Devices

Reverse ‘Calif. Consumer Protection Regime’: WLF

Washington Legal Foundation is asking the Supreme Court to review and overturn a California Court of Appeal decision that imposed $300 million in civil penalties on Johnson & Johnson’s Ethicon unit for marketing its pelvic mesh product in the state. WLF says (includes a link to the amicus brief) the state court decided that every communication the company made about its pelvic mesh product, whether to doctors or patients, written or verbal, violated the state’s consumer protection laws.

Its brief, the advocacy group says, “details how a series of statutory and prosecutorial overreaches have radically transformed California’s well-intentioned consumer protection laws into a trap for the wary and unwary alike. As applied today, California law fails to put the public on fair notice of what kind of conduct constitutes a violation. With no definition of a ‘violation’ for purposes of assessing penalties, courts are left to interpret and apply amorphous, elastic, and imprecise language, such as whether a practice is ‘unlawful,’ ‘unfair,’ or ‘fraudulent,’ on a case-by-case basis. This deprives businesses of the benefit of fair notice and due process.”

WLF says the state laws’ vagueness has resulted in an increasingly standardless and often arbitrary application of the laws by California state courts and, at times, their federal counterparts. “The chaos has snowballed over time, providing even greater opportunities and incentives for abuse of the judicial process by government entities and others who seek to enforce one or both statutes (Unfair Competition Law and False Advertising Law),” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome