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.
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 eases “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.
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[J” 21 U.S.C.A. § 360c(a)(l)(C)(ii)(l). “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.,
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 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
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 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
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.
I.
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,
In Kentucky, on the other hand, the limitation period for a personal injury claim is one year. Ky.Rev.Stat. Ann. § 413.140(l)(a) (LEXIS 2010); Fluke Coup. v. LeMaster,
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,
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,
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,
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,
(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)J
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-La Roche, Inc., 189 N.J. 615, 629,
On the other hand, the fact that Cordis’ parent company, J & J, is headquartered and incorporated in New Jersey is of tenuous relevance absent any showing that the subsidiary is merely its corporate parent’s alter ego and lacks a separate corporate existence. Nor is it sufficient that Florida-based Cordis maintains one of a number of its facilities in New Jersey without any demonstration that specific and identifiable activities in the New Jersey operation contributed to decedent’s injury. In this regard, plaintiffs only allegation even remotely related to New Jersey is that Cordis’ Warren facility was among five others that, after plant inspections, received warnings from the FDA about certain manufacturing processes conducted on premises.
In any event, while New Jersey undoubtedly has an interest in regulating the safety of any activities in Cordis’ Warren facility that might have contributed to the injury, see Smith v. Alza Corp., 400 N.J.Super. 529, 545,
These distinctions imply a different balancing of, on the one hand, the need to regulate product safety and, on the other, the need to avoid undue inhibition of the availability of products to consumers. Consequently, they reflect different “interests underlying the field of tort law[.]” See P.V., supra, 197 N.J. at 147-50,
Applying New Jersey law would thus threaten “the values of uniformity and predictability” that are the main interests of judicial administration, by impairing Kentucky’s ability to regulate conduct within its borders according to its own standards. Id. at 153-54,
Even were New Jersey law to apply, we find that plaintiff would fare no better. On its face, plaintiffs September 2008 complaint, alleging decedent’s May 29, 2005 death from a blood clot in Cordis’ medical device diagnosed on May 18, 2005, is time-barred. N.J.S.A 2A:14-2(a); N.J.S.A 2A:31-3. Plaintiff argues, however, that the causative link would not have been discovered until December 2006 when the FDA convened an advisory panel to examine the risks of thrombosis related to drug-eluting stents, and therefore, New Jersey’s equitable discovery rule should operate to defer the accrual of her cause of action. We, as did the motion judge, disagree.
Generally, a cause of action accrues at the time of injury. Tevis v. Tevis, 79 N.J. 422, 431,
Here, on May 18, 2005, a “sub acute stent thrombosis” was observed “in the area where the Cypher stent was placed.” Thus, we may reasonably characterize the May 18, 2005 diagnosis of decedent’s stent thrombosis as the date of the injury itself. The thrombosis was immediately apparent, and its diagnosis approximately five months after decedent received his stent on December 16, 2004, with no alleged intervening events, coupled with his death eleven days later, should have made plaintiff at least realize that Billie’s death may have been related to a defect in the device or in its use. Vispisiano, supra, 107 N.J. at 427,
Plaintiff nevertheless contends that the cause of action did not accrue until the medical community reached a consensus as to causation. But neither medical nor legal certainty is required if the state of facts would alert a reasonable person to the possibility of an actionable claim, Lapka, supra, 162 N.J. at 555-56,
II.
The Law Division dismissed the remaining counts in the master complaint for the consolidated matters, ruling that the express preemption provision for medical devices in the federal statutes precluded all of the plaintiffs’ claims. In particular, the claimed express warranty was the patient information card and guide that the FDA had specifically approved as part of Cypher’s label, so a claim “that these materials failed to conform with the materials expressly approved by the FDA ... would be patently false.” The claim for breach of express warranty was thus “nothing more than a defective labeling/failure to warn claim, which is preempted” for a device approved under the FDA’s premarket approval regime.
The court further found that plaintiffs were simply declaring their claims to be parallel to federal requirements in order to invoke that exception to preemption, without using facts or legal authority to demonstrate that the standards for proving their claims were indeed equivalent to the federal requirements. Even if claims concerning off-label use were not categorically preempted, the amended complaint contained no allegations that defendants had promoted any particular off-label use.
On appeal, plaintiffs contend the court erred in finding their master complaint was preempted by federal law. They argue that federal law permits claims for violation of state-law duties that parallel federal requirements for medical devices, and that they pleaded each claim in conformity with that test. For reasons that follow, we conclude that some of plaintiffs’ claims were properly dismissed as preempted, but that others should not have been rejected on a motion to dismiss.
