Medical Device Safety Act of 2009

Public Law 111-148 - Patient Protection and Affordable Care Act - PPACA (Implementation) H.R. 2 - Repealing Jobs - Killing Health Care Law Act H.R. 5 - Help Efficient, Accessible, Low-Cost Timely Health Care (HEALTH) Act H.R. 1150 - Competitive Health Insurance Reform Act (McCarran Repeal) H.R. 1217 - To Repeal the Prevention and Public Health Fund H.R. 1309 - Flood Insurance Reform and Modernization Act of 2011 S. 528 - Safe Teen and Novice Driver Uniform Protection (STANDUP) Act S. 637 - Earthquake Insurance Affordability Act S. 886 - Catastrophe Obligation Guarantee Act S. 3994 - Flood Insurance Affordability and Risk Notification Act S. 137 / H.R. 416 - Health Insurance Rate Review Act H.R. 2126 - Risk Retention Modernization Act H.R. 623 - The National Commission on State Worker's Comp Laws H.R. 1063 - Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART) Act Potential legislation similar to H.R. 1346/S. 540, Medical Device Safety Act (111th Congress) Department of Justice FY2012 budget submission dealing with medical liability grants Various issues relating to the Patient Protection and Affordable Health Care Act of 2012, P.L. 111-148

Client expense: $608,983 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011 S. 197, Medical Care Access Protection Act of 2011 Potential legislation similar to H.R. 1346 / S. 540, Medical Device Safety Act (111th Congress) Various issues relating to the Department of Justice FY 2012 budget submission dealing with medical liability grants; the Patient Protection and Affordable Healthcare Act of 2012 (P.L. 111-148)

Client expense: $5,670,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

Public Law 111-148 - Patient Protection and Affordable Care Act - PPACA (Implementation) H.R. 2 - Repealing Jobs - Killing Health Care Law Act H.R. 5 - Help Efficient, Accessible, Low-Cost Timely Health Care (HEALTH) Act H.R. 1150 - Competitive Health Insurance Reform Act (McCarran Repeal) H.R. 1217 - To Repeal the Prevention and Publican Health Fund H.R. 1309 - Flood Insurance Reform and Modernization Act of 2011 S. 528 - Safe Teen and Novice Driver Uniform Protection (STANDUP) Act S. 637 - Earthquake Insurance Affordability Act S. 886 - Catastrophe Obligation Guarantee Act S. 3994 - Flood Insurance Affordability and Risk Notification Act S. 137 / H.R. 416 - Health Insurance Rate Review Act H.R. 2126 - Risk Retention Modernization Act H.R. 623 - The National Commission on State Worker's Comp Laws H.R. 1063 - Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART) Act) Potential legislation similar to H.R. 1346/S. 540, Medical Device Safety Act (111th Congress) Department of Justict FY2012 budget submission dealing with medical liablity grants Various issues relating to the Patient Protection and Affordable Healthcare Act of 2012, P.L. 111-148

Client expense: $710,626 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011 Potential legislation similar to H.R. 1346/S. 540, Medical Device Safety Act (111th Congress) Department of Justice FY2012 budget submission dealing with medical liability grants Various issues relating to the Patient Protection and Affordable Healthcare Act of 2012, P.L. 111-148

Client expense: $4,270,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Securities & Exchange Commission (SEC)

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $286,383 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; FDA-PDUFA reauthorization. Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011 Potential legislation similar to H.R. 1346/S. 540, Medical Device Safety Act(111th Congress)

Client expense: $5,610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $331,937 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $352,625 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; FDA-PDUFA reauthorization. Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Potential legislation similar to the following: S. 540 / H.R. 1346, Medical Device Safety Act (111th Congress)

Client expense: $6,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

H.R. 1346/S. 540, Medical Device Safety Act of 2009

Client expense: $25,120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Pipeline & Hazardous Materials Safety Administration, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), St. Lawrence Seaway Development Corporation, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1346/S. 540, Medical Device Safety Act of 2009 H.R. 3962, Affordable Health Care for America Act H.R. 3590, Patient Protection and Affordable Care Act

