A prescription drug inquiry can involve a wide variety of situations, regulations, and organizations. Depending on the circumstances of the event into which the inquiry is being made, multiple agencies and people may be involved. The FDA is responsible for drug regulation across the nation. States also have laws that regulate drugs and, on occasion, will conflict with the federal laws.
In the case of PLIVA, Inc. v. Mensing the Supreme Court considered a generic pharmaceutical manufactures’ liability in warning users of potential side effects. In this case, the FDA regulations conflicted and thus preempted the state’s claim that the generic pharmaceutical manufactures failed to provide adequate warning labels. The drug in question was called metoclypramide which also held the brand name of Reglan. The court decided that the generic drug manufacturer was only responsible for placing labels that were equal to that of the brand name drug.
In contrast, had the defendant been the manufacturer that produced the name brand drug, Reglan, they would be subject to the legal actions. The reason being because the brand name companies are allowed to strengthen or add to a label upon the discovery of additional adverse effects. This leaves the people effected by drugs from the generic manufacturer without legal recourse.
This is a wonderful example of the complexity of a prescription drug inquiry. Much like in any highly regulated industry, legal actions often consider a conflict between the various regulatory agencies.
A different example of a prescription drug inquiry that illustrates a course of action that results from harm inflicted by a drug is the case of Yaz. Yaz is a birth control pill that, in some cases, resulted in deep vein thrombosis, strokes, gallbladder disease, pancreatitis, and benign liver tumors. Along with many other birth control manufacturers, the Bayer company, makers of Yaz, were subject to legal action seeking payment of damages that were a direct result of taking the medication.
If Yaz is connected to potentially life threatening diseases, Bayer may be held liable for the damages. Between the years of 2004-2007, the FDA received more than 50 reports of death attributed to oral contraceptives. A number of these were and are manufactured by Bayer. Despite these numbers, Bayer continued to insist their products were safe if used according to the label.
The burden that rests upon companies such as Bayer, is to show that they were not negligent in putting a potentially dangerous product to market. They must prove that they did everything within reason to test and properly label the drug.