Yosowitz et al v. Covidien LP
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
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
BRENDA s. YOSOWITZ and
EDWARD E. YOSOWITZ, M.D.
April 25, 2016
David J. Bradley, Clerk
CIVIL ACTION NO. H-15-2902
MEMORANDUM OPINION AND ORDER
Plaintiffs Brenda S.
Yosowitz and Edward E.
"Covidien") in the 215th Judicial District Court of Harris County,
Texas . 1
Defendant removed the case to this court. 2
the court is Defendant Covidien LP's Motion to Dismiss Plaintiffs'
First Amended Complaint
(Docket Entry No.
For the reasons
the motion to dismiss will be granted,
action will be dismissed with prejudice.
Factual Allegations and Procedural Background
One of the Plaintiffs underwent a procedure to repair two
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.
See Notice of Removal, Docket Entry No. 1.
Complaint"), Docket Entry No. 17, p. 2 ~ 7.
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
negligence, strict products liability (§ 402-A), breach of express
breach of implied warranty,
failure to comply with 21
Plaintiffs filed an Amended Complaint after Covidien
removed the action to federal court alleging the same causes of
Covidien had previously filed Defendant Covidien LP's
arguments in that motion by reference in its present motion. 8
Id. at 2.
See Plaintiffs' Original Petition, Exhibit B to Notice of
Removal, Docket Entry No. 1-2, pp. 11-13.
See Amended Complaint, Docket Entry No. 17, pp. 3-5.
Plaintiffs' Original Petition, but removes defects in design,
testing, and packaging from the strict products liability section.
See Docket Entry No. 21, p. 3 (incorporating and adopting by
reference the arguments, authority, and exhibits set forth in
Docket Entry No. 14).
opinion references the original Motion to Dismiss unless noted
Covidien moved to dismiss pursuant to Federal Rule of
Civil Procedure 12(b) (6) on federal preemption grounds and because
Procedure pleading requirements.
Plaintiffs respond that not all
Covidien' s motion is premature. 10
Standard of Review
pleading must contain "a short and plain statement of the claim
showing that the pleader is entitled to relief."
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.
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.
To defeat a motion to dismiss pursuant to Rule 12(b) (6),
plaintiff must plead "enough facts to state a claim to relief that
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.
See Plaintiffs' Response in Opposition to Defendant's Motion
to Dismiss Plaintiffs' First Amended Complaint ("Plaintiffs'
Response"), Docket Entry No. 25.
is plausible on its face."
S. Ct. 1955, 1974
Bell Atlantic Corp. v. Twombly,
uA claim has facial plausibility when
the plaintiff pleads factual content that allows the court to draw
standard is not akin to a
Ct. at 1965).
liable for the
(quoting Twombly, 127 S. Ct. at 1965).
'probability requirement,' but it asks
sheer possibility that
possibility and plausibility of uenti tlement to relief."'"
(quoting Twombly, 127 S. Ct. at 1966).
district courts are
When considering a motion
ulimited to the complaint,
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."
required to dismiss
Lone Star Fund V (U.S.), L.P. v. Barclays Bank
claims based on invalid legal theories,
even though they may be otherwise well-pleaded."
Farm Fire & Casualty Insurance Co.
820 (W.D. Tex. 2009)
Flynn v. State
(Texas), 605 F. Supp. 2d 811,
(citing Neitzke v. Williams, 109 S. Ct. 1827,
certain publicly available Food and Drug Administration
records that Covidien attached to the Motion to Dismiss. 11
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
Motion to Dismiss, Docket Entry No. 14, p. 12.
summary page for Pipeline Embolization Device, PMA No. P100018,
Exhibit C to Motion to Dismiss, Docket Entry No. 14-4; Pipeline
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.
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.
