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Does FDA approval mean a drug maker isn't liable for injuries?

Having the Good Housekeeping Seal of Approval doesn't seem to be touted as much as it used to be. There was a time when, if a product had earned the seal, ads on TV and radio made a big deal out of it.

Older readers in Texas likely know that having the seal means that the manufacturer has subjected its product to rigorous independent testing by Good Housekeeping's labs. And those tests have shown that the product is safe and effective. Many think that when the Food and Drug Administration issues its approval of a new pharmaceutical product that it's as good as that Good Housekeeping seal, but that isn't necessarily the case.

The FDA does establish the criteria by which all drugs are supposed to be tested, and they are essentially the standard for the industry. But just because a drug gets an FDA license doesn't mean a manufacturer is necessarily off the hook in terms of liability if a pharmaceutical causes harm.

If a drug hits the market and proves to be defective in some way or the company's marketing and sale of the product is found to be inappropriate and it ends up causing injury or death, the company could be subject to a lawsuit and held accountable.

We saw this in play just last month when a jury in Missouri decided that Abbott Laboratories should pay $38 million in compensatory and punitive damages to a Minnesota girl. The jury said the company's drug Depakote, which the girl's mother had taken during pregnancy, caused the girl's birth defects.

The claim made in the suit was that the drug for preventing seizures was defective in design and that Abbott had failed to ensure that doctors and potential patients were aware of all possible risks. The jury agreed.

If a drug maker fails to properly inform users of possible dangers when they are known, liability may attach. If you believe you're the victim of a dangerous drug, you should consult an attorney to see if you have a case for seeking compensation.

Source: FindLaw, "Pharmaceutical Drug Liability," accessed June 4, 2015

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