Blood pressure medications can save a life.
You might take them daily if your blood pressure is uncontrollable via diet, exercise, or other lifestyle changes. When your physician prescribes a medication, you assume that it is safe. After all, the FDA has approved it for use, and it wouldn’t be on the market if it were unsafe, right?
Unfortunately, this is incorrect.
Most medications later removed from the shelves and deemed “unsafe” still circulate the market. Even if they worked well in trial runs, it could take months or years for a medication to reveal side effects – patients tend to be the guinea pigs in these situations.
One medication that has been recalled recently was that of blood pressure medications, manufactured overseas, due to cancer-causing impurities found in the product.
The Food and Drug Administration (FDA) conducted inspections of factories in India and China that were creating blood pressure medications. Over the past few months, the FDA has been slowly recalling these prescriptions because their investigations uncovered that the medications contained a carcinogen-tainted ingredient.
The drug companies have since then issued recalls on dozens of lots, including medications like:
These drugs, in combination with one another or alone, have high levels of these cancer-causing agents – while others only contain trace amounts. For the FDA, however, any amount of a carcinogen is enough to issue a recall and remove the drugs from the shelves.
The FDA is still investigating the cause of the impurities, and they have not yet completed their inquiry. The inspection reports did discuss problems found at both plants, including the Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India, long before the carcinogens were even found in the drugs.
The recalls were part of a large class of medications known as angiotensin II receptors blockers (ARB). These medications work by blocking the effects of the body’s hormone that makes blood vessels naturally narrow and lead to higher blood pressure. The most commonly prescribed medications in this category were not affected by the recall; therefore, most patients will not have to worry. The FDA website does outline which medications were recalled specifically for those who are concerned.
More drug manufacturers are sending their products overseas for manufacturing, but that does not excuse them from creating tainted products. The issue, however, is that the U.S. does not get to inspect these units as frequently, which can lead to a massive backlog.
The FDA only recently was able to work through this backlog and found multiple unchecked foreign drug manufacturing plants. The backlog started because more companies were outsourcing overseas, and over the past ten years, there has been an accelerated rate of production. This led to more companies utilizing these overseas options instead of manufacturing in the U.S.
The FDA has revised its strategy for checking domestic and foreign plants once every two years. Now they are putting plants at the top of the list when they pose a potential threat to U.S. consumers.
While the FDA might recognize and report back with an issue, they are not always enough to prevent these drugs from getting out onto the market and affecting consumers. The agency has a hard time keeping up with the number of prescriptions sent out each year and the manufacturing of those prescriptions. It can still take a few months or weeks in between the release and the inspection to identify tainted medications. This means thousands are already distributed by the time it is discovered and a recall is sent out.
While the FDA is increasing the number of inspectors they have hired specifically for overseas inspections, it may still not be enough to protect U.S. consumers. A vast majority of jobs posted by the FDA for these positions remain unfilled. Therefore, despite their efforts to increase inspections and the timely manner of those inspections, they are understaffed to do so.
One of the plants in China, where the FDA cited issues with the safety, included reports of fraying gaskets, rusted screws, and missing components.
Even though these issues were found in an inspection, the factory was allowed to continue operating without any interruptions. It was only after another product tested positive for the cancer-causing impurities that it was flagged. The agents found in the medications were known as nitrosodimethylamine (NDMA), and the FDA issued a recall a month after the substance was found.
A few months later, there was a warning letter issued by the FDA, requesting that all products form that plant be blocked as they tried to enter the country. The warning label discussed impurity control issues, contamination from line to line, and a few other offenses. The FDA stated that the manufacturing overseas did not follow the findings of the initial report and it was unclear how long tainted products had been leaving the factory.
One thing that was noted was that, in order to save on costs, the factory changed how they had made one medication. Their cost-cutting technique is most likely the cause of the contamination.
Yes, you can.
When a contaminated medication is allowed to enter the market, it puts consumers at risk. Even if the drug company used an overseas manufacturer, they are responsible for the products they distribute under their brand label.
In the case of these blood pressure medications under recall, the contamination involved carcinogens. Therefore, patients may not know for several months or years if they will develop cancers related to the drug.
NDMA is a probable human carcinogen and labeled as such by the U.S. Environmental Protection Agency (EPA). This product was used to make everything from softeners to rocket fuel to industrial products; therefore, it has no place in something a human consumes. Likewise, NDMA in studies was shown to create liver tumors in rats, and researchers use the substance to create tumors in rats for other studies. NDMA comes from pesticides and rubber tire byproducts.
If you are a patient that has taken a contaminated medication, whether it is one of the recently recalled or another type, you can file a lawsuit against the drug company and the pharmacy that issued the medication. Some of these do fall under class action lawsuits, depending on the severity of the case and the number of plaintiffs involved.
Patients were sold medications that turned out to be defective and could harm them. They could develop cancer, which will increase medical costs, reduce their life expectancy, and dramatically change their quality of life.
Not only does a patient have the right to request their money back – especially considering the rise in prescription costs for consumers – but they also have the right to request compensation for further expenses that come from taking tainted medication, including extra medical costs, lost wages, pain, suffering, and more.
Just some allegations made in lawsuits such as these include:
As you can see, there are multiple grounds for filing a lawsuit and seeking the compensation you deserve in your case.
Cases like these, even though they might seem straightforward, are challenging in court. You need to show, through medical and legal expertise, that you have a valid claim against the companies involved in the distribution chain. This often requires hiring experts to testify on your claim’s behalf, discuss the effects of your exposure, and show how it will likely affect you in the future. Without legal assistance, you may not receive the compensation you deserve.
Likewise, companies may offer to pay you quickly rather than take the case to trial. If so, you want an attorney negotiating your settlement. This is because these companies give millions of dollars to the law firms they use to lessen how much they actually pay out on their claims.
You can protect yourself and ensure you receive the compensation you need.
Compensation in cases like this can be extensive, and you may qualify for compensation for:
For your claims, work alongside a law firm that has extensive experience handling cases just like this. You can work with our team of caring, understanding attorneys who aggressively protect your right to compensation.
Contact Berkowitz Hanna today to schedule a no-obligation case evaluation.
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