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Two Synthes Inc. Execs Enter Guilty Pleas
July 22, 2009By Carmelina G. Allis –
We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The defendants allegedly conducted clinical trials of medical devices without obtaining prior authorization from the Food and Drug Administration. Now the New York Times and the Philadelphia Business Journal report that two Synthes executives, Michael D. Huggins and John J. Walsh, “pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines.” Mr. Huggins’s attorney issued a statement, indicating that his client’s guilty plea “‘is grounded in the principle that Mike Huggins was a responsible corporate officer at Synthes’ . . . Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong.” The attorney’s statement was likely made in reference to the Supreme Court’s 1975 decision in United States v. Park concerning responsible corporate officer liability.
Each defendant faces the possibility of one year in prison and a $100,000 fine.
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- GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program March 29, 2024
- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- 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