PREEMPTION AND THE PHYSICIAN PAYMENTS SUNSHINE ACT TOPICS. Overview of Preemption. Recent Developments. Consequences and Strategies
|
|
|
- Victor Shaw
- 6 years ago
- Views:
Transcription
1 PREEMPTION AND THE PHYSICIAN PAYMENTS SUNSHINE ACT Robert N. Weiner October 22, 2008 TOPICS Overview of Preemption Recent Developments Consequences and Strategies
2 OVERVIEW OF PREEMPTION SUPREMACY CLAUSE Federal law is the supreme Law of the Land Judges in every state are bound any Thing in the Constitution or Laws of any state to the Contrary notwithstanding. OVERVIEW OF PREEMPTION Pro-Business v. States Rights Pro-Regulatory v. Pro-Plaintiff Intertwined Issues Cross Currents
3 OVERVIEW OF PREEMPTION Express Preemption Implied Preemption Field Preemption Conflict Preemption Impossibility Obstacle OVERVIEW OF PREEMPTION Key Issues Presumption Against Preemption Congressional Intent
4 OVERVIEW OF PREEMPTION Presumption Against Preemption OVERVIEW OF PREEMPTION Congressional Intent
5 TOPICS Overview of Preemption Recent Developments Consequences and Strategies RECENT DEVELOPMENTS Preemption Preambles NHTSA CPSC FRSA FDA
6 RECENT DEVELOPMENTS Riegel v. Medtronic Inc. (2008) RECENT DEVELOPMENTS Express Preemption Under the MDA [N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter
7 RECENT DEVELOPMENTS Altria Group, Inc. v. Good Express Preemption of Consumer Fraud Claims Involving Tobacco Products Argued October 6, 2008 RECENT DEVELOPMENTS Altria Group, Inc. v. Good No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter
8 RECENT DEVELOPMENTS Wyeth v. Levine IMPLIED PREEMPTION OF CLAIMS INVOLVING PRESCRIPTION DRUGS TOPICS Overview of Preemption Recent Developments Consequences and Strategies
9 CONSEQUENCES AND STRATEGIES CONSEQUENCES AND STRATEGIES Medical Device Safety Act of 2008 S H.R No Effect on Liability Under State Law- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.
10 CONSEQUENCES AND STRATEGIES State AGs (Editors) Congressman Henry Waxman Preemption Foes David Kessler CONSEQUENCES AND STRATEGIES Physician Payments Sunshine Act Sec. 1128G(d): RELATION TO STATE LAWS. The provisions of this section shall preempt any law or regulation of a State or of a political subdivision of a State relating to the disclosure or reporting of information regarding payments or other transfers of value provided to covered recipients by applicable manufacturers to the State or to any other governmental entity for purposes of including such information in any State-sponsored database or other repository of information.
11 CONSEQUENCES AND STRATEGIES State Laws Potentially Preempted Laws and Regulations on: Clinical Trial Registration? Prescriber Identifiable Data? Marketing Disclosure? Gifts and CME? Licensing of Sales Representatives? CONSEQUENCES AND STRATEGIES State Laws Potentially Preempted LAWSUITS?
New Federal Initiatives Project. Executive Order on Preemption
New Federal Initiatives Project Executive Order on Preemption By Jack Park* September 4, 2009 The Federalist Society for Law and Public Policy Studies www.fed-soc.org Executive Order on Preemption On May
The Federal Preemption Battle Has Just Begun
Portfolio Media, Inc. 648 Broadway, Suite 200 New York, NY 10012 www.law360.com Phone: +1 212 537 6331 Fax: +1 212 537 6371 customerservice@portfoliomedia.com The Federal Preemption Battle Has Just Begun
Preemption in Nonprescription Drug Cases
drug and medical device Over the Counter and Under the Radar By James F. Rogers, Julie A. Flaming and Jane T. Davis Preemption in Nonprescription Drug Cases Although it must be considered on a case-by-case
Bender's Health Care Law Monthly September 1, 2011
Bender's Health Care Law Monthly September 1, 2011 SECTION: Vol. 2011; No. 9 Federal Pre-Emption Under The Food, Drug & Cosmetic Act From Medtronic, Inc. V. Lohr; Pliva, Inc. V. Mensing By Frederick R.
