Carlson v. Bioremedi Therapeutic Systems, Inc. , 822 F.3d 194 ( 2016 )

Case: 14-20691 Document: 00513506799 Page: 1 Date Filed: 05/16/2016
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
United States Court of Appeals
Fifth Circuit
No. 14-20691 FILED
May 16, 2016
Lyle W. Cayce
DAVID CARLSON; BETSEY CARLSON, Clerk
Plaintiffs - Appellants
v.
BIOREMEDI THERAPEUTIC SYSTEMS, INCORPORATED; LIGHT
EMITTING DESIGNS, INCORPORATED,
Defendants - Appellees
Appeal from the United States District Court
for the Southern District of Texas
Before PRADO, SOUTHWICK, and GRAVES, Circuit Judges.
LESLIE H. SOUTHWICK, Circuit Judge:
David Carlson suffered severe injuries soon after being treated with the
defendants’ product, the ProNeuroLight. He and his wife brought this
products liability suit against the defendants. At trial, the defendants’ only
witness was a chiropractor who had examined Carlson and had been trained
to use the ProNeuroLight. We agree with the Carlsons that the district court
erred in allowing that witness to give expert testimony without first making a
determination about his qualifications.
We REVERSE and REMAND.
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FACTUAL AND PROCEDURAL BACKGROUND
In 2010, David Carlson began to lose nerve sensation in his feet, a
diabetic condition known as “peripheral neuropathy.” Carlson visited Dr.
Lance Durrett, “a chiropractor and alternative medicine specialist” who had
been promoting a new treatment for “diabetic neuropathy.” Dr. Durrett
examined Carlson and recommended treatment using the ProNeuroLight
device. The ProNeuroLight uses infrared light “to heat up the area to increase
the presence of nitrous oxide, which . . . dilates the vessels to allow more
circulation to get to the area.” 1 Dr. Durrett did not personally perform
Carlson’s ProNeuroLight treatment; it was performed by a staff member in the
same treatment facility.
Carlson did not experience complications during treatment, and he was
not examined before leaving the treatment facility. Within 48 hours, Carlson
discovered ulcers on the bottom of his heels. Carlson’s diabetic podiatrist
determined these ulcers were in fact “burn eschar.” Ultimately, Carlson’s
podiatrist concluded these burns caused a bone infection that required “over a
year of hospitalization culminating in a below the knee amputation on one leg,
as well as a heel amputation on the opposite foot.”
The Carlsons brought this suit against both the manufacturer and the
distributor of the ProNeuroLight device, respectively Light Emitting Designs,
Incorporated and Bioremedi Therapeutic Systems, Incorporated. The Carlsons
sought damages on three counts of alleged products liability: (1) design defect;
(2) manufacturing defect; 2 and (3) marketing defect, i.e., a failure to warn.
1 In the defendants’ brief on appeal, they provide a different explanation for how the
device works: “The whole purpose of the ProNeuro device was to stimulate the nerves to make
them function again.”
2 During trial, in response to the defendants’ motion for judgment as a matter of law,
the Carlsons conceded their manufacturing defect claim should be withdrawn. The district
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Before trial, the Carlsons filed a motion to exclude Dr. Durrett’s medical
testimony. The district court denied the motion without explanation. Dr.
Durrett was the defendants’ only witness during the five-day trial. The jury
returned a unanimous verdict for the defendants. The Carlsons timely
appealed, challenging only the admission of Dr. Durrett’s expert testimony.
DISCUSSION
The Carlsons contend the district court abused its discretion by allowing
Dr. Durrett, a chiropractor, to “opine[] on medical matters relating to wound
care, podiatry, neurology, nephrology and diabetic medicine,” as well as “the
temperature necessary to cause a burn injury” and “opinions on the
[ProNeuroLight] device itself.” When asked whether the ProNeuroLight
caused the injuries to Carlson’s feet, Dr. Durrett testified, “I couldn’t conclude
the device did it or did not do it.” Later, though, he stated clearer opinions. He
testified that Carlson’s injuries “look[ed] like diabetic ulcers.” When asked to
comment on a different witness’s conclusion that the ProNeuroLight did cause
Carlson’s injuries, Dr. Durrett stated: “There is not enough data to make that
decision.” Dr. Durrett also testified that the ProNeuroLight could not have
caused Carlson’s injuries. Indeed, he stated the device was incapable of
causing burns because, by design, it cannot raise surface temperatures by more
than two degrees Fahrenheit.
The parties appear to agree the challenged testimony is properly labeled
expert testimony, instead of lay opinion testimony. Though the defendants
never designated Dr. Durrett as an expert, it is the content of testimony, not a
witness’s formal designation as an expert witness, which determines whether
court granted the defendants’ motion on this count alone. The district court allowed the
Carlsons’ two other claims to proceed.