Client expense: $25,120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Pipeline & Hazardous Materials Safety Administration, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), St. Lawrence Seaway Development Corporation, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

General issues on comprehensive health reform, including all aspects relating to coverage, financing, and delivery reform (no specific legislation introduced) H.R. 3590, Patient Protection and Affordable Care Act, provisions on Coverage, Delivery Reform and Financing H.R. 4872, Health Care and Education Reconciliation Act, provisions on Coverage, Delivery Reform and Financing H.R. 850, Small Business Cooperative for Healthcare Options to Improve Coverage for Employees (CHOICE) Act of 2009 H.R. 1322, Emergency Retiree Health Benefits Protection Act of 2009 H.R. 1346/S.540, Medical Device Safety Act of 2009 H.R. 3962, Affordable Health Care for America Act H.R. 4626, Health Insurance Industry Fair Competition Act H.R. 3200, America's Affordable Health Choices Act of 2009 Ongoing legislative issues related to health care reform in Senate HELP & Finance Committees, and House Education & Labor, Energy & Commerce, and Ways & Means (legislation not yet introduced) General issues related to medical liability reform and ERISA preemption (specific legislation not yet introduced) H. Res. 1203, a resolution providing for consideration of the Senate amendments to the bill (H.R. 3590) to amend the Internal Revenue Code of 1986 to modify the first-time homebuyers credit in the case of members of the Armed Forces and certain other Federal employees, and for other purposes, and providing for consideration of the bill (H.R. 4872) to provide for reconciliation pursuant to section 202 of the concurrent resolution on the budget for fiscal year 2010, provisions on health care

Client expense: $25,120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Pipeline & Hazardous Materials Safety Administration, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), St. Lawrence Seaway Development Corporation, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Restoring American Financial Stability Act (bill number not yet assigned) H.R. 1346/S. 540, Medical Device Safety Act of 2009 S. 414/H.R. 627, Credit Card Accountability Responsibility and Disclosure Act of 2009 S. 43, Permanent Internet Tax Freedom Act of 2009 H.R. 1521, Cell Tax Fairness Act of 2009 S. 1192, Mobile Wireless Tax Fairness Act of 2009 S. 788, m-SPAM Act of 2009 H.R. 2271, Global Online Freedom Act of 2009 H.R. 2309, Consumer Credit and Debt Protection Act H.R. 2221, Data Accountability and Trust Act H.R. 690/S. 144, Modernize Our Bookkeeping In the Law for Employee's Cell Phone Act of 2009 H.R. 3458, Internet Freedom Preservation Act of 2009 S. 773, Cybersecurity Act of 2009 S. 1490, Personal Data Privacy and Security Act of 2009 H.R. 2267/S. 1597, Internet Gambling Regulation, Consumer Protection and Enforcement Act S. 3155, a bill to require reporting on certain information and communications technologies of foreign countries, to develop action plans to improve the capacity of certain countries to combat cybercrime, and for other purposes H.R. 4962, International Cybercrime Reporting and Cooperation Act H.R. 3126, Consumer Financial Protection Agency Act H.R. 4173, Wall Street Reform and Consumer Protection Act of 2009 S.1490, The Personal Data Privacy and Security Act of 2009 Potential legislation regarding Offline and Online Privacy (not yet introduced) Potential FTC Reauthorization Legislation (not yet introduced)

Client expense: $25,120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Pipeline & Hazardous Materials Safety Administration, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), St. Lawrence Seaway Development Corporation, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Grandfathering Regulation H.R. 3590, Patient Protection and Affordable Care Act Implementation H.R. 3962, Affordable Health Care for America Act Health Care Reform, general Medical Loss Ratios S. 540, H.R. 1346, Medical Device Safety Act S.J.Res. 39 to disapprove the Interim Final Rule re. grandfather status under new health care law

