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RECORD RETENTION AND eDISCOVERY Massachusetts Biotechnology Council Dawn M. Curry December 16, 2008 Nutter McClennen & Fish LLP World Trade Center West 155 Seaport Boulevard Boston, Massachusetts 02210 Telephone 617.439.2000 www.nutter.com Topics of Discussion • • • • • • • • • • The Benefits of Having a Record Retention Policy Why Such a Policy is Particularly Important in Your Industry Why Now is the Time to Re-evaluate/Implement a Policy Critical Record Retention Policy Directives Retention Schedules When Does the Duty to Preserve Arise Litigation Holds Other Steps to Take Upon Reasonable Anticipation of Litigation Collection, Reduction and Production of Documents Use of Technology for Electronic Record Management Nutter McClennen & Fish LLP • www.nutter.com 2 Electronic Records Management Survey (By Cohasset Associates): • 2007 Survey of 1600 records management professionals: – 35% of respondents evaluated their records management programs as "marginal" or "fair." – 40% of organizations represented that they still do not include electronic records in their retention schedules. – 68% affirmed that their organization had "some" (38%), "considerable" (20%) or "great" (10%) difficulty finding and retrieving information from backup and archival storage media in response to court-ordered discovery. Nutter McClennen & Fish LLP • www.nutter.com 3 Why Have A Records Retention Policy? • Provides for the systematic review, retention and destruction of records. • Compliance with statutory and regulatory duties and requirements. • Manages information generated and received by the Company. • Reduces strain on computer and information systems, and reduces storage expense. • Reduces unnecessary expense during litigation. • May help protect the Company in litigation. Nutter McClennen & Fish LLP • www.nutter.com 4 Why Is This Important For Companies In Your Industry? • Heavily regulated industry • Companies have been generating more and more electronic records. • Documents in this industry are the most valuable assets. • Original records today often include digital records with electronic signatures that need to be preserved and accessed over time. Nutter McClennen & Fish LLP • www.nutter.com 5 21 CFR Part 11 • 21 CFR Part 11 changed the landscape • Companies can choose to electronically submit various documents: Biologics License Applications, New Drug Applications and Abbreviated New Drug Applications; IND Applications; related submissions; premarket notification applications (510(k)) and Medwatch 3500A forms for medical device adverse event reports. • If a Company chooses to use records in electronic format in place of paper format, Part 11 will apply. • 21 CFR 11.10(c) requires the protection of records to enable their accurate and ready retrieval throughout the records retention period. Nutter McClennen & Fish LLP • www.nutter.com 6 Why Take Action Now? • Changes in the Fed. Rules of Civil Procedure • Electronically stored information (“ESI”) must be discussed early on in the litigation at the Rule 26 conference. • Companies must adopt a new approach to litigation preparedness – including record retention policies. • Fed. R. Civ. P. 37(e) - creates a safe harbor from sanctions for spoliation if the ESI is lost in the regular course of business. The rule states that “[a]bsent extraordinary circumstances, a Court may not impose sanctions under these rules on a party for failing to provide ESI lost as a result of the routine, good-faith operation of an electronic information system.” Nutter McClennen & Fish LLP • www.nutter.com 7 Why Take Action Now? (cont’d) • The Pharmaceutical and Medical Device Manufacturer Code of Conduct. 105 CMR 970.000 (proposed regs) • New regs will require disclosure of financial interactions between the industry (pharmaceutical and medical device companies) and certain health care providers. • Companies must report the value, nature, purpose and recipient of any fee, payment or subsidy over $50 for a company’s sales and marketing activities. • The first disclosure report would be due July 1, 2010 for the time period July 1, 2009 through December 31, 2009. In future years, the disclosure would cover the entire previous calendar year. • Public hearings - Jan. 9 and Jan. 12 Nutter McClennen & Fish LLP • www.nutter.com 8 Records Retention Policy Directives • The policy must be established based on sound business practices. • All records, including ESI, must be covered by the program. • The policy should address the proper handling of confidential records. • You must establish records retention schedules