JUUL MDL 2913 DESIGNATED BY JPML

“E-cigarette docket transferred to USDC ND California”

Mark A. York (October 3, 2019)

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

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

 

 

 

 

 

 

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

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

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

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

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

FDA WARNING ISSUED

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

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

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

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

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

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

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

PHILLIP MORRIS SHUTS DOWN JUUL MERGER

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

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

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

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

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

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

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

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

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

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

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

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

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

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

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

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

JUUL Changed Nicotine Disclosures

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

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

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

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

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

 

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JUUL: The unregulated killer of teens for profit!

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

MASS TORT NEXUS MEDIA (September 23, 2019) 

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

Why is Juul so popular among teens?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is Juul?

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

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

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

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

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

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

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

What are the main ingredients in Juul pods?

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

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

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

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

How much nicotine is in a Juul pod?

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

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

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

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

 

 

 

 

 

 

 

 

 

Is Juul addictive? Is Juul more addictive than cigarettes?

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

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

What are the health effects of vaping?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What’s the FDA’s stance on Juul?

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

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

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

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

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

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

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

How did Juul get its start?

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

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

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

Juul copycats

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

Zonk E Liquid

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

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

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

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

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

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

 

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

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

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF OHIO

EASTERN DIVISION

 

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION

 THIS DOCUMENT RELATES TO:

 All Cases

MDL 2804

)     Case No. 1:17-md-2804

)     Judge Dan Aaron Polster

)     OPINION AND ORDER REGARDING

)     DEFENDANTS’ SUMMARY

)     JUDGMENT MOTIONS ON RICO AND OCPA

 

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

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

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

1.

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

II.

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

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

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

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

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

A.  The Existence of An Enterprise

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

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

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

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

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

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

B.  Causation

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

C.  Other Arguments

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

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

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

IT IS SO ORDERED.

  

/s/Dan Aaron Polster September 10, 2019

DAN AARON POLSTER

UNITED STATES DISTRICT JUDGE

 

 

 

 

 

 

 

 

 

 

 

 

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

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

 

 

 

 

 

 

 

 

 

By Mark A. York (August 30, 2019)

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

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

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

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

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

Types of PAEs

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

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

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

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

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

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

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

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

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

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

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

Preventing Hospital Medical Errors/sciencedaily

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

“MORE BAD CONDUCT SHOWN IN OKLAHOMA OPIOID TRIAL”

By Mark A. York (August 26, 2019)

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

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

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

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

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

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

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

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

J&J HISTORY OF BAD CONDUCT

Payments To Industry Insiders

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

Bad Science

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

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

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

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

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

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

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

Risperdal Off-Label Drug Marketing

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

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

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

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

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

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

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

Risperdal Male Breast Growth

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

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

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

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

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

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

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

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

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

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

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

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

Richard Sackler of Purdue Pharma Deposition Transcript Re: Oxycontin Train

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

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

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

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

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

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

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

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

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

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

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

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

 

Addiction Recovery Issues

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

OPIOD LITIGATION UPDATE: FOR FEDERAL AND STATE COURT DOCKETS

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

Mass Tort Nexus “CLE Immersion Course”

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

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

  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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Bayer’s Roundup Litigation Headaches Continue to Grow – When Will They Settle?

How many billions is Bayer AG setting aside?

By Mark A. York (August 9, 2019)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The Bayer AG executive suite seems to be leaning toward settling the Monsanto (Bayer) Roundup MDL 2741 litigation, along with the thousands of cases in state courts around the country. A previous statement on settlement was, this is “financially reasonable” to review settlement of all litigation over the weedkiller Roundup, and is under review.

Bayer engaged additional senior defense counsel from Skadden, Arps and there is word of casual settlement discussions among people directly involved in the litigation. MDL Judge Chhabria has set a hard remand docket, and also appointed mediator Ken Feinberg to help move settlement along. How this all comes together in settlement discussions remains to be seen.

Is this where all plaintiff counsel remain together in forcing Bayer into high-value settlement, or where individual firms will attempt to carve out settlements based on their firm inventory?

The number of lawsuits from people in the U.S. who say the herbicide caused them to develop cancer rose by about 5,000 to 18,400. That is an enormous increase in lawsuits and there’s now an effort to make sure Bayer pays a premium settlement as the docket continues to grow.

BAYER IS SELLING ASSETS

Bayer is selling units to sharpen its focus after the $63 billion purchase of Monsanto, which saddled it with thousands of lawsuits claiming that the Roundup weedkiller it acquired in that deal causes cancer. The German giant agreed to unload its majority stake in a chemicals venture Wednesday in a deal valued at $3.9 billion, and two Roundup trials have been delayed as pressure builds to settle. Cash received from Bayer asset sales, may be going directly into the Roundup settlement fund.

Quarterly sales and earnings missed estimates and the German company questioned its ability to meet its full-year forecast. The shares fell 3.4 percent in Frankfurt.

Baumann has staked his credibility on last year’s $63 billion takeover of Monsanto Co., claiming the company is better off balancing its portfolio between agriculture and health care. But the surge in U.S. lawsuits alleging that Roundup — which Bayer inherited from Monsanto — causes cancer suggest settling the claims will become more much more expensive than previously thought.

“The jump in lawsuits is worrying,” said Mustaq Rahaman, a credit analyst at Bloomberg Intelligence. “This set of results will do little to stem calls for more dramatic action including a split.”

The chemicals and pharmaceutical giant said it would create a special committee of eight supervisory board members to monitor Roundup lawsuits and consult with management on legal strategies.

Bayer named U.S. lawyer John H. Beisner, an expert on mass tort and product litigation at Skadden, Arps, Slate, Meagher & Flom LLP, to advise the board on all Roundup legal matters, including trial tactics and mediation.

Bayer cited Mr. Beisner’s experience in negotiating high-profile settlements and said it looked forward to “constructively engaging in the mediation process.” A U.S. judge has provisionally appointed Kenneth Feinberg to serve as mediator in the consolidation of hundreds of Roundup cases filed in federal court. Mr. Feinberg has served as mediator in high-profile cases, including the Deepwater Horizon oil spill in the Gulf of Mexico in 2010.

U.S. hedge fund Elliott Management Corp., which owns some €1.1 billion ($1.25 billion) worth of Bayer shares, or about 2% of the company, backed Bayer’s latest steps. It said the new committee would provide “a new level of oversight and a fresh perspective to a litigation strategy in need of radical overhaul and help guide the company towards a rational, fair and swift settlement.”

U.S. Judge Vince Chhabria is handling the Roundup MDL 2471 lawsuits and has been moving the docket at a very fast pace, and denied Bayer’s Motion to Overturn the recent jury verdict, for case information see,  ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

Baumann said on a conference call that he is open to a settlement as long as it resolves all Roundup litigation. He repeated that the herbicide is safe, that the cases have no merit and that the company is “constructively engaging” with court-appointed mediator Ken Feinberg.

After the call, Bayer declined to say how much a “financially reasonable” sum would be or whether Baumann was referring only to the current load of cancer cases or the possibility of future Roundup suits tied to other ailments.

Bayer’s definition of what a reasonable settlement amount would be for all the Roundup cases isn’t likely to match up with estimates from lawyers for users of the weed-killer, said Carl Tobias, a professor at the University of Richmond’s law school who teaches about mass-tort litigation. “They aren’t going to like the numbers the plaintiffs are going to demand,” Tobias said. “Maybe Ken Feinberg can work something out.”

Bayer’s legal woes at the agricultural unit are being compounded by bad weather. In North America, heavy flooding has delayed planting season for farmers, while trade tensions with China hurt U.S. farmers’ ability to export soybeans, curbing demand for Bayer’s products. Just as Bayer reported earnings, U.S. President Donald Trump lashed out at China for what he said is an unwillingness to buy American agricultural products.

Bayer’s pesticide sales struggled in Europe too, due to unusually dry weather. Revenue at the crop science unit fell 3.1% after adjusting for currency and portfolio effects associated with the Monsanto takeover, Bayer said.

New Medicines

The Leverkusen, Germany-based company reiterated its annual financial forecast and its plan to defend itself in the Roundup litigation, while saying it will “constructively engage” in the mediation process ordered by a California judge. The company has aimed for about 46 billion euros ($51 billion) in revenue and profit of about 6.80 euros a share for this year.

Bayer’s other challenges include selling off its animal health division, rekindling growth at its ailing consumer-health division and coming up with promising new medicines for its pharma unit, where top-selling treatments Xarelto and Eylea both face losing patent protection next decade.

