MEMORANDUM
This disposition is not appropriate for publication and is not precedent except as provided by 9th Cir. R. 36-3.
Appellant David Riggins, aka Dawud Halisi Malik ("Appellant") appeals the grant of summary judgment to various employees of the State of Washington Department of Corrections ("DOC"). Appellant is a prisoner who brought this action under 42 U.S.C. § 1983 to challenge the enforcement of DOC Policy 400.280 (the "Policy"), which requires that all prisoners use their committed name before any other official or religious name on all incoming and outgoing correspondence. Appellant argues that the enforcement of the Policy by Appellees violates his First Amendment right to use of the mail. The district court granted summary judgment in favor of Appellees, holding that, as to incoming mail, there was no constitutional violation, and that, as to outgoing mail, summary judgment was inappropriate on the merits but Appellees were entitled to qualified immunity. We have jurisdiction under 28 U.S.C. § 1291, and we now affirm the grant of summary judgment in Appellees' favor.
I.
A district court's grant of summary judgment is reviewed de novo. Davis v. City of Las Vegas, 478 F.3d 1048, 1053 (9th Cir. 2007) (citing Buono v. Norton, 371 F.3d 543, 545 (9th Cir. 2004)). Its decision as to whether an officer is entitled to qualified immunity is likewise reviewed de novo. Id. (citing Bingham v. City of Manhattan Beach, 341 F.3d 939, 945 (9th Cir. 2003)). Federal Rule of Civil Procedure 56(c) provides that a movant is entitled to summary judgment where "there is no genuine issue as to any material fact and [] the moving party is entitled to a judgment as a matter of law."
II.
Appellant argues that the district court erred in granting summary judgment in favor of Appellees because, in enforcing the Policy, prison officials prevented Appellant from exercising his First Amendment right to use the mail. Prisoners have a First Amendment right to send and receive mail. Witherow v. Paff, 52 F.3d 264, 265 (9th Cir. 1995) (per curiam). A prison may adopt regulations that infringe on an inmate's constitutional rights if those regulations are "reasonably related to legitimate penological interests." Turner v. Safley, 482 U.S. 78, 89, 107 S.Ct. 2254, 96 L.Ed.2d 64 (1987). Restrictions on outgoing mail are given closer scrutiny than those on incoming mail, as internal mail has an obvious effect on the internal environment of a prison, while outgoing mail poses less threat to prison security. Thornburgh v. Abbott, 490 U.S. 401, 413-14, 109 S.Ct. 1874, 104 L.Ed.2d 459 (1989).
As was noted by the magistrate judge, the Policy does not prohibit Appellant from using his religious name on his mail in conjunction with his committed name. The burden that the Policy does place on Appellant's rights is in the requirement that his committed name be placed first on all incoming and outgoing correspondence. Thus, we must determine whether enforcement of the Policy's requirement as to the order of the names on prisoner mail is justified by a legitimate penological interest.
We conclude that it is. We hold that the DOC has adequately demonstrated that regulating the order in which an inmate places his committed name versus any other official or religious name is justified under Turner by the need for orderly and efficient administration of prison mail. Accordingly, while Appellant has an established constitutional right to use both his committed and religious name on all outgoing and incoming correspondence, that right does not extend so far as to allow him to place those names in any order that he chooses. Enforcement of the Policy by the DOC did not, therefore, violate his First Amendment rights.
Because we hold that summary judgment was properly granted to Appellees on the merits of Appellant's constitutional claim, we need not reach the issue of qualified immunity.
III.
Appellant also argues that the district court erroneously granted Appellees summary judgment as to his request for injunctive and declaratory relief. In light of our ruling, he is not entitled to either form of relief.
With respect to prison conditions, "[t]he court shall not grant or approve any prospective relief unless the court finds that such relief is narrowly drawn, extends no further than necessary to correct the violation of the Federal right, and is the least intrusive means necessary to correct the violation of the Federal right." 18 U.S.C. § 3626. "To obtain injunctive relief against government actions which allegedly violate the law, the injury or threat of injury must be both real and immediate, not conjectural or hypothetical." OrantesHernandez v. Thornburgh, 919 F.2d 549, 557 (9th Cir. 1990) (citing Los Angeles v. Lyons, 461 U.S. 95, 101-02, 103 S.Ct. 1660, 75 L.Ed.2d 675 (1983)) (internal quotation marks omitted).
The district court previously dismissed Appellant's claims under the Eighth, Fifth, and Fourteenth Amendments, a holding that Appellant does not now appeal. Therefore, Appellant's requests for injunctive and declaratory relief as to these claims were properly denied. Second, because the Policy does not prevent Appellant from using his legal and religious name in conjunction with this committed name on all correspondence, it does not violate this court's previous rulings, and relief on this basis was also properly denied. Finally, because we have concluded that the Policy's enforcement does not violate Appellant's First Amendment right to use the mail, his request that Appellees "cease withholding his mail" was also properly denied. The district court ruling with respect to Appellant's claim for equitable relief is affirmed.
IV.
Appellant alleges that Appellee's refusal to allow him to purchase prayer oils violated his First Amendment right to exercise his religion and the Religious Land Use and Institutionalized Persons Act (RLUIPA).
In order to establish a free exercise violation under the First Amendment, a prisoner must show that the government burdened the practice of his religion by preventing him from engaging in conduct mandated by his faith, without any justification reasonably related to legitimate penological interests. Freeman v. Arpaio, 125 F.3d 732, 736 (9th Cir. 1997) (citing Turner, 482 U.S. at 89, 107 S.Ct. 2254). Section 3 of RLUIPA provides, in relevant part, that "[n]o government shall impose a substantial burden on the religious exercise of a person residing in or confined to an institution . . . even if the burden results from a rule of general applicability," unless the government establishes that the burden furthers "a compelling governmental interest," and does so by "the least restrictive means." 42 U.S.C. § 2000ccl(a)(lM2). Under RLUIPA, Appellant bears the initial burden of establishing a prima facie claim that the Policy constitutes a substantial burden on the exercise of his religious beliefs. See Warsoldier v. Woodford, 418 F.3d 989, 994 (9th Cir. 2005).
The record does not demonstrate that possessing prayer oils was a religious practice mandated by Appellant's faith. In addition, nothing in the record suggests that a lack of prayer oils placed a substantial burden on Appellant's ability to practice his religion, and it is clear that Appellant's request for transfer of funds to purchase these oils was eventually processed. Therefore, the district court properly granted summary judgment in Appellees' favor on the First Amendment freedom of religion and RLUIPA claims.
V.
Because Appellant's constitutional rights were not violated, summary judgment was properly granted in favor of Appellees. The judgment of the district court is AFFIRMED.
no more than five thousand dollars for each violation.
Id. at § 46A-7-lll(2).
The Act defines "trade or commerce" as "the advertising, offering for sale, sale or distribution of any goods or services" that directly or indirectly affects West Virginia citizens. Id. at § 46A--102(6). In denning "unfair methods of competition and unfair or deceptive acts or practices," the Act sets forth a non-exhaustive list of prohibited activities, which includes, in relevant part:
"(E) Representing that goods or services have . . . characteristics, . . . uses, [or] benefits . . . that they do not have . . .;
(H) Disparaging the goods . . . of another by false or misleading representation of fact;
(1) Engaging in any other conduct which similarly creates a likelihood of confusion or of misunderstanding;
(M) The act, use or employment by any person of any deception, fraud, false pretense, false promise or misrepresentation, or the concealment, suppression or omission of any material fact with intent that others rely upon such concealment, suppression or omission, in connection with the sale or advertisement of any goods or services, whether or not any person has in fact been misled, deceived or damaged thereby;
(N) Advertising, printing, displaying, publishing, distributing or broadcasting . . . any statement or representation with regard to the sale of goods . . . which is false, misleading or deceptive or which omits to state material information which is necessary to make the statements therein not false, misleading or deceptive;"
Id. at §§ 46A-6-102(7)(E), (H), (1), (M) (N).
In a 2005 amendment to West Virginia Code § 46A-6-102, the Legislature changed the numbering and lettering of the relevant subsections, without changing their substance. Although the State filed this case before this amendment, the Court here cites to the subsections as they are currently designated.
