Flu Vaccine Preparedness Press Kit | Drug Safety News

Editorial Boards Nationwide Have Criticized Efforts to Give Broad Liability Protections to Vaccine Makers

San Jose Mercury News: “A sneaky handout to makers of vaccines”

“In the dead of the night Sunday, Sen. Bill Frist, R-Tenn., used his power as Senate majority leader to attach liability protections for pharmaceutical companies making flu vaccines to the Defense Appropriations Bill, which funds military operations in Iraq and Afghanistan… If you are struggling to see the connection between liability protections for vaccine makers and military funding, join the growing line.” [December 21, 2005]

The Washington Post: “A Bad Finish”

“As unattractive as the substantive choices lawmakers made were the procedures they resorted to. Drug companies were given special protection against lawsuits for flu vaccines—a provision put in the defense spending bill after members of the conference committee signed what was supposed to be the final agreement. Whether or not this provision is a good idea, it's not one that should be crammed into a take-it-or-leave-it, must-pass measure without a single member of Congress having a separate chance to consider its wisdom.” [December 21, 2005]

Houston Chronicle: “Wrong prescription: Vaccine bill would block media scrutiny and exempt drug companies from legal challenges.”

“With Congress rushing to adjourn for the holidays, Frist attached his bill to the defense spending authorization to prevent colleagues from voting against it. Manipulating such a controversial measure to avoid debate on its merits reinforces the appearance that this is a sweetheart deal for a powerful industry lobby at the expense of the American people.” [December 20, 2005]

Milwalkee Journal Sentinel: “Immunizing the drug-makers.”

“While it's reasonable to have some liability protections in place for drug companies against frivolous lawsuits, consumer advocates, including the Center for Justice and Democracy, argue convincingly that this legal shield, which would get triggeredby a declaration of emergency from the secretary of health and human services, amounts to blanket immunity. Injured parties would have to prove that the companies engaged in "willful" misconduct or neglect—an exceedingly difficult task.” [December 20, 2005]

The News & Observer (Raleigh, NC): “Wrong-way immunity”

“With the measure stalled in the Senate, the sponsors [of a bill originally introduced by Republican Sen. Richard Burr of North Carolina] appear intent on trying to pass it as a rider to the defense appropriations bill. This kind of end run around fuller consideration would be a mistake.The Senate especially needs a more complete exposition of the Burr bill's proposal that the Biomedical Advanced Research and Development Agency (BARDA) be exempt from the Freedom of Information Act.

Even more sweeping is a provision empowering the new agency to shield from any legal action those producing vaccines, drugs, medical equipment or other products turned out to combat pandemics or bioterrorism. Such a broad exemption from liability is hardly justified on the record. A study reported by the Journal of the American Medical Association found, for example, that there had been only 10 lawsuits in 20 years over flu vaccines. Drug companies don't get out of the vaccine business because of liability, the study's authors said, but because of low profit margins and unpredictable demand. These are two factors that clearly should be more fully dealt with in any legislation to spur the production of vaccines, for instance, for an avian-flu pandemic.” [December 16, 2005]

Detroit Free Press: “Vaccine Makers: Lawmakers serve people, not drug companies”

“As panicky as Americans may some day become about getting vaccinated against bird flu, that urgency does not translate into walling off vaccine makers from lawsuits or invoking secrecy around medical research. Attempts to add those measures to year-end bills piling up in Congress are subterfuges to dodge the full debate that would probably sink them. … Shielding drug companies completely could undermine confidence in the vaccines they do develop for an epidemic, which would heighten the risk if bird flu mutates into a form easily transmitted from human to human. … Congress needs to remember that its first responsibility is to the health of people in this country, not to the companies that get contracts to help protect it.” [December 15, 2005]

The New York Times: “The Stealth Liability Provision”

“Republicans are using the last days of this Congressional session to try to grant extraordinary liability protection to the drug companies that will make the vaccines and other medicines to combat a possible influenza pandemic. But they have been slow to mount a comparable effort to help the people who may be harmed by adverse side effects. …Republican leaders would allow suits only if there was willful misconduct. The companies could be reckless or grossly negligent and escape responsibility. As for victims' compensation, the Republicans have been vague and secretive, but claim that they will produce a fair and robust compensation system. Their provision is expected to be attached to a defense appropriations bill that is now before a conference committee and, once approved, cannot be amended on the floor. The conferees ought to shun that provision and leave the complexities to fuller discussion early next year.” [December 14, 2005]

The Orlando Sentinel: “Drug firms don't deserve virtually unlimited protection against vaccine lawsuits.”

