The high cost of 1 Motrin

[BurghStudent]

http://boston.cbslocal.com/2013/02/...lion-to-mass-family-in-childrens-motrin-case/

What a tragic story. As a physician, do you hold any responsibility if you prescribed a seemingly harmless drug like this?

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[HughMyron]

The only thing tragic about this story is how it shows the desperate need for tort reform in this country.

 

[Geebeejay]

http://boston.cbslocal.com/2013/02/...lion-to-mass-family-in-childrens-motrin-case/

What a tragic story. As a physician, do you hold any responsibility if you prescribed a seemingly harmless drug like this?

This article doesn't really have anything to do with physicians as the medication was over the counter.

In medicine adverse reactions happen all the time. As long as there were no contraindications to the medication you prescribed and you are able to clearly justify your reasons for prescribing in, and the patient is informed, then you can't be held responsible for the 1 in a million side effects.

 

[CyclistOK]

No, absolutely not. Neither should the drug company. Without knowing the intimate details of the case this looks like a frivolous lawsuit where the jury just felt bad for the family and wanted someone to blame.

We prescribed WAY more dangerous crap than ibuprofen. What a joke.

 

[DoctwoB]

http://boston.cbslocal.com/2013/02/...lion-to-mass-family-in-childrens-motrin-case/

What a tragic story. As a physician, do you hold any responsibility if you prescribed a seemingly harmless drug like this?

Motrin is not harmless. Motrin is an NSAID, and as such can cause ulcers, GI bleeds, kidney damage, platelet dysfunction, hypersensitivity reactions, and rare cases of SJS or TEN. The patient suffered a rare but known side effect of the drug. As a physician you have to consider the ADRs of any drug you prescribe, but ultimately freak incidents like this will happen. Morally, you're only responsible if you prescribed something that wasn't necessary in the first place. Legally, its all about what a jury can be convinced of.

 

[BurghStudent]

Good to know.

Interestingly, tort reform was completely disregarded in the PPACA.

I wonder how they arrive to a figure like $63M.

 

[CyclistOK]

Motrin is not harmless. Motrin is an NSAID, and as such can cause ulcers, GI bleeds, kidney damage, platelet dysfunction, hypersensitivity reactions, and rare cases of SJS or TEN. The patient suffered a rare but known side effect of the drug. As a physician you have to consider the ADRs of any drug you prescribe, but ultimately freak incidents like this will happen. Morally, you're only responsible if you prescribed something that wasn't necessary in the first place. Legally, its all about what a jury can be convinced of.

As a rule nothing is harmless. I'm sure we've all seen pulmonary edema from IVF as an example. The problem is the public assumes that they will not be the ones to have an adverse reaction, and when something does happen they look for someone to blame.

 

[HughMyron]

Good to know.

Interestingly, tort reform was completely disregarded in the PPACA.

I wonder how they arrive to a figure like $63M.

Because the plaintiff's lawyers concocted a sob story to manipulate the jury into coming up with such excessive amounts. It's disgusting really.


Tort reform was disregarded because Obama and the Democrats are a party of lawyers, and they really don't care about it.

 

[JBOB]

Motrin is not harmless. Motrin is an NSAID, and as such can cause ulcers, GI bleeds, kidney damage, platelet dysfunction, hypersensitivity reactions, and rare cases of SJS or TEN. The patient suffered a rare but known side effect of the drug. As a physician you have to consider the ADRs of any drug you prescribe, but ultimately freak incidents like this will happen. Morally, you're only responsible if you prescribed something that wasn't necessary in the first place. Legally, its all about what a jury can be convinced of.

You are a med student and clearly know more about this than I do, so I'm asking out of genuine curiosity, but aren't aspirin, ibuprofen, Advil, ect also NSAIDs? Most people in the US, I would imagine, take those without even thinking about the risks or consulting a physician before hand.

 

[LizzyM]

The lawsuit was against the Johnson & Johnson, not any physician

Consider too that this was a child (age 7, now a teen) who was "in and out of the hospital for months, is now legally blind, and cannot walk more than 150 yards without exhaustion, her family said.

