Pharmaceuticals Potentially Contaminated with The Deadly Toxin Diethylene Glycol

Apparently the FDAs crackdown on foreign outsource drug manufacturers arising from the revelation that certain pharmaceutical products found to be contaminated with NDMA, NDEA and other N-Nitro’s made offshore and sold in the United States, has led to the discovery that other pharmaceutical products produced by offshore manufacturers are also potentially contaminated with Diethylene Glycol (DEG), a lethal toxin.

Thus far, three offshore pharmaceutical contract manufacturers have received warning letters from the FDA related to DEG found in lots of product. All three of these manufacturers are major importers to the United States to whom many U.S. drug makers outsource production of various prescription as well as over the counter drugs.

It is safe to assume that more recalls like those that have recently been issued related to products contaminated with NDMA, NDEA and other N-Nitro Substances (Valsartan and Zantac et.al.) will be forthcoming soon related to DEG Contamination.

Company/Individual Product/Issue Issue Date
Sunstar Guangzhou Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/22/2020
Dental-Kosmetik GmbH & Co. KG

CGMP/Finished Pharmaceuticals/Adulterated 1/16/2020
Huaian Zongheng Bio-Tech Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

What Is Diethylene Glycol?

Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, poisonous, hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used in antifreeze solutions and as a solvent.

DEG is produced by the partial hydrolysis of ethylene oxide. Depending on the conditions, varying amounts of DEG and related glycols are produced. The resulting product is two ethylene glycol molecules joined by an ether bond, Diethylene glycol is derived as a co-product with ethylene glycol and triethylene glycol.

DEG is highly toxic to humans as well as other animals.

Injuries Associated with Diethylene Glycol

Acute kidney injury often leading to death

Liver Failure

Heart Damage including Heart Failure

Lung Damage

Neurological Damage Brain Damage

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Zantac MDL Established in Southern District of Florida (West Palm Beach) Over Cancer-Causing Impurity NDMA

A panel of federal judges consolidated 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court in West Palm Beach, FL. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and they charge that the manufacturers, sellers, and distributors of Zantac and other Ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers.

The defendants include Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline LLC; Pfizer Inc.; Sanofi-Aventis U.S. LLC; Sanofi US Services Inc.; and Chattem, Inc.

US District Judge Robin L. Rosenberg will preside over the new MDL No. 2924. The JPMDL transfer order can be found here.

The Judicial Panel for Multidistrict Litigation ruled that all the cases involve common questions of fact:

  • How Ranitidine forms NDMA.
  • The nature and extent of the health risks posed by NDMA and the NDMA levels at issue.
  • Defendants’ knowledge of the NDMA-associated risks of Ranitidine.
  • The impact of any findings made by the U.S. Food and Drug Administration, which is investigating this issue.

The Food and Drug Administration is investigating why NDMA is turning up in drugs used to control high blood sugar in patients with type 2 diabetes, in prescription antacids like Zantac and in Valsartan and Losartan, which treat high blood pressure and heart failure.

Glenmark Pharmaceutical Inc., USA announced on December 17, 2019, the voluntary recall of all unexpired lots of Ranitidine (Zantac) Tablets, 150 mg and 300 mg, to the consumer level. Zantac provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years.

Also recalling Ranitidine products are Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.

Research by supplement company Valisure, titled Valisure Detects NDMA in Ranitidine, “found that NDMA was the result of the; ‘inherent instability’ of the Ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of Ranitidine-containing medications are affected and could generate high levels of NDMA in the human body.”

In a 2016 study on oral intake of Ranitidine, scientists examined urine samples from five female and five male healthy volunteers over 24-hour periods before and after consumption of 150 mg of Ranitidine. Following intake, the urinary NDMA excreted over 24 hours increased 400-fold from 110 to 47,600 ng, while total N-nitrosamines increased by 5-fold.

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Nuedexta Used to Drug Hapless Seniors into Submission – and to Rip Off Medicare

Backed by a hyper-aggressive sales force, Avanir Pharmaceuticals is paying huge kickbacks to doctors to falsely prescribe its Nuedexta to subdue seniors with dementia and Alzheimer’s disease.

Nuedexta is being abused as a “chemical restraint” for elderly patients in long-term care, and they are at a high risk of falling or death as a result.

Avanir sales reps have taught doctors to fraudulently diagnose the elderly with the rare ailment Pseudobulbar Affect (PBA) so that Medicare will pay for the expensive drug. As a result, the number of Nuedexta pills dispensed to long-term care facilities jumped nearly 400% in recent years.

