Gannon v. Bayer Healthcare Pharmaceuticals Inc et al

Filing 30

ORDER granting in part and denying in part 23 Motion for Judgment on the Pleadings. Signed by Chief Judge David R. Herndon on 4/23/2014. (dsw)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF ILLINOIS
------------------------------------------------------------

X

IN RE YASMIN AND YAZ (DROSPIRENONE)
MARKETING, SALES PRACTICES AND
PRODUCTS LIABILITY LITIGATION

3:09-md-02100-DRH-PMF
MDL No. 2100

-----------------------------------------------------------Judge David R. Herndon

This Document Relates to:
Gail Gannon v. Bayer Healthcare
Pharmaceuticals, Inc., et al. No. 3:13-cv10143-DRH-PMF

ORDER
HERNDON, Chief Judge:
I. INTRODUCTION
Before the Court is defendant Teva Pharmaceuticals USA’s (“Teva”) motion
to dismiss under Fed.R.Civ.P. 12(c) (Doc. 23). Teva moves for judgment on the
pleadings and dismissal of plaintiff Gail Gannon’s (“plaintiff”) claims against it.
Plaintiff has filed a response in opposition (Doc. 28), to which defendant has
replied in accordance with Local Rule 7.1(c) (Doc. 29). Teva contends that the
plaintiffs allegations fail under Iqbal/Twombly and/or are pre-empt under federal
law. The Court finds that the plaintiff’s claims are adequately pled. Accordingly,
the Court’s order focuses on the issue of federal pre-emption. For the following
reasons, defendant's motion is GRANTED IN PART AND DENIED IN PART.

1

II. BACKGROUND AND ALLEGATIONS
Plaintiff, a citizen of Illinois, directly filed her complaint in this Court on
February 15, 2013, based on diversity of citizenship (Doc. 1). The plaintiff filed
her first amended complaint on September 30, 2013 (Doc. 20). According to the
pleadings, plaintiff purchased and ingested the brand-name combination oral
contraceptive Yaz (drospirenone; ethinyl estradiol) in November 2009. Shortly
thereafter, in June 2010, the plaintiff began using Gianvi, a generic iteration of
Yaz (drospirenone; ethinyl estradiol) (Doc. 20 ¶ 3). Plaintiff contends that as a
result of using Gianvi she suffered an acute bilateral pulmonary embolus on or
about March 12, 2011 (Doc. 20 ¶ 3).
Plaintiff asserts claims against Bayer Healthcare Pharmaceuticals, Inc.,
Bayer Pharma AG (collectively, “Bayer”) and Teva Pharmaceuticals USA (“Teva”).
In her complaint, the plaintiff alleges that Bayer is the designer, developer,
manufacturer, and seller of YAZ (Doc. 20 ¶¶ 3-21, 25, 60). The plaintiff further
alleges and Teva admits that it is the distributor of Gianvi (Doc. 20 ¶ 24, 61).
The question of which entity manufactured the Gianvi ingested by the
plaintiff is not a question that can be resolved by the Court at this stage in the
litigation. The allegations appropriately considered by the Court at this time
indicate the Gianvi ingested by the plaintiff was manufactured by either Bayer or a
third entity not named as a defendant in this complaint – Barr Laboratories Inc
(“Barr”). Barr is an entity that has entered into agreements with Bayer pursuant to

2

which Bayer supplied Barr with generic versions of both Yaz (Gianvi) and
Yasmin. 1 Barr has been a wholly owned subsidiary of Teva since December 2008
(Doc. 63 ¶ 64). Barr submitted an Abbreviated New Drug Application (“ANDA”) for
a generic version of Yaz (distributed under the trade-name Gianvi), which was
approved on March 30, 2009 (Doc. 23 p. 14 citing publically available records on
the FDA’s website). The Gianvi under Barr’s ANDA is associated with national
drug code numbers 0093-5661-58 and 00093-5661-28 (Doc. 23 p. 14 citing
publically available records on the FDA’s website).
Bayer has also manufactured Gianvi. The authorized generic version of YAZ
(sold under the trade-name Gianvi) manufactured by Bayer is associated with
national drug code numbers 0093-5423-58 and 0093-5423-28 (Doc. 20 ¶ 67, Doc.
22 ¶¶ 68-70).
Teva has distributed Gianvi under Barr’s ANDA (i.e. associated with
national drug code numbers 0093-5661-58 and 00093-5661-28) and under
Bayer’s NDA for the authorized generic version of Yaz (i.e. associated with
national drug code numbers 0093-5423-58 and 0093-5423-28). Teva announced
the introduction and availability of Gianvi under Barr’s ANDA in June of 2010
(Doc. 20 ¶ 64). The “start marketing date” associated with Teva’s distribution of
1

