Case No COMP/M.2192 - 3* SMITHKLINE BEECHAM / BLOCK DRUG
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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. -
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. -
Réglementation De La Pharmacie
R E C U E I L D E T E X T E S S U R L A P H A R M A C I E Mis à jour le 13 février 2017 par l’Inspection de la pharmacie P R É A M B U L E La réglementation relative à la pharmacie en vigueur en Nouvelle-Calédonie résulte de la coexistence des dispositions adoptées par la Nouvelle-Calédonie au titre de ses compétences en matières d’hygiène publique, de santé et de professions de la pharmacie1, et de celles adoptées par l’Etat au titre de ses compétences en matières de garanties des libertés publiques, de droit civil et de droit commercial2. Sur le contenu du recueil En 1954, la Nouvelle-Calédonie s’est vue étendre les articles L. 511 à L. 520 et L. 549 à L. 665 de l’ancien Livre V relatif à la Pharmacie du code de la santé publique métropolitain par la loi n° 54-418 du 15 avril 1954 étendant aux territoires d'outre-mer, au Togo et au Cameroun certaines dispositions du Code de la santé publique relatives à l'exercice de la pharmacie3, dont les modalités d’application ont été fixées par le décret modifié n° 55-1122 du 16 août 1955 fixant les modalités d'application de la loi n° 54-418 du 15 avril 1954 étendant aux territoires d'outre-mer, au Togo et au Cameroun certaines dispositions du code de la santé publique relatives à l'exercice de la pharmacie4. Depuis sont intervenues la loi- cadre Defferre5, la loi référendaire de 19886 et la loi organique n° 99-209 du 19 mars 1999 dont les apports ont eu pour résultat le transfert de ces articles de la compétence de l’Etat à la compétence de la Nouvelle-Calédonie, permettant à celle-ci de s’en approprier et de les modifier à sa guise par des délibérations du congrès de la Nouvelle-Calédonie7. -
Zebrafish Behavioral Profiling Links Drugs to Biological Targets and Rest/Wake Regulation
www.sciencemag.org/cgi/content/full/327/5963/348/DC1 Supporting Online Material for Zebrafish Behavioral Profiling Links Drugs to Biological Targets and Rest/Wake Regulation Jason Rihel,* David A. Prober, Anthony Arvanites, Kelvin Lam, Steven Zimmerman, Sumin Jang, Stephen J. Haggarty, David Kokel, Lee L. Rubin, Randall T. Peterson, Alexander F. Schier* *To whom correspondence should be addressed. E-mail: [email protected] (A.F.S.); [email protected] (J.R.) Published 15 January 2010, Science 327, 348 (2010) DOI: 10.1126/science.1183090 This PDF file includes: Materials and Methods SOM Text Figs. S1 to S18 Table S1 References Supporting Online Material Table of Contents Materials and Methods, pages 2-4 Supplemental Text 1-7, pages 5-10 Text 1. Psychotropic Drug Discovery, page 5 Text 2. Dose, pages 5-6 Text 3. Therapeutic Classes of Drugs Induce Correlated Behaviors, page 6 Text 4. Polypharmacology, pages 6-7 Text 5. Pharmacological Conservation, pages 7-9 Text 6. Non-overlapping Regulation of Rest/Wake States, page 9 Text 7. High Throughput Behavioral Screening in Practice, page 10 Supplemental Figure Legends, pages 11-14 Figure S1. Expanded hierarchical clustering analysis, pages 15-18 Figure S2. Hierarchical and k-means clustering yield similar cluster architectures, page 19 Figure S3. Expanded k-means clustergram, pages 20-23 Figure S4. Behavioral fingerprints are stable across a range of doses, page 24 Figure S5. Compounds that share biological targets have highly correlated behavioral fingerprints, page 25 Figure S6. Examples of compounds that share biological targets and/or structural similarity that give similar behavioral profiles, page 26 Figure S7. -
Annual Report 2013