As a threshold matter, we note the standard of review for the dismissal of a complaint under R. 4:6-2(e), for failure to state a claim on which relief can be granted, is whether the pleadings even “suggestf ]” a basis for the requested relief. Printing Mart-Morristown v. Sharp Elecs. Corp., 116 N.J. 739, 746,
A. The statute and regulations.
The Food, Drug, and Cosmetic Act, 21 U.S.C.A. §§ 301-399 (FDCA), did not cover devices until Congress enacted the Medical Device Amendments of 1976 (MDA), which added 21 U.S.C.A §§ 360c-360m to the FDCA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-476, 116 S.Ct. 2240, 2246,
A device is misbranded if the label is “false or misleading” in any way. 21 U.S.C.A. § 352(a). A device is also misbranded “[ujnless its labeling bears ... warnings against use in those pathological conditions ... where its use may be dangerous to health,” and any necessary warnings against unsafe “methods ... of administration!)]” 21 U.S.C.A § 352(f).
As noted, Cypher was a new kind of Class III device, which required premarket approval (PMA). 21 U.S.C.A § 360e(a)(l)(C). The applicant for PMA of a Class III device had to demonstrate its safety and effectiveness in “the persons for whose use the device is represented or intended” and “with respect to the conditions of use prescribed, recommended, or suggested in the label[.]” 21 U.S.C.A. § 360c(a)(2)(A)-(B). The applicant thus had to provide “a detailed description of the proposed conditions of use of the device,” 21 U.S.C.A § 360c(a)(3)(D)(i); a sample label delineating the intended uses, 21 U.S.C.A § 360e(e)(l)(F); and “full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective[.]” 21 U.S.C.A § 360e(c)(l)(A).
A manufacturer is required to follow the design controls process as enumerated in 21 C.F.R. § 820.30. In addition to design controls, the manufacturer must also comply with manufacturing controls outlined at 21 C.F.R. § 814.20(b)(4) and § 820. These controls require the manufacturer to submit to the FDA a complete description of the methods used in, and the facilities and controls used for, the manufacture, processing, packing, storage, and where appropriate, installation of the device. As to labeling of the medical device, 21 C.F.R.
PMA approval thus incorporates an FDA finding that the device is safe and effective under the conditions of use included on the label and that the label is not false or misleading. 21 U.S.C.A § 360e(d)(l)(A), (2). The manufacturer may not change the label, even to add warnings, until it submits the proposed change as part of a “supplemental” PMA application and obtains FDA approval. 21 U.S.C.A § 360e(d)(6); Riegel, supra, 552 U.S. at 319, 128 S.Ct. at 1005, 169 L.Ed.2d at 900. This preserves the balance that the FDA is presumed to have struck, during the “exhaustive” PMA process, between the imperative of safety and Congress’s recognition in 21 U.S.C.A. §§ 360k and 396, discussed below, of the importance of off-label use to the continuing improvement of medical practice. See Buckman, supra, 531 U.S. at 349-51, 121 S.Ct. at 1017-19,
After approval, the device’s manufacturer must report to the FDA whenever it “becomes aware of information that reasonably suggests” a “significant adverse device experience!.]” 21 U.S.CA § 360i(a)(l), (3). It must also perform whatever post-marketing surveillance, evaluation, and reporting the FDA ordered as a condition of approval. 21 U.S.C.A. § 3601.
The MDA includes an express preemption provision against state standards for PMA-approved devices that would be stricter than the MDA:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and
(2) whieh relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.
[21 U.S.C.S. § 860k(a).]
Two decades after it enacted the MDA, Congress clarified that the off-label use of devices was not illegal per se, by denying the FDA any power “to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21 U.S.C.A. § 396. It also 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.CA §§ 360aaa, 360aaa-l. However, if a manufacturer wishes to do so, it must also apply for approval of such a use. 21 U.S.C.A § 360aaa-3(a).
