Judge Approves Settlement in Kaopectate Lead-Content Lawsuit

San Francisco Superior Court Judge Richard Kramer yesterday approved a settlement between Pharmacia and Attorney General Bill Lockyer (D) requiring the company to reduce the amount of lead in the anti-diarrhea medicine Kaopectate by 80% to 90%, the Sacramento Bee reports. In November 2001, Lockyer's office filed a lawsuit against Pharmacia, which was acquired by Pfizer in April, and several drug stores and distributors alleging that Kaopectate had unsafe levels of lead in violation of Proposition 65. Under Proposition 65, businesses with 10 or more employees must warn people if their property or product could expose anyone to one of hundreds of chemicals known to the state to potentially cause cancer, birth defects or other reproductive harm (Esters, Sacramento Bee, 6/27). Proposition 65 requires a warning label if the product exposes a consumer to more than 0.5 micrograms of lead per day; Kaopectate contained 25 micrograms of lead in each adult dose and six micrograms to 12 micrograms in each child dose, the AP/Long Island Newsday reports (Fouhy, AP/Long Island Newsday, 6/26). Under the settlement, Pharmacia could owe the state as much as $1 million in fines; however, the company can reduce the fine by lowering the amount of lead in Kaopectate "on an accelerated timetable," the San Francisco Chronicle reports. Since the suit was filed, Pharmacia has removed 80% of the lead in its liquid Kaopectate but has not removed any of the lead from its Kaopectate capsules.

Except for Lil' Drug Store, the other defendants in the case, including RiteAid, Walgreens, Hi-Tech Pharmacal and Columbia Laboratories, have not settled (Say, San Francisco Chronicle, 6/27). Lil' Drug Store was fined $2,500, the Bee reports. The state says that none of the companies are shipping or selling high-lead anti-diarrhea products. "Kaopectate has been used safely and effectively for close to 50 years. In the interest of avoiding costly and unnecessary litigation, Pharmacia already has reformulated the majority of its Kaopectate products -- including all Kaopectate liquid -- and expects to complete the process in the near future," Bryant Haskins, a spokesperson for Pfizer, said. Haskins added, "While civil penalties are built into the agreement as an incentive to complete the reformulation process on an expedited basis, Pharmacia anticipates that any penalties will be minimal, based on the company's progress to date" (Sacramento Bee, 6/27). However, Lockyer said, "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" (San Francisco Chronicle, 6/27).