CORNETT v. JOHNSON JOHNSON

safety, effectiveness, or benefit of a use not described in the approved labeling[.]" 21 U.S.C.A. §§ 360aaa, 360aaa-1. 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 FDA regulation that required even manufacturers that engaged in no promotion of off-label uses to add label warnings about any off-label use of which it had "notice." Riley, supra, 625 F.Supp.2d at 781-83.

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.

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, 148 L.Ed.2d; at 862 n. 4. That prohibition requires a plaintiff to characterize his or her claims about a device as violations of state law, which 21 U.S.C.A. § 360k or 21 U.S.C.A. § 396 may then preempt as the following case law elucidates.

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, 135 L.Ed.2d at 709-10, 715-16. Even with the passage of the MDA, Congress did not intend to insulate medical devices from all state common law causes of action, because if that were the true intention, Congress could easily have drafted 21 U.S.C.A. § 360k to preclude all "remedies" under state law. Id. at 487-88, 116 S.Ct at 2251-52, 135 L.Ed.2d at 717.

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, 135 L.Ed.2d at 718. The other was state requirements relating to the safety or effectiveness of devices, a construct that "appears to presume that the State is imposing a specific duty upon the manufacturer" in relation to the device's safety or effectiveness. Id. at 487-88, 116 S.Ct. at 2251-52, 135 L.Ed.2d at 717.

"[S]pecific 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, 135 L.Ed.2d at 717-18, 723-24. Only requirements specific to devices would merit the deferential presumption that "the [f]ederal [g]overnment has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers." Id. at 500-01, 116 S.Ct. at 2258, 135 L.Ed.2d at 725. Federal requirements "regarding a specific device or [the] field of device regulation[,]" as opposed to requirements that "reflect important but entirely generic concerns about device regulation generally," were the only ones that Congress was concerned "to protect from potentially contradictory state requirements." Id. at 501, 116 S.Ct. at 2258, 135 L.Ed.2d at 725.

Turning to the nature of the state law claims before it, Lohr acknowledged that common-law duties that "parallel federal requirements" but then add elements, such as the existence of negligent conduct, may literally be "different from" the federal requirement. Id. at 495, 116 S.Ct. at 2255, 135 L.Ed.2d at 721-22. However, because they do not impose additional burdens on the manufacturer, and instead compel additional proofs to afford a remedy, they are actually more protective of the manufacturer. Id. at 495-96, 116 S.Ct. at 2255-56, 135 L.Ed.2d at 721-22. 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, 135 L.Ed.2d at 725.

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, 169 L.Ed.2d at 900. Riegel suffered a heart attack, and shortly after the heart attack underwent a coronary angioplasty. Ibid. His artery was heavily calcified and diffusely diseased. Ibid. During surgery, his surgeon attempted to dilate the artery by using the catheter, despite the label's contraindications, which stated the catheter was not for use in patients with calcified or diffuse stenoses. Ibid. Also, during this operation, Riegel's surgeon inflated the catheter to a pressure of 10 atmospheres five times, in spite of the label's warning that the catheter should not be inflated beyond a pressure of eight atmospheres, the rated burst pressure. Ibid. On the fifth inflation, the catheter burst. Ibid. Riegel then developed a heart block, had to be placed on life support, and ultimately, emergency coronary bypass surgery was necessary. Ibid.

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, 169 L.Ed.2d at 900-01. He did not allege that the manufacturer violated any federal requirements. Riegel v. Medtronic, Inc., 451 F.3d 104, 106 (2d Cir. 2006), aff'd, 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). In its answer, Medtronic raised the affirmative defense of federal preemption. Id. at 107.

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)(1)). 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 Lohr, 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 the violation of a substantive legal obligation, which in the context of a negligence or strict liability claim amount to a "requirement," and 21 U.S.C.A. § 360k preempted all such requirements. Id. at 323-24, 128 S.Ct at 1007-08, 169 L.Ed.2d at 902-03. The Court reasoned that the mere existence of federal and state requirements created the potential for multiple standards of conduct for the design and marketing of devices, which was precisely what Congress intended to avoid. Id. at 323-24, 128 S.Ct at 1007-08, 169 L.Ed.2d at 902-03. It was irrelevant that the state common law obligations applied to all products rather than just medical devices, because 21 U.S.C.A. § 360k prohibited any state requirement whenever there was a federal requirement specific to devices, no matter how general the state requirement may be. Id. at 327-28, 128 S.Ct at 1009-10, 169 L.Ed.2d at 905. Thus, the Court interpreted the statutory language as preempting all state causes of action that created the possibility of "a jury determination that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings." Id. at 329, 128 S.Ct. at 1011, 169 L.Ed.2d at 906.

