Warning: contains FDA approved drug

The tort system is the favorite whipping boy of the anti-regulation crowd. That's because once you remove regulation, something the Bush administration has championed and done effectively, the only recourse someone injured by the fraud or negligence of a product or drug manufacturer is through a lawsuit for damages. Since the anti-regulation crowd serves Big Pharma and their cronies, this is the perfect solution: no constraints. The propaganda machine, aided an abetter by a compliant congress and a business dominated media, has been extremely successful in promoting the idea that tort suits are overwhelmingly "frivolous" (e.g., the McDonald's hot coffee case) and are jamming the courts, although tort suits constitute only about 10% of the docket, the majority being taken up by routine business cases like contract disputes. But if you want to see frivolous lawsuits you don't have to look any farther than the MPAA and RIAA copyright actions against teenagers and grannies. But that's another story. Meanwhile the tort suit is one of the most important behavior modifiers for careless manufacturers. But "meanwhile" might not last much longer, if a case currently before the Supreme Court goes the way Big Pharma and the Bush administration want it to. They want labeling decisions made by the Food and Drug Administration to pre-empt an cause of action brought by any person under the laws of their state:

The pharmaceutical industry, and the Bush administration, say patients are amply protected by the Food and Drug Administration, which approves drugs after reviewing their benefits and risks. In the case called Wyeth vs. Levine, business groups and the government are asking the Supreme Court to impose strict new limits on lawsuits against drug firms.

Such suits, industry advocates say, can expose drugmakers to a conflicting hodgepodge of jury decisions in multiple state courts that often contradict the expert judgment of the FDA when it decides what warnings belong on a drug label. The FDA-approved label, they argue, should trump the findings of juries who lack the same expertise. Wyeth and its supporters want the high court to rule that the FDA's powers pre-empt state court lawsuits that claim stricter drug warnings were needed.


That logic is known as the pre-emption argument, which maintains that the federal government has the last word on drug labeling. And, therefore, government warnings override legal challenges after a drug has been approved. (Bernadette Tansey, San Francisco Chronicle)

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Information obtained by Representative Henry Waxman (D., CA) show that neither FDA staffers nor FDA experts agree with the pre-emption position of the Bush administration:

"We know that many currently approved drug labels are out of date and in many cases contain incorrect information," the committee report quoted top FDA official Dr. John Jenkins as saying in a 2003 internal policy memo.

What makes the whole thing especially outrageous is that the Bush FDA now requires approval to change a warning label when new adverse event information becomes known to the manufacturer. In previous administrations the FDA actually encouraged drug makers to update their labels immediately.

A recent Supreme Court decision upheld federal pre-emption clauses in legislation for medical devices, but this language isn't in the same statutes concerning drugs. Nevertheless, Big Pharma and the Bush administration argue it is "implied."

There is now a developing consensus, even amongst in the public health establishment that FDA is a broken agency. Thus to maintain that this hollow husk of a regulatory agency's warning labels is all we need to protect consumers is a very cruel joke.

But cruelty and bad jokes are a hallmark of the Bush administration. 76 days left.

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Stella Liebeck, the 79 year old victim of scalding hot coffee, received 3rd degree burns on 6% of her body. She spent 8 days in a hospital and received multiple skin grafts If you any way try to mock or call her case frivolous you are simply a sadist. I have never understood the need to mock her suffering.

McDonald's served their coffee at a temperature (185 degrees) that was determined based on taste and aroma not customer safety (they now serve their coffee in the 150's and most people let it cool 10 to 20 degrees before drinking it). Hundreds of people were burned by McDonald's coffee and until that lawsuit they seemed not to be concerned by the pain and suffering they unnecessarily caused. There are many "frivolous" lawsuits--that case was never even close to being frivolous.

By floormaster squeeze (not verified) on 04 Nov 2008 #permalink

floormaster: Please click the link in my post for "McDonald's hot coffee case". It is the ATLA account.

I should have been clearer; I realize I was repeating what was known elsewhere and what you linked to. I did not mean to say you were the one mocking Stella. It is just such an appalling case of media manipulation and the incurious echo chamber that it still peeves me. There are a lot of media cases from the 80's and 90's in which the actual agreed to facts of things were far different than the public's perception.

By floormaster squeeze (not verified) on 04 Nov 2008 #permalink

"the Bush FDA now requires approval to change a warning label when new adverse event information becomes known to the manufacturer"

That right there be the problem. It's not impossible to change a label to make it more safe, more accurate, etc. It's just really, really hard and expensive. The process involves a lot of time, money, lawyers, quality experts, clinical data processing contractors, etc. So there's an incentive not to do it.

I do question, though, this particular case--it does seem that the package label does state that injecting as IV push was risky and that the nurse who performed the injection screwed up. The supervising doc even admits it was their screw-up. So, shouldn't it fall under malpractice? The victim's whole argument rests on, "Well the warning shoulda been BIGGER and MEANER." Honestly, where does malpractice leave off and manufacturer liability begin? I see a serious problem with clinicians who commit malpractice or simply half-ass patient care for whatever reason, then blame drug manufacturers for not making the product literature shiny and sparkly enough, blame patients for not being "proactive" enough, blame pharmacists for not double-checking their work (same docs tend to read the riot act to pharmacists who dare question their logic), and so on.

I don't have a problem with Big Pharma taking on that kind of responsibility, but think about this for a minute: Do you really want the process of drug-prescribing to be idiot-proofed by a bunch of lawyers cracking the whip at a bunch of geeks? The kind of solutions that they are capable of implementing are, like, making a lot of diagnostics and prescribing computerized (i.e. do-able by a PA rather than a doc), pushing to make more things OTC, removing physicians' ability to use things off-label, making more drugs in pre-filled tamper-proof systems so they physically cannot be dosed or delivered differently from the indications in the clinical trials. If Big Pharma has an incentive to do all the doctor-thinking for you, do you really want them to do that?

Lora: The legal issue here is preemption. If this challenge is successful it will affect all sorts of liability issues, which will be beyond reach of someone who is harmed and not get a chance for their day in court. I think it's hard to know if the facts warranted the judgment here from the summary reports, which are often inaccurate. A jury heard the facts and made their own judgment, which is what I go on pending further info.

The McDonald's case is famous because it can be summarized in a sound bite that sounds ridiculous. Since most people don't have the time to pay attention to the details of everything that happens, these pithy summaries often *become* the reality that everyone accepts about the world, even when they're grossly wrong. Some really dismaying fraction of the world is run on this theory.

A related phenomenon is finding something horribly evil that can be pithily summarized in a harmless-sounding way. ("Torture? We're not torturing these detainees! We're merely making them stand around for a while, getting them a little wet, and keeping them up late." "Give terrorism suspects trials? What, do you want Osama Bin Laden to repeat the OJ trials?")

By albatross (not verified) on 07 Nov 2008 #permalink