Business Litigation Article Archives
This article offers Maryland contractors and subcontractors a practical outline of some of the legal principles applicable to their daily business activities in an effort to help them anticipate problems and to be better equipped to resolve potential disputes with a minimum of difficulty and expense. A limited outline such as this cannot provide legal…
The “Right to Try” refers to the right of terminally or seriously ill patients to acquire investigational drugs without waiting for FDA approval. It grants these patients the right to access certain drugs, specifically those drugs that have completed only phase one of the FDA three-phase drug approval process. Advocates of the Right to Try contend that the decision to try an investigational drug should be between a patient and his or her physician and, thus, exclude the government, i.e., the FDA. Opponents support the FDA’s role in the drug approval and distribution process. The Right to Try debate boils down to one question: Who should decide whether a drug is too risky to try?
This brave new world of social media poses a host of challenges, both substantive and procedural, for judges, attorneys, and litigants. Though some have refused to recognize the reality of social media,6 most jurists and attorneys are now dealing head-on with issues raised by its use. By Marisa A. Trasatti and Anna C. Horevay. View…
This Article provides an overview of current State and legislative developments after Riegel. It begins with a history of medical device regulation and highlights the recent case of Stengel v. Medtronic, in which the Ninth Circuit adhered closely to Riegel to hold State law claims preempted by the MDA. Stengel also highlights the uncertainty lower court’s face in the wake of Riegel when determining which claims are encompassed in the Supreme Court’s 2008 holding.