Valsartan, Losartan, and Irbesartan - Q1 2022 Update
The past six months in this litigation has been focused on the motions of a few of the defendants to be let out of the case. Generic manufacturers have been dismissed. Plaintiffs’ have appealed those dismissals. However, the United States Supreme Court ruled in 2011 that generic manufacturers cannot be held liable for injuries or damages caused by a generic drug based on failure to warn of dangerous side effects. That case, Pliva,Inc. v Mensing, was over the serious injury of tardive dyskinesia, a severe neurological disorder that causes involuntary repetitive movements, caused by the generic form of Reglan (metoclopramide) which was manufactured by PLIVA, Inc. The Supreme Court recognized that the FDA prohibits generic-drug manufacturers from independently altering their labels to reflect newly acquired information about the effects of their drug, and therefore cannot be liable for failing to make such changes. The Court held that it was impossible for generic manufacturers of the drug in question to comply with both their state-law duty to change the drug’s label to a different, safer label that adequately warned of the injuries alleged, and their federal law duty to keep the label the same. You can read the Pliva,Inc. v Mensing opinion by clicking this link
| pliva-v-mensing.pdf |
You can read all Orders entered by the Court in this litigation at https://www.njd.uscourts.gov/orders-opinions-valsartan-mdl-2875.
Q4 2021 Update
The MDL (Multi District Litigation) Court has been busy entertaining the dozens of Motions to Dismiss filed by a different category of defendant, which is at a separate level in the drug supply chain. The defendants are the manufacturers, which include manufacturers of the Active Pharmaceutical Ingredient and manufacturers that make the finished Valsartan drug product, the business entities in the U.S. that obtain the finished drug product from the Manufacturers [“Wholesalers”] and distribute it to retail businesses in the U.S., and the retail businesses in the U.S. from which individuals can obtain the finished drug [“Pharmacies”]. These motions were brought on various state’s laws and legal theories, and the Court waded through each state’s laws to make its decision. Rest assured that this litigation is still very much alive, only narrowed down. You can read these Order at https://www.njd.uscourts.gov/orders-opinions-valsartan-mdl-2875.