             Case: 10-15327     Date Filed: 11/07/2012       Page: 1 of 21


                                                                    [DO NOT PUBLISH]



               IN THE UNITED STATES COURT OF APPEALS

                        FOR THE ELEVENTH CIRCUIT
                         ________________________

                                No. 10-15327
                          ________________________

                       D.C. Docket No. 0:08-cv-60931-LRJ



STEPHEN HORRILLO,
as Personal Representative of the Estate of Margaret Horrillo,

                                  llllllllllllllllllllllllllllllllllllllllPlaintiff - Appellant,


                                       versus


COOK INCORPORATED,
d.b.a. Cook Medical,
                               llllllllllllllllllllllllllllllllllllllllDefendant - Appellee.
                          ________________________

                   Appeal from the United States District Court
                       for the Southern District of Florida
                         ________________________

                                (November 7, 2012)

Before WILSON, PRYOR and MARTIN, Circuit Judges.
               Case: 10-15327       Date Filed: 11/07/2012       Page: 2 of 21

MARTIN, Circuit Judge:

       Mr. Stephen Horrillo, as the personal representative of the Estate of Ms.

Margaret Horrillo, appeals the district court’s grant of summary judgment in favor

of Cook Incorporated in this product liability action.

                                              I.

       On May 31, 2007, Dr. Michael Rush performed an angioplasty and inserted

a Formula 418 biliary stent into Ms. Horrillo’s renal artery to treat her arterial

stenosis.1 The surgery was performed at Holy Cross Hospital in Fort Lauderdale,

Florida. Although Dr. Rush considered the procedure a success in the hours

immediately after surgery, Ms. Horrillo suffered a non-hemorrhagic stroke within

twenty-four hours of the procedure, which resulted in serious injuries.

       The Formula 418 biliary stent that Dr. Rush used was manufactured by

Cook Incorporated. The Food and Drug Administration (FDA) had approved the

stent for biliary use, but had not approved its use in renal arteries. This being the

case, Cook included the following disclosures in the stent’s instructions for use.

First, it stated that the device was “intended for use in palliation of malignant

neoplasms in the biliary tree,” which is to say, treatment for cancer in the bile


       1
         On a motion for summary judgment, the facts shown are viewed in the light most
favorable to the nonmoving party and all inferences are drawn in favor of the nonmoving party.
See Anderson v. Liberty Lobby, Inc. 477 U.S. 242, 252-55, 106 S. Ct. 2505, 2512-14 (1986).

                                               2
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ducts. Second, under a heading entitled, “WARNINGS,” the instructions for use

cautioned that “[t]he safety and effectiveness of this device for use in the vascular

system have not been established.”2

       Depositions in this case suggest that it was common knowledge that biliary

stents, like Cook’s, were frequently used “off-label” to facilitate peripheral

circulation, including in the renal arteries. In fact, Dr. Rush stated during his

deposition that he had performed many angioplasty procedures and had previously

used the Formula 418 biliary stent to treat arterial stenosis, to the point where he

felt experienced with its off-label use.

       In February 2007, the FDA contacted various medical device manufacturers,

including Cook, to attend a meeting because of the extensive off-label use of

biliary stents and the high rate of bad medical outcomes reported in connection

with that off-label use. The FDA cited complications including “air embolism,

seizure, stroke and death.” For Cook, forty percent of the adverse medical

incidents associated with its Formula 418 biliary stent originated in off-label use.

The FDA held the meeting with the stent manufacturers, including Cook, on

March 12, 2007. On October 18, 2007, Cook sent a letter to Holy Cross


       2
          Cook eventually filed an application with the FDA to approve the use of the Formula
418 stent in renal arteries, but the application had not been approved at the time this lawsuit was
filed.

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Hospital—where Dr. Rush had performed Ms. Horrillo’s surgery on May 31,

2007—warning of the risks associated with the off-label use of the biliary stent.

Among the risks listed in the October 2007 letter was stroke.

                                           II.

      In January 2008, Ms. Horrillo filed a complaint against Cook in Florida

state court, asserting claims for negligence, strict liability, and breach of warranty

under Florida law. Cook removed the case to the District Court for the Southern

District of Florida on the basis of diversity jurisdiction.

