Will the Recall of J&J Baby Powder Breathe New Life into Asbestos Litigation?

Will the Johnson and Johnson Talcum Powder Asbestos issue breath new life into “Asbestos Mesothelioma Practice Area”? The events of the past few days may lead one to believe that it is very possible that the need for plaintiffs lawyers to represent mesothelioma victims who allege their cancer was caused by Johnson and Johnson Talcum Powder, may breath new life into a practice area that was in decline.

On October 18, 2019 the FDA Announced” Johnson’s Baby Powder voluntarily recalled after testing positive for asbestos: Johnson & Johnson voluntarily recalled one lot of baby powder, after a sample tested positive for asbestos. The recalled product is Johnson’s Baby Powder Lot #22318RB. The lot number can be found on the back of the bottle, directly underneath the cap. https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products.

The FDA is inspecting other lots of Johnson & Johnson talcum powder and MTN expects further recalls to be forth coming.

Does the Problem End With A Single Lot?

Johnson & Johnsons problems are not likely to end with one or even a few recalled lots of baby powder.

It may (likely will be) possible to prove that Johnson & Johnson products, sold at specific retail locations over the past few decades contained asbestos. So, no, it is not likely that Johnson & Johnsons problems arising from a small number of recalled lots will represent the extent of their potential liability.

Would You Like to Be Ahead of the Curve This Time?

Attendees of the Mass Tort Nexus Four Days to Mass Tort Success Course (Friday, November 8 – Monday, November 11, 2019)  will receive and in depth presentation as well all of the information needed, including Qualifying and Disqualifying criteria, to start accepting Talcum Powder Mesothelioma Cases.  Contact Anne Marie Kopek a by email at annemarie@masstortnexus.com, or call her at 954-837-3432 for more information. You may also request course information by filling out the form at https://www.masstortnexus.com/Course/Enroll.

Qualifying (or disqualifying) Talc Mesothelioma cases will be particularly challenging given that the disqualifying factors are more numerous that the qualifying factors however, considering the likely jury verdicts that may arise from meritorious, Talc Mesothelioma cases are worth the extra effort. The average Mesothelioma verdict comes in at approximately $2.4 million and the largest Mesothelioma Verdict Mass Tort Nexus is aware of to date was $250 million. Given the b

Not all-natural Talc deposits contain asbestos. The geological circumstances under which the talc was formed, determine whether any given Talc deposit also contains asbestos. Mass Tort Nexus will provide November Course attendees with the information they need to determine whether an individual potential client used Talc likely sourced from a mine containing asbestos.  In most cases, it should be possible to determine if an individual was exposed to Talc containing asbestos even if the exposure occurred decades in the past.

Does the Stock Market Think the Problem Ends with a Single Lot?

On October 8, the market got the news that Johnson & Johnsons was hit with an 8-Billion-dollar verdict, the pharma giants stock took a down word turn.

On October 15th Johnson & Johnson announced 3rd quarter results that exceeded market expectations and their stock began to trend upward.

On October 18th, the FDA announces the recall of a single lot of Johnson & Johnson Talcum Powder.  By 3:50 pm the Pharma Giants stock had dropped by 5.89% and by 4:00 (closing bell) the stock had sunk by 6.23% to $127.72 per share as compared to the previous day’s closing price of $136.18.  If we have our math right, Johnson & Johnson took a hit to their market capitalization of around $18 billion, in a single day, after the FDA recall of a single lot of Johnson and Johnson Baby powder due to asbestos found in the individual lot.

So, no, it does not appear that the market believes that Johnson and Johnson’s Talc/ Asbestos problem begins nor ends with a single recalled lot and if you are a plaintiffs lawyer, you may want to get ahead of the curve on the new breath of life that may have been given to the asbestos mesothelioma practice area.

 

 

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Should Taxotere Plaintiffs be Concerned After First Bellwether Trial? Absolutely Not.

Taxotere Trial Defense Strategy

“The Devil Did It”

A jury in Louisiana federal court handed the defendant a victory in the first Taxotere Bellwether presided over by U.S. District Judge Jane Triche Milazzo in New Orleans. The case, filed in December 2016 by Louisiana resident Barbara Earnest, had been designated as a Bellwether in a multidistrict litigation consolidated before Judge Milazzo.

http://www.laed.uscourts.gov/case-information/mdl-mass-class-action/taxotere

https://www.reuters.com/article/products-liability-taxotere/sanofi-wins-first-bellwether-trial-in-taxotere-litigation-idUSL2N26I1P6

Should other Taxotere Plaintiffs be concerned about this initial trial loss? Not really, and we will explain why.
Barbara Earnest’s case was unusual in that she required more than one round of chemotherapy to treat her cancer. She received a round of Taxotere and round of Doxorubicin.

Doxorubicin is a cytotoxic chemotherapy drug and an antitumor antibiotic; it deservedly has been nicknamed the Red Devil. Doxorubicin is a bright, almost florescent, red color.

Despite Doxorubicin not being associated with significant incidents of permanent hair loss, unlike Taxotere, defense counsel took full advantage of the Doxorubicin nick name “Red Devil” and was able to persuade the jury that it was not Taxotere that caused Barbara Earnest permanent hair loss, it was the Devil that did it.

The next Taxotere case up for trial does not involve a dual Taxotere followed by Doxorubicin or vice versa, circumstance. Defense counsel will not be able to claim the devil did it, in the next case.

So, in answer to the question, “Should other Taxotere Plaintiffs be concerned about this initial trial loss?” the answer is no. There are more trials to come and the “facts” of the first case tried are, by no means, the same as those in the majority of other Taxotere plaintiffs’ cases.

If making reference to Bayer’s past connection to Nazis is so inflammatory and prejudicial to be uttered before a jury, where Bayer is a defendant, one would think that using the term “Red Devil” to describe Doxorubicin, the drug’s actual name, in the Barbara Earnest case should equally qualify as too inflammatory and prejudicial for the jury to hear. Plaintiffs counsel objected to the use of “Red Devil”; however, Judge Milazzo nonetheless allowed the Louisiana jury to be led to believe that the Devil had worked some Voodoo, and that was the actual cause of Barbara Earnest’s permanent disfigurement, vs the drug Taxotere, that has actually been shown to cause the type of injuries suffered by Barbara Earnest.

If Judge Milazzo presides over another Taxotere trial in which Doxorubicin was also administered, the Honorable Judge may consider making the defendant refer to the drug by its proper name rather than leading a jury to believe the devil did the deed.

In light of the recent $8 Billion dollar verdict in a Risperdal trial, and multiple other recent Billion Dollar verdicts in mass litigation cases, Sanofi, the maker of Taxotere, may want to think twice about how many times it rolls the dice with a jury trial. If they can’t blame the devil in other cases, they may find that one or more juries find them liable and award more to a single plaintiff that it would take to settle the entire litigation, disposing of all plaintiffs’ cases.

Read the ALM Taxotere Defense Verdict

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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The 3 Keys to Success in Mass Torts

Multi-billion dollar jury verdicts are becoming common in Mass Tort litigations, and these verdicts make headlines and create “hype”; however, the majority of “Mass Tort Billionaires” did not achieve their success from individual jury verdicts, these firms “made it big” through involvement in numerous mass tort cases over many years.

Over 50% of the entire Federal Judiciary Docket is within Multidistrict Litigation cases. Most of these individual client cases are essentially plucked from the “State Court Litigation Market Place”. This fact alone has generated an ever-increasing interest in Mass Torts, from personal injury firms, at least in part wanting to “reclaim” a portion of the client cases being “plucked” from their “State Court”, market.

More simply stated, PI firms are increasingly interested in Mass Torts because that is where the clients are.

Mass Torts, however, is not a get rich quick scheme. As with any other “business”, understanding the keys to success as well as the keys to avoiding failure is of paramount importance when considering expanding your personal injury practice to include mass torts. You do not want to be the firm that jumps into the mass tort practice area blind and ends up disappointed.

 

Mass Tort Success Key #1

Ignore the Cheerleaders or At Least Take the Cheers with A Grain of Salt

It is common for leadership firms, the firms that generally file the first claims and assume leadership positions in Multidistrict Litigations to hold conferences in which they encourage other law firms to get involved in the “their” litigations. Generally, firms conducing these “Mass Tort” conferences hope to receive referrals from other firms they convince to follow them into a litigation. This comment is no way meant to be disparaging, simply factual.

The inherent problem with deciding to become involved in a mass tort based on information provided by firms already involved in a litigation is not difficult to understand. Once a law firm is involved in a litigation, they are advocates for the cause (cause of action). It would be unreasonable to expect any law firm involved in a mass litigation to be anything less than a “cheer leader”. Again, this comment is no way meant to be disparaging, simply factual.

To be clear, there is value in hearing what the cheerleaders for a litigation have to say however, deciding to take a financial risk on a given litigation based solely on the “cheers” voiced by those already advocating for the litigation, is unwise.

 

Mass Tort Success Key #2

Conduct Independent Reasoned Analysis

Undertaking an, independent, systematic, reasoned analysis of the legal and business metrics relevant to a given mass litigation, is the key to success in mass torts. This process does not differ, in principle from the “due diligence” that should be employed prior to making any type of business investment.

Applying basic business principles to Mass Torts by identifying metrics and factors specific to the business and financial aspects of Mass Torts.

There are certain immutable laws of business, if you think they do not apply to your specific business, you are wrong, you simply have yet to realize how these immutable laws of business apply to your specific business.

Recognizing how the immutable laws of business apply to a specific type of business, and then applying those laws to their fullest advantage is how billionaires are made. The “Mass Tort Practice Area” has produced more billionaire attorneys than any other. The primary difference in these “Mass Tort” billionaires and other attorneys has little to do with their skills as an attorney and far more to do with their understanding of how to apply the business metrics relevant to mass torts.

 

Mass Tort Success #3

Take The Course

The Mass Tort Nexus Four Days to Mass Tort Success Course is designed to provide Personal Injury attorneys with the knowledge and tools used by “Mass Tort Billionaires” as well as a road map for applying the knowledge and using these tools.

The Course begins at the most rudimentary level, beginning with explaining the difference in a Class Action and MDL. Once the basics are covered, we quickly move to defining and providing an understanding of the basic metrics which must be considered prior to making an investment in each mass tort case.

The goal of the Mass Tort Nexus Four Days to Mass Tort Success Course is to demystify the practice area and provide not only the tools and knowledge needed to be successful in Mass Torts but also the confidence that comes from having a base of knowledge that “levels” the playing field.

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JUUL MDL 2913 DESIGNATED BY JPML

“E-cigarette docket transferred to USDC ND California”

Mark A. York (October 3, 2019)

See Mass Tort Nexus Briefcase MDL 2913 for the full docket:

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The JPML heard Juul arguments on Sept. 26 in Los Angeles, and on October 2, 2019 they issued the MDL 2913 transfer order, consolidating the Juul e-cigarette docket in the U.S. District Court, Northern District of California in front of Judge William Orrick.

In a move to get out in front of plaintiffs, JUUL Labs Inc. filed a motion on Aug. 29 to stay all cases in the litigation and requested the JPML assign the docket to the court in California

JUUL is accused of deceptive marketing practices and failing to warn consumers about the risks of its e-cigarette products. Lawsuits allege JUUL unlawfully marketed its products to teens, and failed to disclose the true amount of nicotine contained in its products.

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

FDA WARNING ISSUED

FDA Warning Letter to JUUL Labs, Inc. (September 9, 2019)  https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth

In November 2018, the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since a year earlier. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States.

There were communications between FDA officials in mid-October 2018, which detailed allegations of seizures related to Juul use The FDA found “no proof of causality, but at a minimum, an association with Juul,” Mitch Zeller, the director of the FDA’s Center for Tobacco Products, wrote to Scott Gottlieb, the FDA commissioner at the time. In an interview, Zeller said that the FDA had not been able to confirm that Juul use was associated with the seizures in two of the three initially reported cases

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.

  1. 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.
  2. Nobody ever disclosed this comparative and now there are thousands of addicted young people who had no clue.
  3. 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.

PHILLIP MORRIS SHUTS DOWN JUUL MERGER

What had once looked like a smart pair-up to rejoin the international cigarette giant with its former domestic parent has now crumbled under the weight of doubts about where the regulatory fist would fall. Altria owns a 35% stake in Juul Labs, the leading e-cig maker by far and the primary scapegoat for industry criticism because it is the face of the vaping market.

After careful consideration, Philip Morris CEO Andre Calantzopoulos said in a statement that it and Altria “have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future.” All that other stuff they were discussing could be forgotten.

Juul said it’s suspending all broadcast, print and digital product advertising in the U.S., and will refrain from lobbying the Trump administration on its draft guidance. The announcement comes after a crackdown on e-cigarettes by the U.S. Food and Drug Administration, that has accelerated following a recent outbreak of severe lung disease that appears to be related to vaping. More than 530 Americans have been diagnosed with the illness and at least eight people have died. Juul is now the subject of a criminal probe in California.

FDA investigators are looking at the use of vitamin E acetate, a compound often used as a cutting agent to allow black market operators to use less pure cannabis oil when filling cartridges. While vitamin E is considered to be safe as a dietary or health supplement ingested in capsule or pill form, it can cause respiratory illness including pneumonia when inhaled.

About 55 lawsuits brought against Juul across the country were among the matters before the JPML panel at the hearing.

Recently,  Juul announced that CEO Kevin Burns would step down immediately and the company would suspend all advertisements of its products. The new CEO, K.C. Crosthwaite, comes from Philip Morris USA parent corporation Altria Group Inc., which has a 35% stake in Juul.

Recent developments include stores like Walmart have stopped selling e-cigarettes and vaping products and cities and states have banned the products. Juul also faces mounting regulatory pressure from the U.S. Food and Drug Administration, which is investigating Juul’s marketing claims to children, as have many state attorneys general.

JPML panel chairwoman Sarah Vance, who sits on the Eastern District of Louisiana, started by announcing this would be her last hearing as head of the MDL panel. U.S. District Judge Karen Caldwell of the Eastern District of Kentucky a current panelist, will be the new chairwoman.

Juul counsel, Austin Schwing, a partner at Gibson, Dunn & Crutcher in San Francisco, argued for the cases go to a court near his client’s headquarters in San Francisco before U.S. District Judge William Orrick of the Northern District of California, but was also open to U.S. District Judge Brian Martinotti of the District of New Jersey, while some plaintiffs counsel also supported Orrick.

In briefs before the panel, there was an initial request for two MDL’s to be created, with plaintiff’s counsel initially advocating for Orrick to oversee the Juul litigation related to misleading marketing that failed to disclose the nicotine in its products. While also requesting that Judge  Martinotti  hear the personal injury cases whose claims focused on pulmonary disease, seizures and other serious health problems.

