The opinion
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA
JENNA THOMPSON
CIVIL ACTION
VERSUS
NO. 21-CV-594-JWD-RLB
BOSTON SCIENTIFIC
CORPORATION
RULING AND ORDER
Before the Court is Defendant Boston Scientific Corporation’s Motion to Dismiss
Plaintiff’s Complaint (“Motion”) brought by defendant Boston Scientific Corporation (“BSC” or
“Defendant”). (Doc. 7.) It is opposed by plaintiff Jenna Thompson (“Plaintiff” or “Thompson”).
(Doc. 16.) BSC filed a reply. (Doc. 19.) The Court has carefully considered the law, the facts as
alleged in the Complaint, and the arguments and submissions of the parties and is prepared to rule.
For the reasons which follow, the Motion is granted in part and denied in part. The Motion is
granted in that Plaintiff’s claim for punitive damages and attorney’s fee is dismissed. In all other
respects, the Motion is denied.
I. BACKGROUND
On June 2, 2020, Plaintiff Jenna Thompson underwent an operation by Dr. Randall Brown
at Woman’s Hospital in Baton Rouge, Louisiana, to surgically implant a pelvic mesh stress device
called a “Lynx.” (Doc. 1, ¶¶ 1, 81.) The Lynx was designed and manufactured by BSC primarily
for the treatment of stress urinary incontinence (“SUI”), the condition for which Plaintiff was
undergoing surgery. (Id. ¶¶ 10-11.)1 “Four months after Dr. Brown implanted the Lynx pelvic
mesh device, it was found to be buried in her vaginal wall, causing [Plaintiff] to experience
1 According to BSC, “[t]he Lynx is a prescription-only medical device that is used as a mid-urethral sling to provide
support and prevent urine leakage.” (Doc. 7-1 at 2-3.)
significant dyspareunia (painful intercourse), neuromuscular pain, disabling pelvic pain,
abdominal pain, groin pain, recurrence of incontinence, erosion and vaginal scarring.” (Doc. 16 at
2 (citing Doc. 1, ¶¶ 82, 86-87).)
In her Complaint, Thompson alleges that the Lynx device was defective in design, (Doc.
1, ¶¶ 54-65), and that BSC failed to adequately warn her physician of Lynx’s defects (id. ¶¶ 66-
76). In addition to requesting compensatory damages, (id. ¶ 127, Prayer ¶ 1a-g), Thompson
demands punitive damages and attorney fees (id. ¶ 125, Prayer ¶ 2).
II. ARGUMENTS OF THE PARTIES
A. BSC’s Opening Brief (Doc. 7)
Defendant argues that Plaintiff’s unreasonably dangerous design claim and her failure to
warn claim are insufficiently pled, fail as a matter of law, and must be dismissed. (Doc. 7 at 1;
Doc. 7-1 at 1-2.) Plaintiff’s demand for punitive damages and attorney fees should also be
dismissed since these items of damage are not allowed under the Louisiana law of products
liability. (Id.)
a. Failure to Warn
As to her failure to warn claim, BSC charges that Plaintiff admits that “the adverse effects
and injuries she claims to have suffered were of the same type that were publicly disseminated by
FDA and medical organizations, and thus well-known to the medical community, years before her
2020 implant.” (Doc. 7-1 at 5 (citing Doc. 1, ¶ 37).) Because Louisiana recognizes the learned
intermediary doctrine, a plaintiff’s failure to warn claim is “premised on ‘the manufacturer[’s]
fail[ure] to adequately warn the treating physician.’ ” (Id. at 6 (quoting Celino v. Biotronik, Inc.,
536 F. Supp. 3d 89, 108 (E.D. La. 2021) (emphasis in Celino).) A plaintiff can only succeed in
such a claim “if the warnings were inadequate with respect to the prescribing physician, and the
physician relied upon those warnings in prescribing the product.” (Id. (citations omitted); see also
id. at 15 (“Plaintiff’s failure to warn claims should be dismissed to the extent they are premised on
any duty owed by [BSC] to anyone other than Ms. Thompson’s treating physician.”).)
Plaintiff states in her Complaint that beginning in 2008, the FDA publicly warned of certain
risks and complications associated with transvaginal pelvic mesh products, (id. at 3 (citing Doc. 1,
¶¶ 17, 32-43), and, starting in 2011, professional medical organizations like the American College
of Obstetricians and Gynecologists (“ACOG”) and the American Urogynecologic Society
(“AUGS”) did the same (id. (citing Doc. 1, ¶¶ 36-37).)2 Defendant urges that, because “the adverse
effects and injuries [Plaintiff] claims to have suffered were of the same type that were publicly
disseminated by FDA and medical organizations, and thus well-known to the medical community,
years before her 2020 implant[,]” (id. at 5), BSC had “no duty to warn of those risks” since they
were “obvious or already known to the product’s user” (id. at 6).
According to Defendant, Plaintiff must show “that the defendant failed to warn the
physician of a risk associated with the use of the product, not otherwise known to the physician.”
(Id. at 7 (quoting Willett v. Baxter Int’l., Inc., 929 F.2d 1094, 1098 (5th Cir. 1991)) (emphasis by
BSC).) Because the mesh-related risks of which Plaintiff is complaining were “well known to the
FDA and to the medical community years before she was implanted with the Lynx[,] [BSC] cannot
be held liable based on a failure to warn of known risks. . . . [and] Plaintiff’s warning-based claims
therefore fail as a matter of law.” (Id. at 8.)