Adherence to those rules made the safe harbor absolute: “Notwithstanding ... any other provision of law, the dissemination of information relating to a new use of a drug or device, in accordance with” it “shall not be construed ... as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device.” 21 U.S.C.A. § 360aaa-6(b). The safe harbor thus mitigated the effect of 21 C.F.R. § 801.4, the 1976 PDA regulation that required even manufacturers that engaged in no promotion of off-label uses to
As for enforcement, all “proceedings for enforcement” of the FDCA must by brought “by and in the name of the United States.” 21 U.S.C.A § 337(a). The statute leaves “no doubt” that it prohibits private actions in which the only wrongdoing is violation of a federal law or standard. Buckman, supra, 531 U.S. at 349 n. 4, 121 S.Ct. at 1018 n. 4,
B. The governing federal case law.
In areas of traditional state regulation like health and safety, which for the first thirty-eight years of the FDCA included medical devices, the presumption against federal preemption is reinforced by requiring a “clear and manifest purpose of Congress” of having intended such preemption. Lohr, supra, 518 U.S. at 475-76, 484-86, 116 S.Ct. at 2245-46, 2250-51,
Instead, Congress chose to preclude only two types of state “requirements” that differed from federal requirements. One was state requirements that differed from requirements in “statutory and regulatory law that exists pursuant to the MDA itself[.]” Id. at 489, 116 S.Ct. at 2252,
“[SJpecific duty,” in turn, means “device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries” that the state cause of action would impose on all manufacturers, not just those of medical devices. Id. at 488-89, 497-500, 116 S.Ct. at 2252, 2256-57,
Turning to the nature of the state law claims before it, Lohr acknowledged that common-law duties that “parallel federal
Lohr’s seeming openness to state causes of action, however, occurred in reference to a medical device introduced into the market through a much less rigorous federal review process than the Cypher at issue here. In Lohr, the question of preemption arose in the context of an approval of a medical device under the alternate statutory requirement of 21 U.S.C.A. § 360k, as being “substantially equivalent” to the relevant pre-1976 devices and therefore “grandfathered” into approval. Because the device at issue in Lohr was covered only by generally applicable federal labeling and manufacturing requirements, and there was no federal requirement directed specifically to that particular device, there was no prospect of conflict in the dual schemes specific to device safety and effectiveness, and consequently the MDA did not preempt the plaintiffs’ state tort claims. Supra, 518 U.S. at 501, 116 S.Ct. at 2258,
By contrast, Riegel involved a balloon catheter, a Class III device approved under the PMA regime. Supra, 552 U.S. at 320, 128 S.Ct. at 1005,
The patient brought state claims for strict liability, breach of implied warranty, and “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale” of the device, which were dismissed on summary judgment. Id. at 320,128 S.Ct. at 1005-06,
The Supreme Court explained that its first task was to determine just what federal “requirements” were applicable to the specific device. Riegel, supra, 552 U.S. at 321, 128 S.Ct. at 1006, 169 L.Ed.2d at 901 (quoting 21 U.S.C.A. § 360k(a)(l)). The second task was to determine whether the state-law claims were “based upon” state requirements that related to safety or effectiveness, and if so, whether they were “different from, or in addition to[,]” the federal requirements. Ibid.
Turning to the state claims, and distinguishing Lokr, Riegel observed that they were not just related to, but rather centered on, the device’s safety and effectiveness in its approved use. Id. at 327-30, 128 S.Ct. at 1009-11, 169 L.Ed.2d at 904-07. Common law claims are premised on
Riegel expressly recognized that its interpretation of 21 U.S.C.A. § 360k would categorically deny judicial redress under state law for consumers injured by devices to which the FDA gave premarket approval. Id. at 326, 128 S.Ct. at 1008-09,
Having said all that, Riegel did not strip plaintiffs of any and all recourse for injuries from a medical device. To the contrary, the Court expressly held that the MDA preempted only state claims that applied substantive standards of liability different from the federal requirements specific to devices. Id. at 330, 128 S.Ct. at 1011,
Lohr and Riegel did not involve a claim that a device’s manufacturer had intended or promoted an off-label use.
Buckman distinguished the fraud claims before it, which “exist solely by virtue of the FDCA disclosure requirements!,]” from the claims in Lohr that “arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.” Id. at 352-53, 121 S.Ct. at 1019-20,
Furthermore, Buckman addressed a detail about “parallel” state claims that Lohr did not have to reach. Buckman explained that a claim describes a “traditional” state law cause of action not simply because it contains required elements for the manufacturer’s conduct beyond the violation of a federal requirement, but rather because it would provide the required elements of a state cause of action even with no reference to federal requirements as the measure of the reasonableness or wrongfulness of the manufacturer’s conduct. Id. at 351-52, 121 S.Ct. at 1019, 148 L.Ed.2d at 863 (distinguishing claim in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615,
PMA approval imposes a continuing duty on the manufacturer to report adverse events relating to the device that it knows or should know, as well as any studies or investigations about the device’s safety or effectiveness. However, if such information indicates the need for an enhanced warning, the manufacturer must seek FDA approval before adding it to the label. Manufacturers have a safe harbor for promoting an off-label use, namely, distributing certain clinical study reports to physicians, as long as they also seek FDA approval for it.
