IN RE: REGLAN LITIGATION

NOT FOR PUBLICATION WITHOUT THE

APPROVAL OF THE APPELLATE DIVISION

SUPERIOR COURT OF NEW JERSEY

APPELLATE DIVISION

DOCKET NO. A-0

IN RE: REGLAN LITIGATION

_______________________________________

November 12, 2014

Argued October 15, 2014 Decided

Before Judges Yannotti, Fasciale and Whipple.

On appeal from Superior Court of New Jersey, Law Division, Atlantic County, Docket No. L-3865-10.

Michael D. Shumsky (Ulmer & Berne) of the New York bar, admitted pro hac vice, argued the cause for appellants PLIVA Inc., Barr Pharmaceuticals, LLC, Barr Laboratories, Inc., and Watson Laboratories, Inc. (Goldberg Segalla LLP, and Mr. Shumsky, attorneys; Anita Hotchkiss, H. Lockwood Miller, III, Joseph P. Thomas, and Frederick M. Erny (Ulmer & Berne) of the Ohio, Pennsylvania and Kentucky bars, admitted pro hac vice, on the briefs).

McElroy, Deutsch, Mulvaney & Carpenter LLP, attorneys for appellants Actavis Elizabeth LLC, Teva Pharmaceuticals USA, Inc., Mutual Pharmaceutical Company, Inc., and United Research Laboratories, Inc., join in the briefs of appellants.

Harris Beach PLLC, attorneys for Actavis Elizabeth LLC,, join in the briefs of appellants.

Glenn S. Kerner (Goodwin Procter LLP), attorney for Teva Pharmaceuticals USA Inc., joins in the briefs of appellants.

Archer & Greiner, P.C., attorneys for appellants Mutual Pharmaceutical Company, Inc., and United Research Laboratories, Inc., join in the briefs of appellants.

Louis M. Bograd of the Washington D.C. bar, admitted pro hac vice, argued the cause for respondents (Jason Lee Pullman and Mr. Bograd, attorneys; Mr. Pullman, on the brief).

PER CURIAM

Appellants are the manufacturers of a generic prescription drug called metoclopramide, which is sold under the brand-name Reglan.1 They appeal, on leave granted, from orders entered by the Law Division on June 13, 2013, which denied their motions to dismiss or for summary judgment on claims relating to the warnings of the risks arising from long-term use of the drug. We affirm.

I.

In November 2010, plaintiffs filed a so-called "Amended Master Long Form Complaint and Jury Demand" against an array of pharmaceutical companies, alleging that they sustained personal injuries as a result of consuming Reglan and/or generic metoclopramide. Among other things, plaintiffs asserted claims of negligent misrepresentation of the risk of physical harm; defective design; failure to warn; breach of express warranties; wrongful death; negligence; fraud; fraudulent concealment; constructive fraud; negligent misrepresentation; negligent infliction of emotional distress; breach of express and implied warranties; violation of consumer protection laws; and wrongful death. They sought compensatory and punitive damages, attorneys' fees and other relief.2

The "Generic Defendants" thereafter filed motions pursuant to Rule 4:6-2(e), arguing that the claims against them are preempted by federal law. In support of their motions, they relied upon the Supreme Court's decision in Pliva, Inc. v. Mensing, 564 U.S. ___, 131 S. Ct. 2567, 2574, 180 L. Ed. 2d 580, 588 (2011). The trial court entered orders dated May 4, 2012, granting the motions in part, and denying the motions in part.

In an accompanying opinion, the trial court noted that while plaintiffs had asserted various causes of action, their claims were essentially traditional product-liability claims for injuries caused by the manufacturers' failure to provide adequate warnings for the product. The court stated that, as in Mensing, the core of plaintiffs' claims is the contention that defendants failed to provide adequate warnings about the risks arising from the long-term use of metoclopramide.

