37 State AGs Object to Fee Structure in Opioid MDL

A group of 37 state attorneys general filed a motion objecting to a fee payment plan for private lawyers working in the national opioid litigation. U.S. District Judge Dan A. Polster is overseeing 2,725 lawsuits in MDL 2804, IN RE: National Prescription Opiate Litigation.

The payment plan submitted on January 28 by the Plaintiff’s Executive Committee proposes a “common benefit fund” to award attorney fees and litigation costs, with funding from the cities private lawyers represent, but also the sates – over which the court lacks jurisdiction.

The AGs said that the Plaintiff’s Committee plan to establish a common benefit fund “goes well beyond what is necessary to ensure fair compensation for private counsel. The proposed order violates state sovereignty, including by purporting to apply to some aspects of State Attorney General settlements and to other state court actions over which this Court lacks jurisdiction.
Their objection came in a letter and motion on February 24 to Judge Polster, whose court is in Cleveland.

The proposed plan “would require local governments to pay more in attorneys’ fees rather than simply reallocate fees among attorneys with cases in the MDL, as common benefit fees are typically intended to do.”

“Moreover, if entered, the proposed order will disrupt – perhaps irreparably so – the substantial progress that has been made to negotiate a large national settlement with several defendants.”
The settlement negotiations are produced no results. More than 20 state attorneys general on February 14 rejected an $18 billion settlement offer from three major drug wholesalers meant to end litigation against their role in the opioid crisis.

The states are seeking between $22 billion and $32 billion.
The distributors — McKesson Corp., AmerisourceBergen Corp., and Cardinal Health Inc. — had reportedly been discussing the settlement since October, and had offered to pay $18 billion over 18 years.

Head of negotiation class dies

In related news, the architect of the Opioid MDL “negotiation class” died on February 24. Francis McGovern, age 75, died from a fall at his home.

Under the negotiation class concept, attorneys for the class would try to reach nationwide settlements with individual drug companies. Any settlement would be put to a vote and require approval by 75% of voting governments by number, by population and by the allocation of settlement funds.

No replacement for McGovern has been named.

Seeking a fair common benefit fund

Nearly every state and more than 2,727 cities, tribes and municipalities have filed suits against opioid manufacturers, distributors, and pharmacies over their roles in the opioid epidemic.
The distributors – McKesson, AmerisourceBergen, and Cardinal Health — have so far paid hundreds of millions of dollars in settlements and fines for failing to monitor suspicious orders of opioids. In October, they reached a $215 million settlement in Ohio just an hour before a landmark trial was set to begin.

Every day, 128 people in the US die after overdosing on opioids. The misuse of prescription pain relievers, heroin, and synthetic opioids like fentanyl—is a national. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

The letter from the 37 AGs said the attorneys general were ready to find a “reasonable and equitable way” for everyone who devoted time and resources to the litigation to be “fairly compensated.”

But it must be “done in a way that is fair to all parties, does not risk disrupting a nationwide settlement, and does not divert vital resources from going to address the opioid crisis effectively,” the attorneys general added.

Paul T. Farrell Jr., Paul J. Hanly Jr. and Joe Rice — the co-leads of the plaintiffs’ executive committee — said in a joint statement that the concerns of the attorneys general stemmed from a “lack of understanding on how common benefit fees are paid.”

The letter was signed by the attorneys general of North Carolina, Alaska, Arkansas, Colorado, Idaho, Indiana, Kansas, Maine, Michigan, Mississippi, Nevada, New Jersey, New York, Oklahoma, Pennsylvania, Vermont, Wisconsin, Texas, Arizona, California, Hawaii, Illinois, Iowa, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, Tennessee, Virginia, the District of Columbia, Guam and the Northern Mariana Islands.

The second bellwether case in the MDL is set for October 2002. Cuyahoga and Summit counties from Ohio are next in line for their day in court.

The trial is tentatively set for October 7, 2020, to begin jury selection with opening statements beginning October 13, 2020.

Meanwhile, Ex-Insys CEO Michael Babich was sentenced to 30 months in prison in the Insys opioid fraud case.

Babich was accused of arranging bribes for doctors to prescribe more prescription opioid drugs.

Many of the opioid drugmaker defendants involved in the opioid multi-district litigation have sued doctors across Ohio claiming that physicians are the true culprits in the nation’s opioid crisis.

Major chains such as CVS, Walgreen CO., Walmart, Rite Aid, and others claim that opioid prescribers, aka physicians, bear the burden of responsibility for the opioid epidemic although the physicians are not set to defend themselves in trial this coming October against Summit and Cuyahoga counties.


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13,000 Kidney Patients Await Trial Over Deadly Proton Pump Inhibitors

The invidious aspect of heartburn medicines called “proton pump inhibitors” (PPIs) is that there are no specific symptoms of the kidney damage that they cause.

Victims take the medicine for years and suffer general symptoms such as decreased urine output, tiredness, difficulty concentrating, problems sleeping, loss of appetite and dry, itchy skin. Only when they visit their doctor do they discover – to their shock — that they have deadly kidney disease.

The patients unwittingly took PPIs for acid reflux, GERD, dyspepsia, and peptic or stomach ulcers. Little did they know that the “little purple pill” and other PPIs were giving them chronic kidney disease, acute kidney failure, acute interstitial nephritis, and end-stage renal disease.

Now they faced agonizing dialysis, a kidney transplant or death.

“You can treat and hopefully cure infections. Fractures can heal, though they can be catastrophic events for older people, but chronic kidney disease doesn’t go away,” Dr. Adam Schoenfeld, an internal medicine resident at the University of California, San Francisco, told The New York Times in 2016.

The patients charge in 13,338 federal lawsuits that multiple drug makers knew that PPIs caused kidney damage but they failed to warn doctors and patients. The cases are consolidated in MDL 2789 before US District Judge Claire C. Cecchi in Newark, New Jersey, IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II).

More than 15 million Americans are taking PPIs, including the biggest PPI brand names in the U.S. market:

  • Nexium (esomeprazole)
  • Prilosec (omeprazole)
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole)
  • Dexilant (dexlansoprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • AcipHex (rabeprazole)
  • Vimovo (esomeprazole and naproxen)

Reducing stomach acid

Stomach acid is essential for proper digestion, but it’s also highly corrosive. It’s as powerful as battery acid and potent enough to dissolve metal or to eat a hole through wood.

When your body produces too much gastric acid, it can eat through the protective stomach lining. This leads to a painful ulcer. If the valve that keeps the stomach acid from rising up from the stomach and into your esophagus doesn’t work, that acid can damage your esophagus.

Stomach acid is produced by glands — proton pumps — in the stomach’s lining. PPIs inhibit the amount of acid they produce.

The root of the litigation started in 1989 when the FDA approved Prilosec (Omeprazole) as a heartburn drug, sold in prescription-strength capsules and over the counter forms. Quickly, many PPI’s were approved for the market, and total sales skyrocketed to $14 billion by 2016.

However, researchers began documenting problems with PPIs shortly after the first drug hit the market. Patients had no idea there was a connection between their heartburn medication and kidney failure.

In 1992, just three years after Prilosec got FDA approval, an article appeared in The American Journal of Medicine detailing the first case of acute interstitial nephritis caused by a PPI.

Some Prilosec lawsuits allege that AstraZeneca knew of the risk of kidney damage since 2004 before warning the public.

  • In 2004, researchers writing in the journal Nephrology, Dialysis, and Transplantation concluded Prilosec and Prevacid are the “drugs most commonly associated with interstitial nephritis.”
  • In 2007, other researchers writing in Clinical Nephrology identified an “ever-increasing number of cases of acute interstitial nephritis associated with PPI therapy” and that “all PPIs have been documented to cause AIN [acute interstitial nephritis].”

Despite numerous studies finding a connection between drugs and acute interstitial nephritis, the FDA did not require manufacturers to add acute interstitial nephritis warnings to labels until December 2014.

In 2015, a study in CMAJ Open found that those who started PPI therapy had an increased risk of acute kidney injury and acute interstitial nephritis.

A 2016 study in the Journal of American Nephrology found long-term users were 28 percent more likely to suffer from chronic kidney disease. They were also 95 percent more likely to experience kidney failure. This is also called end-stage renal disease.

A different 2016 study in the journal JAMA Internal Medicine associated long-term use with a 20 to 50 percent higher chance for developing chronic kidney disease.

