In early August, there will be a hearing in federal court in San Francisco to determine whether Celebrex can increase the risk of serious cardiovascuar events - otherwise known as heart attacks and strokes - and under what circumstances.

Over the course of two days, US District Court Judge Charles Breyer will be faced with reams of expert reports, depositions and testimony before ultimately deciding whether there’s reliable scientific evidence to suggest Celebrex presents a serious cardiovascular risk.

The event, which is known as a Daubert hearing in legal circles, is part of the Multi-District Litigation concerning Pfizer’s Celebrex, as well as Bextra, a newer Cox-2 painkiller that was pulled from the market two years ago due to - that’s right - cardiovascular concerns.

No one is talking for attribution, but the hearing is only for Celebrex and appears to be an interesting gambit. Keep in mind that there already exists medical literature, such as an article from the American Heart Association’s Circulation journal, suggesting Celebrex poses cardiovascular risk.

Of course, should Breyer decide otherwise, Pfizer can proclaim that Celebrex - which, of course, is still on the market - is safe enough. And suddenly, that big chunk of litigation will look smaller and, perhaps, worth settling.

On the other hand, should Breyer determine there is, indeed, a serious cardiovascular risk, his ruling may resonate beyond the courtroom, dampening enthusiasm for the painkiller just as Pfizer accelerates an FDA-approved effort to advertise Celebrex once again.

Such a ruling wouldn’t affect Celebrex’s availability; that’s a decision the FDA would have to make. But a decision against Pfizer could easily provide Cox-2 critics with still more ammunition to marginalize the drug.

A Pfizer spokesman downplayed the implications and wrote: “If the court rules in Pfizer’s favor, Pfizer believes it will streamline the Celebrex litigation. If, however, the court does not rule in Pfizer’s favor, it merely means that certain types of claims may be resolved by juries on a case-by-case basis.”

You can read the order here;

And this is the study in Circulation.[tags]Celebrex, Pfizer[/tags]