### IN THE UNI TED STATES COURT OFAPPEALS FOR THE FIF TH CIRCUIT

No. 11-30812

AKZO NOBEL INC.; GENERAL CHEMICAL CORP.; MISSISSIPPI LIME MANAGEMENT CO; MORTON INTERNATIONAL; OCI OF WYOMING; LONNY BADEAUX; JOSEPH VENDETTI; METHANE AWARENESS RESOURCE GROUP; DIESEL COALITION, Plaintiffs-Appellees
v. UNITED STATES OF AMERICA; KATHLEEN SEBELIUS, SECRETARY, DEPARTMENT OF HEALTH & HUMAN SERVICES; JOHN HOWARD, Director, National Institute for Occupational Safety and Health; HAROLD VARMUS, Director, National Cancer Institute, Defendants-Appellants

Appeal from the United States District Court for the Western District of Louisiana

(6:96-CV-2430)

Before BENAVIDES, PRADO and GRAVES, Circuit Judges. PER CURIAM: * This appeal involves a Diesel Exhaust in Miners Study, commenced two decades ago in 1992 and conducted by the National Ins titute for Occupational U n i te d S ta te s C o u rt o f A p p ea l s

F i ft h C i rc u i t 

### F I L E D May24 , 20 12 Lyle W . Cayce Clerk

Pursua nt to 5 T H C IR

. R. 47.5 , the court hasd ete rm inedthat this op inion s houldnot * be publ ish ed and is not pr ece dent excep t unde r the lim ite d cir cum st ance s se t forth in 5 T H C IR

. R. 47.5 .4. Case: 11-30812 Document: 00511866647 Page: 1 Date Filed: 05/24/2012No. 11-30812

Safety and Health (“NIOSH”) and the National Cancer Institute (“NCI”) – two 1 2 components of the United States Department of Health and Human Services (collectively , “ H H S ” )

. In this appeal – the third in a series of related appeals spanning thirteen years – HHS challenges the district court’s order granting the motion for injunctive relief, civil contempt, and fees and expenses brought by the plaintiffs-appellees, Methane Awareness Resource Group (“MARG”) and Lonny Badeaux (collectively “Plaintiffs”). Once again, HHS’s appeal is successful. We 3 VACATE and REVERSE.

I. FA C T UA L AN D P R O C E D U RA L BA C K G R O U N D A. The Diesel Exhaust in Miners Study Between 1992 and 1995, NIOSH and NCI develope d a dr af t protocol for the study. In 1996, HHS decided t o u s e a particular advisory committee, the NIOSH’s Board of Scientific Counselors (“BSC”), to provide peer review for the draft protocol. In January, April and July 1997, BSC held public meetings to

NIO SH is a com pone nt of HH S. 29 U. S. C. § 671( a). N IO S H cond uct s sc ient ifi c 1
res earc h rela ted to occ upat ional saf ety and health. Id

. §§ 669( a)( 1). NIO SH ’s res earc h is use d, inter al ia , to genera te rec om me ndat ions regar ding per mi ss ible expo sur e levels for pot enti ally harm ful sub st ance s. Id

. §§ 669( a)( 3), 671( d)

. Congres s ha s r e c o gn i zed a partic ular role for NIO SH in mi ne- rela ted res earc h. Fede ral Min e Saf ety and H e a l th Act of 1977, 30 U. S. C. § 801. Congres s dir ect ed N IO SH to im pr ove and expand res earc h pr ogram s to pr event occ upat ional dis eas es in the mi ning indu st ry. Id

. U. S. C. §§ 801( g), 951( a)( 9); see also 29 U. S. C. § 6 71. Con gres s dec lare d that“ther e i s an urgentne ed to pr ovidem oreef fec tive me ansand me asu r e s f

or im pr oving the wo rk ing conditio ns and pr actices in the Nat ion' s coal or othe r mi nes in ord er to pr even t dea th and se riou s phys ical harm , and in ord er to pr event occ upat ional dis eas esoriginat ing i n s uch min es .” 30 U .S .C. § 801(c)

. NCI is another com pone nt of HH S. See 42 U. S. C. §§ 2 8 1 ( a) , (b ) ( 1 ); id

. § 202. NCI 2 cond uct s and sup ports re se arch , inform atio n dis se mi natio n, and othe r act ivitie s rela ted to “th e caus e, diagno sis , pr event ion, and tre atm ent of canc er. ” Id

