The team at Drug Law Journal created our Legal Center to serve as a tool for users who seek more information about how drugs and devices get into the marketplace as well as how people injured by dangerous drugs and medical devices can utilize legal resources to seek compensation for their injuries.
The journey a drug or medical device takes from the moment of conception, through development and trials and then to the market is a long and winding one. In the United States, prescription medication and medical devices must go through an approval process administered by the Food and Drug Administration (FDA) that involves not only “pre-market” studies as to the safety and effectiveness of a drug or device, but also “post-market surveillance” to collect evidence of ill-health effects or injuries. To comply with federal rules, drug and device manufacturers spend millions of dollars every year on patent attorneys, teams collecting data and scientific specialists filing applications with the FDA. They do this because once a drug or device is approved for the market, it can represent billions of dollars in revenue for the manufacturer and its shareholders.
At the other end of the drug and device life cycle, are the men and women who have suffered injury or death as a consequence of a drug or device that was approved, but then later is revealed to have serious side effects, issues with toxicity, design defects or carcinogenic propensities. These are individuals who sometimes have endured unimaginable pain that can be life-altering because they were prescribed a drug that they later found out was dangerous or had a medical device implanted into their bodies which they were told would help, but instead inflicted pain. Once a drug or device is discovered to cause illness, injury or death, the FDA and the manufacturer can “recall” or “withdraw” the drug or device from the market to prevent further harm. However, this after-the-fact action does little to alleviate the suffering of those who were injured.
As a service to our users, we have compiled easy-to-navigate and read summaries of both the drug and device FDA approval processes as well as the legal issues and complications facing sufferers who have questions about compensation for their injuries. Specifically, Drug Law Journal resources cover:
