The opinion
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA
STANLEY P. BAUDIN NO. 18-1063
V. JUDGE SHELLY D. DICK
ASTRAZENECA PHARMACEUTICALS LP; MAG. JUDGE ERIN
ASTRAZENECA LP; AND MERCK SHARP WILDER-DOOMES
& DOHME CORPORATION
RULING
This matter is before the Court on the Motion to Dismiss1 by Defendants,
AstraZeneca Pharmaceuticals LP, AstraZeneca LP, and Merck Sharp & Dohme
Corporation (“Defendants”). Plaintiff, Stanley P. Baudin (“Plaintiff”), has filed an
Opposition2 to which Defendants replied.3 Oral argument is not necessary. For the
following reasons, the Court finds that Defendants’ motion should granted in part, denied
in part, and Plaintiff will be allowed to amend his Complaint within 30 days to cure the
deficiencies as to his state law claims.
I. FACTUAL BACKGROUND
Plaintiff brings this lawsuit after suffering from gastric cancer and severe personal
injuries and other damages allegedly as a result of taking the prescription drug Nexium.4
Defendants are the alleged designers, researchers, manufacturers, testers, advertisers,
promoters, marketers, sellers, and distributers of Nexium.5 Generally, Plaintiff claim that
1 Rec. Doc. No. 8.
2 Rec. Doc. No. 21.
3 Rec. Doc. No. 25.
4 Rec. Doc. No. 1-1, p. 1.
5 Id.
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Defendants negligently represented that Nexium was tested and found to be safe and
effective for treating peptic disorders. Defendants allegedly knew and concealed that
Nexium was defective as it allegedly causes gastric cancer.6 Plaintiff alleges in abundant
detail: the genesis of Nexium;7 what it is prescribed for;8 the difference between “PPI’s”,
including Nexium, and “H2 antagonists”;9 the stomach and digestive system;10 the
physiology of gastric acid and gastrin;11 how PPI’s affect the stomach and digestive
system and cause gastric cancer;12 what gastric cancer is;13 the epidemiology between
PPI’s and gastric cancer;14 the scientific studies supporting these allegations;15 and how
Defendants allegedly concealed this information to manufacture, market, and sell Nexium
as a safe pharmaceutical to treat peptic disorders.16
Plaintiff originally instituted this suit in the 19th Judicial District Court, Parish of East
Baton Rouge, State of Louisiana, which was removed to this Court based on diversity
jurisdiction.17 Plaintiff asserts state law claims of fraud, negligent misrepresentation, and
redhibition based on non-economic losses. Plaintiff also asserts claims under the
Louisiana Products Liability Act (“LPLA”), and asserts a redhibition claim under Louisiana
law for economic losses.18 This Court has jurisdiction over this matter pursuant to 28
6 Rec. Doc. No. 1-1, p. 2.
7 Rec. Doc. No. 1-1, pp. 6-8.
8 Rec. Doc. No. 1-1, p. 7.
9 Rec. Doc. No. 1-1, pp. 6-10.
10 Rec. Doc. No. 1-1, p. 9.
11 Rec. Doc. No. 1-1, pp. 9-12.
12 Rec. Doc. No. 1-1, pp. 12-16.
13 Id.
14 Rec. Doc. No. 1-1, pp. 16-27.
15 Id.
16 Id.
17 Rec. Doc. No. 1.
18 Rec. Doc. No. 1-1.
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U.S.C. § 1332. Because subject matter jurisdiction in this case is based on diversity of
citizenship, the substantive law of Louisiana governs this dispute.
II. LAW AND ANALYSIS
A. Motion to Dismiss under Rule 12(b)(6)
When deciding a Rule 12(b)(6) motion to dismiss, “[t]he ‘court accepts all well-
pleaded facts as true, viewing them in the light most favorable to the plaintiff.’”19 The
Court may consider “the complaint, its proper attachments, documents incorporated into
the complaint by reference, and matters of which a court may take judicial notice.”20 “To
survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead ‘enough facts to state
a claim to relief that is plausible on its face.’”21 In Twombly, the United States Supreme
Court set forth the basic criteria necessary for a complaint to survive a Rule 12(b)(6)
motion to dismiss. “While a complaint attacked by a Rule 12(b)(6) motion to dismiss does
not need detailed factual allegations, a plaintiff’s obligation to provide the grounds of his
entitlement to relief requires more than labels and conclusions, and a formulaic recitation
of the elements of a cause of action will not do.”22 A complaint is also insufficient if it
merely “tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’”23 However,
“[a] claim has facial plausibility when the plaintiff pleads the factual content that allows the
court to draw the reasonable inference that the defendant is liable for the misconduct
19 In re Katrina Canal Breaches Litigation, 495 F.3d 191, 205 (5th Cir. 2007)(quoting Martin v. Eby Constr.
Co. v. Dallas Area Rapid Transit, 369 F.3d 464, 467 (5th Cir. 2004)).
20 Randall D. Wolcott, M.D., P.A. v. Sebelius, 635 F.3d 757, 763 (5th Cir. 2011).
21 In re Katrina Canal Breaches Litigation, 495 F.3d at 205 (quoting Martin, 369 F.3d at 467).
22 Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)(internal citations and brackets
omitted)(hereinafter Twombly).
23 Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)(internal citations
omitted)(hereinafter “Iqbal”).
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alleged.”24 In order to satisfy the plausibility standard, the plaintiff must show “more than
a sheer possibility that the defendant has acted unlawfully.”25 “Furthermore, while the
court must accept well-pleaded facts as true, it will not ‘strain to find inferences favorable
to the plaintiff.’”26 On a motion to dismiss, courts “are not bound to accept as true a legal
conclusion couched as a factual allegation.”27
B. The LPLA
The LPLA establishes the exclusive theory of liability for manufacturers regarding
damages caused by their products. The applicable standard under the LPLA is as follows:
“The manufacturer of a product shall be liable to a claimant for damage proximately
caused by a characteristic of the product that renders the product unreasonably
dangerous when such damage arose from a reasonably anticipated use of the product
by the claimant or another person or entity.”28 Thus, to maintain a successful claim under
the LPLA, a claimant must establish four elements: (1) that the defendant is a
manufacturer of the product; (2) that the claimant’s damage was proximately caused by
a characteristic of the product; (3) that this characteristic made the product “unreasonably
dangerous”; and (4) that the claimant’s damage arose from a reasonably anticipated use
of the product by the claimant or someone else.29
24 Twombly, 550 U.S. at 570.
25 Iqbal, 556 U.S. at 678.
26 Taha v. William Marsh Rice University, 2012 WL 1576099, at *2 (quoting Southland Sec. Corp. v. Inspire
Ins. Solutions, Inc., 365 F.3d 353, 361 (5th Cir. 2004)).
