Tuesday, April 10, 2007
Blog Roundup
Beck/Herrman at the Drug and Device Law Blog have an interesting post on Filing Fees Due After Severance For Misjoinder.
Ted Frank at Point of Law has an interesting post on Accutane mass tort litigation for inflammatory bowel disease.
BGS
April 10, 2007 | Permalink | Comments (0) | TrackBack (0)
Public Citizen Asks FDA to Stop Celebrex Ad
Article in the New York Times -- Watchdog Asks FDA to Stop Celebrex Ad, by the Associated Press. Here's an excerpt:
A consumer advocacy group called on the government Monday to order Pfizer Inc. to stop running a television ad for painkiller Celebrex, calling the ad dangerous and misleading because it downplays the drug's risks.
Public Citizen alleged that the 2 1/2-minute ad asserts, in spite of scientific evidence, that the cardiovascular dangers of Celebrex are no greater than those of any of the other nonsteroidal anti-inflammatory painkillers.
The ad also claims that Celebrex has gastrointestinal benefits over two popular nonprescription painkillers and plays down the risk of bleeding, ulcers and other serious stomach and intestinal problems associated with nonsteroidal anti-inflammatory painkillers, Public Citizen said in its letter to the Food and Drug Administration.
''The ad violates FDA law and regulations because it contains several false or misleading statements that will lead many viewers to underestimate the cardiovascular and gastrointestinal risks of Celebrex and use it in preference to equally effective, safer alternatives,'' Dr. Sidney Wolfe, director of Public Citizen's health research group, wrote in the letter. The letter cited the drugs ibuprofen and naproxen.
BGS
April 10, 2007 | Permalink | Comments (0) | TrackBack (0)
FDA Assesses Risks of Vioxx Successor Drug Arcoxia
Article in the New York Times -- FDA Weighs Risk of Vioxx Successor Drug, by the Associated Press. Here's an excerpt:
New painkillers in the same class as Vioxx that increase the risk of stroke and heart attack shouldn't be approved if safer alternatives are available, according to federal documents released Tuesday.
That opinion came as a panel of government advisers prepares to weigh Merck & Co. Inc.'s proposed successor to its now-withdrawn Vioxx.
That puts the cardiovascular safety of the drug, called Arcoxia, front and center Thursday, when the panel of Food and Drug Administration advisers discusses whether to make a nonbinding recommendation that the prescription painkiller receive agency approval. Merck voluntarily pulled Vioxx from the market in 2004 after it was linked to a higher risk of stroke and heart attack when compared to dummy pills.
The FDA said its focus in evaluating Merck's application for Arcoxia, and all other drugs from that class, will be specifically on its risks to the cardiovascular system. Any nonsteroidal anti-inflammatory drugs, or NSAIDs, merit approval only if they fill an unmet need for a particular group of patients who have no relatively safer options available, the FDA said in a March 21 memorandum released Tuesday.
BGS
April 10, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)
Study Shows Smokers Take More Than A Week Extra Annual Sick Time Than Non-Smokers
Article in the New York Times -- Patterns: Smokers Take More Sick Time Than Nonsmokers, Study Says , by Nicholas Bakalar. Here's an excerpt:
A study of Swedish workers has found that smokers take more than a week more annual sick leave than nonsmokers, even after adjusting for smokers’ general health and their tendency to take more stressful or physically taxing jobs.
Using data on 14,272 workers ages 16 to 65, researchers studied sick leave reports from a nationwide survey conducted from 1988 to 1991. According to background information in the article, smokers are known to choose more dangerous jobs than nonsmokers and are more likely to be involved in risky activities. Those tendencies, the article said, rather than smoking, might contribute to the greater number of sick days among smokers. But even after statistically controlling for these factors, the large difference between smokers and nonsmokers was evident.
BGS
April 10, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
Monday, April 9, 2007
Judges to Discuss Managing Electronic Discovery at Fordham
As part of the Philip D. Reed Chair Lecture Series, Fordham Law School is hosting a panel of judges to discuss Managing Electronic Discovery on April 17, 2007 at 6 p.m. Among the judges is Judge Lee Rosenthal of United States District Court for the Southern District of Texas -- see our prior post linking an interview with Judge Rosenthal.
BGS
April 9, 2007 in Conferences | Permalink | Comments (0) | TrackBack (0)
Roscoe Pound Symposium
Hamline University Law School in St. Paul, Minnesota is hosting a symposium this Friday on A 21st Century Vision for Law as a Profession: 100 Year After Roscoe Pound’s Call for Change in the Administration of Justice. The idea is to talk about the current state of civil litigation and the legal profession in light of the famous speech Pound delivered a century ago in St. Paul, "The Causes of Popular Dissatisfaction with the Administration of Justice." I'm giving a presentation called "Roscoe Pound, Popular Dissatisfaction, and Modern Mass Litigation." I am enjoying the opportunity to think in modern terms about some of the problems Pound identified in 1906, such as the inefficiencies of concurrent jurisdiction, partisan expert witnesses, press reporting on litigation as if it were a sporting event, the effect on public attitudes about law when lawyers and judges treat litigation as a game, and the friction between the individualism of the common law and the collectivism of modern society.
HME
April 9, 2007 in Conferences | Permalink | Comments (0) | TrackBack (0)
Results-Based Expert Compensation?
