Corporate Liability of Pharmaceutical Companies Producing Unsafe Drugs (Lesson-Learnt from the USA)


  • Hanifah Febriani Universitas Muhammadiyah Surakarta
  • Bagus Mulia Pandu Winoto
  • Carissa Maharani



Unsafe Drug, Corporate liability, Pharmaceutical Companies


Since the end of 2022, Indonesia has been concerned with cases of kidney failure in children. Long before that, United States of America (USA) have experienced in handling the case of pharmaceutical company. This research aims to examine the Corporate Liability Settlement for the Pharmaceutical Industry Producing Unsafe Drugs in United States and Indonesia as well as to elaborate more about what Indonesia can improve reflecting from the cases in America. This is normative legal research, using comparative methodology as an approach. The research has found that Indonesia shall address the idea to settle the case with plea agreement, civil lawsuit, as well as oblige the corporation to enter in corporate integrity agreement. Furthermore, a higher amount of fine is required in order to deter the company.


Download data is not yet available.


AFP. (2022). Child Deaths Blamed on Syrup Medicines Rise to 195 in Indonesia. Jakarta Post.

Alexander, C. R., & Cohen, M. A. (2015). The Evolution of Corporate Criminal Settlements: An Empirical Perspective On Non-Prosecution, Deferred Prosecution, and Plea Agreements.

Almashat, S., Preston, C., Waterman, T., & Wolfe, S. (2010). Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry : 1991 to 2010. Washington, DC: Public Citizen’s Health Research Group., 1–35.

Almashat, S., Wolfe, S. M., & Carome, M. (2018). Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015.

Amrullah, M. S. (2019). Reconstruction of Law Criminal Development on Victims of Restoration as Form of Renewal Criminal law. Jurnal Hukum Volkgeist, 3(2), 160–165.

Andriadin, A., Absori, A., & Yuspin, W. (2021). Business Actors Accountability Model in The Criminal Act of Illegal Logging in Bima NTB. Jurnal Hukum Volkgeist, 6(1), 58–68.

Berenson, A. (2007). Plaintiffs Find Payday Elusive in Vioxx Cases. The New York Times.

BMJ. (2012). Big Pharma Often Commits Corporate Crime, and This Must Be Stopped.

Braithwaite, J. (1984a). CORPORATE CRIME: in the pharmaceutical industry. Routledge & Kegan Paul pic.

Braithwaite, J. (1984b). Corporate Crime in the Pharmaceutical Industry. In Economic and Political Weekly. Routledge & Kegan Paul pic.

Cockburn, A. (n.d.). When Half a Million Americans Died and Nobody Noticed. Retrieved July 12, 2023, from

Dimyati, K. (2016). Metodologi Penelitian Hukum.

Empat Perusahaan Jadi Tersangka Kasus Gangguan Ginjal Akut. (n.d.). BBC News Indonesia.

Hidayat, R. (n.d.). Menjerat Korporasi Bidang Farmasi dalam Kasus Gagal Ginjal Akut. Hukum Online. Retrieved October 25, 2023, from

Ilham. (2019). Criminal Law Policy about KPK Authorities in the Perspective of Criminal Action in Corruption in Indonesia. Jurnal Hukum Volkgeist, 3(2), 140–146.

Jupri, J., Ilyas, A. S. K., Rais, S., Rusmulyadi, R., & Saharuddin, S. (2022). The Role of the Saber Extortion Task Force (Sweeping Illegal Charges Task Force) In The Eradication of Criminal Acts of Corruption. Jurnal Hukum Volkgeist, 6(2), 186–195.

Khanna, V. S. (1996). Corporate Criminal Liability : What Purpose Does It Serve ? The Harvard Law Review, 109(7), 1477–1534.

Library University Of West London. (n.d.). LAW : PRIMARY SOURCES - CASES & LEGISLATION.

Marzuki, P. M. (2005). Penelitian Hukum. Kencana.

