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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.

FCPA Individual-Liability Prosecutors Want YOU!

Over the last ten years, U.S. corporations conducting business outside the country have witnessed a dramatic increase in the enforcement of the Foreign Corrupt Practices Act (FCPA) and the severity of the financial penalties assessed. Now the DOJ and SEC have upped the ante.

In the Spotlight: Negotiating a Rooftop Antenna Contract

This article addresses some of the legal issues that a landowner needs to consider when negotiating a cell tower lease or license with a telecommunications company for the installation of equipment on its rooftop.

Case Notes

Recent rulings of interest.

Plug Pulled on Live Video Testimony

The first part of this article described <i>People v. Wrotten</i>, in which the complainant was too fragile to travel, and the court granted the prosecution's request to allow him to testify by video. The conclusion of the article herein discusses the issues raised by video testimony.

A Case of Mistaken Identity?

Accurate assays for lead and phthalates in consumer products are critically important. Current analytical methods have not been subjected to rigorous peer review and validation to demonstrate that they are reliable and reproducible at the levels required for legal determination of compliance.

Practice Tip: Keys to Successful Negotiation of Clinical Trial Agreements

Clinical trial agreement ("CTA") negotiation has become the most common cause of delay in studies. Because the cost of bringing a new drug to market is astronomical, pharmaceutical companies typically lose millions of dollars per week as a result of any delay in the process.

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Supreme Court Rules Rejection of Trademark License Does Not Rescind Rights of Licensee
Mission Product Holdings, Inc. v. Tempnology, LLC The question is whether a debtor's rejection of its agreement granting a license "terminates rights of the licensee that would survive the licensor's breach under applicable nonbankruptcy law."
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Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
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Bankruptcy Court Cannot Surcharge Credit Bidding Asset Buyer with Expenses of Sale
Explaining that the "bankruptcy court had no jurisdiction to take such action," the Fifth Circuit also vacated the district's court's improper ruling that the bankruptcy judge could enter a personal judgment against the asset buyer.
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Ex Parte Trademark Appeals to District Court — Lessons Learned from the Front Lines
Although pursuit of an appeal to the Federal Circuit may under some circumstances prove to be quicker and less expensive, appeals to district courts are becoming increasingly attractive given recent changes in the law and USPTO practice in defending these actions.
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When Is a Promise Enough?: Contractual Duties and Insider Trading
Two criminal appeals before the Second Circuit require the Court of Appeals to decide whether the violation of a fiduciary relationship is required to create insider trading liability or if a breach of contract is sufficient.
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