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: 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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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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SUPREME COURT OF THE UNITED STATES in “MERCK SHARP & DOHME CORP. v. ALBRECHT” May 20, 2019

SUPREME COURT OF THE UNITED STATES

MERCK SHARP & DOHME CORP. v. ALBRECHT ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 17–290. Argued January 7, 2019—Decided May 20, 2019
Petitioner Merck Sharp & Dohme Corp. manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. However, the mechanism through which Fosamax treats and prevents osteoporosis may increase the risk that patients will suffer “atypical femoral fractures,” that is, a rare type of complete, low-energy fracture that affects the thigh bone. When the Food and Drug Administration first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculativerisk of atypical femoral fractures associated with the drug. But stronger evidence connecting Fosamax to atypical femoral fractures developed after 1995. And the FDA ultimately ordered Merck to add a warning about atypical femoral fractures to the Fosamax label in 2011. Respondents are more than 500 individuals who took Fosamax andsuffered atypical femoral fractures between 1999 and 2010. Respondents sued Merck seeking tort damages on the ground that statelaw imposed upon Merck a legal duty to warn respondents and their doctors about the risk of atypical femoral fractures associated withusing Fosamax. Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-empted by federal law. Merck conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010, but Merck asserted that the FDA would have rejected that attempt.In particular, Merck claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk ofatypical femoral fractures associated with the drug. The District Court agreed with Merck’s pre-emption argument and
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Syllabus
granted summary judgment to Merck, but the Third Circuit vacatedand remanded. The Court of Appeals recognized that its pre-emption analysis was controlled by this Court’s decision in Wyeth v. Levine, 555 U. S. 555, which held that a state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals, however,suggested that the “clear evidence” standard had led to varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d 268, 284.
Held:
1. “Clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change tothe drug’s label to include that warning. Pp. 9–15.
(a)
The Wyeth Court undertook a careful review of the history of federal regulation of drugs and drug labeling and found both a reluctance by Congress to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associatedwith their drugs and an insistence by Congress that drug manufacturers bear the responsibility for the content of their drug labels. Accordingly, this Court held in Wyeth that “absent clear evidence that the FDA would not have approved a change” to the label, the Court“will not conclude that it was impossible . . . to comply with both federal and state requirements.” 555 U. S., at 571. Applying that ruleto the facts of that case, the Court said that Wyeth’s evidence of preemption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. And second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. Pp. 10–13.
(b)
Thus, in a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfystate law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning. These conclusions flow from this Court’s precedents on impossibility pre-emption and the statutory and regulatory scheme thatthe Court reviewed in Wyeth. See 555 U. S., at 578. In particular,this Court has refused to find clear evidence of impossibility wherethe laws of one sovereign permit an activity that the laws of the othersovereign restrict or even prohibit. And as explained in Wyeth, FDA
Cite as: 587 U. S. ____ (2019) 3
Syllabus
regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” 21 CFR §314.70(c)(6)(iii)(A). Pp. 13–14.
(c) The only agency actions that can determine the answer to thepre-emption question are agency actions taken pursuant to the FDA’s congressionally delegated authority. The Supremacy Clause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And pre-emption takes place “ ‘only when and if [the agency] is acting within the scope of its congressionally delegated authority.’ ” New York v. FERC, 535 U. S. 1, 18 (some alterations omitted). P 15.
2. The question of agency disapproval is primarily one of law for a judge to decide. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped toevaluate the nature and scope of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statutory and regulatory context. While contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury. Pp. 15–17.
852 F. 3d 268, vacated and remanded.
BREYER, J., delivered the opinion of the Court, in which THOMAS, GINSBURG, SOTOMAYOR, KAGAN, and GORSUCH, JJ., joined. THOMAS, J., filed a concurring opinion. ALITO, J., filed an opinion concurring in thejudgment, in which ROBERTS, C. J., and KAVANAUGH, J., joined.
_________________