Product Safety & Liability Reporter
Product Safety & Liability Reporter Reproduced with permission from Product Safety & Liability Reporter, 30 PSLR 840, 08/01/2011. Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman Lieff Cabraser Heimann & Bernstein, LLP
Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman October 5, 2010 1 I. The Medical Device Amendments Act The Medical Device Amendments of 1976
State Attorney General Investigations and Litigation. Barry H. Boise November 3, 2011
State Attorney General Investigations and Litigation Barry H. Boise November 3, 2011 The State Compliance Environment Increasing efforts by states to regulate: Advertising and promotional spend limits/disclosures
on significant health issues pertaining to their products, and of encouraging the
Number 836 March 17, 2009 Client Alert Latham & Watkins Wyeth v. Levine and the Contours of Conflict Preemption Under the Federal Food, Drug, and Cosmetic Act The decision in Wyeth reinforces the importance
DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION
DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION Publication DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION July 16, 2009 On March 4, 2009, the United States Supreme Court issued its much anticipated
) ) ) ) ) ) ) ) ) ) ) )
Case :0-cv-00-RCC Document Filed /0/0 Page of 0 0 Richard Stengel, et al., vs. Medtronic, Inc. Plaintiffs, Defendant. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA No. CV 0--TUC-RCC ORDER
Dobbs V. Wyeth: Are We There Yet, And At What Cost?
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Dobbs V. Wyeth: Are We There Yet, And At What Cost?
Drug Preemption v. Medical Device Preemption: A Study in Contrast
Journal of the Kansas Association for Justice u Product liability Drug Preemption v. Medical Device Preemption: A Study in Contrast By Leslie Overfelt and Patrick A. Hamilton Leslie Overfelt, is a staff
Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval
report from washi ngton Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval March 6, 2008 To view THE SUPREME COURT S DECISION IN riegel V. medtronic, Inc.
pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë=
No. 13-1379 IN THE pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë= ATHENA COSMETICS, INC., v. ALLERGAN, INC., Petitioner, Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT CHRISTINA MCCLELLAN, Plaintiff-Appellant, v. I-FLOW CORPORATION, a Delaware corporation; DJO, L.L.C., a Delaware corporation; DJO INCORPORATED,
The Reverse Read and Heed Causation Presumption: A Presumption That Should Be Given Little Heed
b y J o h n Q. L e w i s, P e a r s o n N. B o w n a s, a n d M a t t h e w P. S i l v e r s t e n The Reverse Read and Heed Causation Presumption: A Presumption That Should Be Given Little Heed Failure-to-warn
SUPREME COURT OF MISSOURI en banc
SUPREME COURT OF MISSOURI en banc JODIE NEVILS, APPELLANT, vs. No. SC93134 GROUP HEALTH PLAN, INC., and ACS RECOVERY SERVICES, INC., RESPONDENTS. APPEAL FROM THE CIRCUIT COURT OF ST. LOUIS COUNTY Honorable
NO IN THE SUPREME COURT OF THE UNITE STATES. October Term, 2017 ALICE IVERS. Petitioner, WESTERLY PHARMACEUTICAL, INC. Respondent.
NO. 17-230 IN THE SUPREME COURT OF THE UNITE STATES October Term, 2017 ALICE IVERS Petitioner, v. WESTERLY PHARMACEUTICAL, INC. Respondent. On Writ of Certiorari to the Twelfth Circuit Court of Appeals
A Change is Gonna Come: How Will the New HHS and FDA Affect Pharmaceutical and Medical Device Companies?
A Change is Gonna Come: How Will the New HHS and FDA Affect Pharmaceutical and Medical Device Companies? Cathy L. Burgess Robert Roth January 29, 2009 Thompson Publishing Audio Conference Topics for Discussion
Preemption After Wyeth v. Levine
Preemption After Wyeth v. Levine DOUGLAS G. SMITH * TABLE OF CONTENTS I. THE BACKGROUND OF THE WYETH DECISION... 1437 A. The History of Federal Regulation of Pharmaceutical Products... 1438 B. The Regulatory
Medicare Prescription Drug Anti-Fraud Act of [Discussion Draft] H.R.
