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Informed consent: a jury’s look at the consent decree that will shape the field

Don’t be misled. This jury verdict is not about a simple civil suit against a pharmaceutical company. This is much bigger than that. It’s about a legal pact, or consent decree, that will transform the development, testing, and approval of drugs and medical devices in the U.S. It will have a profound impact on the safety and efficacy of drugs and medical devices. It will have a significant impact on how clinical trials are conducted, and the decisions that doctors make about prescribing new drugs.

Informed consent is the single most important legal principle behind the development, testing, and approval of new drugs and medical devices in the United States. That’s why the pharmaceutical and medical device industries are fighting so hard to destroy it.

Informed consent is a key component of the law’s basic tenet of justice. It has always been the responsibility of the doctor to provide the patient with complete information about the medical treatment about which the doctor is discussing. That means that the doctor, and his or her representatives, have an ethical responsibility to disclose all available information to the patient about the risks and benefits of any treatment. The law has put that ethical responsibility on the patient as well. So the patient also has a responsibility to be as informed as possible about the risks and benefits of any treatment. It’s how a doctor and patient make a decision that’s best for each other.

How was this Consent Decree developed? The lawsuit was brought by the federal government in an effort to reform the system for getting new drugs and medical


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