Tsavaris v. Pfizer Inc. et al

Filing 79

ORDER granting 41 Motion to Dismiss for Failure to State a Claim and granting 63 Motion for Judgment on the Pleadings. Signed by Chief Judge K. Michael Moore on 1/7/2016. (mg00)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
Case No. 1:15-cv-21826-KMM
MAGGIE TSAVARIS,
Plaintiff,
vs.
PFIZER, INC., WYETH, Inc. and its
divisions WYETH PHARMACUETICALS,
INC. AND ESI LEDERLE, and WYETH
LLC.; NOVO NORDISK A/S, a Denmark
corporation; NOVO NORDISK, INC., a
Delaware corporation; BRECKENRIDGE
PHARMACUETICAL, Inc., a Delaware
corporation,
Defendants.
/
OMNIBUS ORDER GRANTING BRECKENRIDGE’S MOTION FOR JUDGMENT ON
THE PLEADINGS AND NOVO NORDISK’S MOTION TO DISMISS
This cause is before the Court on Defendant Breckenridge Pharmaceutical, Inc.’s
(“Breckenridge”) Motion for Judgment on the Pleadings (ECF No. 63) and Defendant Novo
Nordisk Inc.’s (“Novo Nordisk”) Motion to Dismiss (ECF No. 41). Upon consideration of the
motions, pertinent portions of the record, and being otherwise fully advised in the premises, the
Court enters the following order.
I.

BACKGROUND
This is an action by Plaintiff Maggie Tsavaris against several pharmaceutical companies,

including Defendants Novo Nordisk and Breckenridge, for designing, manufacturing, and
distributing Hormone Therapy Replacement (“HRT”) drugs that Plaintiff alleges caused her to
develop breast cancer. Am. Comp. ¶ 1 (ECF No. 30). Specifically, Plaintiff is suing Novo
Nordisk as the brand name manufacturer, distributor, and seller of the HRT drug Activella. Id. at

¶¶ 1, 5–6. Plaintiff is suing Breckenridge as the manufacturer, distributor, and seller of the
generic version of Activella, estradiol/norethindrone acetate (1.0mg/0.5mg). Id. at ¶¶ 1, 5, 8.
Plaintiff is suing both Defendants for strict products liability based on defective design (Count
II), negligence (Count VI), and negligent misrepresentation (Count VIII). And Plaintiff is suing
Novo Nordisk individually for strict products liability based on a failure to warn (Count IV).
Plaintiff is also suing Pfizer, Inc. and Wyeth LLC (the “Wyeth Defendants”) as the
manufacturers of the HRT drug Prempro for strict products liability based on defective design
and failure to warn (Counts I and III), negligence (Count V), and negligent misrepresentation
(Count VII).1 As relief for her injuries, Plaintiff seeks compensatory and punitive damages,
attorney’s fees and costs, and a recall of Prempro and Activella. Id. at ¶ 72.
While Plaintiff was going through menopause, she experienced severe hot flashes and
night sweats. Id. at ¶ 14.2 Plaintiff’s physician, Dr. Ellen Schwartzbard, prescribed Plaintiff a
combination of HRT drugs to alleviate her symptoms. Id. at ¶ 14.
On January 21, 2005, Dr. Schwartzbard gave Plaintiff a prescription for the HRT drug
Prempro (0.45mg/1.5mg). Id. at ¶ 18. As previously mentioned, Prempro is manufactured and
distributed by the Wyeth Defendants. Id. at ¶ 3. On or before January 21, 2005, Plaintiff
informed Dr. Schwartzbard that her mother had developed breast cancer at age 79 or 80. Id. at ¶

1

The Court will address the motion to dismiss filed by the Wyeth Defendants by separate order.
The facts relevant to the Wyeth Defendants are included in this section in order to give Plaintiff’s
full medical history.
2

Menopause describes a time in the natural aging process of a woman when her body’s
production of the natural hormones such as progesterone and several types of human estrogens is
dramatically reduced. Am. Compl. at ¶ 13. The physical symptoms of these decreased levels of
estrogen and progesterone can include any one or a combination of the following: mood swings,
hot flashes, loss of bone density, depression, irritability, night sweats, vaginal dryness, and
forgetfulness. Id. These symptoms range from severe and disabling in some women to a minor
inconvenience or even nonexistent for other women. Id.
2

19. Dr. Schwartzbard informed Plaintiff that her mother’s age at the time of her breast cancer
was too advanced to be considered a factor as to any family history of breast cancer. Id.
On March 28, 2005, Plaintiff was asked by one of the partners in Dr. Schwartzbard’s
practice to discontinue Prempro because he believed that Plaintiff’s ovaries were producing
hormones. Id. at ¶ 20. Plaintiff discontinued taking Prempro at that time, but at a follow-up visit
six weeks later, probably began taking Prempro again because on November 3, 2005, Dr.
Schwartzbard wrote during an office visit that Plaintiff “stopped taking Prempro 4 months ago . .
. and notices changes in her breasts.” Id. That would mean that Plaintiff stopped taking Prempro
around July 3, 2005. Id. Dr. Schwartzbard also noted that, during this office visit, she discussed
“[r]isks and benefits of both pill and HRT . . . including heart attack, stroke, and breast cancer.”
Id. According to the Amended Complaint, Dr. Schwartzbard “always advised” Plaintiff “that the
studies showing breast cancer risks included an entirely different group of older woman [sic] and
that the risks of breast cancer were very remote and insignificant compared to the quality of life
that the HRT drugs could provide to [Plaintiff].” Id. Plaintiff ceased taking Prempro around
July 2005 and did not resume taking the drug again.
From July 2005 to August 2008, Plaintiff did not take any HRT drugs. Id. at ¶ 22. On
September 17, 2008, and continuing through December 31, 2009, Plaintiff was prescribed
Activella (1.0mg/0.5mg). Id. at ¶ 23. As previously mentioned, the brand name version of
Activella is manufactured and distributed by Novo Nordisk. Id. at ¶¶ 1, 6–7. While Plaintiff was
prescribed Activella, she never took the brand name version of the drug. Id. at ¶ 23. Instead, the
pharmacy provided Plaintiff with the generic version of Activella—estradiol/norethindrone

3

acetate (1.0mg/0.5mg).3 Id. Breckenridge manufactured the generic version of Activella taken
by Plaintiff. Id. at 8.
Again, when Dr. Schwartzbard prescribed Plaintiff Activella, she advised her “that the
studies showing breast cancer risks included a different group of women and that the risks of
breast cancer were very remote and insignificant compared to the quality of life that the HRT
drugs could provide to [Plaintiff].” Id. at ¶ 23.
From December 2009 to February 2010, Plaintiff did not take any HRT drugs. Id. at ¶
25. In March 2010, Plaintiff was again prescribed Activella (1.0mg/0.5mg) and was again given
Breckenridge’s generic version of Activella, estradiol/norethindrone acetate (1.0mg/0.5mg). Id.
Plaintiff continued to take Breckenridge’s generic from December 2010 through May 2013. Id.
On January 31, 2012, Plaintiff’s prescription for Activella was reduced from
(1.0mg/0.5mg) strength tablets to one (0.5mg/0.1mg) strength tablet once daily, and Plaintiff
began to take Breckenridge’s generic version of Activella, estradiol/norethindrone acetate
(0.5mg/0.1mg). Id. at ¶ 26.
On May 15, 2013, Plaintiff was diagnosed with breast cancer and was advised by the
diagnosing radiologist to immediately cease taking any HRT drugs, which she did. Id. at ¶ 27.
Pathology results from tests conducted on or sometime after May 21, 2013, showed that
Plaintiff’s type of breast cancer was invasive ductal carcinoma and was both estrogen and
progesterone receptor positive. Id. at ¶ 28. This is commonly referred to as “hormone receptor
positive breast cancer.” Id. The reports also showed negative for HER2 (a gene mutation that is
not inherited) and negative for BRCA1 and BRCA2 (genes that are inherited). Id.

3

Pharmacists in most states, including Florida, are under a duty to substitute the generic version
of a drug for the brand name version written on the prescription, unless the prescribing physician
or the patient specifically request otherwise. See Resp. to Mot. to Dismiss, at 6 (ECF No. 48).
4

Hormone receptor positive breast cancer requires hormones to fuel its growth. Id. at ¶ 29.
Plaintiff was hormone deficient prior to taking Prempro and Activella, as evidenced by her
hormone deficient symptoms, including hot flashes and night sweats. Id. at ¶¶ 30–31. Plaintiff
claims that she did not have the endogenous hormones to fuel the growth of hormone receptor
positive breast cancer prior to taking Prempro and Activella. Id. at ¶ 30. Furthermore, had she
not ingested exogenous hormones via the HRT drugs, she would not have had the hormones to
fuel the growth of hormone receptor positive breast cancer, and she would not have developed
hormone receptor positive breast cancer. Id. at ¶ 31.
Plaintiff filed the instant case on May 14, 2015 claiming that Defendants’ HRT drugs
caused her breast cancer and that Defendants knew or should have known of the risk of breast
cancer of their HRT drugs. Breckenridge moves for judgement on the pleadings while Novo
Nordisk moves to dismiss. The Court will address each motion separately.
II.

BRECKENRIDGE’S MOTION FOR JUDGMENT ON THE PLEADINGS
Breckenridge is moving for judgment on the pleadings arguing that Plaintiff’s claims for

strict products liability, negligence, and negligent misrepresentation are preempted by federal
law and further fail to meet the applicable pleading standard. Specifically, Breckenridge argues
that “Plaintiff fails to identify any action that could have been taken by Breckenridge to cure the
alleged defect in the generic version of Activella, or to cure the allegedly defective warnings or
misrepresentations made to the prescriber, given that federal law prohibits Breckenridge from
making changes to either the chemical composition of the generic version of Activella or its
labeling.” Mot. for J. on the Pleadings (“Mot. for J.”), at 4 (emphasis in original) (ECF No. 63).
Plaintiff responds that federal law does not preempt her claims because they are not failure to
warn claims. Resp. to Mot. for J., at 3 (ECF No. 65). Plaintiff further focuses on the actions that
Breckenridge could have taken “prior to FDA approval” to design a safer drug. Id. at 3–4.
5

