Small et al v. Amgen, Inc. et al

Filing 97

OPINION AND ORDER granting in part and denying in part 82 defendants' Motion for Summary Judgment. The Clerk shall enter judgment in favor of defendants as to Count II and Count IV, to the extent it asserts a claim for the negligent failure to warn. The motion is otherwise denied. See Opinion and Order for details. Signed by Judge John E. Steele on 9/25/2015. (MAB)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
FORT MYERS DIVISION
REBECCA
A.
SMALL
LAWRENCE W. SMALL,

and

Plaintiffs,
v.

Case No: 2:12-cv-476-FtM-29MRM

AMGEN, INC., PFIZER, INC.,
and WYETH, INC.,
Defendants.

OPINION AND ORDER
This matter comes before the Court on the defendants’ Motion
for

Summary

Judgment

(Doc.

#82)

filed

on

December

23,

2014.

Plaintiffs filed a Response in Opposition (Doc. #89) on January
20, 2015.

Defendants filed a Reply (Doc. #92) on February 2, 2015,

and plaintiffs filed a Sur-Reply (Doc. #95) on February 10, 2015.
I.
Plaintiffs

Rebecca

and

Lawrence

Small

filed

this

action

against defendants Amgen, Inc., Wyeth, Inc., Pfizer, Inc., and
Does 1-20 to recover damages for the injuries Ms. Small allegedly
sustained as a result of her use of the prescription drug Enbrel.
Plaintiffs allege that Ms. Small started using Enbrel in 2002 to
treat her rheumatoid arthritis.

Ms. Small continued her treatment

with Enbrel until August 29, 2008, when she was admitted to the
hospital on an emergency basis and was diagnosed with a perforated

bowel from a diverticulitis infection that was allegedly caused by
her use of Enbrel.

Plaintiffs allege that multiple surgeries were

required to treat the infection.
In their Fourth Amended Complaint, filed on December 23, 2014,
plaintiffs set forth the following five claims against Amgen, Inc.,
Wyeth, Inc., and Pfizer, Inc.: (I) strict liability based on a
design defect; (II) strict liability based on a failure to warn;
(III) breach of an express warranty; (IV) negligence; and (V) loss
of consortium.

(Doc. #54.)

On March 6, 2014, the Court entered

an Opinion and Order dismissing Count IV to the extent plaintiffs
asserted a claim for the negligent failure to test or inspect, and
to the extent that plaintiffs asserted a claim of negligence per
se.

(Doc. #66.)

Defendants now move for summary judgment on the

remaining claims, arguing that they are barred by Florida’s learned
intermediary doctrine.
II.
Summary

judgment

is

appropriate

only

when

the

Court

is

satisfied that “there is no genuine issue as to any material fact
and that the moving party is entitled to judgment as a matter of
law.”

Fed. R. Civ. P. 56(a).

“An issue of fact is ‘genuine’ if

the record taken as a whole could lead a rational trier of fact to
find for the nonmoving party.”

Baby Buddies, Inc. v. Toys “R” Us,

Inc., 611 F.3d 1308, 1314 (11th Cir. 2010).

A fact is “material”

if it may affect the outcome of the suit under governing law.

2

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

“A

court must decide ‘whether the evidence presents a sufficient
disagreement to require submission to a jury or whether it is so
one-sided that one party must prevail as a matter of law.’”
Hickson Corp. v. N. Crossarm Co., Inc., 357 F.3d 1256, 1260 (11th
Cir. 2004) (citing Anderson, 477 U.S. at 251).
In ruling on a motion for summary judgment, the Court views
all evidence and draws all reasonable inferences in favor of the
non-moving party.

Scott v. Harris, 550 U.S. 372, 380 (2007); Tana

v. Dantanna’s, 611 F.3d 767, 772 (11th Cir. 2010).

However, “if

reasonable minds might differ on the inferences arising from
undisputed facts, then the court should deny summary judgment.”
St. Charles Foods, Inc. v. America’s Favorite Chicken Co., 198
F.3d 815, 819 (11th Cir. 1999) (quoting Warrior Tombigbee Transp.
Co. v. M/V Nan Fung, 695 F.2d 1294, 1296-97 (11th Cir. 1983)
(finding summary judgment “may be inappropriate even where the
parties agree on the basic facts, but disagree about the factual
inferences that should be drawn from these facts”)).

“If a

reasonable fact finder evaluating the evidence could draw more
than one inference from the facts, and if that inference introduces
a genuine issue of material fact, then the court should not grant
summary judgment.”

Allen v. Bd. of Pub. Educ., 495 F.3d 1306,

1315 (11th Cir. 2007).

3

III.
A.

Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease that occurs

when the body’s immune system mistakenly attacks joints, cells,
tissues, and other organs of the body.

(Doc. #82-1, p. 10.)

Rheumatoid arthritis typically causes inflammation in the body’s
joints,

but

can

also

cause

symptoms

such

as

fatigue,

joint

stiffness, low grade fevers, rashes, ulcerations in the mouth,
shortness of breath, and chest pains.

(Id.)