Client expense: $1,570,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Education, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 1020 / S. 931 - Arbitration Fairness Act H.R. 1237 / S. 512 - Fairness in Nursing Home Arbitration Act H.R. 991 - Consumer Fairness Act S. 458 - False Claims Clarification Act H.R. 1178 - False Claims Corrections Act S. 386 - Fraud Enforcement and Recovery Act H.R. 1346 / S. 540 - Medical Device Safety Act H.R. 759 - Food and Drug Administration Globalization Act H.R. 609 - Right to Clean Vehicles Act S. 537 / H.R. 1508 - Sunshine in Litigation Act H.R. 1105 - Omnibus Appropriations Act H.R. 1214 - Payday Loan Reform Act of 2009 S. 263 - Servicemembers Access to Justice Act of 2009 H.R. 1748 - Fight Fraud Act S. 448 / H.R. 985 - Free Flow of Information Act S. 1504 - Notice Pleading Restoration Act of 2009 H.R. 4115 - Open Access to Courts Act S. 1606 - Foreign Manufacturers Legal Accountability Act of 2009 S. 1551 - Liability for Aiding and Abetting Securities Violations Act of 2009 H.R. 3871 - Investor Protection Act H.R. 3200 - Medicare Secondary Payer provisions in the "America's Affordable Health Choices Act" H.R. 3200 - Medical Malpractice Issues in the "America's Affordable Health Choices Act" H.R. 3451 - Arbitration related provisions in the "America's Affordable Health Care Act S. 560 / H.R. 1409 - all provisions of the Employee Free Choice Act H.R. 1788 - All provisions of the False Claims Act Correction Act S. 2831 (110th Congress bill) - All provisions of the 110th Congress' Federal Trade Commission Reauthorization Act P.L. 110-314 - All provisions of the Consumer Product Safety Improvement Act H.R. 1 / Senate Amendment 570 to the same, P.L. 111-5 - the State AG HIPPA enforcement provisions of the American Recovery and Reinvestment Act H.R. 1106 / Senate Amendment 673 to the same, P.L. 111-8 - the State AG HIPPA enforcement provisions of the American Recovery and Reinvestment Act No bill number - General background on U.S. capitol markets competitiveness and regulation No bill number - General background on securities litigation and P.L. 104-67, the Private Securities Litigation Reform Act No bill number - Potential legislation dealing with attorney pay-to-play issues in securities litigation No bill number - General background on arbitration and other alternative dispute resolution mechanisms No bill number - General background on State AGs and their enforcement authority / activities H.R. 2309 - State AG enforcement provisions of Consumer Credit Protection Improvement Act H.R. 609 - All provisions of the Right to Clean Vehicles Act S. 585 - Arbitration provisions of the Taxpayer Abuse Prevention Act No bill number - All provisions of the Non-Deductibility of Punitive Damages Proposal in the President's Budget Submission

Client expense: $1,202,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138, Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations 510(k) REform Patient Safety Organizations S 3737, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1451, FAA Air Transportation Modernization and Safety Improvement Act HR 4994, Medicare and Medicaid Extenders Act of 2010

Client expense: $7,240,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S.540/H.R.1346, Medical Device Safety Act - Discussed legislation would make clear congressional intent that state tort claims are not preempted by the FFDCA. Medical malpractice in health reform. (no bill)

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

S.540/H.R.1346, Medical Device Safety Act - Discussed legislation would make clear congressional intent that state tort claims are not preempted by the FFDCA. Medical malpractice in health reform. (no bill)

Client expense: $9,120,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

HR 1346/S.540 Medical Device Safety Act of 2009 - To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Elizabeth Sharp, Brett Loper, Elizabeth Kegler] Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Brett Loper, Elizabeth Kegler, Julie Cohen] HR 5440 (Rep. Patrick Kennedy) - To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments and for other purposes. [Elizabeth Sharp] Sen. Orrin Hatch draft BETTER Patient Care Act. To restructure how the FDA regulates certain advanced diagnostics [Brett Loper, Elizabeth Sharp] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Julie Cohen, Elizabeth Sharp] Issues related to international standards involving small bore connectors [Elizabeth Sharp] HR 6331 Generating Antibiotic Incentives Now Act of 2010 [Elizabeth Sharp]

Client expense: $359,565 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "To amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes", regarding all provisions. - S. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications. - H.R. 2923, "A bill to Enhance the ability to combat Methamphetamine", regarding all provisions. - H.R. 5786, "Safe Cosmetics Act of 2010", regarding all provisions.

