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Vonnie Cornett, Individually and On Behalf of the Estate of Billie v. Johnson & Johnson and Cordis Corp

August 9, 2012

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.



On certification to the Superior Court, Appellate Division, whose opinion is reported at 414 N.J. Super. 365 (2010).

SYLLABUS BY THE COURT

SYLLABUS (This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the interest of brevity, portions of any opinion may not have been summarized.)

The opinion of the court was delivered by: Judge Cuff

Vonnie Cornett v. Johnson & Johnson and Cordis Corp.

A-88/89-10; 066671

Argued January 30, 2012

Decided August 9, 2012

CUFF, P.J.A.D. (temporarily assigned), writing for a unanimous Court.

In this appeal, the Court considers whether plaintiff filed her complaint within the statute of limitations, whether the law of Kentucky or New Jersey applies, and whether the various state statutory and common law claims in this case are preempted by federal law governing approval of the Cypher® stent, a Class III medical device that was subject to the rigorous pre-market approve (PMA) process of the Food & Drug Administration (FDA).

Billie Cornett resided in Kentucky and suffered from coronary artery disease. On December 16, 2004, Billie received an implant of a Cypher® stent, manufactured by Cordis Corp., a wholly-owned subsidiary of Johnson & Johnson, a New Jersey corporation with its principal place of business in New Jersey. Billie 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. On May 18, 2005, five months after surgery, Billie suffered a subacute stent thrombosis in the area where the Cypher® stent was placed. He died on May 31, 2005, as a result of the thrombosis. Billie lived and worked in Kentucky. He received all medical care in Kentucky.

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. 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), plaintiffs requested permission to file an amended complaint and did so bearing the Cornett caption. All complaints have been consolidated and the Cornett complaint was designated the Master Complaint. Defendants moved to dismiss the amended Master Complaint. The motion judge dismissed the amended Master Complaint in its entirety.

The motion judge held the Cornett complaint time-barred and all claims preempted by federal law. 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 (App. Div. 2010). The panel concluded a conflict of laws existed and the law of Kentucky governed, and held the complaint barred by Kentucky's one-year statute of limitations. 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; 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, preempted by federal law. In addition, 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.

The Supreme 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 (2011).

HELD: The Cornett complaint is time-barred. The failure to warn claim as to approved and off-label uses is preempted, except to the extent plaintiffs base the claim on allegations of deliberate non-disclosure 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 breach of express warranty claim is also preempted, 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.

1. A New Jersey court will apply the statute of limitations of another state if that state has a greater interest in the litigation. When this state and another state have conflicting statutes of limitations, the Court applies the same test governing choice of substantive law. Choice of law is not an issue unless there is a real conflict between the law of two jurisdictions. In Kentucky, a personal injury action must "be commenced within one (1) year after the cause of action accrued . . . ." Ky. Rev. Stat. Ann. § 413.140(1)(a). Generally, a cause of action accrues at the time of the harm; however, in some cases the cause of action accrues when the plaintiff discovers the injury or should have reasonably discovered it. The question is at what point did information become available that would have alerted a reasonable person to begin an inquiry into a possible cause of action? (pp. 9-14)

2. N.J.S.A. 2A:14-2 provides that a cause of action for personal injury must be filed within two years of accrual of the cause of action. In a product liability action, a cause of action generally accrues on the date of injury. However, the discovery rule is applied to product liability actions, including actions alleging defects in medical devices. Here, it is clear that 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 this state. Applying Kentucky law, the Court concludes that a person exercising reasonable diligence should have discovered by December 2006 that the Cypher® stent implanted in December 2004 may have caused the May 18, 2005 thrombosis. Accordingly, the September 15, 2008 complaint was not timely, and the Cornett action was properly dismissed. (pp. 14-18)

3. Plaintiffs' failure to warn and breach of express warranty claims implicate the preemption rule. An applicant for pre-market approval (PMA) of a Class III device must demonstrate its safety and effectiveness. PMA incorporates an FDA finding that a device is safe and effective under the conditions of use included on the label and that the label is not false or misleading. In addition, Congress has provided a safe harbor for manufacturers of Class III devices to "disseminate" to health-care providers peer-reviewed articles or "reference publications" "concerning the safety, effectiveness, or benefit of a use not described in the approved labeling . . . ." 21 U.S.C.A. §§ 360aaa, 360aaa-1. Congress chose to include in the Medical Device Amendments of 1976 (MDA) an express preemption provision against state standards for PMA devices that would be stricter than the MDA, but a state common law claim may also be impliedly preempted. On the other hand, when the so-called fraud-on-the-FDA claim is founded on deliberate non-disclosure of material information or deliberate misrepresentations of known facts, the claim may not be preempted. (pp. 18-29)

4. The permissible theories of a product liability action are manufacturing defect, defective design, or failure to warn through adequate warnings or instructions. N.J.S.A. 2A:58C-2. The standard for liability is that the product is "not reasonably fit, suitable or safe for its intended purpose . . . ." Ibid. 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 in this case 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. To the extent plaintiffs' failure to warn claim is based on other allegations of wrong-doing apart from defendants' failure to comply with FDA disclosure requirements, it is not preempted. To the extent plaintiffs' failure to warn claim is founded on promotion by defendants of off-label uses of the device beyond the safe harbor, that claim is not preempted. However, to the extent the breach of express warranty claim is based on statements not approved by the FDA or mandated by the FDA about the use or effectiveness of the product for on-label or off-label uses, a breach of express warranty claim may proceed because federal law requires any warranty statement to be truthful and accurate. If discovery reveals this claim is based solely on representations or statements derived from the FDA approved label or packaging, a motion for summary judgment would be appropriate. (pp. 29-40)

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.

Argued January 30, 2012

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 stent thrombosis. 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.*fn1

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.*fn2 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 stent thrombosis 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.*fn3 Defendants moved to dismiss the amended Master Complaint. The motion judge dismissed the amended Master Complaint in its entirety.*fn4

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 (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, and held the complaint barred by the Kentucky one-year statute of limitations, id. at 382-83. 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;*fn5 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. 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.

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 (2011). We also granted ...


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