Federal Trade Commission Volume Decision 102 (July
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Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs
International Journal of Business and Social Science Vol. 9 • No. 8 • August 2018 doi:10.30845/ijbss.v9n8p2 Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs Richard J. Hunter, Jr. Professor of Legal Studies Seton Hall University United States John H. Shannon Professor of Legal Studies Seton Hall University United States Henry J. Amoroso Associate Professor of Legal Studies Seton Hall University United States Abstract A spirited public policy debate has raged in the United States for more than four decades revolving around the responsibility of drug manufacturers for their products that cause injury to unsuspecting plaintiffs. An important part of the debate centers around a drug—DES—that was marketed as a benefit to women in preventing miscarriages. Some interesting or "alternate" theories for assessing liability have received attention in the generic area of products liability. This article will discuss three of the most prominent and still controversial theories—alternative liability, enterprise liability, and market share liability. In addition, the article will include several case studies exemplifying the legal principles discussed — some coming to very difficult conclusions — regarding the efficacy and application of these theories to particular facts developed during litigation. Keywords: Alternative Liability; Enterprise Liability; Market Share Liability 1. Introduction DES (Diethylstilbestrol, a synthetic form of the female hormone estrogen) litigation in the United States has been both extensive and controversial. Forty years ago, at the height of the DES crisis, in a seminal law review article in the Fordham Law Review, Sheiner (1978) estimated that the number of women who took DES during pregnancy ranged from 1 1/2 million to 3 million. -
Cholesterol How Kos Beat Big Pharma to HDL
The Other Cholesterol How Kos Beat Big Pharma to HDL www.pharmexec.com | ANADVANSTAR★ PUBLICATION Kos CEO Adrian Adams PHARMACEUTICAL EXECUTIVE Contents OCTOBER 2004 www.pharmexec.com Cover Story Under Construction Patrick Clinton Editor-in-Chief How Kos Pharmaceuticals turned a 50-year-old drug for raising HDL cholesterol into a brand-new, burgeoning business. Mulling the Future Kos CEO Adrian Adams, seated, maps strategy with key executives: (from left) Ralf Rosskamp, Christopher Kiritsy, Richard King, and Mark McGovern “We didn’t start with the idea of being a $200 million company. Growing as fast as possible: That was our goal from the get-go.” Kos Pharmaceuticals was first to market with a product to raise HDL cholesterol, and it wants to join pharma’s billion-dollar club by 2007. Big plan. Under Here’s how it’s going. Construction t’s hard to imagine that many pharma companies experienced more plain old good news this summer than Kos Pharmaceuticals. First, there were the second-quarter financials. Revenues for the quarter were $120.3 million, almost double last year’s figure. Net income for the quarter grew 245 percent to $38.5 million. The company raised its guidance for the year, predicting that full-year sales would be $480 million, 60 percent over last year— and CEO Adrian Adams boasted that Kos was the fastest-growing specialty pharma company in the United States. A few weeks later came encouraging results from a Phase II trial of IKos’ new inhalable insulin product for diabetes, and recruitment began for pivotal trials of a new combination product to consolidate Kos’ position in the burgeoning cholesterol market. -
V. : Civil Action No. DKC 14-3607
Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 1 of 73 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND : MALLINCKRODT INC. : v. : Civil Action No. DKC 14-3607 : UNITED STATES FOOD AND DRUG ADMINISTRATION, et al. : MEMORANDUM OPINION Plaintiff Mallinckrodt Inc. (“Mallinckrodt”), a pharmaceutical manufacturer, brings this action seeking judicial review of actions taken by the United States Food and Drug Administration (“FDA”), regarding its methylphenidate hydrochloride extended-release tablets, a generic version of the brand-name drug Concerta. Presently pending and ready for review in this action are several motions: (1) a motion to dismiss filed by Defendants FDA and United States of America (“Defendants”) (ECF No. 30); (2) a motion to compel production of the administrative record filed by Mallinckrodt (ECF No. 31); (3) a motion for summary judgment filed by Mallinckrodt (ECF No. 34); and (2) two motions to seal filed by Mallinckrodt (ECF Nos. 4 and 20). The relevant issues have been briefed, and the court now rules, no hearing being deemed necessary. Local Rule 105.6. For the following reasons, Defendants’ motion to dismiss will be granted in part, and summary judgment will be granted in part Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 2 of 73 against Plaintiff. Mallinckrodt’s motion to compel production of the administrative record will be denied as moot, and Mallinckrodt’s motions to seal will be denied. I. Background A. Statutory and Regulatory Background The FDA regulates the approval, manufacture, sale, and labeling of prescription drugs. -