Although Defendant acknowledges that Plaintiff “makes vague, general allegations that
[BSC] failed to warn her doctors about the risks of mesh devices and thus prevented her doctors
2 In support of its position, BSC quotes from and attaches to its Motion FDA publications. (Doc. 7-1 at 9 (citing to
and quoting Docs. 7-3, 7-4, 7-5, 7-6.) BSC argues that the Court can and should consider these outside documents.
(Doc. 7-1 at 4-5 (including n.1 at 5) and Doc 19 at 5.) Plaintiff argues the Court should not consider them. (Doc. 16
at 10-11.) The Court resolves the issue later in this Ruling.
from knowing about those risks,” this is inconsistent with Plaintiff’s specific allegation that her
injuries were “of the type reported in the FDA Safety Communication and in the ACOG/AUGS
Joint Committee Opinion.” (Id. at 10 (quoting Doc. 1, ¶ 37).) Thus, “there can be no causation
when the failure to warn involves a risk that . . . is already known in the medical community.” (Id.
at 10 (quoting Toups v. Synthes, Inc., 2015 WL 6738541, at *7 (E.D. La. Nov. 4, 2015).)
Furthermore, Plaintiff’s allegations regarding inadequate warning are deficient in that they
fail to “explain how such warnings were inadequate, or show that her physician’s receipt of an
adequate warning would have changed the prescribing decision to use the Lynx.” (Doc. 7-1 at 15.)
b. Defective Design
Regarding Plaintiff’s second products liability claim, unreasonably dangerous design, BSC
argues that “Plaintiff has failed to plead basic facts necessary to state her claims under Louisiana
law.” (Id. at 11.) Specifically, BSC contends that Plaintiff’s allegations regarding alternative
design are fatally defective in three ways. First, Plaintiff “must show that an alternative design
existed for the Lynx device itself, as opposed to other products, (id. at 12 (citing Braswell v. Agri-
Fab, Inc., 2007 WL 9701056, at * 5 (M.D. La. Mar. 14, 2007)), and yet, Plaintiff’s proposed
alternative designs are “tie[d] to different products entirely, including those that treat conditions
other than SUI” (id. at 12-13). Secondly,
Plaintiff fails to plead facts adequately identifying: a design that would have been
safer than the Lynx product at issue in this case; how this alternative design would
have been safer than the Lynx; and/or how these unspecified alternative designs
would have prevented or significantly reduced the risk of Plaintiff’s injuries.
(Id. at 13.)
Finally, BSC maintains that “Plaintiff fails to allege how ‘the improvements represented
by . . . alternative design[s] outweighed the burden on the manufacturer of adopting such
alternative design.’ ” (Id. (quoting Baptist v. C.R. Bard, Inc., 2018 WL 1843937, at *4 (E.D. La.
Apr. 17, 2018) and citing Dubroc v. Bristol-Myers Squibb, 2019 WL 3756469, at *4 (M.D. La.
Aug. 8, 2019)) (quotation marks omitted).) Plaintiff’s allegation in this respect is merely
conclusory and insufficient to meet this pleading requirement. (Id. at 14.)
c. Punitive Damages and Attorney Fees
BSC argues that Plaintiff’s demand for these two items of damage must be dismissed since
neither is allowed under the Louisiana law of products liability. (Id. at 16-17.)
B. Plaintiff’s Opposition Brief (Doc. 16)
While Plaintiff “acknowledges that neither [punitive damages nor attorney fees] are
recoverable under Louisiana law on the allegations currently pled in her complaint,” (Doc. 16 at
2, n.1), Plaintiff argues that Defendant’s Motion should be denied in all other respects. Specifically,
Plaintiff contends her claims for failure to warn and defective design are “sufficient to satisfy the
requirements of Federal Rule of Civil Procedure 8(a).” (Id. at 2.)
a. Failure to Warn
Plaintiff points the Court to paragraph 67 of her Complaint, where she identifies 15 specific
deficiencies in BSC’s warnings, (Id. at 3 (citing Doc. 1, ¶ 67)), and paragraph 117, where Plaintiff
“outlines in detail the specific information she contends BSC omitted ‘[i]n their [Directions for
Use], as well as marketing materials they prepared and disseminated to patients and healthcare
providers’ ” (id. (quoting Doc. 1, ¶ 117)). Plaintiff states that paragraph 118 “further outlines how
BSC failed to instruct her healthcare providers ‘as to the proper candidates for, and the safest and
most effective methods of, implantation and use of’ the Lynx pelvic mesh device.” (Id. (quoting
Doc. 1, ¶ 118).) Finally, she quotes paragraph 119, wherein Plaintiff alleges, in pertinent part,
that “[h]ad Defendant properly and adequately warned and instructed [Plaintiff] and her healthcare
providers . . . , [Plaintiff] would not have been recommended implantation of the Lynx pelvic mesh
product[.]” (Id. at 3-4 (quoting Doc. 1, ¶ 119).)
These and other facts alleged in the Complaint, argues Plaintiff, “sufficiently establish
BSC’s liability under governing Louisiana law.” (Id. at 5 (citing Holbrook v. Bos. Sci. Corp., 487
F. Supp. 3d 100, 110 (D. Mass. 2020) (applying Louisiana law)).) The erroneous and fatal premise
of BSC’s argument is that the proper standard is what is “known to the medical community” rather
than what was known to Plaintiff’s treating physician. (Id. at 6.) “BSC fails to cite a single
Louisiana or Fifth Circuit case that applies the ‘known to the medical community’ standard it
presses this Court to adopt.” (Id.) Plaintiff distinguishes the cases cited by BSC because BSC either
misreads the standard applied by the court or because the facts were different in significant
respects. (Id. at 6-7.) “Even read generously,” none of the cases from other jurisdictions cited by
BSC apply the “known in the medical community” standard. (Id. at 8.)
Assuming arguendo, however, that this is the proper standard, Plaintiff’s Complaint
satisfies it because, contrary to BSC’s misreading of Plaintiff’s Complaint, key information was
not known by the medical community and was withheld by BSC from the medical community.
[W]hile some of the problems associated with the pelvic mesh products, including
the Lynx pelvic mesh product, were made known to physicians, the magnitude and
frequency of these problems were not disclosed and were hidden from physicians.
(Doc. 16 at 9 (quoting Doc. 1, ¶ 61) (emphasis by Plaintiff); see id. at 9-10 (Plaintiff points the
Court to paragraph 52 as another example of Defendant’s withholding of important information).)
Plaintiff takes issue with BSC’s suggestion that the Court take judicial notice of the FDA
documents attached to BSC’s Motion since “the medical facts set forth in the FDA documents, and
the medical community’s ‘knowledge’ of those fact, are not ‘adjudicative facts’ appropriate for
judicial notice as BSC proposes.” (Doc. 16 at 10 (citing Jackson v. Biedenharn, 429 F. App’x 369,
373 (5th Cir. 2011).) Plaintiff points out that BSC itself “refuses to concede ‘the accuracy of the
validity of any of the statements or findings’ in the FDA documents.” (Id. at 10-11 (citing Doc. 7-
1 at 4, n.7).)
However, regardless of whether the Court can consider the FDA documents, Plaintiff
contends that these documents do not discuss all of the risks and injuries involved in this case. (Id.
at 11 (“As just one example, the risks that the Lynx pelvic mesh device can cause neuromuscular
pain, and long-term, life-altering pain when used to treat[ ] stress urinary incontinence are nowhere
discussed in these materials.”).)
Plaintiff concludes by stressing that “whether Dr. Brown already knew the risks of using
BSC’s Lynx pelvic mesh device is a question for the jury and not for this Court to decide as a
matter of law based on the purported knowledge of the ‘medical community.’ ” (Id.)
Regarding Plaintiff’s allegation that, had Dr. Brown been properly advised and warned,
her damages would have been avoided, Plaintiff argues that the allegations found in paragraphs
67, 117, 118, and 119 adequately allege the causation element of her case. (Id. at 15.)
b. Defective Design
Plaintiff insists that she has “alleged more than enough factual detail [regarding a safer
alternative design] to satisfy Federal Rule of Civil Procedure 8(a).” (Doc. 16 at 12.) Plaintiff agrees
with BSC that part of Plaintiff’s burden at trial is to prove that, “at the time the product left BSC’s
control, (1) ‘an alternative design existed for the product that was capable of preventing the alleged
damage,’ and (2) ‘the alternative design would prevail in a traditional risk/utility analysis.’ ” (Id.
(quoting Grenier v. Med. Eng’g Corp., 99 F. Supp. 2d 759, 764 (W.D. La. 2000) (citing La. R.S.
9:2800.56)).) But Plaintiff stresses that for purposes of the sufficiency of the Complaint, the
question “is not whether the plaintiff has proven the elements to succeed on a products liability
claim, or even whether he has made ‘detailed factual allegations.’ Rather, the Court must simply
determine whether the plaintiff ‘has plausibly alleged enough information that, with discovery, he
could prove’ the defendants are liable.” (Doc. 16 at 12 (quoting Flagg v. Stryker Corp., 647 F.
App’x 314, 319 (5th Cir. 2016) (emphasis in Flagg)) (cleaned up).)
Plaintiff claims her alternative design pleadings “far exceed[ ] the pleading that the Fifth
Circuit found sufficient in Flagg, by specifically identifying multiple examples of safer alternative
designs[.]” (Id. at 13 (citing Doc. 1, ¶¶ 64, 107).) The level of detail provided by Plaintiff in this
case distinguishes some of the cases relied on by BSC and others are distinguishable because the
cases involved a motion for summary judgment and not a motion to dismiss. (Id. at 13-14.)
c. Punitive Damages and Attorney Fees
As mentioned earlier in this ruling, Plaintiff admits that the Louisiana law of products
liability does not allow the recovery of punitive damages and attorney fees. (Doc. 16 at 2, n.1.)
C. BSC’s Reply Brief (Doc. 19)
a. Failure to Warn
To support its position that “what is known to the medical community” and not just the
prescribing physician governs the failure to warn standard, BSC points the Court to the wording
of La. R.S. 9:2800.57(B)(1).
A manufacturer is not required to provide an adequate warning about his product
when . . . [t]he product is not dangerous to an extent beyond that which would be
contemplated by the ordinary user or handler of the product, with the ordinary
knowledge common to the community as to the product’s characteristics.
(Doc. 19 at 2 (quoting La. R.S. 9:2800.55(B)(1)) (emphasis by BSC).)
BSC argues that when this rule is placed in the context of the learned intermediary doctrine,
the duty to warn only “require[s] an adequate warning of inherent dangers not within the
knowledge of or obvious to the average learned intermediate.” (Id. (quoting Willett, 929 F.2d at
1098, n.16) (emphasis by BSC).) Thus, argues BSC, it “had no duty to warn Plaintiff’s prescribing
physician of risks that [were] ‘common knowledge’ or generally known within the medical
community.” (Id. at 3 (citation omitted).) BSC returns to Plaintiff’s Complaint, highlighting the
specific passages in which it is alleged that the problems about which she now complains “were
generally known to the medical community.” (Id.) Indeed, Plaintiff admits that her injuries were
“of the type reported in the FDA Safety Communication and in the ACOG/AUGS Joint
Committee Opinion.” (Id. at 4 (quoting Doc. 1 at ¶ 37) (emphasis by BSC).)
BSC denies Plaintiff’s charge that it is attempting to create new law; rather, it is merely
maintaining that a manufacturer has no duty to warn a prescribing physician of risks which are
commonly known in the medical community, “regardless of whether Plaintiff alleges that she and
her prescribing physician were uniquely unaware of these risks.” (Id.)
b. Defective Design
BSC reiterates that Plaintiff’s defective design claim fails because she has failed to
sufficiently plead an alternative design specific to the Lynx device (Id. at 5-6 (citing Braswell v.
Agri-Fab, Inc., 2007 WL 9701056, at *5 (M.D. La. Mar. 14, 2007)).) Additionally, she has failed
to properly plead how Plaintiff’s alternative design would meet the risk/utility analysis, Plaintiff
merely “parrot[ing] the pleading requirement established by the LPLA.” (Id. at 6.) Finally, BSC
repeats its charge that Plaintiff has failed to sufficiently allege that a proper warning would have
changed the outcome. (Id. at 7-8.)
III. STANDARD
In Johnson v. City of Shelby, 574 U.S. 10, 11 (2014), the Supreme Court explained:
“Federal pleading rules call for ‘a short and plain statement of the claim showing that the pleader
is entitled to relief,’ Fed. R. Civ. P. 8(a)(2); they do not countenance dismissal of a complaint for
imperfect statement of the legal theory supporting the claim asserted.”
Interpreting Rule 8(a) of the Federal Rules of Civil Procedure, the Fifth Circuit has explained:
The complaint (1) on its face (2) must contain enough factual matter (taken as true) (3)
to raise a reasonable hope or expectation (4) that discovery will reveal relevant
evidence of each element of a claim. “Asking for [such] plausible grounds to infer [the
element of a claim] does not impose a probability requirement at the pleading stage; it
simply calls for enough facts to raise a reasonable expectation that discovery will reveal
[that the elements of the claim existed].”
Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 257 (5th Cir. 2009) (quoting Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 556 (2007)).
Applying the above case law, the Western District of Louisiana has stated:
Therefore, while the court is not to give the “assumption of truth” to conclusions,
factual allegations remain so entitled. Once those factual allegations are identified,
drawing on the court's judicial experience and common sense, the analysis is
whether those facts, which need not be detailed or specific, allow “the court to draw
the reasonable inference that the defendant is liable for the misconduct alleged.”
[Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 1949 (2009)]; Twombly,
55[0] U.S. at 556, 127 S. Ct. at 1965. This analysis is not substantively different
from that set forth in Lormand, supra, nor does this jurisprudence foreclose the
option that discovery must be undertaken in order to raise relevant information to
support an element of the claim. The standard, under the specific language of Fed.
R. Civ. P. 8(a)(2), remains that the defendant be given adequate notice of the claim
and the grounds upon which it is based. The standard is met by the “reasonable
inference” the court must make that, with or without discovery, the facts set forth a
plausible claim for relief under a particular theory of law provided that there is a
“reasonable expectation” that “discovery will reveal relevant evidence of each
element of the claim.” Lormand, 565 F.3d at 257; Twombly, 55[0] U.S. at 556, 127
S. Ct. at 1965.
Diamond Servs. Corp. v. Oceanografia, S.A. De C.V., No. 10-177, 2011 WL 938785, at *3 (W.D.
La. Feb. 9, 2011).
The Fifth Circuit further explained that all well-pleaded facts are taken as true and viewed
in the light most favorable to the plaintiff. Thompson v. City of Waco, 764 F.3d 500, 502–03 (5th
Cir. 2014). The task of the Court is not to decide if the plaintiff will eventually be successful, but
to determine if a “legally cognizable claim” has been asserted.” Id. at 503.
IV. DISCUSSION
“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.” La. R.S. 9:2800.54(A). Thus, as the Fifth Circuit has explained:
To maintain a successful products liability action under the LPLA, a plaintiff 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.
Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 260–61 (5th Cir. 2002) (citing La. R.S.
9:2800.54(A)).
A product is “unreasonably dangerous” under the LPLA “if and only if” the product is (1)
“unreasonably dangerous in construction or composition”; (2) “unreasonably dangerous in
design”; (3) “unreasonably dangerous because an adequate warning about the product has not been
provided”; or (4) the product fails to “conform to an express warranty of the manufacturer about
the product.” La. R.S. 9:2800.54(B) (referencing definitions in La. R.S. 9:2800.55 – 58).
Plaintiff’s Complaint is 45 pages and 127 paragraphs long and provides an exquisitely
detailed history of pelvic mesh products generally and the Lynx product specifically. It is also
detailed in its criticism of the product’s design and warnings. Plaintiff focuses her allegations that
the Lynx pelvic mesh device was unreasonably dangerous in design in Doc. 1, ¶¶ 54-65, although
references to the allegedly defective design are scattered elsewhere in the Complaint (see, e.g.,
Doc. 1, ¶ 30(a)-(h)). Her allegations regarding the allegedly inadequate instructions and warnings
are detailed in Doc. 1, ¶¶ 66-76, but other references to the deficient warnings are found throughout
the Complaint (see, e.g., id. at ¶¶ 29-31, 45, 46, 49, 52). Plaintiff alleges that these deficiencies in
warnings and design entitle her to, among other items of damage demanded, punitive damages and
attorney fees. (Id. ¶ 125 and Prayer, ¶ 2.)These matters will be taken up in turn.
A. Matters Which May Be Con sidered
In her Complaint, Plaintiff makes repeated references to the FDA’s involvement in the
collection of information regarding the dangers and risks of the pelvic mesh products and the
FDA’s notifications regarding same to the public and the medical profession. (See, e.g., Doc. 1, ¶¶
32-35, 37-44.) Plaintiff does the same with respect to the ACOG/AUGS. (Id. ¶¶ 36, 37, 44.) In
these paragraphs, Plaintiff alleges that the risks described by the FDA and ACOG/AUGS were
known to BSC, but that additional risks known only to BSC were withheld from the public and
medical community.
Attached to Defendant’s Motion are four FDA publications regarding pelvic mesh
products. (Docs. 7-3, 7-4, 7-5, 7-6.) Throughout its briefing, Defendant argues that these
publications demonstrate that the risks of pelvic mesh devices like the Lynx device were already
known to the medical community and therefore it had no duty to warn of same to Dr. Brown or
anyone else. BSC contends that the Court can consider the FDA documents for two reasons. First,
for purposes of a motion to dismiss, a court can consider “the complaint, its proper attachments,
documents incorporated into the complaint by reference, and matters of which a court may take
judicial notice. . . .” (Doc. 7-1 at 4 (quoting Jones v. Caliber Home Loans, Inc., 2020 WL 4342219,
at * 4 (M.D. La. 2020) (in turn quoting Randall D. Walcott, M.D., P.A. v. Sebelius, 635 F.3d 757,
763 (5th Cir. 2011))).) Second, argues BSC, the Court can take judicial notice of these records
under Federal Rule of Evidence 201. (Id. at 5.)
Plaintiff counters that “the medical facts set forth in the FDA documents, and the medical
community’s ‘knowledge’ of those facts, are not ‘adjudicative facts’ appropriate for judicial notice
as BSC proposes.” (Doc. 16 at 10 (citing Jackson v. Biedenharn, 429 F. App’x 369, 373 (5th Cir.
2011)).) In its reply, Defendant responds by pointing the Court to multiple instances in which
Plaintiff referred to FDA publications. (Doc. 19 at 3-4.)
This Court recently summarized the pertinent rule as follows:
The general rule regarding what may be considered in deciding a Rule 12(b)(6)
motion is well known.
In determining whether a plaintiff's claims survive a Rule 12(b)(6)
motion to dismiss, the factual information to which the court
addresses its inquiry is limited to (1) the facts set forth in the
complaint, (2) documents attached to the complaint, and (3) matters
of which judicial notice may be taken under Federal Rule of
Evidence 201.
Gomez v. Galman, 18 F.4th 769, 775 (5th Cir. 2021) (per curium) (quoting Walker
v. Beaumont Indep. Sch. Dist., 938 F.3d 724, 735 (5th Cir. 2019)). See also Innova
Hosp. San Antonio, Ltd. P'ship v. Blue Cross & Blue Shield of Georgia, Inc., 892
F.3d 719, 726 (5th Cir. 2018).
However, there is an exception to this rule: a court may consider documents
attached to a motion to dismiss “where the complaint refers to the documents and
they are central to the claim.” Kane Enters. v. MacGregor (USA) Inc., 322 F.3d
371, 374 (5th Cir. 2003) (citing Collins v. Morgan Stanley Dean Witter, 224 F.3d
496, 498–99 (5th Cir. 2000)). See also Wilson v. GMFS LLC, No. 18-840, 2019
WL 8301667, at *3 (M.D. La. May 24, 2019); McCann v. Best Buy Co., No. 17-
108, 2017 WL 5985570, at *2 (M.D. La. Dec. 1, 2017).
Liberty Mut. Fire Ins. Co. v. Shaw Grp., Inc., No. 20-871, 2022 WL 896804, at *10 (M.D. La.
Mar. 25, 2022) (deGravelles, J.).
Because the FDA documents are referred to extensively in Plaintiff’s Complaint and
because of the central role they play in Plaintiff’s narrative and allegations, it is proper to consider
the FDA documents attached to BSC’s Motion, (Docs. 7-3 through 7-6), as well as the allegations
regarding same in Plaintiff’s Complaint.
B. Punitive Damages and Attorney Fees
Plaintiff candidly admits that Louisiana’s law of products liability does not provide for the
recovery of punitive damages and attorney fees. (Doc. 16 at 2, n.1.) Plaintiff is correct and this
part of Plaintiff’s claim is therefore dismissed with prejudice. Saienni v. Peters, 2015 WL 520765,
at *1 (M.D. La. Feb. 9, 2015); Bladen v. C.B. Fleet Holding Co., 487 F. Supp. 2d 759, 770 (W.D.
La. 2007). (“The [LPLA], which specifically limits those claims which can be made against a
manufacturer for use of its product by a consumer provides the exclusive theory of liability
available against a manufacturer and does not authorize punitive damages.”) Nor does the LPLA
include attorneys’ fees within its statutory definition of allowable damages. See La. R.S. 9:2800.53
(“Attorneys’ fees are not recoverable under this Chapter”); Chevron USA, Inc. v. Aker Mar., Inc.,
604 F.3d 888, 900–901 (5th Cir. 2010); Holbrook v. Bos. Sci. Corp., 487 F. Supp. 3d 100, 111 (D.
Mass. 2020) (accord, interpreting Louisiana law).
C. Failure to Warn
To recover for a failure to warn under this doctrine, a plaintiff must show: (1) that
the defendant failed to warn the physician of a risk associated with the use of the
product, not otherwise known to the physician, and (2) that the failure to warn the
physician was both a cause in fact and the proximate cause of the plaintiff's injury.
