USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 1 of 20
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`IN THE UNITED STATES COURT OF APPEALS
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`FOR THE ELEVENTH CIRCUIT
`________________________
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`No. 20-10900
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`D.C. Docket No. 1:18-cv-23643-UU
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`CHARLOTTE SALINERO,
`DR. EFRAIN SALINERO,
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` Plaintiffs - Appellants,
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`versus
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`JOHNSON & JOHNSON,
`ETHICON, INC.,
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` Defendants - Appellees.
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`________________________
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`Appeal from the United States District Court
`for the Southern District of Florida
`________________________
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`(April 29, 2021)
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`Before LAGOA, ANDERSON and MARCUS, Circuit Judges.
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`MARCUS, Circuit Judge:
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` [PUBLISH]
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`IN THE UNITED STATES COURT OF APPEALS
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`FOR THE ELEVENTH CIRCUIT
`________________________
`
`No. 20-10900
`________________________
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`D.C. Docket No. 1:18-cv-23643-UU
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`
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`CHARLOTTE SALINERO,
`DR. EFRAIN SALINERO,
`
` Plaintiffs - Appellants,
`
`versus
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`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.
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`MARCUS, Circuit Judge:
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 2 of 20
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`In 2012, Charlotte Salinero underwent surgery to address pelvic organ
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`prolapse. Her doctor, Jaime Sepulveda, implanted Artisyn Y-Mesh, a
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`polypropylene mesh designed and manufactured by Ethicon, Inc. But after
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`surgery, Mrs. Salinero suffered new health issues, which she attributed to the mesh
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`implant. She underwent surgery again to remove it and, with her husband, sued
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`Ethicon and its parent company, Johnson & Johnson, in the Southern District of
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`Florida for failure to warn of the adverse health consequences of an Artisyn Y-
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`Mesh implant (among other claims).
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`The defendants successfully moved for summary judgment, arguing that
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`Florida’s learned intermediary doctrine operates as a complete defense in this case,
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`breaking the chain of causation. The doctrine imposes on medical device
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`manufacturers a duty to adequately warn physicians, rather than patients, of the
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`risks their products pose. The Salineros claim, however, that the doctrine is
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`unavailable to these defendants because Dr. Sepulveda has a long-standing
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`financial relationship with both defendants and thus it was not reasonable for them
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`to expect him to adequately communicate the risks surrounding an Artisyn Y-Mesh
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`implant. The Salineros ask us to create a “financial bias” exception to the learned
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`intermediary doctrine, although the Florida courts have never recognized -- much
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`less discussed -- one.
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`2
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`As a federal court sitting in diversity, we are Erie bound to follow the
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`decisions of the Florida courts. Without any indication from Florida’s appellate
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`courts that they would create a “financial bias” exception to the learned
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`intermediary doctrine insofar as it applies to physicians, we hold that the learned
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`intermediary doctrine is available and that, under the facts of this case, it plainly
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`entitles the defendants to summary judgment on the failure-to-warn claim. Dr.
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`Sepulveda’s testimony makes it crystal clear that he was both aware of the risks
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`surrounding the Artisyn Y-Mesh implant and stood by his decision to use the
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`implant to treat Mrs. Salinero’s prolapse. Under Florida law, an inadequate
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`warning could not be the proximate cause of Mrs. Salinero’s injuries and,
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`therefore, the learned intermediary doctrine bars a failure-to-warn claim.
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`Accordingly, we affirm the judgment of the district court.
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`I.
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`A.
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`These are the essential facts surrounding this controversy. In 2012, at the
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`age of 56, Charlotte Salinero suffered from a persistent vaginal bulge and
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`constipation. A doctor referred her to Dr. Jaime Sepulveda, a board-certified
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`surgeon in gynecology, female pelvic medicine, and reconstructive surgery. Dr.
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`Sepulveda diagnosed Mrs. Salinero with pelvic organ prolapse, a potentially
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`debilitating condition where one or more of the pelvic organs -- such as the
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`3
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 4 of 20
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`bladder, rectum, or uterus -- shift downward into the vagina, and recommended
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`corrective surgery. Over the next few months, Mrs. Salinero’s condition worsened
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`into a Stage IV prolapse, the most severe form. Mrs. Salinero’s prolapse was so
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`advanced that, at times, her uterus extended outside her vaginal opening.
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`Mrs. Salinero elected to have surgery, which Dr. Sepulveda and a team of
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`surgeons performed in December 2012 at South Miami Hospital in Miami, Florida.
