IN THE SUPREME COURT OF MISSISSIPPI
NO. 2019-IA-00033-SCT
JOHNSON & JOHNSON AND JOHNSON & JOHNSON CONSUMER COMPANIES, INC.
v.
LYNN FITCH, ATTORNEY GENERAL OF THE STATE OF MISSISSIPPI EX REL. STATE OF MISSISSIPPI
DATE OF JUDGMENT: 12/18/2018 TRIAL JUDGE: HON. J. DEWAYNE THOMAS COURT FROM WHICH APPEALED: HINDS COUNTY CHANCERY COURT ATTORNEYS FOR APPELLANTS: MEADE W. MITCHELL JOHN C. HENEGAN ORLANDO R. RICHMOND MARK A. DREHER CHARLES A. BYRD PETER C. HARVEY ERIN P. LANE ATTORNEYS FOR APPELLEE: PATRICK C. MALOUF TA’SHIA S. GORDON TIMOTHY W. PORTER LAUREL LI HARRIS R. ALLEN SMITH, JR. WENDY R. FLEISHMAN PAULINA DO AMARAL GEORGE W. NEVILLE DONALD L. KILGORE JACQUELINE H. RAY NATURE OF THE CASE: CIVIL - OTHER DISPOSITION: AFFIRMED AND REMANDED - 04/01/2021 MOTION FOR REHEARING FILED: MANDATE ISSUED:
EN BANC.
COLEMAN, JUSTICE, FOR THE COURT: ¶1. The case sub judice case comes before the Court on interlocutory appeal. The appeal
presents two questions of law concerning the validity of a cause of action brought by the
Mississippi Attorney General under the Mississippi Consumer Protection Act, Mississippi
Code Section 75-24-5. The first is whether the Act covers the State’s claim, and the second
is whether that claim is preempted by federal law. The Chancery Court of Hinds County
denied the summary judgment motion made by Johnson & Johnson and Johnson & Johnson
Consumer, Inc. Johnson & Johnson then filed an interlocutory appeal of the chancellor’s
decision, which the Court granted.
FACTS AND PROCEDURAL HISTORY
¶2. Johnson & Johnson is a New Jersey corporation and is one of the largest companies
in the world. Johnson & Johnson is engaged in the business of, among other things,
manufacturing, selling, and marketing consumer products that include talc. One of Johnson
& Johnson’s most popular products is Johnson’s Baby Powder, which it has sold since the
1890s. Up until 2020, one of the primary ingredients of the popular product was talc.
¶3. Talc is a hydrous magnesium silicate, an inorganic mineral that is mined from the
earth. Talc has been used in the manufacture of many goods, such as plastic, rubber,
ceramics, and cosmetics. Talc is commonly known as talcum powder. For decades, talc has
been at the center of controversy. During that time, many studies gave rise to claims of risk
of cancer associated with the use of products containing talc.
¶4. In 2014, the State commenced an action against Johnson & Johnson for what it alleged
to have been unlawful, unfair, and deceptive business practices related to its cosmetic talcum
2 powder products. The specific cosmetic products at issue are Johnson & Johnson’s
Johnson’s Baby Powder and Shower to Shower. Specifically, the State alleged that Johnson
& Johnson failed to warn of the risk of ovarian cancer in women who used talc. In its
complaint, the State relied on “numerous studies over the last several decades” that the State
alleged “revealed a significant link between the use of talcum powders with an increased risk
of ovarian cancer.” The State’s complaint sought, among other things, an injunction pursuant
to the Consumer Protection Act to require Johnson & Johnson to warn of the hazards
associated with talc use. The State further sought a civil penalty of up to $10,000 for each
violation of the Act.
¶5. Johnson & Johnson then moved for summary judgment. Johnson & Johnson argued
that the chancery court should grant summary judgment because the Act does not apply to
the labeling of products regulated by the federal Food and Drug Administration.
Additionally, Johnson & Johnson argued that even if the Act applies, summary judgment was
still proper because federal law preempts the State’s labeling claim. Johnson & Johnson
heavily relied on the Administration’s consideration of two citizen petitions, one from 1994
and another from 2008. Both petitions requested that the Administration to “require a cancer
warning on cosmetic talc products.” After careful review, however, the Administration
denied both citizen petitions because it “did not find that the data submitted presented
conclusive evidence of a causal association between talc use in the perineal area and ovarian
cancer.”
