Court filing

Plaintiff's response to Pfizer's motion to intervene — PHMPT v. FDA

Record facts

Court	U.S. District Court for the Northern District of Texas
Filed	2022-01-25

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 47 · 2022-01-25 · Docket on CourtListener

Summary

Plaintiff Public Health and Medical Professionals for Transparency's response to Pfizer Inc.'s motion for leave to intervene for a limited purpose, filed January 25, 2022 as Document 47 in Public Health and Medical Professionals for Transparency v. Food and Drug Administration, Civil Action No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas. The plaintiff states it does not object to intervention that expedites release of the requested documents, but opposes the motion as untimely to the extent Pfizer may seek to alter the January 6, 2022 order requiring production of 55,000 pages every 30 days. Applying four timeliness considerations under Rule 24, it asks that any intervention be limited. The proposed limits include barring conduct intended to delay production and directing Pfizer to identify documents without trade secrets by February 1, 2022.

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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS

PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,

Plaintiff,

-against-

FOOD AND DRUG ADMINISTRATION,

Defendant.

Civil Action No. 4:21-cv-01058-P

PLAINTIFF’S RESPONSE TO PFIZER INC.’S MOTION FOR LEAVE TO
INTERVENE FOR A LIMITED PURPOSE

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TABLE OF CONTENTS
TABLE OF AUTHORITIES ..................................................................................................... iii
INTRODUCTION........................................................................................................................ 1
ARGUMENT ................................................................................................................................ 2
I.
STANDARD FOR TIMELINESS UNDER RULE 24 ....................................................... 3
II. PFIZER’S MOTION IS UNTIMELY IF THE COMPANY SEEKS TO ALTER THE
EXISTING SCHEDULE ..................................................................................................... 4
A.
Consideration 1: Pfizer’s Delay is Unreasonable if it Hopes to Alter the
Production Schedule ................................................................................................... 5
B.
Consideration 2: A Motion to Delay Production Would Prejudice the Existing
Parties…………………………………………………………………………... ...... 6
C.
Consideration 3: Pfizer’s Motion Fails to Establish What, if Any, Prejudice the
Company Will Suffer if it’s Current Motion is Denied .............................................. 6
D.
Consideration 4: The Unprecedented Urgency of this Matter Calls for Even
Greater Caution when Evaluating the Timeliness of Intervention ............................. 9
CONCLUSION .......................................................................................................................... 10

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iii

TABLE OF AUTHORITIES

Cases
Effjohn Int’l Cruise Hldgs., Inc. v. A&L Sales, Inc.,
346 F.3d 552 (5th Cir. 2003) ...................................................................................................... 3

New Orleans Pub. Serv., Inc. v. United Gas Pipe Line Co.,
732 F.2d 452 (5th Cir. 1984) ..................................................................................................... 4

Nikon Corp. v. ASM,
222 F.R.D. 647 (N.D. Cal. 2004) ................................................................................................ 4

Payne Enters., Inc. v. United States,
837 F.2d 486 (D.C. Cir. 1988) ................................................................................................. 10

Script Sec. Sols. LLC v. Logitech Inc.,
No. 216CV01400JRGRSP, 2017 WL 10242574 (E.D. Tex. Nov. 8, 2017)…………….passim

Sierra Club v. Espy,
18 F.3d 1202 (5th Cir. 1994) .................................................................................................. 3, 5

Wal–Mart Stores, Inc. v. Texas Alcoholic Beverage Commn.,
834 F.3d 562 (5th Cir. 2016) ..................................................................................................... 5

Statutes
21 C.F.R. 20.61 ............................................................................................................................... 7

