, 2004); see also Balder v. Haley, 399 N.W.2d 77, 81
(Minn. 1987) (where warnings are ignored, there is no causal relationship between the failure to
warn and the injury). Similarly, in South Dakota, to survive summary judgment, the plaintiff
must show a genuine issue of material fact regarding whether a failure to warn was the proximate
cause of the injuries. See Burley v. Kytec Innovative Sports Equip., Inc., 737 N.W.2d 397, 410
(S.D. 2007) (“Causation is an essential element in a failure to warn claim.”).
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warn as twofold: “(1) [t]he duty to give adequate instructions for safe use; and (2) the
duty to warn of dangers inherent in improper usage.” Glorvigen v. Cirrus Design Corp.,
816 N.W.2d 572, 582 (Minn. 2012) (quoting Frey v. Montgomery Ward & Co., 258
N.W.2d 782, 787 (Minn. 1977)).
The plaintiff must establish a causal link between the failure to warn and the
injury. See Balder v. Haley, 399 N.W.2d 77, 81 (Minn. 1987). The Court can rule on
causation as a matter of law at summary judgment when “an adequate warning could not
have prevented a plaintiff’s injuries.” Johnson v. Zimmer, Inc., No. 02-1328, 2004 WL
742038, at *9 (D. Minn. Mar. 31, 2004); see also Balder, 399 N.W.2d at 81 (where
warnings are ignored, there is no causal relationship between the failure to warn and the
injury); see also 27 Minn. Prac., Prods. Liab. § 16.7 (2012) (“Even if a warning is
inadequate, the manufacturer is not liable for a failure to warn . . . if the physician would
have prescribed the drug or device regardless of any additional information or warnings
the manufacturer could have supplied.”).
In its summary judgment motion, Breg argues that causation does not exist as a
matter of law because Dr. Looby admitted that he did not read the package insert with the
pain pump.6 Although Dr. Looby did not read the package insert, the Court finds that
there remains a genuine issue of material fact regarding whether Dear Doctor letters,
communications from sales representatives, or other warnings would have prevented
6
Breg does not currently challenge whether Bonander has met the elements of duty, the
adequacy of the warning, breach of duty, or injury, so the Court will not address these issues.
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Bonander’s injuries. Dr. Looby never said that he would not have listened to a warning
from a medical device company through, for example, a sales representative or a Dear
Doctor letter.7 Indeed, he indicated that he would have responded to strong scientific
information about a lack of safety in pumps. Although Dr. Looby did not rely on
medical device companies to provide such information, he may still have responded to a
warning – particularly a forceful one – they actually communicated to him.8 There is a
particularly significant question about whether Dr. Looby would have heeded warnings
from Breg since he stopped using pain pumps intra-articularly in shoulders in 2007 when
he became aware of the risk involved. Thus, the Court cannot say as a matter of law that
a warning from Breg would not have had the same effect. See Schilf v. Eli Lilly & Co.,
687 F.3d 947, 951 (8th Cir. 2012) (finding a genuine issue of material fact as to causation
when a doctor’s “deposition [was] unclear whether he would have” prescribed a drug if
he had been given information about clinical trials or information about the “causal role”
the drug played in inducing suicides). Therefore, whether Dr. Looby would have listened
7
See Schedin v. Ortho-McNeil-Janssen Pharms., Inc., 808 F. Supp. 2d 1125, 1135
(D. Minn. Aug. 26, 2011) (considering that a doctor could have received a warning from other
doctors who read a drug label) (distinguishing Zimmer, Inc., 2004 WL 742038, at *10); Wehner
v. Linvatech Corp., No. 06-CV-1709, 2008 WL 495525, at *5 (D. Minn. Feb. 20, 2008)
(considering methods of communication other than package inserts for failure to warn claim)
(distinguishing Zimmer, Inc., 2004 WL 742038, at *10).
8
Although Dr. Looby does not remember receiving any Dear Doctor letters, it appears
that he did not receive any such letters from Breg – at least warning of the risk at issue – making
his lack of memory of little import. Furthermore, Dr. Looby’s statement that he did not
remember reading Dear Doctor letters does not necessarily establish that he never read such
letters or would not have been impacted by a strong warning in a letter from Breg. See In re
Levaquin Prod. Liab. Litig., MDL No. 08-5742, 2011 WL 6826415, at *4 (D. Minn. Dec. 28,
2011) (declining to grant summary judgment where a doctor stated that she did not remember
reading a package insert but never stated that she had not read the insert).