In June of 2008, Bayer and Barr entered into an agreement pursuant to which Bayer would
supply an authorized generic version of Yasmin to Barr (Doc. 20 ¶ 62). In June 2010 (after
acquiring Barr), Teva announced the availability of Gianvi (the generic version of Yaz) (Doc. 20 ¶
64). Thereafter, litigation between Bayer and Teva/Barr ensued regarding patent infringement and
the distribution of Gianvi (Doc. 20 ¶ 65). The litigation eventually settled and, according to the
complaint, an agreement was reached pursuant to which Bayer would supply Barr with the
product for Gianvi (Doc. 20 ¶ 65). Plaintiff contends that Bayer has supplied Barr with the product
for Gianvi since December 2010 (Doc. 20 ¶ 65).

3

Gianvi under Bayer’s NDA for Yaz is March 30, 2011 (Doc. 23 p. 14 citing
publically available records on the FDA’s website).
Based on the above, Teva contends that it did not distribute an authorized
generic version of drospirenone; ethinyl estradiol under Bayer’s NDA prior to
April 2011 and therefore, the Gianvi ingested by the plaintiff was necessarily
Gianvi distributed by Teva under Barr’s ANDA for drospirenone; ethinyl
estradiol. 2 The plaintiff has alleged that some Gianvi prescriptions filled before
April 1, 2011 contain national drug code numbers 0093-5423-28 and 0093-542358, the national drug code numbers associated with Gianvi manufactured by
Bayer and distributed by Teva (Doc. 20 ¶ 69). Accordingly, the plaintiff contends,
it is possible that Bayer-manufactured Gianvi was available prior to April 1, 2011.
The plaintiff has also alleged that the Gianvi distributed by Teva under
Barr’s ANDA for drospirenone; ethinyl estradiol was made with drospirenone
supplied by Bayer (See Doc. 20 ¶¶ 61-66) (alleging that pursuant to an agreement,
Bayer supplied Barr with the product for Gianvi since December 2010). The
plaintiff contends that this alleged agreement establishes that Bayer and Teva
acted in concert to market, manufacture and supply Gianvi.

2

In addition to pointing to the above publically available records, Teva notes that the pharmacy
records accompanying the plaintiff’s fact sheet indicate her Yaz prescriptions were filled with
Gianvi with National Drug Code Numbers 0093-5661-58 (generic Gianvi distributed by Teva under
Barr’s ANDA for drospirenone; ethinyl estradiol) (Doc. 23 p. 15). This is a matter outside the
pleadings that cannot be considered by the Court without converting the current motion into a
motion for summary judgment. Accordingly, for purposes of this motion, the Court disregards this
assertion.

4

Based on the above the Court finds that a question of fact exists with regard
to which entity manufactured the Gianvi ingested by the plaintiff. However, in any
of the alternative scenarios presently before the Court, Teva’s involvement
amounts to that of a generic distributor. 3 Accordingly, the Court’s analysis
proceeds under the assumption that Teva is the entity that distributed the Gianvi
ingested by the plaintiff. 4
III. LEGAL STANDARD
Federal Rule of Civil Procedure 12(c) allows a party to move for judgment
on the pleadings, which include the complaint, the answer, and any written
instruments, including contracts, that are attached as exhibits. N. Ind. Gun &
Outdoor Shows, Inc. v. City of S. Bend, 163 F.3d 449, 452–53 (7th Cir. 1998). In
reviewing a Rule 12(c) motion, a court applies the same standards applicable to a
Rule 12(b)(6) motion seeking dismissal for failure to state a claim. See
Buchanan–Moore v. County of Milwaukee, 570 F.3d 824, 827 (7th Cir. 2009).
Thus, a court accepts as true all well-pled factual allegations and draws all
reasonable inferences in the plaintiff's favor. See Rujawitz v. Martin, 561 F.3d
685, 688 (7th Cir. 2009). Only when it appears beyond a doubt that the plaintiff
cannot prove any facts to support a claim for relief and the moving party
3

The plaintiff’s complaint contains at least one allegation that Teva may have manufactured the
Gianvi ingested by the plaintiff. Any such allegations, however, amount to mere speculation.
Further, even if sufficiently alleged, the contention would merely establish that Teva was a generic
manufacturer. For reasons discussed below, the assertion that Teva is a generic manufacturer (as
opposed to a generic distributor) does not help the plaintiff’s case and does not alter the Court’s
analysis.
4
The plaintiff argues that the alleged agreement involving Bayer and Barr/Teva establishes that
Teva and Bayer were acting in concert and are jointly and severally liable for the plaintiff’s alleged
injuries. The Court addresses this issue below.

