Unless you have succeeded in watching 100% of your TV using a DVR and completely avoided commercials forever, you've seen these commercials. The prominent Law Offices of Dewey, Cheatham and Howe declare in sonorous tones that the drug Bftsplkabib has been linked to significant side effects, and if you or a loved one has experienced any of these, such as teeth growing out of your fingers, knee cancer, delirium or other injury or serious death, you should call them to get justice.
We are so glad that attorneys now have the privilege of advertising on TV, aren't we. They don't have to be ambulance chasers anymore; they just need to advertise in the hope of winning the lottery with a class-action suit, those ones where the lawyers walk away with swimming pools and Rolls-Royces and the actual injured party gets $78.42. Because of one of those lawsuits, the State of Maryland recognized me as "black", but I digress.
Most of those ads that don't relate to auto injury cases have to do with pharmaceutical companies, and that's the topic of today's happy piece. The thesis is quite simple: Given the fact that the FDA has to approve a new drug before it can be released to the public, at what point should pharmaceutical companies be insulated from lawsuits associated with the use of their products?
Why should we have a hard time with this? To me, as long as we're not talking about contamination in the product, there should be complete protection from lawsuits for the drug companies whose untainted product is provided through the prescription process (sorry for the alliteration).
Why? Because of the Side Effect Principle; i.e., all outcomes of the use of a drug are side effects. You take acetylsalicylic acid (aspirin) to reduce pain, which is its most common (side) effect, pain inhibition. It is also, of course, a blood thinner (another side effect) and a stomach irritant (yet another).
Aspirin is approved by the FDA for use as a pain reliever, with warnings on the label about the other effects. I daresay that if someone taking aspirin bled to death from the stomach from excessive use, they'd have their case thrown out in court if they tried to sue. We know about those effects, because aspirin is so widely used that that there is an immense statistical baseline to show that in 83% of patients, it relieves pain, and 2.3% have gastric bleeding, and so forth.
Obviously we have that data because pretty much everyone has pain and gazillions of aspirins have been taken. So what happens with drugs that are not for headaches, but rather for much more obscure conditions? The manufacturer has to submit to the FDA for testing for safety and effectiveness, and only when the right clinical studies show whatever FDA thinks it needs, can the drug be approved.
However, you can only study a drug in so many patients, generally not enough to be able to document every side effect, for which you would have to test huge populations. We know that. It's the price we pay for effective medications. So why, then, do we not simply acknowledge that truth and hold the drug companies harmless from financial damages once they pass FDA testing?
Stuff happens, very often without malice. Drug companies are in business to make a profit for their shareholders, which they can only do if they produce effective medicines. To prevent their being produced willy-nilly, we have the FDA to be the Federal gatekeeper, testing away to make sure drugs pass muster before being released. Make the "gate" real.
We know that, particularly for rare treatments for rare maladies, eventually we'll see unforeseen side effects. We are sad for the patient when it happens, but stuff happens. The drug companies do not want to see injured patients; they want their products to be seen as effective and safe, and should be assumed to have taken appropriate steps -- as should the FDA be equally assumed.
The proper outcome in such a case is that the insurance company is the accountable party, not the pharmaceutical manufacturer. The job of the insurer is to reckon the risk and charge for it. They themselves have lists of drugs they will and will not pay for, based on perceived risk. If the patient takes on the risk by agreeing to a drug outside the insurer's approval, they take on the obligation in the event of unforeseen harm.
And a note -- this also is colored by the post hoc, ergo propter hoc rule, i.e., that just because you took the drug and your toes turned lavender doesn't mean that it was the drug that tinted your tootsies.
Although the outcome would be that we'd get some high-end arguments between patients and their insurance companies, those are the right arguments to have. If we suitably indemnify drug makers if they do their job properly and if the FDA has blessed their product, the liability cost built into pharmaceuticals will take a dive, and the price of the products to the public will drop as well.
Which is better -- a lower across-the-board cost for drugs for all, or a fat payment from a lawsuit to one or two aggrieved parties, most of which goes to their lawyers. I vote for "A".
That would be a side effect I'd like to see.
Copyright 2017, 2014 by Robert Sutton
