Valsartan Lawsuit Signed Cases
A drug that supposed to help with your high blood pressure shouldn’t cause cancer, but that’s what Valsartan may do. The drug has been recalled and there’s extensive litigation over this medication because tests showed it contained a chemical once used to make rocket fuel that’s linked to causing cancer.
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The federal Food and Drug Administration (FDA) requested companies (Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.) to recall their Valsartan products. NDMA is an organic chemical that can form through industrial and natural processes. It’s been used to make liquid rocket fuel, softeners and lubricants. It may be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
The dangers of NDMA
The FDA announced that the Valsartan sold by these companies failed to meet their safety standards. The agency estimates it’s reasonably safe to consume up to 0.096 micrograms of NDMA a day. Tests of recalled Valsartan showed levels ranging from 0.3 micrograms to 17 micrograms, which is between three and 177 times the level considered safe.
The FDA also estimated there would be on additional cancer diagnosis for every 8,000 people using the highest dose of Valsartan. Symptoms of high level NDMA exposure may include headaches, fever, nausea, jaundice, vomiting and reduced kidney, liver and lung function. The chemical, also found in cured and grilled meat, has long been known as a carcinogen.
Earlier in 2018, the European Medicines Agency stated it started reviewing medications with an active Valsartan ingredient supplied by Zhejiang Huahai Pharmaceuticals, a China-based company, for the same reason. The FDA has stated it believes NDMA was present in Zhejiang’s products as an unintentional byproduct of their manufacturing processes.
Contaminated Valsartan the pills may have been sold for as long as four years before the problem was found, according to the FDA. The long-term cancer risks posed by the NDMA are not certain, but the greater the amount the higher the risk, Dr. Erin Michos, an associate professor and associate director of preventive cardiology at Johns Hopkins Medicine, told CNN.
Most of what’s known is based on laboratory studies which show it can affect the liver and cause scarring and tumors in rats. Exposure to high levels of NDMA may cause liver damage in humans, according to the US Environmental Protection Agency. Other tests of NDMA’s impact on animals have resulted in tumors mostly in the oral cavity, esophagus (the tube connecting the throat to the stomach), stomach, bladder and brain, according to a 2000 Dutch study of workers in the rubber industry. We can be exposed to NDMA many ways, but the highest concentrations measured have been in the rubber industry. The study results showed “significant excess risks of lip, oral and pharyngeal cancers among workers” exposed to high concentrations of NDMA.
Many of those who’ve used potentially contaminated Valsartan are filing lawsuits against a number of defendants. Some of these plaintiffs blame their cancer diagnosis on the drug. Federal lawsuits have been sent to the US District Court, District of New Jersey in Camden, organizing then as multi-district litigation (MDL), according to the South China Morning Post.
Thousands of more cases are expected to be filed. Defendants include drug makers and sellers who put into the marketplace these tainted drugs which were consumed by millions of Americans. The primary defendants are:
- Zhejiang Huahai and its affiliates
- Teva Pharmaceutical Industries and Mylan
- CVS Health, which operates a pharmacy chain and drug-benefit management businesses
Almost 40 defendants have been sued so far. At a Zhejiang Huahai plant in Linhai at the center of the recall, an FDA inspector found some of the drugs manufactured there were substandard 14 months before the agency took steps to take Valsartan and its combinations off the US market.
The FDA stated in early 2019 it plans to change rules covering how pharmaceuticals are manufactured to ensure their safety of the nation’s drug supply. Former agency Commissioner Scott Gottlieb has admitted insufficient quality controls have caused “a lot of instances” of contaminated products.
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