Litigating a testosterone replacement therapy lawsuit in Boston can involve many complex issues. One recently litigated issues deals with the challenges in filing certain claims against generic drug manufacturers involving failure to warn of a known danger. This is a claim that the manufacturer of a drug did not adequately include warnings about certain known dangers or adverse events (side effects) on the information given to doctors or the monograph warnings given to patients at pharmacies when they go to get their prescriptions filled.
The specific problems arise when a patient gets a generic version of a prescription drug. The makers of generic drugs still must have their products approved by the U.S. Food and Drug Administration (FDA), but they are not applying for approval under a new drug application. Since they are making a generic version of a brand name drug, as long as the generic is substantially similar to the brand name, the generic drug manufacturer is prohibited under federal law from changing warnings used by the brand-name drug manufacturer. In other words, the generic manufacturer must simply copy the warnings use by the brand-name drug maker. This was confirmed in two landmark cases entitled PLIVA Inc. v. Messing, and Wyeth v. Levin. Continue reading