## Facts

- Kyle Hamer underwent open-heart surgery in July 2017 using the LivaNova 3T Heater-Cooler System.
- He developed a post-surgical incision infection suspected to involve non-tuberculosis mycobacterium (NTM); the hospital had an outbreak of NTM infections in other 3T patients.
- No swab or culture ever isolated NTM, but Hamer was treated for suspected NTM infection and alleged lasting injuries from treatment, including possible hearing loss.
- Hamer sued under the Louisiana Products Liability Act (LPLA) on design-defect and failure-to-warn theories.
- The case was transferred into a federal MDL in the Middle District of Pennsylvania concerning alleged NTM infections linked to the 3T System.
- A case management order required “proof of NTM infection” via positive bacterial culture results; Hamer could not comply.
- The MDL court dismissed Hamer’s claims with prejudice for noncompliance and denied his motion to remand to the transferor court as moot.

## Issues

1. Whether the MDL court abused its discretion by dismissing with prejudice solely for failure to comply with a case-management order requiring a positive NTM culture, without determining whether the complaint stated a prima facie LPLA claim or considering less severe alternatives.
2. Whether the MDL court should have pursued remand procedures where the plaintiff’s theory (suspected infection and treatment-related injury) diverged from the MDL’s culture-confirmed NTM cases.

## Decision

- The Third Circuit reversed the dismissal and remanded.
- The court held the MDL court abused its discretion by treating the MDL’s culture-confirmation requirement as a de facto merits element and dismissing with prejudice without a substantive state-law analysis.
- The court stated the MDL court had permissible alternatives: dismiss without prejudice as a case-management measure, suggest remand under 28 U.S.C. § 1407, or dismiss with prejudice only after finding no prima facie claim under Louisiana law.
- On remand, the district court was directed to forward the case to the JPML for remand to the Eastern District of Louisiana.

## Legal Principles

- MDL courts have broad pretrial case-management authority, but that authority cannot be used to impose proof requirements that effectively add elements beyond governing state substantive law.
- A dismissal with prejudice in an MDL must rest on a merits-based determination (e.g., failure to state a claim under applicable state law), not solely on noncompliance with an MDL order that functions as a heightened substantive prerequisite.
- When an individual case no longer fits the MDL’s common factual nucleus, the proper procedural response may be to pursue remand through the JPML rather than terminate potentially viable state-law claims.
- Under the LPLA, a product-liability claim may be plausibly stated without a specific diagnostic test result if the pleaded facts plausibly support defect and causation under state standards.

## Conclusion

The Third Circuit held that an MDL court may not use a uniform diagnostic requirement to end a case with prejudice where state law does not require that proof and the court has not decided the claim’s substantive sufficiency; the case was returned to the transferor court through the JPML remand process.


Hamer v. LivaNova Deutschland GmbH, 994 F.3d 173 (3d Cir. 2021)