1. ICPHSO February 25, 2011 ABA Law Seminar: CPSC Public Database

2. ICPHSO February 25, 2011 ABA Law Seminar: CPSC Public Database Jason Levine – CPSC David Baker – Law offices of David Baker, LLC Andrew DiMarsico - NHTSA Ami Gadhia – Consumers Union Cary W. Mergele – Kmart/Sears

3. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC NHTSA FDA (MAUDE) 2/25/2011 - ABA

4. CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Year Debuted20111996 Reports per year Unknown 10-15,000 (previously) 36,000 on avg./60k + in 2010 (NHTSA has rec’d over 475,000 complaints since 2000) 100,000 + / year (MAUDE contains over 600,000 reports) Consumers Report?Yes Requirements for entering complaint 8 fields, including: Description of Consumer Product must include information “sufficient to distinguish the product” as one within CPSC’s jurisdiction. Submitters are encouraged to include more specific information such as brand name, model name, serial number, date of manufacture (if known) or date code, date of purchase, price paid, retailer, or any other descriptive information about the product. 5 Fields, including: Make, model, and model year. Brand name AND common device name required – Mfr name, model #, catalog #, etc. are requested but not required. (“Important fields to correctly identify product” – but not required) FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES 2/25/2011 - ABA

5. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Pre-Posting ScrubPII (MII/CBI claim)PII/ Profanity In general everything is posted – but reports filled with obscenities are removed/edited. Likely a PII check also. Speed of Reports to Database 15 business days from receipt / 10 business days from sending to Mfr 1 dayNo required time frame for posting – usually within a few days to a week. 2/25/2011 - ABA

6. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Accuracy “verification” by consumer? “I certify that the information submitted in this report is true and accurate to the best of my knowledge, information, and belief.” (and 18 U.S.C. Sec. 1001 – not explicitly referenced on site) No. 18 U.S.C. Sec. 1001 applies, but is not explicitly referenced on site. No. 18 U.S.C. Sec. 1001 applies, but is not explicitly referenced on site. Anonymous submissions allowed? No – submitter’s name does not appear in database – but may be made available to Mfr if agreed to by submitter No - submitter’s name does not appear in database – but may be made available to Mfr during investigation or recall. No- the reporter’s identity may be shared with the manufacturer if a box is checked. “The FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.” 2/25/2011 - ABA

7. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Mfrs Required to Report Yes (but not in database) Yes (in database) Mfr notified before publishing complaint Yes No (Mfr is notified if agency opens an investigation) No Mfr receives complaint before publication YesNo Mfr CommentsPosted as written – either simultaneously with complaint – or as soon as received thereafter No opportunity to submit comments for publication in database. 2/25/2011 - ABA

8. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Material Inaccuracy claim process If a Mfr believes a Report of Harm contains: “information that is false or misleading, and which is so substantial and important as to affect a reasonable consumer’s decision making about the product” then the Mfr may make a MII claim. CPSC has said it will work to resolve all MII claims prior to the required posting deadline (10 days). There is an expedited process (5 pgs or less). None Confidential Business Info claim process If Mfr believes there is information that in a Report of Harm that is a trade secret or trade secret equivalent (CBI) – it may make such a claim – and the specified information will be withheld from the database until the matter of the CBI is resolved. None FDA is required to delete “any information that constitutes trade secrets, and confidential, commercial, or financial information;” 2/25/2011 - ABA

9. FEDERAL GOVERNEMENT PUBLICLY ACCESSIBLE/SEARCHABLE DATABASES CPSC/SaferProducts.govNHTSA/Safercar.gov FDA/MAUDE “Manufacturer and User Facility Device Experience” Disclaimer“The Commission does not guarantee the accuracy, completeness or adequacy of the contents of the Consumer Product Safety Information Database, particularly with respect to the accuracy, completeness, or adequacy of information submitted by persons outside of the CPSC.” NoneDisclaimer is related only to the “reporting entity”: "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event.“ (this doesn’t really apply to consumers) 2/25/2011 - ABA