News Articles and Editorials
Editorial: Plaintiff's Attorneys May Be The One Saving Grace For Those Wronged By Big BusinessWichita Fall(TX) Record News, 8/05/2002
"I can't believe I'm doing this, but it's time somebody came out in defense of.... the oft-disparaged and frequently misunderstood plaintiff's attorney. Note I said 'plaintiff's attorney,' not 'corporate attorney.' Those guys can rot in you- know-where. Why so harsh? Well, I'll put it this way. When the Ken Lays of the world realize that they are not completely dishonest enough - when their own capacity for evasiveness and chicanery just won't get the job done - would you want to be the one guy they think is morally bankrupt enough to get them off the hook?... There are no plaintiff's lawyers without plaintiffs....Yes, there are outrageous claims demanding outrageous sums of money. But there are laws and regulations in place that (should) punish lawyers and plaintiffs who bring bad faith claims.... As for sky-high damage judgments, they are handed down by juries and judges, not lawyers....So, if you're looking for someone to blame for the state of civil litigation, don't be so quick to single out the lawyers. Blaming the lawyer for the lawsuit is like blaming the gun for the bullet hole....there was a time when innocent victims had no access to the courtroom....Let's say you were the obvious victim of a corporation's negligence - the food server gave you a cup of bleach instead of Sprite - and you were severely injured. Assuming you would ultimately prevail, could you afford to hire an attorney, pay his retainer up front and continue to pay his hourly fees, expenses and court costs for however long it took to be compensated for your injury? Furthermore, if the restaurant's parent corporation knew you were financing your litigation, how inclined would they be to expedite your claim or your lawsuit? Now flip that around. If the corporation knew your lawyer was working for free unless and until his client prevailed - and prevail you would, with bleach burns on your esophagus as evidence - do you think they would they be a bit more motivated to do the right thing? I do. Plaintiff's lawyers give the common man access to the courthouse, access to justice. It's that simple. And corporations, like the politicians who are owned by them, have a single, overriding objective - to eliminate that access, to increase the distance between themselves and the public, to conduct their affairs free of scrutiny and liability. Make no mistake, the corporate greed and moral ambivalence that brought us sweat shops, unsafe products and institutional discrimination are still with us. Human nature has not changed. And the only thing that keeps some of these people in line is the very real threat to their bottom line. And if the courthouse doors close even a little bit, you're fooling yourself if you think you could never be left standing out on the lawn."
In Most Such Cases, the Verdicts are Either Later Rejected or the Amounts are Severely Lowered.By Myron Levin
Los Angeles Times Staff Writer
The Los Angeles Times
August 15, 2005top
When a jury sticks it to a huge corporation, it's always big news. A crushing verdict of $4.9 billion against General Motors Corp. in Los Angeles drew massive media coverage, as did a $5-billion award in the Exxon Valdez oil spill case and a $144.8-billion thrashing of the tobacco industry in a Florida class action.
Mega-verdicts such as these have helped fuel legislative campaigns to overhaul the legal system by limiting lawsuits and jury awards. Driving the crusade for what business groups call tort reform is the notion that frivolous suits and jackpot judgments are strangling the economy.
While acknowledging that excesses no doubt occur, many legal observers say there is no evidence that people are filing more lawsuits or that juries are getting more generous — indeed, there is some data to the contrary. And mammoth verdicts, in the rare cases in which they occur, almost always are tossed out or sharply reduced later.
Feeding the perception of a crisis in the legal system, they say, is the way the news media cover the courts.
After the big headlines, critics say, the media often drop the ball, losing interest in what happens later. Published studies of news content and a Times examination of major recent cases show that when the immense verdicts were overturned or dramatically reduced, the news frequently was banished to the inside pages or simply not reported.
Legal experts and media observers say such coverage gives a distorted picture of the civil justice system while lending credence to fears of irrational jury awards. News coverage has reinforced the message "that the system's out of control, and that juries are using the tort system to redistribute wealth in some unjust and unprincipled way," said Robert MacCoun, a professor of law and public policy at UC Berkeley.
The popular view that there are more lawsuits and bigger damage awards than ever before is not supported by available evidence.
A 35-state survey by the National Center for State Courts found that the number of tort filings declined 4% from 1993 through 2002 despite population growth. And in the nation's 75 largest counties, the median award to victorious plaintiffs was $37,000 in 2001 — much less than the inflation-adjusted median of $63,000 in 1992, according to the Bureau of Justice Statistics, a branch of the U.S. Department of Justice.
