GlaxoSmithKline Settles Class-Action Suits

Associated Press

Last Updated: July 10, 2003 at 11:56:51 a.m.

PHILADELPHIA - The maker of the discontinued Lymerix Lyme disease vaccine has agreed to settle class-action lawsuits alleging that it could cause an arthritic condition in some people, but those who received the vaccine will get nothing from the settlement.

SmithKline Beecham, now GlaxoSmithKline, took Lymerix off the market in February, which the plaintiffs' attorneys said accomplished the main goal of the lawsuits.

The only money to change hands will be fees of $926,250 and costs of $137,997 that GlaxoSmithKline agreed to pay the lawyers, an amount that concerned Chester County Judge Jacqueline C. Cody.

A half dozen class-action lawsuits filed in New York, New Jersey and Pennsylvania were consolidated in her court, and Cody said 34 attorneys and paralegals submitted bills for work. Cody said she trimmed the amount requested by five percent before approving the fees and costs.

``Although we do not question whether the hours were actually worked, we question whether the efforts were reasonably efficient,'' wrote Cody, citing ``concerns regarding the size of the award of counsel fees in relation to the outcome of the litigation.''

``This lawsuit has two primary purposes at its inception: to warn patients of the drug's potential dangers, and to provide funds to plaintiffs for ongoing medical monitoring. The first goal is met by removal of the drug from the market; the second was not pursued because it was deemed unnecessary,'' Cody wrote.

Stephen A. Sheller, an attorney for the plaintiffs, said the litigation was started at the urging of doctors worried that the vaccine could cause a risk of arthritis in some genetically susceptible people.

Dr. Don Marks, a Birmingham, Ala., physician who has studied Lyme disease and the vaccine and acted as an expert witness for the plaintiffs, said that in such cases, ``The vaccine causes an autoimmune response. The vaccine itself can cause an inflammatory arthritis.''

Marks said he presented data to the Food and Drug Administration, which was reviewing his findings, but in the meantime Lymerix was withdrawn from the market.

GlaxoSmithKline denied that the vaccine caused any illness and said it was proven safe and effective in clinical trials. The company said it agreed to the settlement only to avoid the costs of lengthy litigation.

The company took the vaccine off the market in February 2002 for financial reasons, not because of health risks or lawsuits, said Danielle Halstrom, a GlaxoSmithKline spokeswoman.

After it had been given to hundreds of thousands of people, market research indicated that fewer than 10,000 would seek the vaccinations in 2002, Halstrom said. ``We discontinued it for commercial reasons because the market was just not there.''

The settlement said the company wouldn't reintroduce Lymerix without FDA-approved label changes. Halstrom said the company doesn't plan to reintroduce the product.

On the Net:

Lymerix lawsuit site: http://www.sheller.com/lymerix.htm

GlaxoSmithKline: http://www.gsk.com (PROFILE (COUNTRY:United States; ISOCOUNTRY3:USA; UNTOP:021; APGROUP:NorthAmerica;) )