Thimerosal and Autism: A Paradigm for Judges to Act As Gatekeepers
One of the principal problems in our civil justice system is holding a defendant responsible for some very bad harm that it did not cause. Acting as 'gatekeepers,' judges are the key persons who can prevent this injustice, and many keep out both so-called 'junk science' and preserve the integrity of our legal system. Some very well meaning judges, however, do not do so. Sometimes, they can be persuaded to allow a jury to have a look at a case that should have been dismissed.
The Changing Face of FDA Consent Decrees
Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.
IP News
Highlights of the latest intellectual property news from around the country.
Trademark Investigations Revisited
The use of investigations to uncover and evaluate potential infringement and unfair competition claims can be an extremely effective weapon for any trademark owner. Usually, a key to successful trademark investigations rests in having the mark owner's investigator pose as an ordinary consumer ' essentially misrepresenting his or her true identity or purpose to the potential infringer. This practice of attempting to gain information through the arguable use of deception or invented scenario is now commonly referred to as 'pretexting' and has led to controversy in the general corporate context. This article concludes that properly conducted and supervised pretext investigations remain in harmony with both the relevant case law and the policy goals of trademark and unfair competition law.
Trends in Financial Services Patents
Armed with a well-stocked patent portfolio, a company can effectively corner valuable markets for a limited amount of time. While this concept is second nature for most makers of tangible products, pharmaceuticals, or even software, it is only now becoming widely accepted in the financial services sector. As a result, another battlefield is emerging in which patents are becoming the weapon of choice, and trading floors and back-office processing centers have become the new settings for patent disputes.
Drug Companies and Failure to Warn
For more than one year, product liability cases have been pending against Merck's osteoporosis drug, Fosamax'. Despite having one of the highest side effect profiles of any drug in the U.S. prescription database, Fosamax remains on the market, and available by prescription. When a drug remains on the market during litigation but the manufacturer refuses to warn about a known risk, places the information about the risk in an obscure location or provides inadequate information about the severity of the risk, there is a public problem ' for both patients and prescribers alike ' in the form of a health hazard about which most prescribers have insufficient information.
Intra-Law Firm Communications
Can a firm decline to produce the e-mails, notes and memoranda relating to its internal investigation on the grounds that the material is protected by the firm's own attorney-client or work product privileges?<br>The answer is a definite 'maybe.'
Clause & Effect
Net-Profit Rights/Movies Based on TV Shows<br>Insurance/Contract-Breach Exclusion<br>Insurance/Copyright-Infringement Coverage
