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Vaccines and Victims: limiting liability for Pharmaceutical companies
Posted by: McQ on Friday, May 05, 2006

Harry Reid issued a statement concerning the White House pandemic flu plan. It's the usual mix of faint praise and "we can do it better" rhetoric one has come to expect from the left side of the isle. But one paragraph struck me as worth discussing:
"Finally, we need to make protecting the American people - not special interests - our highest priority. To accomplish this task, we need to address a provision that was inserted into legislation in the dead of night without any debate last December. This new law gives unprecedented and sweeping liability protections to the pharmaceutical industry even when Americans are harmed by their medicines. The liability provisions do not provide for compensation to victims who are injured and shield manufacturers even if their actions constitute reckless wrongdoing. I support reasonable protections for vaccine makers whose products may cause unforeseen or unpreventable harm, but protections must be narrowly tailored and must be accompanied with protections and compensation for injured patients."
Aside from the complaint about a provision which was, per Reid, "inserted into the legislation in the dead of night without any debate", I'm interested in the fact that liability protections have been afforded the pharmeceutical industry. On the face of it, and having not read the provisions, I find that to be more good than bad. One reason is because we are completely at the mercy of foreign providers for flu vaccine. If there is indeed a pandemic looming, that is not a position we wish to find ourselves. However, because of the lack of such liability protection has all but dried up vaccine providers here in the US.

Medicines and vaccines have different effects on different people. And we all risk our health to some degree when we take any medicine. Side effects found in testing are stated and expected, to include a certain percentage of the population for which the dose may be lethal. For most of us, it's a crap shoot everytime we take a new med.

One of the primary reasons the FDA exists is to ensure rigorous testing of new drugs and vaccines and determine whether the risk to benefit ratio is acceptable. Few, if any meds are approved that don't carry a risk for someone. It has, for the most part, done a good job (with some spectacular exceptions). I won't go into how I believe its procedures are sometimes too extensive and hold good medicines off the market longer than is necessary. But for the most part, our system seems to work.

What doesn't work is the expectation that life is risk free and that we should assume it is and thus are entitled to unlimited compensation when our false assumption doesn't prove true. While large corporations like oil and pharmaceutical are popular targets for politicians, our lives have been immeasurably helped by their products. They should certainly take reasonable responsibility and liability for their products. But that liability shouldn't be unlimited and open ended. "Reckless wrongdoing" is one thing. Acceptable risk is another. No one will support a company which recklessly endangers the health of consumers.

However, because of the unique makeup of every human being we have to accept the risk medicines and vaccines bring as weighed against the vast good they do. We also need to understand and accept the consequences of using them if we so choose too without expecting to own the pharmaceutical company should our expectations not be met. Limiting liability, on the whole, is a smart move by Congress, especially if we want to be independent of foreign providers who may provide an inferior product and puts even more consumers at risk with no legal recourse.
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Previous Comments to this Post 

But the liability is not "unlimited" — it’s limited to what a trial by a jury of peers (and overseen by a judge and an appeals system) would award.
Written By: Mithras
And there are no constraints on the award or acknowledgment that there is an inherent risk in taking medicine which the person taking it implicitly accepts by choosing to do so.
Written By: McQ
Although limiting liability just reeks of anti-free market leftism.
Written By: Doug A
URL: http://
Reid sounds like the lawyers doing scare commercials about lawsuit reform along the lines of "Do you want the government limiting the amount of damages you can receive if you’re harmed by (medicine/lawn mower/fill in the blank)?

What they don’t mention is that, at least in OK, the limits were being put on the ’pain & suffering’ awards only; ACTUAL damages were still pretty much wide open. But the lawyers make less money that way.
Written By: Mark
One of the primary reasons the FDA exists is to ensure rigorous testing of new drugs and vaccines and determine whether the risk to benefit ratio is acceptable.
I must admit that I don’t understand how a company which faithfully complies with the FDA regulations could be found liable. Although I’m not sure how suing the federal government would be an improvement.

So we have the worst of both worlds. A large amount of federal hoop-jumping which delays the entry of new drugs but doesn’t provide any protection to the company against liability.
Written By: Mark A. Flacy
URL: http://
Mithras, and that’s why drug companies would rather produce the special blue pill (which Dale’s comment spam system will not let me name) than vaccines. Less risk and more money. It’s a conditioning mechanism.

The trial lawyers lobby is happy with your reasoning because it allows them to gin up a scandal at will. Look at the breast implants frameup and countless others. We can note the comfortable alliance that democrats and trial lawyers have. I guess there is the "pretense" that they are "helping" people instead of lining their pockets. You reap what you sow.
Written By: capt joe
URL: http://
Although limiting liability just reeks of anti-free market leftism.
How so, given I’ve agreed they should be resonably responsible in terms of liability?

For instance, when a vaccine has side effects and those side effects are made known prior to use, anyone who chooses to use the vaccine does so knowing what could possibly happen to them. At that point, as far as I’m concerned, the manufacturer’s liability ends. The consumer has been informed and made a decision. If the med acts upon them in a way they were told it might, why is that something the company should pay for?

If, in fact, it reacts in a way that was not made known to the consumer, then I think there is a liability question there.

But I’m against unlimited liability simply because the consumer chose to take a med they understood at the outset could react in the way it did.

There is an implied risk in taking every medicine and the only thing a consumer can demand is the knowledge necessary to assess the risk and make a reasonable decision.

For instance, if you’re alergic to penicillin, then you are probably alergic to it’s derivatives. If a company puts out a med and doesn’t inform the public it is a derivative, sue their pants off. If however, that information is readily available to all who would consume the drug and a consumer doesn’t avail themselves of the information prior to taking the drug, that’s not the drug company’s fault. Why should they have to defend themselves from consumer ignorance?
Written By: McQ
How so, given I’ve agreed they should be resonably responsible in terms of liability?
First of all don’t get me wrong; I don’t necessarily disagree with you. I agree that if a consumer ignores readily available information about a drug to their detriment, tough luck. Frankly the pharma company should have zero liability in such cases.

Where things get messy is when a situation occurs as a result of information that neither the consumer nor the pharma company were aware of. In such a case is the pharma company liable or not? If so is their liability limited? In this situation I see limits as problematic since "reasonable" is incredibly subjective. In this case I think laissez-faire works best at defining the balance point.
Written By: Doug A
URL: http://
Where things get messy is when a situation occurs as a result of information that neither the consumer nor the pharma company were aware of. In such a case is the pharma company liable or not?
Possibly. Especially if it can be proven that further testing would have yielded that effect.
In this situation I see limits as problematic since "reasonable" is incredibly subjective.
We may be talking about two different aspects of this problem. It is reasonable to expect meds to act on people in the manner claimed by the drug company. It is equally resonable to expect there to be exceptions as described in the side effects. It is not reasonable then to expect a pharaceutical company to be liable for expected results, even if they aren’t optimum.

Last, it is reasonable to expect there to be no other side effects than those listed.

In the situation you’re describing, I believe it would be reasonable for the person or persons that are seeking redress to sue the company because the latter situation applies.

In that case I’m with you ... l-f works best. But I don’t see those situations or circumstances as being in the majority. I’m more concerned about open-ended awards being applied in the face of what most reasonable people would consider proper behavior by the pharma that happens to end a tragic occurrance because of a publicly known side effect and patient’s choice to risk it. I don’t believe those cases should have any legal standing (just as I don’t think a 40 year smoker should have any legal standing to sue tobacco companies, given the public warnings available about tobacco usage).

It is that scenario which ran our vaccine producers out of business previously.
Written By: McQ

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