Client expense: $850,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

Patent reform and liability issues including: H.R.1260 / S.515 - Patent Reform Act of 2009 - all provisions S.610 - Patent Reform Act of 2009 - all provisions S.506 - Stop Tax Haven Abuse Act - tax patent provision S.931/H.R.1020 Arbitration Fairness Act of 2009 all provisions H.R.1346 / S.540 Medical Device Safety Act of 2009 liability issues H.R.4094 Drywall Victim Insurance Protection Act - all provisions S.739 Drywall Safety Act of 2009 all provisions S. 3217- Restoring American Financial Stability Act of 2010 expansion of third party liability (Stoneridge) The Domestic Manufacturing and Energy Jobs Act of 2010 (Draft Text) tax and liability provisions H.R.847 / S.1334 - James Zadroga 9/11 Health and Compensation Act of 2010 liability provisions H.R.3534 Consolidated Land, Energy, and Aquatic Resources Act of 2009 (CLEAR Act) liability provisions

Client expense: $710,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Drug safety including H.R. 579, the Food and Drug Administration Globalization Act; Drug importation including S. 525/H.R. 1298, the Pharmaceutical Market Access and Drug Safety Act of 2009; S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009; Authorized generics including H.R. 573; S. 501, Fair Prescription Drug Competition Act; Drug company settlements including S. 369, Preserve Access to Affordable Generics Act; H.R. 1706, Protecting Consumer Access to Generic Drugs Act; and FY 2011 Financial Services and General Government Appropriations bill; Federal preemption for drugs and devices including H.R. 1346/S. 540, Medical Device Safety Act of 2009; Prescription drug advertising; Congressional oversight issues; and General health care reform (Patient Protection and Affordable Care Act).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346 & S. 540 - Medical Device Safety Act of 2009 P.L. 111-148 - The Patient Protection and Affordable Care Act; relating phyisican payment sunshine and Patient-Centered Outcomes Research Institute (PCORI). Issues relating to the 510(k) review process

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346 & S. 540 - Medical Device Safety Act of 2009; Safe Injection Practices; Drug Pedigree H.R. 6543 - Drug Safety Enhancemetn Act of 2011

