According to the Stengels, the FDA discovered the risks, and discovered that Medtronic already knew about them, when it inspected a Medtronic facility in late 2006 and early 2007. Id. The FDA sent a warning letter to Medtronic in July 2007, stating that Medtronic had “misbranded” its Class III device by concealing known risks, in violation of 21 C.F.R. §§803.50(a)(1) and - 7 - PLAINTIFF’S OPPOSITION TO DEFENDANTS’ RENEWED MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 806.10(a)(1). Id. In response to the FDA warning letter, in early 2008, Medtronic sent a medical device correction letter to doctors and shortly afterward recalled the device.

Plaintiff’s failure to warn claim is expressly preempted to the extent it is based on an alleged failure to warn Mr. Perez or his physicians. This Court held that, under Stengel, a failure to warn claim may survive express preemption if it is based on alleged failure to inform the FDA of adverse events as required by 21 C.F.R. § 803.50, and the allegations “establish[] that ‘if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached [Francisco’s] doctors in time to prevent his injuries.’” (Or. at 8, [Doc.

Plaintiffs’ basis for the adverse events now appears to be the vague “monitoring process.” (SAC ¶ 45.) But monitoring “end user clients such as Plaintiff”—even if taken as true—would not be an event reasonably suggesting a device may have a caused or contributed to a death or serious injury, so it would not qualify as a reportable event under 21 C.F.R. § 803.50(a).

52 and 5 days after becoming aware that a reportable MDR event requires remedial action to prevent an unreasonable risk of substantial harm to the public health. The manufacturer is responsible for submitting a baseline report on FDA Form 3417 fora device when the device model is first reported under 21 CFR 803.50. This baseline report is to include the PMA reference number.

5 CGMPs are merely an 5 Several of the statutory and regulatory provisions Plaintiffs list in their negligence, negligence per se, and strict liability manufacturing defect claims concern alleged misrepresentations or failure to report adverse events. See, e.g., 21 U.S.C. §§ 352(a), 331(a), 352(q), 360i(a), 360(q), 360(r); 21 C.F.R. §§ 803.50, 814.80, 814.

The Court will, however, grant Plaintiffs leave to amend as to these claims. Plaintiffs also seek to pursue a parallel claim based on Defendants' failure to report adverse events associated 2015 U.S. Dist. LEXIS 43141, *53 Case 3:17-cv-00294-ARC Document 13-1 Filed 05/08/17 Page 59 of 69 Page 18 of 20 Pamela Sandillo with use of the R3 metal liner in hip replacement procedures to the FDA, in violation of 21 U.S.C. § 360i, 21 C.F.R. § 803.50, and other FDA regulations. See Second Am. Compl.

You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of devices. For example, in accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50 and 21 CFR 803.52, you are required to report adverse events for this device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise becomes aware of information, from any source, that reasonably suggests that one of their marketed devices: 1. May have caused or contributed to a death or serious injury- or 2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

..............................22 Mattingly v. Hubbard, No. 07-cv-12014, 2008 WL 3895381 (Ky. Cir. Ct. July 30, 2008) .........................................12 McCann v. Foster Wheeler LLC, 225 P.3d 516 (Cal. 2010) .........................................................................................................15 Norgart v. Upjohn Co., 21 Cal. 4th 383 (1999) ............................................................................................................17 Pooshs v. Philip Morris USA, Inc., 51 Cal. 4th 788 (2011) .......................................................................................................17, 19 Rita M. v. Roman Catholic Archbishop, 187 Cal. App. 3d 1453 (1986) ................................................................................................18 Federal Regulations 21 C.F.R. § 10.30 .............................................................................................................................5 21 C.F.R. § 803.50 ...........................................................................................................................5 21 C.F.R. § 814.29 ...........................................................................................................................5 21 C.F.R. § 814.39 ..........................................................................................................................5 21 C.F.R. § 814.44 ...........................................................................................................................4 21 C.F.R. § 814.84 ...........................................................................................................................5 Federal Statutes 21 U.S.C. § 337(a) ...............................................................................................................5, 13, 14 21 U.S.C. § 360c .....................................................................................................................

Id. (citing 21 C.F.R. §§ 803.50(a), 814.84(b)(2)).

• Not false or misleading • No scienter 4 184 2/6/2012 Intuitive “There is also the possibility that defects in the design or manufacture of our products might necessitate a product recall.” • Not false or misleading • No scienter 5 186 2/6/2012 Intuitive Intuitive’s 2011 Form 10-K further set forth the specific regulations the Company was required to follow in connection with da Vinci and its accessories, including, but not limited to: (i) “the QSR, which requires manufacturers to follow elaborate design, testing, control documentation and other quality assurance procedures during the manufacturing process;” (ii) “the Medical Device Reporting regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur” (21 C.F.R. § 803.50); and (iii) “the reporting of Corrections and Removals, which requires that manufacturers report to the FDA recalls and field corrective actions taken to reduce a risk to health • Not false or misleading • No scienter Case5:13-cv-01920-EJD Document53 Filed12/16/13 Page35 of 45 793783.01 or to remedy a violation of the FDCA [Federal Food, Drug, and Cosmetic Act] that may pose a risk to health” (21 C.F.R. § 806.