27 Twombly, 550 U.S. at 556 (quoting Papassan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d
209 (1986)).
28 La. R.S. 9:2800.54(A).
29 Ayo v. Triplex, Inc., 457 Fed. Appx. 382, 385-86 (5th Cir. 2012)(citing Jack v. Alberto-Culver USA, Inc.,
949 So.2d 1256, 1258 (La. 2007))(citing La. R.S. 9:2800.54(A)).
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A product is “unreasonably dangerous” under the LPLA in one of four ways: (1)
construction or composition; (2) design; (3) inadequate warning; or (4) failure to conform
to an express warranty.30 The “unreasonably dangerous” characteristic must exist at the
time the product left the manufacturer’s control or result from a reasonably anticipated
modification or alteration of the product.31 An unreasonably dangerous condition cannot
be presumed solely from the fact that injury occurred.32 Rather, the claimant has the
burden of proving the required elements under the LPLA.33
1. The LPLA is Exclusive
As an initial matter, Defendants correctly argue that all of the non-LPLA claims
against it for fraud, negligent misrepresentation, and redhibition based on non-economic
losses must be dismissed.34 The LPLA establishes the exclusive theory of liability for
manufacturers for damages caused by their products.35 “A claimant may not recover from
a manufacturer for damage caused by a product on the basis of any theory of liability that
is not set forth in” the LPLA.36 Plaintiff concedes this point and “requests leave to amend
his Complaint to remove such references to barred claims”.37 Therefore, any claims of
state law for fraud,38 negligent misrepresentation, and redhibition based on non-economic
30 La. R.S. § 9:2800.54(B).
31 Id. at § 2800.54(C).
32 Woodling v. Hubbell Inc., 35 Fed. Appx. 386, *4 (5th Cir. 2002)(citing Krummel v. Bombardier Corp., 206
F.3d 548, 551 (5th Cir. 2000))(quoting McCarthy v. Danek Med., Inc., 65 F.Supp.2d 410, 412 (E.D. La.
1999)).
33 La. R.S. 9:2800.54(D).
34 Rec. Doc. No. 8-1, pp. 3-5.
35 La. R.S. 9:2800.52.
36 Id.
37 Rec. Doc. No. 21, p. 3.
38 The Court notes that Defendants seek to dismiss all fraud allegations under Rule 9 at page 17 of their
motion. Rec. Doc. No. 8-1, p. 17. Because this Court is dismissing Plaintiff’s claim of fraud due to the
exclusivity of the LPLA, the Court elects not to specifically address Defendants’ alternative arguments under
Rule 9. As Plaintiff is granted leave to amend his Complaint, the Court will allow Defendants to re-urge
their arguments under Rule 9, if necessary, once Plaintiff amends his Complaint.
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losses are improper and are dismissed with prejudice. The Plaintiff’s motion for leave to
amend to remove reference to the dismissed claims is unnecessary and therefore denied.
2. Sufficiency of Pleading Claims under the LPLA
Defendants argue that Plaintiff fails to plead a viable LPLA claim with sufficient
specificity to state a claim upon which relief may be granted.39 Plaintiff contends that the
Complaint “contains the requisite factual allegations to state viable claims under the
LPLA, including claims for (a) design defect; (b) failure to warn; (c) breach of warranty;
and (d) redhibition”.40 The Court considers Plaintiff’s pleading of each of these claims
under the LPLA.
a. Design Defect
Under Section 9:2800.56 of the LPLA, a product is unreasonably dangerous in its
design if, when the product left the manufacturer’s control: (1) there existed an alternative
design for the product that was capable of preventing the claimant’s damage; and (2) the
likelihood that the product’s design would cause the claimant’s damage and the gravity
of that damage outweighed the burden on the manufacturer of adopting such alternative
design and the adverse effect, if any, of such alternative design on the utility of the
product.
This test requires a plaintiff to prove both “that an alternative design existed” at the
time the product was manufactured and “that the risk avoided by using the alternative
design (magnitude of damage discounted by the likelihood of its occurrence) would have
exceeded the burden of switching to the alternative design (added construction costs and
39 Rec. Doc. No. 8-1, p. 5 (citing Twombly/Iqbal standard).
40 Rec. Doc. No. 21, p. 4.
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loss of product utility).”41 The occurrence of an injury does not give rise to the presumption
that the design was unreasonably dangerous.42 A conclusory allegation that an alternate
design exists will not suffice, but the plaintiff need not allege in detail “that the product’s
design would cause the claimant’s damage,” that “the gravity of that damage outweighed
the burden on the manufacturer of adopting such alternative design,” and “the adverse
effect, if any, of such alternative design on the utility of the product.”43
Plaintiff’s complaint alleges that “alternative safer methods” existed for treating his
peptic disorder “that provided the same benefits but acted through a different mechanism
and were not associated with stomach cancer”.44 Plaintiff contends that one “safer
alternative” is “the class of drugs collectively known as the H2 antagonists, also called H2
blockers”, which includes Tagamet, Tagamet HB, Pepcid, Pepcid AC, Axid, and Zantac.45
Plaintiff specifically alleges that Defendants are liable for defects in the design of its
medication.46 Plaintiff pleads its “First Claim for Relief” as a “design defect” claim “under
LSA-RS 9:2800.56”,47 including a specific plea of a “safer alternative design that would
have prevented the harm without substantially impairing the reasonably anticipated or
intended function of Nexium”, such as other medications which had a “more established
profile and a considerably lower risk profile”.48
41 Roman v. W. Mfg., Inc., 691 F.3d 686, 700-01 (5th Cir. 2012)(citing Lawrence v. Gen. Motors Corp., 73
F.3d 587, 590 (5th Cir. 1996)).