The requirements for a PMA device are “device-specific” because they focus on the safety and effectiveness of such devices, and are applied to each device’s particular characteristics. They are not the generic standards applied by the FDA to “substantially equivalent” devices. Therefore, to avoid the statutory preemption of state requirements that vary from federal requirements, a state claim concerning PMA devices must be parallel to the federal requirements, meaning that the state requirements it embodies must not impose any duty on the manufacturer beyond satisfying the federal requirements. However, to avoid the implied preemption of claims outside the traditional areas of state regulation, a claim concerning PMA devices must also represent a traditional state cause of action that would impose a duty on the manufacturer even if there were no federal requirements at all to be referenced, much less violated.
While plaintiffs are correct that the FDA does not literally “approve” off-label uses, because approval would axiomatically make them label uses, they are incorrect to argue that the absence of affirmative approval mandates the finding that no federal requirements exist. Federal requirements for off-label use manifestly exist, in the form of the safe harbor for their promotion, and the obligation to seek a supplemental PMA to add warnings to the label for off-label uses even when the manufacturer has no desire to promote them. Furthermore, plaintiffs’ argument presumes off-label use to be inherently suspect or substandard, which Congress rejected by enacting 21 U.S.CA § 396 to protect off-label use. See Buckman, supra, 531 U.S. at 350-51, 121 S.Ct. at 1018-19, 148 L.Ed.2d at 862-63. See also Riley, supra,
C. Application of the federal law to plaintiffs’ claims.
Plaintiffs brought their striet-liability claims under the Product Liability Act,
(i) Design Defect
Plaintiffs alleged that Cypher’s design was less safe and no more effective than bare-metal stents or drug-eluting stents using different polymer coating, as well as alternative medical treatments not involving stents, because, among other things, the polymer allegedly prevents healing of the artery and results in blood clots. The PLA would allow a jury to agree, without regard to the federal requirements for PMA approval, and without regard to any determination the FDA may have made that the device’s design had advantages compared to the alternatives that justified a certain degree of increased risks. Because the PLA is a state law that provides a different standard for the adequacy of the device’s design than the federal requirements, plaintiffs’ design defect claim is not “parallel” to them and is thus squarely within Riegel’s preemption holding. Brooks v. Howmedica, Inc., 273 F.3d 785, 796 (8th Cir.2001) (stating a claim that would allow a jury to require a different component in a PMA device is “surely” preempted by Section 360k), cert. denied, 535 U.S. 1056, 122 S.Ct. 1914, 152 L.Ed.2d 823 (2002); Funk v. Stryker Corp., 673 F.Supp.2d 522, 531 (S.D.Tex.2009) (holding differing state law to be preempted); Hughes v. Boston Scientific Corp.,
(ii) Manufacturing Defect
Unlike their claim for design defect, plaintiffs limit their allegations of manufacturing defect to what the FDA warning letter identifies as potential deviations from the device’s approved design and manufacturing processes, or from the federal requirements under 21 C.F.R. §§ 820, 814.20(b)(4), and 814.39 on manufacturing practices crafted to identify and prevent product deviations. This claim reflects the traditional state regulation of the sale of adulterated products. In effect, it incorporates the federal requirements of having to maintain fidelity to the manufacturer’s own design and performance standards without allowing an alternative measure of the manufacturer’s duty. The additional requirement that this state claim imposed on plaintiffs, proving that the deviations actually rendered the device unsafe or unsuitable for the intended uses, was acceptable because it narrowed the circumstances in which manufacturers could be liable compared to the federal scheme, instead of enlarging them.