The court noted that Mensing was premised "on the notion that as long as generic manufacturers of a product obey the 'sameness' requirement [imposed by federal law] and mimic the brand-name product's labels, then preemption applies and state tort claims cannot be brought against those manufacturers." The court also noted that additional warnings were added to the brand-name product in 2004 and 2009. The court determined the Generic Defendants had not shown that the federal law prevented them from including the additional warnings for their generic metoclopramide tablets.

The court stated that the Generic Defendants had a duty under federal law to adopt the changes to the brand-name warnings. The court wrote

[I]f labels belonging to generic manufacturers of tablets did not match the brand-name manufacturers of tablets, then there are [at] least some changes to their labels that federal law would allow, or even require, these defendants to make, and state tort law in this situation does not conflict with federal law. Consequently, . . . to the extent that generic manufacturers of metoclopramide tablets failed to update the labels to be the same as the brand-name label, they are excluded from preemption.

The court accordingly decided to dismiss all counts of the complaints against the Generic Defendants, "except for any claims that are made against a generic manufacturer of the tablet that did not change the label on [its] product to match the brand-name's label." The court also decided that the claims against the manufacturers of generic syrup products must be dismissed because these manufacturers could not change their labels since there was no brand-name manufacturer of these products.

The trial court thereafter permitted discovery concerning the dates on which the Generic Defendants implemented the label changes to incorporate the July 2004 changes to the warnings used by the brand-name manufacturers. The discovery revealed that the generic drug manufacturers, other than PLIVA, had submitted applications to the federal Food and Drug Administration (FDA), and were authorized to add the additional warnings to their metoclopramide labels on various dates.

After the completion of discovery on this issue, the Generic Defendants filed motions to dismiss or for summary judgment. They again argued that plaintiffs could not pursue state-law claims for failure to update warnings to FDA-approved generic drugs because those claims are preempted by federal law. Actavis, Teva, Mutual, and United further argued that the failure-to-update claims failed because they did, in fact, update their warnings to conform to those of the brand-name product and did so within a reasonable time.

PLIVA also argued that it did not change its warnings because it had divested itself of the product in 2008, and was not informed of the approved label change to the brand-name product until 2009, when the FDA sent out notices to all manufacturers of the drug. PLIVA further argued that any duty to update the warnings was a duty imposed by federal law, not state law.

In addition, Watson argued that it purchased the product from PLIVA in 2008, and learned about the changes to the warnings in 2009. Watson maintained that it implemented the change in its warnings in a timely manner.

The trial court denied the motions, for reasons stated on the record on May 3, 2013. The court re-affirmed its earlier ruling that claims based on the failure to update warnings to conform to changes made to the warnings and labels of the brand-name drug are not preempted by federal law. The court also determined that there were genuine issues of material fact as to whether the Generic Defendants changed their warnings in a timely manner and whether the warnings provided were adequate. The court memorialized its decisions in orders filed on June 13, 2013.

The Generic Defendants thereafter filed motions with this court for leave to appeal pursuant to Rule 2:2-4. We denied the motions. The Generic Defendants then filed motions for leave to appeal with the Supreme Court, which granted the motions and remanded the appeals to this court for disposition.

II.

The Generic Defendants argue that: (1) state law does not provide a cause of action for failure to comply with the federal requirements pertaining to warnings for generic drugs; (2) federal law bars "private enforcement" of FDA requirements; (3) permitting plaintiffs to pursue their claims would frustrate the purposes and objectives of federal law; and (4) plaintiffs lack standing to assert their claims.3

In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, known as the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetics Act ("FDCA"). Pub. L. 98-417, 98 Stat.1585. See also21 U.S.C. 355(j). Before these amendments were enacted, all drug manufacturers, including generic manufacturers, were required to file a complete new drug application ("NDA") to receive FDA approval to manufacture and distribute the drug. Mensing, supra, 564 U.S.at ___, 131 S. Ct.at 2574, 180 L. Ed. 2d at 588.