Cite as: 587 U. S. ____ (2019) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in thepreliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in orderthat corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE BREYER delivered the opinion of the Court. When Congress enacted the Federal Food, Drug, and
Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21
U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safefor use under the conditions prescribed, recommended, orsuggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, it makes careful judgmentsabout what warnings should appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that “clear evidence” that the FDA would not have approved a changeto the drug’s label pre-empts a claim, grounded in statelaw, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.See Wyeth v. Levine, 555 U. S. 555, 571 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justificationsfor the warning required by state law and that the FDA, in
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Opinion of the Court
turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
I The central issue in this case concerns federal preemption, which as relevant here, takes place when it is“‘impossible for a private party to comply with both stateand federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated withdrugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulatesthe information that appears on brand-name prescriptiondrug labels. The alleged conflict between state and federallaw in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certainassociated risks.
A The FDA regulates the safety information that appearson the labels of prescription drugs that are marketed in the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR§201.57(a) (2018). Although we commonly understand a drug’s “label” to refer to the sticker affixed to a prescription bottle, in this context the term refers more broadly to the written material that is sent to the physician whoprescribes the drug and the written material that comeswith the prescription bottle when the drug is handed to the patient at the pharmacy. 21 U. S. C. §321(m). These (often lengthy) package inserts contain detailed information about the drug’s medical uses and health risks. §355(b)(1)(F); 21 CFR §201.57(a).
Cite as: 587 U. S. ____ (2019) 3
Opinion of the Court
FDA regulations set out requirements for the content, the format, and the order of the safety information on the drug label. §201.57(c). Those regulations require druglabels to include, among other things: (1) prominent “boxed” warnings about risks that may lead to death or serious injury; (2) contraindications describing any situation in which the drug should not be used because the riskof use outweighs any therapeutic benefit; (3) warnings and precautions about other potential safety hazards; and
(4) any adverse reactions for which there is some basis to believe a causal relationship exists between the drug and the occurrence of the adverse event. Ibid.
As those requirements make clear, the category inwhich a particular risk appears on a drug label is anindicator of the likelihood and severity of the risk. The hierarchy of label information is designed to “preventoverwarning” so that less important information does not “overshadow” more important information. 73 Fed. Reg. 49605–49606 (2008). It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.” Id., at 2851.
Prospective drug manufacturers work with the FDA to develop an appropriate label when they apply for FDA approval of a new drug. 21 U. S. C. §§355(a), 355(b),355(d)(7); 21 CFR §314.125(b)(6). But FDA regulationsalso acknowledge that information about drug safety may change over time, and that new information may requirechanges to the drug label. §§314.80(c), 314.81(b)(2)(i). Drug manufacturers generally seek advance permissionfrom the FDA to make substantive changes to their druglabels. However, an FDA regulation called the “changesbeing effected” or “CBE” regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to “add or strengthen a . . . warning”where there is “newly acquired information” about the
4 MERCK SHARP & DOHME CORP. v. ALBRECHT
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“evidence of a causal association” between the drug and a risk of harm. 21 CFR §314.70(c)(6)(iii)(A).
B Petitioner Merck Sharp & Dohme manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. App. 192; In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F. 3d 268, 271, 274–275 (CA3 2017). Fosamax belongs to a classof drugs called “bisphosphonates.” Fosamax and other bisphosphonates work by affecting the “bone remodeling process,” that is, the process through which bones are continuously broken down and built back up again. App.102, 111. For some postmenopausal women, the two parts of the bone remodeling process fall out of sync; the body removes old bone cells faster than it can replace them.That imbalance can lead to osteoporosis, a disease that is characterized by low bone mass and an increased risk ofbone fractures. Fosamax (like other bisphosphonates)slows the breakdown of old bone cells and thereby helps postmenopausal women avoid osteoporotic fractures. Id., at 102. However, the mechanism through which Fosamax decreases the risk of osteoporotic fractures may increase therisk of a different type of fracture. Id., at 400–444, 661–
663. That is because all bones—healthy and osteoporoticalike—sometimes develop microscopic cracks that are not due to any trauma, but are instead caused by the mechanical stress of everyday activity. Id., at 102. Those so-called “stress fractures” ordinarily heal on their own through the bone remodeling process. But, by slowing the breakdown of old bone cells, Fosamax and other bisphosphonates may cause stress fractures to progress to complete breaks that cause great pain and require surgical intervention to repair. Id., at 106–109, 139, 144–145. When that rare type of complete, low-energy fracture
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affects the thigh bone, it is called an “atypical femoral fracture.” Id., at 101.
The Fosamax label that the FDA approved in 1995 did not warn of the risk of atypical femoral fractures. 852
F. 3d, at 274–275. At that time, Merck’s scientists were aware of at least a theoretical risk of those fractures. Indeed, as far back as 1990 and 1991, when Fosamax was undergoing preapproval clinical trials, Merck scientists expressed concern in internal discussions that Fosamaxcould inhibit bone remodeling to such a “‘profound’” degree that “inadequate repair may take place” and “‘microfractures would not heal.’” App. 111–113. When Merck applied to the FDA for approval of Fosamax, Merck brought those theoretical considerations to the FDA’s attention. 852 F. 3d, at 274–275. But, perhaps because the concerns were only theoretical, the FDA approved Fosamax’s label without requiring any mention of this risk. Ibid.
Evidence connecting Fosamax to atypical femoral fractures developed after 1995. Merck began receiving adverse event reports from the medical community indicating that long-term Fosamax users were suffering atypical femoral fractures. App. 122–125. For example, Merckreceived a report from a doctor who said that hospital staffhad begun calling atypical femoral fractures the “‘Fosamax Fracture’” because “‘100% of patients in his practice who have experienced femoral fractures (without being hit by a taxicab), were taking Fosamax . . . for over 5 years. ’” Id., at 126. Merck performed a statistical analysis of Fosamax adverse event reports, concluding that these reports revealed a statistically significant incidence offemur fractures. 3 App. in No. 14–1900 (CA3), pp. A1272– A1273, A1443. And about the same time, Merck began to see numerous scholarly articles and case studies documenting possible connections between long-term Fosamax use and atypical femoral fractures. App. 106–110, 116–
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122.
In 2008, Merck applied to the FDA for preapproval tochange Fosamax’s label to add language to both the “Adverse Reaction[s]” and the “Precaution[s]” sections of thelabel. Id., at 670. In particular, Merck proposed adding a reference to “‘low-energy femoral shaft fracture’” in theAdverse Reactions section, and cross-referencing a longerdiscussion in the Precautions section that focused on the risk of stress fractures associated with Fosamax. Id., at
728. The FDA approved the addition to the Adverse Reactions section, but rejected Merck’s proposal to warn of a risk of “stress fractures.” Id., at 511–512. The FDA explained that Merck’s “justification” for the proposedchange to the Precautions section was “inadequate,” because “[i]dentification of ‘stress fractures’ may not be clearly related to the atypical subtrochanteric fracturesthat have been reported in the literature.” Id., at 511. The FDA invited Merck to “resubmit” its application and to “fully address all the deficiencies listed.” Id., at 512; see 21 CFR §314.110(b). But Merck instead withdrew its application and decided to make the changes to the Adverse Reactions section through the CBE process. App.654–660. Merck made no changes to the Precautionssection at issue here. Id., at 274.
A warning about “atypical femoral fractures” did notappear on the Fosamax label until 2011, when the FDA ordered that change based on its own analyses. Id., at 246–252, 526–534. Merck was initially resistant to the change, proposing revised language that, once again,referred to the risk of “stress fractures.” Id., at 629–634. But the FDA, once again, rejected that language. And this time, the FDA explained that “the term ‘stress fracture’ was considered and was not accepted” because, “for most practitioners, the term ‘stress fracture’ represents a minorfracture and this would contradict the seriousness of the atypical femoral fractures associated with bisphosphonate
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use.” Id., at 566. In January 2011, Merck and the FDA ultimately agreed upon adding a three-paragraph discussion of atypical femoral fractures to the Warnings and Precautions section of the Fosamax label. Id., at 223–224. The label now refers to the fractures five times as “atypical” without using the term “stress fracture.” Ibid.
C The respondents here are more than 500 individuals who took Fosamax and who suffered atypical femoralfractures between 1999 and 2010. Brief for Respondents
7. Respondents, invoking federal diversity jurisdiction, filed separate actions seeking tort damages on the groundthat, during the relevant period, state law imposed uponMerck a legal duty to warn them and their doctors aboutthe risk of atypical femoral fractures associated with usingFosamax. Id., at 1. One respondent, for example, filed a complaint alleging that she took Fosamax for roughly 10years and suffered an atypical femoral fracture. One dayin 2009, when the respondent was 70 years old, she turned to unlock the front door of her house, heard a poppingsound, and suddenly felt her left leg give out beneath her.She needed surgery, in which doctors repaired her leg witha rod and screws. She explained she would not have usedFosamax for so many years if she had known that she might suffer an atypical femoral fracture as a result. See id., at 18–19.
Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-emptedby federal law. Both Merck and the FDA have long been aware that Fosamax could theoretically increase the riskof atypical femoral fractures. But for some period of timebetween 1995 (when the FDA first approved a drug label for Fosamax) and 2010 (when the FDA decided to requireMerck to add a warning about atypical femoral fracturesto Fosamax’s label), both Merck and the FDA were unsure
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whether the developing evidence of a causal link between Fosamax and atypical femoral fractures was strongenough to require adding a warning to the Fosamax druglabel. Merck conceded that the FDA’s CBE regulationwould have permitted Merck to try to change the label toadd a warning before 2010, but Merck asserted that the FDA would have rejected that attempt. In particular,Merck pointed to the FDA’s rejection of Merck’s 2008 attempt to amend the Fosamax label to warn of the risk of “stress fractures” associated with Fosamax. On that basis, Merck claimed that federal law prevented Merck from complying with any state-law duty to warn the respondents of the risk of atypical femoral fractures associatedwith Fosamax.
The District Court agreed with Merck’s pre-emption argument and granted summary judgment to Merck, In re Fosamax (Alendronate Sodium): Products Liability Litigation, 2014 WL 1266994, *17 (D NJ, Mar. 22, 2017), but theCourt of Appeals vacated and remanded, 852 F. 3d, at 302.The Court of Appeals concluded that its pre-emption analysis was controlled by this Court’s decision in Wyeth. Ibid. The Court of Appeals understood that case as making clear that a failure-to-warn claim grounded in state law is pre-empted where there is “‘clear evidence that the FDA would not have approved a change to the . . . label.’” Id., at 280 (quoting Wyeth, 555 U. S., at 571). The Court of Appeals, however, suggested that this statement had ledto varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d, at 284.
