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SUPREME COURT OF THE STATE OF NEW YORK Motion #005
COUNTY OF NEW YORK
TRICIA RANCE, Index No.: 150123/2024
Plaintiff,
Hon. Mary V. Rosado – Part 33
-against-
L’ORÉAL USA, INC.; L’ORÉAL USA
PRODUCTS, INC.; SOFTSHEEN-CARSON
LLC; SOFTSHEEN-CARSON (W.I.), INC.;
GODREJ SON HOLDINGS, INC.;
STRENGTH OF NATURE, LLC,
Defendant(s).
PLAINTIFF’S MEMORANDUM OF LAW
IN OPPOSITION TO STRENGTH OF NATURE LLC AND GODREJ SON HOLDINGS,
INC.’S MOTION TO DISMISS
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TABLE OF CONTENTS
I. INTRODUCTION AND SUMMARY OF RESPONSE ...............................................1
II. RELEVANT FACTS ......................................................................................................2
A. Defendants’ Marketing of Hair Relaxers .................................................................2
B. The Known Dangers of Hair Relaxers .....................................................................2
C. SON’s Failure to Ensure the Safety of Its Products .................................................3
III. LEGAL STANDARD ....................................................................................................4
IV. ARGUMENT AND AUTHORITIES ............................................................................4
A. This Court Has Personal Jurisdiction Over SON.....................................................4
B. Plaintiff Has Adequately Provided SON with Fair Notice ................................... ..7
C. The MDL Court Denied a Substantively Similar Motion ..................................... ..7
D. Plaintiff’s Non-Product Liability Claims Are Not Preempted .............................. ..9
1. Plaintiff’s Claims Are All Claims Under State Product Liability Law ........... ..9
2. Plaintiff’s State Law Claims Parallel SON’s Duties Under Federal Law ....... 10
E. Plaintiff’s Product Liability Claims Are Sufficiently Pled ................................... 12
1. Plaintiff’s Failure to Warn Claims are Sufficiently Pled ................................ 12
a. Plaintiff has adequately alleged the Products are dangerous and
defective .................................................................................................... 12
b. Plaintiff has adequately alleged that SON knew of should have known of
the dangers posed by its Products ..............................................................13
c. Plaintiff has adequately alleged proximate cause ......................................13
2. Plaintiff’s Design Claims Are Sufficiently Pled ..............................................14
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F. Plaintiff Has Adequately Pled General Negligence and Gross Negligence ...........15
G. Plaintiff Has Adequately Alleged Negligence Per Se ............................................16
H. Plaintiff’s Fraud-Based Claims Are Sufficiently Pled ...........................................17
I. Plaintiff’s GBL Claim Is Sufficiently Pled ............................................................18
J. Plaintiffs’ Express and Implied Warranty Claims Are Sufficiently Pled ...............19
K. Plaintiff’s Unjust Enrichment Claim Is Adequately Pled ......................................20
L. Plaintiff’s Claims for Negligent Failure to Recall and Punitive Damages Should
Not Be Dismissed at This Stage.............................................................................20
M. SON’s Statute of Limitations Argument Fails .......................................................21
N. Plaintiff Requests Leave to Amend Her Complaint Prior to Dismissal .................22
V. CONCLUSION ............................................................................................................22
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TABLE OF AUTHORITIES
Cases
Aybar v US Tires and Wheels of Queens, LLC,
211 AD3d 40, 48 [2d Dept 2022] ...................................................................................................6
Barkany Asset Recovery & Mgt. v S.W. Securities Inc.,
41 Misc 3d 673, 684 [NY Sup 2013] .................................................................................17
Bates v Dow Agrosciences LLC,
544 US 431, 447-48 [2005] ...............................................................................................10
Benn v Benn,
82 AD3d 548, 548 [1st Dept 2011]....................................................................................22
Binyan Shel Chessed, Inc. v Goldberger Ins. Brokerage, Inc.,
18 AD3d 590, 592 [2d Dept. 2005] ...................................................................................17
Braniff Airways, Inc. v Curtiss-Wright Corp.,
411 F2d 451, 453 [2d Cir 1969], on reh, 424 F2d 427 [2d Cir 1970] ...............................20
Cabrera v Picker Intern., Inc.,
2 AD3d 308, 308-09 [1st Dept 2003] ................................................................................22
Campaign for Fiscal Equity Inc. v State,
86 NY2d 307, 318 [1995] ....................................................................................................4
Chenango County Indus. Dev. Agency v Lockwood Greene Engineers, Inc.,
114 AD2d 728, 730 [3d Dept 1985] ..................................................................................19
Critcher v L’Oreal USA, Inc.,
959 F3d 31 [2d Cir 2020]...................................................................................................11
Datlof v Turetsky,
111 AD2d 364, 365 [2d Dept 1985] ....................................................................................4
Dulberg v Mock,
1 NY2d 54, 56 [1956] ..........................................................................................................4
