Yosowitz et al v. Covidien LP

Filing 28

MEMORANDUM OPINION AND ORDER granting 21 MOTION to Dismiss Plaintiffs' First Amended Complaint (Signed by Judge Sim Lake) Parties notified. (aboyd, 4)

United States District Court
Southern District of Texas

ENTERED

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
BRENDA s. YOSOWITZ and
EDWARD E. YOSOWITZ, M.D.

§
§
§
§
§
§
§
§
§
§

I

Plaintiffs,
v.
COVIDIEN LP

I

Defendant.

April 25, 2016
David J. Bradley, Clerk

CIVIL ACTION NO. H-15-2902

MEMORANDUM OPINION AND ORDER

Plaintiffs Brenda S.
(together,

"Plaintiffs")

Yosowitz and Edward E.
sued

Covidien

LP

Yosowitz,

("Defendant"

M.D.
or

"Covidien") in the 215th Judicial District Court of Harris County,
Texas . 1

Defendant removed the case to this court. 2

Pending before

the court is Defendant Covidien LP's Motion to Dismiss Plaintiffs'
First Amended Complaint
stated below,

(Docket Entry No.

21).

For the reasons

the motion to dismiss will be granted,

and this

action will be dismissed with prejudice.
I.

Factual Allegations and Procedural Background

One of the Plaintiffs underwent a procedure to repair two
intracranial

aneurysms

on

February

18 ,

2015. 3

Covidien

1

See Plaintiffs' Original Petition, Exhibit B to Defendant
Covidien LP' s Notice of Removal ("Notice of Removal") , Docket Entry
No. 1-2, pp. 9-15.
2

3

See Notice of Removal, Docket Entry No. 1.

See
Plaintiffs'
First
Amended
Complaint
Complaint"), Docket Entry No. 17, p. 2 ~ 7.

("Amended

manufactures the Pipeline Embolization Device (the "Pipeline") used
which is coated with polytetrafluorothylene. 4

in the procedure,

Plaintiffs allege the coating delaminated and detached from the
delivery wire during surgery, allowing coating particulate to cause
a blockage to a blood vessel in the Plaintiff's brain and resulting
in mini-strokes

from

which

the

Plaintiff

has

suffered

serious

injuries. 5
Plaintiffs

filed

suit,

asserting

causes

of

action

for

negligence, strict products liability (§ 402-A), breach of express
warranty,

breach of implied warranty,

C.F.R.

820.30

Design

Act

521(a),

§

Cosmetic

negligence. 6

§

Controls
21

and

failure to comply with 21
Federal

U.S.C.A.

§

Food,

360k(a),

Drug,
and

and
gross

Plaintiffs filed an Amended Complaint after Covidien

removed the action to federal court alleging the same causes of
action. 7
Motion

Covidien had previously filed Defendant Covidien LP's
to

("Motion

Dismiss
to

Plaintiffs'

Dismiss")

(Docket

Petition
Entry

No.

and
14)

Brief
and

in

Support

adopted

arguments in that motion by reference in its present motion. 8

4

This

Id. at 2.

5

the

Id.

6

See Plaintiffs' Original Petition, Exhibit B to Notice of
Removal, Docket Entry No. 1-2, pp. 11-13.
7

See Amended Complaint, Docket Entry No. 17, pp. 3-5.
The
Amended Complaint
is
nearly
identical
to
the
state-court
Plaintiffs' Original Petition, but removes defects in design,
testing, and packaging from the strict products liability section.
8

See Docket Entry No. 21, p. 3 (incorporating and adopting by
reference the arguments, authority, and exhibits set forth in
Docket Entry No. 14).
-2-

opinion references the original Motion to Dismiss unless noted
otherwise.

Covidien moved to dismiss pursuant to Federal Rule of

Civil Procedure 12(b) (6) on federal preemption grounds and because
the

claims

otherwise

fail

to meet

Procedure pleading requirements.

9

of

to

their

claims

are

subject

the

Federal

Rules

of

Civil

Plaintiffs respond that not all
federal

preemption

and

that

Covidien' s motion is premature. 10
II.
Under Rule

8 of

the

Standard of Review

Federal

Rules

of

Civil

Procedure,

a

pleading must contain "a short and plain statement of the claim
showing that the pleader is entitled to relief."
8(a)(2).

Fed. R. Civ. P.

A Rule 12(b) (6) motion tests the formal sufficiency of

the pleadings and is "appropriate when a defendant attacks the
complaint because it fails to state a legally cognizable claim."
Ramming v. United States, 281 F.3d 158, 161 (5th Cir. 2001), cert.
denied sub nom.

Cloud v. United States,

122 S. Ct.

2665

(2002).

The court must accept the factual allegations of the complaint as
true, view them in a light most favorable to the plaintiff, and
draw all reasonable inferences in the plaintiff's favor.

Id.

To defeat a motion to dismiss pursuant to Rule 12(b) (6),

a

plaintiff must plead "enough facts to state a claim to relief that

9

See Motion to Dismiss, Docket Entry No. 14, pp. 8-9.
Covidien also argues that Plaintiffs' warranty claims fail for lack
of privity between the parties.
Id. at 9.
10

See Plaintiffs' Response in Opposition to Defendant's Motion
to Dismiss Plaintiffs' First Amended Complaint ("Plaintiffs'
Response"), Docket Entry No. 25.
-3-

is plausible on its face."
S. Ct. 1955, 1974

Bell Atlantic Corp. v. Twombly,

(2007).

127

uA claim has facial plausibility when

the plaintiff pleads factual content that allows the court to draw
the reasonable

inference

misconduct alleged."
(2009)

that

Ashcroft v.

(citing Twombly,

127

standard is not akin to a
for more

than a

unlawfully."
complaint

Id.

s.

Iqbal,

is

129 S.

Ct. at 1965).

liable for the
Ct.

1937,

uThe plausibility

a

defendant

has

(quoting Twombly, 127 S. Ct. at 1965).
facts

liability,

1949

'probability requirement,' but it asks

sheer possibility that

pleads

defendant's

the defendant

that
it

are

'stops

'merely
short

consistent
of

the

line

acted

uwhere a
with'

between

possibility and plausibility of uenti tlement to relief."'"
(quoting Twombly, 127 S. Ct. at 1966).
to dismiss,

district courts are

a

Id.

