Wolicki-Gables et al v. Arrow International, Inc. et al

Filing 126

ORDER granting 66 Motion for Partial Summary Judgment; granting 80 Motion for summary judgment; denying without prejudice 81 Motion in limine; granting 82 Motion for summary judgment; denying 85 Motion for summary judgment. The Clerk of Court shall enter a final judgment in favor of Defendants against Plaintiffs Linda Wolicki-Gables and Robert Gables, and close this case. Signed by Judge Elizabeth A. Kovachevich on 7/22/2009. (JM)

UNITED MIDDLE

STATES TAMPA

DISTRICT OF DIVISION

COURT

DISTRICT

FLORIDA

LINDA WOLICKI-GABLES,
and ROBERT GABLES, etc.,

Plaintiffs,
v.

CASE NO.
INTERNATIONAL, & SHURTLEFF, INC., INC.,

8:08-CV-151-T-17TBM

ARROW CODMAN

JOHNSON
GREG

&

JOHNSON,

and

NELSON,

Defendants.

ORDER

This

cause

is

before

the

Court

on:

Dkt.

66 7078

Motion
Counts

for

Partial

Summary Judgment

IV and VII

Dkts. Dkt.
Dkt.
Dkt. Dkt.

Depositions
Response

90

85

Motion

for

Summary Judgment

101 80 82 89 95100

Response

Motion

for

Summary Judgment

Dkt. Dkt.
Dkts. Dkt.
Dkt. Dkt.
Dkt.

Motion Order -

for Summary Judgment Joinder

Depositions

102 103 115
81

Deposition
Response

Supplemental Authority
Motion in Limine to Exclude

Plaintiffs'
Dkt. Dkt.

Experts

104
109

Response

Notice

Case

No.

8:08-CV-151-T-17TBM

The Second Amended Complaint
Count
Count
Count

includes
Arrow Arrow

the

following claims;

I
II

Strict Liability Negligence
Consortium Strict Liability
Negligence Consortium

III IV V
VI VII

Arrow

Count

Codman

Count Count
Count Count

Codman
Codman
J&J

Strict

Liability

VIII

Negligence Consortium Negligence Vicarious Vicarious Vicarious Consortium Consortium Consortium Liability Liability Liability

J&J

Count
Count Count Count

IX X XI XII
XIII

J&J

Nelson
Arrow

Codman
J&J

Count
Count

XIV

Nelson
Arrow

Count Count

XV
XVI
XVII

Codman
J&J

Count

Consortium

The Court previously dismissed Count
claims for negligence & Johnson as to Defendants 51).

V and Count VIII,
& Shurtleff, Inc.

Codman

and Johnson

(Dkt.

A Stipulation of
Count XI, Arrow Vicarious 69),

Dismissal with

Prejudice was
and Count 7 9).

filed as

to

Liability

- Arrow,

XV,

Consortium -

(Dkt.

which was

granted

(Dkt.

Defendants

Codman

&

Shurtleff,

Inc.,

Johnson

&

Johnson,

and

Greg Nelson,

have

joined in the Motion

for Summary Judgment

of

Defendant Arrow
Exclude

International,
Experts

Inc.,

and the Motion

in Limine to

Plaintiffs'

(Dkt.

89).

I.

Standard of

Review

Summary
discovery and show that

judgment

should be

rendered
on as

if

the
and

pleadings,

the

disclosure is no

materials issue

file, to

any affidavits fact and

there

genuine

any material

Case

No.

8:08-CV-151-T-17TBM

that

the movant

is

entitled

to

judgment

as

a matter of

law.

Fed.R.Civ.P.

56(c).

The plain language of Rule 56(c) mandates the entry of summary judgment after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which
that party will bear the burden of proof at trial."
Celotex Corp. v. Catrett, 477 U.S. 317 (1986).

The

appropriate

substantive

law will

guide

the

determination

of which

facts

are material

and which
Inc.. 477

facts
U.S.

are...irrelevant.
248 (1986). All

Anderson v.

Liberty Lobby.

242,

reasonable doubts
are resolved in

about
of

the

facts

and all

justifiable
See

inferences
City

favor

the non-movant.

Fitzpatrick v.

of Atlanta.
genuine
return a

2 F.3d 1112,

1115
is

(11th Cir.
a

1993).

A dispute

is

"if the evidence
verdict for the

such that

reasonable

jury could
477

non-moving party."

See Anderson.

U.S.

at

248.

But,

"[i]f

the

evidence

is merely colorable...or

is

not
Id.

significantly probative...summary judgment may be granted."
at 249-50.

II.

Statement

of

Facts

1. Plaintiff

On April

30,

2002,

Dr.

Brian to

James a

performed drug

surgery on

Linda Wolicki-Gables for treatment of

implant

delivery pump 103-3,

and catheter
Operative

chronic pain.

(Dkt.

Note).

Case No. 2.

8:08-CV-151-T-17TBM The components implanted in Plaintiff Linda Wolicki-

Gables

included a pump that released pain medication,
catheter through which the medicine was and a metal connector that

an

intrathecal

delivered

into the spinal catheter to the

canal,

linked the pump

intrathecal catheter.

3.

The

identifying information

for the pump

follows:

ARROW
Model MADE 3000

Implant Model: Codman/Arrow
Cont. No. AP-07009

Serial No. 8035 IN U.S.A. CE 0128"

Lot No.: 335918 Size: 105 cm, ID 0.5 mm Diopters: N/A

Co.: Exp.
4.
follows:

N/A Date:

2006-03 catheter kit

The

identifying

information

for the

Arrow
Lot

Flextip
312737

Plus

Intraspinal

Kit

Catalog No. No.

AP-07009

The catheter kit

includes

a connector.

(Dkt.

66-8, (Dkt.

p.

80). p.

The 85).

catheter connector also

comes

individually.

66-8,

5.

After implantation,

over a period of time,

Dr.

James

adjusted the dosage

of the pain medication

to be administered to
Dr. James

Plaintiff Linda Wolicki-Gables testified that it was a

through the pump. to

common process

start with a low dosage

and gradually find a balance of the amount of medicine with the
level of pain relief. Dr. James testified that although his

records state the diagnosis as
the diagnosis should have

"malfunctioning implanted device,"

stated "failed back surgery syndrome."

Dr.

James testified that there was no finding during those days

Case No. of

8:08-CV-151-T-17TBM the pump. {Dkt. 96, pp. 95-109.)

any malfunction of

6.

On August

15,

2002,

at

Plaintiff

Linda

Wolicki-Gables'

request,

Dr.

James performed a
infusion pump leaks
dye.

dye injection test
working properly.

to assess
Dr. James intrathecal
the test,

whether the observed no
spread of

was

in

the

system and
103-6,

saw appropriate
Note).

the

(Dkt.

Procedure

After

Plaintiff Linda Wolicki-Gables
the pump. (Dkt. 103-7).

complained of pain

radiating to

7.
103-9,

On July
Progress

10,

2003,
In

Dr.
Dr.

James
James'

again

tested the pump
Dr. James

(Dkt.

Note).

records,

states:

"...When
back out

the

dye was
the

injected,
nipple

it

just

came

through

and extravasated

near both
the

the

needle

entry the

site, side

coming of

externally on

and dripping sides.
pump is

down

the patient
The rep for

Clearly,
Greg

the bolus
was

function of
contacted.

malfunctioning. Nelson,

Arrow Medical,

We will

schedule

Linda

for

replacement

of her

malfunctioning pump.

She is to continue on her present meds.
reviewed her pump
fact receiving

We
in It

refill

notes. the

She

is

the medication

through

the

regular is just

functioning the bolus

system of is

pump.

function

malfunctioning..." 8. On July 15, 2003, Plaintiff Linda and
the

Wolicki-Gables Disclose
Informed

executed an
at Doctors

"Informed Consent
Same Day Surgery

to Treat
In

Information"
Consent

Center.

Plaintiff
inter

signed,
to the

Plaintiff Linda Wolicki-Gables
admittance of students and

did

not

consent,

alia,

persons

required

for technical

support

to

the

room

in which

the

procedure

[was]

performed,

and did not

consent

to the disposal

of any tissues

or

Case No.

8:08-CV-151-T-17TBM

body parts...removed in accordance with customary practice.
Plaintiff initialed "We want old pump." on the form (Dkt. 103-

11).

9. Same

On July

15,

2003,

Dr.

James performed surgery at infusion pump.

Doctors

Day Surgery Center to replace the
the pump was removed,

During the
and the

surgery,

a connector was

replaced,

same pump was

reimplanted.

(Dkt.

103-12).

10.

Defendant

Greg Nelson,

sales

representative

for

Defendant Arrow International,

was present
15,

in the Operating Room
2003.

during the revision procedure of July

11.

On July 17,

2003,

Dr.

James

examined Plaintiff Linda

Wolicki-Gables, properly,
fine,

refilled her pump, Plaintiff's

confirmed it was working incision site looked

noted that

surgical
signs

and identified no clinical

of any infection.

12.

On July 29,

2003,

Plaintiff Linda Wolicki-Gables was and was admitted to

unable to move her lower extremities, Sarasota Memorial Hospital (Dkt.

103-15).

Plaintiff Wolicki8, 2003, after which

Gables remained hospitalized until August

Plaintiff was transferred to another facility for rehabilitation.

The discharge diagnosis was transverse myelitis of undetermined
cause.

13.
Memorial (Dkt.

Plaintiff Wolicki-Gables was readmitted to Sarasota
Hospital on August 11, 2003 for the removal of the pump At that

103-17).

Dr.

Raymond Priewe

removed the pump.

time Dr.

Priewe found a
"No pus

superficial skin infection;
spine,

Dr.

Preiwe's

note states:

in pump pocket or dorsal

only

Case No.

8:08-CV-151-T-17TBM

superficial

skin."

(Dkt.

77,

p.

39).

14.

After

removal,

the

pump was

cultured

at

Sarasota

Memorial of

Hospital.

The pump and catheter

is

now

in the custody

Plaintiff's

counsel.

15. request to

Small save

parts, or test

such the

as

the

connector, are

in

the

absence in

of a

part,

discarded

as waste

accordance with the policies Linda Burns
waste is

of

Doctors

Same

Day

Surgery Center.

testified that
it in a

in 2003
"red bag

the policy to discard medical
situation" to be discarded

to place

under the universal
Linda Burns

biohazardous protocol.

(Dkt.

102,

p.

60).

further testified that sales
left.

there was

no policy that would the connector

have prohibited
with him when he

rep.

Greg Nelson
102, p.

from taking

(Dkt.

49.)

16.

The

following of

chronology of events Greg Nelson
& Johnson:

shows

the Codman &

relationship
Shurtleff,

Defendant
and

to

Defendants

Inc.

Johnson

December,

1998

Greg Nelson

forms

Venture

Medical Devices, Inc., which served as a distributor of Arrow's implantable pump products
to a

in

Florida pursuant

contract;

Pre-March,

2002

Arrow

designed,

manufactured and

distributed the pump and catheter kit like those
implanted in

Plaintiff;

Case No.

8:08-CV-151-T-17TBM

March

1,

2002

Codman acquired Arrow's pump division. Codman assumed the distribution contract between Arrow and VMD; VMD continued as an independent contractor authorized to distribute Codman products;

April

30,

2002

Pump and catheter

kit

implanted in

Plaintiff; Greg Nelson attended the implant procedure and delivered the
pump;

July,

2003

Greg Nelson became Codman employee.

a

17.
Medical

The distribution contract between Arrow and Venture
Devices, Inc. provides that: "nothing in the Agreement is

to be construed as creating a principal/agent

relationship,

an

employer/employee relationship,
partnership." (Dkt. 66, Exh. E,

or a joint venture or
Par. 17).

18.

Defendant Arrow admits

that

Defendant Arrow designed,

manufactured,
Plaintiffs & Johnson

tested and sold the subject pump and catheter kit.
Defendants design, Codman & Shurtleff, test or Inc. sell and Johnson the pump and

admit did not

manufacture,

catheter

kit.

Plaintiffs

contest only the
kit by Defendants

alleged distribution
Codman & Shurtleff,

of the pump Inc.

and catheter &

and Johnson

Johnson.

19.

In Count X of

the

Second Amended Complaint

(Dkt.

30),

Plaintiffs allege a negligence claim as to

Defendant Greg Nelson, reasonable to the care in

based on the alleged breach of the duty to use the instruction and education of physicians that it would be
8

as

implantable for its

drug delivery system so

reasonably safe

Case No.

8:08-CV-151-T-17TBM

intended use. ensure that the

Plaintiffs

also allege a breach

of the duty to functioning

implantable drug delivery system was

properly before allowing it to be implanted.
allege a duty to ensure that
Nelson's presence in the

Plaintiffs

further

Plaintiffs
room,

consented to
and a duty

Defendant
to verify

operating

that

Plaintiffs

consented the destruction of the pump parts

removed.

In the Second Amended Complaint,

Plaintiffs

include no

allegations which

refer to the

liability of

Defendant Nelson on

the basis of Defendant Nelson's distribution of the
products.
of

subject

The allegations
Codman

of

Paragraph 7
&

refer

to the liability
the actions

Defendants

and Johnson

Johnson,

based on

of

Defendant Nelson while a

representative or employee of

Defendants.

20.

Dr.

Brian

James was

deposed on October

15,

2008,

November
James

19,

2008,

January 7,

2009 and

February 4,

2009.
of

Dr.

testified that (Dkt. 95,

he had only a vague p. 12.) Dr. James

recollection

Plaintiffs.

testified that

it was

a

common practice

for sales

representatives (Dkt. are not 95, p.

of device 9.) Dr.

companies to testified

attend surgical procedures. that sales representatives in the

James

in the

sterile (Dkt.

field and do 95, pp. 9-11).

not participate Dr. James

surgical procedure.

further testified:

"A. The decisions regarding patient care that I'm immediately involved in are under my discretion and my decisions. What I don't see when I'm not around I obviously don't have any say-so in.
I mean, there's periods where the product's

Case No.

8:08-CV-151-T-17TBM

brought in where it's handled. I don't participate in that. I'm not aware what's going on. My decisions are not involved. There's periods when the product is then given to the staff of the facility.

I'm not involved in many of the decisionmaking that-any of those encounters, I would not be involved in that. I'm involved in the immediate surgical field and patient care
issues
Dkt. 95., p. 11,

regarding that."
Lines 6-18).

Dr.

James testified as to Plaintiff Linda Wolicki-Gables' relying upon the medical records of that

revision surgery,
surgery. Dr.

James testified that the revision surgery was
function of the pump did not work July 10, 2003. During the revision

performed because the bolus when Dr. James tested it on

procedure,

after the catheter was cut,
Dr. James testified:

the bolus

function of the

pump did work.

Q. When you went in intraoperatively and cut the catheter so there was no potential catheter blockage or crimp, the bolus function of the pump worked just fine.
A. Q. Apparently. the

Now, you made the decision to put original pump back in, correct?

A. According to the operative note I new connector was used to connect the
intrathecal catheter, the catheter

have,
was

a

that

presently catheter

in

the patient,

to the

pump

system.

It was then bolused and

rechecked with the dye and spread within the spinal canal where it's supposed to go was
10

Case No.

8:08-CV-151-T-17TBM

confirmed.

No leaks were seen.

Then I took out the old medication that was in the pump, because I did not think she had been receiving it; or I wasn't wanted to drop the dosage down
be-it's better to be safe than

certain; just to
sorry

and I

in that

aspect to avoid any respiratory depression or potential overdose. So that's what was done.
So I'm-all right. Strike that. The decision was made after you bolused the pump and saw that the bolus function was working fine to return the original pump into
Ms A. Q. Gables' pump pocket, correct.

Q.

Apparently. So the only-well, not only apparently. operative

That's what
report,

happened based on the

correct.

A.

Right.

(Dkt.

95,

pp.

36-38).

21.

In his deposition of

February 4,

2009,

Dr.

James
in the 193). Dr.

testified that he has implantation of James

a wealth and depth of experience (Dkt. 72-2, p.

intrathecal pain pumps.

further testified that
for use,

intrathecal pain pumps
Dr. James was aware

come with
of all an

instructions

and that

information offered by the manufacturer before performing

implantation,

including all of the known complications reported

by the manufacturer associated with the intrathecal pain pump.
(Dkt. 72-2, p. 199-200) .

