FDA

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…
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This Week’s Life Science Headlines

January 16, 2014
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Class Action FDA Litigation News Pharmaceuticals Product Liability Recalls Regulatory
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Life Science Matters

Litigation

Roche Loses Last Shot at Booting NJ Accutane Judge (subscription required)
NuvaRing Lawsuits Remain on Hold, as Trial Date Cancelled
Pfizer Faces Whistleblower Suit Over Lipitor Marketing (subscription required)
Forest Can’t Nix Mo. Class In Antidepressant Marketing MDL (subscription required)
Third Bellwether Trial in Bard Avaulta Mesh Litigation Delayed Indefinitely
8^th Circ. Affirms Novartis Loss in Aredia, Zometa Suit (subscription required)
NJ High Court Stays Accutane Case, Weighs Judge’s Recusal (subscription required)

Regulatory

FDA to Reopen Comment Period on

First Drugs Approved for Combination Treatment of Melanoma by the FDA

January 16, 2014
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FDA Pharmaceuticals
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Lisa M. Robinson

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…
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FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

January 12, 2014
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FDA Regulatory
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Life Science Matters

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…
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Claims Regarding Post-FDA Approval Problems Not Preempted

First Drugs Approved for Combination Treatment of Melanoma by the FDA

FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

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