JUUL: The unregulated killer of teens for profit!

How the FDA missed a deadly corporate marketing campaign–AGAIN!

MASS TORT NEXUS MEDIA (September 23, 2019) 

  • Juul’s popularity was fueled by the company’s social media marketing that featured attractive young people in fun, trendy settings
    A report by Stanford University researchers concluded that Juul’s launch marketing was “patently youth oriented” and “subsequently Juul’s principal advertising themes have been closely aligned with that of traditional tobacco advertising.”

Why is Juul so popular among teens?

Although Juul demands age verification upon navigating to its website and holds a firm stance against minors’ use of Juuls, these vapes are still wildly popular with teens.

Depending on the state, no one under 18 or 21 is supposed to be able to purchase e-cigarettes or any tobacco products. But according to a report from the CDC, e-cigarette use is rising among middle school and high school students, and more than 3.5 million of them used e-cigarettes in 2018.

  • Juul delivers massive doses of nicotine, putting youth users at greater risk of addiction
    The manufacturer has stated that each Juul “pod” (cartridge of nicotine) delivers as much nicotine as a pack of 20 cigarettes. However, research by Truth Initiativehas found that many young Juul users don’t know the product always contains nicotine.
  • Nobody ever disclosed this comparative and now there are thousands of addicted young people who had no clue.
  • In addition to the patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL.

Advertising is part of the problem. According to the CDC, more than 18 million high school and middle school students combined were exposed to e-cigarette ads in 2014. And Stanford researchers point out that Juul’s marketing hasn’t been congruent with its adults-only stance.

One can guess it’s so popular for a few reasons:

  • It’s relatively inexpensive: You can buy Juul’s “starter kit,” which includes the e-cigarette, USB charger and four pods for $50. After that, packs of four pods cost $21.
  • It’s discreet:People may be more inclined to use Juul because its compact design is easy to hide from parents, teachers and other authority figures.
  • It doesn’t smell like a cigarette:Cigarette smoke permeates the air in a relatively large radius. Juuls, on the other hand, don’t give off the smell of tobacco or smoke.
  • It comes in many flavors: Juul’s sweet flavor options make it a more palatable option than regular cigarettes and many other e-cigarette options. One CDC survey notes that 31 percent of survey respondents(all students in grades 6 to 12) chose e-cigarettes because of  “flavors such as mint, candy, fruit, or chocolate.”

The explosive popularity of Juul and others like it among kids is particularly troubling because they often do not see it as harmful. A report showed that 63% of people aged 14 to 25 aren’t even aware that vaporizers like Juul contain nicotine at all.

To a remarkable degree, a single company is front and center in one of the biggest public-health crises facing the country: the sharp rise in vaping among teenagers and young adults. In 2018, 30% of the nation’s 12th-graders reported vaping nicotine at least once in the past year, according to a January 2019 study sponsored by the National Institute on Drug Abuse. The study said the increase in vaping last year was “the largest ever recorded for any substance in the 44 years” that it has tracked adolescent drug use.

The issues have escalated recently. More than 530 people in the US have been either hospitalized, and seven have died from vaping and developing mysterious lung injuries, according to the CDC. Both the FDA and the CDC are working together to find potential causes.

  • Top Juul Labs investor Altria has lost $31 billion in market value since April, when the Food and Drug Administration launched a new investigation into vaping.
  • Altria bought a $12.8 billion stake in Juul back in December.
  • A litany of setbacks have weighed on Juul and Altria since, including a growing number of illnesses and deaths related to vaping and e-cigarette use. 

Top Juul Labs investor Altria Group has gone down in smoke since the Food and Drug Administration launched a new probe into vaping in April.

The traditional tobacco company has seen $30 billion in market valuation since the FDA announced a new investigation into the link between vaping and seizures. That translates to roughly one-third of Altria’s market value wiped out. For context, the S&P 500 has climbed 5% over the same period.

Altria is vulnerable to such negative developments in the vaping space after paying $12.8 billion in December for a major stake in Juul, a leading vape company responsible for roughly 70% of the e-cigarette market. The company’s products are particularly popular with teens

Given the possible risks to the nation’s youth, Juul’s rapid growth has been accompanied by remarkably little oversight or regulation. And while there is a legitimate debate over whether e-cigarettes are safer for adult smokers than traditional cigarettes, and whether they can help addicts quit smoking, critics argue that Juul has assiduously followed Big Tobacco’s playbook: aggressively marketing to youth and making implied health claims a central pillar of its business plan. Juul maintains that it is not Big Tobacco 2.0. In eight months, unless e-cigarette companies can prove to the FDA that vaping is “appropriate for the protection of public health,” the products could be pulled from the market. That would curtail youth use, but some fear it could also cut off adult smokers’ access to a potentially beneficial product.

