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Deference to Agency Decisions: Lessons from Recent Pharmaceutical Pre-emption Decisions
One question that has been raised in pre-emption decisions is the degree of deference to be shown an agency's explicit statement that it intends certain failure-to-warn claims to be pre-empted. For example, in the pharmaceutical arena, the Food and Drug Administration ('FDA') through the Department of Justice ('DOJ') filed amicus briefs in several lawsuits to reiterate its position on pre-emption of state law tort claims. In these briefs, the United States stressed that in the context of warnings, 'more is not always better.' <i>Amicus</i> Brief for the United States, <i>Kallas v. Pfizer</i>, No. 04-00998 (D. Utah Sept. 29, 2005) at 28. The FDA's regulation of prescription drugs ensures each drug's optimal use by requiring inclusion of only scientifically substantiated warnings. <i>Id.</i> Plaintiffs' failure-to-warn claims therefore 'stand as an obstacle' to the FDA's accomplishment of its congressionally mandated purpose of ensuring the public health and are therefore pre-empted. <i>See Id.</i> The FDA has also stated its position on pre-emption in the preamble to its Rulemaking for Labeling requirement, which became effective on June 30, 2006. <i>See</i> 21 C.F.R. '10.85(d)(1) (2006).
The Leasing Hotline
Highlights of the latest commercial leasing cases from around the country.
Features
May We Waive Goodbye to Juries?
Like most rights, the right to a jury trial can be waived. In general, commercial landlords disfavor jury trials, especially when the opposing party is an individual, finding the outcomes of such trials to be either too uncertain, or if consistent, consistently against the landlord's interest. The general perception is that juries tend to favor individuals in disputes against institutional parties as a way to rectify a perceived injustice that corporations and other institutions allegedly inflict on the public. Jury trials are also more costly than non-jury trials, and parties may waive their right to a jury trial to avoid the added expense.
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Negotiating Broker Agreements
Your company (the 'Company') has decided it needs to find additional space for lease and/or to dispose of excess space and, after extensive due diligence, the Company has identified the ideal real estate broker (the 'Broker') to work with in the transaction(s). You and your new Broker have shaken hands on the basic terms of engagement (such as term and commission rates), and you have received and are now asked to review your Broker's standard form of retention agreement (the 'Agreement'). The Agreement, as is customary with most broker's standard forms of retention agreements, is only a couple of pages long. Should the Company sign it? After you have considered the issues described in this article and negotiated to protect the Company's interests to fit your particular circumstances, the answer is 'yes.' This article discusses some of the common issues that you may want to explore before the Company signs and delivers the Broker's form of retention agreement.
Features
In the Spotlight: Unenforceable Lease Provisions
Leases keep getting longer and tougher. Unfortunately, sometimes the people drafting them outsmart themselves and include unenforceable provisions.
Features
Real Property Law
Rulings of importance to you and your practice.
Avoiding the Sand Trap: Silica Liability and the Premises Owner
Many landlords have commissioned refurbishing or cleaning that involved sand blasting, concrete cutting, or masonry drilling on or at a building that remained in use. Some have leased premises to tenants that engage in these activities or that engage in production steps that include sanding, blasting, or scouring. There are special concerns about these activities that landlords should address, and this article explains why.
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Cooperatives & Condominiums
The latest cases for your review.
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