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`One of the surgeries performed was an abdominal sacrocolpopexy, during which
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`Dr. Sepulveda implanted Artisyn Y-Mesh. Artisyn Y-Mesh is a prescription
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`medical device made out of polypropylene mesh. It is designed and manufactured
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`by Ethicon, Inc., a wholly owned subsidiary of Johnson & Johnson. Artisyn Y-
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`Mesh works as a bridging material, which is implanted through the abdomen to
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`provide support to the pelvic organs. According to Dr. Sepulveda, approximately
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`half of the mesh implant dissolves into the body, while the other half stays in place
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`to provide support to the pelvic organs. Although Dr. Sepulveda discussed the
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`risks of the surgery with Mrs. Salinero, including the risks surrounding the use of a
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`mesh implant, he did not specifically recommend Artisyn Y-Mesh to her. Instead,
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`he unilaterally chose to use it as the implant in the surgery.
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`A few years after the sacrocolpopexy, Mrs. Salinero began suffering from
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`further health issues, including bleeding, pain, vaginal discharge, bowel
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`obstruction, urinary tract infection, and constipation. In April 2017, a doctor
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`4
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`diagnosed Mrs. Salinero with a rectovaginal vesical fistula -- or connection
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`between organs -- which Mrs. Salinero attributed to the Artisyn Y-Mesh implant.
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`Later that year, she underwent surgery to remove the implant, which was again
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`performed by Dr. Sepulveda and a team of surgeons. Dr. Sepulveda testified that
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`he separated the adhesion within Mrs. Salinero’s bladder and rectum, identified the
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`implant, disconnected, dissected, and lifted it out in one piece, but that there were
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`“two little segments underneath that [he] took later on.” Despite the removal, Mrs.
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`Salinero continued to suffer from permanent, debilitating health complications,
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`including fecal incontinence, small bowel obstructions, chronic pain, and
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`dyspareunia (pain during intercourse), which she alleges are due to the Artisyn Y-
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`Mesh.
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`B.
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`On September 6, 2018, the Salineros sued Ethicon and Johnson & Johnson
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`in the United States District Court for the Southern District of Florida. They
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`alleged that a polypropylene mesh is “biologically incompatible with human tissue
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`and promotes an immune response in a large subset of the population[,] . . .
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`[which] promotes degradation of the polypropylene mesh, as well as the pelvic
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`tissue, and can contribute to the formation of severe adverse reactions.” They also
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`lodged several product liability claims against the defendants, though only one --
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`5
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 6 of 20
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`failure to warn -- is relevant in this appeal.1 The Salineros claimed that at the time
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`of the surgery, the Artisyn Y-Mesh Instructions for Use (“IFU”) failed to properly
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`and adequately warn of the risks related to the implantation and use of the Artisyn
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`Y-Mesh and, therefore, the defendants were strictly liable for Mrs. Salinero’s
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`injuries.
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`In May 2019, the defendants moved for summary judgment. As for the
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`failure-to-warn claim, the defendants argued that under Florida law they only had a
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`duty to warn the physician -- in this case, Dr. Sepulveda -- rather than Mrs.
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`Salinero, and that they properly discharged their duty. In support, they cited to Dr.
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`Sepulveda’s deposition, in which he testified that he believed he was fully apprised
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`of the risks of implanting Artisyn Y-Mesh before Mrs. Salinero’s surgery. He
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`unambiguously said that he viewed his December 2012 decision to use Artisyn Y-
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`Mesh in Mrs. Salinero’s surgery as an appropriate one, even knowing exactly what
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`adverse effects she developed after the surgery. When asked whether he stood by
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`his decision to use Artisyn Y-Mesh with Mrs. Salinero, he responded, “[y]es.”
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`When asked whether he still believed that the surgery he performed in December
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`2012 was the “best option” for Mrs. Salinero, again he said “[y]es.” And when
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`asked if he thought “that the sacrocolpopexy with ArtisynTM Y-Mesh was a safe
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`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
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`that.” Dr. Sepulveda explained that Artisyn Y-Mesh remained his “preferred
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`implant” for similar surgeries and that he would use Artisyn Y-Mesh for an
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`implant at the next opportunity.
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`The Salineros opposed the motion, urging that Dr. Sepulveda was not an
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`“objective” practitioner and therefore his testimony should not be relied upon to
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`establish the learned intermediary defense. For support, they pointed to Dr.
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`Sepulveda’s long-running relationship with both Ethicon and Johnson & Johnson,
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`a relationship that goes back decades and has been very lucrative to Dr. Sepulveda.
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`The record shows that Dr. Sepulveda served as an expert witness for Ethicon in
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`over 20 cases and as a consultant on product evaluations, mesh product trials, and
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`training programs. Dr. Sepulveda also reviewed cases and performed consulting
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`work for Johnson & Johnson. He admitted to earning some $2 million from
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`Johnson & Johnson over the course of his career. He explained that he does this
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`work for the defendants “to continue training” and “to understand the anatomy
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`better and to keep [himself] in shape for all the surgeries.” There is no evidence
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`that Dr. Sepulveda performed any work for either Ethicon or Johnson & Johnson
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`specifically related to Artisyn Y-Mesh.
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`The Salineros argued that this uncontested evidence demonstrated that Dr.
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`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
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`there were triable issues of fact as to Dr. Sepulveda’s knowledge, the adequacy of
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`the IFU warnings, and whether Dr. Sepulveda actually would have prescribed
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`Artisyn Y-Mesh if he had received adequate warnings.
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`The district court acknowledged that Florida’s courts have not treated the
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`learned intermediary as a complete defense, noting that “a bright-line rule that
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`Florida’s learned intermediary doctrine always applies to bar failure-to-warn
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`claims in cases involving prescription medical devices” would be inappropriate.
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`However, the court predicted that the Florida Supreme Court would not recognize
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`a “financial bias” exception to the doctrine based solely on proof of some financial
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`relationship between the physician and the manufacturer, and, therefore, granted
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`summary judgment to the defendants on the failure-to-warn claim.
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`The case proceeded to trial on the remaining claims. The jury returned a
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`unanimous verdict for Ethicon.2 The Salineros filed a timely appeal, only raising
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`issues related to the failure-to-warn claim.3
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`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.
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` 3
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` 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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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 9 of 20
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`II.
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`“We review a district court’s grant of summary judgment de novo, viewing
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`the evidence and drawing all reasonable inferences in the light most favorable to
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`the nonmoving party.” Hubbard v. Bayer HealthCare Pharms. Inc., 983 F.3d 1223,
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`1232 (11th Cir. 2020). Summary judgment is appropriate only when “there is no
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`genuine dispute as to any material fact and the movant is entitled to judgment as a
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`matter of law.” FED R. CIV. P. 56(a). “Where the record taken as a whole could
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`not lead a rational trier of fact to find for the non-moving party, there is no genuine
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`issue for trial.” Tesoriero v. Carnival Corp., 965 F.3d 1170, 1177 (11th Cir. 2020)
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`(quotation marks and citation omitted).
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`A.
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`In this diversity action, Florida law applies to the Salineros’ failure-to-warn
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`claim. To succeed on a failure-to-warn claim, the “plaintiff must show (1) that the
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`product warning was inadequate; (2) that the inadequacy proximately caused her
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`injury; and (3) that she in fact suffered an injury from using the product.” Eghnayem
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`v. Bos. Sci. Corp., 873 F.3d 1304, 1321 (11th Cir. 2017) (citing Hoffmann-La Roche
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`Inc. v. Mason, 27 So.3d 75, 77 (Fla. 1st DCA 2009)).
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`reach the issue whether the district court abused its discretion in excluding Dr. Margolis’s
`testimony.
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`9
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 10 of 20
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`However, in cases involving medical products like Artisyn Y-Mesh, “the
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`duty of [a device] manufacturer to warn of dangers involved in [the] use of a
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`[device] is satisfied if [it] gives adequate warning to the physician who prescribes
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`[the device].” Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 823 (Fla. 5th
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`DCA 1981) (quotation omitted); see also Eghnayem, 873 F.3d at 1321. The
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`physician acts as a “learned intermediary” between the manufacturer and the
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`patient, “weighing the potential benefits of a device against the dangers in deciding
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`whether to recommend it to meet the patient’s needs.” Eghnayem, 873 F.3d at
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`1321. Thus, in order to satisfy the causation requirement in a medical device
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`failure-to-warn claim, “a plaintiff must show that her treating physician would not
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`have used the product had adequate warnings been provided.” Id.
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`The learned intermediary doctrine is a longstanding feature of Florida law,
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`first recognized by the Fifth District Court of Appeal in 1981. In Buckner v.