Medicare spending on Nuedexta has soared from $3.9 million in 2011 to $138 million in 2015. Avanir sales reps have helped doctors make false diagnoses so that Medicare will pay for the drug – priced up to $12.60 per pill.

Research shows that nearly 50% of the Nuedexta claims filed with Medicare in 2015 came from doctors who took cash, travel or food from Avanir. Some were paid more than $300,000 to promote the drug to doctors and patients.

In recent news:

  • Avanir admitted on Sept. 26, 2019, to targeting elderly victims and to paying kickbacks to doctors to promote the drug. In the settlement of a whistleblower lawsuit, Avanir agreed to pay $109 million in criminal and civil damages. It also agreed to assist in the prosecution of a sales rep, a regional business manager and an Ohio doctor they manipulated.
  • Dr. Franklin Price, a doctor in Mayfield, Ohio, pleaded guilty on Jan. 20, 2020, to wrongful disclosure of patient records. He gave confidential patient medical files to Avanir sales rep Gregory Hayslette – without notifying patients – to get Medicare approval to pay for Nuedexta prescriptions. Price has resigned as an MD.
  • In 2019, a federal grand jury indicted Hayslette, his regional manager Frank Mazzucco, Dr. Deepak Raheja, a neurologist, and Dr. Bhupinder Sawhny, a neurosurgeon. They were charged for being in a kickback scheme to pay doctors to promote Nuedexta to subdue seniors with dementia or Alzheimer’s – a treatment not approved by the FDA.

How the Kickback Scheme Worked

Avanir promoted Nuedexta through a “speaker’s bureau” where company sales reps reached out to doctors to speak about and promote the drug. A typical engagement involved a dinner at an expensive restaurant where a doctor presented information about the drug through a slideshow provided by the company, according to the FBI. There was no educational value for the presentation.

Raheja joined Avanir’s speaker’s bureau in February 2011. He gave more than 200 presentations between 2011 and 2016 and Avanir paid him $331,500, according to prosecutors. Over those five years, Raheja wrote 10,088 prescriptions for Nuedexta — the most of any doctor in the country, prosecutors said.

Raheja falsely diagnosed patients with PBR and Sawhny permitted unauthorized access to patient health records.

Hayslette illegally promoted the use of Nuedexta that were not approved by the FDA, accessed patient health information without authorization and helped to submit false diagnoses for Pseudobulbar Affect to Medicaid programs.

“Kickbacks have the power to corrupt a provider’s medical judgment,” said Assistant Attorney Jody Hunt of the DOJ’s Civil Division. “And it is particularly concerning when a pharmaceutical company uses kickbacks to drive up sales in connection with a vulnerable population, such as elderly patients in nursing care facilities.”
Thanks to the kickbacks and falsified prescriptions, Avanir reaped $300 million in total sales of Nuedexta in 2016.

A Sordid Past

Nuedexta is a combination of 2 ingredients: dextromethorphan and quinidine. Dextromethorphan works in the brain, though it is not known exactly how it helps treat Pseudobulbar Affect. Quinidine is added to this medication to increase the effect of dextromethorphan.

The FDA approved Nuedexta in 2010 for treating PBA in patients with dementia. PBA is extremely rare in dementia patients. It is characterized by involuntary, sudden and frequent episodes of laughing and crying as the result of a brain injury or disease.

The FDA required that Nuedexta carry the black box warning for an increased risk of death in elderly dementia patients.

In earlier years, the federal government had cracked down on dangerous antipsychotic drugs. This created an opening or Nuedexta to control unruly and erratic behavior in nursing home patients.
Soon after Nuedexta hit the market in 2011, doctors, nurses and family members began filing reports of potential harm from Nuedexta — ranging from rashes, dizziness and falls to comas and death.

Internal company emails show a culture of intense pressure to sell the drug, with sales reps being encouraged to directly target hapless dementia and Alzheimer’s patients.

From 2013 to 2016, Avanir paid doctors nearly $14 million for consulting, promotion and public speaking for Nuedexta. The company also spent $4.6 million on travel and dining for doctors being targeted by salespeople.

Dr. Jason Kellogg, a geriatric psychiatrist at nursing homes in California, got $612,000 in cash, food, and travel from Avenir, according to government data. He was the top Medicare prescriber for the drug in 2015.

Doctors began to falsely diagnose PBR to have their prescriptions filled. In one example, the government charged that one doctor, who was also a paid speaker for Nuedexta, had “entire units” of patients on Nuedexta at the LTC facility where he worked, which contained a large number of dementia patients with behavioral issues. Meanwhile, another doctor who also worked in the same LTC, facility routinely discontinued Nuedexta for patients, only to have the doctor paid by Avanir “constantly re-initiate” the treatment.

CNN identified more than 80 cases in 19 states since 2013 where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta — often because residents hadn’t exhibited any symptoms of PBA. Many of the cases — about 40% — were clustered in Southern California, where Avanir is based and where former employees said there has been aggressive marketing.

“Doctors should prescribe medicine based on what is best for their patients, not on which drug company is paying for their travel and meals,” said U.S. Attorney for the Northern District of Ohio Justin Herdman.

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J&J Must Pay $344 Million Penalty for Deceptive Marketing of Pelvic Mesh

Johnson & Johnson withheld the risks and horrendous side effects of its Ethicon vaginal mesh but touted the dangerous product anyway to tens of thousands of women. For those lies, a California judge has blasted the company with a $343.99 million civil penalty.

“While J&J’s marketing vividly portrayed the benefits of the company’s products, J&J misstated, downplayed and omitted the risks of its pelvic mesh products,” wrote San Diego Superior Court Judge Eddie Sturgeon.

“J&J knew the grievous risks and also knew full well why they should have disclosed them.” The omissions were in the product’s instructions for use and in educational and marketing materials provided to doctors and patients.

Judge Sturgeon’s 128-page ruling on January 29, 2020, came in a suit filed by former California Attorney General Kamala Harris in 2016. The verdict was characterized as a penalty instead of damages. Sturgeon may grant additional injunctive relief as well.

Even the medical director for Ethicon, who designed and manufactured the mesh, testified that the company knew “that its mesh slings caused severe, long-term complications such as excessive contraction or shrinkage of tissue surrounding the mesh” and “debilitating and life-changing chronic pain, pain to their sexual partner,” among other issues, according to Sturgeon’s ruling.

Profits before patients

“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies,” said current California Attorney General Xavier Becerra.

“Johnson & Johnson knew the danger of its mesh products but put profits ahead of the health of millions of women. Today we achieved justice for the women and families forever scarred by Johnson & Johnson’s dishonesty.”

The company, which has been held liable for making addictive opioids and cancer-causing baby powder, is facing 20,000 plaintiffs alleging injuries caused by its pelvic mesh.

In separate federal litigation, there are 2,554 lawsuits pending before Sr. District Judge Richard W. Story regarding Ethicon Composite Hernia Mesh in MDL 2782 in Atlanta.

J&J has previously settled litigation charging that the pelvic mesh was deceptively marketed, including an October 2019 agreement to pay $116.9 million to 41 states and the District of Columbia, plus an April 2019 settlement of $9.9 million in a case by the Washington Attorney General.

The total payouts by a handful of mesh manufacturers to injured women now stand at nearly $8 billion. Earlier this month, 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 pelvic mesh products, also called transvaginal mesh, are permanent surgical implants designed to treat stress urinary incontinence and pelvic organ prolapse. The mesh causes bleeding, searing pain, permanent incontinence and loss of the ability to have sex. Many women have undergone surgeries unsuccessfully to remove the implants.

After years of complaints, the Food and Drug Administration stopped the sale of pelvic mesh in 2019 to treat organ prolapse, but J&J and other manufacturers still sell similar products to treat urinary incontinence.

Judge Sturgeon said Johnson & Johnson had abused its trust by “depriving physicians of the ability to properly counsel” patients about the risks of having a synthetic device implanted in their bodies. “This abuse of trust is particularly egregious when it comes to selling a permanent implant with no exit strategy while hiding its risks,” he said.

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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.

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

Taxotere Trial Defense Strategy

“The Devil Did It”

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

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

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

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

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

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

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

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

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

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

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

Read the ALM Taxotere Defense Verdict

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

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

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

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The 3 Keys to Success in Mass Torts

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

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

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

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

 

Mass Tort Success Key #1

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

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

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

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

 

Mass Tort Success Key #2

Conduct Independent Reasoned Analysis

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

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

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

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

 

Mass Tort Success #3

Take The Course

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

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

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

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