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Supported efforts to implement 2008 Consumer Product Safety Commission Improvement Act, which added resources, regulated dangerous and/or toxic products. Provided comments to hill, signed letters, lobbied on all aspects of legislation and proposed regulations pertaining to reform. Testified in previous quarters. Specific new law is PL 110-314 (HR 4040, Consumer Product Safety Modernization Act). 2) Supported efforts, Medical Device Safety Act (S. 540, HR 1346) to overturn Supreme Court decision in Riegel v. Medtronic limiting state common law remedies against certain medical device manufacturers. 3) Broadly support all other efforts to preserve consumer private rights of action and to oppose preemption of stronger state consumer financial or health and safety laws. 4) Supported Representative Weiners amendment to H.R. 3200, Americas Affordable Health Choices Act of 2009, to require transparency by pharmacy benefit managers (PBMs) who contract with health plans in the national insurance exchange or with the public plan. OTHER ACTIVITIES: Supported various efforts to protect consumers from unfair business or marketplace practices by signing letters, lobbying or commenting on various proposals: 1) Mandatory Arbitration: Support (letters) for HR 1020, the Arbitration Fairness Act to ban mandatory arbitration in consumer laws. 2) Opposed (letter) S. 202 and S. 164, the "Passenger Vehicle Loss Disclosure Act of 2009" 3) Letters limited to opposition to elimination of inequitable conduct defense in the Patent Reform Act (S 515, HR 1260), to encourage generic substitutes for brand name pharmaceuticals. 4) Opposition to the Consumer Rental Purchase Agreement Act, S 738, HR 1744, which would legalize unfair practices of predatory rent to own stores. 5) Supported aspects of Federal Aviation Administration reforms pertaining to Airline Passengers Bill of Rights (HR 915, FAA Reauthorization and S. 213 (Boxer-Snowe). 5) Support strong enforcement of antitrust laws, including opposition to merger of Ticketmaster and LiveNation (testimony in House in previous quarter). Supported DOJ action against Mastercard and Visa re credit card fees. 6) Signed letters to White House urging amendments to GM/Chrysler bankruptcy negotiations to reinstate compensation rights of injured victims. 7) Supported variety of efforts, including Equal Employment for All Act (Cohen, House) to amend Fair Credit Reporting Act. 7) Urged support for legislation (not yet filed) to overturn Supreme Court in Leegin, reinstating ban on resale price maintenance. 8) Opposed aspects of Chrysler car company bankruptcy negotiations with administration that limited crash victim rights. 9) Supported Congressional efforts to overturn limits on oil company spill liability. PRIVACY: Support efforts to ensure that federal law provides consumers with strong privacy protection, prevents identity theft, and holds companies and government agencies accountable when they lose consumer data. Support includes lobbying, letters, and communications as necessary. Support HR 2221 in part/oppose in part. 2) Testified on Internet privacy on 22 July 2010 on HR 5777 (Rush) and a discussion draft (Boucher) on notice and consent on Internet-- supported in part/opposed in part.

Client expense: $88,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Credit Union Administration (NCUA), Natl Economic Council (NEC), Office of Thrift Supervision (OTS), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1020/ S. 931. Arbitration Fairness Act (entire bill) H.R. 1237/ S. 512. Fairness in Nursing Home Arbitration Act (entire bill) H.R. 991. Consumer Fairness Act (entire bill) S. 458. False Claims Clarification Act (entire bill) H.R. 1788. False Claims Corrections Act (entire bill) S. 386. Fraud enforcement and Recovery Act, Section 4 H.R. 1346/ S. 540. Medical Device Safety Act (entire bill) H.R. 759. Food and Drug Administration Globalization Act (entire bill) H.R. 609. Right to Clean Vehicles Act (entire bill) H.R. 1508/ S.537. Sunshine in Litigation Act (entire bill) H.R. 812. Commonsense Consumption Act of 2009 (entire bill) S. 1504. Notice Pleading Restoration Act (entire bill) S. 1551. Liability for Aiding and Abetting Securities Violations Act (entire bill) H.R. 3326. FY 2010 DOD Appropriations ( Sec 8116. Arbitration) H.R. 4115. Open Access to Court (entire bill) S. 3305/ H.R. 5214. Big Oil Bailout Prevention Liability Act (entire bill) S. 3472. Big Oil Bailout Prevention Unlimited Liability Act (entire bill) H.R. 5069. Fair Payment of Court Fees Act (entire bill) H.R. 5419. Sunshine on Litigation Act (entire bill) H.R. 5503. SPILL Act (entire bill) H.R. 5629. Oil Spill Accountability Act (entire bill)

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT), Treasury, Dept of

**see addendum page H.R. 756 - National Pain Care Policy Act, pain management S. 1213 Patient-Centered Outcomes Research Act of 2009, comparative effectiveness S. 301/H.R. 3138 Physician Payments Sunshine Act of 2009, disclosure H.R. 1346/S. 540 Medical Device Safety Act of 2009, preemption PL 111-148 - The Patient Protection and Affordable Care Act, implementation Import Safety H.R. 759 - Food and Drug Administration Globalization Act of 2009 S. 510 - FDA Food Safety Modernization Act ***, no specific bill(s), import safety, price transparency, health care reform, 510k reform

