Court Opinion

ID: 4682357
Source: CourtListenerOpinion
Date Created: 2021-04-29 16:00:40.85511+00
Date Added: 2024-06-11T08:04:07.666050
License: Public Domain

USCA11 Case: 20-10900   Date Filed: 04/29/2021      Page: 1 of 20

                                                                        [PUBLISH]

              IN THE UNITED STATES COURT OF APPEALS

                      FOR THE ELEVENTH CIRCUIT
                        ________________________

                               No. 20-10900
                         ________________________

                     D.C. Docket No. 1:18-cv-23643-UU

CHARLOTTE SALINERO,
DR. EFRAIN SALINERO,

                                                  Plaintiffs - Appellants,

versus

JOHNSON & JOHNSON,
ETHICON, INC.,

                                                  Defendants - Appellees.

                         ________________________

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

                               (April 29, 2021)

Before LAGOA, ANDERSON and MARCUS, Circuit Judges.

MARCUS, Circuit Judge:
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      In 2012, Charlotte Salinero underwent surgery to address pelvic organ

prolapse. Her doctor, Jaime Sepulveda, implanted Artisyn Y-Mesh, a

polypropylene mesh designed and manufactured by Ethicon, Inc. But after

surgery, Mrs. Salinero suffered new health issues, which she attributed to the mesh

implant. She underwent surgery again to remove it and, with her husband, sued

Ethicon and its parent company, Johnson & Johnson, in the Southern District of

Florida for failure to warn of the adverse health consequences of an Artisyn Y-

Mesh implant (among other claims).

      The defendants successfully moved for summary judgment, arguing that

Florida’s learned intermediary doctrine operates as a complete defense in this case,

breaking the chain of causation. The doctrine imposes on medical device

manufacturers a duty to adequately warn physicians, rather than patients, of the

risks their products pose. The Salineros claim, however, that the doctrine is

unavailable to these defendants because Dr. Sepulveda has a long-standing

financial relationship with both defendants and thus it was not reasonable for them

to expect him to adequately communicate the risks surrounding an Artisyn Y-Mesh

implant. The Salineros ask us to create a “financial bias” exception to the learned

intermediary doctrine, although the Florida courts have never recognized -- much

less discussed -- one.

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      As a federal court sitting in diversity, we are Erie bound to follow the

decisions of the Florida courts. Without any indication from Florida’s appellate

courts that they would create a “financial bias” exception to the learned

intermediary doctrine insofar as it applies to physicians, we hold that the learned

intermediary doctrine is available and that, under the facts of this case, it plainly

entitles the defendants to summary judgment on the failure-to-warn claim. Dr.

Sepulveda’s testimony makes it crystal clear that he was both aware of the risks

surrounding the Artisyn Y-Mesh implant and stood by his decision to use the

implant to treat Mrs. Salinero’s prolapse. Under Florida law, an inadequate

warning could not be the proximate cause of Mrs. Salinero’s injuries and,

therefore, the learned intermediary doctrine bars a failure-to-warn claim.

Accordingly, we affirm the judgment of the district court.

                                           I.

                                          A.

      These are the essential facts surrounding this controversy. In 2012, at the

age of 56, Charlotte Salinero suffered from a persistent vaginal bulge and

constipation. A doctor referred her to Dr. Jaime Sepulveda, a board-certified

surgeon in gynecology, female pelvic medicine, and reconstructive surgery. Dr.

Sepulveda diagnosed Mrs. Salinero with pelvic organ prolapse, a potentially

debilitating condition where one or more of the pelvic organs -- such as the

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bladder, rectum, or uterus -- shift downward into the vagina, and recommended

corrective surgery. Over the next few months, Mrs. Salinero’s condition worsened

into a Stage IV prolapse, the most severe form. Mrs. Salinero’s prolapse was so

advanced that, at times, her uterus extended outside her vaginal opening.

      Mrs. Salinero elected to have surgery, which Dr. Sepulveda and a team of

surgeons performed in December 2012 at South Miami Hospital in Miami, Florida.

One of the surgeries performed was an abdominal sacrocolpopexy, during which

Dr. Sepulveda implanted Artisyn Y-Mesh. Artisyn Y-Mesh is a prescription

medical device made out of polypropylene mesh. It is designed and manufactured

by Ethicon, Inc., a wholly owned subsidiary of Johnson & Johnson. Artisyn Y-

Mesh works as a bridging material, which is implanted through the abdomen to

provide support to the pelvic organs. According to Dr. Sepulveda, approximately

half of the mesh implant dissolves into the body, while the other half stays in place

to provide support to the pelvic organs. Although Dr. Sepulveda discussed the

risks of the surgery with Mrs. Salinero, including the risks surrounding the use of a

mesh implant, he did not specifically recommend Artisyn Y-Mesh to her. Instead,

he unilaterally chose to use it as the implant in the surgery.

      A few years after the sacrocolpopexy, Mrs. Salinero began suffering from

further health issues, including bleeding, pain, vaginal discharge, bowel

obstruction, urinary tract infection, and constipation. In April 2017, a doctor

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diagnosed Mrs. Salinero with a rectovaginal vesical fistula -- or connection

between organs -- which Mrs. Salinero attributed to the Artisyn Y-Mesh implant.

Later that year, she underwent surgery to remove the implant, which was again

performed by Dr. Sepulveda and a team of surgeons. Dr. Sepulveda testified that

he separated the adhesion within Mrs. Salinero’s bladder and rectum, identified the

implant, disconnected, dissected, and lifted it out in one piece, but that there were

“two little segments underneath that [he] took later on.” Despite the removal, Mrs.

Salinero continued to suffer from permanent, debilitating health complications,

including fecal incontinence, small bowel obstructions, chronic pain, and

dyspareunia (pain during intercourse), which she alleges are due to the Artisyn Y-

Mesh.

                                          B.

        On September 6, 2018, the Salineros sued Ethicon and Johnson & Johnson

in the United States District Court for the Southern District of Florida. They

alleged that a polypropylene mesh is “biologically incompatible with human tissue

and promotes an immune response in a large subset of the population[,] . . .

[which] promotes degradation of the polypropylene mesh, as well as the pelvic

tissue, and can contribute to the formation of severe adverse reactions.” They also

lodged several product liability claims against the defendants, though only one --

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failure to warn -- is relevant in this appeal. 1 The Salineros claimed that at the time

of the surgery, the Artisyn Y-Mesh Instructions for Use (“IFU”) failed to properly

and adequately warn of the risks related to the implantation and use of the Artisyn

Y-Mesh and, therefore, the defendants were strictly liable for Mrs. Salinero’s

injuries.

       In May 2019, the defendants moved for summary judgment. As for the

failure-to-warn claim, the defendants argued that under Florida law they only had a

duty to warn the physician -- in this case, Dr. Sepulveda -- rather than Mrs.

Salinero, and that they properly discharged their duty. In support, they cited to Dr.

Sepulveda’s deposition, in which he testified that he believed he was fully apprised

of the risks of implanting Artisyn Y-Mesh before Mrs. Salinero’s surgery. He

unambiguously said that he viewed his December 2012 decision to use Artisyn Y-

Mesh in Mrs. Salinero’s surgery as an appropriate one, even knowing exactly what

adverse effects she developed after the surgery. When asked whether he stood by

his decision to use Artisyn Y-Mesh with Mrs. Salinero, he responded, “[y]es.”

When asked whether he still believed that the surgery he performed in December

2012 was the “best option” for Mrs. Salinero, again he said “[y]es.” And when

asked if he thought “that the sacrocolpopexy with ArtisynTM Y-Mesh was a safe

1
  The Salineros brought nine claims in all: negligence, manufacturing defect, design defect,
failure to warn, false information negligently supplied for the guidance of others, negligent
infliction of emotional distress, gross negligence, loss of consortium, and punitive damages.
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and effective surgery for Mrs. Salinero,” he again responded, “[y]es, I believe

that.” Dr. Sepulveda explained that Artisyn Y-Mesh remained his “preferred

implant” for similar surgeries and that he would use Artisyn Y-Mesh for an

implant at the next opportunity.

      The Salineros opposed the motion, urging that Dr. Sepulveda was not an

“objective” practitioner and therefore his testimony should not be relied upon to

establish the learned intermediary defense. For support, they pointed to Dr.

Sepulveda’s long-running relationship with both Ethicon and Johnson & Johnson,

a relationship that goes back decades and has been very lucrative to Dr. Sepulveda.

The record shows that Dr. Sepulveda served as an expert witness for Ethicon in

over 20 cases and as a consultant on product evaluations, mesh product trials, and

training programs. Dr. Sepulveda also reviewed cases and performed consulting

work for Johnson & Johnson. He admitted to earning some $2 million from

Johnson & Johnson over the course of his career. He explained that he does this

work for the defendants “to continue training” and “to understand the anatomy

better and to keep [himself] in shape for all the surgeries.” There is no evidence

that Dr. Sepulveda performed any work for either Ethicon or Johnson & Johnson

specifically related to Artisyn Y-Mesh.