When considering a motion

ulimited to the complaint,

any

documents attached to the complaint, and any documents attached to
the motion to dismiss that are central to the claim and referenced
by the complaint."
PLC,

594

F.3d 383,

required to dismiss

Lone Star Fund V (U.S.), L.P. v. Barclays Bank
387

(5th Cir.

2010).

uFederal

claims based on invalid legal theories,

even though they may be otherwise well-pleaded."
Farm Fire & Casualty Insurance Co.
820 (W.D. Tex. 2009)

courts are

Flynn v. State

(Texas), 605 F. Supp. 2d 811,

(citing Neitzke v. Williams, 109 S. Ct. 1827,

1832 (1989)).

-4-

III.
A.

Analysis

Judicial Notice

Covidien requests

that

the

court

take

judicial notice

certain publicly available Food and Drug Administration
records that Covidien attached to the Motion to Dismiss. 11

of

("FDA")
These

records relate to the FDA premarket approval application ("PMA")
process that certain medical devices must undergo,

and are all

screenshots of the FDA website or PDF-format documents available
through the FDA website. 12

A district court reviewing a motion to

dismiss must consider the entire complaint

"'as well as other

sources courts ordinarily examine when ruling on Rule 12 (b) ( 6)
motions to dismiss, in particular, documents incorporated into the
complaint by reference,

and matters of which a

court may take

11

Motion to Dismiss, Docket Entry No. 14, p. 12.
See PMA
summary page for Pipeline Embolization Device, PMA No. P100018,
Exhibit C to Motion to Dismiss, Docket Entry No. 14-4; Pipeline
Embolization Device
P100018, Device Approvals, Denials and
Clearances, Exhibit D to Motion to Dismiss, Docket Entry No. 14-5;
April 6, 2011, Letter to Dr. Cher from Christy Foreman ("PMA
Approval Letter"), Exhibit E to Motion to Dismiss, Docket Entry
No. 14-6; Summary of Safety and Effectiveness Data (SSED),
Exhibit F to Motion to Dismiss,
Docket Entry No.
14-7;
Instructions for Use for Pipeline Embolization Device, Exhibit G to
Motion to Dismiss, Docket Entry No. 14-8; Recently-Approved Devices
Summary for Pipeline Embolization Device - P100018, Exhibit H to
Motion to Dismiss, Docket Entry No. 14-9.
12

All are available at http://www.fda.gov and at links from
that website.
See Exhibit B to Motion to Dismiss, Docket Entry
No. 14-3.
-5-

judicial notice.'" 13

Funk v. Stryker Corp., 631 F.3d 777, 783 (5th

(quoting Tellabs, Inc. v. Makar Issues & Rights, Ltd.,

Cir. 2011)

127 S. Ct. 2499, 2509 (2007)).
Under Federal Rule of Evidence 201 (b) (2),

"[t] he court may

judicially notice a fact that is not subject to reasonable dispute
because it

can be accurately and readily determined from

sources whose accuracy cannot reasonably be questioned."
this

jurisdiction

have

recognized

that

"judicial

Courts in
notice

of

publicly-available documents and transcripts produced by the FDA,
which were matters of public record directly relevant to the issue
at hand" is appropriate.
was

appropriate

for

Funk, 631 F.3d at 783 ("[W]e hold that it

the

court

to

take

judicial

notice,

under

Rule 12(b) (6), of the PMA the FDA granted to Stryker for marketing
its

Trident

Medtronic,

System."),

Inc.,

747 F.

id.;
Supp.

see

also U.S.

2d 745,

ex

rel.

Bennett v.

756 n.9

(S.D.

Tex.

2010)

(taking judicial notice of FDA 510k premarket notification cited by
the

parties

website) .

in a

motion

to

dismiss

and

available

on

the

FDA

Plaintiffs do not dispute the fact that the Pipeline

received the FDA's PMA approval and do not argue that the court

13

Generally, "[w]hen 'matters outside the pleadings' are
submitted in support of or in opposition to a Rule 12(b) (6) motion
to dismiss, Rule 12 (b) grants courts discretion to accept and
consider those materials, but does not require them to do so." Ace
American Ins. Co. v. Huntsman Corp., 255 F.R.D. 179, 188 (S.D. Tex.
2008) (citations omitted). If the court chooses to do so, it must
treat the Rule 12(b) (6) motion as a motion for summary judgment
under Rule 56.
Id. (citing Fed. R. Civ. P. 12(d)).
-6-

should not

take

judicial

notice

of

these

records.

The

court

concludes that Covidien's exhibits satisfy the requirements of Fed.
R. Evid. 201(b) and will take judicial notice of them. 14

B.

Plaintiffs' Claims Are Subject to Dismissal

1.

The Medical Device Amendments to the Federal Food, Drug,
and Cosmetic Act

To properly address Covidien's preemption arguments,
necessary to examine the Medical Device Amendments
U.S.C.

§§

it is

( "MDA") ,

21

360c et seq., to the Federal Food, Drug, and Cosmetic Act

( "FDCA") , 21 U.S. C.

§§

301 et seq.

The MDA was enacted "to provide

for the safety and effectiveness of medical devices intended for
human use."

Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2245 (1996)

(quoting the MDA' s preamble) .

