Features
Off-Label Promotion of Drugs and Medical Devices
A spate of billion- and hundred-million-dollar settlements with the Department of Justice (DOJ) illustrates how the investigation of off-label promotions of drugs and devices has emerged as a predominant theory in pharmaceutical and medical-device prosecutions.
The Consequences of Truth
Few states have instituted compulsory medical error admissions. One state that has is New Jersey, which, in 2004, enacted the Patient Safety Act (PSA). This landmark legislation changed the way medical errors are dealt with in New Jersey. This article discusses the changes.
Features
Legal Issues Swell if Swine Flu Spreads
Just one week into the swine flu outbreak, health authorities in Baltimore detained 117 passengers on a flight from Cancun, Mexico. And Texas, Maryland and New York officials closed schools. Although the flu strain isn't an official pandemic yet, state and local officials are already flexing legal muscles ' many for the first time.
Features
The Autism Cases
In last month's issue, we discussed the Vaccine Court's (Office of Special Masters of the U.S. Court of Federal Claims) trio of decisions that found no causative links between childhood vaccinations and the onset of autism and gastrointestinal problems in three children. The discussion continues herein.
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- Protecting Innovation in the Cyber World from Patent TrollsWith trillions of dollars to keep watch over, the last thing we need is the distraction of costly litigation brought on by patent assertion entities (PAEs or "patent trolls"), companies that don't make any products but instead seek royalties by asserting their patents against those who do make products.Read More ›
- Private Equity Valuation: A Significant DecisionInsiders (and others) in the private equity business are accustomed to seeing a good deal of discussion ' academic and trade ' on the question of the appropriate methods of valuing private equity positions and securities which are otherwise illiquid. An interesting recent decision in the Southern District has been brought to our attention. The case is <i>In Re Allied Capital Corp.</i>, CCH Fed. SEC L. Rep. 92411 (US DC, S.D.N.Y., Apr. 25, 2003). Judge Lynch's decision is well written, the Judge reviewing a motion to dismiss by a business development company, Allied Capital, against a strike suit claiming that Allied's method of valuing its portfolio failed adequately to account for i) conditions at the companies themselves and ii) market conditions. The complaint appears to be, as is often the case, slap dash, content to point out that Allied revalued some of its positions, marking them down for a variety of reasons, and the stock price went down - all this, in the view of plaintiff's counsel, amounting to violations of Rule 10b-5.Read More ›
- Meet the Lawyer Working on Inclusion Rider LanguageAt the Oscars in March, Best Actress winner Frances McDormand made “inclusion rider” go viral. But Kalpana Kotagal, a partner at Cohen Milstein Sellers & Toll had already worked for months to write the language for such provisions. Kotagal was developing legal language for contract provisions that Hollywood's elite could use to require studios and other partners to employ diverse workers on set.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 ›
- The DOJ Goes Phishing: The Rise of False Claims Act Cybersecurity LitigationWhile the DOJ Civil Cyber-Fraud Initiative is still in its early stages and cybersecurity regulations are evolving, whistleblower plaintiffs have already begun leveraging the FCA to pursue alleged noncompliance with government cybersecurity requirements.Read More ›