Vaping has become one of the biggest public health issues of our time, and at the center of it is San Francisco-based e-cigarette company Juul. While there are many nicotine vapes on the market, Juul has gained popularity (especially among teenagers) for its sleek design and easy-to-use pods. Even after the company was forced to shutter its social media presence while the FDA investigated concerns that Juul was promoting underage use of tobacco products, Juul continues to prove popular with rising sales and affectionate nicknames, such as the “iPhone of vaporizers.”

But what is a Juul, and is it safe to use one? Here’s everything you need to know about Juul, including what’s in the e-juice, the long-term health effects and how Juul compares to regular cigarettes.

What is Juul?

Juul is like many other e-cigarettes, but with a couple of caveats that set it apart. First, this vape is sleek and hardly noticeable: Its USB-drive design can be enclosed in the palm of a hand, and it doesn’t produce a massive plume of vapor like some other e-cigarettes. Second, the nicotine content in its cartridges, or “pods,” set a new precedent for the e-cigarette market.

E-cigarettes work by converting liquid nicotine into a vapor that the user inhales. They’re battery-operated and intend to provide a similar stimulus to that of smoking regular cigarettes.

Developed by two former smokers, Juul’s mission is to “improve the lives of 1 billion adult smokers by eliminating cigarettes.” One way the company encourages the switch from cigarettes to Juul is with its Juul calculator, where people can estimate how much money they’d save if they used a Juul instead.

Juul vs. other e-cigarettes: What’s the difference?

Juul’s high nicotine content used to be an anomaly in the e-cigarette market, but now researchers note it seems to be the rule. After Juul’s surge in popularity, other e-cigarette manufacturers began bumping up the nicotine content in their products.

Juul uses a closed system, which means users can’t refill the pods themselves, a helpful factor for quality control.  Some e-cigarettes, such as the Suorin Drop, use open systems that allow users to refill the vape themselves with bottles of e-liquid or e-juice.

Juul’s small size, compact design and minimal plume make it more discreet than many other brands. With no buttons or switches — just disposable, snap-on cartridges — Juul is simple, and its built-in temperature regulation prevents you from experiencing a “dry hit.” Dry hits occur when vape cartridges get too low on liquid or when they overheat, producing a burnt taste and throat irritation.

What are the main ingredients in Juul pods?

The Juul comprises two parts. There’s the e-cigarette itself, which contains the battery, temperature regulator and sensors that read the charge level. Then there’s the pod, which contains Juul’s patented e-liquid formula. A mixture of nicotine salts, glycerol, propylene glycol, benzoic acid and flavorings.

  • Glycerolserves as a humectant, which means it adds moisture to the solution. Glycerol is classified as “generally recognized as safe” by the FDA, so it’s approved for consumption.
  • Propylene glycolis a synthetic compound commonly used in polyester production, but it’s also approved as an additive for food, cosmetic and pharmaceutical products.
  • Benzoic acidoccurs naturally in many plants, but its synthetic form is also widely used as a food additive and preservative. It’s “generally recognized as safe” for those uses, but can be an environmental and health hazard in large quantities.
  • Flavoringsis an ambiguous term, but most often refers to various natural and synthetic ingredients that companies use to flavor their products. For example, Juul doesn’t specify what’s in its mint-flavored pod, but it probably contains peppermint extract or oil.

The nicotine salts in Juul vape juice are a type of nicotine that supposedly feels more like a cigarette when inhaled, as opposed to other vapes that use freebase nicotine. Freebase nicotine, which can cause coughing and leave a film in people’s throats, is harsher and commonly found in cigars.

Juul pods currently come in eight flavors; cucumber, creme, mint, mango, menthol, fruit, Virginia tobacco and classic tobacco. It’s worth noting that the FDA’s Family Smoking Prevention and Tobacco Control Act banned flavored cigarettes in 2009, so it’s possible that this might come into play for vapes one day, too.

