Wednesday, November 22, 2006
Editorial in the Chicago Tribune -- A reversal on breast implants:
It took nearly 15 years, but last week, the Food and Drug Administration essentially admitted that it made a mistake when it outlawed silicone breast implants on grounds of safety, deciding to repeal the ban at last.
It's a good day for women who would like access to these devices for reconstructive or cosmetic purposes, and a good day for anyone who thinks individuals should be free to assess risks and make their own choices. But it comes a decade and a half too late for women who were deprived of a largely safe option because of fears that now turn out to be mostly groundless.
Back in the early 1990s, panic-mongers sounded alarms about all the horrors awaiting any woman getting silicone implants--cancer, connective tissue disorders, chronic fatigue and more. Even though more than a million women had them, and even though the great majority expressed satisfaction, the FDA under Commissioner David Kessler ordered them off the market. The only exception was for women getting them for reconstruction after cancer surgery, and then only in rigidly controlled, FDA-approved clinical trials. He acted against the unanimous recommendation of his agency's own expert panel.
Article in the Los Angeles Times -- Ford to pay $15 million in Explorer rollover death, by Bloomberg News "Ford Motor Co. must pay $15 million for the death of a teenager in a sport utility vehicle rollover accident, a Tulsa, Okla., a jury decided."
Article in the Los Angeles Times -- Breast implant makers, plastic surgeons expect boost from silicone, by Daniel Costello:
Plastic surgeons and the two dominant Southern California-based makers of silicone breast implants are gearing up for what they expect will be a boom in sales of the devices. The only question: How big of a windfall can they expect?
More than 290,000 women had breast augmentation surgery in the U.S. last year, most with the saltwater-filled versions that have been legal for years. With last week's Food and Drug Administration approval of silicone implants — generally considered to have a more natural look and feel — many in the industry believe a large percentage of women could quickly switch. In countries where both products are sold, silicone implants make up nearly 90% of the market.
Some doctors also predict that overall growth in breast augmentations could accelerate, as women waiting for approval of silicone implants visit their doctors and others with saline implants consider replacing them.
Article in the Wall Street Journal -- FDA Sets Deal With Drug Firms On TV-Ad Vetting, by Anna Wilde Mathews. One wonders about the possible preemption effects. Here's an excerpt:
The Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require companies, for the first time, to pay fees to the agency for vetting their television advertisements, in exchange for speedier reviews.
The fees from the proposed agreement would help pay for new staff to be hired by the FDA to review the industry's TV ads, people familiar with the deal said. Many drug makers are voluntarily submitting ads to be reviewed by the FDA.
The agreement would be proposed in tandem with a separate, five-year pact setting new user fees to be paid by drug makers to the FDA when the agency reviews their applications to market new medicines. That agreement is expected to require the industry to pay substantially more money to the FDA, with a large chunk going to fund drug-safety initiatives, said people familiar with the matter.
Article in the Wall Street Journal -- Marketing New Antismoking Pill Poses Challenges for Pfizer, by Scott Hensley:
For Pfizer Inc., the easiest part of marketing its new antismoking pill may have been winning Food and Drug Administration approval for the drug in May.
Chantix, the first medicine in a decade to help smokers quit, would seem a surefire blockbuster. Smoking remains the leading preventable cause of death in the U.S., and about 70% of the nation's 45 million smokers say they want to quit, according to government estimates. In addition, existing treatments work poorly, and Chantix got speedy FDA approval in large part because of its superior performance.
But in launching the drug, Pfizer has had to negotiate a marketing obstacle course that illustrates some of the challenges facing the industry, as well as the idiosyncrasies of the huge antismoking market. Aware of increased consumer cynicism and unfulfilled promises made for smoking treatments in the past, Pfizer has adopted a softer sell that it hopes will build Chantix steadily over time. Meanwhile, because insurers are slow to cover smoking treatments, it has priced Chantix so that consumers will be willing to pay for it themselves.
