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Wyeth v. Levine May Affect Device Litigation, Notwithstanding Riegel v. Medtronic
March 12, 2009By James P. Ellison –
Despite the Supreme Court’s 2008 ruling in Riegel v. Medtronic, in which the Court found express preemption for devices subject to premarket approval based on express statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine. The judge’s order is significant because just two months ago this same judge granted a motion to dismiss the claims in those device cases based on preemption.
While it is not clear that the judge overseeing these cases believes that Wyeth affects Riegel and device preemption, the order provides tangible evidence that even if none of the pending bills (here and here) to undo device preemption (which seem to have been motivated by Wyeth) become law, Wyeth may nevertheless have implications for device litigation.
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- To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA September 19, 2023
- Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats September 18, 2023
- HP&M’s Faraz Siddiqui to Speak at Informa’s Medicaid Drug Rebate Program (MDRP) Summit 2023 on Value Based Programs September 15, 2023
- Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45 September 13, 2023
- 510(k) Modernization 2023 September 12, 2023
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
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- Cosmetics
- COVID19
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- FDA News
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- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
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- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
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- Product Jurisdiction and Combination Products
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- Uncategorized