Source: http://newslawonline.blogspot.com/2016/01/
Timestamp: 2019-04-24 18:55:43+00:00

Document:
Once upon a time there was a federal judge . . . . When we were little, we liked it when our mom spun free-form fairy tales for us. We would contribute the object of the "was" ("Once upon a time there was a . . . bullfrog"), and she would make up the rest as she went along. Which is fine for mommies, but less so for federal judges, as today's (very short) case illustrates.
In Fay v. Depuy Orthopedics, Inc., et al, 2015 U.S. Dist. LEXIS 175344 (D.N.D. June 11, 2015), plaintiff's hip was replaced with a metal-on-metal hip system. The system consisted of various components, two of which were at issue: the femoral head and the acetabular cup. Both components come in various sizes, but, for the system to work correctly, matched sizes of the two components must be implanted in the patient.
In Fay, it was undisputed that Plaintiff received mismatched components and had to undergo revision surgery. One of the defendants was a distributor that marketed and sold the system. Plaintiff's surgeon testified that two specific sales reps employed by the distributor were always in the operating room when he implanted that particular hip system. According to the surgeon (who was not sued), the reps were responsible, based on a process called "templating" of the patient's x-rays, for placing an appropriate range of sizes of the two components on a table in the operating room before the surgeon arrived. From the prepared template, the surgeon would determine what size acetabular cup would be implanted, and would ask for that size cup and the correspondingly-sized femoral head. The sales reps were allegedly responsible for selecting the components from the implant table, verifying for both that they had pulled the size the surgeon requested, and handing the packaged components to the circulating nurse, who unpacked them and placed them in the sterile field. In the absence of sales reps, the circulating nurse would be responsible for selecting the correct sizes of components.
The distributor moved for summary judgment, arguing that there was no evidence that its sales reps were ever actually in the operating room on the day of the plaintiff's surgery, as the intraoperative report, in which the circulating nurse was responsible for recording the names of everyone in the operating room, omitted any mention of sales rep participation. Plaintiff argued that the nurse had simply forgotten to include the names of the sales reps, and the surgeon took an affidavit swearing that he never implanted this system without the assistance of his chosen reps.
Wrong. Glossing over the legal vacuum to (silently) superimpose an imaginary duty, the judge held that there was a genuine issue of material fact as to whether the reps were present for the surgery, and denied summary judgment. We shake our figurative head on several levels. First, call us old-fashioned, but we're pretty sure a plaintiff shouldn't be able to maintain a lawsuit when she has no legal claim, and that it wasn't the defense's burden to find precedent affirmatively rejecting nonexistent duties. Second, on a more personal level (we represent device manufacturers), we are horrified at the notion that a judge can "make up" a duty that could subject sales representatives to liability for a surgeon's conduct in an operating room. In any event, we can only hope that one federal judge in the District of North Dakota will come to his senses as the case progresses. And that all will live happily ever after.
Still working on technical blog problems, so here's another email.
The demise of the New Jersey Accutane litigation under the new mass tort judge continues apace. Today 31 more Accutane cases were dismissed for failure to establish warning causation under the learned intermediary rule. The order is here, but the actual opinion is about halfway through the PDF, so keep looking, you'll find it.
It's worth looking for, too.
In each claim, there was a "willing patient" who only thought differently upon acquiring new information via the litigation process. Because the doctors, in each and every instance, testified that even with a different warning they still would have prescribed the medicine, the manufacturer's duty is fulfilled. Because the warning is directed to the prescribing physician, she/he is afforded the opportunity to engage in "hindsight" and opine on what they would have done had they known then what they knew at the time of their deposition, Plaintiffs are not afforded an opportunity at "hindsight."
Slip op. at 9. In only one case was summary judgment denied, without prejudice, because a deposition hadn't been completed. Id. at 11-12.