If such context is absent from news reports, it's not because of media bias but "the holler of the dollar," said William Haltom, a professor of politics and government at the University of Puget Sound and co-author of "Distorting the Law: Politics, Media and the Litigation Crisis."
News coverage is "in favor of the noteworthy and the attention-arresting," Haltom said. Journalists "are expected to produce something that someone is going to want to watch, listen to or read."
"From the media's perspective, extremes are news," New York University law professor Stephen Gillers said. The humdrum workings of the legal system, with its minor traffic cases and contract disputes, he said, is "completely distorted by the emphasis on what I would call the grotesque or extreme cases."
At the same time, no one would argue for covering fender-bender suits instead of big cases with broad implications. And plaintiff victories are legitimately more newsworthy because they change the status quo — moving money around and exposing dangerous products or financial wrongdoing.
But that can give a skewed impression of what typically happens in the courts, because research shows that news coverage shapes perceptions of the frequency of events.
For example, surveys show that people generally believe they face a greater risk of dying from widely publicized disasters such as fires and murders than from diseases like diabetes — when the opposite is true. Haltom said "it's reasonable to presume that people who read about all sorts of plaintiffs' victories get an inflated notion of how often plaintiffs win."
Certainly, plaintiffs prevail less often in the real world than they appear to in the news media. Consider:
A 1999 survey by Rand Corp.'s Institute for Civil Justice found auto liability cases were 12 times more likely to draw news coverage when plaintiffs won than when defendants did, a difference the study called "very stark." In its review of 351 trials conducted during the 1980s and '90s, the institute found that 38 of 92 plaintiff verdicts, or 41%, were featured in news reports, versus 9 of 259 verdicts for the defense — or about 3%.
A plaintiff win "is perceived to be more newsworthy than a headline that says 'jury rejects arguments that a product is unsafe,'" said Theodore Boutros Jr. of law firm Gibson, Dunn & Crutcher, who has represented Ford Motor Co., Wal-Mart Stores Inc. and various news organizations, including The Times.
Reflecting the pattern was news coverage of a June 2004 verdict in which a San Diego jury ordered Ford to pay $367 million to Benetta Buell-Wilson, who was paralyzed when her Explorer SUV rolled over and its roof collapsed. Ford previously had won a dozen similar Explorer cases but the media hardly batted an eye. Ford's victories received a smattering of coverage, mainly in business and legal publications, whereas the Buell-Wilson verdict was widely reported by the mainstream news media.
A 1995 article in the Hofstra Law Review showed that personal injury verdicts reported in the New York Times and Newsday were dramatically higher than typical awards in the New York courts. According to the survey, awards covered by the New York-based papers over a five-year period were 13 times and 9 times higher than average, respectively.
A 1996 survey of leading magazines such as Time, Newsweek and Fortune showed that plaintiff verdicts were "considerably overrepresented" in reports on civil litigation. The examination of 249 articles by Daniel S. Bailis and UC Berkeley's MacCoun found that plaintiffs were victorious in 85% of cases cited in the articles, compared with a real-world average of no more than 50%. Damage awards cited in the articles were also several times above the norm, leaving "little doubt that the selective reporting practices … provide a tremendously distorted picture of the jury award distribution," the study said.
A review of some recent high-profile cases by The Times showed newspapers that extensively covered huge damage verdicts seemed to lose interest when the awards were slashed or overturned. The review involved a computer database survey of articles about the cases and follow-up queries to newspaper librarians.
One such story was the $5-billion punitive damage award in the Exxon Valdez oil spill case. At the time of the verdict in September 1994, front-page reports appeared in such major dailies as The Times, New York Times, Chicago Tribune, Philadelphia Inquirer, San Francisco Chronicle, Houston Chronicle, Detroit Free Press, Dallas Morning News, Seattle Times and St. Petersburg Times.
When a federal appeals court overturned the award in November 2001, three of the 10 papers reported it on the front page.
When a Los Angeles jury in July 1999 ordered General Motors to pay a then-record $4.9 billion in compensatory and punitive damages to six people burned when the gas tank of their Chevrolet Malibu exploded after a rear-end collision, the story made the front page of leading U.S. papers — including the Washington Post, Chicago Tribune, Chicago Sun Times, Boston Globe, Philadelphia Inquirer, Detroit Free Press, San Francisco Chronicle, Ft. Worth Star Telegram, San Jose Mercury News and The Times.
Coverage was sparser a few weeks later when the trial judge trimmed the punitive damages to a still-huge $1.2 billion. Two of the 10 papers ran the story on the front page.
Then in July 2003, while the case was on appeal, it was settled for an undisclosed sum. Brief items appeared in four of the papers, while no mention could be found in the other six.
When a Florida jury socked top cigarette makers with a $144.8-billion punitive damage award, it was the lead story for many print and broadcast outlets. Front-page reports on the July 2000, verdict appeared in The Times, New York Times, Washington Post, Chicago Tribune, Boston Globe, Miami Herald, Dallas Morning News, San Francisco Chronicle, Houston Chronicle and Indianapolis Star, among others.
When a Florida appeals court overturned the award in May 2003, two of the 10 papers ran front-page reports.
Other cases reviewed by The Times showed a similar pattern.
By Rita Rubin, USA TODAY
top
As drugmakers scramble to grab Vioxx's multi-billion-dollar share of the arthritis and pain-relief market, patients might find themselves wondering whether the competing medications are much safer.
Dr. Eric Topol of the Cleveland Clinic is critical of how the FDA handled Merck and Vioxx.
By Tony Dejak, AP
The fact that no one can answer that question conclusively, and the fact that Vioxx remained on the market as long as it did, point to serious deficiencies in how the Food and Drug Administration regulates prescription drugs, critics say.
Merck yanked Vioxx on Sept. 30 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo. The move was a stunning denouement for a blockbuster drug that had been marketed in more than 80 countries with worldwide sales totaling $2.5 billion in 2003. Vioxx, hawked by the likes of Olympic gold medalists Dorothy Hamill and Bruce Jenner, had been sold in the USA for more than five years.
But the new Vioxx study was not the first to raise concerns about heart attack and stroke risk. "We have been concerned and aware of the potential for cardiovascular effects for the last few years," Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the day Merck announced the withdrawal. "This is not a total surprise."
In fact, in April 2000 the FDA required Merck to add labeling information about a possible link to such problems. Yet 2 million Americans were taking Vioxx when it was pulled.
Critics describe the rise and fall of Vioxx as a cautionary tale of masterful public relations, aggressive marketing and ineffective regulation. "The FDA didn't do anything," says Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic. "They were passive here."
Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive. Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France.Vioxx timeline
May 1999: FDA approves Vioxx.
March 2000: Merck reveals that a new study found Vioxx patients had double the rate of serious cardiovascular problems than those on naproxen, an older nonsteroidal anti-inflammatory drug, or NSAID.
November 2000: The New England Journal of Medicine publishes the study, called VIGOR.
February 2001: An advisory panel recommends the FDA require a label warning of the possible link to cardiovascular problems.
September 2001: The FDA warns Merck to stop misleading doctors about Vioxx's effect on the cardiovascular system.
April 2002: The FDA tells Merck to add information about cardiovascular risk to Vioxx's label.
Aug. 25, 2004: An FDA researcher presents results of a database analysis of 1.4 million patients; it concludes that Vioxx users are more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex or an older NSAID.
Sept. 23, 2004: Merck says it learned this day that patients taking Vioxx in a study were twice as likely to suffer a heart attack or stroke as those on placebo.
Sept. 30, 2004: Merck withdraws Vioxx from the U.S. and the more than 80 other countries in which it was marketed.
The study, an analysis of a database of 1.4 million Kaiser Permanente members, found that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, Vioxx's main rival. Based on their findings, Graham and his collaborators linked Vioxx to more than 27,000 heart attacks or sudden cardiac deaths nationwide from the time it came on the market in 1999 through 2003.
Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement. "Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions.
Rep. Tom Davis, R-Va., chair of the House Government Reform Committee, last week wrote acting FDA commissioner Lester Crawford to ask what the agency knew about Vioxx and when. Davis also asked whether the FDA plans to collect more data on related drugs.
"In light of Merck's withdrawal of Vioxx ... and other recent news stories examining FDA's review of the safety and efficacy of antidepressant drug use by children, I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety," Davis wrote.
Topol, in a column posted last week on The New England Journal of Medicine's Web site, called for a congressional review of the Vioxx "catastrophe." "The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
So far, Vioxx is the only drug in its class linked to a significant increase in heart attacks and strokes. But the European Agency for the Evaluation of Medicinal Products last week announced it will review all long-term cardiovascular safety data for Vioxx and the four other related drugs licensed in Europe.