In the instant case, neither party disputes that the Appellants engaged in commerce in West Virginia, as defined by the Consumer Protection Act. The questions before the circuit court, therefore, were (1) whether the Appellants engaged in "unfair or deceptive acts or practices" when Janssen disseminated the Risperdal DHCP letter and the Duragesic file card to healthcare providers in West Virginia and, if so, then (2) whether Janssen's distribution of these materials constituted a "course of repeated and willful violations." See W. Va. Code § 46A-6-104; W. Va. Code § 46A-7-11K2). In granting the State's motion for partial summary judgment, the circuit court ruled that the first question could be decided as a matter of law, while the second question was an issue of fact to be decided at trial. It then ruled, as a matter of law, that Janssen's statements and omissions in the Risperdal DHCP letter and the Duragesic file card were false and misleading and, thus, constituted "unfair or deceptive acts or practices." See W. Va. Code § 46A-6-104.
In reaching this conclusion, the circuit court relied on federal law. Initially, it noted that the Consumer Protection Act does not contain specific guidelines for determining whether a representation is misleading in the context of communications between a prescription drug companies and physicians. Under the Consumer Protection Act, however, "courts [are to] be guided by the interpretation given by the federal courts to the various federal statutes dealing with the same or similar matters." W. Va. Code § 46A-6-101(1). The circuit court, therefore, looked for guidance from the Federal Food Drug and Cosmetic Act, 21 U.S.C. §§ 301 to -399 ("FDCA"), the federal law governing the labeling and advertising of prescription drugs.
As set forth by the Legislature, the purpose of the Consumer Protection Act "is to complement the body of federal law governing . . . unfair, deceptive and fraudulent acts or practices in order to protect the public and foster fair and honest competition." W. Va. Code § 46A-6-101(1). To this end, the Legislature directs courts to be "guided by the interpretation given by the federal courts to the various federal statutes dealing with the same or similar matters." Id. Courts are to liberally construe the Act "so that its beneficial purposes may be served." Id.
Among other things, the FDCA prohibits the misbranding of any drug in interstate commerce. 21 U.S.C. § 331(b). As relevant to this case, a drug is considered "misbranded" if "its labeling is false or misleading in any particular." Id., at § 352(a). The term "labeling" is construed broadly to encompass not only the label affixed to a drug container, but also other material accompanying the drug, including advertisements. Kordel v. U.S., 335 U.S. 345, 350, 69 S.Ct. 106, 93 L.Ed. 52 (1948); 21 U.S.C. § 321(m) (2009); 21 C.F.R. § 202.10)(2) (2008).
As the agency charged with enforcing the FDCA, the FDA has promulgated regulations that set forth specific standards for prescription drug labeling and advertising. See 21 U.S.C. § 371. Under these regulations, "advertisements" include, among other things, letters and file cards containing drug information "which are disseminated by or on behalf of [the drug] manufacturer." 21 C.F.R. § 202.1(0(2). The FDA's regulations provide that "[a]ll advertisements for any prescription drug . . . shall present a true statement of information in brief summary relating to side effects, contraindications . . . and effectiveness." Id. at § 202.1(e)(1).
An advertisement does not satisfy the requirement that it present a "true statement" of information in brief summary relating to side effects, contraindications, and effectiveness if:
(i) It is false or misleading with respect to side effects, contraindications, or effectiveness; or
(ii) It fails to present a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug . . .; or
(iii) It fails to reveal facts material in the light of its representations or material with respect to consequences that may result from the use of the drug as recommended or suggested in the advertisement.
Id. at § 202.1(e)(5).
To assist in determining whether the information contained in an advertisement is false or misleading, the FDA promulgated extremely specific and detailed guidelines. 21 C.F.R. §§ 202.1(e)(6) (7). For example, an advertisement is false or misleading if it "[c]ontains a representation or suggestion, not approved or permitted for use in the labeling, that a drug is better, . . . safer, has fewer, or less incidence of, or less serious side effects or contraindications than has been demonstrated by substantial evidence. . . ." Id. at § 202.1(e)(6)(i). Similarly, an advertisement may be false or otherwise misleading if it "[c]ontains favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions," or if it "[u]ses the concept of `statistical significance' to support a claim that has not been demonstrated to have clinical significance or validity, or fails to reveal the range of variations around the quoted average results." Id. at §§ 202.1(e)(7)(i) (ii).
