On appeal from the Superior Court of New Jersey, Law Division, Middlesex County, L-7812-08 (Cornett), L-7789-08 (Williamson), L-7790-08, L-7791-08, L-7792-08, L-7793-08, L-7794-08, L-7795-08, L-7796-08, L-7797-08, L-7798-08, L-7799-08, L-7800-08, L-7802-08, L-7804-08, L-7806-08, L-7808-08, L-7809-08, L-7810-08, L-7811-08, L-7814-08, L-7815-08, L-7816-08, L-7817-08, L-7818-08, L-7819-08, L-7821-08, L-7825-08, L-7827-08, L-7829-08, L-7831-08, L-7832-08, L-7833-08, L-7834-08, L-7835-08, L-7836-08, L-7838-08, L-7840-08, L-7843-08, L-7847-08, L-7850-08, L-7852-08, L-7854-08, L-7855-08, L-7856-08, L-7857-08, L-7858-08, L-7859-08, and L-1851-09.
The opinion of the court was delivered by: Parrillo, J.A.D.
Before Judges Parrillo, Lihotz, and Ashrafi.
At issue in these consolidated appeals is whether State causes of action in strict product liability, breach of express and implied warranty, and derivative claims for alleged defects in a medical device, the Cypher(r) Sirolimus-Eluting Coronary Stent (Cypher or device), manufactured by defendant Cordis Corporation (Cordis or defendant) are preempted by the Medical Device Amendments of 1976 (MDA), 21 U.S.C.A. §§ 360c-360m, to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.A. §§ 301-399. Also at issue is whether Kentucky's or New Jersey's statute of limitations applies to one of these matters for purposes of determining whether the action is time barred. We hold that under either State's law of repose, the action filed by plaintiff Vonnie Cornett, individually and on behalf of the estate of her deceased husband Billie Cornett, is untimely and therefore, affirm the dismissal of her complaint. We also hold that certain claims of all remaining plaintiffs are federally preempted and accordingly affirm the Law Division's dismissal of those claims, but otherwise reverse the dismissal of their other claims and remand.
In September 2008, plaintiffs Vonnie Cornett (Vonnie) and Ernie and Alisha Williamson (collectively Williamsons) filed separate actions in the Law Division for alleged defects in the Cypher drug-coated arterial stent, a medical device manufactured by defendant Cordis, a wholly owned subsidiary of co-defendant Johnson & Johnson (J & J). They claimed negligence and strict product liability for design defect, manufacturing defect, and failure to warn; breach of implied and express warranties; negligent misrepresentation and fraud; statutory punitive damages for product liability; and for the Williamsons, loss of consortium. In January 2009, Vonnie filed an amended complaint, which dropped the negligence claims, as well as negligent misrepresentation and fraud, while adding claims for wrongful death, survivorship, and loss of consortium.*fn1
Forty-six other cases were consolidated with the Williamsons' action, which was further consolidated with Vonnie's action. The court granted plaintiffs' motion to adopt a "master complaint," and ordered that Vonnie's amended complaint "be deemed to have amended" the complaints in all the cases "with respect to those allegations and causes of action that are common[.]"
In January 2009, defendants moved to dismiss in lieu of answering, pursuant to Rule 4:6-2(e). Following argument on April 17, 2009, the court, applying Kentucky's statute of limitations, dismissed Vonnie's action as, among other reasons, untimely, and dismissed the remaining actions on the ground that federal approval of the device preempted all State causes of action.
By way of background, the first arterial stents were made of bare metal. A stent is a tiny metal mesh tube that is implanted in the coronary artery to open the artery and improve blood flow through the heart. The healing process after the implantation of any stent is the beneficial regrowth atop the stent and arterial wall of endothelial tissue, the normal artery lining that reduces the risk that a blood clot, or thrombus, will form and adhere. To prevent such clots during the period that regrowth was believed to require, patients were prescribed an antiplatelet drug like Plavix.
Cordis, incorporated in Florida with its principal place of business there, is a wholly-owned subsidiary of J & J, a New Jersey corporation with its principal place of business here. Cordis operates facilities worldwide, including one in Warren, New Jersey.
