FILED

U.S. COURT OF APPEALS

ELEVENTH CIRCUIT

JULY 24, 2002

THOMAS K. KAHN

CLERK

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS 

FOR THE ELEVENTH CIRCUIT

________________________

No. 01-16209

________________________

D.C. Docket No. 99-01250-CV-FAM

CHARLES MCCORVEY,

Plaintiff-Appellant,

SCHENELL MCCORVEY,

Plaintiff,

versus

BAXTER HEALTHCARE CORP.,

Defendant-CrossClaimant-Appellee,

C.R. BARD, INC.,

Defendant-CrossClaimant-Appellee.

__________________________

Appeals from the United States District Court

for the Southern District of Florida

_________________________

(July 24, 2002)
2

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
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

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
4

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
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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 crossexamination, 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
7

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)
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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,
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.” 

9

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
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 overinflation 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

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
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.

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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
12

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
13

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. 
14

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
15

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.