Babich-Zacharias v. Bayer Healthcare Pharmaceuticals Inc.

Filing 37

MEMORANDUM OPINION & ORDER denying 8 Motion to Dismiss for Failure to State a Claim. Signed by Senior Judge Thomas B. Russell on 2/13/2015. cc: Counsel(KJA)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
PADUCAH DIVISION
CIVIL ACTION NO. 5:14-CV-00101-TBR

ASHLEY BABICH-ZACHARIAS

Plaintiff,

v.
BAYER HEALTHCARE
PHARMACEUTICALS, INC.

Defendant.

MEMORANDUM OPINION AND ORDER
This matter comes before the Court upon the motion to dismiss of Defendant Bayer Healthcare
Pharmaceuticals, Inc. (“Bayer”). (Docket No. 8.) Plaintiff Ashley Babich-Zacharias has responded,
(Docket No. 12), and Bayer has replied, (Docket No. 15). Fully briefed, this matter stands ripe for
adjudication. For the reasons set forth below, the Court will DENY Bayer’s motion to dismiss.
Factual Background
This lawsuit raises products liability claims arising from Babich-Zacharias’s use of an intrauterine
device (“IUD”) known as “Mirena.” Mirena is produced by Bayer, a Delaware corporation in the
business of designing, manufacturing, marketing, testing, and distributing prescription drugs and
women’s healthcare products. The device consists of a T-shaped polyethylene frame with a steroid
reservoir that releases a certain amount of levonorgesterel, a synthetic hormone that acts as a
contraceptive, into the uterus each day. A healthcare provider inserts the device into the uterus during an
office visit, after which it may remain in use for up to five years.
Babich-Zacharias, a Kentucky resident, alleges that after her Mirena IUD was inserted, she
developed severe headaches and vision problems that caused her to seek emergency care. After a lumbar
puncture, a neurologist diagnosed Babich-Zacharias with pseudotumor cerebri, also known as idiopathic
intracranial hypertension (“PTC/IIH”).

PTC/IIH occurs when fluid builds up in the skull, causing
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increased pressure and triggering “severe migraines or migraine-like headaches with blurred vision,
diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies.” (Docket No. 1 at
¶ 31.) If not correctly diagnosed and treated, PTC/IIH may cause permanent vision loss and blindness.
(Docket No. 1 at ¶ 38.) Although the condition is treatable, positive outcomes are not assured.
Babich-Zacharias now maintains that levonorgestrel “causes or contributes to the development of
PTC/IIH, increases the risk of developing PTC/IIH, and/or worsens or exacerbates PTC/IIH.” (Docket
No. 1 at ¶ 52.) She contends that Mirena’s label and its patient information booklet fail to warn users of
this “known link.” (Docket No. 1 at ¶¶ 26-29.) She further argues that despite medical literature
reflecting a need for additional research, Bayer failed to conduct clinical tests investigating this purported
connection. (Docket No. 1 at ¶ 30.) Finally, she points to Bayer’s “Mirena Simple Style Statements
Program,” which she alleges were consumer-directed live presentations directed toward “busy moms.”
According to Babich-Zacharias, the Simple Style script omitted information regarding serious risks
associated with using Mirena. (Docket No. 1 at ¶ 69-73.) She insists that Bayer concealed its knowledge
of Mirena’s defects from herself and other patients, the FDA, prescribing physicians, the healthcare
community, and other foreseeable users.
Babich-Zacharias filed suit on May 15, 2014, invoking this Court’s diversity jurisdiction pursuant
to 28 U.S.C. § 1332. She asserts claims against Bayer for negligence, design defects, failure to warn, strict
liability, breach of implied and express warranties, negligent and fraudulent misrepresentation, and fraud
by suppression and concealment. She also seeks punitive damages.
Legal Standard
The Federal Rules of Civil Procedure require that pleadings, including complaints, contain a
“short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P.
8(a)(2). A complaint may be attacked for failure “to state a claim upon which relief can be granted.” Fed.
R. Civ. P. 12(b)(6). When considering a Rule 12(b)(6) motion to dismiss, a court will presume that all the

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factual allegations in the complaint are true and will draw all reasonable inferences in favor of the
nonmoving party. Total Benefits Planning Agency v. Anthem Blue Cross & Blue Shield, 552 F.3d 430,
434 (6th Cir. 2008) (citing Great Lakes Steel v. Deggendorf, 716 F.2d 1101, 1105 (6th Cir. 1983)). “The
court need not, however, accept unwarranted factual inferences.” Id. (citing Morgan v. Church's Fried
Chicken, 829 F.2d 10, 12 (6th Cir. 1987)).
Even though a “complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed
factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more
than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citations
omitted). Instead, the plaintiff's “[f]actual allegations must be enough to raise a right to relief above the
speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in
fact).” Id. (citations omitted). That is, a complaint must contain enough facts “to state a claim to relief that
is plausible on its face.” Id. at 570. A claim becomes plausible “when the plaintiff pleads factual content
that allows 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, 173 L.Ed.2d 868 (2009) (citing Twombly,
550 U.S. at 556). If, from the well-pleaded facts, the court cannot “infer more than the mere possibility of
misconduct, the complaint has alleged—but has not ‘show[n]’—‘that the pleader is entitled to relief.” ’ Id.
at 679 (quoting Fed. R. Civ. P. 8(a)(2)). “[O]nly a complaint that states a plausible claim for relief
survives a motion to dismiss.” Id.
Moreover, when a plaintiff’s claims sound in fraud, those claims are subject to the heightened
pleading standard of Federal Rule of Civil Procedure 9(b), “designed to prevent ‘fishing expeditions,’ to

