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
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
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
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.
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
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