"The jury found that Johnson & Johnson and the division that makes the medicine, McNeil Consumer & Speciality Pharmaceuticals, failed to provide warnings about potential side effects on the versions of Motrin that are sold over-the-counter. The jury awarded the girl $50 million and each parent $6.5 million. The decision must still be reviewed by the trial judge. "

Of course, lawyers will get 1/3rd of that for their troubles. Consider the care this child has needed all these years and will need, and the dreams that will not come true because she's lost her vision and her stamina, not to mention the months of pain.

 

[darkjedi]

You are a med student and clearly know more about this than I do, so I'm asking out of genuine curiosity, but aren't aspirin, ibuprofen, Advil, ect also NSAIDs? Most people in the US, I would imagine, take those without even thinking about the risks or consulting a physician before hand.

Those are all indeed NSAIDS. Aspirin actually has the highest risk of bleeding/stomach ulcers.

This is why drugs like Vioxx and Celebrex were invented, to have all the benefits of the NSAIDs without the GI/bleeding side effects. Unfortunately, those came with their own side effects as well, causing Vioxx to be pulled off the market after it looked like it may have caused strokes and heart attacks.

Most people take these pills in low doses and also not chronically. Many of these side effects begin to manifest when patients are prescribed high-dose medication and are on them for a long time.

 

[def1]

Sad story but I dont really think Johnson and Johnson are to blame. SJS is such a rare disease that its possible they did not even know it was a potential side effect.

Also does anyone really think that had the motrin been labeled with SJS as a side effect, considering how completely rare it is, that it would have prevented the parents from giving it to their daughter? Somehow I don't. Z-paks are really commonly prescribed and they have a risk of SJS, so I don't think that this would have been an issue, but I don't have a problem with J&J adding it as a side effect now.

 

[BurghStudent]

Because the plaintiff's lawyers concocted a sob story to manipulate the jury into coming up with such excessive amounts. It's disgusting really.


Tort reform was disregarded because Obama and the Democrats are a party of lawyers, and they really don't care about it.

True. I feel though the problem is in both parties. Both sides have too many conflicting interests.

 

[BurghStudent]

I know a physician wasn't sued in the news article. But its still a little scary to think that something as inconsequential and routine as an OTC drug could lead to such disaster.

 

[EnergyDrink]

I don't know how people are forming opinions about this when the article was so brief. How was J&J held responsible?

 

[LizzyM]

J&J failed to disclose the risk of a severe side effect. I presume the side effect was known at the time of the incident but not disclosed on the package insert/label.

They might have used the drug anyway but they would have done so with access to the information that the drug could cause serious and life threatenig side effects. This way they could say, "You knew but didn't disclose it to your customers and our child was permanently impaired because we used your product as directed and without access to information you had about this side effect."

 

[a2014]

J&J failed to disclose the risk of a severe side effect. I presume the side effect was known at the time of the incident but not disclosed on the package insert/label.

They might have used the drug anyway but they would have done so with access to the information that the drug could cause serious and life threatenig side effects. This way they could say, "You knew but didn't disclose it to your customers and our child was permanently impaired because we used your product as directed and without access to information you had about this side effect."

I agree they probably knew about the side effect before this case, as it isn't exactly a new thing. What I always have a problem with is where you draw the line as far as disclosing possible outcomes, and whether or not it would have changed anything anyhow. If you decide that every possible outcome needs to be listed even if it has a probability of happening of <0.01%, labels start to become ridiculous and I'd argue that it makes it harder for the end user to really know what they're getting themselves into. If you want an example of what happens when you labels become overly cautious, try looking up the MSDS for water or siliaca (sand).

 

[IslandStyle808]

Good to know.

Interestingly, tort reform was completely disregarded in the PPACA.

I wonder how they arrive to a figure like $63M.

Mainly non-economical damages (this is where you can thrown in any BS reason that is plausible to pay the plaintiff)

Because the plaintiff's lawyers concocted a sob story to manipulate the jury into coming up with such excessive amounts. It's disgusting really.


Tort reform was disregarded because Obama and the Democrats are a party of lawyers, and they really don't care about it.

Having a medical opinion from a physician who can reason "that the drug caused this" also weighs in heavy.