5

demonstrates that there are no material issues of fact to be resolved will a court
grant a Rule 12(c) motion. Brunt v. Serv. Employees Int'l Union, 284 F.3d 715,
718-719 (7th Cir. 2002) ( citing N. Indiana Gun & Outdoor Shows, Inc. v. City of
South Bend, 163 F.3d 449, 452 (7th Cir.1998)). Although the court should accept
as true all well-pleaded allegations and should view the complaint in a light most
favorable to the plaintiff, the “[f]actual allegations must be enough to raise a right
to relief above the speculative level.” Twombly, 550 U.S. at 555.
If the Court considers evidence outside the pleadings, a motion for
judgment on the pleadings is treated as one for summary judgment. FED. R. CIV.
P. 12(d). However, a district court may take judicial notice of matters of public
record without converting a Rule 12 motion into a motion for summary judgment.
Gen. Elec. Capital Corp. v. Lease Resolution Corp., 128 F.3d 1074, 1080 (7th
Cir.1997). Further, a court may consider “documents attached to a motion to
dismiss * * * if they are referred to in the plaintiff's complaint and are central to
his claim.” Brownmark Films, LLC v. Comedy Partners, 682 F.3d 687, 690 (7th
Cir.2012) (internal quotation omitted).
IV. DISCUSSION
A. Preemption
Teva asserts that it is entitled to judgment on the pleadings because the
plaintiff’s state tort claims are preempted by federal law. The Supremacy Clause
states that federal law “shall be the supreme Law of the Land ... and any Thing in
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the Constitution or Laws of any State to the Contrary notwithstanding.” U.S.
Const. art. VI, cl. 2. Implied preemption, the type of preemption at issue in this
motion, occurs when it is “impossible for a private party to comply with both state
and federal requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115
S.Ct. 1483, 131 L.Ed.2d 385 (1995). In other words, when state law requires
what federal law forbids, state law must give way. See Wyeth v. Levine, 555 U.S.
555, 583, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).
Federal preemption is an affirmative defense upon which the defendants
bear the burden of proof. Village of DePue, III v. Exxon Mobil Corp., 537 F.3d
775, 786 (7th Cir. 2008).
B. The Hatch-Waxman Act
The labeling of prescription drugs is governed by the Federal Food, Drug,
and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq. Pursuant to the FDCA, before
bringing any new drug to market, approval must be obtained by filing a New-Drug
Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”). To
secure the approval of the FDA, a manufacturer of a new drug must file an
application demonstrating the drug is safe, effective, and adequately labeled. 21
U.S.C. § 355(b), (d); 21 C.F.R. § 314.1 et seq. The NDA process is time
consuming, arduous and expensive.
In 1984, Congress passed the Drug Price Competition and Patent Term
Restoration Act, 98 Stat. 1585, commonly known as the Hatch-Waxman Act. The
7

Act amended the FDCA to permit generic drug manufacturers to bypass the
approval

practice

by

submitting

an

“abbreviated

new drug

application”

(“ANDA”)—an application showing the proposed generic drug to be the same as a
reference listed drug (“RLD”) that has already gained FDA approval. 21 U.S.C. §
355(j)(2); 21 C.F.R. § 314.94. This abbreviated process allows generic drug
manufacturers “to gain FDA approval simply by showing that its drug is
equivalent to an already-approved brand-name drug, and that the safety and
efficacy labeling proposed for its drug is the same as that approved for the brandname drug.” PLIVA Inc. v. Mensing, 131 S.Ct. 2567, 2574, 180 L.Ed.2d 580
(2011).
Under this streamlined approach, the generic must be bioequivalent to and
have the same labeling as the RLD. 21 U.S.C. § 355(j)(2)(A)(iv), (v); 21 C.F.R. §
314.94(a)(7), (8). The Supreme Court recently provided the following summary
with regard to the ANDA process:
First, the proposed generic drug must be chemically equivalent to the
approved brand-name drug: it must have the same “active ingredient”
or “active ingredients,” “route of administration,” “dosage form,” and
“strength” as its brand-name counterpart. 21 U.S.C. §§
355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be
“bioequivalent” to an approved brand-name drug. § 355(j)(2)(A)(iv).
That is, it must have the same “rate and extent of absorption” as the
brand-name drug. § 355(j)(8)(B). Third, the generic drug
manufacturer must show that “the labeling proposed for the new
drug is the same as the labeling approved for the [approved brandname] drug.” § 355(j)(2)(A)(v).
Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466, 2471 (2013).

