49 Cited authorities

Wyeth v. Levine
555 U.S. 555 (2009) Cited 1,435 times 101 Legal Analyses
Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims
Riegel v. Medtronic, Inc.
552 U.S. 312 (2008) Cited 1,034 times 62 Legal Analyses
Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”
Buckman Co. v. Plaintiffs' Legal Committee
531 U.S. 341 (2001) Cited 1,188 times 80 Legal Analyses
Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA
In re Medtronic, Inc., Sprint Fidelis Leads
623 F.3d 1200 (8th Cir. 2010) Cited 310 times 5 Legal Analyses
Holding "[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is pre-empted."
Warner-Lambert Co. v. Kent
552 U.S. 440 (2008) Cited 53 times 10 Legal Analyses
Finding same Michigan statute similar to the Texas statute not preempted
Riley v. Cordis Corp.
625 F. Supp. 2d 769 (D. Minn. 2009) Cited 155 times 2 Legal Analyses
Holding that components of a PMA-approved device "work together as a single medical device" and thus "it makes no sense . . . to pick apart the components of a medical device and apply different preemption analyses to different components"
Riegel v. Medtronic, Inc.
451 F.3d 104 (2d Cir. 2006) Cited 157 times 1 Legal Analyses
Holding that state tort claims which impose "liability as to a PMA-approved medical device, notwithstanding that device's adherence to the standards upon which it obtained premarket approval from the FDA, are preempted"
Gomez v. St. Jude Medical Daig Division Inc.
442 F.3d 919 (5th Cir. 2006) Cited 144 times 2 Legal Analyses
Holding that design defect, failure-to-warn, and breach of express warranty claims under LPLA were preempted by § 360k
In re Medtronic, Inc. Sprint Fedelis Leads Prods.
592 F. Supp. 2d 1147 (D. Minn. 2009) Cited 123 times 2 Legal Analyses
Holding that claims for breach of an express warranty of a medical device's safety would require a jury to determine that the device was unsafe
Horowitz v. Stryker Corporation
613 F. Supp. 2d 271 (E.D.N.Y. 2009) Cited 113 times 1 Legal Analyses
Holding that, under New York law, "an action for breach of express warranty requires...reliance on th[e] promise or representation" (citing CBS Inc. v. Ziff–Davis Pub. Co. , 75 N.Y.2d 496, 554 N.Y.S.2d 449, 553 N.E.2d 997, 1000–01 (1990) )
Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing
Fed. R. Civ. P. 12 Cited 348,708 times 930 Legal Analyses
Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss
Rule 201 - Judicial Notice of Adjudicative Facts
Fed. R. Evid. 201 Cited 28,568 times 26 Legal Analyses
Holding "[n]ormally, in deciding a motion to dismiss for failure to state a claim, courts must limit their inquiry to the facts stated in the complaint and the documents either attached to or incorporated in the complaint. However, courts may also consider matters of which they may take judicial notice."
Section 360k - State and local requirements respecting devices
21 U.S.C. § 360k Cited 1,027 times 21 Legal Analyses
Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause
Section 360c - Classification of devices intended for human use
21 U.S.C. § 360c Cited 789 times 22 Legal Analyses
Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."
Section 337 - Proceedings in name of United States; provision as to subpoenas
21 U.S.C. § 337 Cited 671 times 19 Legal Analyses
Restricting FDCA enforcement to suits by the United States
Section 360e - Premarket approval
21 U.S.C. § 360e Cited 494 times 17 Legal Analyses
Granting FDA authority to conduct hearings regarding PMA withdrawal
Section 360h - Notification and other remedies
21 U.S.C. § 360h Cited 56 times 3 Legal Analyses
Granting FDA authority over device recall orders and timetables
Section 814.39 - PMA supplements
21 C.F.R. § 814.39 Cited 152 times 4 Legal Analyses
Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"
Section 803.50 - If I am a manufacturer, what reporting requirements apply to me?
21 C.F.R. § 803.50 Cited 149 times 8 Legal Analyses
Requiring device manufacturers to report adverse medical device events to the FDA
Section 10.30 - Citizen petition
21 C.F.R. § 10.30 Cited 140 times 35 Legal Analyses
Describing the requirements for filing a citizens' petition
Section 10.45 - Court review of final administrative action; exhaustion of administrative remedies
21 C.F.R. § 10.45 Cited 48 times 1 Legal Analyses
Providing that " request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25 . . . before any legal action is filed in a court complaining of the action or failure to act"
Section 814.44 - Procedures for review of a PMA
21 C.F.R. § 814.44 Cited 35 times 1 Legal Analyses
(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. If FDA refers an application to a panel, FDA will forward the PMA, or relevant portions thereof, to each member of the appropriate FDA panel for review. During the review process, FDA may
Section 7.40 - Recall policy
21 C.F.R. § 7.40 Cited 16 times 1 Legal Analyses
Noting that "recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products"
Section 814.46 - Withdrawal of approval of a PMA
21 C.F.R. § 814.46 Cited 5 times 1 Legal Analyses
(a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that: (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act applies. (2) Any postapproval requirement imposed by the PMA approval order or by regulation has not been met. (3) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed

Kinetic Co., Inc, The v. Medtronic, Inc

49 Cited authorities

Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

Holding "[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is pre-empted."

Finding same Michigan statute similar to the Texas statute not preempted

Holding that components of a PMA-approved device "work together as a single medical device" and thus "it makes no sense . . . to pick apart the components of a medical device and apply different preemption analyses to different components"

Holding that state tort claims which impose "liability as to a PMA-approved medical device, notwithstanding that device's adherence to the standards upon which it obtained premarket approval from the FDA, are preempted"

Holding that design defect, failure-to-warn, and breach of express warranty claims under LPLA were preempted by § 360k

Holding that claims for breach of an express warranty of a medical device's safety would require a jury to determine that the device was unsafe

Holding that, under New York law, "an action for breach of express warranty requires...reliance on th[e] promise or representation" (citing CBS Inc. v. Ziff–Davis Pub. Co. , 75 N.Y.2d 496, 554 N.Y.S.2d 449, 553 N.E.2d 997, 1000–01 (1990) )

Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

Authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause

Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."

Restricting FDCA enforcement to suits by the United States

Granting FDA authority to conduct hearings regarding PMA withdrawal

Granting FDA authority over device recall orders and timetables

Authorizing medical device manufacturers to change labels to "add or strengthen a contraindication, warning, precaution, or information about an adverse reaction"

Requiring device manufacturers to report adverse medical device events to the FDA

Describing the requirements for filing a citizens' petition

Noting that "recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products"