Here's a link to the New York Times article, Judge: No Class - Action Suit Over Vioxx, by the Associated Press, and the Washington Post article, Judge: No Federal Class in Vioxx Suits, by Janet McConnaughey of the Associated Press.
In the Vioxx MDL, the judge today rejected a class action for personal injury and wrongful death cases. Judge Eldon Fallon denied the Plaintiffs' Steering Committee's motion to certify a nationwide class. Here's a link to Judge Fallon's Nov. 22 order denying class certification.
This should come as little surprise, given the reluctance of courts to certify mass tort personal injury class actions in general, and the extent of individual issues in the Vioxx litigation in particular. The court's order cites similar rejections of class certification in other recent mass torts including Prempro, Baycol, Propulsid, Rezulin, tobacco, and Firestone tires.
Applying New Jersey choice of law rules (because the class representatives originally filed the action in New Jersey before it was transferred to E.D. La. as part of the multidistrict litigation), Judge Fallon determined that he would apply the substantive tort law of each plaintiff's home state. He emphasized that the application of multiple states' laws made class certification very difficult, citing the Fifth Circuit's opinion in Castano and the Seventh Circuit's opinion in Bridgestone/Firestone.
Beyond the choice of law problem, Judge Fallon emphasized the extent of individual issues in the Vioxx cases. He concluded that although the class met the Rule 23 requirements of numerosity and commonality, it failed on typicality, adequacy, predominance, and superiority. The court distinguished single-situs mass accidents, suggesting that class cert may be easier in such cases than in mass pharmaceutical products liability litigation. Judge Fallon made it clear that this decision applies only to the personal injury and wrongful death class action, not to class actions for purchase claims or medical monitoring.
Tuesday, November 21, 2006
Article in the Washington Post -- New Justices Take the Podium, Putting Personalities on Display, by Robert Barnes. The article notes that both Justices Roberts and Alito recently publicly emphasized the important role of elected officials rather than the courts deciding important questions, suggesting a modest approach to Supreme Court decisionmaking. It's perhaps too early to tell the extent to which these statements are indicative of judicial deference in their opinons. Here's an excerpt:
The two newest Supreme Court justices took off the robes and took to the stump last week, providing glimpses of the fresh personalities that will reshape a court that had remained constant for more than a decade.
The settings could not have been more different. Chief Justice John G. Roberts Jr. was interviewed before a crowd of 3,000 last Monday night at the University of Miami, and his telegenic message of moderation was then broadcast to the nation on ABC's "Nightline."
Justice Samuel A. Alito Jr. spoke to his fellow members of the Federalist Society, a coalition of conservative lawyers and legal scholars who have gone from rebel outsiders to Washington insiders -- the group drew 1,500 people to its annual banquet and warranted appearances by administration leaders from Vice President Cheney on down.
Roberts's turn on the stage was the most complete, and it showed that his sure-footed performance in his confirmation hearings, where he left even senators opposed to his conservative philosophy aglow, was no fluke.
Boston mass tort plaintiffs' lawyer Alex MacDonald has left Robinson & Cole to join Rothweiler Eisenberg. MacDonald's mass torts group at Robinson & Cole was a rare example of a significant mass tort plaintiffs' practice within a large corporate firm. (Robins Kaplan in Minnesota is the other prominent example.) Plaintiffs' practices in large defense-oriented firms have certain advantages -- resources, infrastructure, lawyers with varied experience -- but inevitably run into conflicts of interest and sometimes culture clashes as well. The question is whether the benefits outweigh the costs. Apparently, MacDonald found that the big-firm association no longer made sense for his practice.
Here's a clip from a Connecticut Law Tribune article -- High-End Plaintiffs Cases an Uneasy Fit at Defense Firms:
In the end, multimillion-dollar contingency fee recoveries couldn't keep Hartford, Conn.-based Robinson & Cole and the chairman and founder of its nationally prominent mass tort group together under the same roof.
Like for other high-end plaintiff practices operating within large defense-oriented law firms, client conflicts eventually convinced Alex H. MacDonald that greener pastures lay elsewhere, he said.