8

After a generic or brand-name drug is approved, “the manufacturer is
prohibited from making any major changes to the ‘qualitative or quantitative
formulation of the drug product, including active ingredients, or in the
specifications provided in the approved application.’ ” Bartlett, 133 S.Ct. at 2471
(quoting 21 C.F.R. § 314.70(b)(2)(i)). Generic manufacturers (but not brand-name
manufacturers) “are also prohibited from making any unilateral changes to a
drug's label,” thus “approval for a generic drug may be withdrawn if the generic
drug's label is no longer consistent with that for the brand name drug.” Id.
(quotation and alteration omitted) (citing 21 C.F.R. §§ 314.94(a)(8)(iii),
314.150(b)(10)).
C. Levine, Mensing and Bartlett
Three decisions of the United States Supreme Court, Wyeth v. Levine, 555
U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), PLIVA, Inc. v. Mensing, 131
S.Ct. 2567, 180 L.Ed.2d 580 (2011), and Mutual Pharm. Co. v. Bartlett, 133
S.Ct. 2466 (2013) are at the center of recent products liability actions alleging
inadequate warnings by drug manufacturers, including this one.
In Levine, the plaintiff developed gangrene after using the intravenous form
of Phenergan, an antihistamine used to treat nausea. The plaintiff filed an action
against the brand-name manufacturer alleging negligence in connection with the
drug’s warning label. Ultimately, the Supreme Court considered and rejected the
brand-name manufacturer’s claim that it would have been impossible to comply
with its state law duty to warn without violating FDCA and FDA regulations. The
9

Supreme Court concluded that the brand-name manufacturer could have
unilaterally strengthened its warnings without prior FDA approval through the
“changes being effected” process, 21 D.F.R. § 314.70(c)(6)(iii), which enables
certain labeling changes to be implemented simultaneous to submitting the
changes to the FDA for review.
The fact that the manufacturer in Levine was a brand-name manufacturer,
with the ability to “unilaterally strengthen its warning”, was critical to the
Supreme Court’s decision on preemption. See Levine, 555 U.S. at 573. See also
Mensing, 131 S.Ct. at 2581 (no preemption in Levine because federal regulation
allowed brand-name manufacturer to unilaterally strengthen its warning without
prior FDA approval). Two years later, in Mensing, the Supreme Court would
reach a different result with regard to generic manufacturers.
In Mensing, the plaintiffs were prescribed brand-name metoclopramide, a
drug commonly used to treat digestive tract problems. Mensing, 131 S.Ct. 257273. The plaintiffs alleged that their use of the drug caused them to develop tardive
dyskinesia, a severe neurological disorder. Id. at 2573.
Although the plaintiffs were prescribed brand-name metoclopramide, their
prescriptions were ultimately filled with generic metoclopramide. Id. The plaintiffs
brought failure to warn claims against the generic manufacturers. Id. The
plaintiffs alleged the generic manufacturers violated state tort laws by failing to
change the labels for metoclopramide to adequately warn of the risk of tardive

10

dyskinesia. Id. The state tort laws involved required manufacturers that are “or
should be aware of [their] product's danger to label that product in a way that
renders it reasonably safe.” Id. at 2573
The Supreme Court concluded that the plaintiffs’ claims were preempted by
federal law, specifically, the Hatch-Waxman Act. Id. at 2577-78. In so ruling, the
Supreme Court deferred to the FDA’s interpretation of its regulations that, under
the Hatch-Waxman Amendments, the labeling of a generic drug must be the same
as the labeling of the RLD. Id. at 2574-76 (accepting the FDA's interpretation that
changes unilaterally made by a generic manufacturer would violate federal
requirements that the generic label be the same as the brand-name label). The
Supreme Court explained that this ““federal duty of ‘sameness' “ requires “generic
drug labels be the same at all times as the corresponding brand-name drug
labels.” Id. at 2574–75, 2578. Accordingly, “[i]f the [generic] Manufacturers had
independently changed their labels to satisfy their state-law duty, they would have
violated

federal

law.” Id. at

2578.

In

other

words,

unlike

brand-name

manufacturers, generic manufacturers have no ability to unilaterally alter a drug’s
warning label. 5

5

The plaintiff alleges in her complaint that she “was injured years after the implementation of the
Food and Drug Administration Amendment Act of 2007 (“FDAAA”) Pub. L. No. 110-85” (Doc. 20 ¶
98). As such, she contends, Teva had the power to unilaterally seek a label change to Gianvi (Doc.
20 ¶ 98). The Court notes that in Mensing the Supreme Court relied on pre–2007 FDA statutes
and regulations and “express[ed] no view on the impact of the 2007 Act.” Mensing, 131 S.Ct.
2572. The plaintiff, however, fails to address this issue in her briefing. Further, The Court has
reviewed the 2007 Amendments to the FDCA, and the statutes and regulations cited in Mensing
appear to be unaltered. Accordingly, the Court finds that the 2007 FDCA Amendments do not
remove this case from Mensing's scope.

