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Bextra, a non-steroidal anti-inflammatory drug (NSAID) approved by the FDA in 2004 for treating arthritis and related pains but taken off the market as year later, has been the subject of multiple product liability lawsuits. Plaintiffs over the years allege manufacturer Pfizer concealed results and engaged in illegal marketing practices.
FDA Warning and Eventual Recall
While Bextra had only been prescribed for a short time, the FDA warned about its extensive list of side effects:
- Elevated risk of heart attacks, strokes, and sudden cardiac death.
- Increased risks of ulcers and stomach and intestinal bleeding.
- Related kidney and liver problems.
- Life-threatening skin rashes
- Life-threatening allergic reactions, such as rashes, swelling of lips, face, or tongue, and hives.
- Stevens Johnson Syndrome
Further, a 2004 American Heart Association study revealed that Bextra’s side effects double heart attack and stroke risks.
By 2005, the FDA required Bextra be removed from shelves. The statement cited Pfizer’s illegal marketing practices, which claimed and sourced a study showing Bextra is more effective than similar, existing medications and further pushed it and offered kickbacks for off-label prescriptions. Further defending its stance, the FDA stated Bextra has far more side effects associated with it than similar NSAIDs.
As a result of the FDA’s decision, other drug manufacturers were required to change the labels for over-the-counter and prescription NSAIDs, providing the patient with more detailed information about the side effects.
Lawsuits against Pfizer began almost immediately after Bextra was removed. Pfizer settled a class action lawsuit in 2009, with plaintiffs alleging the manufacturer charged more for a less effective, harmful drug and falsely informed consumers by overstating its effectiveness. At the time, Pfizer allotted $745 million toward 90 percent of the claimants.
Two years later, the Department of Justice fined Pfizer for $2.3 billion after a whistleblower, a Florida sales representative, came forward about the company’s off-label marketing. The whistleblower and 100 other representatives involved in off-label sales allege in a qui tam lawsuit that Pfizer promoted Bextra in greater doses and other, non-FDA approved uses and then gave kickbacks to prescribing doctors.
A shareholder lawsuit followed in 2013, with Pfizer attempting to convince a judge to drop it. The plaintiffs in this case allege the manufacturer misrepresented Bextra’s safety and understated its cardiovascular risks.
If a doctor prescribed Bextra to you, a potential plaintiff is recommended to prove the following before pushing forward with a claim:
- Were you injured?
- Were the side effects unreasonably dangerous?
- Did a doctor or pharmacist adequately provide a warning?
- Did Bextra directly cause the injury?
Patients prescribed Bextra in that brief time frame expected to experience relief from arthritis-related pains, stiffness, and menstrual cramps, rather than go through a traumatic, life-threatening cardiovascular or allergic episode.