Paxil Birth Defect Litigation - Battle of the Decade

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By Evelyn Pringle (about the author) Page 4 of 6 page(s)

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In one of the only three cases to ever go to trial, Eli Lilly was caught corrupting the judicial process by making a deal with the plaintiff's attorney to throw the case, in part by not disclosing damaging evidence to the jury.

The case involved a Kentucky man on Prozac, who went to his workplace and opened fire with an assault rifle killing 8 people, and injuring 12 others before turning the gun on himself. The jury returned a 9-to-3 verdict in favor of Lilly.

In the media, Lilly touted the verdict as a vindication for Prozac, but the judge in the case figured out what had happened and was outraged that a secret settlement occurred behind his back. He complained to a reporter from the British Broadcasting Company, stating:

"After the verdict came in, Eli Lilly gave it a great deal of publicity and various people went on television and on the radio and in newspapers proclaiming that this was a vindication of Prozac.

"I think the public has a right to expect that a trial is a bona fide contest and not some sort of show that one side puts on with the consent of the other to influence public opinion. Because it was done to discourage other plaintiffs and to help settle the pending lawsuits for less money than they might have been settled otherwise."

The judge, in the end, took the matter to the Kentucky Supreme Court, which found that "there was a serious lack of candor with the trial court and there may have been deception, bad faith conduct, abuse of judicial process and, perhaps even fraud."

The judge later revoked the verdict and instead, recorded the case as settled. The value of the secret settlement deal has been reported to be over $20 million.

Will Birth Defect Cases Follow Suit?

The few cases that have made it to a jury illustrate why the drug makers work so hard to get these cases dismissed or settled before trial. For instance, in a Paxil case in Wyoming in 2001, a jury awarded a surviving family member over $6 million after it determined that Paxil had caused a man to kill his wife, daughter and granddaughter before killing himself.

In addition, drug companies should be concerned over trial publicity because medical experts estimate that there are hundreds, if not thousands, of infants who were born with SSRI-related birth defects to mothers who do not know that the drugs could be to blame. After the PPHN study was published, the lead author, pediatric researcher, Dr Christina Chambers, told the Wall Street Journal that she heard from women all across the US who used SSRIs and gave birth to babies with PPHN.

In avoiding publicity, companies must consider that nagging little matter of profits. According to the Wall Street Journal, "Whether or not pregnant women continue or stop the use of antidepressants has big ramifications for makers of those drugs."

Citing US government estimates, the Journal reports that women are at a 25% risk for developing depression, with the highest risk period being in childbearing years.

Fighting Preemption

As for industry influence on regulatory agencies, legal experts predict that GSK will file motions in an attempt to dismiss the birth defect cases using the FDA's new preemption policy announced in January 2006, which basically says that state failure-to-warn claims are barred against drug companies if a drug and its label were approved by the FDA.

"In essence," Ms. Menzies says, "the government's position is that unless and until the FDA takes action regarding a safety risk associated with an approved drug, nobody else can -- not a drug company, not another state, and not a plaintiff in a lawsuit."

Before the Bush Administration took control of the FDA, the agency's consistent position was that the drug's label did not preempt state laws except in rare circumstances, precisely because the label would not reflect advances in knowledge about drugs once they were on the market. Critics point to the preemption policy as evidence of the administration's commitment to protect the profits of its largest political contributors.

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