S.S., et al v Leatt Corporation

Filing 94

Memorandum Opinion and Order: This is a products liability case. Five motions to exclude expert opinion testimony are pending before the Court: (1) Defendant's Motion to Exclude Proposed Expert Testimony by William F. Kitzes (Doc. 54 ); Defendant's Motion to Exclude Proposed Opinion by Richard L. Stalnaker (Doc. 59 ); Defendant's Motion to Exclude Proposed Opinion Testimony by Joseph Burton (Doc. 68 ); Defendant's Motion to Exclude Proposed Opinion Testimony by C arol Pollack-Nelson (Doc. 70 ); and Plaintiffs' Motion to Exclude Mitchell Garber as an Expert Witness (Doc. 72 ). For the reasons stated below, Defendant's motions to exclude the expert testimony of William F. Kitzes and Carol Pollack-Nelson are granted. The remaining motions to exclude expert testimony are all denied. Judge Patricia A. Gaughan on 7/15/13. (LC,S)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
EASTERN DIVISION

S.S., et al.,
Plaintiffs,
vs.
Leatt Corporation,
Defendant.

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CASE NO. 1: 12 CV 483
JUDGE PATRICIA A. GAUGHAN

Memorandum of Opinion and Order

This is a products liability case. Five motions to exclude expert opinion testimony are
pending before the Court: (1) Defendant’s Motion to Exclude Proposed Expert Testimony by
William F. Kitzes (Doc. 54); Defendant’s Motion to Exclude Proposed Opinion by Richard L.
Stalnaker (Doc. 59); Defendant’s Motion to Exclude Proposed Opinion Testimony by Joseph
Burton (Doc. 68); Defendant’s Motion to Exclude Proposed Opinion Testimony by Carol
Pollack-Nelson (Doc. 70); and Plaintiffs’ Motion to Exclude Mitchell Garber as an Expert
Witness (Doc. 72). For the reasons stated below, Defendant’s motions to exclude the expert
testimony of William F. Kitzes and Carol Pollack-Nelson are granted. The remaining
motions to exclude expert testimony are all denied.

1

Background
Plaintiffs, sixteen-year-old Scott Scarvelli and his parents Timothy and Sheri
Scarvelli, filed this lawsuit against defendant Leatt Corporation (Leatt) alleging products
liability and other state law claims. Plaintiffs allege that Scott Scarvelli was seriously and
permanently injured in February 2011 while using a Moto GPX neck brace manufactured by
Leatt (the “Leatt Brace”) while he was riding a motocross motorcycle at the Ram Jam
Sportsplex facility located in Lorain, Ohio. During a riding maneuver, Scott Scarvelli became
separated from his motorcycle and landed on the dirt track surface. Plaintiffs allege that, as a
result of using the Leatt Brace, Scott Scarvelli sustained spine and spinal cord injuries leaving
him permanently paralyzed.
Plaintiffs’ complaint alleges claims against Leatt for “common law” negligence,
product liability, misrepresentation, violation of Ohio’s deceptive consumer sales practices
act, and loss of consortium.
Plaintiffs’ negligence claim alleges that defendants failed to exercise reasonable care
in the design, testing, manufacture, modification, marketing, product warning, and
distribution of the Leatt Brace and failed to prevent the Leatt Brace from creating an
unreasonable risk of harm to Scarvelli. They allege that the Leatt Brace was “unreasonably
and inherently dangerous to human health and safety, in particular to the spine and spinal
cord, and became so, when applied to its usual, customary and intended use; and said defect
existed at the time the Leatt Brace left the hands of the Defendant, and until it caused the
spine and spinal cord injury and paraplegia, to the Plaintiff.” (Complt., ¶11.)
Plaintiffs’ products liability claim alleges: (1) the Leatt Brace “was defective in

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testing, manufacture, formulation, and/or design that when it left the hands and control of said
Defendant, it deviated materially from the industry performance standards, and/or differed
from otherwise identical units manufactured to the same design formula”; (2) “the foreseeable
risk of harm i.e., spine and spinal cord injury associated with the design and/or formulation
exceeded its benefits”; (3) “it was more dangerous than an ordinary and reasonably prudent
consumer would expect when used in its reasonably foreseeable manner”; (4) “Defendant
knew or should have known that the product was such to create an unreasonable risk of harm
to consumers, and the Defendant failed to exercise reasonable care to warn of said risks”; (5)
“Defendant . . knew or should have known of the risks involved with the use of said product
and failed to exercise reasonable care to provide inadequate warning to users of the product”;
and (6) “it did not conform to representations of the Defendant that it was safe for use by
consumers, which the Plaintiff relied upon.” (Complt., ¶¶ 17-22.) Plaintiffs allege that
Leatt’s alleged conduct violates the Ohio Product Liability Act, Ohio Revised Code
§§2307.72 through 2307.80.
The misrepresentation claim alleges that Leatt “made misleading statements and
omissions about the safety of the Leatt Brace in its labeling, advertising, warnings,
promotional materials and other marketing efforts” and “misrepresented the safety of the
Leatt Brace and recklessly, intentionally and negligently misrepresented the quality of the
product and concealed the adverse effects of the safety of the product to include but not
limited to the failure to serve its intended purpose.” (Complt., ¶¶ 26-27.)
Plaintiffs’ fourth cause of action alleges that Leatt’s conduct “constitutes unfair
deceptive consumer practices and unconscionable acts and practices” as defined in Ohio’s

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Unfair Deceptive and Unconscionable Sales Practices Act. (Complt., ¶31.)
The fifth and sixth causes of action allege claims for loss of consortium on behalf of
Timothy and Sheri Scarvelli. (Complt., ¶¶ 33-38.)
Plaintiffs also allege a claim for punitive damages (seventh cause of action).
On November 30, 2012, plaintiffs filed reports of nine proposed witnesses, including
Joseph L. Burton, Richard L. Stalnaker, Carol Pollack-Nelson, and William F. Kitzes. (Doc.
47.) On February 4, 2013, Leatt filed its designation of witnesses and the expert reports of six
proposed witnesses, including the expert report of Dr. Mitchell Garber. (Doc. 53-10.) Leatt
moves to exclude opinions and testimony of plaintiffs’ proposed witnesses Kitzes, Burton,
Stalnaker, and Pollack-Nelson. Plaintiff moves to exclude the testimony of Garber.
Legal Standards on Expert Opinions and Testimony
Federal Rule of Evidence 702, which pertains to testimony by expert witnesses, was
most recently revised by amendments that became effective on December 1, 2011 and
provides:
A witness who is qualified as an expert by knowledge, skill, experience,
training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help
the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the
case.
Fed. R. Evid. 702.
The Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
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U.S. 579 (1993) and its progeny require that the trial court act as a “gatekeeper” with respect
to expert testimony under Federal Rule of Evidence 702. Pursuant to Daubert, the trial court
must determine whether proffered expert testimony is both reliable and relevant. The
Supreme Court stated in Daubert that:
Faced with a proffer of expert scientific testimony, . . . the trial judge must
determine . . . whether the expert is proposing to testify to (1) scientific
knowledge that (2) will assist the trier of fact to understand or determine a fact
in issue. This entails a preliminary assessment of whether the reasoning or
methodology underlying the testimony is scientifically valid and of whether
that reasoning or methodology properly can be applied to the facts in issue.
Daubert, 509 U.S. at 592-93. The court stated that “[m]any factors will bear on [this]
inquiry,” and there is no “definitive checklist or test.” Rather, the test for admissibility of
expert testimony is a “flexible” one focused on the “principles and methodology” of the
expert. Id. at 594-95. The court set forth the following non-exhaustive list of factors for trial
courts to use in assessing the reliability of scientific expert testimony: (1) whether the
expert's technique or theory can be or has been tested; (2) whether the technique or theory has
been subject to peer review and publication; (3) the known or potential rate of error of the
technique or theory when applied; (4) the existence and maintenance of standards and
controls; and (5) whether the technique or theory has been generally accepted in the scientific
community. Daubert, 509 U.S. at 593-94; Avery Dennison Corp. v. Four Pillars Enterprise
Co., 45 Fed.Appx. 479, 483 (6th Cir. Sept. 3, 2002). The trial court’s overall task is to
ensure that a testifying expert “employs in the courtroom the same level of intellectual rigor
that characterizes the practice of an expert in the relevant field.” Kumho Tire Co., Ltd. v.
Carmichael, 526 U.S. 137, 152 (1999).
The Sixth Circuit has acknowledged that “[t]he trial judge has considerable leeway in
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deciding . . . how to go about determining whether particular expert testimony is reliable.”
U.S. v. Sanders, 59 Fed.Appx. 765, 767 (6th Cir. March 7, 2003), citing Kumho Tire, 526
U.S. at 152. “As a baseline premise, ‘[i]n rulings on the admissibility of expert opinion
evidence[,] the trial court has broad discretion and its rulings must be sustained unless
manifestly erroneous.’” Brainard v. American Skandia Life Ins., 432 F.3d 655, 663 (6th Cir.
2005). But the Sixth Circuit has developed further guidance by outlining a number of “[r]ed
flags that caution against certifying an expert.” Newell Rubbermaid, Inc. v. Raymond Corp.,
676 F.3d 521, 527 (6th Cir. 2012), citing Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 177
(6th Cir.2009). These include “reliance on anecdotal evidence, improper extrapolation,
failure to consider other possible causes, lack of testing, and subjectivity.” Id. In addition, if
an expert's testimony was prepared solely for litigation, this may also be grounds for
exclusion. Id.
Finally, the proponent of an expert bears the burden of demonstrating that the expert’s
testimony satisfies Daubert. Nelson v. Tennessee Gas Pipeline Company, 243 F.3d 244, 251
(6th Cir. 2001).
Federal Rule of Evidence 703 provides:
An expert may base an opinion on facts or data in the case the expert has been
made aware of or personally observed. If experts in the particular field would
reasonably rely on those kinds of facts or data in forming an opinion on the
subject, they need not be admissible for the opinion to be admitted. But if the
facts or data would otherwise be inadmissible, the proponent of the opinion
may disclose them to the jury only if their probative value in helping the jury
evaluate the opinion substantially outweighs their prejudicial effect.
Fed. R. Evid. 703.
Federal Rule of Evidence 705 provides:

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Unless the court orders otherwise, an expert may state an opinion – and give
the reasons for it – without testifying to the underlying facts or data. But the
expert may be required to disclose those facts or data on cross-examination.
Fed. R. Civ. P. 705.
Fed R. Civ. P. 26 governs discovery and provides that the written report of an expert
witness must provide contain all of the following information: (i) a complete statement of all
opinions the witness will express and the basis and reasons for them; (ii) the facts or data
considering by the witness; (iii) any exhibits that will be used to summarize or support the
witness’s opinions; (iv) the witness’s qualifications; (v) a list of all other cases in which the
witness has testified as an expert during the previous four years; and (vi) a statement of the
compensation to be paid for the study and testimony in the case. Fed. R. Civ. P. 26(a)(2)(B).
Fed. R. Civ. P. 37(c)(1) provides that “[i]f a party fails to provide information or
identify a witness as required by Rule 26(a) . . ., the party is not allowed to use that
information or witness to supply evidence on a motion, at a hearing, or at a trial, unless that
failure was substantially justified or is harmless.” Fed. R. Civ. P. 37(c).
Discussion
1. Defendant’s Motion to Exclude Joseph L. Burton
Pursuant to Fed. R. Civ. P. 702 and Daubert, Leatt moves to exclude the proposed
opinions of Joseph L. Burton, M.D., dealing with whether Scott Scarvelli’s “incapacitating
injuries are casually related to the performance of the Leatt neck brace.”1 Burton is a doctor

1

Other than Dr. Burton’s “causation” opinions, Leatt does not challenge Burton’s
expert testimony. It asserts that Burton “apparently used medically reliable methods to
describe Scott Scarvelli’s physical injuries in the way pathologists customarily describe
and document injuries at autopsy.” (Leatt Mem. at 2, n.3.)
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and forensic pathologist with over thirty years of experience in forensic medicine, including
as a Medical Examiner for DeKalb County, Georgia. His Curriculum Vitae also lists
professional experience regarding kinematics and biomechanics in connection with head and
spine injuries.
Leatt asserts in its brief that, included among the opinions Burton expresses in his
report, are the following opinions on causation:
It is my opinion with reasonable scientific probability and certainty that the
Leatt brace worn by Mr. Scarvelli was a direct and proximate cause of his
catastrophic thoracic spine-spinal cord injury.
It is my opinion had Scott not been wearing the neck brace at the time of his
incident on 2/13/11 he would not have suffered this catastrophic vertebral
column injury.
The brace limited his head movement and increased axial loading of his spine.
Had the brace not been worn such increase would not have occurred and Mr.
Scarvelli would have been better able to tuck and roll, avoiding the
catastrophic axial force.
The design of the helmet, brace and strut virtually guarantees that a load will
be concentrated on the upper thoracic spine area of the user.
Anyone putting on this brace and strut, having it rest against their back and
having someone hold it tight against the spinous processes between the
shoulder blades without a shirt on can clearly see that the strut will interfere
with lateral rotation of the spine.
(Leatt Mem. at 2-3, citing Burton Report.)2
2

Although not set out in Leatt’s brief, Burton’s report also includes the following
opinions “concerning the kinematics of Mr. Scarvelli’s crash that lead to his catastrophic
thoracic spine injury”:
1. When Mr. Scarvelli’s front wheel impacted the berm it suddenly
decelerated the bike. Mr. Scarvelli’s body continued to move forward, his
head striking the handlebars, glancing off, and his body continuing
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Leatt contends Dr. Burton’s causation opinions are inadmissible because his “Rule 26
forward and downward.
2. His shoulders struck the ground decelerating his torso and lower
extremities creating sufficient force to cause the axial load compression
fracture of his thoracic spine.
3. Previously quoted studies show that the Leatt brace increases axial load
of the spine. Had the brace not been worn such increase would not have
occurred and Mr. Scarvelli would have been better able to tuck and roll,
avoiding the catastrophic axial force.
Not only is it important to consider what injury that Mr. Scarvelli
sustained in understanding what happened to him, but it is also important
to understand what injuries he did not sustain. He did not sustain any
major deceleration injury to the organs of his chest or abdomen such as an
aortic injury, cardiac injury, injury to the small and large intestines or
momentum or impact trauma to the liver, spleen or other solid organs of
the abdomen. He did not sustain a brain injury. . . .
The strut [of the Leatt Brace] is made of Kevlar and carbon fiber. It will
afford substantial resistance to bending.
It will also supply substantial resistance to the spine. In other words, it
will focus on a point, as in this case, approximately at the lowest level that
the strut would be impinging upon the back which is around the T4/T5/T6
level of most adult male individuals. This would mean all of the vertebral
column below the level of the strut will move in one direction whereas the
column along the strut will be prevented from similar movement since the
strut will abut the vertebra from the tip of the strut to the base of the
helmet. Increases in axial load can not be dissipated through flexion
bending of the spine since this is prevented by the strut. (Reference:
Burton & Associates Thoracic Spine Injury Bibliography.)
The design of the helmet, brace and strut virtually guarantees that a load
will be concentrated on the upper thoracic spine area of the user.
Depending on the vertical impact force of the body to the ground and the
motion of the body relative to the head and shoulders upon impact, severe
injury to the thoracic spine will result at the T3 to T6 level.
(Burton Rep. at 13-14.)

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report does not furnish logical foundations or lines of reasoning leading to rational
conclusions,” and Burton’s opinions as to the consequences of wearing or not wearing a Leatt
Moto GPX neck brace are not grounded in any actual physical or mechanical tests,
measurements, calculations, medical literature, or other scientific methodologies meeting the
threshold reliability requirement of Federal Rule of Evidence 702 and Daubert.
Leatt argues that, instead of reliable scientific or medical techniques, Burton relies in
his opinions only on “simplistic pictures” to show that a significant relationship exists
between the shape of the Leatt Brace and the vertebral levels of Scott Scarvelli’s thoracic
fractures. Leatt refers to photos in Burton’s report which depict Burton wearing a Leatt Brace
and another “unidentified young man” wearing a brace that is “overlaid with an illustration of
the human spinal column.” (Leatt Mem. at 4, 5, 7.) Leatt argues that these “pictures alone”
are not a “reliable methodology.” It asserts that other “specific protocols” exist “to measure
either instability or fusions and describe loss of motion in the human spine regardless of
cause,” but Dr. Burton conducted no actual physical or mechanical tests of his own regarding
the Leatt Brace and thoracic spine injuries. (Id. at 6, 10.)
Leatt also argues that a “second set” of images depicted in Burton’s report, consisting
of “two computer-generated images depicting alleged shearing action [on the spine] resulting
in paraplegia,” is also lacking in “a reliable methodology.” Leatt refers to two computergenerated images appearing in Burton’s report purporting to depict the shearing action of the
spine as well as normal spine anatomy. Leatt contends these computer-generated models are
inadmissible and unreliable “because Burton did not supply any explanation for or [the]
process used in creating his depiction of the shearing action on Scarvelli’s spine.” (Id. at 8.)