      The Salineros argued that this uncontested evidence demonstrated that Dr.

Sepulveda was biased toward the defendants, therefore barring the application of

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the learned intermediary doctrine as an affirmative defense. They also claimed that

there were triable issues of fact as to Dr. Sepulveda’s knowledge, the adequacy of

the IFU warnings, and whether Dr. Sepulveda actually would have prescribed

Artisyn Y-Mesh if he had received adequate warnings.

       The district court acknowledged that Florida’s courts have not treated the

learned intermediary as a complete defense, noting that “a bright-line rule that

Florida’s learned intermediary doctrine always applies to bar failure-to-warn

claims in cases involving prescription medical devices” would be inappropriate.

However, the court predicted that the Florida Supreme Court would not recognize

a “financial bias” exception to the doctrine based solely on proof of some financial

relationship between the physician and the manufacturer, and, therefore, granted

summary judgment to the defendants on the failure-to-warn claim.

       The case proceeded to trial on the remaining claims. The jury returned a

unanimous verdict for Ethicon.2 The Salineros filed a timely appeal, only raising

issues related to the failure-to-warn claim.3

2
 The district court dismissed Johnson & Johnson as a defendant after the company stipulated it
was not involved in the design or manufacture of Artisyn Y-Mesh.

3
 The Salineros also appeal a decision by the district court excluding their medical expert, Dr.
Michael Margolis, on the grounds that he was not qualified to testify about the adequacy of the
Artisyn Y-Mesh IFU. Without this testimony, the district court held, as an alternative ground for
summary judgment, that the plaintiffs could not meet their burden of establishing that the
defendants’ warnings were inadequate. Because we hold that the defendants were entitled to
summary judgment as a matter of law based on the learned intermediary doctrine, we do not
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                                                II.

       “We review a district court’s grant of summary judgment de novo, viewing

the evidence and drawing all reasonable inferences in the light most favorable to

the nonmoving party.” Hubbard v. Bayer HealthCare Pharms. Inc., 983 F.3d 1223,

1232 (11th Cir. 2020). Summary judgment is appropriate only when “there is no

genuine dispute as to any material fact and the movant is entitled to judgment as a

matter of law.” FED R. CIV. P. 56(a). “Where the record taken as a whole could

not lead a rational trier of fact to find for the non-moving party, there is no genuine

issue for trial.” Tesoriero v. Carnival Corp., 965 F.3d 1170, 1177 (11th Cir. 2020)

(quotation marks and citation omitted).

                                                A.

       In this diversity action, Florida law applies to the Salineros’ failure-to-warn

claim. To succeed on a failure-to-warn claim, the “plaintiff must show (1) that the

product warning was inadequate; (2) that the inadequacy proximately caused her

injury; and (3) that she in fact suffered an injury from using the product.” Eghnayem

v. Bos. Sci. Corp., 873 F.3d 1304, 1321 (11th Cir. 2017) (citing Hoffmann-La Roche

Inc. v. Mason, 27 So.3d 75, 77 (Fla. 1st DCA 2009)).

reach the issue whether the district court abused its discretion in excluding Dr. Margolis’s
testimony.
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      However, in cases involving medical products like Artisyn Y-Mesh, “the

duty of [a device] manufacturer to warn of dangers involved in [the] use of a

[device] is satisfied if [it] gives adequate warning to the physician who prescribes

[the device].” Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 823 (Fla. 5th

DCA 1981) (quotation omitted); see also Eghnayem, 873 F.3d at 1321. The

physician acts as a “learned intermediary” between the manufacturer and the

patient, “weighing the potential benefits of a device against the dangers in deciding

whether to recommend it to meet the patient’s needs.” Eghnayem, 873 F.3d at

1321. Thus, in order to satisfy the causation requirement in a medical device

failure-to-warn claim, “a plaintiff must show that her treating physician would not

have used the product had adequate warnings been provided.” Id.

      The learned intermediary doctrine is a longstanding feature of Florida law,

first recognized by the Fifth District Court of Appeal in 1981. In Buckner v.

