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Litigation Project Detail


Health Care Project
The U.S. Food and Drug Administration (FDA) is charged with responsibility with protecting the public from dangerous foods, drugs, and medical devices. In its zeal to regulate, FDA occasionally steps over the line by excessively delaying important medical breakthroughs or by improperly prohibiting truthful communications about approved drugs and devices. WLF is the most visible and effective FDA watchdog in Washington, and has had a significant impact in reforming FDA policies. WLF also litigates to ensure that the development of new lifesaving products continues unabated by supporting an effective patent system, opposing unwarranted antitrust suits against patent holders, and opposing state efforts to impose price control schemes on medical products, and by advocating for rational reimbursement policies on the part of the Centers for Medicare and Medicaid Services (CMS).
Cases in this Project:
Regulatory Proceeding:
In re: Use of “Natural” on Food Labels
Case Date: 5/10/2016
 
Johnson & Johnson v. Reckis
Case Date: 11/9/2015
 
Amarin Pharma, Inc. v. FDA
Case Date: 6/12/2015
King v. Burwell
Case Date: 12/29/2014
In re: Emergency Eyewash Products
Case Date: 3/7/2014
Regulatory Proceeding:
In re: MMDA Petition on 510(k) Medical Device Evaluation
Case Date: 10/16/2013
In re FDA Medical Device Reporting
Case Date: 10/11/2013
 
Medtronic, Inc. v. Stengel
Case Date: 6/13/2013
 
Jones v. Abbott Laboratories
Case Date: 6/3/2013
 
Regulatory Proceeding:
In re Final Rules on Transparency Reporting
Case Date: 5/15/2013
 
FTC v. Actavis, Inc.
Case Date: 2/28/2013
 
Regulatory Proceeding:
In re FDA Approval of Biosimilars
Case Date: 2/13/2013
 
 
Regulatory Proceeding:
In Re Cipro I & II
Case Date: 7/27/2012
 
Centocor, Inc. v. Hamilton
Case Date: 12/2/2011
In re Research Use Only Devices
Case Date: 8/31/2011
Regulatory Proceeding:
In re 510(k) Advisory Committee
Case Date: 6/28/2011
ViroPharma Inc. v. Hamburg
Case Date: 1/28/2011
 
Thomas More Law Ctr. v. Obama
Case Date: 12/22/2010
 
Bruesewitz v. Wyeth, Inc.
Case Date: 7/30/2010
Sottera, Inc. v. FDA
Case Date: 7/21/2010
 
Commonwealth of Va. v. Sebelius
Case Date: 6/17/2010
 
United States v. Caronia
Case Date: 4/22/2010
 
Friedman v. Sebelius
Case Date: 3/22/2010
 
Allergan v. United States
Case Date: 11/19/2009
Regulatory Proceeding:
In re FDA Transparency Task Force
Case Date: 8/6/2009
 
Tafas v. Doll
Case Date: 6/18/2009
 
In re Sheila Engdahl
Case Date: 6/17/2009
 
Regulatory Proceeding:
In re INDs for ALS Patients
Case Date: 3/5/2009
Conte v. Wyeth, Inc.
Case Date: 1/5/2009
Regulatory Proceeding:
In re CMS Coverage Determination for BiDil
Case Date: 8/7/2008
Regulatory Proceeding:
In re Physician-Owned Implant Companies
Case Date: 7/28/2008
 
Wyeth v. Levine
Case Date: 6/3/2008
 
Regulatory Proceeding:
In re Reprints Guidance
Case Date: 4/21/2008
Regulatory Proceeding:
Report on FDA First Amendment Abuses
Case Date: 1/30/2008
Regulatory Proceeding:
Response to DDMAC Warning Letter to GlaxoSmithKline
Case Date: 12/10/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Scios
Case Date: 11/15/2007
Riegel v. Medtronic
Case Date: 10/19/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Eli Lilly and Co.
Case Date: 10/16/2007
Merck & Co. v. Apotex Corp.
Case Date: 9/20/2007
 
Warner-Lambert Co. LLC v. Kent
Case Date: 7/20/2007
Pfizer v. Apotex Corp.
Case Date: 6/29/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to Allergan, Inc.
Case Date: 6/15/2007
Regulatory Proceeding:
Proposed Restrictions on Medicare/Medicaid Coverage for ESAs
Case Date: 6/11/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to KV Pharmaceutical Co.
Case Date: 6/11/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to Enzon Pharmaceuticals, Inc.
Case Date: 6/11/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letters to Schering and GlaxoSmithKline
Case Date: 5/21/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to DUSA Pharmaceuticals.
Case Date: 5/1/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to Alcon Laboratories
Case Date: 4/27/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Takeda
Case Date: 3/19/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to Cephalon
Case Date: 3/19/2007
Regulatory Proceeding:
FDA Regulation of Clinical Labs and ASRs
Case Date: 3/5/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to MGI PHARMA, Inc.
Case Date: 2/6/2007
Regulatory Proceeding:
Response to DDMAC Untitled Letter to WellSpring
Case Date: 1/29/2007
Regulatory Proceeding:
Response to DDMAC Warning Letter to Daiichi Sankyo
Case Date: 1/29/2007
 
IMS Health Inc. v. Ayotte
Case Date: 11/30/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Mallinckrodt, Inc.
Case Date: 11/6/2006
Regulatory Proceeding:
Response to Warning Letter to BioMarin Pharmaceuticals
Case Date: 10/19/2006
 
