Pipitone v. Biomatrix Inc ( 2002 )

Revised April 30, 2002
UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
_____________________________________
No. 01-30654
_____________________________________
Thomas PIPITONE,
and Bonnie PIPITONE,
Plaintiffs-Appellants,
v.
BIOMATRIX, INC.,
Defendant-Appellee.
__________________________________________________
Appeal from the United States District Court
for the Eastern District of Louisiana
__________________________________________________
April 18, 2002
Before GARWOOD, JOLLY, and DAVIS, Circuit Judges.
W. EUGENE DAVIS, Circuit Judge:
Thomas Pipitone and his wife, Bonnie, brought suit against
Biomatrix, Inc. (“Biomatrix”), alleging that a product that
Biomatrix manufactures, known as Synvisc, caused Mr. Pipitone to
develop a salmonella infection in his knee after a physician
injected his knee with Synvisc. The district court excluded the
testimony of the plaintiffs’ experts, Doctors Millet and Coco,
under the standard set forth in Daubert v. Merrell Dow
Pharmaceuticals, Inc..1 The district court concluded that
without the testimony of their two witnesses, the plaintiffs
could not establish their case and granted summary judgment in
favor of Biomatrix. Because we conclude that the district court
abused its discretion in excluding the testimony of Dr. Coco, we
reverse the district court’s grant of summary judgment in favor
of Biomatrix and remand the case to the district court.
I.
In June 1999, Thomas Pipitone sought treatment from his
physician, Dr. Murray, for an ulcer that had developed on his
toe. Because Pipitone was a 58 year-old, insulin-dependent
diabetic, Dr. Murray hospitalized Pipitone and placed him on
antibiotics as a precaution. Dr. Chad Millet, an orthopedic
surgeon, examined Pipitone in the hospital and agreed with Dr.
Murray’s diagnosis and prescription of antibiotics. Dr. Millet
continued treating Pipitone for the ulcer on his toe until
September 1999, when Dr. Millet noted that the ulcer was healing.
In October 1999, Pipitone returned to Dr. Millet, this time
complaining of severe osteoarthritic pain in his knees. Dr.
Millet specializes in joints, especially hips and knees, for
which he undertook an additional year of training at John Hopkins
Hospital. Dr. Millet injected Pipitone’s left knee with
Cortisone in an attempt to alleviate the pain.
1
509 U.S. 579 (1993).
-2-
In November 1999, Pipitone suffered a stroke. As a result,
when Pipitone returned to Dr. Millet on January 11, 2000, still
complaining of knee pain, he was no longer a candidate for knee
replacement surgery. As an alternative to surgery, Dr. Millet
suggested treatment with Synvisc.
Synvisc is a replacement synovial fluid manufactured by
Biomatrix. Synvisc is made from rendered rooster combs, which
are bathed in formaldehyde for a full day and then subjected to
other chemical and detergent treatments. The product is put
through a sterile filtration system and into syringes. Biomatrix
packages Synvisc in boxes of three, factory-sealed syringes to be
administered by injection directly into the knee once a week for
three weeks. When injecting Synvisc, the doctor supplies only
the needle.
The Food and Drug Administration (“FDA”) granted Biomatrix’s
pre-market approval application in August of 1997, and classified
Synvisc as a “Class III” device for purposes of the Medical
Devices Act. Over four million syringes of Synvisc have been
manufactured since 1998, but it is unclear from the summary
judgment record how many have actually been consumed.
Pipitone decided to go forward with the Synvisc treatment.
He filled the prescription for Synvisc at a Walgreen’s pharmacy
and returned to Dr. Millet’s office on the morning of January 25,
2000, to receive the injection. Dr. Millet’s nurse, who was not
-3-
scrubbed down, opened the Synvisc package and one of the shrink-
wrapped syringes inside. She also opened the packaging for the
needle and aspiration syringe, both of which Dr. Millet’s office
supplied. The nurse then attached the needle, still in its
sterile sheath, to the empty aspiration syringe, and placed all
of these items on an injection tray next to unsterile gauze.
Wearing unsterile gloves, Dr. Millet prepared Pipitone’s
knee with an antibiotic cleanser and then with alcohol.
Following Biomatrix’s instructions, Dr. Millet inserted the
needle attached to the empty aspiration syringe into Pipitone’s
knee and withdrew a small amount of synovial fluid. He noted
that the fluid was clear and normal in appearance and indicated
no sign of infection. Dr. Millet then detached the fluid-filled
aspiration syringe from the needle, which remained in place in
Pipitone’s knee, removed the rubber tip from the Synvisc syringe,
and attached the Synvisc syringe to the needle. Dr. Millet then
injected the Synvisc and removed the needle. He placed a bandage
over the entry site, and Pipitone went home.
