Hardwick v. Bayer Healthcare Pharmaceuticals Inc.

Filing 80

MEMORANDUM OPINION signed by Senior Judge Charles R. Simpson, III on 11/20/2015, re 70 MOTION TO DISMISS filed by Bayer Healthcare Pharmaceuticals Inc. For the reasons set forth, Bayer's Motion to Dismiss will be granted in part and denied in part. A separate order will be entered in accordance with this Opinion.cc: Counsel (RLK)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
LOUISVILLE DIVISION
LAUREN HARDWICK
vs

PLAINTIFF
CIVIL ACTION NO. 3:14CV-82-CRS

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

DEFENDANTS

MEMORANDUM OPINION
This matter is before the Court on motion of Defendant Bayer Healthcare Pharmaceuticals
Inc. to dismiss certain counts of Plaintiff Lauren Hardwick’s Second Amended Complaint for
failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6) [DN 70]. This motion mirrors other
such motions filed in a number of cases which have now been transferred to this court for further
proceedings. These actions are related inasmuch as they seek to redress alleged personal injuries
purportedly suffered from the plaintiffs’ use of the Mirena® interuterine system (“IUS”)

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prescribed and placed by their healthcare providers. These motions to dismiss have generated
decisions which employ a similar analysis of claims, with the exception of the challenge to the
claims for negligent misrepresentation associated with the sale of the product. This court will now
issue its own opinion, with the benefit of learned views on both sides of the issue.

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Also referred to from time to time as an “interuterine device” or “IUD.”

I. BACKGROUND
Plaintiff, Lauren Hardwick (“Hardwick”), filed this action against Defendants, Bayer
Healthcare Pharmaceuticals Inc., Bayer Pharma AG, and Bayer Oy,2 for personal injuries she
alleges she suffered after she had the Mirena® I U S placed by Dr. Kristi Horlander for purposes
of contraception. (2d Am. Compl., ¶ 7 0 ) . T h e M i r e n a ® I U S , manufactured by B a ye r
and approved by the Federal Food and Drug Administration in December of 2000, is a
prescription intrauterine system that must be inserted by a healthcare practitioner during an office
visit. The Mirena® is described as a levonorgestrel-releasing implant, consisting of a t-shaped
polyethylene frame with a steroid reservoir that releases levonorgestrel (“LNG”), a synthetic
progestogen, into the uterus for birth control.
Hardwick alleges that Dr. Horlander placed the device on April 16, 2008, and later
she began experiencing severe migraine-like headaches and vision problems, including blurred
vision. She alleges that although her symptoms were at first manageable, they continued to
worsen, prompting her to seek medical treatment in April 2012. She claims that on April 12,
2012, she was diagnosed with bilateral papilledema. Hardwick had an MRI performed to evaluate
her for idiopathic intracranial hypertension, also known as pseudotumor cerebri“IIH/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. The MRI allegedly revealed bilateral visual
disturbance and papilledema.

On April 18, 2012, she was purportedly diagnosed with

IIH/PTC. She had the Mirena® removed on March 6, 2013. Hardwick alleges that the use
of the Mirena® caused, contributed to, and/or triggered her development of IIH/PTC.
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Bayer Pharma AG was served October 2, 2015 through the Hague Convention. Bayer OY has not been served. By agreement with
the plaintiff, Bayer Pharma AG is not required to answer the complaint until Bayer OY is also served through the Hague Convention,
at which time these two defendants will file one answer. (DN 79).

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On January 17, 2014, Hardwick filed suit in the Jefferson County, Kentucky, Circuit Court
asserting claims of negligent design, failure to warn, strict liability, breach of express and implied
warranties, negligent and fraudulent misrepresentation, and fraud by concealment.

