Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc. et al
Filing
13
OPINION AND ORDER granting in part and denying in part 4 Motion to Dismiss. Plintiff is granted leave to file an amended complaint within 20 days. Failure to comply will result in dismissal of this action. (Signed by Judge Melinda Harmon) Parties notified.(htippen, )
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
SIRIA GONZALEZ
Plaintiff,
VS.
BAYER HEALTHCARE
PHARMACEUTICALS, INC. and
PLANNED PARENTHOOD OF HOUSTON
AND SOUTHEAST TEXAS,
Defendants.
§
§
§
§
§
§
§
§
§
§
§
§
CIVIL ACTION H-12-1412
OPINION AND ORDER
Pending before the Court in the above referenced
products
liability case, removed from state court and alleging strict
products liability, breach of express warranty, breach of implied
warranty, gross negligence, and negligence relating to Defendant
Bayer Healthcare Pharmaceuticals, Inc.’s (“Bayer’s”) contraceptive
drug-releasing
intrauterine
system
Mirena®
(“Mirena”)
and
intrauterine contraceptive device (“IUD”), is Bayer’s motion to
dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6)
(instrument #4).
Bayer removed this case on diversity jurisdiction, arguing
that Defendant Planned Parenthood of Houston and Southeast Texas
(“Planned Parenthood”) was fraudulently joined and never served.
Plaintiff Siria Gonzalez did not challenge that contention and
filed an amended complaint (#6) omitting Planned Parenthood as a
-1-
party defendant,1 thus mooting portions of the motion to dismiss
directed toward Planned Parenthood.
The Court therefore addresses
the remainder of the motion to dismiss as it pertains to the
amended pleading and Plaintiff’s claims against Bayer.
Standard of Review
Federal Rule of Civil Procedure 8(a)(2) provides, “A pleading
that states a claim for relief must contain . . . a short and plain
statement of the claim showing that the pleader is entitled to
relief.”
pursuant
When a district court reviews a motion to dismiss
to
Fed.
R.
Civ.
P.
12(b)(6),
it
must
construe
the
complaint in favor of the plaintiff and take all well-pleaded facts
as true. Randall D. Wolcott, MD, PA v. Sebelius, 635 F.3d 757, 763
(5th Cir. 2011), citing Gonzalez v. Kay, 577 F.3d 600, 603 (5th Cir.
2009).
“While a complaint attacked by a Rule 12(b)(6) motion to
dismiss does not need detailed factual allegations, . . . a
plaintiff’s
obligation
‘entitle[ment]
to
to
relief’
provide
the
‘grounds’
requires
more
than
of
his
labels
and
conclusions, and a formulaic recitation of the elements of a cause
of action will not do . . . .”
S.
Ct.
1955,
1964-65
Bell Atlantic Corp. v. Twombly, 127
(2007)(citations
1
omitted).
“Factual
Under the newly amended Federal Rule of Civil Procedure
15(a)(1)(B), a plaintiff may amend its original pleading as a
matter of course inter alia within 21 days after service of a
motion under Rule 12(b).
-2-
allegations must be enough to raise a right to relief above the
speculative level.”
Federal
Practice
Id. at 1965, citing 5 C. Wright & A. Miller,
and
Procedure
§
1216,
pp.
235-236
(3d
ed.
2004)(“[T]he pleading must contain something more . . . than . . .
a statement of facts that merely creates a suspicion [of] a legally
cognizable right of action”).
“Twombly jettisoned the minimum
notice pleading requirement of Conley v. Gibson, 355 U.S. 41 . . .
(1957)[“a complaint should not be dismissed for failure to state a
claim unless it appears beyond doubt that the plaintiff can prove
no set of facts in support of his claim which would entitle him to
relief”], and instead required that a complaint allege enough facts
to state a claim that is plausible on its face.”
St. Germain v.
Howard,556 F.3d 261, 263 n.2 (5th Cir. 2009), citing In re Katrina
Canal Breaches Litig., 495 F.3d 191, 205 (5th Cir. 2007)(“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.’”),
citing Twombly, 127 S. Ct. at 1974).
“‘A claim has facial
plausibility when the pleaded factual content allows the court to
draw the reasonable inference that the defendant is liable for the
misconduct alleged.’”
Montoya v. FedEx Ground Package System,
Inc., 614 F.3d 145, 148 (5th Cir. 2010), quoting Ashcroft v. Iqbal,
129 S. Ct. 1937, 1940 (2009).
Dismissal is appropriate when the
plaintiff fails to allege “‘enough facts to state a claim to relief
that is plausible on its face’” and therefore fails to “‘raise a
-3-
right to relief above the speculative level.’”
Montoya, 614 F.3d
at 148, quoting Twombly, 550 U.S. at 555, 570.
The plausibility
standard is not akin to a “probability requirement,” but asks for
more than a “possibility that a defendant has acted unlawfully.”
Twombly, 550 U.S. at 556.
“[T]hreadbare recitals of the elements
of a cause of action, supported by mere conclusory statements do
not suffice” under Rule 12(b).
plaintiff
must
plead
Iqbal, 129 S. Ct. at 1949.
specific
allegations, to avoid dismissal.
facts,
not
merely
The
conclusory
Collins v. Morgan Stanley Dean
Witter, 224 F.3d 496, 498 (5th Cir. 2000).
On a Rule 12(b)(6) review, although generally the court may
not look beyond the pleadings, the Court may examine the complaint,
documents attached to the complaint, and documents attached to the
motion to dismiss to which the complaint refers and which are
central to the plaintiff’s claim(s), as well as matters of public
record.
Lone Star Fund V (U.S.), L.P. v. Barclays Bank PLC, 594
F.3d 383, 387 (5th Cir. 2010), citing Collins, 224 F.3d at 498-99;
Cinel v. Connick, 15 F.3d 1338, 1341, 1343 n.6 (5th Cir. 1994). See
also United States ex rel. Willard v. Humana Health Plan of Tex.,
Inc., 336 F.3d 375, 379 (5th Cir. 2003)(“the court may consider .
. . matters of which judicial notice may be taken”).
Taking
judicial notice of public records directly relevant to the issue in
dispute is proper on a Rule 12(b)(6) review and does not transform
the motion into one for summary judgment.
-4-
Funk v. Stryker Corp.,
631 F.3d 777, 780 (5th Cir. 2011).
“A judicially noticed fact must
be one not subject to reasonable dispute in that it is either (1)
generally known within the territorial jurisdiction of the trial
court or (2) capable of accurate and ready determination by resort
to sources whose accuracy cannot reasonably be questioned.”
R. Evid. 201(b).
Fed.
Here Bayer has submitted a copy of the United
States Food and Drug Administration’s (“FDA’s”) approval letter for
the prescription drug Mirena (#4-1, Ex. A), which is a public
record of which the Court may take judicial notice.
See, e.g.,
U.S. ex rel. Bennett v. Medtronic, Inc., 747 F. Supp. 2d 745, 75556 & n.9 (S.D. Tex. 2010).
“Dismissal is proper if the complaint lacks an allegation
regarding a required element necessary to obtain relief . . . .“
Rios v. City of Del Rio, Texas, 444 F.3d 417, 421 (5th Cir. 2006),
cert. denied, 549 U.S. 825 (2006).
Dismissal under Federal Rule
of Civil Procedure 12(b)(6) is “appropriate when a defendant
attacks
the
complaint
because
it
fails
to
state
a
legally
cognizable claim.” Ramming v. United States, 281 F.3d 158, 161 (5th
Cir. 2001), cert. denied sub nom. Cloud v. United States, 536 U.S.
960 (2002), cited for that proposition in Baisden v. I’m Ready
Productions, No. Civ. A. H-08-0451, 2008 WL 2118170, *2 (S.D. Tex.
May 16, 2008).
See also ASARCO LLC v. Americas Min. Corp., 382
B.R. 49, 57 (S.D. Tex. 2007)(“Dismissal “‘can be based either on a
lack of a cognizable legal theory or the absence of sufficient
-5-
facts
alleged
under
a
cognizable
legal
theory.’”
[citation
omitted]), reconsidered in other part, 396 B.R. 278 (S.D. Tex.
2008).
When a plaintiff’s complaint fails to state a claim, the court
should generally give the plaintiff at least one chance to amend
the complaint under Rule 15(a) before dismissing the action with
prejudice.
Great Plains Trust Co v. Morgan Stanley Dean Witter &
Co., 313 F.3d 305, 329 (5th Cir. 2002)(“District courts often afford
plaintiffs at least one opportunity to cure pleading deficiencies
before dismissing a case, unless it is clear that the defects are
incurable
or
the
unwilling
or
unable
to
The
court
dismissal.”).
plaintiffs
advise
amend
in
should
the
a
deny
court
manner
leave
that
that
to
they
will
amend
are
avoid
if
it
determines that “the proposed change clearly is frivolous or
advances a claim or defense that is legally insufficient on its
face . . . .”
6 Charles A. Wright, Arthur R. Miller & Mary Kay
Kane, Federal Practice and Proc. § 1487 (2d ed. 1990).
Relevant Substantive Law
As a general rule under Texas law, the manufacturer of a
product must instruct consumers regarding safe use of the product
and warn them of dangers or potential harm in its use of which the
manufacturer has actual or constructive knowledge at the time the
product is sold.
Centocor, Inc. v. Hamilton, 372 S.W. 3d 140, 153-
54 (Tex. 2012), citing Bristol Myers Co. v. Gonzales, 561 S.W. 2d
-6-
801, 804 (Tex. 1978); Pavlides v. Galveston Yacht Basin, Inc., 727
F.2d 330, 338 (5th Cir. 1984).
With certain products however,
including prescription drugs, “the manufacturer’s or supplier’s
duty to warn end users of the dangerous propensities of its product
is limited to providing an adequate warning to an intermediary, who
then assumes the duty to pass the necessary warnings on to end
users.”
Centocor, 372 S.W. 3d at 154.
is
prescription
that
drugs
are
“[T]he underlying premise
complex
and
vary
in
effect,
depending on the unique circumstances of an individual user, and
for
this
reason,
patients
can
obtain
them
only
through
a
prescribing physician.” Id., citing Reyes v. Wyeth Labs., 498 F.2d
1264, 1276 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974). The
Texas Supreme Court further explained,
Prescription drugs are likely to be complex medicines,
esoteric in formula and varied in effect. As a medical
expert, the prescribing physician can take into account
the propensities of the drug, as well as the
susceptibilities of his patient.
