August 2, 2007
Mass Torts and Legal Writing
All mass tort practitioners know that the intricate and unsettled issues in mass tort litigation often require the highest quality briefing. My Southwestern Law School colleagues Professors Dennis Yokoyama and Austen Parrish have written an excellent and concise guide to legal writing, Effective Legal Writing: A Checklist Approach to Legal Writing and Oral Argument, which has just been published by Carolina Academic Press. I read and commented on the book before its publication, and recommend it highly.
August 1, 2007
NYU Law Discussion on Class Actions
Interesting class actions article from the the NYU Law School magazine (Autumn 06) -- Download heads_of_the_class.pdf . The article provides a transcript of numerous civil procedure experts discussing class actions. Among those whose comments are included are Arthur Miller (Harvard), Steven Bennett (Jones Day), Sheila Birnbaum (Skadden), Oscar Chase (NYU), Evan Chesler (Cravath), Ken Feinberg (Feinberg Group), Samual Issacharoff (NYU), Geoffrey Miller (NYU), Linda Silberman (NYU), Melvin Weiss (Milberg Weiss), and Bert Neuborne (NYU).
Senate Panel Votes for FDA Regulation of Tobacco
Article on cnn.com -- Senate panel pushes FDA's tobacco powers: Bill would allow administration to regulate, not ban tobacco products, restrict ads, mandate labels, and control additives, by Reuters. Here's an excerpt:
A U.S. Senate committee voted on Wednesday to let the Food and Drug Administration regulate but not ban tobacco products, a proposal supported by public health groups and the nation's largest cigarette maker.
The bill would allow the FDA to restrict tobacco advertising, prevent cigarette sales to minors, mandate stronger warning labels, bar misrepresentation of tobacco's dangers and order removal of dangerous ingredients from cigarettes.
J&J Cuts Jobs Amid Safety Concerns for Stents and Anemia Drugs
Article in the Wall Street Journal -- J&J to Reduce Staff by 3% to 4%: Cuts Come Amid Slowdown In Stents and Expectation Of a Decline in Drug Sales, by Avery Johnson and Peter Loftus. Here's an excerpt:
Johnson & Johnson is cutting costs and consolidating operations as the company braces for a downturn in drug sales and endures a sluggish market for drug-coated stents.
The company, based in New Brunswick, N.J., said it will reduce its global work force by 3% to 4%, or as many as 4,820 jobs. J&J pledged to consolidate some operations in its pharmaceutical group and combine medical-device businesses that make stents, the metal scaffolds that prop open arteries in the heart, legs and other parts of the body.
As of 4 p.m. composite trading on the New York Stock Exchange, J&J shares were at $60.50, up 43 cents.
The diversified health-products maker is in so many different businesses, from Band-Aids to biotech, that downturns in one area often are offset by gains in another. But J&J is now battling problems on an unusual number of fronts. The company faces patent expirations and safety concerns for some of its biggest sellers, ranging from anemia drugs to stents. Just two weeks ago, J&J tempered its 2007 sales outlook.
FDA Announces Voluntary Food Standards, Looks to States
Article in the Wall Street Journal -- Strapped FDA Turns to States: Amid Food-Safety Scares, Agency Asks for Help With Inspections, by Jane Zhang. Here's an excerpt:
For several months, amid food scares ranging from tainted pet food to canned chili with botulism, the Food and Drug Administration's cash-strapped food program has been struggling to demonstrate that it can police the nation's food supply. Now, it is taking steps to rely more heavily on the states for help.
Yesterday, the FDA announced new voluntary standards that it said would lead to uniform, high-quality state food-safety programs. Margaret Glavin, associate commissioner for regulatory affairs, called the shift a significant step toward "integrating our food-safety system."
The move amounted to an acknowledgment, increasingly discussed within the FDA in recent months, that federal and state officials need to combine forces to combat food-safety problems.
July 31, 2007
FDA Advisory Panel for Avandia Votes, Finds Heart Risk
Article in the Wall Street Journal -- Panel Keeps Avandia on Market: Glaxo's Diabetes Drug May Require Warning On Label for Heart Risks, by Anna Wilde Mathews. Here's an excerpt:
A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's diabetes drug Avandia is tied to a risk of heart attacks, but it stopped short of voting to pull the medication off the market.
Several panel members said the drug should get a new heart-risk warning in its label, which would be a blow to the company but far less serious than a recommendation to end sales of Avandia. Last year, it was the company's second-biggest-selling drug with global sales of $3.38 billion, and it has been used by more than seven million patients world-wide.
The heart-risk warning is likely to accelerate the reshuffling of the growing market for diabetes drugs, boosting sales of older medications and Takeda Pharmaceutical Co.'s Actos, the only marketed rival that works the same way as Avandia. So far, Actos hasn't been linked to a heart-attack risk. The FDA doesn't have to follow the advice of its expert panels, but it typically does. An agency official said after the meeting that the FDA would aim to reach a decision quickly.
New Medicare and Medicaid Rules for Anemia Drugs
Article in the Wall Street Journal -- A Victory for Anemia Patients? Advocates Beat Back Effort To Limit Use of Popular Drugs That May Carry Heart Risks, by Marilyn Chase. Here's an excerpt:
The Centers for Medicare and Medicaid Services -- amid pressure from patient advocacy groups, medical societies and legislators -- released new rules on its coverage of anemia drugs that are significantly less stringent than what the agency had originally planned.
The proposed changes, aimed at improving patient safety, had caused a public uproar for the past two months. More than 2,600 public comments were filed, many complaining that the proposals were Draconian and threatened to compromise patients' quality of life by withholding needed treatment.
The new guidelines apply mostly to people with cancer who are receiving chemotherapy that causes anemia -- a lack of red blood cells that ferry oxygen around the body. They also apply to myelodysplasia, a disorder of the bone marrow. Anemia can cause crushing fatigue, shortness of breath and cardiac arrhythmia.