Because the defective aspect of the product must cause the injury, the plaintiff must
show that a proper warning would have changed the decision of the treating
physician, i.e. that but for the inadequate warning, the treating physician would not
have used or prescribed the product.
Willett v. Baxter Int'l, Inc., 929 F.2d 1094, 1098–99. See also In re Taxotere (Docetaxel) Prod.
Liab. Litig., 994 F.3d 704, 708 (5th Cir. 2021).
Defendant makes two main arguments in support of its motion to dismiss Plaintiff’s failure
to warn claim: first, that Defendant has no duty to warn about risks and injuries which are already
known in the medical community and to the “average learned intermediate.” (See, e.g., Doc. 19 at
2 (quoting Willett, 929 F.2d at 1099, n.16).) Because Plaintiff alleges that her injuries were of the
type reported to the medical community years before her surgery by way of the FDA Safety
Communication and in the ACOG/AUGS Joint Committee Opinion, her failure to warn claim fails
as a matter of law. (Id. at 4 (quoting Doc. 1, ¶ 37).) Second, Plaintiff fails to “explain how such
warnings were inadequate, or show that her physician’s receipt of an adequate warning would have
changed the prescribing decision to use the Lynx[.]” (Doc. 7-1 at 15.)
Plaintiff responds to Defendant’s first argument in three ways. Plaintiff argues first that
BSC misconstrues and misrepresents the scope of its duty as a designer, manufacturer, and
distributor of a medical product. Correctly stated, “the learned intermediary doctrine requires the
plaintiff to show that the defendant failed to warn of a risk “not otherwise known to the physician.”
(Doc. 16 at 6 (quoting Willett, 929 F.2d at 1098) (emphasis by Plaintiff).) There is no “known to
the medical community” component in the standard and since Plaintiff alleges that her treating
doctor was not warned, it is irrelevant what may have been known by “the medical community.”
(Id. at 6-7.)
Second, even if Defendant’s interpretation of its duty was correct, Plaintiff has alleged
fifteen “specific deficiencies in BSC’s warnings,” (Doc. 16 at 3 (citing Doc. 1, ¶ 67)); has
“outline[d] in detail the specific information she contends BSC omitted from its” directions for use
and marketing materials, (id. (citing Doc. 1, ¶ 117)); and has “outline[d] how BSC failed to instruct
her healthcare providers ‘as to the proper candidate for and the safest and most effective methods
of implantation and use (id. (citing Doc. 1, ¶ 118); see also id. at 11).
Third, Plaintiff points to her Complaint at paragraph 67, where she specifically alleges that
BSC failed to provide information not provided earlier by FDA and ACOG/AUGS.
Further, while some of the problems associated with the pelvic mesh products,
including the Lynx pelvic mesh product, were made known to physicians, the
magnitude and frequency of these problems were not disclosed and were hidden
from physicians.
(Doc. 16 at 9 (quoting Doc. 1, ¶ 61) (emphasis by Plaintiff).)
Regarding BSC’s second grounds for dismissal of this claim (failing to explain how the
warnings were inadequate or why and how adequate warnings would have altered the outcome),
Plaintiff responds that she has indeed addressed the specifics of BSC’s warning deficiencies in the
above paragraphs and alleged specifically that had Plaintiff’s doctors been “properly and
adequately warned and instructed . . . [Plaintiff] would not have been recommended implantation
of the Lynx pelvic mesh product, and [Plaintiff] would not have proceeded with implantation[.]”
(Id. at 3-4 (quoting Doc. 1, ¶ 119).)
The Court finds that Defendant is correct that Plaintiff alleges that her injuries “are of the
type reported in the FDA Safety Communication and in the ACOG/AUGS Joint Committee
Opinion.” (Doc. 1, ¶ 37.) Defendant is also correct that Plaintiff details the research done before
Plaintiff’s surgery that identified certain dangers and risks associated with pelvic mesh implants,
(see, e.g., Doc. 1, ¶¶ 17-21), which were disseminated to the public and medical community
through FDA communications, (see e.g., id. ¶¶ 32-36, 39-43), and that of professional medical
groups (id. ¶ 36).
But Defendant ignores numerous paragraphs in which she alleges that, despite this
research, BSC, in its advertising, marketing, and other communications to the medical profession
and public, “exaggerated and misle[d] expectations as to the safety and utility of this product.” (Id.
¶ 29.) According to Plaintiff, “contrary to [its] representations and marketing[,]” BSC failed to
report “high failure, injury, and complication rates” and instances in which its product “caused
severe and irreversible injuries, conditions and damage . . .” (Id. ¶ 30.) Indeed, Plaintiff charges:
Defendant has consistently underreported and withheld information about the
propensity of . . . the Lynx pelvic mesh product to fail and cause injury and
complications, and misrepresented the efficacy and safety of these products,
through various means and media, actively and intentionally misleading the public.
Id. ¶ 31.
Defendant knew and had reason to know that the Pelvic Mesh Products could and
would cause severe and grievous injury [and] were inherently dangerous in a
manner that exceeded any purported, inaccurate, or otherwise downplayed
warnings.
Id. ¶ 52.
In paragraph 67 (A-V), Plaintiff details twenty-two specific ways in which BSC’s warnings
were deficient. (Doc. 1, ¶ 67 (A) – (V).) In paragraph 117, Plaintiff again details the allegedly
defective warnings, specifying 28 ways in which the warnings were inadequate. (Id. ¶ 117 (a. –
bb); see also id. ¶¶ 45(C), 46, 49, 67, 68, 72.) Plaintiff alleges that not only did BSC withhold
information, underreport data, and “actively and intentionally” mislead the profession and
regulators regarding the dangers and risks of its product, but it failed to advise of “magnitude and
frequency of those risks.” (Id. ¶ 73.)