 

[IslandStyle808]

I agree they probably knew about the side effect before this case, as it isn't exactly a new thing. What I always have a problem with is where you draw the line as far as disclosing possible outcomes, and whether or not it would have changed anything anyhow. If you decide that every possible outcome needs to be listed even if it has a probability of happening of <0.01%, labels start to become ridiculous and I'd argue that it makes it harder for the end user to really know what they're getting themselves into. If you want an example of what happens when you labels become overly cautious, try looking up the MSDS for water or siliaca (sand).

In big pharma, there will always be a lawsuit over something that is unforeseen. The main thing is that their profits for making this drug exceed the amount of a potential lawsuit. There will always be potential side effects that have a miniscule chance of happening. If they stopped their production of drugs due to these small chance occurrences, they would not sell anything and would go bankrupt real easily. As long as the profits far outweigh the cost of selling the drug, they will keep going.

 

[a2014]

In big pharma, there will always be a lawsuit over something that is unforeseen. The main thing is that their profits for making this drug exceed the amount of a potential lawsuit. There will always be potential side effects that have a miniscule chance of happening. If they stopped their production of drugs due to these small chance occurrences, they would not sell anything and would go bankrupt real easily. As long as the profits far outweigh the cost of selling the drug, they will keep going.

You're responding to an argument that I didn't make. This case seems to hinge on the fact that J+J likely knew that this was a side effect, but that it was not disclosed on a label. I was specifically talking about labeling requirements for known adverse reactions.

If you want to talk about cost of cases like this and how they impact the pharmaceutical industry, we can. It's a different discussion though.

 

[jde1223]

http://www.wcvb.com/health/Massachu.../18534968/-/3f1niu/-/index.html?absolute=true

It's hard to put a price on the pain of a child but I guess $109 million is great place to start

 

[Mehd School]

I'm torn on this one. Typically I'm not a fan of frivolous and lucrative medical lawsuits, but in this case the girl's life was ruined. The amount of pain she must have experienced is unimaginable. I just can't put a price on that.

 

[a2014]

I'm torn on this one. Typically I'm not a fan of frivolous and lucrative medical lawsuits, but in this case the girl's life was ruined. The amount of pain she must have experienced is unimaginable. I just can't put a price on that.

I agree. For me, this falls into one of those "life just isn't fair" categories. It completely sucks for that girl and her parents. You can't fix what's happened, but at the same time it seems like it would be adding insult to injury to make the family cover the cost of all of this.

On the other hand, I don't really see J+J being at fault here. Should they have put it on the label that this was a possible outcome? Maybe. I have a suspicion that it wouldn't have stopped them from using it. I also don't think that disclosing every possible outcome on a label is actually a good thing because at some point the entire label becomes meaningless and nobody is going to read it anyhow.

So what's the solution?

 

[PharmD87]

Definitely tragic, but I do not believe any liability should rest with J&J and there are many other factors not mentioned in this article that may have influenced the course (when they sought care, how soon it was recognized, if they were at a facility where they could receive adequate care, quality of care, etc) . Certainly no one likes to see it happen, however poor outcomes/adverse reactions are part of the game when dealing with drugs (yes, even OTC products). Problem is the court of public opinion has a difficult time distinguishing an undesirable outcome from liability. Certainly there is a greater risk of the unknown when dealing with newer products because the phase 3/4 trials cannot possibly enroll enough patients to detect rare adverse effects. But for a product that's been around as long as ibuprofen, I have a difficult time believing it was never discovered, reported, and added to the package insert. This case is a decade old so looking at today's package inserts is not relevant.

If someone is going agree to take a drug based on competent medical advice (or an OTC on their own), it's a reality that there may be undesirable consequences. Often, patients won't take responsibility to even learn the name and dosage of medication, let alone what it may to do their body. And we wonder about the rush to blame doctor's and drug companies? While it's easy to point the finger at Big Pharma, let's not forget about the astronomical costs of failed drugs, getting successful drugs approved, and that many diseases (HIV for one) would still be a death sentence if not for their work.

I'm not sure what the best solution for problems such as these. Perhaps a requirement that they set funds aside to help with cover medical care as a cost of doing business.

 

[LizzyM]

Definitely tragic, but I do not believe any liability should rest with J&J and there are many other factors not mentioned in this article that may have influenced the course (when they sought care, how soon it was recognized, if they were at a facility where they could receive adequate care, quality of care, etc) . Certainly no one likes to see it happen, however poor outcomes/adverse reactions are part of the game when dealing with drugs (yes, even OTC products). Problem is the court of public opinion has a difficult time distinguishing an undesirable outcome from liability. Certainly there is a greater risk of the unknown when dealing with newer products because the phase 3/4 trials cannot possibly enroll enough patients to detect rare adverse effects. But for a product that's been around as long as ibuprofen, I have a difficult time believing it was never discovered, reported, and added to the package insert. This case is a decade old so looking at today's package inserts is not relevant.

If someone is going agree to take a drug based on competent medical advice (or an OTC on their own), it's a reality that there may be undesirable consequences. Often, patients won't take responsibility to even learn the name and dosage of medication, let alone what it may to do their body. And we wonder about the rush to blame doctor's and drug companies? While it's easy to point the finger at Big Pharma, let's not forget about the astronomical costs of failed drugs, getting successful drugs approved, and that many diseases (HIV for one) would still be a death sentence if not for their work.

I'm not sure what the best solution for problems such as these. Perhaps a requirement that they set funds aside to help with cover medical care as a cost of doing business.

Why be an apologist for the drug company? Obviously, they had highly paid, competent legal representation but the plantiff proved that J&J knew and failed to disclose the risk of a very serious adverse event that cost this family millions in health care costs and cost this child her vision.

How can a family take responsibility if the information that was known to J&J was not disclosed to them?

 

[EnergyDrink]

J&J failed to disclose the risk of a severe side effect. I presume the side effect was known at the time of the incident but not disclosed on the package insert/label.

They might have used the drug anyway but they would have done so with access to the information that the drug could cause serious and life threatenig side effects. This way they could say, "You knew but didn't disclose it to your customers and our child was permanently impaired because we used your product as directed and without access to information you had about this side effect."

That's what I figured, but I didn't want to make the assumption that they previously knew about it.

Why be an apologist for the drug company? Obviously, they had highly paid, competent legal representation but the plantiff proved that J&J knew and failed to disclose the risk of a very serious adverse event that cost this family millions in health care costs and cost this child her vision.

How can a family take responsibility if the information that was known to J&J was not disclosed to them?

I would guess that the thinking is that these costs need to be made up in other ways, increasing the price of their other products, increasing the burden on the customer. Since medications are always in demand, and the way the patent system is, its not like the option exists to switch to a cheaper alternative. I'm just advocating this though.

I'm glad this family got some restitution though. I don't think 60 million makes up for what they're experiencing. Unfortunately, it's a lose-lose situation.

 

[a2014]

Why be an apologist for the drug company? Obviously, they had highly paid, competent legal representation but the plantiff proved that J&J knew and failed to disclose the risk of a very serious adverse event that cost this family millions in health care costs and cost this child her vision.

How can a family take responsibility if the information that was known to J&J was not disclosed to them?

I don't think PharmD is being an apologist for the drug company, and I think there is a lot of room for discussion on the topic outside of just saying that the drug companies should always disclose everything. I think cases like this can be the starting point for a lot of discussion on what should be required to be disclosed on a label, what should be included in informed consent, etc. There are a lot of problems with the pharmaceutical industry, and I think there is a huge amount of room for reform. However, I don't think the answer should always be to blame the drug company.

LizzyM, what do you think should be required to be disclosed on labels? In informed consent? It seems that you support disclosing every possible adverse event on a label, is this the case? If so, don't you worry that at some point the warning label becomes essentially useless due to there being too much information? How much of this information would the general consumer understand anyway? How much of this is focused on actually informing the consumer rather than covering the pharmaceutical company's a$s?

Again, I'd like to refer you to some MSDS (material safety data sheets) that are out there, which essentially evolve to cover the chemical manufacturer's as$es. You'll find things saying sand is a carcinogen, and that water is corrosive, with the end results that most MSDS information doesn't actually tell you very much.

 

[calvnandhobbs68]

I agree. For me, this falls into one of those "life just isn't fair" categories. It completely sucks for that girl and her parents. You can't fix what's happened, but at the same time it seems like it would be adding insult to injury to make the family cover the cost of all of this.

