Stanley v. Bayer Healthcare Pharmaceuticals, Inc. et al

Filing 13

MEMORANDUM OPINION AND ORDER granting in part and denying in part 10 Motion to Dismiss for Failure to State a Claim. Plaintiffs breach of implied warranty claim (Count V) against Bayer Healthcare Pharmaceuticals Inc. is dismissed consistent with this opinion. Signed by Chief Judge Joseph H. McKinley, Jr on 7/23/2015. cc: Counsel(JBM)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
LOUISVILLE DIVISION
CIVIL ACTION NO. 3:15CV-00230-JHM
KARA STANLEY

PLAINTIFF

VS.
BAYER HEALTHCARE PHARMACEUTICALS INC.,
BAYER PHARMA AG, AND BAYER OY

DEFENDANTS

MEMORANDUM OPINION AND ORDER
This matter is before the Court on a motion by Defendant, Bayer Healthcare
Pharmaceuticals Inc., to dismiss certain portions of Plaintiff’s complaint for failure to state a
claim pursuant to Fed. R. Civ. P. 12(b)(6) [DN 10]. Fully briefed, this matter is ripe for decision.
I. BACKGROUND
Plaintiff, Kara Stanley, filed suit against Defendants, Bayer Healthcare Pharmaceuticals
Inc., Bayer Pharma AG, and Bayer Oy, for personal injuries suffered as a result of Plaintiff being
prescribed and using the product Mirena which is manufactured by Defendants. Mirena is an
intrauterine system (“IUS”) that is inserted by a healthcare practitioner during an office visit.
Mirena is a t-shaped polyethylene frame with a steroid reservoir that releases levonorgestrel
(“LNG”), a synthetic progestogen, directly into the uterus for birth control. The Federal Food
and Drug Administration approved Mirena in December of 2000. Plaintiff alleges that she had
Mirena inserted into her body Dr. Kerrin Dunn at Women’s Healthcare of Southern Indiana in
May of 2012. Plaintiff claims that on December 22, 2012, she began experiencing severe
headaches and vision problems, losing vision in her left eye. Within 48 hours, Plaintiff was
diagnosed with bilateral optic nerve swelling (papilledema), most likely due to pseudotumor
cerebri (“PTC”). PTC is a potentially permanent brain condition that arises when too much

cerebrospinal fluid in the brain causes increased intracranial pressure and increased pressure on
the optic nerve leading to vision problems, and in some cases, blindness. Plaintiff maintains that
her Mirena was removed on March 27, 2013. Although her Merina was removed, she has
permanent damage to the optic nerve, retinal hemorrhage, and lost forty percent of vision in her
left eye due to her PTC. Plaintiff alleges that her injuries were caused and/or triggered by her
Mirena.
On March 23, 2015, Plaintiff filed suit asserting claims of negligence, design defect,
failure to warn, strict liability, breach of implied warranty, breach of express warranty, negligent
misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment. On
May 22, 2015, Defendant, Bayer Healthcare Pharmaceuticals Inc., filed a motion to dismiss the
strict liability claim (Count IV), breach of implied warranty claim (Count V), and the negligent
misrepresentation claim (Count VII).
II. STANDARD OF REVIEW
Upon a motion to dismiss for failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6),
a court “must construe the complaint in the light most favorable to plaintiff[],” League of United
Latin Am. Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007) (citation omitted), “accept all
well-pled factual allegations as true[,]” id., and determine whether the complaint “states a
plausible claim for relief[,]” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). Under this standard,
the plaintiff must provide the grounds for his or her entitlement to relief which “requires more
than labels and conclusions, and a formulaic recitation of the elements of a cause of action.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). A plaintiff satisfies this standard only
when he or she “pleads factual content that allows the court to draw the reasonable inference that
the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. A complaint falls

