الف) منابع فارسی
- سید روحالله قاسمزاده. تحلیل حقوقی خطر توسعه. تهران: انتشارات شرکت سهامی انتشار، 1394.
- مشایخ، میلاد و غفور خوئینی. سه گفتار پیرامون مسئولیت ناشی از عیب تولید. تهران: انتشارات مخاطب، 1397.
- مشایخ، میلاد، مرتضی شهبازی نیا و غفور خوئینی. «مسئولیت مدنی ناشی از عیب تولید با رویکردی بر تولید محصولات تراریخته (به همراه مطالعهای تطبیقی)». مجلس و راهبرد، 24، 92(1396)، 29-56.
ب) منابع خارجی
- “CFR - Code of Federal Regulations Title 21”. 2024. Available at: https://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/cfrsearch.cfm?fr=312.32
- “Drug Definition”. Stedman’s Medical Dictionary. Retrieved 2014-05-01. Available at Drugs.com
- Apesac: Association d’Aide aux Parents d’Enfants Souffrant du Syndrome de l’Anti-Convulsivant. Available at: https://metropole.nantes.fr/infonantes/association/23208-association-daide-aux-parents-denfants-souffrant-du-syndrome-de-lanti-convulsivant-
- Beck, James and Anthony Vale. Drug and Medical Device Product Liability Deskbook. New York: Law journal press, 2004.
- Becker, Zoey. Sanofi ordered by French court to compensate for epilepsy drug side effect: report. May 16, 2022. Available at: https://www.fiercepharma.com/pharma/sanofi-ordered-french-court-compensate-epilepsy-drug-side-effects-report
- BELLE BONFILS M. BL. CTR. v. Dist. Court, 763 P.2d 1003 (Colo. 1988). Supreme Court of Colorado. See: https://www.courtlistener.com/opinion/1281579/belle-bonfils-m-bl-ctr-v-dist-court/
- Brazier, Yvette. “All about side effects”. 2017. available at: https://www.medicalnewstoday.com/articles/196135
- Buckner v. Allergan Pharmaceuticals, Inc. 400 So.2d 820,821 (Fla. App. 1981)
- Class action against Sanofi wins French court backing. 05/01/2022. Available at: https://www.france24.com/en/live-news/20220105-class-action-against-sanofi-wins-french-court-backing
- Dépakine: une décision inedited. 13.01.2022. Available at: https://www.editions-legislatives.fr/actualite/depakine-une-decision-inedite/
- District of New Jersey. Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Available at: https://www.njd.uscourts.gov/elmiron-pentosan-polysulfate-sodium-products-liability-litigation
- EC Product Liability Directive (1985).
- Edwards, I. R. & J. K. Aronson. Adverse drug reactions: definitions, diagnosis, and management. The Lancet Journal, 356, (2000), 1255-1259. doi: 10.1016/S0140-6736(00)02799-9
- ELMIRON: pentosan polysulfate sodium, Capsules 100 mg, Toronto, Ontario: Janssen Inc, 2020. Available at: https://www.janssen.com/canada/sites/www_janssen_com_canada/files/prod_files/live/elmiron_cpm.pdf
- Entry into force: 23 March 1976, in accordance with Article 49. Available at: https://www.ohchr.org/en/instruments-mechanisms/instruments/international-covenant-civil-and-political-rights
- FDA Food Safety Modernization Act (2011)
- Food and Drug Administration Amendments Act (2007)
- Food and Drug Administration Modernization Act (1997)
- Food and Drug Administration Safety and Innovation Act (2012)
- Hines v. St. Joseph’s Hospital527 P.2d 1075 (1974)86 N.M. 763 Paul Hines and Tommie Hines, Plaintiffs-Appellants, v. ST. JOSEPH’S HOSPITAL, a non-profit corporation, and Blood Services, Inc, d/b/a Blood Services of New Mexico, Defendants-Appellees.No. 1316. Court of Appeals of New Mexico.September 18, 1974. See: http://law.justia.com/cases/new-mexico/court-of-appeals/1974/1316-1.html
- Judgments of the Court in Cases C-157/96 and C-180/96. The Queen v Ministry of Agriculture, Fisheries and Food ex parte: National Farmers’ Union and Others United Kingdom v Commission of the European Communities... . see: http://curia.europa.eu/en/actu/communiques/cp98/cp9831en.htm
- Kim, James and Anthony Scialli. “Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease”. Toxicology Journal, 122, 1(2011), 1-6. doi: 10.1093/toxsci/kfr088
- Laurence, D.R. & J.R. Carpenter. A dictionary of pharmacology and allied topics. Amsterdam: Elsevier, 1998.