His is the task of
weighing the benefits of any medication against its
potential dangers. The choice he makes is an informed
one, an individualized medical judgment bottomed on a
knowledge of both patient and palliative. Pharmaceutical
companies then, who must warn ultimate purchasers of
dangers inherent in patent drugs sold over the counter,
in selling prescription drugs are required to warn only
the prescribing physician, who acts as a ”learned
intermediary” between the manufacturer and consumer.
Id. at 159.
Texas
courts
apply
the
learned
intermediary
prescription drug products-liability cases.
doctrine
in
Id. at 155, citing
Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W. 3d 87, 91 (Tex. App.--7-
Texarkana 2000, no pet.)(“In prescription drug cases, the courts
found that it is reasonable for the manufacturer to rely on the
health care provider to pass on its warnings.
This is reasonable
because the learned intermediary understands the propensities and
dangers involved in the use of a given drug, and as the prescriber,
he stands between this drug and the ultimate consumer.”).
In
Centocor, joining the overwhelming majority of courts that have
considered the issue, the Texas Supreme Court adopted the doctrine
in the prescription drug context within the physician-patient
relationship
and
“squarely”
held
“that
a
prescription
drug
manufacturer fulfills its duty to warn end users of its product’s
risks by providing adequate warnings to the intermediaries who
prescribe the drug, and, once fulfilled, it had no further duty to
warn the end users directly. . . . But, as we have previously
indicated,
when
inadequate
or
the
warning
misleading,
to
the
the
prescribing
prescription
drug
physician
is
manufacturer
remains liable for the injuries sustained by the patient.”
Id. at
157-58, 159, citing Humble Sand & Gravel, Inc, v. Gomez, 146 S.W.
3d 170, 185-96 (Tex. 2004); Alm v. Aluminum Co. of America, 717
S.W. 2d 588, 590-92 (Tex. 1986); and Gravis v. Parke-Davis & Co.,
502 S.W. 2d 863, 870 (Tex. App.--Corpus Christi 1973, writ ref’d
n.r.e.).
In a pre-Centocor case, In re Norplant Contraceptive Products
Litigation, 165 F.3d 374 (5th Cir. 1999)(“Norplant II”), affirming,
-8-
955 F. Supp. 700 (E.D. Tex. 1997)(“Norplant I”), based on an “Erie
guess”2 that the Texas Supreme Court would apply the learned
intermediary doctrine to the prescriptive contraceptive Norplant,
affirmed summary judgment for the drug manufacturer in a case
brought by plaintiffs who claimed they were injured by it because
“even though physicians may seek to provide greater freedom to
their patients in selecting an appropriate form of contraception,”
it is nevertheless a prescription drug and “physicians play a
significant role in prescribing Norplant and in educating their
patients about the benefits and disadvantages to using it.” Id. at
379.
The Texas Supreme Court in Centocor also held that “within the
prescriptive drug context, the learned intermediary doctrine is
more akin to a common-law rule rather than an affirmative defense.”
Centocor, 372 S.W. 3d at 164.
defendant--usually a
It is used to identify “to whom a
prescription drug manufacturer--owes a duty
to warn”; it is not used to show that Plaintiff has no valid claim.
Id.
Thus it is not a defense that must be pleaded and proven by
the drug manufacturer.
While
the
learned
intermediary
doctrine
shifts
the
manufacturer’s duty to warn from end user to intermediary, the
2
Erie v. Tompkins, 304 U.S. 64, 78 (1938)(where the state’s
highest court has not ruled on an issue under state law, the
federal court must make an “Erie guess” and determine as best as it
can what that highest court would most likely decide).
-9-
plaintiff’s burden of proof remains the same, i.e., to prove the
product’s warning was inadequate.
Centocor, 372 S.W. 3d at 166.
Even if the plaintiff shows that the warning was inadequate,
the plaintiff must also show that the inadequate warning was the
producing cause of the plaintiff’s injuries.
Id. at 170.
While
usually the jury determines the factual issue of the adequacy of a
warning,3 “when the prescribing physician is aware of the product’s
risks and decides to use it anyway, any inadequacy of the product’s
warning, as a matter of law, is not the producing cause of the
patient’s injuries.”
at
780
(“[W]here
Id., citing inter alia Ebel, 536 F. Supp. 2d
the
physicians
were
unequivocal
that
new
information about the risks would not have changed their decision
to prescribe the medication, an inadequate warning was not the
proximate cause of plaintiff’s injury” and “where a physician
testifies that he was aware of the risks of which plaintiff
complains, it is then the plaintiff’s burden to prove that a
different warning would have changed the physician’s decision to
prescribe the medication.”), and McNeil v. Wyeth, 462 F.3d 364, 373
(5th Cir. 2006)(“Where the physician would have adequately informed
3
Although adequacy of the warning usually is a jury
question in prescription drug cases where the learned intermediary
doctrine applies, when “‘a warning specifically mentions the
circumstances complained of, the warning is adequate as a matter of
law.’” McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006), quoting
Rolen v. Burroughs Wellcome Co., 856 S.W. 2d 607, 609 (Tex. App.Waco, 1993, writ denied). Plaintiff’s complaint here is that there
was no mention of Lupus or autoimmune reactions to the Mirena IUD.
