116 F. Supp. 3d 1361
N.D. Ga.2013Background
- Alcon designed and sold Air Optix contact lenses; plaintiff Jessica Thomas alleged injuries from use starting September 22, 2010.
- Thomas developed conjunctivitis, ulcers on the cornea, pseudomonas infection, and underwent a left corneal transplant around September 24, 2010.
- Plaintiff claimed the lenses had latent, dangerous properties increasing infection risk and violated the FDCA.
- Plaintiff filed suit in Georgia state court on September 21, 2012; defendant removed to federal court on October 22, 2012.
- Thomas amended her complaint to add state-law claims (negligence, strict liability, breach of warranties) and sought medical costs, damages, punitive damages, and litigation costs; defendant moved to dismiss as preempted or inadequately pled.
- Court ultimately dismissed defendant’s initial motion as moot and granted the amended-motion to dismiss, holding preemption barred the state-law claims and parallel claims were not properly pleaded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption framework applicability | Thomas asserts claims under state law and parallel federal regulations. | Alcon argues MDA preempts state-law claims relating to device safety/efficacy. | Preemption framework applies; parallel claims insufficient. |
| Parallel claim viability | Plaintiff pleads federal regulation violations connected to device safety. | CGMP and QSR provisions are too general to support parallel claims. | Parallel claims not adequately pled; dismissed. |
| Sufficiency of pleading federal regulations | Plaintiff cited regulations claiming violations. | Regulations cited are improper or non-specific; no actionable PMA requirements identified. | Plaintiff failed to plead specific PMA requirements violated. |
| Remedy/Relief viability | Discovery could flesh out PMA specifics; punitive damages remain possible. | Dismissal warranted given preemption and lack of actionable claims; punitive damages depend on underlying claims. | Pure state-law and punitive claims precluded; dismissal with prejudice. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (establishes two-prong preemption test for MDA claims)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (U.S. 2001) (preemption considerations in federal regulatory contexts)