Cordis, as well as other manufacturers, developed "drug-eluting stents," which were coated with slow-release drugs intended to inhibit excessive regrowth and thus prevent the artery from being narrowed through the build-up of new tissue. The drug-eluting stent at issue here is Cordis' Cypher stent, which Cordis coated with sirolimus, a chemotherapy drug from Wyeth that slows cell growth and, in turn, the healing process. Cordis used the polymer PEVA/PBMA to bind sirolimus to the device's metal surface.
The Cypher is a Class III medical device regulated by the Food and Drug Administration (FDA) pursuant to the MDA. Class III devices are used for "supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health[.]" 21 U.S.C.A. § 360c(a)(1)(C)(ii) (1). "Class III devices receive more extensive federal oversight than any other class of medical devices and are subject to a comprehensive and rigorous process known as premarket approval ("PMA")." Riley v. Cordis Corp., 625 F. Supp. 2d 769, 774 (D. Minn. 2009); see Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 1004-05, 169 L.Ed. 2d 892 (2008); 21 U.S.C.A. § 360e. As part of its application for PMA, a manufacturer must provide the FDA with "reasonable assurance" that the device is both safe and effective. 21 U.S.C.A. § 360e(d)(2). The manufacturer must comply with all design, manufacturing, and labeling specifications set forth in a PMA approval order. 21 C.F.R. § 814.80. The FDA continues its oversight of the safety and effectiveness of PMA-approved devices after approval. See, e.g., 21 C.F.R. § 814.39(a).
On April 24, 2003, the FDA approved Cordis' application for premarket approval of Cypher. The approval letter stated that Cypher was "indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.5 to ≤ 3.5 mm." The letter instructed that advertising "and other printed materials . . . should not include indications or claims not included in the FDA-approved labeling[,]" with the examples of "use in diabetic patients, small vessels (< 2.5="" mm="" diameter),="" in-stent="" restenosis,="" bifurcation="" lesions,="" or="" patients="" with="" acute="" myocardial="">
The letter noted that the "[l]ong-term outcome (beyond [twelve] months) for this permanent implant is unknown at present[,]" and it imposed several conditions on the approval. For five years, Cordis was to collect and submit annual updates on the clinical outcomes of the patients in the preapproval clinical studies. Defendant was also to collect such information on 2,000 other United States patients "to evaluate the potential for less frequent adverse events" that "could not be detected in your initial clinical trials" or that "may have resulted from changes in the manufacturing process between the production of the clinical trial lot and commercial scale-up." In addition, Cordis had to monitor and report changes made in the label for sirolimus, and seek supplemental PMA to effect any appropriate corresponding changes to the device's label. Other manufacturers also obtained FDA approval of their drug-eluting stents.
In April 2004, the FDA sent Cordis a warning letter that described several failures at its facilities, in Warren and outof-state, to satisfy federal requirements for manufacturing processes and administrative practices that validate conformity to a device's design, and to identify nonconforming product and prevent its distribution. At Cordis's multiple facilities, the FDA noted there were incidents in which Cordis decided that laboratory test results of "[o]ut-[o]f-[s]pecification" for some lots were invalid, or, with respect specifically to its Florida facility, in which lots of devices with "[redacted] coated defects" were released without "adequate data or justification" for Cordis' conclusion that the nonconformity posed a minimal safety risk.
According to the master complaint, in the meantime, Cordis began marketing the device. Defendants represented at medical conferences that significant endothelial regrowth occurred within thirty days of implantation, and that patients would only have to take antiplatelet drugs for ninety days. The master complaint further alleges that Cordis also promoted off-label uses. A May 2004 press release said that clinical studies "suggest" the device also had the "potential" to "treat higher-risk and more challenging blockages" and an October 2005 press release asserted that a study of patients with chronic total occlusions had better clinical outcomes with the device than with bare-metal stents. In March 2007, another press release declared that a two-year study including off-label uses showed a low rate of adverse events, and no differences in the rates of mortality or stent thrombosis between patients who had received the device for approved versus off-label uses.
