December 9, 2006
FDA Panel on Coated Stents
Article in the New York Times -- Panel Urges Caution on Coated Stents, by Barnaby J. Feder:
A panel of experts recommended Friday that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents in high-risk patients.
The panelists also recommended that the Food and Drug Administration warn doctors that if possible, such patients should remain on aspirin and Plavix, an anticlotting drug, for at least a year after a drug-coated stent implant.
The label on the Cypher stent, from Johnson & Johnson, approved for sale in the United States in 2003, calls for the anticlotting therapy for just three months. The label on the Taxus stent, from Boston Scientific, approved the next year, calls for six months on the drug.
At the end of the two-day hearing here, the panelists struggled to reach a consensus on most of the questions posed to it by the F.D.A. about whether it should restrict the use of the tiny devices, which are implanted to prop open heart arteries.
December 7, 2006
The End of the Wild West Era of Mass Torts?
Very interesting couple of articles in the American Lawyer -- It's Over: Tort reformers, business interests, and plaintiffs lawyers themselves have helped kill the mass torts bonanza, by Alison Frankel; and Mass Tort Roll Call. The former article provides an in-depth history of mass torts, tracing in particular the efforts of tort reformers to restrain plaintiff counsel's success in mass torts. The latter article provides a useful summary of major mass tort litigations.
I would agree with Ms. Frankel that the "Wild West" era of mass torts seems to be over, and that the litigations seem to be growing more predictable and orderly. Interestingly, Ms. Frankel largely neglects discussion of one of the most significant factors -- the decline of personal injury mass tort class actions. As I detail in my article, Resolving the Class Action Crisis: Mass Tort Litigation as Network, 2005 Utah L. Rev. 863, courts (especially federal courts) have largely converged in rejecting certification of such class actions, because of the many individualized issues accompanying such actions. In the 1990s, that judicial consensus had not yet emerged, and many courts, facing such issues for the first time, improvised in certifying mass tort class actions in which lurked many problems relating to substantive, procedural, and constitutional law.
As mass torts become more orderly, the real question becomes . . . what order will it be? Apart from outliers, such as the interesting and ongoing efforts by Judge Weinstein in the Eastern District of New York (see, e.g., the reversed Simon class action and the appeal-pending Schwab class action), the new order seems to involve pre-trial MDL management (in coordination with state judges), trying individual cases (perhaps to determine accurate claim values for settlement consideration), and then likely non-class settlement. Hence the title of Richard Nagareda's forthcoming book, Mass Torts in a World of Settlement. The new order also draws upon recent advances in information technology that enable enormous informal coordination via litigation networks of counsel, judges, and clients, all of which enhance the efficiency and effectiveness of representation.
Finally, the end of the Wild West phase of mass torts doesn't mean the end of mass torts. To the contrary, some trends suggest the greater expansion overall of mass tort litigation. Science finds new routes to factual causation. Our society increasingly uses pharmaceuticals and medical devices. As companies consolidate and grow larger, they increasingly market products nationally and internationally. Asbestos litigation continues to chug forward even as new mass torts such as Vioxx start up and threaten bankruptcy. On the march upward toward globally available superior products, devices, and medicines, the periodic missteps will continue to injure large groups of people, and mass tort litigation will surely follow.
E.Coli, Produce, and the FDA
Article in the New York Times -- Green Onions Identified as Source of E. Coli Cases, by Andrew Martin and Bruce Lambert. Given the E.coli infections earlier this year related to spinach, we might expect growing calls for reforming FDA oversight of produce. The New York Times article notes:
“I think we are really at a tipping point for consumer confidence with fresh fruits and vegetables,” said Caroline Smith DeWaal, the group’s director of food safety. She noted that the F.D.A.’s guidelines for safe farming practices were voluntary and that the number of inspectors had been pared by budget cuts.
The F.D.A. regulates the produce and seafood industries, while the Department of Agriculture oversees poultry and meat production.
“We are doing a number of things to address food-borne outbreaks and recognize that the system is not perfect,” said an F.D.A. spokeswoman, Julie Zawisza. “But fresh produce does carry risks, and we are committed to finding effective ways to prevent and reduce incidents and have made good progress using available resources in a more targeted and strategic way.”
For additional coverage, see the L.A. Times article, Outbreak triggers calls for tougher produce guidelines, by Jerry Hirsch and Ellen Barry.
Missouri Not Spending Any Tobacco AG Settlement Money On Prevention
Article in the New York Times -- Mo. Lags in Protecting Kids From Tobacco, by the Associated Press. The article notes that according to a report by public health organizations, "Missouri will collect nearly $246 million combined this year from the 1998 settlement with tobacco companies and tobacco taxes, but will spend none of it on prevention efforts."
December 6, 2006
Article in the New York Times -- 9/11 Cleanup to Resume, E.P.A. Says, by Anthony DePalma:
More than five years after contaminated dust from the World Trade Center seeped into apartments and offices throughout Lower Manhattan, the federal Environmental Protection Agency announced plansyesterday to start a final indoor cleanup program next month, despite widespread criticism that the program is seriously flawed.
Agency officials said residents and owners of commercial buildings below Canal Street would have 60 days to sign up for the voluntary program, which will test for asbestos, lead, vitreous fibers and harmful soot that may have come from the collapse of the trade center.
If any one of the contaminants is found, the space will be professionally cleaned at no cost to the resident or owner.
The new program is almost identical to one that was rejected in November 2005 as inadequate by the agency’s advisory panel of experts as well as by community groups, labor unions and the city’s Congressional delegation. The City Council passed a resolution condemning that program, calling it “technically and scientifically flawed.”
Taco Bell Green Onions & E. Coli
Article in the Wall Street Journal -- Taco Bell Removes Green Onions After They Are Tied to E. Coli, by the Associated Press:
Taco Bell ordered scallions removed from its 5,800 U.S. restaurants yesterday after tests suggested they may be responsible for the E. coli outbreak that has sickened at least three dozen people in three states.
The fast-food chain said preliminary testing by an independent lab found three samples of green onions appeared to have a dangerous strain of the bacteria.
"In an abundance of caution, we've decided to pull all green onions from our restaurants until we know conclusively whether they are the cause of the E. coli outbreak," said Greg Creed, president of Irvine, Calif.-based Taco Bell, a subsidiary of Yum Brands Inc.
The company wouldn't immediately identify the supplier of the scallions, so it was unclear whether contaminated green onions reached other restaurants or supermarkets.
For additional coverage, see the New York Times article -- Thousands of Taco Bells Discard Green Onions, by Andrew Martin and John Holusha.
New Jersey Lead Paint Case
Article by Kate Coscarelli in the Star-Ledger -- Lead-paint case reaches top court -- concerning last week's New Jersey Supreme Court argument in the lead paint litigation:
Yesterday, the Supreme Court of New Jersey heard arguments in a high-stakes case pitting a group of local government entities against the companies that made lead pigment and paint over who should pay to remove the stuff from homes and apartments and treat lead-poisoned residents.
In the case, which has attracted national attention, 22 New Jersey towns and four counties are trying to sue the manufacturers and distributors of lead paint. The issue is whether the towns and counties have "inherent police powers" -- in addition to the other powers the Legislature has granted to clean up lead paint -- to sue to stop a public nuisance, such as a health threat.
The towns and counties sued in 2001. A Middlesex County judge dismissed the suit before trial almost four years ago, saying local governments had overstepped their boundaries in suing manufacturers. Last year, a state appeals court revived the suit, ruling that Newark, the counties of Essex and Union, and the others have a right to go to court to recoup costs against not just individual owners but the larger companies, too.
The plaintiffs are the towns of Bayonne, Camden, Collingswood, East Orange, Gloucester City, Highland Park, Hillside, Irvington, Jersey City, Linden, Newark, North Plainfield, Orange, Passaic, Phillipsburg, Plainfield, Roselle, Roselle Park, Union City, Union Township, West New York and West Orange, and the counties of Cumberland, Essex, Gloucester and Union. The defendants are Atlantic Richfield, NL Industries, Millenium Inorganic Chemicals, Sherwin-Williams, American Cynamid, Cytec Industries, ConAgra and DuPont.
California Supreme Court Case on Tobacco Statute of Limitations
Michael Krauss writes today on Point of Law about a case in which the California Supreme Court is asked to decide whether, for purposes of the statute of limitations, a claim accrues when the smoker knows (or should know) that he is addicted, or when the smoker actually develops smoking-related illness.
December 5, 2006
Fen-Phen Lawsuits Claiming PPH
Article in Chicago Tribune -- Wyeth sued by former Fen-Phen users over lung disease, by Jef Feeley of Bloomberg News. The article discusses new claims brought by plaintiffs counsel Alex MacDonald and Kenneth Rothweiler that Fen-Phen caused primary pulmonary hypertension. Here's an excerpt:
Wyeth was sued by five women who claim the fen-phen diet combination caused them to develop an often-fatal lung disease at least eight years after they stopped taking the drugs.
Renee Tedesco of Paramus, New Jersey, says in one of the complaints filed today in state court in Philadelphia that she was diagnosed in April with primary pulmonary hypertension, 10 years after she began using fen-phen. Wyeth has set aside more than $21 billion to resolve litigation over the diet aids since pulling them off the market in 1997.
Wyeth officials engaged in a ``knowingly false campaign of misinformation and disinformation'' about whether the drugs Pondimin and Redux can cause the lung disease, known as PPH, years after a user stopped taking them, Tedesco's lawyers said in the complaint.
The lawsuits challenge Wyeth's assertion that health risks linked to fen-phen persist only a year after use ends. Wyeth, based in Madison, New Jersey, has said it resolved almost all of the 175,000 claims by former fen-phen users, most of them alleging the drugs caused heart problems, through a national settlement and deals with individuals.
The original $3.75 billion settlement program didn't cover PPH claims. The company last month told the U.S. Securities and Exchange Commission that it faced 95 PPH suits as of Oct. 15 and more might be filed.
WSJ on Double-Dipping in Asbestos Trusts
Interesting commentary in the Wall Street Journal detailing alleged fraudulent double-dipping in multiple absestos trusts -- Trusts Busted: The seamy underside of asbestos litigation, by Kimberly A. Strassel. Here's an excerpt:
Harry Kananian died in the year 2000 of mesothelioma--a cancer almost always caused by asbestos. But the legacy that may survive him is the role he is posthumously playing in exposing evidence of asbestos litigation fraud.
In early 2000, the Ohio resident met with the law firm of Early, Ludwick, Sweeney & Strauss to see about collecting compensation from special trusts set up by companies to deal with asbestos liabilities. So the law firm filed a claim to one trust, saying Kananian had worked in a World War II shipyard and was exposed to insulation containing asbestos. It also filed a claim to another trust saying he had been a shipyard welder. A third claim, to another trust, said he'd unloaded asbestos off ships in Japan. And a fourth claim said that he'd worked with "tools of asbestos" before the war. Meanwhile, a second law firm, Brayton Purcell, submitted two more claims to two further trusts, with still different stories. The two firms swept up as much as $700,000 for Kananian and his estate from trusts and settlements.
In the legal trade, this is known as "double dipping"--the process by which lawyers file claims at many different bankruptcy trusts on behalf of a single plaintiff. Each trust is told a different story about how the client got sick, and the plaintiff collects from all of them. Of course, the lawyers collect too. This practice may well have remained unexposed had not Brayton Purcell decided to cash in on Kananian one more time. It sued Lorillard Tobacco, this time claiming its client had become sick from smoking Kent cigarettes, whose filters contained asbestos for several years in the 1950s. That suit has now exploded on Brayton, exposing one of the asbestos bar's more lucrative cash cows.
In Cleveland, Judge Harry Hanna of the Cuyahoga County Court of Common Pleas has been asked to rule on a motion to disqualify Brayton from the suit and bar it from practicing in Ohio. The firm stands accused by Lorillard of lying to the court, defrauding asbestos trust funds and obstructing discovery. Those accusations come via a raft of internal emails and documents, most if which are referred to in the court record, that tell a story of two law firms using contradictory stories to rake in money from bankruptcy trusts, then potentially trying to cover it up. All parties are under a gag order from the judge. Last week, Brayton Purcell, amazingly, requested to withdraw itself from the case.
December 4, 2006
Chicago Tribune: Funding to Study Gulf War Syndrome
According to an article in the Chicago Tribune, Rejected theory still gets funds, Sen. Kay Bailey Hutchinson inserted an earmark in the 2007 federal budget for $15 million to University of Texas Southwestern Medical Center to study Gulf War Syndrome. Funding can be renewed up to four times, for a total of $75 million over five years.
The article also notes that "as recently as September a panel of the National Academy of Science's Institute of Medicine reached the same conclusion that half a dozen other expert groups had: Gulf war syndrome does not exist."
L.A. Times Pro-Defense Editorial
Interesting editorial in today's Los Angeles Times: The mock-amole defense. Combining this editorial with a prior L.A. Times editorial against punitive damages in the Williams tobacco case, one might tentatively conclude a pro-defense litigation position for the L.A. Times editorial board -- noteworthy for a major urban newpaper. Here's an excerpt from today's editorial:
WE NOW KNOW the precise day the United States lost its innocence. On Wednesday, Nov. 29, court papers revealed that Kraft Foods Inc. — the company that has brought us Cheez Whiz, Mallomars and Kool-Aid Mad ScienTwists — markets some foods that are not 100% natural.
In her lawsuit against the prepared-foods giant, Brenda Lifsey of Los Angeles argues that Kraft Dips Guacamole contains such ingredients as partially hydrogenated soybean and coconut oils, corn syrup, whey and food starch, along with yellow and blue food coloring. Only 2% of the product consists of avocado — generally considered the primary ingredient in the popular dip.
Lifsey could have found all that out by reading the label before purchasing the product, but she claims she was unaware of the dip's ingredients until she concluded it didn't taste "avocadoey" enough. That's a surprising oversight from a woman savvy enough to have participated in multiple class-action lawsuits against large retail businesses. An alert shopper would have had plenty of other warnings too — Ray E. Gallo, Lifsey's attorney, has been advertising since this summer for plaintiffs in a guacamole lawsuit, and the Center for Science in the Public Interest has been arguing for three years that guacamole-ish dips like Kraft's should be relabeled.
December 3, 2006
NYT: FDA Probe of Coated Heart Stents
Article in the New York Times -- FDA Probes Safety of Popular Heart Stent, by the Associated Press. An FDA panel is meeting on the issue next Thursday and Friday. Here's an excerpt:
Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.
These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.
Now their long-term safety is in question.
Doctors think these stents may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, an anti-clotting drug whose long-term safety in stent patients has not been established.
For additional coverage, see the Wall Street Journal article, FDA Panel to Review Risks of Drug-Coated Stents, by Anna Wilde Matthews; and the Chicago Tribune article, FDA panel to probe clotting, new stents, by Bruce Japsen.