A. Legal Standard
Federal Rule of Civil Procedure 12(c) provides that “[a]fter the pleadings are closed—
but early enough not to delay trial—a party may move for judgment on the pleadings.” Fed. R.
Civ. P. 12(c). “Judgment on the pleadings is appropriate where there are no material facts in
dispute and the moving party is entitled to judgment as a matter of law.” Cannon v. City of W.
Palm Beach, 250 F.3d 1299, 1301 (11th Cir. 2001). When the defendant is the movant, “[a]
motion for judgment on the pleadings is governed by the same standard as a motion to dismiss
for failure to state a claim on which relief may be granted.” Black v. Kerzner Int’l Holdings Ltd.,
958 F. Supp. 2d 1347, 1349 (S.D. Fla. 2013).
As a result, all material facts alleged in the non-moving party’s pleading are accepted as
true and must be viewed in the light most favorable to the non-moving party. Perez v. Wells
Fargo N.A., 774 F.3d 1329, 1335 (11th Cir. 2014). “If a comparison of the averments in the
competing pleadings reveals a material dispute of fact, judgment on the pleadings must be
denied.” Id.
B. Legal Background
Before turning to the merits of Breckenridge’s Motion, the Court will give a brief
background of the relevant federal pharmaceutical regulations and how these regulations have
impacted claims against generic drug manufacturers.
i.

Federal Pharmaceutical Regulations

Federal law heavily regulates the pharmaceutical industry. “Under the Federal Food,
Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq.,
drug manufacturers must gain approval from the United States Food and Drug Administration
(FDA) before marketing any drug in interstate commerce.” Mutual Pharm. Co. v. Bartlett, 133
S. Ct. 2466, 2470 (2013) (citing 21 U.S.C. § 355(a)). In order to gain FDA approval for a new
6

brand name drug, a manufacturer must prove that the new drug “is safe and effective and that the
proposed label is accurate and adequate.” See Pliva v. Mensing, 131 S. Ct. 2567, 2574 (2011)
(citing 21 U.S.C. §§ 355(b)(1), (d); Wyeth v. Levine, 555 U.S. 555, 567 (2009)). Meeting these
requirements involves “costly and lengthy clinical testing.”

Id. (citing 21 U.S.C. §§

355(b)(1)(A), (d); D. Beers, Generic and Innovator Drugs: A Guide to FDA Approval
Requirements § 2.02[A] (7th ed. 2008)).
For a period of time, all manufacturers had to complete the same approval process,
regardless of whether they were the manufacturer of an entirely new pharmaceutical or merely a
new, generic version of an existing drug. See Weeks v. Wyeth, Inc., No. 1:10-CV-602-WKW,
2015 WL 4635176, at *6 (M.D. Ala. Aug. 3, 2015) (citing Mensing, 131 S. Ct. at 2574). This
onerous approval process did not lend itself to a thriving generic pharmaceutical industry. Id.
Thus, in 1984 Congress enacted the Drug Price Competition and Patent Term Restoration Act,
commonly known as the Hatch–Waxman Amendments, which drastically altered the approval
process for new generic pharmaceuticals. Id. (citing 21 U.S.C. § 355(j); Mensing, 131 S. Ct. at
2574).
The Hatch–Waxman Amendments imposed different obligations on the manufacturers of
brand name drugs and the manufacturers of generic drugs seeking federal approval for new
pharmaceuticals. Now, generic drug manufacturers may be approved without the same level of
clinical testing required for approval of a new brand name drug, provided they show that their
drug is identical to an already approved brand name drug in several key respects. Bartlett, 133 S.
Ct. at 2471. First, the proposed generic drug must be chemically equivalent to the approved
brand name drug. Id. (citing 21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii)). Second, the proposed
generic drug must be “bioequivalent” to an approved brand name drug. Id. (citing 21 U.S.C. §
355(j)(2)(A)(iv)). Third, the generic manufacturer must show that “the labeling proposed for the
7

new drug is the same as the labeling approved for the approved brand-name drug.” Id. (citing 21
U.S.C. § 355(j)(2)(A)(v)) (internal brackets omitted). The impact of this last requirement is that
brand name manufacturers seeking approval for a new drug are still responsible for the accuracy
and adequacy of their label. Mensing, 131 S. Ct. at 2574 (citing 21 U.S.C. §§ 355(b)(1), (d);
Levine, 555 U.S. at 570–71). However, generic manufacturers seeking approval for a new
generic drug are responsible only for ensuring that their label is the same as the brand name
drug’s label. Id. (citing 21 U.S.C. §§ 355(j)(2)(A)(v), (j)(4)(G); 21 CFR §§ 314.94(a)(8),
314.127(a)(7)). Importantly, generic manufacturers are prohibited from making any unilateral
changes to a drug’s label. Bartlett, 133 S. Ct. at 2471.
Once any drug is approved, whether generic or brand name, the manufacturer is
prohibited from making any major changes to the formulation of the drug that is provided in the
approved application. Id. (citing 21 C.F.R. § 314.70(b)(2)(i)).
The Hatch–Waxman Amendments allow manufacturers to develop generic drugs
inexpensively, without duplicating the clinical trials already performed on the equivalent brand
name drug. Mensing, at 131 S. Ct. at 2574. This presumably allows generic drugs to be sold at a
lower price point to more people.
ii.

