Dr. C. Michael White recently called Zantac “the canary in the coal mine for the post-manufacturing creation of NDMA.”
Since NDMA contamination occurs during the shipping and storage processes, a sample might be fine on the factory floor and deadly once it reaches the consumer. A number of studies support this notion.
Dr. White urged regulators to take additional action. “It is always better to be safe than sorry,” he remarked, “particularly when dealing with a possible carcinogen.”
What is NDMA?
N-Nitrosodimethylamine is perhaps the deadliest poison you have never heard of. In 1978, Steven Roy Harper laced his family’s lemonade with NDMA. Two people died, and Harper committed suicide prior to his execution. The case was profiled on a Forensic Files episode.
Other similar episodes are more recent. In 2013, a medical student in China added NDMA to his dormitory’s water cooler. One person died. Lin Senhao claimed the incident was an April Fool’s Day prank which went off the rails. But he was tried, convicted, and executed for his crime. A few years later, in 2018, a graduate student at Queens University gave her lab partner water, cinnamon bread, and apple pie which she had laced with NDMA.
Four grams of NDMA is enough to kill a fully-grown adult almost instantly. Four grams is a little over half a teaspoon.
This chemical has very few practical uses. Sometimes, researchers give it to laboratory animals so they will develop cancerous tumors.
Much more commonly, NDMA is a manufacturing by-product. Processed meats often have extremely low levels of this chemical. Researchers believe that the sodium nitrate in cured meat, beer, fish, and a few other products is a precursor to NDMA.
Another NDMA precursor, UDMH (unsymmetrical dimethylhydrazine), is in rocket fuel. Therefore, groundwater near many Air Force bases has high NDMA levels.
The Food and Drug Administration has labeled NDMA as an extremely hazardous substance, which means that its use is highly-regulated. But the FDA has stopped short of banning it altogether. More on this point below.
Legally, NDMA contamination in medicine is a manufacturing defect. Until the manufacturing process starts, drugs like Zantac are perfectly safe. Then, defects occur, mostly because companies take cost-cutting shortcuts which risk consumer safety.
Takata airbags are a good example. The company started making airbags in the 1980s. At first, Takata used a stable and effective chemical propellant. But this propellant was also costly. So, around 2000, the company switched to ammonium nitrate, a much cheaper compound. Ammonium nitrate is also unstable and explosive. Timothy McVeigh used this chemical in the Oklahoma City truck bomb. If a car with a Takata airbag is in a low-speed collision, roughly the same thing could happen.
Although Takata paid a huge fine and the company went bankrupt, this story is not over. Millions of vehicles with defective airbags are still on the road.
Zantac’s NDMA defect relates to the chemical metabolism of Ranitidine. When Zantac is stored at room temperature, NDMA levels escalate rapidly. According to one recent study, after five days of storage at 158 degrees, which is the temperature inside most unrefrigerated warehouses, NDMA levels were above the legal limit. After twelve days, the NDMA level was almost twice the legal limit.
Sanofi, Zantac’s manufacturer, could easily eliminate this problem and make the drug safe. For example, Sanofi could ship Zantac in climate-controlled trucks in order to lower the temperature. Or, Sanofi could change the label and direct retailers to discard unsold product in a few days.
But these fixes cost money. Frequently, companies run the financial numbers and conclude that it’s cheaper to sell dangerous products and run the risk of lawsuits than it is to invest in product safety.
This is where a Lexington personal injury lawyer comes in. Unless attorneys call companies like Sanofi to task, they might never change the way they sell medicine.
Incidentally, NDMA manufacturing defects are not just a Zantac problem. Regulators have also recalled some lots of Glucophage (metformin), a popular anti-diabetes drug, over similar concerns.
Once upon a time, the FDA was a very effective safety watchdog. Today, things are different. Almost half the agency’s funding comes from user fees.
In other words, the companies which the FDA is supposed to regulate basically pay the bills. If the FDA recalls drugs or devices, these companies don’t make as much money, which means they don’t pay as much money.
So, unless there is overwhelming evidence of a serious problem, the FDA rarely takes drastic action. By that time, the defective product has already affected thousands of people.
Recalls and other drastic actions also put the FDA in an uncomfortable moral position. In most cases, the agency just declared that the drug was safe. Therefore, if it takes adverse action, it’s admitting it made a mistake. No one likes to make such admissions.
Hopefully, Congress will someday address these problems, perhaps by authorizing more funding or splitting the FDA into different screening and enforcement agencies. But unless and until that happens, our professional team must stand in the gap to protect people.
Companies are legally responsible for the dangerous medicines they sell. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. Virtual, home, and hospital visits are available. #goodelawyers