Judge Vance clarified the denial quickly in the hearing, stating the cases were too massive and complex to be divided. “Events in the past few minutes have overtaken me,” she said.

Andy Birchfield, of Beasley Allen, also changed his mind about dividing the cases, said “we need an experienced hand” as a judge. He initially supported Martinotti, a judges who had overseen dockets New Jersey state court’s Multicounty Litigation Center before his appointment to the federal bench.

MDL No. 2913 – IN RE: Juul Labs, Inc., Marketing, Sales Practices, and Products Liability Litigation JPML Initial Transfer Order

Judge Orrick entered Pretrial Order No. 1 on the same day the JPML designated his court as the home of MDL 2913.

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

JUUL Changed Nicotine Disclosures

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.

In the FDA warning letter to JUUL Labs, Inc. of September 9, 2019 the following “unauthorized marketing claims” were cited:
The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:
  • JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
  • JUUL was “totally safe.”
  • A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
  • “FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”

Additionally, a “Letter from the CEO” that appeared on JUUL’s website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child, states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

 

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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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Medical Error Is Not Included On Death Certificates Or CDC Rankings Of Cause Of Death

 

 

 

 

 

 

 

 

 

By Mark A. York (August 30, 2019)

Medical Errors Are Third Leading Cause of Death in the U.S.

Are 10 percent of U.S. deaths due to preventable medical mistakes?

Medical errors are an “epidemic” that claim hundreds of thousands of lives annually, according to medical reports.

MEDICAL ERRORS ARE THE third leading cause of death in the U.S., after heart disease and cancer, causing at least 250,000 deaths every year, according to recently released data indicating that patient safety efforts fall far short.

Medical error—the third leading cause of death in the US – British Medical Journal

Types of PAEs

The cause of PAEs in hospitals may be separated into these categories:

  • Errors of commission,
  • Errors of omission,
  • Errors of communication,
  • Errors of context, and
  • Diagnostic errors

https://www.pbs.org/newshour/show/is-fatal-medical-error-a-leading-cause-of-death

“People don’t just die from heart attacks and bacteria, they die from system-wide failings and poorly coordinated care,” says the study’s lead author, Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins University School of Medicine. “It’s medical care gone awry.”

Medical errors rank behind heart disease and cancer as the third leading cause of death in the U.S., Johns Hopkins researchers say. … Based on an analysis of prior research, the Johns Hopkins study estimates that more than 250,000 Americans die each year from medical errors.

Historical analysis of papers that focused on mortality due to medical errors in 1999-2000, took  a number of different approaches and perspectives, summarized in, “To Err is Human” which estimated that 44,000 to 98,000 deaths per year were due to medical error. There was an uproar, and many pundits dismissed it out of hand. Using a weighted average of four previous studies, a meta-analysis in 2013 “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care” estimated more than 400,000 deaths due to medical error per year. In 2016, “Medical error—the third leading cause of death in the US” estimated 251,454 deaths, based on 35,416,020 hospitalization.

Objectives Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.

Methods A literature review identified 4 limited studies that used primarily the Global Trigger Tool to flag specific evidence in medical records, such as medication stop orders or abnormal laboratory results, which point to an adverse event that may have harmed a patient. Ultimately, a physician must concur on the findings of an adverse event and then classify the severity of patient harm.

Results Using a weighted average of the 4 studies, a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals. Given limitations in the search capability of the Global Trigger Tool and the incompleteness of medical records on which the Tool depends, the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious harm seems to be 10- to 20-fold more common than lethal harm.

Conclusions The epidemic of patient harm in hospitals must be taken more seriously if it is to be curtailed. Fully engaging patients and their advocates during hospital care, systematically seeking the patients’ voice in identifying harms, transparent accountability for harm, and intentional correction of root causes of harm will be necessary to accomplish this goal.

In a Mayo Clinic study with the American College of Surgeons, 8.9% of participating U.S. surgeons reported the belief that they’ve made a major medical error within the last 3 months — and 1.5% believe their error resulted in a patient’s death, according to Tait Shanafelt. “When you think about that for a minute, it’s a staggering number,” Shanafelt says. Suicide ideation doubles in that 3-month window as well, he notes, independent of depression — the risk of which triples. “So when we make mistakes — and all physicians will make mistakes during the course of their career — it has a substantial toll on us. And there’s a strong link there with burnout.”

Preventing Hospital Medical Errors/sciencedaily

The magnitude of the death toll – roughly 10 percent of U.S. deaths annually – is striking coming, as it does, in an era dominated by efforts to reform the health system to ensure safe, high quality, high-value medical care. Patient

no systematic effort to study medical errors or to put effective safeguards in place.

“Throughout the world, medical error leading to patient death is an under-recognized epidemic,” Makary and his co-author, Dr. Michael Daniel, also of Johns Hopkins, write in Tuesday’s British Medical Journal. They define medical errors as lapses in judgment, skill or coordination of care; mistaken diagnoses; system failures that lead to patient deaths or the failure to rescue dying patients; and preventable complications of care.

Their report comes nearly two decades after “To Err is Human,” a report by the Institute of Medicine, asserted that medical mistakes are rampant in health care. The IOM, a quasi-public think tank made up of leading scientists, drew on existing data to estimate that 44,000 to 98,000 people die in U.S. hospitals each year. Even then, some researchers claimed the estimates were low and based on outdated information.

The new estimate is drawn from more-recent studies indicating the number may be much higher. For instance, a report published in the journal Health Affairs in 2011 calculated that just over 1 percent of hospital patients die each year because of medical errors. When applied to the more than 35 million people hospitalized each year, Makary and Daniel say, this would “translate into 400,201 deaths per year, more than four times the original IOM report estimate.”

The Hopkins team used evidence from four studies that analyzed medical death rate data from 2000 to 2008, including one by the U.S. Department of Health and Human Services’ Office of the Inspector General and the Agency for Healthcare Research and Quality. Using these data, they were able to calculate a mean death rate for medical errors in U.S. hospitals. Applying this rate to the 35 million admissions in 2013, they calculated that 251,454 deaths resulted from medical mistakes.

The researchers acknowledge that this figure most likely represents an undercount, because they were unable to capture data from deaths that occur in outpatient clinics, nursing homes and other non-hospital settings where health care workers care for fragile patients who need complex care.

“It’s fair to say that this number is controversial,” says Dr. Robert Wachter, a professor of medicine at UCSF School of Medicine. “I wouldn’t take this number to the bank.”

Dr. Ashish Jha, a patient-safety expert and director of the Harvard Global Health Institute, agreed that many researchers will be temped to debate which of the estimates are the most accurate.

“It doesn’t matter,” he says, “because all these numbers are so big. They’re a reminder of how big the problem is and how little is being done to address it.”

Much of the effort put into patient safety and performance improvement over the last two decades has been misdirected or ineffective, Jha says. “If you called the CEO of a big hospital and asked, ‘How many medical errors did you have last month? How many falls? How many falls that resulted in serious injury?’ They won’t know.”

Another issue, Wachter says, is that patient safety is being crowded out by newer initiatives. “My concern,” he says, “is that patient safety efforts, which gained so much momentum following the publication of the IOM report, have lost ground in recent years, defused by all the other performance improvement mandates that have come down the highway.”

