- Boehringer Ingelheim
Defendant Law Firm:
- Sanofi is represented by Anand Agneshwar of Arnold & Porter.
- Pfizer is represented in the MDL by Joseph G. Petrosinelli of Williams & Connolly LLP.
- Boehringer is represented by Paul Schmidt of Covington & Burling LLP.
- GlaxoSmithKline is represented by Mark Cheffo of Dechert LLP.
Allegations: Lawsuits have been filed against the manufacturers of Zantac, alleging that drug manufacturers failed to warn about the presence of carcinogen NDMA. Plaintiffs allege manufacturers knew or should have known about Zantac cancer risks problems for decades, yet aggressively marketed and sold brand-name prescription, generic and over-the-counter versions of Zantac for years, without warning the users about the risk of developing cancer.
Plaintiff Steering Committee
Rosemarie Riddell Bogdan- Martin, Harding & Mazzotti, LLP
Mark J. Dearman- Robbins Geller Rudman & Dowd LLP
Elizabeth A. Fegan- Fegan Scott LLC
Marlene J. Goldenberg- GoldenbergLaw, PLLC
Roopal P. Luhana- Chaffin Luhana LLP
Ricardo M. Martinez-Cid- Podhurst Orseck, P.A.
Lauren S. Miller- Cory Watson, P.C.
Melanie H. Muhlstock- Parker Waichman LLP
Daniel A. Nigh- Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.
Carmen S. Scott- Motley Rice LLC
Mikal C. Watts- Watts Guerra LLP
Sarah N. Westcot- Bursor & Fisher PA
Conlee S. Whiteley-Kanner & Whiteley LLC.
R. Brent Wisner- Baum, Hedlund, Aristei & Goldman P.C.
Frank Woodson- Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.
In February 2020, the U.S Judicial Panel on Multidistrict Litigation (JPML) consolidated and centralized the growing number of Zantac lawsuits before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.
MDL Status: Active and on appeal
Important Verdicts & Settlements: Currently there are no settlements made.
May 2021: Lawyers of more than 70,000 former patients who sued Sanofi accused that the company has deleted email links related to a 2019 recall of the heartburn medication Zantac. The mails deleted by Sanofi included some mails from the head of regulatory affairs for the company’s U.S. Consumer Healthcare division. It will be difficult for the consumers without the emails to prove that Zantac contains a suspected carcinogen. The lawyers for the patients requested the judge to give them some more time to prepare for their first trials, to begin the following year. The lawyers further explained that the deleted emails were very important and would delay in getting the key Sanofi testimonies.
The authorities of Sanofi stated that the company would thoroughly investigate the email destruction and will also provide a detailed report to the judge overseeing the Zantac cases. Although the company had already provided the required documents of relevant discovery to the plaintiffs, it intentionally disclosed the mishandling of certain emails requested by the plaintiffs. The spokesperson for Sanofi defending the company said that the data loss was not intentional and the company was making the necessary arrangements to gather as much as data possible from alternative sources. The company stated it was confident about the safety of Zantac and this issue will not have any impact on Sanofi's strong defenses in the litigation.
December 2020: A study was published in December 2020, in the medical journal Organic Process Research & Development in which U.K. researchers working with Zantac manufacturer GlaxoSmithKline (GSK) suggested that the degradation of the active pharmaceutical ingredient ranitidine results in the formation of the cancer-causing chemical N-nitrosodimethylamine (NDMA).
Ranitidine hydrochloride is a drug sold under the name of Zantac, used to treat and prevent ulcers in the stomach and intestine. Earlier that year, the FDA requested manufacturers to discontinue all versions of Zantac from the market after finding that the cancer-causing chemical NDMA levels in the drug exceeded the set daily acceptable limit. According to this latest study, the researchers conducted a root cause analysis and confirmed that the heat produced by the human body’s digestive processes aids in the transformation of the ranitidine molecule into the toxic chemical. The researchers further found that the impurities did not play any role in Zantac NDMA contamination.
The analysis was done using suitably isotopically labeled ranitidine hydrochloride, which revealed that the factors that influence the transformation were heat, humidity, and the crystal morphology of ranitidine hydrochloride with the material that exhibits a columnar habit showing a slower rate of degradation.