Coal Tar Lawsuit #1
This is a reprint of the first 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.
Coal tar products target of California lawsuit alleging cancer risk
FDA rules products safe, declines to act
Manufacturers of coal tar shampoos and skin products for psoriasis are being sued in California to place cancer warnings on the products in that state. A status conference that may result in a trial date is set for June.
Perry Gottesfeld, a private citizen, and California Attorney General Bill Lockyer are suing at least 22 companies under Proposition 65, an initiative passed by California voters in 1986 that requires warnings on products that contain chemicals known to the state to be carcinogens or reproductive toxicants. The lawsuits were filed separately but consolidated by the court because of their similarity.
The lawsuit seeks an injunction and civil penalties against the defendants for exposing individuals without clear warning to coal tar chemicals known to cause cancer since 1986 (when “soots, tars and mineral oils” were placed on Proposition 65’s list of carcinogens). According to the law, penalties up to $2,500 per day for each violation may be imposed by the state, with the plaintiff — Gottesfeld, in this case — standing to gain 25 percent of penalties collected.
In connection with the lawsuit, Gottesfeld petitioned the U.S. Food and Drug Administration (FDA) to review the safety of coal tar products and restrict their sale to prescription sales. The FDA conducted a review and concluded that “at this time, there is no evidence that topical treatment of dermatological disorders with [over-the-counter] coal tar shampoo, soap, or ointment drug products increases the risk of skin cancers.” The agency said no change in the status of coal tar products was necessary.
Making the case
According to California Deputy Attorney General Susan Fiering, under Proposition 65, the burden of proof is on the defendants to prove the level of exposure to carcinogens is below the “no significant risk level” set by the law. The law defines a “no significant risk level” (NSRL) as the amount that will not cause more than one excess cancer case out of 100,000 people exposed to the product over 70 years.
All three parties in this lawsuit — Gottesfeld, the California attorney general, and the defendants — have submitted risk assessments that establish different NSRLs.
Gottesfeld submitted a risk assessment by a national consulting company which suggests the NSRL for coal tar shampoo is 0.02 micrograms per day. The attorney general hired the environmental consulting firm Gradient Corporation, based in Cambridge, MA, to determine a NSRL — the result, 1.51 micrograms per day. Both of these levels are below the amount of coal tar estimated to be absorbed into the skin by people who actually use coal tar shampoo.
On behalf of the defendants in the case, ICF Kaiser, one of the country’s largest consulting companies, estimated a NSRL of 29 micrograms per day, which is above the level of coal tar a shampoo user is estimated to absorb through the skin.
In the end, manufacturers may be forced to place warning labels on their coal tar products in California and pay hefty fines, or no changes will be required in coal tar labeling. Another possibility is that the parties will settle the case out of court.
Impact of FDA decision
The case was originally scheduled to go to trial on September 11, 2000. However, a Superior Court judge granted a stay of the lawsuit pending a decision by the FDA on Gottesfeld’s petition.
The FDA formally responded to the petition in a letter on February 22. In the letter, the agency states: “We do not find adequate basis to change the status of coal-tar containing drug products for the treatment of dandruff, seborrheic dermatitis, and psoriasis from [over the counter] to prescription or to require additional warning statements on product labeling.”
Whether the FDA’s response to the petition will have any bearing on the lawsuit in California is unclear. Even though the FDA denied his requests, in a recent statement, Gottesfeld said the FDA’s response provides the California lawsuit “a boost.”
Fiering said the FDA’s decision to leave federal regulations as they are regarding coal tar products should have no impact on the case, because the lawsuit is a matter of state rather than federal law.
The state of California and Gottesfeld are not working together and have no ties, Fiering added. “We have no relationship with them other than they are a private plaintiff in this consolidated lawsuit,” she said.
NPF monitoring the situation
The NPF and its Medical Advisory Board recognize that over-the-counter 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 has written a letter to the California attorney general, outlining its position on the pending lawsuit. We 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 March 22, 2001
First posted March 22, 2001
Last updated May 4, 2001
This document was reprinted with the permission of the National Psoriasis Foundation. The original can still be found in the Internet Archive.