In attempting to do so itself, the Court of Appeals held that “the Supreme Court intended to announce a standard of proof when it used the term ‘clear evidence’ in Wyeth.” Ibid. That is, the Court of Appeals believed that “[t]heterm ‘clear evidence’ . . . does not refer directly to the typeof facts that a manufacturer must show, or to the circumCite
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stances in which preemption will be appropriate.” Id., at
285. “Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” Ibid. And in the Court of Appeals’ view, “for a defendant to establisha preemption defense under Wyeth, the factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug’s label.” Id., at 286. Moreover and importantly, the Court of Appeals also held that “whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” Ibid.
Merck filed a petition for a writ of certiorari. Merck’s petition asked the Court to decide whether Merck’s case and others like it “must . . . go to a jury” to determine whether the FDA, in effect, has disapproved a state-lawrequired labeling change. In light of differences and uncertainties among the courts of appeals and state supreme courts in respect to the application of Wyeth, we granted certiorari. See, e.g., Mason v. SmithKline Beecham Corp., 596 F. 3d 387, 391 (CA7 2010) (“The Supreme Court . . . did not clarify what constitutes ‘clear evidence’”); Reckis v. Johnson & Johnson, 471 Mass. 272, 286, 28 N. E. 3d 445, 457 (2015) (“Wyeth did not define ‘clear evidence’ . . . ” (some internal quotation marks omitted)).
II We stated in Wyeth v. Levine that state law failure-towarn claims are pre-empted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning that state law requires. 555 U. S., at 571. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way.
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A We begin by describing Wyeth. In that case, the plaintiffdeveloped gangrene after a physician’s assistant injected her with Phenergan, an antinausea drug. The plaintiffbrought a state-law failure-to-warn claim against Wyeth,the drug’s manufacturer, for failing to provide an adequatewarning about the risks that accompany various methods of administering the drug. In particular, the plaintiff claimed that directly injecting Phenergan into a patient’s vein (the “IV-push” method of administration) creates a significant risk of catastrophic consequences. And those consequences could be avoided by introducing the druginto a saline solution that slowly descends into a patient’s vein (the “IV-drip” method of administration). A juryconcluded that Wyeth’s warning label was inadequate, and that the label’s inadequacy caused the plaintiff ’s injury.On appeal, Wyeth argued that the plaintiff ’s state-law failure-to-warn claims were pre-empted because it wasimpossible for Wyeth to comply with both state law dutiesand federal labeling obligations. The Vermont Supreme Court rejected Wyeth’s pre-emption claim. Id., at 563. We too considered Wyeth’s pre-emption argument, and we too rejected it. In rejecting Wyeth’s argument, we undertook a careful review of the history of federal regulation of drugs and drug labeling. Id., at 566–568. In doingso, we “assum[ed] that the historic police powers of theStates were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id., at 565 (internal quotation marks omitted). And we found nothing within that history to indicate that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.Rather, we concluded that Congress enacted the FDCA“to bolster consumer protection against harmful products;”that Congress provided no “federal remedy for consumersharmed by unsafe or ineffective drugs”; that Congress was
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“awar[e] of the prevalence of state tort litigation;” andthat, whether Congress’ general purpose was to protectconsumers, to provide safety-related incentives to manufacturers, or both, language, history, and purpose allindicate that “Congress did not intend FDA oversight to bethe exclusive means of ensuring drug safety and effectiveness.” Id., at 574–575 (emphasis added). See also id., at 574 (“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during theFDCA’s 70-year history”).
We also observed that “through many amendments tothe FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.” Id., at 570–571. A drug manufacturer “is charged both with crafting an adequate label and withensuring that its warnings remain adequate as long as the drug is on the market.” Id., at 571. Thus, when the risks of a particular drug become apparent, the manufacturerhas “a duty to provide a warning that adequately describe[s] that risk.” Ibid. “Indeed,” we noted, “prior to2007, the FDA lacked the authority to order manufacturers to revise their labels.” Ibid. And even when “Congressgranted the FDA this authority,” in the 2007 Amendments to the FDCA, Congress simultaneously “reaffirmed the manufacturer’s obligations and referred specifically to theCBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior toFDA approval.” Ibid.
In light of Congress’ reluctance to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associated with their drugs,and Congress’ insistence on requiring drug manufacturers to bear the responsibility for the content of their drug
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labels, we were unpersuaded by Wyeth’s pre-emption argument. In Wyeth’s case, we concluded, “when the riskof gangrene from IV-push injection of Phenergan becameapparent, Wyeth had a duty” under state law “to provide a warning that adequately described that risk, and the CBEregulation permitted it to provide such a warning beforereceiving the FDA’s approval.” Ibid.
At the same time, and more directly relevant here, we pointed out that “the FDA retains authority to rejectlabeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application, just as it retains such authority in reviewing all supplemental applications.” Ibid. We then said that, nonetheless, “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with bothfederal and state requirements.” Ibid. (emphasis added).
We reviewed the record and concluded that “Wyeth has offered no such evidence.” Id., at 572. We said that Wyeth’s evidence of pre-emption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. We could find “no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of IV-push versus IV-drip administration”—the matter at issue in the case. Id., at 572 (internal quotation marks omitted). Second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. The “FDA had not made an affirmative decision to preserve” the warning asit was or “to prohibit Wyeth from strengthening its warning.” Id., at 572. For those reasons, we could not “credit Wyeth’s contention that the FDA would have prevented it from adding a stronger warning about the IV-push method
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of intravenous administration.” And we could not conclude that “it was impossible for Wyeth to comply withboth federal and state requirements.” Id., at 573. We acknowledged that meeting the standard we set forth would be difficult, but, we said, “[i]mpossibility preemption is a demanding defense.” Ibid.
B The underlying question for this type of impossibility pre-emption defense is whether federal law (includingappropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law. And, of course, in order to succeed with that defense the manufacturer must show that the answer to this question is yes. But in Wyeth, we confronted that question in the context of a particular setof circumstances. Accordingly, for purposes of this case,we assume—but do not decide—that, as was true of the warning at issue in Wyeth, there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamaxlabel. In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that theFDA would not approve changing the drug’s label to include that warning.These conclusions flow from our precedents on impossibility pre-emption and the statutory and regulatory scheme that we reviewed in Wyeth. See 555 U. S., at 578. In particular, “it has long been settled that state laws thatconflict with federal law are without effect.” Mutual Pharmaceutical Co., 570 U. S., at 480. But as we have cautioned many times before, the “possibility of impossibil14
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ity [is] not enough.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 625, n. 8 (2011) (internal quotation marks omitted). Consequently, we have refused to find clear evidence of such impossibility where the laws of one sovereign permit an activity that the laws of the other sovereign restrict oreven prohibit. See, e.g., Barnett Bank of Marion Cty.,
N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, and n. 21 (1984).
And, as we explained in Wyeth, 555 U. S., at 571–573, federal law—the FDA’s CBE regulation—permits drugmanufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association,” without prior approval from the FDA. 21 CFR §314.70(c)(6)(iii)(A). Of course, the FDA reviews CBE submissions and can reject label changes even after themanufacturer has made them. See §§314.70(c)(6), (7). And manufacturers cannot propose a change that is not based on reasonable evidence. §314.70(c)(6)(iii)(A). But in the interim, the CBE regulation permits changes, so adrug manufacturer will not ordinarily be able to show thatthere is an actual conflict between state and federal law such that it was impossible to comply with both.
We do not further define Wyeth’s use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, as we shall discuss, infra, at 15–17, courts should treat the critical question not as a matter of fact for a jury but as a matter of law for thejudge to decide. And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws “irreconcilably conflic[t].” Rice v. Norman Williams Co., 458 U. S. 654, 659 (1982); see ibid. (“Theexistence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute”).
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We do note, however, that the only agency actions thatcan determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’scongressionally delegated authority. The SupremacyClause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And preemption takes place “‘only when and if [the agency] isacting within the scope of its congressionally delegatedauthority, . . . for an agency literally has no power to act,let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’” New York v. FERC, 535 U. S. 1, 18 (2002) (some alterations omitted). Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labelingstandards, see, e.g., 21 U. S. C. §355(d); 21 CFR §§201.57,314.105; by formally rejecting a warning label that would have been adequate under state law, see, e.g., 21 CFR §§314.110(a), 314.125(b)(6); or with other agency actioncarrying the force of law, cf., e.g., 21 U. S. C. §355(o)(4)(A). The question of disapproval “method” is not now before us.And we make only the obvious point that, whatever the means the FDA uses to exercise its authority, those meansmust lie within the scope of the authority Congress has lawfully delegated.
III We turn now to what is the determinative questionbefore us: Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a questionof law, normally for a judge to decide without a jury?The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not ajury. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are
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not in dispute. Moreover, judges, rather than lay juries,are better equipped to evaluate the nature and scope of anagency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize itsconsidered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges arebetter suited than are juries to understand and to interpret agency decisions in light of the governing statutoryand regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agencyaction”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questionsrespecting the . . . terms of any agency action” and its“application” are “questions of law”). To understand the question as a legal question for judges makes sense giventhe fact that judges are normally familiar with principles of administrative law. Doing so should produce greateruniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.
We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drugconsumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision),the litigants may dispute whether the drug manufacturersubmitted all material information to the FDA.
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But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury.Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiaryfactual disputes” that are part and parcel of the broader legal question. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewherebetween a pristine legal standard and a simple historicalfact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circum-stances, “‘the fact/law distinction at times has turned on adetermination that, as a matter of the sound administration of justice, one judicial actor is better positioned thananother to decide the issue in question.’” Markman, 517
U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.
IV Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards wehave described in Part II of our opinion, we vacate its judgment and remand the case to that court for furtherproceedings consistent with this opinion.
It is so ordered.
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THOMAS, J., concurring
