Moncibaiz et al v. Pfizer Inc et al

Filing 31

MEMORANDUM AND OPINION GRANTING MOTION TO DISMISS re: 12 MOTION to Dismiss 6 Amended Complaint/Counterclaim/Crossclaim etc. . Plaintiffs may seek leave to amend by 04/23/2021. (Signed by Judge Charles Eskridge) Parties notified.(jengonzalez, 4)

United States District Court
Southern District of Texas

ENTERED

March 31, 2021

Nathan Ochsner, Clerk

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
PAULINE and RICK
MONCIBAIZ,
Plaintiffs,
vs.
PFIZER INC, et al,
Defendants.

§ CIVIL ACTION NO.
§ 4:20-cv-01315
§
§
§
§ JUDGE CHARLES ESKRIDGE
§
§
§
§

MEMORANDUM AND OPINION
GRANTING MOTION TO DISMISS
The motion by Defendants Pfizer, Inc, Wyeth LLC, and
Wyeth Holdings, LLC to dismiss the claims brought by Plaintiffs
Pauline and Rick Moncibaiz is granted. Dkt 12.
1. Background
This action relates to the manufacture and use of Prempro,
a drug available by prescription to treat symptoms of menopause
and to prevent osteoporosis in menopausal women. Dkt 12
at 11–12. Clinical studies have shown that some women who take
Prempro experience an increased risk of breast cancer. Dkt 6
at ¶¶ 11–14.
A black-box warning appears with each prescription and
explains this risk. That warning is approved for use by the United
States Food and Drug Administration. See Dkt 12 at 10–13.
It states in pertinent part:
The estrogen-plus-progestin substudy of the
Women’s Health Initiative (WHI) reported
increased risks of myocardial infarction, stroke,
invasive breast cancer, pulmonary emboli, and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment with conjugated

estrogens (CE 0.625 mg) combined with
medroxyprogesterone acetate (MPA 2.5 mg)
per day relative to placebo. (See CLINICAL
STUDIES and WARNINGS, Cardiovascular disorders and Malignant neo-plasms,
Breast cancer.)
Dkt 5-1 at 3 (emphasis in original). Other references to the risk
of breast cancer appear in the Warnings section. Id at 24–28. The
approved patient-information leaflet also contains a similar
warning. Id at 41.
Pauline Moncibaiz took Prempro from 2008 to 2018, when
she was diagnosed with breast cancer. She alleges that Prempro
was the cause. She also alleges that she was unaware of several
studies that discuss the risks associated with using Prempro,
including the heightened risk of breast cancer. And she alleges
that Defendants failed to inform her of safer alternative
medicines. For example, she says, so-called bioidentical
hormones have been shown to provide the same benefits as
Prempro without involving the same risks. Dkt 6 at ¶¶ 11–17.
Together with her husband, Rick Moncibaiz, she filed suit
against Pfizer and the Wyeth entities in the 189th Judicial District
Court of Harris County in April 2020. Dkt 1-1. Defendants
removed based on diversity jurisdiction. Dkt 1. Plaintiffs at that
time asserted claims for strict liability based on allegation of
design defect, breach of the implied warranty of merchantability,
negligence, and gross negligence. This was done with reference
to a failure-to-warn theory. See Dkt 1-1 at 1–2, 6. Defendants
moved to dismiss, arguing (among other things) that the claims
were all substantively based upon a failure to warn. Dkt 5.
Plaintiffs sought and received leave to file an amended complaint
to respond to those arguments. Dkts 7, 13.
Plaintiffs filed an amended complaint, reasserting claims for
design defect, negligence, and breach of the implied warranty of
merchantability. Dkt 6. Defendants filed the subject motion to
dismiss. Dkt 12. They again argue that Plaintiffs’ claims are in
substance failure-to-warn claims—even though not formally
pleaded as such—and thus subject to dismissal under Texas
products-liability law. See Dkt 12 at 14–19. They argue further