. § 285. NCI is als o autho rized to coo rdinate its res earc h act ivitie s wi th othe r publ ic and private enti tie s, suc h as NIO SH , that perfor m sim ilarw ork

. See id

. § 2 84(c)( 1). MARG rep res ents a majo rity of the mi ne ope rat ors wi th mi nes in the st udy. Curre nt 3 MARG com pany me mbe rs inclu de Cargill , Inc., De tro it Salt , Mo ss aic Potas h (f orm erly IMC) , Mo rto n Salt , Ge nera l Chem ical (no w Tata Chem ical s, US) , FMC Wyom ing, and Navis tar and Lonny Badea ux wh o is a plai ntif f in his ow n per so nal cap acity, as a for me r mi ner and subject of the st udy. 2 Case: 11-30812 Document: 00511866647 Page: 2 Date Filed: 05/24/2012No. 11-30812

review the draft protocol, for which BSC provided notice and allowed for public comment. Plaintiffs offered their comments at the meeting. After the meetings, BSC voted to approve the protocol for the study.
Then in 1 9 99, however, Plaintiffs sued, alleging that HHS had violated the Federal Advisory Committee Act (“FACA”) by using BSC to review the draft protocol. Pur s u a n t t o FACA, the government must file the charter for an advisory committee (such as BSC) with a certain congressional s tanding committee, depending on the federal agency that the advisory committee advises. 5 U.S.C. Appx. § 2. HHS had mistakenly filed the charter for BSC with the House Commit t e e o n Commerce, rather than the House Committee on Education and the Workforce (“the House Committee”). On a ppeal, this court held that HHS had indee d m a d e a m istake by filing BSC’s charter with the wrong congressional committee. Cargill, Inc. v. United States , 173 F.3d 323, 334 (5th Cir. 1999). Although inadvertent, HHS’s mistake required correction. To

ensure proper congressional oversight of BSC, and to ensure that BSC’s review of the draft protocol was valid, the appropriate congressional committee with the requisite expertise needed to be involved. This court further held that Plaintiffs h a d standing to compel HHS to refile the charter because the validity of the study protocol affected Plaintiffs’ interests. Id. at 342. The study findings would form the basis for n e w a d m i ni strative regulations. An invalid study protocol would generate an invalid study, which could lead to unnecessarily re s t rictive regulations on Plaintiffs. This court ultimately instructed the district court to fashion an injunction that promoted FACA’s goals of en suring public accountability and of reducing economic waste. Id.
On remand on March 13, 200 0 , the district court issued an injunctive order to remedy this FACA violation (“2000 Ord er”), which required HHS to provide study drafts and requested study data to th e H ouse Committee, and gave the

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House Committee veto power over the study. HHS appealed the order as overly broad, and this court agreed with HHS, instructing the district court to enter a
narrower order, stating that there was “little reason for future injunctive relief” beyond refiling the charter with the correct House committee. Akzo-Nobel, Inc.

v. United States , 2001 WL 34772 2 0 6 , a t *2–*3 (5th Cir. 2001). “[A]n order requiring [House C o m m it t e e] approval before the study can be released is not appropriate for HHS’s inadvertent mistake in filing the [BSC’s] charter with the wrong House committee.”Id . at *2.
HHS did not hide from Congressional o v e r s i ght. It tried to make itself accountable to the public. It unknowingly filed BSC's charter with the wrong House com m it t e e and filed it with the correct Senate committee. Plaintiffs and other interested parties had actual notice that the BSC was reviewing th e s tudy protocol and were informed of and invited to every meeting of the BSC panel. Id

. This court noted concern “that the [House] Committee should have sufficient time to examine the misfiled study data” and become familiar on the validity of the study protocol and BSC’s corresponding advice. Id . at *3. Accordingly, we instructed the district court to “revise its order so that HHS will be barred from publicly releasing any of the information it sends to the [House] Committee until 90 days after its submission.” Id

. On rema nd again in 2001, the district court issued a new two-part injunctive order (“2001 Order”). In the first part of the order, the district court 4 required HHS t o submit BSC work product to the House Committee and to Plaintiffs. The last line of the first pa rt s t ates: “Defendants shall provide Plaintiffs with c op ie s of all documents submitted to the Committee in compliance with this Order.” In the second part of th e o r d e r , the district court required HHS to submit to the House Committee (i) study data requested by the

