United States District Court, N.D. California
ORDER RE MOTIONS TO DISMISS RE: DKT. NOS. 78,
DONATO UNITED STATES DISTRICT JUDGE
case involves a generic heart medication, Amiodarone, which
is used to treat irregular heartbeat. Plaintiff Raymond
Collette took Amiodarone and developed pulmonary fibrosis. He
alleges a causal connection between the drug and his lung
illness. Defendants are Wyeth Pharmaceuticals, Inc., which
makes the brand-name version of the drug (Cordarone), and
Sandoz, Inc. and its subsidiary Eon Labs, Inc., which
manufacture the generic version (Amiodarone) used by
Court granted defendants' motions to dismiss the first
amended complaint with leave to amend most, but not all, of
the alleged claims. Dkt. No. 76. Collette filed a second
amended complaint that largely ignored the pleading
deficiencies that he was advised to address. Dkt. No. 77.
Defendants ask to dismiss the second amended complaint. Dkt.
Nos. 78, 79. It is dismissed with a limited and likely final
opportunity to amend.
second amended complaint repeats the same seven claims from
the prior iteration: (1) strict products liability -- failure
to warn; (2) negligence -- failure to warn; (3) negligence
--sale and marketing; (4) negligence per se; (5) violation of
California Business & Professions Code § 17200 et
seq. (Unfair Competition Law or “UCL”); (6)
violation of California Civil Code § 1750 et seq.
(Consumer Legal Remedies Act or “CLRA”); and (7)
fraud and deceit. Dkt. No. 77. This time, the “strict
products liability -- failure to warn” claim is alleged
“against all defendants, ” Dkt. No. 77 at 35, but
plaintiff's brief in response to Wyeth's motion to
dismiss clarifies that this was an error. Dkt. No. 86 at 5
(“every claim but Count I (Strict Products -- Failure
to Warn) is asserted against Wyeth.”). There are
consequently no substantive changes in the second amended
complaint to plaintiff's legal claims or the defendants
against which each claim is alleged.
plaintiff's allegations are identical to the previous
version of the complaint, the Court also follows the same
approach it applied in its prior motion to dismiss order.
INADEQUATE CONTENTS OF WARNINGS / LABELING
Court held in the prior order that “the claims going to
the warnings and labeling for Amiodarone, an FDA-approved
generic drug, are preempted under federal law, ” and
“must be removed from any amended complaint.”
Dkt. No. 76 at 2 (citing PLIVA, Inc. v. Mensing, 564
U.S. 604, 608-09 (2011); Mut. Pharm. Co., Inc. v.
Bartlett, 133 S.Ct. 2466, 2470-76 (2013)).
clarifies in the pending complaint that he “does not
allege that the warning label or package insert used by
defendants is inadequate or should be changed” and that
he “makes no allegations regarding the adequacy of the
label.” Dkt. No. 77 ¶ 114. Nevertheless, the
second amended complaint still contains echoes of the warning
and labeling claim the Court dismissed with prejudice.
See, e.g., id. ¶ 91
(“At all material times, the Cordarone/Amiodarone . . .
was defective due to inadequate post-marketing warning and
instruction.”). These claims have already been
dismissed and are not properly before the Court.
FAILURE TO PROVIDE MEDICATION GUIDES
Collette's claim that defendants failed to distribute
with the drug the “Medication Guide” as required
by the Food and Drug Administration, the Court called for
more detail because the claim as pled was too cursory and
vague to state a plausible cause of action. Dkt. No. 76 at 3.
The Court found, for example, that plaintiff did not even
identify the pharmacy at which he filled his prescription.
Id. The Court also noted that to the extent the
claim was based only on duties arising from federal
regulations, it was likely preempted by Buckman Co. v.
Plaintiffs' Legal Committee, 531 U.S. 341, 348
(2001). Id. at 2-3.
has not supplied any of the additional factual detail called
for by the Court. Surprisingly, he still does not even say at
which pharmacy he filled the prescription, despite the fact
that the particular pharmacy's failure to receive any
Medication Guide would appear to be a critical piece of his
claim. Instead, he continues to allege his claim only in a
vague and conclusory outline fashion. See,
e.g., Dkt. No. 77 ¶ 31 (“[T]he Medication
Guides were not provided by the defendants to the distributor
and pharmacists for distribution to plaintiff with his
prescription.”). This is just one example of the ways
in which plaintiff's claim continues to fail the
plausibility requirements of Rule 8 as articulated in
Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007),
and Ashcroft v. Iqbal, 556 U.S. 662 (2009).
provides an alternative and independent basis for dismissal.
From what the Court can make out about the claim, it does
indeed appear to be based on federal regulatory duties only.
See, e.g., Dkt. No. 77 ¶ 39 (alleging
plaintiff's “pharmacist was not provided a
Medication Guide . . . as required by FDA
regulations”). Collette has not, as directed by the
Court, identified any parallel state duty that would have
required defendants' distribution of the Medication
Guide. Hanging his hat on FDA regulations only is
impermissible. See McDaniel v. Upsher-Smith Labs.,
893 F.3d 941, 944-48 (6th Cir. 2018) (where another
Amiodarone plaintiff sought to “enforce the federal
regulation requiring drug manufacturers to ensure the
availability of Medication Guides for distribution to
patients, ” finding the claim impliedly preempted and
noting that “the majority of district courts to
consider this very issue have found identical claims
Court consequently dismisses plaintiff's Medication Guide
claims without a further opportunity to amend. See Chodos
v. West Publishing Co., 292 F.3d 992, 1003 (9th Cir.
2002) (district court's discretion to deny amendment