All are available at http://www.fda.gov and at links from
See Exhibit B to Motion to Dismiss, Docket Entry
judicial notice.'" 13
Funk v. Stryker Corp., 631 F.3d 777, 783 (5th
(quoting Tellabs, Inc. v. Makar Issues & Rights, Ltd.,
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
can be accurately and readily determined from
sources whose accuracy cannot reasonably be questioned."
publicly-available documents and transcripts produced by the FDA,
which were matters of public record directly relevant to the issue
at hand" is appropriate.
Funk, 631 F.3d at 783 ("[W]e hold that it
Rule 12(b) (6), of the PMA the FDA granted to Stryker for marketing
(taking judicial notice of FDA 510k premarket notification cited by
Plaintiffs do not dispute the fact that the Pipeline
received the FDA's PMA approval and do not argue that the court
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)).
concludes that Covidien's exhibits satisfy the requirements of Fed.
R. Evid. 201(b) and will take judicial notice of them. 14
Plaintiffs' Claims Are Subject to Dismissal
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
( "MDA") ,
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
Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2245 (1996)
(quoting the MDA' s preamble) .
The MDA granted the FDA authority to
Plaintiffs also attached documents to their Response, but did
not request that the court take judicial notice of them.
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
Exhibit D to Plaintiffs'
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.
regulate medical devices and "swept back some state obligations and
Medtronic, Inc., 128 S. Ct. 999, 1003 (2008).
The MDA defines three classes of "devices intended for human
See 21 U.S.C.
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
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
The FDA spends an average of 1,200 hours reviewing each
The FDA reviews the Class III device's proposed labeling and
restrictions upon sale or distribution, or compliance with other
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)).
s. Ct. at 1004.
wants to change design specifications/
or "any other attribute
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
approval 1 Class III devices are subject to reporting requirements.
The FDA issued a PMA letter for the
Pipeline in April of 2011. 16
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
784 F.3d1335 1 1336 (10thCir. 2015).
and Cosmetics Act
(FDCA) . "
Caplinger v. Medtronic,
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
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
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.
See PMA Approval Letter
Docket Entry No. 14-6.
Exhibit E to Motion to Dismiss
Congress thus included 21 U.S.C.
in the MDA,
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,
(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
bars common-law claims challenging the safety and effectiveness of
a medical device given premarket approval by the [FDA] . "
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,
any requirement applicable .
. to the device'
we must determine whether the
Federal Government has established requirements applicable to [the
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"
or "any other matter included in a requirement applicable to the
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 MDA also contains an implied preemption provision.
Id. at 1011.
Buckman Co. v. Plaintiffs' Legal Committee, 121 S. Ct. 1012, 1017
fraud-on-the-FDA claims conflict with, and are therefore impliedly
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
of the United States.
FDCA leaves no doubt
Federal Government rather than private litigants who are authorized
to file suit for noncompliance with the medical device provisions:
of this chapter shall be by and in the name of the
although "some parallel state claims survive
preemption by the MDA," individuals may not bring "a freestanding
proceedings in certain situations.
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
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.
"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)
623 F.3d 1200, 1204
("In re Medtronic II"); see also Hughes, 631 F.3d
like the Court's earlier decision in [Lohr, 116
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
protected from state tort liability when the claim is based on the
manufacturer's violation of applicable federal requirements.").
properly pleaded state-law claim must "parallel" FDA requirements
See Bass v. Stryker Corp.,
669 F.3d 501, 509, 514
(5th Cir. 2012).
Plaintiffs' Claims are All Preempted or Fail to Properly
Allege a Claim
expressly or impliedly preempted by the MDA. 18
that the PMA process does not preempt all state claims and that
their claims are not expressly or impliedly preempted. 19
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.
281 F.3d at 161.
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
A plaintiff must allege that the defendant violated a
See Motion to Dismiss, Docket Entry No. 14, pp. 13-27.
See Plaintiffs' Response, Docket Entry No. 25, p. 3.
particular federal specification referring to the device at issue.
To properly allege parallel claims,
the complaint must set forth
Wolicki-Gables v. Arrow International, Inc., 634 F.3d
(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.