At tac hed is a c opy of the 2001 Or deras ap pendix 1. 4
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Committee and (ii) study “draft reports, publi c a ti o n s, and draft results or risk notification materials.” The district c ourt also barred HHS from publicly releasing i nformation submitted to the House Committee until 90 days after submission. The second part of the order did not mention Plaintiffs.
Nine years passed after the 2001 Order without any controversy. In 2002, BSC finished its oversight of the s t u dy protocol. Between 2002 and 2004, in compliance with the 2001 Order, HHS submitted study drafts and data t o the House Committee. The submitted materials i n cluded final drafts of different parts of the study as they were completed, sample notification letters that were sent to individual miners, and a presentation that the agencies gave at a public meeting regarding the study’s progress. Furth e r m o r e , in 2002, the House Committee wrote to HHS (“2002 Letter”) to:
request that [NIOSH] provide all draft copies of all reports, notifications, recommendations, or alerts, related to or based on the [study], prior to the release or publication of such study, or portion the r e o f

. The [House Committee] also requests submission of study data, in a format capable of b eing analyzed, as the data collection phase of each part of this stu dy i s completed, and preceding the drafting of any reports. I n 2 0 0 3 , the House Committee wrote to Defendants (“2003 Letter”), askin g several questions about the study and requesting specif i c d a t a s ets. HHS complied with these letters; HHS also provided Plaintiffs with copies of the cover letters sent to the House Committee, but not the actual drafts and data. In 2004, the House Committee wrote to Defendants (“2004 L etter”), stating that NIOSH and NCI:

m u s t submit any data requested by the Committee in accordance w ith certain confide nti al ity statutes and the terms specified in the order and
m ust refrain from publicly releasing information submitted t o th e Committee until 90 days after the date of submission. We hereby request NIOSH and NCI to provi d e copies of any submissions that the agencies are required to make to this Committee under the District Court’s order
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to a scientific reviewer designated by the United Steelworkers of America at the same time they make their submission to the Committee. In response, HHS provided some data sets to Plaintiffs and answered Plaintiffs’ questions about the data.
In or about 2009, HHS split the study into seven draft articles and decided to submit the draft articles to scientific journals for peer review. In November 2009, HHS submitted the first four draft articles to the Annals of Occupational Hygiene (“AOH”). HHS se n t A O H a copy of the 2001 Order and asked the j o u r n al to “ensure that its staff and peer reviewers

. . . maintain th e confidentiality of the manuscripts” to “ensure that the [HHS] agencies remain in compliance with [the 2001 Order] during the journal’s review process of these manuscripts.” AOH agreed. In February 2010, AOH accepted the four articles for publication.
On March 1, 2010, HHS submitted the final drafts of these four articles to the House Committee. HHS also s e n t P laintiffs a copy of the cover letter sent to the House Committee, but not the actual artic l e s

– s i milar to HHS’s practice in 2002 and 2003. In April 2010, the Plaintiffs responded by filing two motions for contempt. First, Plaintiffs argued that HHS had violated the 2001 Order by submitting the final drafts of the four articles to the House Committee but not to Plaintiffs. Second, Plaintiffs argued that HHS had violated the 2001 Order by submitting the four articles to AOH before sending them to the House Committee and to Plaintiffs and then waiting 9 0 d ay s . In its order (“2010 Order”), the distric t c o u rt denied the contempt motions. The 2010 Order 5 required HHS to submit the final drafts of the four articles to the H o u s e Committee and Plaintiffs, and required HHS to wait 90 days before further distributing the study articles so that the House Committee and Plaintiffs would

At tac hed is a c opy of the 2010 Or deras ap pendix 2. 5 6 Case: 11-30812 Document: 00511866647 Page: 6 Date Filed: 05/24/2012No. 11-30812

have an opportuni ty t o review the study articles. The district court further required HHS to prevent AOH from publishing the articles un til th e 90-day review period was complete. Lastly, the district court noted that Plaintiffs may not further disclose the articles during the 90-day period, but may make comments about the articles to HHS or to the House Committee. The district court did not r e s o lve the issue of whether the submission of an article to a scientific journal for peer review constituted “public release” in violation of the 2001 Order

. Furthermore, in a p ri o r hearing, the district court had explained that it was not holding Defendants in contempt because “there is some language in [the 2001 Order] that I can see where they’re coming from.”