How much nicotine is in a Juul pod?

Juul measures nicotine content by weight, which is different from most brands, which usually measure by volume. Juul originally only sold pods with 5% nicotine by weight, but started offering 3% pods in August 2018.

According to an older version of Juul’s FAQ page, one 5% pod contains roughly the same amount of nicotine as one pack of cigarettes, or about 200 puffs. However, this information is no longer available on Juul’s website, and there’s no precise information about 3% pods, either. However, an article in the New England Journal of Medicine says that the 5% pods contain a concentration of 59 milligrams of nicotine per milliliter of liquid.

In contrast, prior to the Juul frenzy most vapes contained roughly 1 to 3% nicotine by volume. A study in the journal Tobacco Control notes that the new average seems to be rising to that 5% mark. Juul’s creators increased the nicotine because they felt other vapes on the market couldn’t compare to the sensations delivered by regular cigarettes.

An older version of Juul’s FAQ page disclosed precise information about the nicotine content in Juul pod—But, his information is no longer on the site.

 

 

 

 

 

 

 

 

 

Is Juul addictive? Is Juul more addictive than cigarettes?

Nicotine is a known addictive substance, and Juul is no exception. There are currently no studies that prove whether or not Juul is more addictive than regular cigarettes, simply because e-cigarettes are a relatively new phenomenon. However, I certainly know people who seem as addicted to their Juul as they are to their iPhones, and I’ve watched friends throw fits when their pod runs dry.

Nicotine is a harmful drug, regardless of delivery method. It’s linked to various changes in the body and brain, and public health officials worry that most people, especially youths, aren’t aware of the potential consequences.

What are the health effects of vaping?

People incorrectly consider vaping a safer alternative to smoking because it eliminates tobacco, which is a known carcinogen. But cigarettes contain many chemicals beyond tobacco, and e-cigarettes contain some of the same. Much of this is based on false-marketing by the tobacco companies.

Studies have detected acetamide (a compound used in industrial solvents), formaldehyde and benzene (another known carcinogen) in various e-cigarettes brands.

Not all e-cigarette liquids contain all of these toxic compounds, and even in those that do contain them, the concentration isn’t always high enough to cause concern. One study looked at the benzene formation of Juul and two other vaping systems versus traditional cigarettes, finding that traditional cigarettes present a higher risk of benzene exposure. However, the study authors note that the benzene exposure created by e-cigarettes is not negligible — that is, there’s still a health risk.

Another study looked at adolescents who use e-cigarettes and found that their urine contained significantly higher amounts of five different chemicals, compared to adolescents who never use e-cigarettes.

Another issue arises when companies don’t disclose what’s in their products. Juul openly states its e-liquid ingredients, but research has found that e-cigarette products aren’t always labeled accurately, which can cause people to inhale more nicotine and chemicals than they think they’re breathing in.

Nicotine is a highly addictive substance that causes cravings and bona fide withdrawal symptoms when those cravings are ignored. Whether or not vaping is a “gateway” to cigarette smoking is irrelevant because vaping itself is an addictive habit.

Nicotine isn’t just addictive, but it’s also toxic. It stimulates your adrenal glands, spiking adrenaline production and leading to a series of bodily reactions: People who use nicotine experience a release of glucose and an increase in heart rate, breathing rate and blood pressure.

The drug seems to act as both a stimulant and a depressant at the same time, as it’s linked to increased alertness but also increased relaxation.

Use of nicotine is also associated with a number of side effects on organs and organ systems, including:

  • Increased risk of blood clots
  • Atherosclerosis
  • Peptic ulcers
  • Changes in heart rhythm
  • Lung spasms

Nicotine can also alter or harm the development of the brain in children and teens.

“The prefrontal cortex, the area of the brain responsible for decision-making, logic, personality expression and many other traits integral to one’s personality, is not fully mature until around the age of 25,” Dr. Lawrence Weinstein, chief medical officer of American Addiction Centers, told CNET. “Introducing nicotine to the brain 10 years prior to that, without speaking of the massive amount of nicotine contained in each cartridge, will undoubtedly alter that developing brain.”

Looking beyond nicotine, using e-cigarettes — Juul or otherwise — comes with many health risks, including the possibility for seizures, heart attacks, lung damage and birth defects.