-10-
a
plaintiff
of
the
risks
of
a
disease,
had
the
label
been
sufficient, but fails to do so on that account, and where the
plaintiff would have rejected the drug if informed, the inadequate
labeling could be a ‘producing’ cause of the injury, because it
effectively sabotages the function of the intermediary.”).
See
also Ackermann v. Wyeth Pharms., 526 F.3d 203, 208 (5th Cir.
2008)(where the physician was aware of possible risks in using the
prescriptive medication but decided to use it anyway, the plaintiff
cannot show the inadequacy of the warning was a producing cause; if
the physician was not aware of a risk, 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 prescribed the medication).
Finally, the Texas Supreme Court observes that in Norplant I,
955 F. Supp. at 709-10, plaintiffs brought claims for strict
products liability, negligence, breach of implied warranty of
merchantability, misrepresentation, and consumer fraud under the
Texas DTPA.
The Court dismissed these claims on the grounds that
in actuality they were based on the manufacturer’s failure to warn
or disclose the drug’s side effects and therefore the learned
intermediary doctrine applies. Centocor, 372 S.W. 3d at 168. “‘If
the doctrine could be avoided by casting what is essentially a
failure to warn claim under a different cause of action such a
violation of the DTPA or a claim for misrepresentation, then the
-11-
doctrine would be rendered meaningless.’”
Id., citing Norplant I
at 709, and Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767, 773 (5th
Cir. 2009)(“Where the crux of the suit is based on a failure to
adequately warn, the learned intermediary doctrine may apply to
strict liability, negligence, misrepresentation, and breach of
warranty claims.”), aff’d, 321 Fed. Appx. 350 (5th Cir. 2009).
The
Texas Supreme Court agreed and held that “when a patient alleges a
fraud-by-omission claim against a prescription drug manufacturer
for alleged omissions about a prescription drug’s potential side
effects, (1) the patient cannot plead around the basic requirements
of a failure-to-warn claim, and (2) the learned intermediary
doctrine applies.”
Centocor, 372 S.W. 3d at 169.
It ruled that
the learned intermediary doctrine applies to all of the claims of
the plaintiff before it.
Id.4
In the Texas Civil Practice and Remedies Code, “Texas law
groups
all
[negligence,
inadequate
strict
warning
liability,
causes
breach
of
of
action
implied
together
warranty
of
merchantability] regardless of how they are pleaded” and requires
“some form of fraud on the FDA.”
Del Valle v. Qualitest Pharms.,
Inc., No. B-11-113, 2012 WL 2899406, *2 (S.D. Tex. June 22, 2012),
appeal dismissed in part. No. 12-41148 (5th Cir. Feb. 5, 2012).
4
The Texas Supreme Court stated that it “need not decide
whether the learned intermediary doctrine applies against a
prescription drug manufacturer in a common-law fraud or
misrepresentation claim based on an overt misrepresentation . . .
.” Id. at 169 n.30.
-12-
Texas Civil Practices and Remedies Code § 82.001(2) defines a
“products liability action” as “any action against a manufacturer
or seller for recovery of damages arising out of personal injury,
death, or property damage allegedly caused by a defective product
whether the action is based on strict tort liability, strict
products
liability,
negligence,
misrepresentation,
breach
of
express or implied warranty, or any other theory or combination of
theories.”
Texas Civil Practices and Remedies Code § 82.007(a),
which became effective on September 1, 2003, eliminated common law
causes of action5 and established a presumption of nonliability to
shield the drug manufacturer:
(a) In a products liability action alleging that an
injury was caused by a failure to provide adequate
warnings or information with regard to a pharmaceutical
product, there is a rebuttable presumption that the
defendant or defendants, including a health care
provider, manufacturer, distributor, and prescriber, are
not liable with respect to the allegations involving
failure to provide adequate warnings or information if:
(1)
the
warnings
or
information
that
accompanied the product in its distribution
were those approved by the United States Food
and Drug Administration for a product approved
under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. Section 301 et seq.), as amended,
or Section 351, Public Health Service Act (42
U.S.C. Section 262), as amended, or
(2) the warnings provided were those stated in
monographs developed by the United States Food
and Drug Administration for pharmaceutical
products that may be distributed without an
approved new drug application.
5
Del Valle v. Qualitest, 2012 WL 2899406, at *2.