Today's New Jersey Law Journal contains a story that's troubling for those of us who haven't already become entirely cynical about expert testimony in tort cases. The article -- Court Rebuffs Lawyer's Stab at Cutting Expert's Fee in Lost Case (subscription) -- describes the case of Beilin v. Nagel, Rice & Mazie LLP, in which the court required a plaintiff's law firm to pay its medical expert's full fee in a medical malpractice case even though the plaintiff lost the underlying case. That seems pretty straightforward and unobjectionable. The part I find troubling is the casualness with which the lawyer apparently assumed that an expert witness should charge different amounts based on the outcome of the case:
"We took a blood bath in this case," Nagel continued. "And what I do with experts over the course [of] almost 30 years is that where you take a huge loss, experts will virtually always work with you." ...
Nagel says his firm does not seek discounts from experts on losing verdicts. Rather, expert witnesses who have an ongoing relationship with his firm tend, of their own volition, to increase their bills in the event of a victory and to cut them after a defeat.
Has the legal profession so fully accepted a norm of partisan "experts" that lawyers assume expert witnesses operate on a type of contingent fee? Wouldn't such an expectation, if disclosed, significantly undermine the expert's credibility?
HME
April 9, 2007 | Permalink | Comments (0) | TrackBack (1)
Ohio Lead Paint Suit
At Point of Law, Walter Olson notes that Ohio has followed Rhode Island in pursuing public nuisance claims against lead paint manufacturers. Five Ohio cities had previously filed lead paint suits. Olson emphasizes the separation of powers problem that occurs whenever a state AG uses contingent fee lawyers to pursue litigation, bypassing legislative control over the purse strings. The Motley Rice law firm represents the Ohio municipal plaintiffs as well as the state of Rhode Island, but according to this April 4 story in the Cleveland Plain Dealer, the Ohio attorney general has not yet decided whether the state will be represented by Motley Rice.
HME
April 9, 2007 in Lead Paint | Permalink | Comments (0) | TrackBack (0)
Monday, April 9, 2007
Alleged Plaintiff Counsel Fraud in Connection with Fen-Phen Settlement Money
Interesting article posted on American.com -- Fen-Phen Zen: Some of the lawyers who committed massive fraud are finally being brought to justice, by Ted Frank of the American Enterprise Institute. Overlawyered.com has a follow-up post on Stanley Chesley's connection. Here's an excerpt from the Ted Frank article:
It’s the hoariest of Hollywood clichés: adventurers discover a treasure, and then let greed overwhelm them as they try to split the proceeds. Here, three Kentucky lawyers, William J. Gallion, Melbourne Mills Jr., and Shirley A. Cunningham Jr., managed to snag for themselves a share of a $200 million settlement with American Home Products (now known as Wyeth) for 440 clients who claimed to be injured from their use of the diet drug fen-phen. But the lawyers weren’t satisfied with the tens of millions of dollars their contracts with their clients would have paid them, and administered the settlement to leave their clients with only $74 million, a fraction of what they were supposed to receive.
A “charity” was established with $20 million of leftover fund proceeds, with the attorneys hired as directors for $5,000 a month. $27.7 million more of that $74 million may have been intended to be diverted; it was distributed to clients only after the state bar started sniffing around in 2002. Of course, none of this could have happened had the judge not approved the settlement as “fair and equitable”—but Judge Joseph F. Bamberger was himself being paid $5,000 a month from the same charity as a director. Bamberger’s former law partner was paid a $2 million fee even as he was buying a Florida house jointly with the judge. (Bamberger’s defense is that he approved the settlement without reading it. Let’s hear it for judicial oversight.)
Some of the greed is farcical. Cunningham spent a million dollars to endow a chair in his own name at Florida A&M Law School—and negotiated to sit in his own chair for a six-digit salary. A school audit, according to a report in the St. Petersburg Times, says he never did any work. There was possibly even intramural greed: Court filings claim that Cunningham and Gallion at first hid $50 million of the settlement from Mills; Mills himself was sued by his secretary, who unsuccessfully claimed she had been stiffed of a promised Erin-Brockovich-sized share for her role in thinking up the business strategy of advertising for pharmaceutical plaintiffs.
BGS
April 9, 2007 in Fen-Phen | Permalink | Comments (0) | TrackBack (0)
Trial Over Whether McNeil's Splenda Ads Were Misleading
Article in the Wall Street Journal -- How Sweet It Isn't: Maker of Equal Says Ads For J&J's Splenda Misled; Chemistry Lesson for Jurors, by Avery Johnson. Here's an excerpt:
A battle between makers of artificial sweeteners stands to turn bitter next week, as a trial begins over what a judge has termed a veritable "sugargate."
The fight pits Merisant Co., the maker of Equal and NutraSweet, against health-care giant Johnson & Johnson, which sells market-leader Splenda. Merisant alleges that a J&J consumer-products unit, McNeil Nutritionals LLC, deliberately confused consumers over whether Splenda is a natural product.
The dispute could prove to be a black eye for J&J at a time when sales tactics at its drugs and medical-device units are already under scrutiny. Revenue from Splenda is a tiny slice of J&J's $53 billion in annual sales, but the case is the first in a string of pending suits that could threaten the reputation of a highly visible product.
BGS
April 8, 2007 | Permalink | Comments (0) | TrackBack (0)
FDA Requests Certain Nausea Drugs Not Be Marketed
Article in the Wall Street Journal -- FDA Targets Unapproved Nausea Drugs, by Jennifer Corbett Dooren. Here's an excerpt:
The U.S. Food and Drug Administration said Friday that it was asking manufacturers of a certain type of drug to treat nausea and vomiting to stop making and marketing the products.