![Medicare Prescription Drug Anti-Fraud Act of [Discussion Draft] H.R.](/thumbs/90/101998330.jpg "Medicare Prescription Drug Anti-Fraud Act of [Discussion Draft] H.R.")
Medicare Prescription Drug Anti-Fraud Act of 2015 [Discussion Draft] 114TH CONGRESS 1ST SESSION H.R. To amend title XVIII of the Social Security Act to permit prescription drug plan sponsors to withhold
Federal preemption in the non-drug context after Wyeth v. Levine. by Michael X. Imbroscio. Covington & Burling LLP *
Federal preemption in the non-drug context after Wyeth v. Levine by Michael X. Imbroscio Covington & Burling LLP * The Supreme Court s 6-3 decision in Wyeth v. Levine, 129 S.Ct. 1187 (2009), rejected implied
Recent Developments in Federal Preemption of Pharmaceutical Drug and Medical Device Product Liability Claims. Bryan G. Scott Elizabeth K.
Article originally published in 17 THE DEFENDER, Fall 2009, at 22 (publication of the North Carolina Association of Defense Attorneys). Recent Developments in Federal Preemption of Pharmaceutical Drug
No IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT. ALEXIS DEGELMANN, et al., ADVANCED MEDICAL OPTICS INC.,
Case: 10-15222 11/14/2011 ID: 7963092 DktEntry: 45-2 Page: 1 of 17 No. 10-15222 IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT ALEXIS DEGELMANN, et al., v. Plaintiffs-Appellants, ADVANCED
- F.3d, 2009 WL , C.A.Fed. (Mass.), April 03, 2009 (NO )
CITE AS: 1 HASTINGS. SCI. AND TECH. L.J. 269 ARIAD PHARMACEUTICALS, INC. V. ELI LILLY AND COMPANY - F.3d, 2009 WL 877642, C.A.Fed. (Mass.), April 03, 2009 (NO. 2008-1248) I. STATEMENT OF THE FACTS Defendant-Appellant
State of Arizona v. United States of America: The Supreme Court Hears Arguments on SB 1070
FEDERATION FOR AMERICAN IMMIGRATION REFORM State of Arizona v. United States of America: The Supreme Court Hears Arguments on SB 1070 Introduction In its lawsuit against the state of Arizona, the United
Supreme Court of the United States
No. 17-230 IN THE Supreme Court of the United States Fall Term, 2017 Alice IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. On Writ of Certiorari to the Twelfth Circuit Court of Appeals
Product Liability Update
Product Liability Update In This Issue: July 2011 State Law Rule Mandating Classwide Arbitration of Consumer Claims Stands as Obstacle to Purposes of Federal Arbitration Act and Is Therefore Preempted
FDA REFORM LEGISLATION Its Effect on Animal Drugs TABLE OF CONTENTS
November 12, 1997 FDA REFORM LEGISLATION Its Effect on Animal Drugs TABLE OF CONTENTS I. BACKGROUND II. REFORM PROVISIONS AFFECTING ANIMAL DRUGS A. Supplemental Applications - Sec. 403 B. Manufacturing
SUPREME COURT OF THE UNITED STATES
(Slip Opinion) OCTOBER TERM, 2008 1 Syllabus NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus
IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT
Case: 14-40183 Document: 00512886600 Page: 1 Date Filed: 12/31/2014 IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT RICARDO A. RODRIGUEZ, Plaintiff - Appellant Summary Calendar United States
WASHINGTON LEGAL FOUNDATION
Docket No. FDA-2016-D-2021 COMMENTS of WASHINGTON LEGAL FOUNDATION to the FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH & HUMAN SERVICES Concerning DRAFT GUIDANCE FOR INDUSTRY AND FDA STAFF: DECIDING
IC Chapter 1.3. Medicaid Waivers and Plan Amendments
IC 12-15-1.3 Chapter 1.3. Medicaid Waivers and Plan Amendments IC 12-15-1.3-1 Waivers to implement intent of P.L.46-1995; expiration of section Sec. 1. (a) The terms and conditions of any waivers that
The Supreme Court's Bright Line Ruling in Riegel v. Medtronic, Inc. Gives Manufacturers of Defective Medical Devices Broad Immunity
Journal of the National Association of Administrative Law Judiciary Volume 29 Issue 2 Article 7 10-15-2009 The Supreme Court's Bright Line Ruling in Riegel v. Medtronic, Inc. Gives Manufacturers of Defective
Bioengineered Food Disclosure Rulemaking Update
Bioengineered Food Disclosure Rulemaking Update Karen E. Carr, Partner, Arent Fox LLP LA / NY / SF / DC / arentfox.com February 6, 2018 Federal Disclosure Law: Background Law passed Senate and House in
Product Liability Update
Product Liability Update In This Issue: May 2009 United States Supreme Court Holds State Law Failure-to-Warn Claims Involving Prescription Drugs Not Preempted by FDA Approval of Warnings Absent Clear Evidence
WYETH V. LEVINE: MOVING AWAY FROM THE GEIER TREND
WYETH V. LEVINE: MOVING AWAY FROM THE GEIER TREND INTRODUCTION Federal preemption of state common law actions for injuries often involves a balancing act between congressional intent and state sovereignty.
