On October 14, 2015, the United States Food and Drug Administration released a document providing draft guidance for animal studies used in medical device development and testing. In many lawsuits regarding defective medical devices, studies and guidance documents of this nature are used by the parties’ experts to testify about certain aspects of…
In Buckley v. Align Technology, Inc., a plaintiff brought product liability challenges against the defendant regarding its Invisalign teeth straightening system. This device is a 3D printed product that helps users straighten misaligned teeth. The user receives a customized series of 3D printed mouth inserts that fit snugly around his or…
Since the Essure sterilization device was approved in 2002 by the U.S. Food and Drug Administration (FDA), over 5,000 reports have been made about injuries stemming from the use of the device. In a recent NPR report, a representative from the National Center for Health Research indicated that Bayer, the manufacturer…