Understanding the Potential Pitfalls Arising From Participation in Standards Bodies
Chances are that if your company is involved in research and development of new technology there is a standards setting organization exploring the potential standardization of such technology. While there are clear benefits to participation in standards organizations — keeping abreast of industry developments, targeting product development toward standard compliant products, steering research and intellectual property protection into potential areas of future standardization — such participation does not come without certain risks. Whether you are in-house counsel or outside counsel, you may be called upon to advise participants in standard-setting bodies about intellectual property issues or to participate yourself. You may also be asked to review patent policy of the standard-setting body that sets forth the disclosure and notification requirements with respect to patents for that organization. Here are some potential patent pitfalls that can catch the unwary off-guard.
News from the FDA
The latest information for use in your practice, including rulings, draft guidances, seminars, and more.
We Need a No-Fault Compensation System for Drug Injuries
The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.
AstraZeneca Pleads Guilty in Zoladex Case
Major pharmaceutical manufacturer AstraZeneca Pharmaceuticals LP pleaded guilty to a large-scale health care crime and agreed to pay $355 million to resolve the associated criminal charges and civil liabilities, according to an announcement released by the FDA Office of Criminal Investigations (FDA OCI) on June 20.
When Is Compliance Necessary?
The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.
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As discussed in the article 'Statewide Coordination of Mass Tort Cases Becoming Increasingly Popular,' <i>infra,</i> page 3, three states now provide statewide coordination of mass tort cases similar to the Multidistrict Litigation System (MDL) in the federal courts.
CASE NOTES
Highlights of the latest product liability cases from around the country.
Statewide Coordination of Mass Tort Cases Becoming Increasingly Popular
On January 24, 2002, the New York state courts adopted a rule that provides a procedure for the statewide coordination of mass tort cases that is similar to the Multidistrict Litigation System (MDL) in the federal courts. Uniform Rules for the New York State Trial Courts ' 202.69. With the implementation of Rule 202.69, New York is the third state, following California and Pennsylvania, to institute formal statewide coordination of mass tort cases that share common questions of law or fact (New York had previously followed an ad hoc coordination system). <i>See</i> Daniel Wise, 'New York Courts Adopt Federal Mass Torts Plan,' 2/22/2002 NYLJ 1 (col.5); Ca. Civ. Proc. '' 404.1, <i>et seq.</i>; Ca. St. Trial Ct. Rules 1501, <i>et seq.</i>; Pa. R. Civ. P. '' 213.1, 1041.1, 1041.2.
The Effect of Deflation on Marital Property
With the specter of deflation (falling prices) haunting the U.S. economy, the consequences and problems of the inflationary eras of the 1970s and 1980s may be as far from the minds of matrimonial practitioners as it is from the thoughts of central bankers. Nevertheless, if you have matrimonial clients from long-term marriages, an awareness and understanding of the meaning of inflation may help you obtain a more equitable distribution of marital property for those who brought separate property into the marriage.