that comply with the laws, regulatory requirements and business/scientific needs. Nutter McClennen & Fish LLP • www.nutter.com 9 Records Retention Policy Directives (cont’d) • • • • The policy should provide for appropriate archival media to ensure preservation for the duration of the retention periods. Policy should also address appropriate data security requirements and proper disposal of records. New statutes/regs require anyone holding personal info on a resident of MA to follow certain procedures – see G.L. c. 93H and 93I and 201 CMR 17.00. Upon “reasonable anticipation of litigation” you must suspend the destruction of records to the extent necessary to preserve relevant ESI. Instruct employees to notify legal (or an appointed person at the Company) about potential litigation/investigations. At least one person in the Company should be responsible for auditing/managing the program. (to ensure that it is up to date and that destruction proceeds in an orderly manner) Nutter McClennen & Fish LLP • www.nutter.com 10 Retention Schedules There are general categories of documents that must be maintained for specific periods of time: • E.g., tax records pursuant to IRS regulations, and employment records pursuant to Fair Labor Standards Act (FLSA), Occupational Safety and Health Act (OSHA), and Employment Retirement Income Security Act (ERISA) Then there are industry specific records and regulatory retention periods: • E.g., records required to be maintained pursuant to FDA regulations and HIPAA Nutter McClennen & Fish LLP • www.nutter.com 11 Industry Specific Retention Schedules Applicable to Manufacturers of Drugs, Biologics and Devices Nutter McClennen & Fish LLP • www.nutter.com 12 Financial Records of Clinical Investigators • 21 CFR 54.6 • Who: an applicant who submits a marketing application containing clinical studies to the FDA • What: information pertaining to the financial interests of the clinical investigators who conducted the studies who are not employees of the applicant • How long: for 2 years after the date of approval of the application Nutter McClennen & Fish LLP • www.nutter.com 13 Institutional Review Board Records • 21 CFR 56.115; 45 CFR 46.115. • Who: an institution, or where appropriate an IRB • What: adequate documentation of IRB activities • How long: for at least 3 years after completion of the research Nutter McClennen & Fish LLP • www.nutter.com 14 Dissemination of Info Re: Unapproved/ New Uses for Marketed Drugs, Biologics and Devices • 21 CFR 99.501 • Who: a manufacturer disseminating such information • What: records sufficient to allow the manufacturer to take corrective action as required by the FDA, including a copy of all information, lists, records, and reports required or disseminated under this part • How long: for 3 years after it has ceased dissemination of such information Nutter McClennen & Fish LLP • www.nutter.com 15 Privacy of Individually Identifiable Health Information • 45 CFR 164.530 • Who: covered entities • What: documentation related to policies and procedures implemented with respect to protected health information to comply with HIPAA • How long: for 6 years from the date of creation OR the date when it was last in effect, whichever is later Nutter McClennen & Fish LLP • www.nutter.com 16 Industry Specific Retention Schedules Specific to Drugs Nutter McClennen & Fish LLP • www.nutter.com 17 Prescription Drug Marketing Act Records • 21 CFR 203.60 • Who: any person required to create or maintain reports, lists, or other records under the PDMA • What: these reports, lists or records, including records relating to the distribution of drug samples • How long: for at least 3 years after the date of their creation Nutter McClennen & Fish LLP • www.nutter.com 18 Batch Records • 21 CFR 211.180 • What: production, control, or distribution records associated with a batch of a drug product • How long: for at least 1 year after the expiration of the batch • Exception: for certain OTC drug products lacking expiration dating because they are exempt, the retention period is 3 years after distribution of the batch Nutter McClennen & Fish LLP • www.nutter.com 19 Batch Records • 21 CFR 211.180 • What: records for all components, drug product containers, closures, and labeling • How long: for at least 1 year after the expiration date • Exception: for certain OTC drug products lacking expiration dating because they are exempt, the retention period is 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure or labeling Nutter McClennen & Fish LLP • www.nutter.com 20 Investigational New Drug Applications: Sponsor Record Retention • 21 CFR 