Vioxx, Celebrex, Prozac: Bush Medical Malpractice Bill To Shield Pharma

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Tucked away "like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful", says New York Times columnist Bob Herbert in his latest editorial, A Gift for Drug Makers.

The provision is set to prohibit judges from awarding punitive damages if a drug has received approval from the Food and Drug Administration. Herbert states the obvious: "We know the F.D.A. has failed time and again to ensure that unsafe drugs are kept off the market. To provide blanket legal protection against punitive damages in such cases is both unwarranted and dangerous."

Jim VandeHei writing in the Washington Post, says it even more directly: "The medical malpractice bill backed by President Bush would prevent consumers from seeking punitive damages from the makers of Vioxx and Celebrex, two popular pain medications recently linked to increased risks of heart attacks and strokes, according to legal experts on both sides of the issue."

Are those dangerous drugs really so important that the manufacturers must be shielded from all responsibility? A recent article in Forbes Magazine titled Just Say No says that changes in diet and lifestyle might be every bit as effective as the costly and side-effect laden drugs:

"Millions of us are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise--harped on by physicians for decades--are more effective and a lot cheaper.

The results of pill dependence are insidious and devastating: billions of dollars in ever-higher drug costs; millions of people enduring sometimes highly toxic side effects; and close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the elderly, one major study estimates. And every few years comes the ultimate medical catastrophe: a miracle cure that turns out to be toxic."

Vera Hassner Sharav of the Alliance for Human Research Protection comments that justice would not be served by efforts to block citizens from seeking just compensation from corporate giants who deliberately conceal hazardous effects of drugs, vaccines or medical devices to boost sales. She asks: "Why should drug manufacturers who knew the drugs they sold and advertised as “safe,” to have lethal side effects, be shielded from responsibility?"

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness and Full Disclosure
www.ahrp.org

Knowledgable critics—among them practicing physicians, health care analysts, medical journal editors, journalists, and lay citizens--have reached the conclusion that America’s for-profit health care system—which eats up 16% of the budget--has failed to provide health care to all Americans, failed to improve health or longevity compared to other industrialized counties, and failed to contain costs. Americans pay more per capita for health care than any industrialized country in the world yet, rank 29th in life expectancy;  45 million Americans cannot afford costly insurance or needed treatments. Prescription drugs eat up healthcare budgets--$200 billion--without improving people’s health:

“Millions of us are popping prescription pills for innocuous ills, when simple lifestyle changes of diet and exercise--harped on by physicians for decades--are more effective and a lot cheaper.  The results of pill dependence are insidious and devastating: billions of dollars in ever-higher drug costs; millions of people enduring sometimes highly toxic side effects; and close to 2 million cases each year of drug complications that result in 180,000 deaths or life-threatening illnesses in the elderly, one major study estimates. And every few years comes the ultimate medical catastrophe: a miracle cure that turns out to be toxic.” [ Forbes]

Instead of addressing the real problem which Dr. Jerome Kassirer attributes to “an epidemic of greed,” the President is agressively promoting a bill to cap damages for harm caused by unsafe drugs. The legislation’s intent is not to shield consciencious doctors from frivolous lawsuits—it’s aim is to shield pharmaceutical industry giants and negligent providers who are responsible for those hundreds of thousands of preventable deaths each year.

As New York Times columnist, Bob Herbert, correctly observes, if the malpractice legislation became law, Pfizer, Merck and Eli Lilly would be immunized against even the possibility of punitive damages arising from any harm to patients that resulted from use of these drugs - as long as the companies followed F.D.A. rules. All three drugs—Vioxx, Celebrex, and Prozac-- were approved by the F.D.A.”

The legal system is the last line of defense for citizens who have been harmed and to serve as a deterrent for companies that consider marketing unsafe products. But if enacted the bill would strip citizens of their right to seek just compensation for harm from pharmaceutical companies that have reaped huge profits by knowingly marketing lethal drugs and withholding those risks from the public.

Former Congressman James Greenwood, who shamelessly negotiated a deal on the eve of a hearing he was to chair about industry’s deceptive marketing of SSRI antidepressants, now president of the Biotechnology Industry Organization, is lobbying for legislation that would not only limit punitive damages for corporate wrong doing—such as concealing lethal drug effects--but would also to limit damages for pain and suffering to $250,000.

