FDA Is Sued With Boston Scientific Over Allegedly Faulty Device

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FDA Is Sued Along With Boston Scientific Over Allegedly Faulty Spinal Cord Stimulator Device

Dennis Tosh

May 7, 2025 at 04:16 PM EST

A woman who allegedly was injured by an implanted pain management device has sued both the product’s manufacturer and the FDA, which the plaintiff alleged acted unlawfully by approving “incremental” premarket approval (PMA) supplements for a series of device modifications rather than requiring “full panel-track review or independent clinical validation” (Lawler v. Boston Scien... Read More

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FDA Is Sued Along With Boston Scientific Over Allegedly Faulty Spinal Cord Stimulator Device

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