Annual Report 2013 “ Being active and having a positive outlook on life is what keeps me going every day.” Overview of 2013 “ Our performance in 2013 was defined by remarkable &R D output and further delivery of sustained financial performance for our shareholders.” Please go to page 4 for more More at gsk.com Performance highlights £26.5bn £8.0bn £7.0bn £5.2bn Group turnover Core* operating profit Total operating profit Returned to shareholders 6 112.2p 112.5p 13% Major medicines approved Core* earnings per share Total earnings per share Estimated return on R&D investment 10 6 1st 1st Potential phase III study starts in 2014/15 Potential medicines with phase III data in Access to Medicines Index Pharmaceutical company to sign AllTrials expected 2014/15 campaign for research transparency Front cover story Betty, aged 65, (pictured) has Chronic “ Health is important to me, Obstructive Pulmonary Disease (COPD). She only has 25% lung capacity. This means I try to take care of my she finds even everyday tasks difficult, but medicines and inhaled oxygen allow her to health with all the tools live as normal a life as she can. Betty’s mindset I have and do the best is to stay busy and active, so every week she goes to rehab exercise classes. that I can with it.” COPD is a disease of the lungs that leads to Betty, COPD patient, damaged airways, causing them to become North Carolina, USA narrower and making it harder for air to get in and out. 210 million people around the world are estimated to have COPD. -
Other Statutory Disclosures Continued
Other statutory disclosures continued Strategic reportGroup companies Governance & remuneration Financial statements In accordance with Section 409 of the Companies Act 2006 a full list of subsidiaries, associates, joint ventures and joint arrangements, the country of incorporation and effective percentage of equity owned, as at 31 December 2015 are disclosed below. Unless otherwise stated the share capital disclosed comprises ordinary shares which are indirectly held by GlaxoSmithKline plc. All subsidiary companies are resident for tax purposes in their country of incorporation unless otherwise stated. Country of Effective % % Held by Name incorporation Ownership Security Class of Share Wholly owned subsidiaries 1506369 Alberta ULC Canada 100 Common 100 Action Potential Venture Capital Limited England & Wales 100 Ordinary 100 Adechsa GmbH Switzerland 100 Ordinary 100 Affymax Research Institute United States 100 Common 100 Alenfarma – Especialidades Farmaceuticas, Limitada (iv) Portugal 100 Ordinary Quota 100 Allen & Hanburys Limited (iv) England & Wales 100 Ordinary 100 Allen & Hanburys Pharmaceutical Nigeria Limited Nigeria 100 Ordinary 100 Allen Farmaceutica, S.A. Spain 100 Ordinary 100 Allen Pharmazeutika Gesellschaft m.b.H. Austria 100 Ordinary 100 Aners S.A (iv) Argentina 100 Non-endorsable Nominative Ordinary 100 Barrier Therapeutics, Inc. United States 100 Common 100 Beecham Group p l c England & Wales 100 20p Shares 'A'; 5p Shares B 100 Beecham Pharmaceuticals (Pte) Limited Singapore 100 Ordinary 100 Beecham Pharmaceuticals S.A (iv) (vi) Ecuador 100 Nominative 100 Beecham Portuguesa-Produtos Farmaceuticos e Quimicos, Lda Portugal 100 Ordinary Quota 100 Beecham S.A. (iv) Belgium 100 Ordinary 100 Biddle Sawyer Limited India 100 Equity 100 Biovesta Ilaçlari Ltd. Sti. Turkey 100 Nominative 100 Burroughs Wellcome & Co (Australia) Pty Limited (iv) (vi) Australia 100 Ordinary 100 Burroughs Wellcome & Co (Bangladesh) Limited Bangladesh 100 Ordinary 100 Burroughs Wellcome International Limited England & Wales 100 Ordinary 100 Caribbean Chemical Company, Ltd. -
Clinical Guidelines for Use of Depot Buprenorphine (Buvidal®
Clinical guidelines for use of depot buprenorphine (Buvidal® and Sublocade®) in the treatment of opioid dependence NSW Ministry of Health 100 Christie Street ST LEONARDS NSW 2065 Tel. (02) 9391 9000 Fax. (02) 9391 9101 TTY. (02) 9391 9900 www.health.nsw.gov.au Produced by: NSW Ministry of Health Lintzeris N, Dunlop A, Masters D (2019) Clinical guidelines for use of depot buprenorphine (Buvidal® and Sublocade®) in the treatment of opioid dependence. NSW Ministry of Health, Sydney Australia This work is copyright. It may be reproduced in whole or in part for study or training purposes subject to the inclusion of an