If left untreated,

rheumatoid arthritis can lead to “[t]otal disability, and also a
decrease

in

expectancy.”

quality

of

life

(Id. at 11.)

as

well

as

a

decrease

in

life

Early rheumatoid arthritis treatment

options carried substantial risks, such as increased risk of
lymphoma and nonmelanoma skin cancers, stomach ulcers, kidney
disease,

bone

marrow

depression,

hypertension, and avascular necrosis.

thinning

of

the

skin,

(Id. at 13-14.)

In 1998, the Food and Drug Administration (“FDA”) approved
the release of Enbrel, a drug credited with revolutionizing the
treatment options for those suffering from rheumatoid arthritis.
(Doc. #82, p. 3.)

Enbrel is a “biologic” drug and is “alleged to

be a recombinant human IcGI antibody that neutralizes and/or blocks
the

activity

of

TNFs

[Tumor

Necrosis

occurring substance in the human body.

Factor],”

a

naturally

(Doc. #54, ¶¶ 14-15.)

Enbrel was developed by Amgen and, at all relevant times, the drug

4

was marketed and sold by both Amgen and Wyeth.

(Id. ¶¶ 16-17.)

On October 15, 2009, Wyeth was acquired by Pfizer.
B.

(Id ¶ 18.)

Enbrel’s Warning Label and Medication Guide
Throughout the relevant time period, defendants distributed

an FDA-approved package insert to physicians to inform them about
how Enbrel should be used and what risks were associated with its
use.

(Doc. #82-3.)

The package insert issued in July 2001

identified infections as the primary risk of taking Enbrel.

(Id.)

Specifically, the warning, which was in capitalized and bold font,
stated:
WARNINGS
INFECTIONS
IN POST–MARKETING REPORTS, SERIOUS INFECTIONS AND
SEPSIS, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH
THE USE OF ENBREL. MANY OF THE SERIOUS INFECTIONS HAVE
OCCURRED IN PATIENTS ON CONCOMITANT IMMUNOSUPPRESSIVE
THERAPY THAT, IN ADDITION TO THEIR UNDERLYING DISEASE
COULD PREDISPOSE THEM TO INFECTIONS.
RARE CASES OF
TUBERCULOSIS (TB) HAVE BEEN OBSERVED IN PATIENTS TREATED
WITH TNF ANTAGONISTS, INCLUDING ENBREL.
PATIENTS WHO
DEVELOP A NEW INFECTION WHILE UNDERGOING TREATMENT WITH
ENBREL SHOULD BE MONITORED CLOSELY. ADMINISTRATION OF
ENBREL SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A
SERIOUS INFECTION OR SEPSIS.
TREATMENT WITH ENBREL
SHOULD NOT BE INITIATED IN PATIENTS WITH ACTIVE
INFECTIONS INCLUDING CHRONIC OR LOCALIZED INFECTIONS.
PHYSICIANS SHOULD EXERCISE CAUTION WHEN CONSIDERING THE
USE OF ENBREL IN PATIENTS WITH A HISTORY OF RECURRING
INFECTIONS OR WITH UNDERLYING CONDITIONS WHICH MAY
PREDISPOSE PATIENTS TO INFECTIONS, SUCH AS ADVANCED OR
POORLY CONTROLLED DIABETES (see PRECAUTIONS and ADVERSE
REACTIONS, Infections).

5

(Doc. #82-3, p. 12.)

Defendants also distributed an FDA-approved

medication guide that warned patients of various potential risks
associated with Enbrel, including the risk of serious infection.
(Doc. #82-8, p. 2.)
C.

Ms. Small’s Treatment with Enbrel
Ms. Small first visited her rheumatologist, Catherine Nina

Kowal, M.D. (Dr. Kowal), on September 24, 2001. 1
37.)

(Doc. #82-1, p.

Dr. Kowal determined that Ms. Small’s rheumatoid arthritis

was very active and tried to treat Ms. Small’s condition with nonbiologic medications such as Leflunomide and Methotrexate.

(Id.

at 37.) Ms. Small, however, continued to experience joint swelling
and pain, predominantly in her hands, and was unable to really
function.

(Id. at 38.)

with a biologic.

Dr. Kowal then decided to treat Ms. Small

Because Ms. Small could not afford Enbrel, Dr.

Kowal asked her if she wanted to participate in a clinical study
on Enbrel for which Dr. Kowal was a principal investigator.

(Id.)

After a thorough discussion with Dr. Kowal, Ms. Small voluntarily
decided to enroll in the Enbrel study.

1Dr.

(Id. at 43-44.)

Kowal has been practicing medicine in Naples, FL since
1992, and about 50 to 60 percent of her current patients suffer
from rheumatoid arthritis. (Doc. #81, p. 8.) Dr. Kowal is very
familiar with all of the treatments available for rheumatoid
arthritis, and is part of the American College of Rheumatology and
the Florida Society of Rheumatology. (Id.)

6

Before starting her treatment with Enbrel, Ms. Small was given
a Research Subject Information and Consent Form that contained
information

about

the

study,

including

the

potential

hazards, and discomforts associated with Enbrel.

