In The Line Of Fire Increased Enforcement Efforts Associated With The Foreign Corrupt Practices Act
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Vol. 5 No. 2 May 2012
S OLU T IO NS FOR YOU
In The Line Of Fire
Increased Enforcement Efforts Associated
With The Foreign Corrupt Practices Act
Foreign Clinical Trials
Benefiting From The FDA’s Guidance
In Order To Meet Study Standards
A Bridge To Nowhere
RICO Fraud Consumer Class Actions
Against Pharmaceutical Manufacturers
D Dear Client:
It is no longer a surprise to read about a pharmaceutical or medical device company being investigated
by the United States Department of Justice for violation of the Foreign Corrupt Practices Act. The
Department of Justice has set up special teams to investigate the healthcare industry and potential
violations of the Act. In the Line of Fire discusses this focus and also gives some timely advice on how
to structure a compliance program which will serve you well if your company is investigated.
Plaintiff’s attorneys are always looking for new avenues to bring lawsuits. Racketeering Influenced and
Corrupt Organizations Act (RICO) claims against pharmaceutical companies are part of this effort.
RICO Class Actions are the focus of A Bridge to Nowhere: RICO Fraud Consumer Class Actions Against
Pharmaceutical Manufacturers Post Bridge v. Phoenix Bond.
Clinical studies in foreign countries in support of new pharmaceuticals are now more the norm than the
exception. The New Federal Guidance on Foreign Clinical Studies gives some background on the growth
of foreign clinical studies, as well as the FDA’s most recent advice as to how best to conduct them.
And don’t miss the second installment of our comprehensive fifty state survey on the local federal
court rules on protecting confidential information. This issue contains the remaining twenty-four
states and Puerto Rico and, with part one in the February 2012 issue of Pro Te: Solutio, should be a
handy reference source.
Our goal in Pro Te: Solutio is not only to keep you abreast of some of the topics important to you, as
part of the healthcare industry, but to also offer you some tips and practical suggestions on how to
better meet your demanding jobs. We hope this issue attains that goal.
Charles F. Johnson
Christy D. Jones Co-Chair —
Co-Chair — Litigation Business and Corporate Healthcare
table of contents
Vol. 5 No. 2 May 2012
In the Line Of
Sharing Solutions Fire: Recent
2
FCPA Enforce-
It’s human nature to share problems. But how often is someone
ment Efforts
willing to share solutions? Butler Snow wants to do just that ––
provide scenarios and the solutions that turned a client’s anxiety
into relief and even triumph. That’s why we created this magazine,
The New FDA
Pro Te: Solutio, which explores how real-life legal problems have Guidance
been successfully solved.
That’s also why we at Butler Snow redesigned and expanded our
8 On Foreign
Clinical Trials
unique health-oriented industry group, now comprised of two
major sections that handle business and litigation. The Pharma- A Bridge To
Nowhere: RICO
22
ceutical, Medical Device, and Healthcare Industry Group has more Fraud Consumer
Class Actions
than 50 multi-disciplinary attorneys who provide creative solutions
for the complex issues of the healthcare industry. This group includes
product liability and commercial litigators; corporate, commer-
departments
cial, and transaction attorneys; labor and employment attorneys;
13 Case Law
intellectual property attorneys; and those experienced in govern-
ment investigations.
Pro Te: Solutio is a quarterly magazine available only to the clients
of Butler Snow. If you have questions or comments about its
articles, you’re invited to contact Christy Jones and Charles
Johnson, as well as any of the attorneys listed on the last page of
this publication.
Pro Te: Solutio 1
2 Pro Te: Solutio
IN THE
2012 RECENT FCPA ENFORCEMENT EFFORTS IN THE
LINE OF
FIRE
PHARMACEUTICAL/MEDICAL DEVICE INDUSTRY AND THE
IMPORTANCE OF AN EFFECTIVE COMPLIANCE PROGRAM
“I meant what I said and I said what I meant.”
— DR. SEUSS, Horton Hears a Who!
“Our focus and resolve in the FCPA area will not abate,
and we will be intensely focused on rooting out foreign bribery in your industry.”
— LANNY A. BREUER, Assistant Attorney General, Dept. of Justice,
Address to the Tenth Annual Pharmaceutical Regulatory and Compliance Congress, November 2009
Two and half years ago, the U.S. Depart- two years. In the last twelve months alone, or medical device entity that has any rela-
ment of Justice (DOJ) warned the health- the DOJ announced two significant settle- tion to the United States to heed the express
care industry that federal law enforcement ments with major medical device companies and explicit warnings provided by the DOJ
would be increasing efforts to monitor reaching combined payments over $90 mil- regarding FCPA enforcement would be reck-
pharmaceutical and medical device entities lion. There are at least 78 known ongoing less and the consequences likely to be dire.
for compliance with the Foreign Corrupt corporate investigations, including at least
Practices Act (FCPA). Several high-risk fac- eighteen healthcare industry players.2 Many FCPA BASICS: PRIVATELY HELD
tors make the industry an attractive target perceive the active enforcement of the FCPA ENTITIES BEWARE
for FCPA investigations, including the sig- as a natural expansion of the Anti-Kickback Enforcement of the FCPA against pub-
nificant amount of sales generated outside laws to the international arena. In fact, the licly held corporations attracts significant
the United States where healthcare sys- DOJ has noted that “the types of corrupt attention which may lull smaller, private-
tems are routinely operated by the govern- payments that violate the FCPA because ly held entities into a false sense of safety.
ment.1 Additionally, the industry has seen they are given to obtain or retain business in Yet, both public and private entities are
an increasing number of clinical trials and other countries are not any different than the subject to the reach of the FCPA. There
product development activity conducted items of value that would violate the Anti- are two principal parts to the FCPA: the
overseas where interactions with govern- Kickback Statute if given within the United Anti-bribery Provisions4 and the Books
ment-employed physicians and healthcare States — cash, gifts, charitable donations, and Records Provisions.5 The Anti-bribery
providers are routine and, arguably, signifi- travel, meals, entertainment, grants, speak- Provisions prohibit payments of any “thing
cantly less regulated. ing fees, honoraria, and consultant arrange- of value” to an individual knowing that it
The DOJ is as good as its word. The indus- ments, to name a few.”3 As explained more will be paid to a foreign official in order to
try has been hit hard by the FCPA in the last fully below, failure by any pharmaceutical corruptly influence the official or secure an
Pro Te: Solutio 3
As applied within the healthcare industry, the DOJ has emphasized that the “depth of government
involvement in foreign health systems, combined with fierce industry competition and the closed nature of
many public formularies, creates a significant risk that corrupt payments will infect the process.”
improper advantage in an attempt to obtain payments to “foreign officials” for the pur- pharmaceutical and medical device indus-
or retain business. The Books and Records pose of obtaining or retaining business or try are extensive: AstraZeneca, Baxter Inter-
Provision requires that “issuers” “make and securing any improper business advantage. In national Inc., Biomet, Bio-Rad Laborato-
keep books, records, and accounts, which, his remarks to the pharmaceutical industry, ries, Bristol-Meyers Squibb, Covidien, Eli
in reasonable detail, accurately and fairly Assistant Attorney General Breuer comment- Lilly, GlaxoSmithKline, Grifols SA (Talecris
reflect the transactions and dispositions of ed on the potential complexities involved in Biotherapeutics Holdings Corp.), Ingersoll-
the assets of the issuer.” 6 While the Books interpreting the term, which could encom- Rand, Medtronic Inc., Merck & Co. Inc.,
and Records Provisions apply only to com- pass health ministry and customs officials, Orthofix International NV, Pfizer Inc., Sci-
panies that are SEC-registered or reporting doctors, pharmacists, lab technicians, and clone Pharmaceuticals Inc., Smith & Neph-
“issuers,” the Anti-bribery Provisions have a health professionals at state-owned facilities.
ew, Stryker Corporation, Zimmer Holdings
more extensive reach. The Anti-bribery Pro- As he further explained, “nearly every aspectInc. Because this list is based on SEC filings,
visions apply to “domestic concerns” (United of the approval, manufacture, import, export,it likely represents only a fraction of ongo-
States companies, citizens, or residents); pricing, sale, and marketing of a drug prod- ing FCPA enforcement actions. A review of
any officer, director, employee, or agent of uct in a foreign country will involve a ‘foreign
two of the most recent settlements provides
a domestic concern; issuers who have a class official’ within the meaning of the FCPA.”8 valuable insight into the breadth of the inves-
of securities registered with the SEC; and, Because of this expansive approach, indus-tigations and generous elasticity with which
any person who does not fit within the cat- try personnel face a substantially higher like-
the government applies the FCPA provisions.
egories listed but violated the FCPA within lihood than professionals in other industries United States v. Johnson & Johnson (DePuy
the territory of the United States. Clearly, that they may interact with “foreign officials”
Inc.): In April 2011, the DOJ announced
the last, catch-all provision is expansive and as defined by the FCPA. Accordingly, phar- that it had entered into a three-year Deferred
could apply not only to a publicly held U.S. maceutical and medical device companies Prosecution Agreement (DPA) with Johnson
company, but also to any privately held com- must be aware that the seemingly routine & Johnson, a U.S.-based healthcare company
pany that finances a foreign activity with any engagement of healthcare providers, reim- that manufactures and sells pharmaceuticals,
component occurring in the U.S. Similarly, if bursements for program participation, travel,medical devices, and consumer healthcare
a foreign affiliate is acting as an “agent” of a gifts, entertainment, charitable contributions,
products, to resolve allegations that Johnson
U.S. (domestic) concern in facilitating illegal sponsorships, political contributions, clinical
& Johnson and its subsidiaries had commit-
conduct, then it too will be covered. trials arrangements, and regulatory approvalsted violations of the FCPA. According to the
The DOJ has consistently taken the posi- abroad all pose significant FCPA risks. government’s allegations, foreign subsidiar-
tion that minimum jurisdictional contacts ies of Johnson & Johnson paid kickbacks
include de minimus activities such as emails, to healthcare providers employed at govern-
RECENT FCPA MEDICAL
telephone calls, and transfers through cor- ment-owned hospitals in Greece to use its
DEVICE-RELATED DPAS
respondent bank accounts that occur in surgical implants, Poland to award contracts
the U.S. Due to the expansive interpreta- “I warn you dear child, if I lose my temper, to the company, and Romania to prescribe
tion given the jurisdictional provisions by you lose your head. Understand?” pharmaceuticals. The DOJ also alleged for-
the DOJ, any company with a nexus to the — THE QUEEN OF HEARTS, Alice in Wonderland eign subsidiaries of Johnson & Johnson paid
United States is potentially subject to FCPA kickbacks to officials of the former govern-
enforcement, even if the company and the In late 2009, the DOJ began assembling ment of Iraq in order to receive contracts to
illegal activity are located outside of the U.S. teams to support its FCPA focus on the provide humanitarian supplies under the
As applied within the healthcare industry, healthcare industry by combining the exper- United Nations Oil for Food Program. To
the DOJ has emphasized that the “depth of tise of the healthcare fraud unit with the resolve these charges, Johnson & Johnson
government involvement in foreign health international bribery expertise of the FCPA agreed to pay more than $48.6 million in
systems, combined with fierce industry com- unit.9 Consequently, FCPA enforcement disgorgement and prejudgment interest, as
petition and the closed nature of many public has gained significant momentum and now well as a $21.4 million criminal fine.
formularies, creates a significant risk that trails only terrorism as a DOJ enforcement As mitigating factors supporting the DPA
corrupt payments will infect the process.” 7 priority. The industry has felt the impact. settlement, the DOJ noted that Johnson
10
For instance, the FCPA criminalizes making Currently known investigations in the & Johnson had accepted responsibility for
4 Pro Te: Solutio
Enforcement of the FCPA against
publicly held corporations
attracts significant attention
which may lull smaller, privately
held entities into a false sense
of safety. Yet, both public and
private entities are subject to the
reach of the FCPA.
the offending conduct of its subsidiaries. & Johnson’s pre-existing compliance pro- establish an extensive compliance team net-
The DOJ recognized Johnson & Johnson’s grams, remediation efforts, and enhanced work including separate heads of compliance
prompt voluntary disclosure and extensive compliance commitments included in the within each business sector and corporate
self-investigation of the underlying conduct, DPA, the DOJ did not require the reten- function. The global compliance leadership
the cooperation provided by the company tion of a corporate compliance monitor. Yet, must include regional compliance leaders and
to the government investigators, and the the DPA does require that in addition to business segment compliance leaders. Every
extensive remedial efforts and compliance adhering to the corporate compliance pro- jurisdiction in which the company operates
improvements undertaken by Johnson & gram commitments common to most DPAs, must institute individualized gifts, hospitality,
Johnson. The DOJ also reported that John- Johnson & Johnson must comply with some and travel policies and procedures that con-
son & Johnson received a reduction in its notable “enhanced compliance obligations” tain restrictions regarding interactions with
criminal fine as a result of its cooperation in for the duration of the DPA. Among the government officials — which must explicitly
the ongoing investigation of other companies. more interesting “enhanced” obligations is include public healthcare providers.
