Prop 65 Medical Device Litigation

DEHP
Implanted Devices
Orthodontic/Dental Products

DEHP Litigation

Court Holds No Significant Exposure to DEHP

An October 3, 2002 ruling by Judge Talmadge R. Jones of the Sacramento Superior Court has determined that DEHP poses no risk of cancer in humans. The decision in Baxter Healthcare Corp. v. Denton, Sacramento Superior Court no. 99CS00868, if upheld, could well mean that Proposition 65 warnings for exposures to DEHP will be unnecessary.

The case arose from Baxter's request for declaratory relief on the grounds that DEHP did not pose a significant risk of cancer. Baxter premised its action "that exposure to DEHP does not pose a significant risk of cancer to humans on any of three possible bases: (1) because the mechanism by which it causes cancer in laboratory animals does not function in humans; (2) because, even if the mechanism of carcinogenesis operates in humans, humans exposed to DEHP under all conceivable conditions of exposure receive a 'dose' that is insufficient to cause cancer; or (3) humans have been exposed to DEHP for many years, sometimes at relatively large 'doses', and have not developed cancer as a result." OEHHA's defense, conceding that there was no proof that DEHP caused cancer in humans, was "to attempt to raise sufficient doubt about Baxter’s contentions to prevent Baxter from carrying its burden of proof."

The court determined that "Baxter has carried its burden of proof on the first basis of its argument. Baxter’s expert testimony was credible and persuasive and set forth a coherent and well-supported theory of the manner in which DEHP causes cancer in laboratory animals, and of the differences between animal and human biology that make it improbable that such a mechanism of carcinogenesis could operate in humans. Such evidence, in the Court’s view, established that it is more probable than not that DEHP poses no significant risk of cancer to humans." The court determined that Baxter had not carried its burden of proof on the second and third arguments, although it considered them moot in light of its finding on the first.

The court's decision addressed some fundamental legal questions of general import. It held that "Although the statute by its terms refers to the exemption as a defense to an enforcement action brought by the state or a private party under Proposition 65, the right to the benefit of the exemption may also be established, or not, in the context of a declaratory relief action."

The court also held that Baxter was not required to follow the exposure assessment methodology outlined in the Prop 65 implementing regulations. As argued by OEHHA, "Baxter cannot meet its burden of proof in this action because it has not attempted to establish “no significant risk” in the manner set forth in the regulations. In particular, OEHHA argues, Baxter has not performed a proper quantitative risk assessment, has not tied its evidence to any particular level of exposure, and has not demonstrated that exposure to DEHP at such level will not result in more than one excess cancer case in an exposed population of 100,000." The court rejected this defense, holding that Baxter's methodology "goes directly to the central question of whether there is a significant risk by examining whether there is any risk. 'No risk' is by definition 'no significant risk'. Thus, Baxter’s methodology is entirely in harmony with Proposition 65 and its implementing regulations. Moreover, the Court finds that Baxter’s chosen methodology is accepted by the scientific community."

The court rejected OEHHA's argument that Baxter should be held to proof of its theories by "clear and convincing evidence," rather than the ordinary preponderance of the evidence standard. OEHHA had argued that "[g]iven the inherent uncertainty of scientific knowledge, OEHHA argues that an erroneous decision could result in persons unknowingly being exposed to a substance that may cause cancer despite all evidence to the contrary. The consequences of such exposure might not be known for years, even decades, and would be irreversible." While sympathetic to these arguments, the court recognized that "Proposition 65 reflects an effort to balance the interests of those exposed to chemicals against the interests of those who manufacture or use such chemicals. Imposing a higher standard of proof on the party seeking an exemption from the warning requirements would change that balance."

CISC Litigation

In 1998 The Working Group on Carcinogenic and Immune Suppressing Chemicals (CISC) sued most of the medical device industry over exposures to di(2-ethylhexyl) phthalate (DEHP) from a variety of medical devices. DEHP is used to make soft PVC plastic, and is listed due to an NTP animal bioassy showing carcinogenicity. CISC, represented by Los Angeles attorney Shawn Khorrami, claims that DEHP leaches from plastic products, and that alternative plasticizers and replacement products are available which do not cause exposures to listed chemicals.

