Musgrave et al v. Breg, Inc. et al
Filing
174
ORDER granting in part and denying in part 155 Defendant's Motion in Limine to Exclude Documents and Testimony Regarding Actions that Post-Date Pump Usage. Signed by Judge Gregory L Frost on 9/28/11. (sem1)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
EASTERN DIVISION
KAID C. MUSGRAVE, et al.,
Plaintiffs,
Case No. 2:09-cv-01029
JUDGE GREGORY L. FROST
Magistrate Judge Mark R. Abel
v.
BREG, INC. AND LMA,
NORTH AMERICA, Inc., et al.,
Defendants.
OPINION AND ORDER
This matter is before the Court on Breg, Inc.’s Motion in Limine to Exclude Documents
and Testimony Regarding Actions that Post-Date Pump Usage (ECF Nos. 155, 155-1) and
Plaintiffs’ Memorandum in Opposition to Breg, Inc.’s Motion in Limine to Exclude Documents
and Testimony Regarding Actions that Post-Date Pump Usage (ECF No. 162). For the reasons
that follow, the Court GRANTS IN PART AND DENIES IN PART Breg’s motion.
I. Background
Plaintiff Kaid C. Musgrave was seventeen years old in 2003 when he injured his right
shoulder during a high school football game. On November 4, 2003, Dr. Brad E. Brautigan
performed arthroscopic surgery on Musgrave’s shoulder at the Zanesville Surgery Center in
Zanesville, Ohio. After the surgery, Dr. Brautigan prescribed and implanted the catheter of a
Breg infusion pain pump to administer local anesthetic for post-operative pain control. Dr.
Brautigan used a Breg PainCare 3200 and placed the catheter intra-articularly, i.e., inside the
shoulder joint. Dr. Brautigan prescribed 0.5% Marcaine (an anesthetic known generically as
bupivacaine) for use in the pump. The pain pump was removed two days later, on November 6,
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2003.
Musgrave continued to experience problems with his right shoulder, and on December
17, 2004, underwent a second arthroscopic surgery. During this surgery, Dr. Brautigan observed
osteoarthritic changes to the glenohumeral joint. Less than two years after using the Breg pain
pump, Musgrave developed chondrolysis, which is the rapid loss of joint cartilage following
some chemical, mechanical, infectious, immunological, or thermal insult. See Daniel J.
Soloman, et al., Glenohumeral Chondrolysis After Arthroscopy: A Systematic Review of
Potential Contributors and Causal Pathways, Arthroscopy 25:11:1329 (2009). The result of this
cartilage loss is a joint that no longer has a smooth gliding surface to cover the ends of the bone,
so the joint rubs bone against bone causing pain and stiffness. Due to this condition, Musgrave
underwent a total right shoulder arthroplasty. He has a complete loss of cartilage in his shoulder
and degenerative bone loss.
Musgrave and his parents (together “Plaintiffs”) filed this action on November 13, 2009.
Plaintiffs claim that the post-operative continuous injection of anesthetics directly into
Musgrave’s shoulder joint caused chondrolysis, leaving him with serious and permanent
cartilage damage. Plaintiffs’ complaint contains claims for relief against Breg for products
liability, based on Breg’s alleged inadequate warning regarding intra-articular injection of
anesthetics and/or use of the pain pump after orthopedic surgery, the Breg PainCare 3200 pain
pump’s alleged defective design, and Breg’s alleged breaches of express and implied warranties.
Plaintiffs also alleged claims for common law fraud and punitive damages.
On September 2, 2011, this Court granted Breg’s Motion for Summary Judgment as it
related to Plaintiffs’ common law breach of implied and/or express warranty claims and denied
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the remainder of Breg’s motion.
II. Standard
Although neither the Federal Rules of Evidence nor the Federal Rules of Civil Procedure
explicitly authorize the Court to rule on an evidentiary motion in limine, the United States
Supreme Court has noted that the practice of ruling on such motions “has developed pursuant to
the district court’s inherent authority to manage the course of trials.” Luce v. United States, 469
U.S. 38, 41 n.4 (1984). The purpose of a motion in limine is to allow the Court to rule on issues
pertaining to evidence in advance of trial in order to avoid delay and ensure an even-handed and
expeditious trial. See Ind. Ins. Co. v. Gen. Elec. Co., 326 F. Supp. 2d 844, 846 (N.D. Ohio
2004) (citing Jonasson v. Lutheran Child & Family Servs., 115 F.3d 436, 440 (7th Cir. 1997)).
