Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-4_18-cv-05022/USCOURTS-cand-4_18-cv-05022-4/pdf.json

Nature of Suit Code: 899
Nature of Suit: Other Statutes - Administrative Procedure Act/Review or Appeal of Agency Decision
Cause of Action: 28:1331 Fed. Question: Review Agency Decision

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United States District Court

Northern District of California

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

STEVEN BRUCE,

Plaintiff,

v.

ALEX M. AZAR, et al.,

Defendants.

Case No. 18-cv-05022-HSG 

ORDER DIRECTING ADDITIONAL 

BRIEFING AND DENYING MOTION 

FOR LEAVE TO FILE A REPLY

Re: Dkt. Nos. 65, 66, 67

I. BACKGROUND

On October 25, 2018, Plaintiff Steven Bruce filed a motion to supplement the 

administrative record (“AR”), alleging that the AR did not include “the FDA label for Serostim 

and the AHFS-DI compendium for Serostim.” Dkt. No. 24 at 2. Defendant opposed the motion as 

premature, based on the anticipated AR production date of December 19, 2018. Dkt. No. 34 at 3–

4. 

On January 30, 2019, the parties submitted a joint statement, noting that “the FDA label 

and AFHS-compendium for the drug Serostim are not in the AR,” and that “Defendant [] agreed to 

supplement the AR with these documents and lodge the certified record, with the additions, by 

February 6, 2019.” Dkt. No. 61. The Court vacated the hearing date on Plaintiff’s motion to 

supplement in light of the parties’ joint filing, and directed Plaintiff to file a statement indicating 

whether the issue had been resolved on February 7, 2019. Dkt. No. 62. 

Plaintiff filed a statement on February 6, 2019 indicating that, “[a]lthough DHHS has 

supplemented the record with the FDA label for Serostim,” Defendant had not provided “the 

compendium AHFSDI, contending that no entry for Serostim was in the compendium.” Dkt. No. 

65 at 2. Plaintiff’s statement indicates that Plaintiff still seeks information relating to 

somatotropin, which Plaintiff alleges is the generic compound of the drug Serostim. Id.

Case 4:18-cv-05022-HSG Document 69 Filed 02/12/19 Page 1 of 2
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United States District Court

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Defendant filed a separate statement on the February 7, 2019 deadline, disputing Plaintiff’s 

contention that the requested supplementation had not been provided. Dkt. No. 66. Plaintiff 

subsequently filed an administrative motion for leave to file a reply to Defendant’s statement. 

Dkt. No. 67.

II. DISCUSSION

The scope of Plaintiff’s motion to supplement has changed considerably, such that the 

briefing originally submitted to the Court does not address the present dispute. Therefore, the 

Court DIRECTS Plaintiff to file a fully-noticed motion to supplement the administrative record

addressing the present dispute on or before February 22, 2019. If no dispute exists as of that date, 

the Court DIRECTS Plaintiff to withdraw the still-pending motion to supplement, Dkt. No. 24. 

Plaintiff’s motion for leave to file a reply, Dkt. No. 67, is DENIED.

IT IS SO ORDERED.

Dated:

______________________________________

HAYWOOD S. GILLIAM, JR.

United States District Judge

2/12/2019

Case 4:18-cv-05022-HSG Document 69 Filed 02/12/19 Page 2 of 2