Liability Shield For Vaccine Makers Clears Congress, Seen As Far-Reaching

LIABILITY SHIELD FOR VACCINE MAKERS CLEARS CONGRESS, SEEN AS FAR-REACHING

Protections against lawsuits for makers of flu vaccines remained in a massive House-Senate compromise bill (H.R. 2863) on defense spending, despite efforts by some Democrats to strip the measure out of the legislation.

The compromise bill cleared the House Dec. 22 and the Senate Dec. 21 with the liability protections intact. It now heads to the president's desk for his signature.

Under the provision, drug companies that make pandemic flu vaccine could not be sued by individuals who get sick from flu shots. But if a person could prove "willful misconduct," then the liability shield would not apply, according to a summary of the provision issued by Democrats.  A law firm involved in drafting the liability language confirmed many of the details of the provision. 

This provision also would apply to other medical products that protect against a epidemic, terrorist attack, or natural disaster, both the Democrats and the law firm said. Doctors and hospitals also may be covered by the liability shield, they said.

Kennedy, Obey Charge Secretive Deal
The Democrats, led by Sen. Edward M. Kennedy (D-Mass.), brought to light the bill's liability protections, which they said were slipped into the legislation at the last minute in a "back room deal" brokered by Senate Majority Leader Bill Frist (R-Tenn.) and House Majority Leader Dennis Hastert (R-Ill.). Frist's office has said that the senator has been "very open" about wanting to include the protections against lawsuits.

Rep. David Obey (D-Wis.) Dec. 22 also criticized the way the language found its way into the bill: "The Conference Committee ended its work with an understanding, both verbal and in writing that there would be no--I repeat no--legislative liability protection inserted into this bill." Obey went on to describe the process as "a blatantly abusive power play by two of the most powerful men in Congress." Moreover, he said, the insulation from product liability "applied not just to drugs developed to deal with the flu, but in fact applied to a far broader range of products."

The Center for Justice & Democracy issued a statement Dec. 22 lambasting the provision: "This legislation will remove all financial accountability for drug companies that produce dangerous vaccines that are rushed into production without normal testing, even if the companies' actions were reckless or grossly negligent."

The center, which advocates for trial by jury, charged that, "This proposal will leave innocent victims without any recourse or protection whatsoever, and could discourage people--including first responders--from taking a necessary vaccine."

Several U.S. drug makers left the flu vaccine business in the 1990s, in part, because of low profit margins and costly lawsuits from those sickened by flu shots. Now there are just two flu vaccine manufacturers supplying the U.S. market: Chiron Corp. and Sanofi-Aventis.

Immunity May Lure Companies
''Realizing that the pharmaceutical industry was never eager to do business with the federal government, the bill sends a strong message to the board rooms of pharmaceutical and biotech companies that they can be free to develop countermeasures to help a country in times of pandemic flu and bioterrorism and not be subject to frivolous lawsuits," said Frank Rapoport, an attorney with McKenna Long and Aldridge in Washington, D.C. ''All the drug companies that wouldn't jump into the fray will reconsider because they will be immune from tort liability." 

Congress created a vaccine injury compensation fund in 1986 as an alternative to taking vaccine injury claims to court. Kennedy and other Democrats had proposed a similar trust fund for manufacturers of pandemic flu vaccines, modeled after the Vaccine Injury Compensation Program for childhood vaccines.

Kennedy said a compensation fund is established in the measure if the health and human services secretary makes a declaration of lawsuit immunity. However, no money is appropriated in this bill for such a fund.

Kennedy suggested that chronic diseases could be characterized as epidemics and that drugs for obesity, diabetes, and arthritis also could be immune from lawsuits.

Willful Misconduct Standard Hard to Meet
Under the willful misconduct exception, the firm explained, a plaintiff would have to show that acts or omissions were done intentionally to achieve a wrongful purpose. Prior to any claim of willful misconduct, the Food and Drug Administration or the Justice Department would have to take specific enforcement action establishing the willful misconduct, according to McKenna Long.

The health and human services secretary and attorney general would have to issue a declaration to "immunize" a company from lawsuits, according to Kennedy and McKenna Long said.

A drug manufacturer could act with willful misconduct but could be immune from a lawsuit if the FDA initiates and wins an enforcement action, according to Kennedy's office. An administrator, such as a doctor, can act with willful misconduct and may still be immune if it reports the injury within seven days, the Kennedy summary said.

"Injured persons must meet extraordinary hurdles to bring a lawsuit, including bringing the suit in Washington, D.C., heightened pleading requirements, and very limited discovery," the Kennedy summary said.

Counsel that file frivolous or baseless lawsuits face mandatory penalties, the law firm said. Even if claims proceed, plaintiffs face other restrictions such as limits on damages and reductions in collateral benefits received by a plaintiff.