      In August 2010, Cook filed a motion for summary judgment arguing that

Ms. Horrillo had failed to demonstrate that Cook was the proximate cause of the

harm she suffered. Relying on the learned intermediary doctrine, Cook argued

that because Dr. Rush was aware of the risks associated with the angioplasty

procedure, Ms. Horrillo could not demonstrate that Dr. Rush would not have used

the stent if either he or Horrillo had been warned by the manufacturer of its risks.

      In support of this argument, Cook cited Dr. Rush’s deposition, as well as an

affidavit that the doctor filed on behalf of Cook. In his deposition, Dr. Rush

explained:

             I didn’t think there was anything that I would be doing in her
      renal artery that might cause increased or an excessive risk of a stroke.
      The things that I might do to cause her to have a stroke, potentially,

                                           4
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       might be if I shut the renal artery down, occluded it completely, if she
       had a hypertensive spike, that is, a spike in high blood pressure, and she
       would bleed into her brain.

              That’s a possibility but a remote risk, and I felt that any type of
       risk like that was worth the possible benefit of the procedure.

In his affidavit, Dr. Rush averred that he elected to use the device as a matter of

his own clinical judgment. The magistrate judge granted Cook’s motion.3 The

magistrate judge reasoned that Dr. Rush was “fully aware that [the] stent was not

approved for renal use; he was familiar with the risks associated with the device’s

use including stroke, which he believed to be ‘remote’; [and] he was immensely

experienced in performing renal stenosis surgeries . . . .” Based on this, the judge

held that the learned intermediary doctrine applied as a matter of law. Ms.

Horrillo appealed the grant of summary judgment. After filing her notice of

appeal, Ms. Horrillo passed away. We have since granted a motion to substitute

her son, Mr. Stephen Horrillo, as the personal representative of her estate,

pursuant to Federal Rule of Appellate Procedure 43(a)(1).

                                               III.

       This Court reviews de novo a grant of summary judgment. Fitzpatrick v.

City of Atlanta, 2 F.3d 1112, 1117 (11th Cir. 1993). Summary judgment is proper

       3
        The parties consented to the exercise of jurisdiction by a magistrate judge, pursuant to
28 U.S.C. § 636.

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only if there is no genuine issue as to any material fact and the moving party is

entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). “In reviewing a

grant of summary judgment, we resolve all ambiguities and draw reasonable

factual inferences from the evidence in the non-movant’s favor.” Layton v. DHL

Express (USA), Inc., 686 F.3d 1172, 1175 (11th Cir. 2012).

      Under Florida law, a manufacturer of a “dangerous commodity,” such as a

prescription drug or a medical device, has a duty to warn consumers of the known

risks of using its product. Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 822

(Fla. 5th DCA 1981). Failure to provide that warning may render the

manufacturer strictly liable for any resulting harm. Id. at 822–23. However, in the

context of certain medical products, such as medical devices, the manufacturer

may discharge its duty to warn by providing an adequate warning to the treating

medical professional—the learned intermediary—rather than the patient. Felix v.

Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989); Buckner, 400 So. 2d at

822; see also Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995)

(applying Florida law). This duty to warn also applies to foreseeable off-label

uses of medical products. Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla.

1990). Warning the treating physician discharges the manufacturer’s duty to warn

because the physician “weighs the potential benefits against the dangers in

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deciding whether to recommend” the product to the patient. Felix, 540 So. 2d at

104.

       The learned intermediary doctrine is a corollary to the rule that a medical

device manufacturer’s duty to warn runs to the treating physician. Christopher, 53

F.3d at 1192. This doctrine says that “the failure of the manufacturer to provide

the physician with an adequate warning of the risks associated with a [medical

device] is not the proximate cause of a patient’s injury if the prescribing physician

had independent knowledge of the risk that the adequate warning should have

communicated.” Id. Thus, even if the manufacturer breaches its duty to warn, it

may nevertheless mount an affirmative defense and avoid liability by

demonstrating the treating physician was otherwise aware of the particular risk

associated with the medical device. See id. at 1192-93; Walls v. Armour Pharm.

Co., 832 F. Supp. 1467, 1481–82 (M.D. Fla. 1993); Felix, 540 So. 2d at 105. We

have interpreted this defense to mean that “the causal link between a patient’s

injury and the alleged failure to warn is broken” if the treating physician “had

substantially the same knowledge” of the risks posed by the medical device “as an

adequate warning from the manufacturer should have communicated to [the

physician].” Christopher, 53 F.3d at 1192-93 (quotation marks omitted).

