Bextra Lawsuit

A brief guide to filing a Bextra lawsuit

Common Bextra Side Effects:

Bextra, due to a bevy of illegal marketing practices and side effects, was recalled by the United States Food and Drug Administration in 2005. Bextra side effects include an assortment of serious skin reactions, including skin rashes, swelling of the lips, face or tongue and the development of hives--in addition to skin ailments, Bextra, when consumed in high doses, caused heart problems, kidney damage and severe allergic reactions.

Because of these side effects, the FDA asked Pfizer (maker of Bextra) to remove the drug from the market. Ultimately, this request was initiated because the FDA determined Bextra’s risk-to-benefit profile to be unfavorable—Bextra was no more efficient than existing drugs while carrying a higher risk for heart, liver and skin problems.

Bextra FDA Regulations:

The United States Food and Drug Administration issued supplemental request letters to sponsors of all non-steroidal anti-inflammatory medications requesting that they institute label changes to their drugs. These proposals recommend labeling for both over-the-counter and prescription products. All sponsors have been asked to revise the package insers for their products to include a warning that highlights the potential for increased risk of cardiovascular damage and the serious gastrointestinal bleeding associated with use. Celebrex labeling should also contain safety data derived from long-term treatment trials with celecoxib.

History of Bextra Lawsuits:

Available from 2001 to 2005, the prescription medication Bextra was intended for the treatment of arthritis and related pain. However, a 2004 study concerning Bextra side effects published by the American Heart Association, determined that users were more than twice as likely to suffer a heart attack and stroke. Therefore, in 2005, manufacturer Pfizer withdrew the drug from the market at the FDA's request.

This action prompted many people to file a claim for a Bextra settlement as several forms of litigation followed these disclosures of Bextra side effects. However, no individual Bextra lawsuit has returned a settlement. Instead, Pfizer negotiated each Bextra settlement on a case by case basis. In 2008, for instance, the drug’s manufacturer announced that $745 million had been spent to resolve roughly 90% of litigation concerning Bextra side effects.

Another important Bextra lawsuit was a class action suit which was resolved in 2009. Under the terms of this Bextra settlement, $89 million was set aside for every consumer. There were three important components of this Bextra lawsuit. First, it was claimed that Pfizer fraudulently marketed the drug as more effective than other medications such as over-the-counter ibuprofen. Secondly, the Bextra lawsuit alleged that Pfizer had marketed the drug for non-FDA approved purposes, a violation of the law. Finally, the charges concluded the contention that by charging more for a less effective drug, Pfizer had harmed consumers. This Bextra settlement was settled in 2009.

Another important piece of litigation did not concern Bextra side effects directly. Instead, a Justice Department investigation questioned the marketing of the drug along with three other Pfizer products. The basis for this Bextra lawsuit involved marketing the drug for purposes other than those approved by the FDA. The Bextra settlement was part of a larger legal action that resulted in a $2.3 billion fine being assessed in 2011.

Significant litigation concerning Bextra side effects is now resolved; there are no new reports of any additional Bextra settlement being made following the resolution of the initial lawsuits. Since the drug has not been available for an extended period of time, the statute of limitations to sue over Bextra side effects has expired for the vast majority of potential plaintiffs. Additionally, the funds negotiated through the class action Bextra lawsuit have been distributed.

Therefore, anyone who wishes to file suit over Bextra side effects is unlikely to be allowed to pursuit litigation. Anyone who wishes to speak with a lawyer about filing a Bextra settlement should be aware that an initial consultation is unlikely to be productive. However, if you wish to explore the option of filing a Bextra lawsuit, you should be able to find an attorney experienced in pharmaceutical law. If any new developments concerning compensation for Bextra side effects victims are announced, they will be aware of these. At this time, however, the opportunity to obtain a Bextra settlement has probably expired.

Sources:

1. USFDA http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm103420.html

2. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124649.htm

3. “Pfizer to pay $2.3 billion to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks".

Stop Medicare Fraud, US Dept of Health & Human Svc, and of Justice.