Allergan Pharmaceuticals, the court held that a “manufacturer of a dangerous

commodity, such as a drug, does have a duty to warn but when the commodity is a

prescription drug . . . this duty to warn is fulfilled by an adequate warning given to

those members of the medical community lawfully authorized to prescribe,

dispense and administer prescription drugs.” 400 So. 2d at 822. The court

emphasized that the physician acted as learned intermediary because of the

physician’s duty to “inform himself of the qualities and characteristics of those

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products which he prescribes for or administers to or uses on his patients, and to

exercise an independent judgment, taking into account his knowledge of the patient

as well as the product.” Id. at 823 (quotation omitted).

      The Florida Supreme Court first acknowledged the learned intermediary

doctrine in 1989, citing Buckner approvingly. Florida’s high court described the

doctrine -- and the special role of the physician as an intermediary between the

manufacturer and the patient -- this way:

      At the outset, it is clear that the manufacturer’s duty to warn of [a
      prescription drug]’s dangerous side effects was directed to the
      physician rather than the patient. This is so because the prescribing
      physician, acting as a “learned intermediary” between the manufacturer
      and the consumer, weighs the potential benefits against the dangers in
      deciding whether to recommend the drug to meet the patient’s needs.

Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989). Thus, the

manufacturer’s adequate warning to a physician breaks the causal chain and

precludes a failure-to-warn claim.

      The causal chain may still be broken even if the manufacturer provides an

inadequate warning so long as the physician is aware of the risks or would still

recommend the device despite those risks. In Hoffmann-La Roche Inc. v. Mason,

27 So. 3d at 77, the plaintiff argued that “the warning label was inadequate to warn

physicians that” Accutane, the prescription drug, could lead to the plaintiff

developing inflammatory bowel disease (“IBD”). But Florida’s First District Court

of Appeal explained that “the prescribing physician[] testified that he understood
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the warning label to mean that there was at least a possibility of a causal

relationship between Accutane and IBD,” and that “he would still be willing to

prescribe Accutane to his patients even if there was evidence showing that it could

cause IBD in rare cases.” Id. In fact, the physician “also testified that even if the

warning label contained all of the information suggested by [the plaintiff]’s expert,

he would still have prescribed the medication” for the plaintiff. Id. The court

concluded that “any inadequacies in Accutane’s warning label could not have been

the proximate cause of [the plaintiff]’s injury because [the physician] understood

that there was a possibility that use of the drug could lead to [the plaintiff]

developing IBD and he made an informed decision to prescribe the drug for [the

plaintiff] despite this risk.” Id.

       The Salineros allege that the defendants’ IFU was inadequate; however, Dr.

Sepulveda’s testimony shuts down that line of attack. As he clearly stated in his

deposition, an improved IFU would not have changed his choice of implant for the

surgery. When asked about the Artisyn Y-Mesh IFU, Dr. Sepulveda explained that

he did not rely on it as the primary source of information on the risks associated

with Artisyn Y-Mesh and that instead he relied primarily on other sources:

       Q.      When you decide what type of surgery to do to treat a particular
               patient’s prolapse, what sources of information do you rely on?

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       A.      I rely on the published data, obviously on my training, my
               textbooks, journals, Cochrane reviews 4 . . . society
               recommendation[s], society opinions.

Dr. Sepulveda was also clear that an IFU containing more information on the risks

posed by Artisyn Y-Mesh would not have altered his decision to use the implant in

Mrs. Salinero’s surgery:

       Q.      And we discussed other -- or the potential risks that you were
               aware of back in December 2012. And if the ArtisynTM IFU
               would have specifically, you know, included the risks that you
               were aware of from your review of the literature and other
               materials, including your experience, would that have changed
               your decision to use ArtisynTM Y-Mesh with Mrs. Salinero?

       A.      No.

       Furthermore, and perhaps most importantly, Dr. Sepulveda provided

explicit, uncontroverted testimony that he believed his decision to use Artisyn Y-

Mesh as the mesh implant for Mrs. Salinero’s surgery was correct. See, e.g.,

Hubbard, 983 F.3d at 1233 (holding that the learned intermediary doctrine applied

under Georgia law when the physician testified that he would have prescribed the

drug even with the improved label information); Small v. Amgen, Inc., 723 F.

App’x 722, 725 (11th Cir. 2018) (explaining that the learned intermediary doctrine

“typically” applies under Florida law when a physician “has actual knowledge of

4
 Dr. Sepulveda explained that a Cochrane review is “a scientific collaboration that examines the
efficacy and the safety complications of the different procedures that [physicians] have.”
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the substance of the alleged warning and would have taken the same course of

action even with the information the plaintiff contends should have been

provided”) (quotation omitted). Dr. Sepulveda repeated that he stood by his

decision to use Artisyn Y-Mesh for Mrs. Salinero and still believed that the surgery

he performed in December 2012 was the “best option” for her. He also explained

that Artisyn Y-Mesh remained his “preferred implant” for similar surgeries.