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Rule 702 applies. See FED. R. EVID. 702. That rule must be used to assess “any
part of a witness’s opinion that rests on scientific, technical, or specialized
knowledge . . . .” United States v. Cooks, 589 F.3d 173, 180 (5th Cir. 2009). The
defendants even referred to “Dr. Durrett’s expert opinions” when responding
to the Carlsons’ pretrial motion to exclude his medical testimony and then
described the legal standards a court must use to qualify a witness for expert
testimony. Thus, we assess the challenged testimony under Rule 702.
We also conclude that the Carlsons preserved their challenge to Dr.
Durrett’s testimony. Initially, the Carlsons filed a pretrial motion to exclude
Dr. Durrett’s medical testimony. A “pre-trial objection is sufficient to preserve
the error for appellate review.” Mathis v. Exxon Corp., 302 F.3d 448, 459 &
n.16 (5th Cir. 2002) (citing the 2000 amendment to Federal Rule of Evidence
103). 3 The Carlsons’ motion to exclude did not cite Rule 702 or the caselaw for
analyzing admissibility of expert opinions, but it sufficiently put before the
district court the issue of Dr. Durrett’s qualification to give expert testimony.
The motion argued Dr. Durrett was not qualified “to provide any manner of
expert medical testimony”; for support, the Carlsons cited an out-of-circuit
decision considering the proper scope of a chiropractor’s expert testimony.
Additionally, the Carlsons preserved the issue by twice objecting at trial when
Dr. Durrett began to testify about medical causation. A party need not
repeatedly object to preserve an issue where the district court has already
denied the initial objection. See Douglas v. Alabama, 380 U.S. 415, 420–23
(1965). 4
3 We recently acknowledged conflicting precedent in this circuit. Past opinions have
applied an outdated rule requiring that pretrial objections be renewed at trial to preserve
error. United States v. Lewis, 796 F.3d 543, 545 n.6 (5th Cir. 2015). “Because Mathis is the
earliest of the conflicting panel opinions, it controls.” Id.
4 The Carlsons did not move to exclude Dr. Durrett’s testimony about the technical
capabilities of the ProNeuroLight, and at trial they did not expressly object to his testimony
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Because the issue was preserved for appeal, we review the admission of
expert testimony for an abuse of discretion. Bocanegra v. Vicmar Servs., Inc.,
320 F.3d 581, 584 (5th Cir. 2003). The ruling will be upheld unless it was
“manifestly erroneous.” United States v. Valencia, 600 F.3d 389, 423 (5th Cir.
2010). If we find an abuse of discretion, we still may affirm unless the ruling
“affected the substantial rights of the complaining party.” Nunez v. Allstate
Ins. Co., 604 F.3d 840, 844 (5th Cir. 2010).
I. Abuse of Discretion
The gatekeeping function identified in Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993), “imposes a special obligation upon
a trial judge to ‘ensure that any and all scientific testimony . . . is not only
relevant, but reliable.’” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147
(1999) (quoting Daubert, 509 U.S. at 589). “To trigger a Daubert inquiry, an
expert’s testimony, or its ‘factual basis, data, principles, methods, or their
application,’ must be ‘called sufficiently into question.’” Rodriguez v. Riddell
Sports, Inc., 242 F.3d 567, 581 (5th Cir. 2001) (quoting Kumho, 526 U.S. at
149).
District courts are to make 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.” Pipitone v. Biomatrix, Inc., 288 F.3d 239, 243–44 (5th Cir. 2002)
(quoting Daubert, 509 U.S. at 592–93). “A party seeking to introduce expert
testimony must show ‘(1) the testimony is based upon sufficient facts or data,
that the device could only raise surface temperatures by two degrees Fahrenheit. These
alleged errors are not preserved for our review, and the Carlsons do not address whether we
can or should review for plain error. Regardless, we need not address this testimony because
we reverse on other grounds. The district court may consider its admissibility on remand if
challenged once more.
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(2) the testimony is the product of reliable principles and methods, and (3) the
witness has applied the principles and methods reliably to the facts of the
case.’” Smith v. Goodyear Tire & Rubber Co., 495 F.3d 224, 227 (5th Cir. 2007)
(quoting FED. R. EVID. 702).
An expert witness’s testimony should be excluded if the district court
“finds that the witness is not qualified to testify in a particular field or on a
given subject.” Wilson v. Woods, 163 F.3d 935, 937 (5th Cir. 1999). That said,
“Rule 702 does not mandate that an expert be highly qualified in order to
testify about a given issue. Differences in expertise bear chiefly on the weight
to be assigned to the testimony by the trier of fact, not its admissibility.” Huss
v. Gayden, 571 F.3d 442, 452 (5th Cir. 2009).
