Category Archives: FDA
Last Week’s Important Life Science Headlines
- February 25, 2014
- Class Action,Design Defect,FDA,Litigation,Medical Device,News,Pharmaceuticals,Product Liability,Recalls,Regulatory
Litigation
- Xarelto Lawsuit Filed Over Uncontrollable Internal Bleeding
- Neomedic Cases Added to Vaginal Mesh Litigation in W.Va. Federal Court
- Endo Puts Aside $520M for Vaginal Mesh Litigation (subscription required)
- 9th Circ. Refuses to Revive Novartis Jaw Injury Litigation (subscription required)
- FTC Bags $2M False Ad Win Against Diabetes Supplement Co. (subscription required)
- J&J Mesh Suits Belong in Federal Court, 10th Circ. Told (subscription required)
- New Philly Mass Tort Program Created for Pelvic Mesh Suits (subscription required)
- J&J Wins 1
This Week’s Life Science Headlines
- February 14, 2014
- FDA,Litigation,Medical Device,News,Pharmaceuticals,Preemption,Product Liability,Recalls,Regulatory,Settlements
Litigation
- Mich. Drug Companies Now Less Immune Under Tort Reform (subscription required)
- 9th Circ. To Reconsider Its Remand of Teva Painkiller Suit (subscription required)
- Medtronic Tells 10th Circ. Bone Device Suit is Preempted (subscription required)
- Unilever to Pay $10M Over Hair Loss Tied to Suave Product (subscription required)
- Expert Testimony Barred in Denture-Adhesive Mass Tort (subscription required)
- Roche Looks to Sink $2M Accutane Verdict on Appeal (subscription required)
- Pfizer Says 2nd Circ. Can’t Review Lipitor FCA Suit (subscription
This Week’s Life Science Headlines
- February 6, 2014
- FDA,IP,Litigation,Medical Device,News,Nutritional Supplements,Pharmaceuticals,Product Liability,Recalls,Regulatory,Settlements
Litigation
- Abbott Hit with 5 AndroGel Suits in FDA Probe’s Wake (subscription required)
- Pradaxa Litigation Fines Upheld, Non-Monetary Sanctions Overturned
- J&J Punished for Losing Evidence in Vaginal Mesh MDL (subscription required)
- Negligent Drug Design Claims May Increase in Pa. (subscription required)
- 9th Circ. Urged to Reinstate Expert in Novartis Jaw Injury Suit (subscription required)
- Deferred Sanctions Leave Hope for Takeda in Actos MDL (subscription required)
- 1st Circ. Holds FCA Relator’s Feet to Rule 9(b) Fire (subscription required)
- Biomet To
Claims Regarding Post-FDA Approval Problems Not Preempted
While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims. In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body. The product was removed from the market in 2010, a warning letter was…
Continue Reading....First Drugs Approved for Combination Treatment of Melanoma by the FDA
Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease. Last week the FDA approved GSK’s Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that cannot be removed by surgery or that is metastatic. The drugs were approved under the agency’s accelerated approval program. More information is available click here. Previously both drugs were approved by the FDA as single agents to treat late-stage or unresectable melanoma. Both drugs are…
Continue Reading....FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment
- January 12, 2014
- FDA,Regulatory
In December 2013, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to provide substantial data to demonstrate that “their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Under this proposed rule, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market. The…
Continue Reading....