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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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March 11, 2013

Suing A Generic Drug Maker: When And How?

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Posted by Derek

The great majority of prescriptions in this country are for generic drugs. And generic drugs are cheaper in the US than they are in Europe or many other areas - they're a large and important part of health care. And as time goes on, and more and more medicines move into that category, that importance, you'd think, can only increase.

So a case that's coming before the Supreme Court later this month could have some major effects. It concerns a woman in New Hampshire, Karen Bartlett, who was prescribed sulindac, one of the non-steroidal anti-inflammatory drugs that have been around for decades. All the NSAIDs (and other drugs besides) carry a small risk of Stevens-Johnson Syndrome, which is an immune system complication that ranges from mild (erythema multiforme) to very severe (toxic epidermal necrolysis, and I'm not linking anyone to pictures of that). Most unfortunately, Mrs. Bartlett came down with severe TEN, which has left her permanently injured. She spent months in burn units and under intensive medical care.

But now we come to the question that always comes up in modern life: whose fault is this? She sued that generic drug company (Mutual Pharmaceutical), and won a $21 million dollar judgment, which was upheld on appeal. But the Supreme Court has agreed to hear the next level of appeal, and a lot of people are going to be watching this one very closely. Mutual's defense is that the original manufacturer of the drug (Merck) and the FDA are responsible for these sorts of things (if anyone is), and that they are merely making (under regulatory permission) a drug that others discovered and that others have regulated over the decades.

A case with some similarities came before the court in 2010, Pliva v. Mensing. That one, though, turned on the labeling language, and how much control a generic company had over the label warnings. "Not much", said the court, which limited patients' ability to sue on those grounds. That seems proper, but, as that New York Times article shows, it also has the perverse effect of giving people more potential recourse if they take a drug as made by the original manufacturer as opposed to the exact same substance as made by a generic company, which doesn't make much sense.

This latest case does not argue label warnings; it argues that the drug itself is defective. Now, it does not seem fair that a generic company should have to pay for the bad effects of a drug it did not discover, did not take through the clinic, and did not reap the benefits of during its patent lifetime (when any bad effects in the real world should have become clear). On the other hand, there are problems with going the other way and sending all lawsuits back to the original developers of the drug. After all, sulindac has been on the market since the early 1980s, under the regulatory authority of the FDA, which could have pulled it from the market at any time and has not. The agency has also authorized several generic manufacturers to produce it since that time. From a regulatory standpoint, how defective can it be? Allowing the originating company to be sued for all the generic versions, after such a long interval, would seem to open up a "find the deep pockets" strategy for everyone who comes along. (And as that older post argues, if this is made the law of the land, it will add to the costs of current drugs, whose prices will surely then be adjusted to deal with decades of future liability concerns).

And if I had to guess, I would think that the Supreme Court is going to find a way out of coming down firmly on one side of the issue or the other. A 2008 decision, Riegel v. Medtronic, said that medical device makers were, in some cases, shielded from state-level tort claims because of regulatory pre-emption. (But note that this isn't always the case; nothing is always the case in law, which is so close to a perpetual motion machine that you start to wonder about the laws of thermodynamics). But an earlier attempt to use these arguments in a pharmaceutical case (Wyeth v. Levine) got no traction at all in the court. But to avoid having either of those outcomes in the paragraph above, I still think that the justices are going to find some way to make this more of a federal regulatory pre-emption case, and to distinguish it from Wyeth v. Levine.

And if that happens, it will mean what for Karen Bartlett? Well, it would mean that she has no recourse. Something terrible has happened to her, but terrible things happen sometimes. That's a rather cold way of looking at it, and I would probably not be disposed to look at it that way were it me, or a member of my family. But that might end up being the right call. We'll see.

Update: as detailed over at Pharmalot, the Obama administration has reversed course on this issue, and is now directing the Solicitor General to argue in favor of federal pre-emption in this case. But two former FDA commissioners (David Kessler and Donald Kennedy) have filed briefs in support of Bartlett, arguing that to assume pre-emption would be to assume too much ability of the FDA to police all these issues on its own (without the threat of lawsuits to keep manufacturers on their toes). So there's a lot of arguing to be done here. . .

Comments (30) + TrackBacks (0) | Category: Regulatory Affairs | Toxicology


COMMENTS

1. Anonymous on March 11, 2013 8:41 AM writes...

So everyone who suffers a GI bleed from taking aspirin can sue Bayer? Perhaps it is time to stop inventing drugs until tort lawyers are banded for stupidity.

