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How drugs get approved pulled

As a recent post explained, our law office represents California residents who have been victims of dangerous drugs and had to suffer through very serious and potentially fatal side effects. Specifically, we help victims file products liability or medical malpractice actions. If the victim died because of the drug, we help the family of the victim file a wrongful death case against the drug manufacturer and other responsible parties.

Some might wonder, though, whether these drugs are really all that dangerous when, after all, the Food and Drug Administration (FDA), the federal agency in charge of product safety with respect to prescription medication, approved the drug for sale.

Getting approval to sell a drug in the United States is indeed a lengthy process. However, as even the FDA itself acknowledges, the process cannot pick up all possible negative side effects in its rigorous testing process. After all, even the most elaborate government-sanctioned trials of the product will involved a few thousand patients, which is in all likelihood not nearly the number of people who are actually going to use the drug.

Although the FDA has a system to monitor drugs for safety issues even after they hit the shelves, the important point to remember is that any such reports at that time are after the fact, as someone has already been hurt or killed by the drug. Moreover, the FDA may or may not require the drug to be pulled after a tragic incident; it could just require a warning be added to the drug's label.

In other words, there is a victim or family out there who deserves compensation, as drug manufacturers are strictly responsible to make safe products. When drug manufacturers fail to do so, they can be held liable to pay compensation without regard to what the FDA has approved or not approved.

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