In the instant case, the circuit court concluded that the question of whether the Appellants' statements or omissions in their communications to West Virginia healthcare providers were false or misleading under the Consumer Protection Act should be determined by reference to the federal regulations governing whether drug advertisements are false and misleading under the FDCA. Rather than considering this question to be an issue of fact for determination by a fact finder, however, the circuit court held that the issue could be decided as a matter of law on summary judgment.
While concluding that it should look to the FDCA for guidance, the circuit court acknowledged that, typically, only the United States is entitled to enforce an action under the FDCA. 21 U.S.C. § 337(a). As such, claims brought to enforce violations of the FDCA by any party other than the United States are generally preempted. See Buckman Co. v. Plaintiffs' Legal Comm., 53! U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). A cause of action brought under a state statute, such as the Consumer Protection Act, however, is not an action to enforce the FDCA so long as it "is premised on conduct that would give rise to liability under traditional common law principles." In re Bayer Corp. Combination Aspirin Prods. Mlctg. and Sales Practices Litig., 701 F.Supp.2d 356, 369 (E.D.N.Y. 2010). On the other hand, if a defendant's conduct "would not expose it to liability but for the FDCA, `then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiffs claim is thus impliedly preempted under Buckman.'" Id. (quoting Lefaivre v. KV Pharm. Co., 2010 WL 59125, at *3 (E.D.Mo. January 5, 2010)).
In the instant case, the State alleges that the Appellants disseminated false and misleading drug information to healthcare providers, an area traditionally subject to state law liability. The State is not simply alleging that the Appellants violated the FDCA by, for example, failing to provide the mandated warning information required by the FDA in Risperdal labeling. Rather, the State maintains that this alleged failure resulted in false and misleading information actually being disseminated to providers in West Virginia. Thus, the State's claims are not federally preempted by the FDCA and, in fact, the case provides an instance in which "[t]he FDCA and the state law consumer protection statutes serve complementary, though somewhat overlapping, roles." In re Bayer Corp., 701 F.SuppJd at 370-71.
In concluding that the statements and omissions at issue are false and misleading as a matter of law, the circuit court relied on the FDA's communications with Janssen regarding the two drugs. Specifically, the circuit court reasoned that, in issuing the warning letters, the FDA had determined that certain statements and omissions contained in the Risperdal DHCP letter and the Duragesic file card were false and misleading in violation of the FDCA. The circuit court ruled that "the warning letters sent by the FDA were not informal or advisory by [sic] rather required [Janssen to take] mandatory action." It found that Janssen could have administratively appealed the FDA's determination but chose not to do so. Instead, Janssen acquiesced to the FDA's demands by issuing the respective corrective letters. Thus, the circuit court reasoned, Janssen waived its opportunity to contest the FDA's characterization of its representations. Finally, the circuit court concluded that the contents of the corrective letters — which simply restated the allegations contained in the warning letters — constituted "mandatory FDA action and the FDA's official judgment as to the matters addressed in the letters," because the FDA had directed Janssen to issue those letters and because the letters became part of the drugs' official "labeling" once they were mailed to healthcare providers and made public on the FDA's website.
The circuit court stated in a footnote, without further explanation, that although it was granting preclusive effect to the "FDA corrective letters" in this case, such letters may not necessarily be preclusive in all cases.
In other words, the circuit court found that, through the warning letters and corrective letters, the FDA had issued an official determination that certain statements and omissions in the Risperdal DHCP letter and the Duragesic file card were false and misleading under the FDCA. Because the circuit court had already decided that it should look to the FDCA to determine whether a statement regarding a prescription drug is false and misleading under the Consumer Protection Act, it ruled that it would give "deference to the FDA's findings and actions pertaining to the communications at issue." Consequently, because the FDA had determined that the Appellants' statements and omissions were false under the FDCA, the circuit court ruled, as a matter of law, that the same statements and omissions were false and misleading under the Consumer Protection Act.
The Appellants contend that the circuit court erred by giving preclusive effect to DDMAC's determination that their Risperdal and Duragesic statements were false and misleading. They point out that, pursuant to the FDA's own guidelines, warning letters are merely "informal and advisory" and do not constitute a final judgment of the FDA. The Appellants further assert that, despite the circuit court's finding to the contrary, they did not have the ability to administratively appeal the allegations contained in those warning letters and, thus, were never afforded the opportunity to defend against the FDA's informal determinations. This Court agrees.
The Appellants additionally challenge the circuit court's entry of partial summary judgment on federal preemption and free speech grounds. The Court's decision on issue preclusion, however, renders consideration of the Appellants' alternative arguments unnecessary.
The doctrine of collateral estoppel, or issue preclusion, "forecloses the relitigation of `issues that were actually litigated in an earlier suit even though the causes of action [in the former and subsequent proceedings] are different.'" Peters v. Rivers Edge Mining, Inc., 224 W. Va. 160, 177, 680 S.E.2d 791, 808 (2009) ( quoting Mellon-Stuart Co. v. Hall, 178 W. Va. 291, 298-99, 359 S.E.2d 124, 131-32 (1987)). Specifically, the doctrine of collateral estoppel will bar the relitigation of an issue, thereby giving preclusive effect to the prior determination of that issue, if four conditions are met:
Recently, this Court noted that the doctrine of collateral estoppel "is often more descriptively referred to as `issue preclusion.'" State ex rel. Taylor v. Janes, 225 W. Va. 329, 335, 693 S.E.2d 82, 88 (2010) ( citing Yeager v. U.S., ___ U.S. ___, 129 S.Ct. 2360, 2367 n. 4, 174 L.Ed.2d 78 (2009)).
(1) The issue previously decided is identical to the one presented in the action in question; (2) there is a final adjudication on the merits of the prior action; (3) the party against whom the doctrine is invoked was a party or in privity with a party to a prior action; and (4) the party against whom the doctrine is raised had a full and fair opportunity to litigate the issue in the prior action.
Syl. Pt. 1, in part, State v. Miller, 194 W. Va. 3, 459 S.E.2d 114 (1995). Here, no preclusive effect can be given to the FDA's determination that the statements and omissions in the Risperdal DHCP letter and Duragesic file card are false and misleading, because the FDA did not render a "final adjudication on the merits" on this issue, nor did the Appellants have an opportunity to fully and fairly litigate the question. See id.
Although collateral estoppel may be applied to quasijudicial determinations of administrative agencies, this Court has always been wary of so doing. See Page v. Columbia Natural Res., Inc., 198 W. Va. 378, 393, 480 S.E.2d 817, 832 (1996) ("[W]e are of the opinion that only rarely, if at all, will administrative proceedings provide the same full and fair opportunity to litigate matter as will a judicial proceeding"). Consequently, the Court has held that,
[f]or issue or claim preclusion to attach to quasi-judicial determinations of administrative agencies, at least where there is no statutory authority directing otherwise, the prior decision must be rendered pursuant to the agency's adjudicatory authority and the procedures employed by the agency must be substantially similar to those used in a court. In addition, the identically of the issues litigated is a key component to the application of administrative
res judicata or collateral estoppel.
Syl. Pt. 2, Vest v. Bd. of Educ., 193 W. Va. 222, 455 S.E.2d 781 (1995). A review of the FDA's determinations in the instant case clearly indicates that neither of these prongs are met here.
A close examination of the FDA's actual determinations is required in considering their sufficiency under Vest. Here, the FDA's determinations that Janssen had violated the FDCA were issued in the form of warning letters. Pursuant to the FDA's Regulatory Procedures Manual, a "warning letter" is
a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.
FDA Regulatory Procedures Manual, Exhibit 4-1 at § 4.1 (March 2004). The purpose of warning letters is to give the recipient "an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action." FDA Regulatory Procedures Manual § 4-1-1. The letters, therefore, are "informal and advisory." Id. They communicate the FDA's position on a matter, but do not commit the agency to taking enforcement action. Id.
