Flu Plan Omits Compensation

President Bush’s $7.1-billion pandemic flu plan seeks broad limits on lawsuits against producers of vaccines and antiviral drugs but is silent on how those injured or killed by adverse reactions might be compensated.

The liability shield is contained in the Pandemic Flu Countermeasure Liability Protection Act of 2005, submitted by the Bush administration to the House of Representatives this week. It would protect producers and distributors of emergency vaccines from injury suits except in cases of “willful misconduct,” a term to be defined later by the attorney general and the secretary of Health and Human Services.

An existing federal tribunal, the National Vaccine Injury Compensation Program, already provides lawsuit protection for companies and compensation for the small minority of children and adults who suffer severe reactions to routine immunizations. However, the White House plan does not authorize the filing of claims in the program for injuries linked to pandemic flu vaccines.

In a letter to the White House early last month, House Minority Leader Nancy Pelosi (D-San Francisco) and 14 other House Democrats urged the president to include in a pandemic flu plan “appropriate liability protection” for vaccine makers, along with “a compensation program for those injured by taking the vaccine.”

Rep. Henry A. Waxman (D-Los Angeles), who was among the signers, said Thursday that he was “reluctant to agree to immunization of the manufacturers at all, but if there’s going to be something like that, there’s got to be some sort of compensation system.”

White House spokesman Trent Duffy said Thursday that the president’s proposal was not the last word on the subject. “We anticipate a healthy discussion with Capitol Hill ... on a compensation mechanism,” he said. He offered no specifics.

Critics already have called the plan one-sided. “It would not be fair if it was only a one-way street,” said Carl Tobias, a University of Richmond law professor and expert on tort reform. “Congress ought to make some compensation available so individual members of the public would not have to absorb the harm.”

A Senate bill that would create a biomedical research agency to thwart bioterror and pandemic disease attacks includes legal protections for vaccine makers similar to those in the White House plan. And the bill also provides no recourse for people seeking injury compensation. Although already approved by the Senate Health, Education, Labor and Pensions Committee, negotiations are continuing on including some means of compensation, say members of the committee staff.

The issue also has rekindled debate on whether liability concerns are responsible for the small number of U.S. vaccine producers.

In outlining his pandemic flu plan Tuesday, Bush called “the growing burden of litigation” one of the greatest obstacles to vaccine production.

“In the past three decades, the number of vaccine manufacturers in America has plummeted as the industry has been flooded with lawsuits,” he said.

But critics have called the statement misleading, saying lawsuits have become relatively rare and do not keep drug makers out of the vaccine business.

“He’s totally misinformed,” said Peter H. Meyers, a George Washington University law professor. He added that litigation against vaccine makers has been “drastically reduced” by the Vaccine Injury Compensation Program.

Others said the low profitability of vaccines and uncertain demand were the main reasons there were few companies in the market.

“The industry hates tort, and whenever they can take a whack at it, they will,” said Frank A. Sloan, a health economist at Duke University. But “the prices of vaccines are not sufficiently high, and vaccines are not profitable relative to other pharmaceuticals, and that is the problem.”

A study published last month in the Journal of the American Medical Assn. challenged claims by the Bush administration and others that liability fears were a contributing cause to last year’s flu vaccine shortage.

Until last year, when the flu vaccine was added to the vaccine compensation program, people with injury claims had to take them to court.

But the study’s authors, Michelle M. Mello and Troyen A. Brennan of the Harvard School of Public Health, said their search for all flu-vaccine-related lawsuits over the previous 20 years turned up just 10 cases.

“By all appearances, the situation is not one in which a rational observer would conclude that litigation is a substantial burden” on makers of flu vaccines, the study said.

Mello said she decided to investigate the matter after a presidential debate last fall when Bush used “almost identical language” to his remarks this week.

“We were just unable to find any evidence that would buttress this claim.”

*

Times staff writer Ricardo Alonso-Zaldivar contributed to this report.