That's true, but it's not a slam-dunk case for rushing ahead without sufficient testing. There's a reason that "first, do no harm"[1] is considered one of the fundamental principles of medical ethics. Medical interventions can have disastrous side effects.[2]
It's not a slam-dunk case, just keep in mind it's very easy to measure the harm done by things like Thalidomide, but not so easy to measure the amount of people dead or maimed by not getting treatment due to the glacial pace of regulatory approval. "First, do no harm" could just as easily apply to not dragging your feet in giving someone potentially life-saving treatment.
I'm curious, are there any other examples than Thalidomide? It's a true horror story, but there should be a limit to how much precaution one disaster justifies in the future. Many other drugs with ultimately fatal but initially undiscovered side effects have made it through FDA approval, too.
This example is rather famous in the legal world because a) the drug was off-patent for many years before the problems were identified, and so there were many different manufacturers, and b) the problems were often not apparent until decades after exposure had occurred - two factors which make it very difficult to fairly ascribe liability to those who suffered avoidable injuries. This led to some innovative thing in damages/liability allocation which is now an essential part of understanding tort law.
I mention this because I've had some conversations with libertarian legal thinkers where they bring up this same argument of Thalidomide vs. opportunity cost - and its true that the barriers to approval were so low back in the late 50s that it's very unlikely such a drug could ever get on the market these days. Also, the effects were so drastic that that they were quickly noticed, and the number of birth defects ascribable to Thalidomide are in the low 10,000s. By contrast, millions of people are living with the impact of DES, and the magnitude of the affected class is also a factor in the legal significance of the damages formula. So any lawyer who's talking about balancing innovation and regulation in the drug market without addressing DES is being a bit disingenuous, and you should weight your judgment accordingly.
That's fascinating. The Wikipedia links cover the landmark nature of how liability was distributed, but I'm as curious about how liability was established. I don't know much about tort law, but is it essentially automatic that a manufacturer would be liable for a product that caused such damage, no matter how difficult it would have been for them to have been aware of that potential?
FYI I like tort law but am not a lawyer, just a law school dropout. My view is that liability depends on the degree to which the manufacturer was in a position to be aware of the risks, and also on the relative ability of the consumer to discern such risks.
To take the latter point first, drug consumers are generally in a poor position to evaluate the risks of a given medication. If I set up a wheel manufacturing business, and sell square wheels, you are in a poor position to complain about the resulting bumpy ride [1] because the superiority of round wheels is so glaringly obvious. Unless you hold a medical or pharmaceutical degree, though, your ability to evaluate a drug's safety and efficacy is probably very limited. I'm smart enough to read and get the gist of a biochemistry paper to have an idea of what a drug does, but nowhere near knowledgeable enough to review or spot all but the most egregious errors. So while I am the sort of person who reads all the fine print on drug labels and sometimes digs into the academic research, in the end I'm taking a great deal on faith whenever I take medicine. by contrast, the drug manufacturer has not just one biochemical expert, but whole teams of them. This certainly puts them in the best position to foresee and even look for potential problems.
Now back to the first point: drug discovery is not the exact science we'd like it to be due to the gaps in our knowledge. Accordingly, drug companies must be given some leeway, compared to other manufacturers who enjoy a greater degree of foreseeability. suppose I set up a ladder company, but the ladders I manufacture employ such thin metal rungs that they cannot bear any weight above 100 pounds. They look good enough, but soon consumers begin suffering accidents when using them. I could not claim the accidents were unforeseeable since the tensile properties of metals are so well known and the tests are so easy to perform, that I should have realized the risk when designing my product, never mind before shipping it! It would be unfair to hold drug manufacturers to that degree of liability, but on the other hand a) experimental protocols exist precisely to address this problem and are widely understood within the drug industry, and b) since DES was on sale from 1941 onwards and class action lawsuits were brought against manufacturers in the late 1960s, more than enough time had elapsed for industry participants to have apprised themselves of the risk and limited the risk to consumers to a greater extent than they did.
If you read Judge Mosk's opinion, in footnote 24 [2] he summarizes a 7-point test for establishing (rather than allocating) liability. The answer you seek is there:
The suggested requirements are as follows:
1. There existed an insufficient, industry-wide standard of safety as to the manufacture of the product.
2. Plaintiff is not at fault for the absence of evidence identifying the causative agent but, rather, this absence of proof is due to defendant's conduct.
3. A generically similar defective product was manufactured by all the defendants.
4. Plaintiff's injury was caused by this defect.
5. Defendants owed a duty to the class of which plaintiff was a member.
6. There is clear and convincing evidence that plaintiff's injury was caused by a product made by one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiff's injury.
7. All defendants were tortfeasors.
This is a very brief abstraction of a key theory in a law review article written by a student at Fordham University, referred to in the opinion as 'the Fordham comment.' This unusually influential article [3] basically sets out a whole theory of 'enterprise liability' and damages allocation addressing why the manufacturers should share liability in the context of the DES in much greater detail, although it's rather painful to read for people who are not legal nerds as it approaches some sort of footnote event horizon. Whether the Sindell court's findings allow the legal academy to be held liable for typographically-induced brain trauma remains unresolved.
Doesn't exactly answer your question, but here's a list of formerly approved drugs that were withdrawn due to risks to the patient (22 in the last decade).
That's kind of my point. Does that mean we should ratchet up FDA's precautionary attitude dramatically further, to the point where that number is perhaps 2 instead of 22? I don't think so. There's a sensible tradeoff to be made, but tuning exactly where that tradeoff should be isn't the kind of thing you settle with dramatic examples of things gone wrong.
It's difficult to measure how many lives were saved or made substantially more livable because the FDA was not more cautious than it has been. Surely that number is not zero, and perhaps it's greater than the net harm done by drugs whose effects might have been caught by more prolonged testing. I don't think we know.
There's another aspect to tradeoffs where Lumiracoxib was introduced to compete with Celecoxib. Celecoxib has a known acknowledged issue where it increases the risk of heart attack although its relatively easy on the liver. Unfortunately Lumiracoxib occasionally destroys livers. So superficially you'd think having both on the market would be a great idea, because people with a personal or family history of liver disease would probably be better off with Celecoxib but people with a personal or family history of heart attack would be better off with Lumiracoxib. However, worldwide in general all the .gov disagree with me, and as the new guy on the block Lumiracoxib more or less got the boot. It never even made it to market in the USA as far as I know. Probably has something to do with relative incidence of fatality.
BTW these are not made up names although they look like it. Google them for a good time if you're bored. I'm more interested in the chemistry issues than the politics or biochemisty, so I'd be more comfortable (authoritative?) talking about the location of the methyl groups than liver toxicity, but my first paragraph has no known intentional errors (although it probably has some unintentional errors LOL).
I guess the point of this ramble is if a company exists to provide highly personalized customized services, then using a metric of "joe average" is probably not overly meaningful. The response of joe average to a disease percentage is maybe not relevant to the response of someone with a high percentage to the same result.
We have a pretty good medical system designed for joe average, and its intersection with radically personalized services is unsurprisingly going to be an epic disaster.
Another interesting side effect is most mass shooters were on anti-depressants, although that's probably not the kind of direct fatal side effect you're looking for. Its a challenging google game to track down the toxicology reports for each mass shooter weeks after the smoke clears and identify which anti-depressant they were on at the time. Sometimes its a different kind of med, sometimes they're not on any med at all, although thats kind of rare.
[1] https://en.wikipedia.org/wiki/Primum_non_nocere [2] https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_cris...