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In re National Prescription Opiate Litigation

United States District Court, N.D. Ohio, Eastern Division

September 3, 2019




         Four sets of defendants, some overlapping, have filed separate motions for summary judgment on the issue of federal preemption of state law claims and federal preclusion of federal claims. The moving defendants are identified as follows: Non-RICO Small Distributors[1] (Doc #: 1873), several Pharmacies and Distributors[2] (Doc #: 1883), Manufacturers[3] (Doc #: 1926), and Generic Manufacturers[4] (Doc #: 1860). Plaintiffs filed a single opposition brief addressing Generic Manufacturers' motion (Doc #: 2251), and a consolidated memorandum of opposition addressing the other three motions (Doc #: 2171). The moving Defendants then filed reply briefs. (Doc ##: 2447 (Generic Manufacturers), 2455 (Manufacturers), 2465 (Non-RICO Small Distributors), 2467 (Pharmacies and Distributors)). This Opinion and Order addresses all four motions.


         The allegations underlying the Track One complaints, [5] as well as in much of this multidistrict litigation (“MDL”), have been accurately set forth by Magistrate Judge David A. Ruiz in the Summit County R & R (Doc #: 1025 at 3-11), the Muscogee Nation R & R (Doc #: 1499 at 8-14), and the Blackfeet Tribes R & R (Doc #: 1500 at 4-6). Most preemption issues raised in the four pending motions have already been raised, addressed, and ruled on as a matter of law in the three R & Rs, as set forth in greater detail below. Since no party filed objections challenging Magistrate Judge Ruiz's recommended rulings on the subject of preemption (Doc #: 1203 at 2; Doc #: 1680 at 28), they became rulings of the Court and the law of the MDL.

         A. Summit County R & R (Doc #: 1025).

         In Summit County, Manufacturer Defendants moved to dismiss all of Plaintiffs' state law claims, arguing they were preempted because they conflicted with decisions of the Food and Drug Administration (“FDA”) regarding approval and labeling of prescription opiates. Without repeating in great detail Manufacturers' arguments, they generally contended that: (1) state law claims involving the marketing of opioids were preempted when a claim would require a drug manufacturer to make statements about safety or efficacy in marketing materials that differed from what the FDA required; (2) state law claims involving off-label use were preempted because the FDA was invested with exclusive authority and a variety enforcement options existed to address off-label promotion; and (3) the diversion-monitoring theory advanced by Plaintiffs was preempted because state law would stand as an obstacle to the accomplishment and execution of the FDA's objectives.[6] In other words, Manufacturers argued that each of Plaintiffs' claims would undermine the FDA's decision to make prescription opioids available to the public and would also force Manufacturers to stop selling those drugs over concerns about liability.

         The Court declined to read Plaintiffs' allegations so narrowly. The Court found that the state law claims were “not premised upon inappropriate labeling or a fraud on the FDA, but rather fraudulent marketing in the promotion and sale of their opioids” (Summit R & R at 50); Plaintiffs were not seeking to enforce the provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”), but their allegations were “of the type that would traditionally be brought as state law claims [prior to the enactment of the FDCA]” (id. at 52);[7] and the argument that state law imposed a duty to monitor the sale of opioids with due care was not inherently “inconsistent with the purposes of the FDCA, and thus not preempted” (id. at 54).[8]

         B. Muscogee Nation R & R (Doc #: 1499).

         1. Manufacturers.

         In Muscogee Nation, Manufacturers asserted a new basis for preemption not briefed in the Summit County motion to dismiss.[9] Manufacturers argued that Plaintiffs' state law claims were preempted because it would be impossible for them to comply with federal law requirements and state law judgments arising from those claims. In support, Manufacturers narrowly construed Plaintiffs' claims as seeking label changes and cited the FDA's July 2012 response to a citizen petition from Physicians for Responsible Opioid Prescribing (the “PROP” Petition), which rejected PROP's proposed label changes, as “clear evidence” the FDA would not have approved Plaintiffs' purported label changes.[10]

         The Court agreed with Manufacturers that representations made in their marketing materials must be consistent with specific pre-approved labels submitted to the FDA; state law claims seeking to impose liability on Manufacturers for failing to include statements on their marketing materials regarding the correct dosage and duration of treatments were preempted; and any manufacturer that markets its product with FDA-approved warnings cannot be liable under state law for failing to issue different warnings if the manufacturer can show clear evidence the FDA would have rejected those different warnings.

         The Court also found it was unable to conclude the PROP letter satisfied Wyeth's clear-evidence standard for several reasons. Plaintiff was not seeking label changes; the Court could not rule on the preemptive effect of the FDA letter in the absence of a full record; and, more importantly, even if the Court were to agree with the argument the FDA letter had some preemptive effect, this would not preempt every theory of liability articulated by Plaintiffs, e.g., fraudulent marketing and the failure to monitor and prevent opioid diversion.

