NYT Vaccine Liability Editorial and Editorial Reply by NAA
Posted Oct 01 2008 8:03pm
Op-Ed Contributor A Shot at Justice By DIRK OLIN Published: November 30, 2005
PRESIDENT Bush's recently proposed $7.1 billion plan for pandemic flu protection is admirably ambitious. It is also remarkably self-defeating in two vital areas: manufacturer liability and victim compensation.
Announcing his proposal at the National Institutes of Health on Nov. 1, the president invoked one of his favorite political demons: "In the past three decades," he said, "the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits." So the president's proposal contemplates a ban on lawsuits against vaccine makers, unless plaintiffs can prove willful misconduct. It also provides scant means of redress for the few patients who will inevitably be injured by adverse reactions. And it places legal oversight in the hands of two cabinet secretaries.
But lawsuits are not the reason so few vaccine makers are in business today. Moreover, the existing system for adjudicating vaccine claims is actually working pretty well.
To be sure, vaccine production has a checkered legal history. In 1955, one of the companies that made Jonas Salk's new polio vaccine failed to completely inactivate the embedded virus. A couple of hundred children were permanently paralyzed by inoculation side effects, and a handful died. A jury subsequently found the manufacturer not negligent, but financially liable, thereby casting a pall of uncertainty over vaccine production.
Congress made things worse during the swine flu scare in the mid-1970's. Responding to liability concerns among manufacturers, it declared that any suits would have to be brought against the federal government. When thousands of vaccine recipients suffered nerve and muscle damage, they were able to prevail against the government under a fairly simple liability standard. As a result, pharmaceutical companies feared future exposure to lawsuits under the lower threshold.
But Congress dissipated the legal fog in the 1980's after a wave of claims alleged injury from diphtheria-tetanus-pertussis vaccinations. The 1986 Vaccine Injury Compensation Act created a no-fault system that provides relatively generous payments to victims of specific inoculations recommended by the Centers for Disease Control and Prevention. Special masters at the Court of Federal Claims constitute a vaccine court. The system provides both relief for victims and greater certainty for pharmaceutical companies. (Although claimants are supposed to be able to opt out and bring a suit in state court, such cases face high hurdles - witness the lack of success to date by one group of plaintiffs who claim that inoculations have caused autism.)
Last year, Congress extended the compensation program to include flu shots. But even before that, influenza inoculations did not constitute a trial lawyer boondoggle. A study published in The Journal of the American Medical Association in October found a total of 10 reported cases of flu vaccine litigation during the past 20 years. One case resulted in a $1.9 million award for damages, while the rest were settled for much smaller amounts.
The president is correct that vaccine production in America is anemic. But the main cause is a low profit margin born of high fixed costs and an undependable market, not legal exposure.
In addition to misdiagnosing the problem, the president would misguidedly assign authority for liability determinations to the secretary of health and human services and the attorney general. Yes, the threat posed by a serious pandemic or bioterrorism requires that society recalibrate the balance between plaintiff rights and public safety. But having political appointees serve as arbiters will discourage some Americans from getting shots and thereby undermine the pursuit of universal inoculation.
Moreover, Republicans might ask themselves whether they'd want such determinations made by some future Democratic administration. Would they endorse, say, a Secretary Henry Waxman and an Attorney General Eliot Spitzer exercising similarly autocratic control over such findings?
If the court of claims can't handle the load, we should hire more experts and judges. That's the most sensible means of encouraging manufacturers to make the stuff and the public to take it. An effective pandemic policy must protect pharmaceutical companies from frivolous litigation, but it also must assure the public that the most vulnerable members of our society won't be treated like so many guinea pigs.
Dirk Olin is director of the Institute for Judicial Studies.
------------------------------------------------ re: A Shot at Justice By DIRK OLIN Published: November 30, 2005
"...the president invoked one of his favorite political demons: "In the past three decades," he said, "the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits." So the president's proposal contemplates a ban on lawsuits against vaccine makers, unless plaintiffs can prove willful misconduct. It also provides scant means of redress for the few patients who will inevitably be injured by adverse reactions. And it places legal oversight in the hands of two cabinet secretaries.
TO THE NEW YORK TIMES:
Dirk Olin's article on the moves to indemnify the vaccine makers because of a possible pandemic makes mention of lawsuits, but that is really not the issue. Mr. Olin is right that studies have shown that drug makers don't want to produce vaccines because the market is so unstable and they're not big profit makers.
In speaking of vaccine injury cases, Mr. Olin notes "...the lack of success to date by one group of plaintiffs who claim that inoculations have caused autism." This may be an aside in the article, but it is actually a very relevant issue in the move to protect the vaccine makers.
More and more parents, doctors, and scientists are claiming that the mercury-based preservative THIMEROSAL is responsible for an epidemic of neurological disorders among our children. Under the guise of guaranteeing vaccines to fight a possible pandemic, the Congress is frantically working to protect the pharmaceutical industry in the face of mounting evidence that the use of mercury in vaccines has caused an epidemic of neurological disorders.
Mr. Orlin's states that "that the most vulnerable members of our society won't be treated like so many guinea pigs."
Sadly, it's too late for that. During the past 20 years, the autism rate has gone from one in 10,000 to one in every 166 children today. Furthermore, one in every six schoolchildren now has a diagnosis of attention deficit or some other learning disability. This increase directly coincides with the increase in mercury-containing vaccines in the childhood schedule, The best our federal health agencies can tell us is that it's all due to "better diagnosing." This claim is disputed by more and more independent research that shows that thimerosal is responsible for a medical scandal that looms as a welfare disaster. With eighty per cent of autistic Americans under the age of 18, the dramatic impact of this crisis will be felt by taxpayers in the coming years when these autistic children become adults.
In his new book, Evidence of Harm, author David Kirby points out that "...many researchers had sent the company [Eli Lilly] documents dating back to the 1930's, each raising a red flag about thimerosal." (EOH 207-209). Mr. Kirby chronologically lists over 70 years of scientific research on the damaging and deadly effects of thimerosal that was willfully ignored by Eli Lilly and the CDC. http://www.evidenceofharm.com/
Seventy years after the mercury-based preservative thimerosal was invented and put into use, charges that it is responsible for the epidemic increase in autism caused the Centers for Disease Control to direct the Institute of Medicine to present a study in 2004 that showed no connection between mercury and the disorder. Using population studies with easily flawed and manipulated numbers and ignoring the toxicological studies that showed thimerosal is a deadly additive, they hoped to end the controversy. Despite this report, the number of opponents to the IOM Report clearing thimerosal continues to grow.
We are a society with a growing controversy. We need the press to focus on the generation of children with disorders directly associated with exposure to the second deadliest element on Earth.