This post is from the non-Reed Smith side of the blog.

Have you ever told someone, “I’ll put it in the vault” or “not that there’s anything wrong with that”?  Or yelled “Serenity Now!” in a chaotic situation.  How about offered someone a “you are so good looking” after a sneeze?  If not, you probably still know who we mean by Jerry, Elaine, George and Kramer.  But, if you did answer yes to anyone of those questions, you probably also know Newman, Frank and Estelle, Tim Whatley, Mr. Pitt, Puddy, Jackie Chiles, Crazy Joe Davola, and Uncle Leo with no further introduction.

It’s been off the air for 15 years, but Seinfeld left such an indelible mark on pop culture that certain phrases and quotes bring us right back to the mid-1990s:  Soup Nazi, The Human Fund, shrinkage, stopping short.  We all became much more familiar with the babka and the marble rye.  And, after seeing them on the show, we knew we had met one of these people in real life: the close talker, the high talker, the low talker, the re-gifter, and the double-dipper.  Thanks to Seinfeld we know about anti-dentites, that soup isn’t really a meal, and that “schmoopie” married George Stephanopoulis.

And when it comes to skimming over part of a story, nothing is as effective as “yada yada yada.”  Of all the famous Seinfeldisms, the Paley Center named “Yada Yada Yada” the No. 1 funniest phrase on “TV’s 50 Funniest Phrases.”  So how did Seinfeld propel this rather ordinary saying that dates back to at least vaudevillian times into a pop culture phenomenon?   Because the gag on Seinfeld was what was being yada yada’d.  To most people, the phrase was used to skip mundane, uninteresting or repetitive details in a story.  But George’s girlfriend used it to gloss over habits such as shoplifting and skipping out on checks.  Ah, the beauty of Seinfeld.

Well, we are doing some yada, yada’ing ourselves today in the context of discussing the latest InFuse decision – Harris v. Medtronic, Inc., 2014 WL 866063 (Cal. Super. Feb. 27, 2014) (no pagination provided).  And, in our case we’ll come right out and tell you what we’re skipping – another discussion of Coleman v. Medtronic, Inc. You can read all our thoughts on that case here.    Taking a lesson from Seinfeld and George’s succinct girlfriend, we’re opting not to re-hash the many reasons we don’t like Coleman.  And, instead focus on some of the good we found in Harris; namely its rejection of our other two least favorite Infuse decisions — Ramirez v. Medtronic, Inc., 2013 WL 4446913 (D. Ariz. Aug. 21, 2013) and  Alton v. Medtronic, Inc., 2013 WL 4786381 (D.Or. Sep. 6, 2013).

Harris, being a California trial court decision, is of course bound by that state’s appellate court decision in Coleman.  So, plaintiff Harris got to keep her negligence and strict liability claims premised on a failure to file adverse event reports and her negligence claim premised on off-label promotion, but not her strict liability off-label promotion claim.  Yada, yada, yada.

The Harris court was faced with additional claims, however, not considered in Coleman.  First up – design defect.  Here, the plaintiffs relied heavily on Ramirez, which the court noted is the only Infuse decision to allow a design defect claim to proceed as not preempted.  Recognizing it as the outlier it is, the Harris court rejected the underlying premise of Ramirez that when a device is used off-label it is “effectively a different device than the one for which a PMA had been secured” and therefore the FDA has not established requirements applicable to the specific device at issue (the first step in Riegel preemption).  Instead, the court ruled:

Allowing Plaintiffs’ strict products liability design defect claim to proceed would permit a finding that a design defect rendered the Infuse device unreasonably dangerous even if Medtronic complied with all FDA regulations addressed to design. That would constitute imposition of requirements on the design of the device in addition to those mandated by the FDA through the PMA process.

The clear rejection of Ramirez in California is good news.

Next – fraud.  Again the Harris court refused to follow Ramirez, opting instead to apply the analysis used in Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206 (W.D. Okla. 2013) – discussed in our Infuse post here.   That’s more good news.

To the extent Plaintiff’s fraud claims are based on alleged misrepresentations and omissions in the actual warnings and labels accompanying the Infuse device, such claims are expressly preempted.  . . . To the extent Plaintiffs’ fraud claims are based on alleged misrepresentations and/or omissions regarding its practice of marketing off-label applications of the Infuse device, such as in reports to the FDA, such claims are impliedly preempted under Buckman, as such a claim is in substance a claim for violating the FDCA.

(citations omitted).  Even more good news, the court was unwilling to adopt the reasoning of Alton. Part of the ruling in Alton was that plaintiff’s fraud claim escaped preemption because it fit in “the second category of parallel claims contemplated in Lohr and its progeny, as a claim premised on conduct that contravenes state-law duties of such generality as not to present any risk of interference with the federal medical-device regulatory scheme.”  Alton, 2013 WL 4786381 at *27.  The Harris court disagreed with this reading of Lohr:

The court is unaware of any other decision in which Lohr has been interpreted as establishing two separate categories of parallel claims. . . .  Lohr does state that U.S.C. section 360k does not preempt State or local requirements that are “equal to, or substantially identical to, requirements under the act.”  This language comes directly from 21 CFR sections 808.1(d)(2) and 808.5(b)(l)(i), both of which have to do with the procedures to be followed by States and localities in applying for an exemption from Federal preemption for a particular requirement. Section 360k itself says only that a requirement “which is different from, or in addition to, any requirement applicable under this chapter to the device, and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter” is preempted. In fact, the Lohr court’s discussion of the regulations was to illustrate that there were no State or local requirements at issue in that case that fell within the intended preemptive scope of section 360k(a). This portion of Lohr, however, cannot reasonably be read to mean that a requirement must be “substantially identical” in order to be “parallel.” Nor can the so-called “second category of parallel claims” articulated by the Alton court be reconciled with Riegel, which, while not expressly disapproving Lohr, clearly held that the concept of State or local “requirements” includes common law duties.  Accordingly, the court will not follow the trail blazed in Alton to decide whether Plaintiffs’ fraud claims are “genuinely equivalent” to applicable federal requirements for purposes of the express preemption analysis.

(citations omitted).  That’s a mouthful, but we like it.

But here is where we can get back to more yada yada’ing.  The court ultimately decides that “a state law fraud claim based on fraudulent statements made to promote off-label uses of a device are genuinely equivalent to a claim of misbranding under applicable federal law” and that therefore there is the possibility plaintiff could state a claim for fraud that is not preempted.  This is in line with the majority of Infuse decisions.  So, the last question is whether plaintiff pled this fraud claim with sufficient particularity to withstand a motion to dismiss.  The Harris court, somewhat hesitantly, said yes. Noting it was a “close call,” that the allegations of reliance “are far weaker,” and admonishing that success on the claim will require “proof of an actual link between [plaintiff and/or her surgeon] and the allegedly fraudulent promotional information and materials,” the court nevertheless ruled that for pleading purposes, plaintiff’s allegations were sufficient.

Following Coleman we have to look for bright spots in California where we can, and this is one of them.  The detailed reasoning by the Harris court and its rejection of the Infuse outliers leaves us feeling somewhat satisfied.   We may not be celebrating a Fesitvus quite yet, but the decision is also no Urban Sombrero.