The MDA granted the FDA authority to

14

Plaintiffs also attached documents to their Response, but did
not request that the court take judicial notice of them.
They
include: (1) a letter from Plaintiffs' counsel to Defendant's
counsel regarding inspection of the subject pipeline embolization
devices, Exhibit A to Plaintiffs' Response, Docket Entry No. 25-1;
(2) an email from Plaintiffs' counsel to Defendant's counsel asking
when the guide wire would be made available for inspection by
Plaintiffs' expert, Exhibit B to Plaintiffs' Response, Docket Entry
No. 25-2; (3) a recall notice for Covidien Pipeline Embolization
Device dated April 1, 2014, Exhibit C to Plaintiffs' Response,
Docket Entry No. 25-3; and (4) the affidavit of a Houston Methodist
Hospital employee who was present during the procedure performed on
Plaintiff,
Exhibit D to Plaintiffs'
Response,
Docket Entry
No. 25-4.
The court may take judicial notice on its own, but
declines to do so for any of these documents except for the recall
notice, which is available on the FDA website. The·other documents
are not relevant to preemption, the basis of this court's decision,
and therefore considering them and converting this motion into one
for summary judgment is not "likely to facilitate disposing of the
action." Ace American Ins., 255 F.R.D. at 188.
-7-

regulate medical devices and "swept back some state obligations and
imposed

a

regime

of

detailed

federal

oversight."

Riegel

v.

Medtronic, Inc., 128 S. Ct. 999, 1003 (2008).
The MDA defines three classes of "devices intended for human
use."

See 21 U.S.C.

§

360c.

Plaintiffs do not dispute that the

Pipeline is a "Class III" device.

Class III devices are subject to

the most federal oversight and must undergo the FDA's rigorous PMA
process before the manufacturer may bring them to market. 15
§

See id.

360e; Riegel, 128 S. Ct. at 1003; Lohr, 116 S. Ct. at 2246-47.

The PMA process requires the FDA to weigh any probable benefit to
health from the use of the device against any probable risks of
injury or illness from such use.

See 21 U.S.C.

§

360c(a) (2) (C).

The FDA only approves a device if it finds there is a reasonable
assurance
§

360e(d).

of

can

device's

safety and

effectiveness.

The FDA spends an average of 1,200 hours reviewing each

application.
2247.

the

See Riegel,

128 S.

Ct.

1004; Lohr,

116 S.

Ct.

at

The FDA reviews the Class III device's proposed labeling and
condition approval

on adherence

to

performance

standards,

restrictions upon sale or distribution, or compliance with other

15

A device is assigned to Class III "if it cannot be
established that a less stringent classification would provide
reasonable assurance of safety and effectiveness, and the device is
'purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial
importance in preventing impairment of human health,' or 'presents
a potential unreasonable risk of illness or injury.'" Riegel, 128
S. Ct. at 1003 (quoting 21 U.S.C. § 360c(a) (1) (C) (ii)).
-8-

requirements.

Riegel/

s. Ct. at 1004.

128

wants to change design specifications/
labeling

or "any other attribute[]

1

If the manufacturer

manufacturing processes 1

that would affect safety or

effectiveness" after approval 1 the manufacturer must submit a PMA
supplement and obtain FDA approval for the change.
(citing 21 U.S.C.

§

360e(d) (6); 21 C.F.R.

Id. at 1005

814.39(c))

§

Even after

approval 1 Class III devices are subject to reporting requirements.
Id.

(citing 21

u.s.c.

§

The FDA issued a PMA letter for the

360i)

Pipeline in April of 2011. 16
2.

Express and Implied Preemption Under the MDA

In enacting the MDA "Congress had to balance competing goods
when it enacted the Medical Device Amendments (MDA) to the Federal
Drug

Inc.

784 F.3d1335 1 1336 (10thCir. 2015).

1

1

and Cosmetics Act

(FDCA) . "

Caplinger v. Medtronic,

Food/

Perhaps most notably
it had to weigh the good of
ensuring that proposed medical devices are carefully
scrutinized for safety against the good of preserving the
freedom of patients and doctors to use potentially
life-saving technology as they see fit and without undue
delay.
One arena in which these objectives clashed
during the legislative process involved this question: to
what extent (if any) should states be able to layer
additional rules on top of Congress s? Allowing more
regulation of medical devices could yield benefits for
patient safety.
But it could also mean forcing
manufacturers to abide not one but fifty-one sets of
requirements a prospect that could deter or delay access
to innovative devices and wind up hurting more patients
than it helps.
1

1

1

16

See PMA Approval Letter
Docket Entry No. 14-6.

1

Exhibit E to Motion to Dismiss
-9-

1

Id.

Congress thus included 21 U.S.C.

express

provision

preemption

that

360k(a)

in the MDA,

prohibits

states

§

an

from

establishing any "requirement" for a medical device
(1) which is different from, or in addition to, any
requirement applicable under this chapter to the device,
and
(2) which relates to the safety or effectiveness of the
device or to any other matter included in a requirement
applicable to the device under this chapter.
In Riegel, 128 S. Ct. at 1002, the United States Supreme Court
considered "whether the pre-emption clause enacted in the

[MDA]

bars common-law claims challenging the safety and effectiveness of
a medical device given premarket approval by the [FDA] . "

The Court

held that the plaintiff's claims under New York common law for
strict liability; breach of implied warranty; and negligence in the
design, testing, inspection, distribution, labeling, marketing, and
sale of a balloon catheter were preempted.

Id. at 1006-07, 1011.

Riegel established a two-step analysis for determining whether
state law claims are preempted under the MDA.

First, "[s]ince the

MDA expressly pre-empts only state requirements 'different from, or
in addition to,
under federal

any requirement applicable .

law,

§

360k(a) (1),

. to the device'

we must determine whether the

Federal Government has established requirements applicable to [the
Pipeline]."

Id.

at

1006.

Second,

we must

determine

whether

Plaintiffs' "common-law claims are based upon [state] requirements
with respect to the device that are 'different from, or in addition
to,' the federal ones, and that relate to safety and effectiveness"
-10-

or "any other matter included in a requirement applicable to the
device."

Id.

preempted.

at 1006,

See id.

1007.

If so,

the plaintiff's claim is

To escape preemption by§ 360k(a), a state-law

claim must be premised on the breach of a state-law duty that is
the

same

as

a

duty

imposed

of

its

The MDA also contains an implied preemption provision.

In

implementing regulations).

under

the

FDCA

(or

one

Id. at 1011.

Buckman Co. v. Plaintiffs' Legal Committee, 121 S. Ct. 1012, 1017
(2001)

the

1

Court

held

that

"the

plaintiffs'

state-law

fraud-on-the-FDA claims conflict with, and are therefore impliedly
pre-empted by,

federal law."