Choice of law was no obstacle. These plaintiffs all chose to come to New Jersey and asked for New Jersey law, so they got what they asked for. Id. at 9-10. Ask for a New Jersey mass tort, and you get New Jersey law. Next time, plaintiffs, be more careful what you ask for. But since the learned intermediary rule is virtually universal, even under other states' law (Kansas, Louisiana, California, Texas) the result is the same. Page after page of the slip opinion (pp. 11-36) consist of minor variants on the theme of no change in prescribing behavior equals no causation.
"Many rules amendments are modest and technical, even persnickety, but the 2015 amendments to the Federal Rules of Civil Procedure are different. Those amendments . . . address the most serious impediments to just, speedy, and efficient resolution of civil disputes." 2015 Report at 4.
The amendments "focus discovery − the process of obtaining information within the control of the opposing party − on what is truly necessary to resolve the case" and "address serious new problems associated with vast amounts of electronically stored information." Id. at 5.
"The amended rules . . . mark significant change, for both lawyers and judges, in the future conduct of civil trials. Id.
"The amendments may not look like a big deal at first glance, but they are. That is one reason I have chosen to highlight them in this report." Id.
"Rule 26(b)(1) crystalizes the concept of reasonable limits on discovery through increased reliance on the common-sense concept of proportionality. . . . The amended rule states, as a fundamental principle, that lawyers must size and shape their discovery requests to the requisites of a case. Specifically, the pretrial process must provide parties with efficient access to what is needed to prove a claim or defense, but eliminate unnecessary or wasteful discovery." Id. at 6-7 (block quote from Rule 26(b)(1) omitted).
"The 2015 civil rules amendments are a major stride toward a better federal court system. But they will achieve the goal of Rule 1 . . . only if the entire legal community, including the bench, bar, and legal academy, step up to the challenge of making real change." Id. at 9.
"[T]he 2015 civil rules amendments provide a concrete opportunity for actually getting something done." Id. at 11.
The Chief Justice's 2015 Report was among the authorities cited in Kissing Camels Surgery Center, LLC v. Centura Health Corp., 2016 WL 277721 (Mag. D. Colo. Jan. 22, 2016), medically-related (but not drug/device) litigation involving claims – and counterclaims – between four surgical centers and some of the largest health insurers in Colorado. The lead plaintiff, Kissing Camels, is located in Colorado Springs, which accounts for the unusual name (a rock formation). Very briefly, the subject matter of the lawsuit involves health insurance reimbursements, which vary depending on whether the health care provider is in the insurer's network.
All documents relating to any meeting, discussion, or conversation (whether in person, by telephone, or via e-mail) between you and [a third-party defendant] in which a payor, including [defendants], is directly or indirectly mentioned or referenced.
Id. The "definitions" accompanying this request only made things worse – "including, without limitation, any [long list], or any other person(s) acting or purporting to act with or on behalf of the foregoing." This kind of scattershot approach doesn't cut it any longer. "[T]here appears to be no attempt by Defendants to tailor the discovery request to issues arising from this case." Id.
On the other hand, the plaintiffs' objections to this discovery were "no better."
Boilerplate objections are improper. The responding party has the obligation to explain and support its objections. As far as this court can tell, Plaintiffs fail to provide any specificity to their objections, including their objection that they have already produced responsive documents. Rather, it appears that Plaintiffs' response simply points generally to the production of 1 terabyte of information − conservatively, millions of pages − without providing any type of guidance to Defendants as to where in the production such responsive documents are to be found.
This distinction between a party's obligations with respect to ESI and traditional, hard copy documents permeates the Rules. . . . ESI, and therefore, its treatment, is distinct from hard copy documents. The newly amended Rule 37(e) also distinguishes ESI from other discoverable information.
2016 WL 277721, at *3 (citations omitted). "[P]arties, by mutually agreeing to transmit discovery in ESI format, had chosen to have Rule 34(b)(2)(E)(ii) govern the production." Id. "[P]arties requesting ESI [are] able to organize it themselves − in their own way, to their own satisfactory level of thoroughness, and at their own expense. Id. at *4 (citation and quotation marks omitted).
the volume of the document production to date, the asymmetry of information regarding the production between Plaintiffs . . ., the duration of time during which this case has been pending, and the fact that the Parties suggest that additional discovery must be conducted as to [new] claims.
