Manufacturers of experimental medicines would receive additional legal protection under a bill currently under consideration in the Louisiana House of Representatives. The bill is a modification of the “Right to Try” law passed last year, which allows patients to have access to medication which have not yet received final approval from the FDA.
The Right to Try law is something of an animal of its own, since it nullifies a provision under the Federal Food, Drug and Cosmetic Act which allows patients with life-threatening conditions to access experimental drugs. FDA approval is required under the law, though, whereas Louisiana’s Right to Try law does not require such approval.
The bill currently in the House contains language stating that the law does not create any cause of action “by or on behalf of any person against a manufacturer of an investigational drug, biological product or device.” The aim of the provision is to provide patients in Louisiana greater access to experimental medications under the Right to Try Law by addressing industry concerns about liability.
For businesses in the pharmaceutical industry, of course, avoiding product liability litigation is an important ongoing task. There is an entire industry catering to the legal interests of patients who seek compensation from drug manufacturers for alleged product defects or a failure to properly alert consumers of risks.
Having proper guidance on how to avoid product liability litigation is necessary to reign in the massive costs company’s can face on this front. In a future post, we’ll say more about this issue and how experienced legal counsel can help.