Specifically, the FDA is asking manufacturers of suppository drug products that contain trimethobenzamide hydrochloride to stop making them because they are not FDA-approved.
The action is part of an ongoing agency effort to go after prescription drugs that do not have FDA approval. Many of the unapproved drugs were on the market before a 1962 law that requires the FDA to evaluate a drug's effectiveness and safety before allowing it on the market. Prior laws required the agency to look mostly at safety.
Deborah Autor, the director of FDA's office of compliance, said the agency estimates there are "hundreds" of prescription drugs on the U.S. market that lack FDA approval.
BGS
April 8, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Spotlight On: Professor Richard Nagareda
Professor Richard Nagareda is Professor of Law at the Vanderbilt University School of Law, where he is also Director of the Cecil D. Branstetter Litigation & Dispute Resolution Program and holds the Tarkington Chair in Teaching Excellence.
J.D. University of Chicago
A.B. Stanford University
Professor Nagareda's recent scholarship explores the impact of class action lawsuits on the pursuit of legal rights. In 2003, he was appointed as Associate Reporter for the American Law Institute project on Principles of the Law of Aggregate Litigation. He teaches courses on evidence and complex litigation and a seminar on mass torts. Professor Nagareda previously taught on the faculty of the University of Georgia School of Law and as a visitor at the University of Texas School of Law. Before joining the academy, Professor Nagareda clerked for Judge Douglas H. Ginsburg, of the D.C. Circuit, and practiced in the Office of Legal Counsel of the United States Department of Justice and as an associate at Shea & Gardner in Washington, D.C. In 2002 he won the Hartman Award for Excellence in Teaching.
Representative Publications (SSRN author page)
Books
* Mass Torts in a World of Settlement, University of Chicago Press (forthcoming 2007)
Articles
* "FDA Preemption: When Tort Law Meets the Administrative State," 1 Journal of Tort Law (forthcoming 2007)
* "Aggregation and its Discontents: Class Settlement Pressure, Class-Wide Arbitration, and CAFA," 107 Columbia Law Review (2006)
* "Restitution, Rent Extraction, and Class Representatives: Implications of Incentive Awards," 53 UCLA Law Review (2006)
* "The Allocation Problem in Multiple-Claimant Representations," 14 Supreme Court Economic Review 95 (2006) (with Paul Edelman & Charles Silver)
* "Administering Adequacy in Class Representation," 82 Texas Law Review 287 (2003)
* "The Preexistence Principle and the Structure of the Class Action," 103 Columbia Law Review 149 (2003)
* "Autonomy, Peace and Put Options in the Mass Tort Class Action," 115 Harvard Law Review 747 (2002)
BGS
April 8, 2007 in Mass Tort Scholarship | Permalink | Comments (0) | TrackBack (0)
Senate Inquiry Into FDA Oversight of Tainted Pet Food
Article in the L.A. Times -- Senate panel to question FDA response to tainted pet food: Sen. Durbin says the agency should be able to order a recall rather than rely on companies to do so voluntarily, by Chuck Neubauer. Here's an excerpt:
Seeking ways to ensure that pet food is safe, a Senate subcommittee plans to question Food and Drug Administration officials as soon as Thursday about their response to the contamination that has killed pets and led to the recall of more than 100 brands.
On Saturday, Sen. Richard J. Durbin (D-Ill.), a leading advocate of improving food safety, criticized the federal inspection process for both human and pet food. "The system is broken-down," he said.
Durbin, the second-ranking Democrat in the Senate, called for the hearing last week. He said he would like to see the FDA set national standards and inspection rules for pet food manufacturing facilities.
"The FDA is like a fire department that is only called after the house has burned," Durbin said in a telephone interview.
He also said he would like to see federal law changed to allow the FDA to order a recall of food intended for human or pet consumption rather than rely on companies to do it voluntarily.
The agriculture appropriations subcommittee plans to schedule a hearing for Thursday or sometime next week. Durbin said he expects to hear from FDA Commissioner Dr. Andrew C. von Eschenbach, veterinarians and representatives of the pet food industry.
BGS
April 8, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Friday, April 6, 2007
Product Recalls
The New York Times has a list and description of recent product recalls and the dangers posed by the products.
BGS
April 6, 2007 | Permalink | Comments (0) | TrackBack (0)
Lee Rosenthal on E-Discovery Rules
The Civil Procedure Prof Blog this week has a useful, in-depth interview with Judge Lee Rosenthal (Chair of the Advisory Committee on Civil Rules) about the recent amendments to the Federal Rules of Civil Procedure concerning electronic discovery. Among other things, she discusses the importance of early attention to preservation of information, as well as the need to establish discovery protocols to deal with form of production and problems of accessibility.
HME
April 6, 2007 | Permalink | Comments (0) | TrackBack (0)
Harvard Law School, Asbestos, and April Fools
Here's an early April article in the Harvard Law Record: Ukrainian Institute Leaks Asbestos, Students Sue.
Maybe I've lost my sense of humor. April Fools issues of student papers are a time-honored tradition, and this piece is typically clever. But if you know anything about mesothelioma, it's just hard to find it funny.