The effort to block citizens from seeking just compensation from corporate giants who deliberately concealed hazardous effects of drugs / vaccines / medical devices—thereby endangering human lives to boost sales would result in a gross miscarriage of injustice.  Why should drug manufacturers who knew the drugs they sold and advertised as “safe,” to have lethal side effects, be shielded from responsibility?

1.      See: Just Say No by Robert Langreth, FORBES 11.29.04
or - alternative link on AHRP site
2.      Jerome Kassirer, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health, Oxford Press 2004.

Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

Bad Medicine
By David Morris
(Original on AlterNet)
January 10, 2005, Printed on January 14, 2005

"One of the major cost drivers in the delivery of health care are these junk and frivolous lawsuits," President Bush has told the American people, offering up his proposals to cap non-economic damages to patients injured by medical negligence. Here are seven facts that prove him wrong:

1. Insurance rates do not vary with the amount of claims paid out as much as with the amount of investment income that comes in.

"During the 1990s, insurers competed vigorously for medical malpractice business, and several factors, including high investment returns, permitted them to offer (artificially low) prices ... " according to the Government Accountability Office. When stock prices and bond interest rates fell, insurer income plummeted, prompting companies to increase rates to make up for the losses. Even the Congressional Budget Office has said that at least half of the rate increases from 2000 to
2002 were prompted by declining investment returns. The other half were a result of major companies, like the Saint Paul Company (now Saint Paul Travelers), withdrawing from the malpractice insurance business altogether because of the investment return declines. Thousands of physicians were forced to scramble for alternatives. Many charged exorbitant prices. The insurance crises in some states, like West Virginia, Nevada and Pennsylvania, may largely be attributed to Saint Paul Company's withdrawal.

2. Medical malpractice insurance accounts for less than 2 percent of overall health care spending. Even that percentage is falling because insurance rates have been rising at less than half the rate of increase in overall health costs.

3. Since 1996, the number of malpractice claims has been flat. The average payout has increased only slightly. According to the National Practitioners Data Bank (NPDB), a government service that tracks malpractice claims, verdicts and settlements, the median payout for medical malpractice claims rose from $100,000 in 1997 to $135,000 in 2001. The size of the award closely tracked the severity of the injury.

4. Only 1 of 8 patients who suffer injury due to medical negligence ever file a malpractice claim.

5. Caps on medical malpractice awards for pain and suffering have not resulted in decreased malpractice insurance rates. In the first 10 years after California imposed a $250,000 cap in 1975, state rate increases were the same as the national average. It was only after Proposition 103 passed in 1988 that insurance rates in California began to decline in comparison to those in other parts of the country. The reason? Proposition 103 instituted insurance reforms, not "tort reform." It disallowed unnecessary insurance costs like bloated executive salaries and excessive expenses and it required insurers to open their books to justify rate increases.

6. A tiny fraction of doctors account for the majority of
malpractice awards. From September 1990 to September 2002, only 5.1 percent of doctors paid two or more malpractice awards. But these doctors accounted for 54 percent of all payouts.

7. State medical boards are reluctant to discipline incompetent doctors. One study found that only 1 out of 6 doctors who had five or more malpractice payouts had been disciplined.

In 1986, the New York state legislature commissioned an interdisciplinary team of physicians, attorneys, economists, statisticians and social research experts to diagnose the problem of soaring liability insurance premiums. Their conclusion? "(F)inding fault with the tort system is easy; what is difficult is identifying an alternative that, on balance will do better."

The medical insurance system needs fixing. One remedy is to make insurance companies more accountable. Eight of the 10 states with the lowest medical malpractice insurance rates require an approval process before the companies can raise rates. Another remedy is to require insurance companies to broaden the risk pool by combining doctor specialties so that individual disciplines, like gynecology, where mistakes can be devastating, are not disproportionately burdened.

The medical system needs fixing too. A horrifying statistic in a March 2000 report by the prestigious Institute of Medicine testifies to the problem. Between 44,000 and 98,000 people die each year as a result of medical mistakes. One reason may be the astonishing number of hours – up to 120 hours a week – interns and residents work, including 36-hour shifts for several weeks at a time. Sleeplessness breeds mistakes. A bill introduced in Congress