The

complaint has been amended twice. Bayer has moved for dismissal of the strict liability
claim (Count IV), breach of implied warranty claim (Count V), and the negligent
misrepresentation claim (Count VII).
II. STANDARD OF REVIEW
In considering 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 establish 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 must “plead[] 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 fails t o m eet t hi s st andard 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
Bayer has moved to dismiss the strict liability claim (Count IV), breach of implied
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warranty claim (Count V), and the negligent misrepresentation claim (Count VII). We will
address the grounds asserted for dismissal seriatim.
A. Strict Liability
In moving to dismiss Hardwick’s strict liability claim, Bayer argues, in footnote (DN 701, p. 3, n. 1) that, to the extent this claim is based upon her assertion of a negligent design or a
failure to warn, strict liability is duplicative of other counts and should be dismissed. However,
" [ u ] nder 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)).
Therefore, Bayer’s motion to dismiss the strict liability claim as duplicative will be denied.
Bayer further argues that, to the extent the strict liability claim is based on a
manufacturing defect, Hardwick has failed to allege any specific manufacturing defect in the
product. See Bosch v. Bayer Healthcare Pharms. Inc., 13 F. Supp. 3d 730, 744 (W.D. Ky.
2014). Hardwick has responded that she is not alleging strict liability for a manufacturing defect
in the product. Therefore, Bayer’s motion to dismiss the strict liability claim on this second
ground will also be denied.

B. Implied Warranty Claim
Bayer argues that privity of contract is an essential element in a breach of warranty claim
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(citing Pruitt v. Genie Indus., Inc., 2013 WL 139701, *3 (E.D. Ky. Jan. 10, 2013)). Bayer notes
that Hardwick has not alleged that she purchased t he Mirena® directly from Bayer. Rather,
Hardwick alleged in her complaint that she had the Mirena® placed on April 16, 2008, by Dr.
Kristi Horlander.. Hardwick has failed to respond to t h i s argument addressing the implied
warranty claim. We find, therefore, that she has waived opposition to this ground for dismissal, and
we find that Bayer’s motion is meritorious. Scott v. State of Tennessee, 878 F.2d 382, *2 (Table),
1989 WL 72470 (6th Cir. 1989). Bayer’s motion to dismiss the implied warranty claim will be
granted.

C. Negligent Misrepresentation Claim
Bayer seeks dismissal of Hardwick’s negligent misrepresentation claim on the ground that
such a claim is not viable in product liability cases in Kentucky. Bayer urges that “Kentucky law
limits negligent misrepresentation claims to instances where a party supplies ‘false information for
the guidance of others in their business transactions.’” (quoting Our Lady of Bellefonte Hosp.,
Inc. v. Tri–State Physicians Network, Inc., 2007 WL 2903231, *7 (E.D. Ky. Sept. 27, 2007)).
Accordingly, Bayer asserts that the scope of this tort, historically grounded in the Restatement
(Second) of Torts § 552, does not encompass claims based upon a defective product or statements
in its advertising or packaging. Courts that have reached this conclusion have quoted Giddings &
Lewis v. Industrial Risk Insurers, 348 S.W.3d 729, 746 (Ky. 2011) in which the court noted that
“…the language of Section 552 is poorly suited to a product sale…”

See Bland v. Abbott

Laboratories, Inc., Civil Action No. 3:11-CV-430-H, 2012 WL 524473 (W.D.Ky. Feb. 16, 2012;
Baird v. Bayer Healthcare Pharmaceuticals, Inc., Civil Action No. 6:13-077-DCR, 2013 WL
5890253 (E.D.Ky. Oct. 31, 2013).
We find the better reasoned result in other opinions rendered in this district, however. In
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the cases of Stanley v. Bayer Healthcare Pharmaceuticals, Inc., Civil Action No. 3:15CV-230JHM, 2015 WL 4511973 (W.D.Ky. July 24, 2015); Babich-Zacharias v. Bayer Healthcare
Pharmaceuticals, Inc., Civil Action No. 5:14CV-101-TBR, 2015 WL 711057 (W.D.Ky. Feb. 18,
2015); and Martin v. Bayer Healthcare Pharmaceuticals, Inc., Civil Action No. 3:14CV-398-TBR
(Aug. 25, 2015) the courts cited to Morris Aviation, LLC v. Diamond Aircraft Indus., Inc., 536
Fed.Appx. 558 (6th Cir. 2013). The Sixth Circuit in Morris recognized that the Restatement
(Third) of Torts §9 now applies to 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, as negligent misrepresentation claims associated with the sale of a product
are now governed by the Restatement (Third) of Torts § 9 in Kentucky, Hardwick’s claim will be
permitted to proceed. Bayer’s motion to dismiss Count VII will be denied.

IV. CONCLUSION
For the reasons stated herein, Bayer’s motion to dismiss will be granted in part and denied
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in part. A separate order will be entered herein this date in accordance with this opinion.

IT IS SO ORDERED.

C al R Smpo I , ei J d e
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November 20, 2015

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