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2. Vader on March 11, 2013 8:47 AM writes...

"And if that happens, it will mean what for Karen Bartlett? Well, it would mean that she has no recourse. Something terrible has happened to her, but terrible things happen sometimes. That's a rather cold way of looking at it, and I would probably not be disposed to look at it that way were it me, or a member of my family. But that might end up being the right call."

It *is* the right call.

The precedent set by the Cutter case, in which Cutter was found not negligent but nevertheless liable, set a terrible precedent. It has generated a tort industry so powerful we need not look for it to be overturned in our lifetime.

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3. Hap on March 11, 2013 9:00 AM writes...

1) Just because something bad happens doesn't make it someone's fault, and shouldn't require someone to pay for it.

2) Doesn't the idea of a defective product imply that either 1) the generic manufacturer made it incorrectly (in which case, it is legitimately their fault) or 2) the drug was unsafe from the beginning (which would seem to be the FDA's fault unless the risks and safety profile were hidden from them, which would then make it the developer's fault)? There doesn't seem to be a reasonable point for the generic manufacturer to be at fault if 2) is the rationale.

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4. Pete on March 11, 2013 9:25 AM writes...

Does this have implications for manufacturers and sellers of firearms and ammunition?

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5. Anonymous on March 11, 2013 9:26 AM writes...

I agree. Bad stuff happens. Doesn't mean someone is to blame. When it says on the label that "in rare cases, side effects may include ...", doesn't that mean that there WILL be rare cases where those side effects occur? How can she sue for that? If it was found that the effect occurs more often than was represented on the label, that would be reason to sue, but that doesn't seem to be the case.

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6. MTK on March 11, 2013 9:28 AM writes...

I can't see logically (as opposed to legally) how the original manufacturer, Merck, can be at fault here.

While Merck did discover, test, and market the drug initially, I'm assuming that they are no longer actively doing so. The manufacturer of the drug that caused the damages was the generic manufacturer. They presumably knew that certain adverse effects could occur and assumed the risk and responsibility for those effects once they decided to make and market the drug. No one told them they had to make the drug. They voluntarily chose to do so.

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7. Bear on March 11, 2013 10:06 AM writes...

I'm confused. Is Bartlett suing because sulindac had _undisclosed_ defects, when TEN seems to be a known potential side effect of a drug in use for around 30 years? Or is she arguing that when she rolled the dice to gamble on missing a listed adverse side effect, she should be _guaranteed_ a win? (Like to see her try that in Vegas.) Did she read the medication inserts? Did her doctor/pharmacist give her the inserts?

The articles don't make clear when, or how abrupt, the TEN onset was. Did she noticed skin falling off and think, "Oh, look. How odd. Well, no need to tell my doctor about something like that" until it became critical? Did her doctor notice, and ignore it because of the incredibly low incidence of that side effect? Did it occur too fast to be noticed and treated beforehand?

Assuming any fault, is she suing the right party, or just the deep pockets?

A follow-up link says that TEN occurs in 1-6 in a million of users of the NSAIDs (depending on specific type). Seems to me she had worse odds of being struck by lightning and ending up in the burn ward anyway (odds of 1 in 775,000 over a lifetime).

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8. will on March 11, 2013 10:08 AM writes...

hap has it right - if it's a known side effect, and the dr. advised her of risks/reward of the potential medication, then sometimes bad things happen. our rush to litigate and assign blame in every instance is not healthy

(assuming of course that drug was manufactured, stored, administered properly...)

@ 4 - our congress, in its infinite wisdom, has specifically passed laws preventing gun manufacturers from liability for downstream uses of their products

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9. Bear on March 11, 2013 10:24 AM writes...

@8. will: "our congress, in its infinite wisdom, has specifically passed laws preventing gun manufacturers from liability for downstream uses of their products."

Correction: They passed a law protecting firearms manufacturers against liability for downstream MISUSE of their products. They can (and have- successfully) still be sued for an actual defect or deliberately marketing a product FOR misuse.

Back to sulindac. Side question: Given a maximum incidence rate of 0.0006%, how did researchers even manage to definitively tie TEN to the NSAIDs, and exclude other environmental (or genetic) causes?

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10. RB Woodweird on March 11, 2013 10:34 AM writes...

There should be a small fund set up when a drug goes generic into which manufacturers pay a small sum per year or per unit sale which goes to compensate people like Ms. Bartlett. It could be administered without lawyers.