Dentists have also been noticing that their patients who vape are experiencing more cavities, tooth damage and dental issues. Especially when it comes to the enamel on your teeth, once damage is done it cannot be reversed.

Lastly, e-cigarettes work by heating a liquid into an aerosol that the user inhales. While the amount of aerosol in a single puff isn’t likely to harm anyone, it’s worth noting that inhaling aerosols is associated with impaired judgment and functioning.

As for the long-term health effects of Juul and other vapes, doctors and scientists aren’t sure yet. E-cigarettes are too new for health professionals to make any correlative claims like they can with traditional cigarettes. But with so much research in progress, new claims will certainly surface.

What’s the FDA’s stance on Juul?

Well, the FDA hasn’t monitored Juul very well at all, permitting the teen marketing campaigns to run amok at will. never considering whate “tobacco compinies might do, once again” given the opportunity to craete addicts and and make maoney at the same time. In April 2018, the FDA demanded that Juul submit marketing and research documents, and explain what Juul knows about the use of its products among teens. A month later, as part of the FDA’s Youth Tobacco Prevention Plan, the agency also requested information from several other e-cigarette manufacturers. And in October 2018, the FDA visited Juul’s San Francisco headquarters to gather information on the company’s sales and marketing tactics.

Despite the fact that selling tobacco products to minors is illegal, the FDA has so far uncovered 40 violations for illegal sales of Juul products to young people. Warning letters were issued for those violations. The company also shut down its Facebook and Instagram accounts in November 2018 to avoid promoting its product to teens and nonsmokers — two groups that Juul specifically says it does not want to become customers.

In a statement, FDA Commissioner Scott Gottlieb said, “…the nicotine in these products can rewire an adolescent’s brain, leading to years of addiction.”

But, he continues: “Make no mistake. We see the possibility for electronic nicotine delivery systems (ENDS) products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less-harmful alternative for currently addicted individual adult smokers … But we’ve got to step in to protect our kids.”

The FDA continues to monitor Juul and vaping in general, recently calling Juul out for marketing the device as safer than it really is, as well as investigating the 120-plus vape-related seizure cases.

The Centers for Disease Control and Prevention (CDC) isn’t a fan of Juul or other e-cigarettes, either. The CDC says outright that e-cigarettes aren’t safe, especially for children and teens, and is currently investigating cases of lung disease associated with vaping.

While federal government bodies have been warning people about the health risks of vaping for years, e-cigarette use has become such an epidemic that state and local government bodies are finally taking note. San Francisco — the headquartering city of Juul — became the first city to ban e-cigarette sales completely.

How did Juul get its start?

Juul Labs spun off from Pax Labs in 2015. Founders Adam Bowen and James Monsees co-founded the company when, as former smokers, they decided they wanted a better alternative to cigarettes than anything that was already on the market.

Their idea of “better” manifested as Juul’s high nicotine content and slim design that gives off very little vapor compared to other vapes. Since its debut, Juul has grown to dominate more than 50 percent of the market share.

In December 2018, Altria — one of the world’s largest tobacco products companies — bought a 35% stake of Juul for $12.8 billion dollars. Altria owns Phillip Morris, which owns the brands Marlboro, Virginia Slims, Parliament and other cigarette brands.

Juul copycats

Candy- and dessert-flavored e-juice is enticing to kids who might be otherwise turned off by vaping or smoking.

Zonk E Liquid

Juul’s staggering success prompted many e-cigarette brands to follow suit with high nicotine content and new designs. The FDA isn’t happy with these copycat brands, and neither is Juul, which filed a complaint with the US International Trade Commission for patent infringement.

Everyone should be concerned about copycat Juuls, especially those that openly market to children using enticing flavors like Blue Slushie Lemonade and strawberry whipped cream.

The attributes of these vapes — attractive, compact and free of odor — make them popular with young people because they can easily hide them from authority figures, like teachers and parents.

Juul’s popularity and the influx of similar products raises concern that this new “pod mod” class of e-cigarette products is not just a trend and will influence the decisions and habits of adolescents for their entire lives.

Staying true to its stance on nicotine use among minors, Juul announced that it is going after companies that do market to children and teens, but the FDA warns that this is an ongoing battle that now carries over into the courtrroms across the country.

The JUUL litigation is heating up very quickly and just as Bayer AG soon realized the Mosanto purchase included the now staggering stock-droping Roundup litigation; Altria will quickly see that the $30 billion JUUL buy-in was just the start of a massive litigation debacle that was and will be based on corporate greed and ingmnoring the dangers of yet another drug.

