Another
case in the book on Ethics dumping concerns the issue of compensation for research injury,
written by Cong Yali: Legal and Ethical Issues of Justice: Global and Local
Perspectives on Compensation for Serious Adverse Events in Clinical Trials
The case is
about a phase III trial of a drug developed by the pharmaceutical company Bayer
to prevent blood clots in patients after knee surgery. The clinical trial
compared this drug administered once a day as a tablet against another standard
anti blood clot prevention method given by injection. Two weeks after surgery
the patients underwent a clinical examination and a test for blood clot
formation by angiography. One patient experienced a reaction shortly after completion
of the angiography: low blood pressure, chest tightness, cough and sweating.
The likely diagnosis was hypovolemic shock, and the patient was treated with a
saline solution and dopamine. After about one hour blood pressure was
stabilized and after an additional 90 minutes the patient had recovered. The patient
was discharged, but returned the next day because she was not feeling well, and
was admitted to the hospital again. The doctors suspected possible pulmonary
embolism as a result of a blood clot formation. They did a comprehensive
examination and ordered bed rest and anticoagulant therapy. After two weeks the
patient was discharged but pulmonary embolism had been excluded. Because of the
necessary bed rest there was a worry that normal rehabilitation of the knee
after the operation would be hampered, resulting in possible loss of function.
The event was reported as a serious adverse event.
The patient
wanted compensation for this adverse event. Typically, in order to be awarded
compensation for research injury the patient needs to show that the cause of
the adverse event was a procedure done for research purposes and that there is
a compensable injury. Since the patient was discharged from the hospital, and
the company had already paid the hospital bill, the patient would have to
demonstrate that there is a persistent loss of function or other injury after
discharge. The patient, however, refused to undergo an examination by a
physician to provide evidence of such persistent injury. The company therefore
naturally rejected the claim, since there was no injury to be compensated.
Instead of
bringing a suit against the company based on the presence of persistent injury,
the plaintiff brought a breach of contract case against Bayer. Basically, the
plaintiff claimed that by signing the informed consent form to take part in the
trial sponsored by Bayer, the plaintiff had entered into a contract with Bayer.
This contract specified that the insurance is available for research injury.
Since anaphylactic shock after angiography is mentioned in the informed consent
form as a possible risk of angiography, this event should be covered by the insurance
contract, and consequently by the contract between the plaintiff and Bayer. According
to the insurance policy the maximum compensation amount is 500.000 Euros for
each patient. This would cover all possible injuries, and it would therefore be
reasonable that the plaintiff was awarded a portion of this amount for her
injury. 150.000 Euros was estimated as a reasonable proportion given the
seriousness of the adverse event. The court decided to award the plaintiff an
amount of 50.000 Euros, the plaintiff appealed this decision. The appeal was
denied, and the plaintiff was awarded 50.000 which was paid by Bayer.
The author
of this chapter identifies three specific ethical issues raised by this case.
First there is the cost of litigation, second is the variations in compensation
between countries, and third is the inequality between the sponsor and the
research subject in terms of access to resources. The second issue is to a large
degree a result of differences in national laws, and would be outside the scope
of most issues related to ethics. The first and the third are essentially the
same: Proving causality between research participation and injury is difficult
and can result in costly court procedures. This is indeed a challenge that needs
more attention in research ethics. It may be possible to suggest procedures
that can ease the burdens of proving causation in cases of presumed research
injury. The problem is that the case that is presented in the chapter does not
illustrate this problem at all, because it was not tried as a research injury
case, but as a breach of contract case.
First,
there is the denial of the patient to undergo an examination to provide
evidence of injury. This is a necessary condition for any case of research
injury compensation. Second, it is not even clear that there is a probable causal
relationship between the research procedures and the adverse event. There is no
disagreement that it was not caused by the investigational drug. It could
either be caused by the angiography if it was a reaction to that procedure, or
it could be caused by the surgery if it was a case of pulmonary embolism as a
result of the blood clot. The clinical record leaves both options open. If
caused by the surgery it was definitely not caused by a research procedure. If
caused by the angiography it is less clear. On the one hand the procedure could
be seen as part of the research to establish one of the endpoints of the study
(deep vein thrombosis) or it could be seen as clinical follow to detect thrombosis
and treat it if it is identified. In that case the procedure is actually of
benefit to the patient even though there is an extremely small risk of shock. Based on the questionable causal relationship
and the fact that there was no evidence of injury it is likely that any court
in any of the other countries where the trial also recruited patients would
have awarded any research injury compensation.
The patient,
however, decided to try this case as a breach of contract case. The court
agreed that it could be brought forward on that basis and did award 50.000
Euros to the plaintiff on that basis. It seems that the court argued that any
adverse event mentioned in the informed consent form automatically gives rise
to a compensation claim, in proportion to its severity based on a maximum award
of 500.000. This would be independent of whether the event led to any persistent
injury. The experience of the event itself, whether it was caused by the
research procedures or not, should be compensated.
It may very
well be that this is an appropriate legal analysis of the case based on Chinese
law. From an international perspective it is highly unusual and would probably
be rejected by the legal systems in many countries. The case description,
however, gives the reader no reason to believe that this is an accepted legal
analysis in China. It was reached by a lower court, there is no reference to
other court decisions, and there is no legal analysis of the reasoning of the
court by an expert in Chinese law. Given the uniqueness and extraordinary
nature of the decision by the court, one would have expected that the chapter
contained some legal analysis. Instead it is basically an account of the reasoning
of this particular court supplemented with information from the plaintiff’s
family.
By now it
is generally accepted that if a person is injured as a result of research
participation they should be compensated for that injury. The difficult,
unresolved issues are about one should understand that requirement. One issue
concerns the requirement that there is a causal relationship between the
research participation and the injury. Clearly, not all bad things that happen
to people who are in research should be compensated. People may die in traffic
accidents, they may suffer other injuries, or they may get unrelated diseases.
In clinical research, the underlying disease or the ordinary treatment for the
condition may also cause injury. Only injury that is caused by procedures done
for research purposes should be compensated. The challenge is often how to
identify what is caused by the research and what is caused by something else.
Another issue concerns how much a person should be compensated. There is no
disagreement that direct expenses related to treating the injury should be
compensated, and expenses related to long-term effects of the injury. This
could be economic loss because of need for rehabilitation or diminished ability
to work, resulting in salary loss or reduction. Provisions for any additional
compensation, such as for the fact that one has been injured, for the emotional
effects of injury, or for the restriction in activities that one can carry out,
but which do not result in any economic loss, vary between countries. It would
have been useful to have some discussion of these issues in this chapter and in
this book. Instead we get a misleading description of what appears to be a
unique case, without any attempt at legal analysis by experts in Chinese Law.
And it is difficult to see that this is a typical case of “ethics dumping”, and
should form any basis for recommendations about funding decisions by the European
Commission.
The court's decision is given here (in Chinese).
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