11

Shortly thereafter, in Bartlett, the Supreme Court again addressed the
tension between state tort law and the federal regulatory scheme governing
prescription drugs in a case involving generic manufacturers. Bartlett involved a
generic manufacturer and state-law design-defect claims that turned on the
adequacy of a drug’s warnings. The Supreme Court held that the reasoning of
Mensing extends to “warning-based design-defect cause[s] of action” asserted
against generic manufacturers. Bartlett, 133 S.Ct. at 2477.
The Supreme Court also extended the reasoning in Mensing to claims
asserting that a generic drug is ineffective or unreasonably dangerous. “In the
drug context, either increasing the ‘usefulness' of a product or reducing its ‘risk of
danger’ would require redesigning the drug: A drug's usefulness and its risk of
danger are both direct results of its chemical design and, most saliently, its active
ingredients.” Bartlett, 133 S.Ct. at 2475. But “the FDCA requires a generic drug
to have the same active ingredients, route of administration, dosage form,
strength, and labeling as the brand-name drug on which it is based.” Id. (citing 21
U.S.C. §§ 355(j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. § 320.1(c)). 6
Levine, Mensing and Bartlett establish a distinction between generic and
brand manufacturers that is critical to the instant case. In a nutshell, the brand
manufacturer has the ability to make unilateral changes to a drug’s warning label.
Accordingly, failure-to-warn claims against brand manufacturers are not
6

Under Bartlett, there is some room for argument relating to state law claims that impose a duty
to make changes to the qualitative or quantitative formulation of a drug product (including active
ingredients, or in the specifications provided in the approved application) that do not constitute
“major” changes. This, however, does not appear to be a matter in issue in the present case.

12

preempted by federal law. Generic manufacturers, on the other hand, have no
such ability. When it comes to strengthening a drug’s warning label, generic
manufacturers’ hands are tied because the “ongoing federal duty of ‘sameness'”
precludes manufacturers of generic drugs from unilaterally strengthening their
labeling. Mensing, 131 S.Ct. at 2575–82. Accordingly, in Mensing, the Supreme
Court concluded that state law failure to warn claims involving generic
manufacturers are preempted. In Bartlett the Supreme Court held that the
reasoning of Mensing extends to “warning-based design-defect cause[s] of action”
asserted against generic manufacturers. Bartlett, 133 S.Ct. at 2477. The Bartlett
decision also extends the reasoning of Mensing to claims asserting that a generic
drug is ineffective or unreasonably dangerous – at least to the extent that such
claims impose a duty to redesign the drug in issue that conflicts with federal
regulations. Id. at 2474-2475.
D. Preliminary Consideration – Applicability of Mensing and Bartlett to
Generic Distributors
The Court notes that both Mensing and Bartlett involved generic
manufacturers and not generic distributors. Thus, as an initial matter, the Court
must consider whether Mensing and Bartlett are applicable to Teva – the
distributor of a generic drug. As noted above, the rationale for excusing generic
manufacturers from liability is that generic manufacturers do not have the ability
to unilaterally effectuate a label change. Mensing, 131 S.Ct. at 2575-76. Only
brand manufacturers have the ability to take unilateral action to strengthen a
drug’s warning label. Id. This rationale is equally applicable to generic
13

distributors. Under applicable federal regulations, generic distributors have no
more authority than generic manufacturers to alter a drug’s composition, label, or
design. Accordingly, the principles announced in Mensing and Bartlett are
equally applicable to generic distributors.
E. Joint Liability
Plaintiff contends that regardless of whether Bartlett or Mensing would
preempt Illinois tort claims, neither decision applies here, because Bayer and
Teva are subject to joint and several liability (Doc. 28 pp. 5-10). Plaintiff contends
that the Gianvi she ingested was produced in accord with a December 2010
licensing agreement between Bayer and Barr/Teva pursuant to which Bayer agreed
to supply Barr with the product for Gianvi. As such, the plaintiff argues, the
Gianvi she ingested was manufactured, licensed, and sold pursuant to an
agreement between Bayer and Teva. The plaintiff reasons as follows with respect
to this agreement and the alleged joint liability of Bayer and Teva:
In Mensing, the dissent explained that Mensing did not bar claims
against a brand name manufacturer that produces generic drugs.
Mensing, 131 S. Ct. at 2589, n.12 (Sotomayor, J., dissenting). “In
that case, the manufacturer could independently change the brandname label … triggering a corresponding change to its own generic
label.” Id. Thus, when a brand name manufacturer is involved in the
production of a generic drug, Mensing and Bartlett are inapplicable.
… Bayer, as the brand-name manufacturer, had the ability to make
changes to Yaz without violating the “sameness” requirement of the
FDCA. A change to Yaz would have triggered a corresponding change
in Gianvi pursuant to the very same “sameness” requirement upon
which Teva bases its purported right to judgment. (Def. Mem. at 4.)
Accordingly, impossibility preemption does not apply to Plaintiff’s
14

