Articles Posted in Products Liability

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If you or a loved one has been taking the drug, Valsartan, you may have a claim against pharmaceutical companies for the distribution and sale of Valsartan medication that has been contaminated with toxic, cancer-causing substances.

On July 13, 2018, the FDA recalled the drug, Valsartan.  Valsartan is the generic form of Diovan, which is used to treat high blood pressure and heart conditions.  Because it costs less, the active pharmaceutical ingredient (API) for Valsartan is manufactured in countries outside of the United States.  Several of the foreign API manufacturers changed the manufacturing process in 2012, and this change is believed to have caused unintended byproducts, which contaminated the drug with impurities, including N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and/or N-Methylnitrosobutyric acid (NMBA). These toxic substances are classified as probable human carcinogens, meaning that they are more likely than not to cause cancer in humans.  Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs Limited (Hetero) in India are two of the API manufacturers that used the altered manufacturing process. ZHP has an estimated 45% of the US market share of the Valsartan API production. 

The APIs from ZHP and Hetero are used in finished pills, which are sold in the United States.  Many American pharmaceutical companies have made, distributed, marketed and/or sold Valsartan products containing the API containing toxic substances. It is believed that the contaminated pills have been sold in the United States since 2014 and that there have been millions of contaminated pills taken in the United States.  Based on tests, the API manufacturers were aware that Valsartan contained high levels of the toxic substances. The manufacturers minimized the information, citing testing inaccuracies. Eventually, after additional testing, the European Medicines Agency (EMA) issued recalls for Valsartan and the FDA followed.  The FDA initially issued a report that 1 in 8,000 people taking Valsartan may develop cancer, but scientific evidence show that the number of cancer cases is likely significantly higher.    

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Yesterday, the National Highway Traffic Safety Administration recalled millions of Takata air bags placed in vehicles manufactured by Toyota, Honda, Nissan, Mazda, BMW, and GM. These air bags are defective and have killed at least three Honda drivers so far and injured hundreds of people. The NHTSA issued the recall and urged consumers to act immediately upon the recall. You can search here by VIN number to see if your vehicle is affected.

A New York times article published yesterday and another September article report that an investigation showed that Honda and Takata knew that the Takata air bags have been exploding since 2004. Nonetheless, Honda did not issue a recall until 2008, and it was only on a small fraction of their vehicles. Several recalls have been issued since then, and last month, Honda issued another recall, bringing the total number of recalled Honda and Acura vehicles to 6 million.

The defective Takata air bags explode and send shrapnel or chemicals flying at drivers, killing and injuring them. Those who have died from the exploding air bags have been stabbed by shrapnel from the exploding airbags and basically bled to death. The air bags were designed to deploy using a chemical explosive that is encased in a metal canister; thus, an explosion can occur and rupture the airbag, harming the passengers in the vehicle. Takata’s engineers explained the defect in many different ways, but cannot give one clear explanation for the problem. One explanation was that a defective machine at one of their plants made the explosives contained in the airbag unstable and caused it to burn aggressively rather than inflate the air bag properly. Another explanation was that a switch designed to reject poorly made explosives was in the off position at the plant where the air bags were made.