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that Plaintiffs fail to state a claim even if their claims aren’t subject
to dismissal as failure-to-warn claims. See id at 9–12.
2. Legal standard
Rule 8(a)(2) of the Federal Rules of Civil Procedure requires
a plaintiff’s complaint to provide “a short and plain statement of
the claim showing that the pleader is entitled to relief.”
Rule 12(b)(6) allows the defendant to seek dismissal if the
plaintiff fails “to state a claim upon which relief can be granted.”
Read together, the Supreme Court has held that Rule 8 “does
not require ‘detailed factual allegations,’ but it demands more
than an unadorned, the-defendant-unlawfully-harmed-me
accusation.” Ashcroft v Iqbal, 556 US 662, 678 (2009), quoting Bell
Atlantic Corp v Twombly, 550 US 544, 555 (2007). To survive a
Rule 12(b)(6) motion to dismiss, the complaint “must provide
the plaintiff’s grounds for entitlement to relief—including factual
allegations that when assumed to be true ‘raise a right to relief
above the speculative level.’” Cuvillier v Taylor, 503 F3d 397, 401
(5th Cir 2007), quoting Twombly, 550 US at 555.
A complaint must therefore contain enough facts to state a
claim to relief that is plausible on its face. Twombly, 550 US at 570.
A claim has facial plausibility “when the plaintiff pleads factual
content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.” Iqbal,
556 US at 678, citing Twombly, 550 US at 556. This standard on
plausibility is “not akin to a ‘probability requirement,’ but it asks
for more than a sheer possibility that a defendant has acted
unlawfully.” Iqbal, 556 US at 678, quoting Twombly, 550 US at 556.
Review on motion to dismiss under Rule 12(b)(6) is
constrained. The reviewing court must accept all well-pleaded
facts as true and view them in the light most favorable to the
plaintiff. Walker, 938 F3d at 735 (citations omitted). It must also
accept all inferences that plausibly follow from those specific
allegations. Iqbal, 556 US at 678, citing Twombly, 550 US at 556.
3. Analysis
It’s undisputed that the FDA has approved warnings with
respect to the prescription and dispensation of Prempro. It’s also
undisputed that these warnings came with the prescriptions for

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Prempro used by Pauline Moncibaiz. See Dkt 18 at 9 (referencing
“the FDA-approved warnings”).
These facts are important because, since September 2003,
Texas law has imposed a high burden for pleading failure-to-warn
claims where the FDA has approved such warnings. See Reform
of Certain Procedures and Remedies in Civil Actions, 78th Texas
Legislature, 2003 Reg Sess (Sept 1, 2003). Texas Civil Practice and
Remedies Code § 82.007(a)(1) now provides, “In a products
liability action alleging that an injury was caused by a failure to
provide adequate warnings or information with regard to a
pharmaceutical product, there is a rebuttable presumption that
the defendant or defendants, including a health care provider,
manufacturer, distributor, and prescriber, are not liable with
respect to the allegations involving failure to provide adequate
warnings or information” if the warnings on the drug given
match those approved by the FDA.
Texas law further provides only five ways to rebut this
presumption. These are very specific. See Tex Civ Prac &
Rem Code § 82.007(b)(1)–(5); see also Johnson v Novartis
Pharmaceuticals Corp, --- F Appx ---, 2021 WL 406098, *3–4
(5th Cir) (citations omitted). The first is where the defendant
withheld information from the FDA or made misrepresentations
to it before premarket approval. The second is where the product
used by the plaintiff was purchased after an order by the FDA
requiring the defendant to remove the product from the market.
The third is where the product was advertised for an indication
not approved by the FDA, and the plaintiff’s injury was caused
by the improper advertisement. The fourth is where the product
was prescribed for an indication not approved by the FDA, and
the plaintiff’s injury was caused by the improper prescription.
The fifth is where the warnings approved by the FDA were
approved in violation of 18 USC § 201, which prohibits bribery
of public officials and witnesses.
Plaintiffs don’t allege any of these statutory rebuttals. The
pertinent question is solely whether the design-defect, negligence,
and breach-of-warranty claims brought by Plaintiffs are in
substance failure-to-warn claims. This statutory framework being
relatively new, it appears that neither the Texas Supreme Court

