A new study in the Journal of the American Medical Association has found that almost one-third of new drugs in the United States have a significant safety issue in the first decade after FDA approval. This is a very concerning but not unexpected analysis as our lawyers have worked with many patients harmed by inadequately disclosed drug and medical device side effects over the years.
The researchers examined all 222 prescription drugs approved by the FDA from 2001 through 2010. 71 drugs were flagged for safety issues including top sellers for treating depression, arthritis, infections and blood clots. Dozens of the unexpected side effects were even life-threatening and warranted a black-box warning on the label.
The issue flagged raises the question of whether the pharmaceutical manufacturers bringing the drugs to market are doing sufficient pre-approval testing in order to allow doctors and patients to adequately determine whether they should be using the drugs. It also puts into question the issue of whether Medicare and Medicaid should be paying for the usage of these drugs when substantial safety defects remain unknown to the public.
As we represent both individuals who are harmed by serious yet undisclosed side effects of drugs as well as employees who have information about undisclosed side effects for reporting to Medicare and Medicaid, this is an issue that greatly concerns us. Our personal injury attorneys are involved in
We understand that post-market surveillance of new medicines is a critical ingredient in ensuring safe usage. However, when a drug or device company fails to adequately investigate issues that arise before or after market approval, or fails to adequately disclose potential issues to consumers, a case for liability can develop.
If you are an employee with information about a potential issue with a product at a drug or medical device company, or a patient that has experienced a serious and unexpected side effect from a drug, please call our office at 1-800-590-4116 for a free and confidential initial consultation.