22.

Defendant

Nelson was

deposed

on

September

20,

2008

and

October

1,

2008.

Defendant Nelson testified that

he did not have

an independent 2003.

recollection of the

surgery performed on July 15, in general, the reason

Defendant Nelson testified that,
11

Case No.

8:08-CV-151-T-17TBM

for his presence in the Operating Room was
hand in the event they were needed. his {Dkt. role

so products were on
66-7, p. 34).

Defendant Nelson

testified that

was

limited to handing a

package containing the part to an operating room nurse,
hand the part to a scrubbed-in nurse, who would hand

who would

it to the

doctor

(Dkt.

66-8,

p.

89),

and observation of

the physician's
testified

examination of

the pump

and test.

Defendant Nelson

that,

in a revision surgery, the 14 9). use

it was

routine to

remove

the

connector to visualize fluid) {Dkt. 66-9, a p. p.

free

flow of CSF

(cerebro-spinal testified that the

Defendant Nelson device once

connector is (Dkt. 66-9,

one-time 149).

it's been connected. Defendant

Defendant Nelson testified that replacement of a
(Dkt. 66-9, p.

Nelson did not deem the
modification

connector to be a
152).

of the device

21. 18, 2008,

Plaintiff Linda Wolicki-Gables was September 24, 2008, September 29,

deposed on September 2008 and October 30,

2008.

Plaintiff Linda Wolicki-Gables testified:

Q. Did Doctor-What do you recall Dr. James telling you about the potential complications
of the procedure?

A. You know, I trusted Dr. James with my life. He put the pump in and he was going to fix the pump. He was going to take it out and put a new one in.

Q.

Do

you

recall

him telling you

of

any

potential
A. No.

complications from the procedure?

Q. You understood there was infection?
12

a

risk of

Case No.

8:08-CV-151-T-17TBM

A.
{Dkt. 78-4, p.

There
325).

is

always a

risk of infection.

Plaintiff Wolicki-Gables

testified

in detail as to what 15, 2003.

she

heard and saw before and after the surgery of July (Dkt. 78-3, 78-4, pp. 312-341)

Plaintiff Wolicki-Gables
present and spoke to her

testified that

Defendant Greg Nelson was

after the

surgery.

(Dkt. she
cut

78-4,

p.

327.)

Plaintiff Wolicki-

Gables testified that
that Defendant Nelson

recalled Defendant Nelson telling her
the catheter, and did a connection in

her back.

(Dkt.

78-4,

p.

331).

Plaintiff Linda Wolicki-Gables

later testified that

Plaintiff's best recollection was that
speak with 15, 2003. Plaintiff (Dkt. in the pp. recovery 356-357).

Defendant Nelson did not

room after surgery of July

78-4,

23.

Dr.

Michael Meriwether,

Plaintiff's medical expert,
the connector catheter

testified that there was junction,

an obstruction at

but the obstruction resulted from something unrelated design or manufacture:

to the product's

Q. However, because of some idiosyncratic complication with the patient, whether it was scar tissue, whether it was a granuloma or, with regard to some technique by the surgeon, a tie-down on the suture, something impaired the ability of the properly designed and properly manufactured system to function as designed?
A.
(Dkt. 74, p.

I

would

say,

yes.

72-73).

Dr.

Meriwether

testified that "fail" as

a properly designed and is used medically, but

implanted device might

the term 13

Case

No.

8:08-CV-151-T-17TBM

that does
64).

not mean that

the device was

defective.

(Dkt.

74,

p.

24.

Edward Reese, the

Ph.D.,

Plaintiffs'

regulatory expert,

testified that

specific malfunction of the device was a clog

in the catheter connector.
connector can become also testified that,

Dr.

Reese

further testified that a
Dr. Reese

clogged without being defective. if medicine is flowing out

of the pump

reservoir through its continuous spinal cord,
(Dkt. 75-5,

infusion mechanism into the

there would be no clog in the catheter connector.
p. 483-484). Dr. Reese did not only as 291-292). render an expert

opinion as to a design defect, (Dkt. 75-2, p. 173, 75-4, pp.

to a manufacturing defect.

25.

Dr.

Reese

submitted his

Initial

Report

on

September

1,

2008. Dr. Dr.

Dr.

Reese submitted an Amended Report on December 8, further Amended Report on January 11, further Amended Report on
deposed on January 13,

2008. 2009.

Reese submitted a Reese submitted a
Dr. Reese was

February 16,
and February

2009.
26,

2009,

2009.

26.

In his deposition,

Dr.

Reese testified that Dr.

Reese

did not include any criticism of Greg Nelson in any report,

"signed or scribble amended to this moment"
(Greg Nelson) 3, pp. being present

(1/13/2009)
30, 2002.

of him
(Dkt. 75-

in an OR on April

242-243.)

27.

A "Class is

III" medical device under 21 :

U.S.C.

360c(a)(1)(C)

one

a) for which the Agency could not establish[] that a less stringent classification would provide reasonable

assurance of safety and effectiveness;
14

Case No.
b)

8:08-CV-151-T-17TBM
is purported or represented to be for a use in

which

supporting or sustaining human life or for which a use of substantial importance in preventing
impairment of human health; or

is

for

c)

which

represents or injury.

a

potential

unreasonable

risk of

illness

27.

The

FDA-approved labeling
Model 3000

(Instructions

for

Use

("IFU")for the Arrow

30 mL Constant

Flow

Implantable

Pump with Bolus

Safety Valve

states:

ADVERSE EFFECTS

Possible adverse potential risks delivery device
path occlusion,
seroma, or

effects of

the

Pump are

those

associated with any

implanted drug

and include: catheter thrombosis, bolus vessel thrombosis, pump dislodgement,
hematoma, infection,

recurrent

extravasation, catheter shear, dislodgment or leakage, and migration. Drug extravasation may result if the instructions for use are not followed correctly during a Pump refill (see page 13) or bolus procedure (see
page 19)....
PUMP CATHETER OCCLUSION

SUSPECTED

If difficulty is encountered in administering fluids via the Bolus route,..., consider the following possible causes before proceeding to Fibrinolytic
Therapy:

The Arrow

Special

Bolus

Needle may not

be

perpendicular to the Pump and fully inserted through the septum, making contact with the needle stop. Reinsert in contact with needle
The needle may be

the needle stop.

until

it

is

occluded. to

Remove

from

the

septum and

flush

confirm patency. kinked. Confirm

The catheter may be radiologically.

15

Case No.

8:08-CV-151-T-17TBM

If the occlusion persists after taking the above steps, proceed to prepare appropriate Fibrinolytic agent (urokinase, streptokinase) according to hospital pharmacy guidelines....
If occlusion continues to persist after steps assistance.... 1 through

4,

call

for technical

(Dkt.

80-1,

p.

3,

p.

22).

28. provides

The Medical

Device Amendments'

preemption clause in effect with

"no State....may establish or continue

respect to a device intended for human use
which is different from or in addition to,

any requirement--(1)
any requirement (2) which relates

applicable under this

chapter to the device and

to safety or effectiveness
included in a requirement chapter." 21 U.S.C. Sec.

of the device or to any other matter
applicable 360k(a). to the device under this

III.

Motions

for Summary Judgment - Discussion

A.

Count Count

IStrict Liability - Arrow II - Negligence - Arrow International,
favor of

Defendant Arrow
summary judgment in

Inc.

moves

for entry of
Defendant Arrow

Defendant Arrow.

argues that

Plaintiffs'
21

claims

are preempted by the Medical
360(c), 21 U.S.C. et seq., {"MDA"), et to and

Device Amendments, the Food, Drug

U.S.C.

Sec.

and Cosmetic Act,

Sec.

301,

seq.,

Plaintiffs cannot provide evidence sufficient to sustain Plaintiffs' strict liability claim as required under Florida law.

Plaintiffs Plaintiffs'
Greg Nelson.

respond that there

is no preemption of

claim based on the acts and/or omissions of Defendant
Plaintiffs contend that
16

Defendant Nelson

should

Case

No.