Recently, he took the reputation he gained from brokering a record-breaking fen-phen settlement and joined forces with two high-profile Philadelphia trial lawyers to form MacDonald Rothweiler Eisenberg.
The message to other defense firms: Dabbling in plaintiffs work can be lucrative, but the more lucrative it gets, the more inevitable an eventual breakup becomes.
According to the article, Robinson & Cole's longstanding representation of Pfizer had precluded MacDonald's group from taking on Rezulin cases (because Pfizer was on the verge of acquiring Warner-Lambert) or Vioxx cases (because Pfizer produced similar drugs Celebrex and Bextra).
MacDonald made his name in the fen-phen litigation, in which he represented Mary Linnen and a host of other PPH claimants, and became a central figure on the plaintiffs' side. He was profiled in Alicia Mundy's book, Dispensing with the Truth (St. Martin's Press 2001).
Monday, November 20, 2006
Today's NY Sun editorializes on the FDA's recent decision to permit cosmetic use of silicone gel breast implants. The editorial -- Now They Tell Us -- links breast implants to asbestos and Vioxx, suggesting that the entire mass tort litigation system is out of whack:
The Food and Drug Administration recently lifted its 14-year ban on the use of silicone breast implants for cosmetic purposes, saying that even though the devices are unlikely to last a lifetime — surgeons will need to warn patients of the likelihood of future surgeries — there is no scientific evidence that leaking silicone implants cause cancer or other serious illnesses. So where does Dow Corning go to get its $3.2 billion back?
That's the amount the erstwhile silicone implant manufacturer paid out from the jaws of bankruptcy court in 1998 to settle 170,000 lawsuits filed over its supposedly faulty implants. ...
Indeed, silicone implants join asbestos and Vioxx in the pantheon of products that have been the subject of some of the most irrational litigation in history. Women whose silicone implants had ruptured and leaked couldn't actually prove that their implants had caused the illnesses they were suffering. The majority of today's asbestos plaintiffs can't prove they're suffering any illness at all. And Vioxx's alleged victims can't point to any actual proof that the arthritis drug's cardiac risk is greater than that posed by over-the-counter painkillers. Yet overeager lawyers were happy to sue, and the courts have been only too happy to oblige. Trial lawyers are currently trying to eviscerate Merck, Vioxx's manufacturer.
Merck has elected to fight each Vioxx suit individually, and that strategy seems to be working, but it's hard to fault Dow Corning or asbestos manufacturers for settling the suits against them instead of taking them to trial. The FDA's latest announcement does, however, highlight the broader dangers of leaving the out-of-control liability system unreformed. With the benefit of hindsight it is even clearer than it was before that the only crime Dow Corning committed was selling what was then a perfectly legal product that turns out to be safe. For that transgression, the company was allowed to be eaten alive by the trial bar. Dow Corning managed to survive. Others haven't been so lucky. Congress needs to decide how many more companies will suffer Dow Corning's fate before lawmakers deliver much needed legal reforms.
It's hard to argue with the editorial's 20-20 hindsight on the breast implant litigation, but I question whether it's fair to throw asbestos and Vioxx into the same bucket. The wisdom of "much needed legal reforms" depends on what legal reforms you're talking about, which depends mightily on what problem you're trying to address.
The breast implant litigation is the most egregious example of liability in the face of strong scientific evidence casting doubt on general causation. The scientific community largely rejected the claim that silicone gel breast implants caused autoimmune disease or other systemic disorders. Bendectin and Agent Orange come to mind as other major mass torts where plaintiffs' general causation case was questionable, but neither of those reached the scale of the breast implant litigation. It's worth remembering that the settlement class action in the breast implants case came after Judge Sam Pointer, overseeing the MDL, appointed a National Science Panel to report on whether breast implants caused the alleged harms. Without the court-appointed scientific experts, the defendants' exposure surely would have been larger. Even so, there's power in the editorial's rhetorical question: "So where does Dow Corning go to get its $3.2 million back?" The problem of litigation outpacing science is a serious issue in mass torts. But the editorial gets sloppy, I think, in suggesting that the lessons of the breast implant litigation extend to mass torts generally, rather than to the particular problems of scientific evidence and general causation.
