Proposition 65 Advisory

Attorney General Nixes Medical Implant Device Notices

The Office of the Attorney General has declared that the Notices of Intent to Sue sent by the Proposition 65 bounty-hunter Consumer Cause to manufacturers and distributors of medical implant devices are deficient, and do not confer a right to sue under Proposition 65. This will foreclose temporarily any right of Consumer Cause to initiate Proposition 65 bounty-hunter enforrcement lawsuits regarding those devices.

Proposition 65 Advisory 99-IV reported that Consumer Cause issued Notices to manufacturers and distributors of approximately seventy-seven medical implant devices. On March 29, 1999, Deputy Attorney General Edward G. Weil sent a letter on behalf of the new Attorney General Bill Lockyer to counsel for Consumer Cause, indicating that the Notices are not sufficient to comply with the State's Proposition 65 notice regulations, set forth at 22 Cal. Code Regs. tit. 22, § 12903. Mr. Weil also sent copies of his letter to each of the recipients of the Notices.

The Attorney General found the Notices defective in many ways, but complained primarily of their lack of specificity. Mr. Weil noted that the Notices are directed toward 339 manufacturers and distributors of seventy-six devices alleged to contain twenty-two listed chemicals. The Notices do not "specifically tie the products to the particular chemicals," and do not "identify any particular [alleged] violator as the manufacturer [or distributor] of any particular category of products." The Notices thus fail to provide the State with sufficient information to make an informed decision whether to exercise its authority to prosecute, and do not provide the recipient sufficient information to address the violations alleged. The Notices also are defective in their failure to identify the location or manner of exposure regarding alleged enviornmental exposures, and because they suggest a right in Consumer Cause to negotiate on behalf of the general public prior to expiration of the 60-day notice period. The Attorney General concluded that the Notices are not sufficient to confer on Consumer Cause a right to bring suit, and admonished Consumer Cause to "send a letter to each recipient of the notice formally withdrawing and revoking the notice."

We have not learned whether Consumer Cause intends to issue new Notices. Nevertheless, we are advising clients to treat the Notices, although defective, as warnings that their medical devices have been targeted as the subject of likely Proposition 65 cases in the future. This is an appropriate time for medical device manufacturers and distributors to review their products anew, and determine again whether such products require warnings under Proposition 65. If you need assistance in determining whether any of your company's products require Proposition 65 warnings, or how to communicate warnings that would satisfy Proposition 65, we would be pleased to assist you. Please contact one of the attorneys below. If you would like a copy of the Attorney General's letter, please call Nina Macleay at 213 (243) 6063.

McKenna & Cuneo, L.L.P., distributes its Advisories to clients and friends of the firm free of charge. If you would like to request additions (or deletions) to our distribution list, please call Nina MacLeay at 213-243-6063.

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