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INTRODUCTION

The motion filed by Pfizer Inc. (“Pfizer”) seeks leave for Pfizer to intervene for the limited
purpose of ensuring “expeditious action” and to remain “informed of relevant developments.”
(Dkt. No. 40 at 2.) Plaintiff welcomes Pfizer’s participation in this matter to the extent it will in
fact expedite the release of the requested documents. However, it is what Pfizer has refused to say
that concerns Plaintiff in consenting to the company’s intervention without the Court providing, at
the least, appropriate limitations to assure Pfizer does not cause delay or prejudice to Plaintiff.
Even though the FDA has more than sufficient resources to expeditiously produce the
requested documents, and the agency has repeatedly stated its commitment to protecting Pfizer’s
interests, Pfizer could still assist the FDA with expediting release of the requested documents.
Pfizer, however, provides no reason why it needs to intervene in this matter to render that purported
assistance. Nor can Plaintiff discern why Pfizer needs to intervene in this matter to assist the FDA
with expediting release of the requested documents – it can render this assistance without
intervening. Indeed, Pfizer, for over a year now, has been “working closely with the FDA”
regarding its Covid-19 vaccine and is already working with the FDA to identify, on or before
February 1, 2022, all documents in its application that do not include trade secrets. Nor does Pfizer
have any need now to intervene to protect any trade secrets because Plaintiff has not sought to
challenge any redactions. If the Court has uncertainty as to whether Pfizer has stated an extant
basis for intervening, Plaintiff respectfully requests that the Court ask Pfizer to clarify how
intervening would assist in expediting release of the documents beyond what it could do to assist
the FDA without intervening in this action.
Separately, in conferring with Pfizer’s counsel prior to moving to intervene, Plaintiff
sought confirmation that Pfizer would not seek to challenge the Court’s January 6th order (Dkt.
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No. 35) requiring the FDA to produce at a rate of 55,000 pages every 30 days. Nevertheless, even
though Pfizer said it “does not presently intend to move the Court to reconsider its January 6, 2022
order,” it refused to rule out such a challenge to the rate of production ordered by the Court, stating
that it “is not in a position at this time to waive its ability to do so if circumstances change such
that there is good cause at a later time to do so.” (Dkt. No. 40 at 3.) The position taken by Pfizer
on this issue casts doubt as to its claimed limited purpose to intervene to seek to expedite release
of the underlying documents. Plaintiff is therefore concerned that its involvement will serve as
another way for the FDA, now with assistance from Pfizer, to continue its campaign to delay
production. Hence, to the extent Pfizer is permitted to intervene without limitation, such that it
may seek to challenge orders entered in this action prior to its intervening, or to otherwise delay
the Court-ordered production schedule, Plaintiff opposes Pfizer’s motion as untimely.
On the other hand, if the Court concludes Pfizer intervening in this action will increase the
rate of production beyond what the FDA could do if Pfizer were not granted leave to intervene,
and Pfizer’s involvement is limited to prevent delay or prejudice as set forth below, Plaintiff does
not object to Pfizer intervening.
ARGUMENT

On January 21, 2022, Pfizer moved to intervene in this action pursuant to either Rule 24(a)
or Rule 24(b). It claims that it made this motion for the stated “limited purpose of helping FDA
and the Court ensure expeditious action as ordered by this Court and ensuring that Pfizer is
informed of relevant developments in relation to the case.” (Dkt. No. 40 at 2.) In doing so, the
company explains that it “hopes that engaging in a dialogue with the Government where it has
questions about Pfizer’s view regarding certain portions of the BLA will make it easier for the
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Government to meet the production schedule ordered by the Court.” (Id.) However, Pfizer never
explained why it needs to intervene in this action at this time in order to conduct that dialogue.
I.
STANDARD FOR TIMELINESS UNDER RULE 24

One of the primary cases Pfizer relies on, Sierra Club v. Espy, 18 F.3d 1202 (5th Cir. 1994),
warns that “[c]ourts should discourage premature intervention that wastes judicial resources.” Id.
at 1206. Rather, “[a] better gauge of promptness is the speed with which the would-be intervenor
acted when it became aware that its interests would no longer be protected by the original parties.”
Id. In evaluating the timeliness of a motion to intervene, courts in the Fifth Circuit examine four
considerations: “‘(1) how long the putative intervenor knew, or reasonably should have known, of
its stake in the action; (2) the prejudice, if any, the existing parties may suffer because the putative
intervenor failed to intervene when it knew, or reasonably should have known, of its stake; (3) the
prejudice, if any, the putative intervenor may suffer if intervention is not allowed; and (4) any
unusual circumstances weighing in favor of, or against, finding timeliness.’” Script Sec. Sols. LLC
v. Logitech Inc., No. 216CV01400JRGRSP, 2017 WL 10242574, at *2 (E.D. Tex. Nov. 8, 2017)
(quoting Effjohn Int’l Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552, 560–61 (5th Cir. 2003)).
The Script Sec. Sols. decision provides a relevant example where the court evaluated these
four considerations. 2017 WL 10242574. There, by the time of the motion to intervene, the
existing parties had established a schedule for evaluating the patent claims and the date to move
to invalidate any claims had already passed. Id. at *2. Likewise, the parties had already
commenced claims discovery, and a claims construction proceeding was planned for just a few
months after the motion to intervene. Id. Under those circumstances, the court denied the motion
to intervene. Id. at *1. It was concerned that the intervenor would seek to invalidate some of the
patent claims and seek changes to the existing scheduling order, both of which would prejudice
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the plaintiff. Id. at *2. Nevertheless, recognizing the intervenor’s legitimate interest in the action,
the court encouraged it to move for discretionary intervention pursuant to Rule 24(b), under which
“the court may limit the scope of a movant’s intervention to avoid undue delay and prejudice to
the parties.” Id. at *3. The court suggested that, in any such motion, the intervenor would have to
agree “not … to move any … deadlines without the agreement of the parties, and … to be bound
by all existing orders in this action.” Id. (citing Nikon Corp. v. ASM, 222 F.R.D. 647, 651-52 (N.D.
Cal. 2004) (permitting intervention under Rule 24(b) with certain limitations “so as to minimize
delay and burdens to the parties and keep this case on track”)); see also New Orleans Pub. Serv.,
Inc. v. United Gas Pipe Line Co., 732 F.2d 452, 470-71 (5th Cir. 1984) (“Permissive intervention is
wholly discretionary with the [district] court ... even though there is a common question of law or
fact, or the requirements of Rule 24(b) are otherwise satisfied.” (internal quotations omitted)).
II.
PFIZER’S MOTION IS UNTIMELY IF THE COMPANY SEEKS TO ALTER
THE EXISTING SCHEDULE

Like in Script Sec. Sols., here, Plaintiff is concerned that Pfizer’s intervention will unduly
prejudice Plaintiff if the company seeks reconsideration of the production schedule established by
the Court’s order entered on January 6, 2022, or otherwise seeks to delay production by the FDA.
With this in mind, Plaintiff advised Pfizer’s counsel as part of their meet-and-confer
process that it “does not object to Pfizer moving to intervene, so long as Pfizer intends to only
address decisions going forward and not to ask the Court to reconsider decisions it has already
reached since any motion to intervene as to already adjudicated matters is untimely.” (Dkt. No.
40 at 3.) Pfizer’s refusal to agree to this limitation raised concerns for Plaintiff because it calls
into question the company’s alleged limited purpose for intervening in this action, which is
purportedly to expedite release of the documents. (Id.)
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As such, because Pfizer itself will not rule out the possibility, the Court should analyze the
timeliness of the instant motion assuming there is at least the possibility that Pfizer will move to
amend or delay the Court’s existing schedule. Applying the four considerations noted above, it
would be untimely for Pfizer to intervene in order to alter the Court’s January 6th production
schedule, and therefore, if the company is permitted to intervene, it must be limited by restrictions
similar to those in Script Sec. Sols.
A. Consideration 1: Pfizer’s Delay is Unreasonable if it Hopes to Alter the
Production Schedule

