Featured Cases

• STATE OF FLORIDA et al v. UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES et al

  3:2010cv00091
  Filed in Florida Northern District Court
  Type of Suit: Other Statutory Actions
  Plaintiff: STATE OF FLORIDA, by and through BILL MCCOLLUM, STATE OF SOUTH CAROLINA, by and through HENRY McMASTER, ATTORNEY GENERAL, STATE OF NEBRASKA, by and through JON BRUNING, ATTORNEY GENERAL, STATE OF TEXAS, by and through GREG ABBOTT, ATTORNEY GENERAL, STATE OF UTAH, by and through MARK L. SHURTLEFF, ATTORNEY GENERAL and other. Defendant: UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS, in her official capacity as THE SECRETARY OF THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES DEPARTMENT OF THE TREASURY, TIMOTHY F. GEITHNER, in his official capacity as the Secretary of THE UNITED STATES DEPARTMENT OF THE TREASURY, UNITED STATES DEPARTMENT OF LABOR and other.
  Judge: SENIOR JUDGE ROGER VINSON
  Cause Of Action: Declaratory Judgement
  (March 15, 2011)

• Commonwealth of Virginia, Ex Rel. Kenneth T. Cuccinelli, II v. Sebelius

  3:2010cv00188
  Filed in Virginia Eastern District Court
  Type of Suit: Constitutionality of State Statutes
  Plaintiff: Commonwealth of Virginia, Ex Rel. Kenneth T. Cuccinelli, II. Defendant: Kathleen Sebeliu. Amicu: Ray Elbert Parker, American Center for Law and Justice, Todd Akin, Paul Broun, Rob Bishop and other. Movant: Steven J. Willi, Eve Ellingwood, American Civil Rights Union, Americans for Free Choice in Medicine and Virginia Organizing and other.
  Judge: Henry E. Hudson
  Cause Of Action: Federal Question
  (January 19, 2011)

• GUNVALSON et al v. PTC THERAPEUTICS, INC.

  2:2008cv03559
  Filed in New Jersey District Court
  Type of Suit: Other Contract
  Plaintiff: JACOB GUNVALSON, CHERI AND JOHN GUNVALSON; Defendant: PTC THERAPEUTICS, INC.
  Cause Of Action: Diversity
  (April 6, 2009)

• NOVARTIS VACCINES AND DIAGNOSTICS, INC. v. ...

  1:2007cv02138
  Filed in District Of Columbia District Court
  Type of Suit: Patent
  Plaintiff: NOVARTIS VACCINES AND DIAGNOSTICS, INC. Defendant: UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, NATIONAL INSTITUTES OF HEALTH
  Judge: Richard W. Roberts
  Cause Of Action: Patent Infringement
  (November 26, 2007)

• Advanced Care, Inc. v. Department of Health & Human Services

  2:2007cv04588
  Filed in New York Eastern District Court
  Type of Suit: Other Statutory Actions
  Plaintiff: Advanced Care, Inc. Defendant: Department of Health & Human Services
  Judge: Joseph F. Bianco
  Cause Of Action: HHS: Adverse Reimbursement Review
  (November 1, 2007)

Legislation

• Bill Introduced: S.2097 Comprehensive Cancer Care Improvement Act of 2012

  A bill to amend title XVIII of the Social Security Act to provide for coverage of comprehensive cancer care planning under the Medicare Program and to improve the care furnished to individuals diagnosed with cancer by establishing grants programs for provider education, and related research.
  (February 7, 2012)

• Bill Introduced: S.2092 Religious Freedom Protection Act of 2012

  A bill to amend title XXVII of the Public Health Service Act to provide conscience protections for individuals and organizations.
  (February 7, 2012)

• Bill Introduced: H.R.3897 Religious Freedom Restoration Act of 2012

  To amend title XXVII of the Public Health Service Act to provide religious conscience protections for individuals and organizations.
  (February 1, 2012)

• Bill Introduced: H.R.3847 SOUND Devices Act of 2012

  To amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes.
  (January 29, 2012)

• Bill Introduced: H.R.3839 Drug Shortage Prevention Act of 2012

  To address critical drug shortages.
  (January 29, 2012)

Regulations

• Rule - Medical Devices: Ear, Nose, and Throat Devices; Classification of the Wireless ...

  Food and Drug Administration
  Rule
  Medical Devices:
  Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
  ,
  34845-34847 [2011-14790]
  Rules and Regulations Federal Register Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA-2011-N-0361] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the wireless air-conduction... [read document]
  View Document | Download PDF
  (June 14, 2011)

• Proposed Rule - Medicare Programs: Proposed Changes to the Hospital Inpatient Prospective ...

  Centers for Medicare and Medicaid Services
  Proposed Rule
  Medicare Programs:
  Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections
  ,
  34633-34634 [2011-14679]
  DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 412, 413 and 476 [CMS-1518-CN] RIN 0938-AQ24 Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Correction of proposed rule. SUMMARY: This document corrects technical... [read document]
  View Document | Download PDF
  (June 13, 2011)

• Proposed Rule - Quality Assurance Requirements for Respirators: Withdrawal

  Department of Health and Human Services
  Proposed Rule
  Quality Assurance Requirements for Respirators:
  Withdrawal
  ,
  33188-33189 [2011-14186]
  DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket Number NIOSH-109] RIN 0920-AA04 Quality Assurance Requirements for Respirators; Notice of Withdrawal AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking; withdrawal. SUMMARY: The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of... [read document]
  View Document | Download PDF
  (June 7, 2011)

• Proposed Rule - Medicare Program: Availability of Medicare Data for Performance Measurement

  Centers for Medicare and Medicaid Services
  Proposed Rule
  Medicare Program:
  Availability of Medicare Data for Performance Measurement
  ,
  33566-33588 [2011-14003]
  Vol. 76 Wednesday No. 110 June 8, 2011 Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 401 Medicare Program; Availability of Medicare Data for Performance Measurement; Proposed Rule Federal Register / Vol. 76, No. 110 / Wednesday June 8, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 401 [CMS-5059-P] RIN 0938-AQ17 Medicare Program; Availability of Medicare Data for... [read document]
  View Document | Download PDF
  (June 7, 2011)

• Rule - Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: ...

  Food and Drug Administration
  Rule
  Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements:
  Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability
  ,
  32863-32864 [2011-13950]
  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 320 [Docket No. FDA-2010-D-0482] Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of guidance. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and... [read document]
  View Document | Download PDF
  (June 6, 2011)

Articles

• Further Support for Mental Health Parity Law and Mandatory Mental Health and Substance Use ...

  Annals of Health Law, Vol. 21, p. 147, 2012, UNLV William S. Boyd School of Law Legal Studies Research Paper Stacey A. Tovino University of Nevada, Las Vegas, William S. Boyd School of Law Date Posted: February 17, 2012 Accepted Paper Series 1 downloads If We Can Force People to Purchase Health Insurance, then Let’s Force Them to Be Treated Too American Journal of Law and Medicine, 2012, FSU College of Law, Public Law Research Paper No. 572 Marshall B. Kapp Florida State University, College of Law and College of Medicine Date Posted: February 13, 2012 Accepted Paper Series 3 downloads Protecting Liberty and Autonomy: Desert/Disease Jurisprudence San Diego Law Review, Vol. 48, Pg. 1077, 2011, U of Penn Law School, Public Law Research Paper No. 12-10 Stephen Morse University of Pennsylvania Law School Date Posted: February 13, 2012 Accepted Paper Series 31 downloads Reforming State Mental Health Parity Law Houston Journal of Health Law and Policy, Vol. 11, p. 455, 2011 Stacey A. Tovino University of Nevada, Las Vegas, William S. Boyd School of Law Date Posted: February 13, 2012 Last Revised: February 17, 2012
  (February 16, 2012)

• Healthy by Law: The Missed Opportunity to Use Laws for Public Health

  The Lancet, Vol. 379, pp. 283-285, January 2012 Amir Attaran , Tikki Pang , Judith Whitworth , Andrew Oxman and Martin McKee University of Ottawa - Faculties of Law and Medicine , affiliation not provided to SSRN , affiliation not provided to SSRN , affiliation not provided to SSRN and London School of Hygiene and Tropical Medicine Date Posted: February 07, 2012 Accepted Paper Series 7 downloads Rethinking Fraud Regulation by Rethinking the Health Care System Hamline Journal of Public Law and Policy, Vol. 32, No. 2, pp. 411-427, 2011, Northeastern University School of Law Research Paper No. 85-2012 Kristin M. Madison Northeastern University - School of Law; Northeastern University - Bouve College of Health Sciences Date Posted: February 07, 2012 Last Revised: February 17, 2012
  (February 16, 2012)

• The Chill Sets In: National Security and the Decline of Equality in Canada

  University of New Brunswick Law Journal, Vol. 54, p. 191, 2005 Faisal Bhabha York University - Osgoode Hall Law School Date Posted: January 26, 2012 Accepted Paper Series 1 downloads Sex, Politics, and Lessons Learned from Plan B: A Review of the FDA’s Actions and Future Direction Oklahoma City University Law Review, Vol. 36, 2011 Roseann B. Termini and Miranda Lee Widener University - School of Law and Widener University - Delaware Campus Date Posted: January 25, 2012 Accepted Paper Series 3 downloads Environmental Law in the Context of Article 31(3)(C) of the Vienna Convention on the Law of Treaties: Reconciling Treaty Interpretation and Progressive Environmental Norms: The Pulp Mills Case and Beyond Han van Gellecum affiliation not provided to SSRN Date Posted: January 23, 2012 Working Paper Series 30 downloads Trade Diplomacy, the Rule of Law and the Problem of Asymmetric Risks in TRIPS Quaker United Nations Office Occasional Paper No. 13, FSU College of Law, Public Law Research Paper, FSU College of Law, Law, Business & Economics Paper Frederick M. Abbott Florida State University - College of Law Date Posted: January 23, 2012 Working Paper Series 9 downloads Effective, Proportional and Dissuasive Penalties in the Implementation of the Environmental Crime and Shipsource Pollution Directives: Questions and Challenges European Energy and Environmental Law Review, pp. 256-278, 2010 MICHAEL G. FAURE University of Maastricht - Faculty of Law, Metro Date Posted: January 22, 2012 Accepted Paper Series 5 downloads 'Treaty Congestion' in International Environmental Law ROUTLEDGE HANDBOOK OF INTERNATIONAL ENVIRONMENTAL LAW, Shawkat Alam, Jahid Hossain Bhuiyan, Tareq M.R. Chowdhury and Erika J. Techera, eds., Routledge, 2012, ANU College of Law Research Paper No. 12-05 Donald K. Anton Australian National University (ANU) - College of Law Date Posted: January 21, 2012 Last Revised: February 17, 2012
  (February 16, 2012)

• Online, Distance Legal Education as an Agent of Social Change

  Pacific McGeorge Global Business & Development Law Journal, Vol. 24, pp. 95, 2011, NYLS Clinical Research Institute Paper No. 02/12 Michael L. Perlin New York Law School Date Posted: February 11, 2012 Accepted Paper Series 4 downloads Artificial Reproductive Techniques and Parenting: Trends and Paradoxes International Journal of the Jurisprudence of the Family, Vol. 2, 2012 Nicolas Lafferriere Universidad Católica Argentina Date Posted: February 10, 2012 Accepted Paper Series New Therapies, Old Problems, or, a Plea for Neuromodesty American Journal of Bioethics: Neuroscience, Vol. 3, No. 1, p. 60, 2012, U of Penn Law School, Public Law Research Paper No. 12-09 Stephen Morse University of Pennsylvania Law School Date Posted: February 10, 2012 Accepted Paper Series 12 downloads The Drugs Stop Here: A Public Health Framework to Address the Drug Shortage Crisis Food and Drug Law Journal, Forthcoming, Case Legal Studies Research Paper No. 2012-4 Sharona Hoffman Case Western Reserve University School of Law Date Posted: February 10, 2012 Accepted Paper Series 6 downloads FDA Regulation of Off-Label Promotion: An Answer Coleen Klasmeier Sidley Austin LLP Date Posted: February 09, 2012 Working Paper Series 5 downloads Marriage Fraud California Law Review, Vol. 100, No. 1, 2012, Virginia Public Law and Legal Theory Research Paper No. 2012-12 Kerry Abrams University of Virginia School of Law Date Posted: February 08, 2012 Accepted Paper Series 25 downloads Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not Christopher M. Holman University of Missouri - Kansas City School of Law Date Posted: February 08, 2012 Working Paper Series 37 downloads Elevating TJ: Structural Suggestions for Promoting a Therapeutic Jurisprudence Perspective in the Appellate Courts Phoenix Law Review, Vol. 5, 2012, Arizona Legal Studies Discussion Paper No. 12-03 David B. Wexler University of Puerto Rico - School of Law Date Posted: February 07, 2012 Last Revised: February 17, 2012
  (February 16, 2012)

• Separation of Church and Hospital: Strategies to Protect Pro-Choice Physicians in Religiously ...

  Yale Journal of Law & Feminism, Vol. 15, p. 135, 2003 Leora F. Eisenstadt Temple University - James E. Beasley School of Law Date Posted: January 27, 2012 Accepted Paper Series 2 downloads Smooth and Bumpy Laws Adam J. Kolber NYU School of Law Date Posted: January 27, 2012 Last Revised: February 16, 2012
  (February 15, 2012)

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