(Id.)

risks,

As to the

increased risk of infection, the consent form stated that:
It is possible that Enbrel® may make infections worse or
could lead to life-threatening infections.
These
infections may occur in any body system.
In some
patients[,] very low blood cell counts have been
reported.
If you develop signs and symptoms of a
significant infection, or persistent fever, bruising,
bleeding, or very pale skin, you should immediately
contact your study doctor to determine whether you
should stop taking Enbrel®.
(Doc. #82-4, p. 4.)

Dr. Kowal talked to Ms. Small about the

information in the Research Subject Information and Consent Form
and explained that the serious conditions identified in the form
are rare.

(Doc. #82-1, p. 44.)

Ms. Small also reviewed the

package insert and medication guide that accompanied Enbrel before
starting her treatment.

(Doc. #89-1, ¶ 2.)

Ms. Small treated her rheumatoid arthritis with Enbrel from
2002 until August 29, 2008.

Ms. Small’s use of Enbrel, however,

was not without interruption.

In May 2003, Ms. Small took Dr.

Kowal’s recommendation and temporarily went off Enbrel before
undergoing surgery on her thumb.

(Doc. #82-1, p. 48.)

In October

2003, Dr. Kowal stopped Ms. Small’s treatment with Enbrel and
monitored her for infections because Ms. Small had swollen glands.
(Id.)

Dr.

Kowal

also

stopped

7

treatment

and

monitored

for

infections in December 2004 because Ms. Small had bronchitis. (Id.
at 50.)

No other incidents were recorded.

During a visit on August 25, 2008, Dr. Kowal noted that Ms.
Small’s rheumatoid arthritis was “stable,” meaning she had no new
synovitis, her energy level was okay, and the Enbrel was working.
(Id. at 53.)

On August 29, 2008, Ms. Small was admitted to the

hospital on an emergency basis and was diagnosed with a perforated
bowel from a diverticulitis infection.

(Doc. #54, ¶ 26.)

Until

a few days before her hospitalization, Ms. Small was asymptomatic.
Multiple surgeries were required to treat the infection.
26.)

(Id. ¶

Ms. Small was instructed to stop using Enbrel until she

recovered from the infection.

(Doc. #89-1, ¶ 4.)

On February 24, 2009, Ms. Small met with Dr. Kowal to discuss
whether it was appropriate to resume treatment with Enbrel.
¶ 5.)

(Id.

Ms. Small claims that Dr. Kowal consulted with defendants’

sales representative during the appointment and was assured by the
representative that it was safe to resume Ms. Small’s treatment
with Enbrel.

(Doc. #89-1, ¶ 6.)

Ms. Small asserts that she relied

of the sales representative’s assurances and agreed to restart
Enbrel.

(Doc. #89-1, ¶ 7.)

Dr. Kowal, however, does not recall

speaking to a sales representative.

(Doc #82-1, p. 68.)

Within approximately 60 days of restarting Enbrel, Ms. Small
developed

another

serious

round

of

complications

requiring

additional surgeries and treatments, which are still affecting her

8

today.

(Doc. #54, ¶ 28; Doc. #89-1, ¶ 8.)

Dr. Kowal subsequently

advised Ms. Small to stop taking Enbrel, and Ms. Small complied.
Ms. Small has not taken Enbrel since this incident.

(Id.)

At no time prior to Ms. Small’s injuries were doctors and
patients

warned

that

Enbrel

could

cause

asymptomatic

serious

infections, nor were doctors and patients instructed on how to
mitigate and manage the risks associated with the use of Enbrel.
(Doc. #54, ¶ 61.)
IV.
It is well settled that “summary judgment should not be
granted until the party opposing the motion has had an adequate
opportunity for discovery.”

Snook v. Trust Co. of Ga. Bank, N.A.,

859 F.2d 865, 870 (11th Cir. 1988).

Rule 56(d) provides that a

court may deny a motion for summary judgment as premature “[i]f a
nonmovant shows by affidavit or declaration that, for specified
reasons,

it

opposition.”

cannot

present

facts

essential

to

justify

its

Fed. R. Civ. P. 56(d)(1).

Here, plaintiffs contend that defendants’ motion is premature
because “no discovery from Defendants has taken place and discovery
is still open.” 2

(Doc. #89, p. 19.)

Plaintiffs, however, failed

to submit an affidavit or declaration showing that they are unable

2Although

this case is more than three years old, plaintiffs
have not yet served a single discovery request upon defendants.
(Doc. #89, pp. 1-2.)

9

to

defend

against

the

pending

motion

for

summary

judgment.

Furthermore, defendants’ motion focuses upon a single issue –
whether Dr. Kowal would have prescribed Enbrel to Ms. Small if
Enbrel’s package insert warned of asymptomatic infections.

As

discussed in more detail below, no additional evidence is necessary
to resolve this issue.

The Court, however, finds that defendants’

motion for summary judgment is premature to the extent that it
addresses claims that are not covered by the learned intermediary
doctrine.
V.
Florida tort law provides that the manufacturer of a defective
product may be subject to liability under two theories: negligence
and strict liability.

To prevail on a products liability claim

sounding in negligence, a plaintiff must establish: (1) a duty or
obligation recognized by the law requiring the defendant to protect
others from unreasonable risks; (2) a breach of that duty; (3) a
reasonably close casual connection between the conduct and the
resulting injury; and (4) actual loss or damages.

