Frequently Asked Questions
Q. The Food and Drug Administration (FDA) requires manufacturers of drugs and devices to submit reports of certain adverse events to the agency. What about information about the experiences of plaintiffs in product liability lawsuits? Is this adverse event information that needs to be submitted to the FDA?
A. Information from plaintiffs in product liability litigation might qualify as reportable adverse events. Drug and device adverse event reporting regulations differ, but both require assessment of information from product liability litigation to determine whether it needs to be reported to the FDA.
Drugs. Drug regulations require adverse event reports to the FDA for serious and unexpected adverse events (i.e. not listed in the current labeling). The regulations also require manufacturers to review all adverse events received from any source to determine if the events are reportable. The FDA has said specifically that adverse event information received by a drug manufacturer’s legal department in the course of product litigation must be forwarded to the firm’s drug safety organization for evaluation and possible reporting to the FDA.
Devices. Device regulations require manufacturers to evaluate all complaints received about a product to determine whether the complaint provides information about a reportable adverse event. A complaint is defined by the FDA as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” In a recent guidance document, FDA specified legal documents as one source of complaint information that should be reviewed to determine whether the information is reportable to the FDA.
Q. Some product liability cases have thousands of plaintiffs. Does information about all of them need to be submitted to the FDA?
A. Information about all plaintiffs should be reviewed to determine if the information is reportable to the FDA. In addition, as more information becomes available in the course of the litigation, any initial reports must be supplemented with additional relevant information. This can be quite burdensome to manufacturers because of the number of plaintiffs and the amount of information that must be reviewed in a short period of time.