         2. Generic Manufacturers

         In Muscogee Nation, Plaintiffs contended that Generic Manufacturers had an obligation to send “Dear Doctor” letters to healthcare providers, warning them about the risks associated with opioid use, that the brand-name manufacturers failed to send. Generic Manufacturers countered that liability could not be imposed upon them under state law for failing to send such warning letters because that would violate the “sameness principle” - an FDCA requirement that generic medications must be the same as their branded equivalents in every clinically significant way, including labeling. The Court agreed with Generic Manufacturers, citing PLIVA v. Mensing, wherein the Supreme Court held that Dear Doctor letters qualify as “labeling” for purposes of the FDCA. 564 U.S. 604, 612 (2011). (Doc #: 1499 at 35-36.) Nevertheless, the Court found that preemption did not bar the state law claims “to the extent they were founded upon allegations the Generic Manufacturers engaged in aggressive and misleading marketing and inadequate anti-diversion activities.” (Id. at 42.)

         C. Blackfeet Tribes R & R (Doc #: 1500).

         1. Manufacturers.

         The arguments Manufacturers made in their Blackfeet Tribes motion to dismiss echoed arguments they made in Muscogee Nation, and the Court reaffirmed its rulings.

         2. Generic Manufacturers

         Generic Manufacturers asserted a new basis for preemption, not previously briefed. They contended that, by the very nature of a generic manufacturer's business model, they could neither market nor promote their opioids; thus, they could not be liable under state law for falsely marketing or promoting them. (Doc #: 1500 at 15.) Generic Manufacturers also argued the complaint contained no allegations they engaged in marketing, and accused Plaintiffs of improper group pleading without distinguishing between the various Generic Manufacturers, lumping together as “Marketing Defendants” both generic and brand-name manufacturers. (Id.)

         The Court recognized that, unlike the complaint in Muscogee Nation, the Blackfeet Tribes complaint did not contain specific allegations against Generic Manufacturers. (Id.) The Court concluded, however, that the complaint contained plausible allegations of fraudulent marketing and failure to monitor against all manufacturers, including Generic Manufacturers, and by “merely denying those allegations, the Generic Manufacturers created material issues of fact not suitable for resolution on a motion to dismiss.” (Id.)


         The Court incorporates by reference the summary judgment standard of review articulated in Doc #: 2483 at 2-4.


         A. Manufacturers MSJ (Doc #: 1926).

         On summary judgment, Manufacturers contend discovery has now made it “abundantly clear that Plaintiffs are pursuing preempted claims that challenge FDA-approved labeling for the Manufacturers' opioid medications.”[11] (Doc #: 1926-1 at 10.) Manufacturers contend that the FDA's 2013 reevaluation and rejection of PROP's proposed label changes, and a May 2019 FDA Memo declining to recommend limits on doses, now constitute “clear evidence” the FDA would reject Plaintiffs' purported label changes because it would be impossible for Manufacturers to comply with federal law and also defend state law claims. Furthermore, “[a]s this Court has recognized, the term ‘labeling' as used in the FDCA broadly encompasses representations made in marketing materials.'” (Id. at 11 (citing Muscogee R & R at 30)).

         The Court has previously rejected Manufacturers' narrow construction of Plaintiffs' allegations as effectively demanding nothing more than label changes, and does so again. Plaintiffs allege that Manufacturers, despite knowing the highly addictive properties of opioids, initiated a massive marketing campaign based on false and misleading information, causing a dramatic increase in opioid prescriptions, creation of a black market for opioids, enormous profits for Manufacturers, and the public health crisis we find ourselves in today. Plaintiffs allege Manufacturers engaged in a series of marketing strategies - funding pain advocacy groups, key opinion leaders, and continuing medical education courses - all to spread messages that the risk of addiction is manageable even for patients with a history of drug abuse, signs of opioid addiction are actually attributable to untreated pain (requiring more opioids), withdrawal can be easily managed, and the risk of addiction from chronic opioid therapy is rare. Despite Manufacturers' contention to the contrary, the Court has never held that the term “labeling” is so broad it encompasses the massive marketing campaign alleged here.

         Manufacturers recommend this Court follow State of North Dakota v. Purdue Pharma, LP, et al., No. 08-2018-CV-01300 (N.D. Dist. Ct. May 10, 2019). There, the court construed North Dakota's allegations (similar to those Plaintiffs assert here) as nothing more than challenges to Purdue's FDA-approved labels, and concluded it would be impossible for Purdue to comply with both state and federal law because the FDA's rejection of PROP's label changes constituted clear evidence the FDA would reject Plaintiffs' purported label changes. The district court also determined that Purdue's marketing scheme was consistent with its labels.

         There are several problems with this argument. First, Plaintiffs simply have not proposed any label changes. Second, there is no evidence the FDA approved or endorsed Manufacturers' campaign message that the risk of addiction is manageable for patients with a history of addiction problems, or that signs of opioid addiction are actually pseudoaddiction ameliorated with more opioids. Third, and more importantly, North Dakota is, by leaps and bounds, an outlier on the question of preemption.[12]

         Manufacturers also contend Plaintiffs' state law claims premised upon a fraud on the DEA are preempted. The Court has already ruled Plaintiffs' marketing-based claims are not premised on a fraud upon the DEA, and thus do not run afoul of Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001).” (Doc #: 1499 at 43 (citing Doc #: 1025 at 50-51).)

         Manufacturers assert that Plaintiffs' RICO claims “are based on the same allegations of inappropriate marketing and labeling that underlie their state law claims” and “Plaintiffs seek to impose liability under RICO for the Manufacturers' failure to make certain warnings that the FDA expressly rejected under the FDCA.” (Doc #: 1926-1 at 14.) This argument misrepresents Plaintiffs' allegations as previously noted and is rejected for the same reasons.

         B. Generic ...

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