Id.

This holding was based on 21

U.S.C. § 337(a), which states:
Except as provided in subsection (b) of this section, all
such proceedings for the enforcement, or to restrain
violations, of this chapter shall be by and in the name
17
of the United States.
The Court

stated,

"[t] he

FDCA leaves no doubt

that

it

is

the

Federal Government rather than private litigants who are authorized
to file suit for noncompliance with the medical device provisions:
'[A]ll

such

violations,
United

proceedings

the

enforcement,

or

to

restrain

of this chapter shall be by and in the name of the

States.'"

§ 337(a)).

for

Thus,

Buckman,

121

S.

Ct.

at

1018

n.4

(quoting

although "some parallel state claims survive

preemption by the MDA," individuals may not bring "a freestanding

17

Subsection
(b)
allows a
proceedings in certain situations.
-11-

State

to

bring

enforcement

federal

cause

of

regulations."

action

based

on

violation

of

the

FDA's

See Hughes v. Boston Scientific Corp., 631 F. 3d 762,

775 (5th Cir. 2011)

(discussing Buckman, 121 S. Ct. 1012).

To avoid implied preemption under Buckman a claim must assert
violation

of

requirement.

a

state

See id.

tort

duty

that

also

violates

some

FDA

As described by the district court in Riley

v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)
In other words, the conduct on which the claim is
premised must be the type of conduct that would
traditionally give rise to liability under state law-and
that would give rise to liability under state law even if
the FDCA had never been enacted.
If the defendant's
conduct is not of this type, then the plaintiff is
effectively suing for a violation of the FDCA (no matter
how the plaintiff labels the claim), and the plaintiff's
claim is thus impliedly preempted under Buckman.
Together,

"Riegel and Buckman create a

narrow gap through

which a plaintiff's state-law claim must fit if it is to escape
express or implied preemption."

In re Medtronic,

Fidelis Leads Products Liability Litigation,
(8th Cir. 2010)

Inc.,

Sprint

623 F.3d 1200, 1204

("In re Medtronic II"); see also Hughes, 631 F.3d

at 767

("Riegel,

like the Court's earlier decision in [Lohr, 116

S. Ct.

2240], makes clear that a medical device manufacturer is

protected from liability under state-law tort claims related to a
defective or dangerous device to the extent that the manufacturer
has

complied with

Riegel

and

Lohr

federal
also

make

statutes
clear

and
that

regulations.
a

manufacturer

However,
is

not

protected from state tort liability when the claim is based on the
manufacturer's violation of applicable federal requirements.").
-12-

A

properly pleaded state-law claim must "parallel" FDA requirements
and cannot

impose additional

manufacturer.

or different

See Bass v. Stryker Corp.,

requirements

on

the

669 F.3d 501, 509, 514

(5th Cir. 2012).
3.

Plaintiffs' Claims are All Preempted or Fail to Properly
Allege a Claim

Covidien

argues

that

Plaintiffs'

claims

expressly or impliedly preempted by the MDA. 18

are

all

either

Plaintiffs respond

that the PMA process does not preempt all state claims and that
their claims are not expressly or impliedly preempted. 19
a.

Plaintiffs Have Not Pleaded Any Parallel Claims

In reviewing a motion to dismiss,

the court must accept the

factual allegations of the complaint as true, view them in a light
most favorable to the plaintiff, and draw all reasonable inferences
in the plaintiff's favor.

Ramming,

281 F.3d at 161.

Although

Plaintiffs' claims are addressed individually below, a review of
the factual allegations and scattered allegations of federal law
violations together confirm that Plaintiffs have not adequately
pleaded any parallel claims and have therefore failed to state a
claim for which relief can be granted.
"Parallel claims must be specifically stated in the initial
pleadings.

A plaintiff must allege that the defendant violated a

18

See Motion to Dismiss, Docket Entry No. 14, pp. 13-27.

19

See Plaintiffs' Response, Docket Entry No. 25, p. 3.
-13-

particular federal specification referring to the device at issue.
To properly allege parallel claims,
facts

pointing

to

specific

PMA

the complaint must set forth
requirements

that

have

been

violated."

Wolicki-Gables v. Arrow International, Inc., 634 F.3d

1296,

(11th Cir.

1301

2011)

(citations and quotations omitted).

Plaintiffs allege that Covidien manufactures the Pipeline placed
during the surgery; the Pipeline has a coating to reduce friction,
some of which detached during the surgery;

the detached coating

caused Plaintiff's severe injuries; and Covidien knew prior to the
incident that the coating had a tendency to flake off and cause a
stroke in patients.

After its brief factual statement, the Amended

Complaint lists the causes of action detailed below.
Complaint

does

not

set

forth

facts

pointing

to

The Amended
specific

PMA

requirements that have been violated.
The Fifth Circuit addressed the necessity for plaintiffs to
properly plead their claims to avoid preemption in Rodriguez v.
American Medical Systems,
2014).

Inc.,

597 F. App'x 226,

229

The court compared two of its earlier opinions.

court discussed Bass,

(5th Cir.
First, the

669 F.3d at 512, where "we held that 'if a

plaintiff pleads that a manufacturer of a Class III medical device
failed to comply with either the specific processes and procedures
that

were

approved

by

the

FDA

or

the

[FDA's

Current

Good

Manufacturing Practices] and that this failure caused the injury,
the plaintiff will have pleaded a parallel claim.'"
Wolicki-Gables,

Id.

(citing

634 F.3d at 1301-02, and In re Medtronic II,

F.3d at 1207).
-14-

623

Bass addressed a claim that an FDA-approved Class III hip
implant malfunctioned because of impurities in the
manufacturing process.
We held that the plaintiff did
state parallel claims where the complaint specified which
FDA regulations were violated in the manufacturing
process, alleged that the manufacturer had received a
warning letter from the FDA regarding the manufacturing
defect, and eventually recalled the implant due to the
defect.
Id. at 230 (discussing Bass, 669 F.3d at 510)

(citations omitted).

