209 F. Supp. 3d 994
S.D. Ohio2016Background
- Plaintiffs are several hundred former patients of Dr. Atiq Durrani who allege they were implanted with Medtronic’s Infuse (rhBMP-2 on a collagen sponge) in off-label ways (e.g., without the LT‑Cage, at multiple levels, cervical/thoracic placement) and suffered injuries.
- Infuse is a component of a Class III medical device that received FDA premarket approval (PMA) limited to a specific lumbar procedure and use with the LT‑Cage; Class III devices and any components are subject to stringent FDA regulation and labeling controls.
- The Omnibus Complaint consolidates five cases and asserts: fraud/fraudulent concealment, failure-to-warn (strict liability), design defect (strict liability), misrepresentation (strict products liability), negligence, and breach of express and implied warranties against Medtronic.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6) arguing federal preemption (21 U.S.C. § 360k(a) and § 337(a)), inadequate pleading under Rules 8/9/12 standards, and alternative state-law defenses (Ohio Product Liability Act, Comment k, warranty disclaimers).
- The court found FDA PMA requirements apply to Infuse and its components, held most state-law claims either expressly preempted by § 360k(a) or impliedly preempted by § 337(a)/Buckman, and dismissed the fraud claims for failure to meet Rule 9(b) particularity.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal PMA requirements apply to Infuse component | Infuse’s PMA was for the combination device (Infuse + LT‑Cage); PMA did not impose requirements on Infuse used alone | PMA covers the approved device and its components; FDCA defines “device” to include components | PMA requirements apply to Infuse and its components; § 360k(a) governs |
| Whether state-law claims are preempted under § 360k(a) (express preemption) | Plaintiffs contend some state duties (e.g., to warn, warranty) are parallel or concern off‑label use and thus not preempted | State claims impose requirements different from or in addition to FDA requirements and are therefore preempted | Failure‑to‑warn, design‑defect, and express‑warranty claims are expressly preempted under § 360k(a) |
| Whether claims alleging failure to submit adverse‑event reports or off‑label promotion are subject to implied preemption under § 337(a)/Buckman | Plaintiffs argue reporting/off‑label promotion allegations can support state tort claims | Such claims would effectively enforce FDCA/regulatory duties that only the federal government may enforce | Claims based on failure to report adverse events or off‑label promotion are impliedly preempted and dismissed |
| Whether fraud claims satisfy Rule 9(b) | Plaintiffs allege fraudulent concealment/misrepresentations by Medtronic and by surgeon‑agent Durrani | Defendants argue fraud allegations are contradictory and lack the particularity required by Rule 9(b) | Fraud claims dismissed for failing to plead time, place, content, and consistent factual basis with required particularity |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA'd Class III device claims can be preempted by § 360k(a))
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (private suits that would enforce the FDCA are impliedly preempted; enforcement reserved to federal government)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (state common‑law claims survive § 360k(a) only if they are parallel to federal requirements)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: plausibility required under Rule 8)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must state a plausible claim above speculative level)
- New Albany Tractor, Inc. v. Louisville Tractor, Inc., 650 F.3d 1046 (6th Cir. 2011) (plaintiff must plead specific facts even if information is mostly in defendant’s control)
- Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) (claims that rest on FDCA/agency reporting duties are impliedly preempted under Buckman)