NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS JUL 23 2021
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
PRISCILLA JEANNE COLLETTE, as the No. 20-16406
personal representative of the estate of
Raymond J. Collette, D.C. No. 3:16-cv-01034-JD
Plaintiff-Appellant,
MEMORANDUM*
v.
WYETH PHARMACEUTICALS, INC.; et
al.,
Defendants-Appellees.
Appeal from the United States District Court
for the Northern District of California
James Donato, District Judge, Presiding
Argued and Submitted June 9, 2021
Seattle, Washington
Before: W. FLETCHER, WATFORD, and COLLINS, Circuit Judges.
Concurrence by Judge COLLINS
Raymond Collette appeals from the district court’s dismissal of his claims
alleging that defendants’ conduct led to the injuries he suffered after taking
amiodarone. We affirm.
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
Page 2 of 4
1. The district court properly dismissed the medication guide claims for
failure to satisfy the pleading standard of Federal Rule of Civil Procedure 8.
Collette fails to allege facts plausibly suggesting that defendants’ wrongdoing led
to Collette’s not receiving medication guides with the amiodarone prescriptions he
filled. Notably, he does not allege that defendants failed to meet their obligations
under the federal regulations that impose the medication guide requirement.
Although Collette pleads that defendants did not provide the guides to him directly
and did not provide the guides to the distributors or pharmacies from which he
received the medication, he never alleges that defendants failed to “provid[e] the
means to produce Medication Guides,” which would also have satisfied their
regulatory obligation. See 21 C.F.R. § 208.24(b)(2). Absent factual allegations
plausibly suggesting that defendants violated their federal regulatory obligations,
Collette has not satisfied the pleading requirements of Rule 8 as interpreted in Bell
Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S.
662 (2009).
2. The district court also properly dismissed Collette’s off-label marketing
claims. Under the heightened pleading standards of Federal Rule of Civil
Procedure 9(b), Collette was required to “state with particularity the circumstances
constituting fraud,” Fed. R. Civ. P. 9(b), which requires specifying “the who, what,
when, where, and how of the misconduct charged.” Kearns v. Ford Motor Co.,
Page 3 of 4
567 F.3d 1120, 1124 (9th Cir. 2009) (quotation marks omitted). Collette’s
allegations against the generic defendants are far too general to meet these
requirements, as he offers no factual details explaining how the generic defendants
sought to “capitalize” on Wyeth’s off-label marketing campaign, and he fails to
attribute specific acts of wrongdoing to specific defendants.
The allegations against Wyeth include somewhat more detail about Wyeth’s
promotional activities, but Collette falls short of the Rule 9(b) requirements with
regard to these allegations as well. Although Collette alleges that his physicians
viewed information about amiodarone on third-party platforms and that this
information was misleading because of Wyeth’s promotional activities, he fails to
identify specific statements that Wyeth made, which statements Collette’s doctors
viewed, or how those statements influenced the doctors’ decision to prescribe
Collette amiodarone. That is insufficient to provide defendants with adequate
notice to allow them to defend against the charges, and thus fails to meet Rule
9(b)’s pleading requirements. See Kearns, 567 F.3d at 1125–26.
3. Finally, the district court properly dismissed Collette’s failure-to-report-
adverse-events claim under Federal Rule of Civil Procedure 41(b). In its June
2019 order, the district court clearly stated that Collette’s authorization to amend
was “limited to claims based on his off-label marketing allegations only” and that
addition of new claims would result in dismissal under Rule 41(b). The district
Page 4 of 4
court did not abuse its discretion by following through on this promise when
Collette failed to comply with the court’s instructions. See Pagtalunan v. Galaza,
291 F.3d 639, 642 (9th Cir. 2002).
AFFIRMED.
FILED
Collette v. Wyeth Pharm., Inc., No. 20-16406 JUL 23 2021
MOLLY C. DWYER, CLERK
COLLINS, Circuit Judge, concurring in the judgment: U.S. COURT OF APPEALS
I agree with the majority that the district court properly dismissed the claims
that were asserted below by Plaintiff Raymond Collette,1 but my reasoning differs
in some respects from the majority’s. I therefore concur only in the judgment.
1. I agree with the majority that the medication-guide claims fail, but I
would rely on a different ground.
The majority holds that Collette’s complaint did not adequately allege that
the reason Collette did not receive the required medication guide concerning
amiodarone from the relevant pharmacies was that Defendants failed to comply
with their federal regulatory obligations. In reaching that conclusion, the majority
notes that, while Collette did allege that Defendants did not supply the guide to
him or to his pharmacies, Collette did not specifically allege that Defendants failed
to provide the pharmacies with the means to produce the guide. See Mem. Dispo.
at 2 (citing 21 C.F.R. § 208.24(b)(2)). Because he did not expressly foreclose this
alternative, the majority concludes, Collette did not sufficiently allege that
Defendants actually violated the regulation. Id. The district court, however, did
not rely on this particular omission below, and Defendants do not mention it in
their brief on appeal. It seems to me improper to uphold a dismissal of a claim
1
After Collette’s death, his wife was substituted as Plaintiff-Appellant in this
court.
with prejudice based on a pleading defect that was not relied upon by the district
court or the defendants, and that the plaintiff has had no opportunity to correct.
Indeed, Collette’s opening brief characterizes the existing complaint as already
alleging that “Defendants did not provide sufficient Medication Guides (or the
means of producing them) to the distributer or to the pharmacies where Mr.
Collette filled his prescriptions” (emphasis added). At the very least, that
statement confirms that, if given leave to replead, Collette could amend the
complaint to correct the particular newly-discovered defect identified by the
majority.
I also do not agree with the district court’s given reasons for concluding that
the complaint failed to allege sufficient facts to satisfy the pleading standards set
forth in Ashcroft v. Iqbal, 556 U.S. 662 (2009). The district court stated that the
allegations concerning the medication-guide claims were “too cursory and vague,”
but the only example of an “additional factual detail” that the court said should
have been included was the identity of “the pharmacy at which [Collette] filled his
prescription.” I disagree with the district court’s conclusion that, merely by
omitting the names of the particular pharmacies that filled his prescriptions,
Collette thereby failed to allege enough facts to establish that Defendants violated
the medication-guide regulation. To be sure, I cannot fathom why Collette did not
include this detail in his second amended complaint when the district court in a
2
prior order had specifically asked for it to be included.2 But that does not mean
that this failure amounts to a violation of the pleading standards of Federal Rule of
Civil Procedure 8. Even absent this detail, Collette’s complaint sufficiently alleged
that Defendants simply failed to supply the medication guides to the relevant
distributor and pharmacies and that this failure was the reason why Collette did not
receive those guides when he filled his prescriptions. That is enough to raise a
plausible inference that Defendants violated the regulation, Iqbal, 556 U.S. at 678–
80, and to give Defendants “‘fair notice of what the . . . claim is and the grounds
upon which it rests,’” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)
(alteration in original) (citation omitted).
I would instead affirm the dismissal of these claims on the ground that, as
the district court alternatively held, they are preempted. See McDaniel v. Upsher-
Smith Labs, Inc., 893 F.3d 941, 944 (6th Cir. 2018). Because these claims rest
solely upon Defendants’ alleged failure to provide the medication guide to
pharmacists to give to Collette as required by federal regulations, they are
preempted by federal law under Buckman Co. v. Plaintiffs’ Legal Committee, 531
U.S. 341 (2001). Collette argues that the claims do not “exist solely by virtue of
the [federal medication-guide] requirements,” id. at 353, but rather rely on parallel
2
It is particularly puzzling given that, at oral argument, Collette’s counsel asserted
that the relevant pharmacies were identified during the parties’ exchange of initial
disclosures required under the applicable rules.
3
state-law duties, see McClellan v. I-Flow Corp., 776 F.3d 1035, 1040–41 (9th Cir.
2015). This contention is untenable in light of well-settled California law holding
that a drug manufacturer’s “duty to warn of risks associated with [the drug’s] usage
runs to the physician, not the patient.” Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299,
308 n.5 (Cal. Ct. App. 2008) (emphasis added); see also Bigler-Engler v. Breg,
Inc., 213 Cal. Rptr. 3d 82, 119 (Cal. Ct. App. 2017) (“‘In the case of prescription
drugs and implants, the physician stands in the shoes of the “ordinary user”
because it is through the physician that a patient learns of the properties and proper
use of the drug or implant. Thus, the duty to warn in these cases runs to the
physician, not the patient.’” (citation and emphasis omitted)). Because the relevant
state-law duty does not parallel the federal regulatory obligation to provide a
medication guide for delivery to the consumer, Collette’s medication-guide claims
reflect an attempt to use state common law to enforce an obligation that exists
solely by virtue of federal law. Under Buckman, such a claim is preempted, as the
district court correctly held.
2. I agree with the majority that the district court properly dismissed
Collette’s off-labeling marketing claims as inadequately pleaded, but again my
reasoning differs somewhat from the majority’s.
Collette’s opening brief does not contest that Federal Rule of Civil
Procedure 9(b) applies to these claims, and I agree that Collette’s operative
4
complaint fell short of the standards set by that rule. But contrary to what the
majority suggests, see Mem. Dispo. at 3, I think that the complaint adequately
alleges that Collette’s physician relied on third-party sources incorrectly stating
that treatment of atrial fibrillation is an indicated use of amiodarone. But the
claims nonetheless fail, in my view, because the complaint does not allege
sufficient facts to establish that Defendants are responsible for these third-party
statements. The complaint alleges that Wyeth engaged in certain practices
concerning off-label promotion of amiodarone at a conference in 1998; that Wyeth
received warning letters about off-label promotion of amiodarone from the FDA in
1989, 1992, and 1998; and that a 2011 task force of physicians promoted off-label
use of the drug while having financial connections to Wyeth and other unspecified
entities “that would profit from off-label use of [a]miodarone.” Beyond that,
however, the complaint’s allegations concerning an alleged campaign to promote
off-label uses are entirely conclusory. These meager allegations are not enough,
under Rule 9(b), to establish that Defendants are responsible for the statements in
third-party materials that Collette’s doctor allegedly read in late 2011.
3. I agree with the majority that the district court properly dismissed the
failure-to-report-adverse-events claim, but I disagree with its conclusion that the
dismissal may be upheld under Federal Rule of Civil Procedure 41(b) on the
ground that Collette failed to comply with a court order. We have stated that
5
dismissal under Rule 41(b) “is a harsh penalty and, therefore, it should only be
imposed in extreme circumstances.” See Ferdik v. Bonzelet, 963 F.2d 1258, 1260
(9th Cir. 1992). In my view, no such circumstances exist here. The order that
Collette allegedly violated was the district court’s order that granted him leave to
file a third amended complaint containing “claims based on his off-label marketing
allegations only.” Although Collette may have violated the spirit of the order, and
the district court’s intention in issuing that order, he did not violate its literal terms.
The allegations of fraudulent off-label marketing in Collette’s second amended
complaint already included failure-to-report allegations, and by splitting those
allegations off into a freestanding failure-to-warn claim, Collette thereby literally
alleged a claim that was “based on his off-label marketing allegations.”
Accordingly, the dismissal of these claims cannot be sustained under Rule 41(b).
I agree, however, with the district court’s alternative conclusion that this
claim was inadequately pleaded. The general allegations that Defendants “failed to
report thousands of serious adverse medical events in their exclusive possession to
the FDA, health care professionals, and consumers” lack any meaningful detail
about the nature of the adverse events that Defendants allegedly withheld. While
Collette did not have to allege the details of all of these thousands of alleged
events, he had to provide at least some overall description of them that would be
sufficient to raise a plausible inference that, “‘if [Defendants] had properly
6
reported the adverse events to the FDA as required under federal law, that
information would have reached [his] doctors in time to prevent his injuries.’”
Coleman v. Medtronic, Inc., 167 Cal. Rptr. 3d 300, 312 (Cal. Ct. App. 2014)
(citation omitted). As the district court correctly held, Collette failed to do so.
For the foregoing reasons, I concur in the judgment.
7