 

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OPIATE MDL 2804 RICO CLAIMS STAY IN BELLWETHER TRIAL NEXT MONTH: Opinion /s/Dan Aaron Polster September 10, 2019

“TRIPLE DAMAGES AND ATTORNEYS FEES NOW PART OF DEFENSE TRIAL PREP”

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF OHIO

EASTERN DIVISION

 

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION

 THIS DOCUMENT RELATES TO:

 All Cases

MDL 2804

)     Case No. 1:17-md-2804

)     Judge Dan Aaron Polster

)     OPINION AND ORDER REGARDING

)     DEFENDANTS’ SUMMARY

)     JUDGMENT MOTIONS ON RICO AND OCPA

 

Before the Court are two related motions for summary judgment filed by Defendants regarding Plaintiffs’ claims under the Racketeer Influenced and Corrupt Organizations (RICO) Act 18 U.S.C. § 1961 et seq. and Ohio’s Corrupt Practices Act (OCPA),1 Ohio Rev. Code § 2923.31 et seq.. They are: (1) Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and (2) Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims. (Doc. #: 1930). Only the RICO and OCPA portions of these motions are addressed in this opinion and order.2 Plaintiffs filed an omnibus response (Doc. #: 2182) and Manufacturers and Distributors each filed a Reply (Doc. ##: 2533 and 2547, respectively). Plaintiffs’, with leave of the Court, filed a Sur-Reply (Doc. #: 2500). For the reasons set forth below, Defendants’ summary judgment motions are DENIED.

1 “Ohio’s RICO statute, O.R.C. § 2923.31 et seq., is patterned after the federal RICO statute. Thus, courts “have found that the elements for an [Ohio RICO] violation are the same as those for a [federal] RICO claim.” Robins v. Glob. Fitness Holdings, LLC, 838 F. Supp. 2d 631, 651 (N.D. Ohio 2012) (citing Foster v. D.B.S. Collection Agency, 463 F.Supp.2d 783, 811 (S.D.Ohio 2006)).

2 The Manufacturers’ arguments regarding Civil Conspiracy are addressed in a separate opinion. (Doc. #: 2562).

1.

The Court hereby incorporates the legal standards set forth in the Court’s Opinion and Order regarding Plaintiffs’ Summary Judgment Motions Addressing the Controlled Substances Act, see Doc. #: 2483.

II.

Under the RICO statute, it is “unlawful for any person employed by or associated with any enterprise . . . to conduct or participate, directly or indirectly, in the conduct of such enterprise’s affairs through a pattern of racketeering activity.” 18 U.S.C.A. § 1962. Defendants articulate two principal arguments for summary judgment on Plaintiffs’ RICO and OCPA claims: (1) no evidence of any enterprise and (2) no evidence of causation. Distributors also advance a threshold argument regarding their alleged racketeering activity, which the Court addresses first below.

The RICO statute expressly lists those violations that constitute predicate acts of racketeering activity. See 18 U.S.C.A. § 1961(1). Distributors assert, in a footnote,3 that the Magistrate   Judge’s   Report   &   Recommendation—finding   that   a   violation   of   21 U.S.C.

  • 843(A)(4)(a) can constitute a predicate act—is “wrong as a matter of law.” Dist. MSJ on RICO at 16 n.14 (Doc. #: 1921-1). No party objected to the Magistrate’s finding and it was subsequently adopted by the Court. See Dec. 19, 2018 Order re MTD Summit (Doc. #: 1203). Although the Magistrate Judge expressed that “whether § 842, § 843, or neither was violated is ultimately an issue of fact that cannot be resolved  on  a  motion  to  dismiss,”  Summit  R&R  at  46-47  (Doc. #: 1025), Distributors here do not meaningfully develop any factual bases that convince the Court either to conclude as a matter of law that Distributors did not violate § 843, or to revisit itsprior legal conclusion (that such a violation, if committed, can constitute racketeering activity). In fact, Distributors acknowledge they drafted their summary judgment motion based on the assumption that “the failure to report a suspicious order can constitute a predicate act of racketeering  for  purposes  of  RICO  and  the  OCPA.”  Dist.  MSJ  on  RICO  at  16  n.14  (Doc. #: 1921-1) (emphasis added). Thus, the Court reaffirms its legal conclusion that a violation of 21 U.S.C. § 843(A)(4)(a) can constitute a predicate act under 18 U.S.C. § 1961(1)(D); and the Court further concludes that, at a minimum, Distributors have failed to demonstrate there is no genuine dispute of material fact regarding whether they violated § 842, § 843.

3 It appears that Distributors only raise this argument in a footnote as an aside to their primary argument that, to the extent their alleged failure to report suspicious orders constitutes a racketeering activity, it did not cause Plaintiffs’ injuries. The broader causation elements of Distributors’ argument are addressed further below.

Distributors also imply for the first time in their reply brief that, because Plaintiffs argue in opposition to summary judgment that “Distributor Defendants flatly failed in their obligation not to ship suspicious orders” pursuant to 21 U.S.C. § 823(b), that Plaintiffs abandoned their prior assertions of various categories of racketeering activity including mail fraud, wire fraud, and failure to report suspicious orders (as a potential violation of § 843). Pls. Opp. Resp. re RICO & Civ. Con. at 114 (Doc. #: 2182) (emphasis in original). As stated above in footnote 3, Distributors’ arguments regarding the viability of Plaintiffs’ assertions of predicate acts was made in the broader context of their proximate causation arguments. Thus, Plaintiffs response, which was intended to address proximate cause and not predicate acts, was appropriate under the circumstances. The Court does not construe Plaintiffs’ opposition response as disclaiming any assertion of predicate acts previously made and argued.

A.  The Existence of An Enterprise

“[A]n association-in-fact enterprise is ‘a group of persons associated together for a common purpose of engaging in a course of conduct.’” Boyle v. United States, 556 U.S. 938, 946 (2009) (quoting United States v. Turkette, 452 U.S. 576, 583 (1981)). To satisfy the enterprise requirement, “an association-in-fact enterprise must have at least three structural features: a purpose, relationships among those associated with the enterprise, and longevity sufficient to permit these associates to pursue the enterprise’s purpose.” Id. The concept of an enterprise is intended to be broad and “[s]uch a group need not have a hierarchical structure or a ‘chain of command’; decisions may be made on an ad hoc basis and by any number of methods.” Summit R&R at 36 (Doc. #: 1025) (citing Boyle, 556 U.S. at 944). The Court has previously observed that “[a]n enterprise includes any group of individuals associated together for a common purpose of engaging in a course of unlawful conduct.” Robins, 838 F. Supp. 2d at 651.

Of course, just because an enterprise’s common purpose may include unlawful conduct does not mean the enterprise’s common purpose must be unlawful. In fact, both the Supreme Court and the Sixth Circuit have made clear that the purpose of the enterprise need only be common to its members, and “must be separate from the pattern of racketeering activity in which it engages.” Frank v. D’Ambrosi, 4 F.3d 1378, 1386 (6th Cir. 1993) (citing Turkette, 452 U.S. at 583). That is, if a group of individuals associate together for the common purpose of committing a series of unlawful acts (and those unlawful acts are also RICO predicate acts), the common purpose is not separate from the pattern of racketeering activity, and there is no RICO violation (there is likely just a conspiracy to commit a crime). If, however, the series of unlawful acts is not the ultimate goal of the group of individuals, but instead merely an unlawful method to achieve that goal, then the enterprise can be described as “separate from the pattern of racketeering activity in which it engages,” and may constitute a RICO violation. Id. There is no requirement, however, that the ultimate goal also be unlawful.

Defendants assert there is no evidence of coordination sufficient to form an association in fact. The Court has already concluded, however, that Plaintiffs have produced sufficient evidence for a reasonable jury to conclude that all Defendants, which includes RICO Marketing Enterprise Defendants and RICO Supply Chain Enterprise Defendants, associated together for the common purpose of expanding the prescription opioid market. See Order Re Civ. Con. (Doc. #: 2562). Plaintiffs have produced evidence to raise genuine issues regarding whether and to what extent the various Defendants coordinated (relationship prong) with one another to expand the opioid market and protect the supply chain (common purpose prong), and that it has been going on long enough to pursue the common purpose (longevity prong). Id. at 6-10. Thus, Defendants have not shown an absence of any essential element as described in Turkette and Boyle such that no reasonable jury could find the existence of an enterprise.

Defendants also assert there is no evidence that they directed or controlled the enterprise. The Supreme Court has said that, “[i]n order to ‘participate, directly or indirectly, in the conduct of such enterprise’s affairs,’ one must have some part in directing those affairs.” Reves v. Ernst & Young, 507 U.S. 170, 179 (1993). The Sixth Circuit further clarified that, “[a]lthough Reves does not explain what it means to have some part in directing the enterprise’s affairs, subsequent decisions from our sister circuits have persuasively explained that it can be accomplished either by making decisions on behalf of the enterprise or by knowingly carrying them out.” United States

  1. Fowler, 535 F.3d 408, 418 (6th Cir. 2008). Thus, in order to show that a Defendant “conduct[s] or participate[s], directly or indirectly, in the conduct of such enterprise’s affairs,” Plaintiffs must show that Defendants made decisions or knowingly carried out acts that helped to further the common purpose of the enterprise. 18 U.S.C.A. § 1962(c).

In its September 3, 2019 Opinion and Order regarding Civil Conspiracy, the Court reviewed the evidence produced by Plaintiffs and determined that various decisions made and actions taken by Manufacturers and Distributors ‒ which, again, include the Marketing Enterprise and Supply Chain Defendants ‒ are sufficient to create a genuine issue of material fact as to whether these Defendants conspired with one another to expand the opioid market and protect the opioid supply chain. See Order re Civ. Con. at 6-10 (Doc. #: 2562). The Court now concludes that these same facts create a genuine issue as to whether Marketing Enterprise and Supply Chain Enterprise Defendants participated in the conduct of these enterprises’ affairs. Defendants have failed to demonstrate that no reasonable juror could conclude, based on the evidence, that they did not.

B.  Causation

 Defendants also assert Plaintiffs have produced no evidence that the alleged predicate acts are causally tied to Plaintiffs alleged RICO injuries. The Court has addressed Defendants causation arguments at some length. See Summit R&R at 24-36 (Doc. #: 1025); Order re MTD Summit at 7-10 (Doc. #: 1203); Order re Causation (Doc. #: 2561). In all instances, the Court has concluded that Plaintiffs will be allowed to test their aggregate theory of causation and have produced enough evidence to raise a genuine dispute  of  material  fact.  See  generally,  Order  re  Causation  (Doc. #: 2561).

C.  Other Arguments

 Manufacturers also assert that RICO damages are not available, as a matter of law, for the marketing of their branded products. Manufacturers assert their marketing was independent, competitive behavior and not the conduct of the enterprise. This argument appears to confuse the alleged common purpose of the enterprise with the alleged pattern of racketeering activity. Plaintiffs have alleged that the purpose of the Marketing Enterprise was to expand the opioid market and that the pattern of racketeering activity by which they accomplished this goal was the use of mail and wire communications in the fraudulent marketing of prescription opioids. Defendants’ argue that their alleged unlawful conduct (fraudulent marketing of opioids), cannot— at the same time—benefit both them individually (increasing market share) and the enterprise collectively (expanding the opioid market). Defendants, however, cite no case law that persuades the Court that racketeering conduct cannot serve both the member and the enterprise at the same time.

Finally, Manufacturers assert Plaintiffs have not done enough to demonstrate that their alleged RICO damages do not flow from the personal injuries of their citizens. In its Opinion and Order adopting the Magistrate Judge’s R&R on the motions to dismiss, the Court concluded that Plaintiffs had sufficiently alleged “categories of costs . . . that cannot be said to arise directly out of Plaintiffs’ residents’ personal injuries.” Order re MTD Summit at 16-17 (Doc. #: 1203). Defendants’ argument now urges the Court to reconsider its supposedly too-broad application of Jackson v. Sedgwick Claims Mgmt. Servs., Inc., 731 F.3d 556 (6th Cir. 2013).4 The Court declines to do so.

Accordingly, Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims (Doc. #: 1930) are both DENIED.

IT IS SO ORDERED.

  

/s/Dan Aaron Polster September 10, 2019

DAN AARON POLSTER

UNITED STATES DISTRICT JUDGE

 

 

 

 

 

 

 

 

 

 

 

 

4 Notably, Manufacturers do not assert that the Court’s application is incorrect; merely that it is broad. See Man. MSJ on RICO & Civ. Con. at 27 (Doc. #: 1930-1).

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