¶6. On December 18, 2018, the chancery court denied Johnson & Johnson’s motion for
3 summary judgment. While the chancellor acknowledged Johnson & Johnson’s substantive
arguments, the chancellor ultimately denied summary judgment because of the existence of
factual disputes regarding Johnson & Johnson’s knowledge of a link between talc and
ovarian cancer and Johnson & Johnson’s failure to disclose the risks. Johnson & Johnson
now appeals the chancellor’s denial of its summary judgment motion.
STANDARD OF REVIEW
¶7. An appellate court in Mississippi applies a de novo standard of review when it reviews
a trial court’s grant or denial of summary judgment. WW, Inc. v. Rainbow Casino-
Vicksburg P’ship, L.P., 68 So. 3d 1290, 1292 (¶ 6) (Miss. 2011) (quoting Anderson v. Alps
Automotive, Inc., 51 So. 3d 929, 931 (¶ 11) (Miss. 2010)). Courts must apply a de novo
standard when considering “[m]atters of statutory interpretation[.]” Chandler v. McKee, 202
So. 3d 1269, 1271 (¶ 5) (Miss. 2016) (citing Wallace v. Town of Raleigh, 815 So. 2d 1203,
1206 (¶ 7) (Miss. 2016)). Finally, the issue of preemption is a question of law, that is a “legal
one for the judge, not a jury,” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668,
1679, 203 L. Ed. 2d 822 (2019), and a court reviews a question of law under a de novo
standard of review. Debrow v. State, 972 So. 2d 550, 552 (¶ 6) (Miss. 2007) (citing Biglane
v. Under the Hill Corp., 949 So. 2d 9, 14 (¶ 17) (Miss. 2007)).
DISCUSSION
¶8. The State commenced its lawsuit against Johnson & Johnson pursuant to the
Mississippi Consumer Protection Act. Miss. Code Ann. § 75-24-5 (Rev. 2016). The Act
prohibits acts that constitute “unfair or deceptive trade practices in or affecting commerce[.]”
4 Miss. Code Ann. § 75-24-5(1) (Rev. 2016). The State argues that by failing to include
warning labels on cosmetic talc products, Johnson & Johnson violated the Act by engaging
in impermissible “unfair or deceptive trade practices.” In response, Johnson & Johnson
argues that the State’s labeling claim is excluded from the Act and that federal law preempts
such a claim. Specifically, Johnson & Johnson argues that since the Act is modeled after the
Federal Trade Commission Act, and since the federal Act excludes the regulation of labels,
then the Act must also exclude the regulation of labels, and the State’s claim is barred.
Additionally, Johnson & Johnson contends the federal Food, Drug, and Cosmetic Act
(FDCA) preempts the State’s labeling claim.
I. The Mississippi Consumer Protection Act governs the State’s labeling claim.
¶9. Johnson & Johnson argues that the Act excludes the regulation of labels. Johnson &
Johnson first contends that the Mississippi Legislature modeled the Act after the Federal
Trade Commission Act. Johnson & Johnson points to Mississippi Code Section 75-24-3(c),
which provides that “[i]t is the intent of the Legislature that in construing what constitutes
unfair or deceptive trade practices that the courts will be guided by the Federal Trade
Commission and the federal courts to Section 5(a)(1) of the Federal Trade Commission Act
(15 USCS 45(a)(1)) as from time to time amended.” Miss. Code Ann. § 75-24-3(c) (Rev.
2016) (emphasis added). Thus, since the words “guided by”are included in the Section 75-24-
3(c), Johnson & Johnson argues that “this Court must construe the Act in accordance with
its federal ‘parent’ statute,” the Federal Trade Commission Act.
¶10. Next, Johnson & Johnson argues that the Federal Trade Commission Act explicitly
5 excludes the regulation of labels on cosmetics. Johnson & Johnson contends that the Federal
Trade Commission Act defines “[u]nfair or deceptive act or practice” to include “[t]he
dissemination or causing to be disseminated of any false advertisement[.]” 15 U.S.C. § 52(b)
(emphasis added). Johnson & Johnson then provides the Federal Trade Commission Act’s
definition of false advertisement as “an advertisement, other than labeling, which is
misleading in a material respect[.]” 15 U.S.C. § 55(a)(1) (emphasis added). By defining
unfair or deceptive trade practices to include false advertising and then by defining false
advertising to exclude labeling, Johnson & Johnson argues that the definitions exclude
labeling from the Federal Trade Commission Act’s reach, and since labeling is beyond the
Federal Trade Commission Act’s reach, Johnson & Johnson argues that it is also beyond the
Act’s reach.