8:08-CV-151-T-17TBM

have disallowed the replacement of the connector or replacement of the pump kit). system

suggested

(the infusion pump and catheter

Plaintiffs argue that
of

Defendant Arrow International Inc.,
surgery of

through the presence

Defendant Greg Nelson at the on July 15, 2003,

Plaintiff Linda Wolicki-Gables involved in "off label" use

was directly having

of the

subject product,

provided the replacement
Plaintiffs
be denied.

connector to Dr.

James

at that time.
should

argue

Defendant's Motion

for Summary Judgment

1.

Off Label

Use

"Off label" use

of a medical device occurs when the medical

device is used in a manner that varies
instructions in the device's The Federal labeling, Food, Drug

in some way from the
which are limited to FDA-

approved uses.

and Cosmetic Act

regulates the manufacture and marketing of medical devices,
the practice of medicine. practice of medicine, A physician may, as part different of the

not

lawfully prescribe a

dosage of

prescription medication,

or may otherwise vary the

conditions of

use from those approved in the package
or obtaining approval v. Evers. 453 F.Supp of the 1441,

insert,

without

informing
U.S. 643

Food and Drug Administration. (M.D. Ala. 1978), aff'd,

1449-50

F.2d 1043

(5th Cir.

1981).

Further,

a physician may modify a
Food and Drug
"off label"

legally marketed medical device.
Administration
use of drugs

The

recognizes

no difference between the

and devices.

The 21 U.S.C.

Food and Sec.

Drug Administration Modernization Act provides:

of

1997,

396,

17

Case No.

8:08-CV-151-T-17TBM

"Nothing

in

this

Chapter

shall be construed health any

to

limit

or

interfere with practitioner marketed device

the authority of a to a patient

care legally or

to prescribe or administer health

for any condition

disease within a legitimate patient relationship."

care practitioner-

2.

Express

Preemption 3000 Implantable Pump with Bolus Safety

The Arrow Model

Valve

("infusion pump") kit") are

and Arrow III

Flextip

Plus

Intraspinal which were

Kit

("catheter

Class

medical

devices

approved by the premarket

Food and

Drug Administration ("PMA")(Dkt.

through the The premarket

approval

process

80-13).

approval
submit

process

is

a

"rigorous"
as

process

in which manufacturers
and efficacy of an average Lohr. 518 of

detailed

information which each the

to the

safety

their devices, 1,200 U.S. hours 470, on

FDA then

reviews, Medtronic,

spending Inc. v.

submission. Once a

477

(1996).

device

receives

premarket

approval,

the manufacturer may not manufacturing processes,
would affect
approval. wishes 21

change

its

design,

specifications, attribute which
FDA

labeling,
safety or

or any other

the

device's
Sec.

efficacy without
If for

U.S.C. such

360e(D)(6)(A)(I). an application

a manufacturer a supplemental

to make

changes,

PMA must

be

submitted,

which

is

evaluated under

the

same

criteria

as

the

initial

application.
21 C.F.R.

Rieqel

v.

Medtronic.
Once a

Inc..

128

S.Ct.

999,

1007

(2008);

814.39(c).

device

receives

PMA,

a manufacturer must
events
803.53.

inform the
using the

FDA when
device.

it
21

becomes
C.F.R.

aware
Sees.

of

adverse
803.50,

in

patients

In

Rieael

v.

Medtronic.

Inc..

128

S.Ct.

999

(2008)

the

United

States

Supreme

Court

held

that
18

the preemption

clause

of

Case

No.

8:08-CV-151-T-17TBM

the MDA barred common effectiveness
FDA. The

law claims

challenging

the

safety and approval by the

of

a medical
Court

device given premarket
that

Supreme

explains

the MDA preemption

clause

establishes
claims are

a

two-pronged test
First, a

for determining
court must

if

state

law
the

preempted. imposes If at

determine on

whether

PMA process

device-specific so, a court must

requirements then

manufacturers. state law claims

determine

whether

the or

issue

impose

requirements

"different

from,

in addition
conditions
claims. approval

to"

the

specific

FDA requirements.
applies to bar a

If both
plaintiff's
that which "[pjremarket are

are met,
at

preemption
The

Id.,

1006.

Supreme

Court the

found MDA"

imposes

'requirements'

under

"specific Court

to

individual "the FDA to its

devices." a

Id.,

at that

1007. has

The

Supreme

notes

requires

device

received from the that

premarket

approval in

be made with approval

almost

no

deviations for the

specifications

application,

reason

the

FDA has

determined
assurance of

that

the

approved
and

form provides
Id.

a
After

reasonable premarket

safety are

effectiveness." to reporting

approval,

devices

subject

requirements,

which

include

the

obligation

to

inform the

FDA of

new clinical
device which of...and or to

investigations
the applicant

or

scientific
of or

studies

concerning
should have know

the

knows

reasonably the

report to

incidents death or

in which

device may

caused in a

contributed

serious

injury,

or malfunctioned

manner
injury

that would
if it

likely cause or contribute
The
on

to death

or

serious

recurred.
based

FDA has
newly

the power

to withdraw
or existing

premarket

approval

reported

data

information, device is

and must or

withdraw

approval under

if

it

determines in

that its

a

unsafe

ineffective

the

conditions

labeling.

19

Case

No.

8:08-CV-151-T-17TBM

In

Rieqel.

supra,

the

Supreme Court

further notes

that

claims
which

alleging a
were

failure

to

comply with
the

the

federal
are

standards
preempted.

established

through

PMA process

not

Such claims

are

"parallel"

claims,

which do not

add

to or differ

from federal

requirements.

Id.

at

1011.

The Court

views

Rieael

v.

Medtronic.

supra,

to abrogate the

decision in Goodlin v.
see Blunt v. Court Medtronic.

Medtronic.
760 N.W.2d

167

F.3d 1367
Feb.

(11th Cir.
2009). 129
held
tort

1999);
The 1187

(Wis. v.

17,

also notes
in which

the decision
the
FDA

in Wveth

Levine.
Court
state

S.Ct.
that

(2009),
federal

United
approval

States
do not

Supreme
preempt

law and

claims

relating based on

to prescription medication. implied preemption. Since

Wveth

v.

Levine.

supra,

is

the MDA contains Rieqel v.

an express Medtronic.

preemption provision supra, claims controls

for medical of

devices,

the preemption

individual

and derivative premarket

involving medical

devices

approved through

approval.

Under Rieael Model
Valve,

v.

Medtronic. Flow

supra,

the

PMA approval Pump with
the

of

the Safety

3000
and

30
the

mL Constant
PMA

Implantable
approval of

Bolus

supplemental

Flextip

Plus

Intraspinal
The Court

Kit

establish

requirements
whether

specific

to

those
state

devices.
law

therefore

considers

Plaintiffs'

claims

impose

requirements

different

from,

or

in

addition

to,

the

FDA requirements

for

those medical devices.

3.

Plaintiffs'

Strict

Liability Claim

In

the Amended Complaint,

Plaintiffs

allege

that

Defendant

Arrow defectively designed,

manufactured,
20

tested,

and/or

sold the

Case No.

8:08-CV-151-T-17TBM

implantable drug delivery systems in a defective condition
unreasonably dangerous to its ultimate user,
Wolicki-Gables, in the following respects:

Plaintiff Linda

failing to reasonably design the implantable drug delivery system in a manner which would have prevented injury to those
like Linda Wolicki-Gables;

a)

b) failing to reasonably manufacture the implantable drug delivery systems in a
reasonable manner;

c)

failing to reasonably provide adequate regarding the defective and implantable drug

warnings

unreasonably dangerous

delivery system, having actual or constructive knowledge of the hazards
associated with the product.

In West v.

Caterpillar Tractor.

336

So.2d

80,

84

(Fla.

1976),

the Florida Supreme Court adopted the doctrine of strict
stated by the American Law Sec. 402A: Institute Restatement

liability as (Second)

of Torts,

"(1)

One who sells any product

in a defective

condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his

property if

(a) the seller is engaged in the business selling such a product, and
(b) it is expected to and does reach the

of

user

or consumer without substantial change in the
condition in which it is sold,

21

Case No.

