United States District Court for the District of Columbia
March 25, 2004.
BURTON L. APPLETON, Plaintiff,
FOOD AND DRUG ADMINISTRATION and DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendants
The opinion of the court was delivered by: RICARDO URBINA, District Judge
GRANTING THE APPLICANTS' MOTIONS TO INTERVENE;
DIRECTING THE PLAINTIFF AND THE DEFENDANTS TO SUBMIT A
Pro se plaintiff Burton Appleton, a former Food and Drug Administration
("PDA") chemist, brings this action to compel PDA and the Department of
Health and Human Services ("HHS") (collectively, "the defendants") to
reply fully to his Freedom of Information Act ("FOIA") request for
records regarding the drug levothyroxine sodium ("LS"). In response, the
defendants notified various LS manufacturers of the plaintiff's suit,*fn1
filed a partial answer, and moved the court for an Open America stay of
Five LS manufacturers then moved to intervene.*fn3
court granted the defendants' motion for a stay, but held the production
schedule in abeyance until the parties clarified the scope of the
plaintiff's request. Appleton v. Food & Drug Admin., 254 F. Supp.2d 6
(D.D.C. 2003). At the same time, the court denied
without prejudice the motions to intervene, stating that the LS
manufacturers could refile their motions after the scope of the
plaintiffs request becomes clear. Id.
Pursuant to the court's order, the parties reported that they had
clarified the scope of the plaintiff's request but were at an impasse
over the proposed production schedule. Joint Status Report at 2, 9.
Subsequently, however, the plaintiff asked the court to temporarily stay
the case due to medical difficulties. Pl's Mot. for Stay at 1. The court
granted a stay through February 9, 2004, and directed the plaintiff to
indicate whether he wished to continue with the litigation. Order dated
Jan. 5, 2004. The plaintiff informed the court that his condition had
stabilized and that he was "sufficiently alive . . . so that he is able
to prosecute his case in approximately normal fashion." Pl's Resp. at 1.
In the interim, LS manufacturers Jerome Stevens Pharmaceuticals, Inc.
("Jerome Stevens"), Jones Pharma, Inc. ("Jones Pharma"), and Abbott
Laboratories ("Abbott") (collectively, "the applicants") renewed their
motions to intervene. Given the expiration of the temporary stay and the
plaintiff's stated intent to continue with this action, the court now
turns to the applicants' motions to intervene and the question of an
appropriate production schedule.
Federal Rule of Civil Procedure 24 sets forth the requirements for
intervention as of right and permissive intervention. FED. R. CIV. P.
24; Fund for Animals, Inc. v. Norton, 322 F.3d 728, 731 (D.C. Cir.
2003). First, Rule 24(a) provides for intervention as of right, stating
[u]pon timely application anyone shall be permitted to
intervene in an action . . . when a statute of the
United States confers an unconditional right to
intervene; or . . . when the applicant claims an
interest relating to the property or transaction which
is the subject of the action and the applicant is so
situated that the disposition of the action may as a
practical matter impair or impede the applicant's
ability to protect that interest, unless the
applicant's interest is adequately represented by
Id. As paraphrased by the B.C. Circuit, the rule indicates that an
applicant's right to intervene depends on "(1) the timeliness of the
motion; (2) whether the applicant claims an interest relating
to the property or transaction which is the subject of the action; (3)
whether the applicant is so situated that the disposition of the action
may as a practical matter impair or impede the applicant's ability to
protect that interest; and (4) whether the applicant's interest is
adequately represented by existing parties." Fund for Animals, 322 F.3d
at 731; see also Jones v. Prince George's County, Md., 348 F.3d 1014
1017 (D.C. Cir. 2003) (listing the four elements of Rule 24(a) as
"timeliness, interest, impairment of interest, and adequacy of
representation"). In addition, an applicant must demonstrate that it has
standing. Jones, 348 F.3d at 1017-18; Fund for Animals, 322 F.3d at
Alternatively, Rule 24(b) authorizes permissive intervention for an
applicant who timely files a motion when a federal statute confers a
conditional right to intervene or the applicant's claim or defense has a
question of law or fact in common with the main action. FED. R. Civ. P.
24(b). In considering a motion for permissive intervention, a court must
determine whether the proposed intervention "will unduly delay or
prejudice the adjudication of the rights of the original parties."*fn4
In this case, the applicants move to intervene as of right under Rule
24(a).*fn5 Jerome Stevens Mot. to Intervene ("Jerome Stevens Mot.") at
2; Abbott Mot. to Intervene ("Abbott Mot.") at 1; Jones Pharma Mot. to
Intervene ("Jones Pharma Mot.") at 1-2. The court concludes that each
applicant may intervene as of right. First, all three applicants moved to
intervene in a timely fashion, filing their initial motions within two
months of FDA's notification of the pending suit and their renewed
motions within two months of the report of the plaintiff's
clarified request or the plaintiff's notice of his intent to continue
with the litigation. Fund for Animals, 322 F.3d at 731; Associated
Builders & Contractors, Inc. v. Herman, 166 F.3d 1248, 1257 (D.C.
Cir. 1999) (noting that the court determines timeliness from the
circumstances of the case pursuant to its sound discretion).
Second, the applicants have an interest in the subject of the action.
Fund for Animals, 322 F.3d at 731. Each of the applicants submitted to
FDA a new drug application ("NBA") that allegedly contains trade secrets
and confidential information regarding its LS product.*fn6 Jerome
Stevens Mot. at 11-12; Abbott Mot. at 5; Jones Pharma Mot. at 3-4. Given
that the plaintiffs clarified request seeks all FDA reviews of approved
LS NDAs, the applicants have an interest in the FDA information. Joint
Status Report at 5-6. Third, disclosures resulting from the disposition
of this action could impair the applicants' ability to protect their
trade secrets or confidential information. Fund for Animals, 322 F.3d at
731; Jerome Stevens Mot. at 12-13; Abbott Mot. at 5-6; Jones Pharma Mot.
Fourth, the applicants have met their "minimal" burden of showing that
the existing parties do not adequately represent their interests. Fund
for Animals, 322 F.3d at 731, 735 (quoting Trbovich v. United Mine
Workers, 404 U.S. 528, 538 n.10 (1972)). In contrast to the applicants'
interest in protecting their trade secrets and confidential information,
the plaintiff's interest lies in disclosure and FDA's interest lies in
responding appropriately to the plaintiff's request. Compare Joint Status
Report at 5-6 (listing the information the plaintiff seeks) and 21
C.F.R. § 20.55 (requiring that persons whose FDA records include
trade secrets or confidential information intervene to defend the exempt
status of the records or else risk FDA's public
disclosure of the records) with Jerome Stevens Mot. at 13 (stressing an
interest in avoiding economic injury), Abbott Mot. at 6 (same), and Jones
Pharma Mot. at 4-5 (same). As for standing, the applicants have shown
that FDA's disclosure of their trade secrets or confidential information
would cause them to suffer an injury-in-fact that intervention to defend
against disclosure could redress. Fund for Animals, 322 F.3d at 732-33.
Accordingly, it is this 24th day of March, 2004, hereby
ORDERED that the applicants' motions [#32, #36, #40] to intervene are
GRANTED;*fn7 and it is
FURTHER ORDERED that the Clerk of the Court shall file the applicants'
answers [#23 Ex., #32 Ex. B, #36 Ex. A] on the date of this Memorandum
Order; and it is
ORDERED that by no later than April 6, 2004, the plaintiff and FDA file
a motion jointly proposing a schedule for the realistic, timely
completion of the production process.*fn8