Cornett v. Johnson & Johnson & Cordis Corp.

• Decision Date: 09 August 2012
• Citation: 211 N.J. 362,48 A.3d 1041
• Court: New Jersey Supreme Court
• Parties: Vonnie CORNETT, individually and on behalf of the estate of Billie Cornett, deceased, Plaintiff–Appellant and Cross–Respondent, v. JOHNSON & JOHNSON and Cordis Corp., Defendants–Respondents and Cross–Appellants.

211 N.J. 362

48 A.3d 1041

Vonnie CORNETT, individually and on behalf of the estate of Billie Cornett, deceased, Plaintiff–Appellant and Cross–Respondent,

v.JOHNSON & JOHNSON and Cordis Corp., Defendants–Respondents and Cross–Appellants.

Supreme Court of New Jersey.

Argued Jan. 30, 2012.

Decided Aug. 9, 2012.

Bruce D. Greenberg argued the cause for appellant and cross-respondent (Lite DePalma Greenberg, attorneys; Mr. Greenberg, Mayling C. Blanco, Newark, Peter E. Seidman and Alastair Findeis, members of the New York bar, on the briefs).

Peter C. Harvey argued the cause for respondents and cross-appellants (Patterson Belknap Webb & Tyler, attorneys).

Ellen Relkin submitted a brief on behalf of amicus curiae Kentucky Justice Association (Weitz & Luxenberg, attorneys; Ms. Relkin and Lawrence L. Jones, II, a member of the Kentucky bar, of counsel and on the brief).

Judge CUFF (temporarily assigned) delivered the opinion of the Court.

On December 16, 2004, Billie Cornett received a drug-eluting stent to treat coronary artery disease. Five months later, a blood clot formed near the site of the stent and Billie Cornett suffered a subacute stentthrombosis. Eleven days later, he died. On September 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 this Court to consider whether Vonnie Cornett filed her complaint within the statute of limitations, which requires this Court to determine whether the law of Kentucky or New Jersey applies to this case. The stent used in this case is a Class III medical device that was subject to the rigorous pre-market approval (PMA) process of the Food & Drug Administration (FDA). Therefore, we must also decide whether the various state statutory and common law claims are preempted by federal law governing approval of this medical device.

We conclude that the Kentucky statute of limitations governs this case and that Kentucky applies a discovery rule to product liability actions involving latent injuries and illnesses, but Cornett did not timely file her complaint. We also conclude that the great bulk of the state statutory and common law claims are preempted by federal law. The exceptions 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 breach of express warranty claim for voluntary statements to third parties that deviate from the approved label and packaging information material.¹

I.

A.

Billie Cornett resided in Kentucky and suffered from coronary artery disease. On December 16, 2004, Billie received an implant of a Cypher® stent to treat this condition. The Cypher® stent is manufactured by Cordis Corp., a wholly-owned subsidiary of Johnson & Johnson, which is a New Jersey corporation with its principal place of business in New Jersey.

The purpose of a stent is to prevent narrowing of an artery. The Cypher® stent is coated in a slow-release chemotherapy drug, Sirolimus, intended to inhibit or prevent the artery from narrowing through the buildup of new tissue. Sirolimus inhibits cell growth by blocking a key protein involved in cellular division. It is alleged that the polymer used to bind the drug to the bare metal of the stent irritates the wall of the artery. Also, in some patients Sirolimus prevents a thin layer of endothelial cells from growing over the stent after implantation, which creates a substantial risk of abrupt formation of a blood clot on the exposed stent.

Billie Cornett also had diabetes. Use of the Cypher® stent on a patient with coronary heart disease and diabetes is considered “off-label” but not necessarily medically contraindicated.² The Cypher® stent label recommended that patients should take aspirin or Plavix® for three months after implantation of the stent to prevent formation of a blood clot at the stent site.

On May 18, 2005, five months after surgery, Billie Cornett suffered a subacute stentthrombosis in the area where the Cypher® stent was placed. He died on May 31, 2005, as a result of the thrombosis. Billie Cornett lived and worked in Kentucky. He received all medical care in Kentucky.

B.

