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)

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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RAYMOND J COLLETTE,
Plaintiff,

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United States District Court
Northern District of California

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Case No. 16-cv-01034-JD
ORDER RE MOTIONS TO DISMISS

v.

Re: Dkt. Nos. 48, 49
WYETH PHARMACEUTICALS, INC., et
al.,
Defendants.

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This case involves a generic heart medication, Amiodarone. Plaintiff Raymond Collette

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was prescribed the drug, took it, and later developed pulmonary fibrosis. Defendants are Wyeth

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Pharmaceuticals, Inc., which makes the brand-name version of the drug (Cordarone), and Sandoz,

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Inc. and its subsidiary, Eon Labs, Inc., which manufacture the generic version (Amiodarone)

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ingested by plaintiff. Defendants move to dismiss plaintiff’s first amended complaint. Dkt.

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Nos. 48, 49. It is dismissed with leave to amend most, but not all, of the alleged claims.

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DISCUSSION
The complaint asserts seven claims: (1) strict products liability -- failure to warn;

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(2) negligence -- failure to warn; (3) negligence -- marketing and sale; (4) negligence per se;

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(5) fraud and deceit; (6) violation of California Business & Professions Code § 17200 et seq.

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(Unfair Competition Law or “UCL”); and (7) violation of California Civil Code § 1750 et seq.

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(Consumer Legal Remedies Act or “CLRA”). Dkt. No. 33 ¶¶ 104-63. The first claim is alleged

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against Sandoz and Eon only; the remainder are alleged against all defendants.

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At this initial stage of the case, the Court focuses on the gatekeeping preemption issues

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raised by Sandoz and Eon, and discusses plaintiff’s claims more broadly by type of allegation as

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the parties themselves do. Dkt. Nos. 48, 52, 55.

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I.

INADEQUATE CONTENTS OF WARNINGS/LABELING

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All of plaintiff’s claims in this diversity action are framed under state common and

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statutory law. Dkt. No. 33 ¶¶ 104-63. Several Supreme Court decisions have reviewed state laws

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for drug labeling, and they mandate the conclusion here that the claims going to the warnings and

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labeling for Amiodarone, an FDA-approved generic drug, are preempted under federal law. See

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PLIVA, Inc. v. Mensing, 564 U.S. 604, 608-09 (2011) (state tort-law claims based on an alleged

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failure to provide adequate warning labels for a generic drug held to be preempted by federal drug

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regulations applicable to generic drug manufacturers); Mut. Pharm. Co., Inc. v. Bartlett, 133 S.Ct.

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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

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United States District Court
Northern District of California

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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

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situation where plaintiff is challenging the content of the Medication Guide” and “[p]laintiff does

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not allege defendants should ‘change’ or ‘alter’ the existing warning label”). But his complaint

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does indeed contain these types of allegations. See, e.g., Dkt. No. 33 ¶¶ 27 (plaintiff was “not

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provided up to date warning labels”); 76 (Cordarone/Amiodarone was “unaccompanied by proper

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warnings” and “warnings given did not and do not accurately reflect” severity or duration of side

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effects); 86 (warnings for Cordarone/Amiodarone were “vague, incomplete, and/or otherwise

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wholly inadequate”). These types of allegations are preempted under PLIVA, are dismissed with

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prejudice for that reason, and must be removed from any amended complaint.

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II.

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FAILURE TO PROVIDE MEDICATION GUIDES
Plaintiff also alleges a failure to warn in a different flavor -- he asserts that defendants

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failed to distribute with the drug the “Medication Guide” as required by the Food and Drug

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Administration. Dkt. No. 33 ¶ 18. This claim may or may not be preempted. On the one hand,

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“state-law fraud-on-the-FDA claims” are impliedly preempted by federal law, as “the federal

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statutory scheme amply empowers the FDA to punish and deter fraud against the Administration.”