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`Allergan Pharmaceuticals, the court held that a “manufacturer of a dangerous
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`commodity, such as a drug, does have a duty to warn but when the commodity is a
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`prescription drug . . . this duty to warn is fulfilled by an adequate warning given to
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`those members of the medical community lawfully authorized to prescribe,
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`dispense and administer prescription drugs.” 400 So. 2d at 822. The court
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`emphasized that the physician acted as learned intermediary because of the
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`physician’s duty to “inform himself of the qualities and characteristics of those
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 11 of 20
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`products which he prescribes for or administers to or uses on his patients, and to
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`exercise an independent judgment, taking into account his knowledge of the patient
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`as well as the product.” Id. at 823 (quotation omitted).
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`The Florida Supreme Court first acknowledged the learned intermediary
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`doctrine in 1989, citing Buckner approvingly. Florida’s high court described the
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`doctrine -- and the special role of the physician as an intermediary between the
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`manufacturer and the patient -- this way:
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`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.
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`Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989). Thus, the
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`manufacturer’s adequate warning to a physician breaks the causal chain and
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`precludes a failure-to-warn claim.
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`The causal chain may still be broken even if the manufacturer provides an
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`inadequate warning so long as the physician is aware of the risks or would still
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`recommend the device despite those risks. In Hoffmann-La Roche Inc. v. Mason,
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`27 So. 3d at 77, the plaintiff argued that “the warning label was inadequate to warn
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`physicians that” Accutane, the prescription drug, could lead to the plaintiff
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`developing inflammatory bowel disease (“IBD”). But Florida’s First District Court
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`of Appeal explained that “the prescribing physician[] testified that he understood
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`11
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`the warning label to mean that there was at least a possibility of a causal
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`relationship between Accutane and IBD,” and that “he would still be willing to
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`prescribe Accutane to his patients even if there was evidence showing that it could
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`cause IBD in rare cases.” Id. In fact, the physician “also testified that even if the
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`warning label contained all of the information suggested by [the plaintiff]’s expert,
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`he would still have prescribed the medication” for the plaintiff. Id. The court
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`concluded that “any inadequacies in Accutane’s warning label could not have been
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`the proximate cause of [the plaintiff]’s injury because [the physician] understood
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`that there was a possibility that use of the drug could lead to [the plaintiff]
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`developing IBD and he made an informed decision to prescribe the drug for [the
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`plaintiff] despite this risk.” Id.
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`The Salineros allege that the defendants’ IFU was inadequate; however, Dr.
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`Sepulveda’s testimony shuts down that line of attack. As he clearly stated in his
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`deposition, an improved IFU would not have changed his choice of implant for the
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`surgery. When asked about the Artisyn Y-Mesh IFU, Dr. Sepulveda explained that
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`he did not rely on it as the primary source of information on the risks associated
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`with Artisyn Y-Mesh and that instead he relied primarily on other sources:
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`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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`12
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`A.
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`I rely on the published data, obviously on my training, my
`textbooks,
`journals, Cochrane
`reviews4
`.
`.
`. society
`recommendation[s], society opinions.
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`Dr. Sepulveda was also clear that an IFU containing more information on the risks
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`posed by Artisyn Y-Mesh would not have altered his decision to use the implant in
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`Mrs. Salinero’s surgery:
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`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?
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`A. No.
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`Furthermore, and perhaps most importantly, Dr. Sepulveda provided
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`explicit, uncontroverted testimony that he believed his decision to use Artisyn Y-
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`Mesh as the mesh implant for Mrs. Salinero’s surgery was correct. See, e.g.,
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`Hubbard, 983 F.3d at 1233 (holding that the learned intermediary doctrine applied
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`under Georgia law when the physician testified that he would have prescribed the
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`drug even with the improved label information); Small v. Amgen, Inc., 723 F.
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`App’x 722, 725 (11th Cir. 2018) (explaining that the learned intermediary doctrine
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`“typically” applies under Florida law when a physician “has actual knowledge of
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`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
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`action even with the information the plaintiff contends should have been
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`provided”) (quotation omitted). Dr. Sepulveda repeated that he stood by his
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`decision to use Artisyn Y-Mesh for Mrs. Salinero and still believed that the surgery
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`he performed in December 2012 was the “best option” for her. He also explained
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`that Artisyn Y-Mesh remained his “preferred implant” for similar surgeries.
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`Indeed, he said, that if he were “doing a sacrocolpopexy this afternoon,” he would
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`still use that implant. His testimony unequivocally establishes that he would have
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`used the Artisyn Y-Mesh implant for Mrs. Salinero’s sacrocolpopexy regardless of
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`the risks included in the Artisyn Y-Mesh IFU.