42 Kennedy v. Pfizer, Inc., No. 12-01858, 2013 WL 4590331, *3 (W.D. La. Aug. 28, 2013).
43 Becnel v. Mercedes-Benz USA, LLC, No. 14-0003, 2014 WL 4450431, *4 (E.D. La. Sept. 10,
2014)(finding sufficient plaintiff’s allegations that the defendant used an alternative design in the past before
implementing the new, defective design).
44 Rec. Doc. No. 1-1, p. 27, ¶ 148.
45 Rec. Doc. No. 1-1, p. 27, ¶ 149.
46 Rec. Doc. No. 1-1, p. 30, ¶ 161(e-f).
47 Rec. Doc. No. 1-1, pp. 30-33, ¶¶ 162-183.
48 Rec. Doc. No. 1-1, p. 32, ¶ 177.
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Defendants contend that Plaintiff’s allegations fail to state a claim for design defect
because Plaintiff relied on “nothing more than statutory buzz words” which are “clearly
legal conclusions” that are within the “sole province of the trier of fact”.49 Further,
Defendants argue that Plaintiff’s allegations “fail to explain how any particular Defendant’s
[sic] specific product was allegedly defective or what attributes of each Defendant’s
product [sic] made it unreasonably dangerous”.50 Defendants argue that Plaintiff fails to
adequately plead the alternative design and that “merely referencing other products is not
sufficient to establish an alternative design”.51 Similarly, Defendants argue that Plaintiff
makes purely conclusory allegations that the gravity of the harm outweighed the burden
of adopting an alternative design.52
In opposition, Plaintiff argues that his Complaint is “replete with factual allegations
that explain the action mechanism of Nexium upon ingestion, and how that process
modifies certain cells in the stomach over time which results in a significantly increased
risk in the development of stomach cancer”.53 Indeed, the Complaint reflects detailed
factual allegations of the evolution of Nexium and the conditions it was designed to treat;54
an explanation of “the stomach and digestion”;55 an explanation of the balance between
“gastric acidity and gastrin”;56 identifies Nexium as a proton pump inhibitor or PPI; a
49 Rec. Doc. No. 8-1, p. 6.
50 Id.
51 Rec. Doc. No. 8-1, p. 7 (citing Robertson v. AstraZeneca Pharms., LP, 2015 U.S. Dist. LEXIS 136308,
*11 (E.D. La. Oct. 6, 2015)).
52 Rec. Doc. No. 8-1, pp. 7-8 (citing Purvis v. Procter & Gamble Co., 901 F.Supp.2d 716, 721 (M.D. La.
2012)).
53 Rec. Doc. No. 21, p. 5 (citing Rec. Doc. 1-1, ¶¶ 50-150).
54 Rec. Doc. No. 1-1, pp. 6-8, ¶¶ 31-49.
55 Rec. Doc. No. 1-1, p. 9, ¶¶ 50-53.
56 Rec. Doc. No. 1-1, pp. 9-12, ¶¶ 54-68.
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description of what PPI’s are;57 general background of gastric cancer;58 the purported
relationship of PPI’s and gastric cancer;59 the studies purporting to support a link between
the use of PPI’s and gastric cancer;60 and the alleged link between Defendants, their
product, and gastric cancer.61
Here, Plaintiff has alleged an alternative design existed that would not have caused
his injury, gastric cancer.62 Plaintiff alleges that “other medications”, such as Axid,
Pepcid, Pepcid AC, Tagamet, and Tagamet HB, otherwise known as “H2 receptor
antagonists”, have lower risks, are “safer” than Nexium or PPI’s, are prescribed for the
same conditions as PPI’s, and have not been associated with gastric cancer.63
In Robertson v. AstraZeneca Pharmaceuticals, LP,64 upon which Defendants rely
in support of their motion to dismiss Plaintiff’s design defect claim, the court found that
the existence of alternate products does not demonstrate the existence of a specific
alternate design and granted the defendant’s motion to dismiss the plaintiff’s design
defect claim.65 However, in Robertson, the plaintiff simply alleged what was prescribed
to her, her experienced side effects, and other pharmaceuticals on the market that are
available to treat the same condition.66 The plaintiff in Robertson did not allege the
science and epidemiology behind the purported defect in the pharmaceutical at issue and
57 Rec. Doc. No. 1-1, pp. 11-12, ¶¶ 62-68.
58 Rec. Doc. No. 1-1, pp. 12-13, ¶¶ 69-72.
59 Rec. Doc. No. 1-1, pp. 13-16, ¶¶ 73-88.
60 Rec. Doc. No. 1-1, pp. 16-27, ¶¶ 89-150.
61 Rec. Doc. No. 1-1, pp. 22-27, ¶¶ 126-150.
62 See Jenkins v. Bristol-Myers Squibb, No. 14-2499, 2015 WL 5012130, *4 (E.D. La. Aug. 21,
2015)(“Plaintiff must nevertheless allege that an alternative design existed that would not have caused
Plaintiff’s injuries.”).
63 Rec. Doc. No. 1-1, ¶¶ 66, 89, 110-11, 148-49, 177.
64 Robertson, 2015 WL 5823326.
65 Id. at *4.
66 Id. at *1.
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identify how the design of the other identified pharmaceuticals differed. Here, Plaintiff
makes detailed allegations of the purported defect in the design of Nexium, how that
purported defect is scientifically linked to gastric cancer, the other alternative
pharmaceuticals that exist for the same underlying condition, how those pharmaceuticals
are designed differently, and generally alleges that there is no scientific data linking the
alternative pharmaceuticals to gastric cancer. For these reasons, Robertson is
distinguished from the pleading presently before the Court.
