In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of the carcinogen NDMA, and the links to cancer can be found in the Factual Allegations, beginning on page 39 of the Master Complaint. (Note that I use the brand-name Zantac and its actual name ranitidine mostly interchangeably in this post.)

These are the key elements of the story:

Inventing and Selling Ranitidine

• Ranitidine is a medication relieves heartburn and acid indigestion.
• According to the Master Complaint, it was developed by GlaxoSmithKline (GSK) predecessors to compete with other “histamine H2-receptor antagonists” on the market, particularly Tagamet (cimetidine).
• A scientist working for a Glaxo subsidiary discovered ranitidine in 1976.
• In 1983, the FDA granted approval for Glaxo to sell Zantac.
• The prescription drug was a smash hit for Glaxo, the first drug to make $1 billion in sales.
• GSK turned Zantac into a blockbuster in part by driving sales. It added 800 salespersons to Zantac’s U.S. sales force.
• In 1993, GSK introduced an OTC version of Zantac, which it began selling a few years later.
• Over the next twenty-five years, other Defendants acquired the rights to sell OTC Zantac, including Pfizer, Boehringer Ingelheim, and Sanofi.
• GSK retained control of prescription Zantac in the U.S., which it sold until 2017.
• On October 18, 2019, Defendant Sanofi recalled all brand-name OTC Zantac in the U.S.
• In 1997, the original Zantac patent expired, allowing other companies to sell generic ranitidine products. Seventy-five companies eventually sold generic versions of ranitidine over the next two decades.
• The Brand-Name Manufacturer Defendants continued to sell prescription and OTC ranitidine.
• OTC Zantac antacid tablets had sales totaling $128.9 million in 2018.

Dangers of NDMA

• N-Nitrosodimethylamine (“NDMA”) is a toxic chemical and a danger to human health.
• NDMA is a carcinogen. As the Master Complaint puts it ominously, “its only use today is to cause cancer in laboratory animals.”
• Since 1980, companies have pulled all kinds of products from stores that were found to contain high levels of NDMA.
• In 2018, there have been recalls of several generic drugs to treat high blood pressure, including Valsartan and Losartan, (which I wrote about here).
• Scientists believe any amount of NDMA can increase risk for cancer or other health problems.
• In studies, laboratory animals taking NDMA orally developed liver, lung, bladder, kidney, pancreas, and stomach cancers.
• NDMA is a small particle, which means it can pass easily through the body, including into the brain and into placenta.
• But, studies also show that small amounts of NDMA can be fully metabolized in the liver, while larger amounts move throughout the body.
• In 1995, several studies showed an increased risk in cancer for humans after ingesting small amounts of NDMA.
• Studies in 1999, 2000, 2011, and 2014 reconfirmed the findings that NDMA can cause several cancers in humans.

NDMA Found in Ranitidine Products

• 

  In September 2019, an independent lab found significant levels of NDMA in ranitidine products. Four days later the FDA issued a warning that ranitidine (Zantac) may contain NDMA.
• In the next days and weeks, companies began voluntarily recalling their Zantac and generic-ranitidine products.
• On November 1, 2019, the FDA announced unacceptable levels of NDMA in ranitidine products based on recent testing, and requested that drug makers recall the medication.
• On December 4, 2019, the FDA issued a statement warning consumers who still take ranitidine to limit intake of nitrite-containing foods, like processed meats.
• The Complaint then throws a haymaker, noting that this was the same advice as the advice given by an Italian scientist . . . in 1981. Had GSK listened to the Italian scientists decades earlier, the Complaint argues, then millions of people may not have been exposed to dangerous levels of NDMA over thirty-eight years.
• In 2020 studies showed that ranitidine products can develop NDMA when exposed to temperature changes over time. The conclusion was that ranitidine is time and temperature sensitive, meaning the longer it sits or the more often it is exposed to temperature fluctuations, the more NDMA it is likely to develop.
• On April 1, 2020, the FDA recommended the removal of all ranitidine products.

In Part 3, we will look at the science behind the way ranitidine becomes NDMA.

Remember: These allegations come from the Master Complaint in the Zantac MDL and have not yet been proven in court.

