Senate Bill S3157

                                 BILL NUMBER:  S3157

 TITLE OF BILL :
An act to amend the general business law, in relation to liability in
civil actions brought against manufacturers of prescription drugs or
medical devices in certain cases


 PURPOSE :
To require that pharmaceutical manufacturers who engage in
direct-to-consumer advertising of prescription drugs satisfactorily
advise consumers of the risk involved in the ordinary use of the
prescription advertised. This bill also requires that, in products
liability actions, the adequacy of the warning be a question of fact
for the jury.

 SUMMARY OF PROVISIONS :
Section 1. Adds a new Section 396-aaa to the general business law.
Subsection (1) requires that manufacturers of prescription drugs who
engage in direct-to-consumer advertising inform patients of the
foreseeable risks of harm associated with their products and creates
liability therefore when failure to do so results in harm to a
patient. Subsection (2) defines prescription drug or medical device.
Subsection (3) provides that, in a civil action, the adequacy of the
warnings supplied by the manufacturer of a prescription drug or
medical device is a question of fact to be determined by the jury.
              

Section 2. Effective date.

 JUSTIFICATION :
In 1997 the F.D.A. relaxed its guidelines for direct-to-consumer
advertisement of pharmaceuticals. Since that time, there has been an
onslaught of marketing in an attempt to influence a patient's choice
of a drug. These efforts have become an essential part of
manufacturer's marketing plans, resulting in an increase from $843
million in 1997 to annual costs in the billions for print and
broadcast advertising. This change has also resulted in an increase in
the number of prescriptions written: Fifteen months into the
relaxation of the guidelines, one heavily marketed drug saw an
increase in sales of more than one hundred times that of prescriptions
written prior to advertisement. This controversial new marketing
technique, opposed by the American Medical Association, undermines the
patient-physician relationship by encouraging consumers to ask for
advertised products by name. As "patient choice" becomes an
increasingly popular concept physicians are being relegated to a
passive role where, upon demand, the patient receives a prescription
for the advertised drug 73% of the time. The benefits DTC advertising
provides to the public are questionable at best, as misconceptions
about this type of advertising appear to be extensive. A recent survey
reveals that 43% of the individuals polled believed that only
"completely safe" drugs could be advertised directly to consumers,
while 21% thought only "extremely effective" drugs could be marketed
in this way. An AARP Executive Summary notes that most persons fail to
take away key information from the advertising and that consumers age
60 or older appear to obtain less information from the ads than
others.  Historically, with regard to prescription drugs, our courts
have created an exception to the traditional duty of manufacturers to
warn consumers directly of risks associated with their products
because they warned health care providers of those risks. This made
sense in an era of "doctor knows best," when pharmaceutical
manufacturers directed all of their sales efforts at physicians and
never at consumers.  In light of the recent, and expensive, mass
marketing of prescription drugs, manufacturers should no longer be
relieved of the duty to properly warn their advertising targets about
the dangers of their products. Just as the manufacturer can make
direct claims about the efficacy of its products, so should that
manufacturer warn of its risks. By advertising directly to the
patient, manufacturers make the patient an active participant in the
decision to use the drug and cannot, therefore, claim the potential
adverse effects of using the drug are so complex that they can only be
communicated to physicians.  Advertising prescription drugs is
effective. If it were not, manufacturers would not continue to pursue
their annual multibillion dollar efforts to peddle their wares. It is
shameful enough that pharmaceutical manufacturers continually pass
these costs on to consumers, one effect of which is an annual increase
in the costs of drug benefits of more than 20%. It would be
reprehensible to couple this type of manipulation of the drug market
with civil immunity. A drug manufacturer who engages in direct
consumer advertising, and who reaps the financial benefits of so
doing, should not be able to hide behind the physician whose role it
has usurped.  Understandably, proponents of DTC advertising may argue
that additional civil liability would serve to merely add to the
rising costs of prescription drugs. However, this presupposes that
manufacturers would continue to employ the use of direct to consumer
advertising, and to do so while failing to adequately warn patients of
the potential risks associated with the use of their products. It is
important to note that, under this legislation, manufacturers who
market exclusively to health care professionals will continue to be
afforded civil immunity through the learned intermediary doctrine.

 LEGISLATIVE HISTORY :
New to Senate - In Assembly since 01-02

 FISCAL IMPLICATIONS :
None to the State.

 EFFECTIVE DATE :
This act shall take effect on the sixtieth day after it shall have
become law.