Practice Tip: Navigating the FDA's Recent RiskMAP Guidance
January 06, 2006
As part of the Food and Drug Administration's ("FDA") ongoing and comprehensive efforts to minimize risks while preserving the benefits of medical products, the FDA recently released three industry guidance documents on risk management strategies. These final guidance documents, applicable to various stages of drug and biological product development, will assist manufacturers in developing and improving methods to assess and monitor the risks associated with drugs and biologics. The risk minimization action plan is one of these initiatives that promises to further tip the balance of the risk-benefit profile of drugs and devices.
Punitive Damages: How Much Is Too Much? Two Recent California Supreme Court Opinions Leave the Question Unanswered
January 06, 2006
In June 2005, in two companion decisions, the California Supreme Court for the first time interpreted a line of recent, landmark U.S. Supreme Court opinions on punitive damages. In so doing, the California Supreme Court attempted to bring clarity to the politically charged and legally nettlesome issue of when punitive damage awards become constitutionally excessive. However, the court's decisions may raise more questions than they answer. Instead of setting a bright-line rule for lower courts and litigants to follow (such as a fixed ratio of punitive damages to compensatory damages beyond which punitive damages must not go — something some courts of appeal attempted to do in response to the high court's landmark opinions), the court in <i>Lionel Simon v. San Paolo U.S. Holding Co., Inc.</i> No. S121723 (June 16, 2005) ("<i>Simon</i>"), and <i>Greg Johnson, et al., v. Ford Motor Company,</i> No. S121933 (June 16, 2005) ("<i>Johnson</i>"), elected to constrain, but fundamentally preserve, the possibility of truly punishing punitive damage awards.
Case Notes
January 06, 2006
Highlights of the latest product liability cases from around the country.
Online: Learn About Punitive Damages on the Web
January 06, 2006
There is a wealth of information about punitive damages on the Internet, including the Web sites of various organizations and law schools, as well as blogs. Here is a sample of what's available.
Pre-Certification Discovery of Absent Class Members
January 06, 2006
The battle for class certification makes or breaks many lawsuits. Often, the certification decision hinges on whether there are questions of law or fact common to the class and whether the claims and defenses of the representative parties are typical of those of the class as a whole. Because the defense has no opportunity to question the class members themselves and to compare the claims and defenses of the named plaintiffs with those of the absent class members, it faces a big problem overcoming class certification: How is a defendant to know, let alone prove to the court: 1) that the claims of the class as a whole are not common and 2) that the claims of the named plaintiffs are sufficiently dissimilar to those of the class. In order to provide the court with record evidence on which it can base a decision as to whether individual or common issues predominate, parties should be permitted to engage in discovery of absent class members for class certification purposes.
In The Marketplace
January 06, 2006
Highlights of the latest equipment leasing news from around the country.
The Federal Equipment Marketplace: Vendors and OEMs Benefit from Finance Company Relationships
January 06, 2006
The federal equipment marketplace is one of the bright spots in the economy. Many vendors and OEMs are now working with finance companies that have federal experience to compete for more than $45 billion in transactions that potentially qualify for a lease-financing solution. The size and volume of these transactions are expected to grow over the next several years.
Is Your Computer Leasing Company Responsible for Data Security?
January 06, 2006
Picture this scenario: You are the owner of a small to mid-sized business and have decided that it is in your best interest to lease your company's computer equipment. This may be because prudent financial planning dictates a lease versus buy decision; or you may want to be able to run the most current, up-to-date applications and the short time span of a computer lease allows you to do so. Whatever the case, when you make this decision, you have just assumed a very important responsibility — one that should not be taken lightly. You have just become personally responsible for the security of your own and your clients' personal data. It is your responsibility to personally safeguard the social security numbers, banking information, healthcare data, credit information, or anything else that could lead to catastrophic consequences if found in the wrong hands.