Id. The court would not require page-specific designations "for every Request for Production" because of the gross overbreadth of those requests. Instead, proportionality required prioritization. Defendants could "identify ten limited categories of documents" that had been subject to the boilerplate "already produced" objections. Id. For those ten categories only, "Plaintiffs must identify bates ranges of responsive documents." Id.
This will ensure that Defendants prioritize their requests regarding location of responsive documents within the 1 terabyte of data, and will limit Plaintiffs' obligation to sort through the production on Defendants' behalf and correlate every Request for Production to specific bates ranges.
Moral of story: The new rules require courts to confine discovery "within a proper scope," but producing parties must likewise facilitate that process with "objections [that] are appropriate" and not boilerplate. Id.
Kissing Camels is thus the second case we're aware of that, since the amended rules became effective, has actually restricted discovery due to proportionality concerns. See also State Farm Fire &amp; Casualty Co. v. Gates, Shields &amp; Ferguson, P.A., 2015 WL 8492030, at *4-5, 7 (Mag. D. Kans. Dec. 10, 2015) (contract action between insurer and law firm).
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Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the plaintiff's assertions that the device lacked proper FDA clearance was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).
A lot of you were interested. That post has received over 1000 hits.
The other shoe has now dropped.
[Lohr's] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
531 U.S. at 532-33 (Lohr citation omitted) (emphasis original). "The conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted." Estes, 2016 WL 211691, at *1 (citation and quotation marks omitted).
Plaintiff's claims here are premised on [defendant's] failure to submit a standalone 510(k) premarket notification. . . . [Plaintiff] contends that the [product] should not have been available for use because it was not cleared by the FDA, and that [defendant] was negligent in releasing the system without proper FDA clearance or fraudulently concealed that fact. . . . Accordingly, Plaintiff's fraud claim is based and premised on [defendant's] alleged violation of the FDCA. Plaintiff's fraud claim solely arises out of the alleged violation of the FDCA, not state substantive law. Thus, Plaintiff's claims are preempted.
Id. at *2 (citations omitted). That's about as straightforward as one can get. If, when the FDCA is removed from the picture, the basis for the state-law claim goes away as well, then there never was any claim to start with. Buckman sees to that.
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This isn't how you normally expect to receive our Drug and Device Law blogposts, but we have technical glitches (that we're still trying to work through), and those glitches mean that our new posts have not been distributed to our subscribers since January 14th. We apologize profusely for that. Until we've straightened this out, you may want to visit the blog itself to get our daily new content. As a stopgap we've captured our most recent posts here to make sure you received them. If you can take the time to catch up – especially those of you in the Eastern part of the U.S., who are likely homebound for the next 24-48 hours, be our guest. We hope to have the blog issues worked out by next week (fingers crossed), but until that happens, you may receive the occasional email from us. We appreciate your patience as we work through these issues.
Happy reading and those affected by the storm, stay warm!
Nash is an intelligent, socially-conscious man of diverse talents that include painting and photography. Among the tidbits revealed in the headphone-accessible interview clips interspersed throughout the exhibit was the fact that he is also a serious collector of memorabilia. He seeks to acquire items that capture the seminal moments of significant political and musical events. (For example, his collection includes a piece of the fence that rings the grassy knoll in Dallas.) In today’s case (see – we told you!), a minor cautionary tale from the Mississippi Supreme Court, the seminal moment in the demise of the plaintiff’s case occurred 120 days after she filed her First Amended Complaint. While rock-and-rollers can often flout the rules, it’s always a good idea for lawyers to follow them, as this case demonstrates.
