Warning labels on prescription drugs is a hot legal topic. Drug companies have to be careful to comply with federal regulations. There are some points to consider:
- Warning labels must be on prescription drugs. When a person gets a prescription filled, the warning label will be in the form of a sticker that is placed on the outside of the bottle. Sometimes additional information in a pamphlet will accompany the medication. This serves as a reminder every time the prescription is taken.
- Labels are not standardized. Companies are given wide leeway concerning the color and display of the label. This can cause issues as some with vision or eye problems may not be able to read the font or see the text in contrast to the label display. Studies have shown that most people do not read the entire label and the label may not be eye-catching enough for a patient to inspect.
- The Food and Drug Administration (FDA) dictates the types of warning that companies can place on their drugs. This can be a positive or negative. The positive is that companies cannot hide certain side effects that may be unpleasant and the patient is subsequently more informed and can make a decision as to whether to take the drug. The bad side is that with recent case law, a company may not be able to include additional risks until they have FDA approval which can take years.
Recently, the Supreme Court in several cases has provided a murky road for pharmaceutical companies. These cases involved Wyeth, a pharmaceutical company that manufactures brand-name and generic drugs. In one opinion, the Court held that brand-name manufacturers can be held liable for state failure to warn tort claims and the other held that generic manufacturers cannot be held liable for state failure to warn tort claims. The difference in the holding may be due to the goals with respect to the different classes of drugs. The court was very concerned about the increased costs and liabilities which would defeat the purpose of the generic drug market. Also, brand name drugs must meet much more stringent requirements so the idea may have been that by the time a drug becomes generic, most of the studies and warnings may have been completed. This case divided the court and no doubt an FDA response is needed to clarify the situation.
This article is for general informational purposes only and is not to be construed as legal advice. Do not rely on the above information as all cases are different and different laws apply to different cases. Consult an attorney in your area for further guidance. If you were injured by prescription drugs call one of our attorneys at David K. Kremin & Associates, and we will give you a free consultation. We never charge unless we collect for you. Please call 1(800) ASK-A-LAWYER or 1(800)275-2529, firstname.lastname@example.org, www.1800askalawyer.com.