Johnson & Johnson and Ethicon, Inc. v. Linda Batiste
05-14-00864-CV
| Tex. App. | Nov 5, 2015Background
- Linda Batiste, with a complex medical history, received a transvaginal tape (TVT‑O) polypropylene mesh sling in January 2011 to treat stress urinary incontinence.
- After implantation she reported groin, pelvic, vaginal, and urethral pain; a small vaginal mesh erosion was removed in June 2012 and a portion of the sling was removed in September 2013.
- Batiste sued Johnson & Johnson and Ethicon for strict product liability (design and marketing defects); she nonsuited manufacturing and negligence claims; jury found a design defect and awarded $1.2 million.
- Defendants appealed, arguing the evidence was legally insufficient to show a specific defect in the TVT‑O was a producing cause of Batiste’s injuries (and raising evidentiary objections about excluded/ admitted materials).
- The court reviewed whether plaintiffs offered more than a scintilla of evidence linking identified alleged defects (mechanically cut mesh causing fraying/ curling/ roping, heavyweight small‑pore mesh, and polypropylene degradation/particle loss) to Batiste’s specific injuries.
- Holding: the Court of Appeals reversed and rendered judgment that Batiste take nothing, finding legally insufficient evidence that any alleged defect was a producing cause of her injuries.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation — whether a specific defect in the TVT‑O produced Batiste’s injuries | Batiste: she need only show the TVT‑O was defective and caused her injuries; experts tied known failure modes (fraying, particle loss, degradation, heavy/small‑pore mesh) to her symptoms | Defendants: plaintiff failed to prove a case‑specific causal link; evidence shows only that complications can arise from the device generally, not that an identified defect caused these injuries; experts did not exclude other plausible causes | Court: Reversed — evidence legally insufficient. Experts’ opinions were conclusory or failed to exclude alternative causes; no proof defects existed in vivo at relevant times or that degradation/particle loss reached clinically significant levels. |
| Evidentiary rulings (FDA/ association statements; other lawsuits/issue reports) | Batiste argued exclusion of FDA/position‑statement evidence and admission of other complaints was erroneous | Defendants challenged both evidentiary rulings on appeal | Court did not reach these issues after resolving insufficiency of causation; they were mooted by reversal and rendition. |
Key Cases Cited
- Exxon Corp. v. Emerald Oil & Gas Co., L.C., 348 S.W.3d 194 (Tex. 2011) (legal‑sufficiency standard when appellant did not bear burden)
- City of Keller v. Wilson, 168 S.W.3d 802 (Tex. 2005) (standard for reviewing legal‑sufficiency and crediting favorable evidence)
- BMC Software Belg., N.V. v. Marchand, 83 S.W.3d 789 (Tex. 2002) (more than a scintilla rule)
- Kia Motors Corp. v. Ruiz, 432 S.W.3d 865 (Tex. 2014) (expert must exclude other plausible causes presented by the evidence)
- Genie Indus., Inc. v. Matak, 462 S.W.3d 1 (Tex. 2015) (elements of design‑defect claim: defect, safer alternative, producing cause)
- E.I. DuPont Nemours & Co. v. Robinson, 923 S.W.2d 549 (Tex. 1995) (expert must carefully consider and exclude alternative causes)
- Burrow v. Arce, 997 S.W.2d 229 (Tex. 1999) (ipse dixit of an expert is insufficient)
- City of San Antonio v. Pollock, 284 S.W.3d 809 (Tex. 2009) (conclusory or unsubstantiated expert opinion is legally insufficient)