Makary and Daniel are calling for reforms that would improve the reporting of medical errors, which in turn could inform prevention efforts. In a letter dated May 1, they asked the Centers for Disease Control and Prevention, which gathers births, deaths and other vital statistics, to rank medical errors on the list of leading causes of death. They also asked CDC to alter death certificates so that doctors, medical examiners and coroners can routinely report medical errors that contribute to a patient’s death.

The letter takes pains to point out that the U.S. government and private sector spend “a lot of money” on heart disease and cancer research and prevention. “It is time for the country to invest [a proportional amount] in medical quality and patient safety,” it says.

So far, the researchers have not received an official response, but CDC officials acknowledged that errors are under-reported and that there are ways to capture the data, Makary says. CDC experts were not available for comment.

Wachter is skeptical that the practice of using death certificates to report medical errors will take hold among doctors. “The idea they’ll begin recording this faithfully, or without concern for a malpractice suit, doesn’t strike me as very plausible,” he says.

Makary adds that it was his perception that medical-error research is “underfunded and under-appreciated” that prompted him to embark on an analysis that would elevate fatal mishaps to their proper place near the top of the list of all causes of death.

The findings, Jha says, illustrate that the policies and practices we’re putting in place “are completely inadequate to the size of the problem we have.”

“We can do this,” Jha says. “This is not beyond the creativity and ingenuity of the health care community. We’ve just got to make it a real priority.”

At what point do US consumers start to realize that the healthcare system in the United states is not geared toward “health care” but toward making profits for the medical industry as a whole. Which includes- Big Pharma, For-profit hospitals (owned by non-profits), insurance companies, third party benefit providers, pharmacies that pay and receive rebates (pay to play kickbacks) from drug makers and distributors, doctors paid by Big Pharma to author slanted medical papers and the list goes on and on.

 

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JOHNSON & JOHNSON OKLAHOMA OPIOID TRIAL VERDICT ANNOUNCED – $550 MILLION VERDICT

“MORE BAD CONDUCT SHOWN IN OKLAHOMA OPIOID TRIAL”

By Mark A. York (August 26, 2019)

(MASS TORT NEXUS MEDIA) The first court verdict to come out of the massive litigation over the opioid crisis has resulted in a verdict against Johnson & Johnson for $550 MILLION at 4:05p.m. today, August 26, 2019 in one of the most important drug related lawsuits in U.S. history.

This is the first of several upcoming opioid lawsuits against a drugmaker to go to trial, and it could set a precedent for cases across the country. Depending on how the judge rules, it could give lawyers a new strategy for holding large corporations accountable.

For weeks, the state of Oklahoma has argued that Johnson & Johnson and its pharmaceutical subsidiary Janssen helped create a “public nuisance” by intensely marketing opioid painkillers while downplaying the risk of addiction.

“This is very personal to all of us,” said state attorney Reggie Whitten. “My partner lost a niece to this opioid epidemic. I lost my firstborn son to the opioid epidemic.”

The 2017 filing named multiple defendants. Purdue Pharma and Teva Pharmaceuticals USA settled out of court for a combined total of $355 million, without admitting wrongdoing.

But Johnson & Johnson and Janssen decided to go to trial.

“When you’re right, you fight,” said their attorney, Sabrina Strong, a partner at O’Melveny and Myers. “And that’s what you’re seeing here. We have sympathy for those who suffer from substance abuse. But Janssen did not cause the opioid crisis in this country.”

THIS TYPE OF COMMENTARY SEEMS TO BE A REPEAT OF J&J’s NOW OFT REPEATED CLAIM  “WE’VE DONE NOTHING WRONG” WHICH IS NOW PROVEN TO BE AN OUTRIGHT FALSE STATEMENT, WHETHER BY DEFENSE COUNSEL OR THE COMPANY PR MACHINE. JOHNSON & JOHNSON HAS BEEN SHOWN TO HAVE OUTRIGHT LIED, MISLED THE PUBLIC ANFD MANIPULATED SCIENCE AND MEDICAL INDUSTRY OPINIONS RELATED TO MANY COMPANY PHARMACEUTIAL PRODUCTS AND THE RELATED MARKETING CAMPAIGNS. 

J&J HISTORY OF BAD CONDUCT

Payments To Industry Insiders

Introduction of evidence in J&J Talc cancer trial in the last year, show that two individuals involved in the Cosmetic Industry Review (CIR), which has deemed talcum powder to be safe, which is data J&J has relied on in prior trials, had received payments from Johnson & Johnson for speeches and other engagements. This damaging information was discovered while cross-examining the group’s former director, Alan Andersen, who was a defense witness, and he was forced to disclose the prior unknown financial relationship of the CIR and Johnson & Johnson.

Bad Science

A major blow to J&J’s defense came when a defense witness, Senior Johnson & Johnson epidemiologist, Dr. Douglas Weed, was revealed to have been sanctioned for perjury in another trial in North Carolina, for lying under oath about whether he retained notes to his expert report, which plaintiffs attorneys were able to show.

“J&J presented these unbelievable and non-credible witnesses on an issue that is very important to our case,” Smith said. “Attempts to influence witnesses and alter facts, along with the fact other companies are warning of the cancer link and have been warning for eight to 12 months now. This was new evidence that proved very compelling to the jury as well as a reflection of J&J’s willingness to manipulate the trial process in their favor”, leading many to wonder what else J&J may have done.

In a post trial statement J&J declined to address the specifics of the case, stating: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the U.S. and we will continue to defend the safety of Johnson’s baby powder.”

In response, the Plaintiff team stated “The new evidence that came into the California case could play a role in the next talcum powder trial, which is set for Oct. 16 in Missouri, we certainly think it is evidence that should be presented, and we’ll make every attempt to do so,” Ted Meadows said.

Meanwhile, separate from the Oklahoma opioid trial,  reports are now official that the Department of Justice is pursuing a criminal probe into whether J&J lied about possible cancer risks in its talcum baby powder. The investigation follows a slew of talc-related lawsuits filed against the company, two of which recently resulted in multimillion-dollar plaintiff awards.

Now that ‘OPIOID BIG PHARMA” and their executive suites are being held accountable by the public and in both state and federal courts, there needs to be a formal accounting of how and why these “pharmaceutical titans” were able to develop dangerous drugs and then create horrendous off-label and life threatening marketing campaigns, all the while earning literally billions of dollars annually. At what point do the US consumers and general public say “enough is enough” and demand the corporate decision makers be held criminally liable as a regular part of the executive suite checks and balances oversight?

As long as the drug makers “cost of litigation” remains part of the risk management analysis in the year-end SEC filings, it’s likely that dangerous drugs and the bad conduct that often travels along, will remain a “cost of doing business” and the trail of destruction will continued to be ignored by the Alex Gorskys and Richard Sacklers of the drug industry.

Risperdal Off-Label Drug Marketing

Johnson & Johnson conducted a misleading marketing campaign for their anti-psychotic drug, Risperdal. Approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia, Johnson & Johnson marketed the drug for use in children.

According to the U.S. Department of Justice, Johnson & Johnson, and their subsidiary, Janssen, were aware of the dangers the drug Risperdal posed when used by children. Even so, company representatives marketed the drug to mental health professionals who worked with children.

As a result of their misleading Risperdal marketing campaign, Johnson & Johnson was ordered in 2013 by the U.S. Department of Justice to pay a $2.2 billion fine.

Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. It was not approved for use in children or adolescents until 13 years later, in 2006.