On September 15, 2008, Vonnie Cornett, the executor of the estate of Billie Cornett, and others from sixteen states and New Jersey filed forty-eight complaints against defendants Johnson & Johnson and Cordis for injuries allegedly resulting from use of the Cypher® stent, a medical device produced and distributed by defendants. In response to a motion to dismiss that argued all causes of action pled by plaintiffs were preempted by the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C.A. § 360c to 360m, plaintiffs requested permission to file an amended complaint and did so bearing the Cornett caption. The amended complaint asserted nine causes of action: strict liability for defective design, defective manufacture, and failure to warn; breach of implied warranty; breach of express warranty; consumer fraud; punitive damages; wrongful death; and loss of consortium. All complaints have been consolidated and the Cornett complaint has been designated the Master Complaint.³ Defendants moved to dismiss the amended Master Complaint. The motion judge dismissed the amended Master Complaint in its entirety.⁴

The motion judge held the Cornett complaint was time-barred, and all claims were preempted by federal law. He emphasized that plaintiffs relied heavily on decisions involving medications rather than medical devices and on cases decided before Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The motion judge noted prescription medications are not subject to the express preemption provision of the statutory scheme governing approval of medical devices.

The motion judge did not permit plaintiffs to file another amended complaint regarding the express warranty claim because plaintiffs had already received one opportunity to file an amended complaint. Furthermore, the motion judge observed that the express warranty claim is based on the patient information guide and product identification card provided to the patient at surgery. However, that information had been approved by the FDA, and “is nothing more than a defective labeling/failure to warn claim,” and preempted. Finally, the motion judge found the complaint lacked any allegations that the use of the device was off-label.

On appeal, the Appellate Division affirmed the dismissal of the Cornett complaint as time-barred. Cornett v. Johnson & Johnson, 414 N.J.Super. 365, 382–83, 998 A.2d 543 (App.Div.2010). The panel concluded a conflict of laws existed and the law of Kentucky, the place plaintiff's decedent resided, governed, id. at 381–82, 998 A.2d 543, and held the complaint barred by the Kentucky one-year statute of limitations, id. at 382–83, 998 A.2d 543. Addressing the merits of the various causes of action pled in the Master Complaint, the panel held the following claims were not preempted 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; ⁵ 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. Id. at 405–06, 998 A.2d 543. The panel held the remaining claims, other than the breach of implied warranty, preempted by federal law. Ibid. The panel held the Product Liability Act (PLA), N.J.S.A. 2A:58C–1 to –11, subsumed the breach of implied warranty claim; therefore, the motion judge properly dismissed this claim. Id. at 404, 998 A.2d 543.

This Court granted the parties' 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 breach of express warranty claims are preempted by federal law. 205 N.J. 317, 15 A.3d 325 (2011). We also granted the motion of the Kentucky Justice Association to appear as amicus curiae. We now affirm with modification the judgment of the Appellate Division.

II.

The Appellate Division found a conflict of laws existed. Applying the “most significantrelationship” test of the Restatement (Second) of Conflict of Laws § 145 (1971), recognized in P.V. v. Camp Jaycee, 197 N.J. 132, 138–43, 962 A.2d 453 (2008) as the appropriate test, the panel held that Kentucky law applied. Cornett, supra, 414 N.J.Super. at 379–82, 998 A.2d 543. The panel cited the long-term residency of the Cornetts in Kentucky and the medical care provided to Billie in Kentucky. Id. at 379, 998 A.2d 543. The panel also noted that Billie's health care providers purchased the Cypher® stent in Kentucky and his post-operative care occurred in that state. Ibid. Finally, Billie's health care providers received the warnings provided in that state. Id. at 380, 998 A.2d 543. Accordingly, the panel determined the one-year Kentucky statute of limitations applied and the complaint was untimely. Id. at 382, 998 A.2d 543. In doing so, the panel held that Kentucky law did not apply the discovery rule to product liability claims. Id. at 377, 998 A.2d 543.

Cornett argues the Appellate Division misapplied the most significant relationship test and this state's discovery rule. Defendants respond the Appellate Division correctly concluded Kentucky law applied to plaintiff's claim, and it is barred by the Kentucky statute of limitations. In the alternative, they argue the New Jersey discovery rule would not alter the outcome.

Amicus curiae Kentucky Justice Association argues the Appellate Division panel misconstrued and misapplied Kentucky law. Amicus...