Later that evening, Pipitone began having severe pain in his
knee. His wife took his temperature, which was 101 degrees, but
they did not report these symptoms to a doctor at that time
because they believed that they were attributable to the
injection. As Pipitone’s knee pain worsened, the Pipitones made
several attempts to contact Dr. Millet’s office and succeeded in
-4-
meeting him on the morning of January 27, two days after the
injection. Dr. Millet aspirated some of the synovial fluid from
Pipitone’s knee and found that it was cloudy and turbid,
indicating infection. Dr. Millet immediately hospitalized
Pipitone and drained Pipitone’s infected knee completely. The
hospital laboratory tested the fluid from Pipitone’s knee and
discovered that the infection was salmonella, which is extremely
rare in joints.
Because the culture showed such a rare infection, Dr. Millet
asked Dr. Jeffrey Coco, a physician who limits his practice to
infectious diseases, to examine Pipitone. When Dr. Coco
evaluated Pipitone in the hospital, he found that Pipitone had no
fever, chilled sweats, diarrhea, nausea, or vomiting. Dr. Coco
also found that the ulcer on Pipitone’s toe had scabbed over and
was healing nicely. Dr. Coco ordered a second check of the
synovial fluid from Pipitone’s knee, but the laboratory had
already rechecked the fluid due to the rarity of the result. The
second test showed again that the infection was salmonella.
When Biomatrix was informed of Pipitone’s infection, it
tested the other two syringes in the Synvisc package that
Pipitone purchased and found no evidence of salmonella. It also
tested the twenty syringes held back from the production lot that
had included the Synvisc sold to Pipitone and found no
salmonella.
-5-
In April 2000, the plaintiffs filed suit against Biomatrix
and Wyeth Laboratories2 in Louisiana state court alleging causes
of action arising under state tort, products liability, and
redhibition laws. The defendants timely removed the suit to
federal court.
In February 2001, the Pipitones filed a medical malpractice
action against Dr. Millet. After taking Dr. Millet’s and Dr.
Coco’s depositions, however, the plaintiffs were persuaded that
fault must have been in Biomatrix’s manufacture of the Synvisc.
The plaintiffs then voluntarily dismissed their action against
Dr. Millet.
In April 2001, the district court held a hearing to consider
Biomatrix’s motion for summary judgment. The court first granted
defendant’s motion in limine to exclude the testimony of Dr.
Millet and Dr. Coco as unreliable under Daubert. The district
court then held that the Medical Devices Act preempted most of
plaintiffs’ state law claims.3 The only claims that survived
preemption were the plaintiffs’ claims for manufacturing defect
2
The plaintiffs voluntarily dismissed Wyeth Laboratories
without prejudice on March 21, 2001.
3
Specifically, the district court held that the MDA
preempted plaintiffs’ claims for design defect, inadequate warning,
and nonconformity with express warning under the LPLA, and
therefore, dismissed these claims with prejudice. The plaintiffs
had already moved to voluntarily dismiss these claims without
prejudice, however, and these issues are not before this court on
appeal.
-6-
and redhibition.4 After holding that redhibition claims are
limited to economic loss only, the district court granted summary
judgment to Biomatrix on both claims. The district court
reasoned that without the testimony of Dr. Millet and Dr. Coco,
the plaintiffs had not presented a genuine issue of material fact
tending to show that the injection of Synvisc into plaintiff’s
knee caused his salmonella infection.5 The Pipitones now appeal
the district court’s exclusion of the experts’ testimony, grant
of summary judgment, and holding that redhibition is limited to
economic loss only.
II.
The plaintiffs first argue that the district court erred in
excluding the testimony of Dr. Millet and Dr. Coco as unreliable
under the standard set forth in Daubert v. Merrell Dow
Pharmaceuticals, Inc..6 We review the district court’s
determination of admissibility of expert evidence under
4
Neither party takes issue with this holding, and we do
not consider it.
5
Circumstantial evidence may be sufficient under the facts
of a case to establish causation for purposes of liability under
the LPLA. See Joseph v. Bohn Ford, Inc., 483 So. 2d 934, 940 (La.
