Litigation

• Pharma Can Be Liable for Design Negligence: Pa. High Court (subscription required)
• Pfizer Escapes Whistleblower Suit Over Lipitor Marketing (subscription required)
• 23andMe Faces Suit Over Recently Banned DNA Tests (subscription required)
• Claims and Classes in Medical Monitoring Cases (subscription required)
• Boston Scientific Mesh Lawsuit to Move Forward After SOL Challenge
• Motion Filed to Centralize OxyElite Pro Lawsuits in MDL
• 6^th Circuit Revives Mylan Wrongful Death Suit (subscription required)
• Jury Clears Abbott In Tainted Formula Injury Suit (subscription required)
• Ethicon Vaginal Mesh Plaintiffs Say Company Destroyed, Lost Key Files
• St. Jude Riata Lead Lawsuits Not Pre-empted, Federal Judge Rules
• Conference Set for Bayer Request on Mirena Statute of Limitations Motion
• Status Conferences in Tylenol Liver Failure Litigation Set Through 2014
• DePuy ASR Hip Lawsuit Given Expedited Trial Date in California
• Iovate Stuck in Bodybuilding Supplements False Ad Suit (subscription required)

Regulatory

• Proposed FDA Rule Could Bring Failure-To-Warn Liability (subscription required)
• FDA Overhauls ‘Dear Doctor’ Guidance on Drug Risks (subscription required)
• FDA Updates Mad Cow Disease Guidance for Medical Devices (subscription required)
• Draft Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)
• FDA Warns Medical Food Co. Amid Continuing Crackdown (subscription required)
• Xarelto Risks Lead FDA Panel to Recommend Against Expansion
• CPSC Floats Changes to Product Info Disclosure Rules (subscription required)
• Some Wart Removers are Flammable
• Draft Guidance – Reporting of Computational Modeling Studies in Medical Device Submissions

Recalls

• Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall
• Fresenius Recall Issued Over Problems with Dialysis Machines
• The Mentholatum Company Issues Voluntary Nationwide Recall of Rohto Eye Drops Made in Vietnam
• StemAlive 90 Capsules: Recall – Undeclared Milk

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