Medicaid) Enhanced Care Plus (HARP) 2021 Drug Formulary Emblemhealth Enhanced Care and Enhanced Care Plus Formulary 2021 Formulary (List of Covered Drugs
Enhanced Care (Medicaid) Enhanced Care Plus (HARP) 2021 Drug Formulary EmblemHealth Enhanced Care and Enhanced Care Plus Formulary 2021 Formulary (List of Covered Drugs) PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT some of the drugs covered by your plan. When this drug list (formulary) refers to “we,” “us,” or “our,” it means EmblemHealth. When it refers to “plan” or “our plan,” it means EmblemHealth Enhanced Care (Medicaid) or Enhanced Care Plus (HARP). This document includes a list of the drugs (formulary) for our plan which is current as of 10/1/2021. For a complete updated formulary, please call Customer Service at 888-447-7364 (TTY: 711). Our hours are 8 am to 6 pm, Monday through Friday and 10 am to 1 pm, Saturday and Sunday. A representative will be happy to help. You can also check our website at emblemhealth.com. You must use network pharmacies to use your prescription drug benefit. The formulary and pharmacy network may change. Effective Oct. 1, 2021, New York State Medicaid will implement a single statewide Medication Assisted Treatment (MAT) formulary for opioid dependence agents and opioid antagonists. i EMBLEMHEALTH ENHANCED CARE AND ENHANCED CARE PLUS FORMULARY What is the EmblemHealth Enhanced Care and Enhanced Care Plus Formulary? A formulary is a list of covered drugs selected by our plan with help from a team of health care professionals. It represents the prescription therapies believed to be a necessary part of a quality treatment program. Our plan will cover the drugs listed in our formulary as long as the drug is medically necessary, the prescription is filled at a plan network pharmacy, and other plan rules are followed. -
Poisons and Narcotic Drugs (Amendment) Ordinance 1988
AUSTRALIAN CAPITAL TERRITORY Poisons and Narcotic Drugs (Amendment) Ordinance 1988 No. 96 of 1988 I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Ordinance under the Seat of Government (Administration) Act 1910. Dated 15 December 1988 N. M. STEPHEN Governor-General By His Excellency’s Command, CLYDE HOLDING Minister of State for the Arts and Territories An Ordinance to amend the Poisons and Narcotic Drugs Ordinance 1978 Short title 1. This Ordinance may be cited as the Poisons and Narcotic Drugs (Amendment) Ordinance 1988.1 Commencement 2. This Ordinance commences on such date as is fixed by the Minister by notice in the Gazette. Principal Ordinance 3. In this Ordinance, “Principal Ordinance” means the Poisons and Narcotic Drugs Ordinance 1978.2 (Ord. 79/88)—Cat. No. Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au 2 Poisons and Narcotic Drugs (Amendment) No. 96, 1988 Substances to which Division applies 4. Section 27B of the Principal Ordinance is amended by adding at the end the following paragraphs: “; (f) follicle stimulating hormone; (g) luteinising hormone; (h) thalidomide.”. Grant of authorisation 5. Section 27E of the Principal Ordinance is amended— (a) by omitting from paragraph (1) (a) “or cyclofenil” and substituting “, cyclofenil, follicle stimulating hormone or luteinising hormone”; (b) by omitting from paragraph (1) (b) “and”; and (c) by adding at the end of subsection (1) the following word and paragraph: “; and (d) in the case of an application that relates to thalidomide— the applicant is a specialist physician with no less than 5 years’ experience in the treatment of erythema nodosum leprosum.”. -
Drug Formulary 2019