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE THOMAS, concurring. I join the Court’s opinion and write separately to explainmy understanding of the relevant pre-emption principles and how they apply to this case. The Supremacy Clause of the Constitution provides: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall bebound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” Art. VI, cl. 2.
Under this Clause, “[w]here state and federal law ‘directlyconflict,’ state law must give way.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 617 (2011). Although the Court has articulated several theories of pre-emption, Merck’s sole argument here is that state law is pre-empted because it is impossible for Merck to comply with federal and state law.I remain skeptical that “physical impossibility” is a proper test for deciding whether a direct conflict exists between federal and state law. But even under our impossibility precedents, Merck’s pre-emption defense fails.
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I As I have explained before, it is not obvious that the “‘physical impossibility’ standard is the best proxy for determining when state and federal laws ‘directly conflict’ for purposes of the Supremacy Clause.” Wyeth v. Levine, 555 U. S. 555, 590 (2009) (opinion concurring in judgment). Evidence from the founding suggests that, underthe original meaning of the Supremacy Clause, federal law pre-empts state law only if the two are in logical contradiction. See ibid.; Nelson, Preemption, 86 Va. L. Rev. 225, 260–261 (2000). Sometimes, federal law will logically contradict state law even if it is possible for a person to comply with both. For instance, “if federal law gives an individual the right to engage in certain behavior that state law prohibits, the laws would give contradictorycommands notwithstanding the fact that an individual could comply with both by electing to refrain from the covered behavior.” Wyeth, 555 U. S., at 590 (opinion of THOMAS, J.). Merck does not advance this logical-contradictionstandard, and it is doubtful that a pre-emption defense along these lines would succeed here. “To say, as thestatute does, that [Merck] may not market a drug withoutfederal approval (i.e., without [a Food and Drug Administration (FDA)] approved label) is not to say that federal approval gives [Merck] the unfettered right, for all time, to market its drug with the specific label that was federallyapproved.” Id., at 592. Nothing in the federal brand-name-drug “statutory or regulatory scheme necessarilyinsulates [Merck] from liability under state law simplybecause the FDA has approved a particular label.” Id., at
593. The relevant question would be whether federal law gives Merck “an unconditional right to market [a] federally approved drug at all times with the precise label initially approved by the FDA,” id., at 592, or whether it instead provides a federal floor that can be supplemented by difCite
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ferent state standards, see Brief for Cato Institute as Amicus Curiae 14, n. 4. Absent a federal statutory right tosell a brand-name drug with an FDA-approved label, FDA approval “does not represent a finding that the drug, aslabeled, can never be deemed unsafe by later federalaction, or as in this case, the application of state law.” Wyeth, supra, at 592 (opinion of THOMAS, J.).
II Applying the Court’s impossibility precedents leads tothe same conclusion. The question for impossibility iswhether it was “lawful under federal law for [Merck] to dowhat state law required of ” it. Mensing, 564 U. S., at 618. Because “[p]re-emption analysis requires us to compare federal and state law,” I “begin by identifying the [relevant] state tort duties and federal labeling requirements.” Id., at 611. Respondents’ claim here is “that state lawobligated Merck to add a warning about atypical femur fractures” to the Warnings and Precautions section of Fosamax’s label. In re Fosamax (Alendronate Sodium) Prods. Liability Litig., 852 F. 3d 268, 282 (CA3 2017).Under the Federal Food, Drug, and Cosmetic Act, a manufacturer of a brand-name drug “bears responsibility for thecontent of its label at all times.” Wyeth, 555 U. S., at 570– 571 (majority opinion). The manufacturer “is charged both with crafting an adequate label and with ensuringthat its warnings remain adequate as long as the drug is on the market.” Id., at 571. Generally, to propose labeling changes, the manufacturer can submit a Prior ApprovalSupplement (PAS) application, which requires FDA approval before the changes are made. 21 CFR §314.70(b)(2018). Alternatively, under the FDA’s Changes Being Effected (CBE) regulation, if the manufacturer would liketo change a label to “add or strengthen a contraindication,warning, precaution, or adverse reaction” “to reflect newlyacquired information,” it can change the label immediately
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upon filing its supplemental application with the FDA,without waiting for FDA approval. §314.70(c)(6)(iii); see Wyeth, supra, at 568. If the FDA later disapproves theCBE application, “it may order the manufacturer to cease distribution of the drug product(s)” with the new labeling.§314.70(c)(7).
Here, Merck’s impossibility pre-emption defense failsbecause it does not identify any federal law that “prohibited [it] from adding any and all warnings . . . that would satisfy state law.” Ante, at 13. By its reference to “the Laws of the United States,” the Supremacy Clause “requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentmentprocedures.” Wyeth, supra, at 586 (opinion of THOMAS, J.).Merck’s primary argument, based on various agency communications, is that the FDA would have rejected a hypothetical labeling change submitted via the CBE process.But neither agency musings nor hypothetical future rejections constitute pre-emptive “Laws” under the SupremacyClause.
As the Court describes, in 2008 Merck submitted PAS applications to add certain language regarding fractures tothe Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label. Ante, at 6. In 2009, the FDA sent Merck a “complete response” letter “agree[ing] thatatypical and subtrochanteric fractures should be added” tothe Adverse Reactions section. App. 510–511. But the letter said that Merck’s proposed Warnings and Precautions language, which focused on “the risk factors for stressfractures,” was “inadequate” because “[i]dentification of‘stress fractures’ may not be clearly related to the atypicalsubtrochanteric fractures that have been reported in theliterature.” Id., at 511. In accord with FDA regulations, the letter required Merck to take one of three actions: (1)
Cite as: 587 U. S. ____ (2019) 5
THOMAS, J., concurring
“[r]esubmit the application . . . , addressing all deficienciesidentified in the complete response letter”; (2) “[w]ithdraw the application . . . without prejudice to a subsequent submission”; or (3) “[a]sk the agency to provide . . . an opportunity for a hearing,” after which “the agency will either approve” or “refuse to approve the application.” 21 CFR §314.110(b); see App. 512. As this regulation suggests and the FDA has explained, complete response letters merely “infor[m] sponsors of changes that must be made before an application can be approved, with no implication as to the ultimate approvability of the application.” 73 Fed. Reg. 39588 (2008) (emphasis added). In other words, the 2009 letter neither marked “the consummation of the agency’s decisionmaking process” nor determined Merck’s “rights or obligations.” Bennett v. Spear, 520 U. S. 154, 178 (1997) (internal quotation marks omitted). Instead, it was “of a merely tentative or interlocutorynature.” Ibid. Therefore, the letter was not a final agencyaction with the force of law, so it cannot be “Law” with pre-emptive effect.
Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypotheticalagency action is not “Law.” As Merck acknowledges, itcould have resubmitted its PAS applications, sought a hearing, or changed its label at any time through the CBE process. See Reply Brief 13. Indeed, when Merck instead decided to withdraw its PAS applications, it added atypical femoral fractures to the Adverse Reactions section through the CBE process. That process also enabledMerck to add language to the Warnings and Precautionssection, but Merck did not do so. If it had, it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfyboth sets of duties. Merck’s belief that the FDA would have eventually rejected a CBE application does not make
6 MERCK SHARP & DOHME CORP. v. ALBRECHT
THOMAS, J., concurring
an earlier CBE change impossible. As the Court correctly explains, “‘the possibility of impossibility [is] not enough.’” Ante, at 13–14. The very point of the CBE process is that a manufacturer can “unilaterally” make a labeling changethat does not violate other federal law, Wyeth, 555 U. S., at 573; see id., at 570; e.g., 21 U. S. C. §352, at least until the FDA rules on its application.*
Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law.
—————— *In 2007, Congress “granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval,” but even after this amendment, brand-name-drug “manufacturers remain responsible for updating their labels.” Wyeth, 555 U. S., at 567–568; see 21 U. S. C. §355(o)(4). As I understand the Court’s opinion, if proper agencyactions pursuant to this amendment, or other federal law, “prohibited the drug manufacturer from . . . satisfy[ing] state law,” state law would be pre-empted under our impossibility precedents regardless of whetherthe manufacturer “show[ed] that it fully informed the FDA of the justifications for the warning required by state law.” Ante, at 13; see, e.g., Wyeth, 555 U. S., at 576; id., at 582 (BREYER, J., concurring). Of course, the only proper agency actions are those “that are set forth in, or necessarily follow from, the statutory text,” and they must have the force of law to be pre-emptive. Id., at 586 (opinion of THOMAS, J.). I am aware of no such agency action here that prevented Merck from complying with state law.
_________________
_________________
Cite as: 587 U. S. ____ (2019) 1
ALITO, J., concurring in judgment
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE KAVANAUGH join, concurring in the judgment.
I concur in the judgment because I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed Merck toinclude in the Fosamax label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact. I do not, however, jointhe opinion of the Court because I am concerned that itsdiscussion of the law and the facts may be misleading on remand.
I I begin with the law. The Court correctly notes that a drug manufacturer may prove impossibility pre-emption by showing that “federal law (including appropriate [Food and Drug Administration (FDA)] actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.” Ante, at 13. But in expounding further on the pre-emption analysis,the Court provides a skewed summary. While dwelling on our decision in Wyeth v. Levine, 555 U. S. 555 (2009), see ante, at 9–14, the Court barely notes a statutory provisionenacted after the underlying events in that case that may have an important bearing on the ultimate pre-emption
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
ALITO, J., concurring in judgment
analysis in this case.
Under 21 U. S. C. §355(o)(4)(A), which was enacted in 2007, Congress has imposed on the FDA a duty to initiatea label change “[i]f the Secretary becomes aware of new information, including any new safety information . . . that the Secretary determines should be included in the labeling of the drug.”* This provision does not relieve drugmanufacturers of their own responsibility to maintain their drug labels, see §355(o)(4)(I), but the FDA’s “actions,” ante, at 13, taken pursuant to this duty arguably affect the pre-emption analysis. This is so because, if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified. See United States v. Chemical Foundation, Inc., 272 U. S. 1, 14–15 (1926) (“The presumption of regularity supports the official acts of public officers and, in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties”). The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention. Cf. ante, at 13 (“the drugmanufacturer [must] show that it fully informed the FDAof the justifications for the warning required by statelaw”). Nor does §355(o)(4)(A) require the FDA to communicate to the relevant drug manufacturer that a label change is unwarranted; instead, the FDA could simplyconsider the new information and decide not to act. Cf. ante, at 13 (“[T]he FDA, in turn, [must have] informed the drug manufacturer that the FDA would not approve ——————
*Prior to October 2018, §355(o)(4)(A)’s language contained slight differences not relevant here. See Substance Use–Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. 115–271, §3041(b), 132 Stat. 3942–3943, effective Oct. 24, 2018.
Cite as: 587 U. S. ____ (2019) 3
ALITO, J., concurring in judgment
changing the drug’s label to include that warning”).
Section 355(o)(4)(A) is thus highly relevant to the preemption analysis, which turns on whether “federal law (including appropriate FDA actions) prohibited the drugmanufacturer from adding any and all warnings to thedrug label that would satisfy state law.” Ante, at 13 (emphasis added). On remand, I assume that the Court of Appeals will consider the effect of §355(o)(4)(A) on the preemption issue in this case.
Two other aspects of the Court’s discussion of the legal background must also