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In addition, Leatt challenges Burton’s opinion on the ground that “[s]cattered through
out [the] report are references to, and even express reliance on, two inadmissible categories of
information: (1) other accidents or injuries, and (2) claims and reports by witnesses involved
in unrelated litigation.” (Id. at 11.) As to the second category, Leatt contends that Burton
improperly relied on expert reports of Christopher Van Ee and Martha Bidez at SAFE
Enterprise that were commissioned by plaintiff’s attorneys in another case against Leatt,
Kemmer v. Leatt Corporation, Case No. 5: 09 CV 84 (E.D. Ky.) Leatt contends that:
Every aspect of the reports commissioned by the plaintiff’s attorneys in
Kemmer prevents their re-use by Burton in this lawsuit: (1) neither Van Ee nor
Bidez nor SAFE appear in plaintiff’s initial disclosures . . .; (2) neither Van Ee
nor Bidez nor SAFE appear in plaintiff’s identification of expert witnesses . . .;
(3) neither Van Ee nor Bidez nor SAFE are witnesses subject to crossexamination . . . (4) plaintiff’s counsel are the sole source of the Van Ee,
Bidez, and SAFE reports . . .; (5) testimony by Burton about the Van Ee, Bidez
or SAFE reports constitutes impermissible vouching for the truth of another
person’s statements . . ; and, (6) because the Van Ee, Bidez, and SAFE reports
were prepared solely for litigation involving a different accident and a different
physical injury, their opinions fail the “fit” requirements of FRE 702.
(Id. at 12-13.)
Leatt also contends Burton improperly uses “irrelevant, unreliable, and inadmissible
information about other motocross accidents” to support his opinion by asserting in his report
that others who were approximately the same physical size as Scott Scarvelli and who wore a
Leatt Brace – Bobby Kemmer, Ryan Reddick, and Stephen Barrington – also sustained
upper mid thoracic spine injuries in virtually the same location as Scarvelli. Leatt contends
Burton “does not furnish a factual predicate to show the substantial similarity or relevance of
these other accidents.” (Id. at 13.)
Finally, Leatt challenges as “totally subjective” the portion of Burton’s opinion

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asserting that had Scott Scarvelli not been wearing the Leatt neck brace he would not have
suffered the “catastrophic vertebral column injury” he sustained. Leatt asserts that Burton
offers no source or authority for this notion, but instead relies exclusively on his own
anecdotal experience as a motorcycle rider that Scarvelli would have been better able to “tuck
and roll” had he not been wearing the Leatt Brace at the time of his accident. (Id. at 14.)
Plaintiffs contend Burton’s causation opinions were based on reliable methodologies.
Plaintiffs dispute Leatt’s contention that Burton’s opinions were based only on “simplistic
pictures.” Plaintiffs contend the “simplistic pictures” Leatt criticizes are actually “surrogate
studies” Burton performed “to test his hypothesis that the Leatt Brace’s thoracic strut restricts
the ability of the spine to rotate in the areas which it comes in contact with, specifically the T4 and T-6 vertebrae.” Thus, plaintiffs contend that Burton did perform some testing in
developing his causation opinions (although they do not dispute that Burton did not perform
physical or mechanical testing of his own other than these “surrogate studies”).3 Plaintiffs
also dispute Leatt’s contention that Burton’s causation opinions were derived solely from
these surrogate studies, asserting that Burton also relied on a host of sources of information
allowed by the federal rules of evidence in forming his opinions, including testing and studies
done by others and Leatt itself.
In particular, plaintiffs contend that Burton properly relied on the expert reports of
biomechanical engineers Bidez and Van Ee in forming his opinions. Plaintiffs assert that “the
3

Plaintiffs assert that “while Burton . . . [was] able to rely on studies concerning the
established principles relating to the way the human spine works, it would be impossible to
perform a test that exactly replicates Scott Scarvelli’s accident sequence” as the “only way to
do so would be to use a human being, which would be grossly irresponsible and against all
notions of scientific ethics based on the high likelihood of injury.” (Pltf. Opp. at 13.)
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importance of these expert reports and opinions . . . regarding the Leatt-Brace’s propensity to
cause axial loading is unmistakable,”4 and they contend that Burton may properly rely on the
relevant reports despite Leatt’s objection that Van Ee and Bidez are not subject to cross
examination in the case. Plaintiff rely on the language of Federal Rule of Evidence 703 itself,
which provides that: “An expert may base an opinion on facts or data in the case the expert
has been made aware of or personally observed” and that “[i]f experts in the particular field
would reasonably rely on those kinds of facts or data in forming an opinion on the subject,
they need not be admissible for the opinion to be admitted.” Fed. R. Evid. 703. Plaintiffs
assert that the “[s]tudies, testing, and opinions of other qualified individuals in their same
field are the kinds of things that biomechanical engineers reasonably rely upon regularly as
bases for forming their opinions.” (Pltf. Opp. at 7.) Plaintiffs dispute Leatt’s position that
Burton’s reliance on Van Ee’s and Bidez’s reports “constitutes impermissible vouching for
the truth of another statements” because all of the cases Leatt cites in support of this argument
stand for the proposition that an expert cannot be the mouthpiece of an expert from a
“different field of expertise.” But plaintiffs assert that “[g]iven the fact that Burton, Bidez,
and Van Ee are all biomechanical experts there appears to be no reason for Leatt to make this

4

Burton noted the relevance of these experts’ opinions in his report:
I have previously stated this in the body of this report that virtually
all vertebral column injuries start with axial load. The greater the
axial load the more likely that the column will fail in some manner
as its loads continue to be applied. The testing by others shows
that with the strut and the Leatt brace in place that the axial load
increases in some studies up to 75 percent.

(Report at 14.) It is Burton’s opinion that the Leatt Brace greatly increases the chances
for axial loading injury.
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argument.” (Id. at 12) (emphasis in original.)
Plaintiffs dispute all of Leatt’s other bases for objecting to Burton’s reliance on Van
Ee’s and Bidez’s reports, asserting: “no case or statute” supports Leatt’s position that Burton
is prevented from relying on the reports because neither Bidez nor Van Ee appear in
plaintiffs’ initial disclosures or witness list; the fact that Burton obtained the reports through
counsel “does not deem them an improper basis for Dr. Burton’s opinions” as the reports were
not the “only methodology” Burton employed to reach his opinions, the reports are highly
relevant to the issue of axial loading presented in this case, and Burton explained the
relevance of the reports to this case in detail in his report; finally, the reports are relevant to
the accident in this case despite the fact that the reports were prepared in the context of
litigation involving a different accident and injury because the reports address the issue of the
Leatt Brace’s propensity to cause axial loading, which is at issue here.
Plaintiffs further point out that in reaching his causation opinions, Dr. Burton relied
on the same testing that Leatt and its own experts “relied on in developing its own product,”
citing documents produced by Leatt in discovery regarding “SABS Testing” and a document
entitled “Thoracic Injury Assessment for the Leatt Moto GPX Brace.” (Pltf. Opp. at 14-15.)
Plaintiffs contend Leatt’s testing also supports Dr. Burton’s position that the Leatt Brace
transfers force to the T6-T7 levels of the spinal column, preventing it from rotating in an
accident like Scott Scarvelli’s thereby resulting in shearing fracture. (Id. at 15-16.)
Finally, in addition to all of the above, plaintiffs assert that Burton relied on “a whole
host of other items an expert would normally rely on in forming an opinion,” including:
medical and radiology records of Scott Scarvelli, the Leatt Brace User Manual
and other Leatt materials turned over in discovery in the Barrington matter,
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deposition testimony of Scott, Tim, and Sherri Scarvelli, deposition testimony
of Dr. Christopher Leatt (which Dr. Burton gives two pages of explanation as
to what portions he finds relevant), along with all Leatt-brace static and drop
testing with videos. Finally, Dr. Burton references other independent studies
concerning the human neck and spine, most notably the Cost 327 Study, which
is attached as an Appendix of his report.
(Opp. at 17.)5
In sum, plaintiffs contend that Dr. Burton’s causation opinions were derived from
“much more” than merely simplistic pictures, but were derived from available information
routinely used by experts and allowed by the federal rules of evidence. Plaintiffs contend that
“Leatt may disagree with [Dr. Burton’s] diagnosis” and may not agree with Dr. Burton’s
theory of causation in this accident but that “the questions [Leatt] has concerning Dr. Burton’s
opinions should be fleshed out at trial, during cross-examination. The test of admissibility is
not whether an opinion is demonstrably correct, but rather whether the opinion is based on
valid reasoning and reliable methodology.” (Pltf. Opp. at 5.)
Upon review, the Court is satisfied that Burton’s causation opinions meet the
requirements of Daubert and Fed. R. Evid. 702. As the Supreme Court held in Daubert, an
expert has a “wide latitude to offer opinions” and an expert’s opinion need not be based on
“first-hand knowledge or observation.” See Brown v. Wal-Mart Stores, Inc. Case No. 985965, 1999 WL 1111514, at *3 (6th Cir. Nov. 24, 1999), citing Daubert, 509 U.S. at 592.
This “wide latitude” is “premised on an assumption that the expert’s opinion will have a
5