This Court has found that a complaint sufficiently pleads a design defect claim by
alleging an alternative design in general terms, including the general characteristics of
the alternative design. See, Boutte v. Stryker Biotech, LLC,67 where this Court denied a
motion to dismiss where the alleged alternative design was to promote the
pharmaceutical as approved by the FDA and to not permit its combination with other
specific pharmaceuticals; Crochet v. Bristol-Myers Squibb,68 where this Court found the
plaintiff’s allegation that the defendants “failed to consider the design of other available
drugs that could treat [plaintiff’s] condition that did not have, or had a much lower
incidence and risk of developing [the subject side effect] following treatment” sufficient to
state a design defect claim; and Brooks v. Amgen, Inc.,69 where the Court acknowledged
the “barebones” allegations of the complaint but found that the plaintiff “at least implicitly
plead an alternative design – Prolia or any other medication for osteoporosis that does
not cause jaw necrosis” as sufficient to deny a motion to dismiss. On the other hand, this
Court has found a failure to state a claim of defective design when there are no allegations
67 Boutte v. Stryker Biotech, LLC, 67 F.Supp.3d 732, 736-37 (M.D. La. Dec. 22, 2014).
68 Crochet v. Bristol-Myers Squibb, 2016 WL 3580670, *3 (M.D. La. June 28, 2016).
69 Brooks v. Amgen, Inc., 2019 WL 507491, *5 (M.D. La. Feb. 8, 2019).
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of alternative design or of any weighing of the likelihood and gravity of damages against
the burden of adopting alternative designs.70 Such is not the case here.
Further, this Court is mindful of its findings in Lahaye v. AstraZeneca
Pharmaceuticals,71 an LPLA case regarding the same prescription drug at issue in this
matter, Nexium. In Lahaye, this Court found that the plaintiff “at least implicitly pled an
alternative design – a medication that would not cause C. diff or lead the party who
ingested Nexium to require a colectomy”.72 This Court denied the motion to dismiss in
Lahaye and noted that “much of the evidence in pharmaceutical products liability cases
may be in the defendant’s possession, and thus, without the benefit of discovery, stating
more specific allegations may be nearly impossible at this stage.”73
Both parties address the second element of the design defect claim in a cursory
fashion – the likelihood that the design of prescription Nexium would cause the harm
complained of or that the gravity of that harm outweighed the burden of adopting the
alternative design. Defendants simply argue that Plaintiff’s allegations are conclusory
and his claims should be denied.74 Plaintiff, citing to his Complaint and the pages of
allegations regarding the scientific support for the link between Nexium and gastric cancer
and the lack of scientific support for the link between the alternative pharmaceuticals and
gastric cancer, argues that the likelihood that the design of Nexium could cause gastric
cancer “was great” and has been known “since the 1980s”, and the gravity of developing
70 See, e.g., Morel v. Pinnacle Entertainment, Inc., 2017 WL 3719975, *4 (M.D. La. May 19, 2017).
71 Lahaye v. AstraZeneca Pharmaceuticals, No. 14-00111, 2015 WL 1935947 (M.D. La. Apr. 28, 2015).
72 Id. at *4.
73 Id. at *5 (see Winslow v. W.L. Gore & Assoc., Inc., No. 10-116, 2010 WL 866184, at *2 (W.D. La. Jan.
21, 2011)) report and recommendation adopted as modified sub nom. Winslow v. W.L. Gore & Assoc., Inc.,
No. 10-116, 2011 WL 873562 (W.D. La. Mar. 11, 2011).
74 Rec. Doc. No. 8-1, p. 8.
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gastric cancer “clearly outweighed the burden” to the Defendants of utilizing the alternate
design found in the H2 receptor antagonist pharmaceuticals.75 As cited above, the
Complaint reflects detailed pages of allegations of the relationship between PPI’s and
gastric cancer, unarguably a grave harm. The Complaint sufficiently alleges that the risk
of gastric cancer outweighs the burden of utilizing alternative H2 receptor antagonist
pharmaceuticals in lieu of PPI’s.76
Considering the Complaint, the arguments of the parties, and the jurisprudence,
the Court finds the Complaint plausibly states a design defect claim under the LPLA. The
Defendants’ Motion to Dismiss Plaintiff’s design defect claim is DENIED.
b. Failure to Warn
To maintain a failure to warn claim under the LPLA, “a plaintiff must demonstrate
that the product in question has a potentially damage-causing characteristic and that the
manufacturer failed to use reasonable care to provide an adequate warning about this
characteristic.”77 The manufacturer is liable for an inadequate warning only if the defect
proximately caused the plaintiff’s injury.78 The plaintiff bears the burden of proving that
“but for” the inadequate warning, the accident in question would not have occurred.79
In failure to warn cases, the law not only requires manufacturers to provide an
adequate warning at the time the product left its control, if such warning is necessary to
75 Rec. Doc. No. 21, p. 5.
76 The Court acknowledges Defendants’ argument on the design defect claim in reply to Plaintiff’s
opposition. Rec. Doc. No. 25, pp. 2-4. The Court finds that this detailed argument better targets the merits
and substance of Plaintiff’s claims as opposed to the factual pleading of the plausibility of Plaintiff’s claims
on the face of the Complaint. These arguments, while well-made, would be more appropriate at the
summary judgment stage of this matter.
77 Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 264 (5th Cir. 2002).
78 La. R.S. 9:2800.54(A); see also, Wheat v. Pfizer, 31 F.3d 340, 342 (5th Cir. 1994).
79 See Brown v. Parker-Hannifin Corp., 919 F.2d 308, 311 (5th Cir. 1990).
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apprise ordinary consumers of the danger,80 it also demands they use reasonable care
to provide adequate warnings after the product leaves its control.81 In prescription drug
cases, the learned intermediary doctrine applies.82 In failure to warn claims against
prescription drug manufacturers, therefore, the warning must adequately inform the
prescribing physician of the risks involved in using the drug that was not otherwise known
to the physician.83
Plaintiff’s “Second Claim for Relief” is a claim of “inadequate warning under LSA-
RS 9:2800.57”.84 Plaintiff avers that Defendants “researched, tested, developed,
designed, licensed, manufactured, packaged, labeled, distributed, sold, marketed, and/or
introduced Nexium into the stream of commerce” and advertised or marketed Nexium to
consumers and had a duty to Plaintiff and his physicians to warn of risks associated with
the use of Nexium, including gastric cancer.85 Plaintiff alleges that Defendants had a duty
to warn of adverse drug reactions, including the development of gastric cancer, which
Defendants knew or should have known can be caused by Nexium.86 The Complaint
states that Nexium was defective because it did not include adequate warnings “regarding
all known and significant adverse side effects, including, but not limited to, the
development of gastric cancer, associated with the use of Nexium”, and the “warnings
given by Defendants did not sufficiently and/or accurately reflect the symptoms, type,
scope, severity, or duration of these side effects and, in particular, the risks of developing
80 La. R.S. 9:2800.57(A)-(B).
81 La. R.S. 9:2800.57(C).
82 Stahl, 283 F.3d at 265.
83 Id. at 265-66.
84 Rec. Doc. No. 1-1, p. 33.
85 Rec. Doc. No. 1-1, p. 34, ¶ 185.
86 Rec. Doc. No. 1-1, p. 34, ¶ 186.
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gastric cancer”.87 Plaintiff claims that Defendants failed to adequately warn physicians
and users of the increased risk of developing gastric cancer, “although Defendants
aggressively and fraudulently promoted the product to physicians”.88 The alleged failure
to warn prevented Plaintiff and his physicians from “correctly and fully evaluating the risks
and benefits of Nexium”.89 Had he been “adequately warned”, Plaintiff alleges that he
would not have taken Nexium.90 Plaintiff further alleges, that had his physicians been
“adequately warned”, they could have discussed the risks with Plaintiff or would not have
prescribed it.91 Therefore, Plaintiff alleges that the failure of Defendants to warn Plaintiff
and his physicians caused or was the proximate cause of Plaintiff’s injuries and
development of gastric cancer.92
Defendants argue that Plaintiff’s Complaint fails to state a claim for failure to warn
because the allegations are conclusory and, thus, insufficient. 93 Specifically, Defendants
argue that Plaintiff does not provide the warning or the name of his physician.94
Defendants’ argument focuses mainly on the element of causation. Defendants argue
that Plaintiff must show that a proper warning would have changed the decision of the
treating physician.
In response, Plaintiff argues that the Complaint “specifically cited to language from
Defendants’ product insert for Nexium which failed to provide Plaintiff’s physicians (and
all physicians) with adequate risk information for the development or promotion of gastric
87 Rec. Doc. No. 1-1, p. 34, ¶ 187.
88 Rec. Doc. No. 1-1, p. 34, ¶ 188.
89 Rec. Doc. No. 1-1, p. 35, ¶ 190.
90 Rec. Doc. No. 1-1, p. 35, ¶ 191.
91 Rec. Doc. No. 1-1, p. 35, ¶ 192.
92 Rec. Doc. No. 1-1, p. 35, ¶ 193.
93 Rec. Doc. No. 8-1, p. 9.
94 Rec. Doc. No. 8-1, pp. 8-9.
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cancer from Nexium use”.95 Plaintiff further argues that by alleging that “Plaintiff’s
prescribing physicians of Nexium”, he sufficiently identified which physicians were not
warned.96 Further, Plaintiff argues, citing to Lahaye v. AstraZeneca Pharm., LP, that the
failure to identify a physician by name is not dispositive of this issue.97 Finally, Plaintiff
argues that it is premature to determine the learned intermediary issue at this stage of the
litigation, and Plaintiff’s allegations should be accepted as true.98
The Court finds that the Plaintiff’s allegations plausibly state a failure to warn claim.
Plaintiff pleads in his Complaint:
126.
To date, Defendants’ prescription Nexium lacks adequate risk information
for stomach adenocarcinomas, despite science stating otherwise. The
June 2018 product insert for Nexium merely advises prescribers (and
patients) that ‘… the symptomatic response to therapy does not preclude
the presence of gastric malignancy. Consider additional follow-up and
diagnostic testing in adult patients who have suboptimal response or an
early symptomatic relapse after completing treatment with a PPI. In older
patients also consider an endoscopy.’ In other words, symptom relief could
cloud a ‘pre-existing malignancy’. No language exists which warns the
prescribers and patients of the epidemiological and biological evidence
linking the long-term use of PPIs and the development of gastric cancer.
127.
In addition, the June 2018 ‘HIGHLIGHTS OF PRESCRIBING
INFORMATION’ product insert adds, ‘Interactions with Diagnostic
Investigations for Neuroendocrine Tumors: Increased chromogranin A
(CgA) levels may interfere with diagnostic investigations for neuroendocrine
tumors, temporarily stop NEXIUM at least 14 days before assessing CgA
levels.’99
95 Rec. Doc. No. 21, p. 8 (citing Rec. Doc. No. 1-1, ¶¶ 126-131).
96 Id.
97 Lahaye, 2015 WL 1935947, at *5.
98 Rec. Doc. No. 21, p. 9.
99 Rec. Doc. No. 1-1, pp. 22-23, ¶¶ 126, 127.
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The Court notes that the argument before the Court on Defendants’ Rule 12(b)(6) motion
to dismiss is that Plaintiff did not plead the terms of the warning that is allegedly
insufficient. However, the sufficiency of the warning is not before the Court at this motion
to dismiss stage. When the quoted “warning” is considered in the context of the extensive
facts plead in the Complaint, Plaintiff’s pleading allows the Court to draw the reasonable
inferences necessary to determine the plausibility of Plaintiff’s claim.
The Court now turns to Defendants’ argument that Plaintiff does not sufficiently
identify the physicians who prescribed Nexium to Plaintiff. Defendants are correct that
the Complaint does not reflect the name of Plaintiff’s physicians. Plaintiff makes general
references to his physicians,100 prescribing health care professionals,101 and
prescribers.102 However, Plaintiff is not required to identify his treating physician by name,
even though such information is within the Plaintiff’s knowledge. Further, “healthcare
providers” has been found to satisfy pleading standards under Rule 12(b)(6).103
Defendants’ final and dominant argument is that Plaintiff has not sufficiently plead
causation. The Court notes that the primary case upon which Defendants rely in their
motion is Jenkins v. Bristol-Myers Squibb.104 In this case, the defendants moved to
dismiss the plaintiff’s failure to warn claim on the same grounds and making the same
argument as Defendants advance here. The Jenkins court denied the defendants’ motion
100 Rec. Doc. No. 1-1, p. 23, ¶ 130.
101 Rec. Doc. No. 1-1, p. 28, ¶ 154.
102 Rec. Doc. No. 1-1, p. 24, ¶ 137.
103 Jenkins, 2015 WL 5012130 at *5 (“The Court agrees with Plaintiff that the 12(b)(6) standard does not
require Plaintiff to identify his treating physician, even though such information is with the Plaintiff’s
knowledge.”); and Harris v. Merck & Co., Inc., 2012 WL 5384720, *4 (W.D. La. Nov. 1, 2012)(“[W]e do not
find that plaintiff is required to disclose the name of a particular physician in her complaint. Merck cites no
authority, nor are we aware of any, requiring that a specific physician be identified by name in the
pleadings.”).
104 Jenkins, 2015 WL 5012130.
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and found that the plaintiff sufficiently plead the second element of the learned
intermediary doctrine. In Jenkins, the plaintiff alleged: “If defendants had properly warned
of the severity of Tardive Dyskinesia, of the importance of properly monitoring patients
using Abilify to prevent the onset of Tardive Dyskinesia, and informed health care
providers of what periodic monitoring tests were necessary, Plaintiff would not have
contracted Tardive Dyskinesia.”105 In rejecting the Jenkins defendants’ arguments on this
issue and finding that the quoted allegation was sufficient, the Jenkins court stated:
To allege a failure-to-warn claim upon which relief can be granted under the
LPLA, Plaintiff is not required to detail what an adequate warning would be
and how an adequate warning would have caused Plaintiff’s treating
physician to act differently. Plaintiff is merely required to allege that
Defendants did not adequately warn Plaintiff’s treating physician and that
the inadequate warning constituted the proximate warning [or cause] of
Plaintiff’s injuries.106
Here, Plaintiff’s allegations are much more detailed than that in Jenkins. Plaintiff
alleges what the current warning states and alleges what the proper warning should
contain or how the current warning is inadequate.107 Plaintiff also specifically alleges that
had Defendants issued an adequate warning, Plaintiff’s physicians could have discussed
the risks of gastric cancer with Plaintiff and/or would not have prescribed it and that
Plaintiff would not have taken the Nexium.108 Plaintiff explicitly alleges that Plaintiff’s
physician would have acted differently with a proper warning. The Court finds that Plaintiff
has sufficiently alleged that Defendants did not adequately warn Plaintiff and his treating
physicians and that the allegedly inadequate warning constituted the proximate cause of
105 Jenkins, 2015 WL 5012130, at *5.
106 Id.
107 Rec. Doc. No. 1-1, pp. 22-23, ¶¶ 126, 127.
108 Rec. Doc. No. 1-1, p. 35, ¶¶ 191-193.
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Plaintiff’s injuries. Thus, the Court denies Defendants’ motion to dismiss Plaintiff’s failure
to warn claim.
c. Breach of Express Warranty
To state a viable claim that a product is “unreasonably dangerous because of
nonconformity to express warranty,” a plaintiff must demonstrate that (1) an express
warranty existed, (2) he or she was induced to purchase the product due to the warranty,
and (3) his or her damage was proximately caused because the express warranty was
untrue.109
Plaintiff alleges that Defendants “expressly warranted that Nexium was safe and
well accepted by users”.110 Plaintiff and his physicians “relied on Defendants’ express
warranties” and the express warranties “were a part of the basis for Plaintiff’s and
Plaintiff’s physicians use of Nexium and he relied upon these warranties in deciding to
use Nexium”.111 Plaintiff avers that Defendants breached the express warranties because
Nexium “was and is defective and causes harm and injury”.112 Specifically, Plaintiff
alleges that as a “direct and proximate result of the breach of these warranties, Plaintiff
suffered and will continue to suffer severe and permanent personal injuries,
disfigurement, losses, and damages”.113 Plaintiff continues with allegations that
Defendants had knowledge of the purpose of Nexium and warranted it to be safe,
effective, and proper for such use.114 Defendants allegedly warranted that Nexium was
109 La. Rev. Stat. Ann. § 9:2800.58.
110 Rec. Doc. No. 1-1, p. 36, ¶ 196.
111 Rec. Doc. No. 1-1, p. 36, ¶ 199.
112 Rec. Doc. No. 1-1, p. 36, ¶ 200.
113 Rec. Doc. No. 1-1, p. 36, ¶ 198.
114 Rec. Doc. No. 1-1, p. 36, ¶ 201.
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“safe and fit for use for the purposes intended”, “of merchantable quality”, “did not produce
any dangerous side effects”, “that side effects were accurately reflected in the warnings”
and that this was “false and misleading”.115
Defendants’ arguments in support of dismissing Plaintiff’s breach of express
warranty claim mirror those advanced in support of dismissing Plaintiff’s failure to warn
claim: that the specific warranty was not alleged; that the allegations are “boilerplate” and
conclusory; that Plaintiff does not identify the materials where the warranty appears; and
that Plaintiff does not specify that the warranty prompted any particular physician to
prescribe Nexium.116 In response, Plaintiff argues that his pleading was sufficient, citing
to the specific paragraphs in the Complaint alleging the warranty, facts supporting the
express warranty and alleged breach of same, the inducement to prescribe and use the
product, and the cause of his damages.117
First, it is unnecessary for Plaintiff to cite to a specific express warranty.118 Even
without the legal requirement to do so, Plaintiff alleges that the Defendant manufacturer
expressly warranted Nexium as “safe”. Defendants rely upon Robertson v. AstraZeneca
Pharmaceuticals, LP,119 in which the plaintiff simply and generally plead that the
defendant “expressly warranted that Seroquel is a safe, effective product that can be used
for the treatment of depressive episodes of bipolar disorder” and that this warranty was
located on “materials presented to the FDA”.120 The Robertson court found that “[w]hile
