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Bad Pills

Many medicines are poisons. According to Paracelsus, everything is poisonous in some degree. This fact presents a legal problem, depending on how it is looked at; if a medicine damages the patient, how can the doctor or the manufacturer be held liable? It was generally known that the medicine was harmful, was it not?

The doctor’s case is more straightforward. If the doctor follows general practice and the manufacturer’s instructions, in the prescribing and administering of the medicine she will not be answerable, other things being equal, for any unintended or unanticipated damage caused by the medicine.

The manufacturer’s case is complicated. Pharmaceuticals are subject to the law of products liability. This means that an injured patient does not have to prove negligence on the part of the manufacturer if the product unintentionally injures the patient.

“Unintentionally” is the significant word. The EU products liability directive (Council Directive No. 85/374/EEC) and the  Liability for Defective Products Act 1991 each define defect by reference to safety and the reasonable expectations of “persons”. In modern times, medicinal products are sold with disclosure of possible and probable side effects and, of course, it would be easy for the manufacturer to establish that the product was, to some degree, poisonous anyway. So, the patient is taken to know of the effects of the medicine and can hardly complain if those effects appear. In other words, the patient must successfully plead and prove that the medicine is “defective” within EU products liability directive and The Liability for Defective Products Act 1991, and that may be very difficult.

One response to this is to insure against damage arising from the use of medical pharmaceuticals. This means that there is a source of funding to pay compensation for damage arising from the use of a medicine, subject only to proof of the connection between the medicine and the damage. Some states have adopted this course of action. This happens most often in connection with programmes of mass vaccination. Because of the large numbers involved, it is predictable that the possible undesirable  side effects will no longer be “possible” for some people; they will be actual.

In the absence of such a response there are difficult issues in products liability law when the words “unintentionally” and “disclosure” are looked at.

“Unintentionally” cannot refer to the intentions of the manufacturer only. Otherwise the manufacturer would never be liable for damage, regardless of the facts. In the case of medicinal products it must refer to the intention of the patient as mediated by the intention of the patient’s doctor. The latter is an essential actor; few patients are qualified to know when and by how much a medicine is appropriate for use.

Inevitably, the manufacturer will reveal a comprehensive list of possible and actual undesirable side effects. It is most unlikely that the patient becomes aware of these; it is the doctor who knows of them.

This is, in theory, a disclosure by the manufacturer. However, what the doctor needs to do is to balance risks. A list of possible or actual side effects is not in itself a full disclosure. It will not reveal how likely these effects are in any particular case. What is required is access to the history whereby the manufacturer learned of the possibility of the side effects.

To process this kind of information it is necessary to belong to a community. Doctors belong to such a community. Any individual doctor can seek out literature generated by other, more specialised, doctors (or chemists) wherein the history of the manufacturer’s product is reviewed, permitting a collective independent judgment about risk to be made. The patient’s doctor can then apply that knowledge and judgment to her patient.

The implications of this are substantial. A manufacturer cannot reveal some elements only of the history of the development of the medicine. What were the exact circumstances in which the manufacturer’s drug trials took place? What was the population subjected to them? What were the full results of all trials? Were some trials or their results not released to the public sphere?

In the absence of this information a patient (or her doctor) cannot be said to have an expectation implying knowledge of the likelihood of the relevant adverse event.

There is reason to believe that much of this information is withheld from the public.