Saturday, March 3, 2007
Article in the Wall Street Journal -- Merck Receives a Split Verdict From New Jersey Jury in Vioxx Trial, by Heather Won Tesoriero. Here's an excerpt:
A New Jersey state court jury delivered a split verdict in the first phase of the latest Vioxx trial, finding that Merck & Co. adequately warned doctors of the drug's heart-attack risks in the case of one plaintiff but not of another.
The eight-person jury found that in the case of both plaintiffs the drug maker violated a state consumer-protection statute by misrepresenting the drug's cardiovascular risks in marketing.
The Wall Street Journal also provides an updated trial scorecard for the Vioxx litigation.
Article in the Wall Street Journal -- Report Blasts FDA's System To Track Drugs, by Anna Wilde Matthews. Here's an excerpt:
The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself.
As a result, the agency must continue to rely on its existing "dysfunctional" computer system as a primary tool for tracking the safety of medications sold in the U.S., according to the November 2006 report, which hasn't been made public.
The situation is "frustrating and undermining...the post-marketing drug safety work" of its staff "because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements," says the report. It was prepared by the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo.
The FDA's drug-tracking system, called the Adverse Event Reporting System, consists of a database and other software and hardware that amass and help sift reports of potential side effects that have been filed by drug makers, doctors and others. The data are the FDA's main way to detect drug-related hazards, and can lead to changes in label warnings or even withdrawals of drugs from the market.
But, the report says, FDA safety experts waste time -- an average of 45 minutes per day -- dealing with the inefficiencies and snags caused by the current software. The Adverse Event Reporting System is overwhelmed by the growing volume of adverse-event reports, which exceeds 400,000 a year, the report says.
Friday, March 2, 2007
Article in the Washington Post -- Ex-FDA Chief Gets Probation, Fine for Lying About Stocks, by the Associated Press. Here's an excerpt:
A judge sentenced former Food and Drug Administration chief Lester M. Crawford yesterday to three years of supervised probation and fined him about $90,000 for lying about stocks he owned in companies regulated by the agency.
Magistrate Judge Deborah A. Robinson's sentence is stiffer than the punishment of a $50,000 fine proposed by federal prosecutors and Crawford's attorney.
"While the total fine exceeds what the parties agreed to, the fine is well below the maximum under the statute," Robinson said in a 90-minute hearing in which she sometimes questioned Crawford's remorse.
Robinson also ordered Crawford to perform 50 hours of community service and to pay the costs of his supervised probation.
Article in the Washington Post -- FDA Tracks Salmonella to Georgia Peanut Butter Plant, by the Associated Press. Here's an excerpt:
Federal inspectors found the strain of salmonella that tainted peanut butter made at the ConAgra Foods plant in Sylvester, Ga., the Food and Drug Administration said yesterday.
Government and industry officials have said the contamination may have been caused by dirty jars or equipment.
ConAgra on Feb. 14 recalled all Peter Pan and Great Value peanut butter made at the Sylvester plant, after federal health officials linked the products to an outbreak that began in August and sickened 370 people. The recall now includes all such products made since December 2005, the FDA said.
Wednesday, February 28, 2007
As noted in this article in the New York Times, there has been a product recall of
About 2.8 million pounds of fully cooked Oscar Mayer/Louis Rich chicken breast cuts and strips, manufactured by Carolina Culinary Foods, because it could be contaminated with Listeria monocytogenes, which can cause listeriosis. Listeriosis is an uncommon but potentially fatal disease that can cause serious or fatal infections in children, the elderly or those with weakened immune systems. Symptoms include high fever, severe headache and nausea. No illnesses have been reported.
Timothy Lytton has posted a paper on SSRN entitled Clergy Sexual Abuse Litigation: The Policymaking Role of Tort Law. Here's the abstract:
By all accounts, the prevalence of clergy sexual abuse and its cover-up by Church officials represents a massive institutional failure. Obscured by all of this attention to the Church's failure is the largely untold story of the tort system's remarkable success in bringing the scandal to light in the first place, focusing attention on the need for institutional reform, and spurring Church leaders and public officials into action. Tort litigation framed the problem of clergy sexual abuse as one of institutional failure, and it placed that problem on the policy agendas of the Catholic Church, law enforcement, and state governments. This Article examines these framing and agenda-setting effects of clergy sexual abuse litigation. It argues that private lawsuits can have a powerful and beneficial effect on policymaking.
Several weeks ago, Lytton wrote a related article for the Boston Globe on the the church sexual abuse litigation, press coverage, and policy impact. Lytton has devoted himself to understanding "social policy" mass torts. Before turning his attention to sexual abuse cases, he was one of the country's leading experts on handgun litigation (I wrote a chapter for his book, Suing the Gun Industry: A Battle at the Crossroads of Gun Control and Mass Torts).
Monday, February 26, 2007
Article in the Wall Street Journal -- Popular Pain Relievers Linked To High Blood Pressure Risk, by Peter Loftus. Here's an excerpt:
Men who frequently take popular pain relievers are at increased risk of developing high blood pressure, a new study suggests.
The study included about 16,000 male health professionals who had no history of hypertension. Over four years, researchers at Brigham & Women's Hospital in Boston tracked how often the men used the pain relievers acetaminophen, aspirin and those known as nonsteroidal anti-inflammatory drugs, or NSAIDs. Acetaminophen is sold as Tylenol by Johnson & Johnson, Bayer AG sells aspirin, and NSAIDs are sold under many brands, including Wyeth's Advil.
Men who used acetaminophen six to seven days per week had a 34% higher risk of developing hypertension compared with nonusers, according to the study. Those using NSAIDs with the same frequency had a 38% greater risk of hypertension, while the risk was 26% greater for aspirin, according to the study.
The Staten Island Ferry crash of 2003, in which eleven passengers died and many others were injured, led to numerous wrongful death and personal injury claims against New York City. Many of the claims have settled, but others remain in litigation. The city has contended that under federal maritime law (specifically, the Limitation of Vessel Owner’s Liability Act), its liability is limited to the value of the ship. Today, Chief Judge Edward Korman of the Eastern District of New York ruled against the city on this critical issue, finding that the failure to enforce a two-pilot rule (requiring that two captains be in the front-facing pilot house while the ferry is in motion) was negligent. Judge Korman's opinion -- with an extensive negligence analysis citing such classics as U.S. v. Carroll Towing, The T.J. Hooper, and McCarty v. Pheasant Run -- belongs in a Torts casebook. A New York Times article -- N.Y. Can't Limit Ferry Crash Damages, Judge Says -- reports on the decision:
A federal judge today rejected New York City’s attempt to use an obscure 19th-century maritime law to cap its liability in the 2003 crash of the Staten Island Ferry at $14 million.
The ruling exposes the city to tens of millions of dollars in damage awards to relatives of those killed and to scores of people injured when the boat, the Andrew J. Barberi, crashed into a maintenance pier at the Staten Island ferry terminal.
The city had argued that the accident was covered by an 1851 act, aimed at encouraging investment in the shipbuilding industry, that limited a boat owner’s liability to the value of the boat minus the repair costs — in this case $14.4 million.
The city has already paid out $27.6 million to settle two-thirds of the 186 damage claims. Of the 11 people killed in the crash, the estates of only two have settled with the city, for $3 million and $450,000.
The amounts of many settlements were held down, lawyers for the plaintiffs said, by the city’s argument that if it succeeded in capping the liability, the plaintiffs stood to win relatively little.
Judge Korman wrote: “The blame for this laxity lies squarely on the shoulders of the city.” The 1851 act limiting liability, he added, does not apply when the negligent parties include supervisors.
Article in the Wall Street Journal -- Judge Affirms Verdict Against Lead-Paint Makers, by the Associated Press. Here's an excerpt:
A judge on Monday ordered three former lead paint manufacturers to clean up contamination in Rhode Island and said he would appoint a special master to advise him on exactly what the companies should be required to do. Lawyers and financial analysts have said the cleanup could cost more than $1 billion.
The decision by Providence Superior Court Judge Michael Silverstein marks a major step forward in the state's lawsuit to force the companies -- Sherwin-Williams Co., NL Industries Inc. and Millennium Holdings LLC -- to clean up properties that contain toxic lead paint.
A jury last February found the three manufacturers liable for creating a public nuisance, and Judge Silverstein's 197-page decision affirms that verdict. Judge Silverstein did not predict a dollar figure or specify what the companies might have to do to fix the problem.
"Today's final ruling is validation of our long fight to protect the public health and to ensure that our hardworking taxpayers no longer have to solve the problem themselves," Attorney General Patrick Lynch said in a written statement.
Judge Silverstein also rejected the companies' motion for a new trial, saying the state presented enough evidence to support the jury's verdict. The companies said they plan to appeal to the Rhode Island Supreme Court.