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(SAN FRANCISCO) – Attorney General Bill Lockyer announced the San Francisco County Superior Court today approved the settlement of litigation that has led Pharmacia to reformulate its popular anti-diarrheal product Kaopectate so it no longer contains dangerous levels of lead.
"Hundreds of thousands of consumers in California and across the country – including pregnant women and children – ingested Kaopectate and generic versions for years without knowing the products contained enough lead to pose a health risk," said Lockyer. "This litigation and settlement benefit families nationwide by substantially reducing a significant source of exposure to lead."
In November 2001, Lockyer brought a lawsuit on behalf of the People under Proposition 65, the landmark California toxics initiative enacted by voters in 1986. He prosecuted the action jointly with the Bay Area-based Center for Environmental Health (CEH), which brought the case to the attention of the Attorney General's Office.
"This case proves how valuable Proposition 65 can be in protecting public health," said Michael Green, executive director of CEH. "Some of these products, including Children's Kaopectate, will have more than 95 percent of their lead removed, and that protects families. The fact that these products will be reformulated nationally means that consumers across the nation will be protected from lead."
Kaopectate has been on the market for more than 50 years. It is the largest selling anti-diarrheal with an attapulgite clay-based formula. Attapulgite clay contains high levels of lead. Lead can impair fertility in men and women, and cause neurological damage to fetuses. In children, lead exposure can cause brain damage, kidney damage, impaired growth, hearing loss and other health problems.
Lead has been officially listed under Proposition 65 as a substance known by the state to cause reproductive harm since 1988. Additionally, it has been listed as a known cancer-causing substance since 1993. Proposition 65 requires most businesses and manufacturers to provide "clear and reasonable" warnings when they expose people to known carcinogens or reproductive toxins.
Lockyer and the CEH filed separate Proposition 65 lawsuits – ultimately consolidated – after testing Kaopectate and generic brands for lead. Both sets of tests found that the lead levels exceeded the threshold that triggers Proposition 65's warning requirement.
As a result of the litigation, Pharmacia began reformulating Kaopectate to remove most of the lead hazard. The court-approved settlement provides financial incentives for Pharmacia to quickly complete the reformulation: The faster and more extensively Pharmacia removes lead from Kaopectate, the less it will pay in civil penalties, starting from a base figure of $1 million.
To date, Pharmacia has removed at least 80 percent of the lead from the liquid version. The reduction places the lead level below the quantity that poses a significant health risk, and below the Proposition 65 warning threshold.
The reformulated liquid already is on drug store shelves in California and across the nation. However, consumers should be alert to the fact that some of the old liquid product may still be in stores and homes. Bottles with the reformulated liquid can be identified easily because their labels say, "New, Improved." Pharmacia also manufactures Kaopectate in caplet form. The company has not yet reformulated the caplets.
The amount that Pharmacia will pay in civil penalties cannot be determined at this time. To the extent it reformulates the caplets, and further refines the liquid formula to remove more lead, its penalties will be further reduced.
Another defendant in the case, Li'l Drug Store, formerly distributed a small amount of one anti-diarrheal product that contained attapulgite clay. But after the lawsuits were filed, it ceased distributing the product in California in December 2001.
The settlement requires Pharmacia and Li'l Drug Store to place Proposition 65 warnings on any unreformulated products.
Settlements have not been reached with other defendants in the litigation, including Rite Aid, Walgreens, Hi-Tech Pharmacal and Columbia Laboratories. Negotiations with these defendants are continuing. In the meantime, however, none of these defendants are shipping, distributing or selling high-lead attapulgite anti-diarrheal products in California.