[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT FILED
U.S. COURT OF APPEALS
________________________ ELEVENTH CIRCUIT
JULY 24, 2002
THOMAS K. KAHN
No. 01-16209 CLERK
________________________
D.C. Docket No. 99-01250-CV-FAM
CHARLES MCCORVEY,
Plaintiff-Appellant,
SCHENELL MCCORVEY,
Plaintiff,
versus
BAXTER HEALTHCARE CORP.,
Defendant-Cross-
Claimant-Appellee,
C.R. BARD, INC.,
Defendant-Cross-
Claimant-Appellee.
__________________________
Appeals from the United States District Court
for the Southern District of Florida
_________________________
(July 24, 2002)
Before CARNES, HILL and KRAVITCH, Circuit Judges.
KRAVITCH, Circuit Judge:
Charles McCorvey appeals the grant of summary judgment to defendants
C.R. Bard, Inc. (“Bard”) and Baxter Healthcare Corp. (“Baxter”), respectively the
manufacturer and distributor of a catheter that erupted inside of him, on his strict
product liability action. Additionally, McCorvey challenges the district court’s
exclusion of an affidavit he offered by an engineering expert, on the ground that it
did not have the necessary indicia of reliability.
I. Background
In February 1995, McCorvey underwent a transurethral resection of his
prostate, a surgical procedure, after which a 30 cc-capacity Bard-manufactured
catheter was inserted in his bladder. Written instructions accompanied 30 cc Bard
catheters advising that the device should be filled with no more than 36 cc’s of
sterile water, but McCorvey’s doctor inserted 50 cc’s of saline solution into the
balloon portion of the catheter before insertion to test the device, then deflated the
balloon. The catheter was placed inside McCorvey uninflated, and once inside him
the balloon portion was again inflated with 50 cc’s of saline solution. Deposition
testimony by McCorvey’s medical experts indicated that it was general medical
2
practice to fill catheters to such volumes.
Six hours after insertion, the balloon portion of McCorvey’s catheter
spontaneously erupted and fragmented inside of him. Doctors extracted the
catheter, which hospital employees discarded. McCorvey alleges that he
experienced persistent symptoms of frequent urinary outflows, urgency with
urination, and pain due to the catheter’s eruption, even after its removal.
Approximately a year and a half after McCorvey’s initial operation, a doctor found
an additional fragment of the balloon portion of the catheter lodged inside
McCorvey’s prostate. McCorvey underwent yet another procedure to remove the
additional fragment, after which the hospital employees photographed and then
discarded it.
McCorvey filed a Florida law product defect suit against Bard and Baxter
under a theory of strict liability.1 Bard filed a motion for summary judgment,
adopted by Baxter. In an effort to defeat summary judgment, McCorvey responded
by offering three expert affidavits, two medical and one engineering, all of which
maintained that the subject catheter was defectively designed or manufactured,
and/or was not safe for its intended purpose. Bard then moved to exclude the
1
In one of McCorvey’s amended complaints, his wife joined the suit, claiming loss of
services, enjoyment, and companionship of her husband. She does not, however, appeal the
dismissal of her claims.
3
proffered expert engineering affidavit. The district court struck the engineer’s
opinions for not meeting the criterion of reliability necessitated by Federal Rule of
Evidence 702 and detailed by Daubert v. Merrell Dow Pharm., 509 U.S. 579
(1993). It also entered summary judgment for the defendants, finding that
McCorvey was not entitled to a legal inference of product defect, referred to as a
Cassisi inference under Florida law. McCorvey appeals both rulings.
II. Discussion
We first turn to the decision by the district court to exclude the affidavit
offered by McCorvey’s engineering expert. This court reviews rulings on the
admissibility of expert testimony for abuse of discretion. See Allison v. McGhan
Med. Corp., 184 F.3d 1300, 1306 (11th Cir. 1999); see also Gen. Elec. Co. v.
Joiner, 522 U.S. 136, 138-39 (1997). In addition, we note that “[t]he burden of
laying the proper foundation for the admission of expert testimony is on the party
offering the expert, and the admissibility must be shown by a preponderance of the
evidence.” Allison, 184 F.3d at 1306 (citing Daubert, 509 U.S. at 592, n.10).
