Dozens of Americans file lawsuits claiming to have had cancer from contaminated blood pressure drugs made in a Chinese factory that exposed millions to carcinogenic chemicals
- In July, the FDA discovered that samples of the popular heart and blood pressure drug, valsartan, were infected with a carcinogen called NDMA
- Exposure to NDMA has been associated with increased risk of colorectal, gastric and uterine cancer
- Bloomberg and lawyers are now reporting that thousands of lawsuits have been filed against the Chinese manufacturer who made the contaminated pills
Patients' droves are prosecuting the valsartan manufacturer who has made contaminated pills that they believe have cancer, Bloomberg reports.
Millions of Americans take valsartan-containing medicines, usual blood pressure and heart medication.
Last July, the FDA discovered that valsartan made by Zhejiang Huahai Pharmaceutical, in China, was contaminated with a carcinogen, NDMA.
The FDA has since been recalled more and more from brands that bought and should buy the drugs, but advised patients that they should continue taking the medication and risking exposure.
Now the lawsuits have begun, with at least 50 filed so far in New Jersey – and a lawyer estimated that this year maybe two thousand cases will be about the drugs.
Zhejiang Huahai Pharmaceuticals, as well as several other pharmaceutical companies, are now facing a whole series of lawsuits about a carcinogenic substance found in valsartan blood pressure medications manufactured in the Chinese facility (photo)
After its first discovery, the FDA suggested that the infection could last for four years.
The agency reported that the conditions and materials – some of which may have been reused – involved in the production process of the pills have been communicated to make NDMA, a substance that the World Health Organization has linked to colorectal and stomach cancers.
Nearly 90 brands of valsartan have been recalled for having more than 0.96 particles per million (ppm) NDMA.
The mass recall actions have caused a drug shortage and have prompted the FDA to review its recall, allowing drugs with higher levels of carcinogen to remain on the shelves and be accessible to patients.
Agency officials decided that the risk of heart problems for patients who suddenly took the daily medication was greater than the cancer risk that patients would be exposed to in the next six months (by that time) the supply is expected to be supplemented).
But that doesn't stop patients – especially those who may have been exposed to NDMA for years – to sue Zhejiang Huahai.
Patients look for other companies that have sold valsartan products from the Chinese manufacturer, including Teva, Mylan and CFS.
Cases have been filed against nearly 40 suspects, according to Bloomberg.
Personal injury and drug recall lawyers group TheLawFirm.com says that thousands of suits have been filed and consolidated and will be heard in the District of New Jersey.
In the meantime, investors are reportedly also filing their own lawsuit against companies that have sold the drugs, claiming that this led to inventory losses and failed fiduciary obligations.
It is not entirely clear how many of both types of packages have been submitted.
However, the FDA has said that probably two million people were exposed to carcinogens in the drugs – and that more than half of them are in the US.
A recent study, published in the BMJ, addressed the risks of short-term exposure to NDMA in valsartan.
The researchers followed Danish patients and found that & # 39; the results do not indicate a clearly increased overall risk of cancer in the short term among users of valsartan contaminated NDMA. & # 39;
It continued: & # 39; However, there is still uncertainty about the results of a single cancer, and longer follow-up studies are needed to assess the risk of cancer in the long term. & # 39;
The study examined 104 different types of cancer altogether and found the strongest links between contaminated valsartan and colorectal and uterine cancer.
For its part, the FDA has said it is revising drug manufacturing rules and requirements, in an effort to improve quality controls that have made relatively unbridled drug contamination possible.