-13-
Section 82.007(b) specified the ways in which a claimant could
rebut the presumption:
(b) The claimant may rebut the presumption in Subsection
(a) as to each defendant by establishing that:
(1) the defendant, before or after pre-market
approval or licensing of the product, withheld
from or misrepresented to the United States
Food
and
Drug
Administration
required
information that was material and relevant to
the performance of the product and was
causally related to the claimant’s injury;
(2) the pharmaceutical product was sold or
prescribed in the United States by the
defendant after the effective date of an order
of
the
United
States
Food
and
Drug
Administration to remove the product from the
market or to withdraw its approval of the
product;
(3) (A) the defendant recommended promoted,
or advertised the pharmaceutical product for
an indication not approved by the United
States Food and Drug Administration;
(B) the product was used as recommended,
promoted, or advertised; and
(C) the claimant’s injury was causally
related to the recommended, promoted, or
advertised use of the product;
(4) (A)
the
defendant
prescribed
the
pharmaceutical product for an indication not
approved by the United States Food and Drug
Administration;
(B) the product was used as prescribed; and
(C) the claimant’s injury was
causally related to the prescribed
use of the product; or
(5) the defendant, before or after pre-market
approval or licensing of the product, engaged
-14-
in conduct that would constitute a violation
of 18 U.S.C. § 201 and that conduct caused the
warnings or instructions approved for the
product by the United States Food and Drug
Administration to be inadequate.
Plaintiff relies on § 82.007(b)(1).
Recently in Lofton v.
McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 374 (5th
Cir. 2012), the Fifth Circuit held that unless the FDA itself finds
fraud, federal law preempts § 82.007(b)(1) requiring parties in
failure-to-warn cases to allege that the manufacturer withheld or
misrepresented material information to the FDA in order to rebut
the
presumption
that
the
drug
manufacturer
was
not
liable.
“[W]here the FDA has not found fraud, the threat of imposing state
liability on [a] drug manufacturer for defrauding the FDA intrudes
on the competency of the FDA and its relationship with regulated
entities.
Id. at 380.
The FDA is responsible for policing fraud
and “has the authority to investigate fraud, 21 U.S.C. § 372,
consider citizen petitions, 21 C.F.R. § 10.30, and seek criminal
and civil penalties particular to fraud-on-the-FDA, 21 U.S.C. §
332-32.”
672 F.3d at 376 n.2.
Furthermore § 82.007(b)(1)’s term
“required information” refers to federal requirements under the
[Federal Drug and Cosmetic Act (“FDCA”)] and what is “material” and
“relevant” must be decided by the FDA, not state court juries.
at 379.
Id.
Thus the state law claim would conflict with the FDA’s
authority to punish fraud on the agency, so it is preempted by the
-15-
Id. at 376.6
FDCA.
Therefore if a plaintiff in a failure to warn case fails to
allege that the FDA found fraud on the part of Bayer, he cannot
rebut the § 82.007 presumption of nonliability and the plaintiff’s
failure to warn claim must be dismissed.
Lofton, 672 F.3d at 380.
Allegations in
Plaintiff’s Amended Pleadings/Original Complaint (#6)
Plaintiff alleges that Bayer is in the business of designing
and manufacturing its IUD and designing, manufacturing, selling,
and distributing the drug Mirena to clinics throughout the United
States, including Texas.
Plaintiff was a patient at the Planned Parenthood clinic of
Houston
and
Southeast
Texas
on
May
19,
2009,
where
she
was
prescribed the Mirena IUD system, which was implanted in her.
During the next several months Plaintiff suffered from rashes, hair
loss,
rapid
weight
chronic pain.
Later
that
loss,
weakness,
muscle
deterioration,
and
The Mirena IUD was removed on December 3, 2009.
month
Plaintiff
was
hospitalized
and
subsequently
diagnosed with Systematic Lupus Erythematosus (“Lupus”), which she
contends was caused by the Mirena IUD device.
Plaintiff’s first cause of action is for defective design of
the IUD by Bayer that caused it to be unreasonably dangerous to
6
The Fifth Circuit recognized there is a split in the
Circuits addressing similar provisions in other states. Id. at
377. This Court is bound by the Fifth Circuit’s ruling in Lofton.
-16-
Plaintiff and other persons similarly situated.
She claims that
Bayer failed to adequately test the drug for causing the onset of
autoimmune disorders, including Lupus, before submitting it to the
FDA for approval and before selling and distributing it to the
general public.
She asserts that Bayer failed to conduct a
sufficiently large clinical trial test for this rare disorder
and/or to adequately and completely report the clinical trial data
regarding the drug’s risks.
Alternatively, she argues that Bayer
suppressed and diluted evidence in clinical trials of serious
autoimmune reactions, including Lupus.
Second, in a cause of action titled “marketing defect,”
Plaintiff asserts that the IUD was defective and unreasonably
dangerous because it was marketed without a warning or no adequate
warning
of
disorders.
the
risk
of
side
effects,
including
autoimmune
There was also inadequate instruction about what to do
in the event of serious side effects, including whether removal of
the IUD would alleviate or improve the side effects.
These
marketing defects were the producing cause of Plaintiff’s injuries
and of the delay of treatment for them.
Plaintiff’s third cause of action is for breach of express
warranty. Bayer made express warranties about the IUD’s utility in
preventing pregnancy without making clear the extreme dangers
associated with a toxic reaction to the drug, which was not of the
quality or condition expressly warranted by Bayer, but inherently
-17-
dangerous.
She insists that the drug cannot be used in the manner
intended without serious risk of physical injury to the user.
Plaintiff claims there was no warning about Lupus or other allergic
reactions linked with any other autoimmune disorder even though
Bayer knew, or should have known, about the substantial number of
Lupus cases linked to the use of the Mirena IUD.
The lack of
warning was allegedly a producing cause of Plaintiff’s permanent
injuries.
In addition Plaintiff asserts that Bayer breached an implied
warranty that the IUD was of merchantable quality and was safe and
fit for its intended purpose when used under ordinary circumstances
and in an ordinary and/or foreseeable manner.
She claims that
Bayer knew or had reason to know of the purposes and use for which
Plaintiff
sought
the
IUD
and
that
Plaintiff
was
relying
on
Defendant’s skill and judgment to select and furnish a suitable
IUD.
Plaintiff maintains that the Mirena IUD was not fit for its
intended purpose and use.
Plaintiff’s claim for negligence and/or gross negligence
asserts that Bayer had a duty to use reasonable care in labeling,
packaging,
selling,
distributing Mirena.
advertising,
warning,
and
otherwise
She charges that “even though (1) the
defendant knew there was a causal relationship between the IUD and
Lupus, and that it could result in a serious or life threatening
and
debilitation
reaction;
(2)
-18-
defendant
knew
that
medical
literature had shown a connection between autoimmune disorders and
Mirena defendants deliberately placed the drug on the market
without warning the user or consumer that the insertion of the
Mirena IUD would result in Lupus, or the onset of other severe
autoimmune disorders.”
Bayer also “failed to warn plaintiff and
plaintiff’s physician to remove the IUD immediately and seek
medical attention if the symptoms of Lupus developed.”
actions
or
omissions,
individually
or
together,
These
constituted
negligence or gross negligence and were a proximate cause of
Plaintiff’s injuries. Bayer also failed to report or file with the
FDA literature showing the risks of Lupus associated with the
allergic reactions to Mirena.
Bayer’s Motion to Dismiss (#4)
Bayer contends that Plaintiff’s petition is merely a formulaic
recitation of the elements of her causes of action, bare labels,
and conclusions devoid of factual support, and it must therefore be
dismissed under Rules 8 and 12(b)(6).
Plaintiff
acknowledges
that
Mirena
is
an
FDA
approved
prescription contraceptive, a prescription drug and not a medical
device.
Ex. A, FDA Approval Letter dated December 6, 2000.
Bayer
contends
that
Plaintiff
fails
to
state
a
strict
liability claim. Texas has adopted Section 402A of the Restatement
(Second) of Torts, which requires a plaintiff claiming strict
liability to allege (1) a product defect; (2) that existed at the
-19-
time the product left the manufacturer’s hands; (3) that the
product was unreasonably dangerous; and (4) that it was a producing
cause of the plaintiff’s injuries.
Parsons v. Ford Motor Co., 85
S.W. 3d 323, 329 (Tex. App.--Austin 2002)(citation omitted).
prescription
drug
product
that
is
“properly
prepared[]
A
and
accompanied by proper directions and warnings[] is not defective,
nor is it unreasonably dangerous.”
Hackett v. G.D. Searle & Co.,
246 F. Supp. 2d 591, 595 (W.D. Tex. 2002)(quoting Restatement
(Second) Torts
§ 402A cmt. K (1965).
Plaintiff’s formulaic
recitation of the elements of strict liability claim (that Bayer
placed “into the stream of commerce an unreasonably dangerous
product,” which “was unsafe by reason of the defects in the design,
manufacture, testing, labeling, packaging and marketing,” and which
“directly and proximately caused harm”) is insufficient to state a
claim under Rule 12(b)(6). She does not identify the nature of the
defect, indicate how it made Mirena unreasonably dangerous, nor
explain how Mirena caused her alleged injuries.
Thus the claim
should be dismissed.
Furthermore, contends Bayer, Plaintiff fails to state a claim
under the learned intermediary doctrine.
Plaintiff alleges that
she obtained the prescription drug Mirena through her healthcare
provider.
Therefore the learned intermediary doctrine applies to
all her claims, including any possible failure-to-warn claims
asserted under the doctrine of strict liability. Any duty of Bayer
-20-
to warn ran to Plaintiff’s healthcare provider, Planned Parenthood,
not to Plaintiff.
See Ebel v. Eli Lilly and Co., 536 F. Supp. 2d
767, 772-73 (S.D. Tex. 2008)(“Where the crux of the suit is based
on a failure to adequately warn, the learned intermediary doctrine
may apply to strict liability, negligence, misrepresentation and
breach of warranty claims.”), aff’d, 321 Fed. Appx. 350 (5th Cir.
Mar. 30, 2009)(applying learned intermediary doctrine to strict
liability
and
breach
of
warranty
claims);
In
re
Norplant
Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 709 (E.D. Tex.
1997)(“If
the
doctrine
could
be
avoided
by
casting
what
is
essentially a failure to warn claim under a different cause of
action . . . then the doctrine would be rendered meaningless.”),
aff’d, 165 F.3d 374 (5th Cir. 1999).
Because Plaintiff does not
allege that the warning to her healthcare provider was inadequate
nor identify the warnings or materials which her doctor received or
reviewed, much less demonstrate that the doctor would not have
prescribed Mirena if the warning had been different, and does not
allege facts necessary to show causation, she fails to satisfy
Twombley and Iqbal as a matter of law.