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 1008-09,169 L.Ed.2d at 904. The Court believed that the statutory language "suggests that the solicitude for those injured by" such devices "was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations." Id. at 326, 128 S.Ct. at 1009, 169 L.Ed.2d at 904.

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, 169 L.Ed.2d at 906. Riegel agreed with Lohr that the "different from, or in addition to" language in 21 U.S.C.A. § 360k meant that the statute "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations[,]" because "the state duties in such a case `parallel,' rather than add to, federal requirements." Ibid, (quoting Lohr, supra, 518 U.S. at 495, 116 S.Ct at 2255, 135 L.Ed.2d at 721). Riegel did not, however, reach the plaintiffs' arguments that their state claims were parallel; it deemed them waived for lack of prior assertion. Supra, 552 17 at 330, 128 S.Ct. at 1011, 169 L.Ed.2d at 907.

Lohr and Riegel did not involve a claim that a device's manufacturer had intended or promoted an off-label use. Buckman did, although the device had been approved as a substantial equivalent rather than under the PMA regime. Because such approval did not reflect any federal requirements for demonstrating safety or effectiveness, and with which the plaintiffs state law claims could conflict, such claims arguably were not expressly preempted by § 360k(a). But that did not end the inquiry because even though not expressly preempted, such claim may be impliedly preempted. Buckman, supra, 531 U.S. at 347-18, 121 S.Ct. at 1017, 148 L.Ed.2d at 861.

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, 169 L.Ed.2d at 900-02.

In Buckman, the plaintiff premised his state cause of action on the claimed federal violation that the manufacturer had committed "fraud on the FDA" by failing to disclose that it intended the device for off-label uses. Ibid. The Court explained that "[p]olicing fraud against federal agencies" was not a traditional field of primarily state regulation, which meant that "the relationship between a federal agency and the entity it regulates is inherently federal in character" and therefore, actionable only under federal law. Id. at 347-18, 121 S.Ct. at 1017, 148 L.Ed.2d at 860-61. A state cause of action for fraud on the FDA, including failure to disclose intended off-label uses, would conflict with the flexibility that Congress granted the FDA for two reasons: to balance the regulation of devices that had "potentially beneficial off-label uses" against the concern that "unpredictable civil liability" for off-label use would discourage manufacturers from seeking approval of substantially equivalent devices even for approved uses, and to avoid discouraging physicians from off-label uses despite their legality under 21 U.S.C.A. § 396. Id. at 348-51,121 S.Ct. at 1017-19, 148 L.Ed.2d at 861-63. Lohr's presumption against the preemption of state causes of action accordingly did not apply, so implied preemption due to the conflict with federal law sufficed to preclude the plaintiffs' claims. Id. at 348, 121 S.Ct. at 1017, 148 L.Ed.2d at 861. For that reason, Buckman declined to address whether the express preemption of 21 U.S.C.A. § 360k also applied. Id. at 348 n. 2, 121 S.Ct at 1017 n. 2, 148 L.Ed.2d at 861 n. 2. 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, 148 L.Ed.2d at 864. The state causes of action that had to be preempted, because they were in effect no more than per se claims for violation of a federal requirement, such as the fraud claim before it, were thus distinguishable from "state-law causes of actions that parallel federal safety requirements" as Lohr described. Id. at 353, 121 S.Ct. at 1020, 148 L.Ed.2d at 864.

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, 78 L.Ed.2d 443 (1984), that relied on "traditional state tort law principles of the duty of care owed by the producer of plutonium fuel pins to an employee working in its plant," and "was not based on any sort of fraud-on-the-agency theory"). Regardless of how the plaintiff styles a state claim, if it is a claim that could not be articulated but for the existence of a federal requirement that was allegedly violated, it is functionally equivalent to a claim that is grounded solely on the federal violation, and is therefore impliedly preempted. Id. at 352-53,121 S.Ct. at 1019-20, 148 L.Ed.2d at 864. See also Riley, supra, 625 F.Supp.2d at 776-77 ( Buckman imposed implied preemption on state claims that "would not exist if the FDCA did not exist").