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MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS: What’s Next?

MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS AND CANCER: IS THIS AN EMERGING MASS TORT? 

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

By Mark A. York (May 8, 2019)

 

 

 

 

 

 

 

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

In addition to the warning notice to Mentor Worldwide in March 2018 (above), the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. The FDA shas  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

In the U.S. and Canada, regulators did not impose any consequences after manufacturers lost track of most of the participants in a large-population health study within three years, although a 10-year study was ordered as a condition of allowing silicone implants back on the market.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Typical Breast Implants Placement

Silicone Breast Implant History

History that breast implants have caused serious health problems, but for most of the public, that problem is assumed to be a historical reference, because those implants were removed from the market, so the current implants on the market must be very safe.

While the FDA now openly mentions problems that often occur in many women with breast implants, such as leaking and rupturing, they fail to warn the public about the more dangerous connection to auto-immune disorders.

The FDA actually allowed implants to be put onto the market for over 40 years without formally approving them, so it’s not a best practice to trust what the FDA says.

The lawsuits in the 1990’s involved 450,000 US women who sued  Dow Corning, one of the world’s largest manufacturers of silicone implants.

While Dow Corning never admitted that their implants were dangerous, they paid out enormous amounts to the victims. Their implants of the 1970’s had a very thin outer shell, and had a high leakage rate. Many women even lost their lives from illness caused by these implants, while waiting for a legal resolution of their lawsuits against Dow.

It was disclosed that Dow Corning knew for a very long time that their implants were toxic, yet covered it up for as long as they could.

In their own animal studies, researchers found that silicone could easily leak into the body, and caused tumours in up to 80% of the rats that were being tested on, see Fig. 7. The numbers were so alarming that the FDA, instead of being concerned, called these studies “erroneous,” which basically means they ‘must’ have been incorrect. The FDA then approved the Dow Corning implants, despite protests from some staff members that there were troubling warning signs.

We’ve also heard about the now infamous French PIP implant scandal which hit worldwide news recently. These implants (which were found to contain toxic chemicals used in mattresses and not approved for human use) are now banned, and women in the UK were offered free treatment to have them removed.

Shocking Ingredients Found In Dow Silicone Implants

When women are told that their implants contain silicone or saline, they often don’t tend to ask if anything else is being used alongside it. They certainly aren’t told this by the surgeons, who more than likely don’t even know themselves.

Check out the long list of alarming ingredients used in Dow’s silicone implants which came out during their court case when they were forced to disclose what was in their dangerous implants:

  • Methyl ethyl ketone (neurotoxin)
  • Cyclohexanone (neurotoxin)
  • Isopropyl Alcohol
  • Denatured Alcohol
  • Acetone (used in nail polish remover and is a neurotoxin)
  • Urethane
  • Polyvinyl chloride (neurotoxin)
  • Amine
  • Toulene
  • Dicholormethane (carcinogen)
  • Chloromethane
  • Ethyl acetate (neurotoxin)
  • Silicone
  • Sodium fluoride
  • Lead Based Solder
  • Formaldehyde
  • Talcum powder
  • Oakite (cleaning solvent)
  • Methyl 2- Cynanoacrylates
  • Ethylene Oxide (Carcinogen)
  • Xylene (neurotoxin)
  • Hexon
  • 2-Hedanone
  • Thixon-OSN-2
  • Stearic Acid
  • Zinc Oxide
  • Naptha (rubber solvent)
  • Phenol (neurotoxin)
  • Benzene (carcinogen/neurotoxin)
  • Lacquer thinner
  • Epoxy resin
  • Epoxy hardener
  • Printing Ink
  • Metal cleaning acid
  • colour pigments as release agents
  • heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
  • Platinium
  • Silica * (2)

What’s In Implants Today?

The current problem is we just don’t know. Its very difficult to find out exactly what is in current implants today. There nothing that shows a full ingredient list. Plastic surgeons state they have ‘never seen a full list’ and implant websites, do not disclose what is in their products.

Some scientists have been taking an in-depth look at the platinum, a toxic salt, found in silicone implants and its connection to ill health. However, after looking at this list above, it seems ludicrous to suggest that one individual ingredient would be the sole cause of these health problems. It’s clear that breast implants are completely toxic.

Its important to know that saline implants ALL have silicone outer shells, so these too can leak silicone and other ingredients into the body, either through rupturing or when the textured surface flakes off.

Types of Breast Implants Used Today

Silicone Implants

Many women opt out of having silicone implants due to the Dow Corning Lawsuit. But a growing number of women are now choosing to have them again due to the implant’s ability to look more natural than other types. These implants have an elastic type envelope which is pre-filled with a sticky, clear, jelly-like form of silicone. There are a few varieties of shapes to choose from, with smooth or textured surfaces.

With the FDA allowing silicone implants to come back on the market, it is very concerning to know that statistics show (according to Nancy Bruning, author of Breast Implants — Everything You Need To Know) that almost half of all women who have this type of implant will experience a rupture within 6-10 years, and one in five women were found to have silicone migrate to other parts of their bodies.

 

 

 

 

 

 

According to Dr Susan Kolb, world expert on breast implants, silicone implants should be completely avoided.

 

 

 

 

 

Saline implants – silicone outer shell, saline liquid inserted during surgery by surgeon

Saline Implants

Saline implants are commonly thought to be safer, yet they have their own problems. Saline implants have a silicone shell filled with a saline water, which is salt based and ‘sterile.’ Some types are inserted empty which the surgeon will inflate during surgery with this saline liquid. There is another type of saline implant, which also has a silicone shell, but the inside contains a gel like texture. There are smooth surface saline implants and textured surface saline implants.

According to research experts, 60% of women with these types of implants have complications within four years, and one out of five require additional surgery within three years.  This seems to be a cause for concern, since patients are commonly told that implants either never need to be removed or should be removed every ten years.

Possible Side Effects

This is what your surgeon does not tell you:

  • tenderness, lumpiness, or discomfort around the implants
  • change in the shape of your breast(s)
  • change in the consistency of your breast, such as increased softness
  • change in the way your breast moves – all of these symptoms may be a sign your implant has ruptured.
  • hardening of breast tissue
  • muscle pain
  • pain and swelling of the joints
  • pain in the soft tissues
  • a burning sensation of pain
  • tightness, redness, or swelling of the skin
  • swollen glands or lymph nodes
  • unusual, extreme, or unexplained fatigue
  • swelling of the hands and feet
  • unusualhair loss
  • rashes
  • skin thickening or hardening
  • dry eyes, mouth, or vagina
  • loss of memory, mental confusion, or ‘fogginess’
  • autoimmune disorders such as fibromyalgia, rheumatoid arthritis, scleroderma, multiple chemical sensitivity disorder, cancer, and biotoxicity problems.

Above is an excerpt from Breast Implants – All You Need To Know by Nancy Bruning.

 

 

 

 

 

 

 

 

 

 

A ruptured silicone implant. The red is tissue that had to be removed from the patient. The sticky consistency on the right is what comes out when ruptures and leakage occur.

Breast Implants Can Cause Cancer

It might not surprise some of you reading this to learn that there is a link between cancer and implants. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants.

French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

Suicide Risk

Another little known factor about breast implants is that there is a connection between suicide. While this connection might be more about the woman’s mental status prior to having the surgery (perhaps she suffered from low self esteem and thought implants would make her much happier), it could also be because of the stressful impact the implants have on the body and its many important systems. As we have seen above, implants are linked to neurological disorders, amongst other concerns.

Women who have implants are at least 3 (some sources say 4) times more likely to commit suicide than those who do not have them.

The American Society of Plastic Surgeons (ASPS) reported that 329,396 women have undergone breast augmentation in the United States, an increase of 55% between 2000 and 2006, making it the most frequent US surgical cosmetic procedure for 2006 (ASPS, 2007). Although many studies have explored psychological aspects of this type of surgery, the consistently dramatic increase in numbers of breast augmentations, some that result in adverse psychological outcomes, remains a serious concern for health care providers. Surprisingly, very little is known about either the psychological characteristics of cosmetic surgery patients or the psychological impact of the surgical procedures. This literature review focuses on psychological issues in relation to breast augmentation procedures, including recent suicide findings related to this procedure. Conclusion of this review supports the necessity by health care providers to consistently screen patients for psychological disorders, such as Body Dysmorphic Disorder (BDD), prior to conducting cosmetic surgical procedures, specifically breast augmentation. See https://www.ncbi.nlm.nih.gov/pubmed/19499438, Psychological Issues Associated With Breast Augmentation  2009 Jun;30(6):377-82

Mammograms Can Rupture Breast Implants

 

 

 

 

 

 

 

Mammogram on a patient without implants 

If you have implants, you need to be aware that having mammograms can actually do serious damage to them. Because the procedure involves intense squashing down of the breast tissue, this has been known to cause ruptures, and if the implants do begin to leak, what is inside them will likely leak into your body.

It must be said that there is also alarming information that mammograms are not safe to have, even if you don’t have implants.

Is There A Safe Implant?

If you choose to get implants, then according to breast implant expert Dr. Susan Kolb, the safest type is the saline implant that has a smooth surface and does not have a valve. This is because the textured implants have been found to have particles flake off into the person’s body which can then attack the immune system. If there is a valve, as mentioned previously, a systemic fungal infection can ensue.  But even with this type, problems can happen in the future and lead to drastic complications, and it now seems to be leading toward Breast Implant Litigation Round II.

As discussed in the article What You Need To Know About Breast Implants, the authors wrote about the concerns with breastfeeding and toxicity:

According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding. Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue. A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.

THE FAILS AGAIN

The FDA has also posted an unusually blunt warning on its website. It advises patients that the risk of complications is high and says flatly:  “You should assume that you will need to have additional surgeries.”

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

A Clear Example of What Can Go Wrong

Please check out Susan’s experience that really turned into an utter nightmare for her, which is still affecting her health today. Below is a picture of her implants that she had recently removed.

 

 

 

 

 

 

 

 

 

 

 

 

 

Susan’s implants which were moved back in April this year. The one on the left was so ‘jelly like’ it had to be scraped off her ribs. The right one, although looks quite normal, actually had a small rupture too. The red tissue is what the surgeon also had to remove to ensure all the silicone was gone.

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MDL 2885 – “3M Combat Arms Earplug” JPML Hearing Was Today in Washington D.C.

 (MASS TORT NEXUS MEDIA) 3M Combat Arms earplugs were issued by the U.S. military between 2003 and 2015 and now litigation has begun asserting that 3M designed and distributed defective earplugs designed for use in combat and elevated noise situations, were defective and left hundreds of thousands of soldiers and veterans injured and suffering from hearing loss.

The March 28, 2019 JPML Initial Hearing on 3M Company Combat Arms Earplug MDL 2885 took place in Washington D.C. this morning. One of the lead counsel for plaintiffs, Mark Lanier, of The Lanier Law Firm, PC offered the following statement on MDL 2885, “This is one of the most important litigations in our generation.  It concerns real damage done to our soldiers by American industry, not enemy combatants.  We trust the MDL will go to a court that will prioritize the swift delivery of justice in a complicated and important litigation.”

Primary claims of the military personnel assert that the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. The lawsuits also claim 3M misrepresented the effectiveness of the hearing protection devices to the military during the proposal process when as well as after they obtained the government contract as the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.

Shelly Sanford of Watts Guerra LLP, in Austin, Texas, who spoke at today’s hearing offered this statement “We are keenly focused on the veterans who were sent into combat with these earplugs and came home with hearing loss. The vast majority of these Veterans reside in Texas, and that is just one of the reasons I am requesting that the MDL be assigned there.”

Ms. Sanford also added  “As Judge Charles Breyer, an esteemed former member of the JPML, pointed out in the opioid litigation MDL 2804 hearing, the only issue is ‘what did they know and when did they know it?” With 3M, that question is central to both the claims and potential defenses. I think the core issue is where will the JPML send the MDL.”

OVERVIEW OF EARPLUG PROBLEMS

Combat Arms Earplugs, Version 2 (CAEv2) have been issued by the U.S. Military for each deployed soldier between 2003 and late 2015.

The dual-end or reversible earplugs were used during training and on the battlefield to provide ear protection during service. However, design defects may cause the earplug to imperceptibly loosen in the ear canal, rendering the earplugs useless or less effective.

Aearo Technologies first developed and tested the Combat Arms Earplugs in 2000, and began selling them to the U.S. Defense Logistics Agency in late 2003, at which time they became standard issue.