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to a warning from Breg remains a genuine issue of material fact and the Court will deny
Breg’s motion for summary judgment.
IV.
BREG’S MOTION TO EXCLUDE IMPROPER REGULATORY OPINION
TESTIMONY
Breg moves to exclude improper testimony and evidence that Bonander’s
regulatory expert Dr. Peggy Pence might offer at trial. This motion to exclude testimony
can be divided into two categories. The first category is the testimony that both parties
agree should be excluded. These topics include: (1) opinions regarding Breg’s or the
FDA’s motives or intent; (2) narrative testimony; and (3) testimony regarding causation.
Because the parties appear to agree that this testimony should be excluded, the Court
declines to address this issue further at this time but will entertain objections at or closer
to trial if Bonander in fact attempts to enter such testimony.
The second category is testimony that Bonander seeks to enter over Breg’s
objections pursuant to Federal Rules of Evidence 401-403 and 702. The testimony
includes (1) so-called “legal opinions” offered by Pence, (2) Pence’s opinions about the
“standard of care” applicable to Breg or Breg’s “responsibility”; and (3) evidence about
the Neurontin prosecution.
The Court will grant Breg’s motion to exclude testimony regarding a Department
of Justice criminal prosecution of Pfizer for off-label marketing of Neurontin. While
Bonander claims that the prosecution is merely an example of the type of prosecution that
the United States undertakes when investigating off-label use, the Court finds that the
testimony is of minimal, if any, relevance to this action and is highly prejudicial because
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it inappropriately links Breg’s behavior to that of another company. See Fed. R. of Evid.
403. Accordingly, the Court will exclude it.
The Court will otherwise deny Breg’s motion, however, because it is premature.
This motion is almost entirely related to elements of Breg’s claims that are undeveloped
and not subject to the current summary judgment motion, namely Breg’s alleged failure
to warn. Accordingly, the Court is unable to determine the relevance and appropriateness
of much of this testimony at this stage. Furthermore, the Court will deny the motion
because it asks the Court to exclude broad categories of information such as “legal
opinions.” The parties, of course, must comply with the Federal Rules of Evidence. See
In re Levaquin Prod. Liab. Litig., MDL No. 08-1943, 2010 WL 8399942, at *10
(D. Minn. Nov. 4, 2010) (“expert testimony on legal matters is not admissible”) (quoting
S. Pine Helicopters, Inc. v. Phoenix Aviation Managers, Inc., 320 F.3d 838, 841 (8th Cir.
2003)). However, the Court finds that excluding such broad categories of information as
part of a pre-trial order is not appropriate in this case.9 See In re Levaquin Prod. Liab.
Litig., MDL No. 08-1943, 2010 WL 4676973, at *3 (D. Minn. Nov. 9, 2010) (“Motions
that lack specificity and are ‘essentially repetitive of well-established rules of evidence’
are not generally granted.”). Accordingly, the Court will deny Breg’s motion to exclude
expert testimony, except to the extent it requests exclusion of the Neurontin prosecution.
9
Breg may bring motions to exclude specific testimony at or closer to trial. See United
States v. Stuckey, 255 F.3d 528, 531 (8th Cir. 2001) (“Judges are not like pigs, hunting for truffles
buried in briefs.”) (quoting United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991)).
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ORDER
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
HEREBY ORDERED that:
1.
Defendant’s Motion for Summary Judgment [Docket No. 123] is
GRANTED in part and DENIED in part, as follows:
a.
The motion is GRANTED as to the design defect claim. The claim
for design defect is DISMISSED.
b.
2.
The motion is DENIED in all other respects.
Defendant’s Motion to Exclude Expert Testimony [Docket No. 128] is
GRANTED in part and DENIED in part, as follows:
a.
The motion is GRANTED as to testimony regarding the Neurontin
prosecution. Testimony regarding the Neurontin prosecution is EXCLUDED.
b.
The motion is DENIED without prejudice in all other respects.
DATED: September 18, 2012
at Minneapolis, Minnesota.
____s/
____
JOHN R. TUNHEIM
United States District Judge
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