8:08-CV-151-T-17TBM (2) The rule stated in Subsection (1) applies

although

(a) care

the in

seller the
and user or

has

exercised all and sale

possible of his

preparation

product, (b) the

consumer

has

not

bought

the

product

from or

entered into
seller."

any contractual

relation with

the

To prove

a

strict
prove

liability manufacturing defect
by a preponderance of the

claim,
1) that

Plaintiffs must

evidence:

the Arrow pump system, implanted into that the defect

consisting of the pump and catheter Linda Wolicki-Gables was at the and time 3) the pump

kit, 2)

Plaintiff existed

defective;

system left in the pump

Defendant Arrow's

control,

that

the defect

system proximately caused
injuries. F.Supp.2d See 1314, Colville 1320 v.

Plaintiff Linda Wolicki-Gables'
Pharmacia Fla. & Upiohn Co., LLC. 565

(N.D.

2008).

The

FDA regulates

manufacturing practices

of Class

III

medical devices. 820. Under

See

21

U.S.C. when

Sec.

360e(c)(l); is in

21

C.F.R.

814,

Florida

law, is

the defect if it is

a manufacturing a condition is expected affecting

defect,

"a product

defective to the

unreasonably dangerous to and does reach the

user,

and the product substantial

user without

change

that condition."
(Civil). could

See

Florida Standard Jury
strict

Instruction

PL 4

A fact-finder considering a if

liability claim rendered the even if the After

find liability

a manufacturing defect unreasonably dangerous,

subject medical manufacturer

devices

followed
the

the

FDA's manufacturing practices.
finds
is

consideration,
manufacturing

Court

that

the

strict

liability
and therefore

defect

claim

expressly

preempted,

22

Case

No.

8:08-CV-151-T-17TBM

grants issue.

Defendant

Arrow's

Motion

for

Summary Judgment

as

to this

To a

prove

a

claim show

for that

strict the

liability

for

defective or

design,

plaintiff must

defendant

manufactured

distributed

the

product

in

question,

that

the

product

has

a

defect

that

renders

it

unreasonably dangerous
condition is

and

that
cause

the
of the

unreasonably dangerous

the proximate

plaintiff's
1337, 1346

injury.
(M.D. Fla.

See Marzullo v.
2003) (quoting

Crosman Corp..
Jennings v.

289

F.Supp.2d

Bic Corporation.

181

F.3d 1250,

1255

(11th Cir.

1999).

The
See
the

FDA regulates

the design of Class
21 C.F.R. 814.

III medical devices.
Under
of

21

U.S.C.
is

360e(c)(l);
a

Florida
its

law,

when

defect

design defect,

"if by

reason

design the

product

is

in a is

condition

unreasonably dangerous reach the

to the user,

and

the product substantial

expected to and does that
of

user without A product
if "the

change affecting

condition.
its design

is

unreasonably dangerous

because

product

fails

to perform as

safely as an ordinary consumer would expect in a manner reasonably
risk of danger in the

when used as

intended or
or the

foreseeable by
design outweighs

the manufacturer,

the benefits." (Civil). could find A

See

Florida

Standard Jury

Instruction

PL

5

fact-finder considering a liability if a

strict

liability claim the subject

design defect

rendered

medical devices

unreasonably dangerous,
FDA regulations

even

if the manufacturer

complied with all

addressed to design.

After consideration,
expressly preempted, Summary Judgment as

the Court

finds

that

this

claim is
for even if

and grants to this

Defendant The

Arrow's

Motion that,

issue. 23

Court

notes

Case

No.

8:08-CV-151-T-17TBM

this

claim were not preempted, expert witness, Dr.

this

claim

fails not

because render an opinion

Plaintiff's
as

Reese,

does

to defective

design.

The

FDA

regulates

content

and appearance

of prescription

medical device
801.15,

labels.
814.

See
The

21

360e(c)(l);

21

C.F.R.
such

801.1,
from

801.109,

regulations

exempt

devices

the
use

requirement
the product

that

there be directions
if the package

to a

layperson
inter
and

on how to
alia "any

safely,

describes,
effects

relevant

hazards,

contraindications,

side

precautions"

for

the prescribing physician.

21

C.F.R.

801.109.

To

establish

strict

liability

[for]

failure

to warn,

a

plaintiff must prove
distributor of not the

that

the defendant
at issue and risk

is

a manufacturer
the was and the v. defendant known or

or
did

product of a

that that

adequately warn in light of

particular

knowable

the

generally recognized available at

prevailing best time of

scientific manufacture 289

and medical and

knowledge

distribution. 1347 {M.D.

See Marzullo Fla.

Crosman Corp.. Feravorni v.

F.Supp.2d

1337,

2003)(quoting

Hyundai Motor Co..
fact-finder liability completely

711 So.2d 1167,
a strict warn

1172

(Fla.

4th DCA 1998).
find

A

considering failure to

liability if the

claim could product's

for

even

labeling

conformed to

FDA regulations.

After

consideration,
and

the

Court

finds

that

this

claim is
Arrow's

expressly preempted,

therefore grants

Defendant

Motion

for

Summary Judgment however,

as

to

this

issue. strict

Even

if

this

claim

were not

preempted,

Plaintiffs'

liability claim

for

failure
in

to warn would
case are

fail.

The

subject medical

devices
The

at

issue

this

available

only by prescription.
24

Case

No.

8:08-CV-151-T-17TBM

physician or seller

acts and a

as

a

learned It

intermediary between is the physician's

a

manufacturer to inform

patient.

duty

himself

of

the

qualities

and characteristics
patients, and to

of

the products
an

which he prescribes

for his

exercise

independent
patient as

judgment,
well as the

taking

into account

his

knowledge

of the

product.

Buckner v.

Allerqan

Pharmaceuticals.
duty to warn is members of
prescribe,

Inc..

400

So.2d 820

(Fla.

5th DCA 1981).

The

fulfilled by an adequate warning

given to the

the medical
dispense

community lawfully authorized to
the medical devices such as

and administer

those

involved in the

this

case. inquiry

In determining is whether the it

the is

adequacy of the to warn caused
562

warning,

critical

adequate

the physician of
the

the possibility that
the plaintiff.

[medical
v.

device]

injury alleged by

Upiohn

MacMurdo.

So.2d 680,
question of

683

(Fla.

1990).
the

The adequacy of a
is accurate,

warning
clear

is

a

law where

warning

and

unambiguous.
(Fla. 1989).

Felix v.

Hoffman-LaRoche.

Inc..

540

So.2d

102,

105

In in

this

case,

Plaintiffs'

theory

is

that

product

implanted

Plaintiff
which

Linda Wolicki-Gables
caused Dr. James

contained a manufacturing
revision surgery,

defect,

to perform a

after which

Plaintiff

Linda Wolicki-Gables

contracted an

infection which caused that Dr. James was

Plaintiffs' of all the

injuries.

Dr.

James

testified

aware

information offered by the implantation,
stated the in risk
by

manufacturer prior
of the known

to performing the
which are

including all
"package infection.
adequate

complications, adverse
of

the of

insert."
The duty

Known
to warn

affects

include
is

Defendants

fulfilled

the

warning

to

Dr.

James.

25

Case No. 4.

8:08-CV-151-T-17TBM Negligence Claim

Plaintiffs'

Plaintiffs assert the same claims

Plaintiffs

raise under the Under the

strict liability theory under a negligence theory.

strict liability theory,
under the negligence

the focus in on the product
the focus is on

itself;

theory,

the whether a duty

of care was owed to the injured parties,
defendants breached that duty of care.

and whether the

In Count

II,

Plaintiffs

allege that a duty to

Defendant Arrow owed use of reasonable the care in

Plaintiff Linda Wolicki-Gables the design, manufacture, system so

assembly and that

sale

implantable safe for its

drug delivery intended use.

it would be that

reasonably

Plaintiffs

allege

Defendant Arrow breached

its duty by negligently designing, the

manufacturing and assembling

implantable drug delivery system by:

(a)

failing

to

reasonably design

the in a manner to those

implantable drug delivery system which would have prevented injury

like

Plaintiff Linda Wolicki-Gables;

(b) failing to reasonably manufacture the implantable drug delivery system in a reasonable manner; and
(c) failing to reasonably provide regarding the defective dangerous implantable adequate and drug

warnings

unreasonably

delivery system, having actual or constructive knowledge of the hazards associated with the product.
Plaintiffs allege that Plaintiff Linda Wolicki-Gables

suffered damages as
negligence of

a

direct

and proximate

result

of the

Defendant

Arrow.