1986). The plaintiff need not absolutely negate all other possible
causes of the injury to meet his burden on causation, see Joseph,
483 So. 2d at 940; rather the plaintiff may prove causation by
establishing “with reasonable certainty that all other alternatives
are impossible.” Todd v. State, 699 So. 2d 35, 43 (La. 1997)
(emphasis added).
6
509 U.S. 579 (1993).
-7-
Daubert for abuse of discretion.7
A.
The Supreme Court’s landmark case of Daubert v. Merrell Dow
Pharmaceuticals, Inc.8 provides the analytical framework for
determining whether expert testimony is admissible under Rule 702
of the Federal Rules of Evidence.9 Under Daubert, Rule 702
charges trial courts to act as “gate-keepers,” making 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.”10 In short, expert testimony is admissible only
if it is both relevant and reliable.11 This gate-keeping
7
See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152
(1999); see also St. Martin v. Mobil Exploration & Producing U.S.
Inc., 224 F.3d 402, 405 (5th Cir. 2000).
8
509 U.S. 579 (1993).
9
509 U.S. 579; see also Seatrax, Inc. v. Sonbeck Int’l,
Inc., 200 F.3d 358, 371-72 (5th Cir. 2000).
Rule 702 of the Federal Rules of Evidence provides in full:
If scientific, technical, or other specialized knowledge will
assist the trier of fact to understand the evidence or to
determine a fact in issue, a witness qualified as an expert by
knowledge, skill, experience, training, or education, may
testify thereto in the form of an opinion or otherwise, if (1)
the testimony is based upon sufficient facts or data, (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.
10
Daubert, 509 U.S. at 592-93.
11
Id. at 589.
-8-
obligation applies to all types of expert testimony, not just
scientific testimony.12
Many factors bear on the inquiry into the reliability of
scientific and other expert testimony.13 In Daubert, the Supreme
Court offered an illustrative, but not an exhaustive, list of
factors that district courts may use in evaluating the
reliability of expert testimony.14 These factors include whether
the expert’s theory or technique: (1) can be or has been tested;
(2) has been subjected to peer review and publication; (3) has a
known or potential rate of error or standards controlling its
operation; and (4) is generally accepted in the relevant
scientific community.15 In the later case of Kumho Tire Co. v.
Carmichael,16 the Supreme Court emphasized that the Daubert
analysis is a “flexible” one, and that “the factors identified in
Daubert may or may not be pertinent in assessing reliability,
depending on the nature of the issue, the expert’s particular
expertise, and the subject of his testimony.”17 The district
12
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999).
13
Daubert, 509 U.S. at 593; Skidmore v. Precision Printing
and Packaging, Inc., 188 F.3d 606, 617 (5th Cir. 1999); Seatrax,
200 F.3d at 372.
14
Daubert, 509 U.S. at 593.
15
Id. at 593-94; see also Moore v. Ashland Chem., Inc., 151
F.3d 269, 275 (5th Cir. 1998) (en banc).
16
526 U.S. 137 (1999).
17
Id. at 150.
-9-
court’s responsibility is “to make certain that an expert,
whether basing testimony upon professional studies or personal
experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert
in the relevant field.”18
With these guidelines in mind, we turn to the facts in the
present case. We discuss the district court’s exclusion of the
testimony of plaintiffs’ experts, Dr. Millet and Dr. Coco, in
turn below.
B.
First, plaintiffs argue that the district court abused its
discretion by excluding Dr. Millet’s testimony that Synvisc
caused the salmonella infection in Pipitone’s knee. Plaintiffs’
primary argument is that the district court erred in excluding
the testimony as unreliable under Daubert. They point to the
fact that Dr. Millet is an orthopedist who specializes in joints.
He received one year of specialized training in joints at Johns
Hopkins Hospital and has been performing knee injections for
nearly twenty years.
Assuming, without deciding, that Dr. Millet’s testimony is
sufficiently reliable to meet the Daubert standard, however, we
conclude that his testimony fails the relevancy prong of Daubert
and was properly excluded. As discussed above, expert testimony
18
Id. at 152.
-10-
is admissible under Daubert only if it is both relevant and
reliable.19 In Daubert, the Supreme Court stated that Rule 702
requires that expert testimony “assist the trier of fact to
understand the evidence or to determine a fact in issue.”20
Thus, to be admissible under Daubert, Dr. Millet’s testimony must
not only be reliable, but also must be relevant to the issue of
causation of the salmonella infection.
In his deposition testimony, Dr. Millet stated that it was
as likely as not that the Synvisc syringe that he administered to
Pipitone contained the salmonella bacteria that infected
Pipitone’s knee. He testified that he had no “scientific
evidence” to support the conclusion that it was more likely than
not that the infection occurred in this way. Dr. Millet then
deferred to Dr. Coco for any other explanation of how the joint
became infected.
Dr. Millet’s testimony on causation is not helpful to the
fact-finder because of his inability to conclude that it was more
likely than not that the Synvisc caused the infection in
Pipitone’s knee. A perfectly equivocal opinion does not make any
fact more or less probable and is irrelevant under the Federal
Rules of Evidence.21 Therefore, the district court did not abuse
19
Daubert, 509 U.S. at 589.
20
Id. at 591.
21
See Fed. R. Evid. 401 (“‘Relevant evidence’ means
evidence having any tendency to make the existence of any fact that
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its discretion in excluding Dr. Millet’s testimony.22
C.
The plaintiffs next attack the district court’s exclusion
under Daubert of Dr. Coco’s testimony that the Synvisc syringe
caused the salmonella infection. The district court based its
decision to exclude Dr. Coco’s testimony on several factors.
First, after discussing Dr. Coco’s great expertise in the area of
epidemiology and infectious diseases, the district court noted
that Dr. Coco performed no epidemiological study in the instant
case. The district court also found that Dr. Coco’s literature
search, which yielded no report of any salmonella infection
arising from a contaminated injectable knee product of any kind,
undermined Dr. Coco’s hypothesis that Synvisc caused the
salmonella infection in this case. Finally, the district court
stated that Dr. Coco had failed to eliminate “many viable
alternative sources” for the salmonella infection.
The four factors identified in Daubert form the starting
point of the inquiry into the admissibility of expert
testimony.23 However, as the Supreme Court noted in Kumho Tire,
is of consequence to the determination of the action more probable
or less probable than it would be without the evidence.”).
22
Of course, this is not to say that Dr. Millet cannot
testify as a lay witness to describe the administration of the
injection, his sterilization procedures, or even his experience
with Synvisc or other injectables. See Fed. R. Evid. 602.
23
See Black v. Food Lion, Inc., 171 F.3d 308, 311 (5th Cir.
1999).
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“the factors identified in Daubert may or may not be pertinent in
assessing reliability, depending on the nature of the issue, the
expert’s particular expertise, and the subject of his
testimony.”24 It is a fact-specific inquiry.25
First, Dr. Coco did not test his hypothesis that a Synvisc
syringe that contains salmonella would cause a salmonella
infection in a knee injected with the Synvisc. Neither side
disputes, however, that if the Synvisc was in fact contaminated,
Pipitone’s knee would probably have been infected. Dr. Coco did
not conduct an epidemiological study of Pipitone’s infection. He
explained, however, that such a study is not necessary or
appropriate in a case such as this in which only one person is
infected.
Dr. Coco did conduct a literature search and found no
evidence of a salmonella infection arising from any injectable
knee product, such as Cortisone, which has been injected into
joints for years. Dr. Coco excluded Synvisc from his search.
The district court found that excluding the defendant’s product
from the search discredited Dr. Coco’s conclusion that the
Synvisc was the source of the salmonella.
Dr. Coco decided to exclude Synvisc from his search of the
relevant scientific literature primarily because Synvisc is the
24
Kumho Tire Co., 526 U.S. at 150.
25
See Skidmore, 188 F.3d at 618; Seatrax, 200 F.3d at 372.
-13-
only knee injectable product made from chicken parts, a known
source of salmonella. By excluding Synvisc, he sought to
isolate the question he was researching--whether a salmonella
infection had ever arisen from the injection process. Dr. Coco
reasoned that if Pipitone’s salmonella infection in this case was
caused by unsterile injection technique or some other cause
unrelated to Synvisc, one would reasonably expect to find other
occurrences of salmonella infections arising from injections of
any product into the knee.26
The lack of literature on injection-related salmonella
infections of the joint does not undermine Dr. Coco’s hypothesis.
As the Supreme Court explained in Kumho Tire, “[i]t might not be
surprising in a particular case, for example, that a claim made
by a scientific witness has never been the subject of peer
review, for the particular application at issue may never
previously have interested any scientist.”27 Where, as here,
there is no evidence that anyone has ever contracted a salmonella
infection from an injection of any kind into the knee, it is
difficult to see why a scientist would study this phenomenon. We
conclude, therefore, that the lack of reports in the literature
26
Neither party contends that Dr. Coco would have found
reports in the scientific literature of a salmonella infection
arising from a Synvisc injection. In fact, Nancy Larsen,
Biomatrix’s Vice-President of Biomaterials Research, states in her
affidavit that Biomatrix has not received any other report of a
salmonella infection related to Synvisc.
27
Kumho Tire Co., 526 U.S. at 151.
-14-
that any knee injectable other than Synvisc has caused a
salmonella infection, supports, rather than contradicts, Dr.
Coco’s conclusion that the infection did not arise due to
unsterile technique or other source not related to Synvisc.
There is no known or potential rate of error or controlling
standards associated with Dr. Coco’s hypothesis. Again, however,
this factor is not particularly relevant, where as here, the
expert derives his testimony mainly from first-hand observations
and professional experience in translating these observations
into medical diagnoses.
The final consideration under Daubert is whether Dr. Coco’s
hypothesis is generally accepted in the relevant scientific
community. Dr. Coco based his opinion on how Pipitone contracted
salmonella in large part on accepted medical knowledge of the
ways in which salmonella functions as an organism and how it
infects humans. Dr. Coco’s elimination of various alternative
causes, as discussed more thoroughly below, such as infection
through the gastro-intestinal (“GI”) tract or the blood stream,
were based on generally accepted diagnostic principles related to
these conditions. Dr. Coco personally examined Pipitone in the
hospital and found him to be lacking the symptoms that a
physician would expect to find if salmonella had been introduced
into the body through one of these alternative routes.
In a case such as this one, however, it is appropriate for
-15-
the trial court to consider factors other than those listed in
Daubert to evaluate the reliability of the expert’s testimony.
In this case, the expert’s testimony is based mainly on his
personal observations, professional experience, education and
training. The trial court, therefore, must probe into the
reliability of these bases when determining whether the testimony
should be admitted. The Advisory Committee notes to Rule 702
specifically contemplate this approach:
Nothing in this amendment is intended to suggest that
experience alone–or experience in conjunction with other
knowledge, skill, training or education–may not provide
sufficient foundation for expert testimony. To the
contrary, the text of Rule 702 expressly contemplates that
an expert may be qualified on the basis of experience.28
Likewise, in Kumho Tire, the Court explained that “no one
denies that an expert might draw a conclusion from a set of
observations based on extensive and specialized experience.”29
Accordingly, this circuit has upheld the admission of expert
testimony where it was based on the expert’s specialized
knowledge, training, experience, and first-hand observation while
supported by solid evidence in the scientific community.30
28
Fed. R. Evid. 702 advisory committee’s note.
29
Kumho Tire Co., 526 U.S. at 156.
30
See Skidmore, 188 F.3d at 618 (holding that the district
court properly admitted testimony of a psychiatrist who diagnosed
plaintiff because the psychiatrist “testified to his experience, to
the criteria by which he diagnosed [the plaintiff], and to the
standard methods of diagnosis in his field”); St. Martin v. Mobil
Exploration & Producing U.S., Inc., 224 F.3d 402, 406-07 (5th Cir.
2000) (holding that ecologist’s first-hand observation of flooded
-16-
As stated before, Biomatrix does not dispute Dr. Coco’s
opinion that the Synvisc syringe used by Pipitone, if
contaminated with salmonella, would have caused his infection.
Biomatrix takes issue only with Dr. Coco’s finding that, in light
of all of Dr. Coco’s knowledge of and experience with salmonella
and how people do and do not contract it, as well as his
observation of Pipitone, the Synvisc syringe was the source of
the contamination.
Dr. Coco specializes in infectious diseases. He is employed
by three local hospitals in the area of hospital epidemiology and
concentrates in this area as it relates to infectious diseases
and the prevention thereof. He has been on the Specialty Board
of Infectious Diseases and has written on the subject. For the
last twelve years, Dr. Coco has been a Clinical Assistant
Professor at Louisiana State University School of Medicine in the
Department of Infectious Disease. Dr. Coco drew on this
experience when he personally examined Pipitone in January 2000.
Based on his experience as an infectious disease specialist and
marsh at issue combined with his expertise in marshland ecology
were sufficiently reliable bases of his opinion on causation under
Daubert to admit the testimony). Compare with Moore v. Ashland
Chem., Inc., 151 F.3d 269, 278 (5th Cir. 1998) (holding that the
district court did not abuse its discretion in excluding expert
testimony on the cause of plaintiff’s “RADS” where there was no
evidence that the chemical agent plaintiff was exposed to caused
RADS); Black v. Food Lion, Inc., 171 F.3d 308, 312-13 (5th Cir.
1999) (holding that expert testimony should have been excluded
under Daubert where, contrary to the expert’s opinion, there was no
solid medical evidence that trauma could cause fibromyalgia).
-17-
his personal observation of Pipitone and his symptoms, Dr. Coco
concluded that the most likely cause of Pipitone’s infection was
the Synvisc that had been injected into his knee two days before.
Specifically, Dr. Coco based this opinion on the timeliness of
the infection (symptoms of which began to appear hours after the
Synvisc injection), the source of the Synvisc, the type of
organism (salmonella) that infected Pipitone, and the elimination
of all other likely alternatives.
The district court grounded its decision to exclude Dr.
Coco’s testimony on causation largely because it found that Dr.
Coco had identified “many viable alternative sources” of the
salmonella infection in Pipitone’s knee. After a careful review
of the summary judgment record, we are satisfied that the record
does not support this statement. Dr. Coco methodically
eliminated the alternative sources of the infection as viable
possibilities. After doing so, he stated that he was “99.9%”
sure that the source of the salmonella was the Synvisc syringe.
One of the alternatives rejected by Dr. Coco was that
Pipitone ingested salmonella, the bacteria infected his GI tract
(a condition called gastroenteritis), translocated into his
bloodstream (a condition called bacteremia), and traveled
directly to his knee, causing the infection. Another alternative
source was that the salmonella infected his scabbed-over toe,
traveled in his bloodstream (also producing bacteremia), and
-18-
infected his knee. Dr. Coco rejected both of these alternatives,
however, on the grounds that Pipitone showed none of the symptoms
associated with either gastroenteritis or bacteremia when Dr.
Coco examined him in the hospital. Dr. Coco testified that when
he examined Pipitone, Pipitone “did not have diarrhea, nausea, or
vomiting”–-the symptoms of gastroenteritis. Dr. Coco also
testified that Pipitone was not running a fever at the time of
his entry into the hospital, nor did he have chills or severe
inflammatory response associated with bacteremia.31 Dr. Coco
also noted that it is nearly impossible to contract salmonella
through even an open traumatic wound, much less the scabbed-over
surface of Pipitone’s toe. Based on the lack of these symptoms
and his specialized knowledge and experience, Dr. Coco ruled out
these alternatives.
Another possible cause of the salmonella infection that Dr.
Coco rejected as a viable alternative was Dr. Millet’s technique
in administering the injection. Dr. Coco interviewed Dr. Millet
about the technique he used in giving Pipitone the Synvisc
injection. Dr. Coco testified that the alcohol and the
antibiotic cleanser that Dr. Millet used to clean Pipitone’s knee
before the injection would have killed any salmonella on the
31
Dr. Coco also made clear that the fact that Pipitone was
diabetic and that he was on Zantac only affected his likelihood of
contracting gastroenteritis, not a salmonella infection in any
other way. These facts made Pipitone no more predisposed to
bacteremia, for example.
-19-
skin. Dr. Coco further testified that he learned from Dr. Millet
that the injection needle was in a protective sheath until Dr.
Millet injected Pipitone. Even if the needle had been removed
from the sheath some time before the injection, however, Dr. Coco
stated that salmonella does not exist in sufficient quantities on
the hands to contaminate an injection needle nor does it exist in
saliva in an individual’s mouth. Dr. Coco testified that if
unsterile injection technique could cause salmonella infection in
a joint, he would have expected to have found reports of such an
occurrence in the literature, regardless of the drug being
injected. Yet, Dr. Coco’s research revealed no evidence of any
injectable causing a salmonella infection in a knee. Given all
of this information, Dr. Coco concluded that the content of the
Synvisc syringe injected into Pipitone was the most likely source
of the salmonella that infected his knee.32
Finally, Biomatrix argues that Dr. Coco’s unfamiliarity with
the Synvisc manufacturing process and his “inability” to explain
the lack of salmonella in the other Synvisc syringes held back
32
Dr. Coco rejected a number of other alternatives which we
do not discuss in depth here. For example, he stated that it was
extremely unlikely that salmonella could have entered Pipitone’s
knee through the needle tract, which was open momentarily when the
aspiration syringe was replaced with the Synvisc syringe. He
testified that he had never seen any report in the medical
literature of a salmonella infection occurring in this way.
Moreover, Dr. Coco stated that this alternative is subject to the
same question presented above; that is, if this was likely, one
would expect there to be some evidence of a salmonella infection
occurring in this manner in the past with the injection of any type
of joint injectable.
