- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans January 24, 2023
- FDORA Enacted; HP&M Issues Detailed Summary and Analysis January 23, 2023
- CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices January 19, 2023
- FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests January 17, 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
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.
Search FDA Law Blog
Subscribe
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans January 24, 2023
- FDORA Enacted; HP&M Issues Detailed Summary and Analysis January 23, 2023
- CMS Rolls up its Sleeves on Price Negotiations, Sets Agenda for 2026 Negotiated Prices January 19, 2023
- FDA and Health Canada eSTAR Pilot is Open and Accepting Participant Requests January 17, 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