Preemption

While the Hatch-Waxman Amendments have undoubtedly benefitted the general
population, they have had the effect of preempting certain claims against generic drug
manufacturers. In Pliva v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court addressed
whether a state failure to warn claim against a generic manufacturer was preempted based on
these federal pharmaceutical regulations. The plaintiffs alleged that long-term use of Pliva’s
generic drug, metoclopramide, had caused them to develop tardive dyskinesia, a severe
neurological disorder. 131 S. Ct. at 2572–73. As a result, the plaintiffs alleged that Pliva was
8

liable under state tort law for failing to provide adequate warning labels. Id. In response, the
generic manufacturer argued that the plaintiff’s state tort claims were preempted because federal
statutes and FDA regulations required them to use the same safety and efficacy labeling as their
brand name counterparts. Id. at 2573. Thus, it was impossible for them to comply with both
federal law and any state tort law duty that required them to use a different label. Id. After
identifying the relevant state law duties and the federal labeling requirements applicable to the
generic manufacturers, the Court determined that it was impossible under federal law for the
generic manufacturers to do what state law required of them. Id. at 2577–78. Thus, the Court
held that federal law preempted the plaintiff’s state failure to warn claim. Id.
A couple of years later, the Court addressed whether federal law preempted New
Hampshire’s design defect cause of action in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct.
2466 (2013). New Hampshire law imposed a duty on drug manufacturers to ensure that the
drugs they marketed were not unreasonably dangerous. 133 S. Ct. at 2474. A drug’s safety was
evaluated by reference to both its chemical properties and the adequacy of its warnings. Id. at
2470. The Court determined that Mutual Pharmaceutical, as a generic manufacturer, was unable
to change the drug’s composition to make it safer because, as a matter of federal law, a generic
drug must be the chemical equivalent and bioequivalent of the brand name drug. Id. Because
Mutual Pharmaceutical could not change the drug’s composition, the Court determined that New
Hampshire’s design defect claim effectively required Mutual Pharmaceutical to change the
drug’s labeling to provide stronger warnings. Id. However, the Supreme Court had already held
that failure to warn claims against generic manufacturers were preempted in Mensing. Id.
Thus, because “state law imposed a duty on Mutual [Pharmaceutical] not to comply with federal
law,” the Supreme Court determined that New Hampshire’s defective design cause of action was
preempted. Id. at 2470, 2477.
9

In Guarino v. Wyeth, 719 F.3d 1245 (2013), the Eleventh Circuit had the opportunity to
apply the Supreme Court’s decision in Mensing. In Guarino, the plaintiff appealed the grant of
summary judgment in favor of Teva Pharmaceuticals, the manufacturer of the generic drug
metoclopramide, on her claims of negligence, strict liability, breach of warranty,
misrepresentation and fraud, and negligence per se.4 719 F.3d at 1247. Plaintiff “primarily
argue[d]” on appeal that her negligence claim against Teva Pharmaceuticals was not preempted
insofar as it alleged a “failure to communicate” a label change to medical providers. Id. at 1247,
1249. The Eleventh Circuit found that each of Guarino’s claims against Teva Pharmaceuticals
were premised upon an “allegedly inadequate warning,” and so they were all preempted by
federal law. Id. Specifically, the Eleventh Circuit stated as follows:
Guarino’s attempt to elude Mensing by clothing her allegations as “failure-tocommunicate” claims rather than failure-to-warn claims does not alter our
analysis. No matter the garb in which she attempts to present them, Guarino’s
claims are at bottom allegations regarding Teva’s failure to warn her of the
dangers of long-term metoclopramide use, and they therefore cannot escape
Mensing’s grasp.
Id.5
With this background in mind, the Court turns to Breckenridge’s Motion for Judgment on
the Pleadings.

4

Guarino v. Wyeth, 719 F.3d 1245 (2013), also addressed brand name manufacturer liability,
which this Court will discuss more infra at pages 19–21.
5

The Eleventh Circuit further found that even if they were to hold that plaintiff’s claims against
Teva were not preempted by federal law, they would fail on the merits based on the learned
intermediary doctrine. Guarino, 719 F.3d at 1250–51. While this argument was raised in the
Wyeth Defendants’ motion, which the Court will address in a subsequent order, neither Novo
Nordisk nor Breckenridge raised the argument in their Motions and so there is no reason for the
Court to address it here.
10

C. Discussion
Federal law preempts Plaintiff’s claims against Breckenridge for strict products liability,
negligence, and negligent misrepresentation because they are premised upon failure to warn and
defective design claims. Accordingly, Breckenridge’s Motion for Judgment on the Pleadings is
granted.
i. Count II: Strict Products Liability – Defective Design
Plaintiff’s argues that Breckenridge is liable for defective design because its generic was
“not reasonably safe” and contained “unreasonably dangerous design defects” that “far exceeded
any utility or benefits of the drug.”

