The opinion
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
MICHAEL WAGNER, ET AL., CIVIL ACTION
Plaintiffs
VERSUS NO. 19-2721
GARY REISS, ET AL., SECTION "E" (4)
Defendants
ORDER AND REASONS
Defendant Mederi Theraputics, Inc. (“Mederi”) filed a Motion to Dismiss pursuant
to Federal Rule of Civil Procedure 12(b)(6).1 In response, Plaintiffs filed an amended
complaint.2 Mederi then filed a reurged Motion to Dismiss.3 Defendants’ original motion
to dismiss is DENIED as moot. For the following reasons, Defendants reurged motion to
dismiss is GRANTED IN PART and DENIED IN PART.
BACKGROUND
This action stems from the alleged medical complications Plaintiff Michael Wagner
developed after undergoing a procedure known as “Stretta” on February 21, 2018, to treat
his gastroesophageal reflux disease.4 On February 4, 2019, Michael Wagner and Courtney
Wagner, individually and on behalf of their minor children, filed a negligence claim in the
24th Judicial District Court for the Parish of Jefferson against Wagner’s treating
physician who performed the procedure, Dr. Gary Reiss; a manufacturer, Mederi
Theraputics, Inc. (“Mederi”)5; and a Stretta proponent, Dr. Mark Noar.6 On March 21,
1 R. Doc. 40.
2 R. Doc. 43-1.
3 R. Doc. 45. Plaintiffs oppose both motions. R Doc. 41; R. Doc 46. Mederi filed a reply to the reurged motion.
R. Doc. 49.
4 R. Doc. 1-1 ¶¶ 2, 6–7.
5 Mederi Therapeutics replaced Mederi RF LLC in a supplemental complaint. R. Doc. 32.
6 R. Doc. 1-1.
2019, Dr. Noar and Mederi removed the case to this Court based on diversity jurisdiction.7
As set forth in their initial complaint, Plaintiffs allege Mederi and Dr. Noar are
“primarily responsible for designing, testing, taking to market, marketing, promoting,
selling, labeling, formulating warnings and/or distributing Stretta,”8 which they describe
as a “procedure to treat gastroesophageal reflux disease.”9 Plaintiffs further claim that, in
promoting Stretta, Defendants failed to warn of the procedure’s possible dangers and side
effects.10 This, in turn, allegedly induced Wagner to undergo the Stretta procedure and
suffer harm.11 Accordingly, as made clear in Plaintiffs’ most recent amended complaint,12
Plaintiffs allege Mederi and Dr. Noar are liable under Louisiana Civil Code article 2315
for negligent misrepresentation and under Louisiana Revised Statute 40:625 for false
advertising.13 Although the complaint is in some respects ambiguous, Plaintiffs clearly
and unequivocally state they do not bring any products liability causes of action against
any Defendants.14
On August 12, 2019, Defendant Mederi filed the instant reurged motion to dismiss
for failure to state a claim.15 Mederi argues Plaintiffs’ causes of action are barred by the
Louisiana Products Liability Act (LPLA) because the LPLA establishes “the exclusive
theories of liability for manufacturers for damage caused by their products.”16 Plaintiffs
argue the LPLA does not bar their claims because their causes of action are based on
7 R. Doc. 1. On May 15, 2019, the Court determined the case was properly before this Court based on diversity
jurisdiction because Dr. Reiss—a nondiverse defendant—was improperly joined. R. Doc 22. On June 14,
2019, Dr. Reiss was voluntarily dismissed from the case. R. Doc. 35.
8 R. Doc. 1-1 ¶ 15.
9 Id. ¶ 2.
10 Id. ¶ 22.
11 Id.
12 R. Doc. 43-1.
13 Id.
14 Id.
15 R. Doc. 45.
16 R. Doc. 45-1, at 2.
Mederi’s negligent misrepresentation of the safety of the Stretta procedure and false
advertising regarding the Stretta procedure, not damage done by a product Mederi
manufactures.17
LEGAL STANDARD
Pursuant to Federal Rule of Civil Procedure 12(b)(6), a district court may dismiss
a complaint, or any part of it, for failure to state a claim upon which relief may be granted
if the plaintiff has not set forth factual allegations in support of his claim that would entitle
him to relief.18 “To survive a motion to dismiss, a complaint must contain sufficient
factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’”19
“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.”20 The court, however, does not accept as true legal conclusions or mere
conclusory statements, and “conclusory allegations or legal conclusions masquerading as
factual conclusions will not suffice to prevent a motion to dismiss.”21 “[T]hreadbare
recitals of elements of a cause of action, supported by mere conclusory statements” or
“naked assertion[s] devoid of further factual enhancement” are not sufficient.22
In summary, “[f]actual allegations must be enough to raise a right to relief above
the speculative level.”23 “[W]here the well-pleaded facts do not permit the court to infer
more than the mere possibility of misconduct, the complaint has alleged—but it has not
17 R. Doc. 46, at 2.
18 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007); Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir.
