McCormick v. Medtronic, Inc.
101 A.3d 467
| Md. Ct. Spec. App. | 2014Background
- Plaintiff Steven McCormick received a 2007 posterior-approach spinal fusion using Medtronic’s Infuse Bone Graft device in an off-label manner; he alleges excessive bone growth, revision surgery, disability, and possible increased cancer risk.
- Infuse is an FDA-approved Class III device; FDA approval limited use to an anterior approach and required use with a specific cage; labeling contained FDA-mandated warnings.
- McCormick alleges Medtronic promoted off-label posterior use (including use without the cage), paid and incentivized physicians and key opinion leaders, placed sales reps in ORs, and downplayed risks—leading to widespread off-label sales.
- Claims asserted against Medtronic: negligence (including negligent misrepresentation), strict products liability, breach of warranty (express and implied), fraud, Consumer Protection Act violations; related claims against the surgeon were later dismissed.
- The circuit court dismissed most claims as preempted by federal law (relying on Caplinger); it also held fraud was not pled with particularity. On appeal, the Court of Special Appeals reversed in part and affirmed in part, and remanded with leave to amend fraud allegations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state common-law and statutory claims are expressly preempted by the MDA/FDCA | McCormick: claims based on Medtronic’s off-label promotion and misrepresentations are violations of federal law but also traditional state-law claims that should survive | Medtronic: federal law (MDA/FDCA) preempts state claims that impose requirements different from or additional to federal requirements | Court: Express preemption bars suits attacking FDA-mandated labeling or imposing state duties that differ from FDA; but claims based on voluntary off-label statements/warranties outside FDA labeling are not expressly preempted |
| Whether claims are impliedly preempted as attempts to enforce the FDCA (Buckman) | McCormick: his theories rely on traditional state-law duties (fraud, warranty, negligence), not private enforcement of FDCA | Medtronic: many allegations effectively seek to enforce federal misbranding/labeling rules and are therefore impliedly preempted | Court: Buckman preempts claims that exist solely by virtue of the FDCA (e.g., fraud-on-the-FDA, claims premised only on failure to report to FDA or on the mere fact of off-label promotion); but traditional state misrepresentation/warranty claims that predate FDCA and do not rely solely on federal law survive |
| Whether claims attacking FDA-approved labeling or adequacy of warnings survive | McCormick: alleged failures to disclose/adequately warn about risks (including cancer) support state-law claims | Medtronic: allowing such claims would impose state requirements different from FDA-approved labeling (express preemption) | Court: Challenges to FDA-approved labeling or to adequacy of FDA warnings are expressly preempted; however, omissions or misstatements in voluntary off-label promotion that render other statements misleading may proceed |
| Sufficiency of fraud pleadings (particularity) | McCormick: complaint alleges Medtronic knew of risks and concealed material facts (clinical data, conflicts of interest) | Medtronic: fraud allegations are vague and lack who/when/what/where specificity required for scienter | Court: Fraud not pled with required particularity; dismissal affirmed as to fraud but plaintiffs are granted leave to amend on remand |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (MDA §360k express preemption of state requirements that are different from or in addition to federal device requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law fraud-on-the-FDA claims impliedly preempted because they would conflict with FDCA enforcement scheme)
- Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013) (earlier district-court decision finding broad preemption; relied on by circuit court below)
- Cornett v. Johnson & Johnson, 211 N.J. 362 (2012) (failure-to-warn and off-label promotion analysis; distinguishes FDA-mandated labeling from voluntary communications)
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (First Amendment protects truthful off-label promotion absent false or misleading statements)