26

Case No.

8:08-CV-151-T-17TBM

Proof of negligent design and negligent manufacturing
requires product."
(M.D. Fla.

"evidence Alvarez
Feb. 1,

of the existence of v. General Wire

[a]

defect

in

the 248264
Inc..

Spring Co..
v.

2009 WL

2009)(citing

Broderick

Danek Medical,

1999 WL 1062135
establish a requires
with

(S.D.

Fla.

Apr.

9,

1999).

Further,
action,

in order to
Florida law

prima

facie

case

in a negligence

Plaintiffs

to prove by a preponderance
probability" proximate that cause

of the evidence,
Arrow's

"reasonable medical was

Defendant of

alleged negligence

the

Plaintiffs'

injuries.

Plaintiffs must

show

that

it

is

"more

likely than not"

that Defendant Arrow's
bringing about
causation is

act(s)

was/were a
"A mere

substantial

factor in
such
one of pure at best

the

injuries.

possibility of
remains are

not

enough;

and when or

the matter

speculation or

conjecture,

the probabilities

evenly balanced,
verdict for

it becomes

the duty of
Reaves v.

the

court

to direct a
Industries.

the defendant.

Armstrong

World

569 So.2d 1307,

1309

(Fla.

4th DCA 1990).

Under reasonable

Florida care.

law,

negligence care

is is

the that

failure degree

to use of care which a

Reasonable

reasonably careful

person would use under either in doing
not
a

like

circumstances. that a

Negligence may consist
reasonably careful
or in failing to do

something
under like

person

would

do

circumstances,
person

something

that

reasonably

careful

would do

under

like

circumstances.

Negligence

is

a

legal

cause

of

loss,

injury or damage

if

it directly and in
or contributes so the

a

natural

and
to

continuous producing be

sequence produces such loss, but for

substantially it can

injury or damage, the negligence,

that loss,

reasonably

said that,

injury or damage

would not cause of

have occurred. loss,

In order to be

regarded as

a

legal

injury or damage,

negligence
27

need not be the only

Case No.

8:08-CV-151-T-17TBM

cause.
even

Negligence may be a
it operates in

legal

cause of
with

loss,
the

injury or damage
act of another,

though

combination

if
and

such other cause occurs
if the negligence

at

the

same

time

as

the

negligence,
such

contributes See

substantially Civil Jury

to producing Instructions.

loss,

injury or

damage.

Florida

Model Charge No.

8.

A find

fact-finder for of

considering negligent the design

a

negligent in

design of

claim could FDA's pre-

liability approval

design of the

spite

the

market

subject

medical

devices,

the Court

finds

that

this

claim is

expressly preempted, for

and as

therefore grants
to this issue.

Defendant

Arrow's Motion

Summary Judgment

If

the

claim based

on

negligent

design

were

not

expressly

preempted, render

the

claim would as to to

still

fail

because of a

Dr.

Reese defect,

does

not

an opinion is

the presence establish injuries. a

design

and no

evidence design

offered

causal

link between recognizes

negligent that jury;

and

Plaintiffs' causation

The Court

proximate

will

ordinarily be determined by

the

the Court may make

this

determination as considering

a matter of all facts

law only in

plain and undisputed cases,
inferences in favor of the

and reasonable

non-moving party.

The

FDA's

"good manufacturing practices"
to develop and implement

regulations

require

manufacturers

"appropriate,"

"adequate,"

or

"sufficient"

quality

control,
controls,

quality assurance,
equipment

personnel
testing,

training,

environmental

maintenance,

inspection

and

storage

and distribution

procedures,

to assure

that

devices
of

are

safe and effective.
manufacture

A

fact-finder

considering
could find

claims

negligent

and negligent
28

assembly

Case No.

8:08-CV-151-T-17TBM

liability for these claims,

even though the there was complete

compliance with FDA regulations controlling the manufacture and assembly of the subject medical devices,
differing from or adding to FDA's.

applying

standards

As to negligent manufacture and negligent

assembly,

the

Court finds that these claims are expressly preempted, therefore grants
to this issue.

and

Defendant Arrow's Motion

for Summary Judgment as

B.

Count

III

- Consortium - Arrow

The Court has granted Defendant Arrow's Motion Judgment as to strict liability and negligence.

for Summary

Because the for strict
claim for

claim for consortium is derivative of the claims
liability and negligence, consortium is preempted. the Court finds that

the

The Court grants

Defendant Arrow's

Motion

for Summary

Judgment

as

to this

claim.

C.

Count

IV

-

Strict

Liability - Codman

Defendant Codman Summary Judgment

joined in Defendant Arrow's Motion

for

on the basis of express preemption,

which was

granted.

The Court therefore grants Defendant Codman's Motion preemption.

for Summary Judgment on the basis of express

Defendants Codman have moved for partial

&

Shurtleff,

Inc.

and Johnson on the basis

&

Johnson the

summary judgment

that

undisputed record evidence establishes

that

Defendant Arrow

designed,
devices.

manufactured,

tested and sold the

subject medical

29

Case No.

8:08-CV-151-T-17TBM have moved for entry of partial summary judgment

Plaintiffs

as to Defendants Codman

&

Shurtleff,

Inc.,

Johnson

& Johnson and

Greg Nelson on the issue of distribution of the
catheter kit medical devices.
Defendants are

subject pump and

Plaintiffs
Codman &

seek the Court's
Inc., Johnson &

determination that

Shurtleff, of

Johnson and Greg Nelson

all distributors

the

subject

medical devices.

Plaintiffs
liability of

argue that

Plaintiffs alleged the vicarious
and Johnson & Johnson, in

Defendants

Codman

paragraph 7

of

the

Second Amended Complaint,

for

the

actions

of

Defendant Nelson.

Plaintiffs
that only

request

that,

to the

extent that
distributor,

the Court determines

Defendant &

Nelson is a

Defendants Codman and Johnson Nelson to act as a

Johnson authorized Defendant subject products and are

distributor of the

liable as distributors.

The undisputed record evidence in this that, at the time of the

case establishes

initial implantation of the pump and on April 30, 2002, Venture Medical was the

catheter medical devices Devices, Inc.,

operated by Defendant Greg Nelson,
subject medical devices.

distributor of the

Venture Medical

Devices,

Inc.

is not a party to this

case.

Pursuant

to the

distribution contract between Defendant Arrow and Defendant Nelson, later assumed by Defendant Codman, Venture Medical

Devices,

Inc.

was to act as an
However,

independent
the Court
is

contractor in selling
that the use of
of the Prudential

the medical devices.
descriptive actual legal labels

notes

in a

contract

not determinative Villazon v.

relationship of the parties.

Health Care
status of

Plan,

Inc.,

843

So.2d

842,

854

(Fla.

2003).
of the

The
contract

the parties

depends upon the 30

language

Case No.

8:08-CV-151-T-17TBM in their dealing with each other. .Id at

and all the circumstances
854.

Generally,

the existence of an agency relationship is a

question of fact;
any supportive

however,

when the moving party fails to produce
so

evidence or when the evidence presented is reasonable persons question of could reach but a one

unequivocal that conclusion, that

fact becomes Gabav.

question of So.2d 988,

law to be 990

determined by the court.

Rubin v.

979

(Fla.

4th DCA 2008) .

Actual

agency requires:

1)

acknowledgment by the principal

that the agent will act
undertaking; the agent. and 3)

for him;

2)

the agent's acceptance of the
over the actions 424 n. 5 of

control by the principal Holman, 571

See Goldschmidt v.

So.2d 422,

{Fla.

1990).

The

key element

is establishing actual agency is
of the agent.
So.2d 1265 n. 4

the control by the principal over the actions
Dorse v. Armstrong World Industries. Inc.. 513

(Fla.

1987)(principal must

control means

to achieve

the outcome,

not just the outcome
the existence of
See Pinion v.

itself).