claims against Bayer. As Bayer and Teva jointly participated in the
manufacture, marketing, and sale of Gianvi, they are joint tortfeasors
who acted in concert to cause Plaintiff’s injuries, and are jointly and
severally liable for her damages.
(Doc. 28 p. 5).
The plaintiff’s argument fails as a matter of law for two reasons. First, the
fact that Mensing does not bar claims against a brand-name manufacturer that
produces generic drugs only speaks to Bayer’s liability. Second, the existence of
the alleged supply and distribution agreement between Bayer and Teva does not
change the fact that Teva had no authority to make unilateral changes to Gianvi’s
label. At most, Teva could have sought assistance from the FDA in convincing
Bayer to adopt a stronger label for Yaz so it could do the same with regard to
Gianvi. The same is true with regard to Teva’s ability to alter Gianvi’s design or
composition. Considering the above, the Court finds that the plaintiff’s joint
liability argument does not remove this case from the scope of Mensing or
Bartlett.
F. Analysis of Specific Counts
In light of the Court’s conclusion that both Mensing and Bartlett are
applicable to the instant case, the Court will now assess whether Teva has
established preemption with regard to the relevant counts of the plaintiff’s
complaint.

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1. Count II Strict Products Liability – Design Defect
a. Illinois Design Defect Claims and Duty
The plaintiff notes that in Bartlett the design defect claim in issue “place[d]
a duty on manufacturers to render a drug safer by either altering its composition
or altering its labeling.” Bartlett, 133 S. Ct. at 2479. According to the plaintiff,
Illinois’ design defect law “imposes no affirmative duty [on manufacturers], and
instead serves to spread risk” (Doc. 28 p. 12). Accordingly, the plaintiff argues,
Bartlett does not preempt Illinois design defect claims. The plaintiff misconstrues
Illinois’ strict liability law, and in so doing she actually forwards the very
argument that was rejected by the Supreme Court in Bartlett.
In 2012, the Appellate Court of Illinois reaffirmed the principle that “in a
strict liability cause of action, ‘a manufacturer is under a nondelegable duty to
produce a product which is reasonably safe.’” Baley v. Fed. Signal Corp., 982
N.E.2d 776, 798 (Ill. App. 2012) (quoting Rios v. Niagara Machine & Tool Works,
319 N.E.2d 232, 235-36 (Ill. 1974)). Baley involved a number of strict liability
claims against a manufacturer, including design defect claims. Id. at 789-90. The
Court acknowledged that “duty is typically an element of negligence,” but pointed
to a line of Appellate Court decisions “recogniz[ing] that in strict liability actions a
manufacturer has a duty to produce a reasonably safe product.” Id. at 798-99.
In a 1990 strict liability case brought against a drug manufacturer, the
Illinois Supreme Court was even more explicit that duty is an element of both
16

negligence and strict liability in Illinois: “Both negligence and strict liability
require proof that [a] defendant breached a duty owed to a particular plaintiff.
Each manufacturer owes a duty to plaintiffs who will use its drug or be injured by
it.” Smith v. Eli Lilly & Co., 560 N.E.2d 324, 343 (1990) (internal citations
omitted).
To refute these authorities, the plaintiff offers an argument from silence.
She points to a 2008 Appellate Court decision involving a strict liability claim
against an automobile dealer, Murphy v. Mancari's Chrysler Plymouth, Inc., 887
N.E.2d 569 (Ill. App. 2008), and notes that “[t]he word ‘duty’ is mentioned
nowhere in the Murphy decision.” (Doc. 28 at 12). But Murphy does not hold, or
even suggest, that duty is not an element of strict liability claims in Illinois.
Instead, Murphy focuses on the difference between strict liability and negligence,
noting that fault is an element of the latter but not the former. Id. at 574-75. 7
Fault and duty are distinct concepts. By conflating them, the plaintiff makes the
same error that the Supreme Court addressed in Bartlett.
The plaintiff argues that, because strict liability in Illinois does not require
a finding of negligence, “Teva’s liability is not based on a breach of duty….” (Doc.
28 at 12-13). But the Supreme Court considered, and rejected, this very argument
in Bartlett. 133 S.Ct. at 2473-74. The respondent in Bartlett argued that New
Hampshire’s strict liability law imposes no affirmative duties on manufacturers.
7

Plaintiff’s citations to Connelly v. Uniroyal, Inc., 389 N.E.2d 155, 163 (Ill. 1979), and Liberty
Mut. Ins. Co v. Williams Mach. & Tool Co., 338 NE.2d 857, 860 (Ill. 1975), likewise do not
support her conclusion that duty is not an element of strict liability, as those cases, like Murphy,
only repeat the principle that strict liability is distinct from negligence. (Doc. 28 at 13).

