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ADE Reports: Redaction Required

By James M. Beck and Mark Herrmann

Yes, Virginia, the FDA's regulations requiring redaction of physician identifying information from Adverse Drug Event ("ADE") reports are mandatory - even if plaintiffs obtain them ... well ... irregularly.

That's the lesson of a brand new discovery decision in In Re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 4:08-MD-2004, slip op. (M.D. Ga. July 10, 2009), decided earlier today.

Here's what happened. Certain "former employees" of an overseas affiliate of the defendant turned over unredacted ADE reports to the plaintiffs. We'll leave the characterization of what happened at that. The defendant claimed that the ADEs were privileged to the extent that FDA regulations - expressly preemptive of civil litigation - required redaction of the identities of the of the physicians who filed the reports.

Plaintiffs resisted, claiming: (1) since the irregularly obtained copies had not been "submitted to the FDA" they could keep the full copies, (2) that they should get full copies of any report concerning a plaintiff, and (3) some of the reports were from overseas, and those reporting physicians weren't entitled to protection.

The court responded: "no and hell no."

Plaintiffs' attempt to split hairs with the expressly preemptive FDA regulation failed. The court agreed that:

[T]he policy underlying the regulation is so vitally important to the FDA?s voluntary reporting system that the regulation?s prohibition on disclosure extends to formal and informal voluntary reports of device complaints, regardless of whether such reports were ultimately transmitted to the FDA.

Slip op. at 7. The court thus eliminated any incentive for plaintiffs to acquire copies of reports irregularly before they were submitted to the FDA.

Interestingly, in supporting this conclusion, the Ob Tech court gave "considerable deference" to the positions stated by the FDA in an amicus brief the Agency filed in 1999. Slip op. at 9-10 & n.5. Here's the money quote on the merits, mostly taken from that brief:

The FDA reasons that because a person who voluntarily lodges a complaint with the manufacturer may not know how or whether his complaint will be forwarded to the FDA, ?FDA?s interest in protecting voluntary reporter and patient confidentiality, and in protecting voluntary reporting from the pressures of litigation,? applies with equal force to all ?complaints,? regardless of whether the complaint triggers the manufacturer?s mandatory reporting obligations.

Slip op. at 10 (quoted parts from FDA amicus brief).

This goes to show, that whatever the Supreme Court thought about the positions the FDA took in Levine, that opinion did not somehow create any sort of blanket rejection of all deference to FDA positions - amicus or otherwise - in all situations.

So the identities of reporting physicians remain sacrosanct, no matter when the report was made, or when (if ever) that report was sent to the FDA. Slip op. at 11. And all physician reports of adverse events are covered, because they are all voluntary under FDA's regulations. Slip op. at 13.

Umm ... there's one caveat. Because the FDA regulations don't apply to entirely overseas transactions, reports filed with a European subsidiary by European doctors weren't protected - at least not by FDA regulations. Slip op. at 8. We'll leave that where it lies, because we're not experts on EU medical privacy directives.

After ADE issue was resolved, the court went on to address some document-specific attorney/client privilege issues. Slip op. at 17-22. The moral there is this: If you want a document to be kept confidential, you damn well better put some sort of confidentiality designation on that document. The defendant won the documents that had such a designation from the get go - and lost as to those that didn't.

But the generally applicable, and thus more important aspect of the Ob Tape decision is this: we can keep confidential the identities of physicians who voluntarily report adverse drug and device events - before, during, and after those events are reported to the FDA. And even if they somehow get their hands on them, plaintiffs can't keep them.

Kudos to John Lewis, Pearson Bownas, and Brad Harrison of Jones Day for achieving this victory, and making some new law.

Full post as published by Drug and Device Law on July 10, 2009 (boomark / email).