The master complaint went on to claim that while defendants distributed those studies, they did not include information about the adverse events that the studies reported, and they withheld other relevant treatment information they had about off-label uses. For example, post-marketing studies of clinical results showed that some patients who received a drug-eluting stent did not have endothelium regrow over the stent for at least four years. Others showed that patients who were no longer taking antiplatelet drugs had significantly higher rates of heart attacks and death at eighteen to thirty-six months after implantation. Such patients also had a higher rate of stent thrombosis, which did not diminish over time, but rather increased linearly. The studies indicated that the drug coating had prevented regrowth in those patients by damaging their endothelium.
According to the master complaint, in December 2006, the FDA convened an advisory panel, which reported an increased risk of thrombosis for drug-eluting stents from one to four years after implantation compared to bare-metal stents. The "risk of all causes of death" was no higher overall than for bare-metal stents, although the subgroup of patients who received a drug- eluting stent for off-label use had a significantly increased risk of late thrombosis "associated with death and myocardial infarction" compared to patients who received such stents for approved uses.
Billie Cornett, Vonnie's decedent, resided in Kentucky and was presumably treated there. He had coronary artery disease that was treated with implantation of a Cypher stent on December 16, 2004. He also had diabetes, which made the use of the device in him off-label. On May 18, 2005, a cardiac catheterization disclosed a subacute thrombosis in the artery with the stent. Billie died on June 1, 2005, purportedly from subacute stent thrombosis arising from the device's implantation. As noted, Vonnie filed her complaint in September 2008.
The Williamsons resided in Illinois. Ernie's only asserted injury was that simply having the device required long-term antiplatelet therapy and the exposure to whatever risks that might entail. Their complaint did not state the date when he received the device, name his medical condition, or assert that the use of the device in him was off-label.
As noted, the court, applying Kentucky's statute of limitations, granted defendants' motion to dismiss Vonnie's complaint as untimely. Plaintiffs argue the choice of law should have been that of New Jersey, which has a strong governmental interest in discouraging domestic corporations from manufacturing and distributing unsafe products within the State. Applying New Jersey's discovery rule, plaintiffs further contend that no patient is expected to understand the possibility of injury from a medical device before the medical community has reached such an understanding concerning patients with the same condition. We disagree.
Choice of law analysis is necessary when the statute of limitations of one potential forum would bar a claim as untimely but that of another would not. Gantes v. Kason Corp., 145 N.J. 478, 481-82 (1996). In this regard, in New Jersey, the limitation period for product liability actions is two years after the cause of action "shall have accrued." N.J.S.A. 2A:14-2(a); Burd v. N.J. Tele. Co., 76 N.J. 284, 288 (1978). New Jersey courts apply a "discovery rule," under which a cause of action does not accrue "until the injured party discovers, or by an exercise of reasonable diligence and intelligence should have discovered that he may have a basis for an actionable claim." Lopez v. Swyer, 62 N.J. 267, 272 (1973). The bases of a claim for personal injury are the plaintiff's awareness that he or she sustained an injury, and the understanding that the injury may involve another party's fault. Vispisiano v. Ashland Chem. Co., 107 N.J. 416, 427 (1987). When the plaintiff is aware of a "'state of facts'" indicating that a third party's unreasonable conduct might have contributed to the injury, "medical or legal certainty is not required." Lapka v. Porter Hayden Co., 162 N.J. 545, 555-56 (2000) (internal citation omitted).
In Kentucky, on the other hand, the limitation period for a personal injury claim is one year. Ky. Rev. Stat. Ann. § 413.140(1)(a) (LEXIS 2010); Fluke Corp. v. LeMaster, 306 S.W.3d 55, 60 (Ky. 2010). It may be extended by another year for the representative of a decedent who died before the period ran. Ky. Rev. Stat. Ann. § 413.180(1) (LEXIS 2010).
Kentucky statutes provide a discovery rule in limited circumstances that do not include product liability claims.
