Glaxo Faces First of Many Possible Avandia Trials

The first federal trial over whether GlaxoSmithKline's (GSK) blockbuster diabetes drug Avandia caused a fatal heart attack started Monday morning in Philidelphia, reported the Am Law Litigation Daily. Although Glaxo settled some 10,000 Avandia cases last summer -- for an average of $46,000 -- as many as 50,000 more lurk in the wings.

The multi-district litigation pending in Philadelphia currently involves some 1,600 cases, but according to the Legal Intelligencer, around 50,000 more aren't filed yet. The company and the plaintiffs' attorneys have agreed to put them on hold for now. If plaintiffs lose many of the "bellwether" cases -- like the one starting today -- most of those potential suits never will be filed. If plaintiffs win, the floodgates will open. And then there are the state cases: California has the most, with 3,500.

The ultimate verdict in today's case will be a good sorting tool for two reasons. First, all plaintiffs will have to prove that Glaxo failed to warn doctors, and thus their patients, about Avandia's heart attack risks. You don't get win if you knowingly ran the risk. And then, plaintiffs will need to prove that Avandia -- and not something else -- caused the heart attacks.

Did Glaxo Provide Adequate Warning of Avandia's Risks?

Since this will be the first trial, everyone will get to see what evidence is deemed admissible and how the jury reacts to it. Lots of information has come out that makes Glaxo's handling of Avandia risk information questionable, at best, but as the list of undecided pretrial motions listed in Glaxo's brief shows (p. 11), it's not yet clear how much of it the jury will hear. (As of this morning, no order resolving those motions had been filed in the electronic case file.)

Sponsored Links

If the jury isn't convinced Glaxo failed to warn about Avandia's dangers, the company will have won a huge victory. It wouldn't be binding on any other case, but it would show plaintiffs' attorneys that these won't be easy cases, and probably not worth taking the financial risk of litigating many of them.

But even if the jury agrees that Glaxo failed to warn doctors, for the plaintiffs to win, the jury has to decide that Avandia caused the heart attack. And on that issue, the verdict in today's case will be even more telling.

The lawsuit being heard today was filed by the family of James Buford, who had been taking Avandia for 15 months when he died from a heart attack. That's a pretty long time -- long enough for Avandia to have had an effect on his body. Also, plaintiffs charge that approximately three weeks after Buford started taking Avandia, he suffered symptoms that suggested a mild heart attack.

So far, so good for plaintiffs. But Glaxo has lots of "good" facts on its side as well: Buford was overweight, had a long-standing high cholesterol problem and high blood pressure, took a number of medications besides Avandia, and died from a heart attack from hardened arteries, according to his autopsy. Avandia doesn't harden arteries. Contrast these facts on "causation" with the very strong one the winning plaintiff had in the first Levaquin trial.

Will the Jury Agree?

In today's case, plaintiffs will argue that Buford's various ailments simply made him that much more vulnerable to Avandia's dangers, and Avandia triggered his heart attack. If the jury accepts this, the families of lots of people who were very sick when they started taking Avandia may be able to persuade other juries that Glaxo's drug also killed their loved ones.

Earlier this month, Glaxo announced it was reserving $3.4 billion, in part for these Avandia suits. The verdict in the Buford case may tell us whether or not that's enough.