-20-
from Pipitone’s production lot renders his testimony “unreliable”
under Daubert. We disagree with Biomatrix’s characterization of
Dr. Coco’s deposition testimony. Dr. Coco stated that while he
would have expected other samples of Synvisc in the same
manufacturing lot to be contaminated, the absence of salmonella
in those few other samples tested did not undermine his
conclusion. Dr. Coco explained that only a small number of
Salmonella organisms would be required to infect a joint that was
directly exposed to the organism. He also stated that in his
epidemiological experience, a batch that produces a contaminated
sample may contain no other contaminated samples.33 Therefore,
33
Dr. Coco based this conclusion on basic epidemiologic
principles and his experience as an epidemiologist for three
hospitals, where he has studied incidents of contamination related
to various batched medicines. Specifically, Dr. Coco testified:
Q: I guess in order to understand the contamination of the
injection, is it in your experience then that if one
injection is contaminated, others would be as well?
A: No, it doesn’t have to be.
Q: What’s your experience?
A: The experience is, generally, if a specific product is
batched, the entire batch is suspect. But in
epidemiologic surveys, batches of product, generally, not
all of them are contaminated. Only a small percent of
them. No one understands why this occurs. But, for
instance, you can have 10,000 recalled of a certain thing
and only a few be actually contaminated.
Q: When you say a few, would you expect more than one in a
batch?
A: It could be–it could be between one and all of them. It
does not have to be all of them. It doesn’t have to be
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we disagree with the defendant’s contention that this testimony
renders Dr. Coco’s testimony unreliable under Daubert.
Based on the summary judgment record in this case, we
believe that the answer to the critical causation question will
depend on which set of predicate facts the fact-finder believes:
the plaintiffs’ contention that the content of the Synvisc
syringe administered to Pipitone was contaminated or the
defendant’s that it was not. The Advisory Committee notes to
Rule 702 speak to the precise problem in today’s case:
When facts are in dispute, experts sometimes reach different
conclusions based on competing versions of the facts. The
emphasis in the amendment on “sufficient facts or data” is
not intended to authorize a trial court to exclude an
expert’s testimony on the ground that the court believes one
version of the facts and not the other.34
It bears reminding that “the trial court’s role as
gatekeeper [under Daubert] is not intended to serve as a
replacement for the adversary system.”35 Rather, as Daubert
makes clear, “[v]igorous cross-examination, presentation of
contrary evidence, and careful instruction on the burden of proof
are the traditional and appropriate means of attacking shaky but
more than one.
(R. at 797-98).
34
Fed. R. Evid. 702 advisory committee’s note.
35
Fed. R. Evid. 702 advisory committee’s note, citing
United States v. 14.38 Acres of Land Situated in Leflore County,
Mississippi, 80 F.3d 1074, 1078 (5th Cir. 1996).
-22-
admissible evidence.”36 Thus, while exercising its role as a
gate-keeper, a trial court must take care not to transform a
Daubert hearing into a trial on the merits. In this case, we
conclude that the standard of reliability that the district court
applied to Dr. Coco’s testimony was overly stringent. The fact-
finder is entitled to hear Dr. Coco’s testimony and decide
whether it should accept or reject that testimony after
considering all factors that weigh on credibility, including
whether the predicate facts on which Dr. Coco relied are
accurate.
III.
Biomatrix next argues that even if Dr. Coco’s testimony is
admissible, summary judgment for Biomatrix was still appropriate
because the plaintiffs produced no significant evidence that
Biomatrix deviated from its FDA-approved manufacturing
procedures. The district court apparently agreed.
The parties agree that the mantle of FDA approval protects
the manufacturer from liability arising from defective design of
the product–not defective manufacture or construction. The only
issue we must decide, therefore, is whether plaintiffs have
presented a genuine issue of material fact as to whether
Biomatrix deviated from its FDA-approved procedures in
manufacturing the Synvisc at issue in this case.
36
Daubert, 509 U.S. at 596.
-23-
According to the affidavit of Nancy Larsen, Vice President
of Biomaterials Research at Biomatrix, “[t]he salmonella organism
simply cannot survive the rigorous sterilization, environmental
control, cleaning and testing procedures attendant to the
manufacture of Synvisc.” It follows that if the content of
Synvisc syringe with which Pipitone was injected was in fact
infected with salmonella, a fact-finder could find that Biomatrix
deviated from its prescribed procedures. We conclude, therefore,
that a genuine issue of material fact exists as to whether
Biomatrix deviated from its FDA-approved procedures in
manufacturing the Synvisc syringe at issue. Therefore, we
reverse the district court’s grant of summary judgment in favor
of Biomatrix on plaintiffs’ defective construction and
redhibition claims.