PART I PRELIMINARY MATTERS
MEDICAL DEVICE ACT 2012 (ACT 737) MEDICAL DEVICE REGULATIONS 2012 ARRANGEMENT OF REGULATIONS Regulation 1. Citation and commencement 2. Interpretation PART I PRELIMINARY MATTERS PART II CONFORMITY ASSESSMENT
2013 PA Super 216 DISSENTING OPINION BY PLATT, J.: FILED JULY 29, Wyeth appeals from the order overruling its preliminary objections to
2013 PA Super 216 IN RE: REGLAN LITIGATION IN THE SUPERIOR COURT OF PENNSYLVANIA APPEAL OF: WYETH LLC, WYETH PHARMACEUTICALS, INC. AND WYETH HOLDINGS CORPORATION (COLLECTIVELY WYETH ) No. 84 EDA 2012 Appeal
In the Supreme Court of the United States
Nos. 09-993, -1039, -1501 In the Supreme Court of the United States PLIVA, INC. ET AL., Petitioners, v. GLADYS MENSING, Respondent. ACTIVIS ELIZABETH, LLC, Petitioner, v. GLADYS MENSING, Respondent. ACTIVIS,
Case 4:15-cv JSW Document 55 Filed 03/31/17 Page 1 of 6 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
Case :-cv-0-jsw Document Filed 0// Page of UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA 0 TROY WALKER, Plaintiff, v. CONAGRA FOODS, INC., Defendant. Case No. -cv-0-jsw ORDER GRANTING MOTION
Objectives (same as last class): Objectives (in addition): Administrative Law (REVIEW) Administrative Law
Administrative Law Martha Dye-Whealan RPh, JD Pharm 543 Objectives (same as last class): Identify and distinguish the sources of law in the United States. Understand the hierarchy of laws. Understand the
Chevron's Sliding Scale in Wyeth v. Levine, 129 S. Ct (2009)
Harvard University From the SelectedWorks of Gregory M Dickinson Summer 2010 Chevron's Sliding Scale in Wyeth v. Levine, 129 S. Ct. 1187 (2009) Gregory M Dickinson, Harvard Law School Available at: https://works.bepress.com/gregory_dickinson/4/
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION : : : : : : : : : : : : ORDER
Case 111-cv-04064-AT Document 25 Filed 06/15/12 Page 1 of 19 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION SHERYL D. CLINE, Plaintiff, v. ADVANCED NEUROMODULATION
Supreme Court of the United States
No. 17-230 IN THE Supreme Court of the United States Alice IVERS, v. WESTERLY PHARMACEUTICAL, INC., Petitioner, Respondent. On Writ of Certiorari to the Twelfth Circuit Federal Court of Appeals BRIEF FOR
UPDATE GROWTH OF FEDERAL PREEMPTION. Robert P. Pisani McKenna Storer
DefenseD A publication generated by the IDC Committee. Robert P. Pisani, Chair Vol. 9, No. 1 UPDATE www.iadtc.org GROWTH OF FEDERAL PREEMPTION Robert P. Pisani McKenna Storer In products liability law
Preemption of State Common Law by Federal Agency Action: Striking the Appropriate Balance that Protects Public Safety
Preemption of State Common Law by Federal Agency Action: Striking the Appropriate Balance that Protects Public Safety Victor E. Schwartz ** Cary Silverman I. INTRODUCTION... 1204 II. THE BASICS OF PREEMPTION...
THE CASE AGAINST PREEMPTION: VACCINES & UNCERTAINTY
Mary J. Davis Mary J. Davis is the Stites & Harbison Professor of Law and Associate Dean for Academic Affairs at the University of Kentucky College of Law. She joined the faculty of the University of Kentucky
ORDER GRANTING DEFENDANTS MOTION TO DISMISS PAGE - 1
UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON AT SEATTLE 1 DO SUNG UHM AND EUN SOOK UHM, a married couple, individually, and for all others similarly situated, v. Plaintiffs, HUMANA, INC.,
COLUMBIA LAW REVIEW VOL. 111 JANUARY 2011 NO. 1 ARTICLE FEDERALISM AND FEDERAL AGENCY REFORM. Gillian E. Metzger *
COLUMBIA LAW REVIEW VOL. 111 JANUARY 2011 NO. 1 ARTICLE FEDERALISM AND FEDERAL AGENCY REFORM Gillian E. Metzger * This Article assesses three major preemption decisions from the 2008 2009 Term Altria Group,
FEDERAL PREEMPTION ORIGINS, TYPES AND TRENDS IN THE U.S. SUPREME COURT. WASHINGTON LEGAL FOUNDATION Washington, D.C.
FEDERAL PREEMPTION ORIGINS, TYPES AND TRENDS IN THE U.S. SUPREME COURT Frank Cruz-Alvarez Jennifer Voss Jared Sherr Talia Zucker Shook, Hardy & Bacon L.L.P. Foreword Daniel E. Troy Senior Vice President
Preemptive Effect of the Bill Emerson Good Samaritan Food Donation Act
Preemptive Effect of the Bill Emerson Good Samaritan Food Donation Act The Bill Emerson G ood Samaritan Food Donation Act preem pts state good Samaritan statutes that provide less protection from civil
Choice of Law and Punitive Damages in New Jersey Mass Tort Litigation
Choice of Law and Punitive Damages in New Jersey Mass Tort Litigation by Kenneth J. Wilbur and Susan M. Sharko There is now an emerging consensus that where the alleged wrongful conduct giving rise to
Section moves to amend H.F. No as follows: 1.2 Delete everything after the enacting clause and insert:
1.1... moves to amend H.F. No. 1440 as follows: 1.2 Delete everything after the enacting clause and insert: 1.3 "Section 1. Minnesota Statutes 2016, section 151.252, subdivision 1, is amended to read:
Glennen v. Allergan, Inc.
Glennen v. Allergan, Inc. GINGER PIGOTT * AND KEVIN COLE ** WHY IT MADE THE LIST Prescription medical device manufacturers defending personal injury actions have a wide variety of legal defenses not available
In May, the Houston, Texas, judge overseeing the Texas Vioxx
Medicolegal Issues Preemption, tort reform, and pharmaceutical claims Part one: Who will become the pharmaceutical industry s insurers (or is it prescribing physicians and we do not know it?) Russell G.
Case 6:11-cv CEH-TBS Document 43 Filed 09/27/12 Page 1 of 13 PageID 355 UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA ORLANDO DIVISION
Case 6:11-cv-01444-CEH-TBS Document 43 Filed 09/27/12 Page 1 of 13 PageID 355 UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA ORLANDO DIVISION PEGGY MCCLELLAND as Personal Representative of the
WYETH v. LEVINE: EXAMINING THE DOCTRINE OF IMPLIED PREEMPTION IN STATE- LAW TORT CLAIMS
WYETH v. LEVINE: EXAMINING THE DOCTRINE OF IMPLIED PREEMPTION IN STATE- LAW TORT CLAIMS ALLISON KOSTECKA* I. INTRODUCTION Wyeth v. Levine has been heralded The Mother of all Preemption Cases 1 and the
Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes
Seton Hall University erepository @ Seton Hall Law School Student Scholarship Seton Hall Law 5-1-2014 Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes Christine Anne Gaddis Follow
No In The SUPREME COURT OF THE UNITED STATES. Delbert WILLIAMSON, et al., Petitioners, MAZDA MOTOR OF AMERICA, INC., et al. Respondents.
