Cornett v. Johnson & Johnson, 211 N.J. 362 (2012). This is a long-awaited decision in the tort/medical device realm, involving as it does the issues of choice of law for statute of limitations purposes, the operation of the statute of limitations selected, and federal pre-emption of state law claims involving medical devices. The opinion of the Appellate Division is discussed here, and an analysis of the unique circumstances of this oral argument on January 31, 2012, at which non-Justices outnumbered Justices for what appears to have been the first time in the Court’s history, due to recusals, appears here. [Disclosure: I am co-counsel for plaintiffs, and I argued the matter before the Supreme Court].
The case actually encompasses 49 separate cases, all of which involve the Cypher® stent manufactured by defendant Cordis Corporation, a subsidiary of defendant Johnson & Johnson. All 49 cases were filed in the Law Division, Middlesex County. One case, involving Billie Cornett, a Kentucky citizen into whom the stent was implanted and who later died, allegedly due to the defectiveness of the stent, was selected as the Master Complaint as to the overall allegations regarding the defect and other theories. Defendants moved to dismiss the Cornett case, which was brought by Vonnie Cornett, Billie Cornett’s widow. The Law Division granted that motion on several grounds.
First, the court found that Kentucky’s one-year statute of lmitations, rather than New Jersey’s two-year statute with a discovery rule, applied, and that, as a result, Ms. Cornett’s suit was untimely. Second, the judge held that all claims were pre-empted by the Medical Device Amendments of 1976, 21 U.S.C. §§360c-360m (“MDA”), to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301-399. That was because the stent had received premarket approval from the Food and Drug Administration (“FDA”), and the MDA contained an express pre-emption provision that precluded state standards for medical devices that differ from those of the federal regime.
Since the pre-emption ruling would apply equally to the cases other than Cornett, defendants requested that the remaining cases be dismissed on pre-emption grounds. The Law Division agreed.
Plaintiffs appealed to the Appellate Division. In a published opinion, 414 N.J. Super. 365 (App. Div. 2010), that court affirmed the dismissal of Cornett on limitations grounds. Writing for the panel, Judge Parrillo found that a number of plaintiffs’ claims were pre-empted. But the Appellate Division reversed as to three theories: manufacturing defect; failure to warn concerning both approved and off-label uses, to the extent that plaintiffs alleged failure to satisfy federal requirements as the basis for that claim; and breach of express warranty, to the extent that plaintiffs relied on defendants’ voluntary statements relating to approved uses of the stent or voluntary statements about certain off-label uses. The Appellate Division relied primarily on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which held that claims based on state requirements that were “parallel” to but not based on federal standards were not pre-empted.
Ms. Cornett petitioned the Supreme Court for certification on the choice of law and statute of limitations issues. Defendants cross-petitioned as to the claims that the Appellate Division found not to be pre-empted. The Court granted both petitions.
The Court, speaking through Judge Cuff, affirmed the Appellate Division’s decision, but with a modification as to the claims that were not pre-empted. On the limitations issue, Judge Cuff determined that there was no conflict between New Jersey’s two-year statute of limitations and Kentucky’s one-year statute. Both states applied the discovery rule. The Court applied Kentucky’s one-year statute and found that Ms. Cornett was or should have been on notice of a claim no later than December 2006, when the FDA convened a panel to “examine thrombosis risks” of the stents at issue. Since Ms. Cornett did not file suit until September 2008, her case was barred. On the pre-emption issue, Judge Cuff analyzed the issue exhaustively, and concluded that “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 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 [FDA’s] safe harbor [which privileges certain statements]. The breach of express warrranty 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 and packaging.” Defendants dropped their challenge to the manufacturing defect claim, so the Court did not reach that issue, and that claim remains in the cases.
Plaintiffs got a more favorable pre-emption ruling than most cases in this area have produced. On the limitations issue, the Court seemed not to plow any new legal ground, basing its decision on the particular facts. The Court’s analysis of the choice of law issue did not squarely confront a key issue in the briefing (and the question that may have been a principal reason for the grant of Ms. Cornett’s petition): whether, under the principles of the Restatement (Second) Conflicts of Law, the place where a product such as these stents causes injury is purely “fortuitous,” so that New Jersey, the state of Johnson & Johnson’ s headquarters and the place in which manufacture of the stent was alleged to have occurred, rather than Kentucky, had the “most significant relationship” and therefore should have had its law applied. Had New Jersey’s statute of limitations applied, Ms. Cornett’s complaint would have been timely, since she filed within two years of December 2006. By finding that there was no conflict between New Jersey and Kentucky law, the Court did not reach the “fortuitous” issue.
There are decisions from other courts that hold that, where a product is distributed nationwide, the place of injury is purely “fortuitous,” such that the law of that state should not apply. The Restatement analysis seems clearly to call for that, as plaintiff contended at oral argument in Cornett. It is difficult to see how the divergence between a one-year and a two-year statute of limitations, which was dispositive here, is not a conflict of laws that should have triggered the Restatement analysis. Nonetheless, having disposed of this case by finding no conflict of laws and no reason to apply a law other than that of Kentucky (though the opinion does include terse dicta in a footnote that if there were a true conflict, the Court had “no quarrel” with the use of Kentucky law), the Court left the “fortuitous” issue open for another case.