Daniel Kripke v. Fda

FILED
NOT FOR PUBLICATION
JUL 11 2018
UNITED STATES COURT OF APPEALS MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
DANIEL KRIPKE, on behalf of himself No. 17-55146
and the general public,
D.C. No.
Plaintiff-Appellant, 3:16-cv-01214-H-BLM
v.
MEMORANDUM*
U.S. FOOD & DRUG
ADMINISTRATION; et al.,
Defendants-Appellees.
Appeal from the United States District Court
for the Southern District of California
Marilyn L. Huff, District Judge, Presiding
Argued and Submitted June 7, 2018
Pasadena, California
Before: D.W. NELSON and CHRISTEN, Circuit Judges, and SHEA,** District
Judge.
Daniel Kripke filed this action against the U.S. Food and Drug
Administration (FDA) alleging the FDA unreasonably delayed deciding his citizen
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
**
The Honorable Edward F. Shea, United States District Judge for the
Eastern District of Washington, sitting by designation.
petition. The district court dismissed Kripke’s complaint with prejudice for failure
to state a claim. We have jurisdiction under 28 U.S.C. 1291, and we affirm.
1. The district court erred by dismissing Kripke’s claims on the merits
without first deciding whether Kripke had standing to sue. See Righthaven LLC v.
Hoehn, 716 F.3d 1166, 1172 (9th Cir. 2013). As such, we address standing in the
first instance and independently dismiss Kripke’s complaint on the merits.
2. Kripke has Article III standing. Kripke properly alleged: (1) the FDA has
violated procedural rules—specifically, 5 U.S.C. § 706(1), 21 U.S.C. §§ 351, 352,
355; and 21 C.F.R. § 10.30(e)—by unlawfully withholding or unreasonably
delaying its response to Kripke’s citizen petition; (2) the FDA’s failure to adhere to
these rules affects both his concrete interest as a treating physician and as a
researcher who funds studies on the harmful side effects of hypnotic drugs; and (3)
the FDA’s failure to act on Kripke’s citizen petition threatens those interests. See
Friends of Santa Clara River v. United States Army Corps of Engineers, 887 F.3d
906, 918 (9th Cir. 2018). Kripke also properly alleged that the FDA’s adherence to
these rules may influence the FDA’s stance on the safety and efficacy of hypnotic
drugs. See id.
3. Kripke has standing to pursue his procedural claim under the
Administrative Procedure Act (APA). See Havasupai Tribe v. Provencio, 876 F.3d
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1242, 1253 (9th Cir. 2017). Kripke’s clinical practice comprises of patients with
sleeping disorders who take, or express an interest in being treated with, hypnotic
drugs. He is also a researcher who has devoted many years to studying the side
effects of hypnotic drugs, and he seeks to raise safety and efficacy concerns
associated with the widespread use of hypnotic drugs that have been previously
approved by the FDA. Given these allegations, Kripke’s stake puts him squarely
within the zone of interest of the FDA regulations. See 21 C.F.R. §§ 10.25(a),
10.30.
4. Kripke’s claims fail on the merits. The FDA complied with 21 C.F.R. §
10.30(e) when it responded to Kripke’s citizen petition within 180 days. The
FDA’s response does not constitute an abuse of discretion. As expressly permitted
by 21 C.F.R. § 10.30(e)(2)(iv), the FDA provided Kripke with an interim response
stating that it was unable to reach a decision. The FDA’s failure to resolve
Kripke’s complex citizen petition within seven months of its filing was not
unreasonable—Kripke’s petition included over 100 references and eight requests
concerning at least ten previously approved drugs.
5. The district court did not err by denying Kripke leave to amend his
complaint because any amendment would have been futile. See Newton v. Parker
Drilling Mgmt. Servs., Ltd., 881 F.3d 1078, 1083 (9th Cir. 2018).
3
AFFIRMED.
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