If all the email forwards and social media posts are to be believed, then almost all medications, from over-the-counter painkillers to prescription antibiotics and birth control pills, are conspiring to make you sicker. Actually, drugs must go through a rigorous testing process before they are approved for sale in the United States. The Kefauver Harris Amendment of 1962 requires the FDA to make sure that drugs are safe and effective before they become available for public use. It also legislates against false advertising and exaggerated claims about the effectiveness of medications, and thus its passage curtailed the “snake oil” industry that thrived in the early 20th century. When drugs have serious side effects that did not become apparent in the pre-approval trials, and when drug manufacturers fail to notify consumers about side effects, drug interactions, and contraindications, patients harmed by these drugs may have a case for a “dangerous drugs” lawsuit. Here are some common misconceptions about lawsuits involving controversy around the safety of prescription and over-the-counter drugs.
FACT: Yes and no. The thalidomide crisis was a precipitating event leading to the passage of the Kefauver Harris Amendment, but its distributor was never a defendant in a dangerous drug lawsuit. When the law was passed, Thalidomide had not been approved for sale in the United States. President Kennedy gave an award to FDA scientist Frances Oldham Kelsey for her role in preventing the approval of Thalidomide. She based her refusal to approve the drug on studies from other countries linking the use of Thalidomide to severe congenital illness and death in infants.
FACT: The more likely outcome is that decisions in favor of plaintiffs will require drug manufacturers to change the labeling or advertising on their products to alert patients to potential dangers. A “black box” warning is much more likely than a drug being completely banned. The same drug can cause either benefit or harm, depending on many variables. For example, the and the contraceptive Yaz are still on the market after being the subject of dangerous drug lawsuits. It is still possible for plaintiffs to be awarded damages for injuries resulting from the use of a pharmaceutical drug, even if the court takes no action to change product labeling or regulation. Fenfluramine, an ingredient in the weight loss drug Fen-phen, is a rare example of a drug that was completely withdrawn from the market as a result of dangerous drug lawsuits.
FACT: Medicines sold over the counter can also have side effects, and thus they can also be subject to dangerous drugs lawsuits. The makers of acetaminophen, the active ingredient in Tylenol, have awarded damages to many patients who suffered from liver disease connected to the use of the drug. Acetaminophen is an ingredient in many over-the-counter and prescription medications, including Nyquil, Excedrin, and Theraflu. Many of the patients who sued the makers of acetaminophen had taken several medicines containing acetaminophen, for example, both Tylenol and Theraflu. Thus, a safe dose of Tylenol plus a safe dose of Theraflu added up to an unsafe dose of acetaminophen. The acetaminophen lawsuits led to several new guidelines and regulations for acetaminophen-containing products. For example, the amount of acetaminophen allowed in a single dose of a prescription drug was reduced, although higher amounts are still allowed in over-the-counter drugs. Additionally, the recommended maximum dose was lowered from 4,000 mg per day to 3,000 mg per day. Over the counter drugs containing acetaminophen must now also display clear warnings that the drugs contain acetaminophen. Patients no longer need to read the fine print of the ingredient lists to find this out.
You may be entitled to damages if you have become ill after taking a medication for an approved reason and according to the instructions for use of the drug. Contact an attorney at Hammers Law Firm in Atlanta, Georgia if you have been harmed by one of the drugs mentioned in this post or by any other prescription or over-the-counter drug.