As law teachers, we know the challenge presented by humor. I confess I've often played cases for a laugh. It keeps students engaged, focuses their attention on key points, and builds an environment that encourages participation. And besides, it's fun.
But there's a cost to laughter that distances students from the human drama in the cases. I've learned to be careful about deploying laughter when teaching cases that involve serious harm. For one thing, I work on the assumption that someone among the students has personal experience with the harm. In any large classroom, someone has lost a parent to cancer, someone has been sexually assaulted, someone has a close friend who suffered a disfiguring accident. If I'm making light of a case, that person is silently seething. But more importantly, I want my students to get into the mindset of lawyers who empathize with their clients (and, ideally, who empathize with their clients' adversaries as well, without losing a sense of loyalty to their own clients).
So when I see this funny Harvard Law Record article about "fears that full-fledged mesothelioma has struck members of the law school community," I have to wonder. What were these student authors thinking when they studied asbestos cases in their law school classes? Was the notion of massive numbers of people getting sick and dying just an abstraction? Just a random "fact pattern" as a set-up for issues of proximate causation, product identification, class certification, and reverse auction? Or were they thinking about a generation of workers who spent years working with an insulation fiber in power plants, naval yards, construction, and elsewhere, only to find out later that the fiber would kill many of them? Were they thinking about the families these workers left behind? If that's how you understand asbestos, jokes come harder.
HME
April 6, 2007 in Asbestos | Permalink | Comments (0) | TrackBack (0)
Wednesday, April 4, 2007
New Class Action Watch Issue by Federalist Society
As noted on Point of Law, the Federalist Society has released a new issue of Class Action Watch, which includes articles on vioxx and asbestos, among other topics.
BGS
April 4, 2007 in Asbestos, Mass Tort Scholarship, Vioxx | Permalink | Comments (0) | TrackBack (0)
Tuesday, April 3, 2007
Prof. Doug Rendleman on Defendant's Appeal Bond and Punitive Damages Tort Reform
Interesting article posted on SSRN -- A Cap on the Defendant's Appeal Bond?: Punitive Damages Tort Reform, by Professor Doug Rendleman of Washington & Lee School of Law. Here's the abstract:
The defendant's supersedeas or appeal bond was a servile drudge of appellate procedure until enormous punitive damages verdicts catapulted it out of local courthouses into headlines. From the verdict that exceeded $10 billion in Pennzoil v. Texaco in the 1980s to the punitive damages verdict of $145 billion in Engle v. Liggett Group that was reversed in the summer of 2006, appeal bonds have played a crucial role in huge-verdict litigation. This article's topic - tort reform statutes that cap an appeal bond - stemmed from punitive damages verdicts in smokers' trials against tobacco companies.
Beginning with appellate procedure, the article traces the appeal bond through related topics: federal abstention, bankruptcy, the arguments for and against state tort-reform statutes that cap an appeal bond, and state and federal constitutional doctrines, including the United States Constitution's Full Faith and Credit Clause.
Since constitutions neither compel nor forbid a limited appeal bond, the author resolved that the decision to cap or not to cap resides in the legislature's realm of evaluating public policy. The appeal bond cap's function of facilitating the defendant's entryway to the appellate court whose warranty is a crucial imprimatur for accurate and legitimate judicial decisionmaking convinced the author to commend a cap of $25 to $50 million for a defendant's appeal bond on a jury's verdict for punitive damages.
BGS
April 3, 2007 in Mass Tort Scholarship | Permalink | Comments (0) | TrackBack (0)
Russian Doctors Charged With Doing Glaxo Vaccine Trial Without Consent
Article in the Wall Street Journal -- Doctors Charged Over Trials Of Glaxo Vaccine in Russia, by the Associated Press. Here's an excerpt:
Prosecutors charged three Russian doctors with endangering people's health following a criminal investigation into vaccine trials organized by United Kingdom pharmaceutical giant GlaxoSmithKline PLC, federal authorities said Monday.
The doctors at a hospital in Volgograd, about 550 miles southeast of Moscow, had participated in the tests for pediatric vaccines called Varilrix and Priorix Tetra beginning in late 2005, the prosecutor general's office said in a statement posted on its Web site.
A total of 112 children between the ages of one and two were involved in the trials, prosecutors said. Officials opened their inquiry when a parent complained to prosecutors after her daughter suffered medical complications, apparently from the vaccine.
Parents were allegedly told by the doctors that the vaccines were routine rather than experimental, prosecutors said.
BGS
April 3, 2007 | Permalink | Comments (0) | TrackBack (0)
FDA Blocks Chinese Wheat Gluten Imports After Pet Food Deaths
Article in the Wall Street Journal -- FDA Blocks Wheat Gluten Imports From Chinese Firm After Pet Recall, by the Associated Press. Here's an excerpt:
The U.S. government has blocked imports of wheat gluten from a company in China because of contamination, acting after the recent pet-food-related deaths of cats and dogs.
The Food and Drug Administration took action against wheat gluten from Xuzhou Anying Biologic Technology Development Co. in Wangdien, China, after the U.S. recall of nearly 100 brands of pet food. Tainted pet food apparently has resulted in kidney failure in animals across the country.