No. 08-1314 In The SUPREME COURT OF THE UNITED STATES Delbert WILLIAMSON, et al., Petitioners, v. MAZDA MOTOR OF AMERICA, INC., et al. Respondents. On Petition for a Writ of Certiorari to the Court of
A Primer on MMA Preemption William C. O Neill Michelle A. Jones
Preemption It's Not Just for ERISA Anymore A Primer on MMA Preemption William C. O Neill Michelle A. Jones Medicare Preemption Roadmap Pre-2003 Medicare preemption rule MMA statute & regulations Legislative
Nos , , IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT
Case: 09-5460 Document: 006110791529 Filed: 11/16/2010 Page: 1 Nos. 09-5509, 09-5460, 09-5466 IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT DENNIS MORRIS, Plaintiff-Appellant, v. WYETH INC.,
H. R To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.
I 11TH CONGRESS 1ST SESSION H. R. 21 To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 12, 201 Mr. GRIFFITH
Case 2:09-cv LKK-KJM Document 28 Filed 07/09/2009 Page 1 of 20
Case :0-cv-00-LKK-KJM Document Filed 0/0/00 Page of 0 0 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA MARLENE PRUDHEL, RANDALL S. PRUDHEL, BRADLEY K. PRUDHEL, RYAN K. PRUDHEL, and
NOTES S. Ct (2009). 6. Id. at See id. at Id. 9. Id. at 1204.
NOTES Warning, This Decision Will Increase the Cost of Prescription Drugs: How the Supreme Court s Misapplication of Preemption Doctrine in Wyeth V. Levine Portends Devastating Consequences for Oklahoma
Supreme Court of the United States
No. 17-230 IN THE Supreme Court of the United States October Term, 2017 Alice IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. On Writ of Certiorari to the Twelfth Circuit Federal Court
TADC PRODUCTS LIABILITY NEWSLETTER
TADC PRODUCTS LIABILITY NEWSLETTER Selected Case Summaries Prepared Fall 2013 Editor: I. Summary Joseph S. Pevsner Thompson & Knight LLP Co-Editor: Janelle L. Davis Thompson & Knight LLP Contributing Editor:
SUPREME COURT OF THE UNITED STATES
Cite as: 552 U. S. (2008) 1 NOTICE: This opinion is subject to formal revision before publication in the preliminary print of the United States Reports. Readers are requested to notify the Reporter of
Preemption. What it is, how it works, and why it matters for public health
Preemption What it is, how it works, and why it matters for public health 2009 Developed by the National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN) Support for this paper was
Supreme Court of the United States
NO. 17-230 IN THE Supreme Court of the United States October Term 2017 ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC. Respondent. On Writ of Certiorari to the United States Court of Appeals
No IN THE Supreme Court of the United States WYETH, DIANA LEVINE,
No. 06-1249 444444444444444444444444444444444444444444 IN THE Supreme Court of the United States WYETH, v. DIANA LEVINE, Petitioner, Respondent. On Writ of Certiorari to the Supreme Court of Vermont BRIEF
PLIVA v. Mensing and Its Implications
Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2011 PLIVA v. Mensing and Its Implications Brian Wolfman Georgetown University Law Center, wolfmanb@law.georgetown.edu Dena Feldman Covington
June 28, Mr. HOYER introduced the following bill; which was referred to the Committee on House Administration
HR 3094 IH 109th CONGRESS 1st Session H. R. 3094 To amend the Help America Vote Act of 2002 to improve the fairness and accuracy of voter registration in elections for Federal office, establish a uniform
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION. v. No. 04 C 8104 MEMORANDUM OPINION
Case 1 :04-cv-08104 Document 54 Filed 05/09/2005 Page 1 of 8n 0' IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION GALE C. ZIKIS, individually and as administrator
UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION
Case: 4:17-cv-02584-SNLJ Doc. #: 47 Filed: 01/24/18 Page: 1 of 13 PageID #: 1707 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION NEDRA DYSON, et al. ) ) ) Plaintiffs, ) ) v.
