For example, the FDA can and does sometimes rely on reports that an adverse event is associated with the use of a device even if causation has not been shown. 21 U.S.C. §360i (a)(1)(A) (must report to FDA if device “may have caused or contributed to a death or serious injury”) (emphasis added)By the same token, if the FDA has applied its more consumer-friendly standard and considered adverse event reports when it cleared or classified a device for marketing, the fact that it applies a more consumer-friendly standard than the common law is an argument in favor of admitting the evidence of clearance or classification. Because a more consumer-friendly standard is applied, the plaintiff suffers no prejudice.11.
FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 360i) and the regulations set forth in 21 C.F.R. Part 803.Part 803 requires user facilities, device manufacturers, and importers to submit an MDR when it becomes aware of information which reasonably suggests that a marketed device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to reoccur. The summary reporting program will not obviate the need for many of those reports.
It was passed as part of HIPAA amendments in 2005 to create reporting systems for medical errors, so that such errors could be analyzed and the analysis used to prevent future medical errors. That’s all well and good, but we know how plaintiffs’ lawyers are anytime anything adverse has to be reported – and, more importantly, so did Congress. Just as FDA adverse event reporting is protected, 21 U.S.C. §360i(b)(3) (reports inadmissible); 21 C.F.R. §20.63(f)(2) (discovery of reports preempted), so too is peer review reporting under the PSQIA. This information – data generated by reporting and analysis of medical errors – is called “patient safety work product” (“PSWP”).
On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,”or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July of 2012. (See also §519(f) of the FD&CA or 21 U.S.C. § 360i) The Global Unique Device Identification Database(Or GUDID, pronounced “Good ID”), is a searchable Web site containing a listing of all Unique Device Identifiers, or UDIs. The UDI system is designed to simplify the identification of certain medical devices used in the United States and regulated by the FDA.
A May 24 th presentation at a BNA audioconference by Virginia Gibson, chief of the Civil Division of the U.S. Attorney's Office for the Eastern District of Pennsylvania, outlined these risk areas. Quality of Care/Reporting The Safe Medical Device Act, 21 U.S.C. § 360i(b)(1)(a), requires device user facilities, such as hospitals, when they become aware that a device may have contributed to the death of a patient, to report that information to the government and to the manufacturer within ten working days. Adverse events are reported at medwatch@list.nih.gov.