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RICO and Off-Label Use Don’t Mix
November 7, 2008By Bryon F. Powell –
On November 4, 2008, the United States District Court for the Middle District of Florida granted Defendants AstraZeneca’s and Parexel’s Motions to Dismiss in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP. In this case, the Plaintiffs, various union health and benefit funds and an individual consumer, claimed that the Defendants violated “the federal Rackeeteer Influenced and Corrupt Organizations ("RICO") statute and state consumer protection laws as well as common law claims for fraud, misrepresentation, civil conspiracy and unjust enrichment” on the basis that the Defendants allegedly misrepresented the safety and efficacy of the antipsychotic drug SEROQUEL (quetiapine fumarate), including via alleged off-label promotion. The court dismissed the two RICO claims based on the Plaintiffs’ failure to show that their injuries were caused by the Defendants’ alleged scheme to defraud.
AstraZeneca Pharmaceuticals LP was represented by a number of law firms. Parexel was ably represented by the Boston law firm of Sally & Fitch LLP through attorneys Kurt S. Kusiak, Peter E. Ball, Amber Anderson Villa, and William G. Cosmas.
This case continues a trend by the courts to dismiss off label use cases filed by private (non-government) plaintiffs. See our earlier post on this subject: “Another Court Hammers an Off-Label Use Case.”
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- 2023 IS the Year for OTC Naloxone! March 30, 2023
- What is Special about September 24, 2023 for the UDI System? March 28, 2023
- The “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps” – Availability of HPM’s Presentation Deck and Recording of the Presentation March 28, 2023
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
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- Internet Drug News.com
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- 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
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- Foods and Dietary Supplements
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- Government Pricing
- Hatch-Waxman
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- Orphan Drugs
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- Uncategorized