Under the first consideration, Pfizer claims that it learned about this action “from news
reports in connection with the December 14, 2021 Scheduling Conference.” (Dkt. No. 41 p. 11.)
Even though Pfizer is correct that only a little over five weeks elapsed between this supposed
discovery and the instant motion, “[t]he timeliness inquiry ‘is contextual; absolute measures of
timelines should be ignored.’” Wal–Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834
F.3d 562, 565 (5th Cir. 2016) (cited by Pfizer) (quoting Espy, 18 F.3d at 1205). For instance, in
Wal–Mart Stores, the Fifth Circuit did not look to the exact number of days in order to determine
whether the motion was timely. Id. Rather, the Circuit found that the motion was timely because
the intervenor “sought intervention before discovery progressed and because it did not seek to
delay or reconsider phases of the litigation that had already concluded.” Id.
In contrast to Wal-Mart Stores, Pfizer knew or should have known that Plaintiff was
seeking an expedited production schedule, and that the Court intended to rule on that schedule
quickly. In such circumstances, if Pfizer wanted to have input into the production schedule, it had
more than 3 weeks between its purported discovery of the action and the Court’s order on January
6, 2022, making its delay in filing this motion unreasonable if it hoped to have input into the
production schedule.
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B. Consideration 2: A Motion to Delay Production Would Prejudice the Existing
Parties

The analysis of the second timeliness consideration plays out much as it did in Script Sec.
Sols. If Pfizer wants to slow the production schedule in any way, that will be prejudicial to
Plaintiff. As described in detail in Plaintiff’s brief to the Court regarding the production schedule,
there is an urgent need to have these documents produced in a quick and timely manner. Likewise,
the FDA claims that since the January 6th order, it has moved heaven and earth to try to meet the
deadlines set by that order. Setting aside whether this claim is true (a point called into serious
question by Plaintiff’s opposition papers regarding the FDA’s motion to modify the schedule, Dkt.
Nos. 44-45), a motion even in the next few weeks by Pfizer to further reconsider the production
schedule will mean that much of the FDA’s work in trying to meet the existing schedule may need
to be changed. Thus, any effort by Pfizer to change the existing schedule will serve to prejudice
both existing parties.
C. Consideration 3: Pfizer’s Motion Fails to Establish What, if Any, Prejudice the
Company Will Suffer if it’s Current Motion is Denied

Pfizer’s motion also fails to identify an extant reason to support the third consideration,
i.e., “the prejudice, if any, the putative intervenor may suffer.” Script Sec. Sols., 2017 WL
10242574, at *2.
As confirmed during the meet and confer, and as evidenced by the fact the FDA has already
requested that Pfizer identify documents not containing trade secrets by February 1st, the agency
and the company have already entered into a dialogue. Indeed, the FDA’s regulations include
provisions that specifically permit companies to engage with the FDA with regard to identifying
trade secrets. 21 C.F.R. 20.61(d). Those regulations are particularly enlightening here because
they include a timeline companies must meet in order to ensure that those companies’ involvement
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does not slow down the government’s response to the FOIA request.1 Thus, contrary to Pfizer’s
claims, even if it is not a party to this action, it is not prejudiced in its ability to engage with the
FDA in order to expedite production and relay to the FDA what portions of the documents it
believes require redaction.
Of course, if down the road Plaintiff chooses to challenge any redactions, Pfizer may have
an interest then and could be prejudiced if not permitted to intervene. However, that has not
happened yet, may never happen, and if it happens, will likely not happen for at least several
months, and hence raises the question of why Pfizer needs to intervene at this stage of the litigation
with regard to trade secrets. At the least, there should be some claim made in this action seeking
to lift redactions for trade secrets before Pfizer’s participation is necessary.
Pfizer vaguely claims “that Government entities generally cannot adequately represent the
interests of aspiring intervenors[,]” thereby trying to justify its involvement by appearing to argue
that the FDA will not protect its interests. (Dkt. No. 41 p. 13.) However, this argument contrasts
sharply with the FDA’s repeated attestations throughout this action that it takes very seriously its
obligation to protect private citizen’s data and Pfizer’s trade secrets. If anything, the FDA put
Pfizer’s interests well ahead of the American public’s interest when it originally sought to produce
just 500 pages per month, in large measure to ensure it was protecting Pfizer’s trade secrets and