Am. Compl. at ¶¶ 148–49. As previously mentioned, in

Bartlett, the Supreme Court held that federal law preempted a cause of action against a generic
drug manufacturer for defective design where the defective design claim required that a generic
manufacturer either redesign the drug or change the drug’s warnings. 133 S. Ct. at 2470. Since
federal law preempts state laws imposing a duty to change a drug’s design upon generic drug
manufacturers, Plaintiff’s defective design claim fails.
Plaintiff attempts to circumvent preemption by focusing on the steps that Breckenridge
could have taken prior to FDA approval. Specifically, Plaintiff argues that “in contrast to the
facts of the Mensing and Bartlett cases,” here Breckenridge could have exercised reasonable care
in “the process leading up to placing a drug on the market.” Resp. to Mot. for J., at 7 (emphasis
in the original).

Plaintiff argues that Breckenridge “can establish neither impossibility of

redesign prior to FDA approval and marketing, nor chemical impossibility of redesign.” Id.
(emphasis in the original omitted). However, Plaintiff’s argument that Breckenridge could have
conducted itself differently prior to FDA approval ignores the nature of a generic drug.6

6

As the Plaintiff outlines in the Amended Complaint, Novo Nordisk applied for an initial new
drug application for Activella on November 7, 1997. Am. Compl. at ¶ 89. Activella was
11

Breckenridge’s Reply, at 3 (ECF No. 66). A generic drug must be the chemical equivalent and
bioequivalent of its brand name counterpart. Bartlett, 133 S. Ct. at 2471. If Breckenridge
altered the design of Activella, it would be designing a new drug and Breckenridge would go
through an entirely different process of approval, subject to an entirely different set of
regulations. Breckenridge’s Reply, at 3–4. To find that Plaintiff’s defective design claim is not
preempted because Breckenridge could have designed an entirely new drug, instead of
manufacturing the generic version of Activella, would render Bartlett meaningless.7 It would
also undercut Congress’ purpose in enacting the Hatch-Waxman Amendments, which was to
develop the generic drug market. See Mensing, 131 S. Ct. at 2582.
Additionally, Plaintiff’s reliance upon Trahan v. Sandoz, Inc. No. 3:13-cv-350-j-34MCR,
2015 WL 2365502 (M.D. Fla. Mar. 26, 2015), is misguided. Trahan focused on the container

originally approved by the FDA on or about November 19, 1998 to treat “moderate to severe
vasomotor symptoms associated with menopause and in the treatment of vulvar and vaginal
atrophy in women with an intact uterus.” Id. On July 21, 2003, Novo Nordisk announced that it
was assuming U.S. marketing activities, including product fulfillment and distribution, for
Activella. On March 18, 2004, Novo Nordisk Inc. announced it was “deploy[ing] a force of
specialty sales representatives to provide support for hormone therapy Activella
(estradiol/norethindrone acetate tables)[.]” Id. On or about April 18, 2008, Breckenridge was
granted approval for its Abbreviated New Drug Application (“ANDA”) to market its generic
version of Activella 1.0 mg/0.5mg tablets. Id. at ¶ 90. On or about June 10, 2011, Breckenridge
was granted approval for its ANDA to market its generic version of Activella 0.5mg/0.1mg
tablets. Id.
7

This argument is similar to the argument that the Supreme Court rejected in Bartlett. In
Bartlett, the First Circuit had found that generic drug manufacturer Mutual Pharmaceuticals
could escape the impossibility of complying with both its federal and state law duties by
choosing to stop selling the drug Sulindac altogether. 133 S. Ct. at 2472. In other words,
generic manufacturers facing design defect claims could simply choose not to make the drug at
all and thus comply with both federal and state law. Id. On appeal, the Supreme Court explicitly
rejected the “stop-selling” rationale as “incompatible” with their “pre-emption jurisprudence.”
Id. at 2477. Preemption cases presume that an actor seeking to satisfy both his federal and state
law obligations are not required to cease acting altogether to avoid liability. Id. Following this
reasoning, it would not make sense for this Court to find that Breckenridge could have complied
with its state law design defect duty by selling a new drug altogether, instead of the generic
version of Activella.
12

that was used for the drug known as methotrexate.

Sandoz, the defendant in Trahan,

manufactured a generic version of methotrexate and packaged the product in glass vials. Id. at
*1. Plaintiff’s claim was premised on a defect with the glass vials, which led to small pieces of
glass being mixed with the drug and administered to the plaintiff in her intravenous injections.
Id. Sandoz filed a motion to dismiss contending that the design and packaging of the generic
methotrexate must be identical to the brand name and Sandoz could not change the packaging to
be safer without FDA approval. Id. at *2. The plaintiff in Trahan “concede[d] that Sandoz
[could not] legally alter the chemical composition of methotrexate, but maintain[ed] that her
claims [were] premised not on the design of the drug itself, but on Sandoz’s decision to use
‘substandard glass vials’ to package the methotrexate.” Id. at *5. The court focused on the issue
of whether generic drug manufacturers are required “to use exactly the same container for their
generic drugs as is used to package the brand-name drug.” Id. There is not a packaging problem
at issue in this case and so Trahan is easily distinguishable. The issue here is the composition of
the drug itself, and in Trahan the plaintiff conceded that the generic manufacturer could not alter
the composition of its drug. See id.
Because it would be a violation of federal law for Breckenridge, as a generic
manufacturer, to change the composition of its drug to be safer, Plaintiff’s defective design claim
is preempted.
ii. Count IV: Negligence
Plaintiff’s negligence claim alleges that Breckenridge owed a duty of care to Plaintiff,
which it breached when it failed to “properly conduct adequate pre-clinical testing, failed to
properly and safely design, manufacture, produce, discover latent hazards, study, research,
and/or distribute [its] HRT drugs,” and because it “knew the significant risks of breast cancer of
[its] HRT drugs . . . and . . . [it] kept it quiet so that [its] drug sales in [sic] would not suffer.”
13