Williams v.

Davis, 974 So. 2d 1052, 1056 (Fla. 2007) (citing Clay Elec. Coop.,
Inc. v. Johnson, 873 So. 2d 1182, 1185 (Fla. 2003)).
for

strict

liability,

a

plaintiff

must

As to a claim

establish

(1)

the

manufacturer’s relationship to the product in question, (2) the
defective and unreasonably dangerous condition of the product, and
(3) the existence of a proximate causal connection between such

10

condition and the user’s injuries or damages.

Bailey v. Janssen

Pharmaceutica, Inc., 288 F. App’x 597, 604 (11th Cir. 2008) (citing
West v. Caterpillar Tractor Co., 336 So. 2d 80, 87 (Fla. 1976)). 3
In order to prevail under either theory, the plaintiff must
establish

that

dangerous.

the

product

was

defective

or

unreasonably

Colville v. Pharmacia & Upjohn Co. LLC, 565 F. Supp.

2d 1314, 1320 (N.D. Fla. 2008) (citing Marzullo v. Crosman Corp.,
289 F. Supp. 2d 1337, 1342 (M.D. Fla. 2003)).

Under Florida law,

“a product may be defective by virtue of a design defect, a
manufacturing defect, or an inadequate warning.”

Jennings c. BIC

Corp., 181 F.3d 1250, 1255 (11th Cir. 1999) (quoting Ferayorni v.
Hyundai Motor Co., 711 So. 2d 1167, 1170 (Fla. 4th DCA 1998)).

In

this case, plaintiffs assert all three defects.
A.

Failure to Warn
A plaintiff seeking to recover damages for the failure to

warn must prove that the defendant (1) is a manufacturer or
distributor of the product at issue, and (2) did not adequately
warn of a particular risk that was known or knowable in light of
the

generally

recognized

and

prevailing

3Strict

best

scientific

and

liability differs from negligence in that the
plaintiff does not have to prove specific acts of negligence. See
West v. Caterpillar Tractor Co., 336 So. 2d 80, 90 (Fla. 1976)
(Strict liability is defined as “negligence as a matter of law or
negligence per se, the effect of which is to remove the burden
from the user of proving specific acts of negligence”).

11

medical knowledge available at the time of the manufacture and
distribution.

Thomas v. Bombardier Recreational Prods., Inc. 682

F. Supp. 2d 1297, 1300 (M.D. Fla. 2010).

The plaintiff must also

establish that the inadequate warning was a proximate cause of her
injury.

Hoffmann-La Roche, Inc. v. Mason, 27 So. 3d 75, 77 (Fla.

5th DCA 2009).
When the product is a prescription drug, as is the case in
this

matter,

physicians

the

manufacturer’s

rather

than

intermediary doctrine.”
Inc.,

540

So.

2d

102,

duty

patients

to

under

warn

is

directed

Florida’s

to

“learned

Id. (citing Felix v. Hoffmann-La Roche,
104

(Fla.

1989)).

Thus,

a

drug

manufacturer’s duty to warn is satisfied if it gives an adequate
warning to the physician who prescribes the drug. 4

4The

Buckner v.

rationale behind the learned intermediary doctrine is as

follows:
Prescription drugs are likely to be complex medicines,
esoteric in formula and varied in effect. As a medical
expert, the prescribing physician can take into account
the propensities of the drug, as well as the
susceptibilities of his patient.
His is the task of
weighing the benefits of any medication against its
potential dangers. The choice he makes is an informed
one, an individualized medical judgment bottomed on a
knowledge
of
both
patient
and
palliative.
Pharmaceutical companies then, who must warn ultimate
purchasers of dangers inherent in patent drugs sold over
the counter, in selling prescription drugs are required
to warn only the prescribing physician, who acts as a
“learned
intermediary”
between
manufacturer
and
consumer.

12

Allergan Pharms., Inc., 400 So. 2d 820, 822 (Fla. 5th DCA 1981).
In determining the adequacy of a warning, the critical inquiry is
whether it was adequate to warn the physician of the possibility
that the drug may cause the injury alleged by the plaintiff.
Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990).

The

sufficiency and reasonableness of a warning is generally a question
of fact, but “can become a question of law where the warning is
accurate, clear, and unambiguous.”

Felix, 540 So. 2d at 105.

The learned intermediary doctrine further provides that “the
failure of the manufacturer to provide the physician with an
adequate warning is not the proximate cause of a patient’s injury
if the prescribing physician had independent knowledge of the risk
that an adequate warning should have communicated.”
C.R. Bard, Inc.,

F. Supp. 3d.

Tillman v.

, 2015 WL 1456657, at *21 (M.D.

Fla. 2015) (citing Christopher v. Cutter Labs., 53 F.3d 1184, 1192
(11th Cir. 1995)).

Accordingly, “the adequacy of the warning is

irrelevant if the prescribing physician, as opposed to the patient,
has knowledge of the risks and benefits of the drug and would have
prescribed the drug anyway had the warnings been different.” Chase
v. Novartis Pharm. Corp., 740 F. Supp. 2d 1295, 1297 (M.D. Fla.
2006).

