BH&F Blog

Before being given approval by the Food and Drug Administration (FDA), a prescription medication must be proven to be "safe and effective for its intended use." However, the current rules of the Center for Drug Evaluation and Research (CDER) allow the prospective drug manufacturer, known as the "sponsor," to design and perform the research. This often includes designing the experiments, picking the doctors or scientists to perform the experiments, compiling the experimental data, and reporting that data to the CDER. Because the experiments are designed with the hopes of approval and scientists are often chosen based on their relationship to the sponsor (often including an investment in the drug they are evaluating), drug trials tend to promote the possibilities of a drug while downplaying potential side effects.

As a result, many drugs are approved without a full appreciation of many potentially dangerous characteristics. These can include:

• Serious side effects
• Long-term exposure effects
• Dangerous drug interactions
• Quality control issues

Once a defective drug has made it to the market, it is often accompanied by a big marketing push, similar to any other product, with doctors being invited to promotional seminars on using the new drug and given free samples to distribute. This ensures that a new drug is often widely distributed, sometimes in situations where it is of dubious value. Now that it is being taken by thousands or even millions of people, the real trial begins. This trial will reveal all the dangerous characteristics of the defective drug, but the burden of proof has shifted, and a drug must be proven guilty before it can be recalled.

Researchers have to compile evidence proving the danger posed by the drug, but once this connection is proven, the FDA may not issue an immediate recall. Sometimes, as in the recent case of Trasylol, thousands of people can die between the time that researchers report a dangerous side effect, and when the FDA and the manufacturer decide to issue a recall.

There are many reasons why a defective drug may enter the marketplace, including the simple fact that the human body is an incredibly complex machine and it is impossible to predict all the effects of a drug. But pharmaceutical injury lawsuits play an important role in refining the approval process by making it unprofitable for drug manufacturers to market drugs they know to be dangerous.

If you have been injured by a defective drug, contact the pharmaceutical injury lawyers at Burke, Harvey, and Frankowski, LLC for a free initial consultation.