       Here, in seeking summary judgment, Cook apparently did not dispute that it

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did not, at any point prior to the May 2007 procedure, warn Dr. Rush of the risk of

stroke associated with the use of its Formula 418 biliary stent in renal angioplasty

procedures.4 Instead, Cook mounted an affirmative defense under the learned

intermediary doctrine by arguing that Dr. Rush had independent and adequate

knowledge of the risk of stroke associated with the off-label uses of its biliary

stent. Thus, the question for us on summary judgment is whether, construing all

evidence in favor of Mr. Horrillo as the non-moving party, there is an issue of fact

about whether Dr. Rush had substantially the same knowledge as Cook of the risk

of stroke in using Cook’s Formula 418 biliary stent in renal angioplasty

procedures. See Christopher, 53 F.3d at 1193.

       In asking us to reverse summary judgment, Mr. Horrillo argues that a

question of fact exists as to whether Dr. Rush was aware of the particular risk of

stroke in using the Formula 418 biliary stent in the renal artery. In response, Cook

does not challenge that it was aware its biliary stent posed a risk of stroke. Indeed,

the March 2007 meeting between the FDA and biliary stent manufacturers,

including Cook, identified the risk of stroke in using an expandable biliary stent in



       4
          While Cook offers a number of justifications for why it failed to warn Dr. Rush of the
risks of using its stent in off-label procedures, these justifications are not relevant to the narrow
question before us, which is whether Cook succeeds on its learned intermediary defense as a
matter of law.

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renal arteries, and Cook acknowledged this risk in its October 2007 warning letter.

Rather, Cook argues that Dr. Rush was aware of that risk by pointing us to Dr.

Rush’s deposition in which he opined that the risk of stroke was “remote,” and

that “any type of risk like that was worth the possible benefit of the procedure.”

Cook also notes that Dr. Rush’s decision to use the Formula 418 biliary stent was

based on his own clinical judgment. According to Cook, this demonstrates, as a

matter of law, that Dr. Rush had substantially the same knowledge as Cook of the

risk of stroke associated with the off-label use of its Formula 418 biliary stent in

renal arteries. Cook also emphasizes that Dr. Rush has twenty-seven years of

experience in his field and has used hundreds of stents to treat renal stenosis.5

       The evidence makes clear that Dr. Rush is experienced with the placement

of stents to treat renal stenosis. However, the facts are ambiguous as to whether

Dr. Rush had substantially the same knowledge as Cook of the particular risks

posed by the use of the Formula 418 biliary stent. Mindful that Cook bears the

burden of showing that Dr. Rush was aware of the risk associated with the

Formula 418 biliary stent, Cutter Laboratories, 53 F.3d at 1193, and that all facts,



       5
        Although Dr. Rush has less experience with the Formula 418 biliary stent, having used
it “numerous times,” he is “pretty experienced” with the stent.



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inferences, and ambiguities are construed in favor of Mr. Horillo, see Layton, 686

F.3d at 1175, we conclude that there is a genuine issue of fact as to whether Dr.

Rush was aware of the risks posed by the Formula 418 biliary stent sufficient for

him to shield Cook under the learned intermediary rule.

       First, we cannot conclude that Dr. Rush had substantially the same

knowledge as Cook because the evidence does not indisputably show that Dr.

Rush was aware of the likelihood or severity of potential complications posed by

the Formula 418 biliary stent that was known to Cook after its March 2007

meeting with FDA. Cook argues that Dr. Rush must have been aware of the risk

of stroke because of his education and training. While it is certainly possible that

through his research and experience Dr. Rush independently learned of the serious

risk of stroke described by the FDA, nothing in the record directly supports this

fact. To the contrary, Dr. Rush testified that he believed the possibility of a stroke

was a remote, unreasonable consideration. Although Dr. Rush is significantly

experienced in his field, Mr. Horillo’s expert witness, Dr. Marx, explained that

“practicing physicians don’t read every journal article that’s published” because

“it would be a full-time job.”6 As is proper at the summary judgment stage, we



       6
         Dr. Marx further explained that “it is the responsibility of [the] industry that makes
these products to be aware of the significant findings and give that information to physicians.”

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decline to speculate about what Dr. Rush did or did not know based on his

education and experience. “[T]he drawing of legitimate inferences from the facts

are jury functions, not those of a judge.” Reeves v. Sanderson Plumbing Prods.

Inc., 530 U.S. 133, 149-50, 120 S. Ct. 2097, 2110 (2000) (quotation marks

omitted).