- LAW No. 2016-41 of January 26, 2016 on the modernization of our health system. Available at: https://www.legifrance.gouv.fr/loda/id/JORFTEXT000031912641
- LeBlanc, Ricky A. Elmiron Lawsuit. August 1, 2024. Available at: https://www.sokolovelaw.com/dangerous-drugs/elmiron/
- Llamas, Michelle. Elmiron Lawsuits. August 2, 2024. available at: https://www.drugwatch.com/elmiron/lawsuits/
- Many children in the 1960’s, like the kindergartner pictured above, were born with phocomelia as a side effect of the drug thalidomide, resulting in the shortening or absence of limbs. See: https://helix.northwestern.edu/ article/thalidomide-tragedy-lessons-drug-safety-and-regulation
- Medicines & Healthcare products Regulatory Agency. Available at: www.gov.uk/mhra
- Medicines and Healthcare Products Regulatory Agency expands. 28 March 2013. Available at: http://webarchive.nationalarchives.gov.uk/20141206000813/http://www.mhra.gov.uk/NewsCentre/CON254872
- Medicines, Poisons and Therapeutic Goods Act (2008)
- Nebeker Jonathan R, Paul Barach & Matthew H Samore. “Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting”. Annals of Internal Medicine, 140(2004), 795-801. doi: 10.7326/0003-4819-140-10-200405180-00009
- Reporting Adverse Events to Medicines and Vaccines (2014). Available at: https://www.tga.gov.au/publication/reporting-adverse-drug-reactions
- Richmond, Caroline. Bill Inman: Medical researcher who revolutionised drug safety rules after the thalidomide crisis. The Guardian, 2005. Available at: https://www.theguardian.com/society/2005/nov/04/health.medicineandhealth
- Ryan v Great Lakes Council [1999] FCA 177. 5 March 1999. ATPR (Digest) 46-191 Negligence - Representative claim on behalf of consumers of oysters who contracted hepatitis A from contaminated oysters - Growing area management standards and practices …. See: https://jade.io/j/?a=outline&id=116375
- Santé Info Droits 01 53 62 40 30, Droits des Malades: L’action de Groupe en Santé. Available at: https://www.france-assos-sante.org/wp-content/uploads/2019/01/Action-de-groupe-en-sante.pdf
- Shah, Parth, Imani Thornton, Danielle Turrin & John E. Hipskind. Informed Consent. Treasure Island (FL): StatPearls Publishing, 2024. https://www.ncbi.nlm.nih.gov/books/NBK430827/
- Shkolnik, Napoli. “Medication-Caused Side Effects that Can Lead to a Lawsuit”. 2020. Available at: https://www.napolilaw.com/article/medication-caused-side-effects-lead-to-lawsuit/
- Shkolnik, Napoli. Prescription Drug Elmiron May Cause Vision Loss. April 20, 2020. Available at: https://www.napolilaw.com/article/prescription-drug-elmiron-may-cause-vision-loss/
- Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, 2 A.L.R.4th 1061, CCH Prod. Liab. Rep. P8648. Mar. 20, 1980. See: http://www.casebriefs.com/blog/law/torts/torts-keyed-to-prosser/causation-in-fact/sindell-v-abbott-laboratories
- Soundron, Marina Fabre. Depakine: le tribunal estime que Sanofi a commis une faute et valide le principe d’une action de groupe. 6 janvier 2022. Available at: https://www.novethic.fr/actualite/gouvernance-dentreprise/entreprises-controversees/isr-rse/depakine-le-tribunal-valide-le-principe-d-une-action-de-groupe-contre-sanofi-150466.html
- The Medicines Act (1968). Available at: http://www.drugwise.org.uk/what-are-the-uk-drug-laws/
- Therapeutic Goods Act (1989)
- von Bar, Christian. Non-Contractual Liability Arising out of Damage Caused to Another. Berlin: Walter de Gruyter, 2009.
- Williams, D. G. T. “Contempt and the Thalidomide Case”, The Cambridge Law Journal, 32, 2(1973), 177-181. https://www.jstor.org/stable/4505666
- World Health Organization, “Pharmacovigilance: ensuring the safe use of medicines”. Geneva: World Health Organization, 2004. Available at: http://apps.who.int/medicinedocs/en/d/Js6164e/
- Yellow Card reporting site. Available at: http://yellowcard.mhra.gov.uk/
ج) وبسایتها:
- مؤسسه دائرهالمعارف الفقه الاسلامی. فرهنگ فقه فارسی. جلد 3، 572. دسترسی در:
http://lib.eshia.ir/23017/3/572/%D8%AF%D8%B1%D9%85%D8%A7%D9%86
- آتنولول. دانشنامه رشد. دسترسی در:
https://daneshnameh.roshd.ir
- http://fda.gov.ir/item/1780
- http://fdo.behdasht.gov.ir/uploads/114_1364_25_zard.pdf
- http://io9.gizmodo.com/what-caused-this-deadly-epidemic-in-spain-in-1981-1665574317
- http://webarchive.nationalarchives.gov.uk/20141206000813/
- http://www.fda.gov.ir/item/1106
- http://www.fda.gov.ir/item/2174
- http://www.fda.gov.ir/item/2174
- http://www.fda.gov.ir/item/250
- http://www.pharmtech.com/about-pharmtech
- https://shpmc.sbmu.ac.ir