Valsartan, Losartan, and Irbesartan - Q3 2022 Update
There have been over 3,000 filings, notices and orders in this MDL since its March 2019 creation. Legal wrangling over the qualifications of expert witnesses is common in MDL litigation, and this one is no different. For the most part, these experts are the worldwide preeminent physicians, epidemiologists, and toxicologists. I say for the most part because while they all may be qualified to render expert opinion is their field of expertise, some do not have the expertise needed to render opinions in this litigation. This litigation is regarding cancers caused by N-nitrosodimethlyamine, commonly known as NDMA, that was found in Valsartan, Losartan, and Irbesartan. These experts must be well versed regarding and be able to discuss NDMA and its potential for causing cancer in the human body. The Federal Rules of Evidence require that an expert be qualified to give testimony on a particular matter by knowledge, skill, experience, training, or education. However, the judge will determine if the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue, that the testimony is based on sufficient facts or data, that the testimony is the product of reliable principles and methods, and that the expert has reliably applied the principles and methods to the facts of the case. The federal judge acts as a gatekeeper of expert testimony, including by excluding any proposed expert testimony deemed to be unreliable. Most certainly, we as the Plaintiffs only retain the most qualified experts and rarely, very rarely, are those qualifications not translated into the experts’ reliability. We always attack the Defendants’ experts based on these requirements and their opinions when their opinions, based on the same scientific evidence as the Plaintiffs’ experts, come to different conclusions. This is a very important part of any pharmaceutical litigation.
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.