Donna Cisson v. C. R. Bard, Incorporated
810 F.3d 913
| 4th Cir. | 2016Background
- Plaintiff Donna Cisson received a Bard Avaulta Plus transvaginal mesh implant in 2009 and later suffered pain and loss of sexual function; mesh was partially resected and partly explanted.
- Cisson sued Bard (case consolidated in MDL) asserting design-defect and failure-to-warn claims; jury awarded $250,000 compensatory and $1,750,000 punitive damages (punitive split under Georgia law: 75% to state, 25% to plaintiff).
- At trial the plaintiff presented expert testimony alleging defective mesh arms, pore size causing scar plate/shrinkage, and polypropylene degradation causing inflammation; plaintiff also introduced a polypropylene MSDS and internal Bard emails about it.
- Bard sought to introduce evidence of FDA 510(k) clearance to show reasonableness and to exclude the MSDS as hearsay; Bard also challenged the jury causation instruction and the punitive award as excessive.
- District court excluded 510(k) compliance evidence (Rule 403), admitted the MSDS for limited non-hearsay purpose (and sua sponte under hearsay exceptions), gave Georgia pattern causation instruction, and denied post-trial relief on punitive damages; Fourth Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Bard's FDA 510(k) compliance | 510(k) clearance is probative of reasonableness and lack of willfulness | 510(k) is minimally probative, would create mini-trial and prejudice jury | Exclusion affirmed: court did not abuse Rule 403 discretion; 510(k) offers limited safety value and risk of juror confusion outweighed probative value |
| Admissibility of Phillips Sumika MSDS (hearsay) | MSDS admitted to show Bard received the warning (knowledge) and thus non-hearsay; any use for truth was harmless | MSDS was hearsay and not admissible under exceptions; its use prejudiced Bard | MSDS admission affirmed as non-hearsay (to show receipt/knowledge); court erred admitting it under hearsay exceptions but any use for truth was harmless given trial record |
| Jury instruction on causation / expert "reasonable medical probability" standard | Georgia allows medical and non-medical evidence; pattern instruction (preponderance) is appropriate | Georgia requires expert causation to reasonable medical probability (per malpractice precedent) | Instruction affirmed: product-liability standard is preponderance; medical-malpractice standard inapplicable; plaintiff presented sufficient expert and non-expert proof of causation |
| Constitutional challenge to punitive damages & Takings challenge to GA split-recovery | (Bard) punitive award excessive (7:1 ratio); (Cisson) GA split of punitive damages effects a taking | (Bard) punitive excessive vs. compensatory; (Georgia) split statute lawful | Punitive award affirmed: single-digit multipliers permissible and reprehensibility supported award; cross-appeal denied — no compensable property interest established in the full punitive award as defined by state statute |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (discusses §510(k) equivalence and that 510(k) is not a design-safety requirement)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (characterizes §510(k) clearance as an exemption rather than a safety requirement)
- State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408 (sets due-process guideposts for reviewing punitive-damages excessiveness)
- BMW of N. Am., Inc. v. Gore, 517 U.S. 559 (establishes punitive-damages review factors)
- Allison v. McGhan Med. Corp., 184 F.3d 1300 (implant cases may rely on medical and non-medical evidence to show causation)
- Zwiren v. Thompson, 578 S.E.2d 862 (Ga. 2003) (medical-malpractice causation standard discussed; court explains reasonable medical probability is functionally similar to preponderance)