See Pustejovsky v. Pliva,
623 F.3d 271, 276 (5th Cir. 2010)(“The learned intermediary doctrine
. . . requires that the inadequate warning was a ‘producing cause’
of the plaintiff’s injuries. . . . [P]laintiff . . . must also show
that the alleged inadequacy caused her doctor to prescribe the drug
for her.”)(citation and internal quotation marks omitted); Ebel,
-21-
536 F. Supp. 2d at 777 (holding that a plaintiff claiming failure
to warn through improper marketing practices must show that the
marketing “reached and [a]ffected the prescribing physician”).
Plaintiff’s breach of warranty claims are also subject to the
learned intermediary doctrine claims.
She fails to state a
plausible claim because she does not allege what warranties were
made to her prescribing physician nor state how they were breached,
leaving
only
accusation.”
“an
unadorned,
the-defendant-unlawfully-harmed-me
Iqbal, 129 S. Ct. at 1949.
In addition because Plaintiff failed to plead negligence, as
a matter of law she cannot bring a claim for gross negligence
against Bayer.
Trevino v. Lightning Laydown, Inc., 782 S.W. 2d
946, 949 (Tex. App.--Austin 1990, writ denied)(although gross
negligence
refers
to
a
different
character
of
conduct
than
negligence, “one’s conduct cannot be grossly negligent without
being negligent.”).
Bayer is also immune from liability because the FDA approved
the Mirena warnings.
section
82.007(a)
Texas Civil Practice and Remedies Code
creates
a
rebuttable
presumption
that
pharmaceutical manufacturers are not liable as a matter of law for
an alleged failure to warn if the FDA has approved the warnings.
The Mirena label was approved by the FDA.
Ex. A; 21 U.S.C. A. §
355(b)(1)(F) (West 2012); 21 U.S.C. A. § 355(d).
entitled to this presumption of no liability.
-22-
Thus Bayer is
Plaintiffs have not
alleged any facts that would rebut that presumption.
In sum, because Plaintiff fails to state a cognizable legal
theory against Bayer, Plaintiff’s claims should be dismissed.
Plaintiff’s Response (#10)
Plaintiff claims that Defendant bears the burden of showing
that it properly informed any physicians prescribing its medication
of the risks associated with it.
of
any
risks
associated
Here Bayer claims it did not know
with
Mirena
that
were
related
to
Plaintiff’s injuries and tries to improperly shift the burden to
the Plaintiff to plead a failure to warn case.
Furthermore,
Plaintiff has alleged defective design, manufacture, and marketing
of an inherently dangerous product and argues that the learned
intermediary doctrine should not apply because it would allow
Defendant to avoid liability that does not involve a failure to
warn.
As for the rebuttable presumption created by FDA’s approval of
Mirena’s label, Plaintiff claims she has rebutted it by alleging
that Bayer failed to report or file literature with the FDA about
the risks of Lupus associated with the allergic reactions caused by
Mirena.
Bayer’s Reply (#11)
Because, according to Bayer, pleadings are now closed and
because Plaintiff’s amended complaint still fails to satisfy Rules
8 and 12, Bayer requests the Court to convert its motion to one
-23-
under Rule 12(c)7 and dismiss it with prejudice.
Plaintiff did not
respond to this request.
Bayer asserts that it is clear from the amended complaint that
Plaintiff’s
claims
for
design
defect,8
express
warranty,
negligence, and gross negligence9 are premised on Bayer’s failure
to warn that the use of Mirena could result in the development of
Lupus.
Centecor, Inc. v. Hamilton, 372 S.W. 3d 140, 169 (Tex.
2012)(holding that Plaintiff’s claims “collapse” into a single
failure-to-warn theory).
Under Texas law all causes of action based on a claim of
inadequate warnings or information, regardless of how they are
characterized, are grouped together as inadequate warning cases and
7
A motion for judgment on the pleadings under Federal Rule of
Civil Procedure 12(c) is “designed to dispose of cases where the
material facts are not in dispute and a judgment on the merits can
be rendered by looking to the substance of the pleadings and any
judicially noticed facts.”
Herbert Abstract Co. v. Touchstone
Props., Ltd., 914 F.2d 74, 76 (5th Cir. 1990), citing 5A Charles A.
Wright & Arthur R. Miller, Federal Practice and Procedure § 1367,
at 509-10 (1990).
8
Bayer claims Plaintiff’s defective design claim is based on
Bayer’s alleged failure to “adequately test the drug for causing
the onset of autoimmune disorders . . . and/or [its] fail[ure] to
adequately and completely report clinical trails data regarding the
drug’s risk.” Amended Complaint ¶ 11.
See Am. Tobacco Co. v.
Grinnell, 951 S.W. 2d 420, 437 (Tex. 1997)(rejecting a negligent
testing claim that was predicated on a duty to discover a product’s
inherent dangers because that claim was “inextricably intertwined”
with the plaintiff’s unsuccessful failure-to-warn claim).
9
Bayer points out Plaintiff erroneously styled her negligence
and gross negligence claim as a breach of an implied warranty
claim, but that the body of the claim shows she is alleging
negligence and gross negligence. Amended Complaint ¶¶ 18-21.
-24-
are governed by § 82.007 of the Texas Civil Practice and Remedies
Code.
Del Valle v. Qualitest Pharms., Inc., No. B-11-113, 2012 WL
2899406, *2 (S.D. Tex. June 22, 2012), appeal dismissed in part.
