Jo Huskey v. Ethicon, Inc.
848 F.3d 151
4th Cir.2017Background
- Mrs. Huskey received an Ethicon TVT-O mid-urethral sling (polypropylene heavyweight mesh) in Feb. 2011 to treat stress urinary incontinence; mesh eroded, caused infection, severe chronic pelvic pain, and required partial excision.
- Huskeys sued Ethicon in MDL No. 2327 under Illinois law for strict liability and negligence (design defect and failure to warn) and Mr. Huskey sued for loss of consortium; punitive damages sought but later dismissed for punitive claim.
- After a nine-day trial the jury returned a general verdict for the Huskeys on design defect, failure to warn, and loss of consortium, awarding Mrs. Huskey $3.07M and Mr. Huskey $200,000.
- Ethicon renewed post-trial motions for judgment as a matter of law (JMOL) and for a new trial, arguing (1) plaintiffs failed to prove a specific design defect and (2) Comment k (unavoidably unsafe products) shields Ethicon; it also challenged exclusion of FDA-related evidence.
- The district court denied Ethicon’s motions; the Fourth Circuit affirmed, finding sufficient expert evidence that Ethicon’s use of heavyweight polypropylene mesh rendered the TVT-O unreasonably dangerous and that Comment k did not necessarily apply.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Sufficiency of evidence on design defect | Huskeys: expert testimony showed heavyweight polypropylene mesh produced an adverse foreign-body response and scarring that caused Mrs. Huskey’s injuries | Ethicon: plaintiffs only showed general implantation complications, not a specific design defect causally linked to injury | Held: Sufficient evidence — experts linked quantity/weight of mesh to inflammatory response and pain; jury verdict stands |
| Applicability of Comment k (unavoidably unsafe products) | Huskeys: TVT-O was not unavoidably unsafe; experts testified lightweight mesh could have worked, so safer alternative existed | Ethicon: mesh sling is an inherently risky but socially useful medical device; Comment k should shield from strict liability (burden on defendant) | Held: Comment k did not bar liability as jury could find a safer feasible design; court need not instruct Comment k and omission caused no prejudice |
| Exclusion of FDA 510(k) compliance evidence | Huskeys: 510(k) and FDA findings are tangential and misleading | Ethicon: 510(k) clearance and FDA Advisory Committee findings are probative of device safety | Held: Exclusion proper under Rule 403; 510(k) has only tangential probative value and risked confusing jury (Cisson precedent) |
| Exclusion of FDA Advisory Committee and Prolene regulatory-history evidence | Huskeys: risks of jury confusion and unfair deference to FDA; underlying studies were admissible | Ethicon: Committee conclusions and Prolene approvals show safety of polypropylene used in TVT-O | Held: Exclusion not an abuse — underlying studies were admitted; Prolene history was of limited relevance and risked diversion and confusion |
Key Cases Cited
- Mikolajczyk v. Ford Motor Co., 901 N.E.2d 329 (Ill. 2008) (elements for design-defect claim under Illinois law)
- Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387 (Ill. 1987) (discussing Restatement § 402A and Comment k in Illinois law)
- In re C.R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (upholding exclusion of 510(k) compliance evidence as tangential and confusing)
- Durham v. Jones, 737 F.3d 291 (4th Cir. 2013) (standard of review for denial of JMOL)
- Rowland v. American General Fin., Inc., 340 F.3d 187 (4th Cir. 2003) (abuse-of-discretion standard for jury-instruction challenges)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (explaining the 510(k) substantial-equivalence process)