United States District Court, D. Maryland
K. Bredar Chief Judge.
Moczulski (“Plaintiff”) filed suit against
Ferring Pharmaceuticals, Inc. (“Defendant”),
alleging various state common law and statutory claims.
Plaintiff's claims stem from her purchase and use of a
fertility drug-Bravelle-that is manufactured and sold by
Defendant. Plaintiff originally filed her Complaint in the
Circuit Court for Baltimore City, and Defendant's removed
the case to this Court. Now pending before the Court is
Defendant's unopposed Motion to Dismiss. (ECF No. 18.)
Defendant contends that Plaintiff lacks standing and has
failed to state a plausible claim for relief. No. hearing is
required. See Local Rule 105.6 (D. Md. 2016). For
the reasons set forth below, Defendants' Motion will be
GRANTED IN PART and DENIED IN PART.
develops, manufactures, markets, and sells a prescription
drug called Bravelle. (Compl., ECF No. 2 ¶ 1.)
Bravelle-a urofollitropin-is intended to increase fertility
in women. (Id. ¶ 2.) Specifically, Bravelle
contains follicle stimulating hormone, which stimulates egg
maturation and multiple follicular development.
(Id.) Bravelle is frequently prescribed as part of
an in vitro fertilization procedure. (Id.)
wanted to have a baby and was informed by her doctor that
Bravelle would increase the chances of her successfully
conceiving. On September 25, 2014, Plaintiff began “a
lengthy and expensive medical procedure,
” which included the use of Bravelle.
Despite using Bravelle as prescribed, Plaintiff did not
become pregnant. (Id. ¶ 5.) Plaintiff alleges
that Defendant “knew or should have known” that
the Bravelle sold to Plaintiff “did not and would not
work as advertised and intended” and “would not .
. . accomplish the medical and pharmaceutical effect
intended.” (Id. ¶ 9.)
October 2015, Defendant initiated a voluntary recall of all
Bravelle in the United States after discovering “that
certain lots of the drug did not meet potency
requirements.” (Id. ¶ 6.) Plaintiff
alleges that the Bravelle she purchased and used “was
not capable of stimulating egg maturation and multiple
follicular development, ” and therefore it was part of
the defective batch. (Id. ¶¶ 15, 18.)
Defendant offered to reimburse customers, including
Plaintiff, who had purchased Bravelle; however, Plaintiff
rejected the offer.
Standard for Dismissal under Rule 12(b)(1)
challenge to a plaintiff's standing “implicates
th[e] court's subject matter jurisdiction.”
Long Term Care Partners, LLC v. United States, 516
F.3d 225, 230 (4th Cir. 2008); accord White Tail Park,
Inc. v. Stroube, 413 F.3d 451, 459 (4th Cir. 2005). The
Plaintiff bears the burden of establishing subject-matter
jurisdiction. Frank Krasner Enterprises, Ltd. v.
Montgomery Cty., 401 F.3d 230, 234 (4th Cir. 2005)
(“The burden of establishing standing to sue lies
squarely on the party claiming subject-matter
jurisdiction.”); accord Lujan v. Defs. of
Wildlife, 504 U.S. 555, 561 (1992).
Standard for Dismissal under Rule 12(b)(6)
complaint must contain “sufficient factual matter,
accepted as true, to ‘state a claim to relief that is
plausible on its face.'” Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell
Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)).
Facial plausibility exists “when the plaintiff pleads
factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct
alleged.” Id. An inference of a “mere
possibility of misconduct” is not sufficient to support
a plausible claim. Id. at 679. However, “a
well-pleaded complaint may proceed even if it strikes a savvy
judge that actual proof of those facts is improbable.”
Twombly, 550 U.S. at 556. Even so, “[f]actual
allegations must be enough to raise a right to relief above
the speculative level.” Id. at 555. “A
pleading that offers ‘labels and conclusions' or
‘a formulaic recitation of the elements of a cause of
action will not do.' Nor does a complaint suffice if it
tenders ‘naked assertion[s]' devoid of
‘further factual enhancement.'”
