Subject: Medical Devices

Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

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Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.

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Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

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How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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It’s an MDL World: The JPML issues its first orders of the year, creating two new MDLs

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Centralization of claims in multidistrict litigation has become the new normal—so much so, that MDL proceedings now comprise more than 50 percent of the federal civil caseload. But has MDL practice in the United States peaked? Only time will tell. While the total number of MDL cases remains high (424,720 cases as of mid-February), the vast majority of these cases are concentrated in just a few of the more crowded MDL dockets. And as the annual MDL statistics in recent years show, the total number of new MDL petitions submitted, and granted, has been in decline. In 2021, for example, the Judicial Panel on Multidistrict Litigation received 33 total MDL petitions, granting only 19—compared with 44 petitions (26 granted) the year before.

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FDA Solicits Comments Prior to Regulating 3D Printing of Medical Devices at the Point of Care

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Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have occurred within traditional manufacturing facilities. Over the past two years, however, supply chain disruption caused by the COVID-19 pandemic has created medical device shortages that have amplified the use of 3D printing technologies at the point of care. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts within healthcare facilities. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increasing use of 3D printers within the healthcare setting. In turn, FDA is taking notice and has recently issued a paper to facilitate discussion about potential approaches to regulating 3D printed devices at the point of care.

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Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

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Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care clinics for minor illnesses or simple-to-prescribe medications. The last two years shifted that race into high gear, particularly with new products and platforms being introduced that range from virtual clinic platforms that allow patients—and their programmable implanted medical devices—to connect with their providers from the comfort of their own homes, to passive smart devices that remotely monitor patient vital signs, analyze that data using proprietary algorithms, and evaluate whether a patient is having a medical emergency or needs to schedule an appointment with their provider. These technologies are now so ubiquitous that they are being showcased at the 2022 Consumer Electronics Show.

To be sure, regulatory changes in response to the COVID-19 pandemic made telemedicine more permissible—and reimbursable—than in the past. But that alone is not driving medical device companies forward. Instead, medical device manufacturers are rapidly developing smart or algorithm-driven medical devices that take advantage of the ever-increasing power of those technologies and leveraging telemedicine to make the remote treatment and management of medical conditions less complicated. A recent article in Nature’s npj Digital Medicine confirmed the growth in this area, counting 64 separate smart- or algorithm-driven medical devices currently on the market as of 2020. See Stan Benjamens, et al., The State of Artificial Intelligence-Based FDA-Approved Medical Devices and Algorithms: An Online Database, 3 npj Digital Medicine Article No. 118 (2020). Each of these new devices endeavor to enable physicians to practice more effectively and efficiently than they could before. The future for smart or algorithm-driven medical devices looks promising.

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