Bayer’s shares have plunged about 40% in the past 12 months amid concern over legal claims that Roundup and its main ingredient glyphosate can cause cancer. Activist shareholder Elliott Management Corp., which unveiled a $1.3 billion stake in last month, has said the company could unlock 30 billion euros in shareholder value with a settlement.

Still, some analysts say the company is right to spread its focus between different businesses to help manage the ebbs and flows of each unit.

“If Bayer just had the pharma business, the stock would be super risky, because the pharma business has some medium to long-term concerns,” said Dennis Berzhanin of Pareto Securities. “Yes, they’re having short-term problems right now with crop science, but it reduces the risk of the company in general and supports their growth going forward.”

YEARS OF BAD CONDUCT BY MONSANTO

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Selling Assets For Settlement?

Elanco Animal Health Inc., the business Eli Lilly & Co. listed last year, is aiming to reach an agreement soon, where they would combine with Bayer AG’s animal-health unit. The companies hope to announce a deal around the time of Elanco’s Aug. 13 earnings release, the people said, asking not to be identified as the discussions are private. Elanco, which has a market value of about $12.3 billion, plans to pay at least part of the acquisition cost using stock, the people said.

Elanco lost 4.2% Wednesday to close at $31.47. Bayer rose as much as 2.6% early Thursday in Frankfurt.

Bayer would get a significant minority stake in Elanco under the deal being discussed, according to another person. The companies are currently hammering out potential antitrust issues by identifying which businesses they will likely need to sell to gain regulatory approval, the person said.

While Bayer prefers a deal with Elanco, no final agreements have been reached and the talks could drag on or fall apart, the people said. Bayer may proceed with its previous plans for a broader auction process if it can’t agree on terms with Elanco by early September, one person said.

A deal between Elanco and Bayer would preempt a sale process that was expected to be one of Europe’s most hotly contested deal situations this year. It had attracted a flurry of initial interest from buyout firms ranging from KKR & Co. to Blackstone Group Inc. and CVC Capital Partners, which have increasingly been bidding against each other as they try to spend the record amounts of capital the industry has amassed.

Bayer said in a statement that it’s on track with plans to exit the animal-health business and its primary focus is on a sale. The German company also continues to consider all value-maximizing options, it said in the statement, declining to comment further.

Elanco has grown rapidly through at least 10 acquisitions since 2007, including the $5.4 billion takeover of Novartis AG’s animal-health unit. A representative for Elanco, which is based outside Indianapolis, declined to comment.

The sale of Bayer’s animal-health unit was expected to fetch as much as 8 billion euros ($9 billion). The process was initially slated to kick off in the second quarter, people with knowledge of the matter said in March, though Bayer has repeatedly pushed back the start of the auction.

The Bayer business offers medicine and antibiotics to farm animals and pets. The division’s best-selling product line is the Advantage flea, tick and worm treatments for small animals.

Monsanto (Bayer)  has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

To access the most relevant and real time information on Mass Torts  sign up for:

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 

 

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Opioid MDL 2804 Class Settlement: Judge Polster tells state AGs to come up with a better model

 

Their response: “The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

By Mark A. York (August 8, 2019)

(MASS TORT NEXUS MEDIA) Opiate drugmaker stocks fell sharply after Bloomberg reported that a coalition of state attorneys general had demanded $45 billion from the three leading drug distributors in the U.S. to settle litigation over opioids.

According to Bloomberg, the counteroffer came after the distributors proposed a $10 billion settlement. The reported offers were made in negotiations between the National Association of Attorneys General andMcKesson (ticker: MCK), Cardinal Health (CAH), and AmerisourceBergen(ABC).

The report appears to be spooking investors. Shares of Cardinal were down 6.4% in afternoon trading, McKesson fell 5.9%, and AmerisourceBergen declined 6.1%.

Generic drugmakers also suffered large drops – . Teva Pharmaceutical Industries(TEVA) was down 8.7%, Mylan (MYL) was down 6.6%, and Endo International(ENDP) and Mallinckrodt (MNK)—which both released earnings Tuesday—were down 19% and 11.7%, respectively.

Those amounts appear to be far higher than investors expected. In a note Tuesday, Evercore ISI analyst Ross Muken wrote that investors he had spoken with had expected the distributors to pay $5 billion.

“Ohio Attorney General letter to Opiate MDL Judge Pollster citing caselaw”

The motion excludes state attorneys general, some of whom have brought lawsuits in state courts across the country, and sets up a procedure in which 24,500 cities, counties and other smaller governments could resolve their claims. It comes two days after Alabama Attorney General Steve Marshall voluntarily dismissed the state’s case in federal court and as Oklahoma Attorney General Mike Hunter is in the midst of the first opioid trial in the nation against manufacturer Johnson & Johnson.

