Bextra has been an FDA approved non-steroidal anti-inflammatory drug (NSAID) prescribed mainly for sufferers of osteoarthritis, rheumatoid arthritis and severe menstrual cramps since November of 2001. On April 7th, 2005, the FDA requested that Bextra be taken off the market as a result of its serious side effects. The manufacturer, Pfizer, voluntarily stopped selling it immediately.

The FDA concluded that the overall risk outweighs the benefit of Bextra. They based that conclusion on their findings that Bextra can increase the risk of serious side effects, including heart attack and stroke, and can lead to a skin reaction that can be life threatening. These side effects are worse than those of other NSAIDs, and Bextra has not been shown to offer any unique advantages over the others.

While all drugs, whether over-the-counter or prescription, have some side effects, a drug manufacturer has a legal duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible to patients who are injured as a result of inadequate warnings or the unreasonably dangerous nature of the drug, under the legal rules called “product liability”. All drug products in the United States are wide open to product liability lawsuits.

Drugs and medicines are frequently at the center of products liability lawsuits. Manufacturers of these products have a duty to appropriately test the drugs and medicines before releasing them into the market, using testing criteria from the U.S. Food and Drug Administration. These criteria are industry standards, but the fact that the FDA properly licensed a drug has no effect on the manufacturer's liability to an injured consumer, if the drug proves to be otherwise defective.

As with almost all medical products, with the exception of over-the-counter drugs, there will usually be an intermediary between a drug's manufacturer and the patient. This may be the pharmaceutical sales person who visits the physician, the doctor who prescribes a drug, a nurse who tells the patient how to take it, or the pharmacist who fills the prescription. The lines of liability can be a bit blurry, so you will need an experienced products liability attorney to help determine who may be responsible for the resulting injuries. In other words, an attorney who specializes in products liability cases will tell you whom you can sue in your specific situation. For a free legal evaluation, click here.