All drugs are tested before being offered for sale in the United States. They must also have FDA approval before any doctor can prescribe them. Even then, doctors are often only permitted to prescribe medications for FDA-approved reasons, despite the fact that some drugs also have “off-label” uses.
More than 80 percent of all prescription drugs used in American are generic brands. They are often used because they are cheaper and easier to access. A generic drug is also usually only developed after the name-brand versions have been on the market for some time.
Unfortunately, whether the drug is generic or name brand, and regardless of whether it has surpassed required testing, certain drugs can still be dangerous. There are situations where researchers and doctors may not fully understand all the side effects associated with a particular type of drug. In those and other similar situations, you may have a products liability claim against a pharmaceutical company. This is also true if you lost a loved one due to a negative effect of a specific type of drug. A wrongful death attorney can help you determine your options.
Liability Claims Against Drug Companies
A claim against a pharmaceutical company is usually a products liability claim. “Products” can include anything that can be ingested as well as non-consumable products. In this type of claim, you are alleging that you have been injured or a loved one was killed because of an unsafe product—in this case, a drug.
Drugs are required to have certain warning labels that describe how a drug may be dangerous. For example, warnings about overdose and directions to avoid mixing the drug with other substances are common. An outline of the various side effects associated with the drugs should also be included in the warning. However, if the side effect that you or a loved one experienced was not warned against, or the warning was not clear regarding the danger, you may have a legal claim.
Generic Drugs and Products Liability
In 2011, the United States Supreme Court made a huge change to products liability law as it relates to generic medicines. In Pliva v. Mensing, the Court determined that manufacturers of generic drugs were not liable for injuries caused by their drugs.
The Court’s rationale for doing this stems from the fact that every drug must have approval by the FDA for it to be on the market. State laws regarding drugs are often stricter compared to FDA requirements, however. Products liability laws are based on state law requirements. In addition, the FDA is a federal entity, which functions under federal law. Federal statutes will “trump” state laws under most circumstances.
Because of these factors, the generic drug company in Pliva argued that it could not comply with both state and federal law because they do not determine the makeup of the drug—the brand name does. The Court agreed with this argument and essentially decided that as long the generic pharmaceutical company was using the exact chemical makeup of the brand name company, it could not be liable for injuries and damages associated with the use of their generic drug.
Even where a generic drug caused a loved one’s death, you should still consult a wrongful death attorney to determine if you have any legal options. Call Jim Glaser Law to schedule an appointment.