Significantly, in consideration of Johnson the requirement that Johnson & Johnson On a periodic basis, Johnson & Johnson
Pro Te: Solutio 5
If there is concern that existing compliance
efforts are insufficient, a risk assessment
or gap analysis led by experienced counsel
is highly recommended. Any assessment
should identify high-risk countries and
personnel conducting high-risk activities.
is obligated to conduct FCPA audits and and rights to terminate as a result of any government-employed Greek healthcare pro-
risk assessments of markets where John- breach of anticorruption laws.11 viders to induce the purchase of products. In
son & Johnson has government customers. Smith & Nephew, Inc.: On February 6, total, from 1998 to 2008, Smith & Nephew,
Among other elements, these audits must 2012, the DOJ disclosed that it had entered its affiliates, and employees authorized the
include on-site visits to high-risk loca- into a three-year DPA with Smith & Nephew payment of approximately $9.4 million to
tions, review of a statistically representative Inc., a U.S. subsidiary of Smith & Nephew the distributor’s shell companies; some or all
sample of contracts with and payments to plc, a United Kingdom-based medical device of this payment was passed on to physicians
individual healthcare providers, and a cre- manufacturer, to resolve allegations that cer- employed by government-owned institu-
ation of action plans resulting from issues tain affiliates had committed violations of the tions overseas to corruptly induce them to
identified during audits. Comprehensive FCPA. According to the allegations, Smith & purchase Smith & Nephew medical devices.
due diligence reviews of sales intermediar- Nephew, through certain executives, employ- Smith & Nephew agreed to pay a $16.8
ies must be conducted regularly. Moreover, ees, and affiliates, agreed to sell products at million criminal penalty to settle the crimi-
Johnson & Johnson is directed to include in full list price to a Greek distributor and then nal charges. Additionally, Smith & Nephew
contracts (where permitted by law) standard pay the amount of the distributor discount was required to retain a corporate compli-
provisions designed to prevent violations of to an off-shore shell company controlled by ance monitor for 18 months. In discussing
the FCPA. Such provisions must include the distributor. These off-the-books funds the settlement with Smith & Nephew, the
anticorruption representations, rights to were then used by the distributor to pay DOJ noted Smith & Nephew’s cooperation
conduct audits of the books and records, cash incentives and other things of value to with the DOJ’s investigation, thorough self-
Substantively, there are a number of essential elements that must be present for any FCPA compliance program to
achieve its goals. Regular monitoring and auditing are critical to prevent complacency and enforcement gaps.
Robust due diligence processes must be applied to distributors, agents, joint venture partners, and vendor contracts.
6 Pro Te: Solutio
investigation of the underlying conduct, and tive preventative tool, however, a compliance suspected violations. Finally, detection will
the remedial efforts and compliance improve- program must be active and comprehensive. be meaningless unless there is a prompt and
ments undertaken by Smith & Nephew. If there is concern that existing compli- proper response to detected offenses.
The parent company, Smith & Nephew plc, ance efforts are insufficient, a risk assessment While no compliance program can pre-
also entered into a settlement with the SEC or gap analysis led by experienced counsel vent all illegal conduct, the failure to proac-
to resolve a civil complaint alleging violations is highly recommended. Any assessment tively deploy an effective program can have
of the FCPA. The SEC alleged that Smith & should identify high-risk countries and per- dire consequences. Early detection is key to
Nephew plc and its subsidiaries made illicit sonnel conducting high-risk activities. Simi- avoiding larger scale offenses. Similarly, the
payments to foreign government officials in lar reviews and updates should be conducted existence of robust programs will likely miti-
order to obtain or retain business, failed to on an annual basis — a practice reflected gate any enforcement actions that do occur.
have an adequate internal control system in in the recent Johnson & Johnson DPA
1
place to detect and prevent the illicit payments, enhanced compliance obligations. Identified See, generally, Lanny A. Breuer, Assistant Attorney Gen-
eral, Criminal Division, “Prepared Address to the 22nd
and improperly recorded each of those pay- deficiencies should be promptly addressed National Forum on the Foreign Corrupt Practices Act,”
ments in its accounting books and records. through a detailed remedial plan. (Nov. 17, 2009). Available at .
2
Smith & Nephew plc agreed to settle the SEC’s From a practical standpoint, there are See FCPA Blog at ,
charges by paying more than $5.4 million in certain key elements that are routinely over- identifying investigations based on SEC filing disclosures.
disgorgement and prejudgment interest. looked when FCPA compliance programs The number of FCPA investigations focused on non-pub-
lic entities is unknown.
Following announcement of the settle- are designed and implemented. At a funda-
3
As quoted in Sampson & Wesoloski, “Increased Target-
ment, the SEC cryptically stated that its mental level, any compliance initiative must ing of the Pharmaceutical and Medical Device Industries
investigation of the medical device indus- be supported by the tone at the top level of Under the Foreign Corrupt Practices Act,” 6 MELR 140,
02/22/2012.
try is continuing.12 the company. Similarly, no program will be
4
15 U.S.C. §§ 78dd-1, et seq.
broadly followed if it is not easily understood. 5
15 U.S.C. § 78m.
COMPLIANCE PROGRAMS: The policies and procedures must be written 6
15 U.S.C. § 78m(b)(2)(A).
PREVENTION & REDEMPTION in plain English: short, crisp, concise, avoid- 7
Lanny A. Breuer, Assistant Attorney General, Criminal
ing legalese. Canned policies found on basic Division. “Prepared Address to the 22nd National Forum
“Be Prepared” internet searches should be avoided in favor on the Foreign Corrupt Practices Act.” (Nov. 17, 2009).
PDF available at . Last accessed Apr. 27, 2012.
8
With the looming specter of continuing ties and concerns of the business. Moreover, Id.