Regulatory Proceeding:
Petition to Stop FDA Regulation of Clinical Labs
Case Date: 9/28/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Reliant Pharmaceuticals
Case Date: 9/20/2006
Regulatory Proceeding:
Response to DDMAC Warning Letters to Astellas Pharma US, Inc.
Case Date: 9/13/2006
 
Fox v. Leavitt
Case Date: 8/24/2006
 
Regulatory Proceeding:
Report on FDA First Amendment Abuses
Case Date: 8/7/2006
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Eli Lilly
Case Date: 8/4/2006
Regulatory Proceeding:
Response to DDMAC Warning Letters to PrimaPharm and GlaxoSmithKline
Case Date: 7/6/2006
Regulatory Proceeding:
Response to OCBQ Untitled Letter to Wyeth
Case Date: 6/12/2006
Regulatory Proceeding:
Response to DDMAC Warning Letters to Sandoz, Inc. and BIPI
Case Date: 6/2/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Bioniche Pharma Group Limited
Case Date: 4/21/2006
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Intermune
Case Date: 4/6/2006
Regulatory Proceeding:
Response to OCBQ Warning Letter to VaxGen
Case Date: 4/6/2006
Regulatory Proceeding:
In re Medicare Marketing Guidelines
Case Date: 4/4/2006
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Palatin Technologies, Inc.
Case Date: 3/10/2006
Regulatory Proceeding:
Response to DDMAC Untitled Letter to Biogen Idec Inc.
Case Date: 2/10/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Mayne Pharma (USA), Inc.
Case Date: 2/10/2006
Regulatory Proceeding:
Response to OCBQ Untitled Letter to ZLB Behring LLC
Case Date: 2/10/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Duramed Pharmaceuticals, Inc.
Case Date: 1/20/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Medicis Pharmaceutical Corp.
Case Date: 1/17/2006
Regulatory Proceeding:
Response to DDMAC Warning Letter to Sankyo Pharma Inc.
Case Date: 1/17/2006
Regulatory Proceeding:
In re FDA Petition to Require Warning Labels on Sodas
Case Date: 12/16/2005
Regulatory Proceeding:
In re Food Warning Legislation
Case Date: 11/29/2005
Regulatory Proceeding:
Response to OCBQ Warning Letter to GenTrac, Inc.
Case Date: 11/21/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to ISTA Pharmaceuticals
Case Date: 11/8/2005
Regulatory Proceeding:
In re DTC Advertising
Case Date: 11/2/2005
Regulatory Proceeding:
In re Silicone Breast Implants - Citizen's Petition
Case Date: 10/11/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Nephrx, LLC
Case Date: 10/3/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Alcon Research, Ltd.
Case Date: 9/27/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Allergan, Inc.
Case Date: 9/9/2005
Regulatory Proceeding:
In re Emergency Use Authorization of Medical Products
Case Date: 9/6/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to SuperGen Inc.
Case Date: 8/25/2005
 
Regulatory Proceeding:
In re CMS Guidance on "Part D" Drug Formularies
Case Date: 8/19/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Actelion Pharmaceuticals US, Inc.
Case Date: 7/27/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Pfizer, Inc.
Case Date: 7/27/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Abbott Laboratories
Case Date: 7/20/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Hoffman-LaRoche Inc.
Case Date: 7/19/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Dutch Ophthalmic USA
Case Date: 6/30/2005
Regulatory Proceeding:
Response to DDMAC Warning Letter to Endo Pharmaceuticals
Case Date: 6/30/2005
Regulatory Proceeding:
Response to OCBQ Warning Letter to MedImmune Vaccines, Inc.
Case Date: 6/30/2005
Regulatory Proceeding:
WLF's FDA/DDMAC Watch - In re: DDMAC Oversight of Drug Promotion
Case Date: 6/21/2005
Regulatory Proceeding:
In re CMS Draft Guidance on Coverage With Evidence Development
Case Date: 6/6/2005
 
United States v. Rx Depot, Inc.
Case Date: 5/11/2005
 
Regulatory Proceeding:
In re Restriction on Lung Cancer Drug
Case Date: 4/20/2005
Regulatory Proceeding:
In re Silicone Gel-Filled Breast Implants
Case Date: 3/28/2005
Regulatory Proceeding:
In re Justice Department Oversight of Drug Company Prosecutions.
Case Date: 3/24/2005
Regulatory Proceeding:
In re Oversight of Drug Promotion Investigations
Case Date: 3/24/2005
Regulatory Proceeding:
In re DEA Regulation of Pain Medications
Case Date: 3/21/2005
 
 
Regulatory Proceeding:
In re Task Force on Innovation
Case Date: 8/20/2004
Regulatory Proceeding:
In re CMS Cancer Drug Reimbursement Policy
Case Date: 2/10/2004
Regulatory Proceeding:
In re Tier 1 Initial Approval Program
Case Date: 6/11/2003
Regulatory Proceeding:
In re ACCME's Proposed Standards for Continuing Medical Education
Case Date: 1/30/2003
Regulatory Proceeding:
In re FDA Request for Comments on First Amendment Issues
Case Date: 9/13/2002
HUD v. Rucker
Case Date: 3/26/2002
Board of Education v. Earls
Case Date: 12/26/2001
Marchwinski v. Howard
Case Date: 11/28/2000
Taylor v. SmithKline Beecham Corp.
Case Date: 12/16/1999
Houstoun v. Maldonado
Case Date: 10/9/1998
Doe v. Belshe
Case Date: 6/15/1998
Anderson v. Roe
Case Date: 7/30/1997

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