Courts, however, are generally reluctant to grant broad exclusions of evidence in limine,
because “a court is almost always better situated during the actual trial to assess the value and
utility of evidence.” Koch v. Koch Indus., Inc., 2 F. Supp.2d 1385, 1388 (D. Kan 1998); accord
Sperberg v. Goodyear Tire & Rubber Co., 519 F.2d 708, 712 (6th Cir. 1975). To obtain the
exclusion of evidence under such a motion, a party must prove that the evidence is clearly
inadmissible on all potential grounds. See Ind. Ins. Co., 326 F. Supp. 2d at 846; Koch, 2 F. Supp.
2d at 1388; Cf. Luce, 469 U.S. at 41. “Unless evidence meets this high standard, evidentiary
rulings should be deferred until trial so that questions of foundation, relevancy and potential
prejudice may be resolved in proper context.” Ind. Ins. Co., 326 F. Supp.2d at 846. Denial of a
motion in limine does not necessarily mean that all evidence contemplated by the motion will be
admitted at trial. Denial merely means that without the context of trial, the Court is unable to
determine whether the evidence in question should be excluded. Id. The Court will entertain
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objections on individual proffers as they arise at trial, even though the proffer falls within the
scope of a denied motion in limine. Id. (citing United States v. Connelly, 874 F.2d 412, 416 (7th
Cir.1989); Luce, 469 U.S. at 4). Consequently, the Court declines to make a definitive pretrial
ruling under Federal Rule of Evidence 103(a) as requested by Breg.
III. Federal Rules of Evidence
A. Rules 401 and 402
Federal Rule of Evidence 401provides:
“Relevant evidence” means evidence having any tendency to make the existence of
any fact that is of consequence to the determination of the action more probable or
less probable than it would be without the evidence.
Federal Rule of Evidence 402 provides:
All relevant evidence is admissible, except as otherwise provided by the Constitution
of the United States, by Act of Congress, by these rules, or by other rules prescribed
by the Supreme Court pursuant to statutory authority. Evidence which is not relevant
is not admissible.
B. Rule 403
Federal Rule of Evidence 403 provides:
Although relevant, evidence may be excluded if its probative value is substantially
outweighed by the danger of unfair prejudice, confusion of the issues, or misleading
the jury, or by considerations of undue delay, waste of time, or needless presentation
of cumulative evidence.
C. Rule 407
Federal Rule of Evidence 407 provides:
When, after an injury or harm allegedly caused by an event, measures are taken that,
if taken previously, would have made the injury or harm less likely to occur,
evidence of the subsequent measures is not admissible to prove negligence, culpable
conduct, a defect in a product, a defect in a product's design, or a need for a warning
or instruction. This rule does not require the exclusion of evidence of subsequent
measures when offered for another purpose, such as proving ownership, control, or
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feasibility of precautionary measures, if controverted, or impeachment.
D. Rules 801 and 802
Federal Rule of Evidence 801(c) provides:
“Hearsay” is a statement, other than one made by the declarant while testifying at the
trial or hearing, offered in evidence to prove the truth of the matter asserted.
Federal Rule of Evidence 802 provides:
Hearsay is not admissible except as provided by these rules or by other rules
prescribed by the Supreme Court pursuant to statutory authority or by Act of
Congress.
IV. Discussion
Breg moves to exclude documents generated by the Food and Drug Administration
(“FDA”) and Breg after November 3, 2003, the date of Plaintiff Kaid Musgrave’s surgery. Breg
argues that those documents are inadmissible under Federal Rules of Evidence 401, 402, 407,
801, and 802, and their admission would prejudice Breg unfairly, justifying exclusion under Rule
403.
Plaintiffs first argue that Breg’s motion should be denied because it targets a far-reaching
range of documents with little specificity to guide this Court’s analysis. Plaintiffs contend that
Breg should have specified the particular documents to which it objects rather than shift the
burden to this Court and Plaintiffs to sift through thousands of documents in an attempt to guess.
Further, Plaintiffs argue that, even if the Court did not deny Breg’s request as overbroad, Breg
has not met their burden of showing that the evidence is admissible for any purpose. Plaintiffs’
arguments are well taken .
As Plaintiffs correctly point out, Breg’s request for exclusion is overbroad. Similar to
this Court’s conclusion regarding overly broad requests for exclusion in Hinkle v. Norfolk
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Southern Ry. Co., No. 2:05-cv-574, 2007 WL 496365, at *4 (S.D. Ohio, Feb. 12, 2007), the
requests here ignore the potential admissibility of the targeted evidence on various grounds, as
the Court discusses briefly below. This Court “has the power to exclude evidence in limine only
when evidence is clearly inadmissible on all potential grounds.” Weimer v. Honda of Am. Mfg.,
No. 2:06-cv-844, 2008 WL 4332525, *1 (S.D. Ohio Sept. 17, 2008) (emphasis added) (citations
omitted), aff’d, 356 F. App’x. 812 (6th Cir. 2009) (citing Luce, 469 U.S. at 41 n.4). “A court
should not make a ruling in limine unless the moving party meets its burden of showing that the
evidence in question is clearly inadmissible.” Zugovitz v. Davis, No. 2:06-cv-727, 2008 WL
619357, at *1 (S.D. Ohio Mar. 3, 2008) (citations omitted). Breg’s motion in large part fails to
satisfy this burden.