Initially, we dispose of the defendants’ contention that Dr. Durrett gave
no opinion testimony whatsoever. When asked whether the ProNeuroLight
could have caused Carlson’s injuries, Dr. Durrett explained there were
“conflicting facts” and that he could not reach a conclusion. Dr. Durrett’s
ostensibly equivocal opinion in fact supported the defendants’ case by
suggesting there was insufficient evidence to prove the ProNeuroLight caused
Carlson’s injuries. 5 Further, Dr. Durrett affirmatively testified that “the
placement of the [ProNeuroLight] pads couldn’t have” caused Carlson’s
injuries. This statement alone qualifies as a medical opinion. We thus
consider whether Dr. Durrett’s expert medical testimony was properly
admitted.
Dr. Durrett has been a practicing chiropractor and alternative medicine
specialist for over 31 years. He graduated with honors from Texas Chiropractic
College, has two certifications in acupuncture, and is board certified as a
5 If we agreed that Dr. Durrett provided only “[a] perfectly equivocal opinion,” his
testimony would be irrelevant and inadmissible. See Pipitone, 288 F.3d at 245.
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chiropractic internist and clinical nutritionist. Dr. Durrett had used devices
similar to the ProNeuroLight for approximately 14 years at the time he
testified. Notwithstanding his various professional achievements, Dr. Durrett
is not a medical doctor, cannot prescribe medicine, did not attend medical
school, and does not possess a degree from a four-year university. While he
has considerable experience using the ProNeuroLight, Dr. Durrett’s only
formal training with the device includes two sales seminars.
A medical degree is not a prerequisite for expert testimony relating to
medicine. For example, we have held that scientists with PhDs were qualified
to testify about fields of medicine ancillary to their field of research. See, e.g.,
Dawsey v. Olin Corp., 782 F.2d 1254, 1262–63 (5th Cir. 1986) (holding a
biochemist who studied the effects of phosgene on animals was “well
qualified . . . to extrapolate his research to humans”). In the absence of
expertise in an ancillary field, however, we have held a non-physician is not
qualified to give medical testimony. See, e.g., Edmonds v. Ill. Cent. Gulf R.R.,
910 F.2d 1284, 1286–87 (5th Cir. 1990). In Edmonds, we noted that the
witness, a psychologist, was “not a medical doctor, and [was] not involved in
making medical diagnoses or ordering medical studies or tests,” and so his
testimony about the medical causation of a patient’s heart disease went
“beyond this witness’s expertise in the field of psychology.” Id. at 1287.
Unlike the witness in Dawsey, Dr. Durrett does not possess an advanced
degree in a field of research ancillary to the fields of medicine he testified
about, such as in podiatry, endocrinology, or nephrology. Further, like in
Edmonds, Dr. Durrett is not a medical doctor. While he does make diagnoses
and orders tests as part of his chiropractic and alternative medicine practice,
Dr. Durrett’s qualifications do not align with or support his challenged medical
causation testimony. Dr. Durrett may be well-suited to provide expert
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testimony about the musculoskeletal system, 6 yet there is no evidence to
suggest he is similarly qualified to testify about any other field of medicine.
We need not decide whether Dr. Durrett was qualified to give expert
testimony, however, because the district court clearly abused its discretion by
not conducting a Daubert inquiry or making a Daubert determination on the
record. True, a district court is not always required to hold a formal Daubert
hearing. See United States v. John, 597 F.3d 263, 274–75 (5th Cir. 2010)
(holding a Daubert hearing is not always necessary “in the context of
fingerprint evidence”). Nonetheless, we agree with three of our sister circuits
that a district court must still perform its gatekeeping function by performing
some type of Daubert inquiry and by making findings about the witness’s
qualifications to give expert testimony. See Smith v. Jenkins, 732 F.3d 51, 64
(1st Cir. 2013); Naeem v. McKesson Drug Co., 444 F.3d 593, 608 (7th Cir. 2006);
Dodge v. Cotter Corp., 328 F.3d 1212, 1223 (10th Cir. 2003). 7 At a minimum,
a district court must create a record of its Daubert inquiry and “articulate its
basis for admitting expert testimony . . . .” Rodriguez, 242 F.3d at 581.
Here, the record reflects that no Daubert inquiry took place. After the
Carlsons objected to Dr. Durrett’s medical testimony, the district court
informed the jury: “I find [the testimony] admissible. Whatever weight you give
to this witness’s testimony, just like every witness, that’s strictly up to you.”
