Today’s post is on a short decision from the Court of Appeals of Florida, but it is important. In drug and device litigation, defendants are almost always required to produce the adverse event reports related to the product at issue based on the argument that they go to notice. Beyond notice we take strong issue with their admissibility. Take a look at our AER cheat sheet.  And with so many courts excluding them from evidence, extensive discovery of adverse events is something defendants should push back on. As part of that push back, defendants should never overlook raising the burden of redacting from any adverse event report any information that identifies either the voluntary reporter (physicians, consumers) or the person who used the drug or device (if not one and the same). If you’ve made that argument, you may have had a court question whether redaction is really necessary. The answer is an unequivocal yes.

The FDA requires manufacturers to maintain the confidentiality of this information.

The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report.

21 C.F.R. §20.63(f) (emphasis added). So, whether plaintiffs request them or the court orders their production, the manufacturer is obligated to redact adverse event reports before producing them. So, from a practical standpoint, time must be built into any schedule to allow for this redaction to take place. Further, if plaintiffs’ adverse event request is overly broad, you might have grounds to ask for cost-shifting or at least cost-sharing. May help to refocus plaintiffs on what they really want/need.

It is important to keep in this requirement in mind too when plaintiffs ask for production of a manufacturer’s adverse event database in its native format. With the FDA requiring adverse event reports be electronically submitted, every company maintains such a database. Plaintiffs would prefer to poke around the database rather than limit themselves to hard copies of the reports or even just to the information that is provided to the FDA. But plaintiffs cannot be given unfettered access. There are many reasons for this, not the least of which is making sure our clients do not run afoul of the above privacy regulation. Native productions require redactions too and depending on the system and the production, this could be more or less difficult than redacting hard copies.

And that brings us to today’s case which got us thinking about this issue in the first place. In Howmedica Osteonics Corp. v. Trowbridge, 2017 Fla. App. LEXIS 764, *1 (Fl. Ct. App. Jan. 25, 2017), defendant sought certiorari review of the trial’s court ruling denying defendant’s request to redact information from foreign adverse event reports.  After citing the above regulation, the appellate court clearly stated that “nothing within the text of this regulation limits the identity protection to domestic voluntary reporters.” Id. at *4. There is simply no basis on which to treat adverse events reports originating within the United States any differently than those originating outside its borders. The reason for the strict privacy regulation is that the adverse event system is dependent on voluntary reporting. Voluntary reporting in turn depends substantially on a guarantee of anonymity. Id. at *5. We don’t think doctors would be eager to report adverse events if every time there was a lawsuit regarding the safety and effectiveness of a drug or medical device, he/she were opened to the possibility of becoming a fact witness by nature of having called in an event.

The decision also makes clear that the privacy protection extends from the actual adverse event report (commonly referred to as a MedWatch report in the US) to the underlying supporting or source documents as well. Id. We strongly disagree with court orders requiring the production of the underlying source documents. The only reason for producing the underlying data would be for plaintiffs to challenge the way the manufacturer reported the information to the FDA. That sounds a lot like fraud-on-the-FDA to us, which is a preempted claim that plaintiffs can’t pursue – so why do they need the data. That’s a little far afield from today’s decision, but worth a mention.

Bottom line – foreign adverse events no different from domestic and warrant the same protection.