Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca11-14-15537/USCOURTS-ca11-14-15537-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

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*Hon. Mark Howard Cohen, United States District Judge for the Northern District of Georgia, 

sitting by designation.

[DO NOT PUBLISH] 

 IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

_________________

No. 14-15537

_________________

D. C. Docket No. 0-08-cv-60931-WM

STEPHEN HORRILLO,

As Personal Representative of the Estate of

Margaret Horrillo, on behalf of the Estate of Margaret

Horrillo and on behalf of himself as her surviving son,

Plaintiff - Appellant,

versus

COOK INCORPORATED,

d.b.a. Cook Medical,

Defendant - Appellee.

_________________

Appeal from the United States District Court

for the Southern District of Florida 

_________________

(November 23, 2016)

Before MARCUS and DUBINA, Circuit Judges and COHEN,* District Judge.

PER CURIAM: 

_______________________

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I.

Stephen Horrillo brings this action on behalf of his deceased mother, 

Margaret Horrillo, against Cook Incorporated (Cook) for negligence and negligent 

failure to warn, strict products liability and strict failure to warn, and breach of 

warranty. Cook manufactured and sold a stent designed for use in human bile 

ducts; however, Mrs. Horrillo’s doctor used “off-label” in a surgery to clear her 

renal artery. After a fifteen-day trial spanning nearly four weeks, the jury 

returned a verdict in favor of Cook. Mr. Horrillo moved for a judgment 

notwithstanding the verdict, or in the alternative a new trial. Mr. Horrillo’s 

motion was denied and he appeals.

II. 

The following issues are presented for appellate review:

1. Whether the district court1 abused its discretion when it refused to permit 

Mr. Horrillo to introduce into evidence Cook’s renal stent clinical trials as 

rebuttal evidence.

2. Whether the district court abused its discretion when it refused to permit Mr. 

Horrillo to introduce into evidence Cook’s renal stent warning label as a 

subsequent remedial measure. 

3. Whether the district court abused its discretion in determining Mr. Horrillo 

failed to show the great weight of the evidence warranted a new trial.

4. Whether the district court abused its discretion by approving a 

three-question verdict form, and in its jury instructions. 

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

§ 636 (2012). 

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III.

“We review a district court’s ruling on the admissibility of evidence for 

abuse of discretion, and evidentiary rulings will be overturned only if the moving 

party establishes that the ruling resulted in a substantial prejudicial effect.” 

Piamba Cortes v. Am. Airlines, Inc., 177 F.3d 1272, 1305 (11th Cir. 1999) 

(quotation omitted). “An abuse of discretion arises when the decision of the 

district court rests upon a clearly erroneous finding of fact, an errant conclusion of 

law, or an improper application of law to fact.” Fid. Interior Const., Inc. v. Se. 

Carpenters Reg’l Council of United Bhd. of Carpenters & Joiners of Am., 675 F.3d 

1250, 1258 (11th Cir. 2012) (quotation omitted). “Because it is critical that a 

judge does not merely substitute his judgment for that of the jury, new trials should 

not be granted on evidentiary grounds unless, at a minimum, the verdict is against 

the great—not merely the greater—weight of the evidence.” Lipphardt v. 

Durango Steakhouse of Brandon, Inc., 267 F.3d 1183, 1186 (11th Cir. 2001) 

(quotation omitted). 

“A motion for JNOV challenges the sufficiency of the evidence and raises a 

question of law subject to de novo review.” Wolff v. Allstate Life Ins. Co., 985 

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F.2d 1524, 1528 (11th Cir. 1993). In evaluating the district court’s denial of the 

motion: 

[T]he Court should consider all of the evidence . . . with all reasonable 

inferences most favorable to the party opposed to the motion. If the facts 

and inferences point so strongly and overwhelmingly in favor of one party 

that the Court believes that reasonable men could not arrive at a contrary 

verdict, granting of the motion[] is proper. On the other hand, if there is 

substantial evidence opposed to the motion, that is, evidence of such quality 

and weight that reasonable and fair-minded men in the exercise of impartial

judgment might reach different conclusions, the motion should be denied. 