In September 2010, AOH published the four articles, after Plaintiffs and the House Committee had 90 days to review them. HHS only provided Plaintiffs

a n d th e House Committee with the final proofs of the articles. HHS di d n o t provide Plaintiffs with the underlying study drafts or data. HHS indicated that it planned to produce data in the form of a “public use” dataset that resolv e d confidentiality problems.

B y M ay 2 011, the study’s final three papers were almost ready for publication. One article was ready to be published in AOH, and the other two had been submitted to another pe er-reviewed scientific journal and were undergoing peer review. HHS planned to provide the final drafts of these articles to the House Committee and Plaintiffs once they were accepted for publication, and then wait 90 days before publishing the articles. Accordingly,

on May 31, 2011, HHS moved “for an order extending the provisions of the [2010 Order] to the last three papers remaining for publication in this action.”

In response, Plaintiffs brought a new motion for c o n t e m pt on June 10, 2011. Plaintiffs argued that HHS had been violating the 2001 Order since 2005,

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when it stopped submitting any study drafts or data to the House Com m it tee and to Plaintiffs. They argued further that HHS had violated the 2001 Order by submitting the last three draft articles to outside journals before submitting them to Plaintiffs and the House Committee. Plaintiffs requested that study drafts and data be provided to the House Committee and to Plaintiffs, pursuant to the 2001 Order.

In July 2011, the House Committee wrote to HHS (“2011 Letter”), noting that under the 2001 Order, NIOSH and NCI:

must submit to this Committee and the MARG all data requested by the Committee as well as all draft reports, publications, and draft results or risk notification materials prepared in connection with the NIOSH/NCI Diesel study. The agencies must submit any data r e quested by the Committee in accordance with certain confidentiality statutes and the terms specified in the order, and must refrain from publicly releasing information s ub m it t ed to the Committee until 90 days after the date of submission. In August 2011, the district court held a hearing on the Plaintiffs’ motion for contempt. In its order, the district court found HHS in contempt, and issued

a broad injunctive remedy (“2011 Order”). First, the district court ordered HHS 6 to immediately produce to Plaintiffs and the House Committee, “all nonconfidential documents, data, draft rep o rt s , publications, and draft results or risk notifi c a ti o n m aterials,” relating to the study. Second, the district court ordered HHS t o “immediately inform all recipients, including journals, of the above described study draft reports, not yet published, that they are prohibited from further distributi o n o f s aid drafts until at least 90 days after [HHS has] complied with this Order[.]” Third, the district court noted that Plaintiffs may not further disclose the articles during the 90-day period, but may make comments about the articles to HHS, the publishing journals, or the House

At tac hed is a c opy of the 2011 Or deras ap pendix 3. 6 8 Case: 11-30812 Document: 00511866647 Page: 8 Date Filed: 05/24/2012No. 11-30812

C ommittee. Fourth, the district court awarded Plaintiffs attorneys’ fees. On September 1, 2011, HHS appealed the 2011 Order.
II. S TAN D A R D O F R E VI EW “We review contempt ord e r s and sanctions imposed thereunder for an abuse of discretion.” Whitcraft v. Brown , 570 F.3d 268, 271 (5th Cir. 2009). “We review the district court’s underlying findings of fact for clear error and its underlying conclusions of law de novo.” Id

. III. ANA LY S I S A. Whether the district court abused its discretion by holding HHS in contempt. “[A] court abuses its discretion when it (1) reli e s o n clearly erroneous factual findings, (2) relies on erroneous conclusions of law, or (3) misapplies its factual or legal concl u s i o n s . ” Cargill, Inc. v. United States , 173 F.3d 323, 341 (5th Cir. 1999) (citing Peaches Entertainment Corp. v. Entertainment Repertoire Assocs ., 62 F.3d 690, 693 (5 Cir. 1995)). Here, the di s t ri c t c o u rt made no th findings, and likewise, made no conclusion s o f l a w. Hence, there is no way to determine what the district court either r e l i e d o n or applied. Instead, the district court provided no specificity as to what action by HHS violated the 2001 Order. First, the only finding made by the district court in its 2011 Order was that HHS was in contempt, but the district court does not provide any basis for that finding. The three preceding paragraphs of the 2011 Order are stand alone orders, not reasons for the finding of contempt. Second, a careful review of the hearing transcript regarding P l aintiffs’ contempt motion further supports our conclusion, because it also reveals that the district court made no findings and made no conclusions of law. The district court did not specifically identify any

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violation of the 2001 Order, n o r di d the district court identify, or discuss with specificity, any part of the 2001 Order. Nonetheless, the parties have briefed two grounds for the district court’s contempt order. First, Plaintiffs urge, and HHS denies, that HHS violated the 2001 Order by submitting study articles to out s i d e scientific journals for peer review before submitting the articles to Congress. Second, Plaintiffs urge, and HHS denies, that HHS violated the 2001 Order by failing to submit study drafts and requested study data to both Congress and to Plaintiffs. F o r the reasons stated below, even if we assume that the district court based its contempt order

on these alleg e d vi olations, the contempt order constitutes an abuse of discretion. 1. Whether the district court properly he l d HHS in contempt for submitting study articles to outside scientific journals.
“A movant in a civil contempt proceeding bears the burden of establishing by clear and convincing evidence 1) that a court order was in effect, 2) that the order required certain conduct by the respondent , and 3) that the respondent failed to comply with the court’s order.” Id. It is undisputed that the 2001 Order

w a s in effect. It is further undisputed that the 2001 Order required cert ai n conduct by H H S. Therefore, the remaining question is whether HHS failed to comply with the 2001 Order. The last sente n c e o f the 2001 Order states that HHS “shall refrain from
pu b l i c l y releasing information submitted to the Committee until 90 days after it is submitted to the Committee.” (Emphasis ad d e d

. ) Plaintiffs contend that HHS violated the 2001 Order when it provided draft copies of the study to AOH. HHS maintains that it did not violate the 20 0 1 O r d er, because it provided the draft copies of the study to AOH (1) for the purpose of peer review, which does not qualify as a “public release” and (2) with a s p e c if i c admonition that any manuscripts related to the study remain confidential.

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Documents involved in the peer review process are exempt from disclosure pursuant to the Freedom of Information Act (“FOIA”) exemption that applies to “inter-agency or intra-agency memorandum or letters which would not be available by law to a party other than an agency in litigation with the agency.” 5 U

. S

. C

. § 552(b)(5). This FOIA exemption cannot be invoked for a document that has already been released publicly. See Cooper v. Department of Navy , 594 F.2d 484, 488- 89 (5th Cir. 1979). Here, the 2001 Order does not define “publicly release,” and the 2011 Order specifically exempts confidential documents from production. Therefore, a paper submitted for peer review canno t b e deemed publicly released. This court also recognized that “the government may deem it necessary to seek the objective opinion of outsid e experts rather than rely solely on the opinions of government” empl o y e es, and that documents prepared by these outside experts qualify as “intra-agency” memoranda not subject to dis c l o sure pursuant to the relevant FOIA exemption. Hoover v. U.S. Dep’t of the Interior , 611 F.2d 1132, 1138 (5th Cir. 19 80). Additionally, in the aforementioned 2004 Letter, th e H o u se Committee recognized that “[w]e understand that the participation of the representatives of MARG and the Steelworkers will be dependent upon these representatives entering appropriate confidentiality agreements with the agencies.” (Emphasis added.) Likewise, in 2005, the Executive Office of the President Office of Management and Budget issued its Final Information Quality Bulletin for Peer Review (“Peer Review Final Bulletin”), which are guidelines regarding peer review of scientific information dissemin a t e d b y federal agencies. See Final Information Quality Bulletin for Peer Review , 70 Fed. Reg. 2,664, 2,665 (2005). The Peer Review Final Bulletin states, in relevant part: Peer review should not be confused with public comment and other stakeho l d e r p rocesses. The selection of participants in a peer review is

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based on expertise, with due consideration of independence and conflict of interest. Furthermore, notice-and-comment procedures for agency rulemaking do not provide an adequate substitute for peer review, as some experts – especially those most knowledgeable in a field – may not file public commentswith Federal agencies.

. . . Peer review may take a variety of forms, depending upon the nature and importance of the product. For example,

. . . the n a m e s of each reviewer may be disclosed publicly or may remain anonymous (e.g ., to encourage c a n dor)

. . . For large, complex reports, different reviewers m ay b e assigned to different chapters or topics. Such reports may be reviewed in stages, sometimes with confidential reviews that precede a public process ofpanel review

. As part of government-sponsored peer review, there may be opportunity for written an d/o r oral public comments on the draft product.