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`Just like in Mason, Dr. Sepulveda’s testimony reveals that any claimed
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`inadequacies in the Artisyn Y-Mesh IFU could not have been the proximate cause
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`of Mrs. Salinero’s injuries. 27 So. 3d at 77. The district court, therefore, properly
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`determined that the learned intermediary doctrine was a complete defense to the
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`failure-to-warn claim.
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`B.
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`Nevertheless, the Salineros argue that the learned intermediary doctrine is
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`unavailable here because of the uncontested evidence of a financial relationship
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`between Dr. Sepulveda and the defendants. They claim that there is a “financial
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`bias” exception to the learned intermediary doctrine “where, as here, financial ties
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`14
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`between the treating physician and the manufacturer defeat the assumption of
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`objectivity underlying the defense.”
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`The trouble with the argument is that no Florida court, as best we can tell,
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`has ever recognized, let alone adopted, a “financial bias” exception to the learned
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`intermediary doctrine with respect to prescription drugs or medical devices used by
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`a physician. Indeed, neither party has cited to any Florida case abandoning the
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`doctrine on account of a financial relationship between a physician and a
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`manufacturer of a medical device or a prescription drug. For us to create a wholly
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`new doctrine, virtually out of whole cloth, would work a profound change in
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`Florida’s law. Sitting in diversity, we are Erie bound to follow Florida’s courts as
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`they expound on tort law and nothing we can discern in Florida’s case law would
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`suggest, let alone enable us to predict, this is a path its courts are likely to go down.
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`For starters, the “financial bias” exception is not a legal term of art. Instead,
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`the Salineros use the name to refer to a handful of decisions in which federal courts
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`sitting outside of Florida and outside of this Circuit have declined to apply the
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`learned intermediary doctrine because there was some evidence suggesting a
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`physician was biased toward the drug or device manufacturer. The Salineros
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`primarily rely on In re: DePuy Orthopaedics, Inc., No. 3:11-MD-2244-K, 2016 WL
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`6268090, *6 (N.D. Tex. Jan. 5, 2016), In re Vioxx Prods. Liab. Litig., MDL No.
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`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
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`cases arose under Florida law and none of them suggest that Florida’s courts would
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`create, let alone apply, a “financial bias” exception to the learned intermediary
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`doctrine as applied to physicians.
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`Nor do these cases represent the prevailing approach taken by other courts in
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`other jurisdictions on this issue. In fact, as best we can tell, other federal courts
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`faced with the opportunity to apply some kind of a “financial bias” exception to a
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`physician have declined to do so absent some indication from a state court that
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`such an exception even exists. See, e.g., Calisi v. Abbott Lab’ys, No. CA 11-
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`10671-DJC, 2013 WL 5462274, at *3 (D. Mass. Feb. 25, 2013); DiBartolo v.
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`Abbott Lab’ys, 914 F. Supp. 2d 601, 616 (S.D.N.Y. 2012). Still other courts,
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`sitting in diversity jurisdiction, have refused to consider whether such an exception
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`would be appropriate under state law without proof of bias beyond evidence of
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`compensation. See, e.g., Talley v. Danek Med., Inc., 179 F.3d 154, 163–64 (4th
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`Cir. 1999); In re Trasylol Prods. Liab. Litig.-MDL-1928, No. 08-MD-01928, 2011
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`WL 2117257, at *4 (S.D. Fla. May 23, 2011); In re Zyprexa Prods. Liab. Litig.,
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`No. 04-MD-1596, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010); Miller v.
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`Pfizer Inc. (Roerig Div.), 196 F. Supp. 2d 1095, 1129 n.108 (D. Kan. 2002), aff’d
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`sub. nom. Miller v. Pfizer, Inc., 356 F.3d 1326 (10th Cir. 2004).
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`
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`16
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 17 of 20
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`Over almost four decades, Florida’s courts have applied the learned
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`intermediary doctrine to failure-to-warn cases involving physicians who administer
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`medical drugs and devices to their patients. The Salineros would have us create a
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`new rule largely based on the case of Aubin v. Union Carbide Corp., 177 So. 3d
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`489 (Fla. 2015), which dealt with a bulk asbestos supplier who sold asbestos to
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`intermediary manufacturers for use in construction products.
