FDA Inspections and Product Liability Audits
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 →]
October 23, 2011 Comments Off
Biopharma Company To Expand Dramatically In Danville
Oct. 17, 2011 – In August, we blogged about the Eight Good Reasons Why Product Manufacturers, Distributors, and Retailers Should Locate and Do Business in Virginia. It is good to see that, apparently, Engineered BioPharmaceuticals agrees. [Read more →]
October 17, 2011 Comments Off
UPDATE: Newport News Court Throws Out $ 5.2 Million Personal Injury Verdict
Oct. 7, 2011 - Updating a previous post, last week Judge Peter C. Tench of Newport News Circuit Court set aside the jury’s $5.2 million damages award in a case involving a forklift accident at Best Buy that allegedly resulted in foot injuries to the plaintiff. The judge allowed the jury’s decision on liability to stand, but called the damage award excessive and “shocking to the conscience.” Noting it was the first time he had set aside such an award, the judge ordered a new trial on the issue of damages.
October 7, 2011 Comments Off
Western Virginia Man Sues Over Allegedly Defective Hunting Tree Step
Oct. 5, 2011 - We all know hunting carries with it some inherent risks. Buddies may accidentally shoot you. And sometimes, the animals fight back. A recent Complaint filed in the Roanoke Division of the Federal District Court for the Western District of Virginia, however, describes an entirely different and unfortunate hazard that allegedly befell the plaintiff/hunter. [Read more →]
October 5, 2011 Comments Off
US Chemical Company Not Liable for Saddam Hussein’s Use of Its Product in Chemical Warfare
Sept. 29, 2011 - One interesting decision caught our eye this week because it is not every day that a United States chemical manufacturer is sued for personal injuries under the Torture Victim Protection Act (“TVPA”) or the Alien Torture Statute (“ATS”): Aziz v. Alcolac, Inc., 2011 U.S. App. LEXIS 19227 (4th Cir. Sept. 19, 2011). The TVPA allows civil recovery against “an individual who engages in torture or extrajudicial killing.” Id. at *7. [Read more →]
September 29, 2011 Comments Off
$5.2 Million Verdict for Foot Injury: Outlier or Trend?
Sept. 22, 2011 – The Virginia Lawyers Weekly recently reported that a jury in Newport News, Virginia awarded $5.2 million dollars to a man who suffered an injury to his foot, which apparently was a muscle or ligament injury that later developed into Complex Regional Pain Syndrome (“CRPS”). The injury allegedly occurred in a Best Buy retail store after an unattended forklift struck the plaintiff’s left foot while he was shopping. Not surprisingly, Best Buy filed motions to overturn the award, which will be heard next week. [Read more →]
September 22, 2011 Comments Off
Lawsuits Against FDA Over New Graphic Cigarette Warnings Begin
[These posts come to us from the Troutman Sanders Tobacco Team. We thought they might be of interest to our readers.]
Second Warnings Suit Filed Against FDA by Big Tobacco
September 13, 2011 – In early July, we reported that the four leading tobacco companies were threatening legal action against the Food and Drug Administration (FDA) over the nine new graphic cigarette health warnings that must appear on each cigarette package beginning in September 2012. This threat became a reality last month, when five tobacco companies – R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group, and Santa Fe Natural – filed suit in the United States District Court for the District of Columbia against FDA, claiming that the final regulation specifying the new warnings (the “Rule”) violates the First Amendment as applied to Plaintiffs and was promulgated in violation of the Administrative Procedure Act (“APA”). [Read more →]
September 15, 2011 Comments Off
FDA Taking Comments on Potential New Hurdles for Approval of Medical Devices
[This post comes to us from Diane Romza-Kutz , Robert E. Browne, Jr., John F. Costello, Jr. and Matthew M. Morrissey of Troutman Sanders' Life Sciences Practice Team. We thought it might be of interest to our readers.]
Sept. 12, 2011 - The recent furor in the medical device industry over a new recommendation that the U.S. Food & Drug administration abandon its approval process for medical devices has prompted a new round of public meetings and comment. This provides a critical opportunity for the medical device industry to comment on these potential new hurdles to market entry. [Read more →]
September 12, 2011 Comments Off
Melissa Tannery and Nick Klaiber Publish Article on Pharmacovigilance in DRI’s “For the Defense” Magazine
Aug. 30, 2011 - Virginia Products Liability blog contributors Melissa Tannery and Nick Klaiber published an article entitled, “Defending (and Defending With) Pharmacovigilance After Wyeth v. Levine” in The Defense Research Institute (“DRI”)’s August 2011 issue of For the Defense magazine. In the article, Melissa and Nick offer advice on how to combat attacks on pharmaceutical company clients’ pharmacovigilance programs, including arguments to exclude evidence of lapses in postmarketing surveillance, exclude plaintiffs’ expert on pharmacovigilance and exclude adverse drug event reports (“AERs”) as unreliable evidence of causation. They also suggest ways to use the strong points of a company’s pharmacovigilance program to show that the company quickly discovers and acts on safety information and makes safety a top priority. Lawyers defending claims of negligent pharmacovigilance should present evidence and offer testimony from a knowledgeable and well spoken company witness who will explain how the company carefully and efficiently handles, investigates and responds to the AERs it receives. The article is a useful resource for lawyers defending pharmaceutical products liability claims in Virginia and elsewhere.
August 30, 2011 Comments Off
Why Virginia? Eight Good Reasons Why Product Manufacturers, Distributors, and Retailers Should Locate and Do Business In Virginia
Aug. 29, 2011 - Virginia is among the safest harbors in the storm of products liability litigation. There are many good reasons why product manufacturers, distributors and retailers should locate or increase business in Virginia, including: [Read more →]
August 29, 2011 2 Comments