Evidence from lawsuits showed that pharmaceutical representatives from Johnson & Johnson had been pushing doctors (including the plaintiffs doctor) to prescribe Risperdal to children and teenagers even though it had not yet been tested on young people

Juries have found that Johnson & Johnson failed to adequately warn patients and doctors of harmful potential side effects, and verdicts against J&J and Risperdal marketing have been ongoing in courts for more than five years over this medication.

Johnson & Johnson paid the multi-billion dollar fine to the Department of Justice in criminal and civil fines as a result of the now proven illegally marketing of Risperdal for unapproved purposes, but are now denying in civil lawsuits that they were involved in anything improper in off-label marketing of Risperdal. Individual patients who were harmed by Risperdal, do not yet have a remedy other than filing a lawsuit against Johnson & Johnson.

Risperdal Male Breast Growth

 When used by children and adolescents, Risperdal has been known to cause male breast growth, also known as gynecomastia, due to the drug triggering the production of the hormone prolactin. For some patients who have suffered from gynecomastia as a Risperdal side effect, they have also dealt with decreased psychological and emotional well being as a result of physical changes.

Shareholders Sued J&J Over Off-Label Marketing and Bad Conduct–Complaint Attached

Johnson & Johnson says its opioid products account for less than one percent of the Oklahoma market. But the state disputes that.

Oklahoma Attorney General Mike Hunter told CBS News correspondent Omar Villafranca, “They made money whether they sold their drugs or when somebody else sold opioids, because they were supplying everybody else. And this ‘one percent’ thing, that’s a complete canard.”

If the judge rules against Johnson & Johnson, the “public nuisance” argument that was previously used successfully to fight Big Tobacco could possibly be used in opioid lawsuits set to go to trial in Ohio this fall.

https://www.law.du.edu/documents/corporate-governance/independent-director/johnsonjohnson/Opinion-In-re-Johnson-and-Johnson-10-cv-2033-D-NJ-Sept-29-2011.PDF

“Thousands of people being addicted to prescription opioids, thousands of people  dying, you’ve a public nuisance, you’ve got harm that’s occurring,” said Hunter.

Both sides in Oklahoma say they’ll appeal if the judge rules against them.

In addition to the cases in Ohio, suits were filed last week in West Virginia accusing Johnson & Johnson, as well as Teva, of misrepresenting the risks of their opioid products.

The J&J CEO Alex Gorsky approved bad conduct and medical industry manipulation dovetails perfectly along with the Purdue Pharma and Sackler Family marketing abuses, that were uncovered in a federal criminal indictment. The indictment of Purdue and company executives, was hushed up by a $650 million fine to the US Department of Justice in 2007, by none other than bad-conduct fixer Rudy Giuliani.

Many states including Masschusetts, (see complaint below) have decided to sue the Sackler family directly, to reclaim some of the billions the Sacklers earned over the many years the opioid crisis has killed thousands of people.

Related-Official Court Records: Purdue and Sackler Family Bad Conduct

Richard Sackler of Purdue Pharma Deposition Transcript Re: Oxycontin Train

https://www.documentcloud.org/documents/5745864-Purdue-Statement-in-Response-to-Leak-of-2015.html

State of Massachusetts vs. Purdue and The Sackler Family Amended-Complaint-2019-01-31.html

In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

he Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number over 1,200 cases in state and federal courts.

The entire Sackler brothers’ Oxycontin marketing plan followed their previously proven drug marketing test drive of “Valium” – when Hoffman-LaRoche hired the Sacklers to market their new drug “diazepam” commonly known as Valium and its sister drug Librium.

While running the drug advertising company, Arthur Sackler became a publisher, starting a biweekly newspaper, the Medical Tribune, which eventually reached 600,000 physicians. He scoffed at suggestions that there was a conflict of interest between his roles as the head of a pharmaceutical-advertising company and the publisher of a periodical for doctors. Later it emerged that a company he owned, MD Publications, had paid the chief of the antibiotics division of the FDA, Henry Welch, nearly $300,000 in exchange for Welch’s help in promoting certain drugs. Sometimes, when Welch was giving a speech, he inserted a drug’s advertising slogan into his remarks. After the payments were discovered, Welch was forced to resign from the FDA.

When Purdue Pharma started selling its prescription opioid painkiller OxyContin in 1996, Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters like an earthquake, a hurricane, or a blizzard. The debut of OxyContin, said Sackler — a member of the family that started and controls the company and then a company executive — “will be followed by a blizzard of prescriptions that will bury the competition.”

Five years later, as questions were raised about the risk of addiction and overdoses that came with taking OxyContin and opioid medications, Sackler outlined a strategy that critics have long accused the company of unleashing: divert the blame onto others, particularly the people who became addicted to opioids themselves.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

Sackler’s comments at the party and his email are contained in newly public portions of a lawsuit filed by the state of Massachusetts against Purdue that alleges that the company, the Sackler family, and company executives misled prescribers and patients as they aimed to blanket the country with prescriptions for their addictive medications.

 

Addiction Recovery Issues

White drug users addicted to heroin, fentanyl and other opioids have had near-exclusive access to buprenorphine, a drug that curbs the craving for opioids and reduces the chance of a fatal overdose. That’s according to a study out Wednesday from the University of Michigan. It appears in JAMA Psychiatry.

 Researchers reviewed two national surveys of physician-reported prescriptions. From 2012 to 2015, as overdose deaths surged in many states so did the number of visits during which a doctor or nurse practitioner prescribed buprenorphine, often referred to by the brand name Suboxone. The researchers assessed 13.4 million medical encounters involving the drug but found no increase in prescriptions written for African Americans.

“White populations are almost 35 times as likely to have a buprenorphine-related visit than black Americans,” said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School and the study’s lead author.

 The dominant use of buprenorphine to treat whites occurred while opioid overdose deaths were rising faster for blacks than for whites.

“This epidemic over the last few years has been framed by many as largely a white epidemic, but we know now that’s not true,” Lagisetty said.

What is true, Lagisetty added, is that most of the white patients either paid cash (40%) or relied on private insurance (35%) to fund their buprenorphine treatment. The fact that just 25% of the visits were paid for through Medicaid and Medicare “does highlight that many of these visits could be very costly for persons of low income,” Lagisetty said.

Doctors and nurse practitioners can demand cash payments because there’s a shortage of clinicians who can prescribe buprenorphine, according to Dr. Andrew Kolodny, co-director of Opioid Policy Research at Brandeis University’s Heller School for Social Policy and Management. Only about 5% of physicians have taken the special training required to prescribe buprenorphine.

“The few that are doing it are really able to name their price, and that’s what we’re seeing here and that’s the reason why individuals with more resources — who are more likely to be white — are more likely to access treatment with buprenorphine,” said Kolodny, who was not involved in the study.

Kolodny wants the federal government to eliminate the required special training for buprenorphine and a related cap on the number of patients a doctor can manage on the drug.

Some physicians who’ve studied racial disparities in addiction treatment say the root causes date to 2000, when buprenorphine was approved. At that time, proponents argued that buprenorphine was needed to help treat suburban youth, according to Dr. Helena Hansenat New York University. Those young patients didn’t see themselves as addicted to heroin in the same way as hard-core urban heroin users who went to methadone clinics for treatment.

“Buprenorphine was introduced as private-office treatment, for a private market with the means to pay,” said Hansen, an associate professor of psychiatry and anthropology. “So the unequal dissemination of buprenorphine for opioid dependence is not accidental.”