To recap, as construed by Lohr, Riegel, and Buckman, the federal statutes and regulations apply to a Class III device that must receive premarket approval (a PMA device), and preempt state claims based on requirements different than, or in addition to, those inhering in the FDA's premarket approval. Such approval encompasses the device's design, manufacturing methods, and label, including the information to be given to patients. It represents the FDA's determination that the manufacturer's clinical trials have shown the device to be safe and effective for its intended use, and that the label is accurate and contains adequate warnings against unsafe uses. Deviations from the approved design and manufacturing process make a device "adulterated" and deviation from the approved label make it "misbranded."

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.C.A. § 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, 625 F.Supp.2d at 777-78 ("[g]iven what the Supreme Court said in Buckman about the off-label use of medical devices, it seems highly unlikely" that the Court intended in Riegel to declare off-label use a vacuum of federal requirements and therefore, broadly amenable to state claims).

C. Application of the federal law to plaintiffs' claims.

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.

Plaintiffs brought their strict-liability claims under the Product Liability Act, N.J.S.A. 2A:58C-1 to -11(PLA), which governs all claims for harm caused by a product other than claims for breach of an express warranty. N.J.S.A., 2A:58C-1(b)(3). The allowable theories are that a product was harmful because it "deviated from the design specifications, formulae, or performance standards of the manufacturer or from otherwise identical units manufactured to the same manufacturing specifications or formulae[;]" that it "failed to contain adequate warnings or instructions[]" or that it "was designed in a defective manner." N.J.S.A., 2A:58C-2. The standard of liability is that the product "was not reasonably fit, suitable or safe for its intended purpose[]" Ibid.

(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 FM 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., 669 F.Supp.2d 701, 710 (S.D.Miss. 2009) (same); Wolicki-Gables v. Arrow Int'l Inc., 641 F.Supp.2d 1270, 1285-86 (M.D.Fla. 2009) (same); In re Medtronic, Inc., 592 F.Supp.2d 1147, 1162-64 (D.Minn. 2009) (same).

(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.

A state claim with that effect is therefore parallel under Riegel `s construction of Lohr and not preempted. Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830, 836-37 (S.D.Ind. 2009). Cf. Wolicki-Gables, supra, 641 F.Supp.2d at 1285 (holding that a manufacturing defect claim was preempted because state law allowed liability even without violation of federal requirements); Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 282-83 (E.D.N.Y. 2009) (finding a claim was allowable as parallel, but the pleading of causation failed to satisfy federal standards). Indeed, the court in Hofts, supra, held that a manufacturing defect claim, based on an allegation that the device was adulterated due to failure to comply with federal regulations, was not preempted because a jury could find the defendants breached their duty of care to the plaintiff and that the product was unreasonably dangerous without imposing different or additional requirements. 597 F.Supp.2d at 836-37. See also Riley, supra, 625 F.Supp.2d at 789 (recognizing that a properly pled manufacturing defect claim may not be preempted and allowing the plaintiffs leave to replead their claim). Here, contrary to defendant's contention, plaintiffs' manufacturing defect claim was sufficiently pleaded, because the amended master complaint incorporated the FDA warning letter's assertion of manufacturing defects that could have affected the device's safety, in particular those concerning its polymer coating, along with inadequate controls to prevent or track the release of nonconforming product.

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.

(iii) 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, 628 A.2d 710 (1993). Thus, the manufacturer has a duty to warn of "dangers" that it knew, or that it "should have known on the basis of reasonably obtainable or available knowledge." Feldman v. Lederle Labs., 97 N.J. 429, 434, 479 A.2d 374 (1984). It satisfies that duty by giving "an adequate warning or instruction." N.J.S.A. 2A:58CM.

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, 734 A.2d 1245 (1999).

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 such warnings for approved uses in the absence of deliberate nondisclosure, and such a claim was also expressly preempted under Riegel as an additional state requirement on defendants. Hughes, supra, 669 F. Supp.2d at 710; Riley, supra, 625 F. Supp.2d at 780-81.

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, 669 F.Supp.2d at 709-10. While it is true that the "misconduct" underlying plaintiffs' claims also constitutes a violation of federal regulations — indeed that is precisely why the claims are parallel — the suit was brought to vindicate plaintiffs' rights, not the FDA's. Plaintiffs adequately pled that claim.

