In an Alaska courtroom, drug maker Eli Lilly is finally getting to defend itself against accusations that it failed to warn doctors and patients of health problems from its best-seller, Zyprexa.
The judge suggested Lilly has its work cut out for it.
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.
Jurors have been hearing testimony since March 6 about Zyprexa, used to treat schizophrenia and bipolar disorder.
The state is suing for hundreds of millions of dollars to cover costs to Medicaid for treating what it says are Zyprexa-related health problems including weight gain, high blood sugar and diabetes.
Rindner noted on Wednesday that he had heard only one side, but the state's evidence was strong enough to let the case go forward.
Now it's Lilly's turn. So far, the international pharmaceutical giant has relied on two experts and its own executives to argue that doctors always knew the drug was linked to weight gain. Beyond that studies have been mixed, Lilly says. The company contends it followed FDA rules on what to disclose.
It's an unusual trial for Anchorage and is being closely watched. Nine other states have sued, others are considering it, and 1,200 claims by individuals are in the legal hopper. Lilly already has settled 31,000 claims by individuals for a total of $1.2 billion.
Alaska's suit is the first to go to trial and both sides have brought in high-powered Outside lawyers.
Lilly's first witness was Dr. Silvio Inzucchi, a professor of medicine at Yale University, director of the Yale Diabetes Center, and internal medicine doctor who said he has treated thousands of diabetics.
Under questioning by Lilly lawyer Andrew Kantra, Inzucchi told jurors he had reviewed all the published studies on any connection between Zyprexa and diabetes. His conclusion: "Zyprexa does not cause diabetes."
It doesn't affect insulin resistance or production, he testified.
And while weight gain increases the risk of diabetes, it doesn't cause diabetes, he said. Someone with a healthy pancreas who gained a lot of weight while on Zyprexa might never get diabetes, he said.
Studies found that patients may have had elevated blood sugar while on Zyprexa, but that's not the same thing as diabetes, he told jurors.
Under cross-examination, Inzucchi acknowledged an "association between Zyprexa and diabetes" first shown in studies in the late 1990s.
A diabetes expert for the state previously testified that Zyprexa did cause the disease.
Lilly also called David Kahn, a psychiatrist at Columbia University Medical Center and professor of psychiatry.
He gave jurors a vivid view of the horrors of an extreme case of schizophrenia. Lilly's team played a video of a psychiatrist's interview with Russell Weston, who shot and killed two guards in the U.S. Capitol in 1999 because he wanted to keep the country from being ruined by cannibals.
An early generation of anti-psychotics helped patients but had side effects like muscle tremors and jerking. Those drugs sedated them to the point they went through life with what felt like a "wet blanket over their head," Kahn said.
Drugs like Zyprexa were a "quantum leap forward" but had risks, too, he told jurors. The first of that group to come on the market, Clozaril, had a potentially fatal side effect: It could wipe out a patient's white blood cells.
The psychiatrist said he had been prescribing Zyprexa from the time it was approved in 1996. He knew from colleagues involved in clinical trials that it brought a risk of weight gain.
He told jurors that doctors had many sources of information about drugs and their risks: medical journals, continuing education, package inserts, drug companies and their sales representatives, colleagues, and published guidelines.
Scott Allen, a Houston lawyer representing the state, pressed Kahn on whether he knew what Alaska doctors were told about Zyprexa. Kahn said he didn't.
Is there any source of information that Lilly is not involved in? Allen asked.
No, Kahn said.
Lilly will continue to present its side next week. The jury is expected to get the case by week's end.
Find Lisa Demer online at adn.com/contact/ldemer or call 257-4390.