Furious Seasons

April 09, 2008

Pharma Pursues Its Wet Dream Legal Fantasy, Gets Paxil and Zoloft Suicide Lawsuits Denied

Yesterday, the Third Circuit Court of Appeals made big news when it ruled that the makers of Paxil and Zoloft could not be sued for failing to warn of suicide risks attached to the use of their drugs because the FDA had deemed such warnings unneeded, according to Law.com.

I haven't read the entire ruling, but I assume the court is dealing with cases concerning a lack of suicide warnings on these drugs prior to 2004 after which the FDA did require suicide warnings on the drugs. Anyway, the ruling is a big one for Big Pharma, and especially GlaxoSmithKline and Pfizer. In some circumstances, pharma companies can now get away with behaving badly because of a ticklish clash between federal and state laws. Similarly happy rulings have come down recently in California and elsewhere.

We all know that pharma companies dream about little but money and will go to damn near any length to create a market, hide problems with their drugs from the public and regulators, and manipulate their way to the latest blockbuster. The history of Big Pharma over the last two decades is filled with so many examples of twisted behavior--think Zyprexa and Vioxx here--that its like these guys have a different corporate genetic code than most corporations. Unlike oil companies, pharma companies are dinking around with human lives when they lie, cheat, obfuscate and so on. I'd like to say this isn't the case, but I know of little evidence to the contrary.

For almost as long as pharma has been behaving badly (and sadly the companies almost always do, especially in the world of psych meds), regular folks have been able to drag their butts into state or federal courts to answer all manner of product liability claims and the like. Often, such suits have ended in legal settlements for billions of dollars--again, think Zyprexa and Vioxx.

Predictably, pharma doesn't like this too much and they and the FDA and the Bush Administration have been arguing throughout the courts--state and federal--that the rule of federal preemption should apply. I won't even try to walk you through preemption, since some of what's going on here is based in the US Constitution and some of it is from case law and its all adding up to a big mess for consumers and a big old money shot for Big Pharma.

What preemption--as pharma, the FDA and the Bush Administration have argued for it--boils down to is this: If a drug is approved by the FDA, then citizens don't have a right to sue the manufacturer for flaws in the drug on a state level applying state laws because federal law trumps state law on this matter. In other words, if the FDA says a drug is safe, then tough for you if you are injured by it. Take your claim to federal court, where the standards for challenging big companies are much tougher than on the state level.

I think this argument is legal horse shit. Quite a few states have in their constitutions greater protections for citizens than are afforded under the federal Constitution--think of Oregon's free speech laws--and in these cases I know from my experience writing about these issues that a state's constitution is allowed to trump the federal one. I'm a bit lost as to why that same standard doesn't apply to these pharma cases. I don't know each and every state's constitution, but I would assume that there is some level of law that would address this situation.

Anyhow, this whole mess is headed to the US Supreme Court, as the New York Times reports in a fine article the other day, and it's beginning to look as though Big Pharma is going to get its way with the public. They clearly just did in the Third Circuit, although one suspects that case will be appealed, especially when one judge on the three-judge panel opines in his dissent that:

"In dissent, 3rd Circuit Judge Thomas L. Ambro said he would have allowed both cases to go forward.
"'The FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise,' Ambro wrote.

"Ambro said the 'sea change' in the FDA's position on pre-emption did not come in the form of a formal regulation that was subject to notice and comment, but in a 'preamble' to a regulation. The majority, Ambro said, decided to defer to the FDA because the agency has expertise in deciding the 'optimal warnings" drug labels should carry -- not too lax, not too alarmist -- and that "state tort lawsuits would disrupt this fine system.'

"But Ambro said there is 'an important contrary view that has prevailed until recently: state tort law complements FDA provisions on drug warnings, in part by eliciting more information than the FDA would glean otherwise from pharmaceutical manufacturers.'"

To extrapolate, what he's saying is that Big Pharma so often cooks the results of its clinical trials and they are such short duration that it's impossible for FDA approval to be the gold standard for safety evaluation of drugs and that under our current system state courts are essential.

Now, here's why the other judges ruled as they did:

"Writing for the majority, 3rd Circuit Judge Dolores K. Sloviter said the FDA has 'actively monitored' the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs 'are without scientific basis and would therefore be false and misleading.'"

I assume her honor is referring to a time period before the 2004 black box warnings. But, regardless, her reasoning is deeply flawed. The FDA did a horrible job of monitoring suicidality data following the introduction of SSRIs in the late-1980s. Maybe the judge is just deeply innocent about the real world--judges often are. Federal appeals court judges are also often more supportive of the rights of corporations than they are of regular citizens, despite the fact that both parties are supposed to have equal standing.

Anyway, this whole business is a lousy knot of legal problems, and also deeply affects human lives. It's hard to know if Congress could clear this up somehow, or if it will be left to the various states to address this in their state constitutions, but I do fear where the US Supreme Court will take this. I guess we'll know soon enough.

Evelyn Pringle has a lot more on this in this article and has information about how GlaxoSmithKline is working hand-in-glove with the Bushies. Nice.

Posted by Philip Dawdy at April 9, 2008 12:05 AM

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Comments

You did a great job with this post. I really mean it. But boy does this stuff suck. I can't even believe big Pharma is getting away with this and judges, no less, are saying the FDA is doing their job. All I can say is just run the other way when a doc comes at you with a prescription pad for just about anything because you are going to have no recourse whatsoever when things go south on a med.

Posted by: Sara at April 8, 2008 10:53 PM

Dear Philip:
You wrote an excellent piece here by the way! I would like to say I’m surprised and confounded by the courts decision here. But I’m not really! We are talking about companies that have bottomless pockets full of cash when it comes to legal matters and representation. They will and are finding every avenue and loop hole possible to protect those profits and run their snake oil businesses as usual, no matter how many people are harmed in the process. And when the loop hole doesn’t exist to protect that money train rolling down those influential tracks, you can bet your bottom dollar they are working feverously to create more. Again this is just another status quo reality. Considering the money they flow into Washington through various means including powerful lobbies and deep pocket monetary influences; I would expect nothing less. They know exactly what they are doing and have factored in all the legal cost, settlement payouts, influence peddling, and the advertisement budget (in other words the misinformation machine) into the cost of every prescription written and sold. These are not idiots or morons we are dealing with here; these are cool and calculating mega corporations with untold influence across the board; which creates loop sided odds that are stacked squarely against Mr. Joe Public. There are going to be no easy victories in these ongoing battles. They will make settlement when they are cost effective, and in other cases they will manipulate the legal system and drag these issues on in the courts for many years to come. So for valid health reasons I have decided not to hold my breath at this particular time if that’s OK.
Yours truly
Stan
PS I am looking forward to reading the church of scientology secret documents when I get time. I hoping I can at least get their secret hand shake down, and just maybe gather some info on how many star celebrities have significant holding/investments in this company (whoops! I mean religion LOL) out of those super secret documents. I guess I’m just having another delusional pipe dream moment of capricious caricature idealism guiding me into playing the mental health version of Alice in wonderland once again. Dang, I hate when this happens; it’s like I’m dating again, and playing dress up to meet some bizarre kinky fetish expectation on some disturbing primal level {laughing}.

Posted by: stan at April 9, 2008 12:58 AM

This all reminds me so much of my first run in with big pharma as a women's health advocate who fit cervical caps and was part of a network of people who felt that the birth control patch and injection and of course the IUD were dangerous. Big Pharma didn't leave women many options but we had some and the warnings about various hormonal birth control products really were there if in teeny tiny print on the package insert. Now people go to their doctors in mental distress and are told that they are irresponsible and immoral and well just plain crazy if they don't take these drugs, drugs which then cause them to commit suicide and/or harm others as often as not, drugs which are so expensive many who take them must seriously alter their lives to afford them, and all from big pharma. Grrrrr. And then there's the connections between the Bush family and Eli Lilly. Scary. And the destruction of Spitzer - okay it's true he was a big hypocrite, but most politicians are, and among other things, he had the courage to take on big pharma. However, since the pharmaceutical problem and the FDA issues encompass many more drugs than only psych drugs maybe the public can do something. It seems that the FDA is like the USDA and the EPA, two to other regulatory agencies that have revolving door policies with the industries they are supposed to police. And, sometimes the Supreme Court will surprise you, there is reason to hope that they will in this case.

Posted by: Sally at April 9, 2008 01:37 AM

well, i was witness to Zoloft related suicidal ideation/attempt by a 13 year old in 2001, and all I can say is this is this industry is out of control, unregulated and people will suffer as a result of key opinion leader/pharma funded/ paid off bullies. the FDA is worthless.

Posted by: Stephany at April 9, 2008 02:29 AM

Um, Can't we turn to sueing the FDA? Or are federal regulatory agencies protected from all liability... unless congress takes it on. Sorry for the lack of knowledge here, this is something I should know, it's just that the Seroquel I started taking when I started my political science class wiped me out to much to continue. ... can anyone say mind control? ha! At least it's an effectiive drug for dumbing one down.

Posted by: Katielou82 at April 9, 2008 10:35 AM

The problem with suing the FDA is like suing the City, we, the tax-payers, end up paying for it not the Pharmas who make millions off of these products.

Posted by: Bahamut at April 9, 2008 01:03 PM

The Republican party is begging Americans to remove it from office.

Posted by: growler at April 9, 2008 04:10 PM

I’d like to start by thanking you for attacking the growing issue of pharmaceutical companies in an argumentative fashion that demands attention. I too believe that the growing power of the already colossal Big Pharma within the legal and research spheres is a frightening problem. However, I would like to contest your comment that “We all know that pharma companies dream about little but money and will go to damn near any length to create a market, hide problems with their drugs from the public and regulators, and manipulate their way to the latest blockbuster.” It is my belief that an epidemic of patient ignorance is the only thing truly responsible for these drugs becoming “the latest blockbuster.” If people understood that their marketing, their labels, and the doctors who prescribe them are not to be trusted, I would hope that sales would be on the decrease instead of the rise. Just from my personal experience with individuals on anti-depressants and anti-psychotic medications, I can say that there are still too many people who trust their drugs more than they trust themselves to cope with a problem. I agree with your response to the third circuit court’s ruling and I have little doubt that the reason for this ruling is checks being written on both sides of the table – in fact I just commented on another blog that addressed this issue in particular. The bigger pharmaceutical corporations get, the less chance anyone has of tackling them through the court system. This is why I believe our primary goal should be raising the awareness of consumers about the ineffective and destructive nature of antipsychotic and anti-depressant drugs. Your indirect approach to this matter is quite effective. If people start asking why Big Pharma would hide the suicide risk on drug labels, maybe they’ll start asking why doctors are prescribing them, and why they don’t seem to be getting any better. I appreciate your post and hope to see more like it in the future.

Posted by: mlc at April 14, 2008 10:24 AM

Please go to www.lawjournaltv.com, especially in June 2008 were there will be several programs dealing with this very issue on The Comcast Network and the website.

Posted by: Christopher Naughton at May 25, 2008 06:00 PM