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).
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.
March 31, 2007 in Asbestos, Ethics, Mass Tort Scholarship | Permalink | Comments (1) | 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.
March 31, 2007 in Settlement, 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.
March 31, 2007 in FDA, Food Poisoning | 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.
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.
March 29, 2007 in Conferences, Procedure | 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.
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.
March 29, 2007 in Ethics, Fen-Phen, Settlement | Permalink | Comments (1) | 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.
March 28, 2007 in Medical Devices - Misc. | 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.
March 27, 2007 in Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)
Merck Wins Illinois Vioxx Case
Article in the Wall Street Journal -- Merck Wins First Midwest Case Over Former Painkiller Vioxx, by Heather Won Tesoriero. According to the WSJ's updated trial scorecard, Merck has now won 10 trials and lost 5. Here's an excerpt:
A Madison County, Ill. jury cleared Merck & Co. of responsibility in the fatal heart attack of a woman who took its Vioxx painkiller.
Frank Schwaller, of Granite City, Ill. sued the drug maker over the death of his wife, Patricia. She had taken Vioxx for 20 months and died in 2003. Mrs. Schwaller had a number of cardiovascular risk factors, including morbid obesity, high cholesterol and high blood pressure. The jury deliberated for about six hours before returning the verdict in favor of the defense.
Merck withdrew Vioxx from the market in September 2004 following a study that linked the drug to an increased risk of heart attacks and strokes. The Whitehouse Station, N.J., drug maker now faces some 28,000 lawsuits.
March 27, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)
Monday, March 26, 2007
Closing Arguments in Madison County Vioxx Trial
The first Vioxx trial in Madison County, Illinois, is coming to a close. Newsday has the AP story on today's closing arguments:
Attorneys for a widower who claims the painkiller Vioxx contributed to his wife's 2003 death urged jurors on Monday to punish the maker of the once-blockbuster drug for allegedly failing to adequately warn consumers about potentially deadly side-effects. During closing arguments, Mikal Watts argued that Merck & Co. ignored or stifled credible warnings that Vioxx could cause cardiovascular problems, including warnings that came well before Patty Schwaller collapsed and died of a heart attack after taking Vioxx for about 20 months. ...
Schwaller -- who died suddenly Aug. 8, 2003 after returning home with groceries -- "shall not have died in vain," Watts told the Madison County jury in the Midwest's first trial involving Vioxx. Citing the company's own internal e-mails, Watts said Merck failed to adequately study Vioxx's possible side-effects on people at risk of heart disease and publicly downplayed worries by outside researchers that Vioxx could put users at greater risk of heart attacks or strokes. ...
Attorneys for Merck, based in Whitehouse Station, N.J., were expected to summarize their cases later Monday before jurors began deliberating.
March 26, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (1)
Sunday, March 25, 2007
Results of New Study on Heart Stents Expected This Week
Article in the New York Times -- Test Results Due Out Soon Are Crucial to Stents’ Future, by Barnaby J. Feder. Here's an excerpt:
Physicians and Wall Street analysts are eagerly awaiting news next week about heart stents that could have big implications for patients and stent makers alike.
At a national cardiology meeting on Tuesday, researchers plan to share the results of a major clinical trial investigating whether heart patients with chronic chest pains actually benefit from getting stents placed in their clogged coronary arteries. Financial analysts say any negative findings could hurt the two companies that dominate the $3.2 billion domestic stent business: Boston Scientific and Johnson & Johnson.
Many Wall Street analysts say they expect the trial to show that while stents improve blood flow by propping open the arteries, the devices do not perform any better than drugs in helping such patients live longer or avoid heart attacks. Some analysts predict that such findings would make cardiologists more cautious about recommending stenting to patients.
March 25, 2007 in Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)
Friday, March 23, 2007
NYT and WSJ Offer Dueling Portraits of Dickie Scruggs
Dickie Scruggs, a key architect of the past settlement between tobacco companies and the attorneys general, is the subject of dueling portraits in the New York Times, which offers a favorable sketch, and the Wall Street Journal, which doesn't. Both articles discuss Mr. Scruggs' recent work on behalf of plaintiffs against State Farm in connection with damage from Hurricane Katrina. (Thanks to Professor Richard Nagareda and law student Evan Anziska for mentioning the articles to me.)