The party who

seeks

to establish

such a

relationship carries
Harvester Co.,

the burden of proof.
So.2d 154 (Fla. 3d

International

390

DCA 1980).

There is Shurtleff, means

no evidence or

in the record that Johnson &

Defendant Codman

&

Inc.

Defendant

Johnson controlled the devices.

Defendant

Nelson used to sell medical

Apparent agency

requires:

1)

a

representation by the

purported principal;
third party; and 3) a

2)

reliance on that

representation by a
third party in

change

in position by the 31

Case No.
reliance

8:08-CV-151-T-17TBM
upon such representation. See Ilaen v. Henderson

Properties,

Inc.,

683 So.2d 513,

514

(Fla.

2nd DCA 1996).

A

principal's actions may also give
See Chase Manhattan Mortgage Corp.

rise
v.

to apparent authority.
Scott, Royce, Harris,

Brvan,

Barra & Jorgensen,
agency

P.a.,

694 So.2d 827,

832

(Fla.

4th DCA

1997)(existence of

relationship may be

established

expressly,

by estoppel,

apparent authority,

ratification).

The Court has and Defendant

looked &

for some evidence that

Defendant Codman

Johnson of

Johnson participated in directing or and for evidence that relevant time, such but

managing the acts

Defendant Nelson, Plaintiffs

control was communicated to
has found none.

at the

A partnership exists when two or more persons

join together

or agree to join together in a business or venture
common benefit,

for their

each contributing money or property or services, Each member of a

and each having an interest in the profits. partnership is responsible

for the negligence of any partner if

such negligence occurs while the partner is acting on behalf of the partnership and within the scope of the partnership's
business. See Florida Civil Jury Instructions. Comment on 3.3c.

The Court has Shurtleff, Inc.,

looked for evidence Johnson &

that

Defendant

Codman

&

Defendant

Johnson and Defendant Nelson of Defendant Nelson's sales

each had an interest of medical devices,

in the profits and has

found none.

The Court implantation, Devices, Inc.

concludes Defendant as an

that

on April

30,

2002,

the date

of

Greg Nelson operated Venture Medical and not as an agent,

independent contractor,

32

Case No.

8:08-CV-151-T-17TBM

employee

or partner

of

Defendants

Codman and

Johnson

and Johnson,

relying on the parties'
the distribution

intent as expressed in the provisions

of

agreement.

The

undisputed

record evidence Inc.

further

establishes

that

Defendant Arrow

International,

designed,

manufactured, devices.

tested and sold the pump

and catheter

kit medical

The Court

notes

that

Plaintiffs

assert

only

a

negligence

claim against
Complaint law, the

Defendant
30). of

Greg Nelson
Court

in the

Second Amended
that, been See under Florida

(Dkt.

The

recognizes

doctrine

strict and

liability has distributors.
630 into So.2d a

expanded to Samuel
1068 a

retailers,

wholesalers
v.

Friedland
(Fla. 1994). is

Family Enterprises However, the Court

Amoroso. read

1067,

cannot

complaint

claim which

not

there.

Defendants

are

entitled to and

notice

of

the

claims the claims
a response

asserted against
rest.
to

Defendants,
cannot
for

the grounds

on which
through
through

Plaintiffs

amend

their

Complaint
or

Defendants'

Motion

Summary Judgment,

Plaintiffs'

Motion

for

Summary Judgment.

After

consideration,

the Court grants
Defendants Court

the Motion

for

Partial

Summary Judgment of
& Johnson. The

CodmanS

Shurtleff,

Inc. for

and Johnson Partial

denies

Plaintiffs'

Motion

Summary

Judgment.

D.

Count

VI

-

Consortium

-

Codman

This strict

claim

is

a

derivative

claim based Codman.

on The

the

claim of has granted of

liability against Codman's Motion

Defendant for

Court on the

Defendant

Summary Judgment

basis

express Motion

preemption,

and therefore grants as to this
33

Defendant

Codman's

for Summary Judgment

consortium claim.

Case No.

8:08-CV-151-T-17TBM

E.

Count VII

-

Strict Liability - Johnson

&

Johnson

Defendant

Johnson

&

Johnson joined in the Motion

for Summary

Judgment of Defendant Arrow on the basis
which the Court granted. The

of express preemption/
Defendant

Court therefore grants

Johnson basis.

& Johnson's

Motion

for Summary Judgment on the

same

F.

Count IX - Consortium -

Johnson

&

Johnson

This Plaintiffs

claim is assert

derivative as to

of the

strict &

liability Johnson.

claim The Court

Defendant

Johnson

has

granted Defendant
as to strict

Johnson § Johnson's Motion
liability on the basis Defendant of

for

Summary

Judgment

express & Johnson's

preemption,

and therefore grants

Johnson

Motion

for Summary Judgment

as

to this

consortium claim.

G.

Count

X

- Negligence

- Nelson

In the Second Amended Complaint,

Plaintiffs

allege that

Defendant Nelson,
Plaintiffs to

as

a

sales representative,
and educate

owed a duty to

instruct

Plaintiff Linda Wolicki-

Gables'

operating surgeon to ensure that

the pain pump was
consent to Defendant

functioning properly,

to verify Plaintiff's

Nelson's presence
any devices

in the operating room,
Plaintiff.

and to not dispose of

removed from

The Court Arrow's Motion

notes

that

Defendant Nelson

joined in

Defendant

for Summary Judgment based on express preemption.

Because the Court granted Defendant Arrow's
Judgment, the Court grants

Motion

for Summary
for Summary

Defendant Nelson's Motion
34

Case No.

8:08-CV-151-T-17TBM

Judgment.

If

Plaintiffs'

negligence

claim is

not preempted,

the

negligence claim still

fails.

Defendant Greg Nelson, representative, procedure,
The Court which is

in his

capacity as

a

sales

was present

at the initial records
not

implantation of that procedure.
expert at the opinion

according to the medical
notes that of Dr. Reese does

render an

critical

Defendant

Nelson's presence

implantation procedure of 4/30/2002.
testified that he relied on his

In addition,

Dr.

James

own experience

in performing such

procedures.

Dr.

James tested the pump on 8/15/2002, functioning.

and

confirmed that the pump was
the Court grants as to this issue.

After consideration,
for Summary Judgment

Defendant Nelson's Motion

Defendant

Nelson was present

at the

revision procedure of

7/15/2003.

The undisputed facts show that Defendant Nelson did
in the decision-making during that procedure.
role was limited to carrying "back'up"

not participate
Defendant

Nelson's

products

in their

sterile packages

to have

available

for the

surgeon's use, products.

if necessary,

and to observe preparation of the "scrub in" for the procedure

Defendant Nelson did not

on 7/15/2003,

and did not enter the sterile field.

Defendant

Nelson did not come

into contact with the pump on 7/15/2003, field. Dr. James testified that the
own decisions. information
procedure.

which never left the sterile

decisions made while he performed surgery were his Dr. Reese admitted that
Dr. James by

Dr.

Reese was

aware of no

relayed to

Defendant Nelson during

the

(Cite).
any

The Court

is

not

aware of any evidence that
James and Defendant

establishes
the

interaction between

Dr.

Nelson during

7/15/2003 procedure.

Even

if the
35

finder

of

fact

infers

that

Case

No.

8:08-CV-151-T-17TBM

Defendant

Nelson did

have

some

interaction

with

Dr.

James

during

that

surgery,

the Court

does

not

know of

any evidence

that

establishes
tell James Dr.

that

Defendant Nelson had a duty to affirmatively
while Dr. James the was performing alone. surgery, Dr. James that Dr.

James,

should not

replace

connector

testified that
Dr. Reese

Dr.

James
that

exercised his
Dr. James

own medical
Dr.

judgment,
James' Defendant

and

testified After

acted within the Court

discretion.

consideration,

grants

Nelson's Motion
claim involving
revision

for

Summary

Judgment

as

to

Plaintiffs'

negligence
in the

Defendant

Nelson's

alleged

participation

surgery.

As

to

Plaintiffs'

claim based

on

the

lack

of

informed

consent
the

to

Defendant Nelson's presence
facts show that neither

in the OR on 7/15/2003,
Dr. James nor Defendant
consent notes to

undisputed
knew

Nelson

that

Plaintiff presence the

Linda

Wolicki-Gable The

did not

Defendant Nelson's that liability

in the OR.