On the other hand, I don't really see J+J being at fault here. Should they have put it on the label that this was a possible outcome? Maybe. I have a suspicion that it wouldn't have stopped them from using it. I also don't think that disclosing every possible outcome on a label is actually a good thing because at some point the entire label becomes meaningless and nobody is going to read it anyhow.

So what's the solution?

I have to agree with the fact that this outcome is so incredibly rare that it probably wouldn't have helped if they had put it on the packing slip to begin with. It appears SJS and TEN weren't mentioned on the version of Children's Motrin that the family used but I don't think they would have look at the packing slip and been like "oh no there's a 1 in a million chance she could have a severe allergic reaction....let's not use it!".

And it really is 1 in a million:
http://www.ajhp.org/content/67/3/206

"The risk of SJS or TEN caused by NSAIDs is extremely low (less than 2 per 1 million users per week for oxicam derivatives, less than 1 per 1 million users per week for other NSAIDs, and 6 cases per 1 million person-years for celecoxib). "

 

[Bangersandmash]

I'm torn on this one. Typically I'm not a fan of frivolous and lucrative medical lawsuits, but in this case the girl's life was ruined. The amount of pain she must have experienced is unimaginable. I just can't put a price on that.

You can though. It's called the cost of her medical treatment and care. 109 million dollars won't grow the girl's skin back. Even after lawyer's fees, I'm sure they have more than enough money to cover medical expenses. Why give them an extra 20 million dollars for pain and suffering? Will buying a jet ski and a 3-D television eliminate "pain and suffering?" Hopefully they set up a scholarship fund or trust in the child's name or something. Or donate to research.

What happened is tragic and if there wasn't a warning that this could happen (even if they would have taken it anyway), they deserve JUST compensation. This is in my eyes is the cost of medical expenses + an average of lifetime earnings for an adult (median income around 45k * 35-40 years of work). Just because J&J may have the money to pay them doesn't mean they need to pay them an exorbitant amount.

 

[911 Turbo]

Why give them an extra 20 million dollars for pain and suffering? Will buying a jet ski and a 3-D television eliminate "pain and suffering?" Hopefully they set up a scholarship fund or trust in the child's name or something. Or donate to research.

I doubt this will happen. Parents will probably buy a private island and a jet and live it up.

 

[a2014]

I doubt this will happen. Parents will probably buy a private island and a jet and live it up.

I don't think that sentiment is fair either. This girl really got hurt, and it absolutely devastated the lives of her and her family. Medical care is expensive. Her lost future income is expensive. I think they deserve something.

This "us vs. them" attitude has to go away. People that are hurt by adverse effects and medical errors do deserve some sort of compensation. At the same time, I don't think it should be punitive. I don't really see that J+J did anything wrong in this case, and I would say the same about many other med-mal cases. We really need reform in this area. We need a system that can compensate people who suffer because of adverse events without punishing everyone else tangentially related to the case. As far as that goes, I really like how vaccine funds are set up.

 

[calvnandhobbs68]

I don't think that sentiment is fair either. This girl really got hurt, and it absolutely devastated the lives of her and her family. Medical care is expensive. Her lost future income is expensive. I think they deserve something.

This "us vs. them" attitude has to go away. People that are hurt by adverse effects and medical errors do deserve some sort of compensation. At the same time, I don't think it should be punitive. I don't really see that J+J did anything wrong in this case, and I would say the same about many other med-mal cases. We really need reform in this area. We need a system that can compensate people who suffer because of adverse events without punishing everyone else tangentially related to the case. As far as that goes, I really like how vaccine funds are set up.

It's an interesting idea and not an entirely bad one. I could see doing something like levying a 5 cent tax on every 50 count of ibuprofen sold to go into a fund to compensate people who experience severe adverse events. So much of the medication is sold every year and the amount on each purchase is so small that it might be sustainable (in this case).

However, the problem with OTC medications is that you can't tell who took it and who didn't. With vaccines, you have records showing you got the injection in some office on some date and medical records showing you developed these symptoms within these many days after the injection. You can't do the same thing with OTC meds and the system would likely be overrun with people trying to get some cash for a reaction they had to some other medication or no medication at all.