3M Company acquired Aearo in 2008, and continued to sell the earplugs to the military until at least 2015.

COMBAT ARMS EARPLUGS QUI TAM SETTLEMENT

In July 2018, the U.S. Department of Justice reached a $9.1 million settlement with 3M Company over the Combat Arms earplugs, resolving claims that the manufacturer committed fraud by knowingly selling defective earplugs to the government.

According to allegations raised in a 3M earplug lawsuit that led to the settlement:

  • CAEv2 design defects cause the earplug to imperceptibly loosen in users ears over time, which was not disclosed to the U.S. government or end users;
  • 3M Company provided false and inaccurate noise reduction ratings (NRR) for the earplugs, which employed testing methods that did not comply with required or accepted standards;
  • Combat Arms noise reduction ratings listed on the packaging materials and instructions failed to accurately reflect the true characteristics of the earplugs.

The Justice Department found that the earplugs were too short to fit in many ears and imperceptibly would move out of place, making them ineffective. In addition, critics say neither 3M nor Aearo provided proper use instructions to soldiers, which should have told the wearers to fold back the flanges on the open end of the plug before inserting the closed end into their ears so that they properly fit.

  • Listening to television and radio at high volumes
  • Trouble understanding speech, particularly in noisy environments
  • Often asking people to repeat themselves
  • Needing a hearing aid

Following the announcement of the Qui Tam settlement, veterans started looking at the conduct of 3M and as the bad faith of 3M came to light, lawyers across the country became involved. Litigation against 3M was started by various law firms in late 2018 representing veterans who used the Combat Arms™ earplugs, as instructed and suffered noise-induced hearing loss. As of March 2019, there were over 200 lawsuits in various state and federal courts, which resulted in the JPML Motion for Consolidation. Resulting in the hearing earlier today in the 3M Company Combat Earplug Litigation MDL 2885 in Washington D.C., in front of the JPML Panel, who usually take between 7 and 14 days to issue a ruling.

Where MDL 2885 is finally assigned remains to be seen, as there were several venues presented by the parties and each has viable claims and reasoning. Locations include Texas for the military presence and judicial interest, Minnesota for 3M convenience and home court advantage, Washington D.C. where the military operations are at home or Indianapolis where there’s MDL judicial experience. Perhaps the 3M litigation will open the door for holding those responsible for Department of Defense contracting abuses and similar bad conduct being held accountable for their actions on a regular basis.

 

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Xarelto Litigation Settles for $775 million Bayer and Johnson & Johnson Split Bill  

 

March 25, 2019 Global Xarelto Blood Thinner Settlement Announced 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Bayer AG and J&J’s subsidiary Janssen Pharmaceuticals Inc. have now formalized a $775 million settlement of more than 25,000 lawsuits over their blood-thinning drug Xarelto. The cases are pending in both federal and state courts and this may be seen as a run up to Bayer’s next settlement, in their now seen as a bad-for-earnings purchase of Monsanto and its Federal Roundup MDL 2471 docket, as well as cases filed in state courts.

Plaintiffs alleged the drug caused uncontrollable bleeding, and said that Bayer and Janssen failed to adequately warn of that risk as well as manipulated data related to clinical trial and published studies. To date, plaintiffs have not done well in bellwether trials, having lost three in a row in the Xarelto MDL 2592 litigation in from of Judge Eldon Fallon in the US District Court of Louisiana. In those cases the defense asserted an “learned intermediary” defense which was very successful. The same defense was used in the state court trials in the Philadelphia Court of Common Pleas cases and proved a winning defense in the first two plaintiff bellwether losses there.

The upcoming third Philadelphia court bellwether trial was set for May 2019, and may have had an impact on the settlement timing, or Bayer may have been trying to get a major legal headache off the table in anticipation of the ever-expanding Monsanto Roundup litigation.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, was the judge set to hear the upcoming May trial and also the judge who presided over the Hartmann 2018 verdict reversal, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592. The prior losses  at trial were  heard in the  XARELTO MDL 2592 US District Court ED Louisiana litigation in front of Judge Eldon Fallon, US District Court of Louisiana.

Links to the settlement orders entered March 25, 2019 in the Xarelto MDL 2592 docket:

Xarelto MDL 2592 Settlement CMO No. 9 March 25, 2019 Stay on Litigation

 

Xarelto MDL 2592 Settlement CMO No. 10 March 25, 2019 Case Registration Protocol

 

Xarelto MDL 2592 Settlement CMO No. 11 March, 25, 2019 Docket Control Order

For complete docket information on the Xarelto Multidistrict and Philadelphia, PA state court docket see the Mass Tort Nexus briefcases below:

https://www.masstortnexus.com/Briefcases/4/XARELTO-(rivaroxaban)-MDL-2592-USDC-ED-Louisiana

https://www.masstortnexus.com/Briefcases/33/XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court)

More than five years after the Xarelto™ litigation began, and with Bayer and Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of 775 million U.S. dollars.

The settlement amount will be shared equally between the two companies. It is expected that Bayer’s share will be partially offset by product liability insurance.

The settlement is global and is designed to resolve all of the approximately 25,000 Xarelto™ claims in the US, based in the specific terms of the still confidential settlement agreement. The companies have reserved the right to withdraw from the settlement if certain participation rates of those who are eligible to participate are not satisfied.

Bayer continues to believe these claims are without merit and there is no admission of liability under the agreement. However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation.

Both Bayer and Janssen have faced harsh and ever growing scrutiny related to the recent disclosures that the Rocket AF study and Einstein study data may not have been as favorable towards Xarelto’s push as a “miracle blood-thinner drug” as once viewed in the medical world.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.

The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:

  1. Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
  2. Defendants have not designed and marketed an antidote to counteract a major bleeding event.
  3. In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.

“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.

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For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@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.
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Untitled

BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

 

 

IN RE: CHILDREN BORN                       MDL – _________

OPIOID-DEPENDENT

 

BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR TRANSFER OF

ACTIONS PURSUANT TO 28 U.S.C. § 1407 FOR COORDINATED OR

CONSOLIDATED PRETRIAL PROCEEDINGS

Plaintiffs[1] respectfully move that the Judicial Panel on Multidistrict Litigation (“Panel”), pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Panel, transfer the actions on behalf of children born opioid-dependent listed in the attached Schedule of Actions and subsequent tag-along actions to a separate MDL before the Southern District of West Virginia.; alternatively, Plaintiffs request transfer to the Southern District of Illinois.

I.        Children Born Opioid-Dependent Need A Separate MDL From MDL 2804

Movants seek transfer and coordination or consolidation of all cases filed on behalf of opioiddependent infants into a new MDL for the reasons laid out

[1] Movants are: Deric Rees and Ceonda Rees, individually and as next friend and guardian of Baby T.W.B. on behalf of themselves and all others similarly situated (Illinois Class); Darren and Elena Flanagan, individually and as adoptive parents and next friends of Baby K.L.F., on behalf of themselves and all others similarly situated (Tennessee Class); Rachel Wood, individually and as next friend and adopted mother of Baby O.W., on behalf of themselves and all others similarly situated (Missouri Class); Melissa Ambrosio, individually and as next friend of Baby G.A., and on behalf of themselves and all others similarly situated (California Class); Shannon Hunt, individually and as next friend of Baby S.J., on behalf of themselves and all others similarly situated (Maryland Class); Bobbi Lou Moore on behalf of Baby R.R.C., and all other similarly situated (West Virginia Class); Walter and Virginia Salmons, individually and as the next friend or guardian of Minor W.D. and on behalf of all others similarly situated (National Class).

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Why Isn’t Medical Cannabis Used to Treat Opioid and Substance Abuse Disorders More Often, Since It Works?

IS MEDICAL CANNABIS AN ALTERNATIVE TREATMENT FOR OPIOID ADDICTION?

By Mark A. York (September 20, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) More and more medical treatment professionals, politicians and others have joined in the quickly emerging role of medical marijuana to help in treatment by patients struggling with opioid addiction. Now, two studies are reflecting this emerging treatment to be viable.

Recent studies, published journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.

