Carlino, S. v. Ethicon, Inc.
208 A.3d 92
Pa. Super. Ct.2019Background
- Sharon Carlino underwent implantation of Ethicon’s TVT polypropylene mesh sling in 2005 for stress urinary incontinence; she experienced mesh exposures and pelvic pain with partial removals in 2007 and 2010 and recurrent, chronic pain beginning in 2012–2013.
- Carlino filed suit in Pennsylvania in June 2013 asserting claims for design defect and failure to warn; jury found for plaintiffs and awarded $3.5M compensatory and $10M punitive (judgment ≈ $13.5M).
- Ethicon challenged personal jurisdiction, statute of limitations (discovery rule), exclusion of FDA-related evidence (510(k) clearance and FDA publications), sanction-based exclusion of portions of surgeon Dr. Blechman’s cross-examination, necessity of a safer-alternative instruction, remittitur of compensatory damages, and sufficiency of punitive damages.
- Trial evidence included expert testimony alleging TVT’s high long-term risk (mesh weight, small pore size, degradation, particle loss, pore collapse), Ethicon’s internal knowledge and understatement of risks in Instructions for Use, and testimony that alternative meshes or manufacturing methods were available.
- Trial court denied Ethicon’s JNOV/remittitur motions; this appeal affirms the judgment in all respects.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction | Pennsylvania had specific jurisdiction based on Ethicon’s role in producing TVT mesh (including activities in PA) | Ethicon argued it was NJ-based with no contacts giving rise to claims in PA | Jurisdiction upheld (court relied on facts like Secant Medical production role and precedent Hammons) |
| Statute of limitations / discovery rule | Carlino: she did not know and should not reasonably have known TVT caused her injuries prior to June 26, 2011 | Ethicon: prior exposures (2007, 2010), surgeries, and physician notes put Carlino on notice before cutoff | Jury verdict on discovery-date sustained; conflicting evidence made issue one for jury (Nicolaou, Hammons relied on) |
| Exclusion of FDA 510(k) and FDA publications | Carlino argued 510(k) and general FDA statements were inadmissible/misleading | Ethicon sought admission to show regulatory approval and safety | Exclusion affirmed: 510(k) focuses on equivalence not safety and is not FDA "approval/prescription" under NJ PLA; 2013 FDA publication too vague on long-term risk and risked juror confusion (Bard, Huskey cited) |
| Blechman deposition sanction | Carlino: defendant violated pretrial order re FDA evidence and misled witness; sanction needed | Ethicon: sanction overbroad; excluded material testimony relevant to notice and causation | Sanction affirmed as non-prejudicial error; some exclusion arguably overbroad but harmless because similar testimony was admitted elsewhere |
| Design-defect instruction / safer alternative | Carlino: risk-utility analysis need not always force a mandated alternative when risks outweigh utility | Ethicon: jury must be instructed that a feasible safer alternative is required | Instruction upheld under NJ law (Smith framework); existence of feasible alternatives was properly presented as part of risk-utility analysis |
| Remittitur of compensatory damages | Carlino: award appropriate given chronic, lifelong pain and loss of sexual function | Ethicon: $3.5M excessive | Remittitur denied; trial court’s award not shocking or a clear abuse given permanent injuries and life expectancy; Pennsylvania remittitur standards applied |
| Punitive damages sufficiency | Carlino: evidence shows wanton/willful disregard warranting punitive damages | Ethicon: punitive improper because of FDA clearance/publications and insufficient culpability | Punitive damages sustained: evidence supports clear and convincing standard—Ethicon’s knowledge and alleged concealment/misleading warnings permitted punitive award |
Key Cases Cited
- Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018) (jurisdiction and fact-sensitivity of statute-of-limitations/discovery-rule issues)
- Nicolaou v. Martin, 195 A.3d 880 (Pa. 2018) (discovery rule is fact-intensive; jury determination appropriate when reasonable diligence in dispute)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (overview of Medical Device Amendments and premarket approval vs 510(k))
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (federal regulatory framework and preemption context)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (§510(k) focuses on equivalence, not safety)
- In re C.R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (admitting or excluding 510(k) evidence; limited probative value and risk of juror confusion)
- Huskey v. Ethicon, Inc., 848 F.3d 151 (4th Cir. 2017) (district court within discretion to exclude 510(k) evidence due to marginal relevance and risk of mini-trial)
- Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (standards for jury instructions and appellate review)
- Wilson v. El‑Daief, 964 A.2d 354 (Pa. 2009) (discovery rule standards for accrual)
- Fine v. Checcio, 870 A.2d 850 (Pa. 2005) (accrual of cause of action and limitations principles)