Plaintiffs also dispute Leatt’s contention that the computer-generated images
depicted in Dr. Burton’s report are inadmissible because Burton did not explain the
process and data used to generate them, contending that the images are proper because
they are not used to demonstrate any fact at issue in the case or that Scott Scarvelli’s
injury happened in any particular way but are simply used to assist the jury in
understanding what a shearing fracture looks like. (See Pltf. Opp. at 6.)
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reliable basis in the knowledge and experience of his discipline.” Id. Thus, Dr. Burton is not
required to have performed his own independent testing to determine or measure the effect on
the spine of wearing the Leatt Brace for his causation opinions to be admissible.
Further, plaintiffs have sufficiently demonstrated that Burton’s causation opinions
were not based merely on “simplistic pictures” as Leatt argues, but instead were based on an
adequate foundation of expertise, documentation, available studies and testing, and personal
experience. Plaintiffs have sufficiently demonstrated that Burton’s opinions were based on
his assessment of the Leatt Brace as observed in his surrogate studies, together with other
existing information about the relationship between the Leatt Brace and axial loading,
including expert reports of biomechanical engineers Van Ee and Bidez and Leatt’s own
product testing.
The Court finds that Burton’s causation opinions are not inadmissible because they are
based in part on the reports of Van Ee and Bidez. On this point, the Advisory Committee
Notes to Fed. R. Evid. 702 specifically state that:
expert testimony [must] be based on sufficient underlying “facts or data.” The
term “data” is intended to encompass the reliable opinions of other experts.
Fed. R. Evid. 702 advisory committee’s note.
Further, Fed. R. Evid. 703 is explicit that an expert may base his opinion on “facts or
data . . . the expert has been made aware of or personally observed” and that “[i]f experts in
the particular field would reasonably rely on those kinds of facts or data in forming an
opinion on the subject, they [the facts or data] need not be admissible for the opinion to be
admitted.”
Leatt cites cases standing for the proposition that Daubert does not allow an expert “to
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be the mouthpiece of a scientist in a different specialty,” for example, a “theoretical
economist . . . would not be allowed to testify to the findings of econometric study conducted
by another economist if he lacked expertise in econometrics and the study raised questions
that only an econometrician could answer.” Dura Automotive Systems of Indiana, Inc. v. CTS
Corporation, 285 F.3d 609, 614 (7th Cir. 2002). However, Dr. Burton does not lack
knowledge or expertise in the biomechanics of spine and spinal cord injuries as assessed by
Van Ee and Bidez. To the contrary, plaintiffs have persuasively shown that Van Ee’s and
Bidez’s reports are sufficiently within Dr. Burton’s domain of expertise (i.e., assessing the
biomechanics of spine and spinal injuries) such that Dr. Burton would reasonably rely on their
opinions for purposes of Fed. R. Evid. 703.
Finally, while Leatt contends that specific computer-generated images appearing in
Dr. Burton’s report lack adequate foundation, even assuming that the computer-generated
images would be inadmissible at trial, this does not demonstrate that Burton’s causation
opinions on the whole are completely inadmissible.
The Court finds Dr. Burton’s testimony admissible. Defendant’s motion to exclude
the testimony of Joseph Burton is therefore denied.
2. Defendant’s Motion to Exclude Richard L. Stalnaker
Plaintiffs have submitted an eleven page expert report from Dr. Richard L. Stalnaker,
an engineer with forty years of experience as a safety design manager with particular
experience studying head, neck, and spine injuries. Like Dr. Burton, Dr. Stalnaker opines that
the shearing fracture to Scott Scarvelli’s spine during his accident was caused by the Leatt
Brace.

17

Stalnaker asserts in his report that his “Engineering analysis of the accident which
took place on February 13, 2011, and the ability of the Leatt brace to protect the neck and
upper torso; is based on the laws of physics.” (Stalnaker Rep. at 4.) Stalnaker identifies the
sources of information he reviewed in preparing his report, including Scott Scarvelli’s
medical records; depositions in the case; “Production Documents, Interrogatories, videos,
etc.” produced by Leatt in discovery in the case; material provided by Dr. Bidez, SAFE, and
Mr. Smith for Kemmer v. Leatt; pertinent reconstruction information provided by Rick
Sanford; pertinent medical and biomechanical information provided by Dr. Joseph Burton;
and Stalnaker’s personal inspection and photographs of the helmet and brace worn by Scott
Scarvelli during the accident. (Stal. Rep. at 5.)
Stalnaker asserts that his inspection of the helmet and brace worn by Scarvelli at the
time of the accident shows that Scarvelli’s head was in flexion during the accident and as he
attempted to tuck and roll. Stalnaker states his opinion that:
When something is bent, it produces tension stress on the outside arc of the
bend and compression force on the inside arc of the bend. In Mr. Scarvelli’s
accident, the bending motion of his spine alone may not have provided
sufficient tension or compressive forces to cause the fracture. However, when
combined with the axial load maintained by the brace, the additional
compression force to the anterior thoracic spine caused the vertebrae to fail
and fracture.
The Leatt neck brace is highly resistant to bending and rotation. If the
movement of the body during the accident includes a rotation or bend, this
movement will be focused in a single point located just below the resistance.
With the Leatt brace, this focal point is just below the strut. Dr. Burton’s
surrogate photos from his Biomechanical analysis show that on most adult
males, this focal point of rotation is going to be in the T4 to T6 level of the
spine.
Mr. Scarvelli had been riding motocross since the age of three. It would have
been an automatic reflex for him to perform the tuck and roll maneuver in an
18

accident of this kind if the Leatt brace had allowed it. During the tuck and roll
maneuver, the spine bends in degrees, a few at a time, deflecting the forces
away from the spine and adding additional degrees of flexion as the spine
binds. If the proper execution of this maneuver is restricted, the forces will
focus at the lowest point below the resistance, which in the case of the Leatt
brace is the single point below the strut of the brace.
It is my opinion that had Mr. Scarvelli not been wearing the Leatt Brace, his
spine would have bent gradually deflecting the forces and dissipating any axial
load. Even if Mr. Scarvelli had not been able to make a conscious decision to
maneuver into a roll to deflect the forces, the configuration of his fall and the
articulation of vertebrae would have compressed his body naturally into the
rolling movement. It was the focal point of the forces at the single point
caused by the Leatt brace that caused the severity of Mr. Scarvelli’s injury.
Had Mr. Scarvelli not been wearing the brace, the bending would have
occurred in a rolling motion of deflection rather than a focused bend and he
would not have received this injury. Based on the kinematics and location of
this accident, Mr. Scarvelli, more likely than not, would not have suffered any
serious injury.
Conclusion:
I have come to the following conclusion, based on the above sources of
information, my analysis of the accident and my forty years of experience,
within a reasonable degree of scientific probabilities.
There is no indication that any force in an accident is absorbed by the brace.
The forces are simply redirected into the shoulders and the upper thoracic
vertebrae. . . .
Testing results that were available to Leatt show that the Leatt brace increased
the axial load in some impact conditions. The chance of a spinal injury is
greatly increased by a higher axial load, leading to the conclusion that use of
the brace actually increases the risk of injury. Leatt, knowing that an increased
axial load was being redirected, failed to conduct testing to determine the
consequences of the increased forces to the thoracic area of the body for injury
risk.
The tuck-and-roll maneuver is used by most sport that may involve a fall to
improve neck force parameters on impact. It is obvious by the damage to the
helmet and the brace that the impact between the two prevented Mr. Scarvelli
from performing this maneuver for his safety.
The Leatt brace is defective and unreasonably dangerous in that it fails to
absorb any force, creates an increased axial load, and hinders the wearer from
19