“The leading proposal in Congress, from Senate Majority Leader Bill Frist, would bar lawsuits except where a manufacturer's willful misconduct caused injuries or deaths. That standard is much too permissive; it would even shield manufacturers in cases of gross negligence, such as failing to follow normal safety procedures. Yet Mr. Frist's proposal would not set up an alternative system to compensate victims of severe reactions, which are inevitable in any mass vaccination. Congress made the same mistake preparing for a swine flu pandemic in 1976. That program collapsed amid widespread fears about harm from the vaccine. The country was lucky the pandemic never materialized. Congress gave lawsuit protections to childhood-vaccine manufacturers in 1986, but wisely created a compensation system for severe reactions. Rep. Dave Weldon, a Palm Bay Republican and doctor, is rightly concerned that the lack of a system for a bird-flu vaccine could deter doctors and others on the front lines in a pandemic from getting vaccinated.” [December 13, 2005]

The Des Moines Register: “Drug makers don't need gift”

“President Bush and Congress are trying to give a Christmas present to one of their favorite industries -the drug makers. Senate legislation seeks to create a new government division within the Department of Health and Human Services with the power to shield drug companies from lawsuits. The legislation would allow drug makers to create a product with no threat of civil accountability - even if they're negligent. That's wrong on its face. But there's also no reason for doing it. The motivation appears to be based on an untruth repeated recently by President Bush. Last month, when he outlined a prevention plan for an avian-flu outbreak, he also called on Congress to ‘remove one of the greatest obstacles to domestic vaccine production: the growing burden of litigation.’ He said the industry had been ‘flooded’ with lawsuits. In an independent review of jury verdicts and judicial decisions for cases involving flu vaccine, two Harvard researchers found 10 suits in the past 20 years. Just 10. The industry doesn't need protection from litigation -or any more gifts from its friends in Washington.” [December 9, 2005]

The Las Vegas Sun: “Vaccines and accountability: Bush's proposal to shield avian-flu vaccine makers from liability invites health problems”

“He is asking Congress to absolve the manufacturers of vaccines from all legal liability, meaning they couldn't be sued if people who took the vaccines died or suffered physical harm. We believe this aspect of the plan needs a hard look by Congress. Is there really a good reason to remove accountability from manufacturers of drugs that are intended to safeguard the whole country, if not the whole world? We believe that a solid shield against legal action could lead to a lowering of safety standards by manufacturing executives, who will be under pressure to rush vaccines into production. If the manufacturers want protection from widespread bad outcomes, let them buy insurance.”[November 02, 2005]

Minneapolis Star Tribune: “Tort shield is wrong defense against flu”

“The premise behind the liability shield is familiar, even plausible: American drugmakers have been pulling out of the vaccine business for the last 20 years, and fear of lawsuits must be one reason. But that argument falls apart on close examination. A recent study in the Journal of the American Medical Association found only 10 lawsuits in the last 20 years over flu vaccines; the authors have concluded that drug companies withdrew from the vaccine business mainly because of low-profit margins and unpredictable demand. In fact, shielding drug manufacturers from lawsuits could actually reduce the number of Americans who get flu shots in an emergency. That's not the trial lawyers talking; it's the American Nurses Association, Consumers Union and the American Public Health Association, groups that oppose the liability shield. Why? Every vaccine, no matter how effective, will cause side effects or adverse reactions in a small number of patients. Public-health experts know this, and they say there must be some way to reassure or compensate those who might be injured. … Sen. Christopher Dodd, D-Conn., has been arguing for months that the VIC, or something like it, should be extended to any new federal pandemic vaccine campaign. Instead, a handful of senators are clinging to the broad liability shield and planning to attach it to a defense spending bill that Congress must pass this month. That would be a shameless favor to the drug industry and a dangerous sellout of public health.” [December 7, 2005]

The Times-Tribune (Scranton, PA): “Pandering pandemic”

“Fear of an avian flue pandemic has driven the government to find ways to increase the production of vaccines while improving monitoring and detection technology. Unfortunately, the prospect of a pandemic also is being used in Congress to pander to the pharmaceutical industry. The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 would create a new federal agency that would be exempt from public disclosure laws, while superseding many of the functions now handled by public agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. It would have the power to designate certain drugs as exempt from civil liability litigation. …Congress should not use legitimate concerns about a flu pandemic as a wedge to protect all drug manufacturers from liability. Members should get a copy of the most recent issue of the New England Journal of Medicine, which accuses Merck of misrepresenting the results of clinical trials of Vioxx, the anti-inflammatory medicine that was pulled from the market this year.” [December 12, 2005]

The Vindicator (Youngstown, OH): “Trading on fear to pass vaccine legislation is wrong.”

“When legislators start playing on the worst fears of people, the people should be worried. And when legislators begin attaching complex legislation with far-reaching effects to must-pass bills — a tactic designed to grease the way for passage with virtually no debate — people should be alarmed. The American people should be both worried and alarmed by the efforts of Senate Majority Leader Bill Frist to ram through legislation in the name of protecting the nation from a bird flu epidemic. The bill would not only indemnify the pharmaceutical industry from suits involving death, disability or sickness resulting from the use of pandemic flu vaccines, but would create a new secret bureaucracy to shield the government’s health decisions from public scrutiny.” [December 13, 2005]