115 Rec. Doc. No. 1-1, pp. 36-37, ¶¶ 202-203.
116 Rec. Doc. No. 8-1, pp. 10-11.
117 Rec. Doc. No. 21, pp. 10-11.
118 See, Boutte v. Stryker Biotech, LLC, 67 F.Supp.3d 732, 739 (M.D. La. Dec. 22, 2014)(citing Kennedy,
2013 WL 4590331 at *5).
119 Robertson, 2015 WL 5823326.
120 Id. at *5.
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Plaintiff is not required to quote the specific language of the warranties, she must make
more than a general reference to them. The reference to ‘materials presented to the FDA’
is not specific enough to survive a Rule 12(b)(6) motion to dismiss”.121 However, in the
matter presently before the Court, Plaintiff accompanied his plea of an express warranty
that Nexium was “safe and well accepted by users” with allegations that Nexium failed to
conform to these representations, specific allegations of the side effects of Nexium that
made it unsafe and unacceptable, and details allegations of the correlation between
Nexium and gastric cancer. The distinction between this matter and Robertson is that
Plaintiff alleges with specificity the scientific literature available regarding Nexium and
gastric cancer, the purported knowledge of Defendants of this correlation, how this
information allegedly renders the product unsafe and unacceptable, contrary to the
representations allegedly made by Defendants.
Further, the Court has not been provided with, nor is it aware of, binding or
persuasive authority that the express warranty must appear in a certain location and/or
that Plaintiff must specifically allege where the warranties appear. Defendants again rely
on the same general, vague language from Robertson, as quoted above. The Court does
not read the Robertson court’s finding that the reference to “materials presented to the
FDA” as not being specific enough to require all plaintiffs to specifically allege where
warranties appear. Plaintiff in this matter alleges a scheme of promoting Nexium as safe
and effective while simultaneously having knowledge that Nexium has been allegedly
associated with developing gastric cancer. Plaintiff alleges that Defendants represented
121 Id.
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to the medical community, prescribing physicians, and the public that Nexium was tested
and safe and effective, despite alleged knowledge to the contrary. This pleading of a
broad scheme is similar to that plead in Boutte v. Stryker Biotech, LLC. 122 There, this
Court stated, “[i]n fact, Boutte’s petition alleges what amounts to an ‘elaborate scheme’
by Styker to promote Calstrux as the ‘preferred’ and ‘perfect carrier for OP-1,’ and
assuring the medical community that the combination was ‘safe and effective,’ while
knowing that the combined use of the products remained untested, ineffective, and
unsafe.”123
Considering Plaintiff’s allegations as true and in a light favorable to the Plaintiff,
Plaintiff’s factual pleading of his breach of express warranty claim is sufficient and more
in line with this Court’s findings in Boutte v. Stryker Biotech, LLC,124 than those of
Robertson v. AstraZeneca.125 The Court denies Defendants’ motion with respect to the
breach of express warranty claim.
C. Redhibition
Under Louisiana law, a buyer has a warranty “against redhibitory defects, or vices,
in the thing sold. A defect is redhibitory when it renders the thing useless, or its use so
inconvenient that it must be presumed that a buyer would not have bought the thing had
he known of the defect.”126 Such a defect may give a buyer the right to obtain rescission
of the sale, or, if the buyer would have still bought the product but for a lesser price, a
122 Boutte, 67 F.Supp.3d at 739.
123 Id.
124 Id.
125 Robertson, 2015 WL 5823326, at *5.
126 La. Civ. Code Ann. Art. 2520.
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reduction of the purchase price.127 If a seller is deemed to be in “bad faith,” a buyer can
also recover damages and attorneys’ fees.128 The Louisiana Civil Code makes clear that
recovery under a theory of redhibition is limited to purely economic loss and not recovery
for personal injury.129
Based on the foregoing as well as the established principle that the “LPLA
subsumes all possible causes of action [against a manufacturer] with the exception of
redhibition”,130 the Court turns to whether Plaintiff sufficiently plead a claim of redhibition
and whether similar claims have been allowed to proceed beyond the Rule 12 motion to
dismiss stage.
Defendants contend that the only exception to the LPLA’s exclusivity provision is
a redhibition claim for damage to a product itself or economic loss.131 Defendants argue
that Plaintiff failed to sufficiently state a claim of redhibition based on damage to a product
or economic loss.132 Defendants summarized their argument regarding Plaintiff’s
redhibition claim as, “the Petition fails to provide any factual information about the seller
or how, as alleged, Nexium is useless for its intended purpose or so inconvenient as
judged by the reasonable person standard. In fact, the allegations pled in the Petition
suggest the contrary as Plaintiff claims to have used Nexium for 15 years, further
127 Id.
128 La. Civ. Code Ann. Art. 2545.
129 Alexander v. GlaxoSmithKline, LLC, 2015 WL 5440994, *5 (E.D. La. Sept. 14, 2015)(citing Jefferson v.
Lead Indus. Ass’n, Inc., 106 F.3d 1245, 1251 (5th Cir. 1997)).
130 Marks v. Westwind Helicopters, Inc., 2016 WL 5746292, n. 3 (W.D. La. Jan. 20, 2016)(citing Nelson v.
Mylan Pharmaceuticals, Inc., 2010 WL 3339274, *3 (W.D. La. Aug. 3, 2010).
131 Rec. Doc. No. 8-1, p. 11 (citing Hollybrook Cottonseed Processing, LLC v. Carver, Inc., No. 09-0750,
2010 WL 2195685, *4 (W.D. La. May 28, 2010)(citing La. Rev. Stat. art. 9:2800.53(5); Aucoin v. Southern
Quality Homes, LLC, 2007-1014, p. 7, n. 8 (La. 2/26/08); 984 So.2d 685, 691)).
