Pharmaceuticals are regulated by the Food & Drug Administration (FDA), requiring approval before they are licensed for use by the population. There is a stringent process that must be followed. However, this does not mean there will never be any problems. Testers can make mistakes. Simple negligence still occurs, and sometimes even very simple safety steps are not taken. FDA approval is often only the first step in a long process – after all, clinical trials cannot last years.
Pharmaceutical injuries fall under the rubric of product liability, with a few extra variations in the law to account for the ephemeral and proprietary nature of drug research. There are two main fact patterns that tend to reappear constantly in these types of cases. One is tester or company negligence, and the other is an inadequate or misleading warning label. These correspond to normal product liability causes of action – namely, design defect and failure to warn.
When a design defect is alleged in a product, it means literally that the product was created using a design and methodology that was suboptimal due to its potential dangers to consumers. The most common product litigation in which this theory is invoked is tobacco lawsuits, with consumers alleging that cigarettes are designed to be smoked exactly as they often are, when inhaling tobacco is linked to numerous cancers.
An inadequate or misleading warning label is sometimes referred to as failure to warn, and it implies that a company has been negligent because there is a general duty to warn owed by manufacturers to their consumers. Sellers also have a duty, though it is not as absolute as a manufacturer’s.
Sometimes another cause of action is alleged; a manufacturing defect occurs when there is a temporary fault in the process by which products are created. Not all the products in a given line are affected; this most commonly is seen when product recalls occur. Only a specific subset of a product line is usually affected; for example, Toyota does not recall all its cars, but only the sport utility vehicles from the years 2013 and 2014.
These causes of action are only a starting point. Because drug research is proprietary, sometimes conflicts arise not only between manufacturers and consumers, but between two manufacturers. The case of PLIVA Inc. v. Mensing, 588 F.3d 603 (2011) held that generic drug manufacturers were not liable for any bad reactions suffered by consumers, because they did not create the drug – the manufacturer of the brand name drug did. This can cause problems for consumers, but it also caused problems for the manufacturer of the brand name drug in question, Reglan. The end result for consumers is confusion and a higher risk of injury.
If you or a loved one has been injured by a defective drug, you have a right to be compensated. However, it can be hard to navigate through a complex legal matter without a professional at your side. The attorneys at the New York Lawyers are experienced and have access to a wealth of knowledge they can use to help you. Contact our New York City offices for a free initial consultation.