Court Opinion

ID: 9912206
Source: CourtListenerOpinion
Date Created: 2023-12-21 20:02:21.577066+00
Date Added: 2024-06-11T12:52:56.624509
License: Public Domain

Filed 12/21/23 Regwan v. Abbot Laboratories CA2/2
   NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS

California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions
not certified for publication or ordered published, except as specified by rule 8.1115(b). This opinion
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IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
                         SECOND APPELLATE DISTRICT
                                        DIVISION TWO

 JUDY REGWAN,                                                     B319606
           Plaintiff and Appellant,
                                                                  (Los Angeles County
           v.                                                     Super. Ct. No.
                                                                  BC711263)
 ABBOTT LABORATORIES,
 INC.,
           Defendant and Respondent.

     APPEAL from a judgment of the Superior Court of Los
Angeles County. Daniel M. Crowley, Judge. Affirmed.
     Joseph Farzam Law Firm, Joseph F. Farzam; Law Office of
Ted W. Pelletier and Ted W. Pelletier for Plaintiff and Appellant.
     Winston & Strawn, Andrew E. Tauber, Alexander H. Cote;
Mayer Brown, Daniel L. Ring and Joseph J. Vescera for
Defendant and Respondent.

                __________________________________________
       Judy Regwan (Regwan) appeals from a judgment of
dismissal after the trial court sustained, without leave to amend,
the demurrer of Abbott Laboratories, Inc. (Abbott) to Regwan’s
first amended complaint. Regwan’s lawsuit stemmed from
serious injuries she suffered during the implantation of a medical
device manufactured by Abbott. Reviewing de novo, we conclude
Regwan’s negligence claim against Abbott is expressly preempted
by federal law. We affirm the judgment of dismissal.
         FACTS AND PROCEDURAL BACKGROUND
I.     Facts
       In 2017, Regwan underwent cardiac surgery to implant a
MitraClip to repair a damaged heart valve. The device was made
and sold by Abbott. The implantation procedure requires the
continuous flow of intravenous saline to the heart. During
Regwan’s procedure, the saline bag ran dry, causing her to suffer
an air embolism and serious brain injury.
II.    Procedural Background
       A.    Original Complaint
       In 2018, Regwan sued the hospital, the surgeon, other
physicians, and Does 1-100 for medical malpractice. Two years
later, Regwan added Abbott as Doe 1 by a form amendment,
thereby asserting a medical malpractice claim against Abbott
based on the surgeon’s alleged negligence.
       B.    First Amended Complaint
       In February 2020, Regwan filed a first amended complaint
for medical malpractice, this time against the hospital and the
surgeon alone. Regwan added negligence and products liability
causes of action against Abbott after learning that an Abbott
representative attended the surgery and was “responsible for the
flow of saline.”

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       C.     Demurrer
       Abbott demurred to the first amended complaint, arguing it
was time-barred, failed to allege facts sufficient to state any
cause of action, and was preempted by federal law.
       Regwan failed to timely and substantively oppose the
demurrer. Her position was the demurrer was mooted by the
filing of a second amended complaint.
       At the hearing, the trial court rejected Regwan’s argument
because no second amended complaint had been filed and, in any
event, its filing would have been untimely at this late date. The
court then sustained the demurrer without leave to amend,
finding Regwan’s negligence and products liability causes of
action against Abbott failed as a matter of state law. The court
also ruled the products liability cause of action was preempted by
federal law. The court did not reach Abbott’s argument that
Regwan’s negligence cause of action was federally preempted.
The court dismissed the first amended complaint against Abbott
and entered a judgment of dismissal. Regwan timely filed this
appeal.
                           DISCUSSION
       Regwan’s sole contention on appeal is the judgment of
dismissal should be reversed as to her negligence cause of action
against Abbott.1 We disagree, concluding the claim is federally
preempted.2

      1 Regwan is expressly not challenging the trial court’s
ruling on her products liability cause of action.
      2 We thus do not reach Regwan’s additional contention the
trial court erred in finding her first amended complaint failed to
allege sufficient facts to state a cause of action.

