Maureen Minchin, Geelong, Australia, 2015
Book excerpt reprinted with permission.
Complementary feeding: legal implications and duty of care
How many mothers would be willing to give early formula feeds if fully informed in writing of the real nature of formula? That it is non-sterile, contains fats made by genetically altered marine algae and soil fungi, and may come with industrially produced bacteria as well as foods for those bacteria to grow on; that these substances will affect gut development in ways that cannot be predicted and have not been monitored. And that safer alternatives340 exist: breastfeeding, or if that is difficult or impossible (and it rarely is with the right support) assistance with expressing milk, or the use of donor human milk?
Not to give this information could quite fairly be seen as a failure of the doctor’s legal duty to warn of material risk.341 And if mothers are not given that information, how can any consent they give be informed?342 And if mothers do not give informed consent to the use of such products – as most mothers in the twentieth century certainly did not! – legal opinion is that giving the product to their child may constitute the offence of battery.343 I think it might also be argued nowadays to be a ‘lack of reasonable skill and care’, the basis of many negligence lawsuits; or ‘the loss of a chance for a better outcome’, which surely the unnecessary distortion of the infant microbiome causes. An interesting question that arises is the possible reporting obligation of those who are aware that unnecessary fluids have been given, with their attendant risks. According to one expert group, insured medical practitioners have a duty to report all incidents that they might reasonably know could lead to a claim at a later date, or they will not be covered by their medical insurance. Adverse events that must be notified are those where:
- a patient suffers a major complication
- there is an error in providing health care
- an adverse outcome results in serious anger in the patient or his family
- the doctor concerned is aware that something has happened (including a complaint, investigation, or enquiry) which is thought may lead to a claim.
How soon will it be before there are plaintiff lawyers considering cases of NEC [necrotizing entercolitis] or sepsis or meningitis or juvenile diabetes or even eczema where infant formula has been given to a neonate? When the importance of exclusive breastfeeding is becoming ever more obvious, and parents are often angry that their wishes are disregarded, only the current confusion of scientific studies protects those responsible.
It could be argued in court that
- world and national health authorities already consider it an error to subject infants to unnecessary artificial feeds (or to put it another way, unjustified dietary assaults), particularly where parents are not warned of risks and so do not give informed consent; or there is no proof that they gave such consent;
- not supporting and enabling women to provide their breast milk for sick infants, or not maintaining a breast milk bank, results in the loss of a chance of a better outcome;
- hospitals that do not encourage reporting of incidents of needless exposure to formula, or that fail to take seriously the reports of concerned staff about routine practices, are failing in their duty of care;
- staff who do not consider such practices reportable incidents, and so fail to notify their insurers, will not be covered if claims are made. And given what we are learning about the lifelong effects of early artificial feeding, those claims might arise decades later.
To some this may seem far-fetched. In the 1970s pregnant women, with medical blessing, smoked in hospital wards, making me vomit as I recovered from primary and secondary postpartum haemorrhages. It seemed far-fetched then to imagine smoking in public places would end, but public health awareness increased and the public demanded protection. Infant formula is not poison, not tobacco, and is currently necessary for the survival of many babies. But formula is still a risk, and a needless one wherever breast milk is available, which is wherever women are lactating and society values breast milk. (In Leipzig in 1989, just 95 paid donors supplied 10,000 litres of breast milk over and above the needs of their own infants, and breastfed longer in order to do so.344) Imagine the consequences if infant formula were to be seen as a risk, “the tobacco of the twenty-first century,”345 in as short a space of time. Such a recognition is possible, even likely, despite the powerful forces arrayed against it.
When and how will the message about the potential and real harms of inappropriate formulas reach health professionals? Possibly when industry begins to market their solutions to the problem they have caused: formulas with synbiotics, mixtures of both probiotics and prebiotics, which result in a gut microbiome and infant faeces more like that of [but not the same as] the breastfed infant. If the usual marketing patterns are followed, marketing of synbiotics will be done through inferences and exaggerated claims believed by uncritical health professionals and vested interests, and popularised via the social media and websites. It may not be far away now!346 There must surely be some intelligent commentators who will ask questions about the practice of feeding industrially produced bacteria to infants as we learn more about how bacteria can share genes and morph into different strains of greater virulence.
But of course it’s possible that this recognition will be delayed by the fact of formula faeces and breast milk faeces becoming more alike in some ways. It seems possible that once enough of the industry-produced bugs are being consumed in yoghurts by mothers, fed to babies, and spread everywhere in the postnatal environment, breastfeeding mothers will pick up the bugs of industry’s choice. Hospital comp feeds [neonatal feeds of formula] are the perfect vehicle for changing maternal microbiomes via their breastfeeding infants. Feed the bugs to the newborn baby, bugs colonise baby, mother handles baby, changes nappies, kisses and fondles baby, is herself colonised, and so mother’s milk may come to contain the patented commercial products industry has chosen as suitable for inclusion in infant feeds.347 Those pathways designed to sample the biodiverse natural environment and react appropriately could ensure that breastfeeding mother’s microbiota includes formula-derived organisms! So, ironically, breast milk could become more like formula, and industry can then claim that formula is more like breast milk … If I were a marketing manager, I’d see the provision to hospitals of ready-to-feed formula in neat single doses as an investment likely to repay its cost. Then if a food company, I’d sell yoghurt containing the infant formula bacteria and market it as organisms found in mother’s milk … If they’re not there already, they soon may be!
340 While all options carry risks, I think the greater safety of these alternatives (assuming due care in preparation) is conclusively proven.
341 ‘A risk is material if in the circumstances of a particular case a reasonable person in the plaintiff ’s position, if warned of the risk, would be likely to attach significance to it, or if the doctor is or should be reasonably aware that the patient if warned of the risk would be likely to attach significance to it.’ (FJ Purnell SC. Negligence and Birth Injuries. Transcript of talk at PSANZ (Perinatal Society of Australia and New Zealand) Conference Canberra March 2001.)
342 What informed consent means for legal defence cases in Australia is discussed at length in the manual of the Medical Defence Association of Victoria, Medicine and the Law: A practical guide for Doctors. (MDAV 2006). For the medical duty to disclose risks , and the loss of a chance for a better outcome, see Ch. 17.
343 This has already been argued in one Washington DC court. I predict that with a few decades such a case will be successful. Awareness of this risk is driving the use of ‘informed consent’ forms which are frequently quite inadequate in content and process of administration, but which may enable hospitals to say the mother consented.
344 I visited this milkbank then and was given this information. See ALCA News 1990
345 Professor Peter Hartmann made this statement at a conference some years ago.
346 Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N et al. Safety and efficacy of inulin and oligofructose supplementation in infant formula: Results from a randomised clinical trial. Clinical Nutrition 2013. Doi: 10.1016/j.clnu.2013.02.009). Recruitment was in the first month, not from birth.
347 Perhaps as with GM corn in Canada, mothers will have to pay for the privilege of being contaminated with patented products. Will mothers need a licence to make milk containing patented probiotics? Mad, I know, but who would have guessed that an organic crop contaminated by pollen from a neighbour’s GM crop would result
in confiscation of the organic crop, not damages awarded against the polluters?
For a review of the whole book see Breastfeeding.Support
Milk Matters: Infant feeding & immune disorder is available from Amazon and Book Depository worldwide and also LLLGB Books in the UK. In Australia, orders can be made via the author’s website. If any other LLL Group or entity wishes to order multiple copies, the author can arrange publication in the US or Europe at a substantial discount. Contact Maureen Minchin via her website for further information.