We don't see claims under the Magnuson-Moss Warranty Act, 15 U.S.C. §2301(1) ("MMWA") much in our prescription medical product sandbox.  The MMWA is the federal statute that governs warranties for consumer products, and it was enacted around fifty years ago basically to make warranties more understandable and to limit the use of disclaimers.  Thus, if a seller of consumer products opts to include a warranty (which the law does not require), it has to follow federal guidelines calling for conspicuous warranties in readily understood language.

We thought there were two primary reasons why we don't see the MMWA in our drug and device space..  First, the MMWA doesn't allow recovery of personal injury damages.  15 USC §2311(b)(2) ("Nothing in this chapter . . . shall [] affect the liability of, or impose liability on, any person for personal injury. . . .").  The second is that, such products have usually not been considered to be "consumer" products within the scope of the MMWA.  See Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72, 86 (Cal. App. 2002); Bates v. Monarch Dental Services, 2019 WL 5067904, at *4 (N.D. Tex. Oct. 9, 2019); Bhatia v. 3M Co., 323 F. Supp.3d 1082, 1102-03 (D. Minn. 2018); MHA, LLC v. Siemens Healthcare Diagnostics, Inc., 2017 WL 838797, at *2 (D.N.J. March 2, 2017); In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024 (E.D. Mich. 1993); see also In re DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation, 953 F.3d 890, 896 (6th Cir. 2020) (raising, but not deciding issue).

But what about OTC drugs?

Well, there's another provision in the MMWA that can be useful for such drugs - indeed for any and all FDA-regulated products.  The MMWA is "inapplicable to any written warranty the making or content of which is otherwise governed by Federal law."  15 U.S.C. §2311(d) (emphasis added).  That provision - which we had never seen cited in a drug or device case until recently - is yet another solid basis for dismissing MMWA claims against FDA-regulated products:

Through the FDCA, the FDA extensively regulates the labeling, marketing, and sale of all over-the-counter medications. . . .  As such, the MMWA is inapplicable to any alleged express or implied warranty claims on [such products].

Hernandez v. Johnson & Johnson Consumer, Inc., 2020 WL 2537633, at *5 (D.N.J. May 19, 2020) (citations omitted).  Hernandez cited several cases involving other types of FDA-regulated products in dismissing the MMWA claim at issue.  Id. (citing Dopico v. IMS Trading Corp., 2018 WL 4489677 (D.N.J. Sept. 18, 2018) (pet food), Reid v. GMC Skin Care USA Inc., 2016 WL 403497, at *13 (N.D.N.Y. Jan. 15, 2016) (skin cream), and Jasper v. MusclePharm Corp., No. 14-02881, 2015 WL 2375945, at *5-6 (D. Colo. April 9, 2015) (dietary supplement)).

Seeing no other drug or device cases, we were curious to see whether §2311(d) had ever been invoked to dismiss MMWA claims involving these products before.  So we took a look.  It has.  Kanter did, pointing out that under §2311(d), "the FDCA and its implementing regulations govern the labeling at issue here."  122 Cal. Rptr.2d at 797 (applying §2311(d) to monograph drug).  Section 2311(d) was also cited in dismissing MMWA claims against other nonprescription drugs in Dayan v. Swiss-American Products, Inc., 2017 WL 9485702, at *9 (Mag. E.D.N.Y. Jan. 3, 2017), adopted, 2017 WL 1214485 (E.D.N.Y. March 31, 2017) (suntan lotion), and Mahoney v. Endo Health Solutions, Inc., 2016 WL 3951185, at *8-8 (S.D.N.Y. July 20, 2016) (fluoride tablets).  Given the more intense FDA regulation of prescription medical products, their exclusion from the MMWA should be a fortiori from the non-prescription product cases.

So now there are three reasons (at least) that MMWA claims involving drugs and medical devices (both prescription and nonprescription) should be dismissed - and none of them involve professional wrestling.

This article is presented for informational purposes only and is not intended to constitute legal advice.