Buckner v. Allergan Pharms., Inc., 400 So. 2d 820, 822 (Fla. 5th
DCA 1981) (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th
Cir. 1974)).

13

In this matter, defendants contend that plaintiffs’ failure
to warn claims are barred by the learned intermediary doctrine
because Dr. Kowal would have prescribed Enbrel to Ms. Small even
if the package insert had warned of asymptomatic infections.

In

response, plaintiffs assert that the learned intermediary doctrine
is not implicated in this matter because defendants had a duty to
warn Ms. Small of the risks associated with Enbrel pursuant to 21
C.F.R. § 208.

Alternatively, plaintiffs argue that the learned

intermediary doctrine is pre-empted by 21 C.F.R. § 208.24, and
that defendants’ motion for summary judgment should be denied
because there are disputed issues of material fact.
1.
In

The Duty to Warn
1998,

the

FDA

implemented

regulations

requiring

the

distribution of “patient labeling for human prescription drug
products, including biological products, that the [FDA] determines
pose a serious and significant public health concern.”
§ 208.1(a).

21 C.F.R.

Patient labeling, also known as a medication guide,

is required when the FDA determines that the “patient labeling
could

help

prevent

serious

adverse

effects;”

the

safety

information regarding the drug’s “serious risk(s) (relative to
benefits) . . . could affect patients’ decision to use, or to
continue to use, the product;” or the drug “is important to health
and patient adherence to directions for use is crucial to the
drug’s effectiveness.”

21 C.F.R. § 208.1(c).

14

The manufacturer of a drug for which a medication guide is
required must obtain FDA approval of the medication guide prior to
distribution.

21 C.F.R. § 208.24(a).

The medication guide will

only be approved if it includes certain information, such as the
name of the drug, a specific description of what the patient should
do or consider before taking the drug, the circumstances under
which the drug should not be used, the instructions on how to
properly use the drug, and the possible or reasonably likely side
effects of the drug.

21 C.F.R. § 208.20(b).

After the medication

guide is approved, the manufacture must ensure that medication
guides

are

available

for

distribution

to

patients

by

either

providing medication guides in sufficient numbers to distributors,
packers, or authorized dispensers, or providing the means to
produce medication guides in sufficient numbers to distributors,
packers, or authorized dispensers.

21 C.F.R. § 208.24(b).

Plaintiffs contend that these regulations (the “medication
guide regulations”) were implemented “with the express goal of
allowing the FDA to impose a duty upon manufacturers to provide
pertinent safety information directly to consumers where special
circumstances

existed

that

required

it.”

(Doc.

#89,

p.

6.)

Because this duty was expressly created by the FDA, plaintiffs

15

assert that the learned intermediary doctrine is not implicated by
their failure to warn claims. 5

The Court disagrees.

Florida law clearly provides that the duty to warn of a drug’s
dangerous propensities runs to the physician, not the patient.
See Mason, 27 So. 3d at 77.

The fact that federal law requires

drug manufacturers to warn patients of the risks associated with
certain drug products does not change the analysis under Florida
law.

Indeed, “[d]istrict courts in this Circuit have consistently

held that private actions based on the violation of FDA regulations
are barred because Florida does not recognize such causes of
action.”

Small v. Amgen, Inc., 2 F. Supp. 3d 1292, 1299-1300 (M.D.

Fla. 2014) (citing Kaiser v. Depuy Spine, Inc., 944 F. Supp. 2d
1187, 1192 (M.D. Fla. 2013)).

See also Cook v. MillerCoors, LLC,

872 F. Supp. 2d 1346, 1351 (M.D. Fla. 2012).

Furthermore, the FDA

explicitly stated that it did not intend to change or expand state
tort law when it promulgated the medication guide regulations.
Specifically, the FDA stated that it “does not believe that this
rule would adversely affect civil tort liability” because it “does
not alter the duty, or set the standard of care for manufacturers,”
and

because

“courts

have

not

recognized

an

exception

to

the

‘learned intermediary’ defense in [other] situations where FDA has

5The

undisputed evidence shows that Enbrel was distributed
with a medication guide. (Doc. #82-8.)

16

required patient labeling.”

Prescription Drug Product Labeling;

Medication Guide Requirements, 63 Fed. Reg. 66378, 66384 (Dec. 1,
1998).

See also Bartlett v. Mutual Pharm. Co., No. 08-cv-00358-

JL, 2010 WL 3659789, at *6 (D.N.H. Sept. 14, 2010).
To the extent that plaintiffs are asking the Court to create
a special exception to the learned intermediary doctrine, the Court
declines to do so. 6

Plaintiffs have not identified, nor has this

Court found, any cases supporting their theory that FDA regulations
“inactivate” the learned intermediary doctrine.

In fact, the

courts that have addressed similar arguments have all concluded
that the learned intermediary doctrine is not abrogated by the
medication guide regulations.

See Dreher v. Wyeth Pharms., Inc.,

No. 2:14-cv-280-KOB, 2015 WL 3948961, at *8 (N.D. Ala. June 29,
2015); Frazier v. Mylan Inc., 911 F. Supp. 2d 1285, 1290 (N.D. Ga.
2012); Bartlett, 2010 WL 3659789, at *5-7.

Accordingly, the Court

concludes that defendants’ duty to warn of the risks associated
with the use of Enbrel ran to Ms. Small’s physician, not Ms. Small.

6“[F]ederal

courts must be cautious when making pronouncements
about state law and ‘[w]hen given a choice between an
interpretation
of
[state]
law
which
reasonably
restricts
liability, and one which greatly expands liability, we should
choose the narrower and more reasonable path.’” Germain v. Teva
Pharms., USA, Inc. (In re Darvocet, Darvon, & Propoxyphene Prods.
Liab. Litig.), 756 F.3d 917, 937 (6th Cir. 2014). See also Three
Palms Pointe, Inc. v. State Farm Fire & Cas. Co., 362 F.3d 1317,
1318 (11th Cir. 2004).

17

2.

Preemption of the Learned Intermediary Doctrine

Plaintiffs also argue that the medication guide regulations
preempt the learned intermediary doctrine.

Again, the Court

disagrees.
The Supremacy Clause, U.S. Const. Art. VI, cl. 2, invalidates
state laws that “interfere with, or are contrary to,” federal law.
Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S.
707, 712 (1985).

The Supreme Court has identified three types of

preemption: (1) express preemption; (2) field preemption; and (3)
conflict preemption.

Cliff v. Payco General Am. Credits, Inc.,

363 F.3d 1113, 1122 (11th Cir. 2004) (citing Wisconsin Public
Intervenor

v.

Mortier,

501

U.S.

597,

604-05

(1991)).

Here,

plaintiffs assert that learned intermediary doctrine is preempted
by both field preemption and conflict preemption.
i.

Field Preemption

Field preemption occurs when state law occupies a “field
reserved

for

regulation.

federal

regulation,”

leaving

no

room

for

state

United States v. Locke, 529 U.S. 89, 111 (2000).

It

can also be inferred when “an Act of Congress ‘touches a field in
which the federal interest is so dominant that the federal system
will be assumed to preclude enforcement of state laws on the same
subject.’”

Wiersum v. U.S. Bank, N.A., 785 F.3d 483, 486 (11th

Cir. 2015) (quoting English v. Gen. Elec. Co., 496 U.S. 72, 79
(1990)).

Nonetheless, for field preemption to be applicable,

18

“congressional intent to supersede state laws must be ‘clear and
manifest.’”

English, 496 U.S. at 79.

Plaintiffs argue that field preemption exists because “21
C.F.R § 208 gives the FDA exclusive power to determine whether a
manufacturer has a duty to warn consumers by way of a medication
guide” and “there is no room for a state to determine whether such
a duty exists.”

(Doc. #89, p. 8.)

The Court disagrees.

In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court
held

that

state

common

law

failure

to

warm

claims

against

manufacturers of brand name drugs are not preempted by the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., or
the regulations promulgated by the FDA.

555 U.S. at 581.

In

reaching its conclusion, the Supreme Court noted that, as the FDA’s
powers to ensure the safety of prescription medications expanded,
“Congress

took

care

to

preserve

state

law.”

Id.

at

567.

Specifically, the Court underscored the fact that while Congress
had the opportunity to expressly preempt state law governing the
labeling of prescription medication, it declined to do so.

Id.

The Court further noted that “Congress has not authorized the FDA
to pre-empt state law directly.”

Id. at 576.

Because “Congress

has repeatedly declined to pre-empt state law,” id. at 581, the
Court concluded that neither Congress nor the FDA intended the
FDA’s drug labeling requirements to occupy the field, see Lefaivre

19

v. KV Pharm. Co., 636 F.3d 935, 941 (6th Cir. 2011).

Accordingly,

the Court finds that there is no field preemption in this case.
ii.

Conflict Preemption

“‘Conflict preemption,’ as it is commonly known, arises in
two circumstances: when it is impossible to comply with both
federal and state law and when state law stands as an obstacle to
achieving the objectives of the federal law.”

Cliff, 363 F.3d at

1122 (citing Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363,
372-73 (2000)).

Plaintiffs do not argue that it is impossible for

a drug manufacturer to comply with the medication guide regulations
and the state law duty to provide the prescribing physician with
an adequate warning.

Instead, plaintiffs assert that “the learned

intermediary doctrine is an obstacle to achieving the objectives
of 21 C.F.R. § 208 because it relieves the manufacturer of the
exact duty that § 208 was constructed to impose.”

(Doc. #89, p.

9.)
As
provides

previously
that

a

stated,

drug

the

learned

manufacturer

has

intermediary
a

duty

to

doctrine
warn

the

prescribing physician of the possibility that the drug may cause
the injury alleged by the plaintiff.

See Mason, 27 So. 3d at 77.

If the manufacturer complies with this duty, Florida law provides
that a plaintiff cannot recover damages under a failure to warn
theory.

Id.

In

no

way

does

this

doctrine

relieve

drug

manufacturers of their obligations under the medication guide

20

regulations.

Nor does the learned intermediary doctrine stand as

an obstacle to fulfilling the purposes and objectives of the
medication guide regulations.
the

learned

intermediary

Indeed, the FDA explicitly stated

doctrine

medication guide regulations.

is

not

at

odds

with

the

Prescription Drug Product Labeling;

Medication Guide Requirements, 63 Fed. Reg. 66378, 66384 (Dec. 1,
1998).

Furthermore, plaintiffs’ obstruction theory is undercut by

the fact that the learned intermediary doctrine and the medication
guide regulations have coexisted since 1998.
at 581.

See Wyeth, 555 U.S.

As such, the Court concludes that learned intermediary

doctrine is not preempted by the medication guide regulations.
3.

Application of the Learned Intermediary Doctrine

Defendants maintain that plaintiffs’ failure to warn claims
are

barred

by

the

learned

intermediary

doctrine

because

the

undisputed evidence demonstrates that Dr. Kowal knew of the risks
associated with the use of Enbrel, and would have prescribed Enbrel
to Ms. Small regardless of whether the package insert specifically
warned of asymptomatic infections.

The Court agrees.

Dr. Kowal, as the prescribing physician, served as the learned
intermediary between defendants and Ms. Small.
Wyeth,

LLC,

719

F.3d

1245,

1250

(11th

Cir.

See Guarino v.
2013)

(“[T]he

prescribing physician, acting as a ‘learned intermediary’ between
the manufacturer and consumer of the drug, weighs the drug’s
benefits against its potential harms in deciding whether it is

21

appropriate to the patient’s course of treatment.”); Buckner, 400
So. 2d at 822 (same).

Thus, the issue before the Court is whether

Dr. Kowal was aware of the risk of serious asymptomatic infections
and would have prescribed the drug anyway had the warnings been
different.

See Chase, 740 F. Supp. 2d at 1297.

The undisputed evidence shows that Dr. Kowal’s knowledge of
the risks and benefits associated with the use of Enbrel was
extensive.

Dr. Kowal was the principal investigator in a clinical

study on Enbrel and was privy to all of the available information
regarding the drug’s potential side effects.
22-23.)

(Doc. # 82-1, pp.

Dr. Kowal testified that she understood that Enbrel’s

warnings of infection included all types of infection and that
these infections may occur in any body system.
She also

knew

that

Enbrel

may

cause

(Id. at 35-36.)

abdominal

abscesses

and

digestive system disorders, including intestinal perforations, and
that a patient with a history of infections should be closely
monitored for recurrent infections.

(Doc. #82-1, pp. 33-34, 75;

Doc. #82-3, pp. 17, 20; Doc. #82-5, p. 5.)

This knowledge was

used by Dr. Kowal when she weighed the risks and benefits of
prescribing Enbrel to Ms. Small.

(Doc. #82-1, pp. 35-37.)

With respect to her decision to prescribe Enbrel to Ms. Small
in 2002, Dr. Kowal testified as follows:
Q. So you’re aware that there could be an asymptomatic
infection?

22

A. Absolutely . . . .
Q. And if the package insert had said that infections,
including asymptomatic infections may be possible with
Enbrel, would you still have made the decision to
prescribe Enbrel to Ms. Small?
A. Yeah, because it still works, and asymptomatic
infections, I mean, how can you -- I mean, are you going
to scan everybody? We don’t have MRI scan that we can
just do body scans to see if an infection is brewing, so
you take that risk.
Q. And you -- would you have changed your counseling to
Ms. Small in any way if the package insert had said
asymptomatic infections?
A.

No, not at this time, absolutely not.

(Id. at 46-47.)

As to her decision to resume Ms. Small’s treatment

with Enbrel in 2009, Dr. Kowal testified that her decision would
not have been altered by additional warnings regarding the risk of
asymptomatic infections.

(Id. at 78, 85.)

Based on this testimony, it is clear that Dr. Kowal was aware
of the risk of asymptomatic infections and would not have changed
her decision to treat Ms. Small’s rheumatoid arthritis with Enbrel,
even if the package insert had warned of asymptomatic infections.
Thus,

defendants’

purported

failure

to

warn

of

asymptomatic

infections could not have been the proximate cause of Ms. Small’s
injuries.

See Mason, 27 So. 3d at 77.

Plaintiffs

attempt

to

avoid

the

impact

of

the

learned

intermediary doctrine by arguing that Dr. Kowal cannot be treated
as a learned intermediary because defendants’ pharmaceutical sales

23

representative advised Dr. Kowal that it was safe to resume Ms.
Small’s treatment with Enbrel.

As previously stated, “the failure

of the manufacturer to provide the physician with an adequate
warning is not the proximate cause of a patient’s injury if the
prescribing physician had independent knowledge of the risk that
an adequate warning should have communicated.”
1456657, at *21.

Tillman, 2015 WL

Thus, any representations made by defendants’

sales representative are irrelevant if Dr. Kowal had independent
knowledge of the possibility that Enbrel could cause the injuries
sustained by Ms. Small.

Dr. Kowal’s testimony clearly shows that

she knew of the risks associated with the resumption of Enbrel
(Doc. #82-1, pp.

before she spoke to the sales representative.