2019 PREHOSPITAL FORMULARY EL DORADO COUNTY EMERGENCY MEDICAL SERVICES AGENCY 2900 Fair Lane Court Placerville, CA 95667 17th Edition Effective: July 1, 2019 TABLE OF CONTENTS Acetaminophen ................................................................................................................. 3 Activated Charcoal ........................................................................................................... 4 Adenocard ........................................................................................................................... 5 Albuterol Sulfate .................................................................................................................. 6 Amiodarone ......................................................................................................................... 7 Aspirin ..................................................................................................................................... 9 Atropine Sulfate................................................................................................................. 10 Atrovent (Duoneb) ........................................................................................................... 12 Calcium Chloride .............................................................................................................. 13 Dextrose 50% in Water ..................................................................................................... 14 Dextrose 10% in 100cc NS…………………………………………………………… 14 Diphenhydramine -
Board of Director Candidates
2021 Annual General Meeting Board of Director Candidates James I. Healy, M.D., Ph.D. (Current Board Member) James I. Healy, M.D., Ph.D. has served as a member of our board of directors since November 2014. Dr. Healy has been a General Partner of Sofinnova Investments, Inc. (formerly Sofinnova Ventures), a venture capital firm, since June 2000. Prior to June 2000, Dr. Healy held various positions at Sanderling Ventures, Bayer Healthcare Pharmaceuticals (as successor to Miles Laboratories) and ISTA Pharmaceuticals, Inc. Dr. Healy is currently on the board of directors of Bolt Therapeutics, Inc. (Nasdaq: BOLT), Coherus BioSciences, Inc. (Nasdaq: CHRS), Karuna Therapeutics, Inc. (Nasdaq: KRTX), Natera, Inc. (Nasdaq: NTRA), NuCana plc (Nasdaq: NCNA), ObsEva SA (Nasdaq: OBSV) and Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) and two private companies. Previously, he served as a board member of Amarin Corporation, Auris Medical Holding AG, Edge Therapeutics, Inc., Hyperion Therapeutics, Inc., InterMune, Inc., Iterum Therapeutics PLC, Anthera Pharmaceuticals, Inc., Durata Therapeutics, Inc., CoTherix, Inc., Movetis NV and several private companies. Dr. Healy holds an M.D. and a Ph.D. in Immunology from Stanford University School of Medicine and holds a B.A. in Molecular Biology and a B.A. in Scandinavian Studies from the University of California, Berkeley. Jan Møller Mikkelsen (Current Board Member) Jan Møller Mikkelsen founded Ascendis Pharma and has served as President and Chief Executive Officer as well as Board member since December 2007 and currently serves on the board of Visen. From 2002 to 2006, Mr. Mikkelsen served as President and Chief Executive Officer of LifeCycle Pharma A/S, now Veloxis Pharmaceuticals A/S, which was a publicly traded biotechnology company. -
Brief of Consumers Union of United States, Inc., As Amicus Curiae in Support of Petitioners, Riegel & Riegel V
Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2007 Brief of Consumers Union of United States, Inc., as Amicus Curiae in Support of Petitioners, Riegel & Riegel v. Medtronic, Inc., No. 06-179 (U.S. Aug. 27, 2007) Lisa Heinzerling Georgetown University Law Center Docket No. 06-179 This paper can be downloaded free of charge from: http://scholarship.law.georgetown.edu/scb/40 This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: http://scholarship.law.georgetown.edu/scb Part of the Consumer Protection Law Commons, and the Torts Commons No. 06-179 ~ ~!~! GLE~a~K IN THE £ upreme ¢£ourt of nite tate CHARLES R. RIEGEL AND DONNA S. RIEGEL, Petitioners V. MEDTRONIC, INC., Respondent ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT BRIEF OF CONSUMERS UNION OF UNITED STATES, INC., AS AMICUS CURIAE IN SUPPORT OF PETITIONERS LISA HEINZERLING Counsel of Record 600 New Jersey Ave., N.W. Washington, D.C. 20001 (202) 662-9115 MARK SAVAGE Consumers Union of United States, Inc. 1535 Mission Street San Francisco, CA 94103-2512 Counsel for Amicus Consumers Union of United States, Inc. WILSON-EPES PRINTINGCO., INC. - (202) 789-0096 - WASHINGTON, D. C. 20002 QUESTION PRESENTED Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. -
The Life Cycle of Sterling Drug, Inc.*
