Charlotte Salinero v. Johnson & Johnson, 995 F.3d 959

In 2012 Charlotte Salinero underwent sacrocolpopexy during which Dr. Jaime Sepulveda implanted Ethicon’s Artisyn Y‑Mesh; she later developed serious complications and had the mesh (largely) removed.
The Salineros sued Ethicon and Johnson & Johnson asserting multiple product‑liability claims, including strict liability for failure to warn based on an allegedly inadequate Instructions for Use (IFU).
Defendants moved for summary judgment invoking Florida’s learned intermediary doctrine, arguing their duty was to warn the physician (Dr. Sepulveda), not the patient.
Dr. Sepulveda testified he was aware of the risks, relied on medical literature and training (not primarily the IFU), and would have used Artisyn Y‑Mesh regardless of a more detailed IFU; he stood by his decision.
Plaintiffs argued a “financial bias” exception should bar the learned intermediary defense because Dr. Sepulveda had longstanding, lucrative consulting and expert relationships with Ethicon/J&J.
The district court granted summary judgment to defendants; the Eleventh Circuit affirmed, holding Florida law provides no recognized financial‑bias exception and Dr. Sepulveda’s testimony defeats proximate‑cause for the failure‑to‑warn claim.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether the learned intermediary doctrine bars the failure‑to‑warn claim	The doctrine should not apply because Dr. Sepulveda was financially biased and not an objective intermediary	Duty to warn was to the physician; defendants satisfied that duty and Dr. Sepulveda knew the risks and would have used the mesh anyway	Applied the learned intermediary doctrine; summary judgment for defendants because physician testimony negates causation
Whether a "financial bias" exception to the learned intermediary doctrine exists under Florida law	A physician’s financial relationship with a manufacturer can defeat the doctrine	Florida courts have not recognized such an exception; federal court may not create it under Erie	Refused to create a financial‑bias exception; no indication Florida appellate courts would adopt it
Whether any inadequacy in the IFU proximately caused Salinero’s injuries	IFU was inadequate and, but for inadequate warnings, Dr. Sepulveda would have chosen differently	Dr. Sepulveda testified an improved IFU would not have changed his clinical choice	Any IFU inadequacy could not be the proximate cause because physician would have acted the same
Whether exclusion of plaintiffs’ expert (Dr. Margolis) requires reversal	Exclusion undermines plaintiffs’ ability to prove IFU inadequacy	Expert was unqualified; district court excluded him	Court did not reach this issue because learned intermediary ruling disposed of the appeal

Buckner v. Allergan Pharms., Inc., 400 So. 2d 820 (Fla. 5th DCA 1981) (recognizing learned intermediary doctrine in prescription product cases)
Felix v. Hoffmann‑LaRoche, Inc., 540 So. 2d 102 (Fla. 1989) (Florida Supreme Court endorsing physician as learned intermediary)
Hoffmann‑La Roche Inc. v. Mason, 27 So. 3d 77 (Fla. 1st DCA 2009) (physician’s awareness and continued willingness to prescribe can defeat causation in failure‑to‑warn claims)
Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015) (addresses learned intermediary in supplier/intermediary context; does not displace medical‑use precedent)
Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304 (11th Cir. 2017) (elements for medical device failure‑to‑warn claims under Florida law)
Hubbard v. Bayer HealthCare Pharms. Inc., 983 F.3d 1223 (11th Cir. 2020) (summary judgment standard and application of learned intermediary principles)