Am. Compl. at ¶¶ 184–85; see also Resp. to Mot. for J., at 8. This breach caused Plaintiff to
suffer breast cancer. Id. at ¶ 188. Plaintiff’s allegations regarding the breach element of her
negligence claim are premised on Breckenridge’s failure to warn of the risks associated with its
drug and the drug’s defective design. As a result, Plaintiff’s negligence claim is preempted by
federal law.
To present a viable state tort negligence claim that falls outside the scope of federal
preemption, Plaintiff must allege that Breckenridge: (1) breached its duty to exercise reasonable
care and (2) could have taken actions in line with its federal law obligations that would have also
allowed it to discharge its duty to exercise reasonable care. See Bell v. Wyeth, Inc., No. 2:10CV-973-WKW, 2015 WL 4633601, at *8 (M.D. Ala. Aug. 3, 2015). Breaking Plaintiff’s
negligence claim down, it is clear that there is no action that Breckenridge could have taken to
discharge its duty under state negligence law without violating federal law.
First, Plaintiff alleges that Breckenridge breached its duty to exercise reasonable care
because it “knew the significant risks of breast cancer of [its] HRT drugs . . . and . . . [it] kept it
quiet so that [its] drug sales in [sic] would not suffer.” See Am. Compl. at ¶ 185. This statement
is clearly premised on the notion that Breckenridge was negligent because it failed to warn of the
risks associated with ingestion of its generic drug. As the Court already discussed, and as the
Supreme Court established in Mensing and the Eleventh Circuit found in Guarino, claims
premised on a generic manufacturer’s failure to warn are preempted by federal law.
Plaintiff next alleges that Breckenridge breached its duty to exercise reasonable care
when it failed to “properly conduct adequate pre-clinical testing, failed to properly and safely
design, manufacture, produce, discover latent hazards, study, research, and/or distribute [its]
HRT drugs.” Am. Compl. at ¶ 184. Plaintiff’s allegation that Breckenridge failed to “properly
and safely design, manufacture, produce . . . and/or distribute their HRT drugs” is clearly
14

premised on the notion that Breckenridge breached its duty of reasonable care because it failed to
design a reasonably safe drug. As the Court already discussed, and as the Supreme Court
established in Bartlett, defective design claims against a generic manufacturer are preempted to
the extent that they impose a duty upon the generic manufacturer to redesign a generic drug.
The remainder of Plaintiff’s negligence claim, that Breckenridge breached its duty of
reasonable care when it failed to “properly conduct adequate pre-clinical testing, failed to
properly and safely discover latent hazards, study, [and] research . . . their HRT drugs,” also fails
to elude preemption. Am. Compl. at ¶ 184. While these allegations focus on the actions that
Breckenridge should have taken to discover the alleged hazards associated with ingestion of its
drug, it is unclear what action Breckenridge could have taken had it discovered these hazards in
light of federal regulations. As this Court has already established, Breckenridge was precluded
from strengthening its label and redesigning its generic drug. Accordingly, preemption extends
to these allegations as well.
In any event, the duty to test is a subpart of a manufacturer’s duty to design a product
with reasonable care, and is thus subsumed in a Plaintiff’s claims for defective design and failure
to warn. See Trahan v. Sandoz, 2015 WL 2365502, at *7 (citing Adams v. G.D. Searle & Co.,
576 So. 2d 728, 730–31 (Fla. Ct. App. 1992). The duty to test was discussed in Trahan, a case
cited favorably by Plaintiff. See Resp. to Mot. for J., at 4, 9–12. In Trahan, the plaintiff
contended that the inadequate testing of the vials demonstrated negligence because Sandoz, the
generic manufacturer, should have detected the defective condition of the glass vials and used a
different container. 2015 WL 2365502, at *7. The Middle District found that the plaintiff’s
contention that the manufacturer failed to adequately test or inspect the drug was a subset of her
negligent design and manufacturing claims. Id. In Trahan, the Middle District had already
determined that the plaintiff’s defective design and manufacturing claims were not preempted;
15

thus, the court allowed the plaintiff’s inadequate testing allegation to go forward. Id. Here, the
Court has already concluded that Plaintiff’s defective design claims against Breckenridge, as a
generic manufacturer, are preempted.

