Rooney, et al v. Procter & Gamble Company
ORDER AND REASONS denying as moot 7 Motion to Dismiss for Failure to State a Claim; denying as moot 16 Motion to Dismiss for Failure to State a Claim; granting 26 Motion to Dismiss for Failure to State a Claim Plaintiffs' Second Amended Complaint. The Court further GRANTS plaintiffs leave to file an amended complaint within fourteen days of this Order. Signed by Judge Sarah S. Vance on 11/21/2022. (mm)
Case 2:22-cv-01164-SSV-JVM Document 31 Filed 11/21/22 Page 1 of 14
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
PAMELA ROONEY, ET AL.
THE PROCTER AND GAMBLE
SECTION “R” (1)
ORDER AND REASONS
Before the Court is defendant Procter & Gamble Company’s motion to
dismiss the second amended complaint filed by plaintiffs Pamela and Pat
Rooney. 1 Plaintiffs oppose defendant’s motion. 2 For the following reasons,
the Court GRANTS defendant’s motion.
This case arises from plaintiff Pamela Rooney’s alleged exposure to
benzene from her use of Secret aerosol antiperspirant, a product that
defendant manufactures, advertises, and sells.
R. Doc. 26.
R. Doc. 27.
Plaintiffs contend that
Case 2:22-cv-01164-SSV-JVM Document 31 Filed 11/21/22 Page 2 of 14
Rooney bought Secret antiperspirant at least once a month for several years, 3
which allegedly caused her to develop triple negative breast cancer.
Plaintiffs contend that in 2021, Valisure LLC, an analytical pharmacy,
ran tests on a number of defendant’s antiperspirant products, including
Valisure’s testing allegedly revealed that samples of Secret
antiperspirants contained benzene, a carcinogenic chemical capable of
causing, among other things, triple negative breast cancer.5 The batches of
Secret that Valisure tested included values of benzene ranging from 1.10 to
16.2 parts per million (“ppm”).6 For reference, plaintiffs allege that the
National Institute of Occupational Safety and Health recommends that
protective equipment be worn by workers expecting to be exposed to benzene
at concentrations of 0.1 ppm, and identifies skin absorption as a method of
benzene exposure.7 Plaintiffs contend that both the Centers for Disease
Control and the U.S. Department of Health and Human Services recognize
the carcinogenic properties of benzene. 8 They further allege that the FDA
characterizes benzene as a “Class 1” compound, which, according to FDA
R. Doc. 25 at 2 ¶ 7.
Id. at 4 ¶ 16.
Id.; id. at 3 ¶ 12.
Id. at 4 ¶ 16.
Id. at 13 ¶¶ 37-38.
Case 2:22-cv-01164-SSV-JVM Document 31 Filed 11/21/22 Page 3 of 14
guidance, “should not be employed in the manufacture of drug substances,
excipients, and drug products, because of their unacceptable toxicity or their
deleterious environmental effect.”9
Valisure filed a citizen petition with the FDA asking the agency to recall
all batches of defendant’s antiperspirant products that contained over 0.1
ppm of benzene.10
Although the FDA has not responded to Valisure’s
petition, defendant voluntarily recalled batches of its antiperspirant
products from the market after Valisure filed the petition. 11
Plaintiffs allege that the FDA regulates the manufacture and sale of
antiperspirant products, which it treats as an over-the-counter drug
product.12 The FDA maintains a list of acceptable active ingredients for use
in antiperspirant products. Benzene is not on the FDA’s list of acceptable
active or inactive ingredients, nor does defendant include benzene on the list
of ingredients on its antiperspirants. 13
In fact, defendant allegedly
represents to consumers that benzene is among the materials it does not use
in any of its products. 14 Plaintiffs thus contend that the antiperspirant is both
Id. ¶ 41.
Id. at 5 ¶ 17.
Id. at 7 ¶ 20.
Id. at 7-8 ¶ 20.
Id. at 8 ¶ 20.
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“misbranded” and “adulterated” in violation of the Federal Food, Drug, and
Cosmetics Act (the “FDCA”).
