Unsolved:Zantac settlements

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Ranitidine, a heartburn medicine sold under the brand name Zantac among others, was pulled from shelves in 2019,[1] following disclosure [2] of potential carcinogenic effects,[3][4] which its manufacturers were accused of "engaging in a decades-long scheme to conceal."[5]

By 2020, the US Food and Drug Administration was telling consumers to discard whatever Zantac they still had.[6]

Overview

Zantac was first marketed in 1981,[7] and it was described in 1989 as "one of the most expensive drugs on the market",[8] and "the world's biggest-selling prescription drug".[9] Addiction to taking it ("a habit") was how some of its users described Zantac.[10] The focus of Glaxo, its manufacturer, was to gain market share "from Zantac competitors like Tagamet."[9] Cimetidine, sold under the brand name Tagamet among others, was listed in 2020 as an alternative to Zantac.[11]

The company also introduced a half-strength[12] Line Extension named Zantac 75.[13]The Los Angeles Times headlined "Public Faces Overdose of Similar Drug Names."[14]

The market for Zantac[15] and its competitors was described in 2005 as 13.5 billion US dollars.[16]

The product's problem was described by The New York Times as being "that a potential cancer-causing contaminant can build up in the drug when stored for long periods."[6] Heavy marketing expenditures resulted in Zantac being consumed by those who might have satisficed with less harmful alternatives.[9] As the potential harmful effects were identified, lawsuits were filed.

Oversight

By the time of the FDA's 1983 provisional approval for Zantac, it had already been approved for sale in 31 counties.[17] Marketing expenditures were measured by hundreds of millions of dollars.[18][13][19]

The 2019 New York Times headline "Heartburn Drugs Can Lead to Fatal Heart or Kidney Disease"[20] was a herald for Zantac being pulled from store shelves.[1]

Infants and children

A lower dose version of Zantac[9] had been given to children. A liquid form for ingestion by infants also had been marketed.[6]

Lawsuits

By 2022, a wave of Class action lawsuits was underway, and illegal robocalls were being made, even to those registered on the Federal Do-Not-Call list regarding settlement options.[citation needed] Also by then, "a wave of recalls" had taken place.[21]

Some of the lawsuits, which by October 2021 included over 100,000 plaintiffs,[5] were filed due to impending statute of limitations laws; estimates of how many people used Zantac have been given as high as 15 million.[citation needed] Facets of the legal rangling included:

  • whether or not certain internal eMails were privileged[22] (and that deleting them was or was not a violation of a judge's orders to preserve them).[23]
  • voluntary withdrawal of products and whether this removed them from oversight.[5]

Related to courtroom action were offers for a cash advance on impending settlements. Another money matter related to lawsuits and impending settlements is market timing.[24]

In June 2023, GSK reached a confidential settlement for one of the lawsuits related to Zantac causing cancer. [25][26]

Zantac pill switching settlements

In 2008 settlements were reached regarding switching Medicaid patients taking Zantac from capsules to the "more costly" tablet form. [27] [28]