acknowledgement of the source. It may not be reproduced for commercial usage or sale. Reproduction for purposes other than those indicated above requires written permission from the NSW Ministry of Health. © NSW Ministry of Health 2019 SHPN (CPH) 190431 ISBN 978-1-76081-226-3 Further copies of this document can be downloaded from the NSW Health website www.health.nsw.gov.au August 2019 ii NSW Health Use of depot BPN in the treatment of opioid dependence Authors Professor Nicholas Lintzeris (BMedSci MBBS PhD FAChAM) Director Drug and Alcohol Services, South East Sydney Local Health District Discipline Addiction Medicine, Faculty of Medicine and Health Sciences, University of Sydney NSW Drug and Alcohol Clinical Research and Improvement Network Professor Adrian Dunlop (MBBS, PhD, GdipEpiBiotat, FAChAM) Director Drug and Alcohol Clinical Services, Hunter New England Local Health District School of Medicine and Public Health, Faculty -
In This Section
Strategic report In this section Chairman’s statement 2 CEO’s review 4 Business overview 6 The global context 8 Our business model 12 Our strategic priorities 14 How we performed 16 Risk management 18 Grow 20 Deliver 32 Simplify 44 Our financial architecture 48 Responsible business 50 Financial review 58 Strategic report Chairman’s statement Chairman’s statement To shareholders The value of the significant changes that have been made in recent years is evidenced in our performance this year “ Since Sir Andrew became It is clear from the following pages that Through the Audit & Risk Committee, we the Group made good progress against oversee the issues and challenges faced by CEO, the company has its strategy in 2013. management, and encourage the creation of an environment in which GSK can achieve The Board believes the business is seeing returned £30 billion its strategic ambitions in a responsible and the benefits of the significant changes the sustainable manner. to shareholders.” management team has driven over recent years to deliver sustainable growth, reduce risk and I have no doubt that commercial success is enhance returns to shareholders. directly linked to operating in a responsible way and which meets the changing expectations of The notably strong performance from the society. In this respect, the company continues R&D organisation in 2013 – with six major to adopt industry-leading positions on a range new product approvals in areas including of issues. respiratory disease, HIV and cancer – is critical to the longer-term prospects of the The announcement of plans during 2013 to Group. -
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. -
Glaxosmithkline Plc Annual Report for the Year Ended 31St December 2000
GlaxoSmithKline 01 GlaxoSmithKline plc Annual Report for the year ended 31st December 2000 Contents Report of the Directors 02 Financial summary 03 Joint statement by the Chairman and the Chief Executive Officer 05 Description of business 29 Corporate governance 37 Remuneration report 47 Operating and financial review and prospects 69 Financial statements 70 Directors’ statements of responsibility 71 Report by the auditors 72 Consolidated statement of profit and loss 72 Consolidated statement of total recognised gains and losses 74 Consolidated statement of cash flow 76 Consolidated balance sheet 76 Reconciliation of movements in equity shareholders’ funds 77 Company balance sheet 78 Notes to the financial statements 136 Group companies 142 Principal financial statements in US$ 144 Financial record 153 Investor information 154 Shareholder return 156 Taxation information for shareholders 157 Shareholder information 158 Share capital 160 Cross reference to Form 20-F 162 Glossary of terms The Annual Report was approved by the Board 163 Index of Directors on 22nd March 2001 and published on 12th April 2001. Contact details 02 GlaxoSmithKline Financial summary 2000 1999 Increase Business performance £m £m CER % £ % Sales 18,079 16,164 9 12 Trading profit 5,026 4,378 12 15 Profit before taxation 5,327 4,708 11 13 Earnings/Net income 3,697 3,222 13 15 Earnings per Ordinary Share 61.0p 52.7p 14 16 Total results Profit before taxation 6,029 4,236 Earnings/Net income 4,154 2,859 Earnings per Ordinary Share 68.5p 46.7p Business performance: results exclude merger items and restructuring costs; 1999 sales and trading profit exclude the Healthcare Services businesses which were disposed of in 1999. -