These NDAs often involved "costly and lengthy clinical trials." Ibid.The Hatch-Waxman Amendments permitted manufacturers to obtain FDA approval of a generic drug by demonstrating its chemical and biological equivalence to a drug already approved. 21 U.S.C.A. 355(j)(2)(A). This process has become known as an abbreviated new drug application ("ANDA"). Ibid.See alsoFulgenzi v. PLIVA, Inc., 711 F.3d 578, 581 (6th Cir. 2013).

A brand-name manufacturer seeking FDA approval of a new drug must ensure the accuracy and adequacy of the drug's warnings and label. 21 U.S.C.A. 355(a), (b)(1), (d). Furthermore, a manufacturer seeking approval of a generic drug must ensure that its warning label is the same as the label for the equivalent brand-name drug. 21 U.S.C.A. 355(j)(2)(A)(v); 21 U.S.C.A. 355(j)(4)(G); 21 C.F.R. 314.94(a)(8); 21 C.F.R. 314.127(a)(7). The FDA has interpreted its regulations as imposing upon generic drug manufacturers an ongoing federal duty of "sameness," meaning that their warning labels must always be the same as those of the brand-name drug. Mensing, supra, 564 U.S.at ___, 131 S. Ct.at 2574-75, 180 L. Ed. 2d at 589.

The FDA first approved metoclopramide in 1980, and the drug was marketed under the name Reglan. Fulgenzi, supra, 711 F.3d at 580. Metoclopramide was designed for short-term treatment of gastroesophagel reflux disease and it was available in tablet and syrup form. Ibid.Five years after the FDA approved Reglan, generic manufacturers began marketing the drug. Ibid.

Evidence thereafter arose indicating that that long-term users of metoclopramide faced a significant risk of developing tardive dyskinesia, a severe neurological disorder. Ibid.The original Reglan label stated that "[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended." Ibid.

The FDA approved the first Reglan label change in 1985, when the warnings were modified to add the statement, "tardive dyskinesia . . . may develop in patients treated with metoclopramide. Mensing, supra, 564 U.S.at , 131 S. Ct.at 2572, 180 L. Ed. 2d at 587. The FDA approved a second label change in July 2004, which added the bold-faced statement that "[t]herapy should not exceed 12 weeks in duration." Ibid.

In February 2009, the FDA ordered a "black box warning," its strongest label warning, to be placed on Reglan's label. Ibid.This warning stated that treatment with metoclopramide could cause tardive dyskinesia, "a serious movement disorder that is often irreversible." Ibid.The warning also stated, "Treatment with metoclopramide for longer than 12 weeks should be avoided." Ibid.

Mensing involved lawsuits raising state-law claims based on the alleged failure by drug manufacturers to provide adequate warnings for generic metoclopramide. Id. at , 131 S. Ct. at 2572, 180 L. Ed. 2d at 586. The plaintiffs in Mensing had been prescribed Reglan in 2001 and 2002, respectively, and both had received generic metoclopramide. Id. at , 131 S. Ct. at 2572, 180 L. Ed. 2d at 587. The plaintiffs developed tardive dyskinesia. Ibid.

They claimed that the manufacturers were liable under state law because, despite "mounting evidence" that the long-term use of metoclopramide carried a risk of tardive dyskinesia, the manufacturers failed to change their labels to adequately warn of that danger. Ibid. (quoting Mensing v. Wyeth, Inc., 588 F.3d 603, 605 (8th Cir. 2009)). The Supreme Court held the plaintiffs' state-law claims were preempted by federal law. Id. at , 131 S. Ct. at 2577, 180 L. Ed. 2d at 592.

The Court stated that if, as claimed by the plaintiffs, state law required the defendants to use different and stronger warnings, there was a conflict with federal drug regulations which prevented the defendants from independently changing their generic drug-safety labels. Id. at , 131 S. Ct. at 2576, 180 L. Ed. 2d at 591. The Court held that the state-law claims were preempted because it would be impossible for the manufacturers to comply with both state and federal requirements. Id. at , 131 S. Ct. at , 180 L. Ed. 2d at 592.

