Opinions on that case in the High Court against the Psychiatrist and Gynaecologist

nesf

There's a woman suing two doctors in the High Court over birth defects that her child was born with due to the woman being on anti-depressants at the time.

Honestly I find this case very worrying. The leaflets for most psychiatric medication are literally covered in labels telling you to go to extreme lengths not to get pregnant if you're female and on the medication. Getting pregnant on most of these drugs is just not an option in terms of the potential for birth defects etc.


Is it right for someone to sue because they didn't read the literature that came with their drugs? I mean the first time I get put on any new drug I read the leaflets carefully so I'll know what side effects that will require me to immediately get medical treatment for, e.g. neuroleptic malignant syndrome on most antipsychotics etc.

Opinions?

Bicycle

The judgement should be interesting.

From my perspective, I think we live in a society where personal responsibilty seems to be completely non-existent.

If someone fails in school or college, its never the student's fault, always the school or the system's fault.

If jobs are lost in the retail industry in Ireland because people do their shopping "up North" its never the fault of the consumer and always the fault of the government for not regulating things.

Having been prescribed medication that I am highly allergic to by a doctor that should have known better, and having had the issue picked up by a wonderful pharmacist (who probably saved me a lot of hassle and even my life) I now check everything to see what it contains and what it may do to me BEFORE I take it.

But its sad for the baby though.....

nesf

Yeah that's my thinking on this. I'd really consider it useful for a psychiatrist or pharmacist to mention certain things to me but I'd consider my own responsibility at the end of the day to read the leaflets and be educated about my medication. Especially with something as non-trivial as pregnancy or in my case combining my drugs (a hefty dose of downers) with a large amount of alcohol.

Jessibelle

Whatever for the psychiatrist prescribing her these pills, would she not have to disclose any medication she's on to the gynacologist as par for the course at each visit during the pregnancy? I know I do, and I'm nowhere even comtemplating pregnancy. The judgement will be exceptionally interesting but barring extreme negligence on the parts of the doctors, to me currently this smacks of a lack of personal responsibility by the mother, and her lack of disclosure to one or more of her doctors.

Bicycle

I think there are parallels here with the reported cases of drivers ending up in rivers or hanging over the side of cliffs because they ignored all the logical, intelligent signs and put their trust in an inanimate object on the dashboard called a Sat Nav....

sam34

i dont know any details of the case, other than whats in the posts here

i wonder what meds she was on

there is some responsibility on the part of the prescribing doc, it depends on teh level of risk involved

you have to disclose risks of a certain magnitude - for teh life of me i cant remember the exact figure, maybe 1 in 1000

if for example it was something like lithium, you have to tell the patient about the risks to a foetus of heart defects etc

you cannot take it as a given that the patient will read the leaflet, or indeed can read the leaflet, and can understand it

i would think that it would be negligent not to inform someone of the risks with lithium, and certain other psychiatric drugs

however, in this case it all depends on what teh drug was and what teh risk was

nesf, have you a link to any further info on this? where did you hear about it?

Jessibelle

But would there not be a responibility on the patient to inform the psychiatrist that she was pregnant as soon as she knew? Surely then all resonable care could be taken in altering meds etc. Obviously if there is negligence here, then there should be compensation, but I find it peculiar how it would have been perpetrated by two doctors, especially in an instance such as pregnancy where it's nearly hyper vigalance regarding pills/supplemenst etc as the order of the day.

Sam, this is the article here, I think.

SomeDose

nesf wrote: »

Honestly I find this case very worrying. The leaflets for most psychiatric medication are literally covered in labels telling you to go to extreme lengths not to get pregnant if you're female and on the medication. Getting pregnant on most of these drugs is just not an option in terms of the potential for birth defects etc.

Is it right for someone to sue because they didn't read the literature that came with their drugs? I mean the first time I get put on any new drug I read the leaflets carefully so I'll know what side effects that will require me to immediately get medical treatment for, e.g. neuroleptic malignant syndrome on most antipsychotics etc.

Opinions?

In many cases, and especially when it comes to using medicines during pregnancy, a medicine's information leaflet (PIL) is largely irrelevant. All that does is indemnify the manufacturer against this kind of legal action. What happens in reality is that there is a joint decision made between the patient and doctor, by balancing the harms and benefits of treatment. If a certain drug carries a risk to the foetus, doctors usually make their decision based on extensive information which is not available from the manufacturer or to the public (via PILs or SPCs). There are very, very few medicines which are absolutely contra-indicated in pregnancy.

I know nothing about the case in question, but unless it can be proved that the clinician either deliberately witheld such information or did not research it through their own negligence, I can't see the patient being successful here.

sam34

Jessibelle wrote: »

But would there not be a responibility on the patient to inform the psychiatrist that she was pregnant as soon as she knew? Surely then all resonable care could be taken in altering meds etc. Obviously if there is negligence here, then there should be compensation, but I find it peculiar how it would have been perpetrated by two doctors, especially in an instance such as pregnancy where it's nearly hyper vigalance regarding pills/supplemenst etc as the order of the day.

Sam, this is the article here, I think.

well sure, she should inform the psychiatrist as soon as possible.

but i do think that when the risks are high, teh doc has a duty to inform her, so that she can use adequate contraception.

i would always take the approach of telling someone the risks, and advising them to discuss it with me before planning a pregnancy, so we can decide what to do with meds

the issue with some meds is that if the pregnancy is unplanned,a lot of teh damage will have been done by the time the woman realsies shes pregnant

nesf

Jessibelle wrote: »

Sam, this is the article here, I think.

