Trial Attorneys, Democrats Criticize Proposed Liability Protections for Vaccine Manufacturers
A provision passed by the House that would restrict lawsuits against vaccine manufacturers could allow the companies to avoid liability in cases in which patients are injured because of negligence, according to the Association of Trial Lawyers of America and some congressional Democrats, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 12/20). The House on Monday approved the provision as an attachment to the fiscal year 2006 Department of Defense appropriations bill, which includes $3.8 billion for avian flu prevention.
The provision, supported by Senate Majority Leader Bill Frist (R-Tenn.), would allow lawsuits against flu vaccine manufacturers only in cases in which the companies engaged in "willful misconduct" (California Healthline, 12/19). According to the AP/Philadelphia Inquirer, willful misconduct is "a higher standard than negligence, used in many product liability cases" (Freking, AP/Philadelphia Inquirer, 12/20).
In addition, the provision would establish a federal compensation fund for patients injured by vaccines but, according to opponents, would not finance the fund (Los Angeles Times, 12/20).
The provision also would provide the HHS secretary with authority to designate a health threat as a pandemic or epidemic. According to opponents, the HHS secretary could use the authority to declare chronic conditions such as heart disease or diabetes epidemics, which could provide pharmaceutical companies with liability protections for medications used to treat those diseases (Stolberg, New York Times, 12/20).
The Senate will address the defense appropriations bill on Wednesday or Thursday (AP/Philadelphia Inquirer, 12/20).
Frist said, "To establish a viable, dynamic manufacturing base, it is absolutely critical that we give very targeted liability protection, coupled with a fair compensation package" (New York Times, 12/20).
Frist spokesperson Amy Call said that the provision would provide vaccine manufacturers with "very targeted" liability protections, adding, "The trial lawyers apparently would prefer to keep filing frivolous lawsuits and collecting excessive attorney fees rather than making sure public health is protected."
However, Rep. Henry Waxman (D-Calif.) called the provision "a huge Christmas present for the drug companies" (Los Angeles Times, 12/20). Waxman said, "This liability shield can be granted to any product used to prevent or treat an epidemic or a pandemic, and the secretary gets to decide what that means. No court can review that decision" (AP/Philadelphia Inquirer, 12/20).
Sen. Edward Kennedy (D-Mass.) said he would attempt to remove the provision from the defense appropriations bill (New York Times, 12/20).
Ken Suggs, president of ATLA, said, "In the dead of night when no one was watching, ... Frist provided his corporate friends in the drug industry with an unprecedented giveaway that puts the health and safety of Americans at risk." (AP/Philadelphia Inquirer, 12/20).
Carmen Balber, a spokesperson for the Foundation for Taxpayer and Consumer Rights, said that the provision would create a conflict of interest for Frist and 41 other senators who own stock in pharmaceutical companies. Balber called the provision "a giveaway deal that half the Senate cannot ethically participate in" (New York Times, 12/20).
Carl Tobias, a professor at the University of Richmond School of Law, said, "The question is how high the liability shield needs to be. I think 'willful misconduct' is too high." He added, "We usually use some kind of negligence standard in these situations. It would be very unusual that you could prove that intentional misconduct had happened" (Los Angeles Times, 12/20).