22 Bull. Hist. Chem., VOLUME 25, Number 1 (2000) THE LIFE CYCLE OF STERLING DRUG, INC.* Joseph C. Collins and John R. Gwilt The foundations of Sterling Drug were laid by William partners were bought out. Weiss and Diebold realized E. Weiss and Albert H. Diebold, boyhood friends in that expansion required more product lines and that these Canton, Ohio. Weiss graduated from the Philadelphia would best be obtained by acquisition. This policy con- College of Pharmacy in 1896 and went to work in a tinued throughout the life of the organization, at least drug store in Sistersville, West Virginia. Diebold raised 130 companies being acquired, directly or indirectly, funding from his father’s company, Diebold Safe and Lock, and in 1901 the friends set up business together in Wheeling, WV. In fact, Sterling operated a plant in that town until 1962. The history of the Corporation can conveniently be divided into five periods: 1901-1917 The Neuralgyline Period 1917-1928 Sterling Products I 1928-1933 Drug Inc. 1933-1942 Sterling Products II 1942-1988 Sterling Drug, Inc. The Neuralgyline Period On May 4, 1901, Weiss and Diebold, with three local business men as partners, established the Neuralgyline Company with the sole purpose of manufacturing and Figure 1. Where it all began: in 1901 the selling a pain-relieving preparation which they called Neuralgyline Company occupied two upstairs rooms “Neuralgine.” There is now no company record of its in this house in Wheeling, WV. composition, but it seems to have been a mixture of ac- from 1902 through 1986. Ironically, the eventual fate etanilide, caffeine, and sodium salicylate. -
The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. -
The Organic Chemistry of Drug Synthesis
The Organic Chemistry of Drug Synthesis VOLUME 2 DANIEL LEDNICER Mead Johnson and Company Evansville, Indiana LESTER A. MITSCHER The University of Kansas School of Pharmacy Department of Medicinal Chemistry Lawrence, Kansas A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY AND SONS, New York • Chichester • Brisbane • Toronto Copyright © 1980 by John Wiley & Sons, Inc. All rights reserved. Published simultaneously in Canada. Reproduction or translation of any part of this work beyond that permitted by Sections 107 or 108 of the 1976 United States Copyright Act without the permission of the copyright owner is unlawful. Requests for permission or further information should be addressed to the Permissions Department, John Wiley & Sons, Inc. Library of Congress Cataloging in Publication Data: Lednicer, Daniel, 1929- The organic chemistry of drug synthesis. "A Wiley-lnterscience publication." 1. Chemistry, Medical and pharmaceutical. 2. Drugs. 3. Chemistry, Organic. I. Mitscher, Lester A., joint author. II. Title. RS421 .L423 615M 91 76-28387 ISBN 0-471-04392-3 Printed in the United States of America 10 987654321 It is our pleasure again to dedicate a book to our helpmeets: Beryle and Betty. "Has it ever occurred to you that medicinal chemists are just like compulsive gamblers: the next compound will be the real winner." R. L. Clark at the 16th National Medicinal Chemistry Symposium, June, 1978. vii Preface The reception accorded "Organic Chemistry of Drug Synthesis11 seems to us to indicate widespread interest in the organic chemistry involved in the search for new pharmaceutical agents. We are only too aware of the fact that the book deals with a limited segment of the field; the earlier volume cannot be considered either comprehensive or completely up to date. -
Medication Precautions
MEDICATION PRECAUTIONS If you want to be pro-active to decrease bruising during injection treatments such as Restylane, Botox and Mesotherapy; the following prescriptions and non-prescription medications may be discontinued for at least two weeks prior to having any injection procedure to ensure that your platelets have time to recover. These specific preparations have been found to affect your blood by decreasing the amount of time it takes for coagulation and decreasing the amount of red blood cell production which can lead to increased bruising. If you are taking any antiarthritics or anticoagulants for control of a medical disorder, you will need to consult your treating physician for recommendations as to the alternatives. If you must take these medications, appropriate determinations as to whether they may be a detriment during the procedure may be discussed. NONPRESCRIPTION MEDICATIONS • Aspirin combinations • Alka-Seltzer Effervescent Antacid & Pain Reliever (Miles Laboratories) • Alka-Seltzer (Flavored) Effervescent Antacid & Pain Reliever (Miles Laboratories) • Alka-Seltzer Extra Strength Effervescent Antacid & Pain Reliever (Miles Laboratories) • Anacin Analgesic Coated Caplets (Whitehall) • Anacin Analgesic Coated Tablets (Whitehall) • Anacin Maximum Strength Coated Analgesic Tablets (Whitehall) • Arthritis Pain Formula by the Makers of Anacin Analgesic Tablets and Caplets (Whitehall) • Arthritis Strength BC Powder (Block) • Ascriptin Tablets (Rorer) • Ascriptin A/D Tablets (Rorer) • Bayer Children’s Chewable Aspirin (Glenbrook)