Plaintiffs allege that the benzene in the Secret antiperspirants that
Rooney used caused her cancer. They contend that they currently have in
their possession five cans of adulterated Secret antiperspirant that Rooney
used in the period leading up to her cancer diagnosis, which they represent
they will produce to defendant in discovery. Plaintiffs allege that defendant
violated the Louisiana Products Liability Act (the “LPLA”) by selling Secret
antiperspirants without issuing adequate warnings.15 Plaintiffs also contend
that defendant is liable under theories of negligence, gross negligence, strict
liability, and “fault,” 16 and that defendant violated the FDCA. 17
Plaintiffs filed their first complaint in April of 2022. 18 Defendant
moved to dismiss for failure to state a claim, 19 in response to which plaintiffs
filed an amended complaint. 20 Defendant moved to dismiss the amended
complaint on the same grounds, 21 and plaintiffs filed a second amended
Id. at 15.
Id. at 3 ¶ 14.
Id. at 14 ¶¶ 42-47.
R. Doc. 1.
R. Doc. 7.
R. Doc. 15.
R. Doc. 16.
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Defendant then moved to dismiss the second amended
complaint. 23 That motion is the subject of this Order and Reasons.
In its motion, defendant contends that plaintiffs failed to state a claim
under the LPLA because they failed to plausibly allege (1) causation and (2)
breach of a duty to warn. Regarding causation, defendant contends that
plaintiffs have alleged no facts indicating that Rooney actually used cans of
Secret antiperspirant that contained enough benzene to cause her injury. 24
It also contends that benzene is commonly found in a number of sources,
including gasoline fumes and car exhaust, and that plaintiffs have not
plausibly alleged that Rooney’s cancer was caused by benzene exposure from
Secret antiperspirants rather than some other source. 25 Defendant also
contends it did not breach its duty to warn because it complied with federal
regulations. Defendant contends that to the extent plaintiffs bring any other
claims, those must be dismissed because the LPLA is the exclusive remedy
for lawsuits against manufacturers premised on product defects. 26
Plaintiffs oppose defendant’s motion. The Court considers the parties’
R. Doc. 25.
R. Doc. 26.
R. Doc. 26-1 at 7.
Id. at 3.
Id. at 14-16.
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To survive a Rule 12(b)(6) motion to dismiss, a plaintiff must plead
enough facts to “state a claim to relief that is plausible on its face.” Ashcroft
v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 547 (2007)). A claim is facially plausible “when the plaintiff
pleads factual content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.” Id. at 678. The Court
must accept all well-pleaded facts as true and must draw all reasonable
inferences in favor of the plaintiff. Lormand v. U.S. Unwired, Inc., 565 F.3d
228, 239, 244 (5th Cir. 2009). But the Court is not bound to accept as true
legal conclusions couched as factual allegations. Iqbal, 556 U.S. at 678.
On a Rule 12(b)(6) motion, the Court must limit its review to the
contents of the pleadings, including attachments. Brand Coupon Network,
L.L.C. v. Catalina Mktg. Corp., 748 F.3d 631, 635 (5th Cir. 2014). The Court
may also consider documents attached to a motion to dismiss or an
opposition to that motion when the documents are referred to in the
pleadings and are central to a plaintiff’s claims. Id. “In addition to facts
alleged in the pleadings, however, the district court ‘may also consider
matters of which [it] may take judicial notice.’” Hall v. Hodgkins, 305 F.
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App’x 224, 227 (5th Cir. 2008) (citing Lovelace v. Software Spectrum, Inc.,
78 F.3d 1015, 1017-18 (5th Cir. 1996)).
The Louisiana Products Liability Act
To maintain a products liability action under the LPLA, a plaintiff must
establish that “the defendant is the manufacturer of the product; the
claimant’s damage was proximately caused by a characteristic of the product;
this characteristic made the product unreasonably dangerous; and the
claimant’s damage arose from a reasonably anticipated use of the product.”
Flagg v. Stryker Corp., 647 F. App’x 314, 316 (5th. Cir. 2016) (citing La. Rev.