312.57 • Who: sponsors • What: adequate records showing the receipt, shipment, or other disposition of the investigational drug, including the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each shipment • How long: for 2 years after a marketing application is approved for the drug; or, if not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA has been so notified Nutter McClennen & Fish LLP • www.nutter.com 21 Investigational New Drug Applications: Investigator Record Retention • 21 CFR 312.62 • Who: an investigator • What: adequate records of the disposition of the drug, including dates, quantity, and use by subjects • How long: for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is filed or if the application is not approved, until 2 years after the investigation is discontinued and the FDA has been notified Nutter McClennen & Fish LLP • www.nutter.com 22 Adverse Experiences on Marketed Prescription Drugs Without Approved New Drug Applications • 21 CFR 310.305 • Who: manufacturers, packers and distributors of these drugs • What: records and reports to the FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products • How long: for a period of 10 years, including raw data and any correspondence relating to the adverse drug experiences Nutter McClennen & Fish LLP • www.nutter.com 23 Postmarketing Reporting of Adverse Drug Experiences • 21 CFR 314.80 • Who: applicants having approved applications • What: review and report to the FDA all adverse drug experience information obtained or otherwise received by the applicant from any source, foreign or domestic, including info derived from commercial marketing experience, postmarketing clinical investigations, reports in scientific literature, and unpublished scientific papers • How long: for a period of 10 years Nutter McClennen & Fish LLP • www.nutter.com 24 Industry Specific Retention Schedules Specific to Biologics Nutter McClennen & Fish LLP • www.nutter.com 25 Postmarketing Reporting of Adverse Drug Experiences • 21 CFR 600.80 • Who: any person having a biologics license • What: review and report to the FDA all adverse experience information pertaining to its product obtained or otherwise received from any source, foreign or domestic, including information derived from commercial marketing experience, postmarketing clinical investigations, reports in scientific literature, and unpublished scientific papers • How long: for a period of 10 years Nutter McClennen & Fish LLP • www.nutter.com 26 Blood and Blood Components • 21 CFR 606.160 • What: records regarding the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced. • How long: no less than 10 years after the records of processing have been completed (or 6 months after the latest expiration date for the individual product, whichever is later). Nutter McClennen & Fish LLP • www.nutter.com 27 Industry Specific Retention Schedules Specific to Medical Devices Nutter McClennen & Fish LLP • www.nutter.com 28 Medical Devices – cGMP records • 21 CFR 820.180 • What: all Good Manufacturing Records required to be kept under section 820, including device master records and device history records • How long: shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer. Nutter McClennen & Fish LLP • www.nutter.com 29 Medical Device Reporting • 21 CFR 803.18 • Who: a user facility, importer, or manufacturer • What: MDR event files relating to adverse events • How long: • A user facility: for a period of 2 years from the date of the adverse event. • A manufacturer or importer: for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater Nutter McClennen & Fish LLP • www.nutter.com 30 Investigational Device Records : Investigator Record Retention • 21 CFR 812.140 • Who: a participating investigator • What: records relating to the investigator’s participation in an investigation, inc. correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA; records of receipt, use or disposition of a device; records of each subject’s case history and exposure to the device; and the protocol, with docs showing dates of and reasons for each deviation from the protocol. • How long: during the investigation and for 2 years after the latter of either the date on which the investigation is terminated or completed OR the date that the records are no longer required to support a PMA or a notice of completion of a product development protocol Nutter McClennen & Fish LLP • www.nutter.com 31 Investigational Device Records: Sponsor Record Retention • 21 CFR 812.140 • Who: a sponsor • What: records relating to an investigation, including correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA; records