Importantly, the FDA "does not consider Warning Letters to be final Agency action on which it can be sued." Id. Rather, if a recipient of a warning letter fails to comply with the requested corrective actions, the FDA can, but is not obligated to, proceed with an enforcement action by requesting that the Department of Justice initiate a civil suit seeking an injunction or seizure of products, or a criminal suit seeking penalties, including fines and imprisonment. See 21 U.S.C. §§ 332-34. Therefore, under the FDA's own regulations, its determination that a drug company has violated the FDCA, when stated in a warning letter, is not a final agency action or decision on that issue.
Since the events at issue in this lawsuit, Congress has authorized an additional enforcement mechanism in cases concerning direct-to-consumer advertising. Specifically, the Secretary of Health and Human Resources, which oversees the FDA, is now allowed to assess civil money penalties for direct-to-consumer advertisements that are false or misleading without instituting a lawsuit. See 21 U.S.C. § 333(g) (2009). The statute, however, guarantees certain procedural safeguards, including written notice and an opportunity for a hearing, to protect the entities against which a penalty is being assessed. Id. at § 333(g)(2).
Clearly, in issuing warning letters, the FDA is not acting pursuant to any adjudicatory authority, nor does it employ any due process procedures similar to those accorded defendants in courts of law. See Vest, 193 W. Va. 222, 455 S.E.2d 781, Syl. Pt. 2. Rather, in issuing a warning letter, the FDA, acting pursuant to its regulatory authority, attempts to remedy a perceived violation through informal means. No hearing is provided prior to the issuance of the letters, nor is the recipient notified of the alleged violations. Indeed, the purpose of the warning letters is to provide such preliminary notification, thereby giving the alleged violator an opportunity to resolve the problem in an informal manner before actual adjudication takes place. Accordingly, the warning letters cannot be considered quasi-judicial determinations by the FDA and, thus, are not subject to collateral estoppel under West Virginia law.
This conclusion is further supported by the findings of federal courts from around the country, which have similarly held that FDA warning letters do not constitute adjudications on the merits. In a federal case considering false advertising claims under the Lanham Act, 15 U.S.C. § 1125, the district court found that FDA warning letters did not constitute a final determination of whether a drug company had engaged in misbranding. Schering-Plough Healthcare Prod., Inc. v. Schwarz Pharma, Inc., 547 F.Supp.2d 939, 947 (E.D.Wis. 2008). In so holding, the district court summarized other federal court holdings on this matter:
Indeed, several courts have recognized that letters such as those cited here do not constitute an official agency determination.
See [Western Illinois Home Health Care, Inc. v.] Herman, 150 F.3d [659] at 662 [(1998)] ("An agency action is not final if it is only `the ruling of a subordinate official,' or `tentative.' The core question is whether the agency has completed its decision-making process, and whether the result of that process is one that will directly affect the parties.") (quoting
Franklin v. Massachusetts, 505 U.S. 788, 796-97,
112 S.Ct. 2767,
120 L.Ed.2d 636 (1992));
see also Dietary Supplemental Coalition, Inc. v. Sullivan, 978 F.2d 560, 562-63 (9th Cir. 1992) (" `[T]he type of informal letter issued by the FDA . . . does not constitute . . . formal or final agency action `")(
quoting Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1377 (9th Cir. 1983)),
cert. denied,
508 U.S. 906,
113 S.Ct. 2333,
124 L.Ed.2d 245 (1993);
Genendo Pharmaceutical N.V. v. Thompson,
308 F.Supp.2d 881, 885 (N.D.Ill. 2003) (statements of agency officials below the Commissioner "do not rise to the level of final agency action — even when they are contained in warning letters or other official regulatory correspondence.");
Summit Tech., Inc. [v. High-Line Medical Instruments], 922 F.Supp. [299] at 306 [(1996)] ("regardless of any warning letters that the FDA may have sent to defendants, it is clear that the FDA has not completed this investigation.").
Id. Thus, federal district courts from around the country agree that warning letters are not final agency action.
