Raymond J Collette v. Wyeth Pharmaceuticals, Inc. et al
Filing
76
ORDER RE 48 , 49 MOTIONS TO DISMISS. Amended Pleadings due by 4/2/2018. Signed by Judge James Donato on 3/12/2018. (jdlc2S, COURT STAFF) (Filed on 3/12/2018)
1
2
3
4
UNITED STATES DISTRICT COURT
5
NORTHERN DISTRICT OF CALIFORNIA
6
7
RAYMOND J COLLETTE,
Plaintiff,
8
9
10
United States District Court
Northern District of California
11
Case No. 16-cv-01034-JD
ORDER RE MOTIONS TO DISMISS
v.
Re: Dkt. Nos. 48, 49
WYETH PHARMACEUTICALS, INC., et
al.,
Defendants.
12
13
This case involves a generic heart medication, Amiodarone. Plaintiff Raymond Collette
14
was prescribed the drug, took it, and later developed pulmonary fibrosis. Defendants are Wyeth
15
Pharmaceuticals, Inc., which makes the brand-name version of the drug (Cordarone), and Sandoz,
16
Inc. and its subsidiary, Eon Labs, Inc., which manufacture the generic version (Amiodarone)
17
ingested by plaintiff. Defendants move to dismiss plaintiff’s first amended complaint. Dkt.
18
Nos. 48, 49. It is dismissed with leave to amend most, but not all, of the alleged claims.
19
20
DISCUSSION
The complaint asserts seven claims: (1) strict products liability -- failure to warn;
21
(2) negligence -- failure to warn; (3) negligence -- marketing and sale; (4) negligence per se;
22
(5) fraud and deceit; (6) violation of California Business & Professions Code § 17200 et seq.
23
(Unfair Competition Law or “UCL”); and (7) violation of California Civil Code § 1750 et seq.
24
(Consumer Legal Remedies Act or “CLRA”). Dkt. No. 33 ¶¶ 104-63. The first claim is alleged
25
against Sandoz and Eon only; the remainder are alleged against all defendants.
26
At this initial stage of the case, the Court focuses on the gatekeeping preemption issues
27
raised by Sandoz and Eon, and discusses plaintiff’s claims more broadly by type of allegation as
28
the parties themselves do. Dkt. Nos. 48, 52, 55.
1
I.
INADEQUATE CONTENTS OF WARNINGS/LABELING
2
All of plaintiff’s claims in this diversity action are framed under state common and
3
statutory law. Dkt. No. 33 ¶¶ 104-63. Several Supreme Court decisions have reviewed state laws
4
for drug labeling, and they mandate the conclusion here that the claims going to the warnings and
5
labeling for Amiodarone, an FDA-approved generic drug, are preempted under federal law. See
6
PLIVA, Inc. v. Mensing, 564 U.S. 604, 608-09 (2011) (state tort-law claims based on an alleged
7
failure to provide adequate warning labels for a generic drug held to be preempted by federal drug
8
regulations applicable to generic drug manufacturers); Mut. Pharm. Co., Inc. v. Bartlett, 133 S.Ct.
9
2466, 2470-76 (2013) (“As PLIVA made clear, federal law prevents generic drug manufacturers
from changing their labels”; consequently holding that state-law design-defect claims that turn on
11
United States District Court
Northern District of California
10
the adequacy of a drug’s warnings are also preempted under federal law under PLIVA).
Plaintiff appears to concede as much. See Dkt. No. 52 at 5 (stating that this is not “a
12
13
situation where plaintiff is challenging the content of the Medication Guide” and “[p]laintiff does
14
not allege defendants should ‘change’ or ‘alter’ the existing warning label”). But his complaint
15
does indeed contain these types of allegations. See, e.g., Dkt. No. 33 ¶¶ 27 (plaintiff was “not
16
provided up to date warning labels”); 76 (Cordarone/Amiodarone was “unaccompanied by proper
17
warnings” and “warnings given did not and do not accurately reflect” severity or duration of side
18
effects); 86 (warnings for Cordarone/Amiodarone were “vague, incomplete, and/or otherwise
19
wholly inadequate”). These types of allegations are preempted under PLIVA, are dismissed with
20
prejudice for that reason, and must be removed from any amended complaint.
21
II.
22
FAILURE TO PROVIDE MEDICATION GUIDES
Plaintiff also alleges a failure to warn in a different flavor -- he asserts that defendants
23
failed to distribute with the drug the “Medication Guide” as required by the Food and Drug
24
Administration. Dkt. No. 33 ¶ 18. This claim may or may not be preempted. On the one hand,
25
“state-law fraud-on-the-FDA claims” are impliedly preempted by federal law, as “the federal
26
statutory scheme amply empowers the FDA to punish and deter fraud against the Administration.”