Indeed, he said, that if he were “doing a sacrocolpopexy this afternoon,” he would

still use that implant. His testimony unequivocally establishes that he would have

used the Artisyn Y-Mesh implant for Mrs. Salinero’s sacrocolpopexy regardless of

the risks included in the Artisyn Y-Mesh IFU.

      Just like in Mason, Dr. Sepulveda’s testimony reveals that any claimed

inadequacies in the Artisyn Y-Mesh IFU could not have been the proximate cause

of Mrs. Salinero’s injuries. 27 So. 3d at 77. The district court, therefore, properly

determined that the learned intermediary doctrine was a complete defense to the

failure-to-warn claim.

                                         B.

      Nevertheless, the Salineros argue that the learned intermediary doctrine is

unavailable here because of the uncontested evidence of a financial relationship

between Dr. Sepulveda and the defendants. They claim that there is a “financial

bias” exception to the learned intermediary doctrine “where, as here, financial ties

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between the treating physician and the manufacturer defeat the assumption of

objectivity underlying the defense.”

      The trouble with the argument is that no Florida court, as best we can tell,

has ever recognized, let alone adopted, a “financial bias” exception to the learned

intermediary doctrine with respect to prescription drugs or medical devices used by

a physician. Indeed, neither party has cited to any Florida case abandoning the

doctrine on account of a financial relationship between a physician and a

manufacturer of a medical device or a prescription drug. For us to create a wholly

new doctrine, virtually out of whole cloth, would work a profound change in

Florida’s law. Sitting in diversity, we are Erie bound to follow Florida’s courts as

they expound on tort law and nothing we can discern in Florida’s case law would

suggest, let alone enable us to predict, this is a path its courts are likely to go down.

      For starters, the “financial bias” exception is not a legal term of art. Instead,

the Salineros use the name to refer to a handful of decisions in which federal courts

sitting outside of Florida and outside of this Circuit have declined to apply the

learned intermediary doctrine because there was some evidence suggesting a

physician was biased toward the drug or device manufacturer. The Salineros

primarily rely on In re: DePuy Orthopaedics, Inc., No. 3:11-MD-2244-K, 2016 WL

6268090, *6 (N.D. Tex. Jan. 5, 2016), In re Vioxx Prods. Liab. Litig., MDL No.

1657, 2015 WL 1909859, at *9 (E.D. La. Apr. 21, 2015), and Murthy v. Abbott

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Lab’ys, 847 F. Supp. 2d 958, 964, 971–73 (S.D. Tex. 2012). But none of these

cases arose under Florida law and none of them suggest that Florida’s courts would

create, let alone apply, a “financial bias” exception to the learned intermediary

doctrine as applied to physicians.

      Nor do these cases represent the prevailing approach taken by other courts in

other jurisdictions on this issue. In fact, as best we can tell, other federal courts

faced with the opportunity to apply some kind of a “financial bias” exception to a

physician have declined to do so absent some indication from a state court that

such an exception even exists. See, e.g., Calisi v. Abbott Lab’ys, No. CA 11-

10671-DJC, 2013 WL 5462274, at *3 (D. Mass. Feb. 25, 2013); DiBartolo v.

Abbott Lab’ys, 914 F. Supp. 2d 601, 616 (S.D.N.Y. 2012). Still other courts,

sitting in diversity jurisdiction, have refused to consider whether such an exception

would be appropriate under state law without proof of bias beyond evidence of

compensation. See, e.g., Talley v. Danek Med., Inc., 179 F.3d 154, 163–64 (4th

Cir. 1999); In re Trasylol Prods. Liab. Litig.-MDL-1928, No. 08-MD-01928, 2011

WL 2117257, at *4 (S.D. Fla. May 23, 2011); In re Zyprexa Prods. Liab. Litig.,

No. 04-MD-1596, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010); Miller v.

Pfizer Inc. (Roerig Div.), 196 F. Supp. 2d 1095, 1129 n.108 (D. Kan. 2002), aff’d

sub. nom. Miller v. Pfizer, Inc., 356 F.3d 1326 (10th Cir. 2004).