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nor the Fifth Circuit have addressed this precise issue. But district
courts have each applied the same general framework.
For example, see Parachim v Biogen Inc, 2019 WL 9654875, *2–3
(WD Tex); Gonzalez v Bayer Healthcare Pharmaceuticals, 930
F Supp 2d 808, 819–21 (SD Tex 2013); Del Valle v Qualitest
Pharmaceuticals Inc, 2012 WL 2899406, *3 (SD Tex), affd sub nom
Lashley v Pfizer, Inc, 750 F3d 470 (5th Cir 2014, per curiam);
Eckhardt v Qualitest Pharmaceuticals Inc, 889 F Supp 2d 901, 907
(SD Tex 2012), affd 751 F3d 674 (5th Cir 2014).
The initial inquiry is whether each asserted claim falls within
the definition of products liability action. See Tex Civ Prac & Rem
Code § 82.001(2); see also Sanchez v Liggett & Myers, Inc, 187 F3d
486, 489–91 (5th Cir 1999). For any claim that does, the further
inquiry is whether the claim in substance alleges that the injury
was caused by a failure to warn. This requires scrutiny of the
complaint and determination whether the allegations actually
describe a failure-to-warn claim, despite characterizations and
labels stated by the plaintiff. See Tex Civ Prac & Rem Code
§ 82.007(a); see also Parachim, 2019 WL 9654875 at *2–3;
Gonzalez, 930 F Supp 2d at 819–21. Any claim that in substance
alleges injury caused by failure to warn is subject to the statutory
presumption and thus barred by the Texas Civil Practice and
Remedies Code.
a. Encompassment within products liability action
Texas Civil Practice and Remedy Code § 82.001(2) defines
products liability action to mean “any action against a manufacturer
or seller for recovery of damages arising out of personal injury,
death, or property damage allegedly caused by a defective product
whether the action is based in strict tort liability, strict products
liability, negligence, misrepresentation, breach of express or
implied warranty, or any other theory or combination of
theories.” Texas courts are clear that this definition is to be
applied broadly. For example, see Fresh Coat, Inc v K-2, Inc,
318 SW3d 893, 900 (Tex 2010); Iacono v Stanley Black & Decker,
Inc, 2016 WL 2745401, *4 (Tex App—Houston [1st Dist] no pet).
Plaintiffs allege that Pauline Moncibaiz sustained a personal
injury from the use of a defective product and that such injury
gives rise to claims for strict liability, negligence, and breach of

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warranty. Under Texas law, those claims are products liability actions.
Plaintiffs don’t dispute this. See Dkt 18 at 11–12.
b. Characterization as failure-to-warn claims
The original pleading of this action specifically referenced a
failure-to-warn theory. Plaintiffs amended their claims to address
the prior motion to dismiss in this regard. The question is
whether the claims as amended continue in substance to be ones
for failure to warn.
The complaint by its nature includes failure-to-warn
references. First, it says that Plaintiffs lacked important
information about Prempro. That is, it lists three studies that
purportedly highlight the risks involved in using Prempro, with
allegation that Pauline Moncibaiz “was unaware” of them. Dkt 6
at ¶¶ 11–15. Specifically, the complaint alleges that she “first
became aware that the Prempro could have caused her cancer in
late 2018.” Id at ¶ 15.
Second, the complaint alleges that Defendants should have
warned her that the risk of developing cancer could vary with the
dose used but failed to do so. Id at ¶ 17.
Third, the complaint says that the warnings approved by the
FDA were substantively inadequate:
Defendants[’] warnings and information about
Prempro were inadequate because Defendants
failed to inform Plaintiff’s physician that
bioidentical hormones did not have a risk of
breast cancer and were a safer alternative to
conjugated
hormones
like
Prempro,
represented there was no difference with the
risk of breast cancer at different doses, and
failed to inform Plaintiff’s physician that there
was a lower risk of breast cancer at lower doses
of conjugated estrogens like Prempro.
Id at ¶ 28.
Plaintiffs incorporate these allegations into each of their legal
claims. Id at ¶¶ 26, 35, 39. Defendants thus argue that this
language shows that the claims formally pleaded as those for
design defect, negligence, and breach of warranty are really just