Fogal v Steinfeld,
620 NYS2d 875, 884 [NY County, Sup Ct 1994] .............................................................11
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Fresh Direct, LLC v Blue Martini Software, Inc.,
7 AD3d 487, 489 [2d Dept 2004] ......................................................................................17
Gerschel v Christensen,
40 NYS3d 41, 43[1st Dept 2016] ......................................................................................22
Goel v Ramachandran,
975 NYS2d 428, 435 [2d Dept 2013] ..................................................................................7
Haraden Motorcar Corp. v Bonarrigo,
119CV01079BKSDJS, 2020 WL 1915125, at *10 [NDNY Apr. 20, 2020] .....................20
Horowitz v Stryker Corp.,
13 F Supp 2d 271, 286 [EDNY 2009] ...............................................................................19
In re: Hair Relaxer Marketing Sales Practices and Products Liability Litigation,
MDL No. 3060, Dkt. No. 23-CV-00818, 2023 WL 7531230 [ND Ill Nov. 2023], ECF
No. 291 .................................................................................................................................7
International Shoe Co. v State of Wash.,
326 US 310, 316 [1945] .......................................................................................................5
Jacobson v Princess Hotels International, Inc.,
101 AD2d 757, 757-58[1st Dept 1984] ...............................................................................7
Jayes v Irish Welding Supply Corp.,
71 Misc 3d 1204(A), at *4 [Sup Ct 2021], affd, 206 AD3d 1660 [4th Dept 2022]..........19
Koch v Acker, Merrall & Condit Co.,
18 NY3d 940, 941 [2012] ..................................................................................................18
LaMarca v Pak Mor Mfg. Co.,
95 NY2d 210, 216 [2000] ................................................................................................5, 6
Lanzi v Brooks,
43 NY2d 778, 780 [1977] ..................................................................................................17
Leon v Martinez,
84 NY2d 83, 87 [1994] ........................................................................................................4
Membler.com LLC v Barber,
No. 12-CV-4941 JS GR, 2013 WL 5348546, at *14 [EDNY Sept. 23, 2013]....................20
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Metral v Horn,
213 AD2d 524, 526 [2d Dept. 1995] .................................................................................17
Richbell Info. Servs., v Jupiter Partners,
309 AD2d 288, 289 [1st Dept 2003]....................................................................................4
Seitzman v Hudson Riv. Assoc.,
143 Misc 2d 1068, 1070 [Sup Ct 1989] .............................................................................21
Shafranek v Long Island Processor, Inc.,
762 NYS2d 799, 802 [Sup Ct 2003] ..................................................................................21
Shapiro v Glekel,
380 F Supp. 1053, 1059 [SDNY 1974] .............................................................................14
Tirpack v 125 N. 10, LLC,
130 AD3d 917, 919 [2d Dept 2015] ..................................................................................22
Vectron Intern., Inc. v Corning Oak Holding, Inc.,
106 AD3d 1164, 1168 [3d Dept 2013] ..............................................................................22
Statutes & Other Authorities
1 Michael Weinberger, NY Products Liability 2d § 14:1 [2023] ....................................................9
21 C.F.R. § 740.1 .....................................................................................................................11, 16
21 C.F.R. § 740.10 ............................................................................................................... 4, 11, 16
CPLR § 302(a) .............................................................................................................................4, 5
CPLR § 3016..................................................................................................................................17
CPLR § 3211................................................................................................................................4, 7
S Rep 105-43 105th Cong, 1st Sess ...............................................................................................10
21 U.S.C. § 331 ..................................................................................................................10, 11, 16
21 U.S.C. § 361(a) .........................................................................................................................11
21 U.S.C. § 362(a) ...................................................................................................................11, 16
21 U.S.C. § 379s(d)....................................................................................................................9, 10
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Plaintiff, Tricia Rance (“Plaintiff”), through her undersigned counsel, submits this
memorandum of law in opposition to the motion to dismiss filed by Strength of Nature LLC
(“SON, LLC”) and Godrej Son Holdings, Inc. (“Godrej”) (collectively “SON”) and respectfully
submits that the motion should be denied in its entirety. Plaintiff also submits the accompanying
affirmations of Tricia Rance (“Rance Aff.”) and Tim Goss (with exhibits) (“Goss Aff.”) both
affirmed on March 18, 2024. To the extent the Court finds the Complaint lacking in any regard,
Plaintiff respectfully requests leave to file an amended pleading. (Infra IV.N.).