2007).
19 Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 570).
20 Id.
21 S. Christian Leadership Conference v. Supreme Court of the State of La., 252 F.3d 781, 786 (5th Cir.
2001) (citing Fernandez-Montes v. Allied Pilots Ass’n, 987 F.2d 278, 284 (5th Cir. 1993)).
22 Iqbal, 556 U.S. at 663, 678 (citations omitted).
23 Twombly, 550 U.S. at 555.
show[n]’—that the pleader is entitled to relief.”24 “Dismissal is appropriate when the
complaint ‘on its face show[s] a bar to relief.’”25
LAW AND ANALYSIS
Plaintiffs assert a cause of action against Mederi under Louisiana Civil Code article
2315 for negligent misrepresentation.26 Louisiana Civil Code article 2315 provides, “Every
act whatever of man that causes damage to another obliges him by whose fault it
happened to repair it.”27 Claims for negligent misrepresentation under article 2315 are
evaluated using the duty-risk analysis.28 Under this analysis, a plaintiff must prove “the
conduct in question was a cause-in-fact of the resulting harm, the defendant owed a duty
of care to the plaintiff, the requisite duty was breached by the defendant and the risk of
harm was within the scope of protection afforded by the duty breached.”29
Plaintiffs additionally bring a cause of action against Mederi under Louisiana
Revised Statute 40:625, which provides, “it is unlawful for any person to disseminate false
advertisement by any means for the purposes of inducing, directly or indirectly, the
purchase of food, drugs, devices, or cosmetics.”30
The LPLA took effect on September 1, 1988, and applies to causes of action that
accrued on or after that date.31 The LPLA establishes exclusive theories of liability
plaintiffs may use against manufacturers for damages caused by their products. It
provides, “A claimant may not recover from a manufacturer for damage caused by a
24 Id. (quoting FED. R. CIV. P. 8(a)(2)).
25 Cutrer v. McMillan, 308 F. App’x 819, 820 (5th Cir. 2009) (per curiam) (quotations omitted).
26 R. Doc. 43-1.
27 LA. CIV. CODE art. 2315.
28 Barrie v. V.P. Exterminators, Inc., 625 So. 2d 1007, 1015 (La. 1993).
29 Daye v. General Motors Corp., 97-1653 (La. 9/9/98), 720 So. 2d 654, 659.
30 This claim for relief seems improper in this case because Stretta is not a “food, drug, device, or cosmetic.”
Nevertheless, because the parties did not present argument about this provision’s application, other than
the exclusivity of the LPLA, the Court will not now decide now whether it applies in this case.
31 Brown v. R.J. Reynolds Tobacco Co., 52 F.3d 524 (5th Cir. 1995).
product on the basis of any theory not set forth in the LPLA.”32 Courts often dismiss
claims against manufacturers that do not arise under the LPLA.33
Louisiana courts have recognized, however, that causes of action outside the LPLA
are permissible against manufacturers, so long as the cause of action is not “for damage
caused by a product” the manufacturer creates. For example, in Stanley v. Wyeth, Inc.,
the Louisiana Court of Appeals for the First Circuit considered (though it ultimately
dismissed on the merits) a plaintiff’s negligent misrepresentation claim against a
manufacturer.34 The plaintiffs in Stanley used, and were allegedly harmed by, a generic
version of a particular drug.35 The plaintiffs then brought a negligent misrepresentation
action against the manufacturer of the name brand version of the drug they used.36 The
plaintiffs did not allege they were harmed by a product the defendant manufactured—
they never even mentioned the defendant’s name brand product—but alleged only that
they were harmed by negligent misrepresentations the defendant made about the drug.37
Because the plaintiffs did not allege they were harmed by a “product” the defendant
manufactured, the Louisiana First Circuit Court of Appeals held the LPLA did not bar