Hansen added that the fix must include universal access to treatment in a primary care setting, an end to the criminalization of opioid dependence (which puts more blacks in prison for drug use than whites) and more federal funding to expand access to buprenorphine for all patients.

Several leaders in the fight to reduce opioid overdose deaths say the study results are disturbing.

“It really demands for us to be looking at equitable treatment for addiction for African Americans as we do for white Americans,” said Michael Botticelli, director of the Grayken Center for Addiction at Boston Medical Center and the former director of the Office of National Drug Control Policy.

Botticelli identified key issues that may contribute to the racial treatment gap and deserve further investigation. For example, he wants to know if Medicaid reimbursement rates are simply too low to entice more doctors to work with low-income patients, or if there are too few inner-city doctors prescribing buprenorphine or if African Americans themselves are somehow reluctant to seek this form of treatment.

Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health, called the findings surprising and disturbing. Surprising because the disparity is so large, and disturbing because her agency has prioritized educating doctors about the value of prescribing buprenorphine.

Volkow also expressed disappointment that federal parity laws, which are supposed to guarantee equal access to all types of medications, don’t seem to be working for buprenorphine.

“We need to ensure that we have capacity to provide these treatments,” Volkow said, “because if you say you have to pay for them, but there are no services that can provide the treatments, then the issue of paying for them is secondary.”

Volkow has noted that fewer than half of Americans with an opioid use disorder have access to buprenorphine or two other medications used to treat opioid addiction: methadone and naltrexone. Volkow said she’s glad that the use of buprenorphine is on the rise, but the U.S. needs to understand why this lifesaving treatment isn’t benefiting all patients who need it.

Related materials >Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA

OPIOD LITIGATION UPDATE: FOR FEDERAL AND STATE COURT DOCKETS

To access the most relevant and real time information on the Opioid Litigation, Kevin Thompson (NAS Addicted Infant Litigation) and Steve New (Opioid Adult Injury Litigation) will be speaking at the Mass Tort Nexus Class September 13 – 16, 2019 in Fort Lauderdale, to attend follow the links below. 

Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne-Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for 

For more Mass Tort Nexus Information See: Mass Tort Nexus Newsletters and MDL Updates

Note: (Excerpts within this article include print materials and other online media sources)

 

 

 

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Mass Tort Billionaires

 

Mass Tort Billionaires

What do they know that you don’t?

 

Fact: Mass Torts have made more plaintiff lawyers billionaires (or billionaire adjacent) than any other practice area.

Myth: Most Mass Tort billionaires made their money from the massive trial verdicts we hear about in the news (RoundUp, Talcum Powder etc.).

Fact: The majority of Mass Tort billionaires (or billionaire adjacent) did not reach this lofty status from major trial verdicts, they built their practice over time, accumulating the knowledge and skills required to independently evaluate a mass tort litigation before taking a financial risk.

Most Successful Mass Tort Firms Learned by Trial and Error

There is an easier way!

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error).  It is better to learn from the mistakes of others, than to make those same mistakes yourself.

You may not be willing to take the risk required to become a “mass tort billionaire”, however, if you are interested in working smarter vs harder and reaching the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to get more information about the September Course.

You may also simply call or email Barbara Capasso or Anne Marie Kopek at 954-530-9892, email- barbara@masstortnexus.com or annemarie@masstortnexus.com

How Most Lawyers Get Started in Mass Torts

One Lawyer, we will call him Mr. Mass Tort Big Bucks, gives another lawyer, we will call Mr. Mass Tort Outsider, an inside tip on a great new mass tort in which Mr. Big Bucks is involved. Mr. Outsider takes the tip and runs with it.

One of two things happen:

Scenario A: The litigation does South and Mr. Outsider thinks “Mass Torts is just a big gamble”, I am never doing that again.

Scenario B: The litigation pays off big and Mr. Outsider becomes overly optimistic, thinking, “Wow this Mass Tort thing is great”, I am going to bet on every new case that come along.

Neither Scenario Is Good for Mr. Outsider

In Scenario A, now “mass tort pessimistic” Mr. Outsider is likely to take himself out of the game (mass tort plaintiff law) that has created more plaintiff lawyer billionaires than any other practice area.

In Scenario B, now “mass tort overly optimistic” Mr. Outsider is likely to throw money at every mass tort litigation that comes along and is at risk of eventually losing his shirt.

  1. Big Bucks, who is already sold on a litigation, is not an objective source of information.
  2. Big Bucks can probably afford to lose money that Mr. Outsider may not be able to afford to lose.

Become a Mass Tort Insider!

Instead of relying on tips from other lawyers or the mass tort rumor mill, gain the “insider knowledge“ that will allow you to evaluate mass tort litigation’s objectively. The next time you get a tip from another lawyer, have the information and knowledge that will allow you to do your homework before taking a leap into a mass tort litigation.

The course starts at the most basic level, discussing the difference between Class Actions and Multi-district Litigation and then progresses to providing the tools needed to evaluate the “metrics” relevant to all mass tort litigation’s which need to be considered before taking a financial risk. The basic metrics (below) are explained in detail before the course progresses to how firms can apply these metrics to make decisions and develop strategies that lead to success.

 

On the third day of the course, lead litigators step in and give presentations on various mass torts in which they are currently involved. Course attendees will be armed with the knowledge developed in the first two days of the course, to ask the lead litigators informed questions and use the metrics and other information they have gained thus far in the course to make decisions about which litigation they may be interested in.

The relatively small class size allows course attendees to interact with the lead litigators in the classroom as well as during the outside activities “up close and personal”.

What do past course attendees have to say?

 

 

Visit our YouTube Channel to hear what other past attendees have to say about the course.

https://www.youtube.com/channel/UC8I9zGYo3YC5BhulgxthCOw/videos

 

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Xarelto Settlement Not So Fast Gentlemen

Those Aggrieved by the Proposed Xarelto Settlement

May Still Get a Chance to be Heard

Thus far firms representing absent plaintiffs (those not represented by leadership) have yet to be given an opportunity to be heard by the court regarding any aspect of the proposed Xarelto settlement.  I previously addressed this issue in another article.

https://www.masstortnexus.com/mass-torts-news/xarelto-settlement-judicial-activism-vs-judicial-tyranny/

Due Process Refresher 

The Fifth and Fourteenth Amendments to the United States Constitution each contain a due process clause. Due process deals with the administration of justice and thus the due process clause acts as a safeguard from arbitrary denial of life, liberty, or property by the government outside the sanction of law. The Supreme Court of the United States interprets the clauses broadly, concluding that these clauses provide four protections: procedural due process (in civil and criminal proceedings), substantive due process.

The core of these requirements is notice and a hearing before an impartial tribunal.

Fuentes v. Shevin, 407 U.S. 67, 81 (1972). At times, the Court has also stressed the dignitary importance of procedural rights, the worth of being able to defend one’s interests even if one cannot change the result.

Mathews v. Eldridge, 424 U.S. 319, 333 (1976). “Parties whose rights are to be affected are entitled to be heard.” Baldwin v. Hale, 68 U.S. (1 Wall.) 223, 233 (1863).

Picking Up Where We Left Off

Without Regard to the points made in the prior article, even if the proposed Xarelto settlement agreement reaches the required participation numbers, it should not be a done deal. For Judge Fallon to grant specific common benefit fee requests, it will arguably be necessary to form a “Settlement Class Action” under FRCP 23. Once this occurs, his honor will not have the option of ignoring FRCP 23(e), the requirement to conduct fairness hearings before final approval of the settlement. This will be the time at which firms representing absent plaintiffs may get their chance to be heard and I believe these firms will have much to say.

If Judge Fallon allows the proposed Xarelto settlement to impact plaintiffs, without ever having engaged in any act to protect the rights of absent parties, this egregious failure may well define his legacy, overshadowing and otherwise admirable judicial career.

Note: Nothing would prevent a firm representing a non-settling client from moving to form a Class Action for non-settling plaintiffs, aggrieved by the settlement.

Due to the fact that the proposed Xarelto Settlement did not follow the “opt in” reasoning (see article by Judge Fallon below), the only way the necessity of creating a settlement class could be avoided would be if 100% of all Xarelto plaintiffs accepted the settlement. Even under this circumstance, jurisdictional issues would still exist. I will address this subject more thoroughly later in this article.  First, I will cover recent developments.

Latest Spin on the Xarelto Settlement

I have learned that leadership claims that 26,000 enrollment packages have been received by Brown Greer and they are very confident that they will reach 98% participation. MTN can not verify leaderships statements with Brown Greer as they seem to have been gagged by leadership. Regardless, the proposed settlement only covered 25,000 plaintiffs. The total number of complaints on file in the MDL and Philadelphia Court of Common Pleas has ballooned to over 31,339 plaintiffs since the proposed settlement was first announced. The foregoing begs the question “98% of what”.  26,000 is 82.96% of 31,339. If we take leadership at their word and believe 26,000 plaintiffs have accepted the settlement, then we must assume that the settlement is going to include more than 25,000 plaintiffs and base on “participation calculus” on the total number of cases on file, which is at least 31,339.

Settling 26,000 cases would leave 5339 remaining. I do not believe that the defendants can sell a settlement to their stockholders that leaves 5339 cases (unknown risks) unresolved.

A reliable source has informed me that the “98% participation claim” was based on 98% of the 70% of plaintiffs that have returned the enrollment package, not 98% of all plaintiffs. Maybe leadership is counting on using the “dismissal machine” they have arguably created in co-operation with defense, to get rid of the non-enrollers and therefore do not think these plaintiffs need be counted.

Though I can not verify the foregoing (Brown Greer gagged), I believe the 26,000-enrollment number may be significantly exaggerated or at minimum skewed. Leading non leadership firms to believe the proposed settlement will consummate would be a good way to get firms reluctant to encourage plaintiffs to except the settlement to change course. A self-fulfilling prophecy (stated as fact) if you will.

The Chance and Right to be Heard

I stated, in the previous article (link above) that Judge Fallon arguably lacks subject matter jurisdiction to issue orders related to an MDL settlement. I also stated that since Judge Fallon is an MDL judge that subscribes to the MDLs as Quasi  Class Actions theory and therefore should have held FRCP 23(e) fairness hearings before or currently with issuing in order related to settlement as His Honor did in Vioxx and other MDLs in the past.

Putting aside the above, absent Xarelto plaintiffs (those not represented by leadership firms) may still have a chance to be heard.

How an MDL Judge can properly involve  themselves in settlement:

  1. Plaintiff Leadership and Defense reach a settlement agreement without seeking orders from the court.
  2. Plaintiff Leadership presents the settlement to firms representing absent plaintiffs and if enough those plaintiffs opt into the settlement to meet the required participation threshold, then the settlement can be consummated (only for those that opted in).
  3. Only after the foregoing, would it be proper for the court to become involved. Plaintiff Leadership and Defense can present the consummated agreement (with all opt ins) to the Judge and seek to form a Settlement Class Action (under FRCP 23).

Obviously the ship has sailed with regard to Judge Fallon conducting FRCP 23(3) fairness hearings before or concurrently with issuing orders related to settlement however, it would be inconceivable for His Honor to issue orders granting specific Leadership and PSC Firms common benefit fees without a “Settlement Class Action” being formed.

Why? Without a Settlement Class Action in place, Judge Fallon will have no control over or authority to grant any order related to the global proceeds of the mass settlement.

The Opportunity to Be Heard- Finally?

If the proposed Xarelto Settlement reaches the required participation numbers and is consummated, Judge Fallon will only be able to take control of the global proceeds (in order to grant common benefit fees) via a Settlement Class Action. This will be the point at which firms representing absent plaintiff firms will (as required FRCP 23(e) to be heard). If Judge Fallon neglects to conduct fairness hearings before granting fees, an appellate court is likely to overturn any order granting common benefit fees.

The link below is from a 9th Circuit in the Hyundai Kia MDL. A settlement was reached in this MDL and a Settlement Class Action was granted by the MDL Judge. Suit was filed by firms representing absent plaintiffs related to the common benefit fees awarded arising from the settlement. The

https://www.consumerfinancialserviceslawmonitor.com/wp-content/uploads/sites/501/2019/06/In-re-Hyundai.pdf

Excerpts from Ruling:

On December 23, 2013, the settling parties sought preliminary approval of the nationwide class settlement and moved to certify a settlement class. The district court ordered multiple rounds of briefing concerning the fairness of the settlement, sufficiency of the class notice, the claims process, class certification, choice of law, and other issues. At four hearings held between December 2013 and August 2014, the parties addressed concerns raised by the court sua sponte as well as by objectors and other non-settling plaintiffs. In response to these concerns, the settling parties twice revised the settlement agreement and notice provisions.

After issuing several detailed written rulings, the district court granted preliminary approval of the settlement and certified the class for settlement purposes on August 29, 2014. The court appointed Hagens Berman and McCuneWright as settlement class counsel. In September and October 2014, the district court held four additional hearings, at which it requested that the parties make additional changes to the settlement notices and website, such as adding information about the Reimbursement Program, and rewording the notices to make them easier to understand.

A binding settlement must provide notice to the class in a “reasonable manner” and otherwise be “fair, reasonable, and adequate.” Fed. R. Civ. P. 23(e)(1), (2)

Before the district court approves a class settlement under Rule 23(e), it is “critical” that class members receive adequate notice. Hanlon, 150 F.3d at 1025. To satisfy Rule 23(e)(1), settlement notices must “present information about a proposed settlement neutrally, simply, and understandably.” Rodriguez v. W. Publ’g Corp., 563 F.3d 948, 962 (9th Cir. 2009). “Notice is satisfactory if generally describes the terms of the settlement in sufficient detail to alert those with adverse viewpoints to investigate and to come forward and be heard.’” Id. (quoting Churchill Vill., LLC v. Gen. Elec., 361 F.3d 566, 575 (9th Cir. 2004)).

Rule 23(e) ensures that unnamed class members are protected “from unjust or unfair settlements affecting their rights.” Amchem, 521 U.S. at 623 (1997).

Over the course of several years, the district court performed an admirable job of managing this complex litigation. After the settlement was announced, the district court held multiple status conferences and requested several rounds of briefing to ensure that all of the litigants’ concerns were heard and addressed.

Note: The 9th circuit ruling leave little doubt that had the settlement court failed to comply with FRCP 23(e), that courts grant of attorney’s fees  to “Class Counsel”  would not have withstood appeal.

End Excerpts

 

 

Moving Forward -Two Possible Outcomes

  1. Judge Fallon moves forward with a settlement class (if the settlement consummates) without the required FRCP 23 (e) fairness hearings, in which case any grant of common benefit fees arising from the court would likely be overturned on appeal.

 

  1. Judge Fallon moves forward with a settlement class and does (as required) conduct fairness hearings per FRCP 23(e). Although belated, this would give firms representing absent class members to object to the terms of the settlement as well as any common benefit fees being awarded from the settlement proceeds. Even those plaintiffs that rejected the settlement or were subject to dismissal arising from a settlement related order would arguably have standing (the right to be heard).

 

  1. Leadership Self-Dealing (subject of a future article).
  2. Leadership Conclusion with defense to create a “dismissal machine.
  3. Unwarranted Discounts.
  4. Overly Complex processes created by settlement orders, leading to denial of due process.
  5. Settlement related orders issued absent jurisdiction over the subject matter.

The article below, written by Judge Fallon

COMMON BENEFIT FEES IN MULTI-DISTRICT LITIGATION

https://judicialstudies.duke.edu/sites/default/files/centers/judicialstudies/mdl2014/Common_Benefit_Fees.pdf

By: The Honorable Eldon E. Fallon

Note:. In the article, Judge Fallon, as he has on numerous occasions, referred to “private mass tort settlements” as opt in (vs class actions which are opt outs). His Honors reference to these settlements as Opt In vs Opt Out seems to imply that his jurisdiction over settlement arises from the agreement of the parties that Opt In. By Implication this would mean that any party that does not opt in should not be negatively impacted by the given settlement. This has obviously not held true in the proposed Xarelto Settlement.

The following excerpt from the article by His Honor express the same view he expressed in Vioxx, which involved a settlement very similar to the proposed Xarelto Settlement (with 4 billion additional dollars for roughly the same number of plaintiffs) . In Vioxx, Judge Fallon conducted the Rule 23(e) hearing he references below to allow absent plaintiffs a voice in the settlement. I have yet to discern why His Honor believes Xarelto plaintiffs are less deserving of due process than Vioxx Clients.

Excerpt

The argument used by the courts supporting their equitable authority to review attorneys fees is that Rule 23 of the Federal Rules of Civil Procedure expressly provides that a district court presiding over a class action has a duty to scrutinize the attorneys fees of class counsel to assure that they are reasonable. The transferee judge in MDLs should have the same responsibility because MDLs are quasi class actions since their purpose and function is the same as the traditional class action namely efficiency and coordination before a single court. Furthermore, many MDLs contain multiple class actions along with the individual claims and it is not unusual to utilize the settlement class vehicle provided by Rule 23(e) to resolve the entire Thus Rule 23 is often an integral part of the MDL process.

End Excerpt

 

Has Judge Fallon Became to Chummy with Xarelto Leadership?

Just out of curiosity I have submitted a Form A0 10A to the Judicial Committee on Financial Disclosures, requesting Judge Fallon’s financial disclosures for 2013-2018. I already have copies of his disclosures through 2012 and His Honor discloses that his travel and other expenses are paid by third parties when he attended conferences 2012 and prior. I am curious to find out if MTMP paid Judge Fallon’s expenses when he attended MTMP conferences over the past few years. Paying for trips to lavish resorts in sin city for a Federal Judge before whom a firm currently has matters subject to litigation, is something I find worth exploring.

 

Required Reading for those wanting to improve their knowledge of all things MDL settlement.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

But this book, it may shock even the most cynical!

https://www.amazon.com/Mass-Tort-Deals-Bargaining-Multidistrict-ebook/dp/B07S7DMN7Z

By: Elizabeth Chamblee Burch

Elizabeth Chamblee Burch is the Fuller E. Callaway Chair of Law at the University of Georgia. Her teaching and research interests include mass torts, class actions, and civil procedure. She has been a Visiting Professor at Harvard Law School.

Other worthwhile reading authored by Professor Burch:

Monopolies in Multidistrict Litigation

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

Repeat Players in Multidistrict Litigation

https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=4737&context=clr

DISAGGREGATING

https://openscholarship.wustl.edu/cgi/viewcontent.cgi?article=6002&context=law_lawreview

Judging Multidistrict Litigation 

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1993&context=fac_artchop

Morphing Case Boundaries in Multidistrict Litigation Settlements

By: Margaret S. Thomas

http://law.emory.edu/elj/_documents/volumes/63/6/responses/thomas.pdf

About Professor Thomas: https://www.law.lsu.edu/directory/profiles/margaret-s-thomas/

 

Once Size Doesn’t Fit All: Multidistrict Litigation, Due Process and the Dangers of Procedural Collectivism

http://www.bu.edu/bulawreview/files/2015/02/REDISH.pdf

By: MARTIN H. REDISH & JULIE M. KARABA

Martin H. Redish is the Louis and Harriet Ancel Professor of Law and Public Policy at the Northwestern University Pritzker School of Law. Redish has written 19 books and over a hundred law review articles in the areas of civil procedure and constitutional law.

About Professor Redish: http://www.law.northwestern.edu/faculty/profiles/MartinRedish/

Julie Karaba (Siegal is) currently a Clerk for Chief Justice John Roberts, United States Supreme Court.

https://www.sesp.northwestern.edu/news-center/news/2018/03/sesp-alumna-to-clerk-for-chief-justice-of-the-united-states-john-g.-roberts,-jr..html

 

Judicial Review of Private Mass Tort Settlements

By: Jeremy T. Grabill

https://scholarship.shu.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1418&context=shlr

About Jeremy Grabill: https://www.phelps.com/jeremy-grabill

TAKING A SECOND LOOK AT MDL PRODUCT LIABILITY SETTLEMENTS: SOMEBODY NEEDS TO DO IT

https://kuscholarworks.ku.edu/bitstream/handle/1808/25557/Mueller_FINAL.pdf;jsessionid=DFE28872C148C01DAF73FED1CD91E292?sequence=1

By: Christopher B. Mueller

About Professor Mueller: https://lawweb.colorado.edu/profiles/profile.jsp?id=38

 

DUBIOUS DOCTRINES: THE QUASI-CLASS Action

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

By: Linda S. Mullenix

 

AGGREGATE LITIGATION AND THE DEATH OF DEMOCRATIC DISPUTE RESOLUTION

https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1063&context=nulr

Also by: Linda S. Mullenix

About Professor Mullenix: https://law.utexas.edu/faculty/linda-s-mullenix

Books by Professor Mullenix: https://www.amazon.com/Linda-S.-Mullenix/e/B001HML766

Managing Related Proposed Class Actions in Multidistrict Litigation

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

By: Catherine R. Borden

Government of the United States of America – Federal Judicial Center

GLOBAL SETTLEMENTS IN NON-CLASS MDL MASS TORTS

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

 

https://law.lclark.edu/live/files/25156-saackreadyforwebsitepdf

By: Amy L. Saack

About Amy Sacck: http://www.davisrothwell.com/attorney/amy-saack/

 

 

STANDARDS AND BEST PRACTICES FOR LARGE AND MASS-TORT MDLS

BOLCH JUDICIAL INSTITUTE, DUKE LAW SCHOOL

https://judicialstudies.duke.edu/wp-content/uploads/2018/10/standards_and_best_practices_for_large_and_mass-tort_mdls-Bolch-Judicial.pdf+

 

Disclaimer: The author of this article, John Ray, is not an attorney. Nothing in this article should be considered legal advice. The opinions expressed in this article are those of John Ray. Publication of this article by any third party should not be considered endorsement of nor agreement with the opinions expressed by the author.

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