A Regulatory Lawyer's Perspective: The FDA's Guidances on Risk Assessment, Minimization and Management
February 28, 2006
In the pharmaceutical industry, due to all types of business pressures and constraints, it is not atypical for a company to behave reactively and in triage-mode, rather than considering proactive steps that it can take in the compliance arena. In 2005, the Food and Drug Administration ("FDA") issued three final guidance documents to help focus the industry and encourage companies to consider more thoughtfully and thoroughly the issues of quality risk assessment, minimization, and management collectively.
Think Twice, Click Once: E-mail Guidelines
February 28, 2006
Document retention, and the host of related e-discovery issues, have been front and center for product liability attorneys for a number of years. Nevertheless, even with the best document retention program and the most sophisticated e-discovery system, companies and their attorneys are still going to have to deal with the documents themselves. As many trial lawyers have learned, it can take only one bad document to bring down the house. With respect to the increased use of e-mails as evidence in litigation, companies need to educate their employees on what constitutes appropriate online communication. We recommend that companies focus on training their employees to 'think twice and click once.'
Case Notes
February 28, 2006
Highlights of the latest Product Liability cases from around the country.
Online: 'WHO' Site Provides Health, Vaccination Information
February 28, 2006
For information about vaccines, visit the World Health Organization Web site, <i>www.who.int/immunization/en/</i>. The goal of the World Health Organization ("WHO"), the United Nations specialized agency for health established in 1948, is the attainment by all peoples of the highest possible level of health. Health is defined in WHO's constitution as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.
Protecting E-mail For Complete Client Privacy
February 28, 2006
Attorney-client privilege, liability for breach of confidentiality obligations and damage to a firm's reputation were all reasons originally cited for stopping the use of e-mail at law firms before it even started. Convenience and responsiveness to clients became justification enough to ignore the basic issue that e-mail was inherently insecure. The standard form disclaimer that we now see at the end of every lawyer's e-mail became the solution to protecting the confidential nature of attorney-client communications. Is it sufficient today?
Special Medical Malpractice Courts
February 28, 2006
In the midst of the medical liability crisis and a nationwide movement toward tort reform, including caps on non-economic damages, a new player has appeared on the scene. The "Fair and Reliable Medical Justice Act," S. 1337, was introduced to the U.S. Senate in July 2005 in a bipartisan effort led by Sens. Michael Enzi (R-WY) and Max Baucus (D-MT). The stated purposes of the Act are: "1) to restore fairness and reliability to the medical justice system by fostering alternatives to current medical tort litigation that promote early disclosure of health care errors and provide prompt, fair, and reasonable compensation to patients who are injured by health care errors; 2) to promote patient safety through early disclosure of health care errors; and 3) to support and assist States in developing such alternatives."
Lessons from the First Vioxx Verdict
February 28, 2006
What do you get when you cross Court TV with the Food Channel? One answer: a recipe for a multi-million dollar jury verdict! Drug giant Merck will not see such blended TV programming, but it may have seen stars after getting hit with a $253 million jury award on Aug. 19, 2005. The first product liability trial against its Cox-2 inhibitor drug Vioxx in Angleton, TX, in August, 2005 produced a quarter-billion dollar award, $229 million of which was for punitive damages. Merck plans a vigorous appeal on multiple grounds. (Reportedly, grounds for appeal include: 1) letting in testimony from unqualified experts; 2) letting in testimony not based on reliable scientific evidence; 3) allowing irrelevant but prejudicial evidence in against Merck; and 4) letting in an undisclosed "surprise" witness against Merck.) Even pro-plaintiff observers concede that the award will likely drop to "only" $26 million due to recent Texas tort reform caps on punitive damages. (Merck fared better in its second and third Vioxx trials, which ended with a defense verdict and hung jury, respectively. Three Vioxx cases down -- only about 5998 to go!)
Witness Preparation Checklist for Deposition
February 28, 2006
My field is communications. My specialty is witness preparation. I am not a lawyer. Because I do not have to split my time between preparing a case and preparing a witness, I am free to focus exclusively on the problems and needs of witnesses. Over the years of preparing witnesses for both deposition and trial, I have made some interesting discoveries. For one thing, with proper preparation, there are very few witnesses who will remain bad ones. Almost all of them want to do the best job possible. They are highly motivated. The major reason for the problems and mistakes is lack of understanding of what is expected and lack of practice time to turn instructions into behavior.
Planning For The Inevitable
February 28, 2006
People who negotiate tech deals and draft contracts for legal or other services ' such as partnerships and the instruments that monitor them and give them teeth ' must remember one constant in today's ever-changing world: The technology we depend on every day often does not work. <br>As a result, the traditional wisdom, "failing to plan is planning to fail," has been transformed into a rule of thumb for the tech sector: "plan for failure." Firms that do not explicitly anticipate systems failure run the risk of being unprepared for a catastrophe