I.
INTRODUCTION AND SUMMARY OF RESPONSE
For many years, Plaintiff regularly purchased and used chemical hair straightening
products manufactured by SON (hereinafter, the “Products”). Plaintiff purchased these Products
because they were represented to be a safe, gentle and beneficial means to achieve the straight-
haired beauty ideal fed to her by the cosmetics industry. In actuality, SON knew or should have
known its Products contained toxic and carcinogenic ingredients injurious to users’ health.
Plaintiff developed uterine cancer from using the Products.
SON now seeks to evade liability by arguing (1) this Court lacks personal jurisdiction, (2)
Plaintiff’s non-product liability claims are preempted, (3) virtually all of Plaintiff’s claims exhibit
pleading deficiencies, and (4) the statute of limitations bars certain claims. SON’s arguments
each fail. First, SON is subject to personal jurisdiction in this State under multiple avenues.
Second, all of Plaintiff’s claims are brought against a manufacturer due to personal injuries
caused by its product. As such, they are all “products liability actions” and exempt from
preemption. Moreover, even if they were not all product liability actions, they all seek to impose
liability for conduct prohibited by both federal and state law. Thus, Plaintiff’s claims impose no
different or additional requirements on cosmetic manufacturers and are not preempted. Third,
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SON’s scattered array of supposed pleading deficiencies consists of matters that have been
adequately alleged, unnecessary details, or disputed issues of fact not appropriate for a motion to
dismiss. And fourth, Plaintiff filed her Complaint within the appropriate time.
For the reasons set forth herein, SON’s motion to dismiss should be denied.
II.
RELEVANT FACTS
Plaintiff was a long-time user of chemical hair straightening products designed,
manufactured, marketed, and sold by SON to the Black community. (Compl. ¶ 1). As a result of
exposure to toxic ingredients in SON’s Products, Plaintiff developed, and was diagnosed with,
uterine cancer in or around January 2021. (Compl. ¶ 9).
A. Defendants’ Marketing of Hair Relaxers.
For decades, SON and the hair care industry marketed hair relaxers to Black and Brown
customers by promoting Eurocentric standards of beauty. (Compl. ¶ 37). SON and the other
defendants capitalized on this straight-haired ideal and made affirmative misrepresentations and
material omissions when selling hair relaxers, including:
• Advertising their Products as “organic,” “natural,” “nourishing,” “added protection” or
“healthy.”
• Misrepresenting that “no lye” relaxers or “gentle” treatment relaxers were milder, gentler,
less-toxic and/or more safer than alternative relaxers.
(Compl. ¶ 38-39). These terms were intended to suggest that the Products were not only safe, but
beneficial to the body when they were not. (Compl. ¶¶ 38-39).
B. The Known Dangers of Hair Relaxers.
While it was representing its Products as safe, healthy and nourishing, SON knew or should
have known of the potential harms, including increased risks of uterine and ovarian cancer, caused
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by hair relaxers based on available medical and scientific studies, on-going research and various
government standards and regulations. (Compl. ¶¶ 40, 47).
