Bextra: The Kind of Pain That Never Leaves You

San Francisco, CAJoann Simmons is a name on a court docket now—just two words in a legal document. But those two words represent someone's life partner, who is no longer here. And the life partner left behind, James Simmons, has filed a wrongful death suit against the makers of Bextra.

Bextra, a pain medication manufactured by Pfizer, is off the market now after the US Food and Drug Administration (FDA) asked Pfizer to voluntarily take the drug off the market in April of 2005. However, three years later and probably for many years to come, various lawsuits are expected to percolate through the courts as individuals, or the families of those individuals allegedly harmed at the hands of Bextra, seek their day in court.

The Simmons lawsuit was filed February 6th of this year in Southern California District Court. In addition to the wrongful death claim, Pfizer Pharmacia is facing allegations of negligence, strict liability, breach of express and implied warranty, fraudulent misrepresentation and concealment, and unjust enrichment.

Bextra was a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for arthritis, and worked by blocking the body's production of pain transmission enzymes known as cyclo-oxygenase, or COX.

Of the two forms of COX enzymes, COX-2 appears to have been associated with more elevated risks when attempts are made to block them. For example, well-known COX-1 inhibitors such as ibuprofen, Aspirin and Aleve are widely used, and not known for high risks or dangerous adverse affects.

However, the same cannot be said for COX-2 inhibitors, a class of medication to which Bextra belonged. Another well-known COX-2 NSAID, Vioxx, came to be vilified and was eventually pulled from the market by manufacturer Merck and Co. after studies showed increased cardiovascular risk.

However, Pfizer opted to continue with Bextra and a companion COX-2 selective inhibitor Celebrex, in spite of the warning signs. The company noted in its 2004 year-end review that preliminary results from a study being conducted under the auspices of the National Cancer Institute showed an increased risk in overall cardiovascular events. Pfizer noted that the findings were at odds with data collected from a number of other well-controlled studies of Celebrex.

Pfizer went on to state in its annual review, posted online, that a committee of the European Medicines Evaluation Agency, together with a special FDA Advisory Committee, conducted thorough reviews of all COX-2 medicines and concluded they should remain on the market, albeit with more stringent labeling that highlighted the cardiovascular risk.

Celebrex remains on the market, and does indeed carry warnings of heightened risk to the heart. However, by the start of the second quarter of 2005, Pfizer had to face the removal of Bextra from the market, a drug which, according to the review, was worth $1.29 billion in sales to the company and grew 87 percent in spite of growing concern with regard to the drug through 2004 over cardiovascular risk and rare, but serious skin reactions. It has been reported that the latter amounted to the primary reason why Bextra was pulled.

So Bextra is gone. But that's cold comfort for James Simmons, whose wife died allegedly at the hands of Bextra. And there are others—including a lawsuit launched back in the fall of 2004 after a New Jersey man died at the age of 46, after taking Bextra for nine months.

Lives lost, all for the seemingly innocent act of popping an approved pill for pain.

It is alleged that Pfizer withheld increased risks for fear that consumers would eschew purchasing Bextra, in preference to less-expensive drugs.