6 Texas’s Occupations Code defines a person practicing chiropractic as one who
assesses and treats the “musculoskeletal system.” TEX. OCC. CODE § 201.002(b)(1)–(2). We
do not rely on this definition for our holding, but note it for context. Dr. Durrett’s expert
qualifications are limited by the absence of any Daubert inquiry or determination
demonstrating he was qualified to testify about medical causation, not by Texas’s
Occupations Code.
7 These circuits have also reviewed de novo “whether the district court actually
performed its gatekeeping function in the first place . . . .” See Smith, 732 F.3d at 64;
Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 760 (7th Cir. 2010); Dodge, 328 F.3d
at 1223. We do not decide whether de novo review applies, though, because we find grounds
for reversal even under the more deferential abuse-of-discretion standard of review.
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With this instruction, the district court disregarded its gatekeeping function to
determine the admissibility of evidence outside of the presence of the jury. See
Wellogix, Inc. v. Accenture, L.L.P., 716 F.3d 867, 881 (5th Cir. 2013).
In a similar case from the Seventh Circuit, a prisoner sued the United
States after a van transporting the prisoner collided with another vehicle.
Ueland v. United States, 291 F.3d 993, 994 (7th Cir. 2002). The plaintiff’s
“principal ‘medical’ testimony came from . . . a college dropout who claim[ed]
to be a chiropractor with a practice limited to acupuncture.” Id. at 997. The
United States challenged this expert’s qualifications to testify about “back and
neck injuries,” but the district court “refused to apply Rule 702 or conduct a
Daubert inquiry, ruling instead that [the proposed expert’s] lack of credentials
and experience concerns only the weight to be accorded to his testimony.” Id.
The Seventh Circuit disagreed and remanded the case to the district court,
explaining that “a Daubert inquiry must be conducted.” Id.
We agree with the reasoning in Ueland. An “expert’s testimony must be
reliable at each and every step or else it is inadmissible.” Knight v. Kirby
Inland Marine Inc., 482 F.3d 347, 355 (5th Cir. 2007). While Dr. Durrett is an
experienced chiropractor and alternative medicine specialist, we cannot assess
on appeal whether he has relevant expertise to support his opinions about
whether the ProNeuroLight could have, or did, cause Carlson’s foot injuries.
Admitting this testimony without performing the requisite Daubert inquiry
amounts to an abuse of discretion.
We next consider whether the abuse of discretion affected the Carlsons’
substantial rights.
II. Effect on Substantial Rights
Even where a district court abuses its discretion, we will still affirm if
the error did not affect the substantial rights of the complaining party. We
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must, though, be “sure, after reviewing the entire record, that the error did not
influence the jury or had but a very slight effect on its verdict.” Kelly v. Boeing
Petroleum Servs., Inc., 61 F.3d 350, 361 (5th Cir. 1995).
On the issue of medical causation, the Carlsons presented testimony
from both Dr. Scott Margolis, Carlson’s treating podiatrist, and Dr. Yadin
David, a biomedical engineering consultant. When Dr. Margolis was asked
whether he had an opinion about what caused Carlson’s injuries, he responded,
“I concluded in my opinion that it was due to the infrared therapy that he was
undergoing.” Further, Dr. David testified that, with regard to infrared therapy
devices like the ProNeuroLight, “[t]here are reports of harm, generally burns
associated with infrared therapy. These reports are particularly worrisome
because the population purported to benefit from infrared therapy is already
at a heightened risk for burns due to loss of protective sensation.”
At the close of the Carlsons’ case-in-chief, the district court denied the
defendants’ motion for judgment as a matter of law on the design defect and
failure-to-warn claims. We can infer that at that time, before Dr. Durrett had
testified, the district court found “that a reasonable jury would . . . have a
legally sufficient evidentiary basis to find for the” Carlsons. FED. R. CIV. P.
50(a)(1). Dr. Durrett was the sole witness when the defense presented its case.
Dr. Durrett’s medical causation testimony was also relied upon during the
defendants’ closing arguments. Defense counsel recounted that Dr. Durrett
had testified “that he does not believe the device gets hot enough to cause a
burn,” and that Carlson’s injuries looked like “diabetic ulcers.”
The jury returned a verdict for the defendants on the Carlsons’ two
remaining counts: (1) finding there was no design defect in the ProNeuroLight;
and (2) finding there was no defect in the marketing of the ProNeuroLight. On
this record, it is not credible to categorize the admission of Dr. Durrett’s
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testimony as harmless. Thus, we conclude the district court’s abuse of
discretion affected the Carlsons’ substantial rights.
***
REVERSED and REMANDED for further proceedings.
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