The editorial points out that much recent asbestos litigation involves uninjured plaintiffs (and could have added that the claims are against third-tier defendants rather than against the major producers of asbestos-containing products, all of whom were bankrupted by the litigation). But the problems of exposure-only plaintiffs, latent disease, and substitute defendants differ from the problems of scientific evidence and general causation. The legal reforms to address the former set of problems (e.g., pleural registries, tort law on exposure-only claims and medical monitoring, and reforms of joint-and-several liability) differ dramatically from reforms to address the latter (e.g., court-appointed experts, jury reforms, phased trials, and preemption defenses).
It's too early to judge the Vioxx litigation, but at this point it seems that the most difficult problems there involve individual causation rather than general causation. If that's correct, then again, there's a huge difference in how the legal system ought to respond. In the absence of general causation, a defendant should face zero liability. When there's proof of general causation and a basis for liability, but individual causation remains difficult to establish, then liability serves the policies of deterrence and disgorgement, and the real problems are allocation and the extent to which tort compensation must be individualized.
In other words, to criticize the breast implant litigation is easy. To lump it with asbestos and Vioxx, and to demand "much needed legal reforms" as if it were obvious what those reforms should be, is a lot harder.
Sunday, November 19, 2006
Article in the Chicago Tribune -- LUNG CANCER, To screen or not to screen: A case for early detection, by Hasham A. Hassaballa:
"Is there no way to screen for lung cancer like other cancers?"
That question ignites one of the most contentious debates in modern pulmonary medicine, and the results of a study published last month in the New England Journal of Medicine have only added to the controversy.
Researchers from more than 30 hospitals around the world, led by Weill Cornell Medical College, used CT scans to screen about 31,000 people who were at a high risk for lung cancer.
They found cancer in 484 of those participants, 412 of whom had Stage 1 disease, the earliest stage. Most had surgery, although some were treated with chemotherapy and radiation as an alternative to surgery. Eight patients received no treatment.
The researchers estimated that 88 percent of patients with Stage 1 lung cancer would survive 10 years. And if patients begin treatment within one month of their diagnosis, it is estimated that 92 percent of them would be alive 10 years later. The eight patients who received no treatment all died within five years.
Article in the Chicago Tribune -- Risky drug used on wounded troops, by the Associated Press: " A blood-coagulating drug designed to treat rare forms of hemophilia is being used on critically wounded U.S. troops in Iraq despite evidence it can cause clots that lead to strokes, heart attacks and death in other patients, The Baltimore Sun reported Sunday."
Article in the Washington Post -- Using Nicotine Patch Before Quit Date Ups Success, by Kathleen Doheny:
Giving nicotine patches a two-week "head start" more than doubles the chances they'll help smokers kick the habit, research finds.
A U.S. team found that by applying the patch 14 daysbeforethat last cigarette, users greatly boosted their long-term success rate.
The initial study was published earlier this year in the journalNicotine and Tobacco Research, and a second trial has now replicated those findings, according to Jed E. Rose, medical research professor and director of Duke University's Center for Nicotine Cessation Research. He led the original study and is co-inventor of the nicotine patch.
The Los Angeles Times today ran two opinion pieces regarding the attorney fee petition in the Swiss Bank Holocaust litigation of Professor Bert Neuborne of New York University School of Law. Here is an excerpt from Profiting from the Holocaust, by Menachem Z. Rosensaft, a lawyer in New York who is the founding chairman of the International Network of Children of Jewish Holocaust Survivors:
IF LAWYERS EVER WONDER, in a rare moment of introspection, why they are generally held in low esteem, they need look no further than the obscene fee application pending before a federal magistrate judge in Brooklyn, N.Y.
