We update our cheat sheet devoted to ediscovery for defendants differently than the others.  Because of the broad nature of the topic – these cases arise in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, occasionally even criminal litigation.  That means we have to research them separately to find what

A couple of weeks ago, we reported that, under pressure from the Drug and Device Law Rock Climber, we were headed to New York to see the Broadway production of Orwell’s 1984. Publicity surrounding this spectacle focused on audience members fleeing, fainting, and/or vomiting during the torture scene.  Incautiously well-fed (Vietnamese/Thai food from a singularly

The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States.  The marketed product is used, people claim to have been injured by it, and they sue the manufacturer under various product liability theories.  Often, in the course

This is our quasi-annual update to our cheat sheet about ediscovery for defendants.  Essentially that means using discovery to obtain access to what plaintiffs have said about themselves, and their supposed injuries, on social media.  Such material can be critical to defeating a plaintiff’s case. See Zamudio-Soto v. Bayer Healthcare Pharmaceuticals, Inc., 2017 WL

Charges of discovery abuse get thrown around frequently in product liability litigation.  We have not done a scientific survey, but we guess that such charges are levied against the manufacturer defendants more often than against individual plaintiffs.  For one thing, seeking burdensome discovery, and then discovery on discovery, has been in the product liability plaintiff

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.

Continue Reading Protecting Foreign Adverse Events