A month later, plaintiff filed a Second Amended Complaint (“SAC”) without seeking leave of court or permission of the defendants. Plaintiff served all three named defendants with the SAC. The doctor and the medical center answered the SAC. After unsuccessfully removing the case to federal court, Hologic filed a motion to dismiss plaintiff’s claims against it. The trial court granted the motion, holding that: 1) the SAC should be struck because it was filed without leave of court, in violation of Mississippi rules; and 2) plaintiff’s claims against Hologic were barred by Mississippi’s three-year statute of limitations. Plaintiff appealed, whereupon ensued a battle over the correct interpretation of Mississippi R. Civ. P. 15(a).
Rule 15(a) provides that “a party may amend a pleading as a matter of course before a responsive pleading is served” but otherwise must obtain leave of court or written consent of adverse parties. Plaintiff argued that her right to amend her complaint without leave or consent started over each time she filed a new complaint. Thus, although the doctor and the medical center had filed answers to the original complaint, they hadn’t answered the FAC, so, she argued, she could file the SAC without leave or consent. The court disagreed, holding that, “while no defendant had responded to the new claims in the FAC, [plaintiff] no longer had a right to amend as a matter of course after responsive pleadings were filed to the original complaint, and leave of court or permission from all defendants . . . was required to file the SAC.” Meeks, 2015 Miss. LEXIS 610 at *9. The court concluded that the SAC was improperly filed and must be dismissed, emphasizing that any other result would give plaintiff “a rubber stamp to repeatedly amend her complaint, therefore giving her an unfair advantage.” Id. at *13.
The court next turned to the trial court’s conclusion that the FAC was also improper because it was barred by Mississippi's three-year statute of limitations. The court noted that the FAC was filed two days before the three-year anniversary of plaintiff’s discovery of her injuries, tolling the statute of limitations. However, the court explained, “[w]hile the filing of a complaint tolls the statute of limitations, if service is not made upon the defendant within 120 days . . . , the limitations period begins running at the end of the 120 days.” Id. at *15 (citation omitted). Because plaintiff never served Hologic with the FAC, the statute resumed running at the end of the 120-day period. Only two days were left in the statutory period, and it expired with Hologic still unserved. Despite plaintiff’s arguments to the contrary, the court held that this reality was not altered by plaintiff’s service of the SAC on Hologic within the 120-day service window for the FAC. Since the SAC was filed in violation of the Mississippi rules, it was a nullity, and service of it was irrelevant.
Plaintiff next argued that the statute of limitations wasn’t implicated because Hologic received a copy of the FAC within the 120-day period, as was evident when it attached the copy to its Notice of Removal. The court emphasized, “Regardless of whether Hologic received a copy of the FAC . . . , [plaintiff] didn’t serve the FAC upon Hologic. Proper service is required to toll the statute of limitations.” Id.
Finally, plaintiff argued that the FAC related back to the date of the filing of her original complaint. The court explained that, under Miss. R. Civ. P. 15(c), a claim relates back to the original pleading when it arises out of the conduct set forth in the original pleading. However, when the amendment adds a new defendant, it only relates back if it is served upon the new defendant within 120 days of the filing of the original complaint. Plaintiff never served the FAC upon Hologic, and therefore obviously didn’t effect such service within 120 days of the filing of the original complaint. That didn’t end the inquiry, however. The court explained that “courts also inquire into whether the opposing party had been put on [timely] notice regarding the claim or defense raised by the amended pleadings.” Id. at *18 (citation omitted). In this case, Hologic wasn’t put on such notice until “314 days from the filing of the original complaint, well after the 120-day time period required by Rule 15(c). Id. Thus, there was no “relation back,” and plaintiff’s claims against Hologic were time-barred.
Simple stuff. Read the rules. Know how they have been construed and applied. And, while you’re at it, Teach Your Children Well.
This post is not from the Reed Smith side because they are too involved in the mesh litigation to comment. Here is a link to today’s opinion in Cisson v. C.R. Bard, Inc., No. 15-1102 (4th Cir. Jan. 14, 2016). The plaintiff’s verdict in Cisson was affirmed.