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11. anon the II on March 11, 2013 11:12 AM writes...

@ #10

"It could be administered without lawyers."

That's pretty funny.

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12. Anonymous on March 11, 2013 11:42 AM writes...

When skim reading the court papers I was struck by "but the district court dismissed
Bartlett's warning claim because her prescribing doctor admitted that he had not read the box label or insert"

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13. Bear on March 11, 2013 12:10 PM writes...

@12: "...her prescribing doctor admitted that he had not read the box label or insert"

That answers a couple of my questions. So...
Bartlett is just suing the deep pockets.

I must be unusual; I actually read those inserts when I get a new medication (usually some OTC item). But then... I've been criticized for reading contracts before signing, too.

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14. Another Derek on March 11, 2013 12:11 PM writes...

@10 and 11:
There is such a scheme for vaccines. It was established to ensure that vaccine manufacturers didn't just quit the market but would continue to develop and sell vaccines, given that vaccines carry some risk of causing injury and are administered to huge numbers of people. As I understand it, you basically cannot sue in the usual fashion for an alleged vaccine injury, but have to deal with this specialized scheme, where proof of causation is required (so the injury at least has to be something plausibly related to vaccine administration) but no proof of fault. I don't believe it is administered without lawyers, however.
It makes a lot of sense for vaccines, where there is societal benefit to vaccination (herd immunity; and avoidance of the cost of treating of those whose illness was prevented by vaccination, which is generally at least partly borne by society as a whole) but individual benefit is harder to establish - are you ever going to be exposed to polio or TB and need to be immune to them, for example.
But for therapeutics, where there is clear individual benefit, the question is slightly different - who should bear the risk of a known side effect (or perhaps even an unknown one): the individual who benefits from the drug but risks the side effect, the manufacturer who profits from making and selling the drug, or society as a whole? And if the manufacturer, then what to do when drugs become generic, as here? Here it seems basically that the individual bears the risk unless they can somehow show "wrongdoing" on the part of the manufacturer - that the drug was just unduly dangerous, however that is defined; elsewhere it seems that there may be "no-fault" schemes (I believe that there are some governmental schemes in Europe for thalidomide victims; some countries - New Zealand, for example - have "no-fault" accident compensation schemes, but I don't know if they extend to drug injuries). It's not clear to me what the best solution is.

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15. John Wayne on March 11, 2013 12:53 PM writes...

Health care is just like buying anything else; caveat emptor.

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16. Hap on March 11, 2013 2:55 PM writes...

12: Wouldn't that make the doctor the (or at least an) appropriate target? He was certainly in the best position to assess the risk and benefits of the drug, whether others could be used instead (and what their risks and benefits are), and what his patient might value most so that the best course of action could have been chosen. Not doing those things perfectly isn't malpractice, but not taking the basic steps to know what the risks of the drug are (not reading the package insert or the PDR entry for the drug) and thus not doing them at all should be.

TEN is a really bad cost, but if we insist that drugs can have no potential safety issues (or at least no severe possible side effects), then I'm not sure how many drugs there will be. That probably will be a good situation for almost no one.

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17. ptm on March 11, 2013 4:30 PM writes...

Whose fault is this? God's if you believe in him, or nature's if you don't. Sue them.

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18. fat old man on March 11, 2013 6:39 PM writes...

OK, everybody here seems to be writing like a scientist, and I'm no lawyer, I just listened to some mp3 lectures on business law, but from what I picked up from them, there is a concept called strict liability that means that no matter how high the quality of a product, if the customer has suffered damage from it they are entitled to compensation from the manufacturer. There are endless examples of successful plaintiff cases based on strict liability, many of which are from drugs, even one going through the courts right now from a drug candidate in clinical trials. On the other hand, the defendant can argue that the plaintiff is assuming some level of risk by using the product, and the outcome of the case depends on ?? (who knows). But it certainly earns a great living for huge numbers of lawyers.

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19. Biased Agonist on March 11, 2013 6:42 PM writes...

I agree with you Derek: at a personal level this is a true human tragedy.
At the the population level, however, this is a case of personalized medicine gone the other way (serious adverse reaction).
The difference here is that no one is responsible: the drug has been around for decades and the risks of developing TEN, albeit small, were known, irrespective of who has made the damned molecule.
The philosopher Jean-Paul Sartre would have taken this as yet another evidence that the Universe absurd (or insensitive to our lot, at the very least).
The sad truth is that a drug is a poison that scientists and physician were able to tame.
...except in some circumstances.