performing safety maneuvers to prevent injury. The design of the brace and
strut focus a bending/twisting point just below the strut of the brace virtually
guaranteeing that a load is concentrated on the upper thoracic spine.
The Brace is defective in design and formulation in that the foreseeable risks
associated with the design exceed the benefits. The increased risk in injury to
the thoracic spine far exceeds the benefit of the minimal, if any, protection to
the cervical spine. . . .
The Brace was also defective due to Inadequate Warning. . . .
The Brace was again also defective in that Leatt failed to conform to its
representations. Leatt claims that the brace will protect the neck but it fails to
even do that. . . .
If Mr. Scarvelli had not been wearing the Leatt brace, his spine would have
bent gradually deflecting the forces and dissipating any axial load. Based on
the kinematics and terrain of this accident, Mr. Scarvelli most likely would
have suffered no serious injury if he had not been wearing the brace.
(Stal. Rep. at 9-11.)
Leatt contends Stalnaker’s opinions should not be permitted at trial because they are
inadequately disclosed under Fed. R. Civ. P. 26 and are unreliable under Fed. R. Evid. 702
and Daubert.
First, Leatt contends Stalnaker’s report is insufficient to satisfy Rule 26's disclosure
requirements and should be excluded because the report does not set forth all “facts and data”
legally required under Rule 26; specifically, Stalnaker does not disclose the “testing results
that were available to Leatt” on which Stalnaker relied in rendering his opinion. Leatt argues
that it cannot “cross-examine Stalnaker on [his] accusation” that testing results available to
Leatt show that the Leatt Brace increased the axial load in some impact conditions “because
he does not identify the ‘testing results’ he claims to be referencing.” (Leatt Mem. at 4.)6
6

Leatt also contends that Stalnaker improperly relied on “materials the Rule of
20

Second, Leatt contends Stalnaker’s testimony is inadmissible because he failed to
supply “any discernible reasoning process” to support the conclusion expressed in his report
that “the Leatt brace . . . fails to absorb any force.” Leatt argues:
Stalnaker offers this conclusion without any discernible reasoning process, and
this is a fundamental flaw in any Rule 26 submission. A report that supplies
only a bottom line opinion is automatically excludable under Rule 37(c)(1).
Stalnaker’s opinion also fails to meet the admissibility threshold of FRE 702
because he did not use – and his Rule 26 report does not contain – any
reasoning or methodology that would give this assertion the requisite ‘reliable
foundation.’ A discernible reasoning process connecting the witness’s
conclusions to the underlying facts is absolutely essential. A report lacking ‘a
line of reasoning arising from a logical foundation’ falls short of Rule
26(a)(2)(B).’ Brainard v. American Skandia Life Ins., 432 F.3d 655, 664 (6th
Cir. 2005).
Leatt emphasizes that Stalnaker “does not have any empirical data to support his claim
about the alleged ineffectiveness of the Leatt Brace” and admitted that he conducted no
testing of his own. (Id. at 7.)

Evidence do not permit,” specifically, “Material provided by Dr. Bidez, SAFE, and Mr.
Smith for Kemmer v. Leatt.” (Leatt Mem. at 4.) As it did in connection with its motion to
exclude the causation testimony of Dr. Burton, Leatt argues with respect to Stalnaker’s
opinion that:
Every aspect of the Bidez/SAFE report commissioned by the plaintiff’s
attorneys in Kemmer prevents its re-use here: (1) neither Bidez nor SAFE
appear in plaintiff’s initial disclosures . . .; (2) neither Bidez nor SAFE
appear in plaintiff’s identification of expert witnesses . . .; (3) neither
Bidez nor SAFE are witnesses subject to cross-examination . . . (4)
plaintiff’s counsel are the sole source of the Bidez/SAFE report . . .; (5)
testimony by Stalnaker about the Bidez/SAFE report would be vouching
for the truth of another person’s statements . . ; and, (6) because the
Bidez/SAFE report was prepared solely for litigation involving a different
accident and a different physical injury, it fails both the fit and reliability
prongs of FRE 702.
(Leatt Mem. at 5.)
21

Third, Leatt contends Stalnaker’s testimony should be excluded because his report
contains “no methodology of any kind – no test, experiment, calculation or model – to either
prove or disprove his causation claim” that the “Leatt brace creates . . . an increased axial
load” and “substantially increases the risk of spinal column injury, which due to the design of
the brace and thoracic strut, results in a failure on the thoracic spine at the focal point of
rotation which is where the thoracic strut ends.” (Id. at 8.) Leatt contends Stalnaker’s report
gives “no clue” as to how Stalnaker reached the conclusion that the brace’s design caused the
thoracic spine injury, and it asserts that Stalnaker’s opinion on this point contains none of the
other traditional hallmarks of scientific reliability – testing, peer review, information as to
error rate, or general acceptance in the scientific community. (Id. at 12.)
Finally, Leatt contends that since Stalnaker “failed to use any reliable methodology to
assess the allegedly negative effect” of wearing the Leatt Brace, Stalnaker “cannot logically
support his claim” expressed in his report that Scarvelli “would have suffered no serious
injury” wearing no neck brace at all. On this point, it asserts:
Stalnaker cannot use the accident itself to illustrate his thesis about the
consequence to Scarvelli of not wearing a neck brace since this is an event that
did not occur. And Stalnaker offers nothing else to show that this opinion is
reliable.
(Id. at 13.)
Plaintiffs, however, contend Stalnaker’s testimony is proper under Fed. R. of Evid.
703 and Daubert. They assert that, in rendering his opinions in this case, Stalnaker relied on
the same data and information that plaintiffs’ own expert (Dr. Mitchell Garber) relied upon in
rendering his opinions in the case, including medical records, medical literature, the accident
reconstruction of plaintiffs’ expert Richard Stanford, and “Leatt documents provided in
22

discovery,” including “Leatt testing, BMW testing and SABS testing.” (Opp. at 4.) Plaintiffs
contend this is a sufficient basis to satisfy the standards of admissibility under Fed. R. Civ. P.
703. Plaintiffs emphasize the Supreme Court’s statements in Daubert that an expert is
permitted “wide latitude to offer opinions” based on the premise that the expert’s opinion
“will have a reliable basis in the knowledge and experience of his discipline.” (Opp. at 1112).7 Plaintiffs contend this characterizes Stalnaker’s “methodology” here, asserting that
Stalnaker’s “opinions are rooted in physics and the corresponding formulas and mathematics
associated with the field and [are] not reliant upon physical testing.” (Id. at 14.) And
plaintiffs assert that “[w]hile [Stalnaker] may not have witnessed the testing produced by
Leatt through discovery or that done in the studies and other expert reports he relied on, he is
permitted to interpret this data and use it to form his opinions based on his knowledge and
experience in his field of expertise.” (Opp. at 12.) According to Stalnaker, the effect of
wearing the Leatt Brace was to increase the axial and compressive forces applied to Scott
Scarvelli’s spine during his accident and cause his spine to shear.8

7

Furthermore, plaintiffs contend it is disingenuous for Leatt to attempt to hold
plaintiffs’ expert to a higher standard than its own expert, Dr. Garber, who also did not
conduct any of his own testing.
8

Plaintiffs assert that Dr. Stalnaker repeatedly stated during deposition that he was
prepared to illustrate the forces that occurred based on the laws of physics at trial. They
assert:
In his deposition, Dr. Stalnaker, when asked to show evidence that the
Leatt brace guided the forces in this accident, responded the forces ‘have
to follow the laws of physics and [he] can certainly, and will at trial if
asked to, draw the load paths’ of these forces. Dr. Stalnaker also testified
in his deposition that he could document the differen[ce] in the range of
motion between wearing the brace and not wearing the brace. Dr.
23