Stat. § 9:2800.52). A plaintiff can show that a product was unreasonably
dangerous “under one of four theories: (1) the product’s construction or
composition is defective, (2) the product’s design is defective, (3) the
product’s warnings are inadequate, or (4) by showing a breach of express
Plaintiffs bring an inadequate warning claim. To prevail on such a
claim, a plaintiff must establish that, at the time the product left the
manufacturer’s control, “the product possessed a characteristic that may
cause damage and the manufacturer failed to use reasonable care to provide
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an adequate warning of such characteristic and its dangers to users and
handlers of the product.” Stahl v. Novartis Pharms. Corp., 283 F.3d 254,
261 (5th Cir. 2002).
An “adequate warning” for purposes of the LPLA is “a warning or
instruction that would lead an ordinary reasonable user or handler of a
product to contemplate the danger in using or handling the product and
either decline to use or handle the product or, if possible, to use or handle
the product in such a manner as to avoid the damage for which the claim is
made.” La. Rev. Stat. § 9:2800.53(9). “Whether a particular warning or
instruction is adequate is a question for the trier of fact.” Jack v. AlbertoCulver USA, Inc., 949 So. 2d 1256, 1259 (La. 2007). To determine the
adequacy of the warning, the following factors are relevant: “(1) the severity
of the danger, (2) the likelihood of successful communication of the warning
to foreseeable consumers, (3) the intensity and form of the warning, and (4)
the cost of improving the strength or mode of the warning.” Walker v.
Manitowoc Co., 259 So. 3d 465, 477 (La. App. 3d Cir. 2018) (internal
quotation marks omitted).
Under the LPLA, plaintiffs bear the burden of establishing that
defendant’s failure to issue an adequate warning was the proximate cause of
Rooney’s damages. Marable v. Empire Truck Sales of Louisiana, LLC, 221
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So. 3d 880, 901 (4th Cir. 2017). Proximate cause is defined as “any cause
which, in natural and continuous sequence, unbroken by an efficient,
intervening cause, produces the result complained of without which the
result would not have occurred.” Id. To establish proximate causation under
the LPLA, plaintiffs must show that “but for the inadequate warning,” they
“would not have used” the product. Willett v. Baxter Int’l, Inc., 929 F.2d
1094, 1099 (5th Cir. 1991). Plaintiffs’ allegations regarding causation are
deficient in two respects.
First, plaintiffs have failed to plausibly allege that Rooney actually used
Secret antiperspirants that contained benzene. Plaintiffs state, in conclusory
fashion, that the cans of Secret Rooney used contained benzene.27 But
plaintiffs have alleged no facts supporting this conclusion. Plaintiffs contend
that all of the Secret samples tested by Valisure contained benzene, 28 which,
if true, would make plausible plaintiffs’ contention that the cans Rooney used
likewise contained benzene. But the Valisure citizen’s petition does not state
that every single sample of Secret that Valisure tested contained benzene.29
R. Doc. 25 at 7 ¶ 18(a); id. at 3 ¶ 8(a).
Id. at 4 ¶ 16.
Because the Valisure citizen’s petition is “referred to in the pleadings”
and “central to” plaintiffs’ claims, the Court may consider the
document, which was attached to defendant’s motion, at the motion to
dismiss stage. Brand Coupon Network, LLC, 748 F.3d at 635.
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It indicates that at least some of the Secret batches it tested contained
benzene, but the petition does not state how many Secret batches Valisure
tested total.30 Indeed, the petition states that of the 108 unique batches of
products Valisure tested, only 59 had detectable levels of benzene, and that
“many of the body spray products Valisure tested did not contain detectable
levels of benzene.”31 The Court thus cannot conclude that “all” of the samples
contained benzene. Plaintiffs contend in their opposition to defendant’s
motion that they matched the numbers on their Secret cans with the lot
numbers of products that Valisure confirmed contained benzene, but
because this allegation is not in plaintiffs’ complaint, the Court cannot
consider it at the motion to dismiss stage. See Anyanwu v. Louisiana, No.
18-0778, 2019 WL 3325809, at *2 (“[T]he Court cannot consider new factual
allegations raised in Plaintiff’s opposition that were not specified in the
Plaintiffs have also failed to plausibly allege that benzene exposure can
cause the type of cancer with which Rooney was diagnosed.
plaintiffs’ assertion in their complaint that “[t]he development of triple
negative breast cancer as a result of benzene exposure has been well
R. Doc. 26-2 at 13-18.
Id. at 2.
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documented,” they do not refer the Court to any of the purported
documentation of the link between benzene and breast cancer. Compare
Baudin v. AstraZeneca Pharms. LP, 413 F. Supp. 3d 498, 507 (denying
defendant’s motion to dismiss when plaintiff included “allegations regarding
the scientific support for the link between Nexium and gastric cancer”). This
omission is striking when compared to plaintiffs’ more detailed allegations
about the studies linking benzene to cancer generally. Their allegation that
benzene can cause triple negative breast cancer is an unsupported,
conclusory assertion of fact that is insufficient at the pleading stage. Iqbal,
556 U.S. at 678 (“Nor does a complaint suffice if it tenders naked assertion[s]
devoid of further factual enhancement.” (internal quotation marks
Other Theories of Liability
It is unclear, from the face of plaintiffs’ complaint, whether they assert
any claims other than their claim premised on defendant’s inadequate
warning under the LPLA. The complaint mentions, among other things,
negligence, gross negligence, strict liability, and violations of the FDCA. To
the extent plaintiffs intended to allege these theories as freestanding claims
for relief, they are dismissed. “There is no private right of action to sue for
Case 2:22-cv-01164-SSV-JVM Document 31 Filed 11/21/22 Page 12 of 14
violations of the FDCA or associated regulations.” Vesoulis v. ReShape
LifeSciences, Inc., 2022 WL 989465, at *4 (5th Cir. Apr. 1, 2022). Plaintiffs’
other theories must be dismissed because “[t]he LPLA provides the ‘exclusive
remedy for products liability suits’ under Louisiana law.” Flagg, 647 F. App’x
at 316 (quoting Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 182 (5th
Cir. 2012)); see also Brennon v. Pfizer, Inc., 2009 WL 2525180, at *3 (W.D.
La. Aug. 17, 2009) (dismissing plaintiff’s claims for strict liability, negligence,
gross negligence, and breach of express warranty on the grounds that the
LPLA provided the exclusive remedy plaintiff’s claims against a
Leave to Amend
Plaintiffs request that, in the event the Court grants defendant’s
motion to dismiss, they be given leave to amend their complaint to allege
facts sufficient to support their claim. 32 Defendant opposes this request on
the grounds that any amendment would be futile. 33
The Court should “freely give” leave to amend “when justice so
requires.” Fed. R. Civ. P. 15(a)(2); Leal v. McHugh, 731 F.3d 405, 417 (5th
R. Doc. 27 at 2.
R. Doc. 30 at 1.
Case 2:22-cv-01164-SSV-JVM Document 31 Filed 11/21/22 Page 13 of 14
Cir. 2013). When deciding whether leave to amend should be given, the
Court considers several factors, including “undue delay, bad faith or dilatory
motive on the part of the movant, repeated failure to cure deficiencies by
amendments previously allowed, undue prejudice to the opposing party by
virtue of allowance of the amendment, [and] futility of the amendment.”
Forman v. Davis, 371 U.S. 178, 182 (1962). The Court finds that none of these
factors is present here. Specifically, the Court finds that, with sufficiently
pleaded facts, the “circumstances relied upon by . . . plaintiff[s] may be a
proper subject of relief.”
The Court therefore dismisses plaintiffs’
complaint without prejudice and with leave to amend within fourteen days
of entry of this Order.
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For the foregoing reasons, the Court GRANTS defendants’ motion to
dismiss, and dismisses plaintiffs’ complaint WITHOUT PREJUDICE. The
Court further GRANTS plaintiffs leave to file an amended complaint within
fourteen days of this Order. The Court also DENIES as MOOT defendants’
first two motions to dismiss plaintiffs’ original complaint and their first
amended complaint. 34
21st day of November, 2022.
New Orleans, Louisiana, this _____
SARAH S. VANCE
UNITED STATES DISTRICT JUDGE
R. Docs. 7 & 16.
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