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

**see addendum page H.R. 1346/S. 540 Medical Device Safety Act of 2009, preemption H.R. 759 Food and Drug Administration Globalization Act S. 510 - FDA Food Safety Modernization Act PL 111-148 - The Patient Protection and Affordable Care Act, implementation ***, no specific bill(s), import safety, health care reform, 510K reform

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346 - To amend the Federal food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices- provision related to federal preemption. S. 540 - A bill to amend the Federal food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices- provision related to federal preemption. H.R. 2749 - Food Safety Enhancement Act of 2009- Grants FDA the authority and resources it needs to better oversee the safety of the nations food supply. Includes provisions related to device import safety fee, registration fees and unique identifier provisions H.R. 759 - FDA Globalization Act- Grants FDA the authority and resources it needs to better oversee the safety of the nations food, cosmetic, drug and device supply. Includes provisions related to device import safety fee, registration fees and unique identifier provisions H.R. 4994 -- The Medicare and Medicaid Extenders Act of 2010 - section 112 - reauthorization of the Special Diabetes Program. Patient Protection and Affordable Care Act [P.L. 111-148] - Implementation issues concerning CER, IPAB, excise tax, prevention and wellness, disparaties, pain, payment reform provisions.

Client expense: $1,147,375 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Securities & Exchange Commission (SEC), White House Office

HR 1020, HR 1346, HR 1508, HR 2975, HR 3054, HR 3459, HR 4113, HR 5503, HR 5676, S 1734, S 301, S 386, S 458, S 537, S 540, S 657, S 882, S 931

Client expense: $810,000 · Firm income: Not reported

Government targets: Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

Provide counsel on health care legislation regulatory matters, including S. 2029 and H.R. 5605, Physician Payment Sunshine Act; H.R. 1346, S. 540, Medical Device Safety Act of 2009; America's Health Future Act; Patient Protection and Affordable Care Act; Health Care and Education Reconciliation Act of 2010

Client expense: Not reported · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

The Medical Device Safety Act - H.R. 1346/S.540, all provisions The False Claims Correction Act - H.R. 1788, all provisions

Client expense: $204,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of H.R. 3590, the Patient Protection and Affordable Care Act, to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. Implementation of H.R. 4872, the Health Care and Reconciliation Act of 2010, a bill that makes a number of health-related financing and revenue changes to the Patient Protection and Affordable Care Act, specifically regarding the medical device tax. S.540, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices H.R.1346, Medical Device Safety Act, a bill that would remove federal preemption protection for certain medical devices Reform of the 510 (k) regulatory pathway H.R. 759, Food and Drug Administration Globalization Act, a bill to improve the safety of food, drugs, devices, and cosmetics S. 882, the Drug and Device Accountability Act, a bill to ensure the safety and quality of medical products and enhance the authorities of the FDA H.R. 2502, Comparative Effectiveness Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and create a Comparative Effectiveness Research Trust Fund S.1213, Patient-Centered Outcomes Research Act of 2009, a bill to provide for the conduct of comparative effectiveness research for drugs, devices, and other therapies and to establish a Patient-Centered Outcomes Research Trust Fund H.R. 2824, Doctor-Patient Relationship and Research Protection Act, a bill to support federally funded comparative effectiveness research for drugs, devices, and other therapies S.1142, Informed Health Care Decision Making Act, a bill with respect to the inclusion of effectiveness information in drug and device labeling and advertising H.R. 3090, Health Equity & Accountability Act of 2009, provides for the elimination of racial and ethnic health disparities S.660, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 756, National Pain Care Policy Act, a bill to promote greater access to chronic pain therapies H.R. 4700, the Transparency in All Health Care Pricing Act of 2010, to provide for transparency in health care pricing H.R. 2249, the Health Care Price Transparency Promotion Act of 2009, to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs. H.R. 4803, the Patients Right to Know Act, to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information. H.R.1032, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. S.422, Heart Disease Education, Analysis Research, and Treatment for Women Act to amend the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

Client expense: $450,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Transportation, Dept of (DOT)

