Pfizer Agrees to Settle Zantac Cancer Lawsuits for $250 Million
- by Rishma Parpia
- Published
- Pharma
Pfizer, Inc., the largest pharmaceutical corporation in the world marketing drugs and vaccines,1 has agreed to pay between $200 to $250 million to settle more than 10,000 lawsuits filed in the United States related to cancer risks associated with its over-the-counter heartburn drug Zantac (also known as ranitidine). The acid reflux drug was discontinued in U.S. in 2020 after a cancer-causing substance known as N-Nitrosodimethylamine (NDMA) was found in samples.
The French pharmaceutical company Sanofi SA acquired Zantac in 2017. Prior to that, Pfizer and other companies, such as the UK’s GlaxoSmithKline (GSK), owned rights to market the anti-acid drug.2 The U.S. Food and Drug Administration (FDA) licensed Zantac in 1983 and by 1988 it had become the world’s best selling drug.3 After NDMA was found in samples of Zantac, in 2020 the FDA asked drugmakers to pull Zantac and its generic versions off the market.4
Sanofi Paid $100 Million to Settle Zantac Lawsuits in the U.S
In April 2024, one month prior to Pfizer’s settlement, Sanofi agreed to pay $100 million to 4,000 claimants who had filed lawsuits saying that the company deliberately failed to inform people that Zantac contained cancer-causing compounds. Sanofi said that the allegations were false but that it decided to settle in order to avoid the costs of litigation.5
Peter Pitts, former associate commissioner of the FDA, the federal agency in charge for regulating the safety of drugs and vaccines, suggested that these types of lawsuits and settlements can damage the reputation of the wealthy pharmaceutical industry. He said:
I think when people see ‘settlement,’ they hear ‘guilty.’ And that is not true. When people hear ‘settlement,’ they hear the drug is dangerous and it isn’t effective. What concerns me is that companies are driven to spend money that can otherwise be used for additional research and development. These companies have deep pockets. They’re cash-rich, and they’re viewed as targets.6
Yet, after NDMA was found in samples of Zantac in 2020, the FDA did ask drugmakers to pull Zantac and its generic versions off the market, and plaintiffs suing over the cancer-causing ingredient in Zantac have a different perspective.
One plaintiff, 89-year-old Angela Valadez from Illinois said in her lawsuit that she developed colorectal cancer as a result of taking over-the-counter Zantac and its generic versions from 1995 to 2014. Like other plaintiffs suing over the drug’s cancer risks, she said its active ingredient ranitidine turns into NDMA as it ages.
Valadez’s attorney said, “We’re happy that she’s getting her day in court.”7
Pfizer Settles Zantac Lawsuits for Up to $250 Million
Pfizer’s settlement involving the Zantac lawsuits was disclosed in a court filing in Delaware and is aimed at significantly reducing the company’s potential liability. Pfizer has to pay plaintiffs $200 millions to $250 million to settle the cases. There have been 70,000 cases filed in Delaware state court against multiple drug makers and a few cases in California, Illinois and Pennsylvania.8
Pfizer sold Zantac between 1998 and 2006 and said that the allegations are false and are not supported by “reliable science.” In a statement Pfizer defended the safety of Zantac:
The company is confident that its Zantac products, which were reviewed and approved by the [U.S. Food and Drug Administration], did not cause cancer when used as directed.9
Zantac is back on the market with a new name, Zantac 360, and with an active ingredient, famotidine, that does not contain ranitidine.10
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