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dressed-up failure-to-warn claims. See Dkt 12 at 16–17. In doing
so, they address all three claims together. But the elements of
each cause of action are distinct and warrant separate
consideration.
i. Design defect
To plead a products-liability claim for design defect under
Texas law requires the plaintiff to allege that:
o First, the product was defectively designed so as to
render it unreasonably dangerous;
o Second, a safer alternative design existed; and
o Third, the defect was a producing cause of the injury
for which the plaintiff seeks recovery.
Goodner v Hyundai Motor Co, 650 F3d 1034, 1040 (5th Cir 2011),
quoting Timpte Industries, Inc v Gish, 286 SW3d 306, 311
(Tex 2009).
Plaintiffs’ complaint structurally seeks to follow those
elements:
28. Defendants[’] warnings and information about
Prempro were inadequate because Defendants failed
to inform Plaintiff’s physician that bioidentical
hormones did not have a risk of breast cancer
and were a safer alternative to conjugated
hormones like Prempro, represented there was
no difference with the risk of breast cancer at
different doses, and failed to inform Plaintiff’s
physician that there was a lower risk of breast
cancer at lower doses of conjugated estrogens
like Prempro.
29. The Prempro Plaintiff took was defectively
designed because:
(a) it was made from horse urine and
contained hormones that are not natural
hormones in human women, and increased
the risk of breast cancer, rather than
containing only hormones found in human
woman such as bioidentical hormones that
do not increase the risk of breast cancer;

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(b) it was in a dose that causes breast
cancer.
30. The above design defects were each a
producing cause of Plaintiffs injuries and
damages.
31. One or more of the following safer
alternative designs for the product existed that
would have prevented or significantly reduced
the risk of Plaintiff’s injury without substantially
impairing the product's utility, and that was
economically and technologically feasible at the
time the product left Defendant’s control by the
application of existing or reasonably achievable
scientific knowledge:
(a) bioidentical hormones;
(b) a lower dose conjugated hormone.
32. The above design defect or defects rendered
the product unreasonably dangerous as
designed considering the utility of the product
and the risks involved in its use.
33. The Prempro Plaintiff took was unreasonably dangerous for the reasons more
particularly set forth above.
Dkt 6 at ¶¶ 28–33 (emphasis added).
As emphasized above, a reference to deficient warnings
recurs in the amended complaint. The pertinent question is
whether these allegations actually describe an injury caused by a
failure to warn, when scrutinized against the totality of Plaintiffs’
complaint and despite the labels and characterizations they give
to their claims. See Tex Civ Prac & Rem Code § 82.007(a). They
do, for two reasons.
The first is the asserted causal connection between the use
of Prempro and the allegation of resulting injury. Plaintiffs assert
that Prempro is unreasonably dangerous as designed, and that
Pauline Moncibaiz’s physician should have been informed of the
risks involved in using Prempro and of potentially safer
alternatives. But that latter assertion invokes the learned

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intermediary doctrine as applied under Texas law. For example, see
Murthy v Abbott Laboratories, 847 F Supp 2d 958, 967 (SD Tex
2012), citing Ackermann v Wyeth Pharmaceuticals, 526 F3d 203, 207
(5th Cir 2008). As a general rule, the doctrine provides that a
manufacturer fulfills its duty to warn where it provides adequate
warnings to a credible intermediary. See Alm v Aluminum Co of
America, 717 SW2d 588, 591–92 (Tex 1986) (citations omitted).
The intermediary is then presumed to pass along the warnings to
germane clients. See Porterfield v Ethicon, Inc, 183 F3d 464, 467–68
(5th Cir 1999), citing Alm, 717 SW2d at 591–92. A drug
manufacturer “remains liable for injuries sustained by the
ultimate user” where it provides inadequate warnings to the
physician. Murthy, 847 F Supp 2d at 968, quoting Porterfield,
183 F3d at 467–68.
With this doctrine in mind, any allegation by Plaintiffs that
Defendants failed to adequately inform the prescribing physician
of pertinent risks reduces to allegation that Defendants failed to
adequately inform Pauline Moncibaiz of those risks. But the FDAapproved warnings were provided to the physician. And
regardless, the necessary implication is that Pauline Moncibaiz
would have opted to use an alternative to Prempro had she been
properly warned. As such, the cause of injury is more
appropriately linked to the allegation of alleged inadequate
warnings—not to an allegedly underlying design defect. It
follows, then, that the core of Plaintiffs’ complaint is based on an
alleged failure to warn by Defendants. Other courts in this district
have reached the same conclusion when considering similar
pleadings. For example, see Gonzalez, 930 F Supp 2d at 819 (as to
prescription drug Mirena); Del Valle, 2012 WL 2899406 at *3 (as
to prescription drug Reglan); Eckhardt, 889 F Supp 2d at 907 (also
as to Reglan).
A second and independent reason relates to what it means
for a product to be considered defective and unreasonably dangerous
under Texas law. A plaintiff must show both of those things to
plead a design-defect claim. Timpte Industries, 286 SW3d at 311.
And in relation to these concepts, Texas law incorporates
comment k to § 402A of the Restatement (Second) of Torts.
See McKisson v Sales Affiliates, 416 SW2d 787 (Tex 1967) (adopting