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      Over almost four decades, Florida’s courts have applied the learned

intermediary doctrine to failure-to-warn cases involving physicians who administer

medical drugs and devices to their patients. The Salineros would have us create a

new rule largely based on the case of Aubin v. Union Carbide Corp., 177 So. 3d

489 (Fla. 2015), which dealt with a bulk asbestos supplier who sold asbestos to

intermediary manufacturers for use in construction products.

      The problem with the citation to Aubin is that the case did not involve a

prescription drug or a medical device prescribed by a physician for a patient. In no

way did it implicate the physician-patient relationship, nor did the Florida Supreme

Court borrow from Florida’s medical learned intermediary cases in reaching its

decision. Instead, it drew its support from other decisions involving an asbestos

manufacturer-supplier and an intermediary-manufacturer. Id. at 514–16. Nothing

in the Aubin decision addresses or purports to overturn the analysis in Felix or the

decisions of Florida’s intermediate appellate courts opining on the quite different

circumstances surrounding physicians and their patients.

      In Aubin, the supplier “specifically marketed its product to intermediary

manufacturers for use of the asbestos in products” and “was not involved in the

formulation, packaging, or sale of the end products.” Id. at 496. On appeal, the

Florida Supreme Court confirmed the availability of the learned intermediary

doctrine as a defense, but also noted that in this context the doctrine “is not a

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complete defense,” looking to both the Second and Third Restatement of Torts. Id.

at 514–15. Under this approach, “the critical inquiry is whether the manufacturer

was reasonable in relying on the intermediary to fully warn the end user and

whether the manufacturer fully warned the intermediary of the dangers in its

product.” Id. at 515. It concluded that “a manufacturer may not be able to

reasonably rely on an intermediary to provide warnings if the manufacturer knows

that the necessary warnings would render the product less valuable and provide an

incentive to the intermediary to withhold the necessary information from the

consumer.” Id. The Salineros argue that Aubin generally “holds that an

intermediary’s financial bias can defeat the learned intermediary defense,” which is

consistent with the use of the “financial bias” exception in DePuy. But Aubin does

not go that far, and in any event, it arises in a sharply different context.

      Until Florida’s appellate courts tell us otherwise, as we see it, a physician

who has significant education and training and understands the complexity of a

medical drug or device is in a profoundly different position than an intermediary

manufacturer of construction materials that include asbestos. In this case, and on

this record, we are satisfied that Dr. Sepulveda did just what is expected of

physicians. He used his individualized medical judgment to determine what

treatment to offer Mrs. Salinero. As he explained, polypropylene mesh was the

“current clinical standard” for the treatment of prolapse because it offered the best

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results when used in sacrocolpopexy. This was because of its durability, porosity,

and lower rate of revision compared to alternative implants and procedures. And

when Mrs. Salinero’s prolapse worsened, he concluded that “conservative

measures” would not be available to treat her problems; instead, a mesh implant

would be necessary as reinforcement.

      To read Aubin as having overturned Florida’s extensive precedent and to

hold today that Florida law recognizes a “financial bias” exception in this context

would amount to a sea change in the state’s product liability law. It would upend

how Florida’s courts have considered failure-to-warn claims and the role of the

physician as a learned intermediary. Without some indication that Florida intends

to recognize so significant a change in the law, a federal court sitting in diversity

ought not to do so. See, e.g., Alexander Proudfoot Co. World Headquarters v.

Thayer, 877 F.2d 912, 916 (11th Cir. 1989) (explaining that a federal court sitting

in diversity must apply the law of the state so that “federal decisions mirror those

of a court in the forum state”); see also Nicolaci v. Anapol, 387 F.3d 21, 27 (1st

Cir. 2004) (“Federal courts sitting in diversity should be cautious about pushing

state law to new frontiers.”) (quotation omitted and alterations accepted);

Associated Int’l Ins. Co. v. Blythe, 286 F.3d 780, 783 (5th Cir. 2002) (“When

making an Erie-guess in the absence of explicit guidance from the state courts, we

must attempt to predict state law, not to create or modify it.”) (quotation omitted);

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Lexington Ins. Co. v. Rugg & Knopp, Inc., 165 F.3d 1087, 1092 (7th Cir. 1999)

(explaining that “a federal court sitting in diversity must proceed with caution in

making pronouncements about state law”). Until then, we are obliged to apply the

learned intermediary doctrine as it has been pronounced by the Florida Supreme

Court. In this case, the learned intermediary doctrine bars the failure-to-warn

claim.

         We AFFIRM.

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