Burt Neuborne, the court-appointed lead settlement counsel in a class action brought on behalf of Holocaust survivors against Swiss banks, has turned himself into the poster boy for avaricious attorneys. He demands $4.75 million for his role in administering the $1.25-billion settlement and determining distribution of the money. . . .
Neuborne wants to be paid $700 an hour for the roughly 6,800 hours he claims to have spent on the Swiss banks case between Feb. 1, 1999, and Oct. 1, 2005. (Earlier this year, he agreed to remove 1,500 hours from his fee application after some of his billing practices were challenged.) That averages out to about 20 hours a week, for which he wants to be paid, again on average, $675,000 a year. This would be on top of $4.4 million he received in 2001 from another Holocaust-era settlement with German corporations that had exploited Jews and Roma/Sinti as slave laborers during World War II.
Responding to such criticism, Professor Neuborne wrote What profit? I gave up $10 million. Here's an excerpt:
ATTACKS ON ME for seeking a court-awarded fee for seven years of labor as the lead lawyer in the $1.25-billion Swiss banks Holocaust settlement give new meaning to the phrase "no good deed goes unpunished."
I began my work on behalf of Holocaust survivors in December 1996, when U.S. District Judge Edward R. Korman asked me to serve as counsel in the Swiss banks litigation. I redrafted the complaints, wrote the principal legal brief, argued the case and spearheaded the negotiations that succeeded on Aug. 12, 1998, in obtaining the historic settlement. I then told Korman that although I was entitled to as much as $10 million, I would not seek a fee for those services. At that point, no one expected me to do more work on the Swiss banks case. Instead, beginning in September 1998, I devoted myself to the German slave labor cases that led to the creation of the $5.2-billion German Holocaust Foundation.
In April 1999, Korman asked me to return to the Swiss banks case to carry out the complex settlement. Given the grueling, time-consuming nature of the work, he agreed that I would be entitled to reasonable hourly fees. Korman has publicly acknowledged that he "retained me" and that I am entitled to a fee. My detractors say Korman should have given formal notice that I was no longer working for free. But notice to a class of 1 million people would have cost a fortune (it cost $40 million to give notice of the terms of the settlement) while accomplishing nothing because the class was not entitled to insist that I return to work for them for free.
My work as lead settlement counsel over the last seven years has been massive and unrelenting, requiring me to spend, to date, more than 7,000 hours providing complex legal services to the settlement fund. I appeared in 30 contested legal proceedings, including multiple federal appeals, two Supreme Court proceedings and three trial-type hearings in the district courts.
Article in today's Los Angeles Times -- A peril that dwelt among the Navajos, by Judy Pasternak. The article is the first part of a multi-part series. Here's an excerpt:
Fifty years ago, cancer rates on the reservation were so low that a medical journal published an article titled "Cancer immunity in the Navajo."
Back then, the contamination of the tribal homeland was just beginning. Mining companies were digging into one of the world's richest uranium deposits, in a reservation spanning parts of Arizona, New Mexico and Utah.
From 1944 to 1986, 3.9 million tons of uranium ore were chiseled and blasted from the mountains and plains. The mines provided uranium for the Manhattan Project, the top-secret effort to develop an atomic bomb, and for the weapons stockpile built up during the arms race with the Soviet Union.
Private companies operated the mines, but the U.S. government was the sole customer. The boom lasted through the early '60s. As the Cold War threat gradually diminished over the next two decades, more than 1,000 mines and four processing mills on tribal land shut down.
The companies often left behind radioactive waste piles and open tunnels and pits. Few bothered to fence the properties or post warning signs. Federal inspectors seldom intervened.
Over the decades, Navajos inhaled radioactive dust from the waste piles, borne aloft by fierce desert winds.
They drank contaminated water from abandoned pit mines that filled with rain. They watered their herds there, then butchered the animals and ate the meat.
Their children dug caves in piles of mill tailings and played in the spent mines.
And like the Holidays, many lived in homes silently pulsing with radiation.
Today, there is no talk of cancer immunity in the Navajos.