Thus, it follows that Plaintiff’s allegation that

Breckenridge breached its duty of care when it failed to test, study, research, and discover latent
hazards is similarly preempted.8
iii. Count V: Negligent Misrepresentation
Federal law similarly preempts Plaintiff’s negligent misrepresentation claim. Plaintiff
alleges that Breckenridge “participated and passively cooperated in the dissemination of
misrepresentations and/or concealment, knowing that they were material misrepresentations on
which physicians and consumers, including [Plaintiff], would rely and, as such, foreseeably be
injured.” Am. Compl. at ¶ 219. These misrepresentations failed to communicate the risk of
breast cancer associated with Breckenridge’s drug. Id. at ¶¶ 215, 228. Plaintiff alleges that,
were it not for these misrepresentations, she would “never have taken Activella and/or its generic
and, as such, [would] not have developed breast cancer.” Id. at ¶¶ 216–29.
Plaintiff is pleading a failure to warn claim under the guise of a negligent
misrepresentation claim. “No matter the garb” Plaintiff presents her claim in, though, it is at
bottom an allegation that Breckenridge failed to warn of the dangers associated with its generic
drug. See Guarino, 719 F.3d at 1249. Plaintiff attempts to ground her claim in a “state law duty
not to deceive.” But however similar to the failure to communicate claim that the Supreme

8

To the extent Plaintiff’s negligence claim is not preempted by federal law, Breckenridge argues
that Plaintiff’s Amended failed to meet the Twombly/Iqbal standard because Plaintiff’s Amended
Complaint fails to identify “how Breckenridge failed to exercise reasonable care in the testing,
design, manufacture, production, promotion, sales, supply and/or distribution of its generic
version of Activella.” Mot. for J., at 10. Breckenridge further argues that Plaintiff also does not
“make any allegations regarding specific concealments by Breckenridge” and does not allege
how Breckenridge’s alleged breach of those duties “directly and proximately caused her to suffer
breast cancer.” Id. The Court’s grant of Breckenridge’s motion for judgment on the pleadings
renders this argument moot.
16

Court rejected in Bartlett, this state law duty not to deceive centers around the allegation that
Breckenridge had certain information about the increased risk of breast cancer associated with
ingestion of its drug and failed to warn consumers and medical practitioners about that risk. See
Resp. to Mot. for J., at 14.
Plaintiff also attempts once again to focus on what Breckenridge could have, or should
have, done before it received FDA approval to make its drug reasonably safe for use by
consumers. Id. at 17. The Court has already addressed and rejected this argument.9
Accordingly, Breckenridge’s Motion for Judgment on the Pleadings is granted.10
III.

NOVO NORDISK’S MOTION TO DISMISS
Novo Nordisk’s Motion to Dismiss explores the issue of brand name manufacturer

liability. It is the other side of the coin to Plaintiff’s suit against Breckenridge. Unfortunately
for Plaintiff, her claims against Novo Nordisk fare no better than her claims against
Breckenridge. Since Plaintiff never took a HRT drug manufactured or sold by Novo Nordisk,
the Court finds that Novo Nordisk is not liable to Plaintiff. Accordingly, Novo Nordisk’s
Motion to Dismiss will be granted.
A. Legal Standard
A motion to dismiss for failure to state a claim merely tests the sufficiency of the
complaint; it does not decide the merits of the case. Milburn v. United States, 734 F.2d 762, 765
(11th Cir. 1984). On a motion to dismiss, the Court must accept the factual allegations as true
and construe the complaint in the light most favorable to the plaintiff. SEC v. ESM Group, Inc.,
835 F.2d 270, 272 (11th Cir. 1988). “To survive a motion to dismiss, a complaint must contain

9

Breckenridge also argues that Plaintiffs’ negligent misrepresentation claim fails to plead facts
sufficient to sustain a claim. The Court’s grant of Breckenridge’s motion renders this argument
moot.
10
Also rendered moot by the Court’s grant of judgment on the pleadings is Breckenridge’s
argument that Plaintiff’s request for punitive damages should be dismissed.
17

sufficient factual matter, accepted as true, to ‘state a claim for relief that is plausible on its face.’”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. v. Twombly, 550 U.S. 544, 570
(2007)). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more
than a sheer possibility that a defendant has acted unlawfully.” Id. “But where the well-pleaded
facts do not permit the court to infer more than the mere possibility of misconduct, the complaint
has alleged-but it has not ‘show[n]’-‘that the pleader is entitled to relief.’” Id. at 679.
A complaint must also contain enough facts to indicate the presence of the required
elements. Watts v. Fla. Int’l Univ., 495 F.3d 1289, 1302 (11th Cir. 2007). However, “[a]
pleading that offers ‘a formulaic recitation of elements of a cause of action will not do.’” Iqbal,
556 U.S. at 678 (quoting Twombly, 550 U.S. at 555). “[C]onclusory allegations, unwarranted
deductions of fact or legal conclusions masquerading as facts will not prevent dismissal.”
Oxford Asset Mgmt., Ltd. v. Jaharis, 297 F.3d 1182, 1188 (11th Cir. 2002).
B. Discussion
Under Florida law, it is clear that Plaintiff does not have a claim against Novo Nordisk
“because Florida Law does not permit an injured consumer to recover from the brand name
manufacturer of a prescription drug if the consumer is known to have ingested only the generic
form of that drug.” See Guarino v. Wyeth, 719 F.3d 1245, 1253 (11th Cir. 2013). In fact,
“[e]very court in Florida” that has considered the question of whether a brand name
manufacturer can be held liable if the consumer did not ingest the brand name version of the
drug, “has concluded that the brand manufacturer of a prescription drug cannot be held liable for
injuries suffered by consumers who ingested only the generic form of the drug.” Id. at 1251.
This approach “is [further] fortified by the fact that the overwhelming national consensus—
including decisions of every court of appeal and the vast majority of district courts around the
country to consider the question—is that a brand-name manufacturer cannot be liable for injuries
18