                                  3
       Preliminarily, we note medical device representatives, like
Abbott’s, have been attending device-dependent procedures for
some years. This is particularly true of orthopedic, trauma, and
cardiovascular surgeries. These days, as baby boomers age and
advances in medical technologies rapidly increase, medical device
representatives may have greater knowledge about their
products than the doctors who implant them. Consequently,
medical device representatives are more frequently in the
operating room at the surgeons’ behest to provide advice and
technical support about their product and/or its implantation.
This practice can expose the medical device manufacturer and its
representative to liability. (See Jacxsens et al., Medical Device
Law: Beyond the Basics: Expanding Theories of Liability and
Defenses for Claims Involving Medical Device Sales
Representatives (Jan. 2013) 39 William Mitchell L.Rev. 1087,
1088–1090, and cases cited therein.)
I.     Demurrer and Standard of Review
       In assessing whether a demurrer was properly sustained,
we independently ask “ ‘whether the [operative] complaint states
facts sufficient to constitute a cause of action.’ ” (Loeffler v.
Target Corp. (2014) 58 Cal.4th 1081, 1100, quoting City of
Dinuba v. County of Tulare (2007) 41 Cal.4th 859, 865; see also
Lee v. Hanley (2015) 61 Cal.4th 1225, 1230 [de novo review].) In
answering this question, we “ ‘assume the truth of the
complaint’s properly pleaded or implied factual allegations.’ ”
(Loeffler, at p. 1100, quoting Schifando v. City of Los Angeles
(2003) 31 Cal.4th 1074, 1081.)
II.    Forfeiture
       At the outset, Abbott maintains Regwan has forfeited her
contention that Abbott is liable under the negligent-undertaking

                                4
theory because she failed to oppose the demurrer on this ground.
We reject Abbott’s argument. As the legal sufficiency of a
proposed amended complaint is a question of law reviewable de
novo (Lee v. Hanley, supra, 61 Cal.4th at p. 1230), and the
complaint is invulnerable to a general demurrer if, on any theory,
it states a cause of action (Quelimane Co. v. Stewart Title
Guaranty Co. (1998) 19 Cal.4th 26, 38), forfeiture is inapplicable
here. (See People v. Lexington National Ins. Corp. (2010) 181
Cal.App.4th 1485, 1491–1492.)
III. Federal Preemption
       Abbott argues that, even if Regwan’s state law claim is not
forfeited, it is nonetheless preempted by the Medical Device
Amendments of 1976 (21 U.S.C. § 360c et seq.) (MDA).
       A.     The MDA and Class III Medical Devices
       In 1976, the MDA amended the Food, Drug, and Cosmetic
Act to require “detailed federal oversight” of medical devices.
(Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316 [128 S.Ct. 999,
169 L.Ed.2d 892] (Riegel).) The most intense level of scrutiny is
reserved for Class III medical devices because they pose the
greatest risk of injury or illness. (Id. at p. 317.) A Class III
medical device must undergo a “rigorous” premarket approval
process (ibid.) to “provide reasonable assurance of its safety and
effectiveness.” (21 U.S.C. § 360c(a)(1)(C)(i)(II).) The MitraClip is
a Class III medical device.
       The premarket approval process for a Class III medical
device requires the device manufacturer to submit an application
that presents all available scientific knowledge concerning
investigations into the device’s safety and effectiveness; detailed
information regarding its design, components, ingredients,
properties, and principles of operation; a full description of

