Cornett v. Johnson

• Citation: 414 N.J.Super. 365,998 A.2d 543
• Court: Superior Court of New Jersey
• Decision Date: 23 July 2010
• Parties: Vonnie CORNETT, individually and on behalf of the estate of Billie Cornett, deceased, Plaintiffs-Appellants,v.JOHNSON & JOHNSON and Cordis Corp., Defendants-Respondents.Ernie Williamson and Alisha Williamson, Plaintiffs-Appellants,v.Johnson & Johnson and Cordis Corp., Defendants-Respondents.

414 N.J.Super. 365

998 A.2d 543

Vonnie CORNETT, individually and on behalf of the estate of Billie Cornett, deceased, Plaintiffs-Appellants,

v.JOHNSON & JOHNSON and Cordis Corp., Defendants-Respondents.

Ernie Williamson and Alisha Williamson, Plaintiffs-Appellants,

v.Johnson & Johnson and Cordis Corp., Defendants-Respondents.

Superior Court of New Jersey Appellate Division.

Argued June 8, 2010.

Decided July 23, 2010.

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Bruce D. Greenberg and Peter E. Seidman (Milberg LLP) of the New York bar, admitted pro hac vice, argued the cause for appellants (Lite DePalma Greenberg LLC, Mr. Seidman, and Alastair Findeis (Milberg LLP) of the New York bar, admitted pro hac vice, attorneys; Mr. Seidman and Mr. Findeis, of counsel; Mr. Greenberg and Mayling C. Blanco, Newark, on the briefs).

Peter C. Harvey (Patterson Belknap Webb & Tyler, LLP) argued the cause for respondents.

Before Judges PARRILLO, LIHOTZ, and ASHRAFI.

The opinion of the court was delivered by

PARRILLO, J.A.D.

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® 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.¹

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 (, in-stent restenosis, bifurcation lesions, or patients with acute myocardial infarction.”

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 out-of-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...