No. 12-41148 (5th Cir. Feb. 5, 2012).
Section 82.007(a) of the
Texas Civil Practices and Remedies Code Annotated entitles a
pharmaceutical manufacturer to a rebuttable presumption that it is
not liable for failure to warn if the FDA approved the “warnings
and information” that accompanied the product.
That presumption
can only be overcome if the plaintiff pleads and proves one of the
following: (1) Defendant committed fraud on the FDA; (2) Defendant
sold the product after the FDA ordered it removed from the market;
(3) Defendant promoted the product for an unapproved use and the
injury was caused by that use; or (4) Defendant bribed an FDA
official, causing the FDA approved warnings to be inadequate.
Bayer reiterates Plaintiff has failed to allege any facts to
overcome the presumption of non-liability.
Recently the Fifth Circuit held that the fraud-on-the-FDA
provision of the Texas statute is preempted by the Federal Food,
Drug, and Cosmetic Act unless the plaintiff can show that “the FDA
itself has found fraud.”
Lofton v. McNeill Consumer & Specialty
Pharms., 672 F.3d 372, 380 (5th Cir. 2012)(where “the FDA has not
found fraud, the threat of imposing state liability on a drug
manufacturer for defrauding the FDA intrudes on the competency of
the FDA . . . [and is] a violation of the Supremacy Clause”).
-25-
Plaintiff has not alleged that the FDA has found fraud, nor can
she, and thus her fraud-on-the-FDA claim is preempted and cannot be
used to rebut § 82.007's presumption of non-liability for failure
to warn.
Id.
Thus all of her claims fail as a matter of law.
Court’s Decision
As a threshold matter, the Court agrees with Bayer that
Plaintiff’s
petition
is
a
conclusory,
bare-bones,
formulaic
recitation of the elements of her proposed causes of action
that
fail to meet the plausibility standard of Twombly and Iqbal under
Rule 12(b)(6) review.
Hers are not “well pleaded” statements
entitled to an assumption of truth,
Second,
the
Court
agrees
with
Bayer
that
a
review
of
Plaintiff’s claims for defective design, marketing defect, breach
of express10 and implied warranties, negligence and gross negligence
demonstrates that they are in actuality disguised failure-to-warn,
fraud-by-omission claims subject to Section 82.007 of the Texas
Civil Practices and Remedies Code.
characterizations
to
plead
around
Plaintiff cannot employ such
the
doctrine, which is clearly applicable here.
at 168;
learned
intermediary
Centocor, 372 S.W. 3d
Ebel, 536 F. Supp. 2d at 772-73; Norplant I, 955 F. Supp.
10
Even Plaintiff’s breach of express warranty alleges
omission–-while Bayer informed the physician of the IUD’s utility
in preventing pregnancy, it failed to make clear the extreme
dangers of a toxic reaction, its inherent dangers, the risk of
Lupus and allergic reactions linked with other autoimmune
disorders.
-26-
at 709.
The Court accordingly dismisses the causes of action for
defective
design,
marketing
defect,
negligence and gross negligence.
breach
of
warranties,
Her failure-to-warn claim, to be
viable, must fall under and satisfy Section 82.007 of the Texas
Civil Practice and Remedies Code and rebut the presumption of
nonliability.
Even though Bayer is not liable under the learned intermediary
doctrine to Plaintiff for failure to warn her as end user about the
risks of its Mirena IUD, it may still be liable if its warning to
the physician intermediary at Planned Parenthood was not adequate
and she sustained injuries as a result of using it.
Plaintiff has
not alleged facts specifically showing that the warnings on the
Mirena IUD were inadequate, nor even more so, that the allegedly
inadequate warning was the producing cause of Plaintiff’s injuries.
She claims Bayer knew or should have know abut the connection of
the Mirena IUD with autoimmune disorders from the substantial
number of Lupus cases linked to the Mirena IUD, but does not
identify any or cite any medical literature on the subject nor
allege any other facts showing how or why Bayer knew or should have
known
of
the
risks
of
the
contraceptive
causing
autoimmune
reactions. There are no facts supporting her claim that the Mirena
IUD was the producing cause of her injury nor relating to Planned
Parenthood doctors’ role in deciding to prescribe it for her.
As for the presumption under § 82.007 that Bayer is not liable
-27-
because the FDA approved the warning on its prescription drug,
Plaintiff has failed to show that the FDA found fraud in order to
rebut it under § 82.007(b)(1), nor identified any other exception
that might apply to her case.
For the reasons stated above, the Court
ORDERS that Bayer’s motion to dismiss is GRANTED as to
Plaintiff’s
causes
of
action
for
defective
design,
marketing
defect, breach of express and implied warranties, negligence and
gross negligence, but DENIED as to § 82.007 because the Court can
not say for certain that she cannot state a claim under it.
Therefore the Court
ORDERS that Plaintiff is granted leave to file an amended
complaint within twenty days that meets the requirements of that
statute and Rule 12(b)(6).
Failure to comply will result in
dismissal of this action.
SIGNED at Houston, Texas, this
12th
day of
March , 2013.
___________________________
MELINDA HARMON
UNITED STATES DISTRICT JUDGE
-28-
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?