Court

further Law,

under

Florida Medical

Consent

766.103,

Fla.

Stat..
is a

is

limited

to medical

practitioners.
not a medical

Defendant
doctor.

Nelson

sales

representative,

Plaintiffs

admit

that

Defendant

Nelson

never

received or

saw

the consent
could not

form for
looked

the
at

7/15/2003 surgery.
the consent Dr.

Defendant Nelson
due that to patient no facts Linda
in

have

form himself Reese admits know of

privacy and HIPAA contradict that

regulations. Nelson

Defendant
lack of

did not
to

Plaintiff

Wolicki-Gables'

consent

Defendant

Nelson's

presence

the OR. unable to

In

her

deposition, how

Plaintiff

Linda

Wolicki-Gables was in the OR on Nelson's

explain damaged
Summary

Defendant

Nelson's

presence grants

7/15/2003
Motion for

Plaintiff.
Judgment as

The Court
to this

Defendant

issue.

36

Case No.

8:08-CV-151-T-17TBM

As to Plaintiffs'

claim for negligence based on Plaintiffs' there is a complete

alleged injury from the revision procedure,
absence of evidence establishing a causal

connection between

Defendant Nelson's presence in the OR on 7/15/2003 and Plaintiff
Linda Wolicki-Gables' injury. While it is undisputed that

Defendant Nelson was present

in the OR on 7/15/2003,

the Court

is

not aware of any evidence which documents any interaction between
Dr. James and Defendant Nelson during the procedure. The Court as to this

grants
issue.

Defendant Nelson's Motion for Summary Judgment

As

to Plaintiffs' Dr.

claim based on an alleged "off Reese testified that Dr. James'

label"

use

of the pain pump,

decisions

on 7/15/2003

resulted in an "off label" use of the pain pump and
should have advised Dr. James as such during the

Defendant Nelson

procedure. that Dr.

Dr.

Reese,

who is

not a medical doctor,

testified

James

should have

removed and replaced everything

originally implanted:
catheter. According
James off

pump,
to Dr.

catheter connector,
Reese, the exercise

and intrathecal
of medical

judgment by Dr. resulted in an

went beyond the product use, although Dr.

labeling and acknowledges

label

Reese

that the replacement as
the

catheter connector itself was

used exactly the pump to

indicated in the
catheter.

FDA approved labeling to connect

The Court has already recognized that
within the context not of medical treatment

"off

label

use,"
as the

is not

prohibited,

FDCA does

regulate

the practice of medicine.

37

Case No.

8:08-CV-151-T-17TBM

The Court
label use" is

notes
not

that a

claim for negligence based on "off
as to

pleaded

in the Second Amended Complaint

Defendant Nelson, that Dr.

a

sales

representative. Dr. James'

The Court

also notes

Reese concedes Dr.

that

exercise of medical and that Dr. James was

judgment was within free to do what Dr.

James'

discretion,

James did in replacing only the that the FDCA and its

connector.

The Court recognizes

regulations prohibit

off-label promotion by manufacturers, were present in this case, for violations of the FDCA. there

but,

even

if such a claim right of action

is no private

There is a complete absence of

evidence as to any claim for negligence based on "off label"
marketing and promotion by Defendant Nelson, as well as

Plaintiffs'

claim for negligence against
The Court grants
as to this issue.

Defendant Nelson for

"off label use."
Summary Judgment

Defendant Nelson's Motion for

In the Second Amended Complaint,

Plaintiffs

allege:

69. GREG NELSON had a duty to ensure that prior to being present in the operating room on July 15, 2003, and prior to destroying or discarding any part(s) of the subject pump removed from MRS. GABLES that he first very whether MRS. GABLES consented to his presence in the operating room and to said destruction or
discarding of any part(s) or the pump itself.

71. As a direct and proximate result of Defendant, GREG NELSON's actions of intentionally and recklessly destroying the subject part{s) removed from the subject pump during the July 15, 2003 surgery, Defendant has
precluded Plaintiffs from determining to what extent, if any, other defects within the subject pump existed

and/or contributed to her current physical problems.
In his deposition, Plaintiff Robert 38 Gables testified that

Case No.

8:08-CV-151-T-17TBM

Defendant Nelson approached him after the 7/15/03 surgery,
follows:

as

Q.

What

else did he
the

tell

you

in the

lobby or

outside

lobby area?

A. It was in the lobby area. Told me that he had-he was in the room. They had taken the connectors, connection-some kind of connections out of the pump where-after removing the pump from my wife's body and removing the catheter, they turned it over, took out the connections, replaced them, cut a piece of catheter away, and placed it back in, reattached it to the body, and then sewed
her up.

Q. this A. Q.

Anything initial Yeah. I

else

that

he told

you

during

conversation? asked him where did he say? the parts were.

And what

A.
call

He

manufacturer

said he had to take them back to the for them to test them, I could him in ten business days. pp. 63,64, 11. 18-9.)

(Dkt.

82,

Exh.

A,

Q.

When
to

did you-when was
Greg Nelson?

the next

time

you

spoke

A.

About

two weeks

later.

Q. What prompted you-how did it come about that you talked to Greg Nelson two weeks
later?

A.

I

got

the

number

of Arrow.

39

Case No.

8:08-CV-151-T-17TBM
Q. I'm sorry?

A.

Of--I believe it was Arrow.
the that time. I a number that--it was happened was,

I
a

think it
sure. for number yelled you

was Arrow at He gave ne

I'm not

Greg Nelson and it because what

don't remember who answered Linda

for me as I was in the middle of the conversation. So I didn't actually look, know, blah, it being blah, like, a you know, blah, subsidiary company of

Greg Nelson,

Johnson & Johnson or something like that. You know what I'm saying? I didn't look at
any of that.

He gave me a number. I called Greg, who was not in. I left a message. He got back to me about a day and a half later. I asked him
where the equipment was that we wanted from

the pump.

He told me that

it was disposed

of.

I

says,

what are you talking about?

At

which time, didn't feel

I got very, very upset. And he like taking any abuse from me and

he hung up on me.

{Dkt.

82,

Exh.

A,

pp.

67-68,

11.

16-17).

Q.

With Mr. Nelson. conversation with Mr.

So the substance of the Nelson is that you were

calling to parts A.
I

follow up on the status had been removed? know how I
why not?

of the

that

No.

I wanted to
about I says,

could go--how
He says, I told me

could go

getting the parts. You

you can't.

could call days,
want them.

you

in ten days, them.

ten business days, I

and get

Ten business

And he said, They were destroyed. I said, For what reason? He says, That's our policy. After we check them out we destroy them, and there was nothing wrong with them.

40

Case

No.

8:08-CV-151-T-17TBM

Q.

Anything

else on

you can remember

from that Nelson?

conversation A.

the phone with Mr.

Yeah, I didn't believe him because he--I said, you promised them to me. And I told him it was in writing that I was supposed to get the materials and he told me I was going to get the materials and then he discarded them. And he says, click, and that was it. Q.
A.

Have
No.

you ever spoken to him since?

(Dkt.

82,

Exh.

A.,

pp.

69-70,

11.

15-9).

Defendant Nelson has no recollection of

speaking with

Plaintiff Gables after the surgery of 7/15/2003,
that he did not remove or discard the catheter

and testified
For

connector.

the purpose of this Motion accepts Reese, Plaintiff Plaintiffs' Robert expert

for Summary Judgment, version of the

the Court facts. follows: Dr.

Gables'

witness,

testified as

Q. If you assume, would you agree with me, sir, that on page 64, line 7, Mr. Gables
testified that he was told by Greg Nelson

that Greg to the that

Nelson

had to take connector or back

them, the to the them?

referring

catheter for

components

had been

removed,

manufacturer

them to test

A. Q.

Yes,

that's what

it

says

in

the is

depo. correct,

If you

assume that Mr.

Gables

that is exactly what Mr. Nelson should have done, returned the removed components to the manufacturer for testing. Correct?
A. Absolutely.

41

Case No.

8:08-CV-151-T-17TBM Q. So if you believe-according to what Mr. events were,

Gables'

recollect