Judge: Michael Shultz, Case: 22STCV12268, Date: 2022-09-13 Tentative Ruling
Case Number: 22STCV12268 Hearing Date: September 13, 2022 Dept: A
22STCV12268
[TENTATIVE] ORDER
SUSTAINING
I.
BACKGROUND
The complaint, filed on April 12,
2022, alleges claims for general negligence and products liability arising from
Plaintiff’s use of a product made by Defendant, a LifeVest® 4000 (“LifeVest”)
which was prescribed by Plaintiff’s doctor. Plaintiff alleges the LifeVest
released a shock or jolt due to a defective condition.
II.
ARGUMENTS
A.
Demurrer filed September 6, 2022
Defendant argues that Plaintiff’s
claims are pre-empted by federal law unless Plaintiff can allege a parallel
state claim. Plaintiff has not alleged that the medical device at issue, which
is preapproved by the Federal Drug Administration (“FDA”), violated Federal
Food, Drug, and Cosmetic Act (“FDCA”) that would give rise to recovery under
state law even in the absence of the FDCA. The allegation alone that the device
was defective is insufficient to allege the claims.
B.
No opposition filed.
C.
Reply filed on June 6, 2022
Defendant argues that contrary to
Plaintiff’s opposition [which has not been filed with the court], Defendant is
not asking for complete immunity from state claims. Plaintiff’s recitation to
other case law around the country does not address the Plaintiff’s failure to
allege a violation of federal law that also gives rise to recovery under
California law. Without an allegation that Defendant violated a parallel state
law, Plaintiff’s claims are pre-empted.
III.
LEGAL STANDARDS
A demurrer tests the
sufficiency of a complaint as a matter of law and raises only questions of law.
Schmidt v. Foundation Health (1995) 35 Cal.App.4th 1702, 1706. In testing the
sufficiency of the complaint, the court must assume the truth of (1) the
properly pleaded factual allegations; (2) facts that can be reasonably inferred
from those expressly pleaded; and (3) judicially noticed matters. Blank v. Kirwan (1985) 39 Cal.3d 311, 318.
The court may not consider
contentions, deductions, or conclusions of fact or law. Moore v. Conliffe (1994) 7 Cal.4th 634, 638. Because a demurrer tests the legal
sufficiency of a complaint, the plaintiff must show that the complaint alleges
facts sufficient to establish every element of each cause of action. Rakestraw v. California Physicians Service (2000) 81 Cal.App.4th 39, 43. Where the complaint
fails to state facts sufficient to constitute a cause of action, courts should
sustain the demurrer. Code Civ. Proc., § 430.10(e); Zelig v. County of Los Angeles (2002) 27 Cal.4th 1112, 1126.
Sufficient facts are the
essential facts of the case "with reasonable precision and with
particularity sufficiently specific to acquaint the defendant with the nature,
source, and extent of his cause of action.” Gressley v. Williams (1961) 193 Cal.App.2d 636, 643-644. Whether the
Plaintiff will be able to prove the pleaded facts is irrelevant. Stevens v. Superior Court (1986) 180 Cal.App.3d 605, 609–610.
A demurrer may also be
sustained if a complaint is “uncertain.” Uncertainty exists where a complaint’s
factual allegations are so confusing, they do not sufficiently apprise a
defendant of the issues it is being asked to meet. Williams v. Beechnut Nutrition Corp. (1986) 185 Cal.App.3d 135, 139, fn. 2; Code Civ.
Proc., § 430.10(f).
A pleading is required to
assert general allegations of ultimate fact. Evidentiary facts are not required. Quelimane Co. v. Stewart Title Guaranty Co. (1998) 19 Cal. 4th 26, 47; Lim v. The.TV Corp. Internat. (2002) 99 Cal. App. 4th 684, 690. However, unlike
federal courts, California state courts are not a notice pleading jurisdiction,
and notice alone is not a sufficient basis for any pleading. California
is a fact pleading jurisdiction. Merely putting an opposing party on notice is
not sufficient. Bach
v. County of Butte (1983) 147 Cal.App.3d 554, 561; see Diodes,
Inc. v. Franzen (1968) 260 Cal.App.2d 244, 250.
IV.
DISCUSSION
The court takes judicial notice of
the Premarket Approval Plan for the LifeVest issued by the U.S. Food and Drug
Administration. RJN, Ex. A. The FDA approved the vest on December 18, 2001. RJN
Ex. B. Evid. Code, § 452(c) and (h). https://www.accessdata.fda.gov/ cdrh_docs/pdf/P010030A.pdf.
Pursuant to the Medical Device
Amendments of 1976 (“MDA”), "[e]xcept as provided in subsection (b), 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 matter included in a requirement
applicable to the device under this chapter." 21 U.S.C.A. § 360k (West). The
complaint here alleges state law claims for products liability and negligence
arising from the LifeVest’s unsafe condition. Complaint, page 5.
To determine whether preemption
applies , the court first considers whether the Federal Government has
established requirements applicable to the LifeVest, and whether the state-law claims
are “different from, or in addition to,” the federal requirements relating to
safety and effectiveness. Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 322. The FDA granted premarket approval of the use of the LifeVest
subject to conditions. Defendant’s RJN, Ex. B. Among other things, the FDA
required Defendant to submit annual, post-approval reports as a condition of
continued approval. RJN, Ex. B, .pdf page 27, 29. Therefore, Defendant has
satisfied the first prong for express preemption.
The second prong requires a
determination of whether the misconduct violates a parallel state law claim as
the "failure to plead parallel federal and state law violations with
regard to manufacturing defects is fatal” to Plaintiff’s state law claims. De
La Paz v. Bayer Healthcare LLC (N.D. Cal. 2016) 159 F.Supp.3d 1085, 1097
[Plaintiff’s failure to allege a breach of any parallel state law duties that
could escape preemption warranted dismissal]. Here, the complaint does not
allege any state claim that is parallel to any violation of federal
requirements necessary to survive preemption.
V.
CONCLUSION
Based on the foregoing, demurrer to the complaint is
SUSTAINED. Leave to amend is ordinarily given if there is a reasonable
possibility that the defect can be cured. However, it is the Plaintiff’s burden
to show in what manner he can amend his complaint and how that amendment will
change the legal effect of his pleading"].” Association
of Community Organizations for Reform Now v. Department of Industrial
Relations (1995) 41 Cal.App.4th 298, 302.
In the absence of an opposition filed by Plaintiff, the
court cannot determine whether or in what manner Plaintiff can cure the
defects. However, the court will hear from the Plaintiff to determine whether
leave to amend will be granted.