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short if it pleads facts “merely consistent with a defendant’s liability” or if the alleged facts do
not “permit the court to infer more than the mere possibility of misconduct.” Id. at 678, 679.
Instead, the allegations must “‘show[ ] that the pleader is entitled to relief.’” Id. at 679 (quoting
Fed. R. Civ. P. 8(a)(2)).
III. DISCUSSION
Defendant moves to dismiss the strict liability claim (Count IV), breach of implied
warranty claim (Count V), and the negligent misrepresentation claim (Count VII).
A. Strict Liability
Defendant moves to dismiss Plaintiff’s strict liability claim. Defendant argues that to the
extent this claim is based on a design defect or failure to warn theory, it is duplicative and should
be dismissed. “Under Kentucky law, a plaintiff can advance both a strict-liability claim and a
negligence claim against the manufacturer of a product for injury suffered by that product.”
Waltenburg v. St. Jude Medical, Inc., 33 F. Supp. 3d 818, 836 (W.D. Ky. 2014). “Strict liability
typically focuses on the condition of the product while a negligence inquiry examines whether
the manufacturer exercised the proper degree of care to protect against foreseeable dangers when
manufacturing the product for the consumer.” Prather v. Abbott Laboratories, 960 F.Supp.2d
700, 712 (W.D. Ky. 2013)(citing Ostendorf v. Clark Equip. Co., 122 S.W.3d 530, 535 (Ky.
2003)). Examining Plaintiff’s complaint, it does not appear at this time that these claims are
duplicative, and therefore, Defendant’s motion to dismiss is denied.
To the extent the strict liability claim is based on a manufacturing defect, Defendant
moves to dismiss the manufacturing defect claim arguing that Plaintiff failed to allege any
specific manufacturing defect that occurred with her Mirena product. See Bosch v. Bayer
Healthcare Pharms. Inc., 13 F. Supp. 3d 730, 744 (W.D. Ky. 2014). Plaintiff represents that she

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is not making a manufacturing defect claim. Therefore, Defendant’s motion to dismiss the
manufacturing defect claim is moot.
B. Implied Warranty Claim
Defendant argues that Plaintiff’s breach of implied warranty cause of action fails as a
matter of law because privity of contract is an essential element to breach of warranty claims.
Pruitt v. Genie Indus., Inc., 2013 WL 139701, *3 (E.D. Ky. Jan. 10, 2013). Defendant maintains
that Plaintiff has not – and cannot – allege that she purchased Mirena directly from Bayer. In
fact, Plaintiff in her complaint admits that Mirena was inserted by a healthcare practitioner
during an office visit. Plaintiff failed to respond to Defendant’s argument with respect to the
implied warranty claim, and therefore, the motion to dismiss the implied warranty claim is
granted.
C. Negligent Misrepresentation Claim
Defendant also asserts that the Plaintiff’s negligent misrepresentation claim is not viable
because it is inappropriate in the context of product liability claims. Relying upon Restatement
(Second) of Torts § 5521, Defendant maintains that Kentucky law limits negligent
misrepresentation claims to instances where a party is in the business of supplying “false
information for the guidance of others in their business transactions.” Our Lady of Bellefonte
Hosp., Inc. v. Tri–State Physicians Network, Inc., 2007 WL 2903231, *7 (E.D. Ky. Sept. 27,
2007); Presnell Construction Managers, Inc., v. EH Construction, LLC, 134 S.W.3d 575 (Ky.
2004). Defendant contends that a negligent misrepresentation claim does not encompass
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Section 552 of the Restatement (Second) of Torts (1977) which provides in pertinent part:
One who, in the course of his business, profession or employment, or in any other transaction in which he
has a pecuniary interest, supplies false information for the guidance of others in their business transactions, is
subject to liability for pecuniary loss caused to them by their justifiable reliance upon the information, if he fails to
exercise reasonable care or competence in obtaining or communicating the information.