17

Id. at 2473. The Court’s subsequent discussion of the relationship between strict
liability and duty is just as applicable to the law of Illinois as to the law of New
Hampshire.
[The] respondent's argument conflates what we will call a “strictliability” regime (in which liability does not depend on negligence, but
still signals the breach of a duty) with what we will call an “absoluteliability” regime (in which liability does not reflect the breach of any
duties at all, but merely serves to spread risk). New Hampshire has
adopted the former, not the latter. Indeed, the New Hampshire
Supreme Court has consistently held that the manufacturer of a
product has a duty to design his product reasonably safely for the
uses which he can foresee.
Id. (internal quotation marks omitted). Just as in New Hampshire, Illinois’ strict
liability does not mean that manufacturers have no affirmative duties. As
discussed above, Illinois manufacturers have a duty “to produce a product that is
reasonably safe.” Baley, 982 N.E.2d at 798. 8
Bartlett also helps answer the plaintiff’s contentions with regard to
Halperin v. Merck, Sharpe & Dohme Corp., 2012 WL 1204728 (N.D. Ill. Apr. 10,
2012). In Halperin, a United States district court interpreted Illinois’ strict
liability law as imposing liability “regardless of culpability, duty, knowledge, or
fault.” Id. at *3. 9 But Halperin was decided before the Supreme Court decided
Bartlett. Referring to PLIVA, Inc. v. Mensing, 131 S.Ct 2567 (2011), the Halperin

8

As the defendant points out, Baley’s description of an Illinois manufacturers’ duty is remarkably
similar to how Bartlett defined the duty of New Hampshire manufacturers: “New Hampshire tort
law…requires manufacturers to ensure the products they design, manufacture, and sell are not
unreasonably dangerous.” Bartlett, 131 S.Ct. at 2474 (emphasis added).
9
At the outset it must be noted that a federal district court’s interpretation of state law must give
way to a contrary interpretation by the state supreme court. Allstate Ins. Co. v. Menards, Inc., 285
F.3d 630, 633 (7th Cir. 2002) (“[T]he ultimate responsibility of the district courts is to apply the
law of the state in which the court sits”).

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court noted that “[n]either the Mensing opinion, nor the underlying proceedings in
the Fifth and Eighth Circuits, directly address strict liability design defect claims.”
Id. In other words, Mensing left open the question of whether preemption
concerns are avoided where a state imposes strict liability for design defects. But
Bartlett did directly address strict liability design defect claims, and explicitly
held that the state law claim was preempted. 133 S.Ct. at 2468.

Thus, the

reasoning of Halperin does not survive Bartlett.
b. Consumer Expectation Test and Risk-Utility Test
The plaintiff also contends that Bartlett is not controlling because Illinois
assesses the unreasonableness of the danger of a product using a consumerexpectations test while the state whose tort laws Bartlett interprets, uses a riskutility approach. The Court concludes that this is a distinction without a
difference.
In Illinois, “unreasonable dangerousness” can be established using either
the risk-utility test or the consumer expectation test. See Mikolajcyzyk v. Ford
Motor Co., 901 N.E.2d 329, 348 (Ill. 2008). Importantly, the two tests are not
separate theories of liability, but rather two different ways whereby a plaintiff can
prove the same ground of liability – unreasonable dangerousness. The plaintiff’s
implicit argument is that the content of the duty imposed by Illinois law is
different from the law at issue in Bartlett because Illinois uses the consumer
expectations test. However, because the two tests are simply alternative methods