                                 5
manufacturing methods and facilities; any applicable
performance standards; samples of the device; specimens of
proposed labeling; and other information deemed relevant by the
Food and Drug Administration (FDA). (21 U.S.C. § 360e(c)(1).)
Once the application has been approved, the manufacturer is
prohibited from manufacturing, packaging, storing, labeling,
distributing, or advertising the device in a manner inconsistent
with any conditions to approval specified in the premarket
approval order for the device. (21 C.F.R. § 814.80 (2023).)
Moreover, before making any changes that may affect the safety
or effectiveness of an approved device, the manufacturer must
generally submit a supplemental request for FDA review and
approval. (21 C.F.R. 814.39 (2023).)
       B.    The MDA’s Express Preemption Provision and
             Riegel
       Federal preemption is rooted in the Supremacy Clause of
the Constitution, which states the law of the United States “shall
be the Supreme Law of the Land.” (U.S. Const., art. VI, cl. 2.)
State laws are expressly preempted under the Supremacy Clause
when Congress defines “the extent to which its enactments pre-
empt state law.” (English v. General Electric Co. (1990) 496 U.S.
72, 78 [110 S.Ct. 2270, 110 L.Ed.2d 65].) Abbott posits express
preemption applies here.
       The MDA contains an express preemption provision in
which Congress has decreed that “no State or political
subdivision of a State may establish or continue in effect with
respect to a device intended for human use any requirement—[¶]
(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

                                 6
matter included in a requirement applicable to the device under
this chapter.” (21 U.S.C. § 360k(a).) The term “any [state]
requirement” is intended to encompass common law duties as
well as duties created by statutory law. (Riegel, supra, 552 U.S.
at p. 324; accord, Quishenberry v. UnitedHealthcare, Inc. (2023)
14 Cal.5th 1057, 1067–1068; Roberts v. United Healthcare
Services, Inc. (2016) 2 Cal.App.5th 132, 145.)
       With this preemptive provision, Congress established a
centralized regulatory scheme. In other words, because different
or additional state-law requirements are expressly preempted,
medical device manufacturers face only one standard of care,
which is the federal standard of care. Manufacturers are thus
not subjected to a multitude of differing regulations that could
discourage innovation or drive potentially beneficial devices from
the market. (See Riegel, supra, 552 U.S. at p. 326 [inferring the
preemption provision indicates “the solicitude for those injured by
FDA-approved devices . . . was overcome in Congress’s estimation
by solicitude for those who would suffer without new medical
devices if juries were allowed to apply the tort law of 50 States”].)
       Riegel, supra, 552 U.S. 312 is the most recent and
fundamental decision concerning the issue of express preemption
in MDA-related litigation. The Riegel court devised a two-step
analysis to determine whether state law claims are expressly
preempted in medical device cases: First, has the FDA
“established requirements applicable to” the particular device?
(Id. at p. 321.) Second, would the state law claims impose
“requirements with respect to the device that are ‘different from,
or in addition to,’ ” the federal requirements, and that relate to
either (i) “ ‘safety or effectiveness,’ ” or (ii) “ ‘any other matter
included in a requirement applicable to the device’ ” under the

                                 7
MDA? (Id. at pp. 321–323.) If the answer to both steps of the
analysis is “yes,” then the state law claims are expressly
preempted. (Riegel, supra, 552 U.S. at pp. 321–322, 329.) This
analysis has been recognized by California courts. (See Glennnen
v. Allergan, Inc. (2016) 247 Cal.App.4th 1, 10; Coleman v.
Medtronic, Inc. (2014) 223 Cal.App.4th 413, 423; McGuan v.
Endovascular Technologies, Inc. (2010) 182 Cal.App.4th 974,
982.)
       C.    Applying the Riegel Express Preemption
             Analysis
       The first step of the Riegel express preemption analysis is
automatically satisfied, where, as here, the state law claim
involves a Class III device that has received premarket approval
for commercial distribution. (Riegel, supra, 552 U.S. at p. 322.)
       The second step of the analysis requires a comparison
between the duties the state law claims seek to enforce and the
relevant federal requirements. (See Quishenberry v.
UnitedHealthcare, Inc., supra, 14 Cal.5th at p. 1072.) Abbott
urges that Regwan’s negligence claim is based on common law
duties that are “ ‘different from, or in addition to,’ ” the federal
requirements and that “relate to safety and effectiveness” or any
other matter included in a requirement applicable to the device
under the MDA. (See Riegel, supra, 552 U.S. at p. 322.) We
agree.
       Regwan’s first amended complaint asserts Abbott breached
its duty of care under the negligent undertaking theory.3 To