¶11. As previously noted, Section 75-24-3(c) references 15 U.S.C. § 45(a)(1). The State,
however, contends that Johnson & Johnson does not cite 15 U.S.C. § 45(a)(1) to argue the
Federal Trade Commission Act excludes labeling from unfair or deceptive trade practices.
Instead, the State argues that Johnson & Johnson erroneously cites the Federal Trade
Commission Act’s separate false advertising prohibition against labeling found in 15 U.S.C.
§§ 52(b) and 55(a)(1). The State argues that “[t]he FTC Act’s false advertising prohibition
does not include labeling, but that limit explicitly applies only ‘For the purposes of sections
52 to 54,’ not § 45(a)(1), the section in which the Act instructs courts to be ‘guided’ by.” See
15 U.S.C. § 55.
¶12. In construing what constitutes unfair or deceptive trade practices, the Act requires
6 that courts be “guided by the interpretations given by the Federal Trade Commission and the
federal courts[.]” Miss. Code Ann. § 75-24-3(c). Here, the State argues that Johnson &
Johnson misconstrues the Act’s rule of construction. While the Act provides that courts will
be “guided by” the Federal Trade Commission Act, the State contends that “guided by” does
not mean that courts are bound by or limited by the federal Act.
¶13. Recently, in Watson Laboratories, Inc. v. State, 241 So. 3d 573 (Miss. 2018), the
Court addressed a similar issue involving the interpretation of Section 75-24-3(c). In Watson,
the State brought a consumer protection action against prescription drug manufacturers under
the Act. Id. at 576. There, the State alleged that the manufacturers inflated reported prices
which, in turn, caused the Mississippi Division of Medicaid to reimburse pharmacies at the
inflated prices. Id. The chancellor agreed with the State in that case, but on appeal, Watson
argued that the chancellor applied the incorrect legal test or standard. Relying on the “guided
by” language in Section 75-24-3(c), Watson argued that a different test or standard, one that
the Federal Trade Commission adopted, must be applied. Id. at 577, 590 In rejecting
Watson’s argument, the Court announced that
Nothing in Section 75-24-3(c), though, delegates the chancellor’s determination to the federal courts, nor does the statute bind Mississippi judges to varied, changing decisions at the federal level. The judges, as factfinders in bench trials, and the juries of the State of Mississippi are perfectly capable of determining—while being “guided” by federal authority—what are deceptive practices. That is exactly what the chancellor did here.
Id. at 590.
¶14. Johnson & Johnson argues that the case sub judice is unlike Watson because it
involves one federal standard, namely that the Federal Trade Commission Act excludes
7 cosmetic label regulation, so the Act must also exclude such regulation. Johnson & Johnson
distinguishes Watson because it involved a choice between two different federal standards.
Here, however, the State contends that the Court’s reference in Watson to “varied, changing
decisions at the federal level” does not isolate Watson to cases only involving two or more
federal standards.
¶15. Watson merely emphasized the principle that Section 75-24-3(c) does not wholly limit
a Mississippi judge’s determination to federal law. Id. If judges in Mississippi were bound
by the federal Act, then Mississippi would be left without a legal mechanism to address
labeling issues. Unlike Mississippi, the federal system assigns the regulation of labeling
issues to the Food and Drug Administration. There is even an agreement between the
Federal Trade Commission and the Administration that delegates the regulation of labels to
the Administration. No such dual system exists in Mississippi. Instead, the Act is the legal
mechanism available to govern the regulation of labels.1
¶16. Like the chancellor in Watson, the chancellor here is not bound by a federal court or
Federal Trade Commission interpretation of the Federal Trade Commission Act. Instead, a
chancellor is to be guided by such interpretations, just as Section 75-24-3(c) commands.
Accordingly, the Act does not preclude the State’s claim.
1 In 1971, the Federal Trade Commission and the Food and Drug Administration entered into a Memorandum of Understanding. Memorandum of Understanding Between Federal Trade Commission and the Food and Drug Administration, 36 Fed. Reg. 18,539 (Sept. 16, 1971). The agreement between the two agencies provided that, with the exception of prescription drugs, the Commission regulates “the truth or falsity of all advertising (other than labeling) of foods, drugs, devices, and cosmetics.” Id. (emphasis added). Then the Food and Drug Administration regulates “all matters regulating the labeling of foods, drugs, devices, and cosmetics.” Id. (emphasis added).
8 II. Federal law does not preempt the State’s claim.
¶17. Additionally, Johnson & Johnson argues that the chancellor should have granted
summary judgment because federal law preempts the State’s talc labeling claim.
Specifically, Johnson & Johnson contends that the State’s claim is expressly preempted under
the FDCA’s express preemption for cosmetic labels. Also, Johnson & Johnson argues that
a Food and Drug Administration regulation impliedly preempts the State’s claim.
A) An Overview on Preemption
¶18. The Supremacy Clause of Article VI of the United States Constitution provides that
“the Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in
every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. Thus, as the Supreme Court of the
United States has stated, “since our decision in M’Culloch v. Maryland, 17 U.S. (4 Wheat.)
316, 427, 4 L. Ed. 579 (1819), it has been settled that state law that conflicts with federal law
is ‘without effect.’” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (quoting
Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). “Consideration of issues arising under
the Supremacy Clause ‘start[s] with the assumption that the historic police powers of the
States [are] not to be superseded by . . . Federal Act unless that [is] the clear and manifest
purpose of Congress.’” Id. (alterations in original) (quoting Rice v. Santa Fe Elevator
Corp., 331 U.S. 218, 230 (1947)). Therefore, “‘[t]he purpose of Congress is the ultimate
touchstone’ of pre-emption analysis.” Id. (quoting Malone v. White Motor Corp., 435 U.S.
497, 504 (1978)).
9 ¶19. Congress may show “preemptive intent through a statute’s express language or
through its structure and purpose.” Altria Group, Inc. v. Good, 555 U.S. 70, 76 (2008). If
Congress gave an express preemption provision, the provision does not automatically end the
inquiry because a court must still determine the question of “the substance and scope of
Congress’ displacement of state law[.]” Id.
B) Federal law does not expressly preempt the State’s claim.
¶20. Johnson & Johnson argues that federal law expressly preempts the State’s talc labeling
claim. Specifically, Johnson & Johnson contends that the FDCA includes a provision that
expressly preempts state law regulation of cosmetics labels.
¶21. In 1997, to ensure that federal requirements are not frustrated by state law, Congress
added an express preemption provision to the FDCA that specifically covered cosmetics. Id.
(citing Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, §
752, 111 Stat. 2296, 2376 (1997)). That provision provides:
Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
21 U.S.C. § 379s(a) (emphasis added).
¶22. The State sought to require Johnson & Johnson to establish an ovarian cancer warning
on Johnson & Johnson’s talc cosmetic products. Johnson & Johnson argues that the action
is expressly preempted by § 379s(a). While an express preemption provision indeed applies
10 to cosmetics regulation, as stated previously, in order for the provision to fully apply, the
Court must determine whether the State’s sought requirement falls within the provision’s
scope. See Altria, 555 U.S. at 76. The express preemption provision preempts state
requirements that “establish or continue in effect [a] requirement for labeling or packaging
of a cosmetic that is different from or in addition to . . . a requirement specifically applicable
to a particular cosmetic or class of cosmetics under this chapter[.]” 21 U.S.C. § 379s(a)
(emphasis added). However, in the case sub judice, there was no requirement by the Food
and Drug Administration.
¶23. As previously noted, the FDCA vested the Administration with the authority to require
labels for cosmetics. 21 U.S.C. § 371(a). Johnson & Johnson argues that the Food and Drug
Administration’s decision in two citizen petitions establishes preemption.
¶24. Several Administration regulations within Title 21 of the Code of Federal Regulations
govern the Administration’s citizen petition process. First, the Food and Drug
Administration provides that:
(a) An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either:
(1) In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1, for a new drug application in § 314.50, for a new animal drug application in § 514.1, or
(2) in the form for a citizen petition in § 10.30.
21 C.F.R. § 10.25(a)(1)-(2) (West, Westlaw through Mar. 4, 2021) (emphasis added).
¶25. Second, 21 C.F.R. § 10.30 specifically outlines the citizen petition process - a process
11 that is subject to judicial review. See 21 C.F.R. § 10.30(k) (West, Westlaw through Mar. 4,
2021). Finally, “[u]nless otherwise provided, the Commissioner’s final decision constitutes
final agency action (reviewable in the courts under 5 U.S.C. 701 et seq. and, where
appropriate, 28 U.S.C. 2201) on a petition submitted under § 10.25(a)[.]” 21 C.F.R. §
10.45(d) (West, Westlaw through Mar. 4, 2021) (emphasis added). The regulations establish
that a final decision by the Food and Drug Administration on a citizen petition constitutes a
final agency action that is subject to judicial review.
¶26. In 2014, in accordance with the above regulations, the Administration responded by
letter to the Cancer Prevention Coalition’s 1994 and 2008 citizen petitions. Both citizen
petitions requested “that the Food and Drug Administration (FDA or the Agency) require a
cancer warning on cosmetic talc products” because of the risk of ovarian cancer after
applying talc “in the female genital area.” In its letter, the Food and Drug Administration
denied the citizen petitions’ request for ovarian cancer warnings because the “FDA did not
find that the data submitted presented conclusive evidence of a casual association between
talc use in the perineal area and ovarian cancer.” In order to be binding on the public, the
Food and Drug Administration must follow the notice and comment rule making process.
U.S. Food & Drug Admin., The Food and Drug Administration’s Development, Issuance,
and Use of Guidance Documents, 62 Fed. Reg. 8961, 1997 WL 79385 (Feb 27, 1997). While
the Food and Drug Administration letter is considered a final agency action, it does not
follow the notice and comment rule making process. In a similar case, a letter written by the
commissioner of the Food and Drug Administration was deemed inaction, and the United
12 States Court of Appeals for the Third Circuit held, “the FDA has not acted to regulate it in
a manner that could preempt [the plaintiff’s] claims.” Fellner v. Tri-Union Seafoods,
L.L.C., 539 F.3d 237, 253 (3d Cir. 2008). Additionally, the United States Supreme Court has
held that courts “have a duty to accept the reading that disfavors pre-emption.” Bates v. Dow
Agrosciences LLC, 544 U.S. 431, 449 (2005). Through its inaction, the Food and Drug
Administration declined to make a requirement regarding cancer warnings for cosmetic
products that contain talc.
¶27. “Where a statute is unambiguous, the Court must apply the statute according to its
plain meaning, refraining from principles of statutory construction.” Carver v. Pub. Emps.’
Ret. Sys. of Miss., 306 So. 3d 694, 698 (¶ 12) (Miss. 2020) (internal quotation marks
omitted) (quoting OXY USA, Inc. v. Miss. State Tax Comm’n, 757 So. 2d 271, 274 (¶ 12)
(Miss. 2000)). By its plain language, § 379s(a) only applies if the Food and Drug
Administration adopts “a requirement specifically applicable” to a given cosmetic.
Accordingly, the Food and Drug Administration’s decision not to act cannot be deemed to
be a requirement for purposes of § 379s(a). In other words, the preemption statute requires
the existence in federal law of a positive expression of regulation applicable to a specific
product. The Food and Drug Administration’s decision not to adopt any such regulation
cannot, as it were, fit the bill. Accordingly, the State’s claim is not expressly preempted
under 21 U.S.C. § 379s(a).
¶28. Johnson & Johnson also argues that the State’s claim is barred by principles of implied
preemption. Johnson & Johnson argues that obstacle preemption bars the State’s claim,
13 citing International Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987). “[T]he state law . .
. is preempted if it interferes with the methods by which the federal statute was designed to
reach this goal.” Id. However, the Food and Drug Administration has declined to create a
requirement, either positive or negative, regarding the cosmetic or class of cosmetics listed
in the State’s claim, thus no interference could occur. There is no need to guess what
Congress’ goal was when § 379s(a) was enacted. The statute clearly prohibits states from
having a requirement that is different from or in addition to a requirement that is already in
place by the Food and Drug Administration. However, in the case sub judice, there is no
existing requirement in place. Accordingly, the Food and Drug Administration chose not to
exercise its regulatory authority, allowing the states the freedom to regulate cosmetics
instead.
CONCLUSION
¶29. The Act does not exclude the State’s talc labeling claim. Additionally, because of the
lack of any specific requirement by the Food and Drug Administration, the State’s claim is
not barred by the principles of express or implied preemption. Therefore, the judgment of
the Chancery Court of Hinds County is affirmed, and the case is remanded.
¶30. AFFIRMED AND REMANDED.
RANDOLPH, C.J., KITCHENS AND KING, P.JJ., MAXWELL, BEAM, CHAMBERLIN, ISHEE AND GRIFFIS, JJ., CONCUR.