The court contrasted Funk, 631 F.3d at 782, where "we addressed a
similar claim regarding the same hip implant but held that the
plaintiff's pleadings

were

too

conclusory to

state a

parallel

claim."
Specifically, we noted that Funk's complaint did not
specify the manufacturing defect, did not specify a
causal connection between a failure of the manufacturing
process and a specific defect in the process that caused
the personal injury, and did not specify how the process
deviated from the FDA approved manufacturing process.
Id.

Based on this case law, the court held that
Rodriguez's complaint does not plead a violation of any
federal requirement relating to design or manufacturing
of the implant, either those specific to the AMS 700 MS
or those generally applicable to the manufacturing of
medical devices, and he cites no facts supporting a
finding of any such violation.
He fails to allege a
specific defect in the manufacturing process or design,
any
deviation
from
the
FDA-approved
design
or
manufacturing processes, or any causal connection between
a violation of federal requirements and his injuries.
Thus, he has failed to plead a parallel claim .

.

Id.;

see

also

Wolicki-Gables,

634

F.3d

at

1301-02

("These

allegations do not 'set forth any specific problem, or failure to
comply with any FDA regulation that can be linked to the injury
alleged.'

Because

[plaintiffs]

have failed to allege facts in

their complaint demonstrating the presence of the elements of a
-15-

parallel claim, we are persuaded that the District Court did not
err

in

concluding

that

their

preempted." (citation omitted)).

state

common

law

claims

were

In sum, plaintiffs cannot "simply

incant the magic words [that Defendant] violated FDA regulations."
Id.

at 1301.

With this background the court will address the

specific claims in Plaintiffs' Amended Complaint.
b.
The

State-law Claims

Pipeline

is a

premarket approval

from

Class
the

III medical device
FDA.

The

that

received

PMA process establishes

federal "requirements" under the MDA, satisfying the first prong of
Riegel.

See Riegel,

128 S.

Ct.

at 1007

S. Ct. 2240); Hughes, 631 F.3d at 768.
of the

[Riegel]

(discussing Lohr,

116

"Moving to the second prong

test, we must ask whether the state law at issue

creates a requirement that is related to the device's safety or
effectiveness and is 'different from or in addition to' a federal
requirement."
contains

Hughes ,

state-law

liability,

breach

warranty.

The

6 31 F . 3d at 7 6 8 .

claims

of

express

Supreme

Court

for

The Amended Complaint
strict

negligence,

warranty,
recognized

and

breach

that

state

products

of

implied

common-law

duties- such as those underlying negligence, strict-liability, and
implied-warranty claims - impose state "requirements" with respect
to medical devices.

Riegel, 128 S. Ct. at 1009-10; see also In re

Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation,
592 F. Supp. 2d 1147, 1152 (D. Minn. 2009)
aff'd, 623 F.3d 1200 (8th Cir. 2010)
-16-

("In re Medtronic I"),

("In the ten months following

Riegel,
broadly,

courts across

the country have applied Section 360k (a)

preempting all manner of

claims

from

strict products

liability and negligence, to breach of warranty, to failure to warn
and

manufacturing-and-design-defect,

(citations

omitted)) . 20

The

court

to

negligence

concludes

that

per
each

se."
of

Plaintiffs' state-law claims likewise imposes "requirements" with
respect to the Pipeline and will address the claims individually to
determine whether they impose requirements that are different from
or additional

to applicable

federal

requirements

and are

thus

preempted. 21
2

°Courts in this jurisdiction and others have concluded that
these types of state-law claims impose "requirements."
In
Timberlake v. Synthes Spine, Inc., Civ. Action No. V-08-4, 2011
WL 711075, at *6 (S.D. Tex. Feb. 18, 2011), for example, the
federal district court granted summary judgment for the defendant
on the plaintiff's Texas state-law negligence and strict products
liability claims because they "impose[d]
additional safety
requirements such that they would be preempted under Riegel by the
federal requirements inherent in the PMA process." (citing Lewkut
v. Stryker Corp., 724 F. Supp. 2d 648, 658 (S.D. Tex. 2010)). The
court also granted summary judgment for the defendant on the
plaintiff's express warranty claim. Id. at *7 (citing Gomez v. St.
Jude Medical Daig Division Inc., 442 F.3d 919, 932 (5th Cir.
2006)). In Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692, 706-07
(S.D. Tex. 2014), the court held that strict liability design and
manufacturing defect claims, implied warranty, and failure-to-warn
claims were preempted. See also DeLeon v. Johnson & Johnson, Civ.
Action No. C-11-177, 2011 WL 2618957, at *3 (S.D. Tex. July 1,
2011) (dismissing products liability, negligence, gross negligence,
and DTPA claims and collecting cases) .
21

See also Wolicki-Gables,
634 F. 3d at 1301-02
(strict
liability for manufacturing and design defect, failure to warn, and
negligent design, manufacture, and assembly claims preempted);
Walker v. Medtronic, Inc., 670 F.3d 569, 576-81 (4th Cir. 2012)
(negligence, strict liability, and breach of warranty claims
preempted); Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206
(W.D. Okla. 2013), aff'd 784 F. 3d 1335 (lOth Cir. 2015) (dismissing
constructive fraud, strict products liability (failure to warn and
design defect), breach of express and implied warranty, and
negligent failure-to-warn and marketing as preempted) .
-17-

i.

Negligence

Plaintiffs allege that Covidien was negligent "in one or more
of the following acts and/or omissions:"
a.

Failing to manufacture, market and label a product
that would be safe for patientsi

b.

Failing to manufacture, market and label a product
that was consistent with the original designi and

c.

Failing to manufacture, market and label a product
consistent with FDA regulations and guidelines.

"Each

of

these

acts

and/or

omissions,

singularly

and/or

in

combination, proximately caused the injuries to the Plaintiffs." 22
The fact that the Pipeline received PMA approval indicates that the
FDA approved the manufacturing, design,
Covidien.

and labeling proposed by

A state law that requires Covidien to do something other

than what was approved by the FDA imposes a different or additional
requirement.
§

See

Riegel,

552

u.s. at 317

360e(d))i see also Kemp v. Medtronic,

(6th Cir. 2000)

Inc.,

(quoting

21

u.s.c.