Iqbal, 556 U.S. at 678 (alteration in original)
(citation omitted) (quoting Twombly, 550 U.S. at
alleges eight counts under Maryland state law against
Defendant stemming from her purportedly defective dose of
Bravelle. Specifically, she asserts the following causes of
action: (1) negligence; (2) breach of express warranty; (3)
breach of implied warranty; (4) unjust enrichment; (5)
negligent misrepresentation; (6) intentional
misrepresentations; (7) breach of contract; (8) and a
violation of the Maryland Consumer Protection Act
(“MCPA”), Md. Code Ann., Com. Law § 13-101,
et seq. Essentially, Plaintiff contends that
Defendant sold her a defective product that it knew or should
have known was incapable of working as advertised and
intended. Defendant primarily argues that Plaintiff has not
plausibly alleged an injury-in-fact, and therefore she lacks
standing to bring any of her claims. And, even assuming
Plaintiff does have standing, Defendant contends that her
Complaint fails to state a claim for relief, again because
she has not adequately alleged she suffered any injury.
Defendant also makes several additional arguments addressed
to specific claims asserted by Plaintiff.
outset, the Court must assure itself that Plaintiff has
standing. If she does not, then the Court lacks subject
matter jurisdiction and must dismiss the case in its
plaintiff's standing to sue in federal court is “an
integral component of the case or controversy
requirement” of Article III. Miller v. Brown,
462 F.3d 312, 316 (4th Cir. 2006). To demonstrate standing, a
plaintiff must show that: (1) she has suffered an injury in
fact; (2) the injury is fairly traceable to the
defendant's actions; and (3) the injury is likely to be
redressed by a favorable decision of the court.
Lujan, 504 U.S. at 560-61. The injury alleged must
be “concrete and particularized.” Id. at
560. At the pleading stage, however, “general factual
allegations of injury resulting from the defendant's
conduct may suffice, for on a motion to dismiss we presume
that general allegations embrace those specific facts that
are necessary to support the claim.” Hutton v.
Nat'l Bd. of Examiners in Optometry, Inc.,
892 F.3d 613, 620 (4th Cir. 2018) (quoting Lujan,
504 U.S. at 561).
contends that Plaintiff has failed to allege sufficient facts
in support of her claimed injury. According to Defendant,
Plaintiff alleges only that Bravelle “did not work and
would not work as advertised and intended.” (Ferring
Pharmaceuticals Inc.'s Mem. in Supp. of its Mot. to
Dismiss, ECF No. 18-1, at 7.) Defendant also notes that
Plaintiff does not specifically allege that “she did
not ovulate or that she did not develop
multiple follicles after using Bravelle, ”
(id. at 7) nor does she offer any proof that her
Bravelle was “tested and determined to be subpotent,
” (id. at 9).
misconstrues Plaintiff's burden at this stage in the
litigation. The parties agree that Bravelle is intended to
stimulate egg maturation and multiple follicular development.
Plaintiff alleges that she purchased Bravelle and used it as
prescribed. (ECF No. 2 ¶ 5.) She further alleges that
the drug she purchased “did not and would not
work.” (Id. ¶ 9.) And she specifically
alleges that “the . . . [B]ravelle that was sold to
[her] was not capable of stimulating egg maturation and
multiple follicular development.” (Id.
¶¶ 15, 18 (emphasis added).) Later, Plaintiff again
states that the Bravelle that was sold to her “was not
viable or effective.” (Id. ¶ 36.) Indeed,
by the Court's count, Plaintiff alleges no less than
seven times in her Complaint that the Bravelle she purchased
was incapable of working as intended and in fact did not
work. In other words, Plaintiff alleges, repeatedly, that her
Bravelle was incapable of stimulating egg maturation and
multiple follicular development, the exact thing that the
parties agree it was intended to do. Plaintiff also alleges that
she suffered both monetary and non-monetary injuries as a
result of purchasing ineffective Bravelle from Defendant.
These claims are plausible; nothing more is required of
Plaintiff at this stage in the proceeding to establish her
standing. Accordingly, the Court finds that Plaintiff has
standing to pursue her claims against
Counts I and V, Plaintiff alleges negligence and negligent
Maryland law, to state a claim for negligence, the plaintiff
must allege facts showing “(1) that the defendant was
under a duty to protect the plaintiff from injury, (2) that
the defendant breached that duty, (3) that the plaintiff
suffered actual injury or loss, and (4) that the loss or
injury proximately resulted from the defendant's breach
of the duty.” Horridge v. St. Mary's Cty.