9
the procedures must provide specific direc- Id.
government FCPA investigations into the
10
Michael Li-Ming Wong and Emily Proskine, “The For-
medical device industry, prevention and early tions regarding where to obtain guidance on
eign Corrupt Practices Act and Pharma: Is DOJ Following
detection of potential issues should be a pri- complex issues. Once written policies are Through on Its Tough Talk Towards the Industry?” Bloom-
in place, proper training must be provided berg Law Reports: Risk & Compliance (2010), citing
ority for all healthcare entities with ties to the
Charles McKenna, Chief, Criminal Division, U.S. Attor-
United States. While implementation and across all levels of the business. ney’s Office for the District of New Jersey, as a panelist in
enforcement of corporate compliance pro- Substantively, there are a number of essen- the American Bar Association’s Program, “Current Issues in
Medical Device and Pharmaceutical Litigation,” held at the
grams focused on the anti-kickback statute tial elements that must be present for any Schering-Plough Corporation in Kenilworth, New Jersey.
and Stark laws are now the norm, active com- FCPA compliance program to achieve its 11
For a complete discussion of the allegations and settle-
pliance efforts concentrated on the FCPA are goals. Regular monitoring and auditing are ment terms, see Robert Tarun, The Foreign Corrupt Prac-
tices Handbook, p. 401 (2nd Ed., 2012).
notably less prevalent — particularly in pri- critical to prevent complacency and enforce- 12
See “SEC Charges Smith & Nephew PLC with For-
vately held corporations that may not be sub- ment gaps. Robust due diligence process- eign Bribery,” (Feb. 6, 2012). Available at . Last accessed
Apr. 27, 2012.
the FCPA. Not only does this failure expose joint venture partners, and vendor contracts. 13
Lanny A. Breuer, Assistant Attorney General, Speech
the company to liability from rogue actors Along those lines, and as required in the to the 24th National Conference on the Foreign Corrupt
whose activities go undetected, but it also rep- recent Johnson & Johnson DPA, contracts Practices Act, (Nov. 16, 2010). Available at . Last accessed Apr. 27, 2012.
should the company become an FCPA target. tions regarding FCPA compliance, and clear
As stated by DOJ, “[t]here are many steps that grounds for termination related to FCPA
you can be taking that would put your orga- violations. Payments should be subject to an
nization in a better position for the day we approval process involving knowledgeable
do come knocking, or that could prevent us personnel trained to detect at-risk payments,
from coming at all.”13 In order to be an effec- coupled with clear reporting procedures for Written by Amy Pepke
Pro Te: Solutio 78 Pro Te: Solutio
THE NEW
FDA GUIDANCE
one FOREIGN
CLINICAL TRIALS
W I L L YO U R S T U D I E S M E E T T H E S TA N DA R D S ?
Clinical trials are the lifeblood seas — especially in Eastern Europe, Globalization of Clinical Trials: A Growing
of new pharmaceuticals in the United Asia, and South America. Challenge in Protecting Human Subjects.2
States. Investigational new drugs require • There is increasing concern in the This report found that foreign clinical inves-
such studies as proof of the safety and effi- United States over doctors who con- tigators conducting drug research under
ciency of the drug. Over the past fifteen duct studies and who are also paid an Investigational New Drug Application
years, however, it has become increasingly consultants by pharmaceutical com- (IND) had increased sixteen-fold over the
clear that it is not possible or practicable panies, which may mean even fewer past decade.3 The Office of Inspector Gen-
to have all of the clinical trials take place available clinical investigators. eral recommended that the Food and Drug
in the United States. Increasingly, more • In Eastern Europe, South America, Administration obtain more information
trials are being done in Eastern Europe, or Asia, the study subjects are less about the performance of foreign institu-
South America, and Asia.1 These studies likely to already be on drug therapy. tional review boards and encourage sponsors
take place outside the United States for a • Tests can be done out of season. For to obtain attestations from investigators that
variety of reasons: example, tests of an allergy drug can they would adhere to ethically sound prin-
• There are not enough competent be done in South America in January. ciples of research. The OIG also urged the
clinical investigators in the United Over the last decade, however, this trend FDA to take a leadership role in ensuring
States to conduct all the new stud- has also caused some concern and some crit- that there were adequate human safety pro-
ies for the increasing number of new icism. As early as 2001, the Office of Inspec- tections in all non-U.S. clinical trials.
drugs and devices being tested. tor General (OIG) of the Department of Since the release of this report, the use
• Cost of the trials is often less over- Health and Human Services authored The of foreign clinical trials in support of FDA-
Pro Te: Solutio 9approved pharmaceuticals has increased Good clinical practice is defined by regula- will be conducted. The Guidance notes
dramatically. A study in the New England tion as a “standard for the design, conduct, that the sponsor only has to provide to the
Journal of Medicine looked at the Clinical performance, monitoring, auditing, record- FDA the name and address of the IEC that
Trials.gov registry to find the countries in ing, analysis, and reporting of clinical trials reviewed the study along with a statement
which studies were taking place. It found in a way that provides assurance that the that the IEC meets the applicable require-
that, as of November 2007, for the twenty data are credible and accurate and the rights, ments for an IEC, but the sponsor must
largest U.S.-based pharmaceutical compa- safety, and well-being of trial subjects are maintain records supporting this submis-
nies, approximately one-third of the Phase 3 protected.”8 Additionally, the Guidance sion, including qualifications of members
trials were being conducted solely in foreign notes there are certain international ethical of the committee.11 The IEC has to approve
countries and that a majority of study sites and policy standards for clinical trials, such the study and any modifications to it, and
were outside of the United States.4 In recog- as the International Conference on Harmo- must continually review the study. Docu-
nition of this trend, in April 2008, the FDA nization of Technical Requirements for Reg- mentation of such actions, however, need
amended its regulations on the acceptance istration of Pharmaceuticals for Human Use not be submitted to the FDA. Such docu-
of foreign studies not conducted under an (ICH) “Good clinical Practice: Consolidat- mentation should be kept and provided to
Investigational New Drug as support for the ed Guideline” (“ICH E6”), which the FDA the FDA upon request.12
approval of the drug being studied.5 These has adopted for use as further guidance. The IEC must also approve the informed
amendments were made to ensure that all The Guidance states that GCP requires consent. ICH E6 defines informed consent
such studies were conducted in accordance review and approval of a foreign study by as “a process by which a subject voluntarily
A STUDY IN THE NEW ENGLAND JOURNAL OF MEDICINE LOOKED AT THE CLINICALTRIALS.GOV
REGISTRY TO FIND THE COUNTRIES IN WHICH STUDIES WERE TAKING PLACE. IT FOUND THAT,
AS OF NOVEMBER 2007, FOR THE TWENTY LARGEST U.S.- BASED PHARMACEUTICAL COMPANIES,
APPROXIMATELY ONE-THIRD OF THE PHASE 3 TRIALS WERE BEING CONDUCTED SOLELY IN
FOREIGN COUNTRIES AND THAT A MAJORITY OF STUDY SITES WERE OUTSIDE OF THE UNITED STATES.
with good clinical practices. This final rule an independent ethics committee (“IEC”) confirms his or her willingness to partici-
is codified at 21 CFR § 312.120.6 before the study is started to ensure that pate in a particular trial, after having been
In March 2012, the FDA issued the the rights and safety of the participants in informed of all aspects of the trial that are
Guidance for Industry and FDA Staff: FDA the study are being protected. It indicates, relevant to the subject’s decision to partici-
Acceptance of Foreign Clinical Studies Not however, that the FDA is flexible about the pate.”13 The Guidance notes that under 21
Conducted under an IND Frequently Asked requirements of an adequate IEC because CFR section 312.120 (b) (8), a description
Questions (“Guidance”).7 The Guidance the membership and organization of the of how the informed consent was obtained
notes that a sponsor may choose, but is not committee may vary from country to coun- must be provided. It also states that the FDA
required, to conduct a foreign clinical study try based on local needs and customs.9 The believes that the informed consent docu-
under an IND, and in such a case, all the FDA considers an independent ethics com- ments should notify the subjects that inter-
requirements of an IND must be met unless mittee to be adequate if it has “a reason- national regulatory authorities may need to
waived. But if the foreign clinical study is able number of members who collectively have direct access to their medical records
not conducted under an IND, it must com- have the qualifications and experience to for verification of study procedures and
ply with the requirements of 21 CFR Sec- review and evaluate the science, medical data.14 Additionally, the informed consent
tion 312.20. This Guidance seeks to answer aspects, and ethics of the proposed trial.”10 would normally contain a brief statement of
questions as to how sponsors of a new drug The Guidance also refers the sponsor to ICH any type of incentives that were given study
can demonstrate compliance with these E6, section 3.2, which requires there be at participants. If it does not contain such a
regulations regarding foreign clinical stud- least five members of an IEC and at least statement, the FDA should be given a brief
ies, in particular that such studies be con- one member to be someone who is not affili- narrative description of such incentives.15
ducted with good clinical practice (GCP). ated with the institution where the research The Guidance also addresses what must
10 Pro Te: Solutiobe submitted to the FDA about the investi- or publications. A statement should also be solely because a written commitment was
gators for the study. Documentation must submitted describing how the investigators not obtained.”18
be submitted to the FDA to show that each were trained to comply with GCP and to The Guidance also addresses requirements
investigator has the experience and training conduct the study in accordance with the for information about the foreign institu-
“specifically related” to the proposed clinical study protocol. Sponsors are also encour- tions in which the study will take place. It
study.16 Usually, the Guidance states such aged to obtain written commitments that specifically states that the name and address
information would include the investiga- the investigators will comply with GCP and of the research facility is not enough infor-
tor’s CV and, if the study is novel or has the protocol.17 The FDA recognizes, howev- mation to meet the requirements of the
increased risks of mortality and morbidity, er, that such commitments may be prohib- regulations, pointing out that the FDA is
additional information regarding the inves- ited in some countries and does not want to generally less likely to be familiar with for-
tigator’s experience. Such experience might “preclude submission of well-designed and eign facilities. According to the Guidance,
include, for example, recent presentations ethically conducted foreign clinical studies a description of the research facility would
GOOD CLINICAL PRACTICE IS DEFINED BY REGULATION AS A “STANDARD FOR THE DESIGN,
CONDUCT, PERFORMANCE, MONITORING, AUDITING, RECORDING, ANALYSIS, AND REPORTING OF
CLINICAL TRIALS IN A WAY THAT PROVIDES ASSURANCE THAT THE DATA ARE CREDIBLE AND ACCURATE
AND THE RIGHTS, SAFETY, AND WELL-BEING OF TRIAL SUBJECTS ARE PROTECTED.”
Pro Te: Solutio 11INCREASINGLY, PHARMACEUTICAL COMPANIES ARE MULTINATIONAL. CHANCES ARE THAT
YOUR PHARMACEUTICAL COMPANY HAS BEEN GRAPPLING WITH THE ISSUE OF FOREIGN
CLINICAL TRIALS FOR YEARS: WHERE THE STUDY SHOULD TAKE PLACE, WHO WILL BE THE
INVESTIGATORS, HOW GOOD GCP CAN BE ASSURED AND DOCUMENTED. THE GUIDANCE
PROVIDES INFORMATION IN AN EASY-TO-USE QUESTION-AND-ANSWER FORMAT.
include enough information, such as the anticipated if privacy laws in a foreign coun- the scientific evaluation of the drug is adequate to deter-
mine if the drug is safe and effective. 21 CFR § 312.22.
staffing, equipment, and the ability to pro- try prohibit the disclosure of the members 6
See also 21 CFR § 314.106.
vide any emergent or supportive care, to of the IEC or of hospital records. In such 7
This Guidance was issued by the FDA, Center for Drug
enable the FDA to assess the adequacy of situations, the sponsor or applicant has to Evaluation and Research, Center for Biologics Evaluation
the facility. All of this information is needed document all attempts to get the information and Research, Office of Good Clinical Practice. This Guid-
ance is the current thinking of the FDA but is not binding,
to demonstrate that the study is adequate and why the laws prohibit such disclosure. and alternative approaches can be taken if the approach
and well managed. Increasingly, pharmaceutical companies satisfies the requirements of the applicable regulations.
8
The Guidance makes it clear that the FDA are multinational. Chances are that your 21. CFR § 312.120(a)(1)(i).
9
may need to review source documents of the pharmaceutical company has been grap- See p.4 of U.S. Department of Health and Human Ser-
vices, Food and Drug Administration, Center for Drug
study such as hospital records: “If the nec- pling with the issue of foreign clinical trials Evaluation and Research, Center of Biologics Evaluation
essary records are not available, FDA may for years: where the study should take place, and Research, Office of Good Clinical Practice, Guidance
for Industry and FDA Staff, March 2012. PDF available at
not accept the study data in support of an who will be the investigators, how good GCP . Last accessed April 17, 2012.
10
If the records exist but a sponsor cannot ance provides information in an easy-to-use Id. at 9.
11
disclose them to FDA because such disclo- question-and-answer format. It would be Id. at 10.
12
Id. at 10-11.
sure is prohibited by applicable foreign law, prudent to review the Guidance as well as
13
International Conference on Harmonisation of Tech-
the sponsor or applicant may seek a waiv- the international agreements regarding clin- nical Requirements for Registration of Pharmaceuticals
er of this requirement.”19 For such data to ical studies before sponsoring any foreign for Human Use. Guideline for Good Clinical Practice:
E6(R1). 10 June 1996. 1.28. PDF available at . Last accessed April 17, 2012.
14
Guidance for Industry and FDA Staff at p. 8.
should also explain how the foreign data are study is later considered as part of the new
15
Id. at 11.
applicable to the U.S. population and U.S. drug’s approval process with the FDA. 16
Id. at 6.
medical practice.”20 17
Id. at 12.