Plaintiffs contend that the jury should be entitled to judge “who is more qualified and
who is more persuasive” to opine on the information that both parties’ experts have
considered -- Stalnaker, a leading expert in the field “who conducted cadaver testing and
research in [a] spine injury program, and impact studies and research on the head, or the
Defense expert Dr. Garber, who has never conducted any such testing.” (Id. at 9.)
Upon review, the Court denies Leatt’s motion to exclude proposed opinion testimony
of Dr. Stalnaker. Like the report of Dr. Burton, Stalnaker’s report satisfies the basic
requirements of Fed. R. Civ. P. 26(a)(2)(B) and Fed. R. Evid. 702. The report sets forth the
information on which Stalnaker relied in preparing his opinions, including “Production
Materials” produced by Leatt in the case. This is sufficient to disclose that Stalnaker relied
on Leatt’s testing information that was disclosed in discovery. The report also satisfies the
requirement of Fed. R. Evid. 702 that the testimony be the product of sufficiently reliable
principles and methodology. Although Dr. Stalnaker does not specifically illustrate in his
report how the laws of physics operated, he testified that he is prepared to illustrate at trial
how the forces of the laws of physics applied in the accident, and there is no dispute that Dr.
Stalnaker has expertise in this area. Universally accepted laws of physics would constitute
“reliable principles and methods” upon which an expert may base an opinion within the
meaning of Fed. R. Civ. P. 702. Further, as discussed above in connection with the testimony
of Dr. Burton, the federal rules of evidence do not require that an expert base his opinion on

Stalnaker is fully prepared to draw out the load paths of the forces in this
accident, apply these forces to the universally accepted laws of physics
and prove that the Leatt brace directly caused Mr. Scarvelli’s spine injury.
(Pltf. Opp. at 20-21.)
24

his own empirical testing, but may rely on the work of others if experts in the particular field
would reasonably rely on those kinds of facts or data in forming an opinion. Experts in Dr.
Stalnaker’s field would reasonably rely on the information Dr. Stalnaker considered and
reviewed. The report is based on a sufficiently reliable methodology in that Stalnaker
reviewed pertinent information and materials that existed and applied his expertise regarding
the laws of physics and concluded that the Leatt-Brace increased the axial load on Scott
Scarvelli’s spine and caused his spine to shear.
Leatt contends that its own biomechanical expert, Dr. Erick Knox, conducted the
testing that Dr. Stalnaker suggests is impossible 9 and supplied a “detailed critique of
Stalnaker’s work, exposing in the process the lack of scientific support for Stalnaker’s
conclusions.” (Leatt Rep. at 3.) While Leatt is entitled to challenge Dr. Stalnaker’s
conclusions and opinions regarding the Leatt Brace and the forces of the law of physics at
trial (including whether it is possible to test the brace) through the testimony and testing of
Dr. Knox and otherwise, the Court does not find that Dr. Stalnaker’s testimony is
inadmissible on the ground that it is not “reliable” within the meaning of Fed. R. Evid. 702.
The Court finds Dr. Stalnaker’s opinion testimony admissible under Daubert and Fed.
R. Evid. 702. Defendant’s motion to exclude Stalnaker’s proposed testimony is denied.

9

Dr. Stalnaker contends there are no test dummies available to measure axial loads
on the thoracic spine. (See Pltf. Opp. at 15.) His position is that there “are some
computer models for the human thoracic spine, but the dummies, the Hybrid III, even
some of the more complex dummies, the EURODISs and some of the newer ones, don’t
actually have thoracic spines. It’s all a single molded or fabricated piece of metal, and so
there is no ability on currently-available dummy models to measure loads on the thoracic
spine, and there is no criteria by which to judge those loads, even if you could measure
them.”
25

3. Defendant’s Motion to Exclude Carol Pollack-Nelson
Leatt moves to exclude the proposed opinion testimony of plaintiffs’ expert Carol
Pollack-Nelson, Ph.D., a “human factors psychologist” specializing in the field of consumer
product safety. From 1988 through 1993, Dr. Pollack-Nelson was employed by the U.S.
Consumer Product Safety Commission in the Human Factors Division. Since 1994, she has
been working independently as a human factors consultant.
In her report, Pollack-Nelson sets forth the following “human factors” opinions:
1. Leatt’s marketing materials caused Tim Scarvelli to believe that the Leatt-Brace
would reduce Scott’s risk of severe injury or death in a motocross accident and that
the Leatt-Brace was as necessary as a helmet.
2. Leatt’s advertising materials are misleading and deficient in that they not
only exaggerate the extent to which the brace was tested, but also do not
inform consumers of the serious limitations of testing and of the brace. As a
result, the Scarvellis did not know that by wearing the Leatt-Brace, Scott was
at risk for serious injury to the thoracic spine.
3. The Defendant knew, or should have known that the Leatt-Brace can
restrict movement and cause injury. Leatt should have addressed these issues
prior to releasing the brace into the market. Furthermore, upon learning of the
thoracic spine injuries suffered by Leatt-Brace wearers, Leatt should have
immediately recalled the brace from consumers and stopped sale.
4. Mr. Scarvelli’s failure to fully read warnings was to be expected and is
common behavior for consumers. Furthermore, even if Mr. Scarvelli had fully
read the warnings, it would not have changed either his perception of the
product or the outcome of Scott’s accident.
In addition, Pollack-Nelson sets forth the following “conclusions” in her report:
The Leatt-Brace is not only defective for causing permanent injury to Scott
Scarvelli’s spine, but it is egregiously so because it was a piece of safety
equipment that fostered a false sense of security. It is reasonable for
consumers to expect safety gear will reduce their risk, not increase it. The
Leatt-Brace instilled a false sense of security in the Scarvellis who decided to
have their sons wear the brace as a result of information gained through Leatt’s
very extensive marketing and promotional campaign. While warnings
26

provided with the product include the standard caveats, Leatt’s marketing and
advertising of the product overshadow such warnings. Furthermore, Leatt’s
warnings did not elucidate the specific injuries that might result from wearing
the brace. As a result, the Scarvellis believed Scott was safer if he wore the
Leatt-Brace and that the brace could protect him from serious injury or death.
Consumer products should be tested and reasonably safe for their intended use
(and reasonable unintended use). It is the responsibility of the manufacturer to
conduct a risk assessment in the design phase. Identified hazards should be
addressed prior to the product’s entry into the market. In the event that
product hazards do not come to light until after the product is in the market,
such as from injury reports, then upon learning of serious injuries associated
with its product, the manufacturer should take immediate action to ensure that
other consumers do not suffer a similar fate. Leatt should have identified and
addressed the serious hazards posed by its brace before the product was sold to
consumers. Furthermore, upon learning of the catastrophic injuries suffered by
riders who wore the brace Leatt should have taken immediate action to notify
consumers and recall the brace, as well as stop future sales until the hazards
were addressed.
From a human factors perspective, a defective product is one that presents a
risk under normal and foreseeable use but for which that hazard is not apparent
or known to the consumer . . . .
(Rep. at 14)
Leatt argues that Pollack-Nelson’s proposed “advertising opinions” should be
excluded because Pollack-Nelson admits that she does not know, or need to know, what of
Leatt’s actual advertising the Scarvellis actually read or saw. Leatt contends PollackNelson’s opinions are irrelevant because
Missing from Pollack-Nelson’s Rule 26 disclosure is any methodology to: (1)
identify the advertising that either Scott or Tim Scarvelli actually saw or read
before obtaining Scott’s brace in 2007; (2) demonstrate how they were
deceived by any specific advertising; or (3) provide evidence of what Scott or
Tim Scarvelli did or thought in reliance on this advertising.
(Leatt Mem. at 4.)
In addition, Leatt argues that, even if marginally probative, Pollack-Nelson’s