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comment k); see also Reyes v Wyeth Laboratories, 498 F2d 1264,
1271–74 (5th Cir 1974) (recognizing same). Texas expressly
applies comment k in the prescription-drug context. In re DuPuy
Orthopedics, Inc, Pinnacle Hip Implant Product Liability Litigation,
888 F3d 753, 772 (5th Cir 2018), citing Centocor, Inc v Hamilton,
372 SW3d 140, 165 (Tex 2012).
Comment k provides that some products, when “properly
prepared, and accompanied by proper directions and warning,”
are as a matter of law neither defective nor unreasonably
dangerous. Restatement (Second) of Torts § 402A comment k
(ALI 1965). This recognizes that some products “are quite
incapable of being made safe for their intended and ordinary
use.” Ibid. But it’s deemed acceptable that their use will involve
an “unavoidable high degree of risk” because that risk is a
necessary condition of providing beneficial products. Ibid.
Comment k notes that this is true in particular for many “drugs,
vaccines, and the like, many of which for this very reason cannot
legally be sold except to physicians, or under the prescription of
a physician.” Ibid.
This means that prescription drugs are neither defective nor
unreasonably dangerous as a matter of Texas law so long as they
are marketed according to their purpose and accompanied by
proper instructions and warnings. The Texas Supreme Court and
the Fifth Circuit don’t appear to have determined whether the
presumption against liability under Texas Civil Practice and
Remedies Code § 82.007(a) applies to the design-defect analysis
as governed by comment k. But most courts that have considered
the question hold that it does. For example, see McKay v Novartis
Pharmaceutical Corp, 934 F Supp 2d 898, 909–11 (WD Tex 2013);
Holland v Hoffman-La Roche, Inc, 2007 WL 4042757, *3 (ND Tex);
but see Lea v Wyeth LLC, 2011 WL 13192701, *11–14 (ED Tex).
Courts outside of the Fifth Circuit applying Texas law have also
reached the same conclusion. For example, see Solomon v Bristol
Myers Squibb Co, 916 F Supp 2d 556, 571–72 (DNJ 2013); In re
Accutane Products Liability, 2013 WL 7848637, *3 (MD Fla).
This Court agrees that the presumption against liability
applies to the design-defect analysis under comment k, which
recognizes that some products (like prescription drugs) simply

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can’t be produced to eliminate all risk of serious harm—at least
in certain approved uses as to some persons. It is inconsistent to
argue that a prescription drug such as Prempro was designed
defectively simply because it may cause cancer or pose other
health risks. To the contrary, such risks aren’t defects but are
rather unavoidable byproducts of proper design and
manufacture. And under comment k, Defendants’ only duty in
this regard is to manufacture Prempro according to the approved
process and to supply it with the approved directions and
warnings.
Plaintiffs don’t assert that the Prempro taken by Pauline
Moncibaiz was manufactured at variance from the federally
approved process. This means that the only other way to plead a
design-defect claim is to argue Prempro’s warnings were
inadequate. And to do that necessarily means Plaintiffs’ claim is
one for an injury “caused by a failure to provide adequate
warnings or information with regard to a pharmaceutical
product.” Tex Civ Prac & Rem Code § 82.007(a); see also McKay,
934 F Supp 2d at 909–11; Holland, 2007 WL 4042757 at *3.
The claim asserted by Plaintiff for design defect is in
substance one for failure to warn. The presumption against
liability applies, which Plaintiffs don’t attempt to rebut. As such,
the design-defect claim must be dismissed.
ii. Negligence
A manufacturer owes a duty to its customers under Texas
law to design a product such that its use doesn’t involve an
unreasonable risk of harm. See Gonzales v Caterpillar Tractor Co,
571 SW2d 867, 871–72 (Tex 1978), quoting Restatement
(Second) of Torts § 395 (ALI 1965). With that particular duty in
mind, the elements of a negligent-design claim are otherwise the
same as that of a traditional negligence claim—duty, breach,
causation, and damages. For example, see Zakaria v STL
International, Inc, 2020 WL 4368096, *5 (SD Tex), citing Syrie v
Knoll International, 748 F2d 304, 309 (5th Cir 1984) and Gonzales,
571 SW2d at 871.
Neither the Texas Supreme Court nor the Fifth Circuit
appears to have addressed a prescription-drug case where
negligence claims were argued in light of the new statutory

