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unlawful payments of financial kickbacks, Janssen successfully conspired with Omnicare to

switch stabilized patients without any precise medical know-how to complete the switch,

opening the door for side effects such as withdraw and relapse. In addition, this confusing,

complex and ill-defined drug tapering process is likely to confuse the elderly and infirm patients

targeted for the switch about how much of each medication should be taken and when, creating

the risk of dangerous medication errors.


Risperdal contains a number of risk factors associated with its prescription, many

of which were not present in the switched-from medications:

An increased risk of stroke or stroke-like events in elderly patients prescribed Risperdal. See Risperdal Package Insert. The existence of this deadly side effect of Risperdal therapy was not disclosed by Defendant Janssen until, at the earliest, April 2003.

Janssen has also admitted that the elderly exhibit a tendency to orthostatic hypotension during treatment with Risperdal. "Because of its potential for

inducing of other

antagonize the effects of levodopa and dopamine agonists. added).

" Id. (emphasis

the hypotensive effects "RISPERDAL® may

hypotension, therapeutic

RISPERDAL® may enhance agents with this potential.

Janssen further endangered the health and welfare of the elderly because "ltJhe interactions of RISPERDAL® and other drugs have not been systematically evalnated." Residents in long-term care facilities usually are older, in poorer health, and in need of greater care and typically are prescribed several different types of medications. Patients' health was jeopardized by forcing switches to Risperdal without this critical medical data by exposing the elderly patients to adverse drug interactions with the litany of other medications which they had been prescribed.

Janssen also notes in the Risperdal package insert that clinical studies of Risperdal in treatment of schizophrenic patients did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently than YOlmger patients. This is significant because it is widely

differently function. considered

due to changing metabolism and typical decreases in kidney Medications within a particular therapeutic category may be generally comparable in studies comparing two different

known that the elderly are more






susceptible to ages, his or

suffering her body

adverse reactions processes drugs


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