Ohio AG Response

The Ohio AG wrote a letter to Federal Judge Dan Polster, where he challenged the legitimacy of the strategy pursued by private plaintiff attorneys, some of them veterans of the 1997 settlement between the states and the tobacco industry, who have signed up thousands of individual cities and counties as clients to try to pressure opioid manufacturers and distributors into a multibillion-dollar settlement. Private lawyers reaped some $14 billion in fees from the $260 billion tobacco settlement.

Yost criticized “the self-admitted power grab being made by unelected private attorneys to control the distribution of public moneys within the States.”

“The proposed negotiating class, and perhaps this very litigation, threatens the sovereignty of the States like nothing else in recent history,” he wrote. “It seeks to represent not a single political subdivision asserting parens patriae standing, but all of them. In other words, this motion seeks to permit the class to stand in the shoes of the States — nothing short of usurpation.”

Yost also criticized the allocation mechanism the lawyers have proposed. According to an “Allocation Map” the lawyers have placed online, Coshocton County, Ohio, would get $1.99 per capita or a total of $73,265 out of a $1 billion settlement, after lawyers claimed $100 million in fees.

“Distributing a few thousand dollars to local communities is meaningless.”  Ohio was among 27 states, including Texas and California, that filed a letter in June asking Judge Polster to delay any decision on a class.

See OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION

The motion also comes as U.S. District Judge Dan Polster of the Northern District of Ohio has pushed for global settlement talks while setting the first trial in the MDL for Oct. 21. In a brief supporting their motion a settlement class, which included 40 class representatives, including counties in California, Florida, Georgia, New Jersey and New York, and major cities such as Atlanta, Chicago, Denver, Los Angeles and San Francisco.

“This precise vehicle has never been used before, but we are very confident that this is a valid use of the procedure and that the court will, we are hopeful, welcome this as an opportunity to move the resolution of these cases forward,” said co-lead plaintiffs attorney Paul Hanly of Simmons Hanly Conroy in New York.

The federal litigation link is, Opiate Prescription MDL 2804, US District Court of Ohio link.

The move is also designed to provide some assurances to defendants—manufacturers and distributors of the prescription painkillers, as well as pharmacies—about the total scope of lawsuits that are out there.

The federal judge overseeing multidistrict litigation against opioid manufacturers and distributors left little doubt he supports a plan developed by private lawyers to assemble an unprecedented “negotiating class” consisting of every city and county in the U.S.

Rejecting complaints that the proposal would violate federal law and trample on states’ rights, U.S. District Judge Dan Aaron Polster repeatedly said “there has to be a vehicle” for resolving the nearly 2,000 cases by cities and counties that have been concentrated in his court. Along with hundreds of lawsuits still in state court and litigation by individual states, Indian tribes and other entities such as healthcare agencies and pension funds, Judge Polster said, the mass of litigation must be settled somehow.

“Everyone knows that trying 2,500 cases would sink the state and federal judiciaries, but also the amount of private resources would also be staggering and no one would want that,” the judge told lawyers for both sides during 1.5-hour hearing in Cleveland Tuesday morning.

A majority of state attorneys general as well as defendants including drug distributors are opposed to the proposal, under which Judge Polster would certify a procedure that specifying how funds from an opioid settlement are distributed to individual counties before any money is on the table. In filings with the court in late July, Ohio AG Dave Yost called the plan a “power grab” by private lawyers who represent most of the cities and counties in the litigation.

August 6, 2019 Development

“The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

Among other objections, critics of the plan say it would violate Rule 23 of the Federal Rules of Civil Procedure, which governs class actions, and U.S. Supreme Court decisions requiring class action lawyers to fairly represent both their own clients and so-called “absent” class members who aren’t participating in settlement negotiations or may not even be aware of the litigation.

In a back-and-forth exchange with Sonja Winner, a Covington Burling attorney representing McKesson, the judge dismissed the idea the proposal might violate the most important Supreme Court precedent, Amchem v. Windsor. In that 1997 decision, the court said any class action must satisfy Rule 23 requirements, including that the claims are typical across the entire class and the interests of absent class members are represented.

Winner said the proposed mechanism for allocating money under a settlement only reaches as far as the counties, leaving cities to negotiate their share of the money with the counties that theoretically represent them in the class. The conflict between the two groups would be fatal under Amchem, she said.

“I’m not worried about the Supreme Court — the issue is what I will do,” Judge Polster responded.

“I’ve got 2,000 cases. There has to be a vehicle for solving them as a group.”

According to a calculator the plaintiff lawyers have put online, Fremont County in Wyoming would get $98,000 of a hypothetical $1 billion settlement, while the town of DuBois would get nothing because its $98 payout would fall below a $500 minimum. Winner said that was typical of the uneven results that individual cities and counties might not be aware of before they are asked to decide whether to sign off on the settlement procedure or opt out.

The judge also brushed aside objections from other AG’s, who stated that the complex allocation formula would intrude on the power of the states to allocate money among their political subdivisions as they see fit. Judge Polster said he wouldn’t approve any language undermining state sovereignty, but went on to say he also won’t approve any settlement that directs all of the money into state treasuries, as some politicians demand.

He cited the 1997 tobacco settlement, in which little of the money paid over by cigarette companies actually went toward treating smoking-related disease. He said it was a “problem” that “in a number of states any money that the state AG obtains …goes into the general fund.”

Because the litigation in his court “encompasses the cities and counties,” any settlement “has to account for the matter of putting money into state general funds,” the judge said. “Because that idea isn’t going to fly.”

Clearly Judge Polster’s views on the opioid litigation have evolved since the early days, when he envisioned a swift settlement that included significant changes in how the industry does business. He repeatedly agreed with defendant companies that they have no incentive to settle unless plaintiff lawyers can offer them global peace, and that is impossible without the participation of the states and possibly even the federal government.

“Everybody understands no defendant is going to settle with the states alone and not the cities and counties,” or vice versa, he said. “That would be lunacy.”

The judge also told critics, including defendant companies, to come up with a better solution if they don’t like the one the plaintiff lawyers have proposed.

“Nobody has a monopoly on good ideas,” he said. “The more ideas floated, the better.”

He did recognize one glaring conflict of interest in the current proposal: Some of the same lawyers, most prominently Motley Rice, represent states and hundreds of members of the proposed class of cities and counties. He barred those lawyers from participating in the hearing or arguing in favor of the proposal.

“Those lawyers have a conflict at the moment because all or most of the state attorneys general are opposing this motion,” he said.

The judge also said that if he approves the mechanism, which seemed likely from his comments, he will appoint an independent representative on behalf of the tens of thousands of cities and counties that haven’t sued but could belong in the class. He also said he would limit settlement releases to claims under federal law and would have 13 nationwide “families” of defendants.

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

To access the most relevant and real time information on Mass Torts  sign up for:

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 

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

_________________________________________________________________________________________________

Register Now for the September 13th – 16th Mass Tort Nexus 4-Day Immersion Course at the Historic Riverside Hotel on Bustling Las Olas Blvd. in Fort Lauderdale.  Annual Alumni Day is Sunday, September 15th: Fifteen Lead Litigators Presenting on Over Fifteen Current and Emerging Mass Torts.  A few seats remain for the only interactive and collaborative Mass Tort course that teaches process, step-by-step.

RESERVE YOUR SEAT TODAY

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FDA – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Who Knew and When?

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

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.

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

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. 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.

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.

 

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

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

ALCL Deaths from MDRs and Literature reported as MDRs* Deaths through 7/6/29 (n=33)
n %a
Age at time of diagnosis (years) Median 52
Range 37-83
Not specified (# of reports) 13 39
Time from the last implant to diagnosis (years) Median 9
Range 1-20
Not specified (# of reports) 23 70
Implant Surface Textured 15 48
Smooth* history of textured 1 3
Not specified 17 48
Implant Fill Silicone 14 42
Saline 8 24
Not specified 11 33
Reason for Implant Reconstruction 5 15
Augmentation 17 52
Not specified 11 33
Clinical presentation (breast)b Seroma 6 18
Breast swelling/pain 3 9
Capsular contracture 1 3
Peri-implant mass/lump 13 39
Others 7 21
Not specified 7 21
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 12 36
Not specified 21 64
CD30 Statusc Positive 12 36
Negative 0 0
Not specified 21 64
Implant manufacturer Allergan 12 36
Mentor 1 3
Unknown 20 61
Reporter country: US or OUSd US 12 36
OUS 21 64
Not specified 0 0

