Inc., 865 F.Supp. 37, 50 (D.Mass.1994), aff'd, 63 F.3d 25 (1st Cir.1995), cert. denied, 517 U.S. 1230, 116 S.Ct. 1892, 135 L.Ed.2d 169 (1996). But see Purcel v. Advanced Bionics Corp., 2008 WL 3874713 at *3 (N.D.Tex. Aug. 13, 2008). Plaintiff also relies on the Warning Letters to allege that defendants have failed to comply with federal regulations found at 21 C.F.R. §§ 803 (Medical Device Reporting procedures), 806 (recall and notification procedures), and 820 (failure analysis and quality assurance procedures). (Complaint ¶¶ 63 & 64 at 16-17.) Although the Warning Letters provide factual detail as to these alleged failures, plaintiff does not allege that the failure to comply with these particular regulations rendered the Trident System defective. See Heisner, 2008 WL 2940811 at *4-5 (<HOLDING>). Instead, she specifically alleges that the
holding claims based on title vii subject to arbitration holding that court may not accept claims of fraud based on speculation recognizing potential viability of claims based on postapproval events holding that claims based on grounds not objected to at trial cannot be considered on appeal recognizing that the fourth districts decision in harris called into doubt the continued viability of jenkins