- 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
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HP&M Issues Analysis Discussing the Implications of the Supreme Court’s Wyeth v. Levine Decision
March 16, 2009Hyman, Phelps & McNamara, P.C. (“HP&M”) has issued a detailed analysis of the Supreme Court’s recent ruling in Wyeth v. Levine. A copy of the analysis, written by James P. Ellison and Carrie S. Martin, is available here. In Wyeth, the Court ruled that, based on the facts of that case, the Federal Food, Drug, and Cosmetic Act does not preempt state law. Although the immediate effect was to let stand the state law tort judgment against Wyeth, the effects of the case are almost certainly not going to be so limited. In fact, as discussed in HP&M’s analysis, Wyeth is likely to remain an important Supreme Court preemption case for the drug industry for the foreseeable future.
In addition to issuing an analysis of the Wyeth opinion, on March 24, 2009, HP&M's John R. Fleder and Kurt R. Karst will be speaking at a webinar sponsored by FDA News about the implications of Wyeth. Information about the webinar is available here.
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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
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized