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.)

BGS

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.

BGS

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.

HME

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.

BGS

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.

BGS

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).

BGS

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.”

BGS

March 21, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 20, 2007

Risk of Blood Clots Leads to Continuing Drop in Use of Drug-Coated Stents

Article in the Wall Street Journal -- Market Share Slips for Drug-Coated Stents, by Keith J. Winstein.  Here's an excerpt:

The market share for drug-coated coronary stents slipped to 70.1% in February, marking the sixth straight month of decline, according to a survey by a market-research firm that surveys U.S. hospitals.

Doctors continued to pare back their usage in favor of plain, bare-metal stents over fears that the drug-coated variety can cause blood clots in some patients.

Last month, doctors in the U.S. used a drug-coated stent in only 72.5% of their procedures, according to Millennium Research Group, a Toronto research firm that surveys 140 U.S. catheterization labs where stenting procedures are typically performed. The share of stent procedures differs from the share of stents used because doctors often implant more than one stent at a time.

The share of procedures that use coated stents was the lowest since the stents were introduced in 2003 and 2004, and down from highs near 90% in early 2006.

BGS

March 20, 2007 in Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Monday, March 19, 2007

Merck Appeals Third-Party-Payor Class-Action Ruling

Article on cnn.com -- Merck appeals potentially costly NJ suit: Merck wants to strike down class-action lawsuit in New Jersey, vows to keep fighting cases individually, from Reuters.  Here's an excerpt:

Merck & Co. made its latest case Monday to decertify a class-action lawsuit involving pain drug Vioxx, which opposition attorneys said could cost the drugmaker up to $27 billion.

Attorneys made oral arguments before the New Jersey Supreme Court after Merck had earlier failed to persuade a lower appeals court that the suit should not be allowed to go forward as a class action on behalf of health insurers and others who paid for people to use Vioxx.

Merck (up $0.33 to $43.42, Charts) withdrew its once $2.5 billion-a-year drug from the market in September 2004 after a study found it doubled the risk of heart attack and stroke in long-term users. The company is facing more than 27,000 lawsuits from people who claim to have been harmed by the arthritis medicine.

Chris Seeger, an attorney for plaintiff the International Union of Operating Engineers Local 68 Welfare Fund, said insurers and other third parties paid between $8 billion and $9 billion to Vioxx users during the five years it was on the market.

Under New Jersey's Consumer Fraud Act, a court must award three times the amount spent on any product whose maker is found to have violated the law.

The plaintiffs in the class-action suit claim that Merck misrepresented Vioxx and concealed facts about its heart risks, which led the payers to reimburse users for the drug.

BGS

March 19, 2007 in Class Actions, Vioxx | Permalink | Comments (0) | TrackBack (0)

Study Finds Smoking Ages All Skin

Article on cnn.com -- Study: Smoking ages all skin, not just face, from Reuters.  Here's an excerpt:

Smoking not only can wrinkle the face and turn it yellow -- it can do the same to the whole body, researchers reported Monday.

The study, published in the Archives of Dermatology, shows that smoking affects the skin all over the body -- even skin protected from the sun.

"We examined non-facial skin that was protected from the sun, and found that the total number of packs of cigarettes smoked per day and the total years a person has smoked were linked with the amount of skin damage a person experienced," Dr. Yolanda Helfrich of the University of Michigan, who led the study, said in a statement.

"In participants older than 65 years, smokers had significantly more fine wrinkling than nonsmokers. Similar findings were seen in participants aged 45 to 65 years," Helfrich's team added in their report.

The researchers tested 82 people, smokers and nonsmokers, taking pictures of the inner right arms. They ranged in age from 22 to 91 and half were smokers

Independent judges decided how wrinkled each person's skin was.

BGS

March 19, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)

Sunday, March 18, 2007

FDA Voluntary Guidelines for Fresh Food

Article in the New York Times -- F.D.A. Offers Guidelines to Fresh-Food Industry, by Marian Burros.  Here's an excerpt:

The Food and Drug Administration yesterday offered new, nonbinding guidelines to food processors to try to reduce the risk of food poisoning in fresh-cut produce like bagged spinach leaves, sliced tomatoes and imported melons, but acknowledged that it could not say with certainty what caused the recent outbreaks connected to E. coli and salmonella, or how to stop them.

It has taken the F.D.A. seven years to issue advice to the produce industry on how to reduce the risk of food poisoning in fresh-cut produce. The industry can choose to follow it or not: compliance is voluntary. But the agency said this was the first time it had made food safety suggestions to the produce industry that were like the mandatory regulations the meat industry must follow.

The F.D.A. is suggesting that the fresh-cut produce industry constantly monitor and control vulnerable places in the production cycle where the bacteria are likely to form.

The guidelines also call for record keeping for recalls and covers personal health and hygiene of workers and sanitation operations.

According to the agency, the number of illnesses stemming from produce stayed flat from 1998 to 2004 but more have been coming from the fresh-cut category, the fastest-growing segment of the produce industry, which has had $12 billion in annual sales.

BGS

March 18, 2007 in E Coli, FDA, Food Poisoning | Permalink | Comments (0) | TrackBack (0)

New FDA Warnings on Sleeping Pills

Article in the New York Times -- F.D.A. Warns of Sleeping Pills’ Strange Effects, by Stephanie Saul.
Here's an excerpt:

The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, the Food and Drug Administration said yesterday, announcing that strong new warnings will be placed on the labels of 13 drugs.

The agency also ordered the makers of the well-known drugs Ambien and Lunesta and the producers of 11 other commonly used sleeping pills to create patient fliers explaining how to use them safely.

The fliers, which the agency says it requires when it sees a significant public health concern, will be handed out at pharmacies when consumers fill their prescriptions.

Although the agency says that problems with the drugs are rare, reports of the unusual side effects have grown as use of sleeping pills has increased.

Sales in the United States of Ambien and Lunesta alone last year exceeded $3 billion. Use of those medications and other similar drugs has soared by more than 60 percent since 2000, fueled by television, print and other advertising. Last year, makers of sleeping pills spent more than $600 million on advertising aimed at consumers.

The review was prompted, in part, by queries to the agency from The New York Times last year, after some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and — most troubling of all — driving while asleep.

BGS

March 18, 2007 in FDA, Pharmaceuticals - Misc. | Permalink | Comments (1) | TrackBack (0)

Questions Raised on Implant Recalls

Article in the New York Times -- History of Hernia Patch Raises Questions on Implant Recalls, by Barry Meier.  Here's an excerpt:

How do makers of implanted medical devices react when one of their products starts breaking?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.

And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

Bard officials, who declined to be interviewed, said in a statement that they have since addressed the agency’s concerns, and agency officials said they are monitoring the company’s progress.

Still, at a time when the use of implanted medical devices is growing sharply, the episode of the hernia patch is an example of what some experts say is a far wider problem: that some major manufacturers, while contending that they carefully monitor product safety, are not as rigorous as they should be.

BGS

March 18, 2007 in FDA, Medical Devices - Misc. | Permalink | Comments (0) | TrackBack (0)

Judge Kessler Rules Tobacco Companies May Not Market Cigarettes As "Low Tar" or "Light" Overseas

Article in the New York Times -- Judge Says Tobacco Companies Can’t Use ‘Light’ Label Overseas, by the Associated Press.  Much of the debate over "light" cigarettes centers on the notion that unlke the government-mandated testing machines, many smokers compensate for lower tar by covering filter holes with their lips or inhaling more deeply.  But this reasoning seems flawed -- for example, if many people eat more baked potato chips than fried potato chips, it doesn't mean a bag of baked potato chips is as bad as a bag of fried potato chips.  Shouldn't producers just provide the information about the product and let the user decide about how, and how much, to consume?

Here's an excerpt from the article:

A federal judge on Friday prohibited top tobacco companies from marketing cigarettes overseas as “low tar” and “light,” in a move applauded by antismoking activists.

But Judge Gladys Kessler of Federal District Court for the District of Columbia declined to apply internationally an earlier decision ordering companies to post signs in stores in the United States saying such cigarettes are dangerous and addictive and that tobacco companies have manipulated them to deliver nicotine to smokers.

In a landmark lawsuit brought by the government, Judge Kessler ruled on Aug. 17 that the nation’s top cigarette makers violated racketeering laws and deceived the public for years about the health hazards of smoking.

She ordered the companies to stop using terms like “light” on their products.

After the decision, the companies asked Judge Kessler to allow them to use the marketing overseas, a request she rejected on Friday.

BGS

March 18, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)