A bit of background – the defendant’s product is a really cool way of injecting vaccines without the need for needles (millions of little kids, and their parents, will be eternally grateful), and also without the infection potential inherent in needles. See Riley v. Becton Dickinson Vascular Access, Inc., 913 F. Supp. 879 (E.D. Pa. 1995) (one of Bexis’ first medical device cases). We don’t claim to understand all the technology, but the device uses some sort of spring-loaded form of jet injection to push vaccines and other medicines directly through the skin. Anyway here’s a background article, if anyone’s interested.
The injector was FDA-cleared, but unfortunately most vaccines (other entities' products) were labeled only for needle injection. Thus, using the defendant’s product was a different “method of administration,” making it – GASP! – an off-label use. In October, 2011, the FDA issued two “communications” – only the “updated” one is still on the website, here – stating that the manufacturers of the vaccines had not studied this new form of injection. See 2012 WL 380186, at * 2 (discussing FDA communique). It was typical FDA-speak . The Agency did not suggest that there was anything wrong with the new technology, only that “[d]ata to support the safety or effectiveness of inactivated influenza vaccines delivered by jet injector have not been submitted to FDA.” Indeed, the FDA specifically stated (twice) that there was no reason for anybody to get vaccinated a second time:
Based on limited information from recent publications using currently licensed inactivated influenza vaccines, FDA and the Centers for Disease Control and Prevention (CDC) believe that it is not necessary for people who received their influenza vaccine via jet injector to be re-vaccinated.
Doctors, of course, are perfectly free to use any medical device they want off-label. 21 U.S.C. §396. The FDA admitted that what studies there were showed “comparable” effectiveness – but those studies were, of course, limited.
As far as we can tell from the opinion (since none is mentioned), the defendant never received so much as a warning letter from the FDA.
Didn't matter. Within days, a putative class action gets filed under – of course – the local consumer protection statute (this time, Ohio’s). Reeves, 2012 WL 380186, at *2. The plaintiff alleged he got a flu shot with jet injection. The class itself was far more ambitious – seeking to apply the Ohio statute extraterritorially, to every person in the country who got any medication (not just a flu shot) through jet injection. The would-be class consisted of:
all other persons similarly situated, throughout the United States, who are domociled [sic] in one of the fifty states, including Ohio, and who are consumers who received ANY vaccine or drug with a PharmaJet injector device where the specific vaccine or specific drug does not have the stated approval by the FDA for administration with a “needleless injector” or “needle-free injector,” also know [sic] as “jet injectors”.
2012 WL 380186, at *1 (N.D. Ohio Feb. 3, 2012) (emphasis added).
The relief sought was not quite as impressive – but equally overreaching. “Plaintiff seeks the establishment of a national prospective clinical study of all people who received a flu shot via jet injection.” Id. at *2. Anybody who caught the flu (other vaccines/drugs seemed to fall by the wayside) would receive medical monitoring monthly (the Ohio Supreme Court has never recognized medical monitoring in any context – let alone as a remedy for consumer fraud). Essentially, the plaintiffs demanded free insurance, from the injector manufacturer, even though the vaccines themselves are nowhere near 100% effective – 75% at best, according to the Centers for Disease Control.
On top of all that, nothing in the complaint alleged that the purported class representative ever came down with the flu. 2012 WL 380186, at *1. Can you say "atypical" (the court didn't, as it never had to reach certification issues)?
Fortunately, this monstrosity never made it past the starting gate. The court granted the defendant’s motion to dismiss.
First, the court saw the action for what it was – a prohibited attempt by private plaintiffs to enforce the FDCA:
The FDCA, however, does not provide a private right of action for violation of federal regulations. As set forth in the FDCA. . . . [T]he absence of a private right of action to enforce the FDCA means not only is a private party precluded from bringing suit to enforce the provisions of the FDCA, they also may not use other federal statutes or state unfair competition laws as a vehicle to bring a private cause of action that is based on violations of the FDCA. Thus, a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist.
2012 WL 380186, at *4 (citations and quotation marks omitted). This is as fine a statement of the no private enforcement principle as we’ve seen anywhere.
Despite the FDA’s lack of any enforcement activity (or even a revaccination recommendation), plaintiff claimed to be bringing a “parallel” claim under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). The court held otherwise, finding the claims to be “squarely within the parameters” of Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because the claims were 100% dependent upon the alleged FDCA violations, and thus impliedly preempted. 2012 WL 380186, at *4.
Sometimes really bad cases (defining “bad” as “meritless”) can make really good law.
And there’s more.
Reeves also found no valid claim under state law.
Plaintiff tried to package his FDCA claim as a consumer protection action – but not very effectively. For one thing, the Ohio statute (like many others) has a reliance/causation component to it. The purported off-label promotion statements were on the defendant’s website – that the plaintiff never visited. Of course, the plaintiff didn’t plead any sort of reliance, because that would tank any chance of class certification.
So the plaintiff ended up tanking his substantive claim instead:
Whether it be termed an issue of reliance or an issue of proximate cause, an appropriate rule is that where the defendant is alleged to have made material representations or misstatements, there must be a cause and effect relationship between the defendant's acts and the plaintiff's injuries.
Reeves, 2012 WL 380186, at *5 (citation and quotation marks omitted). The only advertising concerning jet injection that the plaintiff actually saw before getting vaccinated was by the store where the vaccine was offered, not by the defendant. Id. at *6.
As the coup de grace, the court also held that prescription medical devices were not “consumer goods” as required by the statute. “[Defendant’s] prescription medical device is not a good for personal, family or household use and thus is not a consumer good as defined by the [Ohio Act].” Id. at *6 n.2.
This last proposition is of particular interest, as many other (but not all) consumer protection statutes contain a similar “consumer” limitation. Reeves thus adds to this list of cases finding prescription drugs or devices not to be “consumer” goods covered by such statutes: Williams v. Purdue Pharma Co., 297 F. Supp.2d 171, 174-175 (D.D.C. 2003); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *10 (D. Me. 2003); 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) (applying Minnesota law); Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72, 86 (Cal. App. 2002); Stein v. Sonus USA, Inc., 2005 WL 6198234 (Ariz. Super. Sep. 8, 2005), aff’d, 150 P.3d 773 (Ariz. App. 2007).
Thanks to Dustin Rawlin of Tucker, Ellis & West for both winning the case and tipping us off.