231 F.3d 216,

230

("To permit a jury to find Medtronic negligent" for

failing to manufacture a PMA-approved device in a manner other than
as

prescribed

in

the

PMA

"would

be

to

impose

a

requirement

Amended Complaint, Docket Entry No. 17, p. 3 ~~ 16-17.
Plaintiffs also allege that "[t]he negligence of the Defendants was
of such a character to make the Defendants guilty of gross
negligence . . . . " Id. at 5 ~~ 34-35. The Amended Complaint does
not provide any information about Covidien' s allegedly grossly
negligent conduct. Because the negligence claim will be dismissed,
the gross negligence claim will also be dismissed.
22

-18-

different from and in addition to those established by the FDA.

11

)

23

Plaintiffs' negligence claim is thus preempted.
Plaintiffs

argue

that

the

"strict

liability

claims

of

manufacturing defect claims premised on manfacture[r] 's alleged
violations of the FDA regulations and requirements should survive 1124
and

"the

[because]

negligent

manufacturing

claim

should

survive

[t]he negligent claims have been pled as parallel claims

that do not impose different or additional requirements than the
FDA regulations because Plaintiff has pleaded that Covidien failed
to abide by the FDA regulations in the manufacture of the pipeline
embolization device.

1125

Plaintiffs cite Bass, 669 F.3d 501, where the court allowed a
manufacturing defect claim to proceed because "to the extent they

23

See also Millman v. Medtronic, Civ. Action No. 14-CV-1465,
2015 WL 778779, at *5 (D.N.J. Feb. 24, 2015) ("Plaintiffs' claims
based on a manufacturing defect, design defect, failure to warn,
negligence and a breach of contract/warranty theory are preempted
because they impose requirements that are different from the
federal requirements set forth in the PMA process. 11 ) ; Zaccarello v.
Medtronic, Inc., 38 F. Supp. 3d 1061, 1067-70 (W.D. Mo. 2014)
(dismissing manufacturing and design defect negligence and strict
liability claims as expressly preempted) ; Blankenship v. Medtronic,
Inc., 6 F. Supp. 3d 979, 988 (E.D. Mo. 2014) (dismissing manufacturing defect, design defect, and failure to warn claims as
expressly preempted and strict liability and negligence claims as
impliedly preempted) .
Prior to Riegel courts found preemption
under § 360k for these types of claims. See, ~. Horn, 376 F.3d
at 179 (negligence and defective design and manufacture claims
preempted by § 360k); Martin v. Medtronic, 254 F.3d 573, 584-85
(5th Cir. 2001) (design, manufacturing process, and failure to warn
claims preempted) .
24

Plaintiffs' Response, Docket Entry No. 25, p. 6.

25

See id.
-19-

are premised on violations of FDA regulations,
claims

that

are

not

preempted."

Bass,

they are parallel

669

F.3d

at

515.

Plaintiffs' claims, however, are more similar to those dismissed in
Funk,

631

F. 3d at

782,

where

the

Fifth Circuit

examined this

manufacturing defect claim:
[3.] The hip prostheses contained a manufacturing defect
in that it was manufactured in such a manner that
impurities,
residues and bacteria remained on the
prosthesis in violation of the FDA standards and
requirements and in violation of the manufacturing
processes and design approved by the FDA.
[4.] The hip prostheses deviated, in its construction or
quality, from the specifications or planned output. As
more particularly set forth below, Plaintiff invokes the
doctrine of res ipsa loquitur as to the manufacturing
defect contained in the hip prosthesis.
The court held the complaint uimpermissibly conclusory and vague;
it does not specify the manufacturing defect; nor does it specify
a

causal

connection

between

the

failure

of

the

specific

manufacturing process and the specific defect in the process that
caused the personal injury.
manufacturing process

Nor does the complaint tell us how the

failed,

or how it deviated from the

approved manufacturing process."

Id.

FDA

(citing Iqbal, 129 S. Ct. at

1949) . 26

26

Plaintiffs' final argument is that the motion is premature
without any discovery being conducted. See id. at 7. They cite a
uvoluntary recall" that Covidien issued in April of 2014 to address
delamination.
See Docket Entry No. 25-3.
Plaintiffs do not
provide argument or support that this recall notice changes the
fact that the FDA issued a PMA for the Pipeline.
Plaintiffs did
not address this in their Amended Complaint, and as discussed at
length, the Amended Complaint fails to allege any proper claims.
(continued ... )
-20-

Plaintiffs plead that Covidien failed to "manufacture, market
and label a product that was consistent with the original design"
and

"a

guidelines. " 27

product

consistent

with

FDA

the

and

These statements provide no information as to how

Covidien deviated from the "original design."
how

regulations

Pipeline

is

inconsistent

with

They do not indicate
FDA

regulations

or

guidelines, or what regulations or guidelines it is inconsistent
with.

Such vague and conclusory statements are not sufficient to

survive a Rule 12 (b) (6)

F. App'x at 229; Zaccarello,
dismisses

this

claim

See Rodriguez,

motion to dismiss.

for

38 F. Supp.

failure

to

3d at 1069

include

597

("The Court

sufficient

facts.

Plaintiff does not allege facts regarding a particular violation of
federal law and, therefore, fails to state a plausible claim.

In

addition,

to

without

more

information,

the

Court

is

unable

determine whether the federal regulations are parallel to the MDA
and whether the claim can exist independent from the MDA. ") .

Thus,

Plaintiffs' negligence claims will be dismissed.

26

( • • • continued)
The voluntary recall notice does not change that conclusion. See
Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1056, 70
Cal. Rptr. 3d 566, 579-80 (2008) (citations omitted) ("The fact the
FDA implemented a Class I recall of the Valve does not alter our
conclusion. When the Valve was implanted in Claudia, it had been
approved by the FDA through the PMA process. And, we have found no
evidence in the record to support the conclusion the FDA revoked
the Valve's PMA.
The fact the FDA has implemented a Class I
recall does not necessarily mean the FDA has completely removed the
device from the marketplace.") ; see generally Bush v. Thoratec
Corp., 837 F. Supp. 2d 603 (E.D. La. 2011).
27

Amended Complaint, Docket Entry No. 17, p. 3
-21-

~

16b and c.

ii.

