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Drug & Device News
News of importance to you and your practice.
Certificate of Merit Laws
A popular way states have encouraged doctors and other health care providers to practice within their borders is by stopping medical malpractice claims in their early stages by requiring the filing of a certificate of merit before a case can proceed.
The Iqbal/Twombly Decisions
One of the most frustrating and wasteful legal expenses for a medical device or pharmaceutical manufacturer is the cost of defending against claims where its product is ultimately found not to be involved. A discussion of the <i>Iqbal/Twombly</i> decisions and what they mean.
The Rise of Patient Safety Organizations
The Patient Safety Act authorizes the creation of a new type of entity, a patient safety organization (PSO), to receive and analyze information relating to patient safety. The Act confers broad federal privilege and confidentiality protections to this information, with significant penalties for breaches.
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- The DOJ's Corporate Enforcement Policy: One Year LaterThe DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.Read More ›
- Delaware Chancery Court Takes Fresh Look At Zone of InsolvencyOver a decade ago, a Delaware Chancery Court's footnote in <i>Credit Lyonnais Bank Nederland, N.V. v. Pathe Communications</i>, 1991 WL 277613 (Del. Ch. 1991), established the "zone of insolvency" as something to be feared by directors and officers and served as a catalyst for countless creditor lawsuits. Claims by creditors committee and trustees against directors and officers for breach of fiduciary duties owed to creditors have since become commonplace. But in a decision that may have equally great repercussion both in the Boardroom and in bankruptcy cases, the Delaware Chancery Court has revisited zone-of-insolvency case law and limited this ever-expanding legal theory.Read More ›
- Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal LiabilityThis article explores legal developments over the past year that may impact compliance officer personal liability.Read More ›
- How Far Can You Reach? The Territorial Limits of Lanham Act Infringement and False Designation of Origin ClaimsOn June 29, 2023, the U.S. Supreme Court set new geographic limits for infringement and false designation of origin claims raised under Sections 1114 and 1125(a) of the Lanham Act. Given the global nature of business today, the decision highlights the need for trademark owners to continually reassess and, perhaps, expand their international trademark registration strategy as product lines and brands become more international in scope.Read More ›
- Use of Deferred Prosecution Agreements In White Collar InvestigationsThis article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.Read More ›
