Federal Court Passes on Condom Suit, Deferring to FDA's Primary Jurisdiction
When I teach Product Safety and Liability, I often find that one of the most difficult questions to answer is who -- or really, what branch of government -- should be making a decision on a particular issue. Institutionally, courts have inherent limitations. They work within the confines of actual disputes between individuals; they are not legislators and have no broad factfinding powers. They often have limited capabilities when it comes to questions of science and require expert testimony. And when the causes of action at issue allow for a jury trial, a group of individuals who are "scientifically challenged" may be the ones actually charged with finding the facts.
Regulatory agencies, too, have their limitations. But often when the question is one of pure science, I often find myself advocating that the question is better left to regulators to decide. You can make that argument in a number of ways. For example, you may in certain circumstances be able to argue that Congress itself made that determination by preempting state law claims. But where preemption is not an option, one can appeal to the judge's inherent discretion under doctrines such as equitable abstention or primary jurisdiction.
Usually, my colleagues give such arguments about a snowball's chance in Hell of prevailing. But a decision reported by Law360 today demonstrates that climate change occasionally affects Hades as well.
In Gordon v. Church & Dwight Co., No. C 09-5585 PJH, Slip op. (N.D. Cal. Apr. 2, 2010) (Law360 subscription required), plaintiffs sued the makers of Trojan-Enz condoms, alleging that the spermicidal lubricant Nonoxynol-9 (which is used in some condoms) can increase the risk of HIV infection. Plaintiffs sued to impose warnings on the products under California's False Advertising Law, its Unfair Competition Law, and its Consumer Legal Remedies Act.
As U.S. District Judge Phyllis J. Hamilton explained, the Food and Drug Administration has been considering the issue of whether to alter the FDA-required warnings on N-9 lubricated condoms to account address this issue. Slip op. at 3. Indeed, FDA already has required that labeling for over-the-counter vaginal contraceptives containing N-9 include the following warnings:
Studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the risk of getting HIV/AIDS from an infected partner.
. . .
Use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors.
73 Fed. Reg. 66522 at n.1.
Judge Hamilton ultimately concluded that it was the FDA -- rather than a court -- that should be making the determination at issue in plaintiffs' suit, and thus she granted the defendant's motion for dismissal without prejudice under the "primary jurisdiction" doctrine. As Judge Hamilton explained, primary jurisdiction is a prudential doctrine in which a court may defer initial decisionmaking where a regulatory agency is considering the question. Courts apply 4 factors in determining whether to apply the doctrine: "'(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.'" Slip op. at 2 (citation omitted).
The court noted that FDA has exerted regulatory authority over condoms as medical devices, including regulating the substance of the warnings, instructions, and statements of use. Judge Hamilton concluded that the primary jurisdiction doctrine was appropriate here:
The issue of medical device labeling requires expertise as well as uniformity in administration. The plaintiffs' claims involve a technical area over which the FDA has more expertise than the courts; and, while the claims are based on state law, their effect is to challenge the wording in the warnings that are required to be included in the latex condom packaging pursuant to federal law.
The court notes in particular that the FDA has stated that it is still considering public comments and other data in connection with warnings similar to those that plaintiffs seek to have the court impose on C&D. Thus, this issue remains under review. It would be inappropriate for this court to assume the FDA's regulatory role, and to interpret scientific studies or other evidence to determine whether the labeling of the N9 latex condoms should be changed to include an additional warning . . .
Slip op. at 3.
The Gordon decision is an excellent example of a court taking stock of its inherent capabilities and limitations and deferring to a regulatory agency to make a decision in the first instance where the agency is better able than the court to do so. It remains to be seen how influential Judge Hamilton's decision will be in other courts.