. . . Similarly, when a government agency sponsors peer review of its own draft doc u m e nts, the peer review reports are an important factor in information dissemination decisions but rarely are the sole consideration. Agencies are not expected to cede their discretion with r e g a r d to dissemination or use of information to peer reviewers; accountable agency officials must make the final decisions.
Id

. at 2,665-2,666 (emphasis added). In addition, the Peer Review Final Bulletin defines “dissemination” as “agency initiated o r s ponsored distribution of information to the p ublic” but specifically excludes from this definition “information distributed for peer review in compliance with this Bulletin.” Id

. at 2,667. “Moreover, the National Academy of Sciences now discloses the names of its peer reviewers, without disclosing the substance of their comments .” Id

. at 2,670 (emphasis added). Her e, HHS submitted drafts of the study to AOH solely for peer-review
purposes. When HHS sub m itted the final three papers for peer review, it transmitted a copy of the 2001 Order to the reviewing journals and admonished them to maintain the confidentiality of the papers during the review process. In a November 2, 2009 letter to AOH, HHS stated:

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NIOSH’s and NCI’s “actions regarding this study are the subject of a court order issued by the United States District Court of the Western District of Louisiana, and request your journal’s assistance to ensure that the a ge nc ies remain in compliance with this order during the journal’s review process of these manuscripts. I have enclosed a c o py f o this order for your information. Paragraph 2 of the order directs the agencies, among other things, to submit draft r e p o rt s and publications to a committee in the United States House of Representatives and to refrain from publicly releasing any information submitted to that committee until 90 days after it is submitted.

. . . Th e r efore, both agencies are requesting that the Annals of Occupational Hygiene ensure that its staff and the peer reviewers it employs maint a i n t h e confidentiality of the manuscripts

. It is my understanding, from your discus s i o n s with representatives of NCI, that the Annals of Occupational Hygiene requests t h a t i t s reviewers maintain the confidentiality of any manuscript w hich they are asked to peer review as part of its normal peer review process . The agencies request, in addition to your normal procedures, that you inform your reviewers and staff, in writing, that this study is subject to a court order that requires the manuscripts and their content to remain confidential

. (Emphasis added.) HHS’s specific confidentiality admonition supplemented the general rule that scientific journals – such as AOH – keep materials submitted for peer review confidential. F o r e x ample, HHS stated – in a March 1, 2010 l e t t e r to the United States House of Representatives Committee on Education and Labor – that “[i]t is the policy of peer-reviewed scientific journals to refuse to publish papers if the information contained in them is disclosed prior to the scheduled publication date.” NIOSH and NCI had followed this practice when HHS submitted the study’s fir s t four papers to AOH for peer review in 2009, and the H o use Committee never objected or indicated that it found this problematic. Accordingly, HHS did n o t vi o late the 2001 Order by submitting study articles to outside scientific journals. Even if submitting study articles to outside scientific journals is the basis for th e contempt order, holding HHS in contempt for such submission constitutes an abuse of discretion.

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2. Whether HHS violated the 2001 Order by failing to produce requested study data and drafts to Plai nt i ffs and to the House Committee.
HHS argues on appeal that it has fully complied w ith the 2001 Order’s mandate to submit to the House Committee: (1) study “data requested by the [House Committee]” and (2) “draft reports, publications, and draft results or risk notification materials ” related to the study. Plaintiffs counter on appeal that HHS violated the 2001 Order by f ailing to provide: (1) Plaintiffs with study materials, (2) the House Committee with requested data from 2005 onward, and (3) the House Committee with study drafts from 2005 onward. First, HHS did not violate the 2001 Order by failing to submit requested study data and study drafts to Plaintiffs. HHS routinely provided Plaintiffs with

cover letters of the study materials sent to the House Com m it t e e . Although HHS did not always provide Plaintiffs with the actual study materials, the 2001 Order did not require HHS to do so. Part 1 of the 2001 Order required HHS to submit BSC’s work product to the House Committee, and required Defendants to submit to Plaintiffs al l th e documentation that it submitted to the House Committee. That latter requirement was the last sentence of Part 1, which read: “[HHS] shall provide Plaintiffs with copies of al l documents submitted to the Committee in compliance with this Order.” Yet, in the entirely separate Part 2