Additionally, three states have approved Medical Cannabis for alternative treatments related to both pain management and substance abuse disorders, where cannabis has been determined as an appropriate treatment. Pennsylvania, New Jersey and Illinois are at the forefront of using changes to state laws regarding medical cannabis in the most effective clinical settings when possible.

PENNSYLVANIA CANNABIS BASED OPIOID ADDICTION TREATMENT

The Pennsylvania Department of Health approved major changes to the state’s medical marijuana program, when the  health department added opioid addiction to the list of conditions eligible for treatment with medicinal cannabis. With that decision, Pennsylvania joins New Jersey and Illinois as the only states that have done so.

Pennsylvania Secretary of Health Dr. Rachel Levine told local media that marijuana won’t be the first treatment for addiction to opioids. Instead, doctors will try more traditional therapies first.

“It’s important to note that medical marijuana is not a substitute for proven treatments for opioid use disorder,” Dr. Levine said. “In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”

A related positive note by Pennsylvania is the Department of Health has approved cannabis research licenses for five Philadelphia area medical schools on Monday. With one topic of research at the institutions being the potential role of cannabis in addiction treatment as a normal treatment protocol.

The schools that received approval to study cannabis are Drexel University College of Medicine, Lewis Katz School of Medicine at Temple University, Sidney Kimmel Medical College at Thomas Jefferson University, Perelman School of Medicine at the University of Pennsylvania, and Philadelphia College of Osteopathic Medicine.

JAMA STUDY RESULTS

The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.

“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.

“And for pain patients in particular, our work adds to the argument that cannabis can be effective.”

Medicare Part D, the optional prescription drug benefit plan for those enrolled in Medicare, covers more than 42 million Americans, including those 65 or older. Medicaid provides health coverage to more than 73 million low-income individuals in the US, according to the program’s website.

“Medicare and Medicaid publishes this data, and we’re free to use it, and anyone who’s interested can download the data,” Bradford said. “But that means that we don’t know what’s going on with the privately insured and the uninsured population, and for that, I’m afraid the data sets are proprietary and expensive.”

Republicans Support Legalizing Medical Cannabis

Earlier this year, the National Academy of Sciences, in a 395-page report, refuted the official US Department of Justice position that cannabis is a “gateway drug” and that using marijuana can lead to opioid addiction and instead found evidence of cannabis having therapeutic and health benefits. Joe Schrank, a social worker who worked at various detox centers and clean houses, is now practicing the report’s findings at High Sobriety treatment center in Los Angeles, where he offers clients medical and therapeutic sessions, and daily doses of marijuana to treat a variety of addictions.

The Opioid Crisis Is Here

The new research comes as the United States remains entangled in the worst opioid epidemic the world has ever seen. Opioid overdose has risen dramatically over the past 15 years and has been implicated in over 500,000 deaths since 2000 — more than the number of Americans killed in World War II.

“As somebody who treats patients with opioid use disorders, this crisis is very real. These patients die every day, and it’s quite shocking in many ways,” said Dr. Kevin Hill, an addiction psychiatrist at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School, who was not involved in the new studies.

“We have had overuse of certain prescription opioids over the years, and it’s certainly contributed to the opioid crisis that we’re feeling,” he added. “I don’t think that’s the only reason, but certainly, it was too easy at many points to get prescriptions for opioids.”

Today, more than 90 Americans a day die from opioid overdose, resulting in more than 42,000 deaths per year, according to the US Centers for Disease Control and Prevention. Opioid overdose recently overtook vehicular accidents and shooting deaths as the most common cause of accidental death in the United States, the CDC says.

 

 

 

 

 

 

 

Doctors must lead us out of our opioid abuse epidemic

Like opioids, marijuana has been shown to be effective in treating chronic pain as well as other conditions such as seizures, multiple sclerosis and certain mental disorders, according to the National Institute on Drug Abuse. Research suggests that the cannabinoid and opioid receptor systems rely on common signaling pathways in the brain, including the dopamine reward system that is central to drug tolerance, dependence and addiction.

“All drugs of abuse operate using some shared pathways. For example, cannabinoid receptors and opioid receptors coincidentally happen to be located very close by in many places in the brain,” Hill said. “So it stands to reason that a medication that affects one system might affect the other.”

But unlike opioids, marijuana has little addiction potential, and virtually no deaths from marijuana overdose have been reported in the United States, according to Bradford.

“No one has ever died of cannabis, so it has many safety advantages over opiates,” Bradford said. “And to the extent that we’re trying to manage the opiate crisis, cannabis is a potential tool.”

Comparing states with and without medical marijuana laws

  • Researchers compared prescription patterns in states with and without medical cannabis laws
  • States with medical marijuana had 2.21 million fewer daily doses of opioids prescribed per year
  • Opioid prescriptions under Medicaid dropped by 5.88% in states with medical cannabis laws

In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.

Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use — Alaska, Colorado, Oregon and Washington — saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study.

“We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon,” Wen said. “And in Alaska and Washington, the magnitude was a little bit smaller but still significant.”

Cannabis legalization by the numbers

The first state in the United States to legalize marijuana for medicinal use was California, in 1996. Since then, 29 states and the District of Columbia have approved some form of legalized cannabis. All of these states include chronic pain — either directly or indirectly — in the list of approved medical conditions for marijuana use, according to Bradford.

The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.

The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries — regulated shops that people can visit to purchase cannabis products — had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.

“We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on — and that was statistically significant — and about a 7% reduction in any opiate use when home cultivation only was turned on,” Bradford said. “So dispensaries are much more powerful in terms of shifting people away from the use of opiates.”

The impact of these laws also differed based on the class of opioid prescribed. Specifically, states with medical cannabis laws saw 20.7% fewer morphine prescriptions and 17.4% fewer hydrocodone prescriptions compared with states that did not have these laws, according to Bradford.

 

 

 

 

 

 

This is fentanyl: A visual guide

Fentanyl prescriptions under Medicare Part D also dropped by 8.5% in states that had enacted medical cannabis laws, though the difference was not statistically significant, Bradford said. Fentanyl is a synthetic opioid, like heroin, that can be prescribed legally by physicians. It is 50 to 100 times more potent than morphine, and even a small amount can be fatal, according to the National Institute on Drug Abuse.

“I know that many people, including the attorney general, Jeff Sessions, are skeptical of cannabis,” Bradford said. “But, you know, the attorney general needs to be terrified of fentanyl.”

MAKING CANNABIS AVAILABLE

This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state’s upward trend in opioid-related deaths.

“There is a growing body of scientific literature suggesting that legal access to marijuana can reduce the use of opioids as well as opioid-related overdose deaths,” said Melissa Moore, New York deputy state director for the Drug Policy Alliance. “In states with medical marijuana laws, we have already seen decreased admissions for opioid-related treatment and dramatically reduced rates of opioid overdoses.”

Sessions: DOJ looking at ‘rational’ marijuana policy

Some skeptics, though, argue that marijuana legalization could actually worsen the opioid epidemic. Another 2017 study, for example, showed a positive association between illicit cannabis use and opioid use disorders in the United States. But there may be an important difference between illicit cannabis use and legalized cannabis use, according to Hill.

“As we have all of these states implementing these policies, it’s imperative that we do more research,” Hill said. “We need to study the effects of these policies, and we really haven’t done it to the degree that we should.”

The two recent studies looked only at patients enrolled in Medicaid and Medicare Part D, meaning the results may not be generalizable to the entire US population.

But both Hill and Moore agree that as more states debate the merits of legalizing marijuana in the coming months and years, more research will be needed to create consistency between cannabis science and cannabis policy.

“There is a great deal of movement in the Northeast, with New Hampshire and New Jersey being well-positioned to legalize adult use,” Moore said. “I believe there are also ballot measures to legalize marijuana in Arizona, Florida, Missouri, Nebraska and South Dakota as well that voters will decide on in Fall 2018.”

Hill called the new research “a call to action” and added, “we should be studying these policies. But unfortunately, the policies have far outpaced the science at this point.”

There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.

The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.

Opioid overdose, which claimed celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

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