Proposition 65 Advisory

June 1, 2000

Proposition 65 Advisory 00-III

HIMA Proposes "Safe Harbor" Regulation
for Medical Devices

The Health Industry Manufacturers Association ("HIMA") filed a petition on February 22, 2000, requesting California's Office of Environmental Health Hazard Assessment ("OEHHA") to adopt a regulation establishing a "safe-harbor" warning method for medical devices. The petition is an industry response to suits initiated against scores of medical device manufacturers in recent years.

The petition asserts that a safe harbor is necessary for Proposition 65 "exposures" from the use of medical devices because prescription medical devices generally are selected and used by health care providers, so that traditional warning methods available to manufacturers such as labeling and point-of-sale warnings are not effective. Thus, any warning that may be required under Proposition 65 as a practical matter must be provided by the health care provider, based on information from the manufacturer.

HIMA submitted with the petition a proposed regulation, crafted as an amendment to Cal. Code Regs. § 12601, "Clear and Reasonable Warnings," which establishes "safe-harbor" warning methods for "consumer products," "occupational," and "environmental" exposures. The proposed regulation would treat exposures to Proposition 65-listed chemicals that arise from the use of medical devices as a form of "consumer product" exposure, and would establish separate safe harbor warning methods for (1) prescription devices administered by various health care providers, and (2) over-the-counter devices sold at retail outlets. Its most noteworthy provision would allow manufacturers of prescription devices to satisfy their obligations under Proposition 65 by providing written notice to their immediate customers that identify a particular device or category of devices, and describe the intended use of the device that the manufacturer reasonably believes may require a Proposition 65 warning. Immediate customers would be required to pass the notice through the chain of distribution until it reached the healthcare provider, which would be required to provide a warning to the patient.

This provision is modeled after a warning scheme agreed to in the case of CISC v. I-Flow, et al, San Francisco Super. Ct. Case No. 995048, a suit against manufacturers of intravenous tubing and other devices that contain the chemical DEHP. McKenna & Cuneo, representing the DEHP Health Care Industry Task Force, negotiated the settlement, and persuaded the Attorney General to agree that these warnings satisfy Proposition 65.

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