Cornett v. Johnson & Johnson
211 N.J. 362
| N.J. | 2012Background
- Billie Cornett, a Kentucky resident with coronary artery disease, received a Cypher stent on December 16, 2004.
- Five months later, Cornett suffered subacute stent thrombosis near the stent site and died on May 31, 2005.
- Vonnie Cornett, Cornett's widow, filed a multi-state action in New Jersey on September 15, 2008 seeking damages for decedent's injuries and estate losses.
- The central issues were which state's statute of limitations applied and whether state claims were preempted by federal law governing FDA PMA-approved Class III devices.
- The court concluded Kentucky law governs the action and applies a discovery rule to latent-product liability injuries, but the complaint was timely filed under Kentucky law.
- The court also held most state claims are preempted by federal MDA/FDCA, with limited exceptions for certain warnings and express warranty statements.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Which state's limitations law applies? | Cornett argues Kentucky law applies due to domicile and injury nexus. | Defendants contend New Jersey law governs or that Kentucky’s limits bar timely filing. | Kentucky law governs and its discovery rule applies to latent injuries. |
| Does Kentucky apply a discovery rule to latent product liability injuries? | Discovery rule should apply to latent device injuries under Kentucky law. | Discovery rule not applicable to all product liability claims under Kentucky law. | Kentucky recognizes and applies discovery rule to latent product liability injuries. |
| Are most state-law claims preempted by federal law? | Some claims should proceed as parallel state claims not precluded by preemption. | Majority claims are preempted under MDA/Riegel Buckman framework. | Great bulk of claims preempted; limited exceptions for certain warnings and express warranty statements. |
| Is the failure to warn claim preempted when it concerns approved uses and off-label uses? | Plaintiffs allege parallel state duties not fully captured by FDA labeling. | Failure to warn for PMA device is preempted by the MDA/Riegel framework. | Failure to warn regarding approved/off-label uses largely preempted, with exceptions for non-FDA-disclosed information not tied to the PMA label. |
| Is the breach of express warranty claim preempted? | Express warranties based on voluntary statements to third parties should be allowed as parallel claims. | Breach of express warranty based on FDA-labeled information is preempted. | Breach of express warranty preempted to the extent based on FDA-labeled information; not preempted for voluntary statements to third parties beyond the label. |
Key Cases Cited
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. Supreme Court 1996) (preemption depends on device-specific federal requirements and parallel state duties)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. Supreme Court 2008) (two-prong test for preemption; PMA-specific labeling governs device safety requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. Supreme Court 2001) (fraud-on-the-FDA preemption limits state-law fraud claims in PMA context)
- Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (limits Buckman preemption; fraud-on-the-FDA claims may survive under certain theory)
- Kendall v. Hoffman-La Roche, Inc., 209 N.J. 173 (N.J. 2012) (discovery rule applied to knowledge of fault, not mere injury, for accrual in N.J.)
- Gantes v. Kason Corp., 145 N.J. 478 (N.J. 1996) (conflict-of-laws approach and issue-by-issue choice of law in product liability)
- Perkins v. Ne. Log Homes, 808 S.W.2d 809 (Ky. 1991) (early adoption of discovery rule in latent-injury product liability)
- Whalen v. Stryker Corp., 783 F.Supp.2d 977 (E.D. Ky. 2011) (application of Kentucky discovery rule to latent-injury device case)