of shipment and disposition; and signed investigator agreements. • How long: same as investigator retained records Nutter McClennen & Fish LLP • www.nutter.com 32 When Does the Duty to Preserve Arise? • Duty to preserve arises upon “reasonable anticipation” of litigation or a government investigation • “Reasonable anticipation of litigation arises when an organization is on notice of a credible threat it will become involved in litigation or anticipates taking action to initiate litigation” Sedona Commentary on Legal Holds, Guideline No. 1. • “The determination of whether litigation is reasonably anticipated should be based on good faith, reasonableness, a reasonable investigation and an evaluation of the relevant facts and circumstances” Sedona Commentary on Legal Holds, Guideline No. 4. Nutter McClennen & Fish LLP • www.nutter.com 33 When Does the Duty to Preserve Arise? • Plaintiff’s side: – Decision to send cease and desist letter or the decision to file a lawsuit • Defendant’s side: – Credible information that you are the target of legal action • Fact intensive analysis. Nutter McClennen & Fish LLP • www.nutter.com 34 Duty to preserve extends only to relevant information (what, who, when, where?) • Analyze claims/defenses to identify what are the relevant categories of information • Identify who are the key custodians involved • Determine when are the relevant time periods • Identify where the relevant data is likely being stored • This will help you to determine: (1) which parts of your records retention policy need to be suspended to preserve all relevant data; and (2) who needs to be notified regarding the duty to preserve Nutter McClennen & Fish LLP • www.nutter.com 35 Litigation Hold Considerations • Depending on the circumstances, send written litigation hold to persons likely to have relevant data. • Form, content, and distribution of a litigation hold will vary depending on the case and client circumstances. • Litigation hold should be periodically re-issued. • Companies should regularly monitor a litigation hold to ensure compliance. Nutter McClennen & Fish LLP • www.nutter.com 36 Other Steps to Take Upon Reasonable Anticipation of Litigation • Counsel should communicate directly with key employees to make sure they understand their preservation obligations. • Companies should document the steps taken to preserve information. Nutter McClennen & Fish LLP • www.nutter.com 37 Collection of Electronic Documents • Determine the scope of the ESI needed to fairly address the issues in the case. • Avoid unreasonable overbreadth, burden and cost. • Only need to produce relevant ESI that is reasonably accessible. • Determine if metadata needs to be produced. Nutter McClennen & Fish LLP • www.nutter.com 38 Collection of Electronic Documents (cont’d) • Establish a procedure for collection of ESI: • Manual collection: items are copied or transmitted by the end-user. • Automated collection: uses computerized processes to collect data. • Establish and maintain chain of custody. Nutter McClennen & Fish LLP • www.nutter.com 39 Vendors • Discuss whether an outside vendor should be hired to assist in the preservation, collection, review and/or production of your data. • Vendors offer a variety of software and services to assist with the electronic discovery process that can substantially reduce overall costs. • Symantec offers a technology solution which works to combine retention needs with discovery needs. Nutter McClennen & Fish LLP • www.nutter.com 40 Reduction of Documents • Examples of ways to reduce the volume of ESI reviewed: • De-duplication tools; simple keyword searches; boolean searches; conceptual searching • Consider sampling techniques. • No perfect search – standard is reasonableness and good faith. • Consider entering into an agreement with opposing counsel to stipulate to the locations to be searched, the individuals whose records are at issue, and the search and retrieval methods to be used. Nutter McClennen & Fish LLP • www.nutter.com 41 Production of Documents • Try to also come to an agreement with opposing counsel regarding the form(s) of production. • Absent agreement of the parties, a responding party must produce ESI in the form in which it is ordinarily maintained or in a reasonably usable form. • The parties can agree to produce different types of ESI in different forms. • Different formats have advantages and disadvantages: Native vs. TIFF Nutter McClennen & Fish LLP • www.nutter.com 42 QUESTIONS? Dawn M. Curry, Esq. Nutter, McClennen & Fish, LLP 617.439.2286 [email protected] www.nutter.com Nutter McClennen & Fish LLP • www.nutter.com 43