Guide on ‘Emerging Signals’ Has Unintended Consequences: Attorney
FDA’s draft guidance on Public Notification of Emerging Postmarket Medical Device Signals could have unintended consequences that may encourage medical device and drug companies to engage in more off-label promotions and lead to more unfounded product liability lawsuits, according to an online post from Reed & Smith attorney James Beck. The guidance describes FDA’s policy for notifying the public about medical device “emerging signals.” It says an emerging signal is defined as new information about a medical device used in clinical practice (1) that the agency is monitoring or analyzing, (2) that has the potential to affect patient management decisions and/or change the device’s known risk/benefit profile, (3) that has not yet been fully validated or confirmed, and (4) for which the agency does not yet have specific recommendations.
Beck portrays FDA’s proposal as an attempt to take “regulatory shots in the dark based on preliminary information that is admittedly scientifically unverified and which the agency can’t even say is significant. The agency knows that there are risks that some of its shots will go off half-cocked.” While the guidance is devoted to device emerging signals, Beck hints that a similar policy for drug signals may soon follow.
Beck notes that one of the interesting issues involving off-label promotion is “how far below the FDA’s ‘substantial evidence’ (two controlled studies) standard may scientific support for truthful off-label promotion go before the science gets too weak to be reliable. We’re not sure where that is, but if the FDA is proposing to take it on itself to provide public information on preliminary data, then we doubt that courts will look kindly on it trying to shut down similarly supported (or unsupported, as the case may be) speech on off-label uses by the entities it regulates... So if the FDA presumes to make public statements on the basis of the slim evidence it describes in this proposed guidance, it should expect that the same rules will apply to other speakers under the First Amendment.”
Regarding product liability implications, Beck predicts that the “premature FDA announcement of unconfirmed potential device risks” will lead to additional “frivolous litigation, generated by lawyer solicitation and advertising that will surely lack any of the disclaimers mentioned by the FDA.” He suggests the agency “ameliorate its proposed actions – which will be inevitably exploited by the other side in litigation solicitation – by specifying that any agency ‘emerging risk’” statements are not admissible for any purpose in civil proceedings. There’s precedent for the FDA doing this; it has prohibited discovery of the identities of persons reporting adverse drug and device reactions, which we discussed here, because preemption was involved.”