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What a sick thing to do...
July 25, 2004 12:41 PM   Subscribe

Bush administration seeks to block consumer drug suits. White House says injury claims undermine FDA.
Gee. I don't know why we might need some legal recourse against drug manufacturers?
Weasels!
posted by jpburns (35 comments total)

 
People who prattle on about "tort reform" and make jokes about ambulance chasers tend to forget that the law is what protects consumers from any industry that fails to adequately test their products, or in this case, lie about the nature of their products.

Case in point.
posted by jpburns at 1:01 PM on July 25, 2004


It's another example of them not understanding that whole "of the people, by the people, for the people" thing.

"The Supreme Court has expressly ruled that FDA regulation does not pre- empt state law and local regulation" in all cases, said Erwin Chemerinsky, a constitutional scholar at the University of Southern California Law School.

Time for yet another case in which a Bush law/regulation will be proven to be unconstitutional.
posted by amberglow at 1:07 PM on July 25, 2004


Remember this the next time the President waxes poetic about the need for tort reform, and talks about how it will help small businesses. Search The State of the Union Address for the word "lawsuits".
posted by ilsa at 1:50 PM on July 25, 2004


I thought Bush "hated science." Now he's wrong for wanting the scientists to regulate drugs instead of lawyers and juries?
posted by techgnollogic at 2:13 PM on July 25, 2004


Now he's wrong for wanting the scientists to regulate drugs instead of lawyers and juries?

No, he's wrong for protecting the interests of Big Business (i.e. the pharmacutical industry) at the expense of individuals like you and me.
posted by junkbox at 2:28 PM on July 25, 2004


technollogic, are you really against a company being financially accountable for the effects of a drug it sells?

The FDA is a good thing. But like any other federal body, it is lobbyable, political, and sometimes, its scientists will mess up. We also know that drug companies aren't necessarily forthcoming about everything they know. Combine those two facts, and then take away even the potential of accountability, and exactly what sort of protection does that leave individuals?

But let's assume none of that is true or matters for a moment. That would make the FDA accountable for drugs instead of businesses. Are we suggesting they should be open to lawsuit?

And finally, it may not happen as often as we like, but court decisions or other investigations don't have to be arrived at solely by non-scientific professionsals. Think Richard Feynman sticking part of a rubber o-ring in the icewater.
posted by weston at 2:33 PM on July 25, 2004


Waitasecondhere. If somebody invents a drug, it takes a good 5-10 years *of people suffering* to get that drug through the FDA approval process. In past, congress has been under intense pressure to "streamline" this approval process. Why? Because people are willing to "take risks" to get a chance, even if the FDA can't guarantee drug safety.

What's it going to be? Invent a drug *and* get it to market quickly *and* safely *and* still get sued if it turns out to not be as safe as you thought?
posted by kablam at 2:42 PM on July 25, 2004


Obviously, kablam, we can count on the legal system to only punish the big old meanie drug companies.
posted by techgnollogic at 2:49 PM on July 25, 2004


What's it going to be? Invent a drug *and* get it to market quickly *and* safely *and* still get sued if it turns out to not be as safe as you thought?

Yup. Peddling an unsafe product is wrong no matter what the product is, or however long it took to get it approved. Whatever had to happen to get it to market is beside the point if it harms or kills.
posted by amberglow at 2:50 PM on July 25, 2004


Invent a drug *and* get it to market quickly *and* safely *and* still get sued if it turns out to not be as safe as you thought?

In a word, yes.

Big pharma has repeatedly shown their willingness to cover-up, lie, and distort factual truth about their drugs. That needs to be actionable.

A drug company can invent a drug, can test it out on a population that is willing to be guinea pigs, can deploy it on a larger scale while honestly monitoring its long-term effects, and can then withdraw it from market should it prove harmful. And it can do that without lies and without subsequent lawsuits.

They just have to behave honourably.

In fact, behaving honourably is a good way to avoid lawsuits. What is surprising are the number of companies and the number of people -- yourselves included -- that don't seem to understand this.
posted by five fresh fish at 3:08 PM on July 25, 2004


Bush/Cheney: making Corporate America safe from Americans (tm).
posted by clevershark at 3:51 PM on July 25, 2004


At what point should pharma get any protection from lawsuits? Never?

How about Wal-Mart, that is sued on average 13 times a day, and yet wins almost all lawsuits because it is willing to contest them, instead of just automatically paying people thousands of dollars for petty crap. It's not crafty lawyers that decide on behalf of Wal-mart, it is usually juries.

There are US States that have almost NO ob/gyn doctors left because they are so liberal with medical malpractice lawsuits. Do you assert that ALL ob/gyn doctors are quacks? And if so, is it better to have no doctors that practice ob/gyn, or laws that restict malpractice awards?

So what do you do for a living? Would it be fair that no matter what you did, you had to pay for it to be approved by the government before you got paid, then after they approved it, you could still be sued?

Then why the HELL have government approval in the first place, if it means nothing? Seriously.
posted by kablam at 4:07 PM on July 25, 2004


Obviously, kablam, we can count on the legal system to only punish the big old meanie drug companies.

tl, your case might be strengthened if you listed some of the tragic cases where the drug companies lost billions due to a crazy suit.

Even if you produced that list, however, you'd still be forced to argue that no accountability on the part of the drug companies is a superior arrangement. Which seems to be what you're doing. Or am I missing the point?
posted by weston at 4:09 PM on July 25, 2004


kablam:

How about Wal-Mart, that is sued on average 13 times a day, and yet wins almost all lawsuits because it is willing to contest them

This actually seems to strengthens the case for leaving the legal system, to me, at least from the corps standpoint. If they're standing vindicated and still taking in healthy profits, then what's the problem?

Then why the HELL have government approval in the first place, if it means nothing? Seriously.

If approval means no accountability on the part of the drug companies, why the hell would approval mean anything? Especially since you haven't addressed any of the points expressed above about the fallibility of the FDA approval process.

When you're creating a system to protect something important (like people's lives and health), you want redundant and diverse systems in place. The FDA is one system. Legal accountability is another. And the fact that neither one is perfect makes it more important the other one is in place.
posted by weston at 4:19 PM on July 25, 2004


I thought that one of the core beliefs of the republican party (or of the conservative philosophy, at the very least) was that government agencies are essentially inefficient and fallible. Is it a good idea to leave people with no recourse against negligence but an inefficient, essentially fallible regulatory agency?
posted by Doug at 4:29 PM on July 25, 2004


Let the people sue the government (FDA) for approving and allowing use of a faulty product.

The FDA monitored testing is supposed to catch issues, and if it didn't, then that is the government's responsibility.

If the FDA did not find the issues because of fraudulent behavior by the drug company, let the FDA in turn sue them.


And being honourable is by no means protection against lawsuits.
posted by obfusciatrist at 5:07 PM on July 25, 2004


The need for tort reform is, essentially, bullshit. I regret that the Bush administration is so wedded to the idea; still, not a reason to vote for Kerry.
posted by ParisParamus at 5:14 PM on July 25, 2004


it's always been one of the standard libertarian lines they they would do away with the FDA and just have the drug companies have contracts which would be actionable in courts. But once again Bush shows that he has nothing in common with real conservative, small government, states rights advocates, and everything to do with being the bitch of big corporations.

And to think the FDA is an objective scientific group with no political ties and no ties to industry is insane and has no basis in reality.
posted by rhyax at 5:15 PM on July 25, 2004


I've never argued that no accountability for drug companies is a superior arrangement. Why are individual consumer lawsuits *necessary* to achieve drug company accountability? Why is Bob going and getting a lawyer and suing Pfizer because Viagra gave him a shrinky dink the only way to hold drug companies to account?
posted by techgnollogic at 5:29 PM on July 25, 2004


It occurs to me that corporate death penalty may be one way to deal with lying pharmaceutical companies.

Alternatively, hard jailtime for the administration of such companies would be another good route.

Accountability seems to often come only through fear of consequence. Make the consequences enormous, and you'll see accountability taken seriously...
posted by five fresh fish at 6:19 PM on July 25, 2004


Why is Bob going and getting a lawyer and suing Pfizer because Viagra gave him a shrinky dink the only way to hold drug companies to account?

It's not the only way. It's one of several ways, and like I said above, when you've got something important at stake, having several ways in place is a good idea.

And once something goes to court, Pfizer would have a clear advantage over most mortals. If they can't make a winning case out of the laywers and experts they can afford to hire, what does that say about their case?

And if court judgements start to go demonstrably wrong (got that list yet?), it seems more likely that it's symptomatic of problems with the law from which courts are making their decision, not of the problem that people can go to court to settle issues. I do believe in tort reform, but tend to believe the problem has a lot more to do with unreasonable damanges and the fact that just going costs so much, rather than the fact that in our society, we have another resort other than just taking it or revolution in the streets.
posted by weston at 6:31 PM on July 25, 2004


Paris, you are wrong. We desperately need tort reform in this country. Good God, you sound like John Edwards.

Sure there are many cases where the lawyers have represented the interests of the little guy against the larger foe in ways that otherwise would never happen. Nevertheless, we have a situation now where many lawyers and firms take cases almost solely to benefit themselves not their clients. These scum should be sued for malpractice and disbarred for ethical lapses. The only thing preventing that happening is the incredibly blurry line between strong representation of a client's interest and representation of the lawyer's interest.

I think liability suits by an individual tend to sort of work out overall and here I advocate little or no change. Perhaps some limit on the percentage fees over target recoveries would be in order. For instance if the recovery is less than half a million let the lawyer charge their 30 to 40% fee, but over that ratchet back the percentage so that the lawyer does not get a windfall at the expense of the client and so that the lawyer is not as induced to bring suit where the potential recovery is high, but the likelihood of success low. The real demon is class action. Too many lawyers pursue suits where the class is expanded to include many thousands, each receiving a de minimus benefit, perhaps just coupons, with the lawyers receiving fees in the tens of millions based upon a percentage of the assessed value of these coupons. Some of these actions effect important change, hence the reluctance to change the system, but many are merely scandalous frauds upon the legal system.
posted by caddis at 6:36 PM on July 25, 2004


Despite what I wrote earlier, I am not limited to a single point of view in this debate.

For example, the FDA has severe internal problems. Scientific problems. Two citations: DMSO, a topical analgesic, sold in health food stores "as a solvent only"--a drug they refuse to test, *because it cannot be double blind tested*--the one technique they use. The second is this nasty, black goop that for almost 100 years dentists put in tooth sockets to prevent infection. The FDA decided that if you *ate* large quantities of it, it would make you sick--so they *banned* it. Unfortunately, dentists had no replacement for it. So, *on the possibility* that someone *might* get sick, the FDA caused thousands of serious dental infections.

Other problems: neither the FDA or the drug companies continue to test new drugs after they have been approved, unlike in Europe and Japan. In addition, while Europe and Japan have similar or better quality controls for new drugs, there is no crossover with the US. A drug used successfully in one place still has to wait years before it can be used elsewhere.

If you *really* want to get pissed at the pharma industry, look at their practice of dumping excess and expired drugs in Africa. Ship-fulls of dangerous drugs, which instantly become black market on arrival, are the entire *continents* preferred abused drugs of choice. "Fruit salads" of who-knows-what are consumed in the hope of getting high, by abusers.

You can also cite price-gouging of the pharma oligopoly, and a dozen other offenses of the federal government, the States, contingency lawyers, insurance companies, and the managed care industry.
posted by kablam at 7:19 PM on July 25, 2004


The USDA still lives the thalidomide decision. Other countries approved it with disastrous results. The FDA held off and was proven right. Forty years later they still take a cautious attitude toward new drugs, which is good. A clinical trial might test the drug in a few hundred or thousand people. If it is an important drug, it will be used by millions in the first year. Humans are sufficiently different that toxic effects may not appear in the clinicals, or at least appear in a fashion that they appear to come from the drug as opposed to being random occurrences. If x people get heart attacks is that significant? It can be hard to tell. For all its faults, I think the FDA is one of the better government agencies.
posted by caddis at 7:35 PM on July 25, 2004


But, caddis, even if the organization is run competently it still keeps drugs out of the hands of people who might be helped by them. It's one thing to have a (theoretically) neutral scientific body, supported by taxpayers, to judge safety and efficacy of drugs. It's quite another to give that body the ability to issue (de facto) laws.

We know that you're going to die without this drug, but we're not sure it'll save you. So, If you take it we're going to throw you and your physician in jail.

--XOXOXO,
FDA

posted by trharlan at 10:20 PM on July 25, 2004


Actually trhalan your physician can prescribe the drug and you can take it (as long as it is not a controlled substance like LSD) all without fear of prosecution. However, no one can actually sell you the drug unless it has been FDA approved. That approval does not have to match the condition for which the physician prescribes it.

The FDA now accelerates approval of drugs for life threatening conditions such as cancer. Also, getting into trials to take the drug while still experimental is now easier. Most of the time however, these unapproved drugs offer more hope than reality and frequently carry dangerous side effect profiles.
posted by caddis at 5:20 AM on July 26, 2004


Caddis, as someone who is attempting to flee the legal profession, all I know is that the BS I hear about frivolous legal suits doesn't make me want "tort reform." I'm not sure if it's possible to make frivolous suits less common without stamping out the rights of genuinely injured people. So, I'll err on the side of the trial lawyers on this one (not that I love them either).

And, I certainly don't trust President Bush's crowd to do tort reform--I don't want the US turned into Europe, in terms of the little guy's right, or lack thereof, to sue.
posted by ParisParamus at 5:25 AM on July 26, 2004


I'm not sure if it's possible to make frivolous suits less common without stamping out the rights of genuinely injured people.

Wha- wha- what?!

It's funny how, once ParisParamus steps out of the ideological abstract and has a little bit of contact with the real world, the poisonous rhetoric is replaced by tempered reason.
posted by jpoulos at 5:54 AM on July 26, 2004


I think most of PP's debates constitute tempered reason; he just happens to usually be on the opposite ideological side from most MeFites. I attempted to goad him into an argument on this in part because it would be interesting to do so with him in the mainstream and me in the minority for a change. He was too smart to fall for it. That doesn't mean I didn't mean what I said, just that my rhetoric could have been ratcheted back a bit.
posted by caddis at 6:37 AM on July 26, 2004


This issue isn't optimum for polarized argument, because there are just too many problems from too many directions to be able to put your foot down and say "these are the bad guys and these are the good guys."
BTW, caddis, I listened, trying to avoid snickering, to a dentist friend rant and rave against the FDA during a 3-HOUR DRIVE. For the entire time! I'm not sure I can think of a topic I could rant on about for even 1/2 hour.

Final note to all: have you ever heard of pharmaceutical compounding? That is, where (usually specialty) pharmacists mix up a special drug and maybe OTC and even herbal compound just for you? It is a popular and growing cottage industry. It is most popular and is widely used in veterinary pharma, too.
The drug companies and the FDA , however, are trying to incrementally ban it, starting with veterinary.
If you want to get ranted at by your veterinarian, ask them about it. I saw my dear, sweet, little old lady vet blow a fuse when I saw a poster about it in her office and asked.
posted by kablam at 8:01 AM on July 26, 2004


It's funny how, once ParisParamus steps out of the ideological abstract and has a little bit of contact with the real world, the poisonous rhetoric is replaced by tempered reason.

Nah, he still had to indulge in a bit of Europe-bashing, even though it was totally irrelevant.
posted by Summer at 3:48 AM on July 27, 2004


I love you, too.
posted by ParisParamus at 4:15 AM on July 27, 2004


And now for a semi-tangent: is there any possible way that the Axis of Evil does not include New York's Duane Reade drugstores, which are one every other block of much of Manhattan? Calling Mr. Spitzer--where are you?
posted by ParisParamus at 4:18 AM on July 27, 2004


Actually, apart from France, and probably most of Europe having an anti-competitive retail pharmacy industry, and most of Europe, apparently, being on maintenance doses of some non-FDA-approved passivity medication...
posted by ParisParamus at 4:21 AM on July 27, 2004


I don't know if anyone reads comments on four-day-old posts, but Marginal Revolution has a great post on the subject.
posted by trharlan at 10:41 PM on July 28, 2004


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