When product-liability plaintiffs suing drug or medical device manufacturers assert California’s Unfair Competition Law (“UCL”) using a purported “violation” of the Food, Drug and Cosmetic Act (“FDCA”) as the hook for the “unlawful” prong of the claim, courts have not clearly addressed how such a claim could be reconciled with the no private right of action clause in the FDCA, 21 U.S.C. §337(a).
Earlier this month, the California Supreme Court provided some guidance on the issue in Rose v. Bank of America, N.A., S199074, slip op. (Cal. Aug. 1, 2013), in a case involving a different federal statute, the Truth in Savings Act (“TISA”). The court allowed a UCL claim to “borrow” from” TISA because “Congress expressly left the door open for the operation of state laws that hold banks to standards equivalent to those of TISA,” even though it had repealed a federal private statutory right of action. Slip op. at 7. Why? Because Congress left alone a savings clause that preserved the authority of states to regulate the same subject so long as state law is consistent with TISA:
[C]onsiderations of congressional intent favor plaintiffs. By leaving TISA?s savings clause in place, Congress explicitly approved the enforcement of state laws [within the express terms of the savings clause]. The UCL is such a state law.
Id. at 4 (TISA-specific savings language omitted).
Why does that interest us – particularly since the result was adverse to the defendant?
Because everything that TISA had, the FDCA doesn’t, and vice versa. (1) TISA originally had an express federal cause of action. The FDCA never had any such thing. Some early drafts back in the 1930s did, but that was deleted before the bill was passed. (2) TISA had an express savings clause that survives to this day. The FDCA doesn’t (except for the food-specific exception discussed in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008), and in our post here). (3) The FDCA contains an absolute bar to private rights of actions pertaining to drugs and medical devices . 21 U.S.C. §337(a). TISA’s provisions contain no equivalent. (4) With respect to medical devices, the Medical Device Amendments (“MDA”) to the FDCA mandate express preemption of private claims. 21 U.S.C. §360k(a). Again, there’s no TISA equivalent.
Thus, regardless of the debatable outcome in Rose, the significance the California Supreme Court has placed on the continued existence of the savings clause in TISA, and on the absence of TISA preemption or no-private-enforcement provisions has us comparing TISA and the FDCA.
Specifically we compare this:
The retention of §4312 [the savings clause], allowing states to maintain laws consistent with TISA, demonstrates the [congressional] intent to permit state law remedies.
Rose, slip op. at 8. With this:
The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.
Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001); and this:
[W]e have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.
Id. at 352 (both citing §337(a)).
Thus, unlike TISA, under the same legislative purpose analysis conducted in Rose, Congress plainly did not intend the borrowing of any FDCA requirements as a basis for a state-law UCL action in the drug or medical device context. The FDCA lacks any general savings clause like the critical language in Rose (except in the food-labeling context mentioned above). To the contrary, the absolute language of §337(a) (“all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States”), is exactly what wasn’t present in TISA. Furthermore, the presence of an express preemption clause (21 U.S.C. §360k(a)) in the Medical Device Amendments is additional good ammunition to preclude UCL actions involving medical devices.
A rose, is a rose, is a rose. But the FDCA (and the MDA), isn’t TISA, and thus shouldn’t be UCL borrowable.