       Second, Dr. Rush’s general experience does not necessarily prove that he

was aware of the specific risks posed by the Formula 418 biliary stent.

Specifically, the differences in safety between the Formula 418 biliary stent and

other stents are disputed.7 Certainly, Cook can argue to the jury that the risks

posed by the Formula 418 biliary stent were the same as other stents and therefore,

Dr. Rush would know of the risks posed by the Formula 418 biliary stent from his

considerable experience with other stents. However, a reasonable juror could

disagree with the assertion that the Formula 418 biliary stent was just as safe as

any other. For example, the stent’s own label provided that “[t]he safety and

effectiveness of this device for use in the vascular system have not been

established.” Further, Dr. Rush expressed interest in participating in trials to


       7
         The record in this case includes an abundance of testifying M.D.’s and Ph.D.’s. Each
party listed ten experts on their respective witness lists, and by our count, at least seven doctors
were deposed. We will not attempt to summarize the testimony of each of these witnesses, but
rather note that the bounty of testifying doctors and/or experts merely underscores the fact-
intensive nature of the dispute with which the jury will be presented here.

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prepare for Cook’s FDA filing for use of the Formula 418 biliary stent in the

vascular system. And finally in this regard, neither Dr. Rush’s general work with

stent placement, nor his specific experience with the Formula 418 biliary stent,

necessarily establishes that he was aware of the risks involved with the Formula

418 stent. A reasonable juror could find that the FDA issued a warning precisely

because the doctors frequently using the Formula 418 biliary stent, like Dr. Rush,

were unaware of the risks and serious complications of stroke and death. Because

Dr. Rush’s general experience with stent placement does not necessarily mean that

he had substantially the same knowledge as Cook, we conclude there are material

facts in dispute which must be decided by a jury.

      Third, a reasonable juror might find that Dr. Rush’s knowledge that the stent

carried a remote risk of stroke was not substantially similar to the FDA’s serious

March 2007 warning of fatal and debilitating complications, including stroke. The

FDA listed a series of “serious” complications, including seizure and death. The

FDA also highlighted that a substantial percentage of the reported problems

associated with the use of the Formula 418 biliary stent occurred with off-label

use. Again, Dr. Rush described the risk of stroke as a remote, unreasonable

consideration and stated that despite the product’s warning regarding off-label use,

he felt “the effectiveness was probably very well established.” Because Dr. Rush

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was required to make sensitive judgments about the possible risks and benefits of

procedures and equipment, a reasonable juror might find that such a serious FDA

warning would have informed and influenced Dr. Rush’s knowledge base and

decision-making differently than his general belief that stents carry a remote risk

of stroke.

      In sum, the evidence does not indisputably inform us that Dr. Rush had

substantially the same knowledge as Cook. Because a juror could reasonably

conclude that Dr. Rush’s education and experience with stent placement did not

equate Cook’s knowledge about the dangers of the off-label use of its stent, and

also that Dr. Rush’s belief of the remote risk of stroke contrasted with the serious

warnings given to Cook in the March 2007 meeting, the evidence allows for

differing interpretations. A jury should resolve this factual dispute. This is

especially true insofar as Cook bears the burden in asserting this affirmative

defense. Hunt v. Cromartie, 526 U.S. 541, 552, 119 S. Ct. 1545, 1552 (1999)

(“Summary judgment in favor of the party with the burden of persuasion . . . is

inappropriate when the evidence is susceptible of different interpretations or

inferences by the trier of fact.”).

                                         IV.




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      In light of the dissent’s position that summary judgment should also be

granted on the ground that there is no evidence that the use of the Formula 418

biliary stent caused Ms. Horillo’s injury, we briefly address the issue of causation

now as well. The complaint alleged generally that Cook was negligent in the

design, manufacture, and distribution of its stent, because, for example:

      The COOK STENT did not come with adequate warnings and
      instructions regarding its appropriate use, or with warnings of its
      dangers when used as a renal stent, or with strict instructions as to the
      type of procedures for which it could be appropriately used, or with
      adequate instructions as to how it was to be utilized under different
      conditions, or with sufficient warnings and instructions to promote its
      safe usage;

      The COOK STENT was a biliary stent and was negligently designed and
      promoted for use as a renal stent and was not approved by the FDA for
      “off-label” vascular use. Additionally, a similar biliary stent was
      recalled by the FDA on May 4, 2004. Thus defendant had knowledge
      of the COOK STENT’s negligent design as a renal stent;

After reviewing the complaint as a whole, we conclude that Mr. Horillo has

sufficiently alleged causation, in light of his alternative assertions of Cook’s

failure to warn; failure to instruct as to proper usage; and failure to act on its

knowledge of the earlier recall of a similar biliary stent.