Daubert requires that trial courts act as “gatekeepers” to ensure that
speculative, unreliable expert testimony does not reach the jury. Federal Rule of
Evidence 702, governing the admissibility of expert evidence, provides that if
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“specialized knowledge will assist the trier of fact, ... a witness qualified as an
expert..., 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.” Fed. R. Evid. 702. In deciding whether
these requirements of Rule 702 are met, Daubert instructs courts to consider the
following factors: (1) whether the expert’s theory can be and has been tested; (2)
whether the theory has been subjected to peer review and publication; (3) the
known or potential rate of error of the particular scientific technique; and (4)
whether the technique is generally accepted in the scientific community. Daubert,
509 U.S. at 593-94.
In concluding that the methodology of McCorvey’s engineering expert was
not scientifically reliable and that his causation opinion was based wholly on
speculation, the district court noted that the expert: did not test alternative designs
for the catheter; did not talk to medical personnel; was unable to cite scientific
literature in support of his theories; and did not consider or test possibilities for
failure that could have come from sources outside the product, such as the effect of
improper storage conditions, contaminants, or human error.
McCorvey argues that his engineering expert’s affidavit was erroneously
5
excluded because the district court weighed the credibility of the expert’s
testimony, a function that is uniquely within the province of the jury and thus
inappropriate for a court ruling on a motion for summary judgment. See Abel v.
Dubberly, 210 F.3d 1334 (11th Cir. 2000). McCorvey further contends that any
critique of the expert’s methodology should have been brought out in cross-
examination, rather than used as a basis to exclude under Daubert. McCorvey’s
contentions, rather than amounting to an argument that the district court abused its
discretion in applying Daubert and the requirements of Federal Rule of Evidence
702, instead seem to implicitly reject the gatekeeper function of the trial courts
specifically prescribed by the Supreme Court. Rulings on admissibility under
Daubert inherently require the trial court to conduct an exacting analysis of the
proffered expert’s methodology.
McCorvey had the burden to show that his expert was “qualified to testify
competently regarding the matters he intend[ed] to address; [] the methodology by
which the expert reache[ed] his conclusions is sufficiently reliable; and [] the
testimony assists the trier of fact.” Maiz v. Virani, 253 F.3d 641, 664 (11th Cir.
2001). Recognizing that our review of evidentiary rulings by trial courts on the
admission of expert testimony is “very limited,” id. at 662, we do not find
reversible error in the district court’s conclusion that McCorvey did not meet this
6
burden, and that his proffered engineering expert’s was not sufficiently reliable
under Daubert and Federal Rule of Evidence 702.
Even with the exclusion of the engineering expert’s affidavit, however,
McCorvey’s two medical expert affidavits remained in evidence. Considering all
the record evidence, the district court awarded summary judgment in favor of the
defendants, reasoning that McCorvey had failed to set forth admissible evidence
necessary to establish his prima facie case of product liability. We review de novo
a district court’s grant of summary judgment, applying the same legal standards as
the district court. See Johnson v. Bd. of Regents of Univ. of Ga., 263 F.3d 1234,
1242 (11th Cir. 2001). A grant of summary judgment is appropriate only where
“the pleadings, depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no genuine issue as to any
material fact and the moving party is entitled to a judgment as a matter of law.”
Fed. R. Civ. P. 56(c). We construe the facts and draw all reasonable inferences in
the light most favorable to the non-moving party. Wideman v. Wal-Mart Stores,
Inc., 141 F.3d 1453, 1454 (11th Cir. 1998).
Under Florida law, a strict product liability action requires the plaintiff to
prove that (1) a product (2) produced by a manufacturer (3) was defective or
created an unreasonably dangerous condition (4) that proximately caused (5)
7
injury. See Edward M. Chadbourne, Inc. v. Vaughn, 491 So.2d 551, 553 (Fla.
1986). In the instant case, the district court based its grant of summary judgment
on its finding that McCorvey had not offered any admissible evidence of either the
third element, a product defect, or the fourth element, a causal link between the
alleged defect and his injuries. McCorvey counters that his expert affidavits, even
excluding the one offered by the engineer, were sufficient to establish these
elements; additionally, McCorvey claims that the court erred in not affording him
an inference of product defect, which also would have allowed him to take his case
to a jury. In Florida strict product liability actions, a legal inference is created that
the subject product was defective at both the time of injury and the time of sale
when that product “malfunctions during normal operation.” Cassisi v. Maytag Co.,
396 So.2d 1140 (Fla. 1st Dist. Ct. App. 1981). This inference is generally referred
to in Florida case law as a Cassisi inference.
We hold that McCorvey is entitled to the benefit of a Cassisi inference of
product defect, and that the district court erred in not affording him this inference.