Under 21 CFR 312.120 (c), requests for 1
This trend means that pharmaceutical companies con- 18
Id. at 12. For more information on this issue, this Guid-
waivers from these regulations are allowed, ducting or sponsoring clinical trials abroad must have ance refers the reader to the FDA’s Guidance, Information
knowledge of foreign laws that will apply to the trial,
but the Guidance makes it clear that the FDA including the European Union Directive on Privacy and
Sheet Guidance for Sponsors, Clinical Investigators, and IRBs:
Frequently Asked Questions – Statement of Investigator (form
expects few requests for such waivers. Since the European Clinical Trial Directive. They should also FDA 1572), available at .
tion of Helsinki: Ethical Principles for Medical Research Last accessed April 17, 2012.
ers have been requested.21 A waiver request Involving Human Subjects. 19
Id. at 8.
must contain at least one of the following 2
September 2001, OEI-01-00-00190. 20
3 Id. at 9.
criteria: Why compliance with the regula- Id. page i. 21
4 Id. at 12.
tion is “unnecessary or cannot be achieved,” Glickman, Seth, M.D., et. al. “Ethical and Scientific 22
Id.
Implications of the Globalization of Clinical Research,”
a description of an alternative action that New England Journal of Medicine Volume 360, No. 8,
satisfies the purpose of the requirement, or February 19, 2009.
5
other information that justifies a waiver from 21 CFR § 312.20 requires that a sponsor submit an
INDA to the FDA if it wishes to conduct a clinical inves-
a specific regulation.22 The Guidance gives tigation of a new drug and cannot begin such a trial until
some examples of the types of situations in it has done so. Under 21 CFR § 312.21, an INDA may be
submitted for one of more phases of an investigation. The
which the FDA might expect a waiver request FDA has to review the application to assure the safety of Written by
to be made. For example, a waiver would be all the subjects and, in Phases 2 and 3, to determine that Melissa Baltz
12 Pro Te: SolutioCASE
V. LAW
PART ¤: A FEDERAL SURVEY ON PROTECTING CONFIDENTIAL INFORMATION
The February 2012 issue of Pro Te: Solutio provides information on how federal district courts across the United States (from Alabama through
Montana) handle the filing of confidential information. Part Two of this article surveys district courts in Nebraska through Wyoming.
Nebraska: The U.S. District Court for the District of Nebraska has and motions seeking leave to seal documents. Rule 16.1-4 regarding
enacted Local General Rule 1.3 regarding restrictions on access to sealed confidentiality mandates that “[d]iscovery and initial disclosures […]
documents and documents containing personal identifying information cannot be withheld on the basis of confidentiality absent court order. Not
protected by the E-Government Act of 2002, Pub. L. No. 107-347, 116 later than fourteen (14) days after the Initial Scheduling Conference, the
Stat. 2899 (Dec. 17, 2002) (codified at 5 U.S.C. §§ 3701-3707 and parties shall file a proposed protective order. Pending entry of a discovery
scattered sections). Parties and their attorneys are responsible under the confidentiality protective order, disclosures deemed confidential by a party
rule for preventing the disclosure of certain confidential information shall be produced with a confidential designation (e.g., ‘Confidential —
in case filings. The clerk does not review case filings for compliance or Attorneys Eyes Only’), and the disclosure of the information will be limited
independently redact or seal non-complying filings. Nebraska District to each party’s outside counsel of record, including employees of outside
Court’s Local Civil Rule 5.0.3 regarding privacy addresses mandatory counsel of record, and used only for litigation purposes.”
and discretionary redaction for all filings with the court. Under this rule,
the filing party may redact the following information from all documents New Hampshire: Rule 37.1 of the Local Rules of the U.S. District Court of
and exhibits filed electronically or non-electronically, unless the assigned New Hampshire Motions provides the process for obtaining a protective
judge orders otherwise: order and sealing documents, which includes a requirement of a verbatim
recitation of each interrogatory, request, answer, response, and objection,
(1) personal identifying numbers, such as driver’s license numbers; or a copy of the actual discovery document which is the subject of the
(2) home street addresses; motion, provided that the party shall file only that portion of the discovery
(3) medical or psychological records; document that is objected to or is the subject of the motion. When the
(4) employment history; court rules on a discovery motion, the discovery requested or relief sought
(5) individual financial information; shall be provided within fourteen (14) days of the court order, unless the
(6) proprietary or trade secret information; order specifies a different time. All filings, orders, and docket entries shall
(7) information that may identify a cooperating individual; be public unless a filing, order, or docket entry must be sealed pursuant
(8) information regarding a crime victim; to state law, federal law, the Federal Rules of Criminal or Civil Procedure,
(9) national security information; or Local Rules; a filing, order, or docket entry has been sealed by order of
(10) sensitive security information as described in 49 U.S.C. § 114(s); another court or agency; or the court issues an order sealing a filing, order,
(11) education records as defined by 20 U.S.C. § 1232g(a)(4)(A); and or docket entry. Rule 37.1 also provides for two levels of sealed filings.
(12) other data as the court orders. Filings, orders, and docket entries sealed at Level I may be reviewed by
any attorney appearing in the action without prior leave of court. Filings,
Nebraska Civil Rule 5.0.3 also provides that a party may restrict access orders, and docket entries sealed at Level II may be reviewed only by the
to unredacted documents with the court’s leave. Nebraska Civil Rule 7.5 filer or, in the case of an order, the person to whom the order is directed
provides the procedure for sealing documents and objects. without prior leave of court.
Nevada: Rule 10-5 of the Local Rules for the U.S. District Court for A motion to seal must be filed before the sealed material is submitted
the District of Nevada provides for notices for in camera submissions or, alternatively, the item to be sealed may be tendered with the motion
Pro Te: Solutio 13and both will be accepted provisionally under seal, subject to the court’s public access shall be available for review by the public. The motion papers
subsequent ruling on the motion. The motion must explain the basis for shall describe: (a) the nature of the materials or proceedings at issue: (b) the
sealing, specify the proposed duration of the sealing order, and designate legitimate private or public interests which warrant the relief sought: (c)
whether the material is to be sealed at Level I or Level II. Any motion to the clearly defined and serious injury that would result if the relief sought
seal, upon specific request, may also be sealed if it contains a discussion is not granted: and (d) why a less restrictive alternative to the relief sought
of the confidential material. If the court denies the motion to seal, any is not available. Proposed Findings of Fact and Conclusions of Law shall be
materials tendered under provisional seal will be returned to the movant. submitted with the motion papers in the proposed order. If the information
This rule sets forth filing procedures for submitting materials under seal or required is not within the knowledge of the movant, supplemental motion
requesting sealed status. papers in support of the motion may be filed by a party, individual, or
entity having such knowledge not later than fourteen (14) days after the
Local Rule 83.8 presents provisions for special orders in “widely filing of the motion. Any materials deemed confidential by a party or
publicized and sensational cases,” including issuance of a special order parties and submitted with regard to a motion to seal or otherwise restrict
governing matters such as extrajudicial statements by parties and witnesses public access shall be filed electronically under the designation “confidential
likely to interfere with the conduct of a fair trial by an impartial jury, materials” and shall remain sealed until such time as the motion is decided.