their negligent misrepresentation claim under article 2315 against the defendant
manufacturer.38
32 LA. STAT. 9:2800.52.
33 Jefferson v. Lead Indus., 106 F.3d 1245, 1251 (5th Cir. 1997) (affirming dismissal of plaintiff's claims of
negligence, fraud by misrepresentation, market share liability, breach of implied warranty of fitness, and
civil conspiracy due to exclusivity of the LPLA); Brown, 852 F. Supp. at 9 (E.D. La. 1994) (dismissing
plaintiff’s claims for fraudulent misrepresentation, concealment, and conspiracy due to LPLA’s
exclusivity); Grenier v. Med. Engineering Corp., 99 F.Supp.2d 759, 765–63 (W.D. La. 2000), aff’d, 243
F.3d 200 (5th Cir. 2001) (holding that plaintiff's claims for strict liability, negligence, breach of warranty of
fitness for particular purpose, breach of implied warranty, misrepresentation, fraud by concealment, false
advertising, negligent infliction of emotional distress, common plan to prevent public awareness of breast
implant hazards, and future product failure were not cognizable under the LPLA).
34 2007-2080 (La. App. 1 Cir. 5/2/08), 991 So. 2d 31, 33.
35 Id. at 32.
36 Id.
37 Id.
38 Id. at 33.
In this case, as in Stanley, Plaintiffs’ causes of action against Mederi for negligent
misrepresentation and false advertising are not based on damage caused by a “product”
Mederi manufactured. Instead, they are based on Mederi’s representations of the safety
of a medical procedure—Stretta. The LPLA defines “product” as “a corporeal movable
that is manufactured for placement into trade or commerce, including a product that
forms a component part of or that is subsequently incorporated into another product
or an immovable.”39 Plaintiffs refer to Stretta as a procedure in their petition for
damages40 and argue that, because it is a procedure, they are not restricted to the LPLA.41
Defendants also consistently refer to Stretta as a procedure.42 Stretta is not a product
under the LPLA’s definition. Accordingly, Plaintiffs’ actions against Mederi under article
2315 for negligent misrepresentation and under Louisiana Revised Statute 40:625 for
false advertising are not barred by the LPLA.43
In its motion to dismiss, Mederi seeks to have all claims against it dismissed, but
it has failed to establish Plaintiffs did not allege facts sufficient to satisfy an element of the
negligent misrepresentation or false advertising claims. Instead, Mederi argues only that
the LPLA bars these causes of action. Because the Court rejects this argument, Plaintiffs’
negligent misrepresentation and false advertising claims remain.
39 LA. STAT. 9:2800.53.
40 R. Doc. 1-1 ¶ 2 (“On or about February 21, 2018, Michael Wagner, underwent a procedure known as
Stretta . . . .”).
41 R. Doc. 46, at 2 (“[T]he Stretta procedure promoted by and advertised by Mederi is not a product under
the Louisiana Products Liability Act.”).
42 R. Doc. 45-1 (“Mederi is the manufacturer of the surgical tool used in the Stretta procedure.”).
43 To the extent Plaintiffs bring any causes of action outside the LPLA against Mederi based on damage
caused by one of its products, Defendants are correct—those claims are barred by the LPLA and dismissed
with prejudice.
CONCLUSION
For the foregoing reasons, and to clarify the record, to the extent any claims were
brought under the LPLA, IT IS ORDERED that the reurged motion to dismiss filed by
Mederi pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure is GRANTED
IN PART, and those claims are DISMISSED WITH PREJUDICE.“
IT IS FURTHER ORDERED that the reurged motion to dismiss filed by Mederi
pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure is DENIED IN PART,
and Plaintiff's causes of action under Louisiana Civil Code article 2315 and Louisiana
Revised Statute 40:625 remain.45
IT IS FURTHER ORDERED that Mederi’s original motion to dismiss is
DENIED as moot.4°
New Orleans, Louisiana, this 20th day of February, 2020.
SUSIE song
UNITED STATES DISTRICT JUDGE
44R, Doc. 45.
45 Id. The Court makes no finding regarding whether Plaintiffs have alleged facts sufficient to support each
element of their negligent misrepresentation and false advertising claims. The Court finds only that those
claims are not barred by the LPLA.
46 R, Doc. 40.