First, the medical expert affidavits here establish that filling a 30 cc-capacity
catheter to 50 cc’s, despite Bard’s recommendations to the contrary, is normal use,
8
and constitutes standard urological practice.2 Although an industry-wide practice
might not defeat a warning, the instant action is not a failure to warn case, but
rather a manufacturing defect suit; the common “misuse” involved here is
sufficient to establish that the occurrence in question, i.e. the fragmentation and
spontaneous eruption of the catheter inside of McCorvey, “differs either from the
manufacturer’s intended result or from other units of the same product line,” which
2
Indeed, one of these affidavits was offered by a doctor who had personally handled and
inserted hundreds of catheters, almost all manufactured by Bard, and who averred that “[w]hile
C.R. Bard, Inc. apparently recommends that the inflation capacity of a 30 cc balloon used in
Charles McCorvey to be 35 cc’s of sterile water, the customary and standard practice for
Urologists is to inflate these 30 cc balloons to at least 50 cc’s when traction of the catheter is
required; venous bleeding is halted with traction and cannot be stopped in any other fashion.”
He continued, “[t]he catheter which fragmented inside Charles McCorvey was inflated to
approximately 50 cc’s which fits squarely within the standard of medical practice for urologists
in and outside of Florida. I customarily fill these same catheters to 50 cc’s with saline or water
and this has been my practice over at least the past 21 years.” This doctor offered that the
inflation of the subject catheter to 50 cc’s before insertion was “appropriate” and usual.” He also
conducted his own experiment with a catheter of identical dimension as the one placed in
McCorvey. He filled the device to 60 cc’s of sterile water and placed twenty pounds on the
inflated balloon for seventy-two hours, “which is far greater pressure than found in a bladder of a
human being.” The catheter which was the subject of this experiment did not deflate or
fragment, as did McCorvey’s.
The second doctor offering an affidavit, the performing doctor, has performed hundreds
of transurethral resection of the prostate operations, as well as hundreds of other transurethral
surgeries. He has also, like the author of the first affidavit, inserted hundreds of catheters,
mostly manufactured by Bard. This doctor offered that he “always” inflates the Bard 30 cc
catheters to at least 50 cc’s to test them. Additionally, he averred that “[f]rom [his] experience
as a urologist in South Florida, all other urologists that I know do the same as I did in relation to
inserting the catheter into Mr. McCorvey, inflating the 30 cc catheter to 50 cc’s, and testing the
device by inflating it to 50 cc’s before insertion into the patient.” It is “customary and standard
practice for Urologists [ ] to inflate these 30 cc balloons to at least 50 cc’s to 60 cc’s of sterile
water or saline for insertion purposes into patients.” This doctor submitted that he “customarily
fill[s] these same catheters to 50 cc’s to 60 cc’s of saline or water and this has been [his] practice
over at least the past 21 years.”
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according to expert testimony, were regularly inflated to similar levels.3 Id. at
1146. We consider these facts sufficient to show that the catheter here erupted
during the course of normal operation. Second, it is apparent that the subject
catheter malfunctioned. Fragments of the catheter were found in McCorvey’s
bladder and prostate after its eruption and up to almost a year and a half
subsequently. This constitutes proof of malfunction, and this, along with the
malfunction having occurred during normal operation, establishes both
prerequisites for application of a Cassisi inference.
The district court here seemed to find significance in the fact that the
catheter was not destroyed, but rather discarded by hospital employees. However,
Cassisi allows, but does not require, that the product be destroyed in the accident
which gives rise to the suit.4 See Cassisi, 396 So.2d at 1151. Although the district
3
The dissent finds it irrelevant to the determination of whether a Cassisi inference applies
that McCorvey’s catheter was subject to treatment and handling no different than hundreds, if
not thousands, of the same catheters, which did not spontaneously fragment. We cannot agree.
We find it extremely significant that, based upon McCorvey’s expert medical affidavits, the
inflation of Bard catheters beyond their recommended levels did not normally result in eruption.
Clearly something was different between these non-erupting catheters and McCorvey’s catheter;
taking all inferences in favor of McCorvey, we must assume that this difference was not a
variation in the inflation levels of the catheters. We therefore can infer, under Cassisi, that the
difference was that McCorvey’s catheter suffered from a manufacturing defect, while the other
Bard catheters which were filled with the same amounts of water or solution did not. We stress,
however, that the defendants remain free to rebut this inference at trial and point to the over-
inflation of McCorvey’s catheter as a possible reason for eruption and fragmentation here.
4
The authority on this point in Florida case law is unanimous. See e.g., Cassisi, 396
So.2d at 1551; see also Miller v. Allstate Ins., 650 So.2d 671, 675 n.4 (Fla. 3d Dist. Ct. App.
