Click on title above for review of civil procedure defense, using Rule 9 (b).
Off label use represents about half of all prescriptions. Off label is the use of a medication for condition not approved by the FDA, after test data have been submitted by the drug companies. It is half of medicine, and can be as scientifically rigorous and prove as on label use.
Off label use represents a gold mine of medical advances at little or no cost. So the blood thinning effect of aspirin is a nuisance to the headache patient in whom it caused a bleeding ulcer. It is a great benefit to the heart patient who needs a mild blood thinner. Is aspirin a pain killer or a blood thinner? One patient's side effect is another's best treatment option.
Therefore, at the policy level, the lawsuits for any off label promotion should be dismissed as damaging to clinical care, by chilling the advocacy for innovative uses of cheap, older, often generic medication.
Beyond the appalling effects on clinical innovation, off label promotion is speech. The Free Speech Clause is a coin with two sides, the freedom to say speech, and the freedom to hear speech. Corporations may not have unlimited rights to free speech. However, doctors and patients have an unlimited right to hear free speech.