The Court noted that if the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Id. at ___, 131 S. Ct. at 2578, 180, L. Ed. 2d at 592. The Court emphasized that federal law "demanded that the generic drug labels be the same at all times as the corresponding brand-name drug labels." Ibid.

Here, the trial court correctly determined that Mensing did not foreclose plaintiffs from pursuing certain state-law claims based on the alleged failure to provide adequate warnings concerning generic metoclopramide. The court found that plaintiffs were precluded from claiming that the Generic Defendants should have employed "different or stronger" warnings than those approved for Reglan. However, the trial court correctly determined that plaintiffs' claims based on the Generic Defendants' failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.

The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve in the Hatch-Waxman Amendments to the FDCA. Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law. They are pursuing state-law products liability claims based on the Generic Defendants' alleged failure to provide adequate warnings concerning their products. See N.J.S.A. 2A:58C-1 to 11. Plaintiffs have standing to assert these claims.

The decision in Fulgenzi v. PLIVA, Inc., supra, 711 F.3d 578, supports our conclusion. In that case, the plaintiff asserted a state-law claim against PLIVA based on the alleged failure to adequately warn of the risks of developing tardive dyskinesia from long-term use of generic metoclopramide. Id. at 580. The Court of Appeals for the Sixth Circuit held that the claim was not preempted by the FDCA, to the extent the plaintiff was claiming that PLIVA's warnings were inadequate because they did not include the warnings added to the Reglan label in 2004. Id. at 584, 588.

The court found that the plaintiff's state-law claim was not preempted because it was not impossible for PLIVA to comply with both the state-law and federal requirements. Id. at 584. The court noted that allowing the plaintiff to pursue her state-law claim would not frustrate Congress' purposes and objectives. Id. at 586.

In addition, the court rejected the contention that, although styled as a state-law tort claim, the plaintiff was actually pursuing a federal claim to enforce a violation of the FDCA. Id. at 586-87. The court pointed out that 21 U.S.C.A. 337(a) bars private actions premised on violations of the FDCA. Id. at 586.

The court determined, however, that the plaintiff's claim was not premised on a violation of the FDCA, but rather on an independent duty imposed by state law. Ibid. The court stated that the federal duty of "sameness" was not a "critical element" of the plaintiff's cause of action. Ibid. (citing Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 353, 124 S. Ct. 1012, 1019-20, 148 L. Ed. 2d 854, 864 (2001)).

We note that the Court of Appeals for the Fifth Circuit in Morris v. PLIVA, Inc., 713 F.3d 774, 775 (5th Cir. 2013), affirmed the dismissal of claims against PLIVA for failing to update its warnings to comply with a FDA-approved label change for brand-name metoclopramide. The court stated that the plaintiff had alleged that the warnings that predated 2009 were not adequate. Id. at 777.

The court found, however, that there could be no tort liability for "failure to attach an inadequate label." Ibid. The court also said that the alleged failure to comply with a federal labeling obligation "sounds exclusively in federal (not state) law and is preempted." Id. at 777 (citing 21 U.S.C.A. 337(a); Buckman, supra, 531 U.S. at 349 n.4, 124 S. Ct. at 1018 n.4, 148 L. Ed. 2d at 854 n.4).

We note that other courts have also determined that claims of the sort asserted here against the Generic Defendants are not preempted by federal law. See, e.g., Huck v. Wyeth, 850 N.W.2d 353 (Iowa 2014); Hassett v. Dafoe, 74 A.3d 202 (Pa. Super. Ct. 2013), appeal denied, ___ A.3d ___ (2014). Some courts have followed the Fifth Circuit's reasoning in Morris. See, e.g., Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013); Dietrich v. Actavis, Inc., 138 So. 3d 1163 (Fla. Dist. Ct. App. 2014).

We are convinced, however, that the reasoning in Fulgenzi is more persuasive than that in Morris. We therefore conclude that the trial court correctly determined that plaintiff's failure-to-warn claims are not pre-empted.

III.

