Protection for vaccine makers
Product liability concerns continue to hinder vaccine development | By Lynne Lederman

Lawsuits are continuing to have a chilling effect on vaccine producers, both reducing the number of companies willing to get into the vaccine business and raising the costs of development, according to legal and industry representatives at the Vaccines meeting held October 22–24 in Arlington, Va. (cosponsored by The Scientist). On the gathering's first day, legislation to limit class-action lawsuits and large damage awards against corporations failed by a single vote in Congress, killing the bill (S 274) for this year and leaving meeting attendees predicting a negative effect on the vaccine industry.

"We don't believe lawyers should exist. They have ruined the vaccine industry and made it impossible to get insurance," said one angry attendee, Stan Yakatan, an industry consultant with Katan Associates in Hermosa Beach, Calif., and a former venture capitalist.

"Class actions are profitable primarily to lawyers," said Neal Halsey, director of the Institute of Vaccine Safety at Johns Hopkins University. "The frequent resolution of these cases by settlement provides the incentive for more lawsuits which do not depend upon scientific evidence," he said.

A number of conditions have been falsely attributed to vaccines, Halsey noted. The public fails to understand that when one event follows another, they are not necessarily causally related. For example, he said, the public has been reluctant to accept that the measles, mumps, rubella vaccine or thimerosal-containing vaccines do not cause autism, despite elegant studies demonstrating this, such as those conducted by Kreesten Madsen at the University of Aarhus in Denmark.

Certain state courts have certified class action suits that should not have been allowed and have admitted "junk science" in the guise of expert testimony, said Victor E. Schwartz, an attorney with Shook, Hardy & Bacon, in Washington, D.C. One tactic of plaintiffs' lawyers has been to vilify the potential defendants to the media in order to affect public opinion long before the trial takes place, Schwartz said. "This can be done with any medicine, no matter how benevolent."

The remedy, Schwartz suggested, lies in part with a compensation program like the one covering childhood vaccines that would cover all vaccines and all the ingredients, including preservatives, other than adulterants, as well as in public education.

Vaccine producers should be immunized from attack by trial lawyers, said James M. Wood, an attorney with Reed Smith Crosby Heafey in Oakland, Calif., who represents manufacturers of prescription medicines and medical devices. These product liability cases ignore the contributions of vaccines to public health and safety, he said.

And without appropriate product liability protection for vaccines for bioterrorism agents, there will be mass tort litigation, Wood warned. "It is a pipe dream that trial lawyers would accept a moratorium on lawsuits for bioterrorism vaccines," he said.

Although the National Childhood Vaccination Injury Act—which is funded by taxes on each dose of vaccine and provides relief to those suffering adverse events due to vaccination—is a good no-fault model, it is still possible for individuals to pull out of the act and to litigate, Wood noted.

Vaxgen of South San Francisco was able to purchase product liability insurance for the anthrax vaccine it';s developing, said Chief Executive Officer Lance Gordon. The cost is reimbursed by the government, which is funding anthrax vaccine development, as long as the company can prove that their costs are fair and reasonable said Gordon. Vaxgen did so by pointing out that their insurance cost per dose is what the government currently taxes for pediatric vaccines. But "the RFP Vaxgen responded to did not address the issue of insurance at all," Gordon noted, "and there is nothing reliable existing in current legislation regarding liability insurance."
Links for this article
Vaccines: from Political, Socio-economic, Scientific Provider, User, and Legal View Points Conference, Arlington, Va., October 22–24, 2003
http://gtcbio.com/ebrochure/vaccine%20brochure.pdf

K.M. Madsen et al.," A population-based study of measles, mumps, and rubella vaccination and autism," New England Journal of Medicine, 347:1477-1482, November 7, 2002.
[PubMed Abstract]

K.M. Madsen et al., "Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data," Pediatrics, 112:604-606, September 2003.
[PubMed Abstract]

J.D. Miller, "Vaccine deal turnaround," The Scientist, July 4, 2003.
http://www.biomedcentral.com/news/20030704/06/