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This post comes courtesy of Troutman Sanders attorneys Diane Romza-Kutz, Robert E. Browne, Jr., and John F. Costello, Jr. , who are members of the Firm’s Life Sciences Team.  We hope you find it useful.

April 18, 2012 – Overview FDA Regulation of Direct-to-Consumer Prescription Drug Advertising

The Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Food, Drug and Cosmetic Act to require that the major statement in direct-to-consumer (DTC) advertisements relating to the side effects and contraindications of prescription drugs be presented in a “clear, conspicuous, and neutral manner.” The FDAAA also directed the FDA to publish regulations establishing the standards for determining whether a major statement meets the “clear, conspicuous, and neutral manner” standard. [Read more →]

Jan. 26, 2012 – On Wednesday, January 25, the Fourth Circuit affirmed a West Virginia federal court’s decision dismissing a claim involving a Class III, FDA-approved Medtronic SynchroMed pump on grounds it was preempted by the express preemption provision of the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetics Act.  The case is  Walker v. Medtronic, Inc., No. 10-2219 (4th Cir. Jan. 25, 2012). [Read more →]

Dec. 15, 2011 — Several newspapers reported recently that both the Norfolk and Virginia Beach Circuit Courts entered default judgments against a Chinese company that allegedly manufactured drywall and sold it to a Norfolk based construction supplier. In each case, the supplier, Venture Supply, filed a Third-Party Complaint against Taishan Gypsom Co., Ltd. seeking contribution and/or indemnity and had the company served in China. [Read more →]

Dec. 12, 2011 – This post comes to us from the Troutman Sanders Tobacco Team.  We thought it might be of interest to our readers, as it provides an update to our Sept. 15, 2011 post.

In November, U.S. District Judge Richard Leon issued a preliminary injunction blocking implementation of FDA’s new graphic warnings requirements, which would have required, beginning September 22, 2012, all cigarette packages to display one of nine new textual warnings showing the dangers of smoking, graphic images on the top fifty percent of both the front and rear panels. The new warnings requirement also would require display of a smoking cessation assistance telephone number. [Read more →]

Dec. 1, 2011 – Regular blog contributor Brian Fowler has co-authored an article with Troutman Sanders partner Dabney Carr concerning the implications of the Supreme Court’s recent decision in Pliva v. Mensing.  The article appears in the November issue of the International Association of Defense Counsel Product Liability Committee’s newsletter, which can be found here.  Please check it out.

Oct. 22, 2011 – [This post comes to us from the Troutman Sanders Tobacco Team.  We thought it might be of interest to our readers.]

In August, we reported that the FDA will begin in October inspecting the facilities of all U.S.-based tobacco product manufacturers subject to the FDA’s authority.  Troutman Sanders has for years been assisting clients in a variety of industries with product liability audits.  These audits can be an invaluable tool for the tobacco industry as it prepares for FDA inspections. [Read more →]

Aug. 1, 2011 -    Four Loko is a great example of a product that disproves the time-honored saying, “there’s no such thing as bad publicity.”  Its manufacturer, Phusion Projects, attempted to capitalize on a classic gap in the market.  For years bartenders had been mixing the energy drink Red Bull with vodka, and consumers had emulated the practice by buying the drink’s component parts and doing the grunt-work themselves.  So Phusion stepped in and provided a combination energy drink and alcoholic beverage readily available in convenience stores. [Read more →]