News from the FDA
The latest news of interest to you and your practice.
Features
When One Patent Application Begets Ten
Restriction practice (ie, the restriction of a patent application to prosecution of a single claimed invention per filing fee) has been around since the mid-1800s. In recent years, hyperproliferation of restriction requirements, especially in the biotechnology, chemical and software arts, has occurred. It has not been uncommon for the U.S. Patent and Trademark Office (PTO) to assert that a patent application contains 10, 20, even 100 distinct inventions.
Features
Designing a Medical Device Surveillance Network
In last month's newsletter, we looked at some helpful Web sites for those who need to track the efficacy and safety of medical devices. Following are more useful Web sites for these purposes.
Case Briefs
Recent rulings of importance to you and your practice.
A Call for Continued State Law Tort Reform
The recent federal trial court decision in <i>Dusek v. Pfizer Inc.</i>, Civil Action No. H-02-3559 (S.D. Tex. 2/20/04) dismissing plaintiffs' products liability claims against Pfizer in connection with the prescription drug Zoloft' on the ground of conflict preemption has given the pharmaceutical industry some hope that compliance with Food and Drug Administration (FDA) regulations will afford protection from common law failure-to-warn claims. The court granted summary judgment on the ground that a cause of action based on the plaintiff's proposed additional warning to the product label that Zoloft can cause suicidal ideation would conflict with the FDA's decision not to add such a warning because no causal link had in fact been established and it would in effect be false and misleading in violation of federal law. This should not deter continued efforts to obtain tort reform at the state level, however, where the continued influx of pharmaceutical product liability claims continues to burden courts and the pharmaceutical industry.
Features
Index
A complete listing of everything contained in this issue.
Features
Development
Recent cases of interest to you and your practice.
Cooperative & Condominiums
The latest cases of importance to your practice.
Landlord & Tenant
Recent rulings of importance to you and your practice.
Real Property Law
Recent rulings of importance to you and your practice.
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MOST POPULAR STORIES
- 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 ›