. . . 

Id. (quoting Boeing Co. v. Shipman, 411 F.2d 365, 374 (5th Cir. 1969) (en banc)). 

On the other hand, the district court’s denial of a party’s motion for a new 

trial is reviewable for a clear abuse of discretion. Id. Unlike a motion for 

judgment as a matter of law, the district court is free to independently weigh the 

evidence when deciding a motion for a new trial. Williams v. City of Valdosta, 

689 F.2d 964, 973 (11th Cir. 1982). “A judge should grant a motion for a new 

trial when the verdict is against the clear weight of the evidence or will result in a 

miscarriage of justice, even though there may be substantial evidence which would 

prevent the direction of a verdict.” Lipphardt, 267 F.3d at 1186 (quotation 

omitted); see also Williams, 689 F.2d at 973 (“A trial judge may grant a motion for 

a new trial if he believes the verdict rendered by the jury was contrary to the great 

weight of the evidence.”). 

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“We apply the same deferential standard of review to a special interrogatory 

verdict form that we apply to a district court’s jury instructions,” McNely v. Ocala 

Star-Banner Corp., 99 F.3d 1068, 1072 (11th Cir. 1996); that is, we review for an 

abuse of discretion, Schafer v. Time Inc., 142 F.3d 1361, 1368 (11th Cir. 1998). 

“Our review of a district court’s charges to the jury is deferential, and the trial 

judge is entitled to wide discretion over the style and wording employed as long as 

the instructions accurately reflect the law.” Id. “We must examine whether the 

jury charges, considered as a whole, sufficiently instructed the jury so that the

jurors understood the issues and were not misled.” Id. (quotation omitted). 

“We do not engage in word-by-word hairsplitting when reviewing the instructions 

given at trial,” so long as the instructions, “accurately reflect the law.” Johnson v. 

Breeden, 280 F.3d 1308, 1314 (11th Cir. 2002). 

IV.

After reviewing the record, reading the parties’ briefs, and having the benefit 

of oral argument, we affirm the judgment entered on the jury’s verdict in favor of 

Cook. 

First, we conclude that the district court did not abuse its discretion when it 

rejected Mr. Horrillo’s request to introduce evidence on rebuttal that four patients 

in a post-incident clinical trial of Cook’s renal stent suffered strokes, where such 

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evidence was both irrelevant and prejudicial, and nothing had occurred during the 

course of the trial to “open the door” to such evidence being introduced on rebuttal. 

Second, we conclude that the district court did not abuse its discretion when 

it excluded from evidence the label attached to Cook’s renal stent years after Mrs. 

Horrillo’s procedure. In addition to being properly excluded as a subsequent 

remedial measure under FED. R. EVID. 407,2 the evidence was also irrelevant, 

more prejudicial than probative, and cumulative. 

Third, the record shows that the jury’s verdict was overwhelmingly 

supported by evidence presented at trial. Cook introduced compelling and 

significant testimony and documents that would easily allow the jury to conclude 

that Cook did not promote off-label uses of the biliary stent, was unaware of any 

risk of stroke associated with its use in renal arteries at the time of Mrs. Horrillo’s 

procedure, did not violate any alleged duty to warn, and did not cause Mrs. 

Horrillo’s injury from either a medical or legal perspective.

Finally, we conclude that the jury instructions and verdict form together 

accurately instructed the jury on the applicable law, and were not misleading or 

confusing in any way. 

 2 “When measures are taken that would have made an earlier injury or harm less likely to occur, 

evidence of the subsequent measures is not admissible to prove: negligence; culpable conduct; a 

defect in a product or its design; or a need for a warning or instruction. But the court may admit this 

evidence for another purpose, such as impeachment or—if disputed—proving ownership, control, 

or the feasibility of precautionary measures.” FED. R. EVID. 407. 

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AFFIRMED.

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