Herbicides have become a way of life. For some, like farmers and ground maintenance men, herbicide application is part of making a living. For homeowners, herbicides are used to grow the perfect weed-free lawn. For all of us, herbicide usage is closely linked to the production of our food. The most common herbicide? Glyphosate-based herbicides. The most well-known brand? Roundup. The alarming part? Glyphosate exposure has been alleged to increase the risk of cancer. More particularly, glyphosate is allegedly related to the increased risk for non-Hodgkin’s lymphoma and other blood cancers. Glyphosate-based herbicides are still widely used in our country.

Glyphosate discovered in the 1970s

In 1970, a chemist working at Monsanto within the herbicide screening program named John Franz discovered glyphosate, an organophosphate compound which would become the active ingredient in Monsanto’s Roundup herbicide. By 1972, Roundup was marketed to the public as an environmentally friendly herbicide that is safe for both human and wildlife alike. Roundup was produced commercially starting in 1974. It would quickly become one of the most popular herbicides of all time.

By the 2000s, studies indicate increased cancer risk with glyphosate use.

By 2008, glyphosate is first identified as a potential risk factor for the development of non-Hodgkin lymphoma. In a May 2014 study, the chemical is determined by the International Agency for Research on Cancer to increase the risk of developing non-Hodgkin’s lymphoma. By March of 2015, that organization makes an official statement that glyphosate should be considered a “probable carcinogen.” What is it about glyphosate that makes it potentially harmful?

First, it is easy to become exposed to glyphosate, especially when it is the key ingredient in popular herbicides. Exposure can occur through skin contact, eye contact, or through inhalation whenever the product is sprayed. Second, studies suggest that once glyphosate enters the body, it poses a threat by acting as an antibiotic that is responsible for killing not only bad bacteria, but good bacteria as well. This poses a hazard by weakening the body’s immune system and damaging cellular DNA. Often, cellular damage occurs in the mouth and throat.

Non-Hodgkin’s lymphoma is a cancer that starts in the white blood cells and affects the body’s entire lymphatic system, the system responsible for protecting the body against disease and infections. This cancer can begin in any part of the body where lymphatic tissue is found, such as lymph nodes, the spleen, bone marrow, tonsils, and digestive tracts. Cancer that begins in the lymphatic system spreads really quickly and can easily spread throughout the rest of the body.

Jury awards groundskeeper Dewayne Johnson $289 million.

In 2018, trial was held on behalf of Dewayne Johnson, one of the first persons to bring a lawsuit against Roundup for its alleged link to cancer. On August 10, 2018, a jury in California state court awarded a $289 million verdict to the 46-year-old former school groundskeeper who contracted terminal cancer after using Roundup to control weeds on the school grounds where he worked. Part of what made this trial significant was that scientific data from the World Health Organizations International Agency for Research on Cancer was presented to the jury to demonstrate the carcinogenic danger glyphosate has on humans. Litigation discovery also revealed internal emails among Monsanto executives in which the cancer risk had been brought to Monsanto’s attention.

Since the groundbreaking verdict in the Dewayne Johnson case, individuals potentially harmed by Monsanto’s glyphosate-based herbicide Roundup have been coming forward to be compensated for the health problems they are now forced to cope with. The legal battle against the Roundup manufacturer Monsanto, which has been recently acquired by Bayer, will continue in the new year. In October 2016, a multidistrict litigation panel had agreed that federal Roundup cancer cases should be consolidated and heard before Judge Vince Chhabria in the Northern District of California. The first glyphosate cancer case in federal court is scheduled to be held on February 25, 2019. Judge Chhabria has selected the case of Edwin Hardeman, out of over 620 pending cases, to be heard in front of a jury. Mr. Hardeman had been using Roundup on his property since 1980 and was diagnosed with large B-cell non-Hodgkins lymphoma in 2015. Undoubtedly, there will be many more federal cases to follow.

I am currently looking at new cases involving people potentially harmed by exposure to Roundup.

Note: Bayer and Monsanto continue to deny the connection between the use of Roundup and the increased risk of developing cancer. Photographs used in this post are for illustrative or editorial purposes only and are not intended for any commercial use.