      The dissent specifically relies on the testimony of Dr. Marx, who explained

that it would be “medically improbable, if not impossible” for the stent to have

caused an air embolism in the brain, because the stent was not inflated with air and

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the renal artery does not flow directly to the brain. However, even accepting Dr.

Marx’s opinion as uncontested, that testimony would not prevent a reasonable

juror from finding that the Formula 418 biliary stent caused a stroke for a reason

other than an air embolism. Indeed, Dr. Marx testified that the stroke was

probably not caused by an air embolism, but by low blood pressure which resulted

from the placement of the stent. He explained that “the placement of the Formula

418 biliary stent in the renal artery . . . caused a destabilization of the

hemodynamics of the kidneys” because after the stent placement, the kidneys,

which regulate blood pressure, received a different amount of blood than they

were accustomed to getting. We are certainly aware that Dr. Marx’s theory that a

drop in blood pressure caused the stroke is contested by yet another expert–Dr.

Meyers. However, and again with regard to this issue as well, we conclude that

this type of dispute among experts about the cause of Ms. Horrillo’s stroke falls

precisely into the province of the jury.

                                           V.

      For these reasons, we REVERSE the magistrate judge’s grant of summary

judgment and REMAND for further proceedings consistent with this opinion.




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PRYOR, Circuit Judge, dissenting:

       I would affirm the summary judgment in favor of Cook. The majority

concludes that the record is “ambiguous as to whether Dr. Rush had substantially

the same knowledge as Cook of the particular risks posed by the use of the

Formula 418 biliary stent.” ante at 9. The majority believes that a reasonable

juror could conclude that “Dr. Rush’s education and experience with stent

placement did not equate Cook’s knowledge about the dangers of the off-label use

of its stent.” Id. at 13

       The problem with the majority opinion is that the record, construed in the

light most favorable to Horrillo, establishes that the “particular risk of stroke”

associated with the Formula 418 stent is no different from the ordinary risk

involved in any stenting procedure. Dr. Rush was aware of this risk independent

of any warning by Cook because he had conducted hundreds of renal angioplasties

with various kinds of stents and affirmed that he knew there was a risk of stroke

involved with the procedure. Dr. Rush has practiced as an interventional

radiologist for over 25 years and has conducted 20 years of protocol research for

the Food and Drug Administration, including research on vascular stents. Dr.

Rush had ample means to gain knowledge of the risk of stroke associated with

stenting procedures independent of any warning by Cook.




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      A review of the testimony by Dr. Rush, particularly in the light of the

testimony of Horrillo’s expert witness, Dr. Marx, makes clear that Dr. Rush

possessed the same knowledge of the risk of stroke that any warning specific to

the Formula 418 stent would have provided him. The testimony of Dr. Marx

establishes that the “particular risks of stroke in using the Formula 418 biliary

stent in the renal artery” represents the risk involved in any stenting procedure.

An experienced interventional radiologist like Dr. Rush would have known about

this risk. Dr. Marx was explicitly asked whether there was anything unique about

the Formula 418 stent that could cause Horrillo’s stroke and answered that there

was not:

      Q. Okay. Was there anything in particular about the Formula 418
      Biliary Stent as opposed to any other biliary stent that produced her
      stroke?
      ….
      A. No.
      Q. Okay. So there’s nothing about our stent in particular, it was the
      procedure that was involved that is — you’re focusing on, am I
      correct in thinking that?
      A. Correct.

Dr. Marx testified that the risk of stroke came from blood pressure fluctuation

caused by increased blood flow to the kidney or embolism in the kidney caused by

emboli formed when the stent broke up the arteriosclerotic vascular disease. Dr.

Marx’s testimony establishes that this ordinary risk would be known by any

interventional radiologist performing a renal stent. As Dr. Marx testified, risks


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from fluctuations in blood pressure after renal stenting are “not something that

would not be known and understood by medical practitioners.” Although Dr.

