Cornett v. Johnson & Johnson, A-88/89 September Term 2010; Supreme Court; opinion by Cuff, P.J.A.D., temporarily assigned; decided August 9, 2012. On certification to the Appellate Division, 414 N.J. Super. 365 (App. Div. 2010). [Sat below: Judges Parrillo, Lihotz and Ashrafi in the Appellate Division; Judge Stroumtsos in the Law Division.] DDS No. 32-1-7326 [43 pp.]

On Dec. 16, 2004, Billie Cornett, a resident of Kentucky, received an implant of a Cypher stent to treat coronary artery disease. The stent was manufactured by Cordis Corp., a wholly owned subsidiary of Johnson & Johnson, a New Jersey corporation with its principal place of business in New Jersey. Five months later, a blood clot formed near the site of the stent and Billie Cornett suffered a subacute stent thrombosis. Eleven days later, he died. On Sept. 15, 2008, his widow, Vonnie Cornett, filed suit in New Jersey seeking damages for the injuries suffered by her husband and his estate.

This appeal requires the court to consider whether Cornett filed her complaint within the statute of limitations, which requires a determination whether the law of Kentucky or New Jersey applies. The Cypher stent is a Class III medical device that was subject to the premarket approval (PMA) process of the Food and Drug Administration (FDA). Therefore, the court must also decide whether the state statutory and common-law claims are pre-empted by federal laws governing approval of this medical device, including the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act (FDCA).

Forty-eight complaints for injuries allegedly resulting from use of the Cypher stent have been consolidated and the Cornett complaint was designated the master complaint. The motion judge dismissed the amended master complaint, holding the complaint time-barred and all claims pre-empted by federal law.

The Appellate Division concluded a conflict of laws existed and the law of Kentucky governed, and held the complaint barred by Kentucky’s statute of limitations. The panel held the following claims were not pre-empted by federal law: manufacturing defect; failure to warn of approved and off-label uses to the extent plaintiffs alleged failure to satisfy federal disclosure requirements or federal limitations on off-label promotion within the statutory safe harbor; and breach of express warranty to the extent plaintiffs based their claim on voluntary statements relating to approved uses or off-label uses outside the safe harbor. The panel held the remaining claims, other than the breach of implied warranty, were pre-empted by federal law. In addition, the panel held the Product Liability Act (PLA) subsumed the claim of breach of implied warranty; therefore, the claim was properly dismissed.

The Supreme Court granted the cross-petitions for certification to consider whether the Cornett complaint is time-barred and whether the failure to warn of approved and off-label uses and claims of breach of express warranty are pre-empted.

Held: The Cornett complaint is time-barred. The failure-to-warn claim as to approved and off-label uses is pre-empted, except to the extent plaintiffs base the claim on allegations of deliberate nondisclosure or fraudulent representations of known adverse information apart from defendants’ failure to comply with FDA disclosure requirements or promotion of off-label uses outside the safe harbor. The claim of breach of express warranty is also pre-empted, except to the extent plaintiffs allege defendants have made voluntary statements to third parties beyond and different from the information on the approved label or packaging.

The court finds no conflict of laws exists between New Jersey and Kentucky. Both states apply the discovery rule. Kentucky requires filing of a complaint within one year of accrual of the cause of action; New Jersey requires filing within two years of accrual. This difference, however, does not create a true conflict of laws, unless the differences are offensive or repugnant to the public policy of New Jersey. Applying Kentucky law, the court concludes that a person exercising reasonable diligence should have discovered by December 2006 that the stent implanted in December 2004 may have caused the May 18, 2005, thrombosis. Accordingly, the complaint was not timely, and the Cornett action was properly dismissed.

Plaintiffs’ claims of failure to warn and breach of express warranty implicate the pre-emption rule. Congress chose to include in the Medical Device Amendments of 1976 (MDA) an express pre-emption provision against state standards for PMA devices that would be stricter than the MDA, but a state common-law claim may also be impliedly pre-empted. On the other hand, when the so-called fraud-on-the-FDA claim is founded on deliberate nondisclosure of material information or deliberate misrepresentations of known facts, the claim may not be pre-empted.

The FDA approval of the Cypher stent, including the label and instructions, communicates that defendants demonstrated the safety and effectiveness of the product for its approved uses. Defendants who comply with FDA requirements are granted a rebuttable presumption that the labeling is adequate. The failure-to-warn claim falls within the rebuttable presumption and the court affirms its dismissal. Moreover, to the extent plaintiffs’ failure-to-warn claim is based solely on a contention that defendants obtained FDA approval for the device only after submitting fraudulent representations to or withholding material information from the FDA, the court affirms its dismissal.

The claims that are not pre-empted are the failure-to-warn claim for approved use to the extent it involves wrongdoing apart from defendants’ failure to comply with FDA disclosure requirements and for off-label use of the stent to the extent defendants improperly promoted that device, and the claim of breach of express warranty for voluntary statements to third parties that deviate from the approved label and packaging information material.

The judgment of the Appellate Division is affirmed as modified.

Justice LaVecchia and Judges Wefing, Rodriguez and Fuentes, all temporarily assigned, join in Judge Cuff‘s opinion. Chief Justice Rabner and Justices Albin, Hoens and Patterson did not participate.

For appellant and cross-respondent — Bruce D. Greenberg (Lite DePalma Greenberg; Greenberg, Mayling C. Blanco, Peter E. Seidman and Alastair Findeis, members of the N.Y. bar, on the briefs). For respondents and cross-appellants — Peter C. Harvey (Patterson Belknap Webb & Tyler). For amicus curiae Kentucky Justice Association — Ellen Relkin (Weitz & Luxenberg).