In the United States, all products must have warning labels notifying consumers of potential and known dangers of the product. For prescription drugs, these requirements are stricter due to the higher risk. The FDA is responsible for approving warning labels on these drugs, and sellers must warn consumers of certain risks.
Dangers Associated with Drug Warning Labels
Unsafe drugs may be deemed dangerous because of contents or packaging. Labeling litigation may arise if a drug has insufficient labeling. Such violations can include inaccurate information, mistakes regarding dosage, or instructions or label omission. These issues pose a significant danger to consumers, and they can bring severe penalties for defendants. In a pharmaceutical lawsuit in Pittsburgh, PA, plaintiffs and attorneys from www.pittsburghjustice.com may be able to recover if they can prove the pharmaceutical company negligently labeled the product.
Off-Label Uses of Drugs
An off-label drug is one that has not yet gained FDA approval. These may be sold, but they must still include the appropriate warning labels. An off-label drug is sometimes touted as a less expensive alternative to prescription medications. However, if a physician recommends a cheaper alternative to a prescription medicine, they must explain why they are doing so, and they must outline additional concerns and risks to the consumer.
Special Rules on Prescription Drug Labeling
Prescription drugs undergo a long approval process via the FDA, which also approves drug warning labels. This can create conflict between the FDA and state courts, which are part of the federal government. Under the supremacy clause in the Constitution, federal law trumps state law; therefore, a state claim for inadequate labeling cannot progress if the label has been approved by the Food and Drug Administration.
Should a Victim Hire an Attorney for Help with a Drug Labeling Case?
A pharmaceutical lawsuit in Pittsburgh, PA involves complicated laws at the federal and state levels. A victim may need to hire an attorney in their area if they need help filing a claim for poor drug labeling. A local attorney can advise clients of state and federal law, and they can tell the client if there are any particular issues or concerns with a certain prescription or over the counter drug.