HR1346, S540 Medical Device Safety Act of 2009: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES

S. 540 & H.R. 1346, Medical Device Safety Act of 2009; Proposed amendments to Medicare Secondary Payer Statute and to H. R. 2641, the Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2009; To ensure patients' right to recover in cases of medical malpractice; Amendments to ERISA preemption.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Care Reform Implementation H.R. 3590 Patient Protection and Affordable Care Act H.R. 4872 Health Care and Education Reconciliation Act of 2010 Implementation of Public Law 111-148, The Patient Protection and Affordable Care Act Implementation of Public Law 111-152, the Reconciliation Act of 2010 H.R. 1548 Pathway for Biosimilars Act S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 422 Heart Disease Education, Analysis Research, and Treatment for Women Act H.R. 4213 American Jobs and Closing Tax Loopholes Act of 2010 Proposals to address reimbursement of diagnostics Reauthorization of The Prescription Drug User Fee Act (PDUFA) Reauthorization of The Medical Device User Fee Act (MDUFA) Biodefense and pandemic preparedness H.R. 1345/S.540 Medical Device Safety Act of 2009 Policies for FDA product approval process Briefings on eye care

Client expense: $650,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

H.R. 1346/S.540 - Medical Device Safety Act of 2009: to amend the Federal Food, Drug and Cosmetic Act with respect to liability under State and local requirements respecting devices. H.R. 3590 - Patient Protection and Affordable Care Act H.R. 2400 - Strategies to Address Antimicrobial Resisance Act H.R. 2813 - National Knee and Hip Replacement Registry Act of 2009 H.R. 1549/S.619 - Preservation of Antibiotics for Medical Treatment Act of 2009

Client expense: $573,687 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1346 S.540

Client expense: $5,356 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations 510(k) REform Patient Safety Organizations S 3737, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1451, FAA Air Transportation Modernization and Safety Improvement Act

Client expense: $9,280,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act HR 3652, Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy Act of 2009 S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S 1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency HR 5461, Virtual Screening for Colorectal Cancer Act of 2010 HR 1213, Screening Abdominal Aortic Aneurysms Very Efficiently Act of 2009 Labor, HHS Appropriations

Client expense: $15,460,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S 756, Prostate Research Imaging and Men's Education Act S 301, Physician Payments Sunshine Act of 2009 HR 759, FDA Globalization Act S 1695 Wired for Healthcare Act S 391, Healthy Americans Act S 391 HR 1346, Medical Device Safety Act of 2009 S 540, Medical Device Safety Act of 2009 Colorectal Cancer Prevention Early Detection and Treatment Act of 2009 Access to Medical Imaging HR 1894, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 HR 3200, America's Affordable Health Choices Act AAA Screening Legislation HR 3138 Physician Payments Sunshine Act HR 2502, Comparative Effectiveness Research Act of 2009 S 1213, Patient Centered Outcomes Research Act of 2009 S1131, Independence at Home Act of 2009 HR 2962, Integrity in Medicare Advanced Diagnostic Imaging Act of 2009 HR 3276, American Medical Isotopes Production Act of 2009 HR 3200, America's Affordable Health Choices Act of 2009 S 1679, Affordable Health Choices Act S 769, Medicare Fracture Prevention and Osteoporosis Testing Act of 2009 S 1100, Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 Medical Imaging Appropriateness Criteria Medical Device Fees Comparative Effectiveness Research Medicare Coverage of CT Colonography Health Information Technology Healthcare Reform MedPAC Reform Mammography Guidelines HR 3962, Affordable Healthcare for America Act HR 3590, Patient Protection and Affordable Care Act HR 4872, Healthcare and Education Affordability Reconciliation Act of 2010 USPSTF Transparency

Client expense: $7,310,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Patent reform and liability issues including: H.R.1260 / S.515 - Patent Reform Act of 2009 - all provisions S.610 - Patent Reform Act of 2009 - all provisions S.506 - Stop Tax Haven Abuse Act - tax patent provision S.931/H.R.1020 Arbitration Fairness Act of 2009 all provisions H.R.1346 / S.540 Medical Device Safety Act of 2009 liability issues H.R.4094 Drywall Victim Insurance Protection Act - all provisions S.739 Drywall Safety Act of 2009 all provisions S. 3217- Restoring American Financial Stability Act of 2010 expansion of third party liability (Stoneridge) The Domestic Manufacturing and Energy Jobs Act of 2010 (Draft Text) tax and liability provisions H.R.847 / S.1334 - James Zadroga 9/11 Health and Compensation Act of 2010 liability provisions H.R.3534 Consolidated Land, Energy, and Aquatic Resources Act of 2009 (CLEAR Act) liability provisions

Client expense: $440,000 · Firm income: Not reported

Government targets: Commodity Futures Trading Commission (CFTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

Supported efforts to implement new Consumer Product Safety Commission Improvement Act, add resources, regulate dangerous and/or toxic products. Provided comments to hill, signed letters, lobbied on all aspects of legislation and proposed regulations pertaining to reform. Testified in previous quarters. Specific new law is PL 110-314 (HR 4040, Consumer Product Safety Modernization Act). 2) Supported efforts, Medical Device Safety Act (S. 540, HR 1346) to overturn Supreme Court decision in Riegel v. Medtronic limiting state common law remedies against certain medical device manufacturers. 3) Broadly support all other efforts to preserve consumer private rights of action and to oppose preemption of stronger state consumer financial or health and safety laws. 4) Supported Representative Weiners amendment to H.R. 3200, Americas Affordable Health Choices Act of 2009, to require transparency by pharmacy benefit managers (PBMs) who contract with health plans in the national insurance exchange or with the public plan. OTHER ACTIVITIES: Supported various efforts to protect consumers from unfair business or marketplace practices by signing letters, lobbying or commenting on various proposals: 1) Mandatory Arbitration: Support (letters) for HR 1020, the Arbitration Fairness Act to ban mandatory arbitration in consumer laws. 2) Opposed (letter) S. 202 and S. 164, the "Passenger Vehicle Loss Disclosure Act of 2009" 3) Letters limited to opposition to elimination of inequitable conduct defense in the Patent Reform Act (S 515, HR 1260), to encourage generic substitutes for brand name pharmaceuticals. 4) Opposition to the Consumer Rental Purchase Agreement Act, S 738, HR 1744, which would legalize unfair practices of predatory rent to own stores. 5) Supported aspects of Federal Aviation Administration reforms pertaining to Airline Passengers Bill of Rights (HR 915, FAA Reauthorization and S. 213 (Boxer-Snowe). 5) Support strong enforcement of antitrust laws, including opposition to merger of Ticketmaster and LiveNation (testimony in House in previous quarter). Supported DOJ action against Mastercard and Visa re credit card fees. 6) Signed letters to White House urging amendments to GM/Chrysler bankruptcy negotiations to reinstate compensation rights of injured victims. 7) Supported variety of efforts, including Equal Employment for All Act (Cohen, House) to amend Fair Credit Reporting Act. 7) Urged support for legislation (not yet filed) to overturn Supreme Court in Leegin, reinstating ban on resale price maintenance. 8) Opposed aspects of Chrysler car company bankruptcy negotiations with administration that limited crash victim rights. 9) Supported Congressional efforts to overturn limits on oil company spill liability. PRIVACY: Support efforts to ensure that federal law provides consumers with strong privacy protection, prevents identity theft, and holds companies and government agencies accountable when they lose consumer data. Support includes lobbying, letters, and communications as necessary. Support HR 2221 in part/oppose in part. 2) Testified on Internet privacy on 22 July 2010 on HR 5777 (Rush) and a discussion draft (Boucher) on notice and consent on Internet-- supported in part/opposed in part.

Client expense: $90,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Credit Union Administration (NCUA), Natl Economic Council (NEC), Office of Thrift Supervision (OTS), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office