the seating and conduct in the courtroom of spectators and news media When a document filed under seal contains both confidential and non-
representatives, the management and sequestration of jurors and witnesses, confidential information, an unredacted version shall be filed under seal,
and any other matters which the court deems appropriate. and a version with only the confidential portions redacted shall be filed
publicly. Any interested person may move to intervene pursuant to Fed.
New Jersey: In the U.S. District Court for the District of New Jersey, Rule R. Civ. P. 24 (b) before the return date of any motion to seal or otherwise
5.3 addresses protective orders and public access under CM/ECF. Subject restrict public access.
to this rule and to statute or other law, all materials and judicial proceedings
are matters of public record and shall not be sealed. Notwithstanding, parties Notwithstanding the above, on emergent application of a party or parties
may enter into written agreements to keep materials produced in discovery or sua sponte, a judge or magistrate judge may seal or otherwise restrict public
confidential and to return or destroy such materials as agreed by parties access to materials or judicial proceedings on a temporary basis. The judge
and as allowed by law. Parties may submit to a judge or magistrate judge an or magistrate judge shall do so by order which sets forth the basis for the
agreed-upon form of order which embodies a written agreement. Any such temporary relief and which shall be filed electronically under the designation
form of order must be accompanied by an affidavit or attorney certification “temporary order to seal.” Any interested person may move pursuant to
filed electronically under the designation “affidavit/certification in support L. Civ. R. 7.1 and Fed. R. Civ. P. 24 (b) to intervene, which motion shall be
of discovery confidentiality order.” The affidavit or attorney certification made returnable on the next available return date.
shall describe: (a) the nature of the materials to be kept confidential: (b) the
legitimate private or public interests which warrant confidentiality: and (c) No party or parties shall submit a proposed settlement agreement for
the clearly defined and serious injury that would result should the order not approval by a judge or magistrate judge unless required to do so by statute
be entered. The affidavit or attorney certification shall be available for public or other law or for the purpose of retaining jurisdiction. Any settlement
review. No form of order submitted by parties shall supersede the provisions agreement filed with the court or incorporated into an order shall, absent
of this rule with regard to the filing of materials or judicial proceedings. an appropriate showing under federal law, be deemed a public record and
The form of order may, however, provide for the return or destruction of available for public review.
discovery materials as agreed by parties. The form of order shall be subject
to modification by a judge or magistrate judge at any time. Any dispute Local Rule 5.3 also contains a comprehensive explanatory note, including
regarding the entry of, or the confidentiality of discovery materials under, the history of the Rule and its amendments, as well as annotations regarding
any order under this section shall be brought before a magistrate judge each subsection.
pursuant to L. Civ. R. 37.1(a)(1).
New Mexico: Rule 37.1 of the Local Rules of the New Mexico U.S. District
Any request by a party or parties to seal, or otherwise restrict public Court sets forth the procedure for submitting a motion for relief sought
access to, any materials or judicial proceedings shall be made by formal by protective order in discovery, including requirements that the movant
motion per L.R. 5.3(c). However, any motion to seal or otherwise restrict attach a copy of the interrogatory, request for production or inspection,
14 Pro Te: Solutiorelevant portion of deposition transcript, or request for admission; and the order of the court, all proposed sealed documents must be accompanied
response or objection thereto, and that the motion must comply with the by a motion to seal. The motion to seal shall be a public document and
requirements of the Local Rules. D.N.M.LR-Civ. 7. noted with a docket entry that gives the public notice of the request to seal.
The docket entry for the proposed sealed document shall identify it as a
New York: The Southern and Eastern Districts of New York do not have “proposed” sealed document and describe the type of document it is (e.g.,
specific local rules addressing the filing of confidential documents. Rule 2.2 affidavit, record) and the substantive motion or other specific proceedings
of the Local Rules for the Northern District of New York provides that not in the case to which it relates (e.g., “in support of defendant’s motion to
later than fourteen days (14) prior to the initial Rule 16 Conference and compel at D.E.____”). The proposed sealed document is deemed to be
after conferring regarding the matter, the parties may, if desired, submit provisionally sealed until the court rules on the motion to seal. If the motion
either a stipulated protective order pursuant to Fed. R. Civ. P. 26(c) or, to seal is granted, the clerk will remove the word “proposed” from the docket
if agreement cannot be reached, may each submit a counter-proposed entry. If the motion to seal is denied, the document will remain sealed and
protective order for the court’s consideration, highlighting for the court the word “proposed” will remain in the docket entry for the document in
any areas of disagreement. In the event that the parties do not request the order to preserve the record. The document will not be considered by the
entry of a different Rule 26(c) confidentiality order at or prior to the Rule court, except as provided by the Rule or as otherwise ordered by the court.
16 scheduling conference, or if otherwise deemed appropriate, the court will A party desiring to remove a proposed sealed document or docket entry
enter a protective order pursuant to Fed. R. Civ. P. 26(c) in the form of that from the docket sheet must file a motion to strike in accordance with Local
provided on the court’s webpage at www.nynd.uscourts.gov. Civil Rule 7.1. A party whose motion to seal is denied but that desires the
court to consider a proposed sealed document as a publicly filed document
In the Western District of New York, Rule 5.3 addresses the sealing of shall file the document as a public document within three (3) days after
complaints and documents in civil cases. This rule sets forth that, except entry of the order denying the motion to seal or within such other period
where restrictions are imposed by statute or rule, there is a presumption as the court directs. This Rule also provides the process for the return of
that court documents are accessible to the public and that a substantial sealed documents.
