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Accessing Experimental Drugs Through the Compassionate Use Doctrine
In last month's issue, we discussed how Jacob Gunvalson, when denied entry into a clinical trial for a drug that might offer valuable treatment for his terminal disease, Duchenne Muscular Dystrophy (DMD), sued the drug manufacturer to compel it to seek a “compassionate use” exemption from the FDA so that he could take the unapproved drug, PTC 124. In conjunction with that suit, he sought a preliminary injunction, which the district court granted. The drug's manufacturer, PTC Therapeutics Inc., appealed to the U.S. Court of Appeals for the Third Circuit, in Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 5227189 (C.A.3 (N.J.), 12/16/08).
The Third Circuit Reverses
The Third Circuit noted that it could reverse the lower court's grant of injunctive relief “only if the court abused its discretion, committed an obvious error in applying the law, or made a serious mistake in considering the proof.” Loretangeli v. Critelli, 853 F.2d 186 (3d Cit. 1988). Despite this high hurdle for the defense, the appellate court found it must reverse. So, what went wrong for Jacob and his family?
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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.