The Zyprexa Chronicles: Judge Says FDA Can't Police Drug Safety

There's been spotty coverage of the Alaska v. Lilly trial ever since Lilly began to mount its defense last week. That's apparently because Lilly's lawyers are taking the tactic of putting an expert on as a witness, who claims that there is no link between Zyprexa and diabetes, and then claiming it properly warned the FDA about any risks associated with the drug and that, thus, its butt was covered. In other words, a very simple argument that will play out over the next day or so before jurors hear closing arguments possibly as early as tomorrow.

The trial judge isn't necessarily buying all of Lilly's arguments.

"Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems 'might well go unaddressed,' Anchorage Superior Court Judge Mark Rindner said from the bench this week.

"The jury was out of the room. The state had just rested. Lilly asked the judge to issue an immediate verdict in its favor, a routine step at that point in a trial.

"Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is a matter for the federal Food and Drug Administration, not any state. Alaska's Unfair Trade Practices and Consumer Protection Act shouldn't apply to drugs, Lehner told the judge.

"Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA 'isn't capable of policing this matter,' he said."

I think the judge is right on both counts, especially in his assertion that the FDA can't police the drug marketplace completely. The FDA is wildly understaffed and the rules they operate under are essentially written by Big Pharma's lobbyists--you all do remember the Medicare Plan D business right?--and that makes it hard for the FDA to do much. As much as some wonks might not care for state court trials over drugs, the sad fact is that this is the only way to hold companies accountable when they misbehave.