*** Further, while some of the problems associated with the Pelvic Mesh Products,
including the Lynx pelvic mesh product, were made known to physicians, the
magnitude and frequency of these problems were not disclosed and were hidden
from physicians.
(Doc. 1, ¶ 61.)
Plaintiff and Defendant disagree on whether it is the prescribing physician or the medical
community who must be made aware of the risks and dangers of the medical product. There is
certainly language in the case law suggesting the former.
An adequate warning is one that “would lead an ordinary reasonable user ... to
contemplate the danger in” the use of the product. LA. STAT. ANN. § 9:2800.53(9)
(West 2013). Under the “learned intermediary doctrine,” however, a patient's
physician acts as an informed intermediary between the drug company and the
patient. Brown v. Glaxo, Inc., 790 So. 2d 35, 38-39 (La. App. 1 Cir. 2000), writs
denied, 785 So. 2d 827 and 785 So. 2d 832 (La. 2001). Thus, a drug manufacturer
has a duty to warn the prescribing physician, rather than the patient, of potential
risks associated with the use of the drug. Mikell v. Hoffman-LaRoche, Inc., 649
So.2d 75, 79-80 (La. App. 1 Cir. 1994).
In re Taxotere (Docetaxel) Prod. Liab. Litig., 994 F.3d, 704, 708 (5th Cir. 2021) (emphasis added).
But Defendant is correct that the Fifth Circuit has also stated, “We, therefore, interpret the
duty to warn in the learned intermediate context to require an adequate warning of inherent dangers
not within the knowledge of or obvious to the average learned intermediate.” Willett v. Baxter
Int’l, Inc., 929 F.2d at 1098, n.16 (emphasis added). The reason for the Fifth Circuit’s statement
seems clear. To adopt Plaintiff’s position would transform a medical product manufacturer’s duty
to warn into a purely subjective one, turning totally on the knowledge (or lack thereof) of one
doctor, the treating doctor, regardless of how competent or incompetent, trained or untrained, that
physician might be. As the Eastern District recently held in the context of another medical product
liability case, “[t]he ordinary users and handlers of the ReShape balloon at issue are bariatric
surgeons like Dr. Lavin, and there is no evidence in the record that Dr. Lavin lacked ‘ordinary
knowledge common to [his] community [of physicians] as to the product's characteristics.’ ”
Vesoulis v. ReShape Lifesciences, Inc., No. CV 19-1795, 2021 WL 1909725, at *5 (E.D. La. May
12, 2021) (emphasis added).
However, for purposes of the present analysis, it makes no difference who is right. Whether
one focuses on the adequacy of the warning vis a vis Plaintiff’s treating physician, Dr. Brown (as
Plaintiff urges), or what was known by “the average learned intermediate,” (as Defendant posits),
the result is the same: Plaintiff’s allegations are sufficient. Although Plaintiff’s Complaint alleges
that the medical community was already aware of some dangers of the product at the time of
Plaintiff’s surgery, Plaintiff also alleges that much more was known to BSC about the product’s
dangers which it failed to disclose in its instructions and warnings. The Court finds that Plaintiff’s
allegations regarding the inadequacy of Defendant’s instructions and warnings are sufficient for
Rule 8(a)(2) purposes.
The Court also finds that Plaintiff has adequately pled the causation element of her
warnings claim. In paragraph 119, Plaintiff alleges:
Had Defendant properly and adequately warned and instructed [Plaintiff] and
healthcare providers with [sic] regarding to [sic] the Lynx pelvic mesh products’
Risks and Potential Complications, upon information and belief, [Plaintiff] would
not have been recommended implantation of the Lynx pelvic mesh product, and
[Plaintiff] would not have proceeded with implantation of the Lynx pelvic mesh
product, thus avoiding the injuries [Plaintiff] has alleged herein.
(Doc. 1, ¶ 119.)
This paragraph also meets Rule 8(a)(2) muster, especially when read in connection with
paragraphs 61, 117, and 118 of the Complaint. Donald v. AstraZeneca Pharms., LP, No. CV 16-
17753, 2017 WL 1079186, at *3 (E.D. La. Mar. 22, 2017) (Approving the plaintiff's complaint
which alleged that her treating physician would not have prescribed her Nexium had the physician
been properly warned of the risks of kidney injuries. “In following with the Fifth Circuit's quite
generous instruction on specificity required at the pleading stage for an LPLA claim, the Court
finds that the plaintiff's complaint provides ‘facial plausibility’ for a failure to warn claim.”).
In sum, the deficient warnings allegations made in Plaintiff’s Complaint more than satisfy
the requirements of Federal Rule of Civil Procedure 8(a)(2). Holbrook v. Bos. Sci. Corp., 487 F.
Supp. 3d 100, 109–10 (D. Mass. 2020) (applying Louisiana law); see also Batiste v. Stryker Corp.,
No. 19-574, 2021 WL 1171880, at *7 (M.D. La. Mar. 26, 2021) (deGravelles, J.).
D. Design Defect – Alternative Design
Defendant alleges that Plaintiff’s allegations regarding proposed safer alternative designs
are deficient in that they are not alternative designs specific to the Lynx mesh product and
furthermore, Plaintiff fails to properly allege the risk/utility evaluation. Plaintiff counters that her
allegations are more than sufficient in both respects, relying on Flagg v. Stryker Corp., 647 F.
