The Supreme Court's decision in Riegel v. Medtronic immunized medical device manufacturers from certain types of state product liability claims. However, this immunization applies only when the devices underlying those claims have been approved through the Food and Drug Administration's most rigorous—and costly—review process, premarket approval (PMA). Exploiting this decision, we examine whether manufacturers strategically respond to this new immunity. We find evidence that, following Riegel, approvals for high‐risk product categories increase relative to the comparable change for low‐risk categories, suggesting that firms are sensitive to the newly immunized risk. We additionally find evidence that physician treatment patterns with respect to medical devices also change, consistent with Riegel shifting liability away from device manufacturers and toward physicians. The analysis provides evidence that sophisticated actors respond to changes in their expected legal liability and that technical legal decisions have important ramifications for the provision of healthcare.

中文翻译：

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对责任免疫的反应：来自医疗器械的证据

最高法院在Riegel诉Medtronic案中的判决免除了某些类型的国家产品责任索赔中的医疗设备制造商。但是，只有当这些要求所依据的设备已通过美国食品药品监督管理局最严格且最昂贵的审查程序，上市前批准（PMA）批准后，这种免疫措施才适用。利用这一决定，我们研究了制造商是否从战略上对这种新的免疫力做出反应。我们发现有证据表明，继里格尔之后，相对于低风险类别的可比变更，对高风险产品类别的批准有所增加，这表明企业对新免疫的风险敏感。我们还发现有证据表明，与Riegel将责任从器械制造商转移到医师身上有关，医疗器械的医师治疗模式也会发生变化。该分析提供了证据，表明经验丰富的参与者对预期法律责任的变化做出了反应，并且技术法律决定对提供医疗保健具有重要影响。