346 F. Supp. 3d 534
S.D. Ill.2018Background
- Plaintiffs (infant A.F. and her mother) sued manufacturers of the Mitroflow Aortic Pericardial Heart Valve after A.F.’s implanted valve (an earlier version without an anticalcification treatment) failed, requiring replacement surgery during which she suffered stroke, partial paralysis, and seizures.
- Defendants obtained FDA premarket approval for the Valve in 2007; the clinical study submitted did not include patients under 27. Defendants later sought approval in 2013–2014 to change manufacturing to add an anticalcification treatment.
- Plaintiffs allege Defendants received adverse-event reports showing premature valve deterioration and failed to timely or adequately report those events to the FDA, or otherwise downplayed them.
- Plaintiffs asserted state-law claims: negligence, strict products liability (design and manufacturing defect), negligent failure to warn, and loss of services; they limited state claims to those parallel to federal requirements.
- Defendants moved to dismiss under Rule 12(b)(6). The court dismissed claims rooted in premarket fraud, design-defect, manufacturing-defect (for failure to plead specifics), and inadequate FDA‑approved labeling, but allowed a failure-to-warn‑the‑FDA claim to proceed; CarboMedics, Inc. was dismissed as a merged-out corporation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are claims alleging fraud in the premarket approval process cognizable under state law? | Plaintiffs suggested defendants hid risks in premarket filings and later concealed adverse events. | Defendants argued fraud-on-the-FDA claims are impliedly preempted. | Dismissed: premarket fraud claims preempted under Buckman. |
| Are design-defect claims viable where FDA approved the device design? | Design was defective because defendants should have used anticalcification treatment. | FDA approval preempts state claims that would require a safer design. | Dismissed: design-defect claims expressly preempted under §360k/Riegel. |
| Can plaintiffs maintain a manufacturing-defect claim? | Plaintiffs alleged the implanted Valve deviated from FDA‑approved specifications. | Defendants argued plaintiffs failed to plead particularized manufacturing deviations. | Dismissed (without prejudice): allegations too conclusory to plausibly show a manufacturing defect. |
| Is a state-law failure-to-warn claim based on alleged violations of FDA adverse‑event reporting requirements preempted or barred by Buckman? | Plaintiffs argue defendants failed to timely/report adverse events to the FDA; had reports been made, the medical community (including A.F.’s doctor) would have had notice. | Defendants contend such claims either are preempted or impermissibly seek to second-guess FDA decisions. | Denied as to this claim: a state duty to warn (which can include reporting to the FDA) can parallel federal reporting duties and is not impliedly preempted; plaintiffs plausibly pleaded such a claim. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (preemption of state-law tort claims that would impose requirements different from FDA premarket approval)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (state-law fraud-on-the-FDA claims are impliedly preempted)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir.) (state failure-to-warn‑FDA claims can be parallel and not expressly preempted)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.) (manufacturing-defect claims that allege departures from FDA‑required manufacturing can avoid §360k preemption)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir.) (failure-to-warn claim premised on violations of FDA adverse‑event reporting was not preempted)