Judge: Michael Shultz, Case: 22STCV12268, Date: 2022-10-03 Tentative Ruling
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Case Number: 22STCV12268 Hearing Date: October 3, 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 June 13,
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.
Opposition filed September 28,
2022
C. Reply filed on September 6, 2022
Defendant argues that contrary to
Plaintiff’s opposition, 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.
Defense counsel met and conferred with Plaintiff’s
counsel about the purported defects in the complaint without resolution.
Demurrer, 2:1-4, Code Civ. Proc., § 430.41.
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, particularly for a manufacturing and design defect, breach of
implied warranty, and for failure to warn. Complaint, attachment L-1, .pdf page
7.
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, and therefore expressly preempted. 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 facts identifying any parallel state law necessary to survive
preemption.
The complaint alleges that the
vest or its component parts did not provide adequate warnings of certain
dangers associated with the use of the vest. Complaint, attachment, L-1 ¶ (ii).
Under De La Paz “a claim based on the failure to warn the FDA of adverse
events is not preempted to the extent state tort law recognizes a parallel duty
(although a claim based on a failure to warn physicians or patients of adverse
events would be preempted).” Stengel, 704 F.3d at 1234. De La Paz at 1096-1097.
The complaint in unclear. It does not state whether Plaintiff is suing
for failure to warn the FDA or failure to warn consumers or physicians.
Accordingly, the claim based on a failure to warn is uncertain. Finally, the
claims for breach of express and implied warranty are also fatally defective
unless Plaintiff alleges parallel federal and state law violations to avoid
preemption. De
La Paz at 1097.
Plaintiff’s assertion that the complaint
is vague because Plaintiff has not conducted any discovery is unpersuasive. Plaintiff
has not stated a cognizable claim in the first instance. Plaintiff must
research the law to determine whether California has parallel claims for manufacturing defect, failure to warn, and breach of
express/implied warranty.
V. CONCLUSION
Plaintiff concedes that the
complaint does not allege facts to avoid preemption. The foregoing authority
establishes a narrow basis for avoiding federal preemption. Based on the
foregoing, demurrer to the complaint is SUSTAINED with leave to amend. Colvig
v. RKO General, Inc. (1965) 232 Cal.App.2d 56, 69–70
[noting the “well-established rule that, even where the defect is one of
substance, a demurrer should not be sustained without leave to amend if there
is a possibility that subsequent amendments will supply omitted allegations and
the plaintiff has not had a fair opportunity to so amend."]. Plaintiff is
ordered to file a First Amended Complaint within 30 days.
The parties are reminded that after an amended complaint
is filed, "the responding party shall meet and confer again with the party
who filed the amended pleading before filing a demurrer to the amended
pleading." Code
Civ. Proc., § 430.41 subd (a). Defendant shall file a declaration
describing the efforts to meet and confer. Id. subd (a)(3).