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of proof, the content of the underlying duty is the same. Moreover, the Fourth
Circuit Court of Appeals has considered and rejected the very argument raised by
the plaintiff. In Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014), the
Fourth Circuit reasoned as follows:
To the extent that there is a difference in approach between the two
states, it is immaterial. The Court in Bartlett did not determine that
the New Hampshire law was preempted because it applied the riskutility approach. Instead, it concluded that there was no action that
the defendant could take under that approach to increase the safety
of its product without violating the restrictions of the [Food, Drug,
and Cosmetics Act, 21 U.S.C. §§ 301 et seq. ]. We have no trouble
concluding that the same is true under either the risk-utility or the
consumer-expectations approach in Maryland. PLIVA cannot be
required to stop selling its product, but at the same time it is
prohibited from making any changes to the product itself or the
accompanying warnings. Regardless of the way in which Maryland
assesses the unreasonableness of a product's risks, if PLIVA's
metoclopramide is unreasonably unsafe, there is no apparent action
that PLIVA can take in compliance with FDCA restrictions to avoid
strict liability.
Id. (footnotes omitted). The plaintiff urges the Court to look to the Eighth Circuit’s
opinion in Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir. 2013). In Fullington,
the Eighth Circuit remanded the design defect claims brought under the
consumer expectation test for further consideration in light of Bartlett. On
remand, however, the district court agreed with the Fourth’s Circuit’s analysis in
Drager See Fullington v. Pliva, Inc. 2014 WL 806149, 3 (E.D. Ark. Feb. 28,
2014) (Holmes, J) (“The Fourth Circuit is Correct, whether a state follows the
risk-utility approach or the consumer-expectations approach does not affect the
application of Bartlett.”). The undersigned also agrees with the Fourth Circuit’s
conclusions as to the consumer expectation test.
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c. Federal Misbranding Statute
In Bartlett, the Supreme Court expressly noted an exception for state law
claims that parallel the federal misbranding statute. Bartlett 133 S.Ct. 2477 n.4
(“We do not address state design-defect claims that parallel the federal
misbranding statute.”). The federal statute requires a manufacturer to pull a drug
from the market (even though approved by the FDA) if it is “dangerous to health”
even when used in accordance with the FDA-approved directions. Id.; cf. 21
U.S.C. § 352(j). This exception only applies where the plaintiff’s claim is based on
scientific information that was not available when the drug was approved by the
FDA. Bartlett, 131 S.Ct. 2477 n.4.
In the instant case, the plaintiff alleges that “the Gianvi birth control pills,
as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, were dangerous to health when used in the dosage,
manner, or with the frequency or duration prescribed, recommended and/or
suggested in its labeling, in violation of 410 ILCS § 620/3, et seq. As such, the sale
of such drugs in this state was strictly prohibited” (Doc. 20 ¶ 134). The plaintiff
also sets forth allegations regarding Gianvi’s allegedly dangerous design that
purportedly was not available to the FDA (Doc. 20 ¶¶ 38-48). The plaintiff
contends that “unlike in Bartlett, the jury will be asked to find whether new
evidence concerning Gianvi that had not been made available to the FDA rendered
Gianvi so dangerous as to be misbranded under the federal misbranding statute”
(Doc. 28 p. 15).
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Considering this argument, the Court finds that, to the extent the plaintiff’s
design defect claim parallels the federal misbranding statute, it is not foreclosed
by Bartlett.
d. Conclusion
Accordingly, as to Teva, Count II Strict Products Liability – Design
Defect – the motion for judgment on the pleadings is DENIED. The plaintiff’s
design defect claim may proceed to the extent that the claim parallels the
federal misbranding statute.
2. Count III Defect Due to Inadequate Warning
The plaintiff admits that, if the Court does not accept her joint liability
argument, this claim is preempt as to Teva under Mensing (Doc. 28 p. 18). For
reasons already discussed, the court finds that Mensing applies to preempt
failure-to-warn claims asserted against Teva, a generic distributor, despite the
plaintiff’s joint liability argument.
Accordingly, as to Teva, Count III Defect Due to Inadequate Warning is
Dismissed with prejudice.
3. Remaining Claims
As previously noted, federal preemption is an affirmative defense upon
which the defendants bear the burden of proof. Village of DePue, III v. Exxon
Mobil Corp., 537 F.3d 775, 786 (7th Cir. 2008). A proper inquiry into the issue of
22

federal preemption requires a separate analysis of each state law claim to
determine whether preemption applies. The Court finds that, as to the remaining
counts, Teva has not met its burden of proof with regard to federal preemption.
Teva merely asks the Court to construe all of the plaintiff’s claims as failure to
warn claims and to conclude that the claims are preempt under Mensing. This is
not sufficient. In order to meet its burden, Teva must identify the state law duties
associated with the remaining causes of action and provide the Court with an
analysis of how those duties conflict with federal law.
Therefore, the motion for judgment on the pleadings as to the following
counts is DENIED:
Count I Strict Products Liability – Defective Manufacturing
Count IV Negligence and Negligent Misrepresentation
Count VI Fraud and Misrepresentation
Count VIII Breach of Express Warranty
Count IX Violation of the Illinois Consumer Fraud and Deceptive
Business Practices Act

SO ORDERED:
Digitally signed by
David R. Herndon
Date: 2014.04.23
17:20:19 -05'00'

Chief Judge
United States District Court

Date: April 23, 2014

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