AdvaMed Files Amicus Brief with California Court of Appeal in Device Labeling Case
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from Pat Fogarty, Senior Vice President, Deputy General Counsel & Director of Litigation regarding this week’s filing of an amicus curiae brief in the case of People v. Johnson & Johnson:
“AdvaMed’s amicus brief asks the California Court of Appeal to reverse the judgment of the trial court.
“We believe the trial court misapplied California’s Unfair Competition Law and Fair Advertising Law by failing to judge the communications from the perspective of the target audience – trained physicians who treat pelvic floor conditions – over 80 of whom confirmed that the marketing materials were not likely to mislead them.
“The decision undermines a manufacturers ability to rely on FDA input when it comes to the adequacy of device labeling and marketing based on FDA review and is inconsistent with how medical professionals view manufacturer labeling and marketing.
“We hope the amicus brief we filed will provide the California Court of Appeal critical insight into how medical device manufacturers label and market their devices, and how the safe harbor provided by California and other states’ laws allows them to manufacture devices that are critical to the health and safety of patients.”
Read a copy of the AdvaMed amicus brief.
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AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.