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Lawyers argue that factors including African-American ethnicity elevated the risk of diabetes before a plaintiff took Seroquel.

With over 15,000 complaints now pending, and AstraZeneca’s determination to try each case on individual merits, Seroquel liability could become the longest, and perhaps the most expensive, legal odyssey in Big Pharma’s legal liability history.

AstraZeneca “is tossing everything it has at legal cases claiming the company’s drug gave people who took it diabetes,” says blogger Philip Dawdy at Furious Seasons, including ‘the race card’. Dawdy, who says he has personally experienced the negative effects of the antipsychotic Seroquel, has a moral and an emotional stake in the outcome, if not financial.

AZ’s lawyers are claiming that ethnicity caused diabetes in Kansas plaintiff Nina Scaife, not Seroquel. They claim that factors including her obesity and being African-American already elevated her risk of diabetes before she took Seroquel.

“I can’t see how the plaintiffs can win,” gloated Michael Kelly, a Wilmington-based partner in the law firm McCarter & English, who’s slated to try the Scaife case for AstraZeneca in late June.

If AZ plays the race card in court, even one black juror could make it interesting indeed.

And you also can’t ignore the 15,000 claims (and counting), who include many who are neither black nor obese, but who got fat and got diabetes after relatively short periods of Seroquel use.

Eli Lilly fought similar claims involving the antipsychotic Zyprexa, and early on claimed that mental illness caused diabetes, not the drug. That strategy failed, and eventually the company settled Zyprexa cases totaling nearly $1.3 billion, involving numerous states, the feds, and some 28,500 individuals.

And Merck tried to block its first big Vioxx case by claiming patient Robert Ernst died while using Vioxx because he already had some degree of arterial disease. We all know what later transpired regarding the painkiller Vioxx — $4.85 billion in settlements, and the drug gone forever from the marketplace.

The real point of any such case was summed up recently by one of Scaife’s lawyers, who said that anyone with any degree of increased risk, whether diagnosed or not, needs even more protection from a drug’s side effects.

If being African American — or any other risk factor — raises the risk of getting diabetes from a drug, the drug company should ensure there are huge warnings in every communication to prescribing physicians and patients, clearly outlining these increased risk factors.

But in fact, AZ buried not one, not two, but nearly half a dozen studies that clearly showed Seroquel presented risks for serious weight gain, and possibly diabetes — regardless of racial or other predisposing factors.

Internal AZ memos reveal that company officials openly discussed and willfully decided to hide, from regulators and from the public, negative findings. Other memos discuss how the positive studies that were released were based on questionable science.

The $billions that AZ has ripped off from the states and federal government, and from tens of thousands of individuals, by selling a drug that causes chronic illness, makes the Bernie Madoff ponzi scheme look like a church bake sale.

And it’s not just the money. These officials carelessly consigned unknown numbers of people to debilitating disease and possible death without a thought of anything but profit.

Such conduct in any other setting is a criminal act. Responsible individuals are charged with fraud, fined, and locked up in jail. If his plea goes through in its present form, Bernie Madoff will be in jail for the rest of his life. And that’s just for a money crime.

Callous disregard for human life and safety is something else again. It’s met with charges of assault, or in the case of death, with manslaughter charges. But with AZ, and other similar Big Pharma cases, the charges should be murder — because they are knowing, and premeditated. And on a colossal scale.

Yet all we ever see with these Big Pharma cases, regardless of how many people are permanently injured or even killed, are fines and cash settlements.

AZ has said it will fight all the Seroquel cases. Some reports say the company has already racked up $500 million in legal bills. But since Seroquel represents close to $4.5 billion a year to the company, I suppose they can afford it.

Meanwhile, AZ wants the FDA to extend approval for Seroquel XR, the extended release version, to cover anxiety and major depression.  This would add to the bipolar disorder and schizophrenia currently approved for Seroquel.

Oh right, let’s get tens of thousands more people fat and diabetic. What’s a few thousand more diseased and dying people when the $billions are rolling in? And the lame-brains at the FDA may actually go for it.

One more interesting fact. Nina Scaife was reportedly taking Seroquel for insomnia. Doesn’t insomnia sound a little distant from bipolar disorder and schizophrenia? How could any doctor, especially a family GP, possibly come up with the idea to prescribe a powerful antipsychotic for insomnia? Could the doctor possibly have gotten such an idea from AstraZeneca?

Oh heavens no. Pharmaceutical companies are legally prevented from promoting off-label drug use. It’s a crime to do so. Only doctors can prescribe off-label.

On the other hand, though, in true Big Pharma tradition, AZ apparently doesn’t mind making lots of people sick or dead. So would they shy away from “hinting” that Seroquel is dandy for simple sleep disorders too? It wouldn’t be the first time. Plenty of other Big Pharma players have been caught with their pants down after promoting off-label drug uses to physicians.

Eli Lily skates after a federal judge tosses out a class action suit by angry investors. But the decision raises questions about the fairness of the law.

Sometimes there just doesn’t seem to be any justice in the world, or so the saying goes, but that all depends on who you ask. Drug-maker Eli Lilly, already battered by a number of other huge law suits concerning alleged misrepresentations about its all time best selling drug Zyprexa, is celebrating justice this week. The company will skate on a class action suit from Lilly investors who claim their investments were damaged by the company’s fraudulent actions.

The suit claims Lilly and numerous employees misrepresented or failed to disclose the link between Zyprexa and serious side effects, including weight gain and diabetes. It also cites the company’s illegal practice of marketing the drug for non-approved off-label uses, all of which negatively affected the company’s stock value. We’re wondering if Lilly’s new CEO John Lechleiter, briefly profiled in the Wall Street Journal’s Health Blog, will try to turn around the company’s marketing ethics as well as improve its stock picture.

But with several other large actions already against the company, including alleged marketing fraud, and $1.2 billion in payouts underway for thousands of Zyprexa deaths and injuries, one can only wonder how a judge could find against the investors who have taken a beating because of Lilly’s illegal actions.

Well, the answer is fairly straightforward, and shows that a judge doesn’t necessarily have to be in Lilly’s pocket to reach a verdict favoring Lilly. In this case, the judge doesn’t need to be changed, just the law.

According to Eastern District of New York Judge Jack B. Weinstein, the suit was dismissed because it wasn’t filed within the required two-year statute of limitations — two years from when plaintiffs “reasonably should have known” that they sustained damages because of Eli Lilly’s purported fraud.

And the judge is probably right. In his 82-page decision, the judge said what is referred to as ‘storm warnings’ about Zyprexa stretch back to the 1990s — he called it an “extended public debate” over Zyprexa — including numerous reports in the medical literature, by investment analysts, and presentations at medical conferences, dating back to within a year of the drug’s release in the mid 1990s.

Attorneys for the plaintiffs argued that the statute should have begun with three articles about Zyprexa in the New York Times in December, 2006. The suit was filed four months later on March 28, 2007. But the judge said that under ruling law, ‘storm warnings’ are available to the stock market and place reasonably astute investors on notice of the need for further inquiry — creating the hypothetical date that begins the two-year statute of limitations. The judge added that “individual unsophisticated investor’s lack of awareness is ignored; the law tilts the . . . balance against such a consumer. It applies the much-debated ‘caveat emptor’ [Let the buyer beware - Ed.] principle favoring greater and freer commerce by limiting litigation, and requiring dismissal of this case.”

“Let the buyer beware” — the principle that the seller of a product cannot be held responsible for its quality unless it is guaranteed, and the buyer alone is responsible for assessing the quality of a purchase before buying — just doesn’t cut it in a case like this.

A two-year statute of limitations favoring a criminal conspiracy is a very, very bad law, and Lilly — which hasn’t escaped its guilt for the thousands of sick, dying and dead Zyprexa patients — should not be allowed to skate from its investors either. American investors are the engine that helps drive business and industry, and this case just gives the whole concept another black eye.

NEXT: What about the ethics of the investors and brokers who ignore a decade of storm warnings about the dangers of Zyprexa? And more importantly, where was the FDA while people sickened and died? Perhaps dozing as usual in the shade of Big Pharma’s money.