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 over-coming 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, 734 A.2d 1245. The allegations of plaintiffs' amended complaint must be accepted as true on a motion to dismiss, and as such, the complaint sufficiently pled such deliberate violations of defendants' federal responsibilities to rebut the presumption. The Law Division erred in requiring plaintiffs to prove such deliberate nondisclosures at the motion to dismiss stage.

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, under federal law manufacturers are "obligated to warn only about intended uses, and, under the safe harbor, evidence of the dissemination of information about an off-label use [is] deemed not to be evidence of an intended use that was different from the use on the label." Riley, supra, 625 F.Supp.2d at 782; see also 21 U.S.C.A. § 360aaa-6(b).

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, 625 F.Supp.2d at 777. Indeed, in Riegel, supra, the plaintiffs' claims were found to be preempted by § 360k(a) even though the balloon catheter at issue there had been used off-label. 552 U.S. at 320, 128 S.Ct. at 1005, 169 L.Ed.2d at 900. And in Buckman, supra, the Supreme Court recognized that off-label usage is not illegal or even disfavored under federal law. 531 U.S. at 350-51, 121 S.Ct. at 1018-19,148 L.Ed.2d at 862-63.

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, 625 F.Supp.2d at 781-82. All such activity is in violation of the federal requirements, so the PLA would then be a parallel requirement, while also reflecting a traditional state law cause of action. A claim that promotion of off-label use beyond the safe harbor was coupled with a failure to warn would not be preempted. Id. at 783-84. ("Insofar as [plaintiff] sufficiently alleges that, in the course of unlawfully promoting the Cypher stent for off-label use, Cordis failed to adequately warn of foreseeable dangers of that use, [plaintiff] may succeed in asserting a claim that is neither expressly or impliedly preempted.") The federal violation did not have to be the with-holding of information from the FDA, because there were other ways in which promotion could exceed the safe harbor.

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. If that were the extent of the allegation, it would not have succeeded as preempted because, as noted, the lack of federal requirements does not mean off-label marketing is prohibited entirely. To the contrary, the FDA's failure to require adequate off-label warnings for devices promoted within the safe harbor is a deliberative decision in and of itself that warrants preemptive force. But plaintiffs' complaint goes much further. Plaintiffs also allege that defendants affirmatively promoted the off-label use of the Cypher stent in a manner that violated federal law, specifically 21 C.F.R. §§ 99.101, 803.10(c), 803.50, 814.39; that defendants were aware or should have been aware of the dangers inherent in the off-label uses from post-approval studies they performed revealing a significant adverse event rate associated with their device's unapproved uses yet affirmatively represented that there were "no stent thrombosis or mortality differences between the off-label [] subgroups . . . [and] indicated [ i.e. on-label subgroups] . . ."; and that while marketing the device in violation of federal law, defendants failed to include adequate warnings about the off-label use they were promoting. Under the liberal standard of review for a motion to dismiss, we conclude that plaintiffs' allegation of off-label promotion without adequate warnings was a sufficient pleading.

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 Plavixe. The [Cypher] stent was defective due to inadequate warnings because after [defendants 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.

(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.M 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 claim[.]" N.J.S.A. 2A:58C-1(b)(3). This preclusion of breach of implied warranty "as a viable separate claim" is "definitive." Tirrell v. Navistar Int'l Inc., 248 N.J.Super. 390, 398, 591 A.2d 643 (App. Div.), certif. denied, 126 N.J. 390, 599 A.2d 166 (1991). Accord Koruba v. Am. Honda Motor Co., Inc., 396 N.J.Super. 517, 531, 935 A.2d 787 (App.Div. 2007), certif. denied, 194 N.J. 272, 944 A.2d 32 (2008).

(vi) PLA Punitive Damages

For PMA devices, the PLA allows punitive damages only "where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the [FDA]'s regulations, which information was material and relevant to the harm in question[.]" N.J.S.A. 2A:58C-5(c). Instead of making punitive damages an aspect of a common-law claim for compensatory damages (or of the statutory replacement for such a claim), the Legislature enacted a separate statute that was "narrowly drawn" with "the single focus upon fraud on the FDA" as unlawful conduct that the State had an interest in punishing. McDarby, supra, 401 N.J.Super. at 90-93, 949 A.2d 223. Buckman accordingly precludes all claims that the FDA would have responded differently to an application if the manufacturer had fully and accurately provided all the information that federal law required. Id. at 93-94, 949 A.2d 223. That is the nature of the punitive damages claim here, and consequently such a claim is preempted.

(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.