A. Internal Breg Documents
Breg anticipates that Plaintiffs will attempt to admit documents that were created after
Breg distributed the pain pump used on Kaid Musgrave (e.g., emails, Product Training
Documents, Sales Training Documents, and draft “Dear Doctor” letters).
1. Relevance
Plaintiffs offer several reasons why the evidence post-dating Kaid Musgrave’s surgery is
relevant to their claims and is properly used for impeachment purposes. For example, Plaintiffs’
inadequate warning and design defect claims both require a showing of foreseeable risk. See
Ohio Rev. Code § 2307.76 (inadequate warning); Ohio Rev. Code § 2307.75 (defective design).
A risk is foreseeable under the Ohio Product Liability Act, Ohio Revised Code §§ 2307.71-.80,
if the manufacturer should have recognized the risk while exercising “the attention, perception,
memory, knowledge and intelligence that a reasonable manufacturer should possess” and any
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superior information that the manufacturer does possess. Ohio Rev. Code § 2307.71(6)(b). The
parties disagree about whether Breg should have known about the risks at issue. Thus, the Court
finds that evidence created post-surgery may be relevant to show what Breg should have known
at the time of manufacture and distribution, particularly if this evidence indicates that there was
information available or information that was actually in possession of Breg during the time of
manufacture and/or distribution of the pain pump at issue here. Consequently, the Court cannot
say that all of the evidence created post-surgery is irrelevant.
Accordingly, the Court concludes that Breg has failed to meet its burden of showing that
the evidence at issue here is clearly inadmissible on all potential grounds.
2. Prejudice
Breg argues that the probative value of post-surgery emails and internal Breg documents
is substantially outweighed by the danger of unfair prejudice, confusion of the issues, and
misleading the jury. Breg contends that “the jury could confuse the issue of what was known
years after the November 2003 surgery with the relevant issue at hand—the issue of what was
known or should have been known at the time of the November 4, 2003 surgery.” (ECF No.
155-1 at 6.) This Court disagrees. There is nothing in this type of evidence that would be
confusing to a jury. Nor is the Court convinced at this time that the probative value of this type
of relevant evidence substantially outweighed by a risk of prejudice to Breg.
3. Subsequent Remedial Measures
Breg argues that it “should not be faulted for looking into a possible product issue.
Because the emails indicate that Breg employees were discussing and debating their best steps in
furtherance of added safety, the emails should not be admitted under Rule 407.” (ECF No. 155-1
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at 7.) This Court disagrees.
The only remedial measure taken by Breg was to change its product warnings and
instructions. Any other conduct referenced in internal communications is not a “measure” for
purposes of Rule 407. See Rocky Mountain Helicopters, Inc. v. Bell Helicopters Textron, a Div.
of Textron, Inc., 805 F.2d 907, 918-919 (10th Cir. 1986) (noting that “the remedial measure was
not the [investigative study] of the [product] but rather the subsequent redesign of the
[product].”); Fasanaro v. Mooney Aircraft Corp., 687 F. Supp. 482, 487 (N.D. Cal. 1988) (“By
its terms Rule 407 includes only the actual remedial measures themselves and not the initial
steps toward ascertaining whether any remedial measures are called for.”); Brett v. Hillerich &
Bradsby Co., No. CIV-99-2001 U.S. Dist. LEXIS 26320, at *4 (W.D. Okla. Oct. 26, 2001) (the
plaintiff may introduce evidence in the form of memoranda and reports, etc., prepared by the
defendant subsequent to the incident at issue). Internal communications discussing, for example,
the need to conduct animal testing on the safety of anesthetics on joints are not evidence of a
remedial measure. They are discussions about proposed plans to study potential causes of an
injury, not to remediate a product failure.
Accordingly, Rule 407 does not apply to the emails that discuss what Breg refers to as “a
possible product issue.” See Rocky Mountain, 805 F.2d at 918 (“We hold that the district court
did not err in admitting evidence from the Photoelastic Study. It would strain the spirit of the
remedial measure prohibition in Rule 407 to extend its shield to evidence contained in post-event
tests or reports.”).
With regard to the remedial measure taken by Breg to change its product warnings and
instructions, that evidence is inadmissible if offered as proof of negligence or culpable
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conduct. That evidence, however, may be introduced for other purposes such as to impeach. See
In re Air Crash Disaster, 86 F.3d 498, 531 (6th Cir. 1996) (noting that Rule 407 does not
preclude evidence of subsequent remedial measures offered for purposes of impeachment); Fed.