Mccarthy, E. (2019). A Call to Prosecute Drug Company Fraud as Organized Crime. McCarthy Author Final Review, 69, 999–1048.

Nurrachman, A. D., & Iksan, M. (2021). Penggabungan Gugatan Ganti Kerugian Sebagai Upaya Perlindungan Terhadap Korban Tindak Pidana [Universitas Muhammadiyah Surakarta]. NASKAH PUBLIKASI REV 18 FEB.pdf

Office of the United States Attorneys U.S. Department of Justice. (n.d.). Plea Bargaining. Retrieved October 25, 2023, from

Prakash, S., & Valentine, V. (n.d.). Timeline: The Rise and Fall of Vioxx. Retrieved July 12, 2023, from

Putri, D. A. M. S. S., & Panjaitan, A. C. D. (2023). Pertanggungjawaban Pidana Industri Farmasi dan BPOM terkait Pencemaran Obat Cair dalam Hukum Kesehatan. 17(1), 82–92.

Rodwin, M. A. (2012). Independent clinical trials to test drugs: the neglected reform. Saint Louis University Journal of Health Law and Policy, 6, 113–166.

Rodwin, M. A. (2015). Do We Need Stronger Sanctions to Ensure Legal Compliance By Pharmaceutical Firms? Food and Drug Law Journal, 70(3), 435–452.

Sjahdeini, S. R. (2006). Pertanggungjawaban Pidana Korporasi. Grafitipers.

Suhariyanto, B. (2017). Pertanggungjawaban Pidana Korporasi Berdasarkan Corporate Culture Model Dan Implikasinya Bagi Kesejahteraan Masyarakat. Jurnal Rechts Vinding: Media Pembinaan Hukum Nasional, 6(3), 441.

Supriyanto, H. (2020). The Nature of Corporate Crime in Law Enforcement of the Criminal Justice System in Indonesia. Jurnal Hukum Volkgeist, 4(2), 166–179.

Tempo. (2023). Tragedi Gagal Ginjal Akut. Kaleidoskop 2022.

The United States Departement of Justice. (n.d.). U.S. Pharmaceutical Company Merck Sharp & Dohme to Pay Nearly One Billion Dollars Over Promotion of Vioxx®. Retrieved May 23, 2022, from

Tripathy, J. P. (2013). Secondary data analysis: Ethical issues and challenges. Iranian Journal of Public Health, 42(12), 1478–1479.

U.S. Department of Justice. (2009). Justice Department Announces Largest Health Care Fraud Settlement in Its History. Office of Public Affairs US Department of Justice.

U.S. Department of Justice. (2011a). Former Executives Of International Medical Device Maker Sentenced To Prison In Unlawful Clinical Trials Case.

U.S. Department of Justice. (2011b). U.S. Pharmaceutical Company Merck Sharp & Dohme to Pay Nearly One Billion Dollars Over Promotion of Vioxx®. Office of Public Affairs US Department of Justice.

U.S. Department of Justice. (2012). GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. Office of Public Affairs US Department of Justice.

Van Hoecke, M. (2016). Methodology of Comparative Legal Research. Law and Method, June 2015.

Widyaningrum, T., & Wijaya, H. (2023). Pengaturan Pidana Korporasi Terhadap Produksi Obat yang Tidak Memenuhi Standar Persyaratan Keamanan Di Indonesia. JIMPS: Jurnal Ilmiah Mahasiswa Pendidikan Sejarah, 8(4).

Wolfe, S. M. (2013). Escalating criminal and civil violations: Pharma has corporate integrity? Not really. BMJ (Online), 347(December 2013), 2013–2014.








How to Cite

Hanifah Febriani, Bagus Mulia Pandu Winoto, & Carissa Maharani. (2023). Corporate Liability of Pharmaceutical Companies Producing Unsafe Drugs (Lesson-Learnt from the USA). Jurnal Hukum Volkgeist, 8(1), 99–107.