Plaintiffs'

Strict Products Liability

second cause of action is for "Strict Products

Liability (§ 402-A) :"
19. Plaintiffs will show that the occurrence giving rise
to this lawsuit was caused by Defendant Covidien, LP,
placing into the stream of commerce an unreasonably
dangerous and defective product.
20. Defendants
manufactured,
marketed,
labeled,
assembled, tested (or failed to test), inspected (or
failed to inspect), packaged, fabricated, constructed,
distributed, and sold the product.
21. The product was unsafe by reason of the defects in
the manufacturing, marketing and labeling. 28
Covidien' s processes for manufacturing, marketing, and labeling the
Pipeline were

FDA approved

Riegel, 552 U.S. at 329-30.

in the

intensive

PMA review.

See

Plaintiffs' strict products liability

claims necessarily impose requirements that are different from or
in addition to

federal

requirements

because

Plaintiffs

do not

allege here that Covidien failed to satisfy federal requirements
imposed by the PMA process.

See,

~'

In re Medtronic I,

592

F. Supp. 2d at 1159 (plaintiffs could not "escape that under their
theory of liability, Medtronic would have been required to provide
warnings

above

and beyond

those

on

the

Sprint

Fidel is

leads'

product label - a label that was specifically approved by the FDA
as part of

the

PMA process,"

which would

"impose requirements

'different from, or in addition to' those approved by the FDA.");
Millman, 2015 WL 778779, at *6 n.5 ("Plaintiffs do not allege the

28

Id. at 3-4

~~

19-21.
-22-

design or manufacture of the Activa System devices deviated in any
way from the design, manufacture or warning approved by the FDA
through

the

PMA process.

design,

manufacturing

and

Thus,

to

failure

prevail

on

to

claims,

warn

their

state-law
Plaintiffs

necessarily would have to prove that the Activa System devices
should have employed a design, manufacture or label different from
that approved by the FDA.
claim.").

Riegel squarely forecloses any such

See also Bass, 669 F.3d at 515; Schouest, 13 F. Supp. 3d

at 704; Lewkut, 724 F. Supp. 2d at 660; Mills v. Warner-Lambert Co.,
581

F.

Supp.

2d 772

(E.D.

Tex.

2008).

Therefore,

the

strict

products liability claims will be dismissed.
iii.

Plaintiffs

Breach of Express Warranty

allege

a

breach

of

express

warranty

cause

action:
23.
Plaintiff will show that the injuries and damages
were caused by the breach of expressed warranties made by
the Defendant.
24. Defendant placed a product into the stream of
commerce that was a violation of its own expressed
warranties.
25. Defendant, in placing the product into the stream of
commerce, utilized advertising media and professional
publications to urge the purchase and use of the product
and expressly warranted to members of the general public,
including Plaintiff that it was effective and proper.
26. Plaintiffs relied upon the representations made by
the Defendant, in the purchase of the product. 29

29

Id. at 4

~~

23-26.
-23-

of

The express and implied warranty claims suffer from similar
infirmities.

"[A]

jury

[Pipeline]

was

unsafe

[Covidien]

breached 'these

WL 711075, at *2.
process,

and

would

still

have

to

find

in

order

to

ineffective
warranties."

See

that

the

find

that

Timberlake,

2011

The FDA determined otherwise through the PMA

so the state claim is based on different or additional

requirements and is expressly preempted by the MDA.
DePuy Spine,

Inc.,

638

F.

Supp.

2d 1226,

1230

See Miller v.
(D.

Nev.

2009)

("Where . . . an essential element of a plaintiff's claim of breach
of express or implied warranty will be proof that a device granted
a

PMA is not safe or effective,

such a

contention necessarily

conflicts with the FDA's contrary finding and its requirement that
the device be made as approved.")
The

express

30

warranty claim does

not

failed to· comply with FDA requirements. 31

allege

that

Covidien

The Amended Complaint

does not identify actual representations or promises that Covidien
made regarding the safety and effectiveness of the Pipeline.
analyzing a similarly cursory complaint,

In

another district court

30

See also Caplinger, 784 F.3d at 1340-47 (dismissing express
and implied warranty claims as preempted) ; Gavin v. Medtronic,
Inc., No. 12-0851, 2013 WL 3791612, at *15 (E.D. La. 2013) (express
and implied warranty claims were preempted) ; Parker v. Stryker
Corp., 584 F. Supp. 2d 1298, 1303 (D. Colo. 2008) ("Plaintiff's
express warranty claim would contradict the FDA's determination
that the representations made on the label were adequate and
appropriate and, thus, impose requirements different from or in
addition to the federal requirements.").
31

See Amended Complaint, Docket Entry No. 17, p. 4.
-24-

held "Plaintiff does not allege any facts showing when and how he
received notice
showing

that

of
the

warranties . .
suggest

that

breached.

such warranties,
pacemaker

nor

did

does

he

allege

facts

with

such

comport

not

Stated simply, Plaintiff has alleged nothing to
any

warranties

made

by

Defendant

were

actually

Plaintiff has therefore not stated a breach of warranty

claim upon which relief can be granted,
dismissed."

Steen v. Medtronic,

Inc.,

and that claim will be
Civ. Action No.

3:10-CV-

936-L, 2010 WL 2573455, at *3 (N.D. Tex. June 25, 2010); see also
Schouest,

13 F. Supp.

3d at 707

("While conceptually an express

warranty claim could avoid express preemption, what is missing from
Schouest's complaint, in its current form, is a description of what
specific

warranties

physicians.") . 32

Medtronic

made

to

Schouest

or

her

The same issues arise here; there are no facts

alleged that show when and how Plaintiffs received notice of the
alleged warranties.

See Twombly, 127 S. Ct. at 1965.

Moreover,

representations such as those made on the label, in warnings, and
instructions

for use were

FDA approved,

and any additional or

different state law requirement would be preempted.

See Gomez, 442

F.3d at 932.

