Dozens of Americans file lawsuits claiming they got cancer from contaminated blood pressure drugs made in 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 contaminated with a carcinogen called NDMA
- Exposure to NDMA has been linked to increased risks of colorectal, stomach and uterine cancers
- Now, Bloomberg and attorneys groups report that thousands of lawsuits have been filed against the Chinese manufacturer that made the contaminated pills
Droves of patients are suing the valsartan manufacturer that made contaminated pills which, they claim, gave them cancer, Bloomberg reported.
Millions of Americans take drugs that contain valsartan, a common 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 rolled out more and more recalls of brands that bought and should the drugs, but advised patients they were better off continuing to take the medication and risking exposure.
Now, the lawsuits have begun to roll in, with at least 50 filed so far in New Jersey – and one attorney estimated courts may see as many as 2,000 cases over the drugs this year.
Zhejiang Huahai Pharmaceuticals, as well as several other drug companies, are now facing a slew of lawsuits over a carcinogen found in valsartan blood pressure medications manufactured at the Chinese facility (pictured)
After its initial discovery, the FDA suggested the contamination might span as far back as four years.
The agency reported that conditions and materials – some of which may have been reused – involved in the manufacturing process for the pills had interacted to create NDMA, a compound that the World Health Organization has linked to colorectal and gastric cancers.
Almost 90 brands of valsartan have been recalled for having over 0.96 parts per million (ppm) NDMA.
The massive recalls have triggered a shortage of the drugs and led the FDA to revise its recall, allowing drugs with higher levels of the carcinogen to stay on the shelves and accessible to patients.
Agency officials decided that the risks of heart problems for patients that suddenly went off the daily drugs were greater than the cancer risks that would be posed to patients over the next six months (by which time the supply is expected to be replenished).
But that isn’t stopping patients – especially those who may have been exposed to NDMA for years – from bringing lawsuits against Zhejiang Huahai.
Patients are going after other companies that sold products made with valsartan from the Chinese manufacturer, too, including Teva, Mylan and CVS.
Cases have been filed against nearly 40 defendants, according to Bloomberg.
Personal injury and drug recall lawyer group TheLawFirm.com says thousands of suits have been filed and consolidated and will be heard in the District of New Jersey.
Meanwhile, investors are also reportedly filing their own lawsuits against companies that sold the drugs, claiming that doing so led to stock losses and amounts to a failure of fiduciary duties.
It’s not clear exactly how many of either type of suit has been filed altogether.
However the FDA has said that two million people were likely exposed to carcinogens in the drugs – and that more than half of them are in the US.
A recent study, published in the BMJ looked at the risks of short-term exposure to NDMA in valsartan.
The researchers followed Danish patients and found that ‘the results do not imply a markedly increased short term overall risk of cancer in users of valsartan contaminated NDMA.’
It continued: ‘However, uncertainty persists about single cancer outcomes, and studies with longer follow-up are needed to assess long term cancer risk.’
The study examined 104 different kinds of cancer altogether, and found the strongest links between contaminated valsartan and colorectal and uterine cancers.
For its part, the FDA has said it will re-tool medication manufacturing rules and requirements in an effort to improve quality controls that have allowed relatively rampant drug contamination.