[Drug and Device Law] Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?
As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label use/promotion. Just about all our readers know that Bexis has been a long-time First Amendment advocate with respect to truthful off-label speech, since the beginning of this blog, and before.
We’re not going to rehash any of that. There are, however, a couple of new First Amendment developments that we learned about at the conference that we want to pass along. The first is that the Ninth Circuit (or at least a panel of that notably fractious court) has fallen into line behind Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), and recognized that Sorrell strengthened First Amendment protections for commercial speech – at least where it’s truthful, which is the assumed cornerstone of our position on off-label promotion in the first place.
The new case is Retail Digital Network, LLC v. Appelsmith, ___ F.3d ___, 2016 U.S. App. Lexis 140, slip op. (9th Cir. Jan. 7, 2016). It’s not about drugs, devices, or the FDCA, but rather about alcoholic beverage advertising. At issue was another absolute ban on commercial speech that failed to take truth or falsity into consideration. The state of California, in order to prevent kickbacks and other preferential treatment (taking the state’s professed interest at face value), flatly prohibits manufacturers of alcoholic beverages from any paid advertising at retail establishments. Id. at *2-3 (citing Cal. Bus. & Prof. C. §25503(f)-(h)). Almost 30 years ago the Ninth Circuit held this provision constitutional under the pre-Sorrell commercial speech test established in Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557 (1980). See Actmedia, Inc. v. Stroh, 830 F.2d 957 (9th Cir. 1986). Retail Digital, however, held that Sorrell toughened First Amendment protections. The Actmedia decision was “clearly irreconcilable” with Sorrell, because “Sorrell requires heightened judicial scrutiny of content-based restrictions on non-misleading commercial speech regarding lawful products, rather than the intermediate scrutiny” of Central Hudson. Retail Digital, 2016 U.S. App. Lexis 140, at *3.
Consistent with Sorrell’s plain language, we rule that Sorrell modified the Central Hudson test for laws burdening commercial speech. Under Sorrell, courts must first determine whether a challenged law burdening nonmisleading commercial speech about legal goods or services is content- or speaker-based. If so, heightened judicial scrutiny is required.
Id. at *17-18 (citing Sorrell, 131 S. Ct. at 2664). Such more exacting scrutiny can be conducted within the Central Hudson framework, but the third prong of a “heightened scutiny” analysis now requires the government to establish that its restriction will alleviate “real” harms “to a material degree.” Id. at *19. Likewise, the beefed-up fourth prong now mandates that “the government bears a heavier burden of showing that the challenged law ‘is drawn to achieve [the government's substantial] interest.’” Id. (quoting Sorrell, 131 S. Ct. at 2667-68).
Sorrell and Actmedia are clearly irreconcilable. . . . Sorrell modified the Central Hudson analysis by requiring heightened judicial scrutiny of content-based restrictions on non-misleading advertising of legal goods or services. . . . Thus, Actmedia’s overall analytical framework of intermediate scrutiny cannot be reconciled with Sorrell’s framework of heightened judicial scrutiny.
Id. at *24-25 (citations and quotation marks omitted).
Like the alcohol advertisement ban in Retail Digital, the FDA’s off-label promotion ban is a content-based and speaker-based flat prohibition of commercial speech without regard to its truth. The “content” (or “topic” as phrased in Reed v. Town of Gilbert, 135 S. Ct. 2218, 2227 (2015)), is off-label use – a completely legal and commonplace medical practice. The targeted speakers are FDA-regulated manufacturers and their personnel. Everybody else, including idiot bloggers, can advocate whatever off-label use they want for whatever reason they want.