BGS
April 3, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Monday, April 2, 2007
Madison County's Reputation After Vioxx Verdict
Whatever you want to call it -- plaintiff-friendly venue, renegade jurisdiction, or judicial hellhole -- it takes time for a forum's reputation to change. Madison County, arguably the most notorious plaintiff-friendly and class-action-friendly jurisdiction of the past decade, has changed in recent years. But will the recent defense verdict in a Vioxx case help the county finally shed its reputation? This AP story in Insurance Journal -- Ill. Vioxx Verdict Helps Madison County Shed Pro-plaintiff Reputation -- suggests that this verdict is a big step, but that these things take time:
Judicial watchdog Ed Murnane long has been critical of Madison County's reputation as a plaintiff's paradise in big-money lawsuits, and he knew changing that would take baby steps. So it was little wonder that the chief of the Illinois Civil Justice League, which sides with business and the insurance industry in fighting for caps on damages and other lawsuit reforms, was encouraged when a jury rejected a widower's request for tens of millions of dollars in damages against Merck & Co. in the death of his wife. ...
Murnane acknowledged Wednesday that jurors might have sided with Merck because Frank Schwaller's case wasn't persuasive enough _ not to prove this county just east of St. Louis didn't deserve being stigmatized by some as a "judicial hellhole.'' Even so, Murnane believes the verdict may be a "watershed"' for Madison County and the nation's perception of it. "This is just a good, positive sign. There is no doubt,'' he said. While "it certainly doesn't erase all of the concern and distrust people have had,'' the county needs to sustain the momentum and "the image of fairness.''
For years, Madison County has been known as a place where lawyers from across the country file cases hoping for big payouts involving everything from asbestos exposure to medical malpractice. ...
Under the watch of Ann Callis, Madison County's chief judge since last May, reforms cheered by Murnane and others are under way. Murnane said recent local rules adopted by Madison County judges that make it tougher for plaintiffs, particularly from out-of-state, to file cases here and moving some cases to arbitrators have weeded out frivolous lawsuits and helped speed cases along. ...
Numbers show improvement. Major civil cases _ those seeking at least $50,000 _ last year totaled 1,145, down from 1,297 in 2005, 1,439 in 2004 and 2,102 in 2003. Asbestos lawsuits dropped to 325 last year, nearly one-third of the 953 such cases in 2003. There were three class-action filings in 2006; just three years before that, there were 106.
Even the American Tort Reform Association has taken notice. In announcing its yearly "judicial hellholes'' ranking, the group in December put Madison County fifth, improved from fourth the previous year after two years atop the list. The association credited the county with "extraordinary changes'' in the past two years that significantly improved fairness, warranting the county's move from "from the worst-of-the-worst to purgatory.'' ...
But shedding the hellhole image doesn't appear imminent. "Such a reputation does not fade fast,'' the group's Web site reads, "and civil defendants still shiver at the prospect of facing a lawsuit in Madison County.''
HME
April 2, 2007 | Permalink | Comments (0) | TrackBack (0)
Sunday, April 1, 2007
Inquiry into Conflicts of Interest at NIH
Article in the Washington Post -- Conflict-of-Interest Inquiry May Be Reopening at NIH, by Rick Weiss. Here's an excerpt:
Federal investigators are reviewing the activities of 103 scientists who may have had improper links to pharmaceutical companies while they were employed at the National Institutes of Health, apparently resurrecting a conflict-of-interest inquiry that many in the agency thought was closed.
In a letter sent to several members of Congress on March 23 and made public yesterday, Daniel R. Levinson, inspector general for the Department of Health and Human Services, said his office is looking into the cases "to determine whether investigation is warranted."
Levinson also wrote that his office is reviewing whether NIH is adequately monitoring potential conflicts of interest among its thousands of grant recipients -- typically university researchers.
BGS
April 1, 2007 | Permalink | Comments (0) | TrackBack (0)
Alpo Dog Food Removed From Shelves To Avoid Pet Sickness
Article in the Washington Post -- Alpo Dog Food Removed From Store Shelves, by Jerry Markon. Here's an excerpt:
The recall of contaminated pet food expanded as stores removed from their shelves a limited number of cans of Alpo dog food, the latest high-profile brand to be caught up in the investigation of what has sickened or killed an unknown number of cats and dogs.
Nestle Purina PetCare Co., which manufactures the 71-year-old brand, announced Friday that it was voluntarily recalling all sizes and varieties of Alpo Prime Cuts in Gravy wet dog food that are marked with specific date codes. The company acted after learning that wheat gluten containing melamine -- a toxin suspected of causing the pet illnesses -- had contaminated cans at one of Purina's 17 pet-food manufacturing facilities.
BGS
April 1, 2007 | Permalink | Comments (0) | TrackBack (0)
Wyeth's Profit Likely Rising as Fen-Phen Payments Nearing End
Article in the Washington Post -- Wyeth shares could rise more than 20 pct: Barron's, from Reuters. Here's an excerpt: "The newspaper said Wyeth may also be near the end of incurring costs for its discontinued fen-phen diet drug, following a nationwide settlement and $21 billion of charges."