– wherein HHS was ordered to submit to the House Committee: (1) study data that th e House Committee requested and (2) study drafts – there was no mention of Plaintiffs. Part 2 includes no requirement that HHS submit this information – requested study data and study drafts – to Plaintiffs. Of course, Plaintiffs urge that the last line of Part 1 of the 2001 Order applies to the entire order. However, because the 2001 Order has been split into two separate parts, there is no reason to read the last sentence of Part 1 as also applying to Part 2, such th at HHS would be required to submit requested study data and study

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drafts to both Plaintiffs and the House Committee. Furthermore, to the extent that HHS submitted any materials to Plaintiffs – s u ch as the materials submitted in 2004 – HHS did so out of an ab u n d ance of courtesy. Lastly, the House Committee itself read the 2001 Order as requiring HHS to submit study materials to the House Committee, but not to Plaintiffs. In the 2004 Letter, the House Committee indicated that the 2001 Order obligated HHS to submit study materials to the House Committee. The letter then proceeded to request HHS to produce to Plaintiffs’ reviewer study materials that had been submitted to the House Committee. HHS provided the reviewer with certain study data. If the 2001 Order on its face required HHS to produce study materials t o Plaintiffs, then the House Committee would not have had to request HHS to produce study

m a t e rials to Plaintiffs. Later, in the 2011 Letter, the House Committ e e indicated that the 2001 Order obligated HHS to submit study materials “to this Committee and to MARG,” one of the Plaintiffs

. I t appears that the House Committee about faced because of the instant litigation. The absence of “MARG” in the 2004 Letter, compared to the 2011 Letter, demonstrates that the original understanding of the 2001 Orde r w a s th at HHS was not required to produce study materials to Plaintiffs. Therefore, HHS did not violate the 2001 Order by failing to submit study materials to Plaintiffs. To be sure, Plaintiffs also argue that HHS violated the 2001 Order by failing to provide th e H o u se Committee with requested data and study drafts f rom 2005 onward. Regardless of the soundness of Plaintiffs’ ar gu m e nt , however, the 2001 Order was ambiguous. I t i s well-settled that the “judicial cont e m p t p o wer”–a “potent weapon”–“should not be used if the court’s order
upon which the contempt was founded is vague or amb i gu o u s . ” Piggly Wiggly Clarks v ille, Inc. v. Mrs. Baird’s Bakeries , 177 F.3d 380, 383 (5th Cir. 1999) (internal quotation marks omitted). Thu s , even if the district court based its contempt order on HHS’s failure to provide Plaintiffs and Congress with certain

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study materials–including the failure to provide Congress with study drafts and request ed study data from 2005 onward–holding HHS in contempt for such a failure constitutes an abuse of discretion. We have concluded that there was n o b a s i s for the district court to hold HHS in contempt. In any event, the district court’s entire record is completely devoid of any stated reason for the contempt order. The district court made no f actual findings or legal conclusions related to the 2011 Order. We th e r e f o r e hold that the district court abused its discretion in holding HHS in contempt. B. Whether the district court abused its discretion in issuing a broad injunctive remedy to ensure compliance with the 2001 Order.
In the 2011 Order, the dist ri c t court required HHS to “immediately produce to Plaintiffs and [the House Committee] all non-c onf i de nti al documents, data, draft reports, publications, and draft results or risk notification materials” related to the seven published or publish-ready articles. The district court also required HHS to warn th e journals not to publish the study materials, and required Plaintiffs not to further disseminate the study materials. The district court also noted that Plaintiffs are permi t t e d t o m ake comments about the articles to HHS, the publishing journals, or the House Committee. We hold that the district court abused its discretion by fashioning a new, broader order in 2011 that went beyond what it had ordered in 2001. Remedial injunctions must be narrowly drawn and precise, and the relief granted must be tailored to fit the nature and extent of the established violation. See, e.g. , Haitian Refugee Center v. Smith , 67 6 F

. 2 d 1023, 1041 (5th Cir. 1982); Fiber Systems Int’l v. Roehrs , 470 F.3d 1150, 1159 (5th Cir. 2006) (“An injunction must be narrowly tailored to remedy the specific action necessitating the injunction.”). The 2011 Order purported t o r e s t a te HHS’s obligations pursuant to the 2001 Order, which remedied a specific violation: the minor FACA violation. Because the 2 0 0 1 O r d e r was issued to remedy the FACA mistake, and the 2011 Order