Epilim is useful in treating depression now apparently. Christ the standard of reporting is woeful these days.

nesf

ThePharmer wrote: »

There are very, very few medicines which are absolutely contra-indicated in pregnancy.

If you have bipolar (or epilepsy) you are very likely to be on a med that is potentially damaging to the foetus. The mood stabiliser I'm on Trileptal isn't just potentially damaging to the foetus but also may reduce the effectiveness of oral contraceptives which is a very nasty mix.

GuanYin

nesf wrote: »

Is it right for someone to sue because they didn't read the literature that came with their drugs? I mean the first time I get put on any new drug I read the leaflets carefully so I'll know what side effects that will require me to immediately get medical treatment for, e.g. neuroleptic malignant syndrome on most antipsychotics etc.

Here, we walk patients through every single aspect of the drug's safety label before we let them near the pharmacy. We explain it as clearly and basically as possible. Most pharmacists or pharmacy technicians will then also ask if the patient needs to be reminded of the proper drug usage and the safety information.

The fact of the matter is, patients are lazy and some of the safety sheets are too technical and intimidating. Here, where the literacy rate is relatively low among some demographs (and interestingly, the litigation rate is quite high among the same demographs) it would be stupid of us not to explain things and ensure the patient crystal clear on potential complications.

sam34

nesf wrote: »

Epilim is useful in treating depression now apparently. Christ the standard of reporting is woeful these days.

well it is mood stabiliser, so technically....

Jessibelle

another article here - what the two doctors feel the patient did.

nesf

sam34 wrote: »

well it is mood stabiliser, so technically....

Ever seen someone with major depression given Epilim monotherapy?

SomeDose

nesf wrote: »

If you have bipolar (or epilepsy) you are very likely to be on a med that is potentially damaging to the foetus. The mood stabiliser I'm on Trileptal isn't just potentially damaging to the foetus but also may reduce the effectiveness of oral contraceptives which is a very nasty mix.

I know this. There are hundreds of drugs that are potentially damaging to the foetus, yet may still be used relatively safely during pregancy. Trileptal, and in fact pretty much all neuro/psychiatric drugs, are not strictly contra-indicated in pregancy either. This is especially true for patients with epilepsy, where the omission of drug treatment can carry a greater risk to the patient than the risk to the foetus if the drug is continued.

I used to spend a significant amount of time answering medicines enquiries from clinicians and other healthcare professionals. By far and away the most common topic was the use of medicines in pregancy and, within this topic, some of the most frequent enquiries were from psychiatrists wishing to assess the safety of psyche/neuro meds in pregnancy. There are very real risks, sure, but there is also good quality evidence which shows benefit outweighs risk for certain types of patient.

Anyway, it looks like that case isn't very clear-cut. I would've thought that examination of medical notes & records would clear up some of the differences in testimonies between the patient and gynaecologist.

angeldelight

It will be interesting but (and I could well be wrong) there seems to be something odd about the case. Maybe it will come out that everything she's saying is true but it's not even like she just accidentally became pregnant - it was after taking Clomid so it was planned... and sodium valproate in particular is one of the anti-epileptics that are particularly not recommended in pregnancy... I forget how many case studies we did in college around this area. Surely if it was a planned pregnancy and her gyne was prescribing Clomid for her she'd have taken a medical history and this is something that would have been flagged. I don't know I find it difficult that there could be such a level of incompetence from someone who works in womens health and should hear alarm bells when certain drugs are mentioned...

sam34

nesf wrote: »

Ever seen someone with major depression given Epilim monotherapy?

well no, but i do use it for depression in bipolar disorder

nesf

sam34 wrote: »

well no, but i do use it for depression in bipolar disorder

Yeah, it's misleading though in the article I think. Depression, unqualified, normally refers to simple depression in common parlance. I'm not questioning the drug's usefulness in bipolar, have been on it myself etc.

AmcD

This is a common dilemma that I come across. As with all drugs in pregnancy, the benefits have to weighed against the risks. Possibly the risk of letting depression go untreated is worse than starting medication.
My understanding about antidepressants in pregnancy is from talking to psychiatrists at maternity hospital study days, contacting the national medicines information centre and other sources. The risks associated with using SSRIs seem to be relatively low-apart from Seroxat. The risk seems to increase beyond this drug class, so lithium and anti-epileptic medications are best avoided if possible.
The rate of congenital abnormalities in all healthy "normal" pregnancies is approximately 3%.

MrCreosote

The second linked article has the diagnosis as mild bipolar disorder, which would make more sense with the other drugs prescribed.

Interesting case alright. You can be sure that if it has hit the courts, as opposed to being settled out of court, that the insurers reckon they have a pretty robust case. Like someone else says the fact clomiphene was used would suggest a planned pregnancy. Would it be usual practice to arrange for assisted reproduction while someone is on lithium and valproate though, (especially for mild symptoms), without documenting that the person taking them is absolutely aware of the risks?

Olduvai

The update on this case in relation to Prof. Patricia Casey and Dr. Holohan was that the High Court judge approved an out of court settlement figure of €500,000 for the eight year old girl and an undisclosed sum for the mother and both payments were made without any admission of liability.

nesf

Olduvai wrote: »

The update on this case in relation to Prof. Patricia Casey and Dr. Holohan was that the High Court judge approved an out of court settlement figure of €500,000 for the eight year old girl and an undisclosed sum for the mother and both payments were made without any admission of liability.

Yeah, interesting it made it to court at all really with that outcome.