IV.
Finally, the plaintiffs argue that the district court
incorrectly held that their redhibition claim was limited to
economic loss only. Specifically, plaintiffs argue that the re-
enactment of the title of the Louisiana Civil Code containing the
redhibition articles impliedly repealed portions of the Louisiana
Products Liability Act (“LPLA”) that had been interpreted to
restrict redhibition to recovery of economic loss only. In light
of our conclusion that the plaintiffs’ redhibition claim survives
summary judgment, we must now address this issue. We review this
-24-
question of law de novo.37
Article 2520 of the Louisiana Civil Code provides a cause of
action against manufacturers for breach of “warranty against
redhibitory defects.”38 The Code defines “redhibitory defects”
as those defects that “render[] the thing useless, or its use so
inconvenient that it must be presumed that a buyer would not have
bought the thing had he known of the defect.”39 The remedy for
such a breach of warranty is recission of the contract.40 If the
seller knew of the defect, he could also be liable for damages
and attorney’s fees.41 If the seller is also the manufacturer of
the product, the seller is conclusively presumed to know of the
defect.42
The LPLA, enacted in 1988, provides that it “establishes the
exclusive theories of liability for manufacturers for damages
caused by their products.”43 The statute defines “damage” by
explicitly excluding amounts recoverable under redhibition for
37
See Waco Intern., Inc. v. KHK Scaffolding Houston Inc.,
278 F.3d 523, 528 (5th Cir. 2002).
38
La. Civ. Code art. 2520 (West 2001).
39
Id.
40
Id.
41
La. Civ. Code art. 2545 (West 2001).
42
See, eg., Dickerson v. Begnaud Motors, Inc., 446 So. 2d
536, 540 (La. Ct. App. 1984).
43
La. Rev. Stat. Art. 9:2800.52 (West 2001).
-25-
damage to the product and other economic loss.44 Courts have
interpreted the LPLA as preserving redhibition as a cause of
action only to the extent the claimant seeks to recover the value
of the product or other economic loss.45
In 1993, the Louisiana legislature reenacted the entire
title of the Louisiana Civil Code which includes the redhibition
provisions. Plaintiffs argue that this re-enactment impliedly
repealed the provisions of the LPLA to the contrary and
resurrected redhibition as a full alternative theory of liability
against a manufacturer.
We are not persuaded. Under Louisiana law, there is a
strong presumption against implied repeals.46 Moreover, laws on
the same subject must be interpreted in reference to each
other.47 The 1993 re-enactment of the redhibition articles did
nothing to change the LPLA’s definition of “damage.” Continuing
to read the redhibition articles in product liability cases as
limited to providing a remedy to recover economic loss harmonizes
the two statutes. We hold, therefore, that the district court
44
See La. Rev. Stat. 9:2800.53(5) (West 2001).
45
See, eg., Greiner v. Medical Eng’g. Corp., 243 F.3d 200,
206 n.5 (5th Cir. 2001); Monk v. Scott Truck & Tractor, 619 So. 2d
890, 893 (La. Ct. App. 1993).
46
See State v. Piazza, 596 So. 2d 817, 819 (La. 1992);
Standard Supply & Hardware Co. v. Humphrey Bros., 26 So. 2d 8, 10
(La. 1946).
47
See La. Civ. Code art. 13 (West 2001).
-26-
correctly held that the plaintiffs’ redhibition claims are
limited to recovery of economic loss only.
V.
In conclusion, we hold that the district court properly
excluded the expert testimony of Dr. Millet. However, we
conclude that the district court abused its discretion by
excluding Dr. Coco’s testimony under the standards set forth in
Daubert. Having concluded that Dr. Coco’s testimony is
admissible, it follows that summary judgment for Biomatrix on
either plaintiffs’ defective construction or redhibition claim is
inappropriate. We also conclude that a genuine issue of material
fact exists as to whether Biomatrix deviated from its FDA-
approved procedures in manufacturing the Synvisc syringe at issue
in this case. Finally, we are persuaded that the district court
properly limited the scope of plaintiffs’ redhibition claims to
economic loss only.
We therefore reverse the judgment of the district court and
remand the case to that court for further proceedings consistent
with this opinion.
REVERSED AND REMANDED.
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