It is known that endocrine disrupting chemicals (“EDCs”) interfere with the normal
activity of the endocrine system. (Compl. ¶ 53). EDCs are present in some hair relaxers under the
guise of fragrance and perfumes. (Compl. ¶ 55). Epidemiological studies have shown a significant
association between EDCs and adverse reproductive outcomes in humans. (Compl. ¶ 60, fn. 14).
In October 2022, the National Institute of Health released a study of approximately 34,000
women which found significantly higher rates of uterine cancer in women who had used hair
relaxers. (Compl. ¶ 65, citing, Che-Jung Chang, et al., Use of Straighteners and Other Hair
Products and Incident Uterine Cancer, Journal of the National Cancer Institute, Oct. 17, 2022,
https://pubmed.ncbi.nlm.nih.gov/36245087). The Chang study found that women who used hair
relaxers had approximately double the risk of developing uterine cancers. (Compl. ¶ 68).
C. SON’s Failure to Ensure the Safety of Its Products.
The law does not require most cosmetic products and ingredients to obtain FDA approval
before going to market. Nevertheless, the Federal Food, Drug, and Cosmetic Act (“FDCA”)
expressly prohibits the marketing of “adulterated” or “misbranded” cosmetics. (Compl. ¶ 73). A
product is adulterated if it contains any poisonous or deleterious substance causing injury to a user.
(Compl. ¶ 75). A product is misbranded if its labeling is false or misleading, does not include
required information, or does not prominently and conspicuously display required information.
(Compl. ¶ 77).
Additionally, cosmetics manufacturers have a legal responsibility to ensure the safety of
their products. (Compl. ¶ 79). Cosmetic safety can be substantiated through existing toxicological
tests on individual ingredients, existing data on product formulations that are similar in
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composition, or the performance of additional testing that is appropriate. (Compl. ¶ 80). If the
safety of a cosmetic cannot be adequately substantiated, it may be considered misbranded unless
it states “Warning—The safety of this product has not been determined.” 21 C.F.R. § 740.10.
Despite these duties, SON failed to disclose: (1) the high risk of dangers when using their
Products, (2) their Products contained potential or known toxic chemicals and carcinogens, (3)
they had not properly tested the safety of their Products, and (4) they had not properly researched
the safety of their Products. (Compl. ¶ 84). As a result of these failures and Plaintiff’s exposure
to the Products, Plaintiff developed uterine cancer. (Compl. ¶ 9).
III.
LEGAL STANDARD
On a motion to dismiss pursuant to CPLR 3211(a)(7), the Court must determine only
whether the facts alleged manifest any cause of action cognizable at law. Campaign for Fiscal
Equity Inc. v State, 86 NY2d 307, 318 [1995]; Richbell Info. Servs., v Jupiter Partners, 309 AD2d
288, 289 [1st Dept 2003]. When deciding whether a plaintiff has sufficiently pled a cause of
action, every allegation set forth in the complaint must be accepted as true. Datlof v Turetsky, 111
AD2d 364, 365 [2d Dept 1985]; Leon v Martinez, 84 NY2d 83, 87 [1994]. The plaintiff must be
afforded the benefit of every possible inference. Id. If the Plaintiff is entitled to recover damages
on any reasonable view of the facts, then the complaint is legally sufficient, and the motion must
be denied. Dulberg v Mock, 1 NY2d 54, 56 [1956].
IV.
ARGUMENT AND AUTHORITIES
A. THIS COURT HAS PERSONAL JURISDICTION OVER SON.
As SON concedes, CPLR § 302(a) outlines how New York courts may exercise specific
jurisdiction over non-domiciliaries. (See Memorandum of Law in Support of SON’s Motion to
Dismiss the Complaint at 6 (hereinafter “Motion to Dismiss.”)). A “court may exercise personal
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jurisdiction over any non-domiciliary … who in person or through an agent:”
(1) “transacts any business within the state or contracts anywhere to supply goods
or services in the state; or”
(2) “commits a tortious act within the state … or”
(3) “commits a tortious act without the state causing injury to person or property
within the state … if he (i) regularly does or solicits business, or engages in any
other persistent course of conduct, or derives substantial revenue from goods
used or consumed or services rendered, in the state, or (ii) expects or should
reasonably expect the act to have consequences in the state and derives
substantial revenue from interstate or international commerce[.]” (CPLR
§ 302(a)).
