Coal Tar Lawsuit #4

This is a reprint of the fourth of eight documents originally published by the National Psoriasis Foundation (NPF) regarding the 2000-2002 lawsuit in California over coal-tar products and Prop 65.


Lawsuit continues against coal tar products in California

January 2002 trial date set; one company settles

A California Superior Court judge has allowed a lawsuit to proceed against approximately 15 companies accused of exposing consumers to cancer-causing agents in their coal tar products.

At least one defendant, Whitehall-Robins, agreed to settle the case rather than defend it in court. The company makes Denorex shampoos. Under conditions of the settlement, the company must pay $400,000 in penalties and reformulate Denorex by December 18, 2001, so it contains lower strengths of coal tar. If the company does not comply, it must place a warning label on the products stating, “This product contains chemicals known to the state of California to cause cancer.”

According to the U.S. Food and Drug Administration (FDA), there is no scientific evidence to support the suggestion that coal tar products used by people with psoriasis cause cancer. The settlement states that Whitehall-Robins agreed to it “for the purpose of avoiding prolonged and costly litigation.” Company representatives could not be reached for comment.

Whitehall-Robins must pay $275,000 of the settlement to the state and $125,000 to a private citizen who filed the lawsuit under California’s Proposition 65. Proposition 65 is an initiative passed by the state’s voters in 1986 that requires warnings on products containing chemicals “known to the state” to be carcinogens or reproductive toxicants.

Coal tar contains up to 10,000 compounds, only 50 percent of which have been identified. Studies show some of the chemicals in coal tar may cause cancer, but only in very high concentrations, such as the types of coal tar used in industrial paving.

The FDA has approved the use of medicinal coal tar for psoriasis in over-the-counter (OTC) products in concentrations from 0.5% to 5%. Coal tar slows the rapid growth of skin cells that cause lesions to appear.

Trial set for San Francisco in January 2002

During a status conference in early June, a trial date of January 7, 2002, was set for the case. California Superior Court Judge David Garcia lifted a stay on the case that he had granted approximately one year ago. At that time, the companies being sued had asked for the stay to await the outcome of an FDA safety review of OTC coal tar products.

The FDA was petitioned to review the products by the same private citizen, Perry Gottesfeld, who filed the lawsuit in California. On February 22, the FDA formally responded to that petition in a letter that concluded: “There is no evidence that topical treatment of dermatological disorders with OTC coal tar shampoo, soap or ointment drug products increases the risk of skin cancers.”

It remains unclear whether the FDA’s finding will have any bearing on the case in California. The NPF and its Medical Advisory Board recognize that OTC coal tar shampoos and skin care products are a valuable and relatively inexpensive therapeutic option for people who have psoriasis, especially those who have mild to moderate involvement.

The NPF wrote a letter to the California attorney general outlining its opposition to the lawsuit, and a response was sent to the NPF explaining the attorney general’s position.

For more details about the lawsuit, see the NPF’s original article on the case. The NPF will continue to monitor this situation and publish updates on the Web, as well as in our member publications, the Bulletin and Psoriasis Resource.

Article reviewed July 27, 2001
First posted and last updated July 27, 2001

This document was reprinted with the permission of the National Psoriasis Foundation. The original can still be found in the Internet Archive.

Coal tar lawsuit documents

[1][2][3] – (4) – [5][6][7][8]