caused by the ingestion of the generic form of a product.” Id. at 1252 (collecting cases); see also
Metz v. Wyeth LLC, 830 F. Supp. 2d 1291, 1293 (M.D. Fla. 2011), affirmed, 525 F. Appx. 893
(11th Cir. 2013) (“The vast majority of courts, in Florida and elsewhere that have addressed the
issue now before the Court have consistently held that consumers may not bring claims for
negligence, fraud, strict liability, misrepresentation, or breach of warranty against a brand name
pharmaceutical manufacturer when the consumers only ingested generic versions of the drug
manufactured by third parties.”).
Brand name manufacturers are not liable to consumers who did not take their products
even though the brand manufacturers are responsible for the label that is on the generic version
of their drug and physicians rely upon that label in prescribing the drug. See, e.g., Smith v.
Wyeth, Inc., 657 F.3d 420, 423–24 (6th Cir. 2011) (“The plaintiffs’ argument—that the namebrand defendants’ liability stems from the fact that the regulatory structure governing namebrand and generic drugs makes it foreseeable that patients and their physicians will rely on the
name-brand labels to use and prescribe generic drugs—has been rejected by all but one of the
courts that have considered it.”).
Plaintiff cites to cases such as Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010), and
Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Ct. App. 2008), in support of her argument that Novo
Nordisk is liable to Plaintiff. See Resp. to Mot. to Dismiss, at 2–3, 7–8, 12. However, these
cases are clearly outliers. In fact, they are both cited in Guarino as cases that go against the
majority. 719 F.3d at 1252–53; see also Levine v. Wyeth, Inc., 684 F. Supp. 2d 1338, 1344
(M.D. Fla. 2010) (“The holding in Conte is not binding on this Court, and runs counter to the
overwhelming majority of case law, including that of Florida.”). Furthermore, there is no reason
for the Court to look to the District of Vermont or a state court decision in California when the
Eleventh Circuit squarely addressed the issue of brand name manufacturer liability in Guarino
19

and Metz v. Wyeth LLC, 830 F. Supp. 2d 1291, 1293 (M.D. Fla. 2011), affirmed, 525 F. Appx.
893 (11th Cir. 2013) (per curiam). In both cases, the Eleventh Circuit found that Florida law
does not permit an injured consumer to recover from the brand name manufacturer of a
prescription drug if the consumer only ingested the generic form of the drug.11 See Guarino, 719
F.3d at 1251; see also Metz, 525 F. App’x at 894.
Plaintiff also cites to Bennett v. Forest Laboratories, 99 F. Supp. 3d 1360 (M.D. Fla.
2015), for support. See Resp. to Mot. to Dismiss, at 8–9. In Bennett, Terri Rene was prescribed
Lexapro, a selective serotonin reuptake inhibitor (“SSRI”) drug. 99 F. Supp. 3d at 1361–62. At
the time Rene’s physician prescribed her the drug he was aware that SSRI drugs had some
relationship to suicidality in certain patients and Rene had suicide risk factors. Id. at 1362.
Tragically, soon after Rene started to consume Lexapro, she committed suicide. Id. Rene’s
estate brought an action against Forest Laboratories.

Id.

Forest Laboratories moved for

summary judgment on the basis that it did not manufacture or design Lexapro. Id. at 1363. The
Court denied Forest Laboratories’ motion because Forest Laboratories was the FDA sponsor of
Lexapro and marketed and drafted the warnings for the drug. Id. at 1364. The facts in Bennett
are clearly distinguishable from the facts in this case. The deceased in Bennett ingested the drug
that Forest Laboratories worked on directly. Here, Novo Nordisk had no direct involvement with
Breckenridge’s generic version of Activella.
Accordingly, the Court finds that Novo Nordisk is not liable to Plaintiff and its Motion to
Dismiss is granted.

11

Plaintiff’s attempt to distinguish Guarino from the facts of this case falls short.
20

IV.

CONCLUSION
For the foregoing reasons, it is ORDERED AND ADJUDGED that Defendant

Breckenridge Pharmaceutical, Inc.’s Motion for Judgment on the Pleadings (ECF No. 63) is
GRANTED and Defendant Novo Nordisk Inc.’s Motion to Dismiss (ECF No. 41) is GRANTED
with prejudice.
7th
Done and ordered in Chambers at Miami, Florida, this ____ day of January, 2016.

________________________________
K. MICHAEL MOORE
CHIEF UNITED STATES DISTRICT JUDGE
c:

Counsel of record

21