a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

Unique ALCL cases1 Cases through 9/30/18
(n=457)
Cases through 7/6/19
(n=573)
n %a n %b
Age at time of diagnosis (years) Median 53 53
Range 27-90 27-90
Not specified (# of reports) 111 24 161 28
Time from the last implant to diagnosis (years) Median 9 8
Range 0-34 0-34
Not specified (# of reports) 110 24 169 29
Implant surface Textured 310 68 385 67
Smooth 24 5 26c 5
Not specified 123 27 162 28
Implant fill Silicone 274 60 343 60
Saline 183 40 197 34
Not specified 0 0 33 6
Reason for implant Reconstruction 108 24 115 20
Augmentation 104 23 111 19
Not specified 245 54 347 61
Clinical presentation (breast)d Seroma 266 58 302 53
Breast swelling/pain 135 30 150 26
Capsular contracture 69 15 73 13
Peri-implant mass/lump 82 18 94 16
Others 43 9 56 10
Not specified 105 23 147 26
Anaplastic lymphoma kinase (ALK) Positive 0  0 0 0
Negative 229 50 255 45
Not specified 228 50 318 55
CD30 statuse Positive 215 47 246 43
Negative 0  0 0 0
Not specified 242 53 327 57
Implant manufacturer Allergan* includes McGhan, Inamed 386 84 481 84
Mentor 36 8 38 7
Sientra 2 0.4 6 1
Other Manufacturerf 5 1 6 1
Unknown Manufacturer 28 6 42 7
Reporter country: US or OUSg US 276 48 320 56
OUS 181 32 253 44
Not specified 0 0 0 0

1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  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.

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.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

  • Weber v. Allergan (2012)
  • Ebrahimi v. Mentor (2016)
  • Mize v. Mentor Nguyen v. Mentor (Spouse Plaintiff) (2017)
  • Gravitt v. Mentor Gravitt v. Mentor (Spouse Plaintiff) (2017)
  • Skelton v. Allergan – BIA-ALCL (2018)
  • Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
  • Rea v. Allergan – BIA-ALCL (2018)
  • Vieira et al v. Mentor Worldwide, LLC et al (2018)
  • Sewell et al v. Mentor (2018)

Saline

  • Laux v. Mentor (2015)
  • Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast ImplantsThe lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

  • 87% (203 out of the 231 report) were with textured surfaces
  • 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

  1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
  2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
  3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
  4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
  5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
  6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
  7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

Government Health Agencies and Other Sources

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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

____________________________________________________________________________

Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard PattenDr. Al LevinDr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

  • Did you have breast implants while pregnant?
  • Did you breastfeed with breast implants?
  • Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

Canada:

Australia:

Netherlands:

UK:

Scotland:

Ireland FB Group: PIP Ireland

France:

Italy FB Page: Protesi PIP and Blog

Sweden:

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

  • Must read, especially if you had Dow
  • D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small VoicesBreast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

 

 

 

Read More

ALLERGAN BREAST IMPLANTS RECALLED WORLDWIDE TODAY JULY 24, 2019

“Textured implants linked to rare form of cancer per FDA”

By Mark A. York (July 24, 2019)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) A worldwide recall of breast implants by Allergan Inc. was issued Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems. The FDA had ruled earlier this year the implants could stay on the market.

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

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

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.

https://www.cbsnews.com/news/breast-implant-recall-allergan-recalls-textured-implant-linked-to-rare-cancer-today-2019-07-24/

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced in 2017.

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.

Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” said FDA deputy commissioner Amy Abernethy in a statement.

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

In May, the country’s three largest breast implant manufacturers — Allergan, Sientra and Mentor — told CBS News textured implants have been extensively tested for safety and comply with FDA monitoring and that patient safety is their top priority.

___________________________________________________________

March 20, 2019   FDA NOTICE ON TEXTURED IMPLANTS

 

 

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have 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 updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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WILL JOHNSON & JOHNSON FACE “OPIOID CRISIS LEGAL JUSTICE” IN OKLAHOMA VERDICT?

Florida, Texas, Nevada, North Carolina, North Dakota, Tennessee, Massachusetts and others have their own Opioid Litigation in state courts across the country

By Mark A. York (July 15, 2019)

Live-video-opening-statements-for-oklahoma-opioid-trial vs. Johnson & Johnson

J&J defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

(MASS TORT NEXUS MEDIA) The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, fit in to the “opioid litigation solution” and if they will actually receive treatment services and assistance on a substantive level.

