In a development that gives a boost to Zantac victims, under pressure from the Food and Drug Administration, Marksans Pharma recalled one of the world’s most popular diabetes drugs.
Metformin reduces blood sugar, so it is a very effective anti-diabetes drug. For some time, the FDA has been monitoring NDMA contamination issues in metformin tablets. The latest action involves Riomet ER and Time-Cat Labs. For some reason, extended release drugs are especially vulnerable to this problem.
Almost 35 million Americans struggle with Type 2 diabetes.
What is NDMA?
N-Nitrosodimethylamine is a nasty, yellow liquid commonly found in drinking water, cured meat, rocket fuel, and stored pharmaceutical products. It is also one of the world’s most dangerous carcinogens.
Decontamination and chlorination cause NDMA buildup in drinking water. NDMA is so potent that most states do not allow more than ten nanograms per liter in water supplies. Making matters worse, most protective measures, such as carbon filtering, do not affect NDMA. The only effective measures are expensive and risky solutions like reverse osmosis and radiation.
NDMA is also a manufacturing by-product of cured meat and rocket fuel. Because cured meat has high concentrations of sodium nitrate, NDMA often forms in the body as proteins degrade. Groundwater near rocket launch sites usually has high contamination levels.
For purposes of this blog, we are most concerned with NDMA and pharmaceutical products, like Zantac. Most drugs are stored for very long times at room temperature, from shipping trucks to store shelves to the insides of medicine cabinets. The mild excess warmth causes NDMA particles to form. That’s one of the reasons many medicines must be refrigerated. But in many cases, that storage method could do more harm than good. Some medicines lose their potency very quickly if they are refrigerated.
Legally, N-Nitrosodimethylamine is an extremely hazardous substance in the United States. Therefore, products which contain it are on par with dynamite, industrial solvents, and other items which are never completely safe no matter what steps the manufacturer takes. This legal status makes it easier for a Lexington personal injury attorney to establish liability, as outlined below.
Basis for Liability
These injuries always involve strict liability. Fault or negligence is usually irrelevant, at least for liability purposes. There are basically three types of product liability actions. NDMA-laced pharmaceutical products could involve any one of them.
Inherently Dangerous Products
Generally, if the manufacturer is careful, the product-making process can be at least reasonably safe.
But that’s not the case with products like the aforementioned explosives and solvents. These products are designed to cause damage, so there is an inevitable possibility of injury. Dynamite is explosive, no matter how carefully it is handled. The best one can do is reduce the risk of an unintentional explosion.
If a dangerous product, like NDMA-laced Zantac, injures someone, the manufacturer could be legally responsible for the injury. No ifs, ands, or buts.
Most products are relatively safe as long as everything goes according to plan throughout the entire process. Any breakdown could cause serious injury. Legally, manufacturers are strictly liable for the following breakdowns:
- Design Defect: In the never-ending quest to increase profits, some manufacturers take shortcuts during the design process. For example, an air conditioner manufacturer might fail to properly insulate wires, making them prone to explosion.
- Manufacturing Defect: Generally, these defects involve shortcuts in the manufacturing process. Frequently, manufacturers replace safe yet expensive ingredients or components with cheaper and less reliable ones. Technically, manufacturers are also responsible for problems which occur during shipping.
Drug makers do not intend for NDMA to build up in stored products. But such incidents are arguably either design or manufacturing defects.
Unforeseeable misuse is about the only defense to defective product claims. Vending machines are a good example. It is foreseeable that someone will ignore the warning label and shake the machine because a Snickers bar did not fall. Other snack-related mishaps are unforeseeable.
Failure to Warn
Frequently, companies know about elevated risks. But they say nothing about these risks, so people will keep buying whatever they are selling.
Conclusive proof of a product-injury link is usually unnecessary. Victim/plaintiffs must only prove there was a higher risk, the company knew about the higher risk, and did not add a disclaimer or anything else to warn consumers.
The risk of NDMA contamination is widely known. It would be very easy to add a few words in the fine print about this risk. But most manufacturers do not even do that.
Damages in a dangerous product claim usually include compensation for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering.
Moreover, since companies often ignore known risks in these situations, additional punitive damages are often available as well. In many cases, these awards are significant. Generally, money is the only language companies speak. Unless the damage ward is very high, companies will write off the award as the cost of doing businesses and not change their ways. As a result, more people get hurt.
Manufacturers are strictly liable for the injuries their dangerous products cause. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. Attorneys can connect victims with doctors, even if they have no money or insurance.