App’x at 319.
In Flagg v. Stryker Corp., 647 F. App'x 314, 315 (5th Cir. 2016), the Fifth Circuit
considered Rule 8(a)(2) pleading requirements in the context of a claim brought under the LPLA.
The Court observed:
[W]e have never squarely addressed how much detail and specificity is required to
plead that a product was unreasonably dangerous under the LPLA due to defective
design, construction, or composition.
We conclude that Flagg's allegations provide sufficient information to “raise a
reasonable expectation that that discovery will reveal evidence” to support the
Manufacturing Defendants' liability. See In re S. Scrap Material Co., 541 F.3d at
587 (citation omitted). Requiring Flagg and other plaintiffs to plead extremely
“detailed factual allegations” that satisfy each element of a products liability action
under the LPLA creates a situation where a manufacturer will not be held liable for
defective products because it has sole possession of the necessary document to
ultimately prove the claim. See Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (noting that
pleadings need not contain “detailed factual allegations” (quoting Twombly, 550
U.S. at 555, 127 S.Ct. 1955)); see also Bertrand v. Eli Lilly & Co., No. 12–0853,
2013 WL 4093556, at *5 (W.D. La. Aug. 13, 2013) (noting plaintiffs in products
liability suits face a likely impossible task of stating more specific allegations about
manufacturing and design when the defendants have possession of the necessary
information).
Flagg, 647 F. App'x at 317–18. See also Price v. Luster Prod. Inc., No. CV 21-1036, 2022 WL
1719274, at *8 (E.D. La. May 27, 2022).
Flagg involved a medical products liability claim against the manufacturer of a toe implant
which broke. Id. at 315. As to his alternative design allegations, the Court stated,
Although Flagg does not plead that the alternative alloy and design were available
when the implants were produced or that the danger of the damage outweighs the
burden of adopting the design, those very detailed and specific allegations are not
required to plead a plausible claim at this this stage, before Flagg has had an
opportunity for discovery. (citations omitted)
Flagg v. Stryker Corp., 647 F. App'x at 318.
Here the Court has carefully considered Plaintiff’s proposed alternative design and
risk/utility allegations. (Doc. 1, ¶¶ 64, 107.) Plaintiff offers eight separate alternative designs
currently in use which, she alleges, were “safer [and] economically and technologically feasible”
at the time the Lynx product “left the control of the Defendant.” (Id. ¶ 64.) Plaintiff alleges these
alternative designs would have prevented or significantly reduced the risk of Plaintiff’s injuries.
(Id. ¶ 107.) Plaintiff alleges that “[t]he likelihood that the Lynx pelvic mesh product’s design would
cause [Plaintiff’s] damage and the gravity of that harm outweighed the burden on Defendant of
adopting such an alternative design[.]” (Id.)
The Court concludes that Plaintiff’s allegations are more than sufficient to meet the
pleading requirements at this stage. Flagg, 647 F. App'x at 318; Guidry v. Janssen Pharms., Inc.,
206 F. Supp. 3d 1187, 1198 (E.D. La. 2016) (although the plaintiff did “not offer a specific
alternative design that would have prevented her injury,” the court found that “whether the plaintiff
can demonstrate an alternative design that satisfies the test under the LPLA is a question of fact to
be assessed upon discovery.”); Kaylor v. Eisai Inc., No. CV 21-58, 2022 WL 983657, at *4 (W.D.
La. Mar. 30, 2022) (finding that “the Amended Petition adequately [pled] that the dangers the
original product posed to consumers like Mrs. Kaylor outweighed the burden of switching to the
proposed alternative design.”); Donald v. AstraZeneca Pharms., LP, No. CV 16-17753, 2017 WL
1079186, at *3 (E.D. La. Mar. 22, 2017) (finding that while “the complaint does not address
whether the danger outweighed the burden on the manufacturer of adopting an alternative design
. . . such an omission is not so fatal as to give rise to dismissal under 12(b)(6) at this stage in the
litigation.”).
Defendant’s claim that Plaintiff’s alternative design must be tied to the specific features of
its product is without merit.
“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.” Baudin v. AstraZeneca Pharm. LP, 413 F. Supp. 3d 498,
506 (M.D. La. 2019) (citing Boutte v. Stryker Biotech, LLC, 67 F. Supp. 3d 732,
736–37 (M.D. La. 2014); Crochet v. Bristol-Myers Squibb, No. 16-36, 2016 WL
3580670, *3 (M.D. La. June 28, 2016); and Brooks v. Amgen, Inc., No. 18-657,
2019 WL 507491, *5 (M.D. La. Feb. 8, 2019)). This Court has also found that the
requirement that a plaintiff plead that the gravity of harm outweighs the burden to
the manufacturer of adopting the suggested alternative design is satisfied by
allegations that the design of other existing comparable products does not contain
the risks associated with the defendant's product. Id. at 507 (finding that “[t]he
Complaint sufficiently alleges that the risk of gastric cancer outweighs the burden
of utilizing alternative H2 receptor antagonist pharmaceuticals in lieu of PPI's.”).
Batiste v. Stryker Corp., 2021 WL 1171880, at *6.
V. CONCLUSION
In conclusion, the Court finds that Defendant Boston Scientific Corporation’s Motion to
Dismiss Plaintiff’s Complaint (Doc. 7) should be and is hereby GRANTED as to Plaintiff’s claim
for punitive damages and attorney fees. In all other respects, the Motion is DENIED.
Signed in Baton Rouge, Louisiana, on September 29, 2022.
S
JUDGE JOHN W. deGRAVELLES
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA