121 F. Supp. 3d 809
E.D. Tenn.2015Background
- Plaintiff received a Coloplast-manufactured Titan Inflatable Penile Prosthesis (originally PMA-approved as Mentor Alpha I) in Sept. 2013 and alleges it failed to deflate on multiple occasions, causing injury and pain.
- The Titan Prosthesis obtained and maintained FDA premarket approval (PMA); Coloplast acquired the device and submitted PMA supplements approved by the FDA.
- Plaintiff filed state-law claims in Tennessee state court for design defect, failure to warn, breach of express warranty, and breach of implied warranty; defendant removed to federal court under diversity jurisdiction.
- Coloplast moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing federal preemption (MDA/21 U.S.C. § 360k) and pleading insufficiency under Twombly/Iqbal; plaintiff largely failed to respond in time but was later given leave and still did not adequately oppose.
- The court took judicial notice of FDA PMA documents and applied the Riegel framework for express preemption of PMA devices.
- Outcome: design defect, failure-to-warn, and implied warranty claims dismissed with prejudice as preempted by the MDA; express warranty claim dismissed without prejudice for inadequate pleading.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by the MDA/§360k for a PMA device | Parker alleges defective design, inadequate warnings, and breached warranties because the device malfunctioned | Coloplast argues PMA imposes federal requirements that preempt state-law duties that are different from or in addition to federal requirements | Court held design-defect, failure-to-warn, and implied warranty claims are preempted and dismissed with prejudice |
| Whether plaintiff pleaded an express-warranty claim adequately | Parker alleges breach of express warranty in boilerplate fashion | Coloplast contends the claim is both preempted if it alleges safety/effectiveness and is inadequately pleaded under Rule 8/Twombly/Iqbal | Court dismissed express-warranty claim without prejudice for insufficient factual detail |
| Whether any state claim can survive as a "parallel" claim based on alleged violations of FDA regulations or GMPs | Plaintiff did not allege any specific FDA or GMP violation | Coloplast notes no allegation of deviation from PMA-approved specifications or labeling | Court found no parallel-claim allegation; therefore the parallel-claim exception did not apply |
| Whether dismissal should be with or without prejudice | Plaintiff sought to respond and obtain counsel but failed to supply substantive allegations | Coloplast sought dismissal (with prejudice) based on merits and preemption | Court dismissed preempted claims with prejudice and allowed express-warranty claim to be repleaded (dismissed without prejudice) |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (distinguishing §510(k) review from PMA and addressing state-law regulation of medical devices)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA-approved devices subject to express preemption under 21 U.S.C. § 360k)
- Bell Atlantic v. Twombly, 550 U.S. 544 (2007) (complaint must plead facts sufficient to state a plausible claim)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard requires more than naked assertions)
- Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005) (discussing preemption of failure-to-warn and failure-to-recall claims for PMA devices)