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,
597 F. App'x 226,
The court compared two of its earlier opinions.
court discussed Bass,
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
Manufacturing Practices] and that this failure caused the injury,
the plaintiff will have pleaded a parallel claim.'"
634 F.3d at 1301-02, and In re Medtronic II,
F.3d at 1207).
Bass addressed a claim that an FDA-approved Class III hip
implant malfunctioned because of impurities in the
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
Id. at 230 (discussing Bass, 669 F.3d at 510)
The court contrasted Funk, 631 F.3d at 782, where "we addressed a
similar claim regarding the same hip implant but held that the
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.
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,
manufacturing processes, or any causal connection between
a violation of federal requirements and his injuries.
Thus, he has failed to plead a parallel claim .
allegations do not 'set forth any specific problem, or failure to
comply with any FDA regulation that can be linked to the injury
have failed to allege facts in
their complaint demonstrating the presence of the elements of a
parallel claim, we are persuaded that the District Court did not
preempted." (citation omitted)).
In sum, plaintiffs cannot "simply
incant the magic words [that Defendant] violated FDA regulations."
With this background the court will address the
specific claims in Plaintiffs' Amended Complaint.
III medical device
PMA process establishes
federal "requirements" under the MDA, satisfying the first prong of
S. Ct. 2240); Hughes, 631 F.3d at 768.
"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
6 31 F . 3d at 7 6 8 .
The Amended Complaint
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)
("In re Medtronic I"),
("In the ten months following
the country have applied Section 360k (a)
preempting all manner of
liability and negligence, to breach of warranty, to failure to warn
omitted)) . 20
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
°Courts in this jurisdiction and others have concluded that
these types of state-law claims impose "requirements."
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]
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) .
See also Wolicki-Gables,
634 F. 3d at 1301-02
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) .
Plaintiffs allege that Covidien was negligent "in one or more
of the following acts and/or omissions:"
Failing to manufacture, market and label a product
that would be safe for patientsi
Failing to manufacture, market and label a product
that was consistent with the original designi and
Failing to manufacture, market and label a product
consistent with FDA regulations and guidelines.
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,
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
u.s. at 317
360e(d))i see also Kemp v. Medtronic,
(6th Cir. 2000)
231 F.3d 216,
("To permit a jury to find Medtronic negligent" for
failing to manufacture a PMA-approved device in a manner other than
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.
different from and in addition to those established by the FDA.
Plaintiffs' negligence claim is thus preempted.
manufacturing defect claims premised on manfacture[r] 's alleged
violations of the FDA regulations and requirements should survive 1124
[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
Plaintiffs cite Bass, 669 F.3d 501, where the court allowed a
manufacturing defect claim to proceed because "to the extent they
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) .
Plaintiffs' Response, Docket Entry No. 25, p. 6.
are premised on violations of FDA regulations,
they are parallel
Plaintiffs' claims, however, are more similar to those dismissed in
F. 3d at
manufacturing defect claim:
[3.] The hip prostheses contained a manufacturing defect
in that it was manufactured in such a manner that
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
manufacturing process and the specific defect in the process that
caused the personal injury.
Nor does the complaint tell us how the
or how it deviated from the
approved manufacturing process."
(citing Iqbal, 129 S. Ct. at
1949) . 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
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.
not address this in their Amended Complaint, and as discussed at
length, the Amended Complaint fails to allege any proper claims.
(continued ... )
Plaintiffs plead that Covidien failed to "manufacture, market
and label a product that was consistent with the original design"
guidelines. " 27
These statements provide no information as to how
Covidien deviated from the "original design."
They do not indicate
guidelines, or what regulations or guidelines it is inconsistent
Such vague and conclusory statements are not sufficient to
survive a Rule 12 (b) (6)
F. App'x at 229; Zaccarello,
motion to dismiss.
38 F. Supp.
3d at 1069
Plaintiff does not allege facts regarding a particular violation of
federal law and, therefore, fails to state a plausible claim.
determine whether the federal regulations are parallel to the MDA
and whether the claim can exist independent from the MDA. ") .
Plaintiffs' negligence claims will be dismissed.
( • • • 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).
Amended Complaint, Docket Entry No. 17, p. 3
16b and c.
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.
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
Riegel, 552 U.S. at 329-30.
Plaintiffs' strict products liability
claims necessarily impose requirements that are different from or
in addition to
allege here that Covidien failed to satisfy federal requirements
imposed by the PMA process.
In re Medtronic I,
F. Supp. 2d at 1159 (plaintiffs could not "escape that under their
theory of liability, Medtronic would have been required to provide
product label - a label that was specifically approved by the FDA
as part of
'different from, or in addition to' those approved by the FDA.");
Millman, 2015 WL 778779, at *6 n.5 ("Plaintiffs do not allege the
Id. at 3-4
design or manufacture of the Activa System devices deviated in any
way from the design, manufacture or warning approved by the FDA
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.
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.,
products liability claims will be dismissed.
Breach of Express Warranty
Plaintiff will show that the injuries and damages
were caused by the breach of expressed warranties made by
24. Defendant placed a product into the stream of
commerce that was a violation of its own expressed
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
Id. at 4
The express and implied warranty claims suffer from similar
WL 711075, at *2.
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.
See Miller v.
("Where . . . an essential element of a plaintiff's claim of breach
of express or implied warranty will be proof that a device granted
PMA is not safe or effective,
conflicts with the FDA's contrary finding and its requirement that
the device be made as approved.")
warranty claim does
failed to· comply with FDA requirements. 31
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,
another district court
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.").
See Amended Complaint, Docket Entry No. 17, p. 4.
held "Plaintiff does not allege any facts showing when and how he
warranties . .
Stated simply, Plaintiff has alleged nothing to
Plaintiff has therefore not stated a breach of warranty
claim upon which relief can be granted,
Steen v. Medtronic,
and that claim will be
Civ. Action No.
936-L, 2010 WL 2573455, at *3 (N.D. Tex. June 25, 2010); see also
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
physicians.") . 32
The same issues arise here; there are no facts
alleged that show when and how Plaintiffs received notice of the
See Twombly, 127 S. Ct. at 1965.
representations such as those made on the label, in warnings, and
for use were
and any additional or
different state law requirement would be preempted.
See Gomez, 442
F.3d at 932.
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.
Breach of Implied Warranty
Plaintiffs next allege breach of implied warranty:
Plaintiffs will show that the injuries were caused
by the breach of implied warranty of merchantability by
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.
Plaintiff believes that Defendant violated federal
requirements that were a producing cause of their
" [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."
669 F.3d at 517.
"Plaintiff believes that Defendant violated federal requirements
that were a producing cause of their injuries" cannot support a
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."
Amended Complaint, Docket Entry No. 17, pp. 4-5
For these reasons,
claim will also be dismissed.
Claims for Failure to Comply with the FDCA and Its
In addition to the state-law claims,
the Amended Complaint
contains a claim for "Failure to Comply with 21 C.F.R.
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
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]
causes of action based on violation of the FDA's regulations," and
created by FDA regulations.
See Hughes, 631 F.3d at 775; Buckman,
"Defendant failed to meet design control requirements of 21 C.F.R.
§ 820.30" merely alleges noncompliance with FDA regulations.
claim thus is preempted by§ 337(a) and will be dismissed.
Amended Complaint, Docket Entry No. 17, p. 5
To the extent it is an attempt to assert a claim for
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
in the process that caused the personal
injury, and did not specify how the process deviated from the FDA
approved manufacturing process."
597 F. App'x at 230
631 F.3d at 782); see Kitchen v. Biomet,
Civ. Action No. 13-18-HRW, 2014 WL 694226, at *5 (E.D. Ky. Feb. 21,
"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,
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] .").
category of federal regulations and failed to allege how the device
subject to dismissal.
Conclusions and Order
For the reasons discussed above,
upon which relief
Plaintiffs have not stated
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.
UNITED STATES DISTRICT JUDGE
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?