The Generic Defendants further argue that the decision of our Supreme Court in Cornett v. Johnson & Johnson, 211 N.J. 362 (2012), supports dismissal of the failure-to-warn claims against them. In Cornett, the decedent's estate and widow asserted various claims arising from the decedent's use of a drug-eluting stent, which allegedly caused his death. Id. at 368. The stent was the subject of a "rigorous pre-market approval (PMA) process" of the FDA pursuant to Medical Device Amendments to the FDCA. Id. at 368, 370 (citations omitted).

The PMA incorporated a 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." Id. at 381 (citation omitted). The manufacturer was not permitted to change the label without FDA approval. Ibid. (citations omitted).

In addition, under the FDCA, off-label uses of the devices are not illegal per se, and the FDA is precluded from limiting or interfering with a health care practitioner's prescribing or administration of a "legally marketed device . . . within a legitimate health care practitioner-patient relationship." Id. at 382 (quoting 21 U.S.C.A. 396). Congress also provided a "safe harbor" for health-care manufacturers who disseminate certain materials pertaining to the safety, effectiveness and benefits of a use not described in the approved labeling. Ibid. (citing 21 U.S.C.A. 360aaa, 306aaa-1).

Among other determinations, the Court in Cornett held that the plaintiffs' claim based on the alleged failure to provide adequate warnings regarding the approved use of the product was preempted by federal law because it was "nothing more than a challenge to the adequacy of the information required by the FDA during the PMA process and label approved by the agency." Id. at 389. The Court noted that the plaintiffs' failure-to-warn claim was based solely on the contention that the defendants obtained FDA approval of the device by submitting fraudulent representations or withholding material information. Ibid. The Court stated that allowing such a claim to proceed would "directly interfere" with the FDA's exclusive authority to enforce the FDCA. Ibid. (citing 21 U.S.C.A. 337(a)).

The Court concluded, however, that the plaintiffs' failure-to-warn claim would not be preempted if it "is based on other allegations of wrong-doing apart from defendants' failure to comply with FDA disclosure requirements[.]" Id. at 390. The Court noted that the plaintiffs were alleging that the defendants had withheld information from the general public and the medical community about the limitations of the device, which were not part of the PMA process. Ibid. The Court stated, "Such a claim falls within a traditional area of state concern and regulation because fraud on the FDA is not an element of the claim and it can be proved by evidence other than by evidence of fraud on the FDA." Ibid.

We are convinced that Cornett does not compel dismissal of plaintiffs' failure-to-warn claims in this case. The claims at issue here do not involve a challenge to the adequacy of information provided to the FDA or the label changes that federal agency approved in 2004 or 2009. In addition, the claims do not involve any allegation of fraud on the FDA. They are grounded in state law and are not based solely upon a federal violation. As in Cornett, plaintiffs' claims fall "within a traditional area of state concern and regulation." Ibid.

Affirmed.

1 Appellants are Actavis Elizabeth, LLC ("Actavis"); Barr Pharmaceuticals, LLC, Barr Laboratories, Inc. (collectively, "Barr"); Mutual Pharmaceutical Company, Inc. ("Mutual"), PLIVA, Inc. ("PLIVA"), Teva Pharmaceuticals USA, Inc. ("Teva"); Watson Laboratories, Inc. ("Watson"), and United Research Laboratories, Inc. ("United"). In this opinion, we refer at times to appellants collectively as the "Generic Defendants."

2 The long-form complaint was filed pursuant to the trial court's case management order, and it was intended to serve the administrative function of allowing the presentation of certain common claims and issues for the court's consideration.

3 We note that, in their appeals, Generic Defendants do not raise the other arguments they raised in support of their post-discovery motions to dismiss or for summary judgment. For purposes of these appeals, these arguments are deemed to have been waived. See N.J. Div. of Youth & Family Servs. v. M.C. III, 201 N.J. 328, 339 (2010) (citing County of Essex v. First Union Nat'l Bank, 186 N.J. 46, 51 (2006)).