Litigation

• 6^th Circ. Won’t Hear Appeal of Darvocet Suit Remand (subscription required)
• Okla. Supreme Court Gives Harsh Take on Abortion Drug Law (subscription required)
• Takeaways from McPhee v. DePuy’s Preemption Pronouncement (subscription required)
• Canadian Court Won’t Shrink Paxil Birth Defect Class (subscription required)
• Major Medical Device Manufacturer Agrees to Pay $13.2 Million to Settle Foreign Corrupt Practices Act (FCPA) Charges
• Dow Seeks En Banc Review of Cancer Cluster Suit (subscription required)
• Lumina Diet Supplement Class Action Stays in Fed. Court (subscription required)
• GSK Can’t Sink Avandia Prescription Coverage RICO Suits (subscription required)
• 6^th Cir. Revives Wrongful Death Suit Against HHS (subscription required)
• Boehringer Ingelheim Seeks to Block Pradaxa Depositions of Executives

Regulatory

• FDA Chides Sunovion Over Misstating Brovana Risks, Benefits (subscription required)
• Post-Market Studies Lag for Drugs Fast-Tracked by FDA: Study
• Bill Risks Confusion to Curb FDA’s Already-Lax App Oversight (subscription required)
• FDA and Partners Launch e-Learning Course on Evaluating Drug Promotion
• EU Parliament Approves Compromise on Device Reforms – But Will It Be Enacted?
• FDA Recommends Reclassifying Vicodin as Harder Drug
• FDA Approves Abbott Device for Leaking Heart Valve

Recalls

• Inclusig (ponatinib) Recalled
• Novo Nordisk Recalls Insulin Pens All Over Europe (subscription required)
• Codman and Shurtleff MedStream Programmable Infusion Pump and Refill Kits – Drug Over Infusion
• Draeger Medical Fabius Series Anesthesia Machines – Failure of Automatic Ventilation

Other Interesting Reads

• 2013 Medical Device Development Report
• CDER Small Business Webinar on Stability Guidance for ANDAs and Draft Questions and Answers Quidance – November 4, 2013 (Guidance found here and webinar registration found here.)
• Medical Device Company Paying $13.2 Million For Civil Bribery Charges

For a look at last week’s important headlines, click here.