Thanks to social media platforms like Facebook and Twitter, adverse events – reports of injury, illness, death or product malfunction to name a few – are part of the public domain. This isn’t breaking news. But FDA’s release of a trove of social media posts linking Bayer’s contraceptive implant Essure with adverse events including serious injuries and death is a reminder of just how public a product safety issue can be – long before AND long after a company or regulator takes action to protect consumers.
According to terms of an agreement between the FDA and Bayer, Bayer will provide the agency with spreadsheets cataloguing social media posts indicating reportable events associated with its Essure device. The first of these documents, which are to be delivered to the FDA monthly, included 1,453 reportable events, including 53 deaths and 24 malfunction reports. Given this is the first tranche of data, we can expect numbers to only grow as time goes on. And with litigation-related discovery ongoing, there’s a chance posts will be uncovered that, until now, went undetected or were hidden behind privacy walls.
While the FDA acknowledges that the posts in Bayer’s reports do not necessarily indicate that each entry is a unique event, it is a reminder of social media risks before, during and after product safety events and recalls. Risks related to how and when you are monitoring public channels for adverse event reports and what you do when you find them.
Let’s take it one step further. We’ve all used social media to share our opinions, concerns, and complaints about any number of topics. Consider what is being said online, at any one moment, about your company. Now imagine if that post is aggregated with similar content over weeks, months, even years. What picture does that paint? Will your actions now stand up to the scrutiny you might receive if those aggregated complaints go public?
As you evaluate those risks for your own organization, we offer the following recommendations based on our experience responding to some of the most notorious product safety recalls and events in recent history:
We all recognize that social media activity is, by nature, content available for everyone to see. But when it involves product safety issues, and gets wrapped up in legal and regulatory matters, its visibility will increase. Possibly exponentially. And when aggregated, those posts will begin to tell a story about your commitment to product safety. Don’t let the posts and data tell your story for you. Prepare now for how you would mitigate the types of risks facing Bayer.
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