33-34, 75; Doc. #82-3, pp. 17, 20; Doc. #82-5, p. 5.)
the

Court

finds

that

the

representations

Accordingly,

allegedly

made

by

defendants’ sales representative are irrelevant.
Plaintiffs’ failure to warn claim is also premised on the
theory that defendants failed to provide guidance on resuming
treatment with Enbrel after an infection.
theory

is

that

manufacturers

are

only

The problem with this
required

to

warn

the

prescribing physician of the possibility that the drug may cause
the injury alleged by the plaintiff.
There

is

no

duty

to

provide

MacMurdo, 562 So. 2d at 683.

guidance

under

Florida

law.

Furthermore, Dr. Kowal testified that requested guidance would not
have changed her decision to resume Ms. Small’s treatment with

24

Enbrel. 7
plaintiffs

(Doc.

#82-1,

cannot

show

pp.
that

78-79,

84-86,

defendants’

96.)

Accordingly,

purported

failure

to

provide guidance as to when it was appropriate to resume treatment
with Enbrel was the proximate cause of her injuries.

See Chase,

740 F. Supp. 2d at 1298.
In conclusion, the Court finds that summary judgment is
warranted as to plaintiffs’ failure to warn claims. Judgment shall
be entered in favor of defendants as to Count II and Count IV, to
the extent it asserts a claim for the negligent failure to warn.
B.

Design and Manufacturing Defects
Plaintiffs allege that “Enbrel® contained an unreasonably

dangerous defect in design or formulation in that, when it left
the

hands

of

the

Defendants,

an

average

consumer

could

not

reasonably anticipate the dangerous nature of Enbrel® nor fully
appreciate the attendant risk of injury associated with Enbrel®.”
(Doc. #54, ¶¶ 46, 74.)
negligently

Plaintiffs also allege that Enbrel was

manufactured.

(Id.)

Defendants

assert

that

plaintiffs’ design and manufacturing defect claims are barred by
the

learned

intermediary

doctrine

because

unavoidably

unsafe

products are exempt from design defect liability if the benefits

7Dr.

Kowal also testified that a warning label cannot tell a
physician when and how to start treatment with a drug because every
patient is unique. (Doc. #82-1, pp. 64, 75.)

25

of the product outweigh the risks and the product is accompanied
by an adequate warning.
Defendants are essentially seeking the protection of comment
k in § 402A of the Restatement (Second) of Torts.

Comment k

addresses “[u]navoidably unsafe products,” described “as products
which, in the present state of human knowledge, are quite incapable
of being made safe for their intended and ordinary use.
especially common in the field of drugs.”
Torts § 402A, cmt. k.

These are

Restatement (Second) of

“Such a product, properly prepared, and

accompanied by proper directions and warning, is not defective,
nor is it unreasonably dangerous.”

Id. (emphasis in original).

Accordingly, the seller of an unavoidably unsafe product that was
properly

prepared

and

accompanied

by

proper

directions

and

warnings will not be strictly liable “for unfortunate consequences
attending its use merely because he or she has undertaken to supply
the public with an apparently useful and desirable product.”

Id.

In order to be protected under comment k, “a defendant must show
that the product is as safe as current testing and research permit,
and that the product’s benefits outweigh the known risks as of the
date the product is distributed.”

Tillman, 2015 WL 1456657, at

*26 (citing Adams v. G.D. Searle & Co., Inc., 576 So. 2d 728, 73233 (Fla. 2d DCA 1991)).
Here, defendants assert that Dr. Kowal’s testimony clearly
shows that the benefits of Enbrel outweigh its risk.

26

Defendants

have not, however, proffered any evidence showing that Enbrel was
as safe as it could be at the time of Ms. Small’s injuries.
Furthermore, defendants’ arguments are premature as the discovery
period has yet to close.
summary

judgment

is

Accordingly, defendants’ motion for

denied

as

to

plaintiffs’

design

and

manufacturing defect claims.
VI.
In Count III of the Fourth Amended Complaint, plaintiffs
allege that defendants expressly warranted in the package inserts,
the Physicians’ Desk Reference, other marketing literature, and
documents provided to the FDA, that Enbrel was of merchantable
quality, fit, safe, and otherwise not injurious to the health and
well-being of Ms. Small.

(Doc. #54, ¶ 66.)

Plaintiffs further

allege that these representations were material to Ms. Small’s
decision to use Enbrel and that product did not conform to the
representations.
was injured.

As a result of the product’s nonconformity, she

(Id. ¶¶ 67-71.)

Defendants assert that this claim is barred by the learned
intermediary doctrine because it is presumably based upon the
failure to warn of asymptomatic infections.

The Court disagrees.

Nowhere in Count III do plaintiffs allege that defendants made an
affirmation or promise as to the adequacy of Enbrel’s warnings.
As such, defendants’ motion for summary judgment is denied as to
Count III of the Fourth Amended Complaint.

27

Accordingly, it is now
Defendants’ Motion for Summary Judgment (Doc. #82) is GRANTED
in part and DENIED in part.

The Clerk shall enter judgment in

favor of defendants as to Count II and Count IV, to the extent it
asserts a claim for the negligent failure to warn.

The motion is

otherwise denied.
ORDERED:
DONE AND ORDERED at Fort Myers, Florida, this
September, 2015.

Copies:
Counsel of record

28

25th

day of