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20. Sisyphus on March 11, 2013 9:09 PM writes...

Blame George W. Bush and that evil Cheney guy, too.

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21. Mad Dog on March 11, 2013 11:15 PM writes...

@15 Only to a point. Health care is much more personal than most other items. I think that there is a serious problem with the societal calibration of expectations when it comes to medicines.

@16 already brought this up that to expect every medication to be 100% effective and 100% safe is not reasonable....but that IS the expectation.

Blame is an ugly word; and tort attourneys are well suited to wield it. Patients and doctors are partially to blame. Going on a new medication should be weighed as seriously as having surgery; however neither the majority of patients nor doctors look at it that way.

If a pharma company makes false or misleading statements about effect or adverse outcomes, then yes, there should be some recourse. But in this case, the medication is beneficial to many and the potential harms caused are known. If the doctor AND the patient treated the pharmaceutical intervention as a serious thing (like surgery), I think that a heightened sense of awarenss could have caught the side effects earlier.

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22. Anthony on March 12, 2013 12:25 AM writes...

Some sort of side-effect compensation scheme, as discussed in #14 above, might be worthwhile, if it reduces the liability premium we pay for drugs. Establish a fund, charge a tax on each drug based on the known risks, and use the money to pay for people who are seriously injured by a drug.

The biggest problem I see is that there would have to be some line drawn as to what is a serious enough side effect to receive compensation - will the fund pay for two aspirin if your drug causes a headache? (What if it's aspirin which *caused* the headache?) Obviously, death or disfigurement should generally be compensated (unless the death or disfigurement was caused by the drug failing to act, perhaps?), but how do you set a cutoff? No claims under $1,000? That's going to create a market in doctors who treat drug side-effects for far more money than is reasonable to charge. How do you draw a line, and how do you keep that line from getting moved, and how do you make sure the fees/taxes on drugs provide enough money to pay for the claims which fit the criteria?

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23. Cyrus on March 12, 2013 12:57 AM writes...

"that they are merely making (under regulatory permission) a drug that others discovered and that others have regulated over the decades"

Risks were minimized but not eliminated. Relying solely on prior tests results in a cheaper price but also carries some risk.

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24. gippgig on March 12, 2013 2:50 AM writes...

I remember a case - I believe it was DES - where the courts ruled that since there was no way for the plaintiff to know which company had manufactured the drug all manufacturers were liable - even ones that definitely didn't make it. Guilty even if proven innocent! The insanity of the legal system...
If you're concerned about side effects, you should be able to buy extra insurance (your regular insurance should already cover the medical bills - if you chose not to have medical insurance that's your tough luck) to cover side effect-caused disability, pain and suffering, etc. That's precisely what insurance is for - to protect you against unlikely but serious misfortune.

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25. Phillip on March 12, 2013 5:05 AM writes...

One quick point. The discussion here seems to have missed out the potential effect of formulation differences.
Generics are required to be bioequivalent, but there's nothing to say they have to use exactly the same ingredients - especially since no innovator is going to reveal their recipe/process.

This would, of course, be more clear if the lady had switched from a branded to a generic drug. But there's also an argument that the generic formulation, being slightly different, could have marginally different side effect profile, especially when we're looking at such low incidence effects. In which case, how is the innovator responsible? They've fulfilled all their duties of care as far as I can see...

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26. Henning Makholm on March 12, 2013 1:27 PM writes...

Economically it seem to make lots of sense to manage the risk of rare side effect by requiring the manufacturer of the drug to arrange for insurance against them (and, of course, factor the cost of said insurance into the price it sells the drug for). We're speaking about probabilities to low that it makes no sense at all for a single patient to make a reasoned decision about them, after all.

A completely different matter, however, is whether such a solution should be brought about by the judicial branch applying tort law to the problem. The tools available to courts are too blunt for this kind of work -- they cannot give the industry notice that they need to conform to such-and-such rule before this-and-that date, but only declare that such-and-such has always been the law, and applies immediately and possibly retrospective. And the fiction of applying tort law where evidently nobody at all did nothing wrong cannot be good for the general respect for the rule of law either.

It would be more honest and less absurd to speak of strict product liability (and drop the fiction that there need to be anything "defective" about the product to trigger it in this case). However, the fact that the Supreme Court is needed in order to determine whether such a concept exists for drugs in the first place sounds like some lawmakers have not been doing their job properly. What risks must be assumed by the manufacturer ought to be spelled out explicitly by the legislature, not left for judges to divine from general principles about tort.