Ky. Rev. Stat. Ann. § 413.140 (LEXIS 2010); Fluke Corp., supra, 306 S.W.3d at 60-61. The discovery rule that Kentucky limits to medical malpractice claims resembles the rule that New Jersey applies to all claims: a claim accrues when "the injury is first discovered or in the exercise of reasonable care should have been discovered[.]" Ky. Rev. Stat. Ann. § 413.140(2) (LEXIS 2010). However, Kentucky also imposes an outer limit of five years from when the alleged negligence occurred. Ibid.*fn2
Assuming, therefore, a reasonable probability that the application of Kentucky versus New Jersey law would have led to different results on the question of Vonnie's timeliness, we next consider which state's law applies. In P.V. ex rel. T.V. and L.V. v. Camp Jaycee, 197 N.J. 132, 138-43 (2008), the Court adopted the standard in the Restatement (Second) of Conflict of Laws (1971) (Restatement) for choice-of-law questions, which was the "most significant relationship" test. See also Fu v. Fu, 160 N.J. 108, 119-39 (1999). P.V. explained how the "governmental-interest" test used in Gantes, Fu, and other cases had become substantially similar to the Restatement's "most significant relationship" test, to the point that it expressly relied on the Restatement's statement of relevant factors and guiding principles. P.V., supra, 197 N.J. at 141-42. Unlike a "pure governmental interest analysis[,]" however, in which the relative strength of each state's governmental interests was "dispositive," the Restatement test used additional factors in assessing the significance of each state's contacts with the matter. Ibid.
Under the Restatement Section 146, the choice-of-law analysis in personal injury cases proceeds with the presumption that the law of the state where the injury occurred will apply "'unless, with respect to the particular issue, some other state has a more significant relationship under the principles stated in § 6 to the occurrence and the parties, in which event the local law of the other state will be applied.'" P.V., supra, 197 N.J. at 141 (quoting Restatement, supra, § 146). Since Section 146 applies to strict liability claims for personal injury, Restatement, supra, § 146 comment a, it therefore covers product liability actions. Dorman v. Emerson Elec. Co., 23 F.3d 1354, 1359 (8th Cir.), cert. denied, 513 U.S. 964, 115 S.Ct. 428, 130 L.Ed. 2d 341 (1994); Kozoway v. Massey-Ferguson, Inc., 722 F. Supp. 641, 642-44 (D. Colo. 1989); McKinnon v. F. H. Morgan & Co., 750 A.2d 1026, 1028 (Vt. 2000). Thus, because Billie Cornett's injury occurred in Kentucky, Section 146 recognizes that state as "likely to have the predominant . . . relationship to the parties and issues in the litigation." P.V., supra, 197 N.J. at 144.
Nevertheless, that presumption could be overcome. The Restatement lists a number of contacts that must be weighed in determining the state having the more significant relationship. Id. at 144-45. They are:
(a) the place where the injury occurred,
(b) the place where the conduct causing the injury occurred,
(c) the domicil, residence, nationality, place of incorporation and place of business of the parties, and
(d) the place where the relationship, if any, between the parties is centered.
[Restatement, supra, § 145(2)(a)-(d).]
The analysis of those contacts is "not merely quantitative." P.V., supra, 197 N.J. at 147. The purpose is to determine their bearing for the guiding touchstones of Section 6 of the Restatement, which, "[r]educed to their essence," are: "(1) the interests of interstate comity; (2) the interests of the parties; (3) the interests underlying the field of tort law; (4) the interests of judicial administration; and (5) the competing interests of the states." Ibid. (internal quotations and citations omitted).
In our view, the factors of Section 145 of the Restatement, when assessed in terms of the standards of Section 6, show that Kentucky had the more significant relationship to this case. The Cornetts were long-time Kentucky residents, and Billie received all medical care relating to his condition and the device there. Kentucky is where the stent was purchased, implanted and allegedly became blocked. See Rowe v. Hoffman LaRoche, Inc., 189 N.J. 615, 629 (2007). This particular plaintiff was neither operated on nor injured in Kentucky by pure "happenstance[,]" so the place of injury could not be discounted as a fortuity. P.V., supra, 197 N.J. at 138, 145-46; Fu, supra, 160 N.J. at 137. Kentucky was also the locus of the parties' relationship, because while Cordis issued its warnings and warranties from Florida, Billie and his ...