32

In Schouest, 13 F. Supp. 3d at 707, the court gave the
plaintiff an opportunity to replead on her request after the
Rule 12 motion.
Here, the court has already granted a postRule 12(b) (6) motion for leave to amend. See Order Granting Leave
to File Amended Complaint, Docket Entry No. 20.
-25-

iv.

Breach of Implied Warranty

Plaintiffs next allege breach of implied warranty:
28.
Plaintiffs will show that the injuries were caused
by the breach of implied warranty of merchantability by
the Defendant.
29. Defendants implied to members of the general public,
including Plaintiff, that the product was of merchantable
quality and safe for the use for which it was intended.
30. The characteristics referenced above resulted in a
condition that rendered the product unfit for the
ordinary purpose for which it was to be used because of
the lack of something necessary for adequacy.
31.
Plaintiff believes that Defendant violated federal
requirements that were a producing cause of their
injuries. 33
" [A] n implied warranty claim is not preempted if the plaintiff
alleges that the defendant violated federal requirements and can
ultimately show a causal link between the violation and the breach
of the implied warranty."

Bass,

not

requirements

identify what

violated.

federal

Plaintiffs'

vague

Plaintiffs do

669 F.3d at 517.

and

they

"believe"

conclusory

Covidien

allegation

that

"Plaintiff believes that Defendant violated federal requirements
that were a producing cause of their injuries" cannot support a
claim.

See Rodriguez, 597 F. App'x at 229; Funk, 631 F.3d at 782.

As discussed at length, Plaintiffs cannot "simply incant the magic
words [that Defendant] violated FDA regulations."
634

F.3d at

33

1301;

see

also

Timberlake,

2011

Wolicki-Gables,
WL

71105,

Amended Complaint, Docket Entry No. 17, pp. 4-5
-26-

~~

at

28-31.

*9

(quotations omitted).

For these reasons,

the

implied warranty

claim will also be dismissed.
c.

Claims for Failure to Comply with the FDCA and Its
Implementing Regulations

In addition to the state-law claims,

the Amended Complaint

contains a claim for "Failure to Comply with 21 C.F.R.

§ 820.30

Design Controls and Federal Food, Drug, and Cosmetic Act§ 521(a),
21 U.S.C.A. § 360k(a) :"
32. Defendant failed to meet design control requirements
of 21 C.F.R. § 820.30 which was a producing cause and/or
a proximate cause of Plaintiff's injuries and damages to
Plaintiff.
33. The manufacture of the Pipeline Embolization Device
by the Defendant failed to comply with either specific
processes or procedures that were approved by the [FDA]
or
Current
Good
Manufacturing
Practices
( CGMPs)
themselves
and
that
failure
caused
injury
to
34
Plaintiffs.
21 U.S.C.

§

337 (a)

does

not

permit

"freestanding federal

causes of action based on violation of the FDA's regulations," and
there

is

no private

cause

of

created by FDA regulations.
121

S.

Ct.

1018

at

n.4;

action

for

duties

independently

See Hughes, 631 F.3d at 775; Buckman,
Lewkut,

724

F.

Supp.

2d at

659-60.

"Defendant failed to meet design control requirements of 21 C.F.R.
§ 820.30" merely alleges noncompliance with FDA regulations.

This

claim thus is preempted by§ 337(a) and will be dismissed.
The
Defendant

34

claim
failed

that
to

"manufacture
comply

with

of

the

either

Pipeline
specific

Amended Complaint, Docket Entry No. 17, p. 5
-27-

[]

by

processes

~~

32-33.

the
or

procedures

that

were

Manufacturing Practices
reason. 35

approved

by

(CGMPs)

the

[FDA]

themselves"

or

fails

Current
for

Good

the same

To the extent it is an attempt to assert a claim for

violation of

the

FDCA or

its

implementing

regulations,

it

is

impliedly preempted by§ 337(a).
Although this language mirrors the language the Fifth Circuit
used in Bass, 669 F.3d at 512, to describe a parallel claim, that
is all it does.

Even when read in conjunction with the state-law

claims discussed above, the Amended Complaint does not allege facts
in support of this bare conclusory statement, such as what specific
processes or procedures approved by the FDA Covidien failed to
comply with, or how Covidien failed to meet any CGMP requirements
in manufacturing the Pipeline.

See Funk, 631 F.3d at 782; Wolicki-

6 3 4 F . 3d at 13 0 1- o2 .

Plaintiffs have not identified a

Gab 1 e s ,

"causal connection between a failure of the manufacturing process
and a

specific defect

in the process that caused the personal

injury, and did not specify how the process deviated from the FDA
approved manufacturing process."
(discussing Funk,

Rodriguez,

597 F. App'x at 230

631 F.3d at 782); see Kitchen v. Biomet,

Inc.,

Civ. Action No. 13-18-HRW, 2014 WL 694226, at *5 (E.D. Ky. Feb. 21,
35

"CGMPs" are set forth in 21 C.F.R. § 820, the Quality System
Regulations applicable to all medical devices.
See In re
Medtronic II, 623 F.3d at 1206; 21 C.F.R. § 820.1(a) (1) ("The
requirements in this part govern the methods used in, and the
facilities and controls used for,
the design,
manufacture,
packaging, labeling, storage, installation, and servicing of all
finished devices intended for human use. The requirements in this
part are intended to ensure that finished devices will be safe and
effective and otherwise in compliance with the [FDCA] .").
-28-

2014)

(dismissing

claims

where

plaintiff

referred

to

a

broad

category of federal regulations and failed to allege how the device
violated

those

injuries).

regulations

Therefore,

the

or

how

court

that

deviation

concludes

that

caused

this

her

claim is

subject to dismissal.
IV.

Conclusions and Order

For the reasons discussed above,
any claims
Complaint.

upon which relief

can be

Plaintiffs have not stated
granted

in

their Amended

Defendant Covidien LP's Motion to Dismiss Plaintiffs'

First Amended Complaint (Docket Entry No. 21) is therefore GRANTED,
and this action will be dismissed with prejudice.
SIGNED at Houston, Texas, on this 25th day of April, 2016.

LAKE
UNITED STATES DISTRICT JUDGE

-29-