Horn v. Thoratec Corp., A "Heartless" Decision: Why Pre-Market Approval Does Not Preempt All State Tort Claims Against Medical Device Manufacturers
St. John's Law Review Volume 80 Issue 2 Volume 80, Spring 2006, Number 2 Article 8 February 2012 Horn v. Thoratec Corp., A "Heartless" Decision: Why Pre-Market Approval Does Not Preempt All State Tort
PREEMPTION OF TORT LAWSUITS: THE REGULATORY PARADIGM IN THE ROBERTS COURT *
PREEMPTION OF TORT LAWSUITS: THE REGULATORY PARADIGM IN THE ROBERTS COURT * Christina E. Wells ** William E. Marcantel *** Dave Winters **** I. INTRODUCTION Federal preemption of state tort lawsuits (especially
MASTER DOCKET NO Ruby Ledbetter IN THE DISTRICT COURT OF. v. HARRIS COUNTY, T E X A S
MASTER DOCKET NO. 2005-59499 Ruby Ledbetter IN THE DISTRICT COURT OF v. HARRIS COUNTY, T E X A S Merck & Co., Inc. 157 th JUDICIAL DISTRICT (Trial Court: 151st Dist. Court of Harris County, Cause No. 2005-58543)
The Other War on Drugs: Federal Preemption, the FDA, and Prescription Drugs after Wyeth v. Levine
Notre Dame Journal of Law, Ethics & Public Policy Volume 25 Issue 2 Symposium On Health Care: Health, Ethics, & the Law Article 19 January 2014 The Other War on Drugs: Federal Preemption, the FDA, and
Tobacco-related Damages and Health Care Costs Recovery Act
FIRST SESSION THIRTY-NINTH LEGISLATURE Bill 43 (2009, chapter 34) Tobacco-related Damages and Health Care Costs Recovery Act Introduced 14 May 2009 Passed in principle 11 June 2009 Passed 18 June 2009
No In The Supreme Court of the United States ALICE IVERS,
No. 17-230 In The Supreme Court of the United States --------------------------------- --------------------------------- ALICE IVERS, v. Petitioner, WESTERLY PHARMACEUTICAL, INC., Respondent, ---------------------------------
The New Presumption Against Preemption
University of Kentucky UKnowledge Law Faculty Scholarly Articles Law Faculty Publications 5-2010 The New Presumption Against Preemption Mary J. Davis University of Kentucky College of Law, mjdavis@uky.edu
Tohono O odham Nation v. City of Glendale, 804 F.3d 1292 (9th Cir. 2015)
Public Land and Resources Law Review Volume 0 Case Summaries 2015-2016 Tohono O odham Nation v. City of Glendale, 804 F.3d 1292 (9th Cir. 2015) Kathryn S. Ore University of Montana - Missoula, kathryn.ore@umontana.edu
Recommendation to Adopt Proposed Ordinance Relating to Pain Management Clinics
TO: FROM: SUBJECT: The Honorable Chairman and Members of the Board of County Commissioners James L. Bennett, County Attorney && Recommendation to Adopt Proposed Ordinance Relating to Pain Management Clinics
H. R SEC ENHANCING TRACKING AND TRACING OF FOOD AND RECORDKEEPING.
H. R. 2751 46 SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD AND RECORDKEEPING. (a) PILOT PROJECTS. (1) IN GENERAL. Not later than 270 days after the date of enactment of this Act, the Secretary of Health
No IN THE. ALICE IVERS Petitioner, WESTERLY PHARMACEUTICALS, INC. Respondent.
