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Clinical Trial Litigation
It is no surprise to anyone that health care spending continues to rise at what is generally considered the fastest rate in U.S. history. As a result, the health care industry is growing exponentially and is under incredible market pressure. Medical device companies and pharmaceutical companies constantly compete to provide newer and better drugs and devices as well as balance issues relating to cost, patient safety and liability. In order to compete in this environment and develop safe and effective products, testing on human volunteers through clinical trials is necessary. Naturally, because they involve human beings, clinical trials have increasingly become the subject of litigation. Due to the rise in our aging population and the market pressures incumbent on medical and pharmaceutical companies, it is anticipated that we will continue to see numerous clinical trials as well as the ensuing litigation based on clinical trials well into the future.
Lawyers have crafted numerous, varied and often creative attempts to file suit on behalf of the subjects or former subjects of clinical trials. This article discusses the various causes of action seen in courtrooms around the United States and whether such causes of action have been successful.
A Brief History of Regulations Protecting Human Research Subjects
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