James v. Diva International, Inc.
803 F. Supp. 2d 945
S.D. Ind.2011Background
- Diva International Inc. manufactured and sold the DivaCup® (Class II medical device) and distributed it upstream; the DivaCup® was approved via 510(k) substantially equivalent to a predicate device.
- Plaintiff Sarah James purchased and used the DivaCup® in March 2008, alleging Toxic Shock Syndrome and injury.
- Plaintiffs allege negligence and violations of Indiana Code §§ 34-20-4-1 and -2 (failure to warn, defective product).
- Diva moved to dismiss under Rule 12(b)(6) alleging failure to state a claim with specificity and federal preemption under the Medical Device Amendments (MDA).
- The court denied the motion to dismiss in part as to Count II (product/strict liability) and granted in part as to Count I (negligence); it denied preemption at this stage but dismissed the negligence count.
- Court relies on MDA’s three-step preemption analysis and distinguishes generic manufacturing regulations from device-specific requirements.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the negligence claim (Count I) is adequately pled. | James pled facts showing injury from DivaCup®; pleaded general duty and breach. | Sorry, insufficient factual pleading to state a plausible negligence claim. | Granted in part; negligence claim dismissed for lack of plausibility. |
| Whether the product/strict liability claims (Count II) survive pleading. | Amended complaint alleges unreasonably dangerous and defective product. | Pleading insufficient but some defects may exist. | Denied; product and strict liability claims survive pleading. |
| Whether state-law claims are preempted by the MDA (360k(a)). | Preemption not warranted; claims mirror federal requirements. | Federal requirements preempt state-law claims. | Not preempted at this stage; preemption denied for count-level analysis. |
| Whether FDA regulations (e.g., QSR) trigger device-specific preemption. | Regulations are umbrella/generic and not device-specific. | Regulatory scheme imposes specific requirements. | Insufficient to preempt; QSR alone not enough to preempt. |
| Whether 510(k) substantially equivalent process and foreign-device status affect preemption. | 510(k) process provides standards but not device-specific requirements. | Predicate-based and foreign-device rules create preemption. | Preemption not established by 510(k) or foreign-device arguments at this stage. |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (plausibility required; conclusory allegations insufficient)
- Twombly v. Bell Atl. Corp., 550 U.S. 544 (U.S. 2007) (claims must be plausible, not merely legal conclusions)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (pleading burden commensurate with information available; defects need not be pled with exact specificity)
- Dow v. Baxter Healthcare Corp., 899 F. Supp. 822 (D. Mass. 1995) (describes FDA regulation hierarchy for medical devices)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (preemption requires device-specific federal requirements and a relation to safety/effectiveness)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (510(k) process is not as stringent as PMA and generally applicable)