The upshot of Retail Digital is that United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015), are, if anything, conservative First Amendment decisions post-Sorrell. While they both cited Sorrell, their Central Hudson analyses reflected only the usual Central Hudson “intermediate scrutiny,” rather than more rigorous “heightened scrutiny” under Sorrell. Caronia, 702 F.3d at 165-68; Amarin, 2015 WL 4720039, at *24-26. These cases’ Central Hudson analyses includes no statements, or citations (as appear in Retail Digital), indicative that anything beyond application of the usual Central Hudson criteria took place. In Caronia, for example, the court found the first two Central Hudson prongs “easily satisfied” and that the latter two required only that “the regulation directly advance the government's interests and be narrowly drawn” – which is plain vanilla Central Hudson. 702 F.3d at 165-66.
The United States’ claims are premised on allegations that defendants’ off-label promotion of the . . . devices for the treatment of [an off-label use] was not solely truthful, but rather was misleading and false. The FDCA does prohibit untruthful off-label promotion. The First Amendment does not protect off-label promotion that is false or misleading.
United States v. Vascular Solutions, Inc., No. SA-14-CR-926-FB, slip op. at 5-6 (W.D. Tex. Nov. 16, 2015) (citations omitted).
Doctors may use medical devices that have been approved or cleared for one use for another use that has not been cleared or approved by the FDA. This is often referred to as unapproved use or off-label use. This is not illegal. It is also not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.
DoJ Proposed Jury Instructions, United States v. Vascular Solutions, Inc., at 31 (W.D. Tex., filed Jan. 7, 2016) (footnote omitted) (emphasis added).
Has anybody else seen the United States government make such a statement in a filed court document before? We haven’t. Heck, this isn’t too far from a jury instruction that we might submit – we don’t use “unapproved use,” of course (only “off-label”), we’d say “legal,” rather than “not a crime,” in a civil suit, and we don’t think “wholly” adds anything, but otherwise the legal proposition is what we’ve (at least Bexis) been arguing for decades.
All told, January 7, 2016, was a very good day for truthful off-label promotion. The ACI Promotional Review Summit wasn’t bad either, since attendees learned about both of these recent developments – and now we’ve told you.
Occasionally, a qui tam action grabs our attention. Usually because it would seek to penalize off-label use. Anything that shuts that down deserves a mention here.
Qui tam plaintiffs seek damages under the False Claims Act based on allegations that a defendant caused the submission of false claims to the government. In some cases, plaintiffs have tried to turn allegations of off-label promotion into false claims cases, such as United States ex rel. Colquitt v. Abbott Labs, 2016 U.S. Dist. LEXIS 1556 (N.D. Tex. Jan. 7, 2016). The case involves vascular stenting procedures in which biliary stents were used – off-label. Id. at *4.
Plaintiffs’ off-label use argument goes like this. Under the Medicare Act, to be reimbursed, the device must be “reasonable and necessary” for diagnosis or treatment. Id. at *9. To qualify as “reasonable and necessary” the device “must be affirmatively determined by the [FDA] to be safe and effective.” Id. at *9-10. Because the FDA has not determined the safety and effectiveness of the off-label use to which the device was put, the device is not eligible for Medicare coverage. Id. at *10. So essentially, plaintiffs’ theory is a ban on off-label use where government health insurance is involved. Plaintiffs want the court to say that off-label use is across the board “not reasonable,” “unnecessary,” and/or “experimental.” As we’ve seen time and time again, however, off-label use is often the standard of care. Medicine leads, regulations follow.
Fortunately, the court rejected plaintiffs’ extreme position that FDA safety and effectiveness determinations are dispositive on Medicare eligibility. The FDA’s review of a device is a not a “substitute” for an insurance eligibility determination. Of more significance, “lack of FDA approval or clearance for a specific use does not categorically disqualify a device from Medicare coverage.” Id. at *13. Maybe it was plaintiffs’ complete overreaching that made this such an easy call for the court. Maybe it was the growing precedent for this proposition (cited in Colquitt). Either way, it’s an important holding from the case.
The rest of the case is more nuanced about Medicare claims and ultimately the court denied both parties' summary judgment motions finding disputed facts on both sides. So, if you’re a qui tam person, you might want to take a peek at the whole decision. If you’re not, the take away is yet another attempt to criminalize off-label use is thwarted.
Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards. As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).
The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a). Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.” 361 P.3d at 871 (citations omitted). See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).
So why are we telling you this? We’re not the food blog, after all. Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.
What interests us most about Quesada isn’t actually the result (which is bad enough), but the court’s discussion of the presumption against preemption. That’s even worse, but apparently isn’t entirely the fault of the California court. Rather, the fault lies at the doorstep of Justice Kennedy. We pointed out a couple of years ago that: (1) the Supreme Court split 4-4 in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), on whether any such presumption existed at all, with Justice Kennedy not voting on the issue; and (2) that in a concurring opinion in Arizona v. Inter Tribal Council, 133 S. Ct. 2247, 2260-61 (2013), Justice Kennedy had questioned the need for a “presumption” in the context of federalism concerns over preemption.
The Quesada decision is illuminating in its detailed discussion of what has happened since regarding the presumption against preemption, and we’re afraid that Justice Kennedy could be headed south on the issue.
In recent years, the continuing vitality of the nearly 70-year-old presumption against preemption has come into question. Four Supreme Court justices have called for its abandonment. [citing CTS Corp. v. Waldburger, 134 S. Ct. 2175 (2014) (concurring opinion), Mensing, and Altria Group, Inc. v. Good (2008) 555 U.S. 70 (2008) (dissenting opinion) – all joined by Roberts, CJ, and Scalia, Thomas & Alito, JJ.] However, this view has yet to command a majority. Nor is it clear those justices arguing for presumptionless preemption analysis would apply that approach to obstacle preemption. CTS Corp. and Altria Group were express preemption cases, while [Mensing] was a conflict preemption case. The separate opinions in the two express preemption cases limited their call for a repeal of the presumption to cases interpreting express preemption clauses, while the conflict preemption case offered a theory of interpretation arguably applicable only to cases where compliance with state and federal law would be impossible. In contrast, both Chief Justice Roberts and Justice Scalia have continued to sign opinions employing the presumption in obstacle preemption cases [citing Hillman v. Maretta, 133 S. Ct. 1943 (2013)], while Justice Alito has complained of the court’s “giv[ing] short shrift to our presumption against pre-emption” in another obstacle preemption case [citing Arizona v. United States, 132 S. Ct. 2492 (2012) (concurring and dissenting opinion].
For now, the original source of the presumption [citing Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947)], and the countless cases that have followed it remain the law. Justices Kennedy, Ginsburg, Breyer, Sotomayor and Kagan still endorse and apply a presumption. [citing, inter alia, CTS, 134 S. Ct. at 2188-89 (Kennedy plurality opinion).
Quesada, 361 P.3d at 878-79 (other citations and footnote omitted) (emphasis added). The Quesada reference to a post-Mensing opinion written by Justice Kennedy asserting a presumption against preemption dismayed us, so we took a look at the CTS case.
Although the natural reading of [preemption clause’s] text is that statutes of repose are excluded, the Court finds additional support for its conclusion in well-established “presumptions about the nature of pre-emption”. . . . The effect of that presumption is to support, where plausible, a narrow interpretation of an express pre-emption provision.
CTS, 134 S. Ct. at 2188-89 (citations and quotation marks omitted). It’s dictum of course, since the Court had already ruled against preemption on the basis of the statute’s “natural reading,” but to some extent that makes what happened in CTS even worse, since Justice Kennedy went out of his way to invoke a presumption against preemption in a case where he didn’t have to.
Thus, the optimism we expressed last year when we noticed that the Supreme Court had not relied on any presumption against preemption in a decision rejecting field preemption (Rice was a field preemption case), may well prove to be misplaced. See Oneok, Inc. v. Learjet, Inc., 135 S. Ct. 1591 (2015). Sadly, we may still have the presumption against preemption to kick around for some time to come (at least until Justice Kennedy changes his mind again).

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