Moreover, in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), the United States Supreme Court recently noted that "because [the Food, Drug and Cosmetic Act] contemplates that federal juries will resolve most misbranding claims, the FDA's belief that a drug is inisbranded is not conclusive." Id. at 1198 (emphasis added). Because the FDA issues warning letters prior to any adjudication of an alleged violation, such letters, by their nature, simply set forth the FDA's belief that an FDCA violation has occurred and are not conclusive. See id. In the instant case, therefore, the FDA's positions, as set forth in the Risperdal and Duragesic warning letters, were not a final adjudications on the merits by that agency, but rather informal and advisory notifications to Janssen that the FDA believed that Janssen's communications violated the FDCA
While the lack of a final adjudication on the merits is, by itself, sufficient to prevent the application of issue preclusion to the FDA's determinations, such application is rendered even more egregious because the Appellants did not have the opportunity to fully and fairly litigate the issue. Indeed, the circuit court clearly erred in finding that Janssen could have, but chose not to, formally appeal the findings in those letters. Specifically, in its summary judgment order, the circuit court indicated that Janssen could have "institute[d] administrative proceedings to challenge the Warning Letter on scientific, First Amendment, or other grounds." For this proposition, the circuit court cited to 21 C.F.R. § 10.33 which states: "[t]he Commissioner may at any time reconsider a matter . . . on the petition of an interested person." Id. at § 10.33(a). That regulation then continues: "[a]n interested person may request reconsideration of part or all of a decision of the Commissioner. . . ." M at § 10.33(b). In this case, however, the warning letters were not a "decision of the Commissioner." Rather, the warning letters were issued by the Director of DDMAC, not the Commissioner. Therefore, this regulation is inapplicable, as there is no "decision of the Commissioner" for which Janssen could request reconsideration. See id.
Furthermore, because warning letters do not constitute "final agency action," they are not susceptible to judicial review and, thus, Janssen could not have initiated a civil lawsuit to challenge the validity of the letters. See FDA Regulatory Procedures Manual § 4-1-1 ("FDA does not consider Warning Letters to be final Agency action on which it can be sued."). Without a final agency action, recipients of warning letters cannot sue the FDA because they cannot establish a sufficiently imminent injury and, as such, their claims are not ripe. Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983).
Accordingly, the circuit court erred in giving preclusive effect to the FDA's determinations that Janssen had violated the FDCA through its statements and omissions in the Risperdal DHCP letter and the Duragesic file card. The FDA's belief that such violations occurred did not constitute a final adjudication on the merits and Janssen did not have the opportunity to fully and fairly litigate those issues. See Vest, 193 W. Va. 222, 455 S.E.2d 781, Syl. Pt. 2.
V. CONCLUSION
In sum, the FDA's belief, as expressed in the warning letters and subsequent corrective letters, that Janssen violated the FDCA is not sufficient to establish, as a matter of law, that the Appellants' communications to healthcare providers were actually false and misleading in violation of the Consumer Protection Act. It is fundamental that every defendant is entitled to defend themselves against allegations of misconduct. See Syl. Pt. 3, In re Charleston Gazette FOIA Request, 222 W. Va. 771, 671 S.E.2d 776 (2008) (" `The due process of law guaranteed by the State and Federal Constitutions, when applied to procedure in the courts of the land, requires both notice and the right to be heard.' Syllabus Point 2, Simpson v. Stanton, 119 W. Va. 235, 193 S.E. 64 (1937)."). Whether Janssen's statements and omissions in the Risperdal DHCP letter and the Duragesic file card are actually false and misleading under the FDCA, and thus constitute "unfair or deceptive acts or practices" under the Consumer Protection Act, is a question of fact to be decided by a finder of fact. The State, therefore, must present evidence that Janssen's specific statements and omissions do, in fact, violate the relevant laws, and the Appellants are entitled to present evidence to the contrary.
For these reasons, the Court reverses the order granting partial summary judgment entered on August 19, 2008, vacates the final order entered on February 25, 2009, and remands the action to the Circuit Court of Brooke County, West Virginia, for further proceedings consistent with this opinion.
Because the circuit court erred in granting the State's motion for partial summary judgment, this Court need not reach the assignments of error pertaining to alleged evidentiary errors during the bench trial and alleged errors in assessing the civil penalty.
Reversed and Remanded.
Justice McHUGH disqualified.
Judge ABOULHOSN sitting by temporary assignment.