R. Evid. 407 (“This rule does not require the exclusion of evidence of subsequent measures when
offered for another purpose, such as proving ownership, control, or feasibility of precautionary
measures, if controverted, or impeachment.”).
B. External Documents
Breg contends that Plaintiffs will likely offer post-distribution documents that were
created outside of Breg, such as the two following statements made by the FDA: (1) a November
13, 2009, posting on the FDA’s website titled “Information for Healthcare Professionals –
Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine,
chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine),” which includes the following
statement: “The FDA has not cleared any infusion devices with an indication for use in
intra-articular infusion of local anesthetics.”; and (2) a February 2010, posting on FDA’s website
titled “Chondrolysis with Continuously Infused Local Anesthetics,” which includes the
statement: “FDA is reminding healthcare professionals that local anesthetics are not approved for
intra-articular infusions, or for use in infusion devices like elastomeric pumps. Because of the
chondrolysis reports, FDA is requiring the manufacturers of local anesthetic drugs to specifically
warn against this use in the products’ labeling. A similar warning will be required for
elastomeric pumps.”
1. Relevance
Breg claims that “the post-distribution FDA statements are not relevant to the issues in
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this case because they have no bearing on the questions of Breg’s representations, intentions, or
whether the Breg Pain Care 3200 was defective at the time of manufacture and distribution.”
(ECF No. 155-1 at 9.) This Court disagrees.
These post-distribution FDA statements are relevant at least for impeachment purposes.
Breg contends that the FDA cleared its pain pumps for intra-articular use. Plaintiffs can present
this evidence showing that the FDA had not cleared the pumps for such use. Breg will have an
opportunity to present its evidence related to its own interpretation of the documents at issue.
2. Prejudice
Relying on Rule 403, Breg argues that “[t]his evidence also has the potential to mislead
the jury and unfairly prejudice Breg.” (ECF No. 155-1at 10.) However, as the Sixth Circuit has
explained, “[u]nfair prejudice ‘does not mean the damage to a defendant’s case that results from
the legitimate probative force of the evidence; rather it refers to evidence which tends to suggest
decision on an improper basis.’ ” United States v. Gibbs, 182 F.3d 408, 430 (6th Cir. 1999)
(citations omitted). Here, the Court finds that the probative value of this evidence is not
substantially outweighed by the danger of unfair prejudice or jury confusion.
3. Hearsay
Breg argues that the FDA statements are hearsay unredeemed by any recognized hearsay
exception. This Court disagrees.
To the extent that the FDA statements at issue are hearsay, the statements fit into the
public records exception to the hearsay rule. Public records are admissible hearsay if they are:
[R]ecords, reports, statements, or data compilations, in any form, of public offices
or agencies, setting forth (A) the activities of the office or agency,or (B) matters
observed pursuant to duty imposed by law as to which matters there was a duty to
report . . . ., or (C) in civil actions . . . factual findings resulting from an investigation
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made pursuant to authority granted by law.
Fed. R. Evid. 803(8).
The FDA bulletins to healthcare professionals state that pain pumps were never
cleared for intra-articular use. These portions of the FDA bulletins fall within the hearsay
exception defined by Rule 803(8) because they are statements directly from the FDA “setting
forth matters observed pursuant to duty imposed by law as to which matters there was a duty to
report.” Fed. R. Evid. 803(8). As Plaintiffs correctly point out, courts have consistently
held that documents like the ones at issue here are admissible. See, e.g., Toole v. McClintock,
778 F. Supp. 1543, n.11 (M.D. Ala. 1991) (holding that FDA report on risks of silicone gel
breast implants was sufficiently reliable to be admissible hearsay); Sabel v. Mead Johnson &
Co., 737 F.Supp. 135 (D. Mass. 1990) (holding that a letter from FDA official recommending
that a warning be included on its label was admissible under public records exception to the
hearsay rule).
V. Conclusion
Based on the foregoing, the Court GRANTS IN PART AND DENIES IN PART Breg,
Inc.’s Motion in Limine to Exclude Documents and Testimony Regarding Actions that Post-Date
Pump Usage. (ECF No. 155.) Specifically, the Court GRANTS the motion as it relates to
Breg’s modifications to the warnings and instructions accompanying its pain pumps and
DENIES the remainder of the motion. As with all in limine decisions, these rulings are subject
to modification should the facts or circumstances at trial differ from that which has been
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presented in the pre-trial motion and memoranda.
IT IS SO ORDERED.
/s/ Gregory L. Frost
GREGORY L. FROST
UNITED STATES DISTRICT JUDGE
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