1 “A person who submits records to the Government may designate part or all of the information
in such records as exempt from disclosure under exemption 4 … The person may make this
designation either at the time the records are submitted to the Government or within a
reasonable time thereafter. 21 C.F.R. 20.61(d) (emphasis added). “When the [FDA] receives a
request for such records and determines that disclosure may be required, the [FDA] will make
reasonable efforts to notify the submitter … The notice will include a copy of the request, and it
will inform the submitter about the procedures and time limits for submission and consideration
of objections to disclosure…The submitter has 5 working days from receipt of the notice to
object to disclosure of any part of the records and to state all bases for its objections.” 21 C.F.R.
20.61(e) (emphasis added).
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confidential business information. (E.g., Dkt. No. 22 p. 10 (“To ensure protection of this
[confidential business and trade secret information of Pfizer], … FDA must carefully review and,
if necessary, redact exempt information on a line-by-line basis.”).) The FDA then reiterated that
same strong desire to protect Pfizer’s interests in its current motion to modify the production
schedule. (E.g., Dkt. No. 37 p. 10 (“while the agency recognizes the public interest in the public
disclosure of the records here at issue, FDA must also ensure that the personal information of
clinical trial participants, as well any trade secret or commercially confidential information
contained within the records, is protected from disclosure”).) Thus, especially with Pfizer now
assisting the FDA, the interest Pfizer has in protecting its trade secrets does not require
intervention.
The lack of a need for Pfizer to intervene, at least at this time before Plaintiff has moved to
challenge any redactions, raises questions for Plaintiff, especially in light of Pfizer’s refusal to rule
out a challenge to the current schedule. Of course, in addition to Pfizer seeking to cause delay,
there is another reason why Pfizer may be seeking to intervene, but which the company did not
discuss outright because it does not support intervention. Pfizer may be seeking to intervene to
protect its public relations image.
As Pfizer states in its brief, this action has received significant media attention. (Dkt. No.
41 p. 15 (referencing “news reports about this Scheduling Conference in December 2021”).) Not
all of that attention has been positive given the FDA’s repeated attempts to delay production in
order to avoid transparency. (Dkt. No. 44.) Therefore, it comes as no surprise that Pfizer’s instant
brief is littered with comments like: “Pfizer supports the public disclosure of the vast majority of
this information, to promote transparency and the public’s confidence in the vaccine” (Dkt. No.
40 at 1.) The company then spends a full page and a half of its brief citing documents to support
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its claim that, “Pfizer, FDA, and others already have made public extensive data and information
about the vaccine,” all of which is otherwise irrelevant to its motion. (Dkt. No. 40 at 1.) In doing
so, the company even includes a highly misleading header for another irrelevant list of studies,
“Preprints of safety and efficacy data as they became available,” which falsely indicates that these
preprints include the underlying safety and efficacy data. (Dkt. No. 41 at 7.) Of course, none of
these documents contain the raw data relied upon to license Pfizer’s vaccine that is sought in this
action, i.e., the underlying data that would permit verifying any of the company’s claims, but rather
they contain only sanitized summaries of information. Pfizer may just be hoping that the next
reporter does not look any closer than the headlines. At any rate, a company’s desire to protect its
public image is not the type of interest that the drafters of Rule 24 had in mind when they permitted
third parties to intervene in court actions, especially because, as the page-and-a-half in Pfizer’s
brief shows, that desire conflicts with the very real need for judicial efficiency.
D. Consideration 4: The Unprecedented Urgency of this Matter Calls for Even
Greater Caution when Evaluating the Timeliness of Intervention

