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"Protecting the health and informed consent rights of children since 1982."

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NVIC Note:

In response to vaccine manufacturer liability protection legislation introduced into the Homeland Security Bill last fall, as well as legislation (S.15) introduced by Senator Bill Frist (R-TN) to reform the federal Vaccine Injury Compensation Program (VICP), this past February the National Vaccine Information Center formed a 501C4 lobbying coalition, Americans for Vaccine Safety and Accountability (AVSA). On behalf of the Coalition, for the past four months NVIC has backgrounded congressional staff on the 16-year history and implementation of the VICP and provided help to Senators Dodd and Frist during their negotiations which led to an agreement on making improvements to S. 15 (see the story below). NVIC co-founders worked on the 1986 law and have monitored its implementation ever since, including bringing a lawsuit against the Secretary of DHHS in 1995 when federal health officials gutted the Table of Compensable Events which resulted in more vaccine injured children being denied compensation. Currently, lobbyists from drug companies making and selling vaccines are on Capitol Hill trying to convince Congress to shield them from all lawsuits for vaccine injuries and deaths. To learn more about Americans for Vaccine Safety and Accountability go to www.909shot.com, where you can also sign up to be on NVIC's email news list and keep up to date on this and other legislation which will affect you and your family.

Friday, May 16, 2003 InsideHealthPolicy.com Daily Updates

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Senate, House to negotiate in 'preconference' as early as next week

Senate GOP Backs Away From Plan To Extend VICP Statute Of Limitations

Senate Republicans are reneging on a key provision of a draft bipartisan agreement on vaccine legislation that would extend the statute of limitations for entering the childhood Vaccine Injury Compensation Program

(VICP) from three to six years, according to a congressional source. Senate and House lawmakers are negotiating the bill in a “preconference” to avoid a deadlock in the Senate health committee and delays in the House, though the House Medicare debate could postpone the VICP conference talks, the source says.

The bill, called the Improved Vaccine Affordability and Availability Act, is supposed to make it easier for parents to be compensated for their vaccine-injured children while also shielding the handful of vaccine makers from class-action lawsuits that threaten to drive them out of business.

The Senate health committee had planned to mark up a draft bipartisan agreement May 14, following three previous markup cancellations. Senate Majority Leader Bill Frist (R-TN), the original VICP-reform bill author, had reached a compromise late at night on April 7 with Sen. Christopher Dodd (D-CT), which the health committee was supposed to pass the next day.

However, Senate health committee chair Judd Gregg (R-NH), who had been involved with the negotiations but was not at the late-night compromise, cancelled the mark up at the last minute. A Gregg spokesperson said the mark-up was postponed because there was not a quorum. Democrat aides and patient advocates said Gregg cancelled the mark-up because he opposes retroactively allowing cases from six years ago to enter the VICP (see FDA Week, April 11, p1).

Gregg proposed forgoing the mark-up to handle the matter in the preconference, allowing a handful of Senate and House lawmakers to privately work out a version of the legislation that could pass both chambers. However, following the cancelled mark-up on April 8, Dodd told reporters that he had gone as far as he could go on negotiations, and it is unclear how much from the original agreement could be changed while keeping the support of Democrat Senators who could block the bill.

A congressional source says the Republicans believe allowing more cases into the VICP retroactively would increase liability to vaccine manufacturers -- which defeats half the purpose of the bill. Under the VICP program, the government pays for the compensation through a “no-fault” system. However, the VICP is not an exclusive remedy, and plaintiffs can opt out of if their claims are denied. Plaintiffs also may opt out -- without affording the respondent or the special master any meaningful opportunity to evaluate the claim -- if the VICP special master does not decide a case within 240 days.

Sources say trial lawyers created a loophole out of the 240-day provision by flooding the VICP with “placeholder” cases that are often incomplete to circumvent the VICP. The medical records that the law requires in these cases often have not been submitted, making it difficult for the VICP special master to resolve a case.

But others say trial lawyers did not ruin the program, HHS did. These sources say the program is in shambles because in the mid 1990s HHS gutted the vaccine-injury table. This table lists vaccines and injuries associated with those vaccines, and the VICP special master “presumes” that these vaccines have caused a listed associated injury given certain circumstances, such as how long it took a child to become sick following an inoculation. Plaintiffs are compensated from a fund that comes from a tax on every vaccine.

After the table was gutted, cases were decided based on the concept of a “limited waiver of sovereign immunity.” This interpretation is contrary to a no-fault compensation system because it errs on the side of government, instead of erring on the side of the plaintiff. Under this system, parents must prove that an immunization has caused their child's disease or condition (see FDA Week, May 2, p7).

These sources also point out that there are many kinds of vaccine injuries, but the need to re-establish a quick, no-fault system for these children has been overshadowed by the debate over whether thimerosal additives in vaccines have caused autism. And both congressional and patient advocates say that few if any plaintiffs have won in cases that have been forced out of the VICP.

Thimerosal was never on the table, but a “causation hearing” is scheduled in the VICP next year. If the approximate 1,500 plaintiffs involved in the suit win, patient groups will petition to get thimerosal included on the table. Once a vaccine or disease is added to the table, anyone who was injured within eight years prior to the table change are allowed to file under the VICP, and they also may sue outside the VICP if their case is denied or if it takes the special master longer than 240 days to decide the case. Under the draft Senate compromise, those injured after 1988 but before the eight-year statute of limitation are only allowed to file their case in the VICP. Sources say Republicans have not indicated that they want to change this retroactive measure.

Other thimerosal class-action lawsuits filed in state courts are the first to actually threaten vaccine manufacturers, and sources say the litigation could cost industry several billion dollars.

Most cases name both the manufacturer of a given vaccine that contained thimerosal and Eli Lilly, according to the annual reports of vaccine makers to their investors. Lilly was once the largest manufacturer of thimerosal, but the company stopped making it in the 1970s.

Thimerosal has never been proven to cause autism, but there is medical literature that claims mercury is a neurotoxin that causes the same symptoms as autism, according to the patient advocate.

The threat of thimerosal litigation also likely is to blame for the debate over the retroactive measures. Plaintiffs did not start suing over thimerosal until the latter 1990s, and in 1999 companies started phasing out thimerosal at the request of FDA, though a handful including the flu vaccine still contain it. If Congress extends the statute of limitations to six years, the new law would capture cases from as early as 1996 depending on when a child was diagnosed with autism. The current statute of limitations is three years.

Frist's VICP bill started receiving much press at the end of last Congress when a provision from the bill that would change the definition of vaccines to include vaccine components was slipped into bioterrorism legislation. Thimerosal is an additive that is included on the insert of vaccine product labels, according to a patient advocate. Redefining vaccines to include their components would clarify that FDA had approved both the vaccine and any components included on the product label as safe, releasing thimerosal manufacturers from liability.

The Senate has taken the lead up to now on the issue. Sens. Gregg, Frist, Dodd and Edward Kennedy (MA), the Senate health committee's ranking Democrat, likely will represent the Senate in the preconference talks, according to congressional sources. House Speaker Dennis Hastert (R-IL) and Reps. John Dingell (D-MI), Henry Waxman (D-CA) and possibly Richard Burr

(R-NC) likely will be included on the House side of the negotiations, a congressional source says. -- John Wilkerson

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