Houston attorney Mark Lanier
CHICAGO – One million American diabetics take Avandia pills, and if more of them would suffer heart attacks attorneys could get rich.
No one has conclusively connected Avandia to wrongful heart attacks, but a statistically insignificant study has excited the interest of attorneys.
On July 13 at the Embassy Suites hotel in downtown Chicago, about 100 attorneys started preparing to sue British drug maker GlaxoSmithKline.
In a glimpse of the future, Mark Lanier of Houston tore into GlaxoSmithKline in a closing argument for fictitious Avandia plaintiff Bobby Lion.
Lanier compensated for lack of proof with oratory about bottom line and public health and pushing Bobby Lion over a cliff.
He displayed a slide reading "Glaxo's agenda" in white letters on a green background of five, ten and twenty dollar bills.
No one at the hotel saw an easy road to a verdict for a real plaintiff. They did not even agree about suing GlaxoSmithKline over heart attacks.
Paul Sizemore of Los Angeles said attorneys should sue over congestive heart failures rather than heart attacks.
Conference chairman Vance Andrus of Lafayette, La., preferred heart attack suits, but not against GlaxoSmithKline.
Andrus recommended medical malpractice litigation.
Plaintiff points of view dominated the day, but Nathan Schachtman of Philadelphia made the most of his moment as voice for the defense.
"Put down a zero and walk away," Schachtman told plaintiff attorneys.
The wisest words came from pharmacologist James O'Donnell of Chicago. He said, "Drugs are a double edged sword."
LexisNexis Mealey's put on the conference, at $695 per person.
Vioxx reminder
Andrus opened on a cautious note, recalling the first litigation conference on Merck painkiller Vioxx, in 2004.
"People were ecstatic," Andrus said. "They were counting their money. It was like the bar scene in Star Wars."
He advised all to conserve energy, save money and build teams.
"I told them, curb your enthusiasm," he said. "They are not going to give this money away."
He said tens of thousands were seriously injured. "Isn't this what you went to law school for?" he said.
He advised all to abandon euphoria, banish despair and keep it real.
Venue: Brotherly Love
Next and not so cautious, Cheryl Jacobs of Philadelphia pitched for her home town.
She recommended the city's Court of Common Pleas for those planning to sue GlaxoSmithKline.
Jacobs said the company has American headquarters near the courthouse and can't remove a Pennsylvania suit to federal court.
She said the Philadelphia court does not disturb a plaintiff's choice of forum except for weighty reasons. And further, Philadelphia runs a mass tort program with master pleadings and coordinated discovery.
She said a plaintiff doesn't need a subpoena for testimony or documents. A plaintiff needs only to send a notice to appear or produce.
She said Philadelphia follows the Frye standard for expert testimony rather than the more restrictive Daubert standard.
"Philadelphia has a wonderful jury pool," Jacobs said. "We feel that the juries in Philadelphia are second to none."
Nissen article
Karen Barth Menzies of Los Angeles said Avandia's label changed in 2001, to note a risk of heart failure.
She said last year a Food and Drug Administration employee recommended a stronger warning but received a reprimand.
Menzies said that on May 21 the New England Journal of Medicine published an article on Avandia by Steven Nissen of the Cleveland Clinic.
Nissen combined 42 studies into a "meta analysis" showing an increase in heart failures but not a statistically significant increase.
The article prompted a June 6 Congressional committee hearing.
Menzies said the crowd at the hearing laughed at FDA director Andrew von Eschenbach when he said his agency needed greater authority.
FDA oversight
Richard Hood, from Andrus's firm, said the FDA regulates more than a fourth of the consumer goods sold in the U.S.
He said the FDA does not test drugs, inspect sites or run clinical trials.
"The FDA gets all of its information from the outside," Hood said.
He said that to the FDA, "safe" means that benefits outweigh risks, and that as diseases get uglier the FDA has more tolerance for side effects.
Hood said the FDA gave Avandia priority because it was less likely to cause liver toxicity than Rezulin, which FDA withdrew from the market.
Benjamin Anderson of Cleveland said that at the Congressional hearing, committee chair Rep. Henry Waxman said there were warnings on Avandia from the day of approval.
"FDA dropped the ball and if FDA dropped the ball, GSK hid the ball," Anderson said.
He said three company executives appeared before the committee. He said Congressman Lynch of Massachusetts "handed it to them all day."
"They looked at each other like Larry, Moe and Curly," Anderson said.
Pharmacologist weighs in
Pharmacologist O'Donnell said that with diabetics, physicians treat not just sugar level in the blood but also vascular complications.
He said 17 million Americans have diabetes, and 11 million of them have been diagnosed. He said doctors diagnose a million new cases a year.
He said diabetes causes blindness, renal failure and amputation and it costs $98 billion a year.
He said cells starve for sugar while the body has an excess of sugar.
He said a doctor can prescribe insulin injections and four classes of pills.
One class increases the patient's insulin production, one reduces sugar production in the liver and one slows the breakdown of carbohydrates.
Avandia's class enhances insulin's action so patients can reduce insulin requirements. That means fewer shots.
"A lot of people don't like needles," O'Donnell said.
He said a doctor chooses a strategy with the least risk. He said a doctor can change treatment or add a second or third treatment.
He said FDA withdrew Rezulin partly because Avandia replaced it.
"Drugs are prescribed for targets but they have effects beyond the targets," O'Donnell said. "Drugs bathe the body."
He called them a double edged sword. He said they must be strong.
Efficacy and marketing
Neil Overholtz of Pensacola, Fla., said liability depended on whether the company overstated Avandia's efficacy.
"Did it keep its promises?" he said.
"The marketing in this case is going to be a significant source of our liability story."
He said that after the first label change, the FDA found that two reps made false and misleading statements about the change.
He said the New York Times reported that Avandia was similar to Vioxx.
"The number of extra deaths being caused is substantial," Overholtz said.
He said doctors are not prescribing Avandia for new patients and they are taking old patients off it.
MIs or congestive heart failure
Sizemore, leading a session on case selection, curbed the enthusiasm.
"Maybe I'm not on the bandwagon totally," he said.
He said Nissen's article did not have the power to answer questions about myocardial infarctions, or MIs.
"I have some questions about MIs," he said. "Maybe I'm being a little cautious at this point."
He said Nissen raised a bigger question about congestive heart failure.
"I would put congestive heart failure number one," he said. "Those are the best cases."
Cases of substance
Fred Thompson III of Mount Pleasant, S.C., said, "We are dealing with a population of people who are walking risk factors."
He said that in choosing clients, attorneys should look for substantial injuries and not minor or transient difficulties.
He said Nissen's article could serve as a statute of limitations marker, but he said the 2001 label change could too.
Science abridged?
Andrus said there were defense lawyers in the room. He said, "We are dangerously close to the line where we plaintiffs need to keep quiet."
They did, and Schachtman rose for the defense. He said, "A pile of stones is not a house and a collection of facts is not science."
He said the media and lawyers were driving an abridgement of the scientific process.
"A splashy New England Journal of Medicine article means tenure, grants, promotions, a corner office and the like," he said.
He said Nissen had an agenda to drive FDA policy. He called the article "shmeta analysis."
He said Nissen submitted it May 1 and the journal published it May 21.
"Time, mature reflection, peer review and scientific judgment were abridged," Schachtman said.
He said the journal has a political agenda. He said the editors knew they were over the line on this article.
He said Nissen put studies with different doses, comparisons and definitions into a blender.
"The bloom will come off the Nissen rose," he said. "Just put down a zero and walk away."
Holy War
Keith Hays of Chicago said defense counsel should put less effort into summary judgment and venue motions.
He said they should focus on the threshold issue of whether the plaintiff was injured by the product.
"There are so many ways these people are sick that you can't point to the drug," Hays said.
That brought the day to the grand finale. Lanier, winner of two recent Vioxx verdicts, tried to blow the roof off the joint.
He said congestive heart failure was a fight he didn't want. He said, "I'm looking forward to trying a heart attack case."
"I think they had information they wouldn't tell and they decided not to tell all they knew about heart risks," he said.
He flashed a slide of Bobby Lion and said his weight, diabetes, age and cholesterol were all pushing him toward a cliff.
He said Bobby's doctor told him Avandia would push him away from the cliff but it shoved him toward the cliff.
"The question is not whether Avandia was the cause," he said. "The question is, was it a risk factor?"
He said the FDA's oversight is minimal at best. He said the FDA is overworked, underfunded, undersupervised and underpowered.
He said drug companies must warn.
"That's where they failed," Lanier said.
He said Glaxo never fully tested Avandia.
"How dare they say, where's your study, when it needs to be their study?" he said.
He said they spent money instead sending sales reps to doctors.
"They pick where they spend their money," he said.
"They sat on risks 11 months before they gave it to FDA.
"The issue is corporate behavior."
He compared it to the Ford Pinto and showed a slide of one in flames.
He mocked Schachtman for saying Nissen had an agenda. He said Time Magazine named Nissen one of the 100 most influential Americans.
He displayed "Glaxo's agenda" – cash.
"To me this is a holy war," Lanier said. "This is a call."