"It is important to note that the results of clinical studies with one drug in a given class are not necessarily applicable to others in a class," Peter Kim, president of Merck Research Laboratories, was quick to say at a news conference announcing Vioxx's withdrawal.
Merck happens to have a Vioxx classmate called Arcoxia in the wings. It is sold in 47 countries but not yet in the USA. The company expects to hear about its application to the FDA by month's end, spokesman Christopher Loder says.
Digesting NSAIDs
Like ibuprofen and naproxen, Vioxx is a non-steroidal anti-inflammatory drug, or NSAID. But Vioxx belongs to a fairly new class of NSAIDs called COX-2 inhibitors. With Vioxx's demise, Pfizer's Celebrex and Bextra are the only COX-2 inhibitors sold in U.S. markets.
No one has ever said that COX-2 inhibitors are more effective than classic NSAIDs. Their selling point always has been that they're less likely to cause bleeding and other digestive tract complications
Although FDA approved the COX-2 inhibitors, it wasn't convinced they were safer. The drugs had to carry the same digestive warning as classic NSAIDs. So Merck and Pharmacia, which later merged with Pfizer, launched studies to prove their drugs shouldn't be lumped with other NSAIDs.
The Celebrex trial failed to convince the FDA that the drug was safer, but it didn't appear to be riskier, either. Merck's trial backfired. Though the study did demonstrate that Vioxx was safer on the digestive tract than naproxen, it also unexpectedly found that the COX-2 inhibitor doubled the risk of cardiovascular problems.In a written response to Topol's New England Journal of Medicine column, Merck said it "promptly disclosed these results to the FDA, the scientific community and the media beginning in March 2000."
But from the start, Merck put a positive spin on the data. A press release on March 27, 2000, led off with the finding that Vioxx caused fewer digestive tract problems than naproxen. It did go on to say that "significantly fewer thromboembolic events (in other words, heart attacks and strokes) were observed in patients taking naproxen."
However, it wasn't that Vioxx caused cardiovascular problems, but that naproxen protected against them, Merck argued for the next 4½ years. Yet, Merck acknowledged in the March 2000 press release, "this effect ... had not been observed previously in any clinical studies for naproxen."
Worrisome findings
In February 2001, Merck tried to convince an FDA advisory committee that Vioxx be allowed to drop the digestive tract warning. But the committee couldn't ignore the cardiovascular findings.
Still, Merck's marketing machine churned on. In September 2001, the FDA ordered the company to send doctors a letter "to correct false or misleading impressions and information" about Vioxx's effect on the cardiovascular system.
In April 2002, the FDA followed its advisory panel's recommendation and required that Merck note a possible link to heart attacks and strokes on Vioxx's label.
"Meanwhile," Topol writes in The New England Journal of Medicine, "Merck was spending more than $100 million a year in direct-to-consumer advertising — another activity regulated by the FDA and a critical mechanism in building the 'blockbuster' status of a drug."
Direct-to-consumer advertising was meant to heighten awareness of drugs, not to hype them, says pharmacologist Raymond Woosley, vice president for health sciences at the University of Arizona. "Do we need to be told how much greater one drug is than the other?" Woosley asks. "The public can't understand the subtle differences."
Merck continued to minimize unfavorable findings up to a month before withdrawing Vioxx. On Aug. 26, the company fired off a press release refuting Graham's study. "Merck stands behind the efficacy, overall safety and cardiovascular safety of Vioxx," it said.
Only randomized, controlled trials, in which patients are randomly assigned to treatment groups (the type of study that first raised heart concerns back in 2000) can provide unimpeachable data about a drug's safety and effectiveness, the release pointed out.
Finally, late last month, Merck confronted unfavorable findings that it could not explain away. Merck had sponsored a three-year, 2,600-patient randomized trial to see whether Vioxx, like Celebrex, could claim that it protects against the recurrence of colon polyps, which can become cancerous.
Again, the study backfired. After 18 months of treatment, researchers observed a higher heart attack and stroke risk in patients on Vioxx, Merck says. The drug was compared with a placebo and not another NSAID, so Merck could not divert blame away from Vioxx. Merck has not yet reported the study results, but the FDA says 3.5% of the subjects on Vioxx had suffered a heart attack or stroke, compared with 1.9% on placebo.