27

advertising opinions run afoul of Fed. R. Evid. 403. They assert that it is “difficult to
envision a greater waste of time than testimony from an industrial psychologist on the content
of advertising that a plaintiff did not see” and that the “confusion likely to be engendered by
such testimony is underscored by the fact that the single most influential piece of information
for Scott Scarvelli’s father, Tim Scarvelli, was an unexpected Internet video [a video referred
to in the briefs as the David Bailey video] that Leatt Corporation did not solicit, make, or
distribute.” (Id. at 5.)
Further, Leatt contends that Pollack-Nelson’s specific opinions expressed in her report
that the Leatt Brace “can restrict movement and cause injury” and that Leatt “should have
immediately recalled the brace from consumers and stopped sale” are also excludable. Leatt
points out that for purposes of her opinions, Pollack-Nelson merely assumed the existence of
product defect. She admitted she “assum[ed] that Dr. Burton’s conclusions” in that regard
were “correct.” (Leatt Mem. at 6-7.)
Plaintiffs contend that Pollack-Nelson’s advertising opinions are admissible regardless
of the extent to which the Scarvellis relied on Leatt’s advertising and marketing materials,
relying primarily on Leichtamer v. American Motors Corp., 67 Ohio St.2d 456, 424 N.E.2d
568 (1981), in which the Ohio Supreme Court held that it was not error to admit evidence of a
defendant’s commercial advertising for the purpose of “establish[ing] consumer expectation
of safety and intended use” in a product liability case brought under Ohio law.
Upon review, however, the Court agrees with Leatt that Pollack-Nelson’s advertising
opinions are inadmissible under Daubert and Fed. R. Evid. 702. As noted above, the
Supreme Court stated in Daubert that when

28

Faced with a proffer of expert scientific testimony, . . . the trial judge must
determine . . . whether the expert is proposing to testify to (1) scientific
knowledge that (2) will assist the trier of fact to understand or determine a fact
in issue.
Daubert, 509 U.S. at 592-93. Pollack-Nelson’s opinions do not satisfy this test. As Leatt
asserts, and Pollack-Nelson admits, her opinions are not based on any scientific knowledge
regarding the existence of a product defect. Rather, Pollack-Nelson admits that for purposes
of her opinions, she assumed a product defect solely on the basis of Dr. Burton’s report.
Accordingly, Pollack-Nelson does not purport to offer testimony based on and expert or
“scientific knowledge” that would be helpful to the jury in regard to determining the existence
of a product defect. Leichtamer, which held that commercial advertising is admissible for
purposes of establishing a product defect in a products liability case, is therefore not
instructive in determining the admissibility of Pollack-Nelson’s proposed “human factors”
expert testimony, which does not purport to pertain to the existence of product defect.
Further, plaintiffs have not persuasively demonstrated that the “human factors”
opinions and conclusions that Pollack-Nelson offers in her report (and that derive from
Pollack-Nelson’s assumption that a product defect exists) will assist or aid the jury in
understanding or determining plaintiffs’ alleged claims. To the contrary, the Court finds that
Pollack-Nelson’s proposed testimony will not aid the jury. The jury is fully able to assess
plaintiffs’ claims, including their contentions of Leatt’s failure to adequately warn consumers
and to recall its product, without the assistance of “expert” testimony of a human factors
psychologist.
Defendant’s motion to exclude the proposed opinion testimony of Pollack-Nelson is
granted. Plaintiffs have not persuasively demonstrated that Pollack-Nelson’s testimony will
29

assist the trier of fact in understanding the evidence or determining any fact in issue.
4. Defendant’s Motion to Exclude William F. Kitzes
Plaintiffs’ final challenged expert is William F. Kitzes, a lawyer and a Board Certified
Product Safety Manager and Hazard Control Manager. Plaintiffs offer Kitzes as an expert in
“product safety management” and contend that he will assist the jury in deciding issues
central to plaintiffs’ claims of negligence, defective design, and failure to warn.
In his report, Kitzes sets out five steps of a system of safety management applied by a
“reasonably prudent” product manufacturer: (1) establish a written safety policy; (2) identify
and evaluate product hazards; (3) perform an adequate risk assessment, including considering
the conditions of use of the product and the environment used; (4) monitor the safety
performance after sale and use and take corrective action where necessary; and (5) develop
adequate warnings and training to motivate consumers to understand and avoid dangers.
(Kitzes Rep. at 5-6). Kitzes then offers the following “opinions” without any further specific
analysis:
1. Leatt failed to act as a reasonably prudent manufacturer and distributor to
adequately protect motocross riders from the catastrophic risk of injury while
wearing the Leatt Moto GPX Brace under foreseeable conditions of use.
2. Leatt has collected and analyzed, through the Leatt Injury Assessment
Protocol, reports of well over 100 riders who were injured while wearing the
Leatt-Brace during a fall or crash. Leatt has provided 7 injury assessment
evaluations concerning significant spinal injury. They have been notified of 5
lawsuits concerning personal injuries sustained while wearing the Leatt-Brace.
3. Leatt promoted the Moto GPX Brace as an “effective neck injury
prevention device” and as “the helmet for your neck” to protect riders from
catastophic injury. Yet the “revolutionary” GPX Brace has failed to provide
users the level of protection claimed by their advertisements and expected by
riders under foreseeable conditions of use. Leatt sponsored racers who
promoted the brace as a major advance in rider safety, yet until the rider picks
30

up or opens the box, there was little, if any, information provided on the
limitations of that protection.
4. The Leatt advertising and promotion campaign for the Moto GPX Brace
presented a misleading and deceptive “net impression” to Tim Scarvelli and
motocross riders that the brace would protect them from neck and spinal
injury. The Federal Trade Commission (FTC) defines false advertising as an
advertisement that is misleading and fails to reveal material facts. If such
misleading and deceptive advertisement can cause serious harm that a
consumer could have avoided with accurate information, the advertising is
deceptive. A claim can be false and misleading because of what it implies, and
the “net impression” of all claims is considered. An ad is deceptive if a
consumer is likely to be misled, and the intention of the advertiser is not
relevant to the analysis. The “net impression” created by Leatt advertising can
lead motocross riders to believe that wearing the GPX Brace will protect them
from injury and that failure to wear the brace can result in catastrophic injury.
According to the FTC, last minute disclaimers are often ineffective in light of
an intensive advertising campaign.
5. Leatt failed to report to the Consumer Product Safety Commission (CPSC)
under the Section 15 of the Consumer Product Safety Act and the regulations
at 16 CFR 1115 that they had obtained information which reasonably
supported the conclusion that the Leatt GPX Brace contains a defect which
“could create” a substantial product hazard. Such failure to report deprives the
CPSC, on behalf of consumers, the opportunity to evaluate the data while
working with the company to substantially reduce the potential for injury.
(Id. at 8-10.)
Leatt moves to exclude Kitzes’s opinion testimony for a host of reasons:
• Kitzes’s first opinion is merely a personal opinion because Kitzes does not
derive this opinion by addressing any of the factors laid out in Ohio’s Products
Liability Act. Further, the first opinion is not supported by a discernible
“methodology.”
• Kitzes’s second opinion “is not an opinion at all” but is a statement
describing a portion of Leatt’s discovery responses; Kitzes did not have a basis
to opine on the topic of Leatt Corporation’s Injury Assessment Protocol
because there is no indication in Kitzes’s report that he received, read, or
analyzed any of the 100 plus rider reports Leatt produced in discovery; and
Kitzes’s statements in this opinion as to other lawsuits are neither relevant nor
admissible in the case as there has been no showing that the circumstances of
accidents in the other lawsuits are substantially similar to the accident at issue
31

here.
• Kitzes’s third opinion is an inadmissible personal opinion that has no
relevance to the legal issues to be decided in this case; Kitzes’s report does not
“supply a process” by which Kitzes reached this conclusion; and Kitzes
furnishes “no method by which he determined or could determine what may be
“expected by riders,” which is not an issue the jurors will be asked to decide.
• Kitzes’s fourth and fifth opinions, which have in common the claim by Kitzes
that Leatt violated federal laws (the Federal Trade Commission’s regulation of
false advertising and the Consumer Product Safety Commission’s Section 15
regulation of “substantial product hazard”), should be excluded because they
do not relate to claims that either can be are being made in this lawsuit;
therefore, these opinions are irrelevant. Further, Kitzes’s legal conclusions are
wrong, and Kitzes did not derive his opinions about Leatt’s advertising from a
reliable methodology.10
Additionally, Leatt points out that other courts have excluded Kitzes’s testimony in
other cases.
Plaintiffs contend Kitzes’s opinion testimony is proper. They argue that Kitzes’s
testimony is relevant because:
Plaintiff have alleged, among other things, that Leatt failed to exercise
reasonable care in the design, testing, manufacture, construction, marketing,
product warning and/or modification of Leatt Brace to assure that it was safe
for its intended use by consumers. In order to prove their negligence and
defect claims, Plaintiffs retained Mr. Kitzes, a product safety consultant, to
evaluate whether the principles of product safety management had been
adequately applied by Leatt Corporation with regard to the subject brace and to
determine whether Leatt’s conduct comported with the generally accepted
10