No. 17-230 IN THE ALICE IVERS Petitioner, v. WESTERLY PHARMACEUTICALS, INC. Respondent. On Writ of Certiorari to the United States Court of Appeals for the Twelfth Circuit BRIEF FOR RESPONDENT TEAM #2629
LEGISLATIVE UPDATE By Amy O Gorman Jenkins, Legislative Advocate
LEGISLATIVE UPDATE By Amy O Gorman Jenkins, Legislative Advocate Below is a summary of cannabis- related bills that have been introduced in the 2017-18 Legislative Session. There are currently 13 bills
21 CFR Part 50 - Protection of Human Subjects
21 CFR Part 50 - Protection of Human Subjects Subpart A General Provisions 50.1 Scope. 50.3 Definitions. Subpart B Informed Consent of Human Subjects 50.20 General requirements for informed consent. 50.21
Supreme Court of the United States
No. 15-449 IN THE Supreme Court of the United States JOHNSON & JOHNSON and MCNEIL-PPC, INC., Petitioners, v. LISA RECKIS and RICHARD RECKIS, Respondents. On Petition for a Writ of Certiorari to the Supreme
AS PASSED BY SENATE S Page 1 S.76 AN ACT RELATING TO THE MEDICAL USE OF MARIJUANA
2003 Page 1 S.76 AN ACT RELATING TO THE MEDICAL USE OF MARIJUANA It is hereby enacted by the General Assembly of the State of Vermont: Sec. 1. FINDINGS AND PURPOSE (a) Modern medical research has discovered
SAFE IMPORTATION OF MEDICAL PRODUCTS AND OTHER RX THERAPIES ACT OF 2004 (SAFE IMPORT ACT) SECTION-BY-SECTION SEC. 1. SHORT TITLE.
SAFE IMPORTATION OF MEDICAL PRODUCTS AND OTHER RX THERAPIES ACT OF 2004 (SAFE IMPORT ACT) SEC. 1. SHORT TITLE. SECTION-BY-SECTION Provides that the short title of the bill is the ASafe Importation of Medical
Case 2:15-cv GP Document 46 Filed 06/30/15 Page 1 of 3
Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 1 of 3 Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 2 of 3 Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 3 of 3 Case 215-cv-00384-GP
Medtronic, Inc. v. Lohr: Bad Medicine for Manufacturers of Unproven Medical Devices
Catholic University Law Review Volume 47 Issue 2 Winter 1998 Article 16 1998 Medtronic, Inc. v. Lohr: Bad Medicine for Manufacturers of Unproven Medical Devices Kenneth T. Sigman Follow this and additional
POCKET REFERENCE DRUG SAMPLE DISTRIBUTION: SELECT FEDERAL LAWS AND REGULATIONS
POCKET REFERENCE DRUG SAMPLE DISTRIBUTION: SELECT FEDERAL LAWS AND REGULATIONS Prepared by the PDMA Alliance, Inc. September 2014 Background This pocket guide is intended as a legal reference guide, covering
Case 5:05-cv IMK-JSK Document 51 Filed 04/03/2007 Page 1 of 43
Case 5:05-cv-00177-IMK-JSK Document 51 Filed 04/03/2007 Page 1 of 43 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF WEST VIRGINIA CLARKSBURG DIVISION STEVEN RATTAY, and SHARON RATTAY,
Will High Court Provide Clarity On 'Clear Evidence'?
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Will High Court Provide Clarity On 'Clear
HOUSE AMENDMENT Bill No. HB 5511 (2012) Amendment No. CHAMBER ACTION
CHAMBER ACTION Senate House. 1 The Conference Committee on HB 5511 offered the following: 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Conference Committee Amendment (with title amendment) Remove everything after
HOUSE ENROLLED ACT No. 1148
First Regular Session of the 120th General Assembly (2017) PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing
Sec. 202(a)(1)(C). Disclosure of Negative Risk Determinations about Financial Company.
Criminal Provisions in the Dodd Frank Wall Street Reform & Consumer Protection Act 1 S. 3217 introduced by Senator Dodd (D CT) H.R. 4173 introduced by Barney Frank (D MASS) (all references herein are to
RECONSIDERING THE TRADITIONAL ANALYSIS: SHOULD BUCKMAN ALONE SUPPORT PREEMPTION OF FRAUD-ON-THE-FDA EXCEPTIONS TO TORT IMMUNITY?
RECONSIDERING THE TRADITIONAL ANALYSIS: SHOULD BUCKMAN ALONE SUPPORT PREEMPTION OF FRAUD-ON-THE-FDA EXCEPTIONS TO TORT IMMUNITY? Joshua D. Lee* INTRODUCTION... 1056 R I. THE TRADITIONAL PREEMPTION ANALYSIS...