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instances involving “a defective product and statements in its advertising and packaging.” Baird
v. Bayer Healthcare Pharms., Inc., 2013 WL 5890253 (E.D. Ky. Oct. 31, 2013)); Bland v.
Abbott Labs., Inc., 2012 WL 524473, *2 (W.D. Ky. Feb. 16, 2012). See also Gaunce v. CL
Medical Inc., 2015 WL 893569, *3 (E.D. Ky. March 2, 2015). In Baird, plaintiffs maintained
that their allegations that Abbott’s marketing and packaging contained false statements sufficient
to state a claim for negligent misrepresentation. Relying on the language of the Restatement
(Second) of Torts § 552, Presnell, and Giddings & Lewis v. Industrial Risk Insurers, 348 S.W.3d
729, 745 (Ky. 2011), the district court held that:
Plaintiffs identify no Kentucky case recognizing a negligent
misrepresentation claim based on a defective product and
statements in its advertising and packaging. Indeed, the Kentucky
Supreme Court has noted “the language of Section 552 is poorly
suited to a product sale.” [Giddings, 348 S.W.3d] at 746. The true
injury in such cases is “the failure of the product to function
properly,” not reliance on false information. Id., at 745 (quoting
Miller's Bottled Gas, Inc. v. Borg–Warner Corp., 955 F.2d 1043,
1054 (6th Cir. 1992) (anticipating Kentucky law would not
recognize a negligent misrepresentation claim in a commercial
product sale). This Court declines any invitation to extend the
negligent misrepresentation cause of action beyond its present
limits set by the Kentucky Supreme Court.
Baird, 2012 WL 524473, *2. Based on this case law, Defendant argues that where a products
liability suit involves personal injury, Kentucky does not recognize a claim for negligent
misrepresentation, and, as a result, dismissal of this claim is appropriate.
The Court disagrees. A review of the Kentucky Supreme Court opinion in Giddings &
Lewis, Inc. v. Industrial Risk Insurers, 348 S.W.3d 729 (Ky. 2011) and the Sixth Circuit opinion
in Morris Aviation, LLC v. Diamond Aircraft Industries, Inc., 536 Fed. Appx. 558 (6th Cir.
2013) suggests that in a product sale case, the Kentucky Supreme Court now applies a different

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section of the restatement than Restatement (Second) of Torts § 552 on which the cases cited by
Defendant are based. Specifically, the Kentucky Supreme Court in Giddings held:
While a negligent misrepresentation claim obviously was
recognized several years later in Kentucky in Presnell
Construction, it was not in the context of a sale of a commercial
product but in the context of construction services where the
parties to the dispute had no contractual relationship. Indeed, the
language of Section 552 is poorly suited to a product sale. While
Section 9 of the Restatement (Third) of Torts now specifically
provides for a negligent misrepresentation claim in the context of a
sale of a defective product, significantly, the Restatement adheres
to the approach we adopt today—the tort claim is for recovery of
damages to persons or other property, not damages to the product
itself or other forms of economic loss.
Giddings, 348 S.W.3d at 746.

Similarly, the Sixth Circuit in Morris recognized that the

Kentucky Supreme Court adopted Restatement (Third) of Torts § 9 for negligent
misrepresentation claims associated with the sale of a product:
The awkward fit of certain cases with the language of § 552 is a
possibility that the Kentucky Supreme Court has recognized after
Presnell: “Section 552 is poorly suited to a product sale.”
Giddings, 348 S.W.3d at 746. Instead, in product-sale cases, the
court has called for application of a different section of the
Restatement, which provides that: “One engaged in the business
of selling or otherwise distributing products who, in connection
with the sale of a product, makes a fraudulent, negligent, or
innocent misrepresentation of material fact concerning the product
is subject to liability for harm to persons or property caused by the
misrepresentation.”
Morris, 536 Fed. Appx. at 567-568 (quoting Giddings, 348 S.W.3d at 746 n. 11 (quoting
Restatement (Third) of Torts: Products Liability § 9 “Liability of Commercial Product Seller or
Distributor for Harm Caused by Misrepresentation”)).
Accordingly, with the adoption of the Restatement (Third) of Torts § 9, Kentucky law
provides for negligent misrepresentation claims associated with the sale of a product. For these
reasons, Defendant’s motion to dismiss Count VII is denied.
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IV. CONCLUSION
For the reasons set forth above, IT IS HEREBY ORDERED that motion by Defendant,
Bayer Healthcare Pharmaceuticals Inc., to dismiss certain portions of Plaintiff’s complaint for
failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6) [DN 10] is GRANTED IN PART
AND DENIED IN PART. Plaintiff’s breach of implied warranty claim (Count V) against
Bayer Healthcare Pharmaceuticals Inc. is dismissed consistent with this opinion.

cc: counsel of record
July 23, 2015

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