Law

It's not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product.  A state-law plaintiff seeking such injunctive relief should bring about an almost Pavlovian response from the defense.  This is an opportunity to make headway on preemption and related issues.  Courts don't like to be in the business of invoking state law to override an FDA approval decision.  We can think of five cases that fit the pattern:  Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000); In re Paxil Litigation, 2002 WL 31375497 (C.D. Cal. Oct. 18, 2002); In re Celexa & Lexapro Marketing& amp; Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015); Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015); and most recently, Stevens v. Boston Scientific Corp., ___ F. Supp.3d ___, 2016 WL 328739 (S.D.W. Va. Jan. 26, 2016).

The first two of these cases, Bernhardt and Paxil, are both notable because they bothered the FDA enough that the government intervened, filing amicus curiae briefs urging preemption and primary jurisdiction as grounds for the respective courts to reject the proposed injunctions.  In Bernhardt, the plaintiffs sought injunctive relief under state law to force a manufacturer to make changes in its FDA-approved labeling and also to issue "Dear Doctor" letters that the FDA had not required.  The court agreed that the FDA had primary jurisdiction over what a drug's labeling (and DHCP letters) should say.  "Under the doctrine of primary jurisdiction, a district court may refer a matter within its original jurisdiction to the appropriate administrative agency if doing so will promote proper relationships between the courts and administrative agencies charged with particular regulatory duties."  Bernhardt, 2000 WL 1738645, at *2 (citation and quotation marks omitted).  Whether the results of a new study required a labeling change or a "Dear Doctor" letter are squarely within the expertise of the FDA:

[P]laintiffs ask this Court to determine, on the basis of presumably scientific and medical principles to be developed at an adversary preliminary injunction hearing, that the [study] findings warrant a notice to all [drug] users and their physicians.  The FDA, not this Court, has the relevant expertise.

Id.  For good reason, the court was uncomfortable with issuing the injunction that the plaintiffs were demanding:

[T]here is no opportunity for inconsistent interpretations of law.  There is, however, a substantial danger of a much more serious inconsistency.  An order by this Court directing [defendant] to issue the notices would not preclude the FDA from either issuing a second notice or requiring [defendant] to do so, thus creating the potential for inconsistent directions concerning a serious medical ailment and how it is best treated.

Id. at *3.

In Paxil, 2002 WL 1940708, plaintiffs actually got a little further.  On the first go-round, the court actually issued an injunction under state law against a manufacturer's continuation of FDA-approved advertising.  In re Paxil Litigation, 2002 WL 1940708 (C.D. Cal. Aug. 16, 2002).  After the FDA itself intervened, the district court reconsidered its order and rescinded the injunction.

While the Court is unwilling to blindly accept FDA's ultimate determination here, it has given careful consideration to the extensive fact-finding engaged in by FDA. . . .  Specifically, FDA has now presented evidence to the Court regarding not only the internal review process involved in the advertisements in question, but also its position that the advertisements are not misleading. . . .  [T]he Court finds FDA's evidence persuasive such that it changes the Court's evaluation of Plaintiffs' likelihood of success on the merits to a degree dictating that the preliminary injunction be denied.

Paxil, 2002 WL 31375497, at *2.

Fast forward to last year.  In Celexa, 779 F.3d 34, another California consumer fraud class action sought (in the context of an MDL) to enjoin the defendant from selling its drug in accordance with its FDA approval.  "In its prayer for relief, plaintiffs request that the court '[p]ermanently enjoin[ ] [defendant] from continuing to sell or market [the drug] with its current drug label and direct[ ] [defendant] to seek FDA approval of a new [drug] label.'  Id. at 38."  The trial court threw out the case due to the "safe harbor" for regulated activities read into the relevant California statutes.  Id. at 35.  The First Circuit didn't go there, but went someplace even better – as we discussed here − the result being the first post-Levine appellate decision finding preemption as to a branded drug because the warning change being demanded could not be accomplished by a changes being effected ("CBE") application to the FDA.  Because plaintiffs were only challenging the defendant's reading of the original studies on which the drug's approval was based, there was no "new information" on which a CBE application could have been based.  Id. at 43.  Claiming only that the underlying data originally submitted to the FDA was "questionable" and "flawed," plaintiffs' complaint "[e]xpress[ed] displeasure with federal law as well as the FDA."  Id. at 38.

Once again, the injunctive allegations were such that the court did not want to go there.  Instead, it found preemption:

Our review of the Supreme Court opinions . . . makes clear that a necessary step in defeating [defendant's] preemption defense is to establish that the complaint alleges a labeling deficiency that [it] could have corrected using the CBE regulation. . . .  The CBE procedure is only available to make changes that, among other things, are based on "newly acquired information". . . .  "[N]ewly acquired information" could be an increasing body of data of an inherent risk with the drug.  Or it could be new data from a clinical study evincing [the drug's] inefficacy. . . .  We have scrutinized the complaint itself to see if it might plausibly be read as relying on "newly acquired information" in contending that [defendant] could have changed its label through the CBE procedures. We find only two fleeting references to academic articles . . . [but] Plaintiffs make no claim that these two academic articles are based on new data.  They instead contend that these two studies . . . were not included in [defendant's original] submission to the FDA.

