Fosamax and the Public Hazards Discovery Doctrine

An observation can be made about the typical method through which mass pharmaceutical litigation begins. Initially, the plaintiff files a lawsuit and serves the manufacturer with written discovery requests, seeking information pertaining to adverse events, clinical trials, direct-to-consumer marketing, and the like. The manufacturer objects to each and every request and does not provide one document. The manufacturer then delays, and the plaintiff frets and finally a compromise is worked out whereby limited production will be obtained; attached to that production will be a manufacturer-imposed presumption of confidentiality. At the same time, while the manufacturer strives to keep secret the internal documents showing what it knew and when it knew it, it will issue a press release talking about the wonderful medicine, claiming it is being wrongfully sued and saying that it has never had a reason to think the medicine was unsafe.

In the event a drug remains on the market during litigation, and the manufacturer does not warn about a known risk, places the warning in an obscure location in the packaging insert, or provides inadequate information about the severity of the risk, litigants and courts have a duty to disclose certain internal information to the public. Physicians and patients need to know the hazards about which the manufacturer was aware and when it became aware of them so that they can make an educated decision regarding the risks linked to the particular agent.