March 23, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
Thursday, March 22, 2007
German Constitutional Court Upholds Contingency Fee Arrangement
As noted by Ted Frank at Point of Law, there's an interesting article on FindLaw -- How an Important German Constitutional Court Decision May Change the Nature of Law Practice in Germany, by Professor Anthony Sebok of Brooklyn Law School.
March 22, 2007 in Ethics, Procedure | Permalink | Comments (0) | TrackBack (0)
Weinstein on Ethics in Mass Torts
In connection with a seminar I'm teaching this week at Vanderbilt Law School on ethics in multiparty litigation, I recently reread Jack Weinstein's classic article, Ethical Dilemmas in Mass Tort Litigation, 88 Nw. U. L. Rev. 469 (1994). It's fascinating to look back at that paper in light of decisions Judge Weinstein has rendered in the years since, such as his tobacco class certifications in Schwab and Simon II, his rejection of a challenge to the Agent Orange settlement in Stephenson, and his settlement approval and fee reduction in Zyprexa.
In 1994, Weinstein already was writing about the "quasi-class action" idea he would revisit in Zyprexa: "It is my conclusion ... that mass consolidations are in effect quasi-class actions. Obligations to claimants, defendants, and the public remain much the same whether the cases are gathered together by bankruptcy proceedings, class actions, or national or local consolidations." (88 Nw. U. L. Rev. at 481) And: "In my view, consolidations should be treated for some purposes as class actions to assure judicial review of fees and settlements." (Id. at 528) He also wrote, naturally, about the need for flexibility when handling mass litigation and the importance of being realistic rather than blindly adherent to norms that were developed in a different framework.
It's impressive to see the extent to which Weinstein recognized in detail the ethical issues that continue to haunt mass tort practitioners. I've generally thought of Weinstein more as a proceduralist than an ethicist, but in this article, he was right on the money in recognizing the ways in which mass litigation alters the attorney-client relationship, and the implications of that shift for attorneys' duties of loyalty, competence, diligence, and communication.
On many of the details, I'm less flexible than Weinstein, less willing to depart from traditional norms of loyalty to client objectives, particularly in the non-class action context. But at a higher level of generality, I can't disagree with his basic point:
These monstrous mega-mass tort litigations can be tamed. They must be examined with a realistic eye, rather than romantic notions of how the law and lawyers once operated when a tort involved only a private matter of two parties, two lawyers, and a passive court. Ethical and legal norms out of touch with real life lead not to morality but to hypocrisy, abuse, and waste. (Id. at 568)
In creating the syllabus for the seminar, I chose to include Weinstein's article as the first reading. Not as a historical artifact, not as an example of how people thought about these problems pre-Amchem, pre-Castano, pre-fen-phen, pre-Vioxx, but rather as a solid, thought-provoking introduction to the ethical problems mass litigators face in 2007. I just hope someone can say something similar about any of my papers 13 years after they're published.
March 22, 2007 in Ethics, Mass Tort Scholarship | Permalink | Comments (0) | TrackBack (0)
Allegations of Political Interference with Government's Tobacco Case
Article in the Washington Post -- Prosecutor Says Bush Appointees Interfered With Tobacco Case, by Carol Leonnig. Here's an excerpt:
The leader of the Justice Department team that prosecuted a landmark lawsuit against tobacco companies said yesterday that Bush administration political appointees repeatedly ordered her to take steps that weakened the government's racketeering case.
Sharon Y. Eubanks said Bush loyalists in Attorney General Alberto R. Gonzales's office began micromanaging the team's strategy in the final weeks of the 2005 trial, to the detriment of the government's claim that the industry had conspired to lie to U.S. smokers.
She said a supervisor demanded that she and her trial team drop recommendations that tobacco executives be removed from their corporate positions as a possible penalty. He and two others instructed her to tell key witnesses to change their testimony. And they ordered Eubanks to read verbatim a closing argument they had rewritten for her, she said.
"The political people were pushing the buttons and ordering us to say what we said," Eubanks said. "And because of that, we failed to zealously represent the interests of the American public."
