Saturday, October 6, 2007

New Data Raises Safety Concerns for Medtronic's Endeavor Drug-Coated Stent

Article in the Wall Street Journal -- New Data Raise Questions About Medtronic's Stent, by Jon Kamp and Jennifer Corbett Dooren.  Here's an excerpt:

The Food and Drug Administration released new data for Medtronic Inc.'s Endeavor drug-coated stent that raise new questions about the heart device's performance and prospects, ahead of a regulatory review Wednesday.

Stents are small devices used to prop open heart arteries, and drug-coated stents use medication to slow renarrowing.

Avoiding stent-related clots has been Endeavor's calling card in a market that has been rattled by concerns about late-developing clots. While there are no new signs that Endeavor doesn't perform well over the long term, new data from the much-anticipated "Endeavor IV" study did show some earlier clots for Medtronic's stent.

BGS

October 6, 2007 in FDA, Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Friday, October 5, 2007

Strip Search Settlement in New York City - Fourth Amendment Mass Tort

Alan Feuer of the New York Times reports here that New York City has once again settled a constitutional mass tort.

The city’s Department of Correction conceded yesterday that tens of thousands of nonviolent inmates taken to Rikers Island on misdemeanor charges had been wrongly strip-searched in violation of a 2002 court settlement, and were entitled to payment for damages.

The number of prisoners wrongfully strip searched may reach 150,000.  The article describes the continuation of this illegal policy despite court rulings and a $50 million dollar settlement.   Anthony Sebok (Cardozo) wrote an interesting FindLaw piece on this settlement in 2001 - it is available here.   More from the New York Times article:

Before July 2002, all inmates at Rikers Island were forced to undergo strip-searches when they first entered the jail. Often in groups of 10 or 12, they were made to stand naked and have their armpits, mouths, ears, noses, navels, genital areas and anal cavities searched by correction officers, according to papers filed in the case.

The policy was kept in place despite a United States Court of Appeals for the Second Circuit ruling in 2001 that strip-searches of misdemeanor suspects were illegal, unless officials suspected that they were carrying contraband. (Inmates accused of felonies are still permitted to be strip-searched at the jail.)

This case is a testament to the importance of objectors and intervenors in class actions.  Here, the firm of Emery Celli Brinckerhoff & Abady intervened in the original lawsuit against the Department of Corrections, arguing that the compensation offered plaintiffs was too low.  (In the interest of full disclosure, I worked for this firm prior to teaching).  As part of discovery in that proceeding, the lawyers discovered that the Department was not complying with the previous court order and continuing with the unconstitutional strip searches.   Although the City had agreed to order gowns to offer prisoners some modicum of privacy, 

Mr. Emery also said he discovered that only 46,000 gowns had been ordered from July 2002 to August 2007, even though some 150,000 inmates who needed the gowns were admitted to Rikers Island in those years. In a separate deposition, the plaintiffs’ lawyers asked Chief Valerie Oliver, another correction official, if she believed that the department was complying with the strip-search ban. According to a transcript of the deposition, Chief Oliver said no.

How is it that a municipal government can continually violate court orders and establish policies that are clearly unconstitutional over a period of years?  It was clear before 2001, but certainly by 2001 that the policy of blanket strip searches of all misdemeanor arrestees violated the Fourth Amendment.  Keeping this policy in place between 2001 and 2007 is a fundamental violation of the rule of law.  This case reinforces the importance of the constant vigilance of citizens and the civil rights bar.  Perhaps it shows that our courts, and the norms of legality, aren't as powerful as we think.  It also illustrates the particular danger of reducing fees for civil rights lawyers, which will predictably reduce the pool of talented litigators who will pursue these cases to the end and, apparently, even after the policy is supposed to be ended. 

ADL

October 5, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, October 3, 2007

Dueling papers on tobacco litigation

Ssrn_25For those interested in tobacco litigation, two new papers have been posted on SSRN from opposite ends of the political-litigation spectrum.  Although they speak to different issues and do not cite each other, they present wildly divergent perspectives on tobacco litigation and even criticize each other's institutional affiliations.

Bootleggers, Baptists and Televangelists: Regulating Tobacco by Litigation, by Bruce Yandle, Joseph Rotondi, Andrew Morriss, and Andrew Dorchak (three of whom are associated with the Mercatus Center at George Mason University), argues that in the tobacco litigation, plaintiffs' attorneys and state attorneys general established alliances with other players that had a pernicious effect and, according to the Mercatus Center summary of the paper, "creat[ed] an unaccountable group whose activities undermine core principles of the Anglo-American legal system."  Here's the abstract from SSRN:

The "bootleggers and Baptists" public choice theory of regulation explains how durable regulatory bargains can arise from the tacit collaboration of a public-interest-minded interest group (the "Baptists") with an economic interest (the "bootleggers"). Using the history of tobacco regulation, this Article extends the bootleggers and Baptists theory of regulation to incorporate the role of policy entrepreneurs like the state attorneys general and private trial lawyers who joined forces to regulate tobacco by litigation. We denominate these actors "televangelists" and demonstrate that they play a pernicious role in regulation.

The Article begins by showing how tobacco regulation through the 1980s fit the traditional bootleggers and Baptists public choice model. It then explores the circumstances that made it possible for the emergence of the televangelists as a regulatory partner that the bootleggers would prefer. The Article then criticizes televangelist-bootlegger bargains as likely to result in substantial wealth transfers from large, unorganized groups to the coalition partners. It also shows how televangelist-bootlegger coalitions are more pernicious than bootlegger-Baptist coalitions. Finally, it concludes with suggestions for how to make televangelist-bootlegger coalitions less durable.

Tobacco Industry Use of Judicial Seminars to Influence Rulings in Products Liability Litigation, Tobacco Control (2006), by Lissy Friedman of the Tobacco Control Resource Center at Northeastern Law School, charges judges with participation in biased seminars funded by the tobacco industry.  In the paper, Friedman criticizes George Mason as "one of the main purveyors of judicial seminars with a pro-business slant." (Turnabout:  the Bootleggers paper by Yandle et al., in passing, criticizes the role of Northeastern and Prof. Richard Daynard as "televangelists" for tobacco litigation and regulation). Here's Friedman's abstract:

Objectives: This paper examines the tobacco industry's efforts to influence litigation by sponsoring judicial seminars.

Methods: Thousands of internal tobacco documents were examined, including memos, reports, presentations, and newsletters. Connections to outside organisations were corroborated by examining tobacco industry financial records, budgets, and letters pledging funds. Facts about outside organisations were triangulated through examining their websites and publicly-filed financial records, and verifying facts through their representatives' statements in newspaper and law review articles.

Results: There are direct financial ties between the tobacco industry and groups that organise judicial seminars in an effort to influence jurisprudence, and judges who attend these seminars may be breaching judicial ethics either by not inquiring about the source of funding or by ignoring funding by potential litigants.

Conclusions: The tobacco industry's attempts to clandestinely influence judges' decisions in cases to which they are a party endangers the integrity of the judiciary.

HME

October 3, 2007 in Mass Tort Scholarship, Tobacco | Permalink | Comments (1) | TrackBack (0)

FDA Letter to Eli Lilly to Stop Misleading Cymbalta Promotion

Article on cnnmoney.com -- FDA tells Lilly to halt Cymbalta campaign.  Here's an excerpt:

Eli Lilly has been asked to stop a Cymbalta promotion that makes misleading claims and understates risk, according to a letter sent to the drug maker by the U.S. Food and Drug Administration.

The letter said a mailer for the fast-selling drug overstates effectiveness and "omits some of the most serious and important risk information associated with its use." The letter was posted on the federal regulator's Web site.

It asked Lilly (Charts, Fortune 500) to "immediately cease" disseminating the material.

BGS

October 3, 2007 in FDA, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

The Problem of Multi-District Litigation: Symposium at Tulane

Tulane Law Review is putting together a symposium entitled The Problem of Multi-District Litigation.  Here is the blurb from the Tulane Law Review's website:

The Tulane Law Review is holding the first national symposium on multidistrict litigation this upcoming February 15th and 16th, 2008. We are pleased that a number of speakers have agreed to join us, specifically Judge John Heyburn, the Chairman of the United States Judicial Panel on Multidistrict Litigation, and Judge Kathryn Vratil, also a member of the Panel.  The symposium will feature several other distinguished federal and state judges who have handled MDL litigation, such as Judges Eldon Fallon (E.D. La.), Stanwood Duval (E.D. La.), Lee Rosenthal (S.D. Tex.), Sarah Vance (E.D. La.), Mark Davidson (Texas), and Carol Higbee (New Jersey); a number of highly respected academics, such as Profs. Francis McGovern, Richard Marcus, Edward Sherman, Alexandra Lahav, and Robin Effron; and distinguished attorneys from both plaintiffs' and defendants' sides, including Richard Arsenault, Dawn Barrios, Judy Barrasso, Mark Herrmann, Russ Herman, Phillip Whitman, and Richard Scruggs.  The symposium will cover a wide range of issues across the national landscape of multidistrict litigation, from the actual workings of the United States Judicial Panel and the selection of the transferee court, to the questions of coordination between simultaneous MDLs in both state and federal courts, the formation of ad hoc districtwide MDLs, the use of bellwether trials and other settlement devices, attorney strategies in multidistrict litigation, and the role of MDL in the solution to the problems of complex litigation.

ADL 
 

October 3, 2007 in Conferences | Permalink | Comments (0) | TrackBack (0)

The Next Big Thing in Tobacco?

Mark Landler and Andrew Martin of the New York Times report that a Swedish smokeless tobacco product called "snus" is about to enter the U.S. market.   Unlike chewing tobacco, snus does not require spitting, making it a way to get a nicotine high without breaching etiquette.  The medical establishment in Sweden seems mixed on the question of snus' healthfulness as compared to other forms of tobacco (the article indicates snus carries less risk of oral and lung cancer than chewing tobacco and cigarettes, but carries an increased risk of pancreatic cancer), but mostly they seem to agree using snus is not a good idea.  Is snus a gateway chew to cigarette smoking?  Will it, along with other purportedly safer tobacco products that seem particularly appealing to younger users, play a role in Congress' debates about whether to allow the FDA to regulate tobacco?   If they state tort lawsuits aren't preempted by federal legislation, it is possible these alternative products will bring the next wave of tobacco litigation.  And if such suits are preempted, can we rely on the FDA to really regulate these products?

From the article:

Still, with the number of American smokers declining every year — there are now about 45 million smokers, or 21 percent of the adult population — American tobacco companies are expanding aggressively into reduced-risk products, notably dip and snus.

R. J. Reynolds is selling snus under the Camel label in eight test markets across the country. Last year, Reynolds American bought Conwood Sales, maker of Grizzly and Kodiak smokeless tobacco, for $3.5 billion.

Philip Morris USA recently introduced Marlboro snus in the Dallas-Fort Worth area, and it continues to test another snus product, Toboka, in Indianapolis. It is set to open a $350 million plant, near its headquarters in Richmond, Va., that will focus partly on developing reduced-risk products. Analysts said the Toboka test has been disappointing, and some are skeptical of the prospects for other snus products.

ADL

October 3, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)

Sunday, September 30, 2007

Blog Roundup

New Issue of Federalist Society Class Action Watch

The Federalist Society has posted the September 2007 issue of Class Action Watch.  Here's the list of articles:

    * Omission in FACTA Might Be Windfall for Plaintiff's Bar by Ted Frank
    * New Jersey and Missouri Supreme Courts Reject Lead Paint Public Nuisance Claims by   Mark Behrens & Christopher Appel
    * ALI Principles and Litigation Trends by James Beck
    * More Searching Fact-Based Scrutiny of Proposed Class Actions Reaches Securities and Antitrust Actions by Brian D. Boyle & Julia A. Berman
    * Fluid Recovery: Manufacturing "Common" Proof in Class Actions? by Jessica D. Miller & Nina Ramos
    * Has the Eleventh Circuit Set a New Standard for Federal Diversity Jurisdiction? by Kenneth J. Reilly & Frank Cruz-Alvarez

BGS

September 30, 2007 in Class Actions, Lead Paint, Mass Tort Scholarship, Procedure | Permalink | Comments (0) | TrackBack (0)

Study Suggests Link Between DDT and Breast Cancer

Article in the L.A. Times -- Study suggests DDT, breast cancer link, by Marla Cone.  Here's an excerpt:

Women heavily exposed to the pesticide DDT during childhood are five times as likely to develop breast cancer, a new scientific study suggests.

For decades, scientists have tried to determine whether there is a connection between breast cancer and DDT, the most widely used insecticide in history. The UC Berkeley research, based on a small number of Bay Area women, tested a theory that the person's age during exposure was critical, and provided the first evidence of a substantial effect on breast cancer.

"There was very broad exposure to this pesticide, and with this study, we have evidence that women exposed when young were the most affected," said Barbara A. Cohn, director of UC Berkeley's Child Health and Development Studies, who led the study of 129 women. "If this finding holds up, those who were young and more highly exposed could be the women at greatest risk."

Women born between 1945 and 1965 were most likely to have been heavily exposed as children to DDT, which was sprayed throughout the United States to kill mosquitoes and other insects. DDT use began in 1945, peaked in 1959 and was banned nationwide in 1972 because it was building up in the environment.

BGS

September 30, 2007 | Permalink | Comments (2) | TrackBack (0)