showing is necessary to restrict access. Upon a proper showing, the court
may, sua sponte, enter an order directing that a case be sealed in its entirety, In the Western District of North Carolina, Rule 6.1 addresses sealed
or as to certain parties or documents. The court may do so when the case filings and public access. Under this rule, no materials may be filed under
is initiated, or at any stage of the proceeding. A party seeking to have a seal except by order of the court, pursuant to a statute, or in accordance
document, party, or case sealed shall comply with the procedures set forth in with a previously entered Rule 26(e) Protective Order. A request by a party
the court’s CM/ECF Administrative Procedures Guide (available at http:// to file materials under seal shall be made by formal motion, separate and
www.nywd.uscourts.gov/mambo/index.php?option=com_content&task= apart from the motion or other pleading sought to be sealed, pursuant to the
view&id=21&Itemid=26). A complaint presented for filing with a motion Local Rules. Such motion shall be filed electronically under the designation
to seal and proposed order shall be treated as a sealed case pending approval “Motion to Seal.” The motion or supporting brief shall set forth:
of the proposed order, and the filing party shall comply with the sealing
procedures set forth in the Guide. Unless otherwise directed by the court, (1) a non-confidential description of the material sought to be sealed;
a sealed document or case shall remain sealed even after final disposition (2) a statement as to why sealing is necessary and why there are no
of the case. A party seeking to have a sealed document unsealed must seek alternatives to filing under seal;
relief by motion on notice. (3) unless permanent sealing is sought, a statement as to the period of time
the party seeks to have the material maintained under seal and as to how
North Carolina: In the Eastern District of North Carolina, Rule 79.2 the matter is to be handled upon unsealing; and
addresses the submission and filing of sealed documents. No cases (4) supporting statutes, case law, or other authority.
or documents may be sealed without an order from the court. A party
desiring to file a document under seal must first file a motion seeking If necessary, information deemed confidential by a party may be
leave in accordance with the court’s CM/ECF Policy Manual (available at redacted from the filed motion or brief and an unredacted version
http://www.nced.uscourts.gov/cmecf/default.aspx). All sealed and proposed submitted under seal for in camera review. Materials deemed confidential
documents shall be maintained electronically in CM/ECF unless otherwise may be submitted under seal for in camera review via cyberclerk. No
ordered by the court. Unless otherwise permitted by the Policy Manual or motion to seal or otherwise restrict public access shall be determined
Pro Te: Solutio 15without reasonable public notice. Notice shall be deemed reasonable and protective orders are disfavored. Sealed documents and confidentiality
where a motion is filed in accordance with the provisions of Rule 6.1. agreements may be approved by the court only upon a showing that a
Other parties, interveners, and non-parties may file objections and briefs legally protected interest of a party, non-party, or witness outweighs the
in opposition or support of the motion within the time provided by L.R. compelling public interest in the disclosure of records. A party seeking
7.1 and may move to intervene under Fed. R. Civ. P. 24. Orders sealing to file a document under seal shall file a motion which meets the specific
or otherwise restricting access shall reflect consideration of the factors requirements of Rule 79.1. Titles of sealed pleadings will be docketed
set forth in Rule 6.1. In the discretion of the court, such orders may publicly, so caution should be taken to remove confidential information
be filed electronically or conventionally and may be redacted. After an from such titles.
order permitting the filing under seal has been entered, any materials filed
pursuant to that order shall be filed electronically with a non-confidential Similarly, in the Northern District of Oklahoma, Local Rule 79.1
description of the materials filed. However, this Local Rule shall not limit provides that sealed documents, confidentiality agreements, and
the right of a party, intervenor, or non-party to file a motion to unseal protective orders — which are disfavored — may be approved by the court
material at any time. Such a motion to unseal shall include a statement only upon a showing that a legally protected interest of a party, non-
of reasons why the material should be unsealed and any change in party, or witness outweighs the compelling public interest in disclosure
circumstances that would warrant unsealing. Unless otherwise ordered by a of records. All protective orders dealing with confidentiality must be
court, any case file or documents under court seal that have not previously approved by a magistrate judge and filed of record. In civil cases in
been unsealed by the court shall be unsealed at the time of final disposition which confidential information covered by a protective order must be
of the case. Unless otherwise ordered by the court, access to documents attached to a pleading, attorneys should file an unsealed pleading with
and cases under court seal shall be provided by the clerk of court only non-confidential exhibits and redacted confidential exhibits. At the same
pursuant to court order. Unless otherwise ordered by the court, the clerk time, attorneys should file a supplemental sealed pleading which contains
of court shall make no copies of sealed cases files or documents. However, the unredacted exhibits covered by the protective order. The court
nothing in this Local Rule limits the ability of parties, by agreement, to strongly urges attorneys to present all arguments and all documents in
restrict access to discovery or other materials not filed with the court or unsealed pleadings. In an effort to do this, the Rule states that attorneys
to submit motions pursuant to Fed. R. Civ. P. for a Protective Order should use good judgment in generically referring to matters covered by
governing such materials. a protective order without revealing confidential information. In those
rare instances where specific confidential documents must be attached
North Dakota: Local Civil Rule 37.1 mandates an obligation to confer to a pleading, attorneys should file the supplemental sealed pleading
prior to a party submitting a motion for protective order, for the purpose referenced above. A person seeking to file a document under seal in a
of making a reasonable, good faith effort to resolve the dispute without public case shall electronically file both a motion to seal and the sealed
involving the court. The filing of sealed documents and sealed files is document separately. The motion seeking such an order must contain
governed by the court’s “Administrative Policy Governing Electronic Filing sufficient facts to overcome the presumption in favor of disclosure and
and Service,” available at http://www.ndd.uscourts.gov/cm_ecf.html. may itself be filed under seal. The relief sought shall be narrowly tailored
to serve the specific interest sought to be protected. A proposed order
Ohio: There is no local rule in the Northern District of Ohio governing shall be submitted. If the motion to seal is denied, the court will direct
confidentiality or sealing of information in civil cases. However, the that the document either be stricken or be unsealed.
Southern District’s Local Rule 26.2 governs the protection of personal
privacy in civil actions. Oregon: In Oregon U.S. District Court, Local Rule 5.2 governs the redaction
of filings, stating that the responsibility to redact filings pursuant to Fed.
Oklahoma: In the Western district of Oklahoma, the court’s form for R. Civ. P. 5.2 rests with counsel and the party or non-party making the
the parties’ Joint Status Report and Discovery Plan provides for the filing. The clerk’s office is not required to review documents filed with the
identification of necessary protective orders in the initial case management court for compliance with Fed. R. Civ. P. 5.2. Local Rule 26-4 sets forth
order. (Local Rules, Appendix II). the provision for motions for protective orders: “A party or person asserting
there is good cause for the court to make an order that would limit access
In the Eastern District of Oklahoma, Local Rule 79.1 provides that it to discovery materials not filed with the court, or would authorize a party
is the court’s policy that sealed documents, confidentiality agreements, or person to file any materials with the court under seal, must show with
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