First Quarter 2019
Press release First quarter 2019 Issued: Wednesday, 1 May 2019, London U.K. GSK delivers sales of £7.7 billion +6% AER, +5% CER Total EPS 16.8p, +50% AER, +42% CER; Adjusted EPS 30.1p, +22% AER, +18% CER Financial highlights • Pharmaceuticals sales £4.2 billion, +4% AER, +2% CER; Vaccines £1.5 billion, +23% AER, +20% CER; Consumer Healthcare £2.0 billion, flat AER, +1% CER. • Total Group operating margin 18.6%. Adjusted Group operating margin 28.2%, +1.6 percentage points AER, +1.0 percentage point CER (Pharmaceuticals 29.8%; Vaccines 40.3%; Consumer Healthcare 21.7%). Benefits from strong sales growth and phasing of R&D. • Total EPS 16.8p, +50% AER, +42% CER. • Adjusted EPS 30.1p, +22% AER, +18% CER, driven by strong operating performance, continued financial efficiencies, reduction in minority share and a one-off benefit to associates. • Net cash flow from operations £663 million. Free cash flow £165 million. • 19p dividend declared for the quarter; continue to expect 80p for full year 2019. • 2019 Guidance reaffirmed. Product and pipeline highlights • Total HIV sales £1.1 billion, +7% AER, +4% CER, including Juluca sales of £70 million. - Dovato (dolutegravir+lamivudine), first once-daily 2-drug regimen for treatment-naive HIV patients, launched in US. - Long-acting cabotegravir+rilpivirine filed in the US for treatment of HIV. • Total new Respiratory product sales £631 million, +29% AER, +25% CER, including Trelegy £87 million; Nucala £152 million. • Shingrix sales £357 million driven by continued strong launch execution in US. • Continued -
Today's Research Tomorrow's Cure
2018 Heart Research Institute Annual Review Accelerating Research Tomorrow’s cure Tomorrow’s Today’s research Today’s 2018 Heart Research Institute Annual Review Hello Future Accelerating 2018 Heart Research Institute Annual Review Research ACCELERATING Discoveries into therapies Knowledge into prevention Breakthroughs into cures Students into leaders Collaborations into partnerships 4 2018 Heart Research Institute Annual Review Inspiring Leaders 2018 Heart Research Institute Annual Review CONTENTS 06 HRI in 2018 08 Chairman’s Report 2018 10 Director of Cardiovascular Research Report 12 2018 Research and Media Highlights 16 Applied Materials Group 18 Atherosclerosis and Vascular Remodelling Group 20 Cardiac Imaging Group 22 Cardiometabolic Disease Group 24 Cardiovascular Medical Devices Group 26 Cell Therapeutics Group 28 Clinical Research Group 30 Haematology Research Group 32 Heart Rhythm and Stroke Prevention Group 34 High Blood Pressure Group 36 Thrombosis Group 38 Vascular Complications Group 40 Vascular Immunology Group 42 Inflammation and Fibrosis Research 44 PhD Students 45 Select Prizes and Awards 46 Select Conferences and Presentations 50 Select Publications 56 Board of Governors 59 International Board of Governors 60 Members of the Institute 62 Fundraising Report 66 Operations Report 6 2018 Heart Research Institute Annual Review The mission of the Heart Research Institute (HRI) is to prevent death and suffering from cardiovascular disease through an understanding of the biological processes that cause atherosclerosis and thrombosis, the major underlying causes of most heart attacks and strokes. 20 18 SHORT TERM LONG TERM The major short-term focus of our research There are four long-term objectives is to understand the development and for our research: progression of atherothrombotic conditions • To investigate mechanisms in which the arteries are narrowed and contributing to the pathogenesis restricted due to a build-up of fatty of cardiovascular disease.