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Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348 (2001). On the other, our circuit

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has recognized that claims that assert violations of state-law duties that parallel duties under
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federal law are not preempted. See McClellan v. I-Flow Corp., 776 F.3d 1035, 1040-41 (9th Cir.

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2015) (door remains open to “state-law claims ‘parallel’ to federal requirements” and plaintiff’s

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failure-to-warn claims not preempted where they “did not arise solely by virtue of the MDA”);

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Stengel v. Medtronic Inc., 704 F.3d 1224, 1233-34 (9th Cir. 2013) (state-law claim not preempted

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where it was “independent of the FDA’s pre-market approval process” and it rested on a “state-

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law duty that parallels a federal-law duty”).

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The Court cannot resolve the preemption question now because the claim in its current

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form is too cursory and vague to state a plausible cause of action. See, e.g., Dkt. No. 33 ¶ 133

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(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

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United States District Court
Northern District of California

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plaintiff’s guidance that what he has said about this claim gives the Court some skepticism that it

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can be successfully re-stated. It appears to seek a change in labeling, see id. ¶ 132 (alleging failure

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to supply Medication Guides violated Sherman Act because the labeling is false or misleading,

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fails to include a warning required by law, and fails to include adequate warnings or directions for

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use), or to be based purely on duties arising from federal regulations. See id. ¶ 133 (pointing to

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FDA regulations); Dkt. No. 52 at 6 (asserting Sandoz/Eon’s “actual and physical failure . . . to

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fulfill their federally mandated responsibility to ensure the Medication Guides are available for

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distribution”); id. at 9 (“[b]y failing to ensure plaintiff received a Medication Guide -- as

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defendants were required to do under federal law . . .”).

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Despite these doubts, Collette has leave to amend this claim. The amendment will need to

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be stated in a way that avoids preemption, and with sufficient factual detail to meet the plausibility

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requirements of Rule 8 as articulated in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and

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Ashcroft v. Iqbal, 556 U.S. 662 (2009). His current allegations, which do not even identify the

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pharmacy at which he filled his prescription, do not suffice.

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III.

OFF-LABEL MARKETING

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Another central assertion in plaintiff’s complaint is that defendants engaged in “off-label”

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marketing, promoting Cordarone/Amiodarone for the treatment of atrial fibrillation and as a “first

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line anti-arrhythmic therapy,” even though it had been approved by the FDA “only as a drug of
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last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation

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and ventricular tachycardia when these conditions would not respond to other available anti-

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arrhythmic drugs and therapies.” Dkt. No. 33 ¶ 18.

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This claim is Collette’s strongest in terms of avoiding federal preemption. There is no

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question that defendants had a state common law duty not to engage in fraud and deceit in the way

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that they marketed and sold their drugs. That duty arises wholly separately from federal law and

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does not necessarily conflict with defendants’ specific labeling and disclosure requirements under

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the FDA’s regulations. This consequently states the germ of a cognizable legal claim. See Dkt.

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No. 33 ¶¶ 135-48.

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As allegations sounding in fraud, however, plaintiff also needed to meet the heightened

United States District Court
Northern District of California

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particularity standard under Federal Rule of Civil Procedure 9(b) for this claim, and this he failed

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to do. Plaintiff’s off-label marketing allegations in their current form are too generalized. In the

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next iteration he will need to say much more about what, specifically, each defendant said and did,

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and how those statements and actions (or lack thereof) relate to plaintiff personally and to his

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physician, Dr. James Yhip. Plaintiff has leave to amend to try to add those more specific

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allegations. And while the Court does not find at this time that defendants’ statute of limitations

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arguments can be granted as a matter of law, Dkt. Nos. 49, 48, defendants may renew those

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arguments in response to a further amended complaint and the Court will take a closer look at

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plaintiff’s amended allegations for issues of timeliness.

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CONCLUSION

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The motions to dismiss are granted. Plaintiff may file an amended complaint that is

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consistent with this order by April 2, 2018.
IT IS SO ORDERED.
Dated: March 12, 2018

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JAMES DONATO
United States District Judge

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