Eubanks, who served for 22 years as a lawyer at Justice, said three political appointees were responsible for the last-minute shifts in the government's tobacco case in June 2005: then-Associate Attorney General Robert D. McCallum, then-Assistant Attorney General Peter Keisler and Keisler's deputy at the time, Dan Meron.
News reports on the strategy changes at the time caused an uproar in Congress and sparked an inquiry by the Justice Department. Government witnesses said they had been asked to change testimony, and one expert withdrew from the case. Government lawyers also announced that they were scaling back a proposed penalty against the industry from $130 billion to $10 billion.
March 22, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
Wednesday, March 21, 2007
New FDA Advisory Board Rules on Financial Conflict of Interest
Article in the New York Times -- F.D.A. Rule Limits Role of Advisers Tied to Industry, by Gardiner Harris. Here's an excerpt:
Expert government advisers who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.
Indeed, such advisers who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall Lutter, although he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.
Here's a link to the Washington Post story.
March 21, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Essay in NYT on Prof. Allan Brandt's Cigarette Book
Interesting essay in the New York Times -- Tracing the Cigarette’s Path From Sexy to Deadly, by Howard Markel, M.D. The essay discusses Professor Allan Brandt's new book, The Cigarette Century: The Rise, Fall, and Deadly Persistance of the Product That Defined America. Interestingly, while Professor Brandt is touted in the essay as the government's "star expert witness," expert witnesses for the tobacco companies are referred to collectively as "tobacco companies -- and their expert surrogates" and the essay also refers to "skeptics of the dangers of cigarettes during the 1950s, many of whom had or would eventually have ties to the tobacco industry." So why is not Professor Brandt a "surrogate" for the government? Does Professor Brandt have "ties" to the plaintiffs' firms or the government through any expert witness fees? Why the seeming double-standard in the essay?
Our litigation system understands the risk of bias from fees or more abstract motives such as the desire for social change. Indeed, postmodern and deconstructionist thought challenges the notion of any completely objective observer. Professor Brandt himself is quoted in the article as saying, "If one of us occasionally crosses the boundary between analysis and advocacy, so be it. . . . The stakes are high, and there is much work to be done." An appreciation of Professor Brandt's contribution should also include assessment of any risks for bias in that work. Just as it should for any tobacco-defendant expert witness. Or for yours truly, who last represented a tobacco defendant six years ago.
Here's an excerpt from the essay in the New York Times:
For many Americans, the tobacco industry’s disingenuousness became a matter of public record during a Congressional hearing on April 14, 1994. There, under the withering glare of Representative Henry A. Waxman, Democrat of California, appeared the chief executives of the seven largest American tobacco companies.
Each executive raised his right hand and solemnly swore to tell the whole truth about his business. In sequential testimony, each one stated that he did not believe tobacco was a health risk and that his company had taken no steps to manipulate the levels of nicotine in its cigarettes
Thirty years after the famous surgeon general’s report declaring cigarette smoking a health hazard, the tobacco executives, it seemed, were among the few who believed otherwise.
But it was not always that way. Allan M. Brandt, a medical historian at Harvard, insists that recognizing the dangers of cigarettes resulted from an intellectual process that took the better part of the 20th century. He describes this fascinating story in his new book, “The Cigarette Century: The Rise, Fall and Deadly Persistence of the Product that Defined America” (Basic Books).
March 21, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
Doctors, Pharmaceutical Consulting, and Potential Bias
Article in the New York Times -- Doctors’ Ties to Drug Makers Are Put on Close View, by Gardiner Harris and Janet Roberts. Here's an excerpt:
Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said interactions between drug companies and doctors were beneficial. “In the end, patients are well-served when technically trained pharmaceutical research company representatives work with health care professionals to make sure medicines are used properly,” he said.
There is nothing illegal about doctors’ accepting money for marketing talks, and professional organizations have largely ignored the issue.
But research shows that doctors who have close relationships with drug makers tend to prescribe more, newer and pricier drugs — whether or not they are in the best interests of patients.
“When honest human beings have a vested stake in seeing the world in a particular way, they’re incapable of objectivity and independence,” said Max H. Bazerman, a professor at Harvard Business School. “A doctor who represents a pharmaceutical company will tend to see the data in a slightly more positive light and as a result will overprescribe that company’s drugs.”
March 21, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)