27
Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348 (2001). On the other, our circuit
28
has recognized that claims that assert violations of state-law duties that parallel duties under
2
1
federal law are not preempted. See McClellan v. I-Flow Corp., 776 F.3d 1035, 1040-41 (9th Cir.
2
2015) (door remains open to “state-law claims ‘parallel’ to federal requirements” and plaintiff’s
3
failure-to-warn claims not preempted where they “did not arise solely by virtue of the MDA”);
4
Stengel v. Medtronic Inc., 704 F.3d 1224, 1233-34 (9th Cir. 2013) (state-law claim not preempted
5
where it was “independent of the FDA’s pre-market approval process” and it rested on a “state-
6
law duty that parallels a federal-law duty”).
7
The Court cannot resolve the preemption question now because the claim in its current
8
form is too cursory and vague to state a plausible cause of action. See, e.g., Dkt. No. 33 ¶ 133
9
(along with California’s Sherman Food, Drug and Cosmetic Act, pointing to “various FDA
regulations” defendants violated by failing to supply Medication Guides). The Court notes for
11
United States District Court
Northern District of California
10
plaintiff’s guidance that what he has said about this claim gives the Court some skepticism that it
12
can be successfully re-stated. It appears to seek a change in labeling, see id. ¶ 132 (alleging failure
13
to supply Medication Guides violated Sherman Act because the labeling is false or misleading,
14
fails to include a warning required by law, and fails to include adequate warnings or directions for
15
use), or to be based purely on duties arising from federal regulations. See id. ¶ 133 (pointing to
16
FDA regulations); Dkt. No. 52 at 6 (asserting Sandoz/Eon’s “actual and physical failure . . . to
17
fulfill their federally mandated responsibility to ensure the Medication Guides are available for
18
distribution”); id. at 9 (“[b]y failing to ensure plaintiff received a Medication Guide -- as
19
defendants were required to do under federal law . . .”).
20
Despite these doubts, Collette has leave to amend this claim. The amendment will need to
21
be stated in a way that avoids preemption, and with sufficient factual detail to meet the plausibility
22
requirements of Rule 8 as articulated in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and
23
Ashcroft v. Iqbal, 556 U.S. 662 (2009). His current allegations, which do not even identify the
24
pharmacy at which he filled his prescription, do not suffice.
25
III.
OFF-LABEL MARKETING
26
Another central assertion in plaintiff’s complaint is that defendants engaged in “off-label”
27
marketing, promoting Cordarone/Amiodarone for the treatment of atrial fibrillation and as a “first
28
line anti-arrhythmic therapy,” even though it had been approved by the FDA “only as a drug of
3
1
last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation
2
and ventricular tachycardia when these conditions would not respond to other available anti-
3
arrhythmic drugs and therapies.” Dkt. No. 33 ¶ 18.
4
This claim is Collette’s strongest in terms of avoiding federal preemption. There is no
5
question that defendants had a state common law duty not to engage in fraud and deceit in the way
6
that they marketed and sold their drugs. That duty arises wholly separately from federal law and
7
does not necessarily conflict with defendants’ specific labeling and disclosure requirements under
8
the FDA’s regulations. This consequently states the germ of a cognizable legal claim. See Dkt.
9
No. 33 ¶¶ 135-48.
10
As allegations sounding in fraud, however, plaintiff also needed to meet the heightened
United States District Court
Northern District of California
11
particularity standard under Federal Rule of Civil Procedure 9(b) for this claim, and this he failed
12
to do. Plaintiff’s off-label marketing allegations in their current form are too generalized. In the
13
next iteration he will need to say much more about what, specifically, each defendant said and did,
14
and how those statements and actions (or lack thereof) relate to plaintiff personally and to his
15
physician, Dr. James Yhip. Plaintiff has leave to amend to try to add those more specific
16
allegations. And while the Court does not find at this time that defendants’ statute of limitations
17
arguments can be granted as a matter of law, Dkt. Nos. 49, 48, defendants may renew those
18
arguments in response to a further amended complaint and the Court will take a closer look at
19
plaintiff’s amended allegations for issues of timeliness.
20
CONCLUSION
21
The motions to dismiss are granted. Plaintiff may file an amended complaint that is
22
23
24
consistent with this order by April 2, 2018.
IT IS SO ORDERED.
Dated: March 12, 2018
25
26
JAMES DONATO
United States District Judge
27
28
4
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?