Monitoring the drugs
FDA spokeswoman Crystal Rice says the agency will continue to monitor drugs in the same class as Vioxx. Besides Merck's Arcoxia, the FDA is considering whether to approve Novartis' Prexige. Pfizer is expected to resubmit an application for parecoxib by year's end. The FDA turned down its original application in 2001 for lack of data.
Since becoming aware of the Vioxx study's finding, Rice says, the FDA is "much more sensitized to the possibility of seeing this adverse event" in related drugs.
Simply looking for heart attacks and strokes in individuals taking the drugs isn't enough, says Alastair Wood, chair of pharmacology at Vanderbilt University.
Sometimes, a drug triggers such an unusual problem that it's fairly easy to connect the dots, Wood says. "But there was no possibility that you could discern a heart attack due to Vioxx from a heart attack not due to Vioxx," he says.
Wood, Topol and others speculate that drugs in the same class as Vioxx may appear to be safe because the FDA has not yet asked for the randomized, controlled trials necessary for definitive answers.
"The spotlight is now on Pfizer and the FDA," says Garret FitzGerald, chair of pharmacology at the University of Pennsylvania. "The agency needs to scrutinize all ongoing trials in the light of these data and to decide swiftly" if all COX-2 inhibitors should carry a warning about heart attacks and strokes.
Topol says the drugs should be specifically tested in patients known to have cardiovascular disease, which is common in patients who need medication for osteoarthritis. So far, such patients have virtually been excluded from trials of the COX-2 inhibitors, Topol says.
In a yearlong study of more than 18,000 osteoarthritis patients published in August, Prexige did not increase heart attack or stroke risk when compared with ibuprofen or naproxen. However, Topol wrote in an accompanying editorial, fewer than 2% of study participants had had a heart attack or undergone bypass surgery or angioplasty before enrolling.
Back in 2000, when Merck first notified the FDA that Vioxx appeared to carry a higher risk of heart attacks and strokes than naproxen, the agency should have quickly ordered a trial comparing Vioxx with a placebo, Wood says. In the end, he notes, "a relatively small study was all that it took to show this problem."
Meanwhile, patients try not to worry.
Marjorie Chepp of Milwaukee had been taking Vioxx for nearly two years. Her doctor first prescribed it for a knee injury, but Chepp found that it also relieved her osteoarthritis and fibromyalgia. She asked to remain on it.
"For years I had refused to take meds other than over-the-counter because I was always afraid of the long-term effects," says Chepp, 47, an exercise instructor who had an ulcer at 16. "Of course, what happens with the first one I take? It gets recalled."© Copyright 2005 USA TODAY, a division of Gannett Co. Inc.
VIOXX CASE: A Failure to Protect the PublicTuesday, November 23, 2004
Page updated at 10:50 A.M.
Editorial: The Seattle TimesThe decision by Group Health Cooperative in Seattle not to give the drug Vioxx to its patients five years ago supports a whistleblower's assertion last week that federal regulators failed consumers.
Dr. David Graham, a Food and Drug Administration drug-safety official testifying at a Senate committee hearing, said the agency ignored evidence that patients who took the painkiller had a higher risk of heart attack. He suggested the FDA, which downplayed the results of a study he did, was too cozy with drug companies it is supposed to monitor. In scathing testimony, he warned more questionable drugs were likely on the market. In September, Merck withdrew Vioxx from the market five years after it was introduced and four years after the company acknowledges it was aware of a study that suggested it might pose a higher risk to patients. The company chose not to do a comprehensive study on the specific risk but rather monitor ongoing studies of Vioxx for other purposes. It was one of those studies that prompted Merck to pull the drug.
But when the drug was new, Group Health officials reviewed existing studies and concluded there was not enough evidence it was safe or effective. Vioxx is more expensive than some traditional painkillers but is less likely to cause ulcers.
Even though Vioxx was approved by the FDA, it was not an option for Group Health's half-million members — a decision that possibly spared some of its members heart attacks.
Graham has estimated that Vioxx use probably has caused 27,000 heart attacks but says the number may be as high as 139,000.
His assertions that the FDA is not scrutinizing new drugs as it should is especially disturbing. The agency has come under fire in recent months for not cracking down more on the use of some anti-depressants in adolescents after evidence suggests they cause some to become suicidal.
In the case of Vioxx, the FDA drug-approval process and subsequent monitoring clearly failed consumers.
But an even larger problem here might be the FDA and whether it is being vigilant enough — before and after drugs are approved — in protecting the public.Copyright © 2004 The Seattle Times Company