protect defendants’ reputations from allegations of fraud, and to narrow potentially wide-ranging
discovery to relevant matters.’” Chesbrough v. VPA, P.C., 655 F.3d 461, 4677 (6th Cir. 2011)
(citing United States ex rel. SNAPP, Inc. v. Ford Motor Company, 532 F.3d 496, 504 (6th Cir.
2008)). “At a minimum, the Sixth Circuit requires the allegations to contain the ‘time, place, and

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contend of the alleged misrepresentation on which he or she relied; the fraudulent scheme; the
fraudulent intent of the defendants; and the injury resulting from the fraud.’” Our Lady of
Bellefonte Hosp., Inc. v. Tri-State Physicians Network, Inc., 2007 WL 2903231, at *6 (E.D. Ky.
Sept. 27, 2007) (quoting Coffey v. Foamex L.P., 2 F.3d 157, 161-62 (6th Cir. 1993)).
“Generalized and conclusory allegations that the Defendants’ conduct was fraudulent do not
satisfy Rule 9(b).” Bovee v. Coopers & Lybrand C.P.A., 272 F.3d 356, 361 (6th Cir. 2001).

Analysis
Bayer contends that because Babich-Zacharias has not provided the requisite detail to support her
claims, her complaint fails to state a claim upon which relief can be granted. According to Bayer, the
complaint contains only “formulaic recitation of elements for certain causes of action” and offers only the
broadest sketches of her allegations, alluding to unnamed doctors and unspecified dates and locations.
(Docket No. 8-1 at 1.)
The Court must agree. The complaint fails to provide certain bedrock facts—including, for
example, the name and locations of the practitioner who placed Babich-Zacharias’s Mirena, the
practitioner who removed the IUD, and the practitioner who diagnosed her with PTC/IIH. Significantly,
she does not indicate when these procedures and diagnoses occurred, which could prove essential to a
statute of limitations analysis.

Moreover, Babich-Zacharias’s complaint does not satisfy the legal

prerequisites of several of her nine claims. These deficiencies raise particular concern in the context of
her fraud-based claims, which fall far short of the detail required by Sixth Circuit precedent. See, e.g.,
Chesbrough, 655 F.3d at 467. Consequently, Babich-Zacharias has failed to state a claim upon which
relief may be granted.
The Court has confronted similar factual and legal deficiencies in other cases involving Mirena
litigation. See Hardwick v. Bayer Healthcare Pharmaceuticals Inc., No. 3:14-cv-00082-JGH (Docket No.
25) (W.D. Ky. Aug. 13, 2014); Bosch v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 5656111,
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Civil Action No. 3:13-cv-00656-JHM, (W.D. Ky. Oct. 16, 2013); Martin v. Bayer Healthcare
Pharmaceuticals, Civil Action No. 3:14-cv-00398-TBR (Docket No. 23) (WD. Ky. Dec. 9, 2014). In
each of these cases, similar complaints were deemed inadequate and the Court granted Plaintiffs leave to
amend their complaints.
Finding that similar relief is appropriate here, and in accordance the liberal amendment policies
articulated in the Federal Rules of Civil Procedure, the Court will grant Babich-Zacharias leave to amend.
See Federal Rule of Civil Procedure 15(a)(2) (instructing that the court should “freely give leave” to
amend a pleading “when justice so requires.”). See also Brown v. Matauszak, 415 F. App’x 608, 614 (6th
Cir. 2011) (“[I]f it is at all possible that the party against whom the dismissal is directed can correct the
defect in the pleading or state a claim for relief, the court should dismiss with leave to amend.”) (quoting
6 Charles Alan Wright, Arthur R. Miller, & Mary Kay Kane, Federal Practice and Procedure § 1483 (3d
ed. 2010).) 1
Conclusion
For the reasons set forth above, IT IS HEREBY ORDERED that Bayer’s motion to dismiss,
(Docket No. 8), is DENIED WITHOUT PREJUDICE. IT IS FURTHER ORDERED that BabichZacharias shall submit an amended complaint no later than twenty days from the entry of this
Memorandum Opinion and Order.

February 13, 2015

cc: Counsel

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Bayer further contends that notwithstanding the pleading deficiencies, Babich-Zacharias’s breach of warranty and
negligent misrepresentation claims must be dismissed as a matter of law. Because an amended complaint is
forthcoming, the Court will reserve ruling on such arguments at this time.

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