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Drug
company liable if information on leaflet is incomplete!!!
Dr
Gopinath Shenoy
 The
‘product information’ leaflet accompanying the drug must mention
all that the medical practitioner ought to know. If the information
is incomplete it may amount to deficiencies in the services
rendered by the pharma company.
Pharmacology
is a very dynamic science. Newer and newer drugs enter the
market every month. Many new drugs are taken up by research
societies all over the world for evaluation of the drug’s
human safety profile. This apart, newer side-effects and untoward
effects are also identified when the drug is used by the masses.
It thus becomes very important that the medical profession
is given a regular update of these side-effects and untoward
effects.
 Law
casts the onus on the drug companies to bring to the notice
of the medical practitioners, these vital facts of a drug.
Law requires that all vital information regarding a drug must
be supplied to the medical practitioner by the drug manufacturer
or the drug marketing company. The ‘product information’
accompanying the drug must mention all that the medical practitioner
ought to know. If the information is incomplete it may amount
to deficiencies in the services rendered by the pharmaceutical
company.
Most pharmaceutical companies are unaware of this fact and
many of them do not even provide a product information leaflet.
Such an issue has not been raised before the Indian courts
so far but the law on this subject has been very lucidly settled
in a landmark Canadian case - Davidson v Connaught Laboratories
et al.
On 17 August 1973, the plaintiff (Paul Davidson) and his brothers
rolled a sick cow over on to its haunches. His sole contact
with the cow was pushing its side. On 18 August, after the
plaintiff had departed on holiday, it was discovered that
the cow had rabies from which it died. When the plaintiff
learned of this on 27 August, he telephoned Dr Hollows who
advised him to take rabies vaccine and warned him about a
‘flu-like reaction’ from this. On 28 August the
plaintiff telephoned Dr Kettyls, a virologist at the British
Columbia Department of Health, who explained the dangers of
the vaccine in detail, saying that it carried a risk of paralysis
and even death with an incidence between 1 in 5,000 and 1
in 8,500.
The plaintiff collected a box of 14 vials of Semple rabies
vaccine. The manufacturer’s warning was that injections
of rabies vaccine ordinarily produce local areas of redness.
The occurrence of encephalitis following the administration
of rabies vaccine has been reported in many countries. On
the plaintiff’s return home to Lindsay, Dr Hollows commenced
the course of rabies vaccine injections which was continued
by Dr Broadfoot. In September 1973, the plaintiff contracted
polyneuritis caused by the rabies vaccine. He sued Dr Hollows,
Dr Broadfoot and the manufacturers. No evidence was given
that the vaccine was defective.
After hearing both the sides, the Ontario Supreme Court held
that the standard of care required of a doctor is to live
up to the standard of reasonable care of other doctors of
his type ‘in the community or similar communities’.
Dr Hollows was not negligent in suggesting the injection of
the rabies vaccine. Although the risk of rabies was slight,
the consequences were potentially fatal. He did not depart
from the standard of care in the Lindsay area when he failed
to tell the plaintiff about the possible risk of paralysis
and death; the risk of polyneuritis was so rare that a doctor
need not necessarily tell a patient about it unless he asks.
The same conclusions applied to Dr Broadfoot who was just
carrying on from Dr Hollows. In any event, the plaintiff had
already received detailed information of the risk from Dr
Kettyls in British Columbia.
The court further held that the written warning on the printed
material placed in the boxes of vaccine given to the doctors
was inadequate and unreasonable in the circumstances. The
defendant manufacturer should have mentioned both myelitis
and neuritis as possible side-effects of their drug. Both
of these reactions were widely known and very serious indeed.
Justice Linden remarked “A drug company cannot rely upon
doctors to read all the scientific literatre outlining the
specific dangers involved in the many drugs they have to administer
each day. They are busy people, administering to the needs
of the injured and the sick. They have little time for deep
research into the medical literature. They rely on the drug
companies to supply them with the necessary data. With very
little effort the defendant company could have included in
the material that it gave to the doctors, who were administering
the injections, all of the necessary facts. They did not.
Even though these severe reactions were ‘extremely rare’,
I think it would have been advisable for the company to have
presented the figures that were available, or at least to
have referred the doctors to publications where those figures
could be learned. Once they have the figures, then the doctors
can properly assess the situation and decide whether they
will recommend the vaccine or not, and how much information
about the risks they should give to their patients. The doctors
however should have as full information as is reasonable in
the circumstances.”
(The author is a medico-legal consultant.
He can be contacted at drgnshenoy@yahoo.com)
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