Plaintiffs injured by contaminated valsartan are fighting attempts by Walgreens, CVS and Rite Aid to avoid claims they misrepresented a generic high blood pressure drug by calling themselves “drug testers” instead of sellers. The pharmacy retailers are attempting to frame their role in the distribution chain as a “pass through” center instead of a seller of the product. If the pharmacies can convince the Judge they acted as a pass through they can avoid liability and paying damages to claimants.
Plaintiffs argue when a drugstore engages in the act of selling a drug, it is a “seller within the chain of distribution” and should be held to the high standard of strict liability under the law. The 130-page brief filed before U.S. District Court for the District of New Jersey claims the drugstores did not meet their duty under federal and state law to make sure valsartan was the same as the high blood pressure medicine Diovan.
In a buyer-seller relationship, implied warranties would be clearly established between the consumers and the drugstore defendants who would serve as the last layer of consumer protection against defective drugs. The pharmacies urged the court to remove them as defendants in the MDL based on lack of evidence showing they knew of the alleged drug contamination. The pharmacies collectively argued plaintiff’s allegations were barred by federal law and that liability rests on the drug manufacturers.
The plaintiff’s brief states “defendants at each stage of the distribution chain had independent obligations to ensure the products they sold were what they said they were. Ordinary course diligence at all distribution levels should have detected the contamination or at least suspected it.”
Background on Valsartan Litigation
MDL 2875 was created after FDA testing found contaminants such as N-nitrosodimethylamine, or NDMA in certain lots of Valsartan. After several recalls of valsartan drugs, plaintiffs filed individual and class action lawsuits claiming injuries and financial loss because the drugs were not therapeutically equivalent to valsartan’s reference-listed drug.
In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan due to contamination with a cancer-causing impurity, NDMA. Other drugs affected by the valsartan recall include losartan and irbesartan. The FDA estimates that millions of Americans take valsartan to treat high blood pressure and heart failure. The initial recall in 2018 involved more than half of the US supply of valsartan causing market shortages of the drug. The agency estimates the tainted drug first entered the US market around 2014.
After a thorough investigation the FDA traced the contaminated drugs to Chinese manufacturers Zhejiang Huahais and Zhejiang Tianyu as well as Hetero Labs Limited located in India. In September 2018, the FDA announced it had found another toxic chemical in tainted valsartan batches called N-nitrosodiethylamine (NDEA). Like NDMA, the chemical has been linked to cancer. Recalls of the tainted lots of Valsartan rolled out over several months and affected hundreds of batches of valsartan. It is estimated that 1.5 million people may have taken tainted Valsartan in 2018.
In an ongoing investigation, the FDA is working to determine what caused the impurities and contamination and what changes need to be made in the manufacturing process to prevent further issues.
In 2016 almost 60 million prescriptions were written for losartan drugs and 14 million for valsartan or a drug that includes valsartan as an ingredient. An additional 3.6 million prescriptions were written for irbesartan in 2016. Because valsartan is so widely used, the list of recalled products continues to evolve. Its best to refer to the FDAs website for the most current list of recalled products.
Injuries linked to contaminated valsartan
Some serious side effects have been linked to valsartan including the following:
- Cancer of the gastrointestinal tract
- Cancer of the digestive organs
Mass Action Litigation for Valsartan
In February 2019, the Judicial Panel on Multidistrict Litigation (JPML) created MDL 2875 consolidating Valsartan lawsuits in the USDC District of New Jersey. Because it is so widely used, there is the potential for thousands of valsartan lawsuits to be filed before any of the cases go to trial.
If your law firm is planning to join the valsartan litigation, we would love the opportunity to schedule a consultation with you.