Marx faulted Cook for not disclosing information about embolic risks to stenting,

he admitted that radiologists, “[i]n general[,] . . . accept minor embolic phenomena

everywhere in the body except in the brain in general.” He admitted that, even

after looking through all the medical charts, depositions, and medical articles that

Horrillo provided him, nothing persuaded him that the risk of embolization in the

kidneys was more than “minimal.”

      Because Dr. Marx’s testimony establishes, without dispute, that the

“particular risk of stroke in using the Formula 418 biliary stent in the renal artery”

is the same risk involved in any stenting procedure, Horrillo is reduced to arguing

that there is an issue of fact as to whether Dr. Rush understood the general risks of

renal stenting, but there is no genuine issue of material fact that Dr. Rush

understood the general risks of renal stenting. Dr. Rush testified that he knew that

the ways the procedure could cause Horrillo “to have a stroke, potentially, might

be if I shut the renal artery down, occluded it completely, if she had a hypertensive

spike, that is, a spike in high blood pressure, and she would bleed into her brain.

That’s a possibility but a remote risk, and I felt that any type of risk like that was

worth the possible benefit of the procedure.” Dr. Rush undoubtedly knew that

there could be an increased flow of blood to the kidney because that was the entire


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reason for implanting the stent. Dr. Marx also testified that radiologists are aware

that any time they break up an atherosclerotic plaque, there is a risk of

embolization. Dr. Rush testified that the purpose of the angioplasty is to “push the

atherosclerotic disease, the hardening[,] out to open up the vessel.” As Dr. Marx

explained, embolization of some of this atherosclerotic disease is a common, well-

known phenomenon with minimal risks to a patient. After we construe all

ambiguities and factual inferences in favor of Horrillo, there is no genuine issue of

material fact as to whether Dr. Rush was aware of the “particular risk of stroke”

associated with the Formula 418 stent because that risk is no different from the

ordinary risk involved in any stenting procedure.

      I would also affirm the summary judgment in favor of Cook because there is

no evidence of a causal connection between the use of the Formula 418 stent and

Horrillo’s injury under the theory Horrillo offers. When we review a summary

judgment, we can affirm “on any legal ground, regardless of the grounds addressed

and relied upon by the district court.” Cuddeback v. Fla. Bd. of Educ., 381 F.3d

1230, 1235 (11th Cir. 2004). Horrillo alleges that the Formula 418 stent likely

caused an air embolism because the stent used a balloon that could leak air into the

artery that could travel to the brain and cause a stroke. Horrillo’s complaint states

only one theory of causation: that the Formula 418 stent caused air to enter Ms.

Horrillo’s artery, which led to her stroke:


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      The COOK STENT was negligently manufactured in that when it is
      implanted for vascular use, air may be introduced into the patient via
      the stent system causing serious complications, including seizure and
      stroke.
      ….
      [T]he stent was misused in that when the stent is implanted for
      vascular use, air may be introduced into the patient via the stent
      system causing serious complications, including seizure and stroke.
      ….
      The COOK STENT was negligently labeled regarding its correct or
      appropriate usage, in that when it is implanted for vascular use, air
      may be introduced into the patient via the stent system causing
      serious complications, including seizure and stroke.

There is no evidence to support this theory of causation because, as Dr. Marx

testified, it would be “medically improbable, if not impossible,” to get an air

embolism in the brain from a renal artery stent of this design. The majority quotes

part of paragraph 11 of Horrillo’s complaint, but that part says nothing—not one

word—about an alternative theory of causation.

      An air embolism in this situation is “medically improbable, if not

impossible” for two reasons. First, the balloon on the Formula 418 stent is

inflated with a saline solution, not air. Second, the blood in the renal artery does

not flow directly to the brain but instead flows to the kidney and down into the

legs, making it “medically improbable, if not impossible, to get an embolus from a

renal artery stenting embolic event to go to the brain.” And Horrillo’s surviving

son never amended his complaint to reflect a different theory of causation. See

Bryant v. Jones, 575 F.3d 1281, 1308 (11th Cir. 2009) (“[A]bsent extraordinary


                                          20
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circumstances, legal theories and arguments not raised squarely before the district

court cannot be broached for the first time on appeal.”).

        We should affirm the summary judgment in favor of Cook. Although I

would affirm the summary judgment in favor of Cook based on the learned

intermediary doctrine, I would also alternatively affirm based on the absence of

evidence to support the theory of causation offered by Horrillo. I respectfully

dissent from the majority opinion that reverses the summary judgment in favor of

Cook.




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