See also

References

  1. ↑ 1.0 1.1 Sandra E. Garcia (September 30, 2019). "Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears". The New York Times. https://www.nytimes.com/2019/09/30//health/zantac-recall-cancer.html. 
  2. ↑ Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S., October 23, 2019, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us 
  3. ↑ Katie Thomas; Sheila Kaplan (September 13, 2019). "Zantac Has Low Levels of a Cancer-Causing Chemical". The New York Times. https://www.nytimes.com/2019/09/13/health/zantac-cancer-ndma.html. 
  4. ↑ Katie Thomas (October 18, 2019). "Zantac Recall Widens as Sanofi Pulls Its Drug Over Carcinogen Fears". The New York Times. https://www.nytimes.com/2019/10/18/health/zantac-recall-carcinogen-sanofi.html. 
  5. ↑ 5.0 5.1 5.2 Nate Raymond (October 7, 2021). "Sanofi, GSK can't escape Zantac proposed class actions, judge rules". Reuters. https://www.reuters.com/legal/litigation/sanofi-gsk-cant-escape-zantac-proposed-class-actions-judge-rules-2021-10-07. 
  6. ↑ 6.0 6.1 6.2 Katie Thomas (April 1, 2020). "Zantac Products Should Not Be Sold or Used, F.D.A. Warns, Citing Cancer Danger". The New York Times. https://www.nytimes.com/2020/04/01/health/zantac-cancer-fda.html. 
  7. ↑ Steve Lohr (March 31, 1986). "Ulcer Drug Succeeds, but GLAXO Won't Relax". The New York Times. https://www.nytimes.com/1986/03/31/business/ucler-drug-succeeds-but-glaxo-won-t-relax.html. 
  8. ↑ Elsie Dragonetti (June 18, 1989). "The Zantac Saga Includes the Cost". The New York Times. https://www.nytimes.com/1989/06/18/sports/l-the-zantac-saga-includes-the-cost-025189.html. 
  9. ↑ 9.0 9.1 9.2 9.3 Steven Prokesch (October 11, 1989). "Glaxo's Search: Son of Zantac". The New York Times. https://www.nytimes.com/1989/10/11/business/glaxo-s-search-son-of-zantac.html. 
  10. ↑ "Reader Responses". The New York Times. October 18, 2006. https://www.nytimes.com/2006/10/18/business/18leonhardt-responses.html. 
  11. ↑ Christina Caron (April 18, 2020). "Should Pregnant Women Avoid Zantac?". The New York Times. https://www.nytimes.com/2020/04/18/parenting/pregnancy/zantac-recall.html. 
  12. ↑ "No Prescription Needed: Zantac, the ulcer medicine". The Los Angeles Times. December 22, 1995. https://www.latimes.com/archives/la-xpm-1995-12-22-fi-16800-story.html. 
  13. ↑ 13.0 13.1 Stuart Elliott (April 23, 1996). "Madison Avenue girds itself for Z-Day today". The New York Times. https://www.nytimes.com/1996/04/23/business/media-business-advertising-madison-avenue-girds-itself-for-z-day-today.html. "with a budget estimated at $100 million -- for Zantac" 
  14. ↑ "Public Faces Overdose of Similar Drug Names". The Los Angeles Times. November 18, 1994. https://www.latimes.com/archives/la-xpm-1994-11-18-fi-64372-story.html. "Quick, what was that prescription your father takes for his ulcer? Zantac? Xanax? Zenate?" 
  15. ↑ "Generic Zantac Marketing Pact". The New York Times. August 5, 1997. https://www.nytimes.com/1997/08/05/business/generic-zantac-marketing-pact.html. 
  16. ↑ Mary Duenwald (February 22, 2005). "Heartburn Relief, From Aciphex to Zantac". The New York Times. https://www.nytimes.com/2005/02/22/health/heartburn-relief-from-aciphex-to-zantac.html. 
  17. ↑ Barnaby J. Feder (May 7, 1983). "GLAXO says Ulcer Drug has Approval of F.D.A.". The New York Times. https://www.nytimes.com/1983/05/07/business/glaxo-says-ulcer-drug-has-approval-of-fda.html. 
  18. ↑ Milt Freudenheim (September 8, 1995). "War on Heartburn Heats Up With Over-the-Counter Blitz". The New York Times. https://www.nytimes.com/1995/09/08/business/war-on-heartburn-heats-up-with-over-the-counter-blitz.html. "A $200 million-plus marketing battle has started" 
  19. ↑ "RKS;ZANTAC ARRIVES WITH $100 MIL CAMPAIGN". Advertising Age. April 29, 1996. https://adage.com/article/news/landmarks-zantac-arrives-100-mil-campaign/79448. 
  20. ↑ Nicholas Bakalar (June 11, 2019). "Heartburn Drugs Can Lead to Fatal Heart or Kidney Disease". The New York Times. https://www.nytimes.com/2019/06/11/well/live/heartburn-drugs-can-lead-to-fatal-heart-or-kidney-disease.html. 
  21. ↑ Christina Jewett (March 23, 2022). "Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk". The New York Times. https://www.nytimes.com/2022/03/23/health/pfizer-recall-blood-pressure-drug-cancer.html. 
  22. ↑ "Sanofi claws back some Zantac emails as privileged". Reuters. July 9, 2021. https://www.reuters.com/legal/litigation/sanofi-claws-back-some-zantac-emails-privileged-2021-07-09. 
  23. ↑ Jef Feeley (May 11, 2021). "Sanofi Accused of Destroying Emails Tied to Zantac Recall". https://www.bloomberg.com/news/articles/2021-05-11/sanofi-accused-of-destroying-internal-emails-about-zantac-recall. 
  24. ↑ Anthony Ramirez (November 5, 1995). "INVESTING IT;Will It Please the Court? A Litigation Analyst Calls the Verdicts". The New York Times. https://www.nytimes.com/1995/11/05/business/investing-it-will-it-please-the-court-a-litigation-analyst-calls-the-verdicts.html. "buying the stock when it dips following negative litigation news" 
  25. ↑ "GSK Settles First Zantac Cancer Lawsuit Set for Trial in US" (in en). Bloomberg.com. 2023-06-23. https://www.bloomberg.com/news/articles/2023-06-23/gsk-gsk-ln-settles-first-zantac-cancer-lawsuit-set-for-trial-in-us. 
  26. ↑ "GSK settles key Zantac cancer lawsuit" (in en). The Times. 2023-07-10. ISSN 0140-0460. https://www.thetimes.co.uk/article/gsk-settles-key-zantac-cancer-lawsuit-kq5jsgj37. 
  27. ↑ "Walgreen Settles Suit On Pill-Switch Claims". The Wall Street Journal. June 5, 2008. https://www.wsj.com/articles/SB121259276426645179. 
  28. ↑ "CVS Caremark Reaches Settlement". The Wall Street Journal. March 19, 2008. https://www.wsj.com/articles/SB120585417674445335. 



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