The fourth timeliness consideration, “any unusual circumstances weighing in favor of, or
against, finding timeliness” also plays an important role in this action. Script Sec. Sols., 2017 WL
10242574, at *2. This Court recognized the unusual circumstances in its order when it
acknowledged “the need for unprecedented urgency in processing this request[.]” (Dkt. No. 35 p.
3.) This matter concerns an issue of national importance, where “stale information is of little
value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). Thus, any delays
now not only prejudice the parties as discussed above, but also prejudice the American public and
its right to transparency when it comes to the unprecedented actions its government has taken
during this pandemic, and in particular with regard to the product at issue – a product which has
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been mandated while Pfizer has been given complete financial immunity by the government for
any safety or efficacy issues with its product.
Nonetheless, Pfizer ends it brief by stating that, it “does not dispute that Plaintiff is entitled
to non-exempt information from the BLA under its FOIA request and Pfizer does not seek any
delay in the production of that information. Rather, Pfizer’s intervention will facilitate production
of the information Plaintiff seeks since Pfizer can assist the Parties in efficiently segregating and
redacting any data and information that are subject to FOIA statutory exemptions.” (Dkt. No. 41
at 15.) If that is all Pfizer truly seeks, then Plaintiff welcomes Pfizer’s intervention for that limited
specific purpose. However, for the reasons discussed above, Pfizer’s refusal to rule out a request
to change the production schedule, and its failure to articulate a convincing reason why it needs to
intervene right now (rather than later if any redactions are challenged), concern Plaintiff.
CONCLUSION

For the foregoing reasons, Plaintiff respectfully asks that the Court deny Pfizer’s motion
under Rule 24(a) as untimely under the circumstances and because its interests are already
adequately represented by the FDA, but that it grant the motion under Rule 24(b) for the limited
purpose of helping FDA and the Court ensure expeditious action as ordered by this Court with the
following limitations similar to those imposed in the Script Sec. Sols. matter:
1. Pfizer is bound by all existing orders in this action;
2. Pfizer is prohibited from seeking to alter the January 6th order, or an amended schedule
set forth in any order regarding FDA’s pending motion to amend the January 6th order;
3. Pfizer is prohibited from engaging in conduct that is intended to delay production of
the documents as ordered by the Court; and
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4. Pfizer is directed to comply with the FDA’s request for it to identify all documents that
do not include trade secrets and confidential information by or before February 1, 2022.

Dated: January 25, 2022

SIRI & GLIMSTAD LLP

/s/ Aaron Siri
Aaron Siri, NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353
Gabrielle G. Palmer, CO Bar No. 48948
200 Park Avenue
17th Floor
New York, New York 10166
Tel: (212) 532-1091
Fax: (646) 417-5967
aaron@sirillp.com
ebrehm@sirillp.com
gpalmer@sirillp.com

HOWIE LAW, PC
John Howie
Texas Bar Number: 24027239
2608 Hibernia Street
Dallas, Texas 75204
Tel: (214) 622-6340
jhowie@howielaw.net

Attorneys for Plaintiff

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CERTIFICATE OF SERVICE

On January 25, 2022, I electronically submitted the foregoing document with the clerk of
court for the U.S. District Court, Northern District of Texas, using the electronic case filing system
of the court. I hereby certify that I have served all counsel and/or pro se parties of record
electronically or by another manner authorized by Federal Rule of Civil Procedure 5(b)(2).

DATED: January 25, 2022

/s/ Aaron Siri_____________

Aaron Siri

200 Park Avenue, 17th Floor

New York, New York 10166

Tel: (212) 532-1091

Fax: (646) 417-5967

aaron@sirillp.com

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Plaintiff's response to Pfizer's motion to intervene — PHMPT v. FDA

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