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27. perlhaqr on March 13, 2013 12:21 PM writes...

Does this have implications for manufacturers and sellers of firearms and ammunition?

While I'm certain there are people who would like for it to be so, the side effect of this drug was not its intended effect. That makes it fundamentally different from a firearm, which is operating as designed when it propels a small metal slug at high velocity, with the potential for injury or death.

Fortunately, as Bear mentioned, [Congress] passed a law protecting firearms manufacturers against liability for downstream MISUSE of their products. Otherwise, that would lead down a very slippery path I doubt anyone wants to go. At the very least, Ford would be sued after some kid raced at 3x the speed limit down main street and crashed into a bus full of nuns, and most likely even more absurd lawsuits would abound as well.

------

Phillip makes an interesting point about bioequivalence. I know that many people claim generics to have different effects than brand name drugs (especially psych meds) and so too, might they have different side-effect profiles? If it turns out that the formulation that Mutual was using actually had a 1:100,000 chance of causing TEN, rather than 1:6,000,000 that would seem like it would give a pretty good opening for them to be sued.

OTOH, if we require all formulations of generics to be re-certified... that's going to reduce their cost benefit quite a bit.

I am, as the name implies, a software nerd and not any sort of chemist (I came here for the "Things I won't work with" series, damned funny stuff, sir.) so my ignorance may show out here, but, what does it cost the original manufacturer to hand out the synthesis process when they license the formula to the generic manufacturer? Or have I made some catastrophic error of assumption in how this "generic drug manufacturing" process works?

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28. Mimer on March 18, 2013 4:49 AM writes...

@6, and more.
Largely agree. Manufacturers of generics pick up and market a lot of old questionable drugs and they should be made responsible for part of the injuries caused by these drugs. The rest of the burden should be placed on the regulatory authorities who are not doing their job.
Sulindac, in contrast with ibuprofen, has caused a number of severe TENS previously and should have been taken off the market since long.

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29. Ltw on March 19, 2013 8:27 AM writes...

what does it cost the original manufacturer to hand out the synthesis process when they license the formula to the generic manufacturer?

Perlhaqr, I'm in much the same position as you when it comes to ignorance on this topic - I'm an engineer (and all industrial processes fascinate me - plus "Things I Won't Work With"!). But I would have thought that a generic manufacturer doesn't need to license an out of patent drug at all - the chemical structure has been documented as part of approval and is now open slather. But the synthesis process would remain the original developer's IP, so a generic manufacturer may well decide to develop their own path rather than buy the established one (or possibly the developer won't want to sell, maybe they have some tricks they might want to apply to other processes and don't want to share). I assume though they still have to do quality testing on their batches to show the end product is what it says on the label, in which case are we back to it being the FDA's fault? Or theirs for not doing their own synthesis well enough? How do you tell?

In the case of rare side-effects, this becomes very tricky. How do you establish a change in incidence from one manufacturer to another from a handful of cases? Let's say there is a few orders magnitude increase of one side effect from one supplier - but how do you prove that? A few cases difference wouldn't cut it in a clinical trial, and shouldn't in tort law either.

Strict liability as mentioned above does matter perhaps - essentially that says whether you knew, or could have known, there was a problem, you're responsible because you sold it. But in my opinion, regulatory pre-emption overrides that.

A comparison to my field. If I have certain national/international standards cited in our contracts, and I am required to meet their prescriptions, and it turns out they're wrong but I followed them anyway, have I been negligent? Almost always, no.

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30. Thomas on March 20, 2013 5:10 PM writes...

Drugs will never be fully safe. Life will never be fully safe. If I take a drug, whether OTC or other, I know there is a risk. Hopefully a small risk, but still. I could die tomorrow from a sudden broccoli allergy too.

Discussing all kinds of side effects also is not too clever, with the placebo effect doing its job there too.

But I do remember a friend dying of leukemia, after being sick from a second treatment. Discussed the side effect, chances and risks with the doctor. Didn't make it, but no-one is suing. That was like a 50/50 bet: the (small) chance of getting better balancing the extra adverse side effects in the remaining months.

Guess that is much harder if one wins the bad luck lottery: wanting to take away what in hindsight must feel like a minor inconvenience, one receives instead major injury.

As long as the medicine is a win compared to doing nothing (or not much worse compared to competing drugs) it should be free from liability claims in this regard.

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