Litigation Surrounding Bextra
What is Bextra?
It was approved by the FDA in November 2001 to treat pain associated with osteoarthritis, rheumatoid arthritis, and primary dysmenorrheal. It is a COX-2 inhibitor that is manufactured by Pfizer.
What were the major problems associated with Bextra?
Since the recall of a similar COX-2 inhibitor, Vioxx, there was increasing concern over the safety of all other COX-2 inhibitors on the market. Bextra is known to cause a deadly skin disease called Stevens-Johnson syndrome as well many other common side effects such as: epidermal necrolysis, severe allergic reactions, indigestion, headache, stomach pain, nausea and diarrhea. Bextra can also cause serious and deadly side effects such as: skin conditions, heart attack, stroke, blood clots, renal failure, GI complications and heart failure.
Why was Bextra removed from the market?
After serious side effects were discovered, the FDA asked Pfizer to increase Bextra warning on their label in 2002. Despite this action, Pfizer failed to comply. Pfizer also failed to inform Bextra users after they knew the cardiovascular risks. On April 7, 2005, after the FDA had requested, Pfizer stopped all sales of Bextra in the U.S. The deadly risks of the drug no longer outweighed the potential benefits. The public citizen consumer group strongly urged the FDA to ban Bextra on January 24, 2005. In that same month, data linked Bextra to an increased risk of stroke and heart attack. “Black box” warnings were requested to be placed on Bextra once news of the cardiovascular side effects emerged.
Lawsuits involving Bextra
Despite many of the FDA warnings, Pfizer continued to market drugs that were known to cause serious and deadly side effects. The company’s failure to comply with the FDA to inform patients about the dangers of Bextra has led to an multiple claims against the pharmaceutical company. Pfizer even refused to add warning labels on Bextra and continued to market the drug as safe, despite that deadly side effects were reported. This supports legal class action lawsuits that claim Pfizer knowingly sold and advertised a drug that was dangerous to consumers. As stated under product liability legal statutes, companies must be held responsible for any damages caused by their product if they continue to supply a drug that is defective.
Case involving Rita Fohne
Rita Fohne took Bextra for 6 months and suffered major cardiovascular injuries due to thrombosis and blood clots. In this lawsuit, Bextra was dangerously defective and the side effects definitely outweighed the benefits of the drug. Fohne claims that Pfizer knew of the risks of this drug but continued to market it due to financial motivation. She also claimed that the pharmaceutical company did not warn doctors of the serious effects of the drug. She sought $250,000 in damages. Pfizer defended its product. In the case, a panel of doctors and scientists advised that Bextra remain on the market despite the fact that most members of the panel said the drug should carry a black box warning. The FDA did something out of the usual and went against the panel, claiming that Bextra’s risks outweighed the benefits and it should be removed from the market immediately. Litigation threats remain since Pfizer defended the drug as safe and effective.