(Hi) Failure to Warn
The PLA is a strict-liability standard that focuses on “the actual condition of the product” rather than on the reasonableness of the manufacturer’s conduct. Coffman v. Keene Corp., 133 N.J. 581, 598,
A warning that “has been approved or prescribed by” the FDA under the FDCA carries a rebuttable presumption of adequacy. Ibid. “For all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of such claims.” Perez v. Wyeth Labs., 161 N.J. 1, 25,
The warnings that plaintiffs allege defendants had a duty to provide related to the duration of antiplatelet therapy needed to ensure the regrowth of endothelium over the device, or to the lack of comparative safety studies of the polymer coating used by Cordis versus the alternatives. The FDA did not require defendants to provide such information for its review of the device’s safety and effectiveness, or to place such information on the label or the patient information materials. The FDCA’s rebuttable presumption thus barred a claim about the failure to give
However, when the claim about the failure to warn for approved uses was combined with allegations of nondisclosure, it became a claim within a traditional area of state regulation that would have existed even in the absence of federal requirements. To that extent, it satisfied Buckman’s test for avoiding implied preemption as a claim that amounted to no more than “fraud on the FDA.” Hughes, supra,
On this score, we also take issue with the Law Division’s holding that plaintiffs’ pleading failed to overcome the presumption that the device’s FDA-approved label was adequate. The basis for the court’s ruling was that the FDA, notwithstanding defendants’ alleged withholding of information and failure to provide warnings about off-label use, was otherwise “well informed” that the off-label use of the device was “prevalent.” The court found further that plaintiffs had “not provided enough evidence to show” that defendants had acted deliberately, which was required for overcoming the presumption. We disagree with the court’s reasoning.
As already noted, 21 U.S.C.A. § 360i requires defendants to submit information after approval that reasonably suggested adverse device experiences. Plaintiffs’ amended complaint clearly implied that defendants commissioned post-marketing studies that contained reportable adverse experiences, and further alleged that these studies demonstrate the label’s inadequacy concerning the need for extended antiplatelet therapy, even for approved uses. While defendants supposedly withheld them from the FDA and the advisory panel, they allegedly distributed altered versions of them to physicians, to promote both approved and off-label uses with misrepresentations about the length of antiplatelet therapy and about overall safety. According to plaintiffs’ complaint, submission of the studies as federal law required would have caused the FDA to improve the label, and any heightened warnings concerning approved uses would also have increased the safety of off-label uses.
The conduct and consequences that plaintiffs alleged constituted the kind of deliberate nondisclosure needed to overcome the PLA’s presumption of adequacy for an FDA-approved label. Perez, supra, 161 N.J. at 25,
Turning to off-label uses, the PLA permits claims only relating to a product’s “intended purpose.” As discussed above, federal law does not treat an off-label use as “intended” when the manufacturer simply has knowledge of it or is promoting it within the safe harbor. Any basis for treating such circumstances as an intended use of the product for PLA purposes would be invalid under Riegel for imposing duties on the manufacturer in addition to the federal requirements. In other words,
On this score, we reject plaintiffs’ argument that because § 360k(a) only applies when a medical device is used in a manner that was reviewed and approved by the FDA, then § 360k(a) should not preempt any of their claims against defendants arising out of the off-label use of the Cypher stent. See Riley, supra,
It is, however, only when the manufacturer promotes an off-label use without abiding the requirements or limitations of the safe harbor that federal law regards the off-label use as an intended use, triggering the duty to provide instructions or warnings about that off-label use. Riley, supra,
Here, plaintiffs alleged Billie Cornett was a diabetic and while the Cypher stent was not FDA-approved for marketing or use in diabetics, defendants marketed the device for such use.
(iv) Breach of Express Warranty
Like other state requirements that exceed federal requirements for a PMA device, a state claim that allows liability for statements in the FDA-approved label and other documentation is preempted. Riley, supra, 625 F.Supp.2d at 787-88 (noting split among decisions that pre-dated Riegel); Horowitz, supra, 613 F.Supp.2d at 285. Thus, to the extent plaintiffs’ complaint alleges that an express warranty was created by a “patient information guide” and a “product identification card,” it is preempted because the FDA already reviewed and approved this information as part of the device’s labeling in conjunction with the Cypher’s PMA. Accordingly, that part of plaintiffs’ express warranty claims premised on the contents of the Cypher’s “label” squarely conflicts with the FDA’s PMA of the Cypher and its labeling and is therefore preempted by § 360k(a).
However, a claim for breach of express warranty based on voluntary statements, meaning any statement that the FDA did not approve or mandate, is not preempted. Riley, supra, 625 F.Supp.2d at 788; Horowitz, supra, 613 F.Supp.2d at 285-86 (the claim foundered instead on a peculiarity of state law). This would apply for voluntary statements concerning approved uses, and for voluntary statements concerning off-label uses that were outside the safe harbor. “Federal law already requires Cordis to ensure that any warranty statements it voluntarily makes are truthful, accurate, not misleading, and consistent with applicable federal and state law.” Riley, supra, 625 F.Supp.2d at 788. Therefore, to the extent plaintiffs seek to impose liability on defendants for voluntarily making warranties, plaintiffs are not imposing any different or additional requirements on defendants.
(v) Breach of Implied Warranty
The preclusion of breach of implied warranty by federal law is moot, because the PLA subsumed those claims. With the sole exception of its accommodation for breach of express warranty, the PLA displaces all other causes of action “for harm caused by a product, irrespective of the theory underlying the claimf.]” N.J.S.A. 2A:58C-l(b)(3). This preclusion of breach of implied warranty “as a viable separate claim” is “definitive.” Tirrell v. Navistar Int% Inc., 248 N.J.Super. 390, 398,
(vi) PLA Punitive Damages
For PMA devices, the PLA allows punitive damages only “where the product
(vii) Wrongful Death, Loss of Consortium and Survivorship
The Law Division dismissed these claims solely for being derivative of the strict liability and breach of warranty claims it found expressly preempted. Thus, to the extent the predicate causes of action survive defendants’ preemption challenge, the derivative claims for wrongful death, loss of consortium and survivorship must stand as well.
III.
In sum, we find the following claims of plaintiffs not to be preempted: manufacturing defect; failure to warn concerning both approved and off-label uses, to the extent that plaintiffs based it on allegations of failure to satisfy federal requirements on disclosure or federal limitations on off-label promotion within the safe harbor, respectively; and breach of express warranty, to the extent that plaintiffs based it on voluntary statements relating to approved uses, or on voluntary statements about off-label uses that were outside the safe harbor. As noted, reversal of the Rule 4:6-2(e) dismissal of these predicate claims compels reinstatement of plaintiffs’ derivative claims for wrongful death, loss of consortium, and survivorship. The dismissal of plaintiffs’ remaining claims, however, was proper as either federally preempted or precluded by the PLA itself. Lastly, the dismissal of plaintiff Cornett’s complaint as untimely was required under both Kentucky’s and New Jersey’s law of repose.
Affirmed in part; reversed and remanded in part.
Plaintiffs do not appeal the dismissal of their Consumer Fraud Act claim, apparently due to our ruling that failure to warn may only be asserted as a product liability claim. McDarby v. Merck, 401 N.J.Super. 10, 94-98,
While Kentucky courts have sometimes applied a discovery rule to avoid legislative infringement of common-law causes of action that existed prior to adoption of the state constitution, they have not extended that principle to "new [statutory] rights unknown at common law." Wright v. Oberle-Jordre Co.,
While the safe harbor statutes expired on September 30, 2006, under a sunset provision, the FDA has continued to take the same position as a matter of policy. See Riley, supra, 625 F.Supp.2d 769 at 781 n. 6, 782 n. 7.
Although the device in Riegel was not indicated for that plaintiff, the Court never addressed whether claims of off-label use and/or marketing are a ground for avoiding preemption. 552 U.S. at 319-22, 128 S.Ct. at 1005-07,
Plaintiffs’ brief suggests that they are also appealing the dismissal of the negligent misrepresentation and fraud claims, but the court did not reach them, because they were stated only in the original complaints, not in the amended master complaint. We are aware of no authority indicating that an amended pleading may only add to prior pleadings instead of entirely superseding them.
Aside from its preemption ruling, we also disagree with the Law Division’s incorporated finding that Vonnie failed to allege the manufacturing defect was the proximate cause of Billie’s injury because she did not directly connect the injury to the violations named in the FDA warning letter. Although not specifically addressed by defendants on appeal and despite the dismissal of Vonnie’s complaint as untimely, we expressly vacate the court's ruling on the adequacy of the pleading to avoid its misapplication to the other plaintiffs on remand.
Although, as noted, Vonnie’s cause of action has been dismissed as untimely, the remaining plaintiffs and the master complaint allege similar off-label deviations against Cordis, and therefore, we proceed to address the issue.
Plaintiffs' master complaint alleges:
Defendants knew or should have known that the [Cypher] stent was a dangerously defective product that posed unacceptable risks unknown and unknowable by the consuming public of serious adverse health events and related conditions and diseases, including, among other things, the necessity of long-term dual and anti-platelet therapy using aspirin and Plavix®. The [Cypher] stent was defective due to inadequate warnings because after [d]efendants knew or should have known of the risk of dangerous side effects and potentially fatal health risks, they failed to provide adequate warnings to consumers of the product and continued to aggressively promote and market the dangerously defective [Cypher] stent.