BGS
April 1, 2007 in Fen-Phen | Permalink | Comments (0) | TrackBack (0)
Saturday, March 31, 2007
Spotlight On: Professor Linda Mullenix
PhD 1977, Columbia University
JD 1980, Georgetown University
MPhil 1974, Columbia University
BA 1971, City College of New York
Linda S. Mullenix holds the Rita and Morris Atlas Chair in Advocacy at the University of Texas School of Law. She is the author of nine books including STATE CLASS ACTION PRACTICE AND PROCEDURE (CCH 2000), UNDERSTANDING FEDERAL COURTS (Matthew Bender 1998), MASS TORT LITIGATION (West Group 1996), FEDERAL COURTS IN THE TWENTY-FIRST CENTURY (Lexis-Matthew Bender 1996), and MOORE'S FEDERAL PRACTICE (2d and 3d eds.). She is a contributing editor and writer for Preview of Supreme Court Cases and a regular columnist on complex litigation for the National Law Journal. Professor Mullenix is a member of the American Law Institute, Associate Reporter for the Restatement of the Law Governing Lawyers, a consultative member of the Transnational Rules of Civil Procedure, and the Complex Litigation Project. She has written hundreds of articles published in Cornell Law Review, Georgetown University Law Journal, Harvard Law Review, Michigan Law Review, Minnesota Law Review, Stanford Law Review, University of Pennsylvania Law Review, Northwestern Law Review, Texas Law Review, and Vanderbilt Law Review.
Professor Mullenix teaches federal civil procedure, mass tort litigation, current issues in class action litigation, class action litigation in a global context, and state class action procedure. She has been a college and law professor since 1974, and has taught complex litigation, federal courts, conflicts, professional responsibility, and civil justice reform. She graduated Phi Beta Kappa from the City College of New York and holds masters and Ph.D. degrees from Columbia University. She received her law degree from Georgetown and practiced in Washington, D.C. During 1989-90 she was a Judicial Fellow at the Federal Judicial Center. Professor Mullenix has been a visiting professor at Harvard, Michigan, and Southern Methodist law schools, the Reuschlein Distinguished Visiting Chair at Villanova law school, and the Katherine Ryan Distinguished Professor at St. Mary's Institute on World Legal Problems in Innsbruck, Austria. In 2002 she was a scholar-in-residence at the Rockefeller Foundation Bellagio Study and Conference Center in Bellagio, Italy. She served as Reporter for an ABA Task Force on Class Actions (1995-97), Reporter for the Southern District of Texas, 1990 Civil Justice Reform Act, Reporter for the National Conference of Federal-State Judicial Relationships (1992), Advisor, Texas Class Action Rules Subcommittee (1998), and Advisor, National Center for State Courts, Study on Civil Discovery (1990-92). Professor Mullenix is an elected member of the International Association of Procedural Law.
Professor Mullenix has worked on numerous complex cases, including Cimino v. Raymark, Georgine v. Amchem, Ahearn v. Fibreboard, In the Matter of Rhone-Poulenc, Castano v. American Tobacco Co., Bolin v. Sears Roebuck, and Ford Motor Company v. Sheldon, Wagner & Brown v. Horwood, as well as breast implant, pacemaker lead, fen-phen, medical monitoring, employment discrimination, securities, insurance, oil and gas, and consumer class actions. She participated in the Symposium on Cutting Edge Issues in Class Action Litigation, The Legal Forum, University of Chicago (2002); Class Action Conference, Judicial Conference Committee on Rules of Practice and Procedure (2001); the Gulf States Class Action Symposium (2000), the University of Pennsylvania Symposium: Mass Torts (1999), the ABA Class Action Institute (1999, 2000), the Mass Tort Working Group, Judicial Conference Committee on Rules of Practice and Procedure (1999-98); the Special Study Conference on Federal Rules Governing Attorney Conduct, Judicial Conference Committee on Rules of Practice and Procedure (1996-2001); the Research Conference on Class Actions, Institute for Judicial Administration and N.Y.U. (1995); the Conference on Civil Procedure and the Future of the Federal Rules, Southwest Legal Foundation and S.M.U. University (1995); and the National Mass Tort Litigation Conference (1994).
BGS
March 31, 2007 in Mass Tort Scholarship | Permalink | Comments (0) | TrackBack (1)
Prof. Lester Brickman on Asbestosis Screenings
Professor Lester Brickman of Cardozo School of Law, Yeshiva University, has posted his article, Disparities Between Asbestosis and Silicosis Claims Generated by Litigation Screenings and Clinical Studies, on SSRN. Here's the abstract:
In 2005, U.S. District Court Judge Janis Jack, presiding over an MDL proceeding involving 10,000 claims of silicosis emanating from litigation screenings, issued a 264 page opinion rejecting the reliability of thousands of medical reports generated by those screenings. Before issuing her opinion, she ordered a Daubert hearing to assess the reliability of these medical reports which had been issued by a handful of doctors. In furtherance of this unprecedented use of a Daubert hearing in a mass tort proceeding, she compelled the production of a large volume of evidence, under threat of contempt, that the screening companies and doctors would not have otherwise produced. She went on to document in great detail the existence of a fraudulent scheme to create bogus medical evidence that lead her to conclude that it is apparent that truth and justice had very little to do with these diagnoses. . . . [Indeed] it is clear that lawyers, doctors and screening companies were all willing participants in a scheme to manufacture. . . [diagnoses] for money.
Judge Jack's findings largely corroborated my own conclusions with regard to the validity of X-rays readings and diagnoses of asbestosis which I had published a year earlier. In that article, I described how an illegitimate entrepreneurial model had been devised by lawyers, doctors and screening companies to screen hundreds of thousands of potential litigants for the sole purpose of generating claims of nonmalignant injury allegedly caused by asbestos exposure and manufacturing the requisite medical reports to sustain the claims.