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framework to be in substance failure-to-warn claims. But
application of fundamental tort-law principles shows that
Plaintiffs’ negligent-design claim is based on failure to warn. This
is because a manufacturer can’t be liable for negligent design
where the product at issue has been shown to not be
unreasonably dangerous under a design-defect analysis. See
Simien v CR Bard, Inc, 2020 WL 4922331, *9 (ED Tex), citing
Garrett v Hamilton Standard Controls, Inc, 850 F2d 253, 257 (5th Cir
1988). True, such actions are distinct insofar as strict liability
“looks at the product itself and determines if it is defective,”
while negligence “looks at the acts of the manufacturer and
determines if it exercised ordinary care in design and
production.” Gonzales, 571 SW2d at 871; see also McClennan v
American Eurocopter Corp, 245 F3d 403, 431 (5th Cir 2001), citing
Syrie, 748 F2d at 307, 309. But the Fifth Circuit in Garrett
explained at length that defeat of the design-defect claim can also
dispose of a related negligence claim:
Thus, although a negligence claim requires a
different showing from a strict liability claim, a
manufacturer logically cannot be held liable for
failing to exercise ordinary care when producing
a product that is not defective because: (1) if a
product is not unreasonably dangerous because
of the way it was manufactured, it was not
negligent to manufacture it that way and (2)
even if the manufacturer was somehow
negligent in the design or production of the
product, that negligence cannot have caused the
plaintiff’s injury because the negligence did not
render the product “unreasonably dangerous.”
850 F2d at 257 (citations omitted).
As shown above, Texas law provides that prescription drugs
aren’t unreasonably dangerous provided that they are properly
prepared and include adequate directions and warnings. In re
DuPuy Orthopedics, 888 F3d at 766, citing Restatement (Second) of
Torts § 402A comment k. Plaintiffs don’t allege that the Prempro
at issue here was improperly prepared. And so their only avenue
to prove unreasonable danger is to prove inadequate warnings. It

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follows, then, that Plaintiffs’ negligence claim is really one for
failure to warn. The presumption against liability again applies,
which Plaintiffs don’t attempt to rebut.
Beyond this, and as with the design-defect claim, the learned
intermediary doctrine also pertains. The Texas Supreme Court holds
that the doctrine applies to all claims where the “crux” of the
asserted claim is the “alleged failure to provide an adequate
warning.” Centocor, 372 SW3d at 169. This being so, Defendants
have discharged any pertinent duty under a negligence theory by
providing Prempro with adequate warnings.
The negligence claim must be dismissed. Courts in this
district have concluded the same when faced with similar claims
and arguments. For example, see Murthy, 847 F Supp 2d at 977;
Del Valle, 2012 WL 2899406 at *2.
iii. Breach of implied warranty
To state a claim for breach of the implied warranty of
merchantability, a plaintiff must plead that the defendant sold or
leased a product to the plaintiff, the product was unmerchantable,
the plaintiff notified the defendant of the breach, and the plaintiff
suffered injury. For example, see Woohouse v Sanofi-Aventis US
LLC, 2011 WL 3666595, *4 (WD Tex), quoting Polaris Industries,
Inc v McDonald, 119 SW3d 331, 336 (Tex App—Tyler 2003, no
pet), in turn citing Tex Bus & Commerce Code §§ 2.314,
2.607(c)(1), 2.714, 2.715. A product is merchantable if, among other
characteristics, it is “fit for the ordinary purposes for which such
goods are used.” Tex Bus & Commerce Code § 2.314(b)(3).
This claim fails for much the same reason as the negligence
claim. In breach-of-warranty parlance, Plaintiffs must prove that
Prempro is unmerchantable—that is, that it’s not fit for the
ordinary purpose of treating menopause symptoms and
preventing osteoporosis in menopausal women. As with
negligence, this claim is linked to the design-defect claim. This is
so because a product “cannot be unfit for ordinary use but not
unreasonably dangerous, nor can it be unreasonably dangerous
but fit for ordinary use; it must be both or neither.” Smith v
Chrysler Group, LLC, 909 F3d 744, 752 (5th Cir 2018), quoting
Hyundai Motor Co v Rodriguez, 995 SW2d 661, 665 (Tex 1999) and
citing Otis Spunkmeyer, Inc v Blakley, 30 SW3d 678, 684 (Tex App—