In this regard, Leatt asserts that Kitzes did not identify any particular testimony to
justify his proposed opinions on the effect of Leatt’s advertising and his report does not
set out any methodology, discussion, or analysis by which he attempts to “(1) identify the
advertising that either Scott or Tim Scarvelli actually saw or read before obtaining
Scott’s brace in 2007; (2) demonstrate how the specific advertising was ‘false’; or (3)
provide evidence of what Scott or Tim Scarvelli did or thought in reliance on the ‘false’
advertising.”
(Leatt Mem. at 11.)
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principles as recognized in the specialized field of Mr. Kitzes’ expertise.
Mr. Kitzes’ testimony assesses whether Leatt’s product safety management
measures reasonably anticipated all foreseeable failure modes of the brace and
the sufficiency of its process in determining these failure modes. Furthermore,
Mr. Kitzes’ opinions relating to product safety management provide a
framework to the jury for determining whether Leatt acted reasonably in
placing the subject brace in the marketplace. These issues of fact are central to
Plaintiffs’ claims of negligence, defective design, and failure to warn and, as
such, are directly relevant to the issues in this case.
(Pltf. Opp. at 4.)
And plaintiffs argue that Kitzes’s testimony will be helpful to the jury because the
general principles of product safety management are not common knowledge to lay people,
and Kitzes’s “testimony will assist the jury in deciding an extremely important fact in issue,
that is, whether Leatt acted as a reasonably prudent manufacturer in designing, producing,
marketing, and adequately warning consumers about potential dangers associated with the
subject brace.” (Pltf. Opp. at 9.)
Plaintiffs contend Kitzes used a “reliable” methodology to generate his conclusions,
stating:
The methodology employed by Mr. Kitze is carefully laid out over eight pages
of his report. He begins with an overview of product safety management,
describing it as “a system that a reasonably prudent manufacturer puts in place
before the first product is conceived to ensure that the final product, along
with its warnings, packing, and marketing materials, is reasonably safe” and
states that its main function is to serve as a “tool to protect consumers before
they purchase products.” He also explains that “a product safety audit as
outlined by the National Safety Council can be used to test the validity of a
company’s program and to identify the objective techniques to be applied.”
After introducing the system of product safety management, Mr. Kitzes spends
two and a half pages outlining the accepted principles of safety analysis that a
reasonably prudent manufacturer should apply to ensure its product is
reasonably safe. Mr. Kitzes concludes the section detailing his methodology
with an excerpt from a Consumer Product Safety Commission (CPSC)
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publication, published in 1975, which addresses design review and risk
assessment. This publication, updated in 2006, states, “[m]anufacturer’s must
assure the safety of consumer products” and identifies the elements of a
comprehensive system approach to achieve this stated goal.[”]
It is this system, covered by over four pages of his report, which Mr. Kitzes
employed as his methodology.
(Id. at 6-7.)
Upon review of Kitzes’s report, however, the Court agrees with Leatt that Kitzes’s
opinion testimony is excludable under Daubert and Fed. R. Evid. 702. Even acknowledging
that Kitzes has expertise in the field of “product safety management” and that such expertise
is or could be relevant to some issue or issues raised in the case, there is insufficient
information and analysis in Kitzes’s report to conclude that Kitzes employed a “reliable”
methodology in reaching his “conclusions” such that his opinions are admissible. The
“opinions” Kitzes purports to provide, set forth above, are not cogent (or cogently linked to
the issues raised in the case) and are not supported by any discernible rationale or
methodology. Kitzes, for example, does not substantively analyze any specific purported
conduct (or omission) of Leatt or explain how Leatt’s conduct fell short of any safety
management principle. Rather, Kitzes merely makes conclusory statements in his opinions
that are devoid of any discernible analysis or methodology and states facts that the jury does
not need his help or expertise to determine. Plaintiffs’ arguments in support of Kitzes’s
proposed testimony are unpersuasive.
Defendant’s motion to exclude to exclude the proposed expert testimony of Kitzes is
granted. The Court finds that Kitzes’s proposed testimony fails to meet the requirements of
Fed. R. Evid. 702 and Daubert.

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5. Plaintiffs’ Motion to Exclude Mitchell A. Garber
Plaintiffs, for their part, move to exclude the testimony of Leatt’s proposed expert, Dr.
Mitchell A. Garber. (Doc. 72.) Dr. Garber is a physician and a biomechanical engineer with
years of experience in transportation investigation. In his report, Garber opines among other
things that:
4. The thoracic strut of the Leatt brace does not significantly interact with the
spinous processes, and, with forward flexion of the head and neck, separates
from the back of the user.
5. Though the Leatt brace, by design, reduces the extent of flexion of the
cervical spine, Mr. Scarvelli’s axial compression spinal injuries would have
occurred well before flexion resulted in any significant interaction between the
helmet and the brace in this accident.
6. Given the nature of this impact, Mr. Scarvelli’s injuries were likely to have
occurred with or without the use of the Leatt brace.
(Garber Rep. at 30.)11
Plaintiffs move to exclude the testimony of Dr. Garber, contending that he “is not
qualified to give expert opinions on causation” and that his “opinion involving the mechanism
of Plaintiff Scott Scarvelli’s spine injury does not meet the legal standard set forth in Fed. R.
of Evid. 702” and Daubert. (Pltfs. Mem. at 1.) Plaintiffs argue that Dr. Garber should be
excluded as a witness because
While Dr. Garber is equipped with the scientific knowledge and direct
experience to qualify him to opine about the causation of “accidents” involving
large vehicles such as tugboats, aircrafts, and motorcoaches, he does not
possess the direct experience or the scientific knowledge to opine about the
“cause” or mechanism of the spinal injury sustained while wearing a brace
designed specifically for dirt bike riders.
11

Thus, Garber, Leatt’s physician expert, reached different conclusions than
plaintiffs’ physician expert, Joseph Burton.
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(Pltfs. Mem. at 5.) Plaintiffs contend that Garber’s experience and background may qualify
him to testify “on matters of medical or human factors and causes of transportation accidents,
such as fatigue, perception, medication use, [or] visual impairment,” but he is “not qualified
to testify on the very specialized and narrow issues of head impact kinematics and resulting
spine injury. (Id. at 7.) They argue:
Dr. Garber simply does not possess the training or professional experience
necessary to be qualified to opine on the mechanism of the spine injury and the
role the brace played in causing or preventing injury. He has not conducted
any relevant testing or research on head impact and spine injury, has not been
involved with any such relevant testing or research, and has not published any
literature or such studies or research.
(Id. at 8.)
Leatt contends Dr. Garber has the requisite “knowledge, skill, experience, training, or
education” necessary to qualify on the matters on which he opines in this case pursuant to
Fed. R. Evid. 702, pointing out that he holds degrees in medicine and biomechanical
engineering. Further, for fifteen years, Dr. Garber was the only full-time medical officer at
the U.S. National Transportation Safety Board where he focused on the “pathology,
toxicology, human performance, and biomechanics of bone fracture” and received a
prestigious award for his work in the field biomechanics in 2011 from the International
Research Council on the Biomechanics of Injury. (Pltf. Opp. at 2-3.) Leatt further disputes
plaintiffs’ contention that Dr. Garber lacks particularized biomechanical expertise for
purposes of his opinions in this case, pointing out that Dr. Garber specifically testified that he
had experience looking at the cause and effect of biomechanical injuries while he worked as
an accident investigator for the NTSB.
In sum, Leatt asserts that plaintiffs cannot credibly claim that Dr. Garber does not
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possess the direct experience or scientific knowledge to analyze the mechanism of spinal
injuries. It argues that all of Dr. Garber’s opinions were reliably derived, fall within the scope
of his education, training, and experience, and are supported by the methods he employed in
his report. (Pltf. Opp. at 4.) Plaintiffs did not dispute any of these assertions in a reply brief.
Plaintiffs’ motion to exclude Dr. Garber is denied. A review of Dr. Garber’s
Curriculum Vitae and related materials makes clear that his qualifications in the field are
significant and qualify him to opine as to the matters covered in his report.
Conclusion
For the reasons discussed above, Leatt’s motions to exclude the proposed opinion
testimony by William F. Kitzes (Doc. 54) and Carol Pollack-Nelson (Doc. 70) are granted.
All of the remaining pending motions to exclude expert testimony are denied.
IT IS SO ORDERED.

/s/ Patricia A. Gaughan
PATRICIA A. GAUGHAN
United States District Judge
Dated: 7/15/13

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