CISC's lawsuits address three other listed chemicals (ethylene dichloride, formaldehyde, and ethylene oxide) which CISC claims leach from medical catheters and tubing. Although the parties have been negotiating settlement, the cases have turned into major pleading battles. The defendants have attempted to forestall CISC from suing over all of the chemicals, since only DEHP was included in the original 60-day notices. They have also attacked CISC's novel use of theories such as battery and negligence (stemming from contact with the listed chemicals) as "unlawful" business practices under the California Unfair Competition Law.

In April 1999, a consent judgment between CISC and the defendants in CISC v. I-Flow was entered by the San Francisco Superior Court. The consent judgment calls for attempts at reformulation of the devices, and for warnings disseminated through hospitals at which devices are used.

Implanted Devices

In March 1999, Consumer Cause, represented by the law firm of Morse Mehrban, sent 60-day notices to over 300 companies alleging that the companies violated Prop 65 by failing to warn of exposures to 22 listed chemicals in 76 different implanted medical devices. The notices brought a sharp reaction from the California Attorney General's office, which sent a letter to Mehrban questioning the validity of the notices. The letter, sent by Deputy Attorney General Ed Weil, asserted that Consumer Cause's notices were invalid, since they appeared to charge every company with manufacturing all 76 devices, all of which caused all 22 exposures. Weil reasoned that either Consumer Cause had no evidence to support such a claim, or that the notices were improperly worded. Mehrban's office has apparently indicated that it will serve new, more narrowly targeted notices in response to Weil's letter.

Through the summer of 2000, Consumer Cause filed enforcement actions against several manufacturers of orthopedic and other implanted devices, directed to exposures to nickel and nickel compounds.  Following a demurrer filed by defendants in Consumer Cause v. Howmedica, et al., Consumer Cause voluntarily dropped its claims relating to exposures to nickel compounds.  The device litigation is consolidated before Judge Victoria Chaney of the Los Angeles Superior Court.  Judge Chaney has ordered related cases notices to be filed in any other implanted medical device litigation filed by plaintiff, and has ordered that plaintiff disclose all settlements it has reached in such cases to the defendants.

On April 4, 2000, Consumer Cause settled with American Medical Systems over nickel exposures from penile implants.  The settlement called for payments of $50,000, half of which was denominated a donation to Consumer Cause, and the other half of which was for plaintiff's attorney's fees.  The settlement called for warning letters to be sent to each direct California customer.

In December 2001, Consumer Cause reached a settlement with several manufacturers of implanted medical devices in Consumer Cause v. Johnson & Johnson. The settlements require warnings for cumulative lifetime nickel exposures above 512 milligrams, pursuant to a formula that is based on nickel content, surface area, and anticipated implant lief. The settlement also allows for other companies that manufacture implanted devices to opt in as settling defendants.

Orthodontic/Dental Products

Concurrent with the implanted device litigation, Consumer Cause has filed several cases against manufacturers of dental and orthodontic products, as well as against dentistry organizations, alleging Prop 65 violations as a result of exposure to nickel from stainless steel devices and mercury from dental amalgam.   Consumer Cause has settled with Western Dental, which took the unique twist of sending 60-day notices to its suppliers of orthodontic products and then entering into a consent judgment with the suppliers which resulted in payments directly to Consumer Cause, and payment of Western Dental's attorney's fees.  Consumer Cause has also settled with Ormco, an orthodontic products manufacturer.  The Western Dental settlements require that Prop 65 warnings signs be sent to dentists and posted in their offices.  The Ormco settlement requires that Prop 65 warnings be given by product labeling.

Also raising dental amalgam claims was the Environmental Law Foundation.  After settling its original action against Kerr Manufacturing, it filed a second enforcement action in November 2000 against more than 20 manufacturers and distributors of dental products.

Through late 2000 and early 2001, Consumer Cause continues to file enforcement actions against manufacturers of orthodontic products.  For up to date filing information, see our enforcement filings.

In a judgment entered on May 15, 2001, in Consumer Cause v. Minnesota Mining & Manufacturing, plaintiff agreed that the level of exposure to nickel from the settling defendant's products posed no risk of cancer and did not require a warning under Prop 65.

This page last updated 11/24/02.