Celexa, 779 F.3d at 41-42 (citations omitted).  Once again, an overly ambitious injunctive request led the court to adopt an FDA-friendly defense.

The same thing occurred in Herazo, 2015 WL 4514510, only this time in the context of homeopathic products.  Such products are of questionable efficacy, but as we discussed here, the FDCA declared them legal in 1938, and that hasn't changed.  Once again plaintiffs sought to enjoin the distribution of a legal product under the FDCA on grounds of state (consumer protection) law.  This time, the court resorted to both preemption and primary jurisdiction, abstaining from deciding (most of) the merits, and shipping the thing to the FDA.  On preemption the court found a rather obvious conflict:

Plaintiffs' suit seeking to change the labeling requirements of Defendant's homeopathic medication conflicts with federal policy and should be impliedly preempted.  . . . [T]he Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration's ability to carry out its oversight of marketing of homeopathic products.

Herazo, 2015 WL 4514510, at *5.  Primary jurisdiction covered the rest:

Courts consider four factors when applying the doctrine of primary jurisdiction:  (1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory scheme that (4) requires expertise or uniformity in administration.  The [FDA] has the necessary experience and expertise in regulating labeling of homeopathic medication and it is within the Agency's purview to decide whether the labels are compliant with federal law and the comprehensive regulatory scheme it has devised. . . .  [G]iven the extensive regulatory scheme to oversee homeopathic drug marketing and the questions presented over the labels in this case, the Court finds abstention appropriate under the primary jurisdiction doctrine.  Having found the doctrine of primary jurisdiction applies, . . . [p]ending the referral to the Food and Drug Administration, the Court stays this case to avoid any prejudice to the parties.

Id. (citations omitted).  Once again, a court recoiled at the prospect of state law precluding the manufacturer of an FDA-approved product from marketing that product at all.

Stevens continues the trend.  Once again, the plaintiffs sought an injunction – this time under RICO as well as state consumer protection statutes – to prevent the defendant from selling a product that the FDA allowed to be marketed.  Plaintiffs made various allegations about how the defendant had violated and/or deviated from FDA requirements, but once again the court decided, in the face of a request that effectively would have removed the product from the market, to respect the FDA regime and let the FDA decide whether these allegations were true, and if so what to do about them.

Primary jurisdiction was the route taken in Stevens.  It was not the same as "exhaustion of remedies."  2016 WL 328739, at *4.  Primary jurisdiction "comes into play whenever [plaintiff's] claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body," even if the agency never had the matter submitted to it before.  Id. (citation and quotation marks omitted).  Likewise primary jurisdiction cannot be waived, and can even be raised sua sponte by a court.  Id.  Instead, "the doctrine exists for the proper distribution of power between judicial and administrative bodies and not for the convenience of the parties." Id.  "Uniformity" is an important consideration – we can't have some states banning products that the FDA allows to be marketed and others not.  Id.  So is "technical expertise."  Courts are competent to decide anything that is merely an issue of law, but not the application of the FDCA to a complex set of facts.  Id.

Oddly, after having boldly made a plethora of charges and sought not only an injunction, but a temporary restraining order, the plaintiffs in Stevens essentially ran and hid from the FDA once primary jurisdiction was raised:

[T]he plaintiff completely avoids any discussion of the FDA, its regulations or statutory authority, or its control over medical device issues in her Brief on Primary Jurisdiction.  Even more, the plaintiff does not refer to any of the safety issues that so permeated the Complaint and Motion for a TRO and for a Preliminary Injunction.

Stevens, 2016 WL 328739, at *6.  The ostrich approach not only didn't work, but probably made things worse for the plaintiffs, since they surrendered the administrative field to the defendant.  The court recognized that plaintiffs were effectively alleging product adulteration by another name.  However, "The FDA's domain includes authority to prevent or ameliorate the introduction of adulterated or misbranded drugs and devices into the market."  Id. at *7.

So, once again, off to the FDA these injunctive allegations go:

[M]any of the factual allegations contained in the Complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.  Congress established an extensive listing of prohibited acts under the FDCA. . . .  Further, the MDA, which establishes the expedited 510(k) clearance process, is enforced by the FDA − necessitating many specialized scientific determinations.  The FDA is in the best position to determine whether [defendant's product] is in compliance with the FDA's own statutes, regulations, and directives − particularly because the FDA was the very agency that cleared [that] device in the first place.

Stevens, 2016 WL 328739, at *7 (emphasis added).  In other words, if the FDA started this, it can damn well finish it.  Sounds good to us.

The moral of this story is this – whenever plaintiffs seek injunctive relief against the distribution of a product that has successfully cleared all relevant FDA-related hurdles to being marketed, defendants should roll out their best implied preemption and primary jurisdiction arguments.  This is prime turf for making good law.