Features
Off-Label Communications
While the FDA has had a long-standing policy of permitting drug, biologics, and medical device companies to respond to unsolicited requests for information about off-label use of their products, there has been significant discussion over what constitutes "unsolicited" in this context.
Practice Tip: Federal Jurisdiction and Venue
With little fanfare or forewarning, the Federal Courts Jurisdiction and Venue Clarification Act of 2011 became effective Jan. 6, 2012. Signed into law on Dec. 7, 2011, the Act reforms or clarifies removal procedures, diversity jurisdiction, and federal venue.
Features
The Mensing Preemption and the Learned Intermediary Doctrine
Few courts have fully or accurately grasped the realities of how physicians receive information about the drugs they prescribe and, correspondingly, how the learned intermediary doctrine should affect the <i>Mensing</i> preemption analysis.
Features
Electronic Discovery in Construction Disputes
This article discusses the current electronically stored information (ESI) law, the impending ESI crisis in arbitration, and how resolving office, industrial and retail claims through alternative dispute resolution helps to corral the burdens of ESI discovery for developers, owners, property managers and contractors by managing ESI with specific agreements, guidelines and rules.
In the Spotlight: Emergency Planning Obligations
Owners and tenants of commercial buildings sometimes fail to recognize that certain chemicals stored on-site, most notably substances used in a building's mechanical system, could trigger annual reporting obligations.
'Green' Leases Support 'Green' Buildings
The interplay between a green building and the traditional legal relationships covered by commercial real property leases forms the nexus of this article.
Facebook Passwords and Child Custody
As matrimonial attorneys, we can learn some lessons from the <i>Gallion v. Gallion</i> case. First, tell your clients that they should envision everything they post on Facebook or tweet on Twitter as being printed out on paper and marked as "Exhibit A."
Features
E.U. Data Protection Law
On Jan. 25, 2012, the European Union Commission published a draft Regulation that is aimed at replacing the currently applicable E.U. Directive of Oct. 24, 1995 "on the protection of individuals with regard to the processing of personal data and on the free movement of such data." The Directive, and the legislation of each E.U. Member State that resulted from it, are of high relevance for any employer employing personnel in any E.U. Member State.
Features
Mandatory Flu Shots?
Although it is only July, it is not too early to start thinking about flu season. Mandatory vaccinations have been the topic of much debate in recent years. This is particularly true for healthcare providers.
Need Help?
- Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
- Need other assistance? email Customer Service or call 1-877-256-2472.
MOST POPULAR STORIES
- Meet the Lawyer Working on Inclusion Rider LanguageAt the Oscars in March, Best Actress winner Frances McDormand made “inclusion rider” go viral. But Kalpana Kotagal, a partner at Cohen Milstein Sellers & Toll had already worked for months to write the language for such provisions. Kotagal was developing legal language for contract provisions that Hollywood's elite could use to require studios and other partners to employ diverse workers on set.Read More ›
- Protecting Innovation in the Cyber World from Patent TrollsWith trillions of dollars to keep watch over, the last thing we need is the distraction of costly litigation brought on by patent assertion entities (PAEs or "patent trolls"), companies that don't make any products but instead seek royalties by asserting their patents against those who do make products.Read More ›
- From the PTO to the FDA: What to Consider When Branding Clinical TrialsThe legal implications of branding generally arise initially for companies during the process of selecting a company name and any initial product or service names. For drug development companies, however, careful consideration should also be paid to the implications of branding a clinical trial.Read More ›
- Disconnect Between In-House and Outside Counsel'Disconnect Between In-House and Outside Counsel is a continuation of the discussion of client expectations and the disconnect that often occurs. And although the outside attorneys should be pursuing how inside-counsel actually think, inside counsel should make an effort to impart this information without waiting to be asked.Read More ›