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Dallas 2000, no pet). And so, Plaintiffs can’t support their breachof-warranty claim if Prempro isn’t unreasonably dangerous. And
they can’t prove that Prempro isn’t unreasonably dangerous
without arguing that its warnings are inadequate.
It follows that the breach-of-warranty claim is in substance a
failure-to-warn claim. The presumption against liability again
applies, which Plaintiffs don’t attempt to rebut. It also means that
the learned intermediary doctrine applies. As such, the failure-to-warn
claim must be dismissed. Other decisions confirm this result. See
Murthy, 847 F Supp 2d at 977; Del Valle, 2012 WL 2899406 at *2.
c. Failure to state a claim
Defendants also argue that even if Plaintiffs’ claims aren’t in
substance based on a failure to warn, they still fail to state a claim
under Rule 12(b)(6). Dkt 12 at 21–23. This argument needn’t be
addressed in light of the above determination.
4. Opportunity to replead
A district court “should freely give leave [to amend] when
justice so requires.” FRCP 15(a)(2). The Fifth Circuit has long
held that this evinces a bias in favor of granting leave to amend.
See Dussouy v Gulf Coast Investment Corp, 660 F2d 594, 597(5th Cir
1981); Carroll v Fort James Corp, 470 F3d 1171, 1175 (5th Cir 2006).
But whether to grant leave to amend is within the sound
discretion of the district court. Pervasive Software Inc v Lexware
GmbH & Co KG, 688 F3d 214, 232 (5th Cir 2012), quoting
Wimm v Jack Eckerd Corp, 3 F3d 137, 139 (5th Cir 1993). It may
be denied “when it would cause undue delay, be the result of bad
faith, represent the repeated failure to cure previous
amendments, create undue prejudice, or be futile.” Morgan v
Chapman, 969 F3d 238, 248 (5th Cir 2020), citing Smith v
EMC Corp, 393 F3d 590, 595 (5th Cir 2004).
Plaintiffs sought and obtained leave to replead their claims
when faced with a prior motion to dismiss raising the same legal
challenges to their original complaint. Even though it is now
determined that the amended complaint fails to plead around a
failure-to-warn claim, this is the first ruling received by Plaintiffs
as to their remaining claims. These are complicated legal issues,
making it quite tenuous to conclude at this juncture that further
amendment would necessarily be futile. The free leave accorded by

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Rule 15(a)(2) suggests that Plaintiffs be allowed one further
attempt to plead their claims, subject to the dictates of Rule 11(b).
Plaintiffs’ claims will be dismissed without prejudice.
5. Conclusion
The motion by Defendants Pfizer, Inc, Wyeth Holdings,
LLC, and Wyeth LLC to dismiss the claims asserted by Plaintiffs
Pauline and Rick Moncibaiz is GRANTED. Dkt 12.
The claims are DISMISSED WITHOUT PREJUDICE.
Plaintiffs may seek leave to amend by April 23, 2021.
SO ORDERED.
Signed on March 31, 2021, at Houston, Texas.

Hon. Charles Eskridge
United States District Judge

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