1995). Florida’s Fifth District Court of Appeals, however, has stated that it is “unwilling to
10
court emphasized that McCorvey’s admissible expert affidavits did not pinpoint a
specific defect in the catheter, Cassisi and its progeny also do not require such
specificity for a plaintiff to be afforded a legal inference of product defect. See id.
at 1153 (holding that it is “immaterial that the plaintiffs failed to identify the
specific cause of the malfunction since it is inferred that the malfunction itself,
under such circumstances, is evidence of the product’s defective condition at both
the time of the injury and at the time of sale”); see also Parke v. Scotty’s, 584
So.2d 621, 623 (Fla. 1st Dist. Ct. App. 1991). Similarly, the district court erred in
finding that McCorvey’s failure to negate alternative grounds of causation, besides
a manufacturing defect, was fatal to his strict liability claim. McCorvey did not
have any such obligation once he met the two requirements of Cassisi discussed
above. See Cassisi 396 So. 2d at 1149, 1150; Jones v. Heil Co., 566 So.2d 565,
567 (Fla. 1st Dist. Ct. App. 1990).
Because the Cassisi inference may be applied to cases in which the subject
product is lost or destroyed, making even the requirement of proving malfunction
extend [the Cassisi inference] to spoliation cases.” Torres v. Matsushita Elec. Corp., 762 So.2d
1014, 1017 (Fla. 5th Dist. Ct. App. 2000). Contra Miller, 650 So.2d 671. The holding of Torres,
though, is limited to the facts of that case, which involved the loss of the subject product by an
agent of the plaintiff, namely her attorney. Here, the subject catheter was discarded by hospital
employees, third parties in no way acting as agents of McCorvey. Moreover, in the instant case
spoliation was never pleaded as an affirmative defense by the defendants, and therefore it is not
considered a spoliation case.
11
difficult, in such cases “absolute positive proof of product malfunction is not
necessary... .” Wortham v. A.H. Robins Co., 734 F.2d 676, 683 (11th Cir. 1984).
It is in these cases that negating other potential causes of the accident becomes
important to the plaintiff’s ability to establish his entitlement to an inference of
product defect. See id. In the instant case, however, as we noted, there is
“absolute positive proof” that the catheter malfunctioned, and therefore McCorvey
may proceed to trial without either pointing to the specific defect involved or
negating other possible causes of the catheter’s malfunction.
Furthermore, despite indications to the contrary by the district court, it is not
necessary that the subject product require only passive participation for the Cassisi
inference to apply. “The type of product is immaterial to the question whether the
[] inference applies, provided it is one subject to Section 402A’s standard for
defectiveness.” Cassisi, 396 So. 2d at 1552, n. 25. See also Miller v. Allstate Ins.,
650 So.2d 671, 674 (Fla. 3d Dist. Ct. App. 1995) (holding the Cassisi inference
available where a new car crashed into a wall and the plaintiff testified that the
accelerator stuck); Parke, 584 So. 2d at 623. Whether or not a product survives the
malfunction, “the facts essential for the inference’s application are simply proof of
the malfunction during normal operation.” Cassisi, 396 So.2d at 1151.
In conclusion, we note that although any alternatives to a manufacturing
12
defect as possible causes of the catheter’s eruption, including McCorvey’s doctor
having over-inflated the catheter beyond manufacturer recommendations, are not
enough to override the Cassisi inference, they may be highly relevant at trial.
Strict product liability and a Cassisi inference of product defect were “designed to
assist the plaintiff in his quest for the jury’s consideration of the issues alleged.”
Cassisi 396 So. 2d at 1147. It is for this reason that summary judgment for the
defendants would be inappropriate here. They remain free, however, to offer
argument and evidence at trial that might negate McCorvey’s inference of product
defect and rebut his prima facie case.
III. Conclusion
Based on the foregoing, we AFFIRM with respect to the exclusion of the
engineering expert’s affidavit, and REVERSE with respect to the grant of summary
judgment to the defendants.
AFFIRMED in part, REVERSED in part.
13
HILL, Circuit Judge, dissenting:
As I read the record, the following facts are clear:
1. A catheter such as the one in this case contains a balloon-like element.
2. The catheter must be inflated with sterile solution to remain properly
positioned in the patient’s body.
3. The written instructions of the manufacturer state that the 30 cc catheter is
designed to be inflated by the introduction of no more than 36 cc’s of
solution.
4. It is my experience from childhood that balloons will inherently burst if
overinflated.
5. Here all agree that the doctor ignored the manufacturer’s instructions. He
inserted 50 cc’s of solution into the 30 cc catheter, observing that folks did
that all the time.
6. The balloon-like element of the catheter, thus overinflated, burst.
The majority interprets Florida products liability tort law to hold that this set
of facts creates an inference that the catheter, with its 30 cc balloon, was defective
because it fractured when overinflated by 66% of its stated capacity. The inference
created by this interpretation is that, if the balloon burst when 166% of the amount
of liquid it was capable of receiving was forced into it, then it also would have
14
burst had the doctor inserted 100%, or the correct amount!
I am not willing to conclude that this inference, which, to me, appears
illogical, is correct under Florida law unless the Supreme Court of the State of
Florida tells me that it is. I would certify this question.
15