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Experimental Drugs and the Compassionate Use Doctrine
People with chronic illnesses and incurable diseases are often willing to do almost anything to improve their health. That includes seeking alternative treatments and trying unapproved drugs. While gaining access to drugs not yet approved by the Food and Drug Administration (FDA) can be a difficult task, many people will go to nearly any lengths to get them, to include suing a drug manufacturer to force it to provide them the drug. That's what happened in the case of Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 4003377 (D.N.J.,2008), a case recently overturned on appeal. In this month's issue, we look at the reasoning of the district court. In next month's issue, we'll see why the appellate court disagreed, and discuss the implications of the compassionate use doctrine for drug research and for individual patient outcomes.
A Boy and His Family Fight for Medication
Jacob Gunvalson is a boy in his teens with the terminal disease Duchenne Muscular Dystrophy (DMD). DMD is a genetic disease that causes muscles, including the heart, to degenerate and become paralyzed. Most DMD victims die by the age of 25. Although no drug is currently available to treat DMD in any long-term meaningful way, there are medications that can help relieve symptoms or slow their progression.
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Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.