Judge Jack's opinion has been widely covered in the news media and is still reverberating around the mass tort world. Much less heralded is the fact that Judge Jack ordered that the X-rays and medical records generated by the unprecedented discovery be placed in a repository where it could be accessed by parties. These records are now being systematically examined.
In this article, I present some of the findings of this ongoing examination as well as other data which has recently become available which addresses the issue of whether the hundreds of thousands of medical reports generated by asbestos litigation screenings have also been manufactured for money. In particular, I present data indicating that a comparative handful of doctors selected by plaintiffs' lawyers (litigation doctors) read 50%-90% of the X-rays sent to them by plaintiffs' attorneys as positive for pulmonary fibrosis and provide findings that these readings are consistent with asbestosis. In addition, I estimate that these same doctors, as well as a small number of others, diagnose at least 80% of those with positive X-ray reads as having asbestosis within a degree of medical certainty.
To properly understand the significance of this data and estimate, I present the results of a review of over 70 clinical studies of the prevalence of fibrosis among workers occupationally exposed to asbestos. Approximately 10% of the reviewed subjects' X-rays were found positive for fibrosis. The litigation doctors' 80 percent plus diagnosis rate of those found positive for fibrosis compares with a diagnosis rate of 15% to 23.2% in clinical studies. The much lower diagnosis rate of asbestosis in clinical studies is a function of the fact there are over 100 causes of pulmonary fibrosis in addition to asbestos exposure.
I also summarize the results of six clinical studies and equivalents in which X-rays generated by litigation screenings and read as positive for fibrosis were re-read by independent medical experts. This comparison indicates that the litigation doctors' error rates range from 62% to 97.5%.
Another facet of litigation screenings is the administration of pulmonary function tests to determine the degree of lung impairment and qualify the litigant for increased compensation. Here, too, I summarize the findings in medical literature and compare that to the outcomes of the pulmonary function tests administered in litigation screenings. Based upon the data presented, I conclude that the substantial majority of lung function tests performed by litigation screening companies are maladministered in order to generate false findings of lung impairment.
I also compare the pandemic of nonmalignant asbestos-related disease claims which were filed in the 1990-2004 period in the tort system and asbestos bankruptcy trusts with the number of hospitalizations primarily for asbestosis in that period. The data on hospitalizations is compelling. In the 15 year period, 1990-2004, during which about 475,000 new claimants each filed claims against 25-75 defendants and asbestos bankruptcy trusts alleging asbestosis or other nonmalignant condition caused by asbestos exposure, a study of approximately 4,500,000 randomly selected medical records of persons discharged from hospitals indicated that a total of 57 hospitalizations were primarily due to asbestosis.
Finally, I examine the possibility that the litigation doctors have predetermined signature percentages of positive X-ray readings and diagnoses. Bearing on this is the detailed evidence I present of the concerted refusal of the litigation doctors to provide records of all of their X-ray readings and diagnoses in response to subpoenas and court orders - records that would enable calculation of their percent positives that could be smoking gun evidence of fraud. This may account for the fact that four doctors and two screening company principals have invoked the Fifth Amendment and refused to testify about their diagnoses or produce their screening records.
The conclusion I draw from the data and evidence presented is that Judge Jack's findings with regard to the medical reports in the silica MDL applies with at least equal force to nonmalignant asbestos litigation: the medical reports are mostly manufactured for money.
BGS
March 31, 2007 in Mass Tort Scholarship | Permalink | Comments (0) | TrackBack (0)
Altria Makes Full $3.5 Billion Payment For Past AG Settlement
Article in the New York Times -- Philip Morris Parent Pays Full $3.5 Billion to States in ’98 Deal, by Bloomberg News. Here's an excerpt:
Altria Group Inc., parent of the world’s largest tobacco company, made its full payment of $3.5 billion to states under a 1998 health care settlement, a move that may bolster the prices of municipal bonds backed by the payments.
The payment includes $400 million that the Altria unit Philip Morris USA disputes it owes, the company said yesterday in a statement distributed by Business Wire.
“While it’s certainly positive news for the tobacco sector, I don’t believe it’s a surprise to most investors,” said Mike Pietronico, a portfolio manager in New York who oversees about $6.1 billion of municipal bonds for Evergreen Investments.
BGs
March 31, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
FDA Finds Pet Food Contained Chemical Found in Plastic
Article in the New York Times -- Pet Food Contained Chemical Found in Plastic, F.D.A. Says, by Brenda Goodman. Here's an excerpt:
The Food and Drug Administration said yesterday that it had not found rat poison in pet food that has been killing animals, but that it had found melamine, a chemical commonly used to make plastic cutlery that is also used in fertilizer.
Hours after the announcement, the nationwide pet food recall, which had involved only so-called wet foods — all manufactured by Menu Foods and sold under a variety of brand names — was expanded to include one brand of dry cat food, Prescription Diet m/d Feline, made by Hills Pet Nutrition.
The brand was found to have been made with a batch of wheat gluten shipped to the United States from China that the F.D.A. said was laced with melamine.
Here's a link to the article in the Washington Post.
BGS
March 31, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Friday, March 30, 2007
FDA Requests Novartis' IBS Drug Zelnorm Be Taken Off Market Because of Cardiovascular Risk
Article in the Wall Street Journal -- Novartis to Suspend U.S. Sales Of Zelnorm on FDA Request, by Anna Wilde Mathews and Jeanne Whalen. Here's an excerpt:
Novartis AG said it will suspend U.S. sales of Zelnorm, a drug for irritable-bowel syndrome, because of an apparent link to risks including angina, heart attacks and strokes.
Zelnorm is the second drug in as many days to come off the market for safety reasons at the request of the Food and Drug Administration, whose handling of drug risks is under close scrutiny from Congress. FDA officials said the timing was coincidental, and the agency's request for the Zelnorm sales halt was based on a finding that the evidence of danger outweighed the benefits. Zelnorm is prescribed for patients with severe constipation from the bowel syndrome or other causes.
"We believe that the risk versus benefit profile for Zelnorm was no longer favorable," said John Jenkins, the head of the agency's office of new drugs. The FDA will work with Novartis on a program that could lead to limited availability of the drug for people with no other treatment options, and might consider allowing it back on the market with restrictions, he said. When Lotronex, an earlier drug for a different type of irritable bowel syndrome, was pulled from the market, patients successfully lobbied for its return.
Here's a link to the article in the Washington Post.
BGS
March 30, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Thursday, March 29, 2007
State Civil Procedure Symposium at Western State
Western State University College of Law, in Fullerton, California, is hosting a Symposium on State Civil Procedure on Friday, April 20, 2007, and Saturday, April 21, 2007.
BGS
March 29, 2007 in Conferences | Permalink | Comments (0) | TrackBack (0)
FDA Asks that Parkinson's Drug Permax Be Withdrawn From Market
Article in the Wall Street Journal -- FDA Asks Makers to Withdraw Parkinson's Drug From Market, by Jennifer Corbett Dooren. Here's an excerpt:
The U.S. Food and Drug Administration said Thursday it asked manufacturers of Permax, a drug used to treat Parkinson's Disease, to withdraw it from the market because it's linked to heart-valve problems.
Eli Lilly & Co. sells brand-name Permax, and FDA said officials at least two other firms sell a generic version.
The drug has carried a "black box" warning about the heart-valve problems and use of the product has been steadily declining since then.
The agency said it decided to ask Permax makers to withdraw the drug because similar drugs used to treat Parkinson's do not carry the heart-valve risk. The agency estimates that fewer than 25,000 people use Permax or a generic version.
BGS
March 29, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Fed-Phen Trial Ordered Over Plaintiff Counsel Ethics Issues in Apportioning Settlement Money
Article in the Washington Post -- Trial Ordered on Fen-Phen Settlement, by Samuel Maull of the Associated Press. Here's an excerpt:
A law firm that negotiated a huge settlement with the makers of the diet drug fen-phen has been ordered to stand trial over whether it manipulated the deal in a way that increased the lawyers' share of the money.
State Supreme Court Justice Charles E. Ramos said Wednesday he was ordering a trial because of questions about whether the firm, Napoli Bern Ripka LLP, violated ethical rules in apportioning shares of the settlement money.
Napoli Bern sued drug maker American Home Products in 2001 on behalf of more than 5,000 of the 6 million former users of fen-phen, which the Food and Drug Administration had recalled after studies showed it might cause heart valve damage.
BGS
March 29, 2007 in Fen-Phen | Permalink | Comments (0) | TrackBack (0)
Wednesday, March 28, 2007
More Debate About Heart Stents
Article in the New York Times -- First, a New Artery Stent Study; Now, Questions About What It All Means, by Barnaby J. Feder. Here's an excerpt:
Is today the first in a new era for angioplasty and stenting, the artery-clearing technology that enchanted doctors while giving birth to a multibillion-dollar industry?
Many heart specialists at the annual scientific meeting here of the American College of Cardiology said it ought to be, based on a report Monday that found little additional value in giving stents to most heart patients as long as they received the right medicines.
“We were amazed at how well people did with medical therapy,” said Dr. William Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del., who is leading the analysis of the economic and quality of life data from the trial. The trial focused on patients with severe constrictions in their arteries that were causing angina chest pains or other symptoms but were not immediately life-threatening.
Device makers and some doctors, however, doubted that the trial would have broad impact. They noted several reasons to question the results, starting with the fact that only 3 percent of the stented patients in the trial received the latest drug-coated models. Those models were just reaching the market when enrollment in the study ended in 2004.
BGS
March 28, 2007 | Permalink | Comments (0) | TrackBack (0)
Tuesday, March 27, 2007
Continued Debate Over Heart Stent Use
Article in the Wall Street Journal -- Debate Widens Over Stent Use In Heart Cases, by Ron Winslow and Keith J. Winstein. Here's an excerpt:
Popular medical devices called stents proved no better than aggressive use of heart medicines in preventing heart attacks and death in a controversial study that is roiling the field of cardiology.
The findings add to a growing body of research suggesting that the tiny metal scaffolds -- which are implanted in about one million U.S. patients a year to prop open diseased coronary arteries -- are being used too often to treat disease that is stable or without symptoms. They are fueling a fierce debate between interventional cardiologists, who deploy the devices, and preventive cardiologists, who support the use of drugs and changes in health habits as front-line treatment.
At stake is how best to treat tens of thousands -- perhaps hundreds of thousands -- of patients with stable chest pain called angina who now undergo the risks and complications of having stents implanted but who might respond just as well or better by taking some pills.
Here's a link to the New York Times article -- In Trial, Drugs Equal Benefits of Artery Stents, by Barnaby J. Feder.
BGS
March 27, 2007 | Permalink | Comments (0) | TrackBack (0)
