Government Recalls Diabetes Drug

Government Recalls Diabetes Drug

June 16, 2020 | Pharmaceutical Litigation

After government inspectors found traces of a cancer-causing chemical in Metformin, the Food and Drug Administration ordered a recall of one of the most commonly-prescribed diabetes drugs in America.

FDA officials discovered a dangerous chemical, N-Nitrosodimethylamine, in five different Metformin versions.

About 34 million Americans have Type 2 Diabetes, and many of them take some form of Metformin.

This drug reduces blood sugar levels. Officials are not worried about a potential Metformin shortage, since generic versions are available.

Despite the danger, Metformin patients should continue taking this drug until their doctors prescribe replacements.

In 2019, the FDA found traces of NDMA in Zantac, a popular heartburn medicine. That discovery prompted a recall as well.

What is N-Nitrosodimethylamine?

In 2013, a college student injected NDMA into a dormitory water cooler. His roommate drank the poisoned water and died.

The student claimed the incident was only an April Fool’s prank that went off the rails. Nevertheless, a court convicted him of murder, and he was executed in 2015.

That story illustrates just how dangerous NDMA can be, even in small amounts.

N-Nitrosodimethylamine is a common manufacturing by-product. NDMA is also sometimes found in drinking water, usually due to chlorination and other treatment processes.

This chemical, even at almost trace levels, has also been conclusively linked to liver cancer.

Cancer survival rates have improved significantly since the 1990s.

But progress has not been cheap. Average cancer treatment costs have increased even faster than survival rates.

These changes are evident in all three phases of most cancer treatments:

  • Radiation: To shrink malignant tumors, doctors blast them with radiation. Previously, patients could only tolerate low radiation doses, so these treatments were often rather ineffective. Today’s targeted radiation treatments minimize collateral cell damage, so higher doses are possible.
  • Surgery: Surgically removing tumors is a delicate process, especially if the tumor is in the liver or another vital organ. Better surgical tools and techniques have improved success rates, but these improvements come at a cost.
  • Chemotherapy: These drugs kill remaining cancer cells. Actually, they target and kill all fast-dividing cells. That’s why chemotherapy patients typically lose their hair. Similar to radiation treatments, today’s chemotherapy drugs are much more powerful than they were before. Often, these drugs have unintended side-effects. Taxotere, a common breast cancer chemotherapy drug, is a good example.

After leveling off during the Great Recession, medical bill inflation is on the rise again.

Now more than ever, NDMA exposure victims need substantial compensation to deal with their serious conditions.

Otherwise, liver cancer is essentially a death sentence.

Manufacturing Defects: A Closer Look

No one, other than the aforementioned student, intentionally places NDMA in drinking water, Metformin, and other consumer products. Rather, N-Nitrosodimethylamine appears in these products largely due to a lack of oversight.

Drug companies and other manufacturers should have testing and other procedures in place that screen out NDMA and other hazardous by-products.

These companies should also warn customers about the potential risk, whether or not they find NDMA in product.

They should do these things, but generally, they don’t.

Speed is a basic manufacturing need. That’s why Ransom Olds (the car guy) invented the assembly line in 1901.

In 1913, Henry Ford (another car guy) greatly improved the process, reducing auto manufacturing time from twelve hours to two-and-a-half hours.

Safety oversight slows the manufacturing process, and to most product makers, time is money.

Manufacturers rarely include product warnings because they believe such warnings will depress sales.

Manufacturers in general, and drug makers in particular, invest so much in product development that they must sell as many pills as possible to make money.

Establishing Liability

Due to these structural manufacturing defect issues, these companies are strictly liable for the damages manufacturing defects cause.

Negligence, or a lack of care, is only relevant to damages.

A lower legal standard, like negligence, is not enough to convince these companies to change the way they do business.

To firmly establish liability, our New York defective drug lawyers typically partner with top experts in the field.

These experts are not just highly credentialed.

They also know how to take complex concepts, like N-Nitrosodimethylamine contamination and effects, and explain them to jurors.

At the same time, the experts we work with never belittle jurors or talk down to them.

Because of our solid approach, we settle most manufacturing defect claims out of court.

These settlements usually include compensation for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering.

Additional punitive damages are usually available in these cases as well, because of the aforementioned corporate misconduct.

Unintentional poisoning victims are usually entitled to significant compensation.

For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. You have a limited amount of time to act.

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CATEGORY: Pharmaceutical Litigation

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