132 Rec. Doc. No. 8-1, p. 12.
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suggesting that the product assisted Plaintiff. Likewise, the Petition fails to detail how the
product is allegedly defective.”133
Plaintiff does not admit that he did not claim damage to a product, but he does not
address his allegation for damage to a product in his Complaint. He argues that
sufficiently plead the facts of a redhibition claim due to the defect in Nexium that causes
gastric cancer and the fact he would not have used Nexium had he known of this defect.134
Plaintiff argues that he plead economic loss due to redhibition “in the form of a return of
the purchase price he paid for Nexium, a return of insurance co-payments paid for
Nexium, interest on these amounts from the dates of purchase, and attorneys’ fees and
costs”.135
As set forth above, the Complaint alleges: detailed facts about the sellers of
Nexium (all of the named Defendants);136 that scientific literature and studies support
findings that Nexium, a PPI, causes or develops gastric cancer; that there is a correlation
between the use of Nexium and the development of gastric cancer; that this information
is known to Defendants; that the current warnings and/or warranties contained in the
product literature do not state that a user of Nexium may develop gastric cancer or that
this has been found to occur in the past; and that had Plaintiff and his prescribing
physicians known this, then Nexium would not have been used and/or prescribed.137 For
the same reasons stated above, the Court finds that Plaintiff meets the Rule 12(b)(6)
standard in pleading an alleged defect in Nexium.
133 Rec. Doc. No. 8-1, p. 13.
134 Rec. Doc. No. 21, p. 12.
135 Rec. Doc. No. 21, p. 13 (citing La. C.C. art. 2545; Rec. Doc. No. 1-1, ¶ 212).
136 Rec. Doc. No. 1-1, pp. 3-6.
137 Rec. Doc. No. 1-1, pp. 6-29.
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Also, a simple review of the Complaint reveals that Plaintiff seeks economic loss
due to redhibition.138
In Harris v. Merck & Co., Inc.,139 Western District Court of Louisiana considered
plaintiff’s products liability claims under the LPLA as well as a redhibition claim adverse
to the pharmaceutical manufacturer. In a very brief address of plaintiff’s redhibition claim,
the Harris court stated:
[T]he LPLA allows for a redhibition claim only to the extent that plaintiff
seeks recovery of economic losses. Merck asserts that plaintiff’s redhibition
claim must fail because plaintiff’s complaint fails, as argued above, to state
a claim for defect. Having already deemed plaintiff’s complaint sufficient as
stating a claim for design defect under the LPLA, we also reject this
argument relating to redhibition and find that plaintiff’s redhibition claim
should be preserved for further proceedings. Accordingly, Merck’s motion
will be denied in this respect.140
A similar finding was made in Nelson v. Mylan Pharmaceuticals, Inc.,141 as well as by this
Court in Boutte v. Stryker Biotech, LLC.142
Based on the allegations in the Complaint and the general challenges to Plaintiff’s
redhibition claim, the Court finds that Plaintiff has plead enough facts to state a claim to
relief that is plausible on its face. Plaintiff pleads not only the essential elements of a
redhibition claim, but also seeks the appropriate relief of economic damages and pleads
the factual content that allows the Court to draw the reasonable inference that the
Defendants may be liable for the misconduct alleged. Further, district courts in Louisiana
138 Rec. Doc. No. 1-1, ¶ 212
139 Harris, 2012 WL 5384720 at *6.
140 Id.
141 Nelson, 2010 WL 3339274 report and recommendation adopted by, No. 10-0591, 2010 WL 3363039
(W.D. La. Aug. 24, 2010).
142 Boutte, 67 F.Supp.3d at 740.
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have similarly preserved redhibition claims for further proceedings, as set forth above.
Therefore, the Court denies Defendants’ motion to dismiss Plaintiff’s redhibition claim.
D. Plaintiff’s Claims under Rule 8
Defendants argue that Plaintiff’s claims should be dismissed for the independent
reason that Plaintiff fails to satisfy the requirements of Rule 8 of the Federal Rules of
Procedure. Rule 8(a) of the Federal Rules of Civil Procedure requires a short and plain
statement of the claim showing that the plaintiff is entitled to relief. A complaint must set
forth a short and plain statement of the facts upon which the claim is based that is
sufficient to give the defendant fair notice of what the plaintiff's claims are and the grounds
upon which they rest.143 An analysis of a challenge of the pleading of claims under Rule
8 is the same as that under Rule 12(b)(6) under Twombly and Iqbal and has been
addressed above.
Overall, Defendants’ argument in support of their motion under Rule 8 are the
same as their arguments on each of Plaintiff’s claims addressed above. Defendants
maintain their theme of Plaintiff’s overly-general pleading and use of conclusory terms
and alleged recitation of elements of their claims.144 The Court finds Defendants’ motion
under Rule 8 redundant in this respect.
For the reasons stated above, the Court finds that the Complaint herein satisfies
the liberal requirements of Rule 8(a). Plaintiff makes distinct allegations as to the actions
143 See Williams v. United Credit Plan of Chalmette, Inc., 526 F.2d 713 (5th Cir. 1976); Conley v. Gibson,
355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).
144 Rec. Doc. No. 8-1, pp. 14-16.
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or inactions of Defendants.145 Defendants’ motion on the grounds of failure to comply with
Rule 8(a) pleading requirements is denied.
III. CONCLUSION
For the reasons set forth above, the Motion to Dismiss146 by Defendants,
AstraZeneca Pharmaceuticals LP, AstraZeneca LP, and Merck Sharp & Dohme
Corporation, is GRANTED IN PART as to the exclusivity of the Louisiana Products
Liability Act. Plaintiff, Stanley P. Baudin, is granted leave of court to amend his Complaint
within thirty (30) days of the date of this Ruling to cure the deficiencies as to his state law
claims.
Defendants’ motion is DENIED IN PART in all other respects.
IT IS SO ORDERED.
Signed in Baton Rouge, Louisiana on August 26, 2019.
S
CHIEF JUDGE SHELLY D. DICK
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA
145 The Court refers Defendants to the “Factual Background” section above which summarizes the
categories of factual allegations of Plaintiff’s Complaint along with specific citations to the pages of the
Complaint where the allegations can be found.
146 Rec. Doc. 8.
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