236 F. Supp. 3d 889
M.D. Penn.2017Background
- Jason Silver sued Medtronic after his implanted SynchroMed II intrathecal pump allegedly overdelivered medication in 2014, causing injury and device removal; suit filed August 12, 2016.
- The SynchroMed II is a Class III device approved by FDA via PMA; Medtronic received multiple FDA warning letters identifying CGMP and PMA nonconformities and numerous Class I recalls; DOJ/HHS obtained a consent decree (2015) restricting manufacture/distribution.
- Silver’s complaint pleads seven counts (manufacturing defect, failure to warn, negligence, breach of express warranty, breach of implied warranties, negligent misrepresentation, and Pennsylvania UTPCPL violations) grounded largely on alleged violations reflected in FDA warning letters and reporting obligations.
- Medtronic moved to dismiss arguing express and implied federal preemption, inadequate pleading (including Rule 9(b) for fraud-like claims), and state-law defenses (e.g., learned-intermediary, Pennsylvania prohibition on implied-warranty claims against device manufacturers).
- The court accepted factual allegations as true for Rule 12(b)(6) review and applied Riegel’s two-step express-preemption framework and Buckman for implied preemption.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are state-law claims expressly preempted by the MDA (§360k) for a PMA device? | Silver says his claims are parallel to federal requirements because they rest on violations found in FDA warning letters/CGMPs and PMA specifications. | Medtronic says state claims would add or differ from federal requirements and thus are preempted. | Court: Denied dismissal on express-preemption ground for claims premised on specific FDA/CGMP/PMA violations; parallel claims survive. |
| Are claims impliedly preempted under Buckman (i.e., do they improperly seek to enforce the FDCA)? | Silver frames claims as traditional state tort duties (duty of care, reporting/warning obligations), not fraud-on-FDA. | Medtronic argues Buckman bars private enforcement of FDA regulations. | Court: Buckman does not bar traditional state-law claims; implied preemption rejected. |
| Does the failure-to-warn claim (based on not reporting adverse events to FDA) survive express-preemption? | Silver contends FDA reporting duties (and public posting) can discharge a state duty to warn under Pennsylvania law (Restatement §388 comment n). | Medtronic contends reporting to FDA is different from a duty to warn physicians/consumers and thus preempted. | Court: Denied dismissal of Count II; holding that reporting obligations can be parallel to state duty to warn and therefore not preempted. |
| Are negligence and manufacturing-defect claims sufficiently pleaded and preempted? | Silver ties negligence/manufacturing-defect to specific FDA warning letters and alleges his device was manufactured out of specification. | Medtronic argues causal link to plaintiff’s device is not plausibly alleged and claims preemption. | Court: Denied dismissal of Counts I and III — factual allegations (linked to facility and warnings) satisfy plausibility for parallel state tort claims. |
| Is breach of express warranty preempted? | Silver asserts contractual express-warranty claims governed by parties’ statements, not state-imposed requirements. | Medtronic argues any challenge to safety/effectiveness is preempted because PMA found device safe/effective. | Court: Denied dismissal of Count V — express warranty is contractual and not a state requirement preempted by MDA. |
| Are implied-warranty claims viable under Pennsylvania law? | Silver asserts implied merchantability/fitness claims. | Medtronic argues Pennsylvania courts bar implied-warranty claims against device manufacturers; alternatively preempted. | Court: Granted dismissal of Count VI as Pennsylvania would not permit implied-warranty claims against device manufacturers. |
| Are negligent misrepresentation and UTPCPL claims adequately pleaded and non-preempted? | Silver alleges false/misleading representations and omissions but does not identify specific statements. | Medtronic argues inadequate pleading (Rule 8/9(b)), and preemption/learned-intermediary defenses. | Court: Granted dismissal of Counts VII and VIII for failure to plead specific representations (insufficient under Twombly/Iqbal); did not reach preemption/learned-intermediary. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (establishes §360k express-preemption two-step framework)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (private claims that are essentially fraud-on-the-FDA are impliedly preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (common-law tort claims are not categorically preempted by the MDA)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (apply Twombly two-step analysis to pleadings)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir.: FDA reporting obligations can support a parallel failure-to-warn claim)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.: CGMP violations can support parallel state-law claims)
- Phillips v. County of Allegheny, 515 F.3d 224 (pleading: accept factual allegations as true on 12(b)(6))