      3 The negligent undertaking theory “requires evidence that:
(1) the actor undertook, gratuitously or for consideration, to
render services to another; (2) the services rendered were of a
kind the actor should have recognized as necessary for the

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support her claim, Regwan alleges the Abbott representative
undertook to render certain services during the implantation
procedure. Those services were “to monitor the surgery,” to
“advise the medical staff as to how much saline should be used,”
and to “ensure that the correct amount of saline was being used.”
Regwan further alleges the Abbott representative breached his or
her duty of care by not alerting the medical staff that more saline
was needed; and, as a result, the saline bag ran dry, causing
Regwan to suffer physical harm. For Regwan to prevail, a fact
finder would have to determine, in part, that (1) a continuous
intravenous flow of saline was necessary for a successful
MitraClip implantation procedure; and (2) the Abbott
representative assumed the duty to make sure that occurred by
telling the medical staff to supply more saline when required.
       There is a relevant federal requirement for comparison. In
applying for the FDA’s premarket approval of the MitraClip,
Abbott had to furnish “specimens of the labeling proposed to be
used for such device” when it became commercially available. (21
U.S.C. § 360e(c)(1)(F).) As approved, the MitraClip came with
numerous labels, including written warnings to medical
professionals. One warning concerns the two 1-liter bags of

protection of third persons; (3) the actor failed to exercise
reasonable care in the performance of the undertaking; (4) the
actor’s failure to exercise reasonable care resulted in physical
harm to the third persons; and (5) either (a) the actor’s
carelessness increased the risk of such harm, or (b) the actor
undertook to perform a duty that the other owed to the third
persons, or (c) the harm was suffered because either the other or
the third persons relied on the actor’s undertaking.” (Paz v. State
of California (2000) 22 Cal.4th 550, 559; Rest.2d Torts, § 324A.)

                                 9
Heparinized saline that Abbott instructed were to be used for the
implantation procedure. That warning reads: “WARNING:
Heparinized saline flush should be continuous throughout the
procedure. Ensure flow is visible through the drip chamber and
that the tubing is free from kinks and/or obstruction and
appropriate pressure of 300 mm Hg is maintained. Discontinuing
flush may result in air embolism and/or thrombus formation.”
      In terms of the second step of the Riegel analysis, the FDA-
approved warning label not only relates to the safety of the
MitraClip but also to “any other matter included in a
requirement applicable” to that device—namely, the duty to
provide a continuous saline flow for a successful implantation
procedure. It is unlike the state law claim, which imposes duties
that are “different from, or in addition to” this federal
requirement. Liability under Regwan’s negligent undertaking
theory hinges on whether there were (additional) oral warnings
during surgery, whereas under the FDA requirement the written
warning label accompanying the device is sufficient. As a result,
Abbott could be found negligent under Regwan’s state law claim
despite having complied with the FDA labeling requirement.
      Regwan’s argument (unsupported by citation to authority)
that her claim is premised on the negligent conduct of an Abbott
employee rather than on the safety or effectiveness of the
MitraClip would have more traction had there been no applicable
federal requirement. (See, e.g., Medtronic, Inc. v. Malander
(Ind.Ct.App. 2013) 996 N.E.2d 412, 418–419 [negligent
interaction during surgery between medical device representative
and physician unrelated to FDA’s device labeling, design, or
manufacturing requirements survived preemption].) The MDA
and Riegel could not be clearer that federal law expressly

                               10
preempts any claim that would allow a fact finder to employ a
duty of care different from or in addition to the FDA’s
requirements. Regwan’s negligence cause of action is preempted.
                          DISPOSITION
       The judgment of dismissal against Abbott Laboratories,
Inc. is affirmed. Parties to bear their own costs on appeal.
       NOT TO BE PUBLISHED.

                                        LUI, P. J.
We concur:

     ASHMANN-GERST, J.

     CHAVEZ, J.

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