Johnson & Johnson used promotional gimmicks for its opioid painkillers that are similar to how criminal drug dealers try to boost sales, a pharmaceutical-industry critic told a judge hearing Oklahoma’s claim that the company helped fuel a crisis of addiction.

J&J’s use of coupons allowing patients to get free Duragesic pain patches was improper, said Andrew Kolodny, a Brandeis University professor and opioid researcher who testified at the trial Wednesday on behalf of the state, which says the company is liable under public-nuisance laws.

Closing arguments are underway today, July 15, 2019 in Oklahoma’s case against Johnson & Johnson alleging the consumer products giant and its subsidiaries helped fuel the state’s opioid crisis.

Each side had about two hours Monday to make their cases to Cleveland County District Judge Thad Balkman, who is expected to issue his ruling at a later date.

See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

https://kfor.com/2019/07/12/defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

Oklahoma Attorney General Mike Hunter has described consumer products giant Johnson & Johnson as the “kingpin” company that helped fuel the state’s opioid crisis during closing arguments in the state’s case against the drugmaker.

Oklahoma claims that J&J aggressively marketed opioids in the state in a way that overstated their effectiveness to treat chronic pain and understated the addiction risks.

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 2000 lawsuits against the opioid industry as a whole.

Bad Conduct of Opioid Big Pharma Outlined

In a June 2017 memo to Purdue officials, titled “Confidential Program Recommendation,” Matt Well, a founding partner of the Washington, D.C.-based public relations firm The Herald Group, details a campaign that included attacks on undisclosed attorneys general. The attacks were intended to deter other states from suing the company.

Link to Purdue Pharma Opioid Marketing Campaign Documents

“Our goal is to make state attorneys general think twice about joining the litigation,” Well wrote in the proposal.

Other recommendations included targeting outside law firms hired to help in the cases by calling into question the attorneys’ credibility and personal profit motive.

The final recommendation included working with journalists and placing stories in specific publications to tell what the firm labeled “the anti-story”. The anti-story refers to the public relations firm finding legal experts to talk to reporters or write op-eds for publications that slam lawsuits filed by states and shift the blame for the epidemic to victims in an attempt to sway public opinion to the company’s favor.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

KEY POINTS AT OKLAHOMA TRIAL 

  • Lawyers for the state, including Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.
  • The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic.
  • J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

Lawyers for the state of Oklahoma on Monday urged a judge to hold Johnson & Johnson responsible for fueling the U.S. opioid epidemic, as the first trial nationally in litigation over the drug crisis came to an end.

Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.

“This company went out and sponsored lies,” Brad Beckworth, a lawyer for the state, said in his closing argument.” They went out and said the risk of addiction was less than 1%.”

He urged Judge Thad Balkmanm, who presided over the multibillion-dollar nonjury trial, to find Johnson & Johnson liable for creating a public nuisance.

The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic. Opioids were linked to a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.

The Oklahoma trial is being closely watched by plaintiffs in other opioid lawsuits, particularly in 1,900 cases pending before a federal judge in Ohio who has been pushing for a settlement ahead of an October trial.

At trial, lawyers for Oklahoma argued that J&J, which sold the painkillers Duragesic and Nucynta, had since the 1990s marketed opioids as “safe and effective for everyday pain” while downplaying their addictive qualities.

The state has accused J&J of acting as the “kingpin” behind the epidemic and says the company was motivated to boost prescriptions not only because it sold painkillers but because it also grew and imported raw materials that opioid manufacturers like OxyContin maker Purdue Pharma LP used.

J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

J&J, whose lawyers were expected to deliver their own closing arguments later on Monday, argues the state is seeking to stretch the bounds of a public nuisance statute in order to force J&J to pay up to $17.5 billion to remedy the crisis.

Purdue and Teva Pharmaceutical Industries Ltd were originally also defendants in the case. Purdue reached a $270 million settlement with the state in March and Teva settled for $85 million in June. Both deny wrongdoin

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

UP TO $500 BILLION SETTLEMENT?

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

INSURERS ARE FIGHTING BACK

In 2018 ravelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

To access the most relevant and real time information on Mass Torts  sign up for:

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 free access.

Note: (Excerpts within this article include reference materials from CBS, ABC, NBC US Department of Ju

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