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`The problem with the citation to Aubin is that the case did not involve a
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`prescription drug or a medical device prescribed by a physician for a patient. In no
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`way did it implicate the physician-patient relationship, nor did the Florida Supreme
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`Court borrow from Florida’s medical learned intermediary cases in reaching its
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`decision. Instead, it drew its support from other decisions involving an asbestos
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`manufacturer-supplier and an intermediary-manufacturer. Id. at 514–16. Nothing
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`in the Aubin decision addresses or purports to overturn the analysis in Felix or the
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`decisions of Florida’s intermediate appellate courts opining on the quite different
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`circumstances surrounding physicians and their patients.
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`In Aubin, the supplier “specifically marketed its product to intermediary
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`manufacturers for use of the asbestos in products” and “was not involved in the
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`formulation, packaging, or sale of the end products.” Id. at 496. On appeal, the
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`Florida Supreme Court confirmed the availability of the learned intermediary
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`doctrine as a defense, but also noted that in this context the doctrine “is not a
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`17
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 18 of 20
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`complete defense,” looking to both the Second and Third Restatement of Torts. Id.
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`at 514–15. Under this approach, “the critical inquiry is whether the manufacturer
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`was reasonable in relying on the intermediary to fully warn the end user and
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`whether the manufacturer fully warned the intermediary of the dangers in its
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`product.” Id. at 515. It concluded that “a manufacturer may not be able to
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`reasonably rely on an intermediary to provide warnings if the manufacturer knows
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`that the necessary warnings would render the product less valuable and provide an
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`incentive to the intermediary to withhold the necessary information from the
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`consumer.” Id. The Salineros argue that Aubin generally “holds that an
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`intermediary’s financial bias can defeat the learned intermediary defense,” which is
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`consistent with the use of the “financial bias” exception in DePuy. But Aubin does
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`not go that far, and in any event, it arises in a sharply different context.
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`Until Florida’s appellate courts tell us otherwise, as we see it, a physician
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`who has significant education and training and understands the complexity of a
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`medical drug or device is in a profoundly different position than an intermediary
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`manufacturer of construction materials that include asbestos. In this case, and on
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`this record, we are satisfied that Dr. Sepulveda did just what is expected of
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`physicians. He used his individualized medical judgment to determine what
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`treatment to offer Mrs. Salinero. As he explained, polypropylene mesh was the
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`“current clinical standard” for the treatment of prolapse because it offered the best
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`
`
`18
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`
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 19 of 20
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`results when used in sacrocolpopexy. This was because of its durability, porosity,
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`and lower rate of revision compared to alternative implants and procedures. And
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`when Mrs. Salinero’s prolapse worsened, he concluded that “conservative
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`measures” would not be available to treat her problems; instead, a mesh implant
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`would be necessary as reinforcement.
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`To read Aubin as having overturned Florida’s extensive precedent and to
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`hold today that Florida law recognizes a “financial bias” exception in this context
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`would amount to a sea change in the state’s product liability law. It would upend
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`how Florida’s courts have considered failure-to-warn claims and the role of the
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`physician as a learned intermediary. Without some indication that Florida intends
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`to recognize so significant a change in the law, a federal court sitting in diversity
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`ought not to do so. See, e.g., Alexander Proudfoot Co. World Headquarters v.
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`Thayer, 877 F.2d 912, 916 (11th Cir. 1989) (explaining that a federal court sitting
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`in diversity must apply the law of the state so that “federal decisions mirror those
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`of a court in the forum state”); see also Nicolaci v. Anapol, 387 F.3d 21, 27 (1st
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`Cir. 2004) (“Federal courts sitting in diversity should be cautious about pushing
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`state law to new frontiers.”) (quotation omitted and alterations accepted);
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`Associated Int’l Ins. Co. v. Blythe, 286 F.3d 780, 783 (5th Cir. 2002) (“When
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`making an Erie-guess in the absence of explicit guidance from the state courts, we
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`must attempt to predict state law, not to create or modify it.”) (quotation omitted);
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`
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`19
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`USCA11 Case: 20-10900 Date Filed: 04/29/2021 Page: 20 of 20
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`Lexington Ins. Co. v. Rugg & Knopp, Inc., 165 F.3d 1087, 1092 (7th Cir. 1999)
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`(explaining that “a federal court sitting in diversity must proceed with caution in
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`making pronouncements about state law”). Until then, we are obliged to apply the
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`learned intermediary doctrine as it has been pronounced by the Florida Supreme
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`Court. In this case, the learned intermediary doctrine bars the failure-to-warn
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`claim.
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`We AFFIRM.
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`20
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