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In order to minimize potential product liability associated with pharmaceutical products, companies regulated by the U.S. Food and Drug Administration ('FDA') should be vigilant in ensuring that adverse drug experiences ('ADEs') are reported to the FDA in a timely and complete manner. FDA regulations contain extensive requirements regarding the reporting of ADEs for companies involved in the distribution chain, such as manufacturers and distributors. Failure to report, when required, can result in an FDA enforcement action and exacerbate liability exposure. A proactive ADE collection and reporting system will place a company in a better position to address unanticipated issues that may arise after full-scale commercial marketing has begun. Therefore, companies must know their regulatory responsibilities and implement procedures to ensure that ADEs are collected and reported, as required by law. This article covers only some of the re-quirements and issues to consider.
It has now been more than 9 months since the U.S. Food and Drug Administration ('FDA') issued its new labeling rule for prescription drugs with an extensive preamble analysis of how many state tort legal claims conflict with and accordingly are pre-empted by the its regulation of such drugs. The FDA re-emphasized its position that state tort law claims threaten its ability to pursue its statutory mandate of protecting public health through balanced labeling. It thus explained that 'under existing pre-emption principles, FDA approval of labeling under the [FDCA] pre-empts conflicting or contrary State law.' 71 Fed. Reg. 3922, 3933 (Jan. 24, 2006).
Features
A spectacular smash-up always draws a crowd. In the outsourcing world, where the wreckage is nearly always kept under wraps, that's even more true. When a problem deal does break into view, it's always worth watching for lessons in how to manage ' or how not to manage ' these complex transactions. Counsel with responsibility for managing outsourcing relationships or contemplating new ones have two new cases to chew over that offer intriguing glimpses into troubled deals: A suit filed by Sprint Nextel against IBM in May, and an English case decided in June involving Vertex Data Sciences and its client Powergen.
Features
Highlights of the latest commercial leasing cases from around the country.
Features
Frequently, commercial lease issues are brought to the attention of a litigation lawyer only after a dispute between the landlord and the tenant has erupted. Oftentimes, the dispute involves the 'boilerplate' provisions that do not raise much interest during the drafting phase because they are not considered to be economic deal points. <i>See</i> 'Revisiting Boilerplate or 'Miscellaneous' Lease Provisions' in the January 2006 issue of <i>Commercial Leasing Law & Strategy</i>. This lack of interest in boilerplate provisions is a mistake because it is much easier to resolve concerns regarding those provisions ' which become very important in the litigation context ' while the parties are amicably moving toward closing a deal, rather than during the pendency of a lawsuit. Many times, disputes could have been either avoided or minimized had the parties clarified certain important issues while they were negotiating and drafting. This article discusses several leasing issues that should be carefully considered while the parties are still on friendly terms.
In the entire universe of legal and business terms that makes up the modern-day commercial lease, there are very few provisions that can change the world of the landlord or tenant. One of those world-changing provisions is the assignment and subletting provision.
For years, careful landlords and tenants have used liquidated damages as a means to avoid the uncertainty of events beyond their control. If the tenant held over beyond its term, or the landlord breached the tenant's exclusive, liquidated damages were considered a dependable remedy to avoid costly and time-consuming litigation. Unfortunately, what seems certain to lease drafters is anything but certain when presented in court. A recent decision from the U.S. District Court for the Middle District of Georgia underscores that point.
