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Class III Medical Device Product Liability Claims Under <i>Twombly</i> and <i>Iqbal</i>
Under Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal' 556 U.S. 662, 678 (2009), complaints must allege “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. A claim is facially plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. Accordingly, “formulaic” or “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id' Mere conclusions “[do] not unlock the doors of discovery. ' ” Id. at 678'79.
It is well founded that the pleading standard set forth in Twombly and Iqbal applies to claims involving Class III medical devices. In these actions, however, federal courts have taken different approaches to the application of Twombly and Iqbal. Some courts have concluded that plaintiffs do not need to allege product-specific information in their complaints to survive motions to dismiss on the grounds that the product-specific information about manufacturing is confidential under federal law and, therefore, is not available to a plaintiff until discovery. Other courts, when analyzing similar claims, have held that general pleading of violations of federal regulations is insufficient to state a viable claim under Twombly and Iqbal.
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