Feb. 3, 2012 – The FDA’s long-awaited draft Guidance for Industry on social media provides non-binding recommendations regarding how manufacturers and distributors of prescription drugs and medical devices can respond to unsolicited requests for off-label information, but does not provide guidelines for appropriate responses to other consumer inquiries or comments posted on Facebook and other electronic media.  [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 →]

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

Jan. 4, 2012 — On January 4, 2011, President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law. The FSMA purports to address perceived problems with the American food safety regime by empowering the United States Food and Drug Administration (FDA) with new regulatory and enforcement authority. The law creates expansive power for the FDA to regulate both domestic food producers and companies importing food products into the United States. Today, January 4, 2012, marks the one year anniversary of the FSMA and many significant steps have been taken to implement the legislation.

This Advisory will highlight a few of the most important regulatory actions taken pursuant to the  FSMA to date and the major implications for business involved in food production and supply. [Read more →]

Jan. 2, 2012 – In June 2009, Plaintiff Danna Blankenship and her infant daughter, both Virginia residents, were involved in an automobile accident in Botetourt County, Virginia which is located in the territory covered by the Federal District Court for the Western District of Virginia.  Plaintiff filed suit against the child safety seat manufacturer and the manufacturer of the child safety seat insert in the Eastern District of Pennsylvania.  Blankenship v. Graco Children’s Products, Inc., 2011 U.S. Dist. LEXIS 115816 (E.D. Pa. Oct. 6, 2011).  Though the accident occurred in Virginia, [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.

Nov. 23, 2011 – As reported in Virginia Lawyers Weekly, on November 14 an Abingdon federal jury returned a defense verdict in a $50-million product defect case alleging that an eight-year-old girl suffered severe brain damage in a 2009 automobile accident as a result of an allegedly defective child safety seat.  The case, which was tried before Judge James Jones, is Musick v. Dorel Juvenile Group, Inc., 1:11cv05 (W.D. Va.).

Although the defense verdict itself is noteworthy and one that will certainly catch the eye of the plaintiff and defense bars alike, the case is also notable due to several interesting rulings made during the nine-month course of the proceedings.   [Read more →]

Nov. 2, 2011 – The Suffolk Circuit Court recently sustained a demurrer filed by defendant Venture Supply, Inc., a company that sold drywall from China that was used to construct Plaintiffs’ residence.  Seeman v. Oxfordshire, LLC, CL 10-936 (Cir. Ct. City of Suffolk Oct. 12, 2011).  [Read more →]

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 →]