7th Circuit Upholds $20 Million Verdict Against Ethicon in Pelvic Mesh Case

Casting aside Ethicon’s “broad-spectrum attack on the judgment,” the 7th US Circuit Court upheld a $20 million verdict to a woman who was permanently injured by the company’s Prolift pelvic mesh device.

Ethicon appealed in Barbara Kaiser v. Johnson & Johnson and Ethicon, Inc., No. 18-2944. An Indiana state jury had awarded $35 million to Barbara Kaiser on March 8, 2018 for negligent design defect and negligent failure to warn about the dangers of the mesh. The trial judge reduced the verdict to $20 million.

It was the latest in a long string of jury verdicts.
Kaiser had the mesh implanted in January 2009. Afterwards she experienced severe pelvic pain, bladder spasms and pain during intercourse. Although she underwent revision surgery to remove the device, it could not be completely extracted.

Kaiser sued in March 2012. She claimed the defendants offered exaggerated and misleading information about the safety of Prolift. The device was later taken off of the market in 2012 following years of complaints and U.S. Food and Drug Administration scrutiny.

Ethicon’s “Kitchen Sink” Appeal faces

The company threw in every legal argument plus the kitchen sink in its appeal, a “broad-spectrum attack on the judgment, starting with an argument about federal preemption and moving through several issues of Indiana product-liability law, a claimed evidentiary error, and challenges to the compensatory and punitive damages,” the court said.

The 7th Circuit was not impressed, criticizing Ethicon’s “flurry of arguments,” and “its highly generalized statements fall far short of satisfying the legal standard.”

“One issue in particular warrants special mention upfront,” Circuit Judge Diane Sykes wrote for the 7th Circuit, that the plaintiff does not have to produce evidence of a reasonable alternative design for the product. It applied TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010), which specifically rejected an alternative-design requirement.

The court also held that the plaintiff’s state-law judgment was not preempted by federal law. Ethicon started marketing Prolift in 2005 and in 2007 submitted a 510(k) premarket application for Prolift when the FDA demanded one. The trial judge rejected Ethicon’s argument that the federal regulatory scheme preempted Indiana law, and the 7th Circuit affirmed.

The 7th Circuit ruled that “On this record a reasonable jury could conclude that Prolift was unreasonably dangerous.”

“Ethicon conceded that it hadn’t conducted any human trials before releasing Prolift, so it couldn’t present a safety record. Instead, it offered testimony that Prolift was generally an improvement over its predecessor.”

Ethicon’s many losses in the courtroom

A total of 1,213 lawsuits against Ethicon have been consolidated before US District Judge Joseph R. Goodwin in MDL 2327, IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation.

Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements, despite many losses in the courtroom, most notably a 2019 verdict from a Philadelphia jury that awarded $120 million:

  • In February 2013, Johnson & Johnson lost the first bellwether trial involving its transvaginal mesh implants. A New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Linda Gross claimed that she required 18 revision surgeries after receiving the mesh implant.
  • In September 2014, Johnson & Johnson’s Ethicon Inc. unit lost a $3.27 million verdict to a West Virginia woman who claimed she was injured by the company’s Gynecare TVT Obturator, or TVT-O, transvaginal mesh device.
  • In December 2015, Johnson & Johnson lost a $12.5 million verdict to a woman who claimed she was injured by the company’s Prolift implant. Patricia Hammons claimed complications from the device forced her to have multiple revision surgeries.
  • In August 2017, Peggy Engleman filed a lawsuit against Ethicon and claimed the company’s TVT-Secur mesh caused serious complications including infections, bleeding and severe pain. A jury awarded her $20 million.
  • In December 2017, a New Jersey jury awarded $15 million to Elizabeth Hyrmoc. The jury awarded $4 million for pain and suffering, $10 million for punitive damages and $1 million for loss of consortium.
  • In January 2019, a Philadelphia jury awarded $41 million to Suzanne Emmett and her husband, Michael. The award included $25 million in punitive damages. She had Ethicon mesh implanted in 2007 and had multiple revision surgeries for bleeding, infections and painful sex.
  • In April 2019 a Philadelphia jury awarded $120 million to Susan McFarland, including $100 million in punitive damages. McFarland had a strip of TVT-O mesh implanted in 2008. She had surgery that did not alleviate pain and constant urinary tract infections. She has not been able to have sex since she received the implant.
  • In May 2019, a Philadelphia jury awarded $80 million to Patricia Mesigian, $50 million of which was for punitive damages. Mesigian had a Prolift implanted in 2008. The mesh eroded tissue and caused pelvic pain, inflammation and infections.

Ethicon does have some success in court. In April 2014, Linda Batiste won a $1.2 million state lawsuit against Johnson & Johnson. A Texas jury found that the mesh bladder sling that Batiste received was defective. Batiste claimed the sling eroded inside of her, causing severe pain and medical problems. An appeals court judge later overturned the verdict, saying Batiste failed to prove that the sling caused her injuries.

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

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

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Attacking and Lying, Johnson & Johnson is Battered by Talcum Powder – Cancer Litigation

Ten years into the nationwide litigation over talcum powder, Johnson & Johnson is bleeding billions of dollars in settlements, legal fees, jury verdicts, and stock valuation. The company faces 15,299 cases nationwide in federal court, but all of the action so far has been in state courts.

The U.S. Justice Department started a criminal investigation in July 2019 into whether Johnson & Johnson lied to the public about the possible cancer risks of its talcum powder. A grand jury in Washington, DC, is examining documents related to what company officials knew about any carcinogens in their products.

The FDA announced on October 18, 2019, that over 33,000 bottles of Johnson’s Baby Powder were voluntarily recalled after testing positive for asbestos. Johnson & Johnson voluntarily recalled one lot of baby powder, after a sample tested positive for asbestos.

Johnson & Johnson has known about cancer-causing asbestos in its talc products since 1957. But in a deny-and-attack litigation strategy, the company has lied about it to consumers and the government, has faked research, has covered up its own findings about asbestos in talc, has bullied independent researchers and has stonewalled litigants.

Juries in state courts, where all the trials took place, have held J&J liable for failing to warn consumers that its baby powder causes fatal ovarian cancer and mesothelioma.

Through it all, J&J implausibly contends that its baby powder and talcum powder is “safe” – a claim that has been proven wrong. Meanwhile, scientists urge consumers not to use baby powder because of the cancer risk.

Plaintiff strategies

Attorney Mark Lanier of Houston, who won a $4.7 billion talc verdict against Johnson & Johnson this summer, told CNBC in December that the recent $50 billion plunge in shares of J&J plays into his hands in seeking a settlement with the company.

“This litigation, these problems can be resolved [for] much, much less than” than the $50 billion loss in J&J’s stock market value, Lanier said. “It serves my purposes as a litigator to say, ‘Yes, get their attention; keep driving the stock down.’”

Lanier represented 22 women with ovarian cancer who proved that J&J’s talc-based products, including its baby powder, contain asbestos and caused them to develop ovarian cancer. In August 2019, a Missouri judge affirmed the nearly $4.7 billion jury award.

“If the company continues to handle [the litigation] wrongly, then I think the company is going to continue to have problems that cost it two, three, four, five times what it should,” Lanier said. “Every case ultimately settles. Every case finds resolution. At some point, it’s a business decision for the litigants as well as for the company. And smart minds can prevail on that.”

The key turning point in the litigation came in 2018 when J&J finally complied with discovery requests, which disclosed damning revelations that its own tests have found asbestos in its talc for 60 years and that the company lied to the FDA about it.

Since then plaintiff lawyers have introduced the internal documents into evidence with devastating results at trial. Most of the standing verdicts have involved plaintiffs with mesothelioma.

  • $4.7 billion awarded in December 2018 to 22 women with ovarian cancer. A Missouri state jury made the award after it heard that Johnson & Johnson has known for decades about the risk of asbestos contamination in its talc.
  • $325 million awarded in May 2019 in New York to Donna Olson, whose mesothelioma was caused asbestos-laced Johnson & Johnson baby powder. The company’s damning internal documents were used as evidence.
  • $117 million awarded by a New Jersey jury in April 2018 to Steven Alonzo, who has mesothelioma.
  • $40.3 million awarded by a California jury in October 2019 to Nancy and Phil Cabibi because the company’s baby powder was tainted with asbestos. In 2017, Nancy was diagnosed with mesothelioma.
  • $37.3 million awarded by a New Jersey jury in September 2019 to four plaintiffs claiming they developed mesothelioma from inhaling asbestos allegedly present in Johnson & Johnson’s cosmetic talc products. The judge actually struck the closing argument by defense lawyer Diane Sullivan for accusing the plaintiffs’ attorneys of creating evidence and being sinister.
  • $29.4 million awarded by a California jury in a March 2019 trial involving a Teresa Leavitt, who proved that her mesothelioma is tied to her regular use of Johnson & Johnson’s talcum powder.
  • $25.75 million awarded by a California jury in May 2018 to Joanne and Gary Anderson. She was diagnosed with mesothelioma and proved that Johnson & Johnson was negligent and did not warn consumers about possible health risks from its Baby Powder.
    • Several additional verdicts are in the $25 to $20 million range. Linda O’Hagan was diagnosed with mesothelioma after using asbestos-laced baby powder and she filed suit in Oakland, CA.

Johnson & Johnson finally began settling cases in 2019, but most are hidden because the company forces plaintiffs to sign a confidentiality agreement. One settlement that went public was for $2 million on January 6, 2020.

Lawyers who won the plaintiff verdicts include Mark Lanier, Eric Holland, Christopher Placitella, Tim Meadows, Joseph Satterley, Jerome Block, David Greenstone, Mark Robinson, and Michael Miller – plus an army of others.

Defense successes

Defense attorneys are led by Peter Bicks of Orrick, Herrington & Sutcliffe and include Allison Brown of Skadden, Morton Dubin of Orrick, and Diane Sullivan of Weil, Gotshal & Manges.

Johnson & Johnson has found courts to overturn large plaintiff verdicts, but they are based on a jurisdictional issue – and not on the merits of the case. Most of the reversed cases are in Missouri, where an appeals court ruled that 1,000 out-of-state plaintiffs could not bring suit in the state.

The company has successfully used the June 19, 2017, US Supreme Court ruling in Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773. The Court held that California courts lacked personal jurisdiction over the defendant on claims brought by plaintiffs who are not California residents and did not suffer their alleged injury in California.

This led to several reversals of ovarian cancer verdicts:

  • A trial judge in California overturned a $417 million talc cancer verdict in October 20, 2017. Relying on the Bristol-Myers Squibb case, the judge reversed the 2016 award to Eva Echeverria, who developed ovarian cancer.
  • A Missouri appeals court threw out a $110 million verdict in October 2019, awarded to Lois Slemp, who got cancer from the company’s baby powder. The court said she should not have been allowed to bring her ovarian-cancer lawsuit to trial in St. Louis because she is a resident of Virginia.
  • A $72 million verdict in 2016 in favor of the family of a woman whose death from ovarian cancer was reversed by the Missouri Court of Appeals, Eastern District in October 2017. The court said the case over Alabama resident Jacqueline Fox’s death from ovarian cancer should not have been tried in St. Louis.
  • Plaintiffs have also suffered dismissals, hung juries and mistrials in mesothelioma and ovarian cancer cases.

Andreas Saldivar has been a leading defense expert for Johnson & Johnson, testifying up to 30 trials. The company was shocked when his lab found asbestos in Johnson’s Baby Powder in September 2019. This prompted the humiliating recall of over 33,000 bottles of Johnson’s Baby Powder in October 2019.

The lab, AMA Analytical Services, Inc. was working under a contract with the FDA, which stood by the finding. When plaintiff lawyer Nate Finch asked an Indianapolis judge to let him tell the jury about it, J&J quickly settled the case with a confidentiality agreement.

Meanwhile, when plaintiff experts testify, they lead to spectacular verdicts like the $4.7 billion award in December 2018 in Missouri state court.

They include Dr. William Longo of Suwanee, GA, who has testified for talc plaintiffs for 30 years. He is a material scientist/electron microscopist who specializes in the analysis of asbestos-containing materials. In 1983, he founded Micro Analytical Laboratories.

Other experts include James R. Millette Ph.D. of Cincinnati, an engineer who is a Fellow of ASTM-International and serves as Vice-Chair for Air Quality. He is also a Fellow of the American Academy of Forensic Scientists.

Another witness is Dr. David Egilman, who served as the editor of a journal that published his 2014 article that lawyers frequently cite as the foundation for opinions talc contains asbestos. Egilman, a clinical professor of family medicine at Brown University, said he was first retained in a talc case two years ago and has billed $1 million in the litigation since.

The litigation will continue for years to come because talc and asbestos are found together in talc mines. The elemental structure of talc and chrysotile asbestos are nearly identical. Both Talc and Chrysotile Asbestos are formed from the same four basic elements: magnesium, silicon, hydrogen, and oxygen.

“It is unlikely that any naturally occurring talc deposit would not also contain some asbestos. Combine the foregoing with the fact that there is no practicable and economical means by which to separate asbestos from talc, it is reasonable to conclude that, it is more likely than not, that all talc contains asbestos,” writes John Ray, who has been a leading consultant to the Mass Tort industry for more than a decade.

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

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

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

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JUUL Vaping Litigation Could Be as Big as Opioid Actions

Plaintiffs in the mounting JUUL mass tort litigation docket are pursuing the same successful legal theories against the maker of addictive nicotine vape pens that are being used against the pharmaceutical companies that made addictive opioids.

With the creation of a JUUL MDL (multi-district litigation docket), the litigation is on its way to being as big as the opioid MDL.
Plaintiffs in the opioid litigation recovered $465 million in November 2019 in State of Oklahoma v. Johnson & Johnson. JUUL, just like J&J, engaged in:

  • Deceptive marketing about the benefits of its products.
  • Downplayed the addictive risks by saying the vape pens were “totally safe.”
  • Caused a public nuisance worse than the opioid crisis.

Opioids were involved in almost 400,000 overdose deaths from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. In comparison, 5.3 million youth were current e-cigarette users in 2019, up from 3 million students in 2017, according to the 2019 National Youth Tobacco Survey.

In the JUUL litigation, plaintiffs are similarly alleging the vaping giant created a public nuisance, violated deceptive trade practice laws and RICO laws, was negligent and is strictly liable for defective design and manufacturing of its “nicotine delivery systems.”
JUUL lawsuits also allege fraudulent concealment, conspiracy with tobacco companies, intentional misrepresentation, and infliction of emotional distress.

Tobacco company influence

The JUUL litigation is also about promoting a habit-forming product that turns customers into addicts. The FDA and Surgeon General both described the underage use of e-cigarettes as an “epidemic.”

JUUL’s market value is $24 billion (down from $38 billion), and there is a deep pocket in the litigation: the cigarette company Altria, which has a $92 billion market capitalization. Altria bought a 35% stake in JUUL in December 2018, paying close to $13 billion.

A few months later the CEO of JUUL stepped down and he was replaced by a top executive from Altria. Altria discontinued its own e-cigarette products and gave JUUL prime shelf-space with its traditional Marlboro cigarettes.

It is no surprise that JUUL’s marketing and advertising targeted minors, following the classic playbook of the tobacco companies. Colorful JUUL ads depicted young people dancing, portrayed the nicotine device as cool and rebellious, and offered kid-friendly flavors like Mango, Fruit, and Crème.

Reaching critical mass

JUUL litigation is in the “litigation phase” now that the MDL was created on October 2, 2019. Many attorneys will seek clients at this point in the litigation because it has reached critical mass, and there are scores of product liability lawsuits filed in federal courts nationwide.

The Judicial Panel on Multidistrict Litigation has recognized that there are common factual issues that are sufficiently complex to merit centralized treatment. The Panel created MDL 2913, JUUL Labs, Inc., Marketing, Sales Practices, and Products Liability Litigation. It designated U.S. District Judge William H. Orrick, III of the Northern District of California to hear the cases in San Francisco, where JUUL is headquartered.

JUUL is the primary defendant because it has a 75% market share of the vaping market. However, there are eight additional defendants: Beard Vape, Direct eLiquid, Electric Lotus, Electric Tobacconist, Eonsmoke, Juice Man, Tinted Brew, and VapeCo.

When it created MDL 2913, there were only 10 cases filed in federal court in 5 states. Now there are 182 cases from across the country. Plaintiffs include school districts, states, counties and individuals.

  • School districts had to divert dollars away from classroom instruction and instead spend it on counseling and programs to help inform students of the dangers of vaping.
  • Individual customers suffered addiction, respiratory system damage, permanent brain damage, mood disorders, stroke, heart attack, and other cardiovascular injuries. The mother of an 18-year old in Florida has filed a wrongful death action, Lisa Marie Vail, individually and on behalf of the Estate of Daniel David Wakefield, deceased vs. JUUL Labs, Inc., in US District Court in the Northern District of California.

Separately, Siddharth Breja, a former senior vice president at JUUL sued the company in October 2019, alleging that JUUL sent to market at least “one million mint-flavored e-cigarette nicotine pods that it admits were contaminated, and against Mr. Breja’s insistence and protests, refused to recall those contaminated pods or even issue a product health and safety warning.”

Harvard researchers announced on January 3, 2020 that they found the microbial toxin Glucan in JUUL pods. Glucan is a component of fungal cell walls that can cause inflammation in the airways and can lead to long-term lung damage, according to the researchers.

Anemic response from the government
A Congressional hearing in July 2019 produced testimony that JUUL said in a school 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….”

The Trump administration’s response has been anemic. The FDA merely issued a warning letter “expressing concern” and saying the agency was “troubled.” In September 2019 the FDA said, “JUUL has ignored the law,” but then it only requested documents and threatened further action.

How JUUL is more dangerous than cigarettes

Just as tobacco use of teens dropped to 5% in 2017, the launch of JUUL has pushed the number of high schoolers using tobacco products back up to nearly 30%.

“Julling” is much more dangerous and insidious than smoking cigarettes. The JUUL pods are easily hidden from parents and teachers because they look like USB drives. A JUUL pod is far less conspicuous than a pack of cigarettes and a lighter. JUUL vapor smells far less than the pungent odor of burning tobacco. Students can exhale the JUUL vapor under their shirts to avoid detection.

The JUUL vapor is much less harsh than tobacco smoke, making JUUL easy to start using. Students call JUUL the “iPhone of vapes” because of its sleek and minimalistic design.

And then there is the JUUL high.

An interview with a 15-year-old describes the kick like this:

“The first time was in the lunchroom. Everyone else was hitting it and I was like “alright, I want to try that.” I guess I knew there was nicotine in it, but I had no idea that it had so much. When I hit it for the first time it was, like, really crazy. I felt a really big buzz off of barely anything.”

“It hurt my throat more than anything else I’ve done. I hit it and coughed immediately. At first, it was just fun and it was something that you could do anywhere. It’s so easy. Then it just became something I was doing nonstop, but I still felt a buzz. Now, I go crazy if I don’t have it. I don’t even feel a buzz anymore.”

The JUUL punch comes from a mega-dose of nicotine. One JUUL pod contains at least as much nicotine as a pack of cigarettes, or 20 cigarettes.

Nicotine is a neurotoxin that is one of the most addictive chemicals in the world. Nicotine is particularly dangerous to young people, whose brains are still developing through age 25. Nicotine is not only addictive but also permanently alters the structure of the brain and causes permanent mood changes and other cognitive disorders.

The Surgeon General concluded that “The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe.”

Marketing JUUL to Kids

JUUL was first launched in summer 2015 in schools, on social media and even billboards in New York City’s Times Square. The company put up YouTube videos, advertising in Vice Magazine, sponsorship of music events, and 50 highly stylized launch parties with free JUUL starter kits.

Just as the opioid companies paid doctors to shill their addictive product, JUUL paid social media influencers to promote its e-cigarette. JUUL’s ad agency said the 2015 “Vaporized “campaign “created ridiculous enthusiasm” for the campaign hashtag, #DoIt4JUUL.

By 2017, JUULing had taken off among America’s young people.

The marketing campaign came to a crashing halt after the FDA raided JUUL’s headquarters in October 2019, seizing more than 1,000 documents about the company’s sales and marketing practice. The JUUL MDL was created the same month.

Now that Juul had a huge base of young, addicted customers, it stopped selling candy flavors, pulled down all of its social media, limited sales to its website at www.JUUL.com, claimed that buyers must be at least 21, and asserted that “JUUL was developed as a satisfying alternative to cigarettes” for adults.

The website has “age verification” screening questions, which are easily spoofed with a parent’s driver license. The age verification is easily avoided by online resellers like eBay and Craigslist that have no age verification.

A starter kit sells for $35, JUUL pods cost $10 to $16, and the device costs $15 to $20. Exactly like cigarettes, the current flavors are Virginia tobacco, classic tobacco and menthol.

Today the company says, “JUUL was developed as a satisfying alternative to cigarettes.” But the lawsuit filed by the state of North Carolina alleges, “In reality, JUUL products are doing exactly the opposite of what JUUL claims, serving not as an “off-ramp” from traditional cigarettes for experienced smokers, but as an enticing “on-ramp” for young, inexperienced, and frequently underaged users.

Once again, it is up to America’s trial lawyers to hold a giant corporation accountable for its dangerous and damaging product.

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

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

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

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Recalls Underway for Zantac and Axid Antacids Because of Cancer Impurity

Drug companies are recalling batches of Zantac (Ranitidine) and Axid (Nizatidine) proton-pump inhibitors because of contamination by a cancer-causing impurity.

  • Mylan Pharmaceuticals is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, (including the 150mg and 300mg strengths).
  • Appco Pharma LLC is voluntarily recalling prescription ranitidine hydrochloride capsules.
  • Northwind Pharmaceuticals is voluntarily recalling prescription ranitidine tablets (150 mg and 300 mg), manufactured by Glenmark Pharmaceutical Inc.

The antacid drugs are being recalled due to detected trace amounts of NDMA, a cancer-causing impurity. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. It has been classified as a probable human carcinogen, according to the International Agency for Research on Cancer.

FDA is alerting patients and health care professionals to the voluntary recalls of ranitidine and Nizatidine.

Used by millions

Zantac is a heartburn medication used by millions of Americans. OTC ranitidine is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.

Mylan’s bottles of Nizatidine were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.
Nizatidine is indicated for the short-term treatment of active duodenal ulcers and active benign gastric ulcers, and for endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Both Zantac and Axid are proton pump inhibitors (PPIs) that reduce the production of acid by blocking the enzyme in the wall of the stomach that produces acid that is responsible for most ulcers in the esophagus, stomach, and duodenum.

Active litigation

As of December 16, 2019, there are 13,245 lawsuits in IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II) before US District Judge Claire C. Cecchi in MDL 2789.

The lawsuits involve people who’ve taken prescription and over-the-counter PPIs such as:

  • Dexilant (dexlansoprazole)
  • Nexium (esomeprazole) and Nexium 24Hr
  • Prevacid (lansoprazole) and Prevacid 24HR
  • Prilosec (omeprazole) and Prilosec OTC
  • Protonix (pantoprazole)

The MDL plaintiffs allege that the heartburn drugs they took damaged their kidneys. They claim that the PPI manufacturers — such as Takeda Pharmaceuticals, AstraZeneca Pharmaceuticals, Pfizer Inc. and The Procter & Gamble Co. — should have known about the risks of these drugs and warned them.

Consumers who’ve filed suit allege the blockbuster drugs have caused them to develop serious kidney problems including:

  • Acute Interstitial Nephritis (AIN)
  • Acute Kidney Injury
  • Chronic Kidney Disease (CKD)
  • End Stage Renal Disease (ESRD)

The proton-pump litigation has proceeded since the MDL was created in 2017.

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

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

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

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Can the Trump/Barr Justice Department Aid Monsanto/Bayer in the RoundUp Litigation?

The news that the Trump/Barr Justice Department and EPA are attempting to come to the rescue of Monsanto in the Roundup litigation emboldened stockholders and caused concern among Roundup plaintiffs and their attorneys. Bayer stock saw its first significant uptick since the beginning of the Roundup litigation and the market reacted with general optimism after the December 20th Amicus brief was filed by the Hardeman v. Monsanto Company et. al. Trump/Barr DOJ/EPA. Apparently, Bayer stockholders are not familiar with the now common axiom “Everything Trump Touches, Fails”.

This article will clarify why Bayer stockholders have nothing to be cheer about and why Roundup Plaintiffs and there counsel should not be overly concerned with the fact that the most corrupt administration in our history has for some reason decided to come to the aide of Monsanto/Bayer.

EPA Amicus Brief: https://usrtk.org/wp-content/uploads/bsk-pdf-manager/2019/12/EPA-amicus-brief-supporting-Monsanto-in-Hardeman-appeal.pdf

Appeal: https://usrtk.org/wp-content/uploads/bsk-pdf-manager/2019/12/Hardeman-appeal-by-Monsanto.pdf

Monsanto’s appeal in the Hardeman case raises numerous issues however, it appears to MTN that Monsanto’s ultimate goal is to use the highly questionable EPA Statements from August of 2019 to argue that all plaintiffs failure to warn claims (all cases arising under all State laws) are preempted as a result of the August of 2019 EPA action.

This article will focus on dispelling the concept that the August of 2019 EPA action could serve as a “litigation killer” and dispose of all plaintiffs’ cases currently on file alleging that Roundup caused them to suffer from Non-Hodgkin’s Lymphoma.

As a preliminary matter, any attempt to use the August of 2019 EPA Statement to dispose of all plaintiffs cases would have to rely on arguments sounding in “The EPA would not have approved the label (warnings) change plaintiffs claim were needed, if Monsanto had actually filed a formal request with the EPA to add the dispute warnings language”. Arguments sounding in what a Federal Agency would or would not have done had a manufacturer actually attempted to effectuate the disputed label change were recently foreclosed on in Merck Sharp & Dohme Corp. v. Albrecht (Fosamax). Without regard to the SCOTUS ruling in Albrecht specifically, we will focus on why any “global” failure to warn defense sounding in Federal Preemption of State Law failure to warn claims fails.


Below is an exact quote from the EPA Statement (link previously provided):

Exact Quote: The EPA will no longer approve (emphasis added) product labels claiming glyphosate is known to cause cancer – a false claim that does not meet the labeling requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Note: The EPA has the power to disapprove statements (on label) that are false and misleading, the EPA does not have the power to determine that a statement that is factually true as stated is a false claim simply because the EPA disagrees with any conclusion that might be drawn from the otherwise truthful statement.

The EPAs own statements provide clear and convincing evidence that the EPA would have approved some form of cancer warning on the Roundup label prior to August of 2019 had the company requested to make such an addition to their label. Any argument by the Monsanto /Bayer defendant that the EPA would not have approved any form of cancer warning prior to August of 2019 fails in as much as the EPA did in fact approve warnings on Glyphosate products prior to August of 2019. Below are three examples, two of these examples contain language that that could not be deemed to be false and misleading and the other would likely be preempted post August of 2019.


May 6, 2015 Label Excerpt:

“Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). In 2015, IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals.”

Comment: This Statement remains true and accurate and could arguably continue to be cited by Plaintiffs as an example of a more adequate warning that the warning provided on the label of Monsanto Products. The , The Statement that “The IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals “ remains true to day in that the IARC did in fact make (and continues to make) the statement to this date. The fact that the EPA disagrees with the IARC statement does not render the fact that the IARC made the statement false and misleading. The Statement made on the above label example remains true to this date, the Statement is not false and misleading nor does the statement constitute a “false claim”. The IARC made the Statement, the label states that the IARC made the Statement. The label does not offer an opinion on the Statement, the label simply informs the user of the fact that the IARC made the Statement.

It would arguable be far falser and more misleading to exclude the IARC Statement, given the fact that the IARC is a worldwide recognized authority on the subject of cancer, than it would be to include the Statement. The label also includes the EPAs statements which contradict the IARC. When contradicting opinions exist between authorities, how would the end user of a product be better served (better warned) by including one authorities conclusion to the exclusion of another’s?


Page 6 1/10/2017 Label

Excerpt: “California Proposition 65: This product does not contain substances known to the state of California to cause cancer and/or reproductive/developmental effects.”

The above is an example of a warning that would be impacted by the August 2019 EPA action however, any argument that the EPA would not have allowed (preempt) this warning be provided to individuals who were exposed to a Monsanto Product label fails as the EPA did in fact allow this warning prior to August 2019.


Page 4 May of 2015

Exerpt: Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). Canada PMRA has classified glyphosate as non-carcinogenic. In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals. Imazapyr did not cause cancer in laboratory animals. EPA has classified imazapyr as a Group E (evidence of non-carcinogenicity for humans) carcinogen.

Comment: Again, the warning that “In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals” is an absolutely true statement and therefore cannot be considered false and misleading. Had the IARC not made such statement, including this language in the warning label would be false and misleading, but this is not the case.

Monsanto is likely to continue to press the relevance and importance of the August 2019 EPA Statements by attempting to conflate the doctrine(s) of Field Preemption with the Doctrine of Express Preemption under “impossibility preemption” theories. These attempts should fail in that Congress having empowered the EPA to preempt (foreclose on) States from passing laws imposing additional labeling requirements (beyond those imposed by the EPA) does not equate to Congress having Expressly Preempting Plaintiffs from arguing that a given defendants could have (it was possible) sought approval to add different, stronger, better or more adequate warnings than those the defendant actually sought to have approved by the agency.


Field occurs when Congress, without expressly declaring that state laws are preempted, nevertheless legislates in a way that is so comprehensive as to occupy the entire field of an issue.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. Through the passage of FIFRA Congress did expressly declare that no State could impose labeling requirements in addition to those imposed under FIFRA. California’s right to impose additional labeling requirements (beyond those imposed by the EPA, is arguably foreclosed on under FIFRA.

Notwithstanding the foregoing, and as expressed by SCOTUS in the seminal case of Wyeth v. Levine, 555 US 555 – Supreme Court 2009, the maker of a Federally Regulated (as to warning labels) always remains the “master of their label”. Plaintiffs remain free to argue that the manufacturer should have submitted a label to the EPA for approval which contained a different (stronger or better) warning than that contained in the label the manufacturer submitted for approval and that their failure to do so renders the warnings provided on the label which was submitted for approval inadequate under State Law. https://www.scotusblog.com/case-files/cases/wyeth-v-levine/

The only exception to the jurisprudence found in Wyeth v. Levine arises when a manufacturer submits a specific label for approval and the EPA (or the FDA) and the agency formally rejects the change sought by the manufacturer. See Merck Sharp & Dohme Corp. v. Albrecht (Fosamax Ruling). We find no argument put forth by Monsanto sounding in “ We requested the label change plaintiffs assert was necessary to “adequately warn” and the EPA rejected our request.” See: Merck Sharp & Dohme Corp. v. Albrecht (Fosamax)


1. California (or others) Plaintiffs in which exposure to RoundUp occurred after August 2019 may not want to cite the language of California Prop 65 (related to Glyphosate) as an example of a more adequate warning.

2. The EPAs action of August 2019, should have no impact on cases in which exposure occurred before August 2019 without regard to California Prop 65 (relevant to the Hardeman case) as the EPA clearly did approve labels with warnings related to California Prop 65 prior to August 2019, including the time period in which Mr. Hardeman was exposed.

The argument that the EPA would not have approved any form of cancer warning prior to 2019 fails for the following reasons:

A. The language of the EPAs August 2019 statement is conclusive of the fact that the EPA would have approved some form of cancer warning prior to August 2019.
B. The EPA did in fact approve labels containing cancer warnings prior to August 2019 on labels submitted for EPA approval, when the manufacturer requested such approvals.

3. Warnings approved by the EPA for other glyphosate products prior to August 2019 which remain factually true, (not false nor misleading) taking into consideration the EPAs August 2019, remain available to plaintiffs to cite as “more adequate” than the warnings provided by Monsanto.


We do not argue that juries should not be allowed to consider any and all Statements made by the EPA. Of course, plaintiffs should also be allowed to conduct discovery to uncover any possible corruption, malfeasance or mistakes relevant to the EPAs statements and conclusions.

We do argue that there is no support under the law for any conclusion that once a Federal Agency makes a statement, expresses an opinion or conclusion, that litigants are foreclosed on entering evidence that contradicts the agency statements, conclusions or opinions under the circumstances relevant to this matter. The concept of “I have thus said, and therefore that which I sayeth is true” is the province and privilege of Kings. American citizens are free to challenge our own government’s lies and misrepresentations. The trier of fact holds the power to determine what is true and what is not.

We do not argue that the FIFRA (via the August 2019 action by the EPA) may not foreclose on the State of California’s right to impose the specific stronger label requirements than imposed by the EPA. We simply argue that the EPA could not (because it was not delegated the authority by congress) issue any Statement that could foreclose on all possible (stronger) warning language a plaintiff might allege would be required to render a label adequate under a given States laws, without the EPA having first having considered and rejected the exact language claimed by Plaintiff as necessary to provide an adequate warning.

We further argue that the two label examples, previously approved by the EPA, remain truthful (in no way false or misleading ) to this day and any plaintiff that puts forth this exact language as that which was needed to render the label adequate would not be arguing that the defendant be required to make a false and misleading statement and therefore the EPA is without the power to intercede on behalf of the defendant claiming that the agencies power to restrict manufacturers from making false and misleading statements extends to restricting statements that are factually true.


How desperate does Monsanto/Bayer have to be to turn to the Trump Administration for help. Then again, both Monsanto and Bayer have a history of being on the wrong side of things.

Bayer stockholders should all be hoping for a Trump re-election. If the U.S. elects a legitimate president later this year, the EPA could easily reverse course shortly thereafter.

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MDL Panel Sends Allergan Breast Implant Cases to the Honorary Brian Martinotti, U.S.District Court, District of New Jersey

The Judicial Panel on Multidistrict Litigation has assigned approximately 30 cases to U.S. District Judge Brian Martinotti of the District of New Jersey, under the style In Re: Allergan Biocell Textured Breast Implant Products Liability Litigation MDL No. 2921.

On December 18 2019 the Panel ruled that though the parties did not oppose centralization, they disagreed on the transferee district. The Plaintiffs had proposed the Central District of California, the Middle District of Tennessee, Southern District of Florida and the District of Kansas. Defendant Allergan had requested the District of New Jersey. The Court stated that “Defendant Allergan, USA, Inc. also has it’s headquarters and principal place of business in that district and a significant number of potential witnesses and common evidence would be located there. There are related cases pending in fourteen additional districts.

Briefly, the lawsuits allege that Allergan, based in Dublin, knew that its Biocell textured breast implants, in tens of thousands of women, increased the chances of getting anaplastic large cell lymphoma but failed to warn about those risks. Allergan recalled its implants July 24, 2019.

Recalled Products include:

Allergan Natrelle BIOCELL Textured Products:

  • Allergan Natrelle Saline-Filled Textured Breast Implants
  • Allergan Natrelle Silicone-Filled Textured Breast Implants
  • Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
  • Allergan Natrelle 133 Plus Tissue Expander
  • Allergan Natrelle 133 Tissue Expander with Suture Tabs

Other pertinent information:

  • Lot numbers: All lots (for complete listing of all styles, see the FDA Safety Communication)
  • Manufacturing Dates: July 25, 2014 – June 21, 2019
  • Distribution Dates: September 14, 2014- July 24, 2019
  • Devices Recalled in the U.S.: 246,381
  • Date Initiated by Firm: July 24, 2019

The Court ruled that they “find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions arise out of Allergan’s announcement on July 24, 2019, of a voluntary worldwide recall of its BIOCELL textured breast implants and tissue expanders. The announcement followed the U.S. Food and Drug Administration’s request to initiate the recall based on the risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) associated with the products.4 All actions share complex factual questions arising from the allegation that Allergan’s BIOCELL textured breast implants and tissue expanders significantly increase the risk of developing BIA-ALCL, and that Allergan failed to warn the FDA, patients, and healthcare providers of this risk.” “The common factual questions include: (1) whether BIOCELL textured breast implants and tissue expanders can cause BIA-ALCL; (2) whether defendants knew or should have known of the risk of BIA-ALCL; (3) whether they provided adequate warnings as to the risk; and (4) the adequacy of defendants’ product.”

MDL No. 2921 – IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation

The Panel then ordered the actions listed on Schedule A of the Order pending outside of the District of New Jersey, be transferred there with the consent of that court.

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The 3 Keys to Success in Mass Torts

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

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

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

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


Mass Tort Success Key #1

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

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

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

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


Mass Tort Success Key #2

Conduct Independent Reasoned Analysis

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

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

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

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


Mass Tort Success #3

Take The Course

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

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

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

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JUUL: The unregulated killer of teens for profit!

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

MASS TORT NEXUS MEDIA (September 23, 2019) 

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

Why is Juul so popular among teens?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is Juul?

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

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

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

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

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

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

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

What are the main ingredients in Juul pods?

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

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

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

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

How much nicotine is in a Juul pod?

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

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

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

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










Is Juul addictive? Is Juul more addictive than cigarettes?

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

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

What are the health effects of vaping?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What’s the FDA’s stance on Juul?

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

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

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

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

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

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

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

How did Juul get its start?

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

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

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

Juul copycats

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

Zonk E Liquid

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

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

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

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

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

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


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










By Mark A. York (August 30, 2019)

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

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

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

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

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

Types of PAEs

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

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


“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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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.”



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.


“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


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


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

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