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Supreme Court Will Review Generic Drug Preemption Cases
December 10, 2010By Kurt R. Karst –
Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501). As we previously reported, the petitions presented almost identical questions for the Supreme Court’s consideration: “Whether the Eighth Circuit [, in its November 27, 2009 decision in Mensing v. Wyeth, Inc.], abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug.”
The Court decided to hear the cases notwithstanding a recommendation from the U.S. Department of Justice (Solicitor General of the United States), which filed an amicus brief in November, that the Court deny review given the current lack of a split of authority among the circuits on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.”
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- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
- Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act November 28, 2023
- FDA Proposes to Ban Brominated Vegetable Oil in Food November 23, 2023
- Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy November 20, 2023
- HP&M Recognized by Best Law Firms® as National Tier 1 – FDA Law and Regional Washington, DC Tier 1 – FDA Law (2024 Edition) November 15, 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
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- FDA News
- Foods
- Foods and Dietary Supplements
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- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
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- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized