April 13, 2007
Merck Expected to Win Vioxx Preemption Ruling from Texas Judge
Article in the Wall Street Journal -- Merck's Vioxx Troubles May Ebb With Ruling Poised to Aid Defense, by Heather Won Tesoriero. Here's an excerpt:
A ruling from a Texas judge coming as soon as Monday is expected to undercut the legal foundation for all 1,000 Vioxx cases brought against Merck & Co. by Texas plaintiffs, providing a potentially significant boon to Merck's defense efforts.
The judge has informed both sides in a state-court Vioxx case that he will dismiss it based on a recently finalized Food and Drug Administration rule, according to a person familiar with the matter. He then told attorneys involved in some of the other 1,000 Vioxx cases in Texas state courts that his ruling could affect the whole group.
Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks. It hasn't been clear how or if the rule would apply to Vioxx, which was approved long before 2006, and this case could prove to be an important test.
The vast majority of pharmaceutical product-liability cases hinge on whether or not a drug maker adequately warned of a drug's risks -- as have most of the Vioxx trials to date, of which Merck has won 10 and lost five.
Merck Shares Rise on Vioxx Legal Wins
Article in the Wall Street Journal -- Merck Shares Jump as Outlook, Tossed Case Trump Arcoxia News, by Peter Loftus. Here's an excerpt:
Merck & Co. shares jumped nearly 9%, hitting a 52-week high Friday, after the company raised its earnings outlook and said a federal judge had dismissed a class-action suit over disclosures related to its pain reliever Vioxx.
This came a day after a Food and Drug Administration panel recommended against approval of Merck's Arcoxia arthritis drug. Normally, such news might have hurt Merck shares, because the company had assumed a 2007 Arcoxia launch in its previous full-year sales forecast.
But the setback was soon overshadowed by the double whammy of good news for Merck.
A little more than two hours after Arcoxia was shot down by the FDA panel, Merck announced its first-quarter and 2007 earnings would come in higher than expected. Merck cited "strong revenue performance across the company's range of products." It's scheduled to report full results Thursday.
Also, Merck scored a couple of victories on its Vioxx litigation front. On Friday morning, Merck said a federal judge in New Jersey had dismissed a securities class-action lawsuit against the company in connection with its disclosures regarding Vioxx. A Texas judge might issue a ruling soon that could undercut the legal foundation for all 1,000 Vioxx product-liability lawsuits brought in the state against Merck, The Wall Street Journal reported Friday. Merck withdrew its Vioxx painkiller from the market in 2004 after a study linked it to higher risk for heart attack and stroke.
April 11, 2007
Point of Law's Walter Olson has a post criticizing the upcoming Roger Williams conference on Genuine Tort Reform as only representing pro-plaintiff perspectives.
Point of Law's Ted Frank has a post on Vioxx class actions.
Civil Procedure Prof's Jeremy Counseller has a post with more links on E-Discovery.
Products Liability Prof's Michael Steenson has a post on assessing damages on pet deaths from recent pet-food poisonings.
As noted by Torts Prof Blog's William Childs, Anthony Sebok has posted on Findlaw the second part of his article examining the expansion of the 9/11 fund.
FDA Position Makes More Difficult Approval of Merck's Arcoxia
Article in the Wall Street Journal -- FDA's Position on New Drugs May Hurt Merck's Arcoxia Bid, by Jennifer Corbett Dooren. Here's an excerpt:
The Food and Drug Administration said proposed prescription painkillers should fill an unmet medical need for patients who have no other "relatively safer" alternatives, suggesting Merck & Co.'s bid to have a Vioxx-like successor drug approved in the U.S. faces a tough road.
The FDA's view was outlined in a March 21 memo posted on the agency's Web site ahead of a meeting tomorrow of outside medical experts who are being asked to weigh in on whether the agency should approve Arcoxia. The Merck drug falls into the same class as Vioxx, which was widely used to treat arthritis and other painful conditions.
Vioxx was pulled off the market in September 2004 after it was linked to an increased risk of heart attacks and strokes, and in 2005, the FDA asked Pfizer Inc. to pull Bextra off the market. Pfizer was allowed to keep its other so-called Cox-2 painkiller, Celebrex, on the market with warnings.
Questionable Emails from State Farm to Engineers Assessing Katrina Damage
Article in the Wall Street Journal -- Emails May Help Homeowners In Fight Against State Farm, by the Associated Press. Here's an excerpt:
Emails sent by officials of an engineering firm that assessed Hurricane Katrina claims suggest that State Farm Insurance Co. wanted engineers to blame damage on flooding so that it could make minimum settlements with policyholders.
The emails, obtained by the Associated Press, indicate that State Farm was threatening to dismiss Raleigh, N.C.-based Forensic Analysis & Engineering Corp. less than two months after Katrina hit on Aug. 29, 2005.
Attorneys for homeowners suing State Farm claim the emails support their argument that the insurer pressured its engineers to alter their reports on storm-damaged homes so that policyholders' claims could be denied.
April 10, 2007
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.
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.
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.
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.
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.
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.
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?
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.
April 8, 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.
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.
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.
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)
* Mass Torts in a World of Settlement, University of Chicago Press (forthcoming 2007)
* "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)
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.