Litigation begins

The first PPI lawsuit was filed against AstraZeneca’s Nexium in May 2016 in federal court in Tennessee. According to the complaint, Charles Bowers took Nexium from 2003 to 2008, when he was diagnosed with acute interstitial nephritis. As a result of his condition, Mr. Bowers was forced to undergo dialysis three times a week and is awaiting a kidney transplant.

In February 2017, the Judicial Panel of Multidistrict Litigation denied a motion to combine 39 PPI cases into centralized proceedings, because it said the cases were too different. By the summer of 2017, there were more than 160 lawsuits filed against five PPI manufacturers.

Due to the huge number of similar cases, MDL 2789 was finally approved on August 2, 2017 to streamline proceedings for more than 60 early lawsuits. A “science day” was held in May 2018, where the parties made presentations about their cases.

The first bellwether trial is scheduled for November 15, 2020.

People who took these drugs and got kidney disease have filed lawsuits against a who’s who of 26 corporate defendants:

  1. Abbott Laboratories
  2. AstraZeneca Pharmaceuticals LP
  3. AstraZeneca LP
  4. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  5. GlaxoSmithKline Consumer Healthcare LP
  6. GlaxoSmithKline Consumer Healthcare Holdings (US) IP LLC
  7. Merck & Co. Inc. d/b/a Merck, Sharp & Dohme Corporation
  8. Novartis Corporation
  9. Novartis Pharmaceutical Corporation
  10. Novartis Vaccines and Diagnostics, Inc.
  11. Novartis Institutes for Biomedical Research, Inc.
  12. Novartis Consumer Health, Inc.
  13. Pfizer, Inc.
  14. The Procter & Gamble Company
  15. Procter & Gamble Manufacturing Company
  16. Takeda Pharmaceuticals USA, Inc.
  17. Takeda Pharmaceuticals America, Inc.
  18. Takeda Pharmaceuticals LLC
  19. Takeda Pharmaceuticals International, Inc.
  20. Takeda California, Inc.
  21. Takeda Development Center Americas, Inc. f/k/a Takeda Global Research & Development Center, Inc.
  22. Takeda Pharmaceutical Company Limited
  23. TAP Pharmaceutical Products, Inc. f/k/a TAP Holdings Inc.
  24. Wyeth Pharmaceuticals, Inc.
  25. Wyeth-Ayerst Laboratories
  26. Wyeth LLC

Penelope Costamagna of California suffered kidney failure and required a kidney transplant after taking Prilosec for “multiple years.” She sued Procter & Gamble and AstraZeneca in February 2017.

Costamagna stopped taking the medication in November 2016, when doctors discovered she had a kidney injury. Her complaint said she was unaware of any risk to her kidney health until doctors diagnosed her injury.

“It is statistically likely that Plaintiff Penelope Costamagna will require another kidney transplant in her lifetime, or will die as a result of not having such a transplant available,” her complaint said.

The court-approved plaintiff’s short-form complaint allows the following claims:

  • Strict Product Liability
  • Strict Product Liability – Design Defect
  • Strict Product Liability – Failure to Warn
  • Negligence
  • Negligence Per Se
  • Breach of Express Warranty
  • Breach of Implied Warranty
  • Negligent Misrepresentation
  • Fraud and Fraudulent Misrepresentation
  • Fraudulent Concealment
  • Violation of State Consumer Protection Laws
  • Loss of Consortium
  • Wrongful Death
  • Survival Action

AstraZeneca is the worst defendant

By far the worst corporate actor is AstraZeneca, headquartered in Gaithersburg, MD. In 2015 the company paid millions in fines and settlements over illegal kickbacks, a “pay for delay” scheme, shortchanging Medicaid and ripping off consumers.

In 2015, AstraZeneca agreed to pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government charged AstraZeneca worked with another company to boost sales.

AstraZeneca had paid pharmacy-benefit manager Medco Health Solutions to maintain Nexium’s “sole and exclusive” status on certain Medco lists. AstraZeneca provided the payment to Medco through price concessions on drugs including Prilosec, Toprol XL, and Plendil.

“Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs,” Joyce R. Branda, the Acting Assistant Attorney General, said at the time.

In 2015, AstraZeneca was accused in a class action of participating in a pay-for-delay scheme, which is when a pharmaceutical company pays another drug manufacturer to hold off on selling a generic version of a particular drug.

The Nexium class-action lawsuit claimed the company paid off Teva Pharmaceuticals to delay its release of a generic version of Nexium. Teva paid a $24 million settlement to the U.S. government, freeing itself from the case.

Also, in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million to settle claims that its underpaid rebates owed under the Medicaid Drug Rebate Program.
In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class-action lawsuit that had lasted for 10 years.

The class action claimed the company spent $260 million on an advertising campaign to mislead consumers into buying more expensive medicine. It accused AstraZeneca of attempting to keep market share as a patent expired.

According to the lawsuit, AstraZeneca’s patent on Prilosec was about to expire, so the company pushed Nexium to replace it. The two drugs were almost chemically identical, but Nexium was far more expensive than Prilosec.

In separate heartburn litigation involving Zantac, US District Judge Robin L. Rosenberg in West Palm Beach, FL, is presiding over the new MDL No. 2924. Some 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

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.


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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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Unexpectedly, J&J Settles Talc-Mesothelioma Case at Start of Trial

In a highly unusual move, Johnson & Johnson abruptly settled the case of a woman with malignant mesothelioma who charged in her state court lawsuit that she got cancer from using the company’s talcum powder.

New York Supreme Court Justice Barbara Jaffe in Manhattan had just finished instructing the jury before opening statements were to begin. Shortly afterwards, attorneys for J&J and plaintiff Laura Shanahan, age 62, met with the judge in chambers. Moments later they emerged and the judge told the jury the case was over.

The amount of the settlement is secret.

It was the latest trial against Johnson & Johnson over claims its Baby Powder and Shower to Shower talcum powders were contaminated with cancer-causing asbestos.

The company faces 15,299 cases nationwide in separate federal litigation in MDL 2738 before Chief United States District Judge Freda Wolfson in New Jersey, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation.

So far, all the action has been in state courts. Jerome Block and Amber Long of Levy Konigsberg represent plaintiff Shanahan.

J&J’s lawyers were John Ewald of King & Spalding, Thomas Kurland of Patterson Belknap, and Shasha Zou and Matthew Bush of Orrick Herrington & Sutcliffe.

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.

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.

Juries in state courts have held J&J liable for failing to warn consumers that its talc products cause 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.

For a summary of J&J’s win-loss record in court, visit https://www.masstortnexus.com/News/5416/Attacking-and-Lying-Johnson-And-Johnson-is-Battered-by-Talcum-Powder–Cancer-Litigation

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Taxotere Victim: ‘I’d rather have lost my breasts than my hair’

The damage caused by the breast cancer drug Taxotere is personal and traumatic. Breast cancer patient Shirley Ledlie, 56, wasn’t told the drug causes total, permanent hair loss. When the drug destroyed her appearance, she wished she had lost her breasts rather than her hair.

“I couldn’t believe it. I felt like a complete freak,” she said. “I just couldn’t accept I would spend the rest of my life without my hair. It was the one part of me everyone complimented me on.”

She’s not the only one. Taxotere patient Christine wrote on the online support group A Head of Our Time, about “the horror of the loss of our hair.”

“I will never forget leaving the dermatologist’s rooms after being told that my lack of hair growth was due to my particular cocktail of chemo drugs, the likely culprit being Taxotere. I was utterly devastated as I felt I had lost my femininity and aged another 20 years, all at once. It was so much worse than losing a breast to cancer,” she wrote.

Four years into the mass tort litigation against Taxotere maker Sanofi, thousands of plaintiffs are still waiting for a verdict or settlement for their damages.

There are 12,658 federal lawsuits pending in MDL 2740, created in 2016, before US District Judge Kurt D. Engelhardt of the Eastern District of Louisiana, IN RE: Taxotere (Docetaxel) Products Liability Litigation.

Meanwhile, there are 350 state Taxotere lawsuits in a multicounty litigation (MCL) docket before Superior Court Judge James F. Hyland in New Brunswick, NJ.

The defendants include a dozen Taxotere manufacturers and distributors:

  1. Sanofi US Services Inc. f/k/a Sanofi-Aventis U.S. Inc.
  2. Sanofi-Aventis U.S. LLC
  3. Sandoz Inc.
  4. Accord Healthcare, Inc.
  5. McKesson Corporation d/b/a McKesson Packaging
  6. Hospira Worldwide, LLC f/k/a Hospira Worldwide, Inc.
  7. Hospira, Inc.
  8. Sun Pharma Global FZE
  9. Sun Pharmaceutical Industries, Inc. f/k/a Caraco Pharmaceutical Laboratories Ltd.
  10. Pfizer Inc.
  11. Actavis LLC f/k/a Actavis Inc.
  12. Actavis Pharma, Inc.

The plaintiffs charge that the companies knew Taxotere could cause permanent hair loss, failed to warn doctors and patients about it, and falsely marketed Taxotere.

Potential plaintiffs are breast cancer survivors who were prescribed Taxotere before December 2015 and suffered permanent baldness, otherwise known as alopecia.

Permanent alopecia is a disfiguring condition, especially for women. Women who have experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including loss of work or inability to work due to significant psychological damage.

The federal short form complaint allows plaintiffs to allege strict products liability – failure to warn, negligence, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, and fraud and deceit.

Defense Verdict in First Trial

The first bellwether trial for plaintiff Barbara Earnest resulted in a defense verdict on September 26, 2019. She was diagnosed with breast cancer in 2011 and was prescribed Taxotere. She lost her hair permanently.

Attorney Karen Barth Menzies of the Gibbs Law Group in Los Angeles, said, “We are certainly disappointed with the verdict. However, the trial was littered with evidentiary violations by the defense from opening statement on. These were highly prejudicial, so much so that the court had to give the jury curative instructions on three separate occasions, and we were compelled to move for a mistrial before closing arguments. Mrs. Earnest intends to seek appropriate post-trial relief.”

The jury did not believe that Barbara Earnest had permanent chemotherapy-induced alopecia caused by Taxotere.

Mrs. Earnest’s additional attorneys were Darin Schanker of Bachus & Schanker in Denver, Rand Nolen of Fleming Nolen Jez in Houston, Christopher Coffin of Pendley, Baudin & Coffin in New Orleans, and David Miceli of Miceli Law in Carrollton, Georgia.

The trial was especially contentious, with Sanofi seeking to delay the trial, filing multiple failed motions to dismiss, and attempting to get information on outside funding for the litigation. The company’s lawyers included Hildy Sastre of Shook, Hardy & Bacon, and lawyers from the New Orleans firm Irwin Fritchie Urquhart & Moore.

No Warnings About Hair Loss

The FDA approved Taxotere in 1996 as a treatment for breast cancer. According to the lawsuits, Sanofi misled the public by falsely assuring them that hair would grow back after chemotherapy. Sanofi falsely assured patients that their hair would grow back.

In 2010, Sanofi-Aventis reported that Taxotere had been used worldwide to treat more than 1.5 million patients and annual sales of Taxotere were $3.1 billion.

According to a 2015 lawsuit filed by one of Sanofi’s former employees, the company engaged in illegal payment of kickbacks to health care professionals to prescribe the drug.

Also, in 2015, the FDA warned that there was a potential for permanent hair loss for users of Taxotere as cases of permanent alopecia had been reported, and required an update to the warning on Taxotere.

Despite informing patients in other countries, Sanofi for years did not warn women in the U.S. of this risk. The words “permanent hair loss” or “alopecia” did not appear in any information published in the U.S., lawsuits say.

Studies the company should have been aware of include:

  • Sanofi sponsored a study 1998 called GEICAM 9805. By 2005, the company knew that the results of this trial revealed 9.2 percent of women who used the chemo drug suffered permanent alopecia.
  • Dr. Scot Sedlacek of the Rocky Mountain Cancer Centers conducted a study in 2006 that revealed Taxotere could cause more than 6 percent of women to suffer permanent alopecia.
  • J. Lemieux et al. published a 2008 review of 38 articles analyzing the impact of hair loss on women with breast cancer. Results showed that “hair loss consistently ranked amongst the most troublesome side effects, was described as distressing, and may affect the body image.”

Going Forward

The next action in the federal MDL litigation is a general status conferences and show cause hearing on March 24, 2020. The second bellwether trial originally set for March 23 has been continued.

Plaintiffs’ Liaison Counsel are Dawn Barrios of Barrios, Kingsdorf & Casteix, LLP in New Orleans, and Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, LLC, also in New Orleans.


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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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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