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w a s issued to ensure compliance with the 2001 Order, the 2011 Order s h o ul d have been narrowly tailored t o f it the minor administrative mishap. By requiring production of all non-confidential study drafts and data to the House Committee and to Plaintiffs, however, the 2011 Order is not so narrowly drawn. After HHS had filed BSC’s charter with the wrong congr e ssional committee, this court instructed the district court to require HHS to file BSC’s charter with the correct congressional committee. Cargill, 173 F.3d at 342. BSC

was tasked with advising HHS on the research protocol for the study. The charter needed to be filed w ith the correct congressional committee to ensure proper congressional oversight of BSC’s review. Other than ordering H H S to refile the charter, how e v e r , we noted that “there was little reason for further injunctive relief.” Akzo-Nobel , 2001 WL 34772206, at *2. We also noted that the

new House Committee would requ ir e s o me time to become familiar with the

s tudy protocol and examine the misfiled study protocol data. Id

. We th u s instructed the district court to revise its o r d e r to bar HHS from publicly releasing any information it sends to the House Committee until 90 days after its submission. Id

. In response, the district court fashioned the 2001 Order to require HHS to submit study drafts and requested study data to the House Committee. Because the 2001 Order was issu e d to remedy such a trivial FACA violation, the 2001 Order should be read narrowly. The violation only concerned BSC, wh i c h w a s t asked with a small role: advising HHS on the research protocol

. Despite the erroneous filing, Plaintiffs had actual notice that BSC was reviewing the study protocol, wer e i nf o rmed of and invited to every BSC meeting, and attended each BSC meeting and provided oral and w ritten comments. Also , f

iling the charter with the correct committee was important merely to enable the House Committee’s oversi gh t r egarding the research protocol, as opposed to the entire study itself.

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The 2011 Order is overly broad and demands mu c h m o r e than the
p roperly-construed 2001 Order. First, although the 2001 Order only require s HHS to produce study materials to the House Committee, th e 2 0 1 1 Order requires HHS to produce study materials to th e House Committee and to Plaintiffs. Second, although the 2001 Order requires HHS to submit to the House Committee data that the House Committee request s , the 2011 Order requires HHS to produce all non-confidential data to the House Committee and to Plaintiffs. Thir d , al th o ugh the 2001 Order requires HHS to submit to the House Committee “draft reports, publications, and draft results or risk notification materials,” the 2011 Order requires HHS to submit all “documents” to House Committee and to Plaintiffs, in addition to draft reports, publications, draft results or risk notification materials. Because the 2011 Order was issued to ensure compliance with the 2001 Order, th e 2011 Order must be as narrowly drawn and precise as the 2001 Order, which was narrowly tailored to remedy the inadvertent FACA mistake. By going beyond the 2001 Order, however, the 2011 Order becomes untethered from the underlying FACA violation to which it must be narrowly fit. As HHS argues: “Ordering the disclosure of inf o rmation completely unrelated to an advisory board and that [P]laintiffs never could have obtained had FACA been complied with goes far beyond FACA’s purpose t o r e gulate boards and committees established to advise the executive branch.” Plaintiffs have no free-standing right to HHS’s study materials. For the district court to issue an injunction to grant Plaintif f s access to HHS’s study materials, Plaintiffs must identify a specific violation that the injunction would remedy. Neither Plaintiffs nor the district court has identified any violation that the 2011 Order was issued to remedy except for the FACA mistake, which HHS remedied a decade ago. More precisely, the 2011 Order was issued to bring HHS i n t o compliance with the 2001 Order, which was issued to remedy the FA CA

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mistake. However, neither Plaintiffs nor the district court has identified some other “violation,” besides the FACA mis t ak e , that HHS committed that would justify issuing a broader injunctive remedy. Consequently, there are no grounds for expanding the scope of the 2011 Order beyond the scope of the 2001 Order. Because the underlying FACA mistake was, at most, administrative, we should narrowly c o n strue the 2001 Order, and we should be wary of any provision of the 2011 Order that goes beyond the 2001 Order. The overly broad injunctive remedy in the 2011 Order – requiring production of all study drafts and data to the House Committee and to Plaintiffs – is an abuse of di s c r e ti o n . IV. C O N C L U S I O N For the foregoing r e a s o n s, we hold that the district court abused its discretion by holding HHS in contempt and by f a s h i o ni ng an overly broad injunctive remedy. With respect to the 2011 Ord e r , th e r e fore, we VACATE in part and REVERSE in part.

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