T.B. v. Orthofix Inc.

Filing 104

MEMORANDUM Opinion and Order Signed by the Honorable John W. Darrah on 2/15/2017. (bg, )

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
TIMOTHY BELLAS,
Plaintiff,
v.
ORTHOFIX, INC.,
Defendant.

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Case No. 14-cv-9623
Judge John W. Darrah

MEMORANDUM OPINION AND ORDER
Plaintiff Timothy Bellas filed a Complaint against Defendant Orthofix, Inc.
(“Defendant”) and others, in the Circuit Court of Cook County. Defendant then removed the
action to federal court on the basis of diversity jurisdiction. The Complaint alleges negligence;
strict liability for manufacturing defects, design defects, and failure to warn; and breaches of
express and implied warranties against Defendant based on the Orthofix LRS external fixator.
Plaintiff retained Dr. Charles A. Rawlings as his proposed expert on the medical device at issue.
Defendant filed a Motion to Bar Plaintiff’s Proposed Expert Charles Rawlings [84] pursuant to
Federal Rule of Evidence 702. For the reasons set forth below, Defendant’s Motion [84] is
denied.
BACKGROUND
Plaintiff was born with a congenital defect, and his right leg is approximately 3.5
centimeters shorter than his left leg. On March 22, 2010, Plaintiff underwent a right femur
osteotomy and placement of the Orthofix LRS fixator on his right leg. The Orthofix LRS is
capable of compressing or lengthening the bone, depending on how it is turned. Whether the
device should be adjusted in a clockwise or counter-clockwise fashion depends on how the

device is assembled by the physician when it is installed. Dr. Edward Abraham, who performed
the surgery, affixed a piece of tape to the Orthofix LRS with an arrow indicating the correct
direction for adjustments.
At a May 28, 2010 follow-up appointment, an x-ray revealed that Plaintiff’s femur had
shortened rather than lengthened. Dr. Abraham determined that the Orthofix LRS device had
been adjusted in the opposite direction of the one he had instructed. The tape showing the
correct direction had not fallen off, and the device was not defective. Plaintiff underwent a
remedial procedure on May 24, 2010, which involved adjusting the Orthofix LRS and
manipulation of the osteotomy site. Defendant distributes the Orthofix LRS but was not
involved with the design, manufacture, or testing of the device.
LEGAL STANDARD
Under the Federal Rule of Evidence 702, trial courts must determine, as a precondition to
admissibility, whether expert evidence rests on a reliable foundation and is relevant.
Manpower, Inc. v. Ins. Co. of Pennsylvania, 732 F.3d 796, 806 (7th Cir. 2013). “Expert
testimony is admissible when the testimony is reliable and would assist the trier of fact to
understand the evidence or determine a fact at issue in a case.” Lewis v. CITGO Petroleum
Corp., 561 F.3d 698, 705 (7th Cir. 2009) (citing Fed. R. Evid. 702; Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579, 589-91 (1993)). The party seeking to introduce expert
testimony bears the burden of demonstrating that the proposed testimony satisfies this standard
by a preponderance of the evidence. Id. The rule on expert testimony is liberal, and doubts
about the usefulness of an expert’s testimony are generally resolved in favor of admissibility.
Davis v. Duran, 277 F.R.D. 362, 366 (N.D. Ill. 2011) (citing Krist v. Eli Lilly & Co., 897 F.2d
293, 298 (7th Cir. 1990); United States v. Finch, 630 F.3d 1057, 1062 (8th Cir. 2011)).

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ANALYSIS
Rule 702 of the Federal Rules of Evidence, which governs the admissibility of expert
testimony, states:
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 inquiry under Rule 702 involves a “three-step analysis,” which asks
“whether the witness is qualified; whether the expert’s methodology is scientifically reliable; and
whether the testimony will ‘assist the trier of fact to understand the evidence or to determine a
fact in issue.’” Myers v. Illinois Central R.R. Co., 629 F.3d 639, 644 (7th Cir. 2010) (quoting
Ervin v. Johnson & Johnson, 492 F.3d 901, 904 (7th Cir. 2007)).
Defendant challenges Rawlings’ expert opinion on two grounds: (1) Rawlings is not an
expert on limb-lengthening medical devices, and (2) Rawlings’ proposed opinions and testimony
are not reliable.
Specialized Knowledge
Defendant argues that Rawlings lacks relevant, specialized knowledge because he does
not have experience with limb-lengthening devices. However, Daubert does not necessarily
require that the expert be a specialist in the subject matter on which they give their opinion.
See Hall v. Flannery, 840 F.3d 922, 929 (7th Cir. 2016) (citing Gaydar v. Sociedad Instituto
Gineco-Quirurgico y Planificacion Familiar, 345 F.3d 15, 24-25 (1st Cir. 2003) (“The proffered
expert physician need not be a specialist in a particular medical discipline to render expert
testimony relating to that discipline.”)). Rather, the question is whether an expert witness has the
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qualifications that “provide a foundation for [him] to answer a specific question.” Gayton v.
McCoy, 593 F.3d 610, 617 (7th Cir. 2010) (quoting Berry v. City of Detroit, 25 F.3d 1342, 1351
(6th Cir. 1994)).
Rawlings has advanced degrees in both physiology and engineering, was a professor
teaching senior and graduate courses in biomedical instrumentation, and researched biomedical
engineering. Rawlings’ background in physiology and engineering provides a foundation to
answer the question on whether there was a design defect in the medical device at issue. Any
argument that Rawlings is not an expert in the specific subspecialty of limb-lengthening devices
goes to the weight of Rawlings’ testimony, not its admissibility. Hall, 840 F.3d at 929 (“The fact
that an expert may not be a specialist in the field that concerns her opinion typically goes to the
weight to be placed on that opinion, not its admissibility.”).
Reliability
Defendant also argues that Rawlings’ proposed testimony and opinions are not
sufficiently reliable.
First, Defendant argues that Rawlings has no basis to state, or to imply, that the Orthofix
LRS’s designers did not consider “human factors” such as whether someone with no medical
training would exercise control over the device. Defendant is correct. There is nothing in the
information considered by Rawlings demonstrating that the Orthofix LRS’s design failed to
consider “human factors.” Therefore, absent a sufficient basis for such an opinion, Rawlings
may not render an opinion in this regard.
Defendant also argues that Rawlings’ report ignores Dr. Abraham’s testimony that a
limb-lengthening device must be able to move in both directions. However, Rawlings’ report
does not say that a proposed ratchet alternative would be limited to only one direction. The

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proposed alternative would be limited to one direction at home, but could be released by medical
personnel using a specialized tool to allow for adjustments in the opposite direction. Whether
Rawlings fully examined all of the factors that go into the feasibility of such a design goes to the
weight of his testimony, not the admissibility.
Finally, Defendant argues that Rawlings does not state what the standard of care is.
Under Illinois law, strict liability for design defects may be proven in two ways: “(1) by
introducing evidence that the product failed to perform as safely as an ordinary consumer would
expect when used in an intended or reasonably foreseeable manner or (2) by introducing
evidence that the product’s design proximately caused his injury and the defendant fails to prove
that on balance the benefits of the challenged design outweigh the risk of danger inherent in such
designs.” Lamkin v. Towner, 563 N.E.2d 449, 457 (1990). Rawlings’ proposed opinion and
testimony speaks to the risk-utility test, and the report does not contain any factors on the
expectations of an ordinary consumer.
Rawlings’ proposed opinions and testimony are sufficiently reliable under Daubert and
Rule 702.
CONCLUSION
Defendant’s Motion to Bar Plaintiff’s Proposed Expert Charles Rawlings [84] pursuant to
Federal Rule of Evidence 702 is denied.

Date:

February 15, 2017

/s/
JOHN W. DARRAH
United States District Court Judge

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