A state may exercise jurisdiction over non-domiciliary defendants, provided they had
certain minimum contacts with State such the suit does not offend traditional notions of fair play
and substantial justice. International Shoe Co. v State of Wash., 326 US 310, 316 [1945]. A non-
domiciliary tortfeasor has “minimum contacts” with the forum State—and may thus reasonably
foresee the prospect of defending a suit there—if it purposefully avails itself of the privilege of
conducting activities within the forum State. LaMarca v Pak Mor Mfg. Co., 95 NY2d 210, 216
[2000].
Notably, SON does not assert (nor could it) that its Products were not legally sold or it was
unaware its Products were being sold in the State of New York during the relevant period. Plaintiff
purchased Defendants’ Products in the State. (Compl. ¶¶ 8, 10, 15; see also Rance Aff.). SON has
thus transacted business within the State or contracted to supply goods in the State, in satisfaction
of § 302(a)(1). 1 The CPLR § 302(a)(1) inquiry is twofold: under the first prong, the defendant
1
Further, SON LLC has been sued in this State by the Workers’ Compensation Board for failure to carry insurance,
and judgment was entered against it. Goss Aff. Exs. A and B. “Virtually all employers in New York State must
provide workers’ compensation coverage for their employees[.]” Workers’ Compensation Coverage Requirements,
New York State Workers’ Compensation Board, https://www.wcb.ny.gov/content/main/coverage-requirements-wc/
(last accessed Mar. 5, 2024).
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must have conducted sufficient activities to have transacted business in the state, and under the
second prong, the claims must arise from the transactions. Aybar v US Tires and Wheels of Queens,
LLC, 211 AD3d 40, 48 [2d Dept 2022]. Both prongs are met here. SON sold significant quantities
of hair relaxers in New York and Plaintiff’s claims arose from her purchase and use of SON
Products that caused her harm.
Alternatively, subsection (a)(3) also applies. “The conferral of jurisdiction under this
provision rests on five elements: First, that defendant committed a tortious act outside the State;
second, that the cause of action arises from that act; third, that the act caused injury to a person or
property within the State; fourth, that defendant expected or should reasonably have expected the
act to have consequences in the State; and fifth, that defendant derived substantial revenue from
interstate or international commerce.” LaMarca, 95 NY2d at 214. Here, SON (i) has committed a
tortious act that caused injury to Plaintiff in New York and gave rise to Plaintiff’s cause of action,
and (ii) regularly solicits business through the selling of its Products in New York and derives
substantial revenue from interstate commerce and sales in New York, and (iii) should expect that
the act of selling its Products has consequences in the New York. (See Compl. ¶¶ 8, 10, 12, 13,
15, 23). Thus, SON is subject to personal jurisdiction in this State. See LaMarca, 95 NY2d at 219
(finding jurisdiction over out-of-state company whose products were sold in New York).
SON further argues that Godrej, a holding company, does not manufacture or sell the
Products, and thus should not be subject to personal jurisdiction. Tellingly, SON provides no case
law to support this notion. SON, LLC is a subsidiary of Godrej, the LLC’s sole member and
interested party. (Compl. ¶¶ 21, 22). “When a company of [Defendant’s] size and scope profits
from sales to New Yorkers, it is not at all unfair to render it judicially answerable for its actions in
this State. Considering that [Defendant’s] long business arm extended to New York, it seems only
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fair to extend correspondingly the reach of New York’s jurisdictional long-arm.” LaMarca, 95
NY2d at 219. Having reaped the benefits of selling its Products to Plaintiff and other consumers
in the New York market for years, it is fair and appropriate that SON be subject to personal
jurisdiction in New York.
In the alternative, should the Court find any aspect of SON’s argument persuasive, Plaintiff
requests jurisdictional discovery pursuant to CPLR § 3211. Plaintiff has alleged SON Products
were sold in this State and shown SON has employees in this state (see supra fn. 1); thus, there is
a reasonable expectation that facts supporting the exercise jurisdiction over SON will be further
developed through discovery. See Goel v Ramachandran, , 975 NYS2d 428, 435 [2d Dept 2013]
(when seeking jurisdictional discovery, “plaintiffs need not make a prima facie showing of
jurisdiction, but instead ‘need only demonstrate that facts “may exist” to exercise personal
jurisdiction over the defendant’”) (emphasis added); see also Jacobson v. Princess Hotels
International, Inc., 101 AD2d 757, 757-58[1st Dept 1984] (finding jurisdictional discovery
proceedings authorized and necessary). Plaintiff has shown—at minimum—facts may exist to
exercise personal jurisdiction in this State.
B. PLAINTIFF HAS ADEQUATELY PROVIDED SON WITH FAIR NOTICE.
SON argues that Plaintiff has failed to provide SON with fair notice of her claims. For the
reasons outlined in each section below (see, infra, Sections IV.C. – M.), SON’s argument fails.
C. THE MDL COURT DENIED A SUBSTANTIVELY SIMILAR MOTION.
SON’s motion should be denied for many of the same reasons that the Northern District of
Illinois denied a substantively similar motion filed by SON (and other defendants) in the MDL
Court. In re: Hair Relaxer Marketing Sales Practices and Products Liability Litigation, MDL No.
3060, Dkt. No. 23-CV-00818, 2023 WL 7531230 [ND Ill Nov. 2023], ECF No. 291 (hereinafter
“MDL Order”). The following aspects of the MDL Order are instructive:
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• MDL Court denied SON’s motion to dismiss on preemption grounds. MDL Court noted
that plaintiffs’ claims for negligent misrepresentations, breach of express and implied
warranties, fraud, fraudulent concealment, DTPA and consumer statute claims, unjust
enrichment and punitive damages were all products liability actions such that FDCA
preemption does not apply. (Id. at 3-4).
• MDL Court denied SON’s motion to dismiss negligence claims because issues as to
whether Defendants had knowledge of their products’ dangers or whether Defendants’
conduct was the proximate cause of plaintiffs’ injuries were deemed inappropriate for
resolution on a motion to dismiss. (Id. at 5).
• MDL Court denied SON’s motion to dismiss design defect claims. The Court noted that
the complaint adequately alleged a defect by identifying multiple toxic ingredients
(including EDCs) and cited scientific studies and secondary sources addressing their
dangers. (Id. at 5).
• MDL Court denied SON’s motion to dismiss claims based on failures to warn. The Court
rejected the arguments that plaintiffs had not adequately identified the specific product at
issue and that Defendants lacked knowledge of the dangers of the product prior to the
Chang study’s release. (Id. at 6).
• MDL Court denied SON’s motion to dismiss the warranty claims based on alleged
affirmations by manufacturers that hair relaxers were safe, healthy, protective and natural.
(Id. at 7-8).
• MDL Court denied SON’s motion to dismiss claims for punitive damages after finding the
complaint’s allegations were adequate to support a claim for punitive damages, whether
viewed as a cause of action or a remedy. (Id. at 8-9).
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A majority of SON’s dismissal arguments in this case are lifted directly from the Defendants’
motion to dismiss in the MDL and should be denied for the same reasons.
D. PLAINTIFF’S NON-PRODUCT LIABILITY CLAIMS ARE NOT PREEMPTED.
As it did unsuccessfully before the MDL Court, SON argues here that what it calls
“Plaintiff’s non-products liability claims” (Counts 5-15) are expressly preempted by the FDCA
and FPLA. (Motion to Dismiss at 12). This argument fails because Plaintiff’s claims are all claims
“under the product liability law of any State” and thus not preempted under 21 U.S.C. § 379s(d).
And, even if this Court were to conclude that one or more of Plaintiff’s claims were not product
liability claims under that provision, Plaintiff’s claims under state law do not seek to impose any
different or additional requirements upon Defendants than those required by the FDCA. Thus, this
Court should hold, as the MDL Court held, that Plaintiff’s claims are not subject to dismissal on
preemption grounds.
1. Plaintiff’s Claims Are All Claims Under State Product Liability Law.
Claims brought “under the product liability law of any State” are exempt from preemption
under 21 U.S.C. § 379s(d). Thus, SON cannot argue that Counts 1 – 4 are preempted.
“Product liability” is an expansive term. Black’s Law Dictionary defines a “products-
liability action” as: “A lawsuit brought against a manufacturer, seller, or lessor of a product—
regardless of the substantive legal theory or theories on which the lawsuit is brought—for
personal injury, death, or property damage caused by the manufacture, construction, design,
formulation, installation, preparation, or assembly of a product.” (11th ed 2019) (emphasis added).
Similarly, a New York treatise notes “[p]roducts liability actions may be brought under various
theories. For example, an injured plaintiff may sue for breach of warranty, negligence, or under
the doctrine of strict products liability. In other circumstances, plaintiff may assert liability as a
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result of a statutory violation, fraud, or some other theory.” 1 Michael Weinberger, NY Products
Liability 2d § 14:1 [2023]. And the Senate Report on the FDA Modernization Act of 1997, which
added section 379s to the FDCA, states that the legislation “shall not be construed to modify or
otherwise affect the traditional product liability law of any State. Tort liability rules and
requirements would remain unchanged and unaffected.” S Rep 105-43 105th Cong, 1st Sess, at
66. Accordingly, Plaintiff’s claims all fit within the definition of a product liability claim and are
exempt from preemption pursuant to 21 U.S.C. § 379s(d). This was the conclusion drawn by the
MDL Court and it is equally applicable here. (MDL Order at 3-4).
2. Plaintiff’s State Law Claims Parallel SON’s Duties Under Federal Law.
Even if this Court were to conclude that one or more of Plaintiff’s claims did not qualify
as a product liability claim under state law, that claim still would not be expressly preempted. 21
U.S.C. § 379s(a) only preempts state laws that impose requirements for labeling or packaging of
a cosmetic that are “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 federal
law. That is not what Plaintiff seeks to do here. Plaintiff seeks only to impose liability for conduct
prohibited by both federal and state law. Because the state tort law requirements upon which
Plaintiff’s claims rest parallel federal requirements, they are not preempted. See Bates v Dow
Agrosciences LLC, 544 US 431, 447-48 [2005].
There are multiple, separate federal requirements concerning cosmetics that are implicated
by this litigation and that parallel Plaintiff’s state law claims. For example, Plaintiff seeks to hold
SON liable under state law for designing and marketing a product that contains toxic ingredients
that harm women’s health when used as intended. This same conduct is prohibited under federal
law, which precludes the marketing of “adulterated” cosmetics. 21 U.S.C. § 331. A cosmetic is
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“adulterated” if, inter alia, it “bears or contains any poisonous or deleterious substance which may
render it injurious to users under the conditions of use prescribed in the labeling thereof, or under
such conditions of use as are customary or usual[.]” 21 U.S.C. § 361(a). Thus, the state law duty
to avoid designing and marketing a product with injurious ingredients parallels the federal
requirement.
Similarly, federal law prohibits the marketing of “misbranded” cosmetics. 21 U.S.C. § 331.
A cosmetic is “misbranded” if, inter alia, “its labeling is false or misleading in any particular.” 21
U.S.C. § 362(a). FDA regulations elaborate on these requirements. 21 C.F.R. § 740.1(a) requires
that “[t]he label of a cosmetic product shall bear a warning statement whenever necessary or
appropriate to prevent a health hazard that may be associated with the product.” And 21 C.F.R.
§ 740.10 requires that “[e]ach ingredient used in a cosmetic product and each finished cosmetic
product shall be adequately substantiated for safety prior to marketing.” If the safety of the
cosmetic or ingredients have not been adequately substantiated, the product’s packaging must
conspicuously state: “Warning—The safety of this product has not been determined.” Id. Plaintiff
here contends that Defendants’ Products lacked necessary warnings, including the warning
required by section 740.10. (Compl. ¶ 84). Because Plaintiff’s claims are consistent with the
requirements of federal law, they are not preempted. See, e.g., Fogal v Steinfeld, 620 NYS2d 875,
884 [NY County, Sup Ct 1994].
SON cites no case where a consumer’s lawsuit based on undisclosed toxins in a cosmetic
product was found preempted. Instead, SON relies upon a factually distinguishable case involving
the accuracy of quantity disclosures on a label approved by the FDA, Critcher v L’Oreal USA,
Inc., 959 F3d 31 [2d Cir 2020]. Not surprisingly, the claim in that case was held preempted
because quantity disclosures are not required by the FDCA. That is entirely different from the
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present case. Here, Plaintiff seeks to hold SON liable under state law for including injurious
ingredients in its Products and then misrepresenting or omitting material information about their
safety. Such acts are also prohibited under federal law. Because acting in compliance with federal
law would also bring the manufacturer into compliance with state law, there is no preemption.
E. PLAINTIFF’S PRODUCT LIABILITY CLAIMS ARE SUFFICIENTLY PLED.
1. Plaintiff’s Failure to Warn Claims Are Sufficiently Pled.
SON raises three supposed deficiencies in Plaintiff’s failure-to-warn allegations: (1) a
failure to identify the specific chemical that made the Products defective, (2) a failure to show that
SON had knowledge of the defect, and (3) a failure to show that the defect caused Plaintiff’s
injuries.
a. Plaintiff has adequately alleged the Products are dangerous and
defective.
SON is keen to force Plaintiff to identify a particular ingredient in its Products that caused
Plaintiff’s injuries. That is not required. The FDA looks at products as a whole. Plaintiff has
properly alleged that the Products, as a whole, caused her injuries. That is enough to state a claim.
Debates about the dangers of individual ingredients and the mechanism of action whereby the
Products cause harm are better taken up after discovery.
Moreover, while not necessary, Plaintiff has identified toxic ingredients contained in the
Products. (Compl. ¶ 48). The Complaint alleges that the harmful ingredients include “phthalates,
parabens, cyclosiloxanes, di-(2-ethylhexly), octamethylcyclotetraxiloxane, lye, formaldehyde, and
other toxic chemicals[.]” (Compl. ¶ 48). The Complaint also states that there are EDCs present in
some products under the guise of fragrance and perfume. (Compl. ¶ 55). These ingredients
“significantly increase the risk of cancers and other negative health conditions.” (Compl. ¶ 150).
Finally, the Complaint explains that the harmful ingredients in hair relaxers “are known to disrupt
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and/or harm a woman’s endocrine system.” (Compl. ¶ 48). Similar allegations contained in the
MDL complaint were deemed sufficient. (MDL Order at 5-6). The same holding should follow
here.
b. Plaintiff has adequately alleged that SON knew or should have known
of the dangers posed by its Products.
The MDL Court rejected SON’s argument, repeated here, that SON was unaware of the
association between hair straighteners and cancer until the Chang study was released in 2022.
(MDL Order at 6). In so doing, the Court noted that the MDL complaint specifically alleged that
Defendants “were aware or should have been aware of both the potential for harm and the increased
risk of developing uterine and ovarian cancer from the use of the hair relaxer products based on
the evolving scientific studies, on-going research and various government standards and
regulations.” (MDL Order at 6). A virtually identical allegation is made here.
SON had unique and private access to the ingredients, manufacturing, development,
design, production, research, and/or testing of the Products, and thus unique access to material
facts regarding the safety of the Products. (Compl. ¶ 182). As a large and sophisticated cosmetics
company, SON should have been aware of information bearing on the safety of its Products such
as: an analysis of ingredients in personal care products finding hair relaxers to be among the worst-
scoring